U.S. Congress - Text of S.510 as Engrossed in Senate FDA Food Safety Modernization Act
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Donate NowS.510 - FDA Food Safety Modernization Act
A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of the food supply.
| Version | Word Count | Changes From Previous Version | Percent Change |
|---|---|---|---|
| Introduced in Senate | 20,801 | n/a | n/a |
| Reported in Senate | 47,278 | 337 | 32% |
| Engrossed in Senate | 42,197 | 739 Show Changes Hide Changes | 71% |
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S 510 RS Calendar No. 247 111th CONGRESS
111th CONGRESSCommentsClose CommentsPermalink
2d SessionCommentsClose CommentsPermalink
S. 510CommentsClose CommentsPermalink
To amend the Federal Food, Drug, and Cosmetic Act with respect to the safety of the food supply.CommentsClose CommentsPermalink
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, CommentsClose CommentsPermalink
[Struck out->]SECTION 1. SHORT TITLE; REFERENCES; TABLE OF CONTENTS.[<-Struck out][Struck out->](a) Short Title- This Act may be cited as the ‘FDA Food Safety Modernization Act’.[<-Struck out]
[Struck out->](b) References- Except as otherwise specified, whenever in this Act an amendment is expressed in terms of an amendment to a section or other provision, the reference shall be considered to be made to a section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 [<-Struck out]
[Struck out->](c) Table of Contents- The table of contents for this Act is as follows:[<-Struck out]
[Struck out->]Sec. 1. Short title; references; table of contents.[<-Struck out]
[Struck out->]TITLE I--IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS[<-Struck out][Struck out->]Sec. 101. Inspections of records.[<-Struck out]
[Struck out->]Sec. 102. Registration of food facilities.[<-Struck out]
[Struck out->]Sec. 103. Hazard analysis and risk-based preventive controls.[<-Struck out]
[Struck out->]Sec. 104. Performance standards.[<-Struck out]
[Struck out->]Sec. 105. Standards for produce safety.[<-Struck out]
[Struck out->]Sec. 106. Protection against intentional adulteration.[<-Struck out]
[Struck out->]Sec. 107. Authority to collect fees.[<-Struck out]
[Struck out->]Sec. 108. National agriculture and food defense strategy.[<-Struck out]
[Struck out->]Sec. 109. Food and Agriculture Coordinating Councils.[<-Struck out]
[Struck out->]Sec. 110. Building domestic capacity.[<-Struck out]
[Struck out->]Sec. 111. Final rule for prevention of Salmonella Enteritidis in shell eggs during production.[<-Struck out]
[Struck out->]Sec. 112. Sanitary transportation of food.[<-Struck out]
[Struck out->]Sec. 113. Food allergy and anaphylaxis management.[<-Struck out]
[Struck out->]TITLE II--IMPROVING CAPACITY TO DETECT AND RESPOND TO FOOD SAFETY PROBLEMS[<-Struck out][Struck out->]Sec. 201. Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report.[<-Struck out]
[Struck out->]Sec. 202. Recognition of laboratory accreditation for analyses of foods.[<-Struck out]
[Struck out->]Sec. 203. Integrated consortium of laboratory networks.[<-Struck out]
[Struck out->]Sec. 204. Enhancing traceback and recordkeeping.[<-Struck out]
[Struck out->]Sec. 205. Surveillance.[<-Struck out]
[Struck out->]Sec. 206. Mandatory recall authority.[<-Struck out]
[Struck out->]Sec. 207. Administrative detention of food.[<-Struck out]
[Struck out->]Sec. 208. Decontamination and disposal standards and plans.[<-Struck out]
[Struck out->]TITLE III--IMPROVING THE SAFETY OF IMPORTED FOOD[<-Struck out][Struck out->]Sec. 301. Foreign supplier verification program.[<-Struck out]
[Struck out->]Sec. 302. Voluntary qualified importer program.[<-Struck out]
[Struck out->]Sec. 303. Authority to require import certifications for food.[<-Struck out]
[Struck out->]Sec. 304. Prior notice of imported food shipments.[<-Struck out]
[Struck out->]Sec. 305. Review of a regulatory authority of a foreign country.[<-Struck out]
[Struck out->]Sec. 306. Building capacity of foreign governments with respect to food.[<-Struck out]
[Struck out->]Sec. 307. Inspection of foreign food facilities.[<-Struck out]
[Struck out->]Sec. 308. Accreditation of qualified third-party auditors and audit agents.[<-Struck out]
[Struck out->]Sec. 309. Foreign offices of the Food and Drug Administration.[<-Struck out]
[Struck out->]TITLE IV--MISCELLANEOUS PROVISIONS[<-Struck out][Struck out->]Sec. 401. Funding for food safety.[<-Struck out]
[Struck out->]Sec. 402. Jurisdiction; authorities.[<-Struck out]
[Struck out->]
TITLE I--IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS[<-Struck out]
SEC. 101. INSPECTIONS OF RECORDS.[<-Struck out][Struck out->](a) In General- Section 414(a) (21 U.S.C. 350c(a) [<-Struck out]
[Struck out->](1) by striking the heading and all follows through ‘of food is’ and inserting the following: ‘Records Inspection-[<-Struck out]
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‘(1) ADULTERATED FOOD- If the Secretary has a reasonable belief that an article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, is’;[<-Struck out]
[Struck out->](2) by inserting ‘, and to any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner,’ after ‘relating to such article’;[<-Struck out]
[Struck out->](3) by striking the last sentence; and[<-Struck out]
[Struck out->](4) by inserting at the end the following:[<-Struck out]
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‘(2) USE OF OR EXPOSURE TO FOOD OF CONCERN- If the Secretary believes that there is a reasonable probability that the use of or exposure to an article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals, each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports such article shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such person, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to such article and to any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, that are needed to assist the Secretary in determining whether there is a reasonable probability that the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals.[<-Struck out]
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‘(3) APPLICATION- The requirement under paragraphs (1) and (2) applies to all records relating to the manufacture, processing, packing, distribution, receipt, holding, or importation of such article maintained by or on behalf of such person in any format (including paper and electronic formats) and at any location.’.[<-Struck out]
[Struck out->](b) Conforming Amendment- Section 704(a)(1)(B) (21 U.S.C. 374(a)(1)(B) [<-Struck out]
[Struck out->]SEC. 102. REGISTRATION OF FOOD FACILITIES.[<-Struck out][Struck out->](a) Updating of Food Category Regulations; Biennial Registration Renewal- Section 415(a) (21 U.S.C. 350d(a) [<-Struck out]
[Struck out->](1) in paragraph (2), by--[<-Struck out]
[Struck out->](A) striking ‘conducts business and’ and inserting ‘conducts business, the e-mail address for the contact person of the facility or, in the case of a foreign facility, the United States agent for the facility, and’; and[<-Struck out]
[Struck out->](B) inserting ‘, or any other food categories as determined appropriate by the Secretary, including by guidance)’ after ‘Code of Federal Regulations’;[<-Struck out]
[Struck out->](2) by redesignating paragraphs (3) and (4) as paragraphs (4) and (5), respectively; and[<-Struck out]
[Struck out->](3) by inserting after paragraph (2) the following:[<-Struck out]
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‘(3) BIENNIAL REGISTRATION RENEWAL- During the period beginning on October 1 and ending on December 31 of each even-numbered year, a registrant that has submitted a registration under paragraph (1) shall submit to the Secretary a renewal registration containing the information described in paragraph (2). The Secretary shall provide for an abbreviated registration renewal process for any registrant that has not had any changes to such information since the registrant submitted the preceding registration or registration renewal for the facility involved.’.[<-Struck out]
[Struck out->](b) Suspension of Registration-[<-Struck out]
[Struck out->](1) IN GENERAL- Section 415 (21 U.S.C. 350d [<-Struck out]
[Struck out->](A) in subsection (a)(2), by inserting after the first sentence the following: ‘The registration shall contain an assurance that the Secretary will be permitted to inspect such facility at the times and in the manner permitted by this Act.’;[<-Struck out]
[Struck out->](B) by redesignating subsections (b) and (c) as subsections (c) and (d), respectively; and[<-Struck out]
[Struck out->](C) by inserting after subsection (a) the following:[<-Struck out]
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‘(b) Suspension of Registration-[<-Struck out]
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‘(1) IN GENERAL- If the Secretary determines that food manufactured, processed, packed, or held by a facility registered under this section has a reasonable probability of causing serious adverse health consequences or death to humans or animals, the Secretary may by order suspend the registration of the facility under this section in accordance with this subsection.[<-Struck out]
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‘(2) HEARING ON SUSPENSION- The Secretary shall provide the registrant subject to an order under paragraph (1) with an opportunity for an informal hearing, to be held as soon as possible but not later than 2 days after the issuance of the order, on the actions required for reinstatement of registration and why the registration that is subject to suspension should be reinstated. The Secretary shall reinstate a registration if the Secretary determines, based on evidence presented, that adequate grounds do not exist to continue the suspension of the registration.[<-Struck out]
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‘(3) POST-HEARING CORRECTIVE ACTION PLAN; VACATING OF ORDER-[<-Struck out]
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‘(A) CORRECTIVE ACTION PLAN- If, after providing opportunity for an informal hearing under paragraph (2), the Secretary determines that the suspension of registration remains necessary, the Secretary shall require the registrant to submit a corrective action plan to demonstrate how the registrant plans to correct the conditions found by the Secretary. The Secretary shall review such plan in a timely manner.[<-Struck out]
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‘(B) VACATING OF ORDER- Upon a determination by the Secretary that adequate grounds do not exist to continue the suspension actions required by the order, or that such actions should be modified, the Secretary shall vacate the order or modify the order.[<-Struck out]
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‘(4) EFFECT OF SUSPENSION- If the registration of a facility is suspended under this subsection, such facility shall not import food or offer to import food into the United States, or otherwise introduce food into interstate commerce in the United States.[<-Struck out]
[Struck out->]
‘(5) REGULATIONS- The Secretary shall promulgate regulations that describe the standards officials will use in making a determination to suspend a registration, and the format such officials will use to explain to the registrant the conditions found at the facility.[<-Struck out]
[Struck out->]
‘(6) NO DELEGATION- The authority conferred by this subsection to issue an order to suspend a registration or vacate an order of suspension shall not be delegated to any officer or employee other than the Commissioner.’.[<-Struck out]
[Struck out->](2) IMPORTED FOOD- Section 801(l) (21 U.S.C. 381(l) [<-Struck out]
[Struck out->](c) Conforming Amendments-[<-Struck out]
[Struck out->](1) Section 301(d) (21 U.S.C. 331(d) [<-Struck out]
[Struck out->](2) Section 415(d), as redesignated by subsection (b), is amended by adding at the end before the period ‘for a facility to be registered, except with respect to the reinstatement of a registration that is suspended under subsection (b)’.[<-Struck out]
[Struck out->]SEC. 103. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS.[<-Struck out][Struck out->](a) In General- Chapter IV (21 U.S.C. 341 [<-Struck out]
[Struck out->]‘SEC. 418. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS.[<-Struck out]
[Struck out->]
‘(a) In General- Each owner, operator, or agent in charge of a facility shall, in accordance with this section, evaluate the hazards that could affect food manufactured, processed, packed, or held by such facility, identify and implement preventive controls to significantly minimize or prevent their occurrence and provide assurances that such food is not adulterated under section 402 or misbranded under section 403(w), monitor the performance of those controls, and maintain records of this monitoring as a matter of routine practice.[<-Struck out]
[Struck out->]
‘(b) Hazard Analysis- The owner, operator, or agent in charge of a facility shall--[<-Struck out]
[Struck out->]
‘(1) identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility, including--[<-Struck out]
[Struck out->]
‘(A) biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives; and[<-Struck out]
[Struck out->]
‘(B) hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced, including by acts of terrorism; and[<-Struck out]
[Struck out->]
‘(2) develop a written analysis of the hazards.[<-Struck out]
[Struck out->]
‘(c) Preventive Controls- The owner, operator, or agent in charge of a facility shall identify and implement preventive controls, including at critical control points, if any, to provide assurances that--[<-Struck out]
[Struck out->]
‘(1) hazards identified in the hazard analysis conducted under subsection (b) will be significantly minimized or prevented; and[<-Struck out]
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‘(2) the food manufactured, processed, packed, or held by such facility will not be adulterated under section 402 or misbranded under section 403(w).[<-Struck out]
[Struck out->]
‘(d) Monitoring of Effectiveness- The owner, operator, or agent in charge of a facility shall monitor the effectiveness of the preventive controls implemented under subsection (c) to provide assurances that the outcomes described in subsection (c) shall be achieved.[<-Struck out]
[Struck out->]
‘(e) Corrective Actions- The owner, operator, or agent in charge of a facility shall establish procedures that a facility will implement if the preventive controls implemented under subsection (c) are found to be ineffective through monitoring under subsection (d).[<-Struck out]
[Struck out->]
‘(f) Verification- The owner, operator, or agent in charge of a facility shall verify that--[<-Struck out]
[Struck out->]
‘(1) the preventive controls implemented under subsection (c) are adequate to control the hazards identified under subsection (b);[<-Struck out]
[Struck out->]
‘(2) the owner, operator, or agent is conducting monitoring in accordance with subsection (d);[<-Struck out]
[Struck out->]
‘(3) the owner, operator, or agent is making appropriate decisions about corrective actions taken under subsection (e); and[<-Struck out]
[Struck out->]
‘(4) there is documented, periodic reanalysis of the plan under subsection (i) to ensure that the plan is still relevant to the raw materials, as well as to conditions and processes in the facility, and to new and emerging threats.[<-Struck out]
[Struck out->]
‘(g) Recordkeeping- The owner, operator, or agent in charge of a facility shall maintain, for not less than 2 years, records documenting the monitoring of the preventive controls implemented under subsection (c), instances of nonconformance material to food safety, instances when corrective actions were implemented, and the efficacy of preventive controls and corrective actions.[<-Struck out]
[Struck out->]
‘(h) Written Plan and Documentation- Each owner, operator, or agent in charge of a facility shall prepare a written plan that documents and describes the procedures used by the facility to comply with the requirements of this section, including analyzing the hazards under subsection (b) and identifying the preventive controls adopted to address those hazards under subsection (c). Such written plan, together with documentation that the plan is being implemented, shall be made promptly available to a duly authorized representative of the Secretary upon oral or written request.[<-Struck out]
[Struck out->]
‘(i) Requirement To Reanalyze- Each owner, operator, or agent in charge of a facility shall conduct a reanalysis under subsection (b) whenever a significant change is made in the activities conducted at a facility operated by such owner, operator, or agent if the change creates a reasonable potential for a new hazard or a significant increase in a previously identified hazard or not less frequently than once every 3 years, whichever is earlier. Such reanalysis shall be completed and additional preventive controls needed to address the hazard identified, if any, shall be implemented before the change in activities at the facility is commenced. Such owner, operator, or agent shall revise the written plan required under subsection (h) if such a significant change is made or document the basis for the conclusion that no additional or revised preventive controls are needed. The Secretary may require a reanalysis under this section to respond to new hazards and developments in scientific understanding.[<-Struck out]
[Struck out->]
‘(j) Deemed Compliance of Seafood, Juice, and Low-acid Canned Food Facilities in Compliance With HACCP- An owner, operator, or agent in charge of a facility required to comply with 1 of the following standards and regulations with respect to such facility shall be deemed to be in compliance with this section, with respect to such facility:[<-Struck out]
[Struck out->]
‘(1) The Seafood Hazard Analysis Critical Control Points Program of the Food and Drug Administration.[<-Struck out]
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‘(2) The Juice Hazard Analysis Critical Control Points Program of the Food and Drug Administration.[<-Struck out]
[Struck out->]
‘(3) The Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards of the Food and Drug Administration (or any successor standards).[<-Struck out]
[Struck out->]
‘(k) Exception for Facilities in Compliance With Section 419- This section shall not apply to a facility that is subject to section 419.[<-Struck out]
[Struck out->]
‘(l) Authority With Respect to Certain Facilities- The Secretary may, by regulation, exempt or modify the requirements for compliance under this section with respect to facilities that are solely engaged in the production of food for animals other than man or the storage of packaged foods that are not exposed to the environment.[<-Struck out]
[Struck out->]
‘(m) Definitions- For purposes of this section:[<-Struck out]
[Struck out->]
‘(1) CRITICAL CONTROL POINT- The term ‘critical control point’ means a point, step, or procedure in a food process at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.[<-Struck out]
[Struck out->]
‘(2) FACILITY- The term ‘facility’ means a domestic facility or a foreign facility that is required to register under section 415.[<-Struck out]
[Struck out->]
‘(3) PREVENTIVE CONTROLS- The term ‘preventive controls’ means those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would have employed to significantly minimize or prevent the hazards identified under the hazard analysis conducted under subsection (a) and that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis. Those procedures, practices, and processes may include the following:[<-Struck out]
[Struck out->]
‘(A) Sanitation procedures for food contact surfaces and utensils and food-contact surfaces of equipment.[<-Struck out]
[Struck out->]
‘(B) Supervisor, manager, and employee hygiene training.[<-Struck out]
[Struck out->]
‘(C) An environmental monitoring program to verify the effectiveness of pathogen controls.[<-Struck out]
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‘(D) An allergen control program.[<-Struck out]
[Struck out->]
‘(E) A recall contingency plan.[<-Struck out]
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‘(F) Good Manufacturing Practices (GMPs).[<-Struck out]
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‘(G) Supplier verification activities.’.[<-Struck out]
[Struck out->](b) Regulations-[<-Struck out]
[Struck out->](1) IN GENERAL- The Secretary of Health and Human Services (referred to in this Act as the ‘Secretary’) shall promulgate regulations to establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of the preventive controls under section 418 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)).[<-Struck out]
[Struck out->](2) CONTENT- The regulations promulgated under paragraph (1) shall provide sufficient flexibility to be applicable in all situations, including in the operations of small businesses.[<-Struck out]
[Struck out->](3) RULE OF CONSTRUCTION- Nothing in this subsection shall be construed to provide the Secretary with the authority to apply specific technologies, practices, or critical controls to an individual facility.[<-Struck out]
[Struck out->](4) REVIEW- In promulgating the regulations under paragraph (1), the Secretary shall review regulatory hazard analysis and preventive control programs in existence on the date of enactment of this Act to ensure that the program under such section 418 is consistent, to the extent practicable, with applicable internationally recognized standards in existence on such date.[<-Struck out]
[Struck out->](c) Guidance Document- The Secretary shall issue a guidance document related to hazard analysis and preventive controls required under section 418 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)).[<-Struck out]
[Struck out->](d) Prohibited Acts- Section 301 (21 U.S.C. 331 [<-Struck out]
[Struck out->]
‘(oo) The operation of a facility that manufacturers, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is not in compliance with section 418.’.[<-Struck out]
[Struck out->](e) No Effect on HACCP Authorities- Nothing in the amendments made by this section limits the authority of the Secretary under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 42 U.S.C. 201 [<-Struck out]
[Struck out->](f) Effective Date-[<-Struck out]
[Struck out->](1) GENERAL RULE- The amendments made by this section shall take effect 18 months after the date of enactment of this Act.[<-Struck out]
[Struck out->](2) EXCEPTIONS- Notwithstanding paragraph (1)--[<-Struck out]
[Struck out->](A) the amendments made by this section shall apply to a small business (as defined by the Secretary) after the date that is 2 years after the date of enactment of this Act; and[<-Struck out]
[Struck out->](B) the amendments made by this section shall apply to a very small business (as defined by the Secretary) after the date that is 3 years after the date of enactment of this Act.[<-Struck out]
[Struck out->]SEC. 104. PERFORMANCE STANDARDS.[<-Struck out][Struck out->]The Secretary shall, not less frequently than every 2 years, review and evaluate relevant health data and other relevant information, including from toxicological and epidemiological studies and analyses, to determine the most significant food-borne contaminants and, when appropriate to reduce the risk of serious illness or death to humans or animals or to prevent the adulteration of the food under section 402 of the Federal Food, Drug, or Cosmetic Act, (21 U.S.C. 342 42 U.S.C. 264 [<-Struck out]
[Struck out->]SEC. 105. STANDARDS FOR PRODUCE SAFETY.[<-Struck out][Struck out->](a) In General- Chapter IV (21 U.S.C. 341 [<-Struck out]
[Struck out->]‘SEC. 419. STANDARDS FOR PRODUCE SAFETY.[<-Struck out]
[Struck out->]
‘(a) Proposed Rulemaking-[<-Struck out]
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‘(1) IN GENERAL- Not later than 1 year after the date of enactment of the FDA Food Safety Modernization Act, the Secretary, in consultation with the Secretary of Agriculture and representatives of State departments of agriculture, shall publish a notice of proposed rulemaking to establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death.[<-Struck out]
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‘(2) PUBLIC INPUT- During the comment period on the notice of proposed rulemaking under paragraph (1), the Secretary shall conduct not less than 3 public meetings in diverse geographical areas of the United States to provide persons in different regions an opportunity to comment.[<-Struck out]
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‘(3) CONTENT- The proposed rulemaking under paragraph (1) shall--[<-Struck out]
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‘(A) include, with respect to growing, harvesting, sorting, and storage operations, minimum standards related to soil amendments, hygiene, packaging, temperature controls, animal encroachment, and water; and[<-Struck out]
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‘(B) consider hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced, including by acts of terrorism.[<-Struck out]
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‘(4) PRIORITIZATION- The Secretary shall prioritize the implementation of the regulations for specific fruits and vegetables that are raw agricultural commodities that have been associated with food-borne illness outbreaks.[<-Struck out]
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‘(b) Final Regulation-[<-Struck out]
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‘(1) IN GENERAL- Not later than 1 year after the close of the comment period for the proposed rulemaking under subsection (a), the Secretary shall adopt a final regulation to provide for minimum standards for those types of fruits and vegetables that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death.[<-Struck out]
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‘(2) FINAL REGULATION- The final regulation shall--[<-Struck out]
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‘(A) provide a reasonable period of time for compliance, taking into account the needs of small businesses for additional time to comply;[<-Struck out]
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‘(B) provide for coordination of education and enforcement activities by State and local officials, as designated by the Governors of the respective States; and[<-Struck out]
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‘(C) include a description of the variance process under subsection (c) and the types of permissible variances the Secretary may grant.[<-Struck out]
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‘(c) Criteria-[<-Struck out]
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‘(1) IN GENERAL- The regulations adopted under subsection (b) shall--[<-Struck out]
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‘(A) set forth those procedures, processes, and practices as the Secretary determines to be reasonably necessary to prevent the introduction of known or reasonably foreseeable biological, chemical, and physical hazards, including hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced, including by acts of terrorism, into fruits and vegetables that are raw agricultural commodities and to provide reasonable assurances that the produce is not adulterated under section 402; and[<-Struck out]
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‘(B) permit States and foreign countries from which food is imported into the United States, subject to paragraph (2), to request from the Secretary variances from the requirements of the regulations, where upon approval of the Secretary, the variance is considered permissible under the requirements of the regulations adopted under subsection (b)(2)(C) and where the State or foreign country determines that the variance is necessary in light of local growing conditions and that the procedures, processes, and practices to be followed under the variance are reasonably likely to ensure that the produce is not adulterated under section 402 to the same extent as the requirements of the regulation adopted under subsection (b).[<-Struck out]
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‘(2) APPROVAL OF VARIANCES- A State or foreign country from which food is imported into the United States shall request a variance from the Secretary in writing. The Secretary may deny such a request as not reasonably likely to ensure that the produce is not adulterated under section 402 to the same extent as the requirements of the regulation adopted under subsection (b).[<-Struck out]
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‘(d) Enforcement- The Secretary may coordinate with the Secretary of Agriculture and shall contract and coordinate with the agency or department designated by the Governor of each State to perform activities to ensure compliance with this section.[<-Struck out]
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‘(e) Guidance- Not later than 1 year after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall publish, after consultation with the Secretary of Agriculture and representatives of State departments of agriculture, updated good agricultural practices and guidance for the safe production and harvesting of specific types of fresh produce.[<-Struck out]
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‘(f) Exception for Facilities in Compliance With Section 418- This section shall not apply to a facility that is subject to section 418.’.[<-Struck out]
[Struck out->](b) Prohibited Acts- Section 301 (21 U.S.C. 331 [<-Struck out]
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‘(pp) The production or harvesting of produce not in accordance with minimum standards as provided by regulation under section 419(b) or a variance issued under section 419(c).’.[<-Struck out]
[Struck out->](c) No Effect on HACCP Authorities- Nothing in the amendments made by this section limits the authority of the Secretary under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 42 U.S.C. 201 [<-Struck out]
[Struck out->]SEC. 106. PROTECTION AGAINST INTENTIONAL ADULTERATION.[<-Struck out][Struck out->](a) In General- Chapter IV (21 U.S.C. 341 [<-Struck out]
[Struck out->]‘SEC. 420. PROTECTION AGAINST INTENTIONAL ADULTERATION.[<-Struck out]
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‘(a) In General- Not later than 24 months after the date of enactment of the FDA Food Safety Modernization Act, the Secretary, in consultation with the Secretary of Homeland Security and the Secretary of Agriculture, shall promulgate regulations to protect against the intentional adulteration of food subject to this Act.[<-Struck out]
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‘(b) Content of Regulations- Regulations under subsection (a) shall only apply to food--[<-Struck out]
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‘(1) for which the Secretary has identified clear vulnerabilities (such as short shelf-life or susceptibility to intentional contamination at critical control points);[<-Struck out]
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‘(2) in bulk or batch form, prior to being packaged for the final consumer; and[<-Struck out]
[Struck out->]
‘(3) for which there is a high risk of intentional contamination, as determined by the Secretary, that could cause serious adverse health consequences or death to humans or animals.[<-Struck out]
[Struck out->]
‘(c) Determinations- In making the determination under subsection (b)(3), the Secretary shall--[<-Struck out]
[Struck out->]
‘(1) conduct vulnerability assessments of the food system;[<-Struck out]
[Struck out->]
‘(2) consider the best available understanding of uncertainties, risks, costs, and benefits associated with guarding against intentional adulteration at vulnerable points; and[<-Struck out]
[Struck out->]
‘(3) determine the types of science-based mitigation strategies or measures that are necessary to protect against the intentional adulteration of food.[<-Struck out]
[Struck out->]
‘(d) Exception- This section shall not apply to food produced on farms, except for milk.[<-Struck out]
[Struck out->]
‘(e) Definition- For purposes of this section, the term ‘farm’ has the meaning given that term in section 1.227 of title 21, Code of Federal Regulations (or any successor regulation).’.[<-Struck out]
[Struck out->](b) Guidance Documents-[<-Struck out]
[Struck out->](1) IN GENERAL- Not later than 1 year after the date of enactment of this Act, the Secretary, in consultation with the Secretary of Homeland Security and the Secretary of Agriculture, shall issue guidance documents related to protection against the intentional adulteration of food, including mitigation strategies or measures to guard against such adulteration as required under section 420 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a).[<-Struck out]
[Struck out->](2) CONTENT- The guidance document issued under paragraph (1) shall--[<-Struck out]
[Struck out->](A) specify how a person shall assess whether the person is required to implement mitigation strategies or measures intended to protect against the intentional adulteration of food;[<-Struck out]
[Struck out->](B) specify appropriate science-based mitigation strategies or measures to prepare and protect the food supply chain at specific vulnerable points, as appropriate;[<-Struck out]
[Struck out->](C) include a model assessment for a person to use under subparagraph (A);[<-Struck out]
[Struck out->](D) include examples of mitigation strategies or measures described in subparagraph (B); and[<-Struck out]
[Struck out->](E) specify situations in which the examples of mitigation strategies or measures described in subparagraph (D) are appropriate.[<-Struck out]
[Struck out->](3) LIMITED DISTRIBUTION- In the interest of national security, the Secretary, in consultation with the Secretary of Homeland Security, may determine the time and manner in which the guidance documents issued under paragraph (1) are made public, including by releasing such documents to targeted audiences.[<-Struck out]
[Struck out->](c) Periodic Review- The Secretary shall periodically review and, as appropriate, update the regulation under subsection (a) and the guidance documents under subsection (b).[<-Struck out]
[Struck out->](d) Prohibited Acts- Section 301 (21 U.S.C. 331 [<-Struck out]
[Struck out->]
‘(qq) The failure to comply with section 420.’.[<-Struck out]
[Struck out->]SEC. 107. AUTHORITY TO COLLECT FEES.[<-Struck out][Struck out->](a) Fees for Reinspection, Recall, and Importation Activities- Subchapter C of chapter VII (21 U.S.C. 379f [<-Struck out]
[Struck out->]‘PART 5--FEES RELATED TO FOOD[<-Struck out]
[Struck out->]‘SEC. 740A. AUTHORITY TO COLLECT AND USE FEES.[<-Struck out]
[Struck out->]
‘(a) In General-[<-Struck out]
[Struck out->]
‘(1) PURPOSE AND AUTHORITY- For fiscal year 2010 and each subsequent fiscal year, the Secretary shall, in accordance with this section, assess and collect fees from--[<-Struck out]
[Struck out->]
‘(A) each domestic facility (as defined in section 415(b)) subject to a reinspection in such fiscal year, to cover reinspection-related costs for such year;[<-Struck out]
[Struck out->]
‘(B) each domestic facility (as defined in section 415(b)) and importer subject to a food recall in such fiscal year, to cover food recall activities performed by the Secretary, including technical assistance, follow-up effectiveness checks, and public notifications, for such year;[<-Struck out]
[Struck out->]
‘(C) each importer participating in the voluntary qualified importer program under section 806 in such year, to cover the administrative costs such program for such year; and[<-Struck out]
[Struck out->]
‘(D) each importer subject to a reinspection in such fiscal year at a port of entry, to cover reinspection-related costs at ports of entry for such year.[<-Struck out]
[Struck out->]
‘(2) DEFINITIONS- For purposes of this section--[<-Struck out]
[Struck out->]
‘(A) the term ‘reinspection’ means--[<-Struck out]
[Struck out->]
‘(i) with respect to domestic facilities (as defined in section 415(b)), 1 or more inspections conducted under section 704 subsequent to an inspection conducted under such provision which identified noncompliance materially related to a food safety requirement of this Act, specifically to determine whether compliance has been achieved to the Secretary’s satisfaction; and[<-Struck out]
[Struck out->]
‘(ii) with respect to importers, 1 or more examinations conducted under section 801 subsequent to an examination conducted under such provision which identified noncompliance materially related to a food safety requirement of this Act, specifically to determine whether compliance has been achieved to the Secretary’s satisfaction; and[<-Struck out]
[Struck out->]
‘(B) the term ‘reinspection-related costs’ means all expenses, including administrative expenses, incurred in connection with--[<-Struck out]
[Struck out->]
‘(i) arranging, conducting, and evaluating the results of reinspections; and[<-Struck out]
[Struck out->]
‘(ii) assessing and collecting reinspection fees under this section.[<-Struck out]
[Struck out->]
‘(b) Establishment of Fees-[<-Struck out]
[Struck out->]
‘(1) IN GENERAL- Subject to subsections (c) and (d), the Secretary shall establish the fees to be collected under this section for each fiscal year specified in subsection (a)(1), based on the methodology described under paragraph (2), and shall publish such fees in a Federal Register notice not later than 60 days before the start of each such year.[<-Struck out]
[Struck out->]
‘(2) FEE METHODOLOGY-[<-Struck out]
[Struck out->]
‘(A) FEES- Fees amounts established for collection--[<-Struck out]
[Struck out->]
‘(i) under subparagraph (A) of subsection (a)(1) for a fiscal year shall be based on the Secretary’s estimate of 100 percent of the costs of the reinspection-related activities (including by type or level of reinspection activity, as the Secretary determines applicable) described in such subparagraph (A) for such year;[<-Struck out]
[Struck out->]
‘(ii) under subparagraph (B) of subsection (a)(1) for a fiscal year shall be based on the Secretary’s estimate of 100 percent of the costs of the activities described in such subparagraph (B) for such year;[<-Struck out]
[Struck out->]
‘(iii) under subparagraph (C) of subsection (a)(1) for a fiscal year shall be based on the Secretary’s estimate of 100 percent of the costs of the activities described in such subparagraph (C) for such year; and[<-Struck out]
[Struck out->]
‘(iv) under subparagraph (D) of subsection (a)(1) for a fiscal year shall be based on the Secretary’s estimate of 100 percent of the costs of the activities described in such subparagraph (D) for such year.[<-Struck out]
[Struck out->]
‘(B) OTHER CONSIDERATIONS-[<-Struck out]
[Struck out->]
‘(i) VOLUNTARY QUALIFIED IMPORTER PROGRAM-[<-Struck out]
[Struck out->]
‘(I) PARTICIPATION- In establishing the fee amounts under subparagraph (A)(iii) for a fiscal year, the Secretary shall provide for the number of importers who have submitted to the Secretary a notice under section 806(e) informing the Secretary of the intent of such importer to participate in the program under section 806 in such fiscal year.[<-Struck out]
[Struck out->]
‘(II) RECOUPMENT- In establishing the fee amounts under subparagraph (A)(iii) for the first 5 fiscal years after the date of enactment of this section, the Secretary shall include in such fee a reasonable surcharge that provides a recoupment of the costs expended by the Secretary to establish and implement the first year of the program under section 806.[<-Struck out]
[Struck out->]
‘(ii) CREDITING OF FEES- In establishing the fee amounts under subparagraph (A) for a fiscal year, the Secretary shall provide for the crediting of fees from the previous year to the next year if the Secretary overestimated the amount of fees needed to carry out such activities, and consider the need to account for any adjustment of fees and such other factors as the Secretary determines appropriate.[<-Struck out]
[Struck out->]
‘(3) USE OF FEES- The Secretary shall make all of the fees collected pursuant to clause (i), (ii), (iii), and (iv) of paragraph (2)(A) available solely to pay for the costs referred to in such clause (i), (ii), (iii), and (iv) of paragraph (2)(A), respectively.[<-Struck out]
[Struck out->]
‘(4) COMPLIANCE WITH INTERNATIONAL AGREEMENTS- Nothing in this section shall be construed to authorize the assessment of any fee inconsistent with the agreement establishing the World Trade Organization or any other treaty or international agreement to which the United States is a party.[<-Struck out]
[Struck out->]
‘(c) Limitations-[<-Struck out]
[Struck out->]
‘(1) IN GENERAL- Fees under subsection (a) shall be refunded for a fiscal year beginning after fiscal year 2010 unless appropriations for the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine and related activities of the Office of Regulatory Affairs at the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) are equal to or greater than the amount of appropriations for the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine and related activities of the Office of Regulatory Affairs at the Food and Drug Administration for the preceding fiscal year (excluding the amount of fees appropriated for such fiscal year) multiplied by 1 plus 4.5 percent.[<-Struck out]
[Struck out->]
‘(2) AUTHORITY- If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate, under subsection (a), notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.[<-Struck out]
[Struck out->]
‘(3) LIMITATION ON AMOUNT OF CERTAIN FEES-[<-Struck out]
[Struck out->]
‘(A) IN GENERAL- Notwithstanding any other provision of this section and subject to subparagraph (B), the Secretary may not collect fees in a fiscal year such that the amount collected--[<-Struck out]
[Struck out->]
‘(i) under subparagraph (B) of subsection (a)(1) exceeds $20,000,000; and[<-Struck out]
[Struck out->]
‘(ii) under subparagraphs (A) and (D) of subsection (a)(1) exceeds $25,000,000 combined.[<-Struck out]
[Struck out->]
‘(B) EXCEPTION- If a domestic facility (as defined in section 415(b)) or an importer becomes subject to a fee described in subparagraph (A), (B), or (D) of subsection (a)(1) after the maximum amount of fees has been collected by the Secretary under subparagraph (A), the Secretary may collect a fee from such facility or importer.[<-Struck out]
[Struck out->]
‘(d) Crediting and Availability of Fees- Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the purpose of paying the operating expenses of the Food and Drug Administration employees and contractors performing activities associated with these food safety fees.[<-Struck out]
[Struck out->]
‘(e) Collection of Fees-[<-Struck out]
[Struck out->]
‘(1) IN GENERAL- The Secretary shall specify in the Federal Register notice described in subsection (b)(1) the time and manner in which fees assessed under this section shall be collected.[<-Struck out]
[Struck out->]
‘(2) COLLECTION OF UNPAID FEES- In any case where the Secretary does not receive payment of a fee assessed under this section within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to provisions of subchapter II of chapter 37 of title 31, United States Code.[<-Struck out]
[Struck out->]
‘(f) Annual Report to Congress- Not later than 120 days after each fiscal year for which fees are assessed under this section, the Secretary shall submit a report to the Committee on Health, Education, Labor, and Pensions of the United States Senate and the Committee on Energy and Commerce of the United States House of Representatives, to include a description of fees assessed and collected for each such year and a summary description of the entities paying such fees and the types of business in which such entities engage.[<-Struck out]
[Struck out->]
‘(g) Authorization of Appropriations- For fiscal year 2010 and each fiscal year thereafter, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted or otherwise affected under the other provisions of this section.’.[<-Struck out]
[Struck out->](b) Export Certification Fees for Foods and Animal Feed-[<-Struck out]
[Struck out->](1) AUTHORITY FOR EXPORT CERTIFICATIONS FOR FOOD, INCLUDING ANIMAL FEED- Section 801(e)(4)(A) (21 U.S.C. 381(e)(4)(A) [<-Struck out]
[Struck out->](A) in the matter preceding clause (i), by striking ‘a drug’ and inserting ‘a food, drug’;[<-Struck out]
[Struck out->](B) in clause (i) by striking ‘exported drug’ and inserting ‘exported food, drug’; and[<-Struck out]
[Struck out->](C) in clause (ii) by striking ‘the drug’ each place it appears and inserting ‘the food, drug’.[<-Struck out]
[Struck out->](2) CLARIFICATION OF CERTIFICATION- Section 801(e)(4) (21 U.S.C. 381(e)(4) [<-Struck out]
[Struck out->]
‘(C) For purposes of this paragraph, a certification by the Secretary shall be made on such basis, and in such form (including a publicly available listing) as the Secretary determines appropriate.’.[<-Struck out]
[Struck out->]SEC. 108. NATIONAL AGRICULTURE AND FOOD DEFENSE STRATEGY.[<-Struck out][Struck out->](a) Development and Submission of Strategy-[<-Struck out]
[Struck out->](1) IN GENERAL- Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services and the Secretary of Agriculture, in coordination with the Secretary of Homeland Security, shall prepare and submit to the relevant committees of Congress, and make publicly available on the Internet Web site of the Department of Health and Human Services and the Department of Agriculture, the National Agriculture and Food Defense Strategy.[<-Struck out]
[Struck out->](2) IMPLEMENTATION PLAN- The strategy shall include an implementation plan for use by the Secretaries described under paragraph (1) in carrying out the strategy.[<-Struck out]
[Struck out->](3) RESEARCH- The strategy shall include a coordinated research agenda for use by the Secretaries described under paragraph (1) in conducting research to support the goals and activities described in paragraphs (1) and (2) of subsection (b).[<-Struck out]
[Struck out->](4) REVISIONS- Not later than 4 years after the date on which the strategy is submitted to the relevant committees of Congress under paragraph (1), and not less frequently than every 4 years thereafter, the Secretary of Health and Human Services and the Secretary of Agriculture, in coordination with the Secretary of Homeland Security, shall revise and submit to the relevant committees of Congress the strategy.[<-Struck out]
[Struck out->](5) CONSISTENCY WITH EXISTING PLANS- The strategy described in paragraph (1) shall be consistent with--[<-Struck out]
[Struck out->](A) the National Incident Management System;[<-Struck out]
[Struck out->](B) the National Response Framework;[<-Struck out]
[Struck out->](C) the National Infrastructure Protection Plan;[<-Struck out]
[Struck out->](D) the National Preparedness Goals; and[<-Struck out]
[Struck out->](E) other relevant national strategies.[<-Struck out]
[Struck out->](b) Components-[<-Struck out]
[Struck out->](1) IN GENERAL- The strategy shall include a description of the process to be used by the Department of Health and Human Services, the Department of Agriculture, and the Department of Homeland Security--[<-Struck out]
[Struck out->](A) to achieve each goal described in paragraph (2); and[<-Struck out]
[Struck out->](B) to evaluate the progress made by Federal, State, local, and tribal governments towards the achievement of each goal described in paragraph (2).[<-Struck out]
[Struck out->](2) GOALS- The strategy shall include a description of the process to be used by the Department of Health and Human Services, the Department of Agriculture, and the Department of Homeland Security to achieve the following goals:[<-Struck out]
[Struck out->](A) PREPAREDNESS GOAL- Enhance the preparedness of the agriculture and food system by--[<-Struck out]
[Struck out->](i) conducting vulnerability assessments of the agriculture and food system;[<-Struck out]
[Struck out->](ii) mitigating vulnerabilities of the system;[<-Struck out]
[Struck out->](iii) improving communication and training relating to the system;[<-Struck out]
[Struck out->](iv) developing and conducting exercises to test decontamination and disposal plans;[<-Struck out]
[Struck out->](v) developing modeling tools to improve event consequence assessment and decision support; and[<-Struck out]
[Struck out->](vi) preparing risk communication tools and enhancing public awareness through outreach.[<-Struck out]
[Struck out->](B) DETECTION GOAL- Improve agriculture and food system detection capabilities by--[<-Struck out]
[Struck out->](i) identifying contamination in food products at the earliest possible time; and[<-Struck out]
[Struck out->](ii) conducting surveillance to prevent the spread of diseases.[<-Struck out]
[Struck out->](C) EMERGENCY RESPONSE GOAL- Ensure an efficient response to agriculture and food emergencies by--[<-Struck out]
[Struck out->](i) immediately investigating animal disease outbreaks and suspected food contamination;[<-Struck out]
[Struck out->](ii) preventing additional human illnesses;[<-Struck out]
[Struck out->](iii) organizing, training, and equipping animal, plant, and food emergency response teams of--[<-Struck out]
[Struck out->](I) the Federal Government; and[<-Struck out]
[Struck out->](II) State, local, and tribal governments;[<-Struck out]
[Struck out->](iv) designing, developing, and evaluating training and exercises carried out under agriculture and food defense plans; and[<-Struck out]
[Struck out->](v) ensuring consistent and organized risk communication to the public by--[<-Struck out]
[Struck out->](I) the Federal Government;[<-Struck out]
[Struck out->](II) State, local, and tribal governments; and[<-Struck out]
[Struck out->](III) the private sector.[<-Struck out]
[Struck out->](D) RECOVERY GOAL- Secure agriculture and food production after an agriculture or food emergency by--[<-Struck out]
[Struck out->](i) working with the private sector to develop business recovery plans to rapidly resume agriculture and food production;[<-Struck out]
[Struck out->](ii) conducting exercises of the plans described in subparagraph (C) with the goal of long-term recovery results;[<-Struck out]
[Struck out->](iii) rapidly removing, and effectively disposing of--[<-Struck out]
[Struck out->](I) contaminated agriculture and food products; and[<-Struck out]
[Struck out->](II) infected plants and animals; and[<-Struck out]
[Struck out->](iv) decontaminating and restoring areas affected by an agriculture or food emergency.[<-Struck out]
[Struck out->]SEC. 109. FOOD AND AGRICULTURE COORDINATING COUNCILS.[<-Struck out][Struck out->]The Secretary of Homeland Security, in consultation with the Secretary of Health and Human Services and the Secretary of Agriculture, shall within 180 days of enactment of this Act, and annually thereafter, submit to the relevant committees of Congress, and make publicly available on the Internet Web site of the Department of Homeland Security, a report on the activities of the Food and Agriculture Government Coordinating Council and the Food and Agriculture Sector Coordinating Council, including the progress of such Councils on--[<-Struck out]
[Struck out->](1) facilitating partnerships between public and private entities to help unify and enhance the protection of the agriculture and food system of the United States;[<-Struck out]
[Struck out->](2) providing for the regular and timely interchange of information between each council relating to the security of the agriculture and food system (including intelligence information);[<-Struck out]
[Struck out->](3) identifying best practices and methods for improving the coordination among Federal, State, local, and private sector preparedness and response plans for agriculture and food defense; and[<-Struck out]
[Struck out->](4) recommending methods by which to protect the economy and the public health of the United States from the effects of--[<-Struck out]
[Struck out->](A) animal or plant disease outbreaks;[<-Struck out]
[Struck out->](B) food contamination; and[<-Struck out]
[Struck out->](C) natural disasters affecting agriculture and food.[<-Struck out]
[Struck out->]SEC. 110. BUILDING DOMESTIC CAPACITY.[<-Struck out][Struck out->](a) In General-[<-Struck out]
[Struck out->](1) INITIAL REPORT- The Secretary shall, not later than 2 years after the date of enactment of this Act, submit to Congress a comprehensive report that identifies programs and practices that are intended to promote the safety and security of food and to prevent outbreaks of food-borne illness and other food-related hazards that can be addressed through preventive activities. Such report shall include a description of the following:[<-Struck out]
[Struck out->](A) Analysis of the need for regulations or guidance to industry.[<-Struck out]
[Struck out->](B) Outreach to food industry sectors, including through the Food and Agriculture Coordinating Councils referred to in section 109, to identify potential sources of emerging threats to the safety and security of the food supply and preventive strategies to address those threats.[<-Struck out]
[Struck out->](C) Systems to ensure the prompt distribution to the food industry of information and technical assistance concerning preventive strategies.[<-Struck out]
[Struck out->](D) Communication systems to ensure that information about specific threats to the safety and security of the food supply are rapidly and effectively disseminated.[<-Struck out]
[Struck out->](E) Surveillance systems and laboratory networks to rapidly detect and respond to food-borne illness outbreaks and other food-related hazards, including how such systems and networks are integrated.[<-Struck out]
[Struck out->](F) Outreach, education, and training provided to States and local governments to build State and local food safety and food defense capabilities, including progress implementing strategies developed under sections 108 and 205.[<-Struck out]
[Struck out->](G) The estimated resources needed to effectively implement the programs and practices identified in the report developed in this section over a 5-year period.[<-Struck out]
[Struck out->](2) BIENNIAL REPORTS- On a biennial basis following the submission of the report under paragraph (1), the Secretary shall submit to Congress a report that--[<-Struck out]
[Struck out->](A) reviews previous food safety programs and practices;[<-Struck out]
[Struck out->](B) outlines the success of those programs and practices;[<-Struck out]
[Struck out->](C) identifies future programs and practices; and[<-Struck out]
[Struck out->](D) includes information related to any matter described in subparagraphs (A) through (G) of paragraph (1), as necessary.[<-Struck out]
[Struck out->](b) Risk-based Activities- The report developed under subsection (a)(1) shall describe methods that seek to ensure that resources available to the Secretary for food safety-related activities are directed at those actions most likely to reduce risks from food, including the use of preventive strategies and allocation of inspection resources. The Secretary shall promptly undertake those risk-based actions that are identified during the development of the report as likely to contribute to the safety and security of the food supply.[<-Struck out]
[Struck out->](c) Capability for Laboratory Analyses; Research- The report developed under subsection (a)(1) shall provide a description of methods to increase capacity to undertake analyses of food samples promptly after collection, to identify new and rapid analytical techniques, including techniques that can be employed at ports of entry and through Food Emergency Response Network laboratories, and to provide for well-equipped and staffed laboratory facilities.[<-Struck out]
[Struck out->](d) Information Technology- The report developed under subsection (a)(1) shall include a description of such information technology systems as may be needed to identify risks and receive data from multiple sources, including foreign governments, State, local, and tribal governments, other Federal agencies, the food industry, laboratories, laboratory networks, and consumers. The information technology systems that the Secretary describes shall also provide for the integration of the facility registration system under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d 21 U.S.C. 381(m) [<-Struck out]
[Struck out->](e) Automated Risk Assessment- The report developed under subsection (a)(1) shall include a description of progress toward developing and improving an automated risk assessment system for food safety surveillance and allocation of resources.[<-Struck out]
[Struck out->](f) Traceback and Surveillance Report- The Secretary shall include in the report developed under subsection (a)(1) an analysis of the Food and Drug Administration’s performance in food-borne illness outbreaks during the 5-year period preceding the date of enactment of this Act involving fruits and vegetables that are raw agricultural commodities (as defined in section 201(r) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(r) [<-Struck out]
[Struck out->](g) Biennial Food Safety and Food Defense Research Plan- The Secretary and the Secretary of Agriculture shall, on a biennial basis, submit to Congress a joint food safety and food defense research plan which may include studying the long-term health effects of food-borne illness. Such biennial plan shall include a list and description of projects conducted during the previous 2-year period and the plan for projects to be conducted during the following 2-year period.[<-Struck out]
[Struck out->]SEC. 111. FINAL RULE FOR PREVENTION OF SALMONELLA ENTERITIDIS IN SHELL EGGS DURING PRODUCTION.[<-Struck out][Struck out->]Not later than 1 year after the date of enactment of this Act, the Secretary shall issue a final rule based on the proposed rule issued by the Commissioner of Food and Drugs entitled ‘Prevention of Salmonella Enteritidis in Shell Eggs During Production’, 69 Fed. Reg. 56824, (September 22, 2004).[<-Struck out]
[Struck out->]SEC. 112. SANITARY TRANSPORTATION OF FOOD.[<-Struck out][Struck out->]Not later than 1 year after the date of enactment of this Act, the Secretary shall promulgate regulations described in section 416(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350e(b) [<-Struck out]
[Struck out->]SEC. 113. FOOD ALLERGY AND ANAPHYLAXIS MANAGEMENT.[<-Struck out][Struck out->](a) Definitions- In this section:[<-Struck out]
[Struck out->](1) EARLY CHILDHOOD EDUCATION PROGRAM- The term ‘early childhood education program’ means--[<-Struck out]
[Struck out->](A) a Head Start program or an Early Head Start program carried out under the Head Start Act (42 U.S.C. 9831 [<-Struck out]
[Struck out->](B) a State licensed or regulated child care program or school; or[<-Struck out]
[Struck out->](C) a State prekindergarten program that serves children from birth through kindergarten.[<-Struck out]
[Struck out->](2) ESEA DEFINITIONS- The terms ‘local educational agency’, ‘secondary school’, ‘elementary school’, and ‘parent’ have the meanings given the terms in section 9101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801 [<-Struck out]
[Struck out->](3) SCHOOL- The term ‘school’ includes public--[<-Struck out]
[Struck out->](A) kindergartens;[<-Struck out]
[Struck out->](B) elementary schools; and[<-Struck out]
[Struck out->](C) secondary schools.[<-Struck out]
[Struck out->](4) SECRETARY- The term ‘Secretary’ means the Secretary of Health and Human Services.[<-Struck out]
[Struck out->](b) Establishment of Voluntary Food Allergy and Anaphylaxis Management Guidelines-[<-Struck out]
[Struck out->](1) ESTABLISHMENT-[<-Struck out]
[Struck out->](A) IN GENERAL- Not later than 1 year after the date of enactment of this Act, the Secretary, in consultation with the Secretary of Education, shall--[<-Struck out]
[Struck out->](i) develop guidelines to be used on a voluntary basis to develop plans for individuals to manage the risk of food allergy and anaphylaxis in schools and early childhood education programs; and[<-Struck out]
[Struck out->](ii) make such guidelines available to local educational agencies, schools, early childhood education programs, and other interested entities and individuals to be implemented on a voluntary basis only.[<-Struck out]
[Struck out->](B) APPLICABILITY OF FERPA- Each plan described in subparagraph (A) that is developed for an individual shall be considered an education record for the purpose of the Family Educational Rights and Privacy Act of 1974 (20 U.S.C. 1232g [<-Struck out]
[Struck out->](2) CONTENTS- The voluntary guidelines developed by the Secretary under paragraph (1) shall address each of the following, and may be updated as the Secretary determines necessary:[<-Struck out]
[Struck out->](A) Parental obligation to provide the school or early childhood education program, prior to the start of every school year, with--[<-Struck out]
[Struck out->](i) documentation from their child’s physician or nurse--[<-Struck out]
[Struck out->](I) supporting a diagnosis of food allergy, and any risk of anaphylaxis, if applicable;[<-Struck out]
[Struck out->](II) identifying any food to which the child is allergic;[<-Struck out]
[Struck out->](III) describing, if appropriate, any prior history of anaphylaxis;[<-Struck out]
[Struck out->](IV) listing any medication prescribed for the child for the treatment of anaphylaxis;[<-Struck out]
[Struck out->](V) detailing emergency treatment procedures in the event of a reaction;[<-Struck out]
[Struck out->](VI) listing the signs and symptoms of a reaction; and[<-Struck out]
[Struck out->](VII) assessing the child’s readiness for self-administration of prescription medication; and[<-Struck out]
[Struck out->](ii) a list of substitute meals that may be offered to the child by school or early childhood education program food service personnel.[<-Struck out]
[Struck out->](B) The creation and maintenance of an individual plan for food allergy management, in consultation with the parent, tailored to the needs of each child with a documented risk for anaphylaxis, including any procedures for the self-administration of medication by such children in instances where--[<-Struck out]
[Struck out->](i) the children are capable of self-administering medication; and[<-Struck out]
[Struck out->](ii) such administration is not prohibited by State law.[<-Struck out]
[Struck out->](C) Communication strategies between individual schools or early childhood education programs and providers of emergency medical services, including appropriate instructions for emergency medical response.[<-Struck out]
[Struck out->](D) Strategies to reduce the risk of exposure to anaphylactic causative agents in classrooms and common school or early childhood education program areas such as cafeterias.[<-Struck out]
[Struck out->](E) The dissemination of general information on life-threatening food allergies to school or early childhood education program staff, parents, and children.[<-Struck out]
[Struck out->](F) Food allergy management training of school or early childhood education program personnel who regularly come into contact with children with life-threatening food allergies.[<-Struck out]
[Struck out->](G) The authorization and training of school or early childhood education program personnel to administer epinephrine when the nurse is not immediately available.[<-Struck out]
[Struck out->](H) The timely accessibility of epinephrine by school or early childhood education program personnel when the nurse is not immediately available.[<-Struck out]
[Struck out->](I) The creation of a plan contained in each individual plan for food allergy management that addresses the appropriate response to an incident of anaphylaxis of a child while such child is engaged in extracurricular programs of a school or early childhood education program, such as non-academic outings and field trips, before- and after-school programs or before- and after-early child education program programs, and school-sponsored or early childhood education program-sponsored programs held on weekends.[<-Struck out]
[Struck out->](J) Maintenance of information for each administration of epinephrine to a child at risk for anaphylaxis and prompt notification to parents.[<-Struck out]
[Struck out->](K) Other elements the Secretary determines necessary for the management of food allergies and anaphylaxis in schools and early childhood education programs.[<-Struck out]
[Struck out->](3) RELATION TO STATE LAW- Nothing in this section or the guidelines developed by the Secretary under paragraph (1) shall be construed to preempt State law, including any State law regarding whether students at risk for anaphylaxis may self-administer medication.[<-Struck out]
[Struck out->](c) School-based Food Allergy Management Grants-[<-Struck out]
[Struck out->](1) IN GENERAL- The Secretary may award grants to local educational agencies to assist such agencies with implementing voluntary food allergy and anaphylaxis management guidelines described in subsection (b).[<-Struck out]
[Struck out->](2) APPLICATION-[<-Struck out]
[Struck out->](A) IN GENERAL- To be eligible to receive a grant under this subsection, a local educational agency shall submit an application to the Secretary at such time, in such manner, and including such information as the Secretary may reasonably require.[<-Struck out]
[Struck out->](B) CONTENTS- Each application submitted under subparagraph (A) shall include--[<-Struck out]
[Struck out->](i) an assurance that the local educational agency has developed plans in accordance with the food allergy and anaphylaxis management guidelines described in subsection (b);[<-Struck out]
[Struck out->](ii) a description of the activities to be funded by the grant in carrying out the food allergy and anaphylaxis management guidelines, including--[<-Struck out]
[Struck out->](I) how the guidelines will be carried out at individual schools served by the local educational agency;[<-Struck out]
[Struck out->](II) how the local educational agency will inform parents and students of the guidelines in place;[<-Struck out]
[Struck out->](III) how school nurses, teachers, administrators, and other school-based staff will be made aware of, and given training on, when applicable, the guidelines in place; and[<-Struck out]
[Struck out->](IV) any other activities that the Secretary determines appropriate;[<-Struck out]
[Struck out->](iii) an itemization of how grant funds received under this subsection will be expended;[<-Struck out]
[Struck out->](iv) a description of how adoption of the guidelines and implementation of grant activities will be monitored; and[<-Struck out]
[Struck out->](v) an agreement by the local educational agency to report information required by the Secretary to conduct evaluations under this subsection.[<-Struck out]
[Struck out->](3) USE OF FUNDS- Each local educational agency that receives a grant under this subsection may use the grant funds for the following:[<-Struck out]
[Struck out->](A) Purchase of materials and supplies, including limited medical supplies such as epinephrine and disposable wet wipes, to support carrying out the food allergy and anaphylaxis management guidelines described in subsection (b).[<-Struck out]
[Struck out->](B) In partnership with local health departments, school nurse, teacher, and personnel training for food allergy management.[<-Struck out]
[Struck out->](C) Programs that educate students as to the presence of, and policies and procedures in place related to, food allergies and anaphylactic shock.[<-Struck out]
[Struck out->](D) Outreach to parents.[<-Struck out]
[Struck out->](E) Any other activities consistent with the guidelines described in subsection (b).[<-Struck out]
[Struck out->](4) DURATION OF AWARDS- The Secretary may award grants under this subsection for a period of not more than 2 years. In the event the Secretary conducts a program evaluation under this subsection, funding in the second year of the grant, where applicable, shall be contingent on a successful program evaluation by the Secretary after the first year.[<-Struck out]
[Struck out->](5) LIMITATION ON GRANT FUNDING- The Secretary may not provide grant funding to a local educational agency under this subsection after such local educational agency has received 2 years of grant funding under this subsection.[<-Struck out]
[Struck out->](6) MAXIMUM AMOUNT OF ANNUAL AWARDS- A grant awarded under this subsection may not be made in an amount that is more than $50,000 annually.[<-Struck out]
[Struck out->](7) PRIORITY- In awarding grants under this subsection, the Secretary shall give priority to local educational agencies with the highest percentages of children who are counted under section 1124(c) of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 6333(c) [<-Struck out]
[Struck out->](8) MATCHING FUNDS-[<-Struck out]
[Struck out->](A) IN GENERAL- The Secretary may not award a grant under this subsection unless the local educational agency agrees that, with respect to the costs to be incurred by such local educational agency in carrying out the grant activities, the local educational agency shall make available (directly or through donations from public or private entities) non-Federal funds toward such costs in an amount equal to not less than 25 percent of the amount of the grant.[<-Struck out]
[Struck out->](B) DETERMINATION OF AMOUNT OF NON-FEDERAL CONTRIBUTION- Non-Federal funds required under subparagraph (A) may be cash or in kind, including plant, equipment, or services. Amounts provided by the Federal Government, and any portion of any service subsidized by the Federal Government, may not be included in determining the amount of such non-Federal funds.[<-Struck out]
[Struck out->](9) ADMINISTRATIVE FUNDS- A local educational agency that receives a grant under this subsection may use not more than 2 percent of the grant amount for administrative costs related to carrying out this subsection.[<-Struck out]
[Struck out->](10) PROGRESS AND EVALUATIONS- At the completion of the grant period referred to in paragraph (4), a local educational agency shall provide the Secretary with information on how grant funds were spent and the status of implementation of the food allergy and anaphylaxis management guidelines described in subsection (b).[<-Struck out]
[Struck out->](11) SUPPLEMENT, NOT SUPPLANT- Grant funds received under this subsection shall be used to supplement, and not supplant, non-Federal funds and any other Federal funds available to carry out the activities described in this subsection.[<-Struck out]
[Struck out->](12) AUTHORIZATION OF APPROPRIATIONS- There is authorized to be appropriated to carry out this subsection $30,000,000 for fiscal year 2010 and such sums as may be necessary for each of the 4 succeeding fiscal years.[<-Struck out]
[Struck out->](d) Voluntary Nature of Guidelines-[<-Struck out]
[Struck out->](1) IN GENERAL- The food allergy and anaphylaxis management guidelines developed by the Secretary under subsection (b) are voluntary. Nothing in this section or the guidelines developed by the Secretary under subsection (b) shall be construed to require a local educational agency to implement such guidelines.[<-Struck out]
[Struck out->](2) EXCEPTION- Notwithstanding paragraph (1), the Secretary may enforce an agreement by a local educational agency to implement food allergy and anaphylaxis management guidelines as a condition of the receipt of a grant under subsection (c).[<-Struck out]
[Struck out->]
TITLE II--IMPROVING CAPACITY TO DETECT AND RESPOND TO FOOD SAFETY PROBLEMS[<-Struck out]
SEC. 201. TARGETING OF INSPECTION RESOURCES FOR DOMESTIC FACILITIES, FOREIGN FACILITIES, AND PORTS OF ENTRY; ANNUAL REPORT.[<-Struck out][Struck out->](a) Targeting of Inspection Resources for Domestic Facilities, Foreign Facilities, and Ports of Entry- Chapter IV (21 U.S.C. 341 [<-Struck out]
[Struck out->]‘SEC. 421. TARGETING OF INSPECTION RESOURCES FOR DOMESTIC FACILITIES, FOREIGN FACILITIES, AND PORTS OF ENTRY; ANNUAL REPORT.[<-Struck out]
[Struck out->]
‘(a) Identification and Inspection of Facilities-[<-Struck out]
[Struck out->]
‘(1) IDENTIFICATION- The Secretary shall allocate resources to inspect facilities according to the risk profile of the facilities, which shall be based on the following factors:[<-Struck out]
[Struck out->]
‘(A) The risk profile of the food manufactured, processed, packed, or held at the facility.[<-Struck out]
[Struck out->]
‘(B) The facility’s history of food recalls, outbreaks, and violations of food safety standards.[<-Struck out]
[Struck out->]
‘(C) The rigor of the facility’s hazard analysis and risk-based preventive controls.[<-Struck out]
[Struck out->]
‘(D) Whether the food manufactured, processed, packed, handled, prepared, treated, distributed, or stored at the facility meets the criteria for priority under section 801(h)(1).[<-Struck out]
[Struck out->]
‘(E) Whether the facility has received a certificate as described in section 809(b).[<-Struck out]
[Struck out->]
‘(F) Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources.[<-Struck out]
[Struck out->]
‘(2) INSPECTIONS-[<-Struck out]
[Struck out->]
‘(A) IN GENERAL- Beginning on the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall increase the frequency of inspection of all facilities.[<-Struck out]
[Struck out->]
‘(B) HIGH-RISK FACILITIES- The Secretary shall increase the frequency of inspection of facilities identified under paragraph (1) as high-risk facilities such that--[<-Struck out]
[Struck out->]
‘(i) for the first 2 years after the date of enactment of the FDA Food Safety Modernization Act, each high-risk facility is inspected not less often than once every 2 years; and[<-Struck out]
[Struck out->]
‘(ii) for each succeeding year, each high-risk facility is inspected not less often than once each year.[<-Struck out]
[Struck out->]
‘(C) NON-HIGH-RISK FACILITIES- The Secretary shall ensure that each facility that is not identified under paragraph (1) as a high-risk facility is inspected not less often than once every 4 years.[<-Struck out]
[Struck out->]
‘(b) Identification and Inspection at Ports of Entry- The Secretary, in consultation with the Secretary of Homeland Security, shall allocate resources to inspect articles of food imported into the United States according to the risk profile of the article of food, which shall be based on the following factors:[<-Struck out]
[Struck out->]
‘(1) The risk profile of the food imported.[<-Struck out]
[Struck out->]
‘(2) The risk profile of the countries of origin and countries of transport of the food imported.[<-Struck out]
[Struck out->]
‘(3) The history of food recalls, outbreaks, and violations of food safety standards of the food importer.[<-Struck out]
[Struck out->]
‘(4) The rigor of the foreign supplier verification program under section 805.[<-Struck out]
[Struck out->]
‘(5) Whether the food importer participates in the voluntary qualified importer program under section 806.[<-Struck out]
[Struck out->]
‘(6) Whether the food meets the criteria for priority under section 801(h)(1).[<-Struck out]
[Struck out->]
‘(7) Whether the food is from a facility that has received a certificate as described in section 809(b).[<-Struck out]
[Struck out->]
‘(8) Any other criteria deemed appropriate by the Secretary for purposes of allocating inspection resources.[<-Struck out]
[Struck out->]
‘(c) Coordination- The Secretary shall improve coordination and cooperation with the Secretary of Agriculture to target food inspection resources.[<-Struck out]
[Struck out->]
‘(d) Facility- For purposes of this section, the term ‘facility’ means a domestic facility or a foreign facility that is required to register under section 415.’.[<-Struck out]
[Struck out->](b) Annual Report- Section 903 (21 U.S.C. 393 [<-Struck out]
[Struck out->]
‘(h) Annual Report Regarding Food- Not later than February 1 of each year, the Secretary shall submit to Congress a report regarding--[<-Struck out]
[Struck out->]
‘(1) information about food facilities including--[<-Struck out]
[Struck out->]
‘(A) the appropriations used to inspect facilities registered pursuant to section 415 in the previous fiscal year;[<-Struck out]
[Struck out->]
‘(B) the average cost of both a non-high-risk food facility inspection and a high-risk food facility inspection, if such a difference exists, in the previous fiscal year;[<-Struck out]
[Struck out->]
‘(C) the number of domestic facilities and the number of foreign facilities registered pursuant to section 415 that the Secretary inspected in the previous fiscal year;[<-Struck out]
[Struck out->]
‘(D) the number of domestic facilities and the number of foreign facilities registered pursuant to section 415 that the Secretary did not inspect in the previous fiscal year;[<-Struck out]
[Struck out->]
‘(E) the number of high-risk facilities identified pursuant to section 421 that the Secretary inspected in the previous fiscal year; and[<-Struck out]
[Struck out->]
‘(F) the number of high-risk facilities identified pursuant to section 421 that the Secretary did not inspect in the previous fiscal year;[<-Struck out]
[Struck out->]
‘(2) information about food imports including--[<-Struck out]
[Struck out->]
‘(A) the number of lines of food imported into the United States that the Secretary physically inspected or sampled in the previous fiscal year;[<-Struck out]
[Struck out->]
‘(B) the number of lines of food imported into the United States that the Secretary did not physically inspect or sample in the previous fiscal year; and[<-Struck out]
[Struck out->]
‘(C) the average cost of physically inspecting or sampling a food line subject to this Act that is imported or offered for import into the United States; and[<-Struck out]
[Struck out->]
‘(3) information on the foreign offices established under section 309 of the FDA Food Safety Modernization Act including--[<-Struck out]
[Struck out->]
‘(A) the number of foreign offices established; and[<-Struck out]
[Struck out->]
‘(B) the number of personnel permanently stationed in each foreign office.[<-Struck out]
[Struck out->]
‘(i) Public Availability of Annual Food Reports- The Secretary shall make the reports required under subsection (h) available to the public on the Internet Web site of the Food and Drug Administration.’.[<-Struck out]
[Struck out->]SEC. 202. RECOGNITION OF LABORATORY ACCREDITATION FOR ANALYSES OF FOODS.[<-Struck out][Struck out->](a) In General- Chapter IV (21 U.S.C. 341 [<-Struck out]
[Struck out->]‘SEC. 422. RECOGNITION OF LABORATORY ACCREDITATION FOR ANALYSES OF FOODS.[<-Struck out]
[Struck out->]
‘(a) Recognition of Laboratory Accreditation-[<-Struck out]
[Struck out->]
‘(1) IN GENERAL- Not later than 2 years after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall--[<-Struck out]
[Struck out->]
‘(A) provide for the recognition of accreditation bodies that accredit laboratories, including laboratories run and operated by a State or locality, with a demonstrated capability to conduct analytical testing of food products; and[<-Struck out]
[Struck out->]
‘(B) establish a publicly available registry of accreditation bodies, including the name of, contact information for, and other information deemed necessary by the Secretary about such bodies.[<-Struck out]
[Struck out->]
‘(2) FOREIGN LABORATORIES- Accreditation bodies may accredit laboratories that operate outside the United States, so long as such laboratories meet the accreditation standards applicable to domestic laboratories accredited under this section.[<-Struck out]
[Struck out->]
‘(3) MODEL ACCREDITATION STANDARDS- The Secretary shall develop model standards that an accreditation body shall require laboratories to meet in order to be included in the registry provided for under paragraph (1). In developing the model standards, the Secretary shall look to existing standards for guidance. The model standards shall include methods to ensure that--[<-Struck out]
[Struck out->]
‘(A) appropriate sampling and analytical procedures are followed and reports of analyses are certified as true and accurate;[<-Struck out]
[Struck out->]
‘(B) internal quality systems are established and maintained;[<-Struck out]
[Struck out->]
‘(C) procedures exist to evaluate and respond promptly to complaints regarding analyses and other activities for which the laboratory is recognized;[<-Struck out]
[Struck out->]
‘(D) individuals who conduct the analyses are qualified by training and experience to do so; and[<-Struck out]
[Struck out->]
‘(E) any other criteria determined appropriate by the Secretary.[<-Struck out]
[Struck out->]
‘(4) REVIEW OF ACCREDITATION- To assure compliance with the requirements of this section, the Secretary shall--[<-Struck out]
[Struck out->]
‘(A) periodically, or at least every 5 years, reevaluate accreditation bodies recognized under paragraph (1); and[<-Struck out]
[Struck out->]
‘(B) promptly revoke the recognition of any accreditation body found not to be in compliance with the requirements of this section.[<-Struck out]
[Struck out->]
‘(b) Testing Procedures-[<-Struck out]
[Struck out->]
‘(1) IN GENERAL- Food testing shall be conducted by either Federal laboratories or non-Federal laboratories that have been accredited by an accreditation body on the registry established by the Secretary under subsection (a) whenever such testing is either conducted by or on behalf of an owner or consignee--[<-Struck out]
[Struck out->]
‘(A) in support of admission of an article of food under section 801(a);[<-Struck out]
[Struck out->]
‘(B) due to a specific testing requirement in this Act or implementing regulations, when applied to address an identified or suspected food safety problem;[<-Struck out]
[Struck out->]
‘(C) under an Import Alert that requires successful consecutive tests; or[<-Struck out]
[Struck out->]
‘(D) is so required by the Secretary as the Secretary deems appropriate to address an identified or suspected food safety problem.[<-Struck out]
[Struck out->]
‘(2) RESULTS OF TESTING- The results of any such testing shall be sent directly to the Food and Drug Administration. Such results may be submitted to the Food and Drug Administration through electronic means.[<-Struck out]
[Struck out->]
‘(c) Review by Secretary- If food sampling and testing performed by a laboratory run and operated by a State or locality that is accredited by an accreditation body on the registry established by the Secretary under subsection (a) result in a State recalling a food, the Secretary shall review the sampling and testing results for the purpose of determining the need for a national recall or other compliance and enforcement activities.[<-Struck out]
[Struck out->]
‘(d) No Limit on Secretarial Authority- Nothing in this section shall be construed to limit the ability of the Secretary to review and act upon information from food testing, including determining the sufficiency of such information and testing.’.[<-Struck out]
[Struck out->](b) Food Emergency Response Network- The Secretary, in coordination with the Secretary of Agriculture, the Secretary of Homeland Security, and State, local, and tribal governments shall, not later than 180 days after the date of enactment of this Act, and biennially thereafter, submit to the relevant committees of Congress, and make publicly available on the Internet Web site of the Department of Health and Human Services, a report on the progress in implementing a national food emergency response laboratory network that--[<-Struck out]
[Struck out->](1) provides ongoing surveillance, rapid detection, and surge capacity for large-scale food-related emergencies, including intentional adulteration of the food supply;[<-Struck out]
[Struck out->](2) coordinates the food laboratory capacities of State food laboratories, including the sharing of data between State laboratories to develop national situational awareness;[<-Struck out]
[Struck out->](3) provides accessible, timely, accurate, and consistent food laboratory services throughout the United States;[<-Struck out]
[Struck out->](4) develops and implements a methods repository for use by Federal, State, and local officials;[<-Struck out]
[Struck out->](5) responds to food-related emergencies; and[<-Struck out]
[Struck out->](6) is integrated with relevant laboratory networks administered by other Federal agencies.[<-Struck out]
[Struck out->]SEC. 203. INTEGRATED CONSORTIUM OF LABORATORY NETWORKS.[<-Struck out][Struck out->](a) In General- The Secretary of Homeland Security, in consultation with the Secretary of Health and Human Services, the Secretary of Agriculture, and the Administrator of the Environmental Protection Agency, shall maintain an agreement through which relevant laboratory network members, as determined by the Secretary of Homeland Security, shall--[<-Struck out]
[Struck out->](1) agree on common laboratory methods in order to facilitate the sharing of knowledge and information relating to animal health, agriculture, and human health;[<-Struck out]
[Struck out->](2) identify the means by which each laboratory network member could work cooperatively--[<-Struck out]
[Struck out->](A) to optimize national laboratory preparedness; and[<-Struck out]
[Struck out->](B) to provide surge capacity during emergencies; and[<-Struck out]
[Struck out->](3) engage in ongoing dialogue and build relationships that will support a more effective and integrated response during emergencies.[<-Struck out]
[Struck out->](b) Reporting Requirement- The Secretary of Homeland Security shall, on a biennial basis, submit to the relevant committees of Congress, and make publicly available on the Internet Web site of the Department of Homeland Security, a report on the progress of the integrated consortium of laboratory networks, as established under subsection (a), in carrying out this section.[<-Struck out]
[Struck out->]SEC. 204. ENHANCING TRACEBACK AND RECORDKEEPING.[<-Struck out][Struck out->](a) In General- The Secretary, in consultation with the Secretary of Agriculture and representatives of State departments of health and agriculture, shall improve the capacity of the Secretary to effectively and rapidly track and trace, in the event of an outbreak, fruits and vegetables that are raw agricultural commodities.[<-Struck out]
[Struck out->](b) Pilot Project-[<-Struck out]
[Struck out->](1) IN GENERAL- Not later than 9 months after the date of enactment of this Act, the Secretary shall establish a pilot project in coordination with the produce industry to explore and evaluate methods for rapidly and effectively tracking and tracing fruits and vegetables that are raw agricultural commodities so that, if an outbreak occurs involving such a fruit or vegetable, the Secretary may quickly identify the source of the outbreak and the recipients of the contaminated food.[<-Struck out]
[Struck out->](2) CONTENT- The Secretary shall select participants from the produce industry to run projects which overall shall include at least 3 different types of fruits or vegetables that have been the subject of outbreaks during the 5-year period preceding the date of enactment of this Act, and shall be selected in order to develop and demonstrate--[<-Struck out]
[Struck out->](A) methods that are applicable and appropriate for small businesses; and[<-Struck out]
[Struck out->](B) technologies, including existing technologies, that enhance traceback and trace forward.[<-Struck out]
[Struck out->](c) Report- Not later than 18 months after the date of enactment of this Act, the Secretary shall report to Congress on the findings of the pilot project under subsection (b) together with recommendations for establishing more effective traceback and trace forward procedures for fruits and vegetables that are raw agricultural commodities.[<-Struck out]
[Struck out->](d) Traceback Performance Requirements- Not later than 24 months after the date of enactment of this Act, the Secretary shall publish a notice of proposed rulemaking to establish standards for the type of information, format, and timeframe for persons to submit records to aid the Secretary in effectively and rapidly tracking and tracing, in the event of an outbreak, fruits and vegetables that are raw agricultural commodities. Nothing in this section shall be construed as giving the Secretary the authority to prescribe specific technologies for the maintenance of records.[<-Struck out]
[Struck out->](e) Public Input- During the comment period in the notice of proposed rulemaking under subsection (d), the Secretary shall conduct not less than 3 public meetings in diverse geographical areas of the United States to provide persons in different regions an opportunity to comment.[<-Struck out]
[Struck out->](f) Raw Agricultural Commodity- In this section, the term ‘raw agricultural commodity’ has the meaning given that term in section 201(r) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(r) [<-Struck out]
[Struck out->]SEC. 205. SURVEILLANCE.[<-Struck out][Struck out->](a) Definition of Food-borne Illness Outbreak- In this section, the term ‘food-borne illness outbreak’ means the occurrence of 2 or more cases of a similar illness resulting from the ingestion of a food.[<-Struck out]
[Struck out->](b) Food-borne Illness Surveillance Systems-[<-Struck out]
[Struck out->](1) IN GENERAL- The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall enhance food-borne illness surveillance systems to improve the collection, analysis, reporting, and usefulness of data on food-borne illnesses by--[<-Struck out]
[Struck out->](A) coordinating Federal, State and local food-borne illness surveillance systems, including complaint systems, and increasing participation in national networks of public health and food regulatory agencies and laboratories;[<-Struck out]
[Struck out->](B) facilitating sharing of findings on a more timely basis among governmental agencies, including the Food and Drug Administration, the Department of Agriculture, and State and local agencies, and with the public;[<-Struck out]
[Struck out->](C) developing improved epidemiological tools for obtaining quality exposure data, and microbiological methods for classifying cases;[<-Struck out]
[Struck out->](D) augmenting such systems to improve attribution of a food-borne illness outbreak to a specific food;[<-Struck out]
[Struck out->](E) expanding capacity of such systems, including working toward automatic electronic searches, for implementation of fingerprinting strategies for food-borne infectious agents, in order to identify new or rarely documented causes of food-borne illness and submit standardized information to a centralized database;[<-Struck out]
[Struck out->](F) allowing timely public access to aggregated, de-identified surveillance data;[<-Struck out]
[Struck out->](G) at least annually, publishing current reports on findings from such systems;[<-Struck out]
[Struck out->](H) establishing a flexible mechanism for rapidly initiating scientific research by academic institutions;[<-Struck out]
[Struck out->](I) integrating food-borne illness surveillance systems and data with other biosurveillance and public health situational awareness capabilities at the Federal, State, and local levels; and[<-Struck out]
[Struck out->](J) other activities as determined appropriate by the Secretary.[<-Struck out]
[Struck out->](2) PARTNERSHIPS- The Secretary shall support and maintain a diverse working group of experts and stakeholders from Federal, State, and local food safety and health agencies, the food industry, consumer organizations, and academia. Such working group shall provide the Secretary, through at least annual meetings of the working group and an annual public report, advice and recommendations on an ongoing and regular basis regarding the improvement of food-borne illness surveillance and implementation of this section, including advice and recommendations on--[<-Struck out]
[Struck out->](A) the priority needs of regulatory agencies, the food industry, and consumers for information and analysis on food-borne illness and its causes;[<-Struck out]
[Struck out->](B) opportunities to improve the effectiveness of initiatives at the Federal, State, and local levels, including coordination and integration of activities among Federal agencies, and between the Federal, State, and local levels of government;[<-Struck out]
[Struck out->](C) improvement in the timeliness and depth of access by regulatory and health agencies, the food industry, academic researchers, and consumers to food-borne illness surveillance data collected by government agencies at all levels, including data compiled by the Centers for Disease Control and Prevention;[<-Struck out]
[Struck out->](D) key barriers to improvement in food-borne illness surveillance and its utility for preventing food-borne illness at Federal, State, and local levels;[<-Struck out]
[Struck out->](E) the capabilities needed for establishing automatic electronic searches of surveillance data; and[<-Struck out]
[Struck out->](F) specific actions to reduce barriers to improvement, implement the working group’s recommendations, and achieve the purposes of this section, with measurable objectives and timelines, and identification of resource and staffing needs.[<-Struck out]
[Struck out->](c) Improving Food Safety and Defense Capacity at the State and Local Level-[<-Struck out]
[Struck out->](1) IN GENERAL- The Secretary shall develop and implement strategies to leverage and enhance the food safety and defense capacities of State and local agencies in order to achieve the following goals:[<-Struck out]
[Struck out->](A) Improve food-borne illness outbreak response and containment.[<-Struck out]
[Struck out->](B) Accelerate food-borne illness surveillance and outbreak investigation, including rapid shipment of clinical isolates from clinical laboratories to appropriate State laboratories, and conducting more standardized illness outbreak interviews.[<-Struck out]
[Struck out->](C) Strengthen the capacity of State and local agencies to carry out inspections and enforce safety standards.[<-Struck out]
[Struck out->](D) Improve the effectiveness of Federal, State, and local partnerships to coordinate food safety and defense resources and reduce the incidence of food-borne illness.[<-Struck out]
[Struck out->](E) Share information on a timely basis among public health and food regulatory agencies, with the food industry, with health care providers, and with the public.[<-Struck out]
[Struck out->](F) Strengthen the capacity of State and local agencies to achieve the goals described in section 108.[<-Struck out]
[Struck out->](2) REVIEW- In developing of the strategies required by paragraph (1), the Secretary shall, not later than 1 year after the date of enactment of the FDA Food Safety Modernization Act, complete a review of State and local capacities, and needs for enhancement, which may include a survey with respect to--[<-Struck out]
[Struck out->](A) staffing levels and expertise available to perform food safety and defense functions;[<-Struck out]
[Struck out->](B) laboratory capacity to support surveillance, outbreak response, inspection, and enforcement activities;[<-Struck out]
[Struck out->](C) information systems to support data management and sharing of food safety and defense information among State and local agencies and with counterparts at the Federal level; and[<-Struck out]
[Struck out->](D) other State and local activities and needs as determined appropriate by the Secretary.[<-Struck out]
[Struck out->](d) Food Safety Capacity Building Grants- Section 317R(b) of the Public Health Service Act (42 U.S.C. 247b-20(b) [<-Struck out]
[Struck out->](1) by striking ‘2002’ and inserting ‘2010’; and[<-Struck out]
[Struck out->](2) by striking ‘2003 through 2006’ and inserting ‘2011 through 2014’.[<-Struck out]
[Struck out->]SEC. 206. MANDATORY RECALL AUTHORITY.[<-Struck out][Struck out->](a) In General- Chapter IV (21 U.S.C. 341 [<-Struck out]
[Struck out->]‘SEC. 423. MANDATORY RECALL AUTHORITY.[<-Struck out]
[Struck out->]
‘(a) Voluntary Procedures- If the Secretary determines, based on information gathered through the reportable food registry under section 417 or through any other means, that there is a reasonable probability that an article of food (other than infant formula) is adulterated under section 402 or misbranded under section 403(w) and the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals, the Secretary shall provide the responsible party (as defined in section 417) with an opportunity to cease distribution and recall such article.[<-Struck out]
[Struck out->]
‘(b) Prehearing Order To Cease Distribution and Give Notice- If the responsible party refuses to or does not voluntarily cease distribution or recall such article within the time and in the manner prescribed by the Secretary (if so prescribed), the Secretary may, by order require, as the Secretary deems necessary, such person to--[<-Struck out]
[Struck out->]
‘(1) immediately cease distribution of such article; or[<-Struck out]
[Struck out->]
‘(2) immediately notify all persons--[<-Struck out]
[Struck out->]
‘(A) manufacturing, processing, packing, transporting, distributing, receiving, holding, or importing and selling such article; and[<-Struck out]
[Struck out->]
‘(B) to which such article has been distributed, transported, or sold, to immediately cease distribution of such article.[<-Struck out]
[Struck out->]
‘(c) Hearing on Order- The Secretary shall provide the responsible party subject to an order under subsection (b) with an opportunity for an informal hearing, to be held as soon as possible but not later than 2 days after the issuance of the order, on the actions required by the order and on why the article that is the subject of the order should not be recalled.[<-Struck out]
[Struck out->]
‘(d) Post-hearing Recall Order and Modification of Order-[<-Struck out]
[Struck out->]
‘(1) AMENDMENT OF ORDER- If, after providing opportunity for an informal hearing under subsection (c), the Secretary determines that removal of the article from commerce is necessary, the Secretary shall, as appropriate--[<-Struck out]
[Struck out->]
‘(A) amend the order to require recall of such article or other appropriate action;[<-Struck out]
[Struck out->]
‘(B) specify a timetable in which the recall shall occur;[<-Struck out]
[Struck out->]
‘(C) require periodic reports to the Secretary describing the progress of the recall; and[<-Struck out]
[Struck out->]
‘(D) provide notice to consumers to whom such article was, or may have been, distributed.[<-Struck out]
[Struck out->]
‘(2) VACATING OF ORDER- If, after such hearing, the Secretary determines that adequate grounds do not exist to continue the actions required by the order, or that such actions should be modified, the Secretary shall vacate the order or modify the order.[<-Struck out]
[Struck out->]
‘(e) Cooperation and Consultation- The Secretary shall work with State and local public health officials in carrying out this section, as appropriate.[<-Struck out]
[Struck out->]
‘(f) Public Notification- In conducting a recall under this section, the Secretary shall--[<-Struck out]
[Struck out->]
‘(1) ensure that a press release is published regarding the recall, as well as alerts and public notices, as appropriate, in order to provide notification--[<-Struck out]
[Struck out->]
‘(A) of the recall to consumers and retailers to whom such article was, or may have been, distributed; and[<-Struck out]
[Struck out->]
‘(B) that includes, at a minimum--[<-Struck out]
[Struck out->]
‘(i) the name of the article of food subject to the recall; and[<-Struck out]
[Struck out->]
‘(ii) a description of the risk associated with such article; and[<-Struck out]
[Struck out->]
‘(2) consult the policies of the Department of Agriculture regarding providing to the public a list of retail consignees receiving products involved in a Class I recall and shall consider providing such a list to the public, as determined appropriate by the Secretary.[<-Struck out]
[Struck out->]
‘(g) No Delegation- The authority conferred by this section to order a recall or vacate a recall order shall not be delegated to any officer or employee other than the Commissioner.[<-Struck out]
[Struck out->]
‘(h) Effect- Nothing in this section shall affect the authority of the Secretary to request or participate in a voluntary recall.’.[<-Struck out]
[Struck out->](b) Civil Penalty- Section 303(f)(2)(A) (21 U.S.C. 333(f)(2)(A) [<-Struck out]
[Struck out->](c) Prohibited Acts- Section 301 (21 U.S.C. 331 [<-Struck out]
[Struck out->]
‘(rr) The refusal or failure to follow an order under section 423.’.[<-Struck out]
[Struck out->]SEC. 207. ADMINISTRATIVE DETENTION OF FOOD.[<-Struck out][Struck out->](a) In General- Section 304(h)(1)(A) (21 U.S.C. 334(h)(1)(A) [<-Struck out]
[Struck out->](1) striking ‘credible evidence or information indicating’ and inserting ‘reason to believe’; and[<-Struck out]
[Struck out->](2) striking ‘presents a threat of serious adverse health consequences or death to humans or animals’ and inserting ‘is adulterated or misbranded’.[<-Struck out]
[Struck out->](b) Regulations- Not later than 120 days after the date of enactment of this Act, the Secretary shall issue an interim final rule amending subpart K of part 1 of title 21, Code of Federal Regulations, to implement the amendment made by this section.[<-Struck out]
[Struck out->](c) Effective Date- The amendment made by this section shall take effect 180 days after the date of enactment of this Act.[<-Struck out]
[Struck out->]SEC. 208. DECONTAMINATION AND DISPOSAL STANDARDS AND PLANS.[<-Struck out][Struck out->](a) In General- The Administrator of the Environmental Protection Agency (referred to in this section as the ‘Administrator’), in coordination with the Secretary of Health and Human Services, Secretary of Homeland Security, and Secretary of Agriculture, shall provide support for, and technical assistance to, State, local, and tribal governments in preparing for, assessing, decontaminating, and recovering from an agriculture or food emergency.[<-Struck out]
[Struck out->](b) Development of Standards- In carrying out subsection (a), the Administrator, in coordination with the Secretary of Health and Human Services, Secretary of Homeland Security, Secretary of Agriculture, and State, local, and tribal governments, shall develop and disseminate specific standards and protocols to undertake clean-up, clearance, and recovery activities following the decontamination and disposal of specific threat agents and foreign animal diseases.[<-Struck out]
[Struck out->](c) Development of Model Plans- In carrying out subsection (a), the Administrator, the Secretary of Health and Human Services, and the Secretary of Agriculture shall jointly develop and disseminate model plans for--[<-Struck out]
[Struck out->](1) the decontamination of individuals, equipment, and facilities following an intentional contamination of agriculture or food; and[<-Struck out]
[Struck out->](2) the disposal of large quantities of animals, plants, or food products that have been infected or contaminated by specific threat agents and foreign animal diseases.[<-Struck out]
[Struck out->](d) Exercises- In carrying out subsection (a), the Administrator, in coordination with the entities described under subsection (b), shall conduct exercises at least annually to evaluate and identify weaknesses in the decontamination and disposal model plans described in subsection (c). Such exercises shall be carried out, to the maximum extent practicable, as part of the national exercise program under section 648(b)(1) of the Post-Katrina Emergency Management Reform Act of 2006 (6 U.S.C. 748(b)(1) [<-Struck out]
[Struck out->](e) Modifications- Based on the exercises described in subsection (d), the Administrator, in coordination with the entities described in subsection (b), shall review and modify as necessary the plans described in subsection (c) not less frequently than biennially.[<-Struck out]
[Struck out->](f) Prioritization- The Administrator, in coordination with the entities described in subsection (b), shall develop standards and plans under subsections (b) and (c) in an identified order of priority that takes into account--[<-Struck out]
[Struck out->](1) highest-risk biological, chemical, and radiological threat agents;[<-Struck out]
[Struck out->](2) agents that could cause the greatest economic devastation to the agriculture and food system; and[<-Struck out]
[Struck out->](3) agents that are most difficult to clean or remediate.[<-Struck out]
[Struck out->]
TITLE III--IMPROVING THE SAFETY OF IMPORTED FOOD[<-Struck out]
SEC. 301. FOREIGN SUPPLIER VERIFICATION PROGRAM.[<-Struck out][Struck out->](a) In General- Chapter VIII (21 U.S.C. 381 [<-Struck out]
[Struck out->]‘SEC. 805. FOREIGN SUPPLIER VERIFICATION PROGRAM.[<-Struck out]
[Struck out->]
‘(a) In General-[<-Struck out]
[Struck out->]
‘(1) VERIFICATION REQUIREMENT- Each United States importer shall perform risk-based foreign supplier verification activities in accordance with regulations promulgated under subsection (c) for the purpose of verifying that the food imported by the importer or its agent is--[<-Struck out]
[Struck out->]
‘(A) produced in compliance with the requirements of section 418 or 419, as appropriate; and[<-Struck out]
[Struck out->]
‘(B) is not adulterated under section 402 or misbranded under section 403(w).[<-Struck out]
[Struck out->]
‘(2) IMPORTER DEFINED- For purposes of this section, the term ‘importer’ means, with respect to an article of food--[<-Struck out]
[Struck out->]
‘(A) the United States owner or consignee of the article of food at the time of entry of such article into the United States; or[<-Struck out]
[Struck out->]
‘(B) in the case when there is no United States owner or consignee as described in subparagraph (A), the United States agent or representative of a foreign owner or consignee of the article of food at the time of entry of such article into the United States.[<-Struck out]
[Struck out->]
‘(b) Guidance- Not later than 1 year after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall issue guidance to assist United States importers in developing foreign supplier verification programs.[<-Struck out]
[Struck out->]
‘(c) Regulations-[<-Struck out]
[Struck out->]
‘(1) IN GENERAL- Not later than 1 year after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall promulgate regulations to provide for the content of the foreign supplier verification program established under subsection (a). Such regulations shall, as appropriate, include a process for verification by a United States importer, with respect to each foreign supplier from which it obtains food, that the imported food is produced in compliance with the requirements of section 418 or 419, as appropriate, and is not adulterated under section 402 or misbranded under section 403(w).[<-Struck out]
[Struck out->]
‘(2) VERIFICATION- The regulations under paragraph (1) shall require that the foreign supplier verification program of each importer be adequate to provide assurances that each foreign supplier to the importer produces the imported food employing processes and procedures, including risk-based reasonably appropriate preventive controls, equivalent in preventing adulteration and reducing hazards as those required by section 418 or section 419, as appropriate.[<-Struck out]
[Struck out->]
‘(3) ACTIVITIES- Verification activities under a foreign supplier verification program under this section may include monitoring records for shipments, lot-by-lot certification of compliance, annual on-site inspections, checking the hazard analysis and risk-based preventive control plan of the foreign supplier, and periodically testing and sampling shipments.[<-Struck out]
[Struck out->]
‘(d) Record Maintenance and Access- Records of a United States importer related to a foreign supplier verification program shall be maintained for a period of not less than 2 years and shall be made available promptly to a duly authorized representative of the Secretary upon request.[<-Struck out]
[Struck out->]
‘(e) Deemed Compliance of Seafood, Juice, and Low-acid Canned Food Facilities in Compliance With HACCP- An owner, operator, or agent in charge of a facility required to comply with 1 of the following standards and regulations with respect to such facility shall be deemed to be in compliance with this section with respect to such facility:[<-Struck out]
[Struck out->]
‘(1) The Seafood Hazard Analysis Critical Control Points Program of the Food and Drug Administration.[<-Struck out]
[Struck out->]
‘(2) The Juice Hazard Analysis Critical Control Points Program of the Food and Drug Administration.[<-Struck out]
[Struck out->]
‘(3) The Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards of the Food and Drug Administration (or any successor standards).[<-Struck out]
[Struck out->]
‘(f) Publication of List of Participants- The Secretary shall publish and maintain on the Internet Web site of the Food and Drug Administration a current list that includes the name of, location of, and other information deemed necessary by the Secretary about, importers participating under this section.’.[<-Struck out]
[Struck out->](b) Prohibited Act- Section 301 (21 U.S.C. 331 [<-Struck out]
[Struck out->]
‘(ss) The importation or offering for importation of a food if the importer (as defined in section 805) does not have in place a foreign supplier verification program in compliance with such section 805.’.[<-Struck out]
[Struck out->](c) Imports- Section 801(a) (21 U.S.C. 381(a) [<-Struck out]
[Struck out->](d) Effective Date- The amendments made by this section shall take effect 2 years after the date of enactment of this Act.[<-Struck out]
[Struck out->]SEC. 302. VOLUNTARY QUALIFIED IMPORTER PROGRAM.[<-Struck out][Struck out->]Chapter VIII (21 U.S.C. 381 [<-Struck out]
[Struck out->]‘SEC. 806. VOLUNTARY QUALIFIED IMPORTER PROGRAM.[<-Struck out]
[Struck out->]
‘(a) In General- Beginning not later than 1 year after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall--[<-Struck out]
[Struck out->]
‘(1) establish a program, in consultation with the Department of Homeland Security, to provide for the expedited review and importation of food offered for importation by United States importers who have voluntarily agreed to participate in such program; and[<-Struck out]
[Struck out->]
‘(2) issue a guidance document related to participation and compliance with such program.[<-Struck out]
[Struck out->]
‘(b) Voluntary Participation- An importer may request the Secretary to provide for the expedited review and importation of designated foods in accordance with the program procedures established by the Secretary.[<-Struck out]
[Struck out->]
‘(c) Eligibility- In order to be eligible, an importer shall be offering food for importation from a facility that has a certification described in section 809(b). In reviewing the applications and making determinations on such requests, the Secretary shall consider the risk of the food to be imported based on factors, such as the following:[<-Struck out]
[Struck out->]
‘(1) The nature of the food to be imported.[<-Struck out]
[Struck out->]
‘(2) The compliance history of the foreign supplier.[<-Struck out]
[Struck out->]
‘(3) The capability of the regulatory system of the country of export to ensure compliance with United States food safety standards.[<-Struck out]
[Struck out->]
‘(4) The compliance of the importer with the requirements of section 805.[<-Struck out]
[Struck out->]
‘(5) The recordkeeping, testing, inspections and audits of facilities, traceability of articles of food, temperature controls, and sourcing practices of the importer.[<-Struck out]
[Struck out->]
‘(6) The potential risk for intentional adulteration of the food.[<-Struck out]
[Struck out->]
‘(7) Any other factor that the Secretary determines appropriate.[<-Struck out]
[Struck out->]
‘(d) Review and Revocation- Any importer qualified by the Secretary in accordance with the eligibility criteria set forth in this section shall be reevaluated not less often than once every 3 years and the Secretary shall promptly revoke the qualified importer status of any importer found not to be in compliance with such criteria.[<-Struck out]
[Struck out->]
‘(e) Notice of Intent To Participate- An importer that intends to participate in the program under this section in a fiscal year shall submit a notice to the Secretary of such intent at time and in a manner established by the Secretary.[<-Struck out]
[Struck out->]
‘(f) False Statements- Any statement or representation made by an importer to the Secretary shall be subject tosection 1001 of title 18, United States Code [<-Struck out]
[Struck out->]
‘(g) Definition- For purposes of this section, the term ‘importer’ means the person that brings food, or causes food to be brought, from a foreign country into the customs territory of the United States.’.[<-Struck out]
[Struck out->]SEC. 303. AUTHORITY TO REQUIRE IMPORT CERTIFICATIONS FOR FOOD.[<-Struck out][Struck out->](a) In General- Section 801(a) (21 U.S.C. 381(a) [<-Struck out]
[Struck out->](b) Addition of Certification Requirement- Section 801 (21 U.S.C. 381 [<-Struck out]
[Struck out->]
‘(p) Certifications Concerning Imported Foods-[<-Struck out]
[Struck out->]
‘(1) IN GENERAL- The Secretary, based on public health considerations, including risks associated with the food or its place of origin, may require as a condition of granting admission to an article of food imported or offered for import into the United States, that an entity specified in paragraph (2) provide a certification or such other assurances as the Secretary determines appropriate that the article of food complies with some or all applicable requirements of this Act, as specified by the Secretary. Such certification or assurances may be provided in the form of shipment-specific certificates, a listing of certified entities, or in such other form as the Secretary may specify. Such certification shall be used for designated food imported from countries with which the Food and Drug Administration has an agreement to establish a certification program.[<-Struck out]
[Struck out->]
‘(2) CERTIFYING ENTITIES- For purposes of paragraph (1), entities that shall provide the certification or assurances described in such paragraph are--[<-Struck out]
[Struck out->]
‘(A) an agency or a representative of the government of the country from which the article of food at issue originated, as designated by such government or the Secretary; or[<-Struck out]
[Struck out->]
‘(B) such other persons or entities accredited pursuant to section 809 to provide such certification or assurance.[<-Struck out]
[Struck out->]
‘(3) RENEWAL AND REFUSAL OF CERTIFICATIONS- The Secretary may--[<-Struck out]
[Struck out->]
‘(A) require that any certification or other assurance provided by an entity specified in paragraph (2) be renewed by such entity at such times as the Secretary determines appropriate; and[<-Struck out]
[Struck out->]
‘(B) refuse to accept any certification or assurance if the Secretary determines that such certification or assurance is no longer valid or reliable.[<-Struck out]
[Struck out->]
‘(4) ELECTRONIC SUBMISSION- The Secretary shall provide for the electronic submission of certifications under this subsection.[<-Struck out]
[Struck out->]
‘(5) FALSE STATEMENTS- Any statement or representation made by an entity described in paragraph (2) to the Secretary shall be subject tosection 1001 of title 18, United States Code [<-Struck out]
[Struck out->](c) Conforming Technical Amendment- Section 801(b) (21 U.S.C. 381(b) [<-Struck out]
[Struck out->](d) No Limit on Authority- Nothing in the amendments made by this section shall limit the authority of the Secretary to conduct random inspections of imported food or to take such other steps as the Secretary deems appropriate to determine the admissibility of imported food.[<-Struck out]
[Struck out->]SEC. 304. PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS.[<-Struck out][Struck out->](a) In General- Section 801(m)(1) (21 U.S.C. 381(m)(1) [<-Struck out]
[Struck out->](b) Regulations- Not later than 120 days after the date of enactment of this Act, the Secretary shall issue an interim final rule amending subpart I of part 1 of title 21, Code of Federal Regulations, to implement the amendment made by this section.[<-Struck out]
[Struck out->](c) Effective Date- The amendment made by this section shall take effect 180 days after the date of enactment of this Act.[<-Struck out]
[Struck out->]SEC. 305. REVIEW OF A REGULATORY AUTHORITY OF A FOREIGN COUNTRY.[<-Struck out][Struck out->]Chapter VIII (21 U.S.C. 381 [<-Struck out]
[Struck out->]‘SEC. 807. REVIEW OF A REGULATORY AUTHORITY OF A FOREIGN COUNTRY.[<-Struck out]
[Struck out->]
‘The Secretary may review information from a country outlining the statutes, regulations, standards, and controls of such country, and conduct on-site audits in such country to verify the implementation of those statutes, regulations, standards, and controls. Based on such review, the Secretary shall determine whether such country can provide reasonable assurances that the food supply of the country is equivalent in safety to food manufactured, processed, packed, or held in the United States.’.[<-Struck out]
[Struck out->]SEC. 306. BUILDING CAPACITY OF FOREIGN GOVERNMENTS WITH RESPECT TO FOOD.[<-Struck out][Struck out->](a) In General- The Secretary shall, not later than 2 years of the date of enactment of this Act, develop a comprehensive plan to expand the technical, scientific, and regulatory capacity of foreign governments, and their respective food industries, from which foods are exported to the United States.[<-Struck out]
[Struck out->](b) Consultation- In developing the plan under subsection (a), the Secretary shall consult with the Secretary of Agriculture, Secretary of State, Secretary of the Treasury, and the Secretary of Commerce, representatives of the food industry, appropriate foreign government officials, and nongovernmental organizations that represent the interests of consumers, and other stakeholders.[<-Struck out]
[Struck out->](c) Plan- The plan developed under subsection (a) shall include, as appropriate, the following:[<-Struck out]
[Struck out->](1) Recommendations for bilateral and multilateral arrangements and agreements, including provisions to provide for responsibility of exporting countries to ensure the safety of food.[<-Struck out]
[Struck out->](2) Provisions for electronic data sharing.[<-Struck out]
[Struck out->](3) Provisions for mutual recognition of inspection reports.[<-Struck out]
[Struck out->](4) Training of foreign governments and food producers on United States requirements for safe food.[<-Struck out]
[Struck out->](5) Recommendations to harmonize requirements under the Codex Alimentarius.[<-Struck out]
[Struck out->](6) Provisions for the multilateral acceptance of laboratory methods and detection techniques.[<-Struck out]
[Struck out->]SEC. 307. INSPECTION OF FOREIGN FOOD FACILITIES.[<-Struck out][Struck out->]Chapter VIII (21 U.S.C. 381 [<-Struck out]
[Struck out->]‘SEC. 808. INSPECTION OF FOREIGN FOOD FACILITIES.[<-Struck out]
[Struck out->]
‘(a) Inspection- The Secretary--[<-Struck out]
[Struck out->]
‘(1) may enter into arrangements and agreements with foreign governments to facilitate the inspection of foreign facilities registered under section 415; and[<-Struck out]
[Struck out->]
‘(2) shall direct resources to inspections of foreign facilities, suppliers, and food types, especially such facilities, suppliers, and food types that present a high risk (as identified by the Secretary), to help ensure the safety and security of the food supply of the United States.[<-Struck out]
[Struck out->]
‘(b) Effect of Inability To Inspect- Notwithstanding any other provision of law, food shall be refused admission into the United States if it is from a foreign facility registered under section 415 of which the owner, operator, or agent in charge of the facility, or the government of the foreign country, refuses to permit entry of United States inspectors, upon request, to inspect such facility. For purposes of this subsection, such an owner, operator, or agent in charge shall be considered to have refused an inspection if such owner, operator, or agent in charge refuses such a request to inspect a facility more than 48 hours after such request is submitted.’.[<-Struck out]
[Struck out->]SEC. 308. ACCREDITATION OF THIRD-PARTY AUDITORS AND AUDIT AGENTS.[<-Struck out][Struck out->]Chapter VIII (21 U.S.C. 381 [<-Struck out]
[Struck out->]‘SEC. 809. ACCREDITATION OF THIRD-PARTY AUDITORS AND AUDIT AGENTS.[<-Struck out]
[Struck out->]
‘(a) Definitions- In this section:[<-Struck out]
[Struck out->]
‘(1) ACCREDITED AUDIT AGENT- The term ‘accredited audit agent’ means an audit agent accredited by an accreditation body under this section.[<-Struck out]
[Struck out->]
‘(2) AUDIT AGENT- The term ‘audit agent’ means an individual who is qualified to conduct food safety audits, and who may be an employee or an agent of a third-party auditor.[<-Struck out]
[Struck out->]
‘(3) ACCREDITATION BODY- The term ‘accreditation body’ means a recognized authority that performs accreditation of third-party auditors and audit agents.[<-Struck out]
[Struck out->]
‘(4) ACCREDITED THIRD-PARTY AUDITOR- The term ‘accredited third-party auditor’ means a third-party auditor accredited by an accreditation body under this section.[<-Struck out]
[Struck out->]
‘(5) CONSULTATIVE AUDIT- The term ‘consultative audit’ means an audit of an eligible entity--[<-Struck out]
[Struck out->]
‘(A) to determine whether such entity is in compliance with the provisions of this Act and with applicable industry standards and practices; and[<-Struck out]
[Struck out->]
‘(B) the results of which are for internal facility purposes only.[<-Struck out]
[Struck out->]
‘(6) ELIGIBLE ENTITY- The term ‘eligible entity’ means a foreign entity, including foreign facilities registered under section 415, in the food import supply chain that chooses to be audited by an accredited third-party auditor or audit agent.[<-Struck out]
[Struck out->]
‘(7) REGULATORY AUDIT- The term ‘regulatory audit’ means an audit of an eligible entity--[<-Struck out]
[Struck out->]
‘(A) to determine whether such entity is in compliance with the provisions of this Act; and[<-Struck out]
[Struck out->]
‘(B) the results of which determine--[<-Struck out]
[Struck out->]
‘(i) whether an entity is eligible to receive a certification under section 801(p); and[<-Struck out]
[Struck out->]
‘(ii) whether the entity is eligible to participate in the voluntary qualified importer program under section 806.[<-Struck out]
[Struck out->]
‘(8) THIRD-PARTY AUDITOR- The term ‘third-party auditor’ means a foreign government, foreign cooperative, or any other qualified third party, as the Secretary determines appropriate, that conducts audits of eligible entities to certify that such eligible entities meet the applicable requirements of this section.[<-Struck out]
[Struck out->]
‘(b) Accreditation System-[<-Struck out]
[Struck out->]
‘(1) ACCREDITATION BODIES-[<-Struck out]
[Struck out->]
‘(A) RECOGNITION OF ACCREDITATION BODIES- Beginning not later than 2 years after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall establish a system for the recognition of accreditation bodies that accredit third-party auditors and audit agents to certify that eligible entities meet the applicable requirements of this Act.[<-Struck out]
[Struck out->]
‘(B) NOTIFICATION- Each accreditation body recognized by the Secretary shall submit to the Secretary a list of all accredited third-party auditors and audit agents accredited by such body.[<-Struck out]
[Struck out->]
‘(C) REVOCATION OF RECOGNITION AS AN ACCREDITATION BODY- The Secretary shall promptly revoke the recognition of any accreditation body found not to be in compliance with the requirements of this section.[<-Struck out]
[Struck out->]
‘(2) MODEL ACCREDITATION STANDARDS- The Secretary shall develop model standards, including audit report requirements, and each recognized accreditation body shall ensure that third-party auditors and audit agents meet such standards in order to qualify as an accredited third-party auditor or audit agent under this section. In developing the model standards, the Secretary shall look to standards in place on the date of the enactment of this section for guidance, to avoid unnecessary duplication of efforts and costs.[<-Struck out]
[Struck out->]
‘(c) Third-party Auditors and Audit Agencies-[<-Struck out]
[Struck out->]
‘(1) REQUIREMENTS FOR ACCREDITATION AS A THIRD-PARTY AUDITOR OR AUDIT AGENT-[<-Struck out]
[Struck out->]
‘(A) FOREIGN GOVERNMENTS- Prior to accrediting a foreign government as an accredited third-party auditor, the accreditation body shall perform such reviews and audits of food safety programs, systems, and standards of the government as the Secretary deems necessary to determine that the foreign government is capable of adequately ensuring that eligible entities certified by such government meet the requirements of this Act with respect to food manufactured, processed, packed, or held for import to the United States.[<-Struck out]
[Struck out->]
‘(B) FOREIGN COOPERATIVES AND OTHER THIRD PARTIES- Prior to accrediting a foreign cooperative that aggregates the products of growers or processors, or any other third party that the Secretary determines appropriate to be an accredited third-party auditor or audit agent, the accreditation body shall perform such reviews and audits of the training and qualifications of auditors used by that cooperative or party and conduct such reviews of internal systems and such other investigation of the cooperative or party as the Secretary deems necessary to determine that each eligible entity certified by the cooperative or party has systems and standards in use to ensure that such entity meets the requirements of this Act.[<-Struck out]
[Struck out->]
‘(2) REQUIREMENT TO ISSUE CERTIFICATION OF ELIGIBLE ENTITIES-[<-Struck out]
[Struck out->]
‘(A) IN GENERAL- An accreditation body may not accredit a third-party auditor or audit agent unless such third-party auditor or audit agent agrees to issue a written and electronic certification to accompany each food shipment for import into the United States from an eligible entity certified by the third-party auditor or audit agent, subject to requirements set forth by the Secretary. The Secretary shall consider such certificates when targeting inspection resources under section 421.[<-Struck out]
[Struck out->]
‘(B) PURPOSE OF CERTIFICATION- The Secretary shall use evidence of certification provided by accredited third-party auditors and audit agents--[<-Struck out]
[Struck out->]
‘(i) to determined the eligibility of an importer to receive a certification under section 801(p); and[<-Struck out]
[Struck out->]
‘(ii) determine the eligibility of an importer to participate in the voluntary qualified importer program under section 806.[<-Struck out]
[Struck out->]
‘(3) AUDIT REPORT REQUIREMENTS-[<-Struck out]
[Struck out->]
‘(A) REQUIREMENTS IN GENERAL- As a condition of accreditation, an accredited third-party auditor or audit agent shall prepare the audit report for an audit, in a form and manner designated by the Secretary, which shall include--[<-Struck out]
[Struck out->]
‘(i) the identity of the persons at the audited eligible entity responsible for compliance with food safety requirements;[<-Struck out]
[Struck out->]
‘(ii) the dates of the audit;[<-Struck out]
[Struck out->]
‘(iii) the scope of the audit; and[<-Struck out]
[Struck out->]
‘(iv) any other info required by the Secretary that relate to or may influence an assessment of compliance with this Act.[<-Struck out]
[Struck out->]
‘(B) SUBMISSION OF REPORTS TO THE SECRETARY-[<-Struck out]
[Struck out->]
‘(i) IN GENERAL- Following any accreditation of a third-party auditor or audit agent, the Secretary may, at any time, require the accredited third-party auditor or audit agent to submit to the Secretary an onsite audit report and such other reports or documents required as part of the audit process, for any eligible entity certified by the third-party auditor or audit agent. Such report may include documentation that the eligible entity is in compliance with any applicable registration requirements.[<-Struck out]
[Struck out->]
‘(ii) LIMITATION- The requirement under clause (i) shall not include any report or other documents resulting from a consultative audit by the accredited third-party auditor or audit agent, except that the Secretary may access the results of a consultative audit in accordance with section 414.[<-Struck out]
[Struck out->]
‘(4) REQUIREMENTS OF AUDIT AGENTS-[<-Struck out]
[Struck out->]
‘(A) RISKS TO PUBLIC HEALTH- If, at any time during an audit, an accredited audit agent discovers a condition that could cause or contribute to a serious risk to the public health, the audit agent shall immediately notify the Secretary of--[<-Struck out]
[Struck out->]
‘(i) the identification of the eligible entity subject to the audit; and[<-Struck out]
[Struck out->]
‘(ii) such condition.[<-Struck out]
[Struck out->]
‘(B) TYPES OF AUDITS- An accredited audit agent may perform consultative and regulatory audits of eligible entities.[<-Struck out]
[Struck out->]
‘(C) LIMITATIONS- An accredited audit agent may not perform a regulatory audit of an eligible entity if such agent has performed a consultative audit or a regulatory audit of such eligible entity during the previous 24-month period.[<-Struck out]
[Struck out->]
‘(5) CONFLICTS OF INTEREST-[<-Struck out]
[Struck out->]
‘(A) THIRD-PARTY AUDITORS- An accredited third-party auditor shall--[<-Struck out]
[Struck out->]
‘(i) not be owned, managed, or controlled by any person that owns or operates an eligible entity to be certified by such auditor;[<-Struck out]
[Struck out->]
‘(ii) in carrying out audits of eligible entities under this section, have procedures to ensure against the use of any officer or employee of such auditor that has a financial conflict of interest regarding an eligible entity to be certified by such auditor; and[<-Struck out]
[Struck out->]
‘(iii) annually make available to the Secretary disclosures of the extent to which such auditor and the officers and employees of such auditor have maintained compliance with clauses (i) and (ii) relating to financial conflicts of interest.[<-Struck out]
[Struck out->]
‘(B) AUDIT AGENTS- An accredited audit agent shall--[<-Struck out]
[Struck out->]
‘(i) not own or operate an eligible entity to be certified by such agent;[<-Struck out]
[Struck out->]
‘(ii) in carrying out audits of eligible entities under this section, have procedures to ensure that such agent does not have a financial conflict of interest regarding an eligible entity to be certified by such agent; and[<-Struck out]
[Struck out->]
‘(iii) annually make available to the Secretary disclosures of the extent to which such agent has maintained compliance with clauses (i) and (ii) relating to financial conflicts of interest.[<-Struck out]
[Struck out->]
‘(C) REGULATIONS- The Secretary shall promulgate regulations not later than 18 months after the date of enactment of the FDA Food Safety Modernization Act to ensure that there are protections against conflicts of interest between an accredited third-party auditor or audit agent and the eligible entity to be certified by such auditor or audit agent. Such regulations shall include--[<-Struck out]
[Struck out->]
‘(i) requiring that audits performed under this section be unannounced;[<-Struck out]
[Struck out->]
‘(ii) a structure, including timing and public disclosure, for fees paid by eligible entities to accredited third-party auditors or audit agents to decrease the potential for conflicts of interest; and[<-Struck out]
[Struck out->]
‘(iii) appropriate limits on financial affiliations between an accredited third-party auditor or audit agent and any person that owns or operates an eligible entity to be certified by such auditor or audit agent.[<-Struck out]
[Struck out->]
‘(6) WITHDRAWAL OF ACCREDITATION- The Secretary shall withdraw accreditation from an accredited third-party auditor or audit agent--[<-Struck out]
[Struck out->]
‘(A) if food from an eligible entity certified by such third-party auditor or audit agent is linked to an outbreak of human or animal illness;[<-Struck out]
[Struck out->]
‘(B) following a performance audit and finding by the Secretary that the third-party auditor or audit agent no longer meets the requirements for accreditation; or[<-Struck out]
[Struck out->]
‘(C) following a refusal to allow United States officials to conduct such audits and investigations as may be necessary to ensure continued compliance with the requirements set forth in this section.[<-Struck out]
[Struck out->]
‘(7) NEUTRALIZING COSTS- The Secretary shall establish a method, similar to the method used by the Department of Agriculture, by which accredited third-party auditors and audit agents reimburse the Food and Drug Administration for the work performed to establish and administer the accreditation system under this section. The Secretary shall make operating this program revenue-neutral and shall not generate surplus revenue from such a reimbursement mechanism.[<-Struck out]
[Struck out->]
‘(d) Recertification of Eligible Entities- An eligible entity shall apply for annual recertification by an accredited third-party auditor or audit agent if such entity--[<-Struck out]
[Struck out->]
‘(1) intends to participate in voluntary qualified importer program under section 806; or[<-Struck out]
[Struck out->]
‘(2) must provide to the Secretary a certification under section 801(p) for any food from such entity.[<-Struck out]
[Struck out->]
‘(e) False Statements- Any statement or representation made--[<-Struck out]
[Struck out->]
‘(1) by an employee or agent of an eligible entity to an accredited third-party auditor or audit agent; or[<-Struck out]
[Struck out->]
‘(2) by an accredited third-party auditor or an audit agent to the Secretary,[<-Struck out]
[Struck out->]shall be subject tosection 1001 of title 18, United States Code [<-Struck out]
[Struck out->]
‘(f) Monitoring- To ensure compliance with the requirements of this section, the Secretary shall--[<-Struck out]
[Struck out->]
‘(1) periodically, or at least once every 4 years, reevaluate the accreditation bodies described in subsection (b)(1);[<-Struck out]
[Struck out->]
‘(2) periodically, or at least once every 4 years, audit the performance of each accredited third-party auditor and audit agent, through the review of audit reports by such auditors and audit agents, the compliance history as available of eligible entities certified by such auditors and audit agents, and any other measures deemed necessary by the Secretary;[<-Struck out]
[Struck out->]
‘(3) at any time, conduct an onsite audit of any eligible entity certified by an accredited third-party auditor or audit agent, with or without the auditor or audit agent present; and[<-Struck out]
[Struck out->]
‘(4) take any other measures deemed necessary by the Secretary.[<-Struck out]
[Struck out->]
‘(g) Publicly Available Registry- The Secretary shall establish a publicly available registry of accreditation bodies and of accredited third-party auditors and audit agents, including the name of, contact information for, and other information deemed necessary by the Secretary about such bodies, auditors, and agents.[<-Struck out]
[Struck out->]
‘(h) Limitations-[<-Struck out]
[Struck out->]
‘(1) NO EFFECT ON SECTION 704 INSPECTIONS- The audits performed under this section shall not be considered inspections under section 704.[<-Struck out]
[Struck out->]
‘(2) NO EFFECT ON INSPECTION AUTHORITY- Nothing in this section affects the authority of the Secretary to inspect any eligible entity pursuant to this Act.’.[<-Struck out]
[Struck out->]SEC. 309. FOREIGN OFFICES OF THE FOOD AND DRUG ADMINISTRATION.[<-Struck out][Struck out->](a) In General- The Secretary shall by October 1, 2010, establish an office of the Food and Drug Administration in not less than 5 foreign countries selected by the Secretary, to provide assistance to the appropriate governmental entities of such countries with respect to measures to provide for the safety of articles of food and other products regulated by the Food and Drug Administration exported by such country to the United States, including by directly conducting risk-based inspections of such articles and supporting such inspections by such governmental entity.[<-Struck out]
[Struck out->](b) Consultation- In establishing the foreign offices described in subsection (a), the Secretary shall consult with the Secretary of State and the United States Trade Representative.[<-Struck out]
[Struck out->](c) Report- Not later than October 1, 2011, the Secretary shall submit to Congress a report on the basis for the selection by the Secretary of the foreign countries in which the Secretary established offices under subsection (a), the progress which such offices have made with respect to assisting the governments of such countries in providing for the safety of articles of food and other products regulated by the Food and Drug Administration exported to the United States, and the plans of the Secretary for establishing additional foreign offices of the Food and Drug Administration, as appropriate.[<-Struck out]
[Struck out->]
TITLE IV--MISCELLANEOUS PROVISIONS[<-Struck out]
SEC. 401. FUNDING FOR FOOD SAFETY.[<-Struck out][Struck out->](a) In General- There are authorized to be appropriated to carry out the activities of the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, and related field activities in the Office of Regulatory Affairs of the Food and Drug Administration--[<-Struck out]
[Struck out->](1) $825,000,000 for fiscal year 2010; and[<-Struck out]
[Struck out->](2) such sums as may be necessary for fiscal years 2011 through 2014.[<-Struck out]
[Struck out->](b) Increased Number of Field Staff- To carry out the activities of the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, and related field activities of the Office of Regulatory Affairs of the Food and Drug Administration, the Secretary of Health and Human Services shall increase the field staff of such Centers and Office with a goal of not fewer than--[<-Struck out]
[Struck out->](1) 3,800 staff members in fiscal year 2010;[<-Struck out]
[Struck out->](2) 4,000 staff members in fiscal year 2011;[<-Struck out]
[Struck out->](3) 4,200 staff members in fiscal year 2012;[<-Struck out]
[Struck out->](4) 4,600 staff members in fiscal year 2013; and[<-Struck out]
[Struck out->](5) 5,000 staff members in fiscal year 2014.[<-Struck out]
[Struck out->]SEC. 402. JURISDICTION; AUTHORITIES.[<-Struck out][Struck out->]Nothing in this Act, or an amendment made by this Act, shall be construed to--[<-Struck out]
[Struck out->](1) alter the jurisdiction between the Secretary of Agriculture and the Secretary of Health and Human Services, under applicable statutes and regulations;[<-Struck out]
[Struck out->](2) limit the authority of the Secretary of Health and Human Services to issue regulations related to the safety of food under--[<-Struck out]
[Struck out->](A) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 [<-Struck out]
[Struck out->](B) the Public Health Service Act (42 U.S.C. 301 [<-Struck out]
[Struck out->](3) impede, minimize, or affect the authority of the Secretary of Agriculture to prevent, control, or mitigate a plant or animal health emergency, or a food emergency involving products regulated under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act.[<-Struck out]
SECTION 1. SHORT TITLE; REFERENCES; TABLE OF CONTENTS.
(a) Short Title- This Act may be cited as the ‘FDA Food Safety Modernization Act’.[<-Struck out](b) References- Except as otherwise specified, whenever in this Act an amendment is expressed in terms of an amendment to a section or other provision, the reference shall be considered to be made to a section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 [<-Struck out](c) Table of Contents- The table of contents for this Act is as follows:[<-Struck out]Sec. 1. Short title; references; table of contents.[<-Struck out]Sec. 101. Inspections of records.[<-Struck out]Sec. 102. Registration of food facilities.[<-Struck out]Sec. 103. Hazard analysis and risk-based preventive controls.[<-Struck out]Sec. 104. Performance standards.[<-Struck out]Sec. 105. Standards for produce safety.[<-Struck out]Sec. 106. Protection against intentional adulteration.[<-Struck out]Sec. 107. Authority to collect fees.[<-Struck out]Sec. 108. National agriculture and food defense strategy.[<-Struck out]Sec. 109. Food and Agriculture Coordinating Councils.[<-Struck out]Sec. 110. Building domestic capacity.[<-Struck out]Sec. 111. Final rule for prevention of Salmonella Enteritidis in shell eggs during production.[<-Struck out]Sec. 112. Sanitary transportation of food.[<-Struck out]Sec. 113. Food allergy and anaphylaxis management.[<-Struck out]Sec. 201. Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report.[<-Struck out]Sec. 202. Recognition of laboratory accreditation for analyses of foods.[<-Struck out]Sec. 203. Integrated consortium of laboratory networks.[<-Struck out]Sec. 204. Enhancing traceback and recordkeeping.[<-Struck out]Sec. 205. Surveillance.[<-Struck out]Sec. 206. Mandatory recall authority.[<-Struck out]Sec. 207. Administrative detention of food.[<-Struck out]Sec. 208. Decontamination and disposal standards and plans.[<-Struck out]Sec. 301. Foreign supplier verification program.[<-Struck out]Sec. 302. Voluntary qualified importer program.[<-Struck out]Sec. 303. Authority to require import certifications for food.[<-Struck out]Sec. 304. Prior notice of imported food shipments.[<-Struck out]Sec. 305. Review of a regulatory authority of a foreign country.[<-Struck out]Sec. 306. Building capacity of foreign governments with respect to food.[<-Struck out]Sec. 307. Inspection of foreign food facilities.[<-Struck out]Sec. 308. Accreditation of qualified third-party auditors and audit agents.[<-Struck out]Sec. 309. Foreign offices of the Food and Drug Administration.[<-Struck out]Sec. 401. Funding for food safety.[<-Struck out]Sec. 402. Jurisdiction; authorities.[<-Struck out][Struck out->]
TITLE I--IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS[<-Struck out]
(a) In General- Section 414(a) (21 U.S.C. 350c(a) [<-Struck out](1) by striking the heading and all follows through ‘of food is’ and inserting the following: ‘Records Inspection-[<-Struck out]‘(1) ADULTERATED FOOD- If the Secretary has a reasonable belief that an article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, is’;[<-Struck out]
(2) by inserting ‘, and to any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner,’ after ‘relating to such article’;[<-Struck out](3) by striking the last sentence; and[<-Struck out](4) by inserting at the end the following:[<-Struck out]‘(2) USE OF OR EXPOSURE TO FOOD OF CONCERN- If the Secretary believes that there is a reasonable probability that the use of or exposure to an article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals, each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports such article shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such person, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to such article and to any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, that are needed to assist the Secretary in determining whether there is a reasonable probability that the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals.[<-Struck out]
‘(3) APPLICATION- The requirement under paragraphs (1) and (2) applies to all records relating to the manufacture, processing, packing, distribution, receipt, holding, or importation of such article maintained by or on behalf of such person in any format (including paper and electronic formats) and at any location.’.[<-Struck out](b) Conforming Amendment- Section 704(a)(1)(B) (21 U.S.C. 374(a)(1)(B) [<-Struck out](a) Updating of Food Category Regulations; Biennial Registration Renewal- Section 415(a) (21 U.S.C. 350d(a) [<-Struck out](1) in paragraph (2), by--[<-Struck out](A) striking ‘conducts business and’ and inserting ‘conducts business, the e-mail address for the contact person of the facility or, in the case of a foreign facility, the United States agent for the facility, and’; and[<-Struck out](B) inserting ‘, or any other food categories as determined appropriate by the Secretary, including by guidance)’ after ‘Code of Federal Regulations’;[<-Struck out](2) by redesignating paragraphs (3) and (4) as paragraphs (4) and (5), respectively; and[<-Struck out](3) by inserting after paragraph (2) the following:[<-Struck out]‘(3) BIENNIAL REGISTRATION RENEWAL- During the period beginning on October 1 and ending on December 31 of each even-numbered year, a registrant that has submitted a registration under paragraph (1) shall submit to the Secretary a renewal registration containing the information described in paragraph (2). The Secretary shall provide for an abbreviated registration renewal process for any registrant that has not had any changes to such information since the registrant submitted the preceding registration or registration renewal for the facility involved.’.[<-Struck out](b) Suspension of Registration-[<-Struck out](1) IN GENERAL- Section 415 (21 U.S.C. 350d [<-Struck out](A) in subsection (a)(2), by inserting after the first sentence the following: ‘The registration shall contain an assurance that the Secretary will be permitted to inspect such facility at the times and in the manner permitted by this Act.’;[<-Struck out](B) by redesignating subsections (b) and (c) as subsections (c) and (d), respectively; and[<-Struck out](C) by inserting after subsection (a) the following:[<-Struck out]‘(b) Suspension of Registration-[<-Struck out]
‘(1) IN GENERAL- If the Secretary determines that food manufactured, processed, packed, or held by a facility registered under this section has a reasonable probability of causing serious adverse health consequences or death to humans or animals, the Secretary may by order suspend the registration of the facility under this section in accordance with this subsection.[<-Struck out]
‘(2) HEARING ON SUSPENSION- The Secretary shall provide the registrant subject to an order under paragraph (1) with an opportunity for an informal hearing, to be held as soon as possible but not later than 2 days after the issuance of the order, on the actions required for reinstatement of registration and why the registration that is subject to suspension should be reinstated. The Secretary shall reinstate a registration if the Secretary determines, based on evidence presented, that adequate grounds do not exist to continue the suspension of the registration.[<-Struck out]
‘(3) POST-HEARING CORRECTIVE ACTION PLAN; VACATING OF ORDER-[<-Struck out]
‘(A) CORRECTIVE ACTION PLAN- If, after providing opportunity for an informal hearing under paragraph (2), the Secretary determines that the suspension of registration remains necessary, the Secretary shall require the registrant to submit a corrective action plan to demonstrate how the registrant plans to correct the conditions found by the Secretary. The Secretary shall review such plan in a timely manner.[<-Struck out]
‘(B) VACATING OF ORDER- Upon a determination by the Secretary that adequate grounds do not exist to continue the suspension actions required by the order, or that such actions should be modified, the Secretary shall vacate the order or modify the order.[<-Struck out]‘(4) EFFECT OF SUSPENSION- If the registration of a facility is suspended under this subsection, such facility shall not import food or offer to import food into the United States, or otherwise introduce food into interstate commerce in the United States.[<-Struck out]
‘(5) REGULATIONS- The Secretary shall promulgate regulations that describe the standards officials will use in making a determination to suspend a registration, and the format such officials will use to explain to the registrant the conditions found at the facility.[<-Struck out]
‘(6) NO DELEGATION- The authority conferred by this subsection to issue an order to suspend a registration or vacate an order of suspension shall not be delegated to any officer or employee other than the Commissioner.’.[<-Struck out]
(2) IMPORTED FOOD- Section 801(l) (21 U.S.C. 381(l) [<-Struck out](c) Conforming Amendments-[<-Struck out](1) Section 301(d) (21 U.S.C. 331(d) [<-Struck out](2) Section 415(d), as redesignated by subsection (b), is amended by adding at the end before the period ‘for a facility to be registered, except with respect to the reinstatement of a registration that is suspended under subsection (b)’.[<-Struck out](a) In General- Chapter IV (21 U.S.C. 341 [<-Struck out]‘SEC. 418. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS.[<-Struck out]‘(a) In General- Each owner, operator, or agent in charge of a facility shall, in accordance with this section, evaluate the hazards that could affect food manufactured, processed, packed, or held by such facility, identify and implement preventive controls to significantly minimize or prevent their occurrence and provide assurances that such food is not adulterated under section 402 or misbranded under section 403(w), monitor the performance of those controls, and maintain records of this monitoring as a matter of routine practice.[<-Struck out]
‘(b) Hazard Analysis- The owner, operator, or agent in charge of a facility shall--[<-Struck out]
‘(1) identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility, including--[<-Struck out]
‘(A) biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives; and[<-Struck out]
‘(B) hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced, including by acts of terrorism; and[<-Struck out]‘(2) develop a written analysis of the hazards.[<-Struck out]‘(c) Preventive Controls- The owner, operator, or agent in charge of a facility shall identify and implement preventive controls, including at critical control points, if any, to provide assurances that--[<-Struck out]
‘(1) hazards identified in the hazard analysis conducted under subsection (b) will be significantly minimized or prevented; and[<-Struck out]
‘(2) the food manufactured, processed, packed, or held by such facility will not be adulterated under section 402 or misbranded under section 403(w).[<-Struck out]‘(d) Monitoring of Effectiveness- The owner, operator, or agent in charge of a facility shall monitor the effectiveness of the preventive controls implemented under subsection (c) to provide assurances that the outcomes described in subsection (c) shall be achieved.[<-Struck out]
‘(e) Corrective Actions- The owner, operator, or agent in charge of a facility shall establish procedures that a facility will implement if the preventive controls implemented under subsection (c) are found to be ineffective through monitoring under subsection (d).[<-Struck out]
‘(f) Verification- The owner, operator, or agent in charge of a facility shall verify that--[<-Struck out]
‘(1) the preventive controls implemented under subsection (c) are adequate to control the hazards identified under subsection (b);[<-Struck out]
‘(2) the owner, operator, or agent is conducting monitoring in accordance with subsection (d);[<-Struck out]
‘(3) the owner, operator, or agent is making appropriate decisions about corrective actions taken under subsection (e); and[<-Struck out]
‘(4) there is documented, periodic reanalysis of the plan under subsection (i) to ensure that the plan is still relevant to the raw materials, as well as to conditions and processes in the facility, and to new and emerging threats.[<-Struck out]‘(g) Recordkeeping- The owner, operator, or agent in charge of a facility shall maintain, for not less than 2 years, records documenting the monitoring of the preventive controls implemented under subsection (c), instances of nonconformance material to food safety, instances when corrective actions were implemented, and the efficacy of preventive controls and corrective actions.[<-Struck out]
‘(h) Written Plan and Documentation- Each owner, operator, or agent in charge of a facility shall prepare a written plan that documents and describes the procedures used by the facility to comply with the requirements of this section, including analyzing the hazards under subsection (b) and identifying the preventive controls adopted to address those hazards under subsection (c). Such written plan, together with documentation that the plan is being implemented, shall be made promptly available to a duly authorized representative of the Secretary upon oral or written request.[<-Struck out]
‘(i) Requirement To Reanalyze- Each owner, operator, or agent in charge of a facility shall conduct a reanalysis under subsection (b) whenever a significant change is made in the activities conducted at a facility operated by such owner, operator, or agent if the change creates a reasonable potential for a new hazard or a significant increase in a previously identified hazard or not less frequently than once every 3 years, whichever is earlier. Such reanalysis shall be completed and additional preventive controls needed to address the hazard identified, if any, shall be implemented before the change in activities at the facility is commenced. Such owner, operator, or agent shall revise the written plan required under subsection (h) if such a significant change is made or document the basis for the conclusion that no additional or revised preventive controls are needed. The Secretary may require a reanalysis under this section to respond to new hazards and developments in scientific understanding.[<-Struck out]
‘(j) Deemed Compliance of Seafood, Juice, and Low-acid Canned Food Facilities in Compliance With HACCP- An owner, operator, or agent in charge of a facility required to comply with 1 of the following standards and regulations with respect to such facility shall be deemed to be in compliance with this section, with respect to such facility:[<-Struck out]
‘(1) The Seafood Hazard Analysis Critical Control Points Program of the Food and Drug Administration.[<-Struck out]
‘(2) The Juice Hazard Analysis Critical Control Points Program of the Food and Drug Administration.[<-Struck out]
‘(3) The Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards of the Food and Drug Administration (or any successor standards).[<-Struck out]‘(k) Exception for Facilities in Compliance With Section 419- This section shall not apply to a facility that is subject to section 419.[<-Struck out]
‘(l) Authority With Respect to Certain Facilities- The Secretary may, by regulation, exempt or modify the requirements for compliance under this section with respect to facilities that are solely engaged in the production of food for animals other than man or the storage of packaged foods that are not exposed to the environment.[<-Struck out]
‘(m) Definitions- For purposes of this section:[<-Struck out]
‘(1) CRITICAL CONTROL POINT- The term ‘critical control point’ means a point, step, or procedure in a food process at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.[<-Struck out]
‘(2) FACILITY- The term ‘facility’ means a domestic facility or a foreign facility that is required to register under section 415.[<-Struck out]
‘(3) PREVENTIVE CONTROLS- The term ‘preventive controls’ means those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would have employed to significantly minimize or prevent the hazards identified under the hazard analysis conducted under subsection (a) and that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis. Those procedures, practices, and processes may include the following:[<-Struck out]
‘(A) Sanitation procedures for food contact surfaces and utensils and food-contact surfaces of equipment.[<-Struck out]
‘(B) Supervisor, manager, and employee hygiene training.[<-Struck out]
‘(C) An environmental monitoring program to verify the effectiveness of pathogen controls.[<-Struck out]
‘(D) An allergen control program.[<-Struck out]
‘(E) A recall contingency plan.[<-Struck out]
‘(F) Good Manufacturing Practices (GMPs).[<-Struck out]
‘(G) Supplier verification activities.’.[<-Struck out](b) Regulations-[<-Struck out](1) IN GENERAL- The Secretary of Health and Human Services (referred to in this Act as the ‘Secretary’) shall promulgate regulations to establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of the preventive controls under section 418 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)).[<-Struck out](2) CONTENT- The regulations promulgated under paragraph (1) shall provide sufficient flexibility to be applicable in all situations, including in the operations of small businesses.[<-Struck out](3) RULE OF CONSTRUCTION- Nothing in this subsection shall be construed to provide the Secretary with the authority to apply specific technologies, practices, or critical controls to an individual facility.[<-Struck out](4) REVIEW- In promulgating the regulations under paragraph (1), the Secretary shall review regulatory hazard analysis and preventive control programs in existence on the date of enactment of this Act to ensure that the program under such section 418 is consistent, to the extent practicable, with applicable internationally recognized standards in existence on such date.[<-Struck out](c) Guidance Document- The Secretary shall issue a guidance document related to hazard analysis and preventive controls required under section 418 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)).[<-Struck out](d) Prohibited Acts- Section 301 (21 U.S.C. 331 [<-Struck out]‘(oo) The operation of a facility that manufacturers, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is not in compliance with section 418.’.[<-Struck out]
(e) No Effect on HACCP Authorities- Nothing in the amendments made by this section limits the authority of the Secretary under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 42 U.S.C. 201 [<-Struck out](f) Effective Date-[<-Struck out](1) GENERAL RULE- The amendments made by this section shall take effect 18 months after the date of enactment of this Act.[<-Struck out](2) EXCEPTIONS- Notwithstanding paragraph (1)--[<-Struck out](A) the amendments made by this section shall apply to a small business (as defined by the Secretary) after the date that is 2 years after the date of enactment of this Act; and[<-Struck out](B) the amendments made by this section shall apply to a very small business (as defined by the Secretary) after the date that is 3 years after the date of enactment of this Act.[<-Struck out]The Secretary shall, not less frequently than every 2 years, review and evaluate relevant health data and other relevant information, including from toxicological and epidemiological studies and analyses, to determine the most significant food-borne contaminants and, when appropriate to reduce the risk of serious illness or death to humans or animals or to prevent the adulteration of the food under section 402 of the Federal Food, Drug, or Cosmetic Act, (21 U.S.C. 342 42 U.S.C. 264 [<-Struck out](a) In General- Chapter IV (21 U.S.C. 341 [<-Struck out]‘SEC. 419. STANDARDS FOR PRODUCE SAFETY.[<-Struck out]‘(a) Proposed Rulemaking-[<-Struck out]
‘(1) IN GENERAL- Not later than 1 year after the date of enactment of the FDA Food Safety Modernization Act, the Secretary, in consultation with the Secretary of Agriculture and representatives of State departments of agriculture, shall publish a notice of proposed rulemaking to establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death.[<-Struck out]
‘(2) PUBLIC INPUT- During the comment period on the notice of proposed rulemaking under paragraph (1), the Secretary shall conduct not less than 3 public meetings in diverse geographical areas of the United States to provide persons in different regions an opportunity to comment.[<-Struck out]
‘(3) CONTENT- The proposed rulemaking under paragraph (1) shall--[<-Struck out]
‘(A) include, with respect to growing, harvesting, sorting, and storage operations, minimum standards related to soil amendments, hygiene, packaging, temperature controls, animal encroachment, and water; and[<-Struck out]
‘(B) consider hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced, including by acts of terrorism.[<-Struck out]‘(4) PRIORITIZATION- The Secretary shall prioritize the implementation of the regulations for specific fruits and vegetables that are raw agricultural commodities that have been associated with food-borne illness outbreaks.[<-Struck out]‘(b) Final Regulation-[<-Struck out]
‘(1) IN GENERAL- Not later than 1 year after the close of the comment period for the proposed rulemaking under subsection (a), the Secretary shall adopt a final regulation to provide for minimum standards for those types of fruits and vegetables that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death.[<-Struck out]
‘(2) FINAL REGULATION- The final regulation shall--[<-Struck out]
‘(A) provide a reasonable period of time for compliance, taking into account the needs of small businesses for additional time to comply;[<-Struck out]
‘(B) provide for coordination of education and enforcement activities by State and local officials, as designated by the Governors of the respective States; and[<-Struck out]
‘(C) include a description of the variance process under subsection (c) and the types of permissible variances the Secretary may grant.[<-Struck out]‘(c) Criteria-[<-Struck out]
‘(1) IN GENERAL- The regulations adopted under subsection (b) shall--[<-Struck out]
‘(A) set forth those procedures, processes, and practices as the Secretary determines to be reasonably necessary to prevent the introduction of known or reasonably foreseeable biological, chemical, and physical hazards, including hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced, including by acts of terrorism, into fruits and vegetables that are raw agricultural commodities and to provide reasonable assurances that the produce is not adulterated under section 402; and[<-Struck out]
‘(B) permit States and foreign countries from which food is imported into the United States, subject to paragraph (2), to request from the Secretary variances from the requirements of the regulations, where upon approval of the Secretary, the variance is considered permissible under the requirements of the regulations adopted under subsection (b)(2)(C) and where the State or foreign country determines that the variance is necessary in light of local growing conditions and that the procedures, processes, and practices to be followed under the variance are reasonably likely to ensure that the produce is not adulterated under section 402 to the same extent as the requirements of the regulation adopted under subsection (b).[<-Struck out]‘(2) APPROVAL OF VARIANCES- A State or foreign country from which food is imported into the United States shall request a variance from the Secretary in writing. The Secretary may deny such a request as not reasonably likely to ensure that the produce is not adulterated under section 402 to the same extent as the requirements of the regulation adopted under subsection (b).[<-Struck out]‘(d) Enforcement- The Secretary may coordinate with the Secretary of Agriculture and shall contract and coordinate with the agency or department designated by the Governor of each State to perform activities to ensure compliance with this section.[<-Struck out]
‘(e) Guidance- Not later than 1 year after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall publish, after consultation with the Secretary of Agriculture and representatives of State departments of agriculture, updated good agricultural practices and guidance for the safe production and harvesting of specific types of fresh produce.[<-Struck out]
‘(f) Exception for Facilities in Compliance With Section 418- This section shall not apply to a facility that is subject to section 418.’.[<-Struck out]
(b) Prohibited Acts- Section 301 (21 U.S.C. 331 [<-Struck out]‘(pp) The production or harvesting of produce not in accordance with minimum standards as provided by regulation under section 419(b) or a variance issued under section 419(c).’.[<-Struck out]
(c) No Effect on HACCP Authorities- Nothing in the amendments made by this section limits the authority of the Secretary under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 42 U.S.C. 201 [<-Struck out](a) In General- Chapter IV (21 U.S.C. 341 [<-Struck out]‘SEC. 420. PROTECTION AGAINST INTENTIONAL ADULTERATION.[<-Struck out]‘(a) In General- Not later than 24 months after the date of enactment of the FDA Food Safety Modernization Act, the Secretary, in consultation with the Secretary of Homeland Security and the Secretary of Agriculture, shall promulgate regulations to protect against the intentional adulteration of food subject to this Act.[<-Struck out]
‘(b) Content of Regulations- Regulations under subsection (a) shall only apply to food--[<-Struck out]
‘(1) for which the Secretary has identified clear vulnerabilities (such as short shelf-life or susceptibility to intentional contamination at critical control points);[<-Struck out]
‘(2) in bulk or batch form, prior to being packaged for the final consumer; and[<-Struck out]
‘(3) for which there is a high risk of intentional contamination, as determined by the Secretary, that could cause serious adverse health consequences or death to humans or animals.[<-Struck out]‘(c) Determinations- In making the determination under subsection (b)(3), the Secretary shall--[<-Struck out]
‘(1) conduct vulnerability assessments of the food system;[<-Struck out]
‘(2) consider the best available understanding of uncertainties, risks, costs, and benefits associated with guarding against intentional adulteration at vulnerable points; and[<-Struck out]
‘(3) determine the types of science-based mitigation strategies or measures that are necessary to protect against the intentional adulteration of food.[<-Struck out]‘(d) Exception- This section shall not apply to food produced on farms, except for milk.[<-Struck out]
‘(e) Definition- For purposes of this section, the term ‘farm’ has the meaning given that term in section 1.227 of title 21, Code of Federal Regulations (or any successor regulation).’.[<-Struck out]
(b) Guidance Documents-[<-Struck out](1) IN GENERAL- Not later than 1 year after the date of enactment of this Act, the Secretary, in consultation with the Secretary of Homeland Security and the Secretary of Agriculture, shall issue guidance documents related to protection against the intentional adulteration of food, including mitigation strategies or measures to guard against such adulteration as required under section 420 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a).[<-Struck out](2) CONTENT- The guidance document issued under paragraph (1) shall--[<-Struck out](A) specify how a person shall assess whether the person is required to implement mitigation strategies or measures intended to protect against the intentional adulteration of food;[<-Struck out](B) specify appropriate science-based mitigation strategies or measures to prepare and protect the food supply chain at specific vulnerable points, as appropriate;[<-Struck out](C) include a model assessment for a person to use under subparagraph (A);[<-Struck out](D) include examples of mitigation strategies or measures described in subparagraph (B); and[<-Struck out](E) specify situations in which the examples of mitigation strategies or measures described in subparagraph (D) are appropriate.[<-Struck out](3) LIMITED DISTRIBUTION- In the interest of national security, the Secretary, in consultation with the Secretary of Homeland Security, may determine the time and manner in which the guidance documents issued under paragraph (1) are made public, including by releasing such documents to targeted audiences.[<-Struck out](c) Periodic Review- The Secretary shall periodically review and, as appropriate, update the regulation under subsection (a) and the guidance documents under subsection (b).[<-Struck out](d) Prohibited Acts- Section 301 (21 U.S.C. 331 [<-Struck out]‘(qq) The failure to comply with section 420.’.[<-Struck out](a) Fees for Reinspection, Recall, and Importation Activities- Subchapter C of chapter VII (21 U.S.C. 379f [<-Struck out]‘PART 5--FEES RELATED TO FOOD[<-Struck out]‘SEC. 740A. AUTHORITY TO COLLECT AND USE FEES.[<-Struck out]‘(a) In General-[<-Struck out]
‘(1) PURPOSE AND AUTHORITY- For fiscal year 2010 and each subsequent fiscal year, the Secretary shall, in accordance with this section, assess and collect fees from--[<-Struck out]
‘(A) each domestic facility (as defined in section 415(b)) subject to a reinspection in such fiscal year, to cover reinspection-related costs for such year;[<-Struck out]
‘(B) each domestic facility (as defined in section 415(b)) and importer subject to a food recall in such fiscal year, to cover food recall activities performed by the Secretary, including technical assistance, follow-up effectiveness checks, and public notifications, for such year;[<-Struck out]
‘(C) each importer participating in the voluntary qualified importer program under section 806 in such year, to cover the administrative costs such program for such year; and[<-Struck out]
‘(D) each importer subject to a reinspection in such fiscal year at a port of entry, to cover reinspection-related costs at ports of entry for such year.[<-Struck out]‘(2) DEFINITIONS- For purposes of this section--[<-Struck out]
‘(A) the term ‘reinspection’ means--[<-Struck out]
‘(i) with respect to domestic facilities (as defined in section 415(b)), 1 or more inspections conducted under section 704 subsequent to an inspection conducted under such provision which identified noncompliance materially related to a food safety requirement of this Act, specifically to determine whether compliance has been achieved to the Secretary’s satisfaction; and[<-Struck out]
‘(ii) with respect to importers, 1 or more examinations conducted under section 801 subsequent to an examination conducted under such provision which identified noncompliance materially related to a food safety requirement of this Act, specifically to determine whether compliance has been achieved to the Secretary’s satisfaction; and[<-Struck out]‘(B) the term ‘reinspection-related costs’ means all expenses, including administrative expenses, incurred in connection with--[<-Struck out]
‘(i) arranging, conducting, and evaluating the results of reinspections; and[<-Struck out]
‘(ii) assessing and collecting reinspection fees under this section.[<-Struck out]‘(b) Establishment of Fees-[<-Struck out]
‘(1) IN GENERAL- Subject to subsections (c) and (d), the Secretary shall establish the fees to be collected under this section for each fiscal year specified in subsection (a)(1), based on the methodology described under paragraph (2), and shall publish such fees in a Federal Register notice not later than 60 days before the start of each such year.[<-Struck out]
‘(2) FEE METHODOLOGY-[<-Struck out]
‘(A) FEES- Fees amounts established for collection--[<-Struck out]
‘(i) under subparagraph (A) of subsection (a)(1) for a fiscal year shall be based on the Secretary’s estimate of 100 percent of the costs of the reinspection-related activities (including by type or level of reinspection activity, as the Secretary determines applicable) described in such subparagraph (A) for such year;[<-Struck out]
‘(ii) under subparagraph (B) of subsection (a)(1) for a fiscal year shall be based on the Secretary’s estimate of 100 percent of the costs of the activities described in such subparagraph (B) for such year;[<-Struck out]
‘(iii) under subparagraph (C) of subsection (a)(1) for a fiscal year shall be based on the Secretary’s estimate of 100 percent of the costs of the activities described in such subparagraph (C) for such year; and[<-Struck out]
‘(iv) under subparagraph (D) of subsection (a)(1) for a fiscal year shall be based on the Secretary’s estimate of 100 percent of the costs of the activities described in such subparagraph (D) for such year.[<-Struck out]‘(B) OTHER CONSIDERATIONS-[<-Struck out]
‘(i) VOLUNTARY QUALIFIED IMPORTER PROGRAM-[<-Struck out]
‘(I) PARTICIPATION- In establishing the fee amounts under subparagraph (A)(iii) for a fiscal year, the Secretary shall provide for the number of importers who have submitted to the Secretary a notice under section 806(e) informing the Secretary of the intent of such importer to participate in the program under section 806 in such fiscal year.[<-Struck out]
‘(II) RECOUPMENT- In establishing the fee amounts under subparagraph (A)(iii) for the first 5 fiscal years after the date of enactment of this section, the Secretary shall include in such fee a reasonable surcharge that provides a recoupment of the costs expended by the Secretary to establish and implement the first year of the program under section 806.[<-Struck out]‘(ii) CREDITING OF FEES- In establishing the fee amounts under subparagraph (A) for a fiscal year, the Secretary shall provide for the crediting of fees from the previous year to the next year if the Secretary overestimated the amount of fees needed to carry out such activities, and consider the need to account for any adjustment of fees and such other factors as the Secretary determines appropriate.[<-Struck out]‘(3) USE OF FEES- The Secretary shall make all of the fees collected pursuant to clause (i), (ii), (iii), and (iv) of paragraph (2)(A) available solely to pay for the costs referred to in such clause (i), (ii), (iii), and (iv) of paragraph (2)(A), respectively.[<-Struck out]
‘(4) COMPLIANCE WITH INTERNATIONAL AGREEMENTS- Nothing in this section shall be construed to authorize the assessment of any fee inconsistent with the agreement establishing the World Trade Organization or any other treaty or international agreement to which the United States is a party.[<-Struck out]‘(c) Limitations-[<-Struck out]
‘(1) IN GENERAL- Fees under subsection (a) shall be refunded for a fiscal year beginning after fiscal year 2010 unless appropriations for the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine and related activities of the Office of Regulatory Affairs at the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) are equal to or greater than the amount of appropriations for the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine and related activities of the Office of Regulatory Affairs at the Food and Drug Administration for the preceding fiscal year (excluding the amount of fees appropriated for such fiscal year) multiplied by 1 plus 4.5 percent.[<-Struck out]
‘(2) AUTHORITY- If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate, under subsection (a), notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.[<-Struck out]
‘(3) LIMITATION ON AMOUNT OF CERTAIN FEES-[<-Struck out]
‘(A) IN GENERAL- Notwithstanding any other provision of this section and subject to subparagraph (B), the Secretary may not collect fees in a fiscal year such that the amount collected--[<-Struck out]
‘(i) under subparagraph (B) of subsection (a)(1) exceeds $20,000,000; and[<-Struck out]
‘(ii) under subparagraphs (A) and (D) of subsection (a)(1) exceeds $25,000,000 combined.[<-Struck out]‘(B) EXCEPTION- If a domestic facility (as defined in section 415(b)) or an importer becomes subject to a fee described in subparagraph (A), (B), or (D) of subsection (a)(1) after the maximum amount of fees has been collected by the Secretary under subparagraph (A), the Secretary may collect a fee from such facility or importer.[<-Struck out]‘(d) Crediting and Availability of Fees- Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the purpose of paying the operating expenses of the Food and Drug Administration employees and contractors performing activities associated with these food safety fees.[<-Struck out]
‘(e) Collection of Fees-[<-Struck out]
‘(1) IN GENERAL- The Secretary shall specify in the Federal Register notice described in subsection (b)(1) the time and manner in which fees assessed under this section shall be collected.[<-Struck out]
‘(2) COLLECTION OF UNPAID FEES- In any case where the Secretary does not receive payment of a fee assessed under this section within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to provisions of subchapter II of chapter 37 of title 31, United States Code.[<-Struck out]‘(f) Annual Report to Congress- Not later than 120 days after each fiscal year for which fees are assessed under this section, the Secretary shall submit a report to the Committee on Health, Education, Labor, and Pensions of the United States Senate and the Committee on Energy and Commerce of the United States House of Representatives, to include a description of fees assessed and collected for each such year and a summary description of the entities paying such fees and the types of business in which such entities engage.[<-Struck out]
‘(g) Authorization of Appropriations- For fiscal year 2010 and each fiscal year thereafter, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted or otherwise affected under the other provisions of this section.’.[<-Struck out]
(b) Export Certification Fees for Foods and Animal Feed-[<-Struck out](1) AUTHORITY FOR EXPORT CERTIFICATIONS FOR FOOD, INCLUDING ANIMAL FEED- Section 801(e)(4)(A) (21 U.S.C. 381(e)(4)(A) [<-Struck out](A) in the matter preceding clause (i), by striking ‘a drug’ and inserting ‘a food, drug’;[<-Struck out](B) in clause (i) by striking ‘exported drug’ and inserting ‘exported food, drug’; and[<-Struck out](C) in clause (ii) by striking ‘the drug’ each place it appears and inserting ‘the food, drug’.[<-Struck out](2) CLARIFICATION OF CERTIFICATION- Section 801(e)(4) (21 U.S.C. 381(e)(4) [<-Struck out]‘(C) For purposes of this paragraph, a certification by the Secretary shall be made on such basis, and in such form (including a publicly available listing) as the Secretary determines appropriate.’.[<-Struck out](a) Development and Submission of Strategy-[<-Struck out](1) IN GENERAL- Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services and the Secretary of Agriculture, in coordination with the Secretary of Homeland Security, shall prepare and submit to the relevant committees of Congress, and make publicly available on the Internet Web site of the Department of Health and Human Services and the Department of Agriculture, the National Agriculture and Food Defense Strategy.[<-Struck out](2) IMPLEMENTATION PLAN- The strategy shall include an implementation plan for use by the Secretaries described under paragraph (1) in carrying out the strategy.[<-Struck out](3) RESEARCH- The strategy shall include a coordinated research agenda for use by the Secretaries described under paragraph (1) in conducting research to support the goals and activities described in paragraphs (1) and (2) of subsection (b).[<-Struck out](4) REVISIONS- Not later than 4 years after the date on which the strategy is submitted to the relevant committees of Congress under paragraph (1), and not less frequently than every 4 years thereafter, the Secretary of Health and Human Services and the Secretary of Agriculture, in coordination with the Secretary of Homeland Security, shall revise and submit to the relevant committees of Congress the strategy.[<-Struck out](5) CONSISTENCY WITH EXISTING PLANS- The strategy described in paragraph (1) shall be consistent with--[<-Struck out](A) the National Incident Management System;[<-Struck out](B) the National Response Framework;[<-Struck out](C) the National Infrastructure Protection Plan;[<-Struck out](D) the National Preparedness Goals; and[<-Struck out](E) other relevant national strategies.[<-Struck out](b) Components-[<-Struck out](1) IN GENERAL- The strategy shall include a description of the process to be used by the Department of Health and Human Services, the Department of Agriculture, and the Department of Homeland Security--[<-Struck out](A) to achieve each goal described in paragraph (2); and[<-Struck out](B) to evaluate the progress made by Federal, State, local, and tribal governments towards the achievement of each goal described in paragraph (2).[<-Struck out](2) GOALS- The strategy shall include a description of the process to be used by the Department of Health and Human Services, the Department of Agriculture, and the Department of Homeland Security to achieve the following goals:[<-Struck out](A) PREPAREDNESS GOAL- Enhance the preparedness of the agriculture and food system by--[<-Struck out](i) conducting vulnerability assessments of the agriculture and food system;[<-Struck out](ii) mitigating vulnerabilities of the system;[<-Struck out](iii) improving communication and training relating to the system;[<-Struck out](iv) developing and conducting exercises to test decontamination and disposal plans;[<-Struck out](v) developing modeling tools to improve event consequence assessment and decision support; and[<-Struck out](vi) preparing risk communication tools and enhancing public awareness through outreach.[<-Struck out](B) DETECTION GOAL- Improve agriculture and food system detection capabilities by--[<-Struck out](i) identifying contamination in food products at the earliest possible time; and[<-Struck out](ii) conducting surveillance to prevent the spread of diseases.[<-Struck out](C) EMERGENCY RESPONSE GOAL- Ensure an efficient response to agriculture and food emergencies by--[<-Struck out](i) immediately investigating animal disease outbreaks and suspected food contamination;[<-Struck out](ii) preventing additional human illnesses;[<-Struck out](iii) organizing, training, and equipping animal, plant, and food emergency response teams of--[<-Struck out](I) the Federal Government; and[<-Struck out](II) State, local, and tribal governments;[<-Struck out](iv) designing, developing, and evaluating training and exercises carried out under agriculture and food defense plans; and[<-Struck out](v) ensuring consistent and organized risk communication to the public by--[<-Struck out](I) the Federal Government;[<-Struck out](II) State, local, and tribal governments; and[<-Struck out](III) the private sector.[<-Struck out](D) RECOVERY GOAL- Secure agriculture and food production after an agriculture or food emergency by--[<-Struck out](i) working with the private sector to develop business recovery plans to rapidly resume agriculture and food production;[<-Struck out](ii) conducting exercises of the plans described in subparagraph (C) with the goal of long-term recovery results;[<-Struck out](iii) rapidly removing, and effectively disposing of--[<-Struck out](I) contaminated agriculture and food products; and[<-Struck out](II) infected plants and animals; and[<-Struck out](iv) decontaminating and restoring areas affected by an agriculture or food emergency.[<-Struck out]The Secretary of Homeland Security, in consultation with the Secretary of Health and Human Services and the Secretary of Agriculture, shall within 180 days of enactment of this Act, and annually thereafter, submit to the relevant committees of Congress, and make publicly available on the Internet Web site of the Department of Homeland Security, a report on the activities of the Food and Agriculture Government Coordinating Council and the Food and Agriculture Sector Coordinating Council, including the progress of such Councils on--[<-Struck out](1) facilitating partnerships between public and private entities to help unify and enhance the protection of the agriculture and food system of the United States;[<-Struck out](2) providing for the regular and timely interchange of information between each council relating to the security of the agriculture and food system (including intelligence information);[<-Struck out](3) identifying best practices and methods for improving the coordination among Federal, State, local, and private sector preparedness and response plans for agriculture and food defense; and[<-Struck out](4) recommending methods by which to protect the economy and the public health of the United States from the effects of--[<-Struck out](A) animal or plant disease outbreaks;[<-Struck out](B) food contamination; and[<-Struck out](C) natural disasters affecting agriculture and food.[<-Struck out](a) In General-[<-Struck out](1) INITIAL REPORT- The Secretary shall, not later than 2 years after the date of enactment of this Act, submit to Congress a comprehensive report that identifies programs and practices that are intended to promote the safety and security of food and to prevent outbreaks of food-borne illness and other food-related hazards that can be addressed through preventive activities. Such report shall include a description of the following:[<-Struck out](A) Analysis of the need for regulations or guidance to industry.[<-Struck out](B) Outreach to food industry sectors, including through the Food and Agriculture Coordinating Councils referred to in section 109, to identify potential sources of emerging threats to the safety and security of the food supply and preventive strategies to address those threats.[<-Struck out](C) Systems to ensure the prompt distribution to the food industry of information and technical assistance concerning preventive strategies.[<-Struck out](D) Communication systems to ensure that information about specific threats to the safety and security of the food supply are rapidly and effectively disseminated.[<-Struck out](E) Surveillance systems and laboratory networks to rapidly detect and respond to food-borne illness outbreaks and other food-related hazards, including how such systems and networks are integrated.[<-Struck out](F) Outreach, education, and training provided to States and local governments to build State and local food safety and food defense capabilities, including progress implementing strategies developed under sections 108 and 205.[<-Struck out](G) The estimated resources needed to effectively implement the programs and practices identified in the report developed in this section over a 5-year period.[<-Struck out](2) BIENNIAL REPORTS- On a biennial basis following the submission of the report under paragraph (1), the Secretary shall submit to Congress a report that--[<-Struck out](A) reviews previous food safety programs and practices;[<-Struck out](B) outlines the success of those programs and practices;[<-Struck out](C) identifies future programs and practices; and[<-Struck out](D) includes information related to any matter described in subparagraphs (A) through (G) of paragraph (1), as necessary.[<-Struck out](b) Risk-based Activities- The report developed under subsection (a)(1) shall describe methods that seek to ensure that resources available to the Secretary for food safety-related activities are directed at those actions most likely to reduce risks from food, including the use of preventive strategies and allocation of inspection resources. The Secretary shall promptly undertake those risk-based actions that are identified during the development of the report as likely to contribute to the safety and security of the food supply.[<-Struck out](c) Capability for Laboratory Analyses; Research- The report developed under subsection (a)(1) shall provide a description of methods to increase capacity to undertake analyses of food samples promptly after collection, to identify new and rapid analytical techniques, including techniques that can be employed at ports of entry and through Food Emergency Response Network laboratories, and to provide for well-equipped and staffed laboratory facilities.[<-Struck out](d) Information Technology- The report developed under subsection (a)(1) shall include a description of such information technology systems as may be needed to identify risks and receive data from multiple sources, including foreign governments, State, local, and tribal governments, other Federal agencies, the food industry, laboratories, laboratory networks, and consumers. The information technology systems that the Secretary describes shall also provide for the integration of the facility registration system under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d 21 U.S.C. 381(m) [<-Struck out](e) Automated Risk Assessment- The report developed under subsection (a)(1) shall include a description of progress toward developing and improving an automated risk assessment system for food safety surveillance and allocation of resources.[<-Struck out](f) Traceback and Surveillance Report- The Secretary shall include in the report developed under subsection (a)(1) an analysis of the Food and Drug Administration’s performance in food-borne illness outbreaks during the 5-year period preceding the date of enactment of this Act involving fruits and vegetables that are raw agricultural commodities (as defined in section 201(r) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(r) [<-Struck out](g) Biennial Food Safety and Food Defense Research Plan- The Secretary and the Secretary of Agriculture shall, on a biennial basis, submit to Congress a joint food safety and food defense research plan which may include studying the long-term health effects of food-borne illness. Such biennial plan shall include a list and description of projects conducted during the previous 2-year period and the plan for projects to be conducted during the following 2-year period.[<-Struck out]Not later than 1 year after the date of enactment of this Act, the Secretary shall issue a final rule based on the proposed rule issued by the Commissioner of Food and Drugs entitled ‘Prevention of Salmonella Enteritidis in Shell Eggs During Production’, 69 Fed. Reg. 56824, (September 22, 2004).[<-Struck out]Not later than 1 year after the date of enactment of this Act, the Secretary shall promulgate regulations described in section 416(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350e(b) [<-Struck out](a) Definitions- In this section:[<-Struck out](1) EARLY CHILDHOOD EDUCATION PROGRAM- The term ‘early childhood education program’ means--[<-Struck out](A) a Head Start program or an Early Head Start program carried out under the Head Start Act (42 U.S.C. 9831 [<-Struck out](B) a State licensed or regulated child care program or school; or[<-Struck out](C) a State prekindergarten program that serves children from birth through kindergarten.[<-Struck out](2) ESEA DEFINITIONS- The terms ‘local educational agency’, ‘secondary school’, ‘elementary school’, and ‘parent’ have the meanings given the terms in section 9101 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 7801 [<-Struck out](3) SCHOOL- The term ‘school’ includes public--[<-Struck out](A) kindergartens;[<-Struck out](B) elementary schools; and[<-Struck out](C) secondary schools.[<-Struck out](4) SECRETARY- The term ‘Secretary’ means the Secretary of Health and Human Services.[<-Struck out](b) Establishment of Voluntary Food Allergy and Anaphylaxis Management Guidelines-[<-Struck out](1) ESTABLISHMENT-[<-Struck out](A) IN GENERAL- Not later than 1 year after the date of enactment of this Act, the Secretary, in consultation with the Secretary of Education, shall--[<-Struck out](i) develop guidelines to be used on a voluntary basis to develop plans for individuals to manage the risk of food allergy and anaphylaxis in schools and early childhood education programs; and[<-Struck out](ii) make such guidelines available to local educational agencies, schools, early childhood education programs, and other interested entities and individuals to be implemented on a voluntary basis only.[<-Struck out](B) APPLICABILITY OF FERPA- Each plan described in subparagraph (A) that is developed for an individual shall be considered an education record for the purpose of the Family Educational Rights and Privacy Act of 1974 (20 U.S.C. 1232g [<-Struck out](2) CONTENTS- The voluntary guidelines developed by the Secretary under paragraph (1) shall address each of the following, and may be updated as the Secretary determines necessary:[<-Struck out](A) Parental obligation to provide the school or early childhood education program, prior to the start of every school year, with--[<-Struck out](i) documentation from their child’s physician or nurse--[<-Struck out](I) supporting a diagnosis of food allergy, and any risk of anaphylaxis, if applicable;[<-Struck out](II) identifying any food to which the child is allergic;[<-Struck out](III) describing, if appropriate, any prior history of anaphylaxis;[<-Struck out](IV) listing any medication prescribed for the child for the treatment of anaphylaxis;[<-Struck out](V) detailing emergency treatment procedures in the event of a reaction;[<-Struck out](VI) listing the signs and symptoms of a reaction; and[<-Struck out](VII) assessing the child’s readiness for self-administration of prescription medication; and[<-Struck out](ii) a list of substitute meals that may be offered to the child by school or early childhood education program food service personnel.[<-Struck out](B) The creation and maintenance of an individual plan for food allergy management, in consultation with the parent, tailored to the needs of each child with a documented risk for anaphylaxis, including any procedures for the self-administration of medication by such children in instances where--[<-Struck out](i) the children are capable of self-administering medication; and[<-Struck out](ii) such administration is not prohibited by State law.[<-Struck out](C) Communication strategies between individual schools or early childhood education programs and providers of emergency medical services, including appropriate instructions for emergency medical response.[<-Struck out](D) Strategies to reduce the risk of exposure to anaphylactic causative agents in classrooms and common school or early childhood education program areas such as cafeterias.[<-Struck out](E) The dissemination of general information on life-threatening food allergies to school or early childhood education program staff, parents, and children.[<-Struck out](F) Food allergy management training of school or early childhood education program personnel who regularly come into contact with children with life-threatening food allergies.[<-Struck out](G) The authorization and training of school or early childhood education program personnel to administer epinephrine when the nurse is not immediately available.[<-Struck out](H) The timely accessibility of epinephrine by school or early childhood education program personnel when the nurse is not immediately available.[<-Struck out](I) The creation of a plan contained in each individual plan for food allergy management that addresses the appropriate response to an incident of anaphylaxis of a child while such child is engaged in extracurricular programs of a school or early childhood education program, such as non-academic outings and field trips, before- and after-school programs or before- and after-early child education program programs, and school-sponsored or early childhood education program-sponsored programs held on weekends.[<-Struck out](J) Maintenance of information for each administration of epinephrine to a child at risk for anaphylaxis and prompt notification to parents.[<-Struck out](K) Other elements the Secretary determines necessary for the management of food allergies and anaphylaxis in schools and early childhood education programs.[<-Struck out](3) RELATION TO STATE LAW- Nothing in this section or the guidelines developed by the Secretary under paragraph (1) shall be construed to preempt State law, including any State law regarding whether students at risk for anaphylaxis may self-administer medication.[<-Struck out](c) School-based Food Allergy Management Grants-[<-Struck out](1) IN GENERAL- The Secretary may award grants to local educational agencies to assist such agencies with implementing voluntary food allergy and anaphylaxis management guidelines described in subsection (b).[<-Struck out](2) APPLICATION-[<-Struck out](A) IN GENERAL- To be eligible to receive a grant under this subsection, a local educational agency shall submit an application to the Secretary at such time, in such manner, and including such information as the Secretary may reasonably require.[<-Struck out](B) CONTENTS- Each application submitted under subparagraph (A) shall include--[<-Struck out](i) an assurance that the local educational agency has developed plans in accordance with the food allergy and anaphylaxis management guidelines described in subsection (b);[<-Struck out](ii) a description of the activities to be funded by the grant in carrying out the food allergy and anaphylaxis management guidelines, including--[<-Struck out](I) how the guidelines will be carried out at individual schools served by the local educational agency;[<-Struck out](II) how the local educational agency will inform parents and students of the guidelines in place;[<-Struck out](III) how school nurses, teachers, administrators, and other school-based staff will be made aware of, and given training on, when applicable, the guidelines in place; and[<-Struck out](IV) any other activities that the Secretary determines appropriate;[<-Struck out](iii) an itemization of how grant funds received under this subsection will be expended;[<-Struck out](iv) a description of how adoption of the guidelines and implementation of grant activities will be monitored; and[<-Struck out](v) an agreement by the local educational agency to report information required by the Secretary to conduct evaluations under this subsection.[<-Struck out](3) USE OF FUNDS- Each local educational agency that receives a grant under this subsection may use the grant funds for the following:[<-Struck out](A) Purchase of materials and supplies, including limited medical supplies such as epinephrine and disposable wet wipes, to support carrying out the food allergy and anaphylaxis management guidelines described in subsection (b).[<-Struck out](B) In partnership with local health departments, school nurse, teacher, and personnel training for food allergy management.[<-Struck out](C) Programs that educate students as to the presence of, and policies and procedures in place related to, food allergies and anaphylactic shock.[<-Struck out](D) Outreach to parents.[<-Struck out](E) Any other activities consistent with the guidelines described in subsection (b).[<-Struck out](4) DURATION OF AWARDS- The Secretary may award grants under this subsection for a period of not more than 2 years. In the event the Secretary conducts a program evaluation under this subsection, funding in the second year of the grant, where applicable, shall be contingent on a successful program evaluation by the Secretary after the first year.[<-Struck out](5) LIMITATION ON GRANT FUNDING- The Secretary may not provide grant funding to a local educational agency under this subsection after such local educational agency has received 2 years of grant funding under this subsection.[<-Struck out](6) MAXIMUM AMOUNT OF ANNUAL AWARDS- A grant awarded under this subsection may not be made in an amount that is more than $50,000 annually.[<-Struck out](7) PRIORITY- In awarding grants under this subsection, the Secretary shall give priority to local educational agencies with the highest percentages of children who are counted under section 1124(c) of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 6333(c) [<-Struck out](8) MATCHING FUNDS-[<-Struck out](A) IN GENERAL- The Secretary may not award a grant under this subsection unless the local educational agency agrees that, with respect to the costs to be incurred by such local educational agency in carrying out the grant activities, the local educational agency shall make available (directly or through donations from public or private entities) non-Federal funds toward such costs in an amount equal to not less than 25 percent of the amount of the grant.[<-Struck out](B) DETERMINATION OF AMOUNT OF NON-FEDERAL CONTRIBUTION- Non-Federal funds required under subparagraph (A) may be cash or in kind, including plant, equipment, or services. Amounts provided by the Federal Government, and any portion of any service subsidized by the Federal Government, may not be included in determining the amount of such non-Federal funds.[<-Struck out](9) ADMINISTRATIVE FUNDS- A local educational agency that receives a grant under this subsection may use not more than 2 percent of the grant amount for administrative costs related to carrying out this subsection.[<-Struck out](10) PROGRESS AND EVALUATIONS- At the completion of the grant period referred to in paragraph (4), a local educational agency shall provide the Secretary with information on how grant funds were spent and the status of implementation of the food allergy and anaphylaxis management guidelines described in subsection (b).[<-Struck out](11) SUPPLEMENT, NOT SUPPLANT- Grant funds received under this subsection shall be used to supplement, and not supplant, non-Federal funds and any other Federal funds available to carry out the activities described in this subsection.[<-Struck out](12) AUTHORIZATION OF APPROPRIATIONS- There is authorized to be appropriated to carry out this subsection $30,000,000 for fiscal year 2010 and such sums as may be necessary for each of the 4 succeeding fiscal years.[<-Struck out](d) Voluntary Nature of Guidelines-[<-Struck out](1) IN GENERAL- The food allergy and anaphylaxis management guidelines developed by the Secretary under subsection (b) are voluntary. Nothing in this section or the guidelines developed by the Secretary under subsection (b) shall be construed to require a local educational agency to implement such guidelines.[<-Struck out](2) EXCEPTION- Notwithstanding paragraph (1), the Secretary may enforce an agreement by a local educational agency to implement food allergy and anaphylaxis management guidelines as a condition of the receipt of a grant under subsection (c).[<-Struck out][Struck out->]
TITLE II--IMPROVING CAPACITY TO DETECT AND RESPOND TO FOOD SAFETY PROBLEMS[<-Struck out]
(a) Targeting of Inspection Resources for Domestic Facilities, Foreign Facilities, and Ports of Entry- Chapter IV (21 U.S.C. 341 [<-Struck out]‘SEC. 421. TARGETING OF INSPECTION RESOURCES FOR DOMESTIC FACILITIES, FOREIGN FACILITIES, AND PORTS OF ENTRY; ANNUAL REPORT.[<-Struck out]‘(a) Identification and Inspection of Facilities-[<-Struck out]
‘(1) IDENTIFICATION- The Secretary shall allocate resources to inspect facilities according to the risk profile of the facilities, which shall be based on the following factors:[<-Struck out]
‘(A) The risk profile of the food manufactured, processed, packed, or held at the facility.[<-Struck out]
‘(B) The facility’s history of food recalls, outbreaks, and violations of food safety standards.[<-Struck out]
‘(C) The rigor of the facility’s hazard analysis and risk-based preventive controls.[<-Struck out]
‘(D) Whether the food manufactured, processed, packed, handled, prepared, treated, distributed, or stored at the facility meets the criteria for priority under section 801(h)(1).[<-Struck out]
‘(E) Whether the facility has received a certificate as described in section 809(b).[<-Struck out]
‘(F) Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources.[<-Struck out]‘(2) INSPECTIONS-[<-Struck out]
‘(A) IN GENERAL- Beginning on the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall increase the frequency of inspection of all facilities.[<-Struck out]
‘(B) HIGH-RISK FACILITIES- The Secretary shall increase the frequency of inspection of facilities identified under paragraph (1) as high-risk facilities such that--[<-Struck out]
‘(i) for the first 2 years after the date of enactment of the FDA Food Safety Modernization Act, each high-risk facility is inspected not less often than once every 2 years; and[<-Struck out]
‘(ii) for each succeeding year, each high-risk facility is inspected not less often than once each year.[<-Struck out]‘(C) NON-HIGH-RISK FACILITIES- The Secretary shall ensure that each facility that is not identified under paragraph (1) as a high-risk facility is inspected not less often than once every 4 years.[<-Struck out]‘(b) Identification and Inspection at Ports of Entry- The Secretary, in consultation with the Secretary of Homeland Security, shall allocate resources to inspect articles of food imported into the United States according to the risk profile of the article of food, which shall be based on the following factors:[<-Struck out]
‘(1) The risk profile of the food imported.[<-Struck out]
‘(2) The risk profile of the countries of origin and countries of transport of the food imported.[<-Struck out]
‘(3) The history of food recalls, outbreaks, and violations of food safety standards of the food importer.[<-Struck out]
‘(4) The rigor of the foreign supplier verification program under section 805.[<-Struck out]
‘(5) Whether the food importer participates in the voluntary qualified importer program under section 806.[<-Struck out]
‘(6) Whether the food meets the criteria for priority under section 801(h)(1).[<-Struck out]
‘(7) Whether the food is from a facility that has received a certificate as described in section 809(b).[<-Struck out]
‘(8) Any other criteria deemed appropriate by the Secretary for purposes of allocating inspection resources.[<-Struck out]‘(c) Coordination- The Secretary shall improve coordination and cooperation with the Secretary of Agriculture to target food inspection resources.[<-Struck out]
‘(d) Facility- For purposes of this section, the term ‘facility’ means a domestic facility or a foreign facility that is required to register under section 415.’.[<-Struck out]
(b) Annual Report- Section 903 (21 U.S.C. 393 [<-Struck out]‘(h) Annual Report Regarding Food- Not later than February 1 of each year, the Secretary shall submit to Congress a report regarding--[<-Struck out]
‘(1) information about food facilities including--[<-Struck out]
‘(A) the appropriations used to inspect facilities registered pursuant to section 415 in the previous fiscal year;[<-Struck out]
‘(B) the average cost of both a non-high-risk food facility inspection and a high-risk food facility inspection, if such a difference exists, in the previous fiscal year;[<-Struck out]
‘(C) the number of domestic facilities and the number of foreign facilities registered pursuant to section 415 that the Secretary inspected in the previous fiscal year;[<-Struck out]
‘(D) the number of domestic facilities and the number of foreign facilities registered pursuant to section 415 that the Secretary did not inspect in the previous fiscal year;[<-Struck out]
‘(E) the number of high-risk facilities identified pursuant to section 421 that the Secretary inspected in the previous fiscal year; and[<-Struck out]
‘(F) the number of high-risk facilities identified pursuant to section 421 that the Secretary did not inspect in the previous fiscal year;[<-Struck out]‘(2) information about food imports including--[<-Struck out]
‘(A) the number of lines of food imported into the United States that the Secretary physically inspected or sampled in the previous fiscal year;[<-Struck out]
‘(B) the number of lines of food imported into the United States that the Secretary did not physically inspect or sample in the previous fiscal year; and[<-Struck out]
‘(C) the average cost of physically inspecting or sampling a food line subject to this Act that is imported or offered for import into the United States; and[<-Struck out]‘(3) information on the foreign offices established under section 309 of the FDA Food Safety Modernization Act including--[<-Struck out]
‘(A) the number of foreign offices established; and[<-Struck out]
‘(B) the number of personnel permanently stationed in each foreign office.[<-Struck out]‘(i) Public Availability of Annual Food Reports- The Secretary shall make the reports required under subsection (h) available to the public on the Internet Web site of the Food and Drug Administration.’.[<-Struck out](a) In General- Chapter IV (21 U.S.C. 341 [<-Struck out]‘SEC. 422. RECOGNITION OF LABORATORY ACCREDITATION FOR ANALYSES OF FOODS.[<-Struck out]‘(a) Recognition of Laboratory Accreditation-[<-Struck out]
‘(1) IN GENERAL- Not later than 2 years after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall--[<-Struck out]
‘(A) provide for the recognition of accreditation bodies that accredit laboratories, including laboratories run and operated by a State or locality, with a demonstrated capability to conduct analytical testing of food products; and[<-Struck out]
‘(B) establish a publicly available registry of accreditation bodies, including the name of, contact information for, and other information deemed necessary by the Secretary about such bodies.[<-Struck out]‘(2) FOREIGN LABORATORIES- Accreditation bodies may accredit laboratories that operate outside the United States, so long as such laboratories meet the accreditation standards applicable to domestic laboratories accredited under this section.[<-Struck out]
‘(3) MODEL ACCREDITATION STANDARDS- The Secretary shall develop model standards that an accreditation body shall require laboratories to meet in order to be included in the registry provided for under paragraph (1). In developing the model standards, the Secretary shall look to existing standards for guidance. The model standards shall include methods to ensure that--[<-Struck out]
‘(A) appropriate sampling and analytical procedures are followed and reports of analyses are certified as true and accurate;[<-Struck out]
‘(B) internal quality systems are established and maintained;[<-Struck out]
‘(C) procedures exist to evaluate and respond promptly to complaints regarding analyses and other activities for which the laboratory is recognized;[<-Struck out]
‘(D) individuals who conduct the analyses are qualified by training and experience to do so; and[<-Struck out]
‘(E) any other criteria determined appropriate by the Secretary.[<-Struck out]‘(4) REVIEW OF ACCREDITATION- To assure compliance with the requirements of this section, the Secretary shall--[<-Struck out]
‘(A) periodically, or at least every 5 years, reevaluate accreditation bodies recognized under paragraph (1); and[<-Struck out]
‘(B) promptly revoke the recognition of any accreditation body found not to be in compliance with the requirements of this section.[<-Struck out]‘(b) Testing Procedures-[<-Struck out]
‘(1) IN GENERAL- Food testing shall be conducted by either Federal laboratories or non-Federal laboratories that have been accredited by an accreditation body on the registry established by the Secretary under subsection (a) whenever such testing is either conducted by or on behalf of an owner or consignee--[<-Struck out]
‘(A) in support of admission of an article of food under section 801(a);[<-Struck out]
‘(B) due to a specific testing requirement in this Act or implementing regulations, when applied to address an identified or suspected food safety problem;[<-Struck out]
‘(C) under an Import Alert that requires successful consecutive tests; or[<-Struck out]
‘(D) is so required by the Secretary as the Secretary deems appropriate to address an identified or suspected food safety problem.[<-Struck out]‘(2) RESULTS OF TESTING- The results of any such testing shall be sent directly to the Food and Drug Administration. Such results may be submitted to the Food and Drug Administration through electronic means.[<-Struck out]‘(c) Review by Secretary- If food sampling and testing performed by a laboratory run and operated by a State or locality that is accredited by an accreditation body on the registry established by the Secretary under subsection (a) result in a State recalling a food, the Secretary shall review the sampling and testing results for the purpose of determining the need for a national recall or other compliance and enforcement activities.[<-Struck out]
‘(d) No Limit on Secretarial Authority- Nothing in this section shall be construed to limit the ability of the Secretary to review and act upon information from food testing, including determining the sufficiency of such information and testing.’.[<-Struck out]
(b) Food Emergency Response Network- The Secretary, in coordination with the Secretary of Agriculture, the Secretary of Homeland Security, and State, local, and tribal governments shall, not later than 180 days after the date of enactment of this Act, and biennially thereafter, submit to the relevant committees of Congress, and make publicly available on the Internet Web site of the Department of Health and Human Services, a report on the progress in implementing a national food emergency response laboratory network that--[<-Struck out](1) provides ongoing surveillance, rapid detection, and surge capacity for large-scale food-related emergencies, including intentional adulteration of the food supply;[<-Struck out](2) coordinates the food laboratory capacities of State food laboratories, including the sharing of data between State laboratories to develop national situational awareness;[<-Struck out](3) provides accessible, timely, accurate, and consistent food laboratory services throughout the United States;[<-Struck out](4) develops and implements a methods repository for use by Federal, State, and local officials;[<-Struck out](5) responds to food-related emergencies; and[<-Struck out](6) is integrated with relevant laboratory networks administered by other Federal agencies.[<-Struck out](a) In General- The Secretary of Homeland Security, in consultation with the Secretary of Health and Human Services, the Secretary of Agriculture, and the Administrator of the Environmental Protection Agency, shall maintain an agreement through which relevant laboratory network members, as determined by the Secretary of Homeland Security, shall--[<-Struck out](1) agree on common laboratory methods in order to facilitate the sharing of knowledge and information relating to animal health, agriculture, and human health;[<-Struck out](2) identify the means by which each laboratory network member could work cooperatively--[<-Struck out](A) to optimize national laboratory preparedness; and[<-Struck out](B) to provide surge capacity during emergencies; and[<-Struck out](3) engage in ongoing dialogue and build relationships that will support a more effective and integrated response during emergencies.[<-Struck out](b) Reporting Requirement- The Secretary of Homeland Security shall, on a biennial basis, submit to the relevant committees of Congress, and make publicly available on the Internet Web site of the Department of Homeland Security, a report on the progress of the integrated consortium of laboratory networks, as established under subsection (a), in carrying out this section.[<-Struck out](a) In General- The Secretary, in consultation with the Secretary of Agriculture and representatives of State departments of health and agriculture, shall improve the capacity of the Secretary to effectively and rapidly track and trace, in the event of an outbreak, fruits and vegetables that are raw agricultural commodities.[<-Struck out](b) Pilot Project-[<-Struck out](1) IN GENERAL- Not later than 9 months after the date of enactment of this Act, the Secretary shall establish a pilot project in coordination with the produce industry to explore and evaluate methods for rapidly and effectively tracking and tracing fruits and vegetables that are raw agricultural commodities so that, if an outbreak occurs involving such a fruit or vegetable, the Secretary may quickly identify the source of the outbreak and the recipients of the contaminated food.[<-Struck out](2) CONTENT- The Secretary shall select participants from the produce industry to run projects which overall shall include at least 3 different types of fruits or vegetables that have been the subject of outbreaks during the 5-year period preceding the date of enactment of this Act, and shall be selected in order to develop and demonstrate--[<-Struck out](A) methods that are applicable and appropriate for small businesses; and[<-Struck out](B) technologies, including existing technologies, that enhance traceback and trace forward.[<-Struck out](c) Report- Not later than 18 months after the date of enactment of this Act, the Secretary shall report to Congress on the findings of the pilot project under subsection (b) together with recommendations for establishing more effective traceback and trace forward procedures for fruits and vegetables that are raw agricultural commodities.[<-Struck out](d) Traceback Performance Requirements- Not later than 24 months after the date of enactment of this Act, the Secretary shall publish a notice of proposed rulemaking to establish standards for the type of information, format, and timeframe for persons to submit records to aid the Secretary in effectively and rapidly tracking and tracing, in the event of an outbreak, fruits and vegetables that are raw agricultural commodities. Nothing in this section shall be construed as giving the Secretary the authority to prescribe specific technologies for the maintenance of records.[<-Struck out](e) Public Input- During the comment period in the notice of proposed rulemaking under subsection (d), the Secretary shall conduct not less than 3 public meetings in diverse geographical areas of the United States to provide persons in different regions an opportunity to comment.[<-Struck out](f) Raw Agricultural Commodity- In this section, the term ‘raw agricultural commodity’ has the meaning given that term in section 201(r) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(r) [<-Struck out](a) Definition of Food-borne Illness Outbreak- In this section, the term ‘food-borne illness outbreak’ means the occurrence of 2 or more cases of a similar illness resulting from the ingestion of a food.[<-Struck out](b) Food-borne Illness Surveillance Systems-[<-Struck out](1) IN GENERAL- The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall enhance food-borne illness surveillance systems to improve the collection, analysis, reporting, and usefulness of data on food-borne illnesses by--[<-Struck out](A) coordinating Federal, State and local food-borne illness surveillance systems, including complaint systems, and increasing participation in national networks of public health and food regulatory agencies and laboratories;[<-Struck out](B) facilitating sharing of findings on a more timely basis among governmental agencies, including the Food and Drug Administration, the Department of Agriculture, and State and local agencies, and with the public;[<-Struck out](C) developing improved epidemiological tools for obtaining quality exposure data, and microbiological methods for classifying cases;[<-Struck out](D) augmenting such systems to improve attribution of a food-borne illness outbreak to a specific food;[<-Struck out](E) expanding capacity of such systems, including working toward automatic electronic searches, for implementation of fingerprinting strategies for food-borne infectious agents, in order to identify new or rarely documented causes of food-borne illness and submit standardized information to a centralized database;[<-Struck out](F) allowing timely public access to aggregated, de-identified surveillance data;[<-Struck out](G) at least annually, publishing current reports on findings from such systems;[<-Struck out](H) establishing a flexible mechanism for rapidly initiating scientific research by academic institutions;[<-Struck out](I) integrating food-borne illness surveillance systems and data with other biosurveillance and public health situational awareness capabilities at the Federal, State, and local levels; and[<-Struck out](J) other activities as determined appropriate by the Secretary.[<-Struck out](2) PARTNERSHIPS- The Secretary shall support and maintain a diverse working group of experts and stakeholders from Federal, State, and local food safety and health agencies, the food industry, consumer organizations, and academia. Such working group shall provide the Secretary, through at least annual meetings of the working group and an annual public report, advice and recommendations on an ongoing and regular basis regarding the improvement of food-borne illness surveillance and implementation of this section, including advice and recommendations on--[<-Struck out](A) the priority needs of regulatory agencies, the food industry, and consumers for information and analysis on food-borne illness and its causes;[<-Struck out](B) opportunities to improve the effectiveness of initiatives at the Federal, State, and local levels, including coordination and integration of activities among Federal agencies, and between the Federal, State, and local levels of government;[<-Struck out](C) improvement in the timeliness and depth of access by regulatory and health agencies, the food industry, academic researchers, and consumers to food-borne illness surveillance data collected by government agencies at all levels, including data compiled by the Centers for Disease Control and Prevention;[<-Struck out](D) key barriers to improvement in food-borne illness surveillance and its utility for preventing food-borne illness at Federal, State, and local levels;[<-Struck out](E) the capabilities needed for establishing automatic electronic searches of surveillance data; and[<-Struck out](F) specific actions to reduce barriers to improvement, implement the working group’s recommendations, and achieve the purposes of this section, with measurable objectives and timelines, and identification of resource and staffing needs.[<-Struck out](c) Improving Food Safety and Defense Capacity at the State and Local Level-[<-Struck out](1) IN GENERAL- The Secretary shall develop and implement strategies to leverage and enhance the food safety and defense capacities of State and local agencies in order to achieve the following goals:[<-Struck out](A) Improve food-borne illness outbreak response and containment.[<-Struck out](B) Accelerate food-borne illness surveillance and outbreak investigation, including rapid shipment of clinical isolates from clinical laboratories to appropriate State laboratories, and conducting more standardized illness outbreak interviews.[<-Struck out](C) Strengthen the capacity of State and local agencies to carry out inspections and enforce safety standards.[<-Struck out](D) Improve the effectiveness of Federal, State, and local partnerships to coordinate food safety and defense resources and reduce the incidence of food-borne illness.[<-Struck out](E) Share information on a timely basis among public health and food regulatory agencies, with the food industry, with health care providers, and with the public.[<-Struck out](F) Strengthen the capacity of State and local agencies to achieve the goals described in section 108.[<-Struck out](2) REVIEW- In developing of the strategies required by paragraph (1), the Secretary shall, not later than 1 year after the date of enactment of the FDA Food Safety Modernization Act, complete a review of State and local capacities, and needs for enhancement, which may include a survey with respect to--[<-Struck out](A) staffing levels and expertise available to perform food safety and defense functions;[<-Struck out](B) laboratory capacity to support surveillance, outbreak response, inspection, and enforcement activities;[<-Struck out](C) information systems to support data management and sharing of food safety and defense information among State and local agencies and with counterparts at the Federal level; and[<-Struck out](D) other State and local activities and needs as determined appropriate by the Secretary.[<-Struck out](d) Food Safety Capacity Building Grants- Section 317R(b) of the Public Health Service Act (42 U.S.C. 247b-20(b) [<-Struck out](1) by striking ‘2002’ and inserting ‘2010’; and[<-Struck out](2) by striking ‘2003 through 2006’ and inserting ‘2011 through 2014’.[<-Struck out](a) In General- Chapter IV (21 U.S.C. 341 [<-Struck out]‘SEC. 423. MANDATORY RECALL AUTHORITY.[<-Struck out]‘(a) Voluntary Procedures- If the Secretary determines, based on information gathered through the reportable food registry under section 417 or through any other means, that there is a reasonable probability that an article of food (other than infant formula) is adulterated under section 402 or misbranded under section 403(w) and the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals, the Secretary shall provide the responsible party (as defined in section 417) with an opportunity to cease distribution and recall such article.[<-Struck out]
‘(b) Prehearing Order To Cease Distribution and Give Notice- If the responsible party refuses to or does not voluntarily cease distribution or recall such article within the time and in the manner prescribed by the Secretary (if so prescribed), the Secretary may, by order require, as the Secretary deems necessary, such person to--[<-Struck out]
‘(1) immediately cease distribution of such article; or[<-Struck out]
‘(2) immediately notify all persons--[<-Struck out]
‘(A) manufacturing, processing, packing, transporting, distributing, receiving, holding, or importing and selling such article; and[<-Struck out]
‘(B) to which such article has been distributed, transported, or sold, to immediately cease distribution of such article.[<-Struck out]‘(c) Hearing on Order- The Secretary shall provide the responsible party subject to an order under subsection (b) with an opportunity for an informal hearing, to be held as soon as possible but not later than 2 days after the issuance of the order, on the actions required by the order and on why the article that is the subject of the order should not be recalled.[<-Struck out]
‘(d) Post-hearing Recall Order and Modification of Order-[<-Struck out]
‘(1) AMENDMENT OF ORDER- If, after providing opportunity for an informal hearing under subsection (c), the Secretary determines that removal of the article from commerce is necessary, the Secretary shall, as appropriate--[<-Struck out]
‘(A) amend the order to require recall of such article or other appropriate action;[<-Struck out]
‘(B) specify a timetable in which the recall shall occur;[<-Struck out]
‘(C) require periodic reports to the Secretary describing the progress of the recall; and[<-Struck out]
‘(D) provide notice to consumers to whom such article was, or may have been, distributed.[<-Struck out]‘(2) VACATING OF ORDER- If, after such hearing, the Secretary determines that adequate grounds do not exist to continue the actions required by the order, or that such actions should be modified, the Secretary shall vacate the order or modify the order.[<-Struck out]‘(e) Cooperation and Consultation- The Secretary shall work with State and local public health officials in carrying out this section, as appropriate.[<-Struck out]
‘(f) Public Notification- In conducting a recall under this section, the Secretary shall--[<-Struck out]
‘(1) ensure that a press release is published regarding the recall, as well as alerts and public notices, as appropriate, in order to provide notification--[<-Struck out]
‘(A) of the recall to consumers and retailers to whom such article was, or may have been, distributed; and[<-Struck out]
‘(B) that includes, at a minimum--[<-Struck out]
‘(i) the name of the article of food subject to the recall; and[<-Struck out]
‘(ii) a description of the risk associated with such article; and[<-Struck out]‘(2) consult the policies of the Department of Agriculture regarding providing to the public a list of retail consignees receiving products involved in a Class I recall and shall consider providing such a list to the public, as determined appropriate by the Secretary.[<-Struck out]‘(g) No Delegation- The authority conferred by this section to order a recall or vacate a recall order shall not be delegated to any officer or employee other than the Commissioner.[<-Struck out]
‘(h) Effect- Nothing in this section shall affect the authority of the Secretary to request or participate in a voluntary recall.’.[<-Struck out]
(b) Civil Penalty- Section 303(f)(2)(A) (21 U.S.C. 333(f)(2)(A) [<-Struck out](c) Prohibited Acts- Section 301 (21 U.S.C. 331 [<-Struck out]‘(rr) The refusal or failure to follow an order under section 423.’.[<-Struck out](a) In General- Section 304(h)(1)(A) (21 U.S.C. 334(h)(1)(A) [<-Struck out](1) striking ‘credible evidence or information indicating’ and inserting ‘reason to believe’; and[<-Struck out](2) striking ‘presents a threat of serious adverse health consequences or death to humans or animals’ and inserting ‘is adulterated or misbranded’.[<-Struck out](b) Regulations- Not later than 120 days after the date of enactment of this Act, the Secretary shall issue an interim final rule amending subpart K of part 1 of title 21, Code of Federal Regulations, to implement the amendment made by this section.[<-Struck out](c) Effective Date- The amendment made by this section shall take effect 180 days after the date of enactment of this Act.[<-Struck out](a) In General- The Administrator of the Environmental Protection Agency (referred to in this section as the ‘Administrator’), in coordination with the Secretary of Health and Human Services, Secretary of Homeland Security, and Secretary of Agriculture, shall provide support for, and technical assistance to, State, local, and tribal governments in preparing for, assessing, decontaminating, and recovering from an agriculture or food emergency.[<-Struck out](b) Development of Standards- In carrying out subsection (a), the Administrator, in coordination with the Secretary of Health and Human Services, Secretary of Homeland Security, Secretary of Agriculture, and State, local, and tribal governments, shall develop and disseminate specific standards and protocols to undertake clean-up, clearance, and recovery activities following the decontamination and disposal of specific threat agents and foreign animal diseases.[<-Struck out](c) Development of Model Plans- In carrying out subsection (a), the Administrator, the Secretary of Health and Human Services, and the Secretary of Agriculture shall jointly develop and disseminate model plans for--[<-Struck out](1) the decontamination of individuals, equipment, and facilities following an intentional contamination of agriculture or food; and[<-Struck out](2) the disposal of large quantities of animals, plants, or food products that have been infected or contaminated by specific threat agents and foreign animal diseases.[<-Struck out](d) Exercises- In carrying out subsection (a), the Administrator, in coordination with the entities described under subsection (b), shall conduct exercises at least annually to evaluate and identify weaknesses in the decontamination and disposal model plans described in subsection (c). Such exercises shall be carried out, to the maximum extent practicable, as part of the national exercise program under section 648(b)(1) of the Post-Katrina Emergency Management Reform Act of 2006 (6 U.S.C. 748(b)(1) [<-Struck out](e) Modifications- Based on the exercises described in subsection (d), the Administrator, in coordination with the entities described in subsection (b), shall review and modify as necessary the plans described in subsection (c) not less frequently than biennially.[<-Struck out](f) Prioritization- The Administrator, in coordination with the entities described in subsection (b), shall develop standards and plans under subsections (b) and (c) in an identified order of priority that takes into account--[<-Struck out](1) highest-risk biological, chemical, and radiological threat agents;[<-Struck out](2) agents that could cause the greatest economic devastation to the agriculture and food system; and[<-Struck out](3) agents that are most difficult to clean or remediate.[<-Struck out][Struck out->]
TITLE III--IMPROVING THE SAFETY OF IMPORTED FOOD[<-Struck out]
(a) In General- Chapter VIII (21 U.S.C. 381 [<-Struck out]‘SEC. 805. FOREIGN SUPPLIER VERIFICATION PROGRAM.[<-Struck out]‘(a) In General-[<-Struck out]
‘(1) VERIFICATION REQUIREMENT- Each United States importer shall perform risk-based foreign supplier verification activities in accordance with regulations promulgated under subsection (c) for the purpose of verifying that the food imported by the importer or its agent is--[<-Struck out]
‘(A) produced in compliance with the requirements of section 418 or 419, as appropriate; and[<-Struck out]
‘(B) is not adulterated under section 402 or misbranded under section 403(w).[<-Struck out]‘(2) IMPORTER DEFINED- For purposes of this section, the term ‘importer’ means, with respect to an article of food--[<-Struck out]
‘(A) the United States owner or consignee of the article of food at the time of entry of such article into the United States; or[<-Struck out]
‘(B) in the case when there is no United States owner or consignee as described in subparagraph (A), the United States agent or representative of a foreign owner or consignee of the article of food at the time of entry of such article into the United States.[<-Struck out]‘(b) Guidance- Not later than 1 year after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall issue guidance to assist United States importers in developing foreign supplier verification programs.[<-Struck out]
‘(c) Regulations-[<-Struck out]
‘(1) IN GENERAL- Not later than 1 year after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall promulgate regulations to provide for the content of the foreign supplier verification program established under subsection (a). Such regulations shall, as appropriate, include a process for verification by a United States importer, with respect to each foreign supplier from which it obtains food, that the imported food is produced in compliance with the requirements of section 418 or 419, as appropriate, and is not adulterated under section 402 or misbranded under section 403(w).[<-Struck out]
‘(2) VERIFICATION- The regulations under paragraph (1) shall require that the foreign supplier verification program of each importer be adequate to provide assurances that each foreign supplier to the importer produces the imported food employing processes and procedures, including risk-based reasonably appropriate preventive controls, equivalent in preventing adulteration and reducing hazards as those required by section 418 or section 419, as appropriate.[<-Struck out]
‘(3) ACTIVITIES- Verification activities under a foreign supplier verification program under this section may include monitoring records for shipments, lot-by-lot certification of compliance, annual on-site inspections, checking the hazard analysis and risk-based preventive control plan of the foreign supplier, and periodically testing and sampling shipments.[<-Struck out]‘(d) Record Maintenance and Access- Records of a United States importer related to a foreign supplier verification program shall be maintained for a period of not less than 2 years and shall be made available promptly to a duly authorized representative of the Secretary upon request.[<-Struck out]
‘(e) Deemed Compliance of Seafood, Juice, and Low-acid Canned Food Facilities in Compliance With HACCP- An owner, operator, or agent in charge of a facility required to comply with 1 of the following standards and regulations with respect to such facility shall be deemed to be in compliance with this section with respect to such facility:[<-Struck out]
‘(1) The Seafood Hazard Analysis Critical Control Points Program of the Food and Drug Administration.[<-Struck out]
‘(2) The Juice Hazard Analysis Critical Control Points Program of the Food and Drug Administration.[<-Struck out]
‘(3) The Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards of the Food and Drug Administration (or any successor standards).[<-Struck out]‘(f) Publication of List of Participants- The Secretary shall publish and maintain on the Internet Web site of the Food and Drug Administration a current list that includes the name of, location of, and other information deemed necessary by the Secretary about, importers participating under this section.’.[<-Struck out]
(b) Prohibited Act- Section 301 (21 U.S.C. 331 [<-Struck out]‘(ss) The importation or offering for importation of a food if the importer (as defined in section 805) does not have in place a foreign supplier verification program in compliance with such section 805.’.[<-Struck out]
(c) Imports- Section 801(a) (21 U.S.C. 381(a) [<-Struck out](d) Effective Date- The amendments made by this section shall take effect 2 years after the date of enactment of this Act.[<-Struck out]Chapter VIII (21 U.S.C. 381 [<-Struck out]‘SEC. 806. VOLUNTARY QUALIFIED IMPORTER PROGRAM.[<-Struck out]‘(a) In General- Beginning not later than 1 year after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall--[<-Struck out]
‘(1) establish a program, in consultation with the Department of Homeland Security, to provide for the expedited review and importation of food offered for importation by United States importers who have voluntarily agreed to participate in such program; and[<-Struck out]
‘(2) issue a guidance document related to participation and compliance with such program.[<-Struck out]‘(b) Voluntary Participation- An importer may request the Secretary to provide for the expedited review and importation of designated foods in accordance with the program procedures established by the Secretary.[<-Struck out]
‘(c) Eligibility- In order to be eligible, an importer shall be offering food for importation from a facility that has a certification described in section 809(b). In reviewing the applications and making determinations on such requests, the Secretary shall consider the risk of the food to be imported based on factors, such as the following:[<-Struck out]
‘(1) The nature of the food to be imported.[<-Struck out]
‘(2) The compliance history of the foreign supplier.[<-Struck out]
‘(3) The capability of the regulatory system of the country of export to ensure compliance with United States food safety standards.[<-Struck out]
‘(4) The compliance of the importer with the requirements of section 805.[<-Struck out]
‘(5) The recordkeeping, testing, inspections and audits of facilities, traceability of articles of food, temperature controls, and sourcing practices of the importer.[<-Struck out]
‘(6) The potential risk for intentional adulteration of the food.[<-Struck out]
‘(7) Any other factor that the Secretary determines appropriate.[<-Struck out]‘(d) Review and Revocation- Any importer qualified by the Secretary in accordance with the eligibility criteria set forth in this section shall be reevaluated not less often than once every 3 years and the Secretary shall promptly revoke the qualified importer status of any importer found not to be in compliance with such criteria.[<-Struck out]
‘(e) Notice of Intent To Participate- An importer that intends to participate in the program under this section in a fiscal year shall submit a notice to the Secretary of such intent at time and in a manner established by the Secretary.[<-Struck out]
‘(f) False Statements- Any statement or representation made by an importer to the Secretary shall be subject tosection 1001 of title 18, United States Code [<-Struck out]
‘(g) Definition- For purposes of this section, the term ‘importer’ means the person that brings food, or causes food to be brought, from a foreign country into the customs territory of the United States.’.[<-Struck out](a) In General- Section 801(a) (21 U.S.C. 381(a) [<-Struck out](b) Addition of Certification Requirement- Section 801 (21 U.S.C. 381 [<-Struck out]‘(p) Certifications Concerning Imported Foods-[<-Struck out]
‘(1) IN GENERAL- The Secretary, based on public health considerations, including risks associated with the food or its place of origin, may require as a condition of granting admission to an article of food imported or offered for import into the United States, that an entity specified in paragraph (2) provide a certification or such other assurances as the Secretary determines appropriate that the article of food complies with some or all applicable requirements of this Act, as specified by the Secretary. Such certification or assurances may be provided in the form of shipment-specific certificates, a listing of certified entities, or in such other form as the Secretary may specify. Such certification shall be used for designated food imported from countries with which the Food and Drug Administration has an agreement to establish a certification program.[<-Struck out]
‘(2) CERTIFYING ENTITIES- For purposes of paragraph (1), entities that shall provide the certification or assurances described in such paragraph are--[<-Struck out]
‘(A) an agency or a representative of the government of the country from which the article of food at issue originated, as designated by such government or the Secretary; or[<-Struck out]
‘(B) such other persons or entities accredited pursuant to section 809 to provide such certification or assurance.[<-Struck out]‘(3) RENEWAL AND REFUSAL OF CERTIFICATIONS- The Secretary may--[<-Struck out]
‘(A) require that any certification or other assurance provided by an entity specified in paragraph (2) be renewed by such entity at such times as the Secretary determines appropriate; and[<-Struck out]
‘(B) refuse to accept any certification or assurance if the Secretary determines that such certification or assurance is no longer valid or reliable.[<-Struck out]‘(4) ELECTRONIC SUBMISSION- The Secretary shall provide for the electronic submission of certifications under this subsection.[<-Struck out]
‘(5) FALSE STATEMENTS- Any statement or representation made by an entity described in paragraph (2) to the Secretary shall be subject tosection 1001 of title 18, United States Code [<-Struck out](c) Conforming Technical Amendment- Section 801(b) (21 U.S.C. 381(b) [<-Struck out](d) No Limit on Authority- Nothing in the amendments made by this section shall limit the authority of the Secretary to conduct random inspections of imported food or to take such other steps as the Secretary deems appropriate to determine the admissibility of imported food.[<-Struck out](a) In General- Section 801(m)(1) (21 U.S.C. 381(m)(1) [<-Struck out](b) Regulations- Not later than 120 days after the date of enactment of this Act, the Secretary shall issue an interim final rule amending subpart I of part 1 of title 21, Code of Federal Regulations, to implement the amendment made by this section.[<-Struck out](c) Effective Date- The amendment made by this section shall take effect 180 days after the date of enactment of this Act.[<-Struck out]Chapter VIII (21 U.S.C. 381 [<-Struck out]‘SEC. 807. REVIEW OF A REGULATORY AUTHORITY OF A FOREIGN COUNTRY.[<-Struck out]‘The Secretary may review information from a country outlining the statutes, regulations, standards, and controls of such country, and conduct on-site audits in such country to verify the implementation of those statutes, regulations, standards, and controls. Based on such review, the Secretary shall determine whether such country can provide reasonable assurances that the food supply of the country is equivalent in safety to food manufactured, processed, packed, or held in the United States.’.[<-Struck out](a) In General- The Secretary shall, not later than 2 years of the date of enactment of this Act, develop a comprehensive plan to expand the technical, scientific, and regulatory capacity of foreign governments, and their respective food industries, from which foods are exported to the United States.[<-Struck out](b) Consultation- In developing the plan under subsection (a), the Secretary shall consult with the Secretary of Agriculture, Secretary of State, Secretary of the Treasury, and the Secretary of Commerce, representatives of the food industry, appropriate foreign government officials, and nongovernmental organizations that represent the interests of consumers, and other stakeholders.[<-Struck out](c) Plan- The plan developed under subsection (a) shall include, as appropriate, the following:[<-Struck out](1) Recommendations for bilateral and multilateral arrangements and agreements, including provisions to provide for responsibility of exporting countries to ensure the safety of food.[<-Struck out](2) Provisions for electronic data sharing.[<-Struck out](3) Provisions for mutual recognition of inspection reports.[<-Struck out](4) Training of foreign governments and food producers on United States requirements for safe food.[<-Struck out](5) Recommendations to harmonize requirements under the Codex Alimentarius.[<-Struck out](6) Provisions for the multilateral acceptance of laboratory methods and detection techniques.[<-Struck out]Chapter VIII (21 U.S.C. 381 [<-Struck out]‘SEC. 808. INSPECTION OF FOREIGN FOOD FACILITIES.[<-Struck out]‘(a) Inspection- The Secretary--[<-Struck out]
‘(1) may enter into arrangements and agreements with foreign governments to facilitate the inspection of foreign facilities registered under section 415; and[<-Struck out]
‘(2) shall direct resources to inspections of foreign facilities, suppliers, and food types, especially such facilities, suppliers, and food types that present a high risk (as identified by the Secretary), to help ensure the safety and security of the food supply of the United States.[<-Struck out]‘(b) Effect of Inability To Inspect- Notwithstanding any other provision of law, food shall be refused admission into the United States if it is from a foreign facility registered under section 415 of which the owner, operator, or agent in charge of the facility, or the government of the foreign country, refuses to permit entry of United States inspectors, upon request, to inspect such facility. For purposes of this subsection, such an owner, operator, or agent in charge shall be considered to have refused an inspection if such owner, operator, or agent in charge refuses such a request to inspect a facility more than 48 hours after such request is submitted.’.[<-Struck out]Chapter VIII (21 U.S.C. 381 [<-Struck out]‘SEC. 809. ACCREDITATION OF THIRD-PARTY AUDITORS AND AUDIT AGENTS.[<-Struck out]‘(a) Definitions- In this section:[<-Struck out]
‘(1) ACCREDITED AUDIT AGENT- The term ‘accredited audit agent’ means an audit agent accredited by an accreditation body under this section.[<-Struck out]
‘(2) AUDIT AGENT- The term ‘audit agent’ means an individual who is qualified to conduct food safety audits, and who may be an employee or an agent of a third-party auditor.[<-Struck out]
‘(3) ACCREDITATION BODY- The term ‘accreditation body’ means a recognized authority that performs accreditation of third-party auditors and audit agents.[<-Struck out]
‘(4) ACCREDITED THIRD-PARTY AUDITOR- The term ‘accredited third-party auditor’ means a third-party auditor accredited by an accreditation body under this section.[<-Struck out]
‘(5) CONSULTATIVE AUDIT- The term ‘consultative audit’ means an audit of an eligible entity--[<-Struck out]
‘(A) to determine whether such entity is in compliance with the provisions of this Act and with applicable industry standards and practices; and[<-Struck out]
‘(B) the results of which are for internal facility purposes only.[<-Struck out]‘(6) ELIGIBLE ENTITY- The term ‘eligible entity’ means a foreign entity, including foreign facilities registered under section 415, in the food import supply chain that chooses to be audited by an accredited third-party auditor or audit agent.[<-Struck out]
‘(7) REGULATORY AUDIT- The term ‘regulatory audit’ means an audit of an eligible entity--[<-Struck out]
‘(A) to determine whether such entity is in compliance with the provisions of this Act; and[<-Struck out]
‘(B) the results of which determine--[<-Struck out]
‘(i) whether an entity is eligible to receive a certification under section 801(p); and[<-Struck out]
‘(ii) whether the entity is eligible to participate in the voluntary qualified importer program under section 806.[<-Struck out]‘(8) THIRD-PARTY AUDITOR- The term ‘third-party auditor’ means a foreign government, foreign cooperative, or any other qualified third party, as the Secretary determines appropriate, that conducts audits of eligible entities to certify that such eligible entities meet the applicable requirements of this section.[<-Struck out]‘(b) Accreditation System-[<-Struck out]
‘(1) ACCREDITATION BODIES-[<-Struck out]
‘(A) RECOGNITION OF ACCREDITATION BODIES- Beginning not later than 2 years after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall establish a system for the recognition of accreditation bodies that accredit third-party auditors and audit agents to certify that eligible entities meet the applicable requirements of this Act.[<-Struck out]
‘(B) NOTIFICATION- Each accreditation body recognized by the Secretary shall submit to the Secretary a list of all accredited third-party auditors and audit agents accredited by such body.[<-Struck out]
‘(C) REVOCATION OF RECOGNITION AS AN ACCREDITATION BODY- The Secretary shall promptly revoke the recognition of any accreditation body found not to be in compliance with the requirements of this section.[<-Struck out]‘(2) MODEL ACCREDITATION STANDARDS- The Secretary shall develop model standards, including audit report requirements, and each recognized accreditation body shall ensure that third-party auditors and audit agents meet such standards in order to qualify as an accredited third-party auditor or audit agent under this section. In developing the model standards, the Secretary shall look to standards in place on the date of the enactment of this section for guidance, to avoid unnecessary duplication of efforts and costs.[<-Struck out]‘(c) Third-party Auditors and Audit Agencies-[<-Struck out]
‘(1) REQUIREMENTS FOR ACCREDITATION AS A THIRD-PARTY AUDITOR OR AUDIT AGENT-[<-Struck out]
‘(A) FOREIGN GOVERNMENTS- Prior to accrediting a foreign government as an accredited third-party auditor, the accreditation body shall perform such reviews and audits of food safety programs, systems, and standards of the government as the Secretary deems necessary to determine that the foreign government is capable of adequately ensuring that eligible entities certified by such government meet the requirements of this Act with respect to food manufactured, processed, packed, or held for import to the United States.[<-Struck out]
‘(B) FOREIGN COOPERATIVES AND OTHER THIRD PARTIES- Prior to accrediting a foreign cooperative that aggregates the products of growers or processors, or any other third party that the Secretary determines appropriate to be an accredited third-party auditor or audit agent, the accreditation body shall perform such reviews and audits of the training and qualifications of auditors used by that cooperative or party and conduct such reviews of internal systems and such other investigation of the cooperative or party as the Secretary deems necessary to determine that each eligible entity certified by the cooperative or party has systems and standards in use to ensure that such entity meets the requirements of this Act.[<-Struck out]‘(2) REQUIREMENT TO ISSUE CERTIFICATION OF ELIGIBLE ENTITIES-[<-Struck out]
‘(A) IN GENERAL- An accreditation body may not accredit a third-party auditor or audit agent unless such third-party auditor or audit agent agrees to issue a written and electronic certification to accompany each food shipment for import into the United States from an eligible entity certified by the third-party auditor or audit agent, subject to requirements set forth by the Secretary. The Secretary shall consider such certificates when targeting inspection resources under section 421.[<-Struck out]
‘(B) PURPOSE OF CERTIFICATION- The Secretary shall use evidence of certification provided by accredited third-party auditors and audit agents--[<-Struck out]
‘(i) to determined the eligibility of an importer to receive a certification under section 801(p); and[<-Struck out]
‘(ii) determine the eligibility of an importer to participate in the voluntary qualified importer program under section 806.[<-Struck out]‘(3) AUDIT REPORT REQUIREMENTS-[<-Struck out]
‘(A) REQUIREMENTS IN GENERAL- As a condition of accreditation, an accredited third-party auditor or audit agent shall prepare the audit report for an audit, in a form and manner designated by the Secretary, which shall include--[<-Struck out]
‘(i) the identity of the persons at the audited eligible entity responsible for compliance with food safety requirements;[<-Struck out]
‘(ii) the dates of the audit;[<-Struck out]
‘(iii) the scope of the audit; and[<-Struck out]
‘(iv) any other info required by the Secretary that relate to or may influence an assessment of compliance with this Act.[<-Struck out]‘(B) SUBMISSION OF REPORTS TO THE SECRETARY-[<-Struck out]
‘(i) IN GENERAL- Following any accreditation of a third-party auditor or audit agent, the Secretary may, at any time, require the accredited third-party auditor or audit agent to submit to the Secretary an onsite audit report and such other reports or documents required as part of the audit process, for any eligible entity certified by the third-party auditor or audit agent. Such report may include documentation that the eligible entity is in compliance with any applicable registration requirements.[<-Struck out]
‘(ii) LIMITATION- The requirement under clause (i) shall not include any report or other documents resulting from a consultative audit by the accredited third-party auditor or audit agent, except that the Secretary may access the results of a consultative audit in accordance with section 414.[<-Struck out]‘(4) REQUIREMENTS OF AUDIT AGENTS-[<-Struck out]
‘(A) RISKS TO PUBLIC HEALTH- If, at any time during an audit, an accredited audit agent discovers a condition that could cause or contribute to a serious risk to the public health, the audit agent shall immediately notify the Secretary of--[<-Struck out]
‘(i) the identification of the eligible entity subject to the audit; and[<-Struck out]
‘(ii) such condition.[<-Struck out]‘(B) TYPES OF AUDITS- An accredited audit agent may perform consultative and regulatory audits of eligible entities.[<-Struck out]
‘(C) LIMITATIONS- An accredited audit agent may not perform a regulatory audit of an eligible entity if such agent has performed a consultative audit or a regulatory audit of such eligible entity during the previous 24-month period.[<-Struck out]‘(5) CONFLICTS OF INTEREST-[<-Struck out]
‘(A) THIRD-PARTY AUDITORS- An accredited third-party auditor shall--[<-Struck out]
‘(i) not be owned, managed, or controlled by any person that owns or operates an eligible entity to be certified by such auditor;[<-Struck out]
‘(ii) in carrying out audits of eligible entities under this section, have procedures to ensure against the use of any officer or employee of such auditor that has a financial conflict of interest regarding an eligible entity to be certified by such auditor; and[<-Struck out]
‘(iii) annually make available to the Secretary disclosures of the extent to which such auditor and the officers and employees of such auditor have maintained compliance with clauses (i) and (ii) relating to financial conflicts of interest.[<-Struck out]‘(B) AUDIT AGENTS- An accredited audit agent shall--[<-Struck out]
‘(i) not own or operate an eligible entity to be certified by such agent;[<-Struck out]
‘(ii) in carrying out audits of eligible entities under this section, have procedures to ensure that such agent does not have a financial conflict of interest regarding an eligible entity to be certified by such agent; and[<-Struck out]
‘(iii) annually make available to the Secretary disclosures of the extent to which such agent has maintained compliance with clauses (i) and (ii) relating to financial conflicts of interest.[<-Struck out]‘(C) REGULATIONS- The Secretary shall promulgate regulations not later than 18 months after the date of enactment of the FDA Food Safety Modernization Act to ensure that there are protections against conflicts of interest between an accredited third-party auditor or audit agent and the eligible entity to be certified by such auditor or audit agent. Such regulations shall include--[<-Struck out]
‘(i) requiring that audits performed under this section be unannounced;[<-Struck out]
‘(ii) a structure, including timing and public disclosure, for fees paid by eligible entities to accredited third-party auditors or audit agents to decrease the potential for conflicts of interest; and[<-Struck out]
‘(iii) appropriate limits on financial affiliations between an accredited third-party auditor or audit agent and any person that owns or operates an eligible entity to be certified by such auditor or audit agent.[<-Struck out]‘(6) WITHDRAWAL OF ACCREDITATION- The Secretary shall withdraw accreditation from an accredited third-party auditor or audit agent--[<-Struck out]
‘(A) if food from an eligible entity certified by such third-party auditor or audit agent is linked to an outbreak of human or animal illness;[<-Struck out]
‘(B) following a performance audit and finding by the Secretary that the third-party auditor or audit agent no longer meets the requirements for accreditation; or[<-Struck out]
‘(C) following a refusal to allow United States officials to conduct such audits and investigations as may be necessary to ensure continued compliance with the requirements set forth in this section.[<-Struck out]‘(7) NEUTRALIZING COSTS- The Secretary shall establish a method, similar to the method used by the Department of Agriculture, by which accredited third-party auditors and audit agents reimburse the Food and Drug Administration for the work performed to establish and administer the accreditation system under this section. The Secretary shall make operating this program revenue-neutral and shall not generate surplus revenue from such a reimbursement mechanism.[<-Struck out]‘(d) Recertification of Eligible Entities- An eligible entity shall apply for annual recertification by an accredited third-party auditor or audit agent if such entity--[<-Struck out]
‘(1) intends to participate in voluntary qualified importer program under section 806; or[<-Struck out]
‘(2) must provide to the Secretary a certification under section 801(p) for any food from such entity.[<-Struck out]‘(e) False Statements- Any statement or representation made--[<-Struck out]
‘(1) by an employee or agent of an eligible entity to an accredited third-party auditor or audit agent; or[<-Struck out]
‘(2) by an accredited third-party auditor or an audit agent to the Secretary,[<-Struck out]shall be subject tosection 1001 of title 18, United States Code [<-Struck out]‘(f) Monitoring- To ensure compliance with the requirements of this section, the Secretary shall--[<-Struck out]
‘(1) periodically, or at least once every 4 years, reevaluate the accreditation bodies described in subsection (b)(1);[<-Struck out]
‘(2) periodically, or at least once every 4 years, audit the performance of each accredited third-party auditor and audit agent, through the review of audit reports by such auditors and audit agents, the compliance history as available of eligible entities certified by such auditors and audit agents, and any other measures deemed necessary by the Secretary;[<-Struck out]
‘(3) at any time, conduct an onsite audit of any eligible entity certified by an accredited third-party auditor or audit agent, with or without the auditor or audit agent present; and[<-Struck out]
‘(4) take any other measures deemed necessary by the Secretary.[<-Struck out]‘(g) Publicly Available Registry- The Secretary shall establish a publicly available registry of accreditation bodies and of accredited third-party auditors and audit agents, including the name of, contact information for, and other information deemed necessary by the Secretary about such bodies, auditors, and agents.[<-Struck out]
‘(h) Limitations-[<-Struck out]
‘(1) NO EFFECT ON SECTION 704 INSPECTIONS- The audits performed under this section shall not be considered inspections under section 704.[<-Struck out]
‘(2) NO EFFECT ON INSPECTION AUTHORITY- Nothing in this section affects the authority of the Secretary to inspect any eligible entity pursuant to this Act.’.[<-Struck out](a) In General- The Secretary shall by October 1, 2010, establish an office of the Food and Drug Administration in not less than 5 foreign countries selected by the Secretary, to provide assistance to the appropriate governmental entities of such countries with respect to measures to provide for the safety of articles of food and other products regulated by the Food and Drug Administration exported by such country to the United States, including by directly conducting risk-based inspections of such articles and supporting such inspections by such governmental entity.[<-Struck out](b) Consultation- In establishing the foreign offices described in subsection (a), the Secretary shall consult with the Secretary of State and the United States Trade Representative.[<-Struck out](c) Report- Not later than October 1, 2011, the Secretary shall submit to Congress a report on the basis for the selection by the Secretary of the foreign countries in which the Secretary established offices under subsection (a), the progress which such offices have made with respect to assisting the governments of such countries in providing for the safety of articles of food and other products regulated by the Food and Drug Administration exported to the United States, and the plans of the Secretary for establishing additional foreign offices of the Food and Drug Administration, as appropriate.[<-Struck out][Struck out->]
TITLE IV--MISCELLANEOUS PROVISIONS[<-Struck out]
(a) In General- There are authorized to be appropriated to carry out the activities of the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, and related field activities in the Office of Regulatory Affairs of the Food and Drug Administration--[<-Struck out](1) $825,000,000 for fiscal year 2010; and[<-Struck out](2) such sums as may be necessary for fiscal years 2011 through 2014.[<-Struck out](b) Increased Number of Field Staff- To carry out the activities of the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, and related field activities of the Office of Regulatory Affairs of the Food and Drug Administration, the Secretary of Health and Human Services shall increase the field staff of such Centers and Office with a goal of not fewer than--[<-Struck out](1) 3,800 staff members in fiscal year 2010;[<-Struck out](2) 4,000 staff members in fiscal year 2011;[<-Struck out](3) 4,200 staff members in fiscal year 2012;[<-Struck out](4) 4,600 staff members in fiscal year 2013; and[<-Struck out](5) 5,000 staff members in fiscal year 2014.[<-Struck out]Nothing in this Act, or an amendment made by this Act, shall be construed to--[<-Struck out](1) alter the jurisdiction between the Secretary of Agriculture and the Secretary of Health and Human Services, under applicable statutes and regulations;[<-Struck out](2) limit the authority of the Secretary of Health and Human Services to issue regulations related to the safety of food under--[<-Struck out](A) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 [<-Struck out](B) the Public Health Service Act (42 U.S.C. 301 [<-Struck out](3) impede, minimize, or affect the authority of the Secretary of Agriculture to prevent, control, or mitigate a plant or animal health emergency, or a food emergency involving products regulated under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act.[<-Struck out](a) Short Title- This Act may be cited as the ‘FDA Food Safety Modernization Act’.CommentsClose CommentsPermalink
(b) References- Except as otherwise specified, whenever in this Act an amendment is expressed in terms of an amendment to a section or other provision, the reference shall be considered to be made to a section or other provision of the Federal Food, Drug, and Cosmetic Act (
(c) Table of Contents- The table of contents for this Act is as follows:CommentsClose CommentsPermalink
Sec. 1. Short title; references; table of contents.CommentsClose CommentsPermalink
TITLE I--IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS
Sec. 101. Inspections of records.CommentsClose CommentsPermalink
Sec. 102. Registration of food facilities.CommentsClose CommentsPermalink
Sec. 103. Hazard analysis and risk-based preventive controls.CommentsClose CommentsPermalink
Sec. 104. Performance standards.CommentsClose CommentsPermalink
Sec. 105. Standards for produce safety.CommentsClose CommentsPermalink
Sec. 106. Protection against intentional adulteration.CommentsClose CommentsPermalink
Sec. 107. Authority to collect fees.CommentsClose CommentsPermalink
Sec. 108. National agriculture and food defense strategy.CommentsClose CommentsPermalink
Sec. 109. Food and Agriculture Coordinating Councils.CommentsClose CommentsPermalink
Sec. 110. Building domestic capacity.CommentsClose CommentsPermalink
Sec. 111. Sanitary transportation of food.CommentsClose CommentsPermalink
Sec. 112. Food allergy and anaphylaxis management.CommentsClose CommentsPermalink
Sec. 113. New dietary ingredients.CommentsClose CommentsPermalink
Sec. 114. Requirement for guidance relating to post harvest processing of raw oysters.CommentsClose CommentsPermalink
Sec. 115. Port shopping.CommentsClose CommentsPermalink
Sec. 116. Alcohol-related facilities.CommentsClose CommentsPermalink
TITLE II--IMPROVING CAPACITY TO DETECT AND RESPOND TO FOOD SAFETY PROBLEMS
Sec. 201. Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report.CommentsClose CommentsPermalink
Sec. 202. Recognition of lLaboratory accreditation for analyses of foods.CommentsClose CommentsPermalink
Sec. 203. Integrated consortium of laboratory networks.CommentsClose CommentsPermalink
Sec. 204. Enhancing tracebackking and tracing of food and recordkeeping.CommentsClose CommentsPermalink
Sec. 205. Pilot project to enhance traceback and recordkeeping with respect to processed food.Sec. 206. Surveillance.CommentsClose CommentsPermalink
Sec. 206. Mandatory recall authority.CommentsClose CommentsPermalink
Sec. 207. Mandatory recall authority.Sec. 208. Administrative detention of food.CommentsClose CommentsPermalink
Sec. 2098. Decontamination and disposal standards and plans.CommentsClose CommentsPermalink
Sec. 21009. Improving the training of State, local, territorial, and tribal food safety officials.CommentsClose CommentsPermalink
Sec. 210. Enhancing food safety.CommentsClose CommentsPermalink
Sec. 211. Grants to enhance food safetImproving the reportable food registry.CommentsClose CommentsPermalink
TITLE III--IMPROVING THE SAFETY OF IMPORTED FOOD
Sec. 301. Foreign supplier verification program.CommentsClose CommentsPermalink
Sec. 302. Voluntary qualified importer program.CommentsClose CommentsPermalink
Sec. 303. Authority to require import certifications for food.CommentsClose CommentsPermalink
Sec. 304. Prior notice of imported food shipments.CommentsClose CommentsPermalink
Sec. 305. Review of a regulatory authority of a foreign country.Sec. 306. Building capacity of foreign governments with respect to food safety.CommentsClose CommentsPermalink
Sec. 3076. Inspection of foreign food facilities.CommentsClose CommentsPermalink
Sec. 3087. Accreditation of third-party auditors and audit agents.CommentsClose CommentsPermalink
Sec. 3098. Foreign offices of the Food and Drug Administration.CommentsClose CommentsPermalink
Sec. 31009. Smuggled food.CommentsClose CommentsPermalink
TITLE IV--MISCELLANEOUS PROVISIONS
Sec. 401. Funding for food safety.CommentsClose CommentsPermalink
Sec. 402. WhistleblowerEmployee protections.CommentsClose CommentsPermalink
Sec. 403. Jurisdiction; authorities.CommentsClose CommentsPermalink
Sec. 404. Compliance with international agreements.CommentsClose CommentsPermalink
Sec. 405. Determination of budgetary effects.CommentsClose CommentsPermalink
TITLE I--IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMSCommentsClose CommentsPermalink
TITLE I--IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMSCommentsClose CommentsPermalink
SEC. 101. INSPECTIONS OF RECORDS.
(a) In General- Section 414(a) (
(1) by striking the heading and all that follows through ‘of food is’ and inserting the following: ‘Records Inspection-CommentsClose CommentsPermalink
‘(1) ADULTERATED FOOD- If the Secretary has a reasonable belief that an article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, is’;CommentsClose CommentsPermalink
(2) by inserting ‘, and to any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner,’ after ‘relating to such article’;CommentsClose CommentsPermalink
(3) by striking the last sentence; andCommentsClose CommentsPermalink
(4) by inserting at the end the following:CommentsClose CommentsPermalink
‘(2) USE OF OR EXPOSURE TO FOOD OF CONCERN- If the Secretary believes that there is a reasonable probability that the use of or exposure to an article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals, each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports such article shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such person, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to such article and to any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, that are needed to assist the Secretary in determining whether there is a reasonable probability that the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals.CommentsClose CommentsPermalink
‘(3) APPLICATION- The requirement under paragraphs (1) and (2) applies to all records relating to the manufacture, processing, packing, distribution, receipt, holding, or importation of such article maintained by or on behalf of such person in any format (including paper and electronic formats) and at any location.’.CommentsClose CommentsPermalink
(b) Conforming Amendment- Section 704(a)(1)(B) (
SEC. 102. REGISTRATION OF FOOD FACILITIES.
(a) Updating of Food Category Regulations; Biennial Registration Renewal- Section 415(a) (
(1) in paragraph (2), by--CommentsClose CommentsPermalink
(A) striking ‘conducts business and’ and inserting ‘conducts business, the e-mail address for the contact person of the facility or, in the case of a foreign facility, the United States agent for the facility, and’; andCommentsClose CommentsPermalink
(B) inserting ‘, or any other food categories as determined appropriate by the Secretary, including by guidance’ after ‘Code of Federal Regulations’;CommentsClose CommentsPermalink
(2) by redesignating paragraphs (3) and (4) as paragraphs (4) and (5), respectively; andCommentsClose CommentsPermalink
(3) by inserting after paragraph (2) the following:CommentsClose CommentsPermalink
‘(3) BIENNIAL REGISTRATION RENEWAL- During the period beginning on October 1 and ending on December 31 of each even-numbered year, a registrant that has submitted a registration under paragraph (1) shall submit to the Secretary a renewal registration containing the information described in paragraph (2). The Secretary shall provide for an abbreviated registration renewal process for any registrant that has not had any changes to such information since the registrant submitted the preceding registration or registration renewal for the facility involved.’.CommentsClose CommentsPermalink
(b) Suspension of Registration-CommentsClose CommentsPermalink
(1) IN GENERAL- Section 415 (
(A) in subsection (a)(2), by inserting after the first sentence the following: ‘The registration shall contain an assurance that the Secretary will be permitted to inspect such facility at the times and in the manner permitted by this Act.’;CommentsClose CommentsPermalink
(B) by redesignating subsections (b) and (c) as subsections (c) and (d), respectively; andCommentsClose CommentsPermalink
(C) by inserting after subsection (a) the following:CommentsClose CommentsPermalink
‘(b) Suspension of Registration-CommentsClose CommentsPermalink
‘(1) IN GENERAL- If the Secretary determines that food manufactured, processed, packed, received, or held by a facility registered under this section has a reasonable probability of causing serious adverse health consequences or death to humans or animals, the Secretary may by order suspend the registration of the facility under this section in accordance with this subsection.‘(2)a facility--CommentsClose CommentsPermalink
‘(A) that created, caused, or was otherwise responsible for such reasonable probability; orCommentsClose CommentsPermalink
‘(B)(i) that knew of, or had reason to know of, such reasonable probability; andCommentsClose CommentsPermalink
‘(ii) packed, received, or held such food.CommentsClose CommentsPermalink
‘(2) HEARING ON SUSPENSION- The Secretary shall provide the registrant subject to an order under paragraph (1) with an opportunity for an informal hearing, to be held as soon as possible but not later than 2 business days after the issuance of the order or such other time period, as agreed upon by the Secretary and the registrant, on the actions required for reinstatement of registration and why the registration that is subject to suspension should be reinstated. The Secretary shall reinstate a registration if the Secretary determines, based on evidence presented, that adequate grounds do not exist to continue the suspension of the registration.CommentsClose CommentsPermalink
‘(3) POST-HEARING CORRECTIVE ACTION PLAN; VACATING OF ORDER-CommentsClose CommentsPermalink
‘(A) CORRECTIVE ACTION PLAN- If, after providing opportunity for an informal hearing under paragraph (2), the Secretary determines that the suspension of registration remains necessary, the Secretary shall require the registrant to submit a corrective action plan to demonstrate how the registrant plans to correct the conditions found by the Secretary. The Secretary shall review such plan in a timely manner.‘(B) not later than 14 days after the submission of the corrective action plan or such other time period as determined by the Secretary.CommentsClose CommentsPermalink
‘(B) VACATING OF ORDER- Upon a determination by the Secretary that adequate grounds do not exist to continue the suspension actions required by the order, or that such actions should be modified, the Secretary shall vacate the order or modify the orderpromptly vacate the order and reinstate the registration of the facility subject to the order or modify the order, as appropriate.CommentsClose CommentsPermalink
‘(4) EFFECT OF SUSPENSION- If the registration of a facility is suspended under this subsection, such facility shall not import food orno person shall import or export food into the United States from such facility, offer to import food into the United Statesor export food into the United States from such facility, or otherwise introduce food from such facility into interstate or intrastate commerce in the United States.CommentsClose CommentsPermalink
‘(5) REGULATIONS-CommentsClose CommentsPermalink
‘(A) IN GENERAL- The Secretary shall promulgate regulations that describe the standards the Commissioner will use in making a determination to suspend a registration, and the format the Commissioner will use to explain to the registrant the conditions found at the facilityo implement this subsection. The Secretary may promulgate such regulations on an interim final basis.CommentsClose CommentsPermalink
‘(6) B) REGISTRATION REQUIREMENT- The Secretary may require that registration under this section be submitted in an electronic format. Such requirement may not take effect before the date that is 5 years after the date of enactment of the FDA Food Safety Modernization Act.CommentsClose CommentsPermalink
‘(6) APPLICATION DATE- Facilities shall be subject to the requirements of this subsection beginning on the earlier of--CommentsClose CommentsPermalink
‘(A) the date on which the Secretary issues regulations under paragraph (5); orCommentsClose CommentsPermalink
‘(B) 180 days after the date of enactment of the FDA Food Safety Modernization Act.CommentsClose CommentsPermalink
‘(7) NO DELEGATION- The authority conferred by this subsection to issue an order to suspend a registration or vacate an order of suspension shall not be delegated to any officer or employee other than the Commissioner.’.CommentsClose CommentsPermalink
(2) SMALL ENTITY COMPLIANCE POLICY GUIDE- Not later than 180 days after the issuance of the regulations promulgated under section 415(b)(5) of the Federal Food, Drug, and Cosmetic Act (as added by this section), the Secretary shall issue a small entity compliance policy guide setting forth in plain language the requirements of such regulations to assist small entities in complying with registration requirements and other activities required under such section.CommentsClose CommentsPermalink
(3) IMPORTED FOOD- Section 801(l) (
) is amended by inserting ‘(or for which a registration has been suspended under such section)’ after ‘section 415’.CommentsClose CommentsPermalink 21 U.S.C. 381(l)
(c) Clarification of Intent-CommentsClose CommentsPermalink
(1) RETAIL FOOD ESTABLISHMENT- The Secretary shall amend the definition of the term ‘retail food establishment’ in section in 1.227(b)(11) of title 21, Code of Federal Regulations to clarify that, in determining the primary function of an establishment or a retail food establishment under such section, the sale of food products directly to consumers by such establishment and the sale of food directly to consumers by such retail food establishment include--CommentsClose CommentsPermalink
(A) the sale of such food products or food directly to consumers by such establishment at a roadside stand or farmers’ market where such stand or market is located other than where the food was manufactured or processed;CommentsClose CommentsPermalink
(B) the sale and distribution of such food through a community supported agriculture program; andCommentsClose CommentsPermalink
(C) the sale and distribution of such food at any other such direct sales platform as determined by the Secretary.CommentsClose CommentsPermalink
(2) DEFINITIONS- For purposes of paragraph (1)--CommentsClose CommentsPermalink
(A) the term ‘community supported agriculture program’ has the same meaning given the term ‘community supported agriculture (CSA) program’ in section 249.2 of title 7, Code of Federal Regulations (or any successor regulation); andCommentsClose CommentsPermalink
(B) the term ‘consumer’ does not include a business.CommentsClose CommentsPermalink
(d) Conforming Amendments-CommentsClose CommentsPermalink
(1) Section 301(d) (
(2) Section 415(d), as redesignated by subsection (b), is amended by adding at the end before the period ‘for a facility to be registered, except with respect to the reinstatement of a registration that is suspended under subsection (b)’.CommentsClose CommentsPermalink
SEC. 103. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS.
(a) In General- Chapter IV (
‘SEC. 418. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS.
‘(a) In General- The owner, operator, or agent in charge of a facility shall, in accordance with this section, evaluate the hazards that could affect food manufactured, processed, packed, or held by such facility, identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards and provide assurances that such food is not adulterated under section 402 or misbranded under section 403(w), monitor the performance of those controls, and maintain records of this monitoring as a matter of routine practice.CommentsClose CommentsPermalink
‘(b) Hazard Analysis- The owner, operator, or agent in charge of a facility shall--CommentsClose CommentsPermalink
‘(1) identify and evaluate known or reasonably foreseeable hazards that may be associated with the facility, including--CommentsClose CommentsPermalink
‘(A) biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color additives; andCommentsClose CommentsPermalink
‘(B) hazards that occur naturally, or may be unintentionally introduced, or; andCommentsClose CommentsPermalink
‘(2) identify and evaluate hazards that may be intentionally introduced, including by acts of terrorism; andCommentsClose CommentsPermalink
‘(23) develop a written analysis of the hazards.CommentsClose CommentsPermalink
‘(c) Preventive Controls- The owner, operator, or agent in charge of a facility shall identify and implement preventive controls, including at critical control points, if any, to provide assurances that--CommentsClose CommentsPermalink
‘(1) hazards identified in the hazard analysis conducted under subsection (b)(1) will be significantly minimized or prevented;CommentsClose CommentsPermalink
and‘(2 ‘(2) any hazards identified in the hazard analysis conducted under subsection (b)(2) will be significantly minimized or prevented and addressed, consistent with section 420, as applicable; and CommentsClose CommentsPermalink
‘(3) the food manufactured, processed, packed, or held by such facility will not be adulterated under section 402 or misbranded under section 403(w).CommentsClose CommentsPermalink
‘(d) Monitoring of Effectiveness- The owner, operator, or agent in charge of a facility shall monitor the effectiveness of the preventive controls implemented under subsection (c) to provide assurances that the outcomes described in subsection (c) shall be achieved.CommentsClose CommentsPermalink
‘(e) Corrective Actions- The owner, operator, or agent in charge of a facility shall establish procedures that a facility will implement if the preventiveo ensure that, if the preventive controls implemented under subsection (c) are not properly implemented or are found to be ineffective through monitoring under subsection (d).‘(f)--CommentsClose CommentsPermalink
‘(1) appropriate action is taken to reduce the likelihood of recurrence of the implementation failure;CommentsClose CommentsPermalink
‘(2) all affected food is evaluated for safety; andCommentsClose CommentsPermalink
‘(3) all affected food is prevented from entering into commerce if the owner, operator or agent in charge of such facility cannot ensure that the affected food is not adulterated under section 402 or misbranded under section 403(w).CommentsClose CommentsPermalink
‘(f) Verification- The owner, operator, or agent in charge of a facility shall verify that--CommentsClose CommentsPermalink
‘(1) the preventive controls implemented under subsection (c) are adequate to control the hazards identified under subsection (b);CommentsClose CommentsPermalink
‘(2) the owner, operator, or agent is conducting monitoring in accordance with subsection (d);CommentsClose CommentsPermalink
‘(3) the owner, operator, or agent is making appropriate decisions about corrective actions taken under subsection (e);CommentsClose CommentsPermalink
‘(4) the preventive controls implemented under subsection (c) are effectively and significantly minimizing or preventing the occurrence of identified hazards, including through the use of environmental and product testing programs and other appropriate means; andCommentsClose CommentsPermalink
‘(5) there is documented, periodic reanalysis of the plan under subsection (i) to ensure that the plan is still relevant to the raw materials, conditions and processes in the facility, and new and emerging threats.CommentsClose CommentsPermalink
‘(g) Recordkeeping- The owner, operator, or agent in charge of a facility shall maintain, for not less than 2 years, records documenting the monitoring of the preventive controls implemented under subsection (c), instances of nonconformance material to food safety, the results of testing and other appropriate means of verification under subsection (f)(4), instances when corrective actions were implemented, and the efficacy of preventive controls and corrective actions.CommentsClose CommentsPermalink
‘(h) Written Plan and Documentation- The owner, operator, or agent in charge of a facility shall prepare a written plan that documents and describes the procedures used by the facility to comply with the requirements of this section, including analyzing the hazards under subsection (b) and identifying the preventive controls adopted under subsection (c) to address those hazards. Such written plan, together with the documentation described in subsection (g), shall be made promptly available to a duly authorized representative of the Secretary upon oral or written request.CommentsClose CommentsPermalink
‘(i) Requirement To Reanalyze- The owner, operator, or agent in charge of a facility shall conduct a reanalysis under subsection (b) whenever a significant change is made in the activities conducted at a facility operated by such owner, operator, or agent if the change creates a reasonable potential for a new hazard or a significant increase in a previously identified hazard or not less frequently than once every 3 years, whichever is earlier. Such reanalysis shall be completed and additional preventive controls needed to address the hazard identified, if any, shall be implemented before the change in activities at the facility is operative. Such owner, operator, or agent shall revise the written plan required under subsection (h) if such a significant change is made or document the basis for the conclusion that no additional or revised preventive controls are needed. The Secretary may require a reanalysis under this section to respond to new hazards and developments in scientific understanding, including, as appropriate, results from the Department of Homeland Security biological, chemical, radiological, or other terrorism risk assessment.CommentsClose CommentsPermalink
‘(j) Deemed Compliance ofExemption for Seafood, Juice, and Low-acid Canned Food Facilities Subject to HACCP-CommentsClose CommentsPermalink
The owner, operator, or agent in charge of a facility required to comply with‘(1) IN GENERAL- This section shall not apply to a facility if the owner, operator, or agent in charge of such facility is required to comply with, and is in compliance with, 1 of the following standards and regulations with respect to such facility shall be deemed to be in compliance with this section, with respect to such facility:‘(1:CommentsClose CommentsPermalink
‘(A) The Seafood Hazard Analysis Critical Control Points Program of the Food and Drug Administration.CommentsClose CommentsPermalink
‘(2B) The Juice Hazard Analysis Critical Control Points Program of the Food and Drug Administration.CommentsClose CommentsPermalink
‘(3C) The Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards of the Food and Drug Administration (or any successor standards).CommentsClose CommentsPermalink
‘(2) APPLICABILITY- The exemption under paragraph (1)(C) shall apply only with respect to microbiological hazards that are regulated under the standards for Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers under part 113 of chapter 21, Code of Federal Regulations (or any successor regulations).CommentsClose CommentsPermalink
‘(k) Exception for Activities of Facilities Subject to Section 419- This section shall not apply to a facility that is subject to section ctivities of a facility that are subject to section 419.CommentsClose CommentsPermalink
‘(l) Modified Requirements for Qualified Facilities-CommentsClose CommentsPermalink
‘(1) QUALIFIED FACILITIES-CommentsClose CommentsPermalink
‘(A) IN GENERAL- A facility is a qualified facility for purposes of this subsection if the facility meets the conditions under subparagraph (B) or (C).CommentsClose CommentsPermalink
‘(B) VERY SMALL BUSINESS- A facility is a qualified facility under this subparagraph--CommentsClose CommentsPermalink
‘(i) if the facility, including any subsidiary or affiliate of the facility, is, collectively, a very small business (as defined in the regulations promulgated under subsection (n)); andCommentsClose CommentsPermalink
‘(ii) in the case where the facility is a subsidiary or affiliate of an entity, if such subsidiaries or affiliates, are, collectively, a very small business (as so defined).CommentsClose CommentsPermalink
‘(C) LIMITED ANNUAL MONETARY VALUE OF SALES-CommentsClose CommentsPermalink
‘(i) IN GENERAL- A facility is a qualified facility under this subparagraph if clause (ii) applies--CommentsClose CommentsPermalink
‘(I) to the facility, including any subsidiary or affiliate of the facility, collectively; andCommentsClose CommentsPermalink
‘(II) to the subsidiaries or affiliates, collectively, of any entity of which the facility is a subsidiary or affiliate.CommentsClose CommentsPermalink
‘(ii) AVERAGE ANNUAL MONETARY VALUE- This clause applies if--CommentsClose CommentsPermalink
‘(I) during the 3-year period preceding the applicable calendar year, the average annual monetary value of the food manufactured, processed, packed, or held at such facility (or the collective average annual monetary value of such food at any subsidiary or affiliate, as described in clause (i)) that is sold directly to qualified end-users during such period exceeded the average annual monetary value of the food manufactured, processed, packed, or held at such facility (or the collective average annual monetary value of such food at any subsidiary or affiliate, as so described) sold by such facility (or collectively by any such subsidiary or affiliate) to all other purchasers during such period; andCommentsClose CommentsPermalink
‘(II) the average annual monetary value of all food sold by such facility (or the collective average annual monetary value of such food sold by any subsidiary or affiliate, as described in clause (i)) during such period was less than $500,000, adjusted for inflation.CommentsClose CommentsPermalink
‘(2) EXEMPTION- A qualified facility--CommentsClose CommentsPermalink
‘(A) shall not be subject to the requirements under subsections (a) through (i) and subsection (n) in an applicable calendar year; andCommentsClose CommentsPermalink
‘(B) shall submit to the Secretary--CommentsClose CommentsPermalink
‘(i)(I) documentation that demonstrates that the owner, operator, or agent in charge of the facility has identified potential hazards associated with the food being produced, is implementing preventive controls to address the hazards, and is monitoring the preventive controls to ensure that such controls are effective; orCommentsClose CommentsPermalink
‘(II) documentation (which may include licenses, inspection reports, certificates, permits, credentials, certification by an appropriate agency (such as a State department of agriculture), or other evidence of oversight), as specified by the Secretary, that the facility is in compliance with State, local, county, or other applicable non-Federal food safety law; andCommentsClose CommentsPermalink
‘(ii) documentation, as specified by the Secretary in a guidance document issued not later than 1 year after the date of enactment of this section, that the facility is a qualified facility under paragraph (1)(B) or (1)(C).CommentsClose CommentsPermalink
‘(3) WITHDRAWAL; RULE OF CONSTRUCTION-CommentsClose CommentsPermalink
‘(A) IN GENERAL- In the event of an active investigation of a foodborne illness outbreak that is directly linked to a qualified facility subject to an exemption under this subsection, or if the Secretary determines that it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with a qualified facility that are material to the safety of the food manufactured, processed, packed, or held at such facility, the Secretary may withdraw the exemption provided to such facility under this subsection.CommentsClose CommentsPermalink
‘(B) RULE OF CONSTRUCTION- Nothing in this subsection shall be construed to expand or limit the inspection authority of the Secretary.CommentsClose CommentsPermalink
‘(4) DEFINITIONS- In this subsection:CommentsClose CommentsPermalink
‘(A) AFFILIATE- The term ‘affiliate’ means any facility that controls, is controlled by, or is under common control with another facility.CommentsClose CommentsPermalink
‘(B) QUALIFIED END-USER- The term ‘qualified end-user’, with respect to a food, means--CommentsClose CommentsPermalink
‘(i) the consumer of the food; orCommentsClose CommentsPermalink
‘(ii) a restaurant or retail food establishment (as those terms are defined by the Secretary for purposes of section 415) that--CommentsClose CommentsPermalink
‘(I) is located--CommentsClose CommentsPermalink
‘(aa) in the same State as the qualified facility that sold the food to such restaurant or establishment; orCommentsClose CommentsPermalink
‘(bb) not more than 275 miles from such facility; andCommentsClose CommentsPermalink
‘(II) is purchasing the food for sale directly to consumers at such restaurant or retail food establishment.CommentsClose CommentsPermalink
‘(C) CONSUMER- For purposes of subparagraph (B), the term ‘consumer’ does not include a business.CommentsClose CommentsPermalink
‘(D) SUBSIDIARY- The term ‘subsidiary’ means any company which is owned or controlled directly or indirectly by another company.CommentsClose CommentsPermalink
‘(5) STUDY-CommentsClose CommentsPermalink
‘(A) IN GENERAL- The Secretary, in consultation with the Secretary of Agriculture, shall conduct a study of the food processing sector regulated by the Secretary to determine--CommentsClose CommentsPermalink
‘(i) the distribution of food production by type and size of operation, including monetary value of food sold;CommentsClose CommentsPermalink
‘(ii) the proportion of food produced by each type and size of operation;CommentsClose CommentsPermalink
‘(iii) the number and types of food facilities co-located on farms, including the number and proportion by commodity and by manufacturing or processing activity;CommentsClose CommentsPermalink
‘(iv) the incidence of foodborne illness originating from each size and type of operation and the type of food facilities for which no reported or known hazard exists; andCommentsClose CommentsPermalink
‘(v) the effect on foodborne illness risk associated with commingling, processing, transporting, and storing food and raw agricultural commodities, including differences in risk based on the scale and duration of such activities.CommentsClose CommentsPermalink
‘(B) SIZE- The results of the study conducted under subparagraph (A) shall include the information necessary to enable the Secretary to define the terms ‘small business’ and ‘very small business’, for purposes of promulgating the regulation under subsection (n). In defining such terms, the Secretary shall include consideration of harvestable acres, income, the number of employees, and the volume of food harvested.CommentsClose CommentsPermalink
‘(C) SUBMISSION OF REPORT- Not later than 18 months after the date of enactment the FDA Food Safety Modernization Act, the Secretary shall submit to Congress a report that describes the results of the study conducted under subparagraph (A).CommentsClose CommentsPermalink
‘(6) NO PREEMPTION- Nothing in this subsection preempts State, local, county, or other non-Federal law regarding the safe production of food. Compliance with this subsection shall not relieve any person from liability at common law or under State statutory law.CommentsClose CommentsPermalink
‘(7) NOTIFICATION TO CONSUMERS-CommentsClose CommentsPermalink
‘(A) IN GENERAL- A qualified facility that is exempt from the requirements under subsections (a) through (i) and subsection (n) and does not prepare documentation under paragraph (2)(B)(i)(I) shall--CommentsClose CommentsPermalink
‘(i) with respect to a food for which a food packaging label is required by the Secretary under any other provision of this Act, include prominently and conspicuously on such label the name and business address of the facility where the food was manufactured or processed; orCommentsClose CommentsPermalink
‘(ii) with respect to a food for which a food packaging label is not required by the Secretary under any other provisions of this Act, prominently and conspicuously display, at the point of purchase, the name and business address of the facility where the food was manufactured or processed, on a label, poster, sign, placard, or documents delivered contemporaneously with the food in the normal course of business, or, in the case of Internet sales, in an electronic notice.CommentsClose CommentsPermalink
‘(B) NO ADDITIONAL LABEL- Subparagraph (A) does not provide authority to the Secretary to require a label that is in addition to any label required under any other provision of this Act.CommentsClose CommentsPermalink
‘(m) Authority With Respect to Certain Facilities- The Secretary may, by regulation, exempt or modify the requirements for compliance under this section with respect to facilities that are solely engaged in the production of food for animals other than man, the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing, or the storage of packaged foods that are not exposed to the environment.CommentsClose CommentsPermalink
‘(mn) Regulations-CommentsClose CommentsPermalink
‘(1) IN GENERAL- Not later than 18 months after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall promulgate regulations--CommentsClose CommentsPermalink
‘(A) to establish science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of the preventive controls under this section; andCommentsClose CommentsPermalink
‘(B) to define, for purposes of this section, the terms ‘small business’ and ‘very small business’, taking into consideration the study described in subsection (l)(5).CommentsClose CommentsPermalink
‘(2) COORDINATION- In promulgating the regulations under paragraph (1)(A), with regard to hazards that may be intentionally introduced, including by acts of terrorism, the Secretary shall coordinate with the Secretary of Homeland Security, as appropriate.CommentsClose CommentsPermalink
‘(3) CONTENT- The regulations promulgated under paragraph (1)(A) shall--CommentsClose CommentsPermalink
‘(A) provide sufficient flexibility to be practicable for all sizes and types of facilities, including small businesses such as a small food processing facility co-located on a farm;CommentsClose CommentsPermalink
‘(B) comply with chapter 35 of title 44, United States Code (commonly known as the ‘Paperwork Reduction Act’), with special attention to minimizing the burden (as defined in section 3502(2) of such Act) on the facility, and collection of information (as defined in section 3502(3) of such Act), associated with such regulations;CommentsClose CommentsPermalink
‘(C) acknowledge differences in risk and minimize, as appropriate, the number of separate standards that apply to separate foods; andCommentsClose CommentsPermalink
‘(D) not require a facility to hire a consultant or other third party to identify, implement, certify, or audit preventative controls, except in the case of negotiated enforcement resolutions that may require such a consultant or third party.CommentsClose CommentsPermalink
‘(4) RULE OF CONSTRUCTION- Nothing in this subsection shall be construed to provide the Secretary with the authority to prescribe specific technologies, practices, or critical controls for an individual facility.CommentsClose CommentsPermalink
‘(5) REVIEW- In promulgating the regulations under paragraph (1)(A), the Secretary shall review regulatory hazard analysis and preventive control programs in existence on the date of enactment of the FDA Food Safety Modernization Act, including the Grade ‘A’ Pasteurized Milk Ordinance to ensure that such regulations are consistent, to the extent practicable, with applicable domestic and internationally-recognized standards in existence on such date.CommentsClose CommentsPermalink
‘(o) Definitions- For purposes of this section:CommentsClose CommentsPermalink
‘(1) CRITICAL CONTROL POINT- The term ‘critical control point’ means a point, step, or procedure in a food process at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce such hazard to an acceptable level.CommentsClose CommentsPermalink
‘(2) FACILITY- The term ‘facility’ means a domestic facility or a foreign facility that is required to register under section 415.CommentsClose CommentsPermalink
‘(3) PREVENTIVE CONTROLS- The term ‘preventive controls’ means those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis conducted under subsection (ab) and that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis. Those procedures, practices, and processes may include the following:CommentsClose CommentsPermalink
‘(A) Sanitation procedures for food contact surfaces and utensils and food-contact surfaces of equipment.CommentsClose CommentsPermalink
‘(B) Supervisor, manager, and employee hygiene training.CommentsClose CommentsPermalink
‘(C) An environmental monitoring program to verify the effectiveness of pathogen controls in processes where a food is exposed to a potential contaminant in the environment.CommentsClose CommentsPermalink
‘(D) A food allergen control program.CommentsClose CommentsPermalink
‘(E) A recall plan.CommentsClose CommentsPermalink
‘(F) Current Good Manufacturing Practices (GMPcGMPs) under part 110 of title 21, Code of Federal Regulations (or any successor regulations).CommentsClose CommentsPermalink
‘(G) Supplier verification activities that relate to the safety of food.’.CommentsClose CommentsPermalink
(b) Regulations-(1Guidance Document- The Secretary shall issue a guidance document related to the regulations promulgated under subsection (b)(1) with respect to the hazard analysis and preventive controls under section 418 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)).CommentsClose CommentsPermalink
(c) Rulemaking-CommentsClose CommentsPermalink
(1) PROPOSED RULEMAKING-CommentsClose CommentsPermalink
(A) IN GENERAL- Not later than 189 months after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this Act subsection as the ‘Secretary’) shall promulgate regulations to establishublish a notice of proposed rulemaking in the Federal Register to promulgate regulations with respect to--CommentsClose CommentsPermalink
(i) activities that constitute on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership for purposes of section 415 of the Federal Food, Drug, and Cosmetic Act (
), as amended by this Act; andCommentsClose CommentsPermalink 21 U.S.C. 350d (ii) activities that constitute on-farm manufacturing or processing of food that is not consumed on that farm or on another farm under common ownership for purposes of such section 415.CommentsClose CommentsPermalink
(B) CLARIFICATION- The rulemaking described under subparagraph (A) shall enhance the implementation of such section 415 and clarify the activities that are included as part of the definition of the term ‘facility’ under such section 415. Nothing in this Act authorizes the Secretary to modify the definition of the term ‘facility’ under such section.CommentsClose CommentsPermalink
(C) SCIENCE-BASED RISK ANALYSIS- In promulgating regulations under subparagraph (A), the Secretary shall conduct a science-based minimum standards for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the implementation of the preventive controls underrisk analysis of--CommentsClose CommentsPermalink
(i) specific types of on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership, as such packing and holding relates to specific foods; andCommentsClose CommentsPermalink
(ii) specific on-farm manufacturing and processing activities as such activities relate to specific foods that are not consumed on that farm or on another farm under common ownership.CommentsClose CommentsPermalink
(D) AUTHORITY WITH RESPECT TO CERTAIN FACILITIES-CommentsClose CommentsPermalink
(i) IN GENERAL- In promulgating the regulations under subparagraph (A), the Secretary shall consider the results of the science-based risk analysis conducted under subparagraph (C), and shall exempt certain facilities from the requirements in section 418 of the Federal Food, Drug, and Cosmetic Act (as added by this section), including hazard analysis and preventive controls, and the mandatory inspection frequency in section 421 of such Act (as added by section 201), or modify the requirements in such sections 418 or 421, as the Secretary determines appropriate, if such facilities are engaged only in specific types of on-farm manufacturing, processing, packing, or holding activities that the Secretary determines to be low risk involving specific foods the Secretary determines to be low risk.CommentsClose CommentsPermalink
(ii) LIMITATION- The exemptions or modifications under clause (i) shall not include an exemption from the requirement to register under section 415 of the Federal Food, Drug, and Cosmetic Act (
), as amended by this Act, if applicable, and shall apply only to small businesses and very small businesses, as defined in the regulation promulgated under section 418(n) of the Federal Food, Drug, and Cosmetic Act (as added under subsection (a)).CommentsClose CommentsPermalink 21 U.S.C. 350d (2) CONTENT- The regulations promulgated under paragraph (1) shall provide sufficient flexibility to be applicable in all situations, including in the operations of small businesses.
(3) RULE OF CONSTRUCTION- Nothing in this subsection shall be construed to provide the Secretary with the authority to apply specific technologies, practices, or critical controls to an individual facility.
(4) REVIEW- In promulgating the regulations under paragraph FINAL REGULATIONS- Not later than 9 months after the close of the comment period for the proposed rulemaking under paragraph (1), the Secretary shallreview regulatory hazard analysis and preventive control programs in existence on the date of enactment of this Act to ensure that the program under adopt final rules with respect to--CommentsClose CommentsPermalink
(A) activities that constitute on-farm packing or holding of food that is not grown, raised, or consumed on such farm or another farm under the same ownership for purposes of section 415 of the Federal Food, Drug, and Cosmetic Act (
), as amended by this Act;CommentsClose CommentsPermalink 21 U.S.C. 350d (B) activities that constitute on-farm manufacturing or processing of food that is not consumed on that farm or on another farm under common ownership for purposes of such section 418 is consistent, to the extent practicable, with applicable domestic and internationally-recognized standards in existence on such date.(c) Guidance Document- The Secretary shall issue a guidance document related to hazard analysis and preventive controls related to the regulations promulgated under section5; andCommentsClose CommentsPermalink
(C) the requirements under sections 418 and 421 of the Federal Food, Drug, and Cosmetic Act, as added by this Act, from which the Secretary may issue exemptions or modifications of the requirements for certain types of facilities.CommentsClose CommentsPermalink
(d) Small Entity Compliance Policy Guide- Not later than 180 days after the issuance of the regulations promulgated under subsection (n) of section 418 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)).(d, the Secretary shall issue a small entity compliance policy guide setting forth in plain language the requirements of such section 418 and this section to assist small entities in complying with the hazard analysis and other activities required under such section 418 and this section.CommentsClose CommentsPermalink
(e) Prohibited Acts- Section 301 (
) is amended by adding at the end the following:CommentsClose CommentsPermalink 21 U.S.C. 331 ‘(uu) The operation of a facility that manufacturers, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is not in compliance with section 418.’.CommentsClose CommentsPermalink
(ef) No Effect on HACCP Authorities- Nothing in the amendments made by this section limits the authority of the Secretary under the Federal Food, Drug, and Cosmetic Act (
et seq.) or the Public Health Service Act ( 21 U.S.C. 301 et seq.) to revise, issue, or enforce product and category-specific regulations, such as the Seafood Hazard Analysis Critical Controls Points Program, the Juice Hazard Analysis Critical Control Program, programs and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards.CommentsClose CommentsPermalink 42 U.S.C. 201 (fg) Dietary Supplements- Nothing in the amendments made by this section shall apply to any facility with regard to the manufacturing, processing, packing, or holding of a dietary supplement that is in compliance with the requirements of sections 402(g)(2) and 761 of the Federal Food, Drug, and Cosmetic Act (
, 379aa-1).CommentsClose CommentsPermalink 21 U.S.C. 342(g)(2)
(g) No Effect on Alcohol-related Facilities-
(1) IN GENERAL- Nothing in the amendments made by this section shall apply to a facility that--
(A) under the Federal Alcohol Administration Act (
et seq.) or chapter 51 of subtitle E of the Internal Revenue Code of 1986 ( 27 U.S.C. 201 et seq.) is required to obtain a permit or to register with the Secretary of the Treasury as a condition of doing business in the United States; and 26 U.S.C. 5291 (B) is required to register as a facility under section 415 of the Federal Food, Drug, and Cosmetic Act (
) because such facility is engaged in manufacturing, processing, packing, or holding 1 or more alcoholic beverages, 21 U.S.C. 350d with respect to the activities of such facility that relate to the manufacturing, processing, packing, or holding of alcoholic beverages.
(2) LIMITED RECEIPT AND DISTRIBUTION OF NON-ALCOHOL FOOD- Paragraph (1) shall not apply to a facility engaged in the receipt or distribution of any non-alcohol food, except that such paragraph shall apply to a facility described in such paragraph that receives and distributes non-alcohol food, provided such food is received and distributed--
(A) in a prepackaged form that prevents any direct human contact with such food; and
(B) in amounts that constitute not more than 5 percent of the overall sales of such facility, as determined by the Secretary of the Treasury.
(3) RULE OF CONSTRUCTION- Except as provided in paragraphs (1) and (2), this subsection shall not be construed to exempt any food, other than distilled spirits, wine, and malt beverages, as defined in section 211 of the Federal Alcohol Administration Act (
(h) Updating Guidance Relating to Fish and Fisheries Products Hazards and Controls- The Secretary shall, not later than 180 days after the date of enactment of this Act, update the Fish and Fisheries Products Hazards and Control Guidance to take into account advances in technology that have occurred since the previous publication of such Guidance by the Secretary.CommentsClose CommentsPermalink), from the requirements of this Act (including the amendments made by this Act). 27 U.S.C. 211 (i) Effective Dates-CommentsClose CommentsPermalink
(1) GENERAL RULE- The amendments made by this section shall take effect 18 months after the date of enactment of this Act.CommentsClose CommentsPermalink
(2) EXCEPTIONFLEXIBILITY FOR SMALL BUSINESSES- Notwithstanding paragraph (1)--CommentsClose CommentsPermalink
(A) the amendments made by this section shall apply to a small business (as defined by the Secretary for purposes of this section, not later than 90 days after the date of enactment of this Act) after the date that is 2 years after the date of enactment of this Actin the regulations promulgated under section 418(n) of the Federal Food, Drug, and Cosmetic Act (as added by this section)) beginning on the date that is 6 months after the effective date of such regulations; andCommentsClose CommentsPermalink
(B) the amendments made by this section shall apply to a very small business (as defined by the Secretary for purposes of this section, not later than 90 days after the date of enactment of this Act) after the date that in such regulations) beginning on the date that is 3 years after the date of enactment of this Act18 months after the effective date of such regulations.CommentsClose CommentsPermalink
SEC. 104. PERFORMANCE STANDARDS.
The Secretary shall(a) In General- The Secretary shall, in coordination with the Secretary of Agriculture, not less frequently than every 2 years, review and evaluate relevant health data and other relevant information, including from toxicological and epidemiological studies and analyses, to determine the current Good Manufacturing Practices issued by the Secretary relating to food, and relevant recommendations of relevant advisory committees, including the Food Advisory Committee, to determine the most significant foodborne contaminants.CommentsClose CommentsPermalink
Based on such review and evaluation(b) Guidance Documents and Regulations- Based on the review and evaluation conducted under subsection (a), and when appropriate to reduce the risk of serious illness or death to humans or animals or to prevent adulteration of the food under section 402 of the Federal Food, Drug, or Cosmetic Act (
(1) shall apply to products or product classes and;CommentsClose CommentsPermalink
(2) shall, where appropriate, differentiate between food for human consumption and food intended for consumption by animals other than humans; andCommentsClose CommentsPermalink
(3) shall not be written to be facility-specific.CommentsClose CommentsPermalink
(c) No Duplication of Efforts- The Secretary shall coordinate with the Secretary of Agriculture to avoid issuing duplicative guidance on the same contaminants.CommentsClose CommentsPermalink
(d) Review- The Secretary shall periodically review and revise, as appropriate, the guidance documents, including guidance documents regarding action levels, or regulations promulgated under this section.CommentsClose CommentsPermalink
SEC. 105. STANDARDS FOR PRODUCE SAFETY.
(a) In General- Chapter IV (
‘SEC. 419. STANDARDS FOR PRODUCE SAFETY.
‘(a) Proposed Rulemaking-CommentsClose CommentsPermalink
‘(1) IN GENERAL-CommentsClose CommentsPermalink
‘(A) RULEMAKING- Not later than 1 year after the date of enactment of the FDA Food Safety Modernization Act, the Secretary, in coordination with the Secretary of Agriculture and representatives of State departments of agriculture (including with regard to the national organic program established under the Organic Foods Production Act of 1990 (
et seq.))), and in consultation with the Secretary of Homeland Security, shall publish a notice of proposed rulemaking to establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death.CommentsClose CommentsPermalink 7 U.S.C. 6501 ‘(B) DETERMINATION BY SECRETARY- With respect to small businesses and very small businesses (as such terms are defined in the regulation promulgated under subparagraph (A)) that produce and harvest those types of fruits and vegetables that are raw agricultural commodities that the Secretary has determined are low risk and do not present a risk of serious adverse health consequences or death, the Secretary may determine not to include production and harvesting of such fruits and vegetables in such rulemaking, or may modify the applicable requirements of regulations promulgated pursuant to this section.CommentsClose CommentsPermalink
‘(2) PUBLIC INPUT- During the comment period on the notice of proposed rulemaking under paragraph (1), the Secretary shall conduct not less than 3 public meetings in diverse geographical areas of the United States to provide persons in different regions an opportunity to comment.CommentsClose CommentsPermalink
‘(3) CONTENT- The proposed rulemaking under paragraph (1) shall--CommentsClose CommentsPermalink
‘(A) provide sufficient flexibility to be applicable to various types of entities engaged in the production and harvesting of raw agricultural commodities, including small businesses and entities thatfruits and vegetables that are raw agricultural commodities, including small businesses and entities that sell directly to consumers, and be appropriate to the scale and diversity of the production and harvesting of such commodities;CommentsClose CommentsPermalink
‘(B) include, with respect to growing, harvesting, sorting, packing, and storage operations, science-based minimum standards related to soil amendments, hygiene, packaging, temperature controls, animal encroachments in the growing area, and water;CommentsClose CommentsPermalink
‘(C) consider hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced, including by acts of terrorism;CommentsClose CommentsPermalink
‘(D) take into consideration, consistent with ensuring enforceable public health protection, conservation and environmental practice standards and policies established by Federal natural resource conservation, wildlife conservation, and environmental agencies;CommentsClose CommentsPermalink
and‘(E) in the case of production that is certified organic, not include any requirements that conflict with or duplicate the requirements of the national organic program established under the Organic Foods Production Act of 1990 (
et seq.), while providing for public health protection consistent with the requirements of this Act.the same level of public health protection as the requirements under guidance documents, including guidance documents regarding action levels, and regulations under the FDA Food Safety Modernization Act; andCommentsClose CommentsPermalink 7 U.S.C. 6501 ‘(F) define, for purposes of this section, the terms ‘small business’ and ‘very small business’CommentsClose CommentsPermalink
‘(4) PRIORITIZATION- The Secretary shall prioritize the implementation of the regulations for specific under this section for specific fruits and vegetables that are raw agricultural commodities that have been associated with foodborne illness based on known risks which may include a history and severity of foodborne illness outbreaks.CommentsClose CommentsPermalink
‘(b) Final Regulation-CommentsClose CommentsPermalink
‘(1) IN GENERAL- Not later than 1 year after the close of the comment period for the proposed rulemaking under subsection (a), the Secretary shall adopt a final regulation to provide for minimum science-based standards for those types of fruits and vegetables that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death, including specific mixes or categories of fruits or vegetables, that are raw agricultural commodities, based on known safety risks, which may include a history of foodborne illness outbreaks.CommentsClose CommentsPermalink
‘(2) FINAL REGULATION- The final regulation shall--CommentsClose CommentsPermalink
‘(A) provide a reasonable period of time for compliance, taking into account the needs of small businesses for additional time to comply;‘(B) provide for coordination of education and enforcement activities by State and local officials, as designated by the Governors of the respective States; and‘(C or the appropriate elected State official as recognized by State statute; andCommentsClose CommentsPermalink
‘(B) include a description of the variance process under subsection (c) and the types of permissible variances the Secretary may grant.CommentsClose CommentsPermalink
‘(c) 3) FLEXIBILITY FOR SMALL BUSINESSES- Notwithstanding paragraph (1)--CommentsClose CommentsPermalink
‘(A) the regulations promulgated under this section shall apply to a small business (as defined in the regulation promulgated under subsection (a)(1)) after the date that is 1 year after the effective date of the final regulation under paragraph (1); andCommentsClose CommentsPermalink
‘(B) the regulations promulgated under this section shall apply to a very small business (as defined in the regulation promulgated under subsection (a)(1)) after the date that is 2 years after the effective date of the final regulation under paragraph (1).CommentsClose CommentsPermalink
‘(c) Criteria-CommentsClose CommentsPermalink
‘(1) IN GENERAL- The regulations adopted under subsection (b) shall--CommentsClose CommentsPermalink
‘(A) set forth those procedures, processes, and practices asthat the Secretary determines to minimize the risk of serious adverse health consequences or death, including procedures, processes, and practices that the Secretary determines to be reasonably necessary to prevent the introduction of known or reasonably foreseeable biological, chemical, and physical hazards, including hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced, including by acts of terrorism, into fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities and to provide reasonable assurances that the produce is not adulterated under section 402;CommentsClose CommentsPermalink
and‘(B ‘(B) provide sufficient flexibility to be practicable for all sizes and types of businesses, including small businesses such as a small food processing facility co-located on a farm; CommentsClose CommentsPermalink
‘(C) comply with chapter 35 of title 44, United States Code (commonly known as the ‘Paperwork Reduction Act’), with special attention to minimizing the burden (as defined in section 3502(2) of such Act) on the business, and collection of information (as defined in section 3502(3) of such Act), associated with such regulations;CommentsClose CommentsPermalink
‘(D) acknowledge differences in risk and minimize, as appropriate, the number of separate standards that apply to separate foods; andCommentsClose CommentsPermalink
‘(E) not require a business to hire a consultant or other third party to identify, implement, certify, compliance with these procedures, processes, and practices, except in the case of negotiated enforcement resolutions that may require such a consultant or third party; andCommentsClose CommentsPermalink
‘(F) permit States and foreign countries from which food is imported into the United States, subject to paragraph (2), to request from the Secretary variances from the requirements of the regulations, where upon approval of the Secretary, the variance is considered permissible under the requirements of the regulations adopted under subsection (b)(2)(C) andsubject to paragraph (2), where the State or foreign country determines that the variance is necessary in light of local growing conditions and that the procedures, processes, and practices to be followed under the variance are reasonably likely to ensure that the produce is not adulterated under section 402 toand to provide the same extent as the requirements of the regulationlevel of public health protection as the requirements of the regulations adopted under subsection (b).CommentsClose CommentsPermalink
‘(2) APPROVAL OF VARIANCES-CommentsClose CommentsPermalink
A State or foreign country from which food is imported into the United States shall‘(A) REQUESTS FOR VARIANCES- A State or foreign country from which food is imported into the United States may in writing request a variance from the Secretary in writing. The Secretary may deny such a request as not reasonably . Such request shall describe the variance requested and present information demonstrating that the variance does not increase the likelihood that the food for which the variance is requested will be adulterated under section 402, and that the variance provides the same level of public health protection as the requirements of the regulations adopted under subsection (b). The Secretary shall review such requests in a reasonable timeframe.CommentsClose CommentsPermalink
‘(B) APPROVAL OF VARIANCES- The Secretary may approve a variance in whole or in part, as appropriate, and may specify the scope of applicability of a variance to other similarly situated persons.CommentsClose CommentsPermalink
‘(C) DENIAL OF VARIANCES- The Secretary may deny a variance request if the Secretary determines that such variance is not reasonably likely to ensure that the producefood is not adulterated under section 402 toand is not reasonably likely to provide the same extentlevel of public health protection as the requirements of the regulation adopted under subsection (b). The Secretary shall notify the person requesting such variance of the reasons for the denial.CommentsClose CommentsPermalink
‘(D) MODIFICATION OR REVOCATION OF A VARIANCE- The Secretary, after notice and an opportunity for a hearing, may modify or revoke a variance if the Secretary determines that such variance is not reasonably likely to ensure that the food is not adulterated under section 402 and is not reasonably likely to provide the same level of public health protection as the requirements of the regulations adopted under subsection (b).CommentsClose CommentsPermalink
‘(d) Enforcement- The Secretary may coordinate with the Secretary of Agriculture and, as appropriate, shall contract and coordinate with the agency or department designated by the Governor of each State to perform activities to ensure compliance with this section.CommentsClose CommentsPermalink
‘(e) Guidance-CommentsClose CommentsPermalink
‘(1) IN GENERAL- Not later than 1 year after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall publish, after consultation with the Secretary of Agriculture, representatives of State departments of agriculture, farmer representatives, and various types of entities engaged in the production and harvesting or importing of fruits and vegetables that are raw agricultural commodities, including small businesses, updated good agricultural practices and guidance for the safe production and harvesting of specific types of fresh produce.‘(2) under this section.CommentsClose CommentsPermalink
‘(2) PUBLIC MEETINGS- The Secretary shall conduct not fewer than 3 public meetings in diverse geographical areas of the United States as part of an effort to conduct education and outreach regarding the guidance described in paragraph (1) for persons in different regions who are involved in the production and harvesting of fruits and vegetables that are raw agricultural commodities, including persons that sell directly to consumers and farmer representatives, and for importers of fruits and vegetables that are raw agricultural commodities.CommentsClose CommentsPermalink
‘(3) PAPERWORK REDUCTION- The Secretary shall ensure that any updated guidance under this section will--CommentsClose CommentsPermalink
‘(A) provide sufficient flexibility to be practicable for all sizes and types of facilities, including small businesses such as a small food processing facility co-located on a farm; andCommentsClose CommentsPermalink
‘(B) acknowledge differences in risk and minimize, as appropriate, the number of separate standards that apply to separate foods.CommentsClose CommentsPermalink
‘(f) Exemption for Direct Farm Marketing-CommentsClose CommentsPermalink
‘(1) IN GENERAL- A farm shall be exempt from the requirements under this section in a calendar year if--CommentsClose CommentsPermalink
‘(A) during the previous 3-year period, the average annual monetary value of the food sold by such farm directly to qualified end-users during such period exceeded the average annual monetary value of the food sold by such farm to all other buyers during such period; andCommentsClose CommentsPermalink
‘(B) the average annual monetary value of all food sold during such period was less than $500,000, adjusted for inflation.CommentsClose CommentsPermalink
‘(2) NOTIFICATION TO CONSUMERS-CommentsClose CommentsPermalink
‘(A) IN GENERAL- A farm that is exempt from the requirements under this section shall--CommentsClose CommentsPermalink
‘(i) with respect to a food for which a food packaging label is required by the Secretary under any other provision of this Act, include prominently and conspicuously on such label the name and business address of the farm where the produce was grown; orCommentsClose CommentsPermalink
‘(ii) with respect to a food for which a food packaging label is not required by the Secretary under any other provision of this Act, prominently and conspicuously display, at the point of purchase, the name and business address of the farm where the produce was grown, on a label, poster, sign, placard, or documents delivered contemporaneously with the food in the normal course of business, or, in the case of Internet sales, in an electronic notice.CommentsClose CommentsPermalink
‘(B) NO ADDITIONAL LABEL- Subparagraph (A) does not provide authority to the Secretary to require a label that is in addition to any label required under any other provision of this Act.CommentsClose CommentsPermalink
‘(3) WITHDRAWAL; RULE OF CONSTRUCTION-CommentsClose CommentsPermalink
‘(A) IN GENERAL- In the event of an active investigation of a foodborne illness outbreak that is directly linked to a farm subject to an exemption under this subsection, or if the Secretary determines that it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with a farm that are material to the safety of the food produced or harvested at such farm, the Secretary may withdraw the exemption provided to such farm under this subsection.CommentsClose CommentsPermalink
‘(B) RULE OF CONSTRUCTION- Nothing in this subsection shall be construed to expand or limit the inspection authority of the Secretary.CommentsClose CommentsPermalink
‘(4) DEFINITIONS-CommentsClose CommentsPermalink
‘(A) QUALIFIED END-USER- In this subsection, the term ‘qualified end-user’, with respect to a food means--CommentsClose CommentsPermalink
‘(i) the consumer of the food; orCommentsClose CommentsPermalink
‘(ii) a restaurant or retail food establishment (as those terms are defined by the Secretary for purposes of section 415) that is located--CommentsClose CommentsPermalink
‘(I) in the same State as the farm that produced the food; orCommentsClose CommentsPermalink
‘(II) not more than 275 miles from such farm.CommentsClose CommentsPermalink
‘(B) CONSUMER- For purposes of subparagraph (A), the term ‘consumer’ does not include a business.CommentsClose CommentsPermalink
‘(5) NO PREEMPTION- Nothing in this subsection preempts State, local, county, or other non-Federal law regarding the safe production, harvesting, holding, transportation, and sale of fresh fruits and vegetables. Compliance with this subsection shall not relieve any person from liability at common law or under State statutory law.CommentsClose CommentsPermalink
‘(6) LIMITATION OF EFFECT- Nothing in this subsection shall prevent the Secretary from exercising any authority granted in the other sections of this Act.CommentsClose CommentsPermalink
‘(g) Clarification- This section shall not apply to produce that is produced by an individual for personal consumption.CommentsClose CommentsPermalink
‘(h) Exception for Activities of Facilities Subject to Section 418- This section shall not apply to a facility that is subject to section ctivities of a facility that are subject to section 418.’.CommentsClose CommentsPermalink
(b) Small Entity Compliance Policy Guide- Not later than 180 days after the issuance of regulations under section 419 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)), the Secretary of Health and Human Services shall issue a small entity compliance policy guide setting forth in plain language the requirements of such section 419 and to assist small entities in complying with standards for safe production and harvesting and other activities required under such section.CommentsClose CommentsPermalink
(c) Prohibited Acts- Section 301 (
), as amended by section 103, is amended by adding at the end the following:CommentsClose CommentsPermalink 21 U.S.C. 331 ‘(vv) The failure to comply with the requirements under section 419.’.CommentsClose CommentsPermalink
(cd) No Effect on HACCP Authorities- Nothing in the amendments made by this section limits the authority of the Secretary under the Federal Food, Drug, and Cosmetic Act (
et seq.) or the Public Health Service Act ( 21 U.S.C. 301 et seq.) to revise, issue, or enforce product and category-specific regulations, such as the Seafood Hazard Analysis Critical Controls Points Program, the Juice Hazard Analysis Critical Control Program, and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards.CommentsClose CommentsPermalink 42 U.S.C. 201
SEC. 106. PROTECTION AGAINST INTENTIONAL ADULTERATION.
(a) In General- Chapter IV (
‘SEC. 420. PROTECTION AGAINST INTENTIONAL ADULTERATION.
‘(a) In General- Not later than 2 years after the date of enactment of the FDA Food Safety Modernization Act, the Secretary, in consultation with the Secretary of Homeland Security and the Secretary of Agriculture, shall promulgate regulations to protect against the intentional adulteration of food subject to this Act.
‘(b) Applicability- Regulations under subsection (a) shall apply only to food--
‘(1) for which the Secretary has identified clear vulnerabilities (including short shelf-life or susceptibility to intentional contamination at critical control points);
‘(2) in bulk or batch form, prior to being packaged for the final consumer; and
‘(3) for which there is a high risk of intentional contamination, as determined by the Secretary, that could cause serious adverse health consequences or death to humans or animals.
‘(c) Determinations- In making the determination under subsection (b)(3), the Secretary shall--
‘(1) conductDeterminations-CommentsClose CommentsPermalink
‘(1) IN GENERAL- The Secretary shall--CommentsClose CommentsPermalink
‘(A) conduct a vulnerability assessments of the food system;‘(2 of the food system, including by consideration of the Department of Homeland Security biological, chemical, radiological, or other terrorism risk assessments;CommentsClose CommentsPermalink
‘(B) consider the best available understanding of uncertainties, risks, costs, and benefits associated with guarding against intentional adulteration of food at vulnerable points; andCommentsClose CommentsPermalink
‘(3C) determine the types of science-based mitigation strategies or measures that are necessary to protect against the intentional adulteration of food.CommentsClose CommentsPermalink
‘(d) Content of Regulations- Regulations under subsection (a)2) LIMITED DISTRIBUTION- In the interest of national security, the Secretary, in consultation with the Secretary of Homeland Security, may determine the time, manner, and form in which determinations made under paragraph (1) are made publicly available.CommentsClose CommentsPermalink
‘(b) Regulations- Not later than 18 months after the date of enactment of the FDA Food Safety Modernization Act, the Secretary, in coordination with the Secretary of Homeland Security and in consultation with the Secretary of Agriculture, shall promulgate regulations to protect against the intentional adulteration of food subject to this Act. Such regulations shall--CommentsClose CommentsPermalink
‘(1) specify how a person shall assess whether the person is required to implement mitigation strategies or measures intended to protect against the intentional adulteration of food; andCommentsClose CommentsPermalink
‘(2) specify appropriate science-based mitigation strategies or measures to prepare and protect the food supply chain at specific vulnerable points, as appropriate.CommentsClose CommentsPermalink
‘(ec) Applicability- Regulations promulgated under subsection (b) shall apply only to food for which there is a high risk of intentional contamination, as determined by the Secretary, in consultation with the Secretary of Homeland Security, under subsection (a), that could cause serious adverse health consequences or death to humans or animals and shall include those foods--CommentsClose CommentsPermalink
‘(1) for which the Secretary has identified clear vulnerabilities (including short shelf-life or susceptibility to intentional contamination at critical control points); andCommentsClose CommentsPermalink
‘(2) in bulk or batch form, prior to being packaged for the final consumer.CommentsClose CommentsPermalink
‘(d) Exception- This section shall not apply to farms, except for those that produce milk.CommentsClose CommentsPermalink
‘(fe) Definition- For purposes of this section, the term ‘farm’ has the meaning given that term in section 1.227 of title 21, Code of Federal Regulations (or any successor regulation).’.CommentsClose CommentsPermalink
(b) Guidance Documents-CommentsClose CommentsPermalink
(1) IN GENERAL- Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services, in consultation with the Secretary of Homeland Security and the Secretary of Agriculture, shall issue guidance documents related to protection against the intentional adulteration of food, including mitigation strategies or measures to guard against such adulteration as required under section 420 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a).CommentsClose CommentsPermalink
(2) CONTENT- The guidance documents issued under paragraph (1) shall--CommentsClose CommentsPermalink
(A) include a model assessment for a person to use under subsection (db)(1) of section 420 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a);CommentsClose CommentsPermalink
(B) include examples of mitigation strategies or measures described in subsection (db)(2) of such section; andCommentsClose CommentsPermalink
(C) specify situations in which the examples of mitigation strategies or measures described in subsection (db)(2) of such section are appropriate.CommentsClose CommentsPermalink
(3) LIMITED DISTRIBUTION- In the interest of national security, the Secretary of Health and Human Services, in consultation with the Secretary of Homeland Security, may determine the time and manner in which the guidance , manner, and form in which the guidance documents issued under paragraph (1) are made public, including by releasing such documents to targeted audiences.CommentsClose CommentsPermalink
(c) Periodic Review- The Secretary of Health and Human Services shall periodically review and, as appropriate, update the regulations under subsection (a)ection 420(b) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), and the guidance documents under subsection (b).CommentsClose CommentsPermalink
(d) Prohibited Acts- Section 301 (
et seq.), as amended by section 105, is amended by adding at the end the following:CommentsClose CommentsPermalink 21 U.S.C. 331 ‘(ww) The failure to comply with section 420.’.CommentsClose CommentsPermalink
SEC. 107. AUTHORITY TO COLLECT FEES.
(a) Fees for Reinspection, Recall, and Importation Activities- Subchapter C of chapter VII (
‘PART 6--FEES RELATED TO FOOD
‘SEC. 743. AUTHORITY TO COLLECT AND USE FEES.
‘(a) In General-CommentsClose CommentsPermalink
‘(1) PURPOSE AND AUTHORITY- For fiscal year 2010 and each subsequent fiscal year, the Secretary shall, in accordance with this section, assess and collect fees from--CommentsClose CommentsPermalink
‘(A) the responsible party for each domestic facility (as defined in section 415(b)) and the United States agent for each foreign facility subject to a reinspection in such fiscal year, to cover reinspection-related costs for such year;CommentsClose CommentsPermalink
‘(B) the responsible party for a domestic facility (as defined in section 415(b)) and an importer who does not comply with a recall order under section 423 or under section 412(f) in such fiscal year, to cover food recall activities associated with such order performed by the Secretary, including technical assistance, follow-up effectiveness checks, and public notifications, for such year;CommentsClose CommentsPermalink
‘(C) each importer participating in the voluntary qualified importer program under section 806 in such year, to cover the administrative costs of such program for such year; andCommentsClose CommentsPermalink
‘(D) each importer subject to a reinspection in such fiscal year, to cover reinspection-related costs for such year.CommentsClose CommentsPermalink
‘(2) DEFINITIONS- For purposes of this section--CommentsClose CommentsPermalink
‘(A) the term ‘reinspection’ means--CommentsClose CommentsPermalink
‘(i) with respect to domestic facilities (as defined in section 415(b)), 1 or more inspections conducted under section 704 subsequent to an inspection conducted under such provision which identified noncompliance materially related to a food safety requirement of this Act, specifically to determine whether compliance has been achieved to the Secretary’s satisfaction; andCommentsClose CommentsPermalink
‘(ii) with respect to importers, 1 or more examinations conducted under section 801 subsequent to an examination conducted under such provision which identified noncompliance materially related to a food safety requirement of this Act, specifically to determine whether compliance has been achieved to the Secretary’s satisfaction;CommentsClose CommentsPermalink
‘(B) the term ‘reinspection-related costs’ means all expenses, including administrative expenses, incurred in connection with--CommentsClose CommentsPermalink
‘(i) arranging, conducting, and evaluating the results of reinspections; andCommentsClose CommentsPermalink
‘(ii) assessing and collecting reinspection fees under this section; andCommentsClose CommentsPermalink
‘(C) the term ‘responsible party’ has the meaning given such term in section 417(a)(1).CommentsClose CommentsPermalink
‘(b) Establishment of Fees-CommentsClose CommentsPermalink
‘(1) IN GENERAL- Subject to subsections (c) and (d), the Secretary shall establish the fees to be collected under this section for each fiscal year specified in subsection (a)(1), based on the methodology described under paragraph (2), and shall publish such fees in a Federal Register notice not later than 60 days before the start of each such year.CommentsClose CommentsPermalink
‘(2) FEE METHODOLOGY-CommentsClose CommentsPermalink
‘(A) FEES- Fees amounts established for collection--CommentsClose CommentsPermalink
‘(i) under subparagraph (A) of subsection (a)(1) for a fiscal year shall be based on the Secretary’s estimate of 100 percent of the costs of the reinspection-related activities (including by type or level of reinspection activity, as the Secretary determines applicable) described in such subparagraph (A) for such year;CommentsClose CommentsPermalink
‘(ii) under subparagraph (B) of subsection (a)(1) for a fiscal year shall be based on the Secretary’s estimate of 100 percent of the costs of the activities described in such subparagraph (B) for such year;CommentsClose CommentsPermalink
‘(iii) under subparagraph (C) of subsection (a)(1) for a fiscal year shall be based on the Secretary’s estimate of 100 percent of the costs of the activities described in such subparagraph (C) for such year; andCommentsClose CommentsPermalink
‘(iv) under subparagraph (D) of subsection (a)(1) for a fiscal year shall be based on the Secretary’s estimate of 100 percent of the costs of the activities described in such subparagraph (D) for such year.CommentsClose CommentsPermalink
‘(B) OTHER CONSIDERATIONS-CommentsClose CommentsPermalink
‘(i) VOLUNTARY QUALIFIED IMPORTER PROGRAM-CommentsClose CommentsPermalink
‘(I) PARTICIPATION- In establishing the fee amounts under subparagraph (A)(iii) for a fiscal year, the Secretary shall provide for the number of importers who have submitted to the Secretary a notice under section 806(ec) informing the Secretary of the intent of such importer to participate in the program under section 806 in such fiscal year.CommentsClose CommentsPermalink
‘(II) RECOUPMENT- In establishing the fee amounts under subparagraph (A)(iii) for the first 5 fiscal years after the date of enactment of this section, the Secretary shall include in such fee a reasonable surcharge that provides a recoupment of the costs expended by the Secretary to establish and implement the first year of the program under section 806.CommentsClose CommentsPermalink
‘(ii) CREDITING OF FEES- In establishing the fee amounts under subparagraph (A) for a fiscal year, the Secretary shall provide for the crediting of fees from the previous year to the next year if the Secretary overestimated the amount of fees needed to carry out such activities, and consider the need to account for any adjustment of fees and such other factors as the Secretary determines appropriate.CommentsClose CommentsPermalink
‘(iii) PUBLISHED GUIDELINES- Not later than June 30, 2010, the Secretary shall180 days after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall publish in the Federal Register a proposed set of guidelines in consideration of the burden of fee amounts on small business. Such consideration may include reduced fee amounts for small businesses. The Secretary shall provide for a period of public comment on such guidelines. The Secretary shall adjust the fee schedule for small businesses subject to such fees only through notice and comment rulemaking.CommentsClose CommentsPermalink
‘(3) USE OF FEES- The Secretary shall make all of the fees collected pursuant to clause (i), (ii), (iii), and (iv) of paragraph (2)(A) available solely to pay for the costs referred to in such clause (i), (ii), (iii), and (iv) of paragraph (2)(A), respectively.CommentsClose CommentsPermalink
‘(c) Limitations-CommentsClose CommentsPermalink
‘(1) IN GENERAL- Fees under subsection (a) shall be refunded for a fiscal year beginning after fiscal year 2010 unless the amount of the total appropriations for food safety activities at the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) is equal to or greater than the amount of appropriations for food safety activities at the Food and Drug Administration for fiscal year 2009 (excluding the amount of fees appropriated for such fiscal year), multiplied by the adjustment factor under paragraph (3).CommentsClose CommentsPermalink
‘(2) AUTHORITY- If--CommentsClose CommentsPermalink
‘(A) the Secretary does not assess fees under subsection (a) for a portion of a fiscal year because paragraph (1) applies; andCommentsClose CommentsPermalink
‘(B) at a later date in such fiscal year, such paragraph (1) ceases to apply,CommentsClose CommentsPermalink
the Secretary may assess and collect such fees under subsection (a), without any modification to the rate of such fees, notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.CommentsClose CommentsPermalink
‘(3) ADJUSTMENT FACTOR-CommentsClose CommentsPermalink
‘(A) IN GENERAL- The adjustment factor described in paragraph (1) shall be the total percentage change that occurred in the Consumer Price Index for all urban consumers (all items; United States city average) for the 12-month period ending June 30 preceding the fiscal year, but in no case shall such adjustment factor be negative.CommentsClose CommentsPermalink
‘(B) COMPOUNDED BASIS- The adjustment under subparagraph (A) made each fiscal year shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2009.CommentsClose CommentsPermalink
‘(4) LIMITATION ON AMOUNT OF CERTAIN FEES-CommentsClose CommentsPermalink
‘(A) IN GENERAL- Notwithstanding any other provision of this section and subject to subparagraph (B), the Secretary may not collect fees in a fiscal year such that the amount collected--CommentsClose CommentsPermalink
‘(i) under subparagraph (B) of subsection (a)(1) exceeds $20,000,000; andCommentsClose CommentsPermalink
‘(ii) under subparagraphs (A) and (D) of subsection (a)(1) exceeds $25,000,000 combined.CommentsClose CommentsPermalink
‘(B) EXCEPTION- If a domestic facility (as defined in section 415(b)) or an importer becomes subject to a fee described in subparagraph (A), (B), or (D) of subsection (a)(1) after the maximum amount of fees has been collected by the Secretary under subparagraph (A), the Secretary may collect a fee from such facility or importer.CommentsClose CommentsPermalink
‘(d) Crediting and Availability of Fees- Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the purpose of paying the operating expenses of the Food and Drug Administration employees and contractors performing activities associated with these food safety fees.CommentsClose CommentsPermalink
‘(e) Collection of Fees-CommentsClose CommentsPermalink
‘(1) IN GENERAL- The Secretary shall specify in the Federal Register notice described in subsection (b)(1) the time and manner in which fees assessed under this section shall be collected.CommentsClose CommentsPermalink
‘(2) COLLECTION OF UNPAID FEES- In any case where the Secretary does not receive payment of a fee assessed under this section within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to provisions of subchapter II of chapter 37 of title 31, United States Code.CommentsClose CommentsPermalink
‘(f) Annual Report to Congress- Not later than 120 days after each fiscal year for which fees are assessed under this section, the Secretary shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to include a description of fees assessed and collected for each such year and a summary description of the entities paying such fees and the types of business in which such entities engage.CommentsClose CommentsPermalink
‘(g) Authorization of Appropriations- For fiscal year 2010 and each fiscal year thereafter, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted or otherwise affected under the other provisions of this section.’.CommentsClose CommentsPermalink
(b) Export Certification Fees for Foods and Animal Feed-CommentsClose CommentsPermalink
(1) AUTHORITY FOR EXPORT CERTIFICATIONS FOR FOOD, INCLUDING ANIMAL FEED- Section 801(e)(4)(A) (
) is amended--CommentsClose CommentsPermalink 21 U.S.C. 381(e)(4)(A)
(A) in the matter preceding clause (i), by striking ‘a drug’ and inserting ‘a food, drug’;CommentsClose CommentsPermalink
(B) in clause (i) by striking ‘exported drug’ and inserting ‘exported food, drug’; andCommentsClose CommentsPermalink
(C) in clause (ii) by striking ‘the drug’ each place it appears and inserting ‘the food, drug’.CommentsClose CommentsPermalink
(2) CLARIFICATION OF CERTIFICATION- Section 801(e)(4) (
) is amended by inserting after subparagraph (B) the following new subparagraph:CommentsClose CommentsPermalink 21 U.S.C. 381(e)(4)
‘(C) For purposes of this paragraph, a certification by the Secretary shall be made on such basis, and in such form (including a publicly available listing) as the Secretary determines appropriate.’.CommentsClose CommentsPermalink
SEC. 108. NATIONAL AGRICULTURE AND FOOD DEFENSE STRATEGY.
(a) Development and Submission of Strategy-CommentsClose CommentsPermalink
(1) IN GENERAL- Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services and the Secretary of Agriculture, in coordination with the Secretary of Homeland Security, shall prepare and submit to thetransmit to the relevant committees of Congress, and make publicly available on the Internet Web sites of the Department of Health and Human Services and the Department of Agriculture, the National Agriculture and Food Defense Strategy.CommentsClose CommentsPermalink
(2) IMPLEMENTATION PLAN- The strategy shall include an implementation plan for use by the Secretaries described under paragraph (1) in carrying out the strategy.CommentsClose CommentsPermalink
(3) RESEARCH- The strategy shall include a coordinated research agenda for use by the Secretaries described under paragraph (1) in conducting research to support the goals and activities described in paragraphs (1) and (2) of subsection (b).CommentsClose CommentsPermalink
(4) REVISIONS- Not later than 4 years after the date on which the strategy is submitted to the relevant committees of Congress under paragraph (1), and not less frequently than every 4 years thereafter, the Secretary of Health and Human Services and the Secretary of Agriculture, in coordination with the Secretary of Homeland Security, shall revise and submit to the relevant committees of Congress the strategy.CommentsClose CommentsPermalink
(5) CONSISTENCY WITH EXISTING PLANS- The strategy described in paragraph (1) shall be consistent with--CommentsClose CommentsPermalink
(A) the National Incident Management System;CommentsClose CommentsPermalink
(B) the National Response Framework;CommentsClose CommentsPermalink
(C) the National Infrastructure Protection Plan;CommentsClose CommentsPermalink
(D) the National Preparedness Goals; andCommentsClose CommentsPermalink
(E) other relevant national strategies.CommentsClose CommentsPermalink
(b) Components-CommentsClose CommentsPermalink
(1) IN GENERAL- The strategy shall include a description of the process to be used by the Department of Health and Human Services, the Department of Agriculture, and the Department of Homeland Security--CommentsClose CommentsPermalink
(A) to achieve each goal described in paragraph (2); andCommentsClose CommentsPermalink
(B) to evaluate the progress made by Federal, State, local, and tribal governments towards the achievement of each goal described in paragraph (2).CommentsClose CommentsPermalink
(2) GOALS- The strategy shall include a description of the process to be used by the Department of Health and Human Services, the Department of Agriculture, and the Department of Homeland Security to achieve the following goals:CommentsClose CommentsPermalink
(A) PREPAREDNESS GOAL- Enhance the preparedness of the agriculture and food system by--CommentsClose CommentsPermalink
(i) conducting vulnerability assessments of the agriculture and food system;CommentsClose CommentsPermalink
(ii) mitigating vulnerabilities of the system;CommentsClose CommentsPermalink
(iii) improving communication and training relating to the system;CommentsClose CommentsPermalink
(iv) developing and conducting exercises to test decontamination and disposal plans;CommentsClose CommentsPermalink
(v) developing modeling tools to improve event consequence assessment and decision support; andCommentsClose CommentsPermalink
(vi) preparing risk communication tools and enhancing public awareness through outreach.CommentsClose CommentsPermalink
(B) DETECTION GOAL- Improve agriculture and food system detection capabilities by--CommentsClose CommentsPermalink
(i) identifying contamination in food products at the earliest possible time; andCommentsClose CommentsPermalink
(ii) conducting surveillance to prevent the spread of diseases.CommentsClose CommentsPermalink
(C) EMERGENCY RESPONSE GOAL- Ensure an efficient response to agriculture and food emergencies by--CommentsClose CommentsPermalink
(i) immediately investigating animal disease outbreaks and suspected food contamination;CommentsClose CommentsPermalink
(ii) preventing additional human illnesses;CommentsClose CommentsPermalink
(iii) organizing, training, and equipping animal, plant, and food emergency response teams of--CommentsClose CommentsPermalink
(I) the Federal Government; andCommentsClose CommentsPermalink
(II) State, local, and tribal governments;CommentsClose CommentsPermalink
(iv) designing, developing, and evaluating training and exercises carried out under agriculture and food defense plans; andCommentsClose CommentsPermalink
(v) ensuring consistent and organized risk communication to the public by--CommentsClose CommentsPermalink
(I) the Federal Government;CommentsClose CommentsPermalink
(II) State, local, and tribal governments; andCommentsClose CommentsPermalink
(III) the private sector.CommentsClose CommentsPermalink
(D) RECOVERY GOAL- Secure agriculture and food production after an agriculture or food emergency by--CommentsClose CommentsPermalink
(i) working with the private sector to develop business recovery plans to rapidly resume agriculture, food production, and international trade;CommentsClose CommentsPermalink
(ii) conducting exercises of the plans described in subparagraph (C) with the goal of long-term recovery results;CommentsClose CommentsPermalink
(iii) rapidly removing, and effectively disposing of--CommentsClose CommentsPermalink
(I) contaminated agriculture and food products; andCommentsClose CommentsPermalink
(II) infected plants and animals; andCommentsClose CommentsPermalink
(iv) decontaminating and restoring areas affected by an agriculture or food emergency.CommentsClose CommentsPermalink
(c) 3) EVALUATION- The Secretary, in coordination with the Secretary of Agriculture and the Secretary of Homeland Security, shall--CommentsClose CommentsPermalink
(A) develop metrics to measure progress for the evaluation process described in paragraph (1)(B); andCommentsClose CommentsPermalink
(B) report on the progress measured in subparagraph (A) as part of the National Agriculture and Food Defense strategy described in subsection (a)(1).CommentsClose CommentsPermalink
(c) Limited Distribution- In the interest of national security, the Secretary of Health and Human Services and the Secretary of Agriculture, in coordination with the Secretary of Homeland Security, may determine the manner and format in which the National Agriculture and Food Defense strategy established under this section is made publicly available on the Internet Web sites of the Department of Health and Human Services, the Department of Homeland Security, and the Department of Agriculture, as described in subsection (a)(1).CommentsClose CommentsPermalink
SEC. 109. FOOD AND AGRICULTURE COORDINATING COUNCILS.
The Secretary of Homeland Security, in coordination with the Secretary of Health and Human Services and the Secretary of Agriculture, shall within 180 days of enactment of this Act, and annually thereafter, submit to the relevant committees of Congress, and make publicly available on the Internet Web site of the Department of Homeland Security, a report on the activities of the Food and Agriculture Government Coordinating Council and the Food and Agriculture Sector Coordinating Council, including the progress of such Councils on--CommentsClose CommentsPermalink
(1) facilitating partnerships between public and private entities to help coordinate and enhance the protection of the agriculture and food system of the United States;CommentsClose CommentsPermalink
(2) providing for the regular and timely interchange of information between each council relating to the security of the agriculture and food system (including intelligence information);CommentsClose CommentsPermalink
(3) identifying best practices and methods for improving the coordination among Federal, State, local, and private sector preparedness and response plans for agriculture and food defense; andCommentsClose CommentsPermalink
(4) recommending methods by which to protect the economy and the public health of the United States from the effects of--CommentsClose CommentsPermalink
(A) animal or plant disease outbreaks;CommentsClose CommentsPermalink
(B) food contamination; andCommentsClose CommentsPermalink
(C) natural disasters affecting agriculture and food.CommentsClose CommentsPermalink
SEC. 110. BUILDING DOMESTIC CAPACITY.
(a) In General-CommentsClose CommentsPermalink
(1) INITIAL REPORT- The Secretary, in coordination with the Secretary of Agriculture and the Secretary of Homeland Security, shall, not later than 2 years after the date of enactment of this Act, submit to Congress a comprehensive report that identifies programs and practices that are intended to promote the safety and supply chain security of food and to prevent outbreaks of foodborne illness and other food-related hazards that can be addressed through preventive activities. Such report shall include a description of the following:CommentsClose CommentsPermalink
(A) Analysis of the need for further regulations or guidance to industry.CommentsClose CommentsPermalink
(B) Outreach to food industry sectors, including through the Food and Agriculture Coordinating Councils referred to in section 109, to identify potential sources of emerging threats to the safety and security of the food supply and preventive strategies to address those threats.CommentsClose CommentsPermalink
(C) Systems to ensure the prompt distribution to the food industry of information and technical assistance concerning preventive strategies.CommentsClose CommentsPermalink
(D) Communication systems to ensure that information about specific threats to the safety and security of the food supply are rapidly and effectively disseminated.CommentsClose CommentsPermalink
(E) Surveillance systems and laboratory networks to rapidly detect and respond to foodborne illness outbreaks and other food-related hazards, including how such systems and networks are integrated.CommentsClose CommentsPermalink
(F) Outreach, education, and training provided to States and local governments to build State and local food safety and food defense capabilities, including progress implementing strategies developed under sections 108 and 2065.CommentsClose CommentsPermalink
(G) The estimated resources needed to effectively implement the programs and practices identified in the report developed in this section over a 5-year period.CommentsClose CommentsPermalink
(H) The impact of requirements under this Act (including amendments made by this Act) on certified organic farms and facilities (as defined in section 415 (
(I) Specific efforts taken pursuant to the agreements authorized under section 421(c) of the Federal Food, Drug, and Cosmetic Act (as added by section 201), together with, as necessary, a description of any additional authorities necessary to improve seafood safety.CommentsClose CommentsPermalink
(2) BIENNIAL REPORTS- On a biennial basis following the submission of the report under paragraph (1), the Secretary shall submit to Congress a report that--CommentsClose CommentsPermalink
(A) reviews previous food safety programs and practices;CommentsClose CommentsPermalink
(B) outlines the success of those programs and practices;CommentsClose CommentsPermalink
(C) identifies future programs and practices; andCommentsClose CommentsPermalink
(D) includes information related to any matter described in subparagraphs (A) through (H) of paragraph (1), as necessary.CommentsClose CommentsPermalink
(b) Risk-based Activities- The report developed under subsection (a)(1) shall describe methods that seek to ensure that resources available to the Secretary for food safety-related activities are directed at those actions most likely to reduce risks from food, including the use of preventive strategies and allocation of inspection resources. The Secretary shall promptly undertake those risk-based actions that are identified during the development of the report as likely to contribute to the safety and security of the food supply.CommentsClose CommentsPermalink
(c) Capability for Laboratory Analyses; Research- The report developed under subsection (a)(1) shall provide a description of methods to increase capacity to undertake analyses of food samples promptly after collection, to identify new and rapid analytical techniques, including commercially-available techniques that can be employed at ports of entry and by Food Emergency Response Network laboratories, and to provide for well-equipped and staffed laboratory facilities.(d) and progress toward laboratory accreditation under section 422 of the Federal Food, Drug, and Cosmetic Act (as added by section 202).CommentsClose CommentsPermalink
(d) Information Technology- The report developed under subsection (a)(1) shall include a description of such information technology systems as may be needed to identify risks and receive data from multiple sources, including foreign governments, State, local, and tribal governments, other Federal agencies, the food industry, laboratories, laboratory networks, and consumers. The information technology systems that the Secretary describes shall also provide for the integration of the facility registration system under section 415 of the Federal Food, Drug, and Cosmetic Act (
(e) Automated Risk Assessment- The report developed under subsection (a)(1) shall include a description of progress toward developing and improving an automated risk assessment system for food safety surveillance and allocation of resources.CommentsClose CommentsPermalink
(f) Traceback and Surveillance Report- The Secretary shall include in the report developed under subsection (a)(1) an analysis of the Food and Drug Administration’s performance in foodborne illness outbreaks during the 5-year period preceding the date of enactment of this Act involving fruits and vegetables that are raw agricultural commodities (as defined in section 201(r) (
(g) Biennial Food Safety and Food Defense Research Plan- The Secretary and the Secretary of Agriculture, the Secretary of Agriculture, and the Secretary of Homeland Security shall, on a biennial basis, submit to Congress a joint food safety and food defense research plan which may include studying the long-term health effects of foodborne illness. Such biennial plan shall include a list and description of projects conducted during the previous 2-year period and the plan for projects to be conducted during the subsequent 2-year period.CommentsClose CommentsPermalink
(h) Effectiveness of Programs Administered by the Department of Health and Human Services-CommentsClose CommentsPermalink
(1) IN GENERAL- To determine whether existing Federal programs administered by the Department of Health and Human Services are effective in achieving the stated goals of such programs, the Secretary shall, beginning not later than 1 year after the date of enactment of this Act--CommentsClose CommentsPermalink
(A) conduct an annual evaluation of each program of such Department to determine the effectiveness of each such program in achieving legislated intent, purposes, and objectives; andCommentsClose CommentsPermalink
(B) submit to Congress a report concerning such evaluation.CommentsClose CommentsPermalink
(2) CONTENT- The report described under paragraph (1)(B) shall--CommentsClose CommentsPermalink
(A) include conclusions concerning the reasons that such existing programs have proven successful or not successful and what factors contributed to such conclusions;CommentsClose CommentsPermalink
(B) include recommendations for consolidation and elimination to reduce duplication and inefficiencies in such programs at such Department as identified during the evaluation conduct under this subsection; andCommentsClose CommentsPermalink
(C) be made publicly available in a publication entitled ‘Guide to the U.S. Department of Health and Human Services Programs’.CommentsClose CommentsPermalink
(i) Unique Identification Numbers-CommentsClose CommentsPermalink
(1) IN GENERAL- Not later than 1 year after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, shall conduct a study regarding the need for, and challenges associated with, development and implementation of a program that requires a unique identification number for each food facility registered with the Secretary and, as appropriate, each broker that imports food into the United States. Such study shall include an evaluation of the costs associated with development and implementation of such a system, and make recommendations about what new authorities, if any, would be necessary to develop and implement such a system.CommentsClose CommentsPermalink
(2) REPORT- Not later than 15 months after the date of enactment of this Act, the Secretary shall submit to Congress a report that describes the findings of the study conducted under paragraph (1) and that includes any recommendations determined appropriate by the Secretary.CommentsClose CommentsPermalink
SEC. 111. SANITARY TRANSPORTATION OF FOOD.
Not later than 1 year(a) In General- Not later than 18 months after the date of enactment of this Act, the Secretary shall promulgate regulations described in section 416(b) of the Federal Food, Drug, and Cosmetic Act (
(b) Food Transportation Study- The Secretary, acting through the Commissioner of Food and Drugs, shall conduct a study of the transportation of food for consumption in the United States, including transportation by air, that includes an examination of the unique needs of rural and frontier areas with regard to the delivery of safe food.CommentsClose CommentsPermalink
SEC. 112. FOOD ALLERGY AND ANAPHYLAXIS MANAGEMENT.
(a) Definitions- In this section:CommentsClose CommentsPermalink
(1) EARLY CHILDHOOD EDUCATION PROGRAM- The term ‘early childhood education program’ means--CommentsClose CommentsPermalink
(A) a Head Start program or an Early Head Start program carried out under the Head Start Act (
(B) a State licensed or regulated child care program or school; orCommentsClose CommentsPermalink
(C) a State prekindergarten program that serves children from birth through kindergarten.CommentsClose CommentsPermalink
(2) ESEA DEFINITIONS- The terms ‘local educational agency’, ‘secondary school’, ‘elementary school’, and ‘parent’ have the meanings given the terms in section 9101 of the Elementary and Secondary Education Act of 1965 (
(3) SCHOOL- The term ‘school’ includes public--CommentsClose CommentsPermalink
(A) kindergartens;CommentsClose CommentsPermalink
(B) elementary schools; andCommentsClose CommentsPermalink
(C) secondary schools.CommentsClose CommentsPermalink
(4) SECRETARY- The term ‘Secretary’ means the Secretary of Health and Human Services.CommentsClose CommentsPermalink
(b) Establishment of Voluntary Food Allergy and Anaphylaxis Management Guidelines-CommentsClose CommentsPermalink
(1) ESTABLISHMENT-CommentsClose CommentsPermalink
(A) IN GENERAL- Not later than 1 year after the date of enactment of this Act, the Secretary, in consultation with the Secretary of Education, shall--CommentsClose CommentsPermalink
(i) develop guidelines to be used on a voluntary basis to develop plans for individuals to manage the risk of food allergy and anaphylaxis in schools and early childhood education programs; andCommentsClose CommentsPermalink
(ii) make such guidelines available to local educational agencies, schools, early childhood education programs, and other interested entities and individuals to be implemented on a voluntary basis only.CommentsClose CommentsPermalink
(B) APPLICABILITY OF FERPA- Each plan described in subparagraph (A) that is developed for an individual shall be considered an education record for the purpose of section 444 of the General Education Provisions Act (commonly referred to as the ‘Family Educational Rights and Privacy Act of 1974’) (
(2) CONTENTS- The voluntary guidelines developed by the Secretary under paragraph (1) shall address each of the following and may be updated as the Secretary determines necessary:CommentsClose CommentsPermalink
(A) Parental obligation to provide the school or early childhood education program, prior to the start of every school year, with--CommentsClose CommentsPermalink
(i) documentation from their child’s physician or nurse--CommentsClose CommentsPermalink
(I) supporting a diagnosis of food allergy, and any risk of anaphylaxis, if applicable;CommentsClose CommentsPermalink
(II) identifying any food to which the child is allergic;CommentsClose CommentsPermalink
(III) describing, if appropriate, any prior history of anaphylaxis;CommentsClose CommentsPermalink
(IV) listing any medication prescribed for the child for the treatment of anaphylaxis;CommentsClose CommentsPermalink
(V) detailing emergency treatment procedures in the event of a reaction;CommentsClose CommentsPermalink
(VI) listing the signs and symptoms of a reaction; andCommentsClose CommentsPermalink
(VII) assessing the child’s readiness for self-administration of prescription medication; andCommentsClose CommentsPermalink
(ii) a list of substitute meals that may be offered to the child by school or early childhood education program food service personnel.CommentsClose CommentsPermalink
(B) The creation and maintenance of an individual plan for food allergy management, in consultation with the parent, tailored to the needs of each child with a documented risk for anaphylaxis, including any procedures for the self-administration of medication by such children in instances where--CommentsClose CommentsPermalink
(i) the children are capable of self-administering medication; andCommentsClose CommentsPermalink
(ii) such administration is not prohibited by State law.CommentsClose CommentsPermalink
(C) Communication strategies between individual schools or early childhood education programs and providers of emergency medical services, including appropriate instructions for emergency medical response.CommentsClose CommentsPermalink
(D) Strategies to reduce the risk of exposure to anaphylactic causative agents in classrooms and common school or early childhood education program areas such as cafeterias.CommentsClose CommentsPermalink
(E) The dissemination of general information on life-threatening food allergies to school or early childhood education program staff, parents, and children.CommentsClose CommentsPermalink
(F) Food allergy management training of school or early childhood education program personnel who regularly come into contact with children with life-threatening food allergies.CommentsClose CommentsPermalink
(G) The authorization and training of school or early childhood education program personnel to administer epinephrine when the nurse is not immediately available.CommentsClose CommentsPermalink
(H) The timely accessibility of epinephrine by school or early childhood education program personnel when the nurse is not immediately available.CommentsClose CommentsPermalink
(I) The creation of a plan contained in each individual plan for food allergy management that addresses the appropriate response to an incident of anaphylaxis of a child while such child is engaged in extracurricular programs of a school or early childhood education program, such as non-academic outings and field trips, before- and after-school programs or before- and after-early child education program programs, and school-sponsored or early childhood education program-sponsored programs held on weekends.CommentsClose CommentsPermalink
(J) Maintenance of information for each administration of epinephrine to a child at risk for anaphylaxis and prompt notification to parents.CommentsClose CommentsPermalink
(K) Other elements the Secretary determines necessary for the management of food allergies and anaphylaxis in schools and early childhood education programs.CommentsClose CommentsPermalink
(3) RELATION TO STATE LAW- Nothing in this section or the guidelines developed by the Secretary under paragraph (1) shall be construed to preempt State law, including any State law regarding whether students at risk for anaphylaxis may self-administer medication.CommentsClose CommentsPermalink
(c) School-based Food Allergy Management Grants-CommentsClose CommentsPermalink
(1) IN GENERAL- The Secretary may award grants to local educational agencies to assist such agencies with implementing voluntary food allergy and anaphylaxis management guidelines described in subsection (b).CommentsClose CommentsPermalink
(2) APPLICATION-CommentsClose CommentsPermalink
(A) IN GENERAL- To be eligible to receive a grant under this subsection, a local educational agency shall submit an application to the Secretary at such time, in such manner, and including such information as the Secretary may reasonably require.CommentsClose CommentsPermalink
(B) CONTENTS- Each application submitted under subparagraph (A) shall include--CommentsClose CommentsPermalink
(i) an assurance that the local educational agency has developed plans in accordance with the food allergy and anaphylaxis management guidelines described in subsection (b);CommentsClose CommentsPermalink
(ii) a description of the activities to be funded by the grant in carrying out the food allergy and anaphylaxis management guidelines, including--CommentsClose CommentsPermalink
(I) how the guidelines will be carried out at individual schools served by the local educational agency;CommentsClose CommentsPermalink
(II) how the local educational agency will inform parents and students of the guidelines in place;CommentsClose CommentsPermalink
(III) how school nurses, teachers, administrators, and other school-based staff will be made aware of, and given training on, when applicable, the guidelines in place; andCommentsClose CommentsPermalink
(IV) any other activities that the Secretary determines appropriate;CommentsClose CommentsPermalink
(iii) an itemization of how grant funds received under this subsection will be expended;CommentsClose CommentsPermalink
(iv) a description of how adoption of the guidelines and implementation of grant activities will be monitored; andCommentsClose CommentsPermalink
(v) an agreement by the local educational agency to report information required by the Secretary to conduct evaluations under this subsection.CommentsClose CommentsPermalink
(3) USE OF FUNDS- Each local educational agency that receives a grant under this subsection may use the grant funds for the following:CommentsClose CommentsPermalink
(A) Purchase of materials and supplies, including limited medical supplies such as epinephrine and disposable wet wipes, to support carrying out the food allergy and anaphylaxis management guidelines described in subsection (b).CommentsClose CommentsPermalink
(B) In partnership with local health departments, school nurse, teacher, and personnel training for food allergy management.CommentsClose CommentsPermalink
(C) Programs that educate students as to the presence of, and policies and procedures in place related to, food allergies and anaphylactic shock.CommentsClose CommentsPermalink
(D) Outreach to parents.CommentsClose CommentsPermalink
(E) Any other activities consistent with the guidelines described in subsection (b).CommentsClose CommentsPermalink
(4) DURATION OF AWARDS- The Secretary may award grants under this subsection for a period of not more than 2 years. In the event the Secretary conducts a program evaluation under this subsection, funding in the second year of the grant, where applicable, shall be contingent on a successful program evaluation by the Secretary after the first year.CommentsClose CommentsPermalink
(5) LIMITATION ON GRANT FUNDING- The Secretary may not provide grant funding to a local educational agency under this subsection after such local educational agency has received 2 years of grant funding under this subsection.CommentsClose CommentsPermalink
(6) MAXIMUM AMOUNT OF ANNUAL AWARDS- A grant awarded under this subsection may not be made in an amount that is more than $50,000 annually.CommentsClose CommentsPermalink
(7) PRIORITY- In awarding grants under this subsection, the Secretary shall give priority to local educational agencies with the highest percentages of children who are counted under section 1124(c) of the Elementary and Secondary Education Act of 1965 (
(8) MATCHING FUNDS-CommentsClose CommentsPermalink
(A) IN GENERAL- The Secretary may not award a grant under this subsection unless the local educational agency agrees that, with respect to the costs to be incurred by such local educational agency in carrying out the grant activities, the local educational agency shall make available (directly or through donations from public or private entities) non-Federal funds toward such costs in an amount equal to not less than 25 percent of the amount of the grant.CommentsClose CommentsPermalink
(B) DETERMINATION OF AMOUNT OF NON-FEDERAL CONTRIBUTION- Non-Federal funds required under subparagraph (A) may be cash or in kind, including plant, equipment, or services. Amounts provided by the Federal Government, and any portion of any service subsidized by the Federal Government, may not be included in determining the amount of such non-Federal funds.CommentsClose CommentsPermalink
(9) ADMINISTRATIVE FUNDS- A local educational agency that receives a grant under this subsection may use not more than 2 percent of the grant amount for administrative costs related to carrying out this subsection.CommentsClose CommentsPermalink
(10) PROGRESS AND EVALUATIONS- At the completion of the grant period referred to in paragraph (4), a local educational agency shall provide the Secretary with information on how grant funds were spent and the status of implementation of the food allergy and anaphylaxis management guidelines described in subsection (b).CommentsClose CommentsPermalink
(11) SUPPLEMENT, NOT SUPPLANT- Grant funds received under this subsection shall be used to supplement, and not supplant, non-Federal funds and any other Federal funds available to carry out the activities described in this subsection.CommentsClose CommentsPermalink
(12) AUTHORIZATION OF APPROPRIATIONS- There is authorized to be appropriated to carry out this subsection $30,000,000 for fiscal year 20101 and such sums as may be necessary for each of the 4 succeeding fiscal years.CommentsClose CommentsPermalink
(d) Voluntary Nature of Guidelines-CommentsClose CommentsPermalink
(1) IN GENERAL- The food allergy and anaphylaxis management guidelines developed by the Secretary under subsection (b) are voluntary. Nothing in this section or the guidelines developed by the Secretary under subsection (b) shall be construed to require a local educational agency to implement such guidelines.CommentsClose CommentsPermalink
(2) EXCEPTION- Notwithstanding paragraph (1), the Secretary may enforce an agreement by a local educational agency to implement food allergy and anaphylaxis management guidelines as a condition of the receipt of a grant under subsection (c).CommentsClose CommentsPermalink
SEC. 113. NEW DIETARY INGREDIENTS.
(a) In General- Section 413 of the Federal Food, Drug, and Cosmetic Act (
(1) by redesignating subsection (c) as subsection (d); andCommentsClose CommentsPermalink
(2) by inserting after subsection (b) the following:CommentsClose CommentsPermalink
‘(c) Notification-CommentsClose CommentsPermalink
‘(1) IN GENERAL- If the Secretary determines that the information in a new dietary ingredient notification submitted under this section for an article purported to be a new dietary ingredient is inadequate to establish that a dietary supplement containing such article will reasonably be expected to be safe because the article may be, or may contain, an anabolic steroid or an analogue of an anabolic steroid, the Secretary shall notify the Drug Enforcement Administration of such determination. Such notification by the Secretary shall include, at a minimum, the name of the dietary supplement or article, the name of the person or persons who marketed the product or made the submission of information regarding the article to the Secretary under this section, and any contact information for such person or persons that the Secretary has.CommentsClose CommentsPermalink
‘(2) DEFINITIONS- For purposes of this subsection--CommentsClose CommentsPermalink
‘(A) the term ‘anabolic steroid’ has the meaning given such term in section 102(41) of the Controlled Substances Act; andCommentsClose CommentsPermalink
‘(B) the term ‘analogue of an anabolic steroid’ means a substance whose chemical structure is substantially similar to the chemical structure of an anabolic steroid.’.CommentsClose CommentsPermalink
(b) Guidance- Not later than 180 days after the date of enactment of this Act, the Secretary shall publish guidance that clarifies when a dietary supplement ingredient is a new dietary ingredient, when the manufacturer or distributor of a dietary ingredient or dietary supplement should provide the Secretary with information as described in section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act, the evidence needed to document the safety of new dietary ingredients, and appropriate methods for establishing the identify of a new dietary ingredient.CommentsClose CommentsPermalink
SEC. 114. REQUIREMENT FOR GUIDANCE RELATING TO POST HARVEST PROCESSING OF RAW OYSTERS.
(a) In General- Not later than 90 days prior to the issuance of any guidance, regulation, or suggested amendment by the Food and Drug Administration to the National Shellfish Sanitation Program’s Model Ordinance, or the issuance of any guidance or regulation by the Food and Drug Administration relating to the Seafood Hazard Analysis Critical Control Points Program of the Food and Drug Administration (parts 123 and 1240 of title 21, Code of Federal Regulations (or any successor regulations), where such guidance, regulation or suggested amendment relates to post harvest processing for raw oysters, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report which shall include--CommentsClose CommentsPermalink
(1) an assessment of how post harvest processing or other equivalent controls feasibly may be implemented in the fastest, safest, and most economical manner;CommentsClose CommentsPermalink
(2) the projected public health benefits of any proposed post harvest processing;CommentsClose CommentsPermalink
(3) the projected costs of compliance with such post harvest processing measures;CommentsClose CommentsPermalink
(4) the impact post harvest processing is expected to have on the sales, cost, and availability of raw oysters;CommentsClose CommentsPermalink
(5) criteria for ensuring post harvest processing standards will be applied equally to shellfish imported from all nations of origin;CommentsClose CommentsPermalink
(6) an evaluation of alternative measures to prevent, eliminate, or reduce to an acceptable level the occurrence of foodborne illness; andCommentsClose CommentsPermalink
(7) the extent to which the Food and Drug Administration has consulted with the States and other regulatory agencies, as appropriate, with regard to post harvest processing measures.CommentsClose CommentsPermalink
(b) Limitation- Subsection (a) shall not apply to the guidance described in section 103(h).CommentsClose CommentsPermalink
(c) Review and Evaluation- Not later than 30 days after the Secretary issues a proposed regulation or guidance described in subsection (a), the Comptroller General of the United States shall--CommentsClose CommentsPermalink
(1) review and evaluate the report described in (a) and report to Congress on the findings of the estimates and analysis in the report;CommentsClose CommentsPermalink
(2) compare such proposed regulation or guidance to similar regulations or guidance with respect to other regulated foods, including a comparison of risks the Secretary may find associated with seafood and the instances of those risks in such other regulated foods; andCommentsClose CommentsPermalink
(3) evaluate the impact of post harvest processing on the competitiveness of the domestic oyster industry in the United States and in international markets.CommentsClose CommentsPermalink
(d) Waiver- The requirement of preparing a report under subsection (a) shall be waived if the Secretary issues a guidance that is adopted as a consensus agreement between Federal and State regulators and the oyster industry, acting through the Interstate Shellfish Sanitation Conference.CommentsClose CommentsPermalink
(e) Public Access- Any report prepared under this section shall be made available to the public.CommentsClose CommentsPermalink
SEC. 115. PORT SHOPPING.
Until the date on which the Secretary promulgates a final rule that implements the amendments made by section 308 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, (
SEC. 116. ALCOHOL-RELATED FACILITIES.
(a) In General- Except as provided by sections 102, 206, 207, 302, 304, 402, 403, and 404 of this Act, and the amendments made by such sections, nothing in this Act, or the amendments made by this Act, shall be construed to apply to a facility that--CommentsClose CommentsPermalink
(1) under the Federal Alcohol Administration Act (
(2) under section 415 of the Federal Food, Drug, and Cosmetic Act (
(b) Limited Receipt and Distribution of Non-alcohol Food- Subsection (a) shall not apply to a facility engaged in the receipt and distribution of any non-alcohol food, except that such paragraph shall apply to a facility described in such paragraph that receives and distributes non-alcohol food, provided such food is received and distributed--CommentsClose CommentsPermalink
(1) in a prepackaged form that prevents any direct human contact with such food; andCommentsClose CommentsPermalink
(2) in amounts that constitute not more than 5 percent of the overall sales of such facility, as determined by the Secretary of the Treasury.CommentsClose CommentsPermalink
(c) Rule of Construction- Except as provided in subsections (a) and (b), this section shall not be construed to exempt any food, other than alcoholic beverages, as defined in section 214 of the Federal Alcohol Administration Act (
TITLE II--IMPROVING CAPACITY TO DETECT AND RESPOND TO FOOD SAFETY PROBLEMSCommentsClose CommentsPermalink
TITLE II--IMPROVING CAPACITY TO DETECT AND RESPOND TO FOOD SAFETY PROBLEMSCommentsClose CommentsPermalink
SEC. 201. TARGETING OF INSPECTION RESOURCES FOR DOMESTIC FACILITIES, FOREIGN FACILITIES, AND PORTS OF ENTRY; ANNUAL REPORT.
(a) Targeting of Inspection Resources for Domestic Facilities, Foreign Facilities, and Ports of Entry- Chapter IV (
‘SEC. 421. TARGETING OF INSPECTION RESOURCES FOR DOMESTIC FACILITIES, FOREIGN FACILITIES, AND PORTS OF ENTRY; ANNUAL REPORT.
‘(a) Identification and Inspection of Facilities-CommentsClose CommentsPermalink
‘(1) IDENTIFICATION- The Secretary shall identify high-risk facilities and shall allocate resources to inspect facilities according to the risk profileknown safety risks of the facilities, which shall be based on the following factors:CommentsClose CommentsPermalink
‘(A) The risk profileknown safety risks of the food manufactured, processed, packed, or held at the facility.CommentsClose CommentsPermalink
‘(B) The facility’s compliance historcompliance history of a facility, including with regard to food recalls, outbreaks of foodborne illness, and violations of food safety standards.CommentsClose CommentsPermalink
‘(C) The rigor and effectiveness of the facility’s hazard analysis and risk-based preventive controls.CommentsClose CommentsPermalink
‘(D) Whether the food manufactured, processed, packed, handled, prepared, treated, distributed, or storeor held at the facility meets the criteria for priority under section 801(h)(1).CommentsClose CommentsPermalink
‘(E) Whether the facility has received a certificate as described in section 809(b)ood or the facility that manufactured, processed, packed, or held such food has received a certification as described in section 801(q) or 806, as appropriate.CommentsClose CommentsPermalink
‘(F) Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources.CommentsClose CommentsPermalink
‘(2) INSPECTIONS-CommentsClose CommentsPermalink
‘(A) IN GENERAL- Beginning on the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall increase the frequency of inspection of all facilities.CommentsClose CommentsPermalink
‘(B) DOMESTIC HIGH-RISK FACILITIES- The Secretary shall increase the frequency of inspection of domestic facilities identified under paragraph (1) as high-risk facilities such that--‘(i) for the first 2 years after the date of enactment of the FDA Food Safety Modernization Act, each high-risk facility is inspected each such facility is inspected--CommentsClose CommentsPermalink
‘(i) not less often than once every 2 years; and‘(ii) for each succeeding year, each high-risk facility is inspectedin the 5-year period following the date of enactment of the FDA Food Safety Modernization Act; andCommentsClose CommentsPermalink
‘(ii) not less often than once each yeavery 3 years thereafter.CommentsClose CommentsPermalink
‘(C) DOMESTIC NON-HIGH-RISK FACILITIES- The Secretary shall ensure that each domestic facility that is not identified under paragraph (1) as a high-risk facility is inspected--CommentsClose CommentsPermalink
‘(i) not less often than once in the 7-year period following the date of enactment of the FDA Food Safety Modernization Act; andCommentsClose CommentsPermalink
‘(ii) not less often than once every 4 years5 years thereafter.CommentsClose CommentsPermalink
‘(D) FOREIGN FACILITIES-CommentsClose CommentsPermalink
‘(i) YEAR 1- In the 1-year period following the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall inspect not fewer than 600 foreign facilities.CommentsClose CommentsPermalink
‘(ii) SUBSEQUENT YEARS- In each of the 5 years following the 1-year period described in clause (i), the Secretary shall inspect not fewer than twice the number of foreign facilities inspected by the Secretary during the previous year.CommentsClose CommentsPermalink
‘(E) RELIANCE ON FEDERAL, STATE, OR LOCAL INSPECTIONS- In meeting the inspection requirements under this subsection for domestic facilities, the Secretary may rely on inspections conducted by other Federal, State, or local agencies under interagency agreement, contract, memoranda of understanding, or other obligation.CommentsClose CommentsPermalink
‘(b) Identification and Inspection at Ports of Entry- The Secretary, in consultation with the Secretary of Homeland Security, shall allocate resources to inspect articles of food imported into the United States according to the risk profileny article of food imported into the United States according to the known safety risks of the article of food, which shall be based on the following factors:CommentsClose CommentsPermalink
‘(1) The risk profileknown safety risks of the food imported.CommentsClose CommentsPermalink
‘(2) The risk profileknown safety risks of the countries or regions of origin and countries of transport of the food imthrough which such article of food is transported.CommentsClose CommentsPermalink
‘(3) The compliance history of the importer, including with regard to food recalls, outbreaks of foodborne illness, and violations of food safety standards.CommentsClose CommentsPermalink
‘(4) The rigor and effectiveness of the foreignactivities conducted by the importer of such article of food to satisfy the requirements of the foreign supplier verification program under section 805.CommentsClose CommentsPermalink
‘(5) Whether the food importer participates in the voluntary qualified importer program under section 806.CommentsClose CommentsPermalink
‘(6) Whether the food meets the criteria for priority under section 801(h)(1).CommentsClose CommentsPermalink
‘(7) Whether the food is from a facility that has received a certificate as described in section 809(b)or the facility that manufactured, processed, packed, or held such food received a certification as described in section 801(q) or 806.CommentsClose CommentsPermalink
‘(8) Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources.CommentsClose CommentsPermalink
‘(c) Interagency Agreements With Respect to Seafood-CommentsClose CommentsPermalink
‘(1) IN GENERAL- The Secretary of Health and Human Services, the Secretary of Commerce, the Secretary of Homeland Security, the Chairman of the Federal Trade Commission, and the heads of other appropriate agencies may enter into such agreements as may be necessary or appropriate to improve seafood safety.CommentsClose CommentsPermalink
‘(2) SCOPE OF AGREEMENTS- The agreements under paragraph (1) may include--CommentsClose CommentsPermalink
‘(A) cooperative arrangements for examining and testing seafood imports that leverage the resources, capabilities, and authorities of each party to the agreement;CommentsClose CommentsPermalink
‘(B) coordination of inspections of foreign facilities to increase the percentage of imported seafood and seafood facilities inspected;CommentsClose CommentsPermalink
‘(C) standardization of data on seafood names, inspection records, and laboratory testing to improve interagency coordination;CommentsClose CommentsPermalink
‘(D) coordination to detect and investigate violations under applicable Federal law;CommentsClose CommentsPermalink
‘(E) a process, including the use or modification of existing processes, by which officers and employees of the National Oceanic and Atmospheric Administration may be duly designated by the Secretary to carry out seafood examinations and investigations under section 801 of this Act or section 203 of the Food Allergen Labeling and Consumer Protection Act of 2004;CommentsClose CommentsPermalink
‘(F) the sharing of information concerning observed non-compliance with United States food requirements domestically and in foreign nations and new regulatory decisions and policies that may affect the safety of food imported into the United States;CommentsClose CommentsPermalink
‘(G) conducting joint training on subjects that affect and strengthen seafood inspection effectiveness by Federal authorities; andCommentsClose CommentsPermalink
‘(H) outreach on Federal efforts to enhance seafood safety and compliance with Federal food safety requirements.CommentsClose CommentsPermalink
‘(d) Coordination- The Secretary shall improve coordination and cooperation with the Secretary of Agriculture and the Secretary of Homeland Security to target food inspection resources.CommentsClose CommentsPermalink
‘(de) Facility- For purposes of this section, the term ‘facility’ means a domestic facility or a foreign facility that is required to register under section 415.’.CommentsClose CommentsPermalink
(b) Annual Report- Section 1003 (
) is amended by adding at the end the following:CommentsClose CommentsPermalink 21 U.S.C. 393 ‘(h) Annual Report Regarding Food- Not later than February 1 of each year, the Secretary shall submit to Congress a report, including efforts to coordinate and cooperate with other Federal agencies with responsibilities for food inspections, regarding--CommentsClose CommentsPermalink
‘(1) information about food facilities including--CommentsClose CommentsPermalink
‘(A) the appropriations used to inspect facilities registered pursuant to section 415 in the previous fiscal year;CommentsClose CommentsPermalink
‘(B) the average cost of both a non-high-risk food facility inspection and a high-risk food facility inspection, if such a difference exists, in the previous fiscal year;CommentsClose CommentsPermalink
‘(C) the number of domestic facilities and the number of foreign facilities registered pursuant to section 415 that the Secretary inspected in the previous fiscal year;CommentsClose CommentsPermalink
‘(D) the number of domestic facilities and the number of foreign facilities registered pursuant to section 415 that were scheduled for inspection in the previous fiscal year and which the Secretary did not inspect in such year;CommentsClose CommentsPermalink
‘(E) the number of high-risk facilities identified pursuant to section 421 that the Secretary inspected in the previous fiscal year; andCommentsClose CommentsPermalink
‘(F) the number of high-risk facilities identified pursuant to section 421 that were scheduled for inspection in the previous fiscal year and which the Secretary did not inspect in such year.CommentsClose CommentsPermalink
‘(2) information about food imports including--CommentsClose CommentsPermalink
‘(A) the number of lines of food imported into the United States that the Secretary physically inspected or sampled in the previous fiscal year;CommentsClose CommentsPermalink
‘(B) the number of lines of food imported into the United States that the Secretary did not physically inspect or sample in the previous fiscal year; andCommentsClose CommentsPermalink
‘(C) the average cost of physically inspecting or sampling a food lineline of food subject to this Act that is imported or offered for import into the United States; andCommentsClose CommentsPermalink
‘(3) information on the foreign offices of the Food and Drug Administration including--CommentsClose CommentsPermalink
‘(A) the number of foreign offices established; andCommentsClose CommentsPermalink
‘(B) the number of personnel permanently stationed in each foreign office.CommentsClose CommentsPermalink
‘(i) Public Availability of Annual Food Reports- The Secretary shall make the reports required under subsection (h) available to the public on the Internet Web site of the Food and Drug Administration.’.CommentsClose CommentsPermalink
(c) Advisory Committee Consultation- In allocating inspection resources as described in section 421 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)), the Secretary may, as appropriate, consult with any relevant advisory committee within the Department of Health and Human Services.CommentsClose CommentsPermalink
SEC. 202. RECOGNITION OF LABORATORY ACCREDITATION FOR ANALYSES OF FOODS.
(a) In General- Chapter IV (
‘SEC. 422. RECOGNITION OF LABORATORY ACCREDITATION FOR ANALYSES OF FOODS.
‘(a) Recognition of Laboratory Accreditation-CommentsClose CommentsPermalink
‘(1) IN GENERAL- Not later than 2 years after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall--CommentsClose CommentsPermalink
‘(A) provide for the recognition of accreditation bodies that accredit laboratories, including laboratories run and operated by a State or locality, with a demonstrated capability to conduct sampling and analytical testing of food products; and‘(B) establish a program for the testing of food by accredited laboratories;CommentsClose CommentsPermalink
‘(B) establish a publicly available registry of accreditation bodies recognized by the Secretary and laboratories accredited by a recognized accreditation body, including the name of, contact information for, and other information deemed necessary by the appropriate by the Secretary about such bodies and laboratories; andCommentsClose CommentsPermalink
‘(C) require, as a condition of recognition or accreditation, as appropriate, that recognized accreditation bodies and accredited laboratories report to the Secretary any changes that would affect the recognition of such accreditation body or the accreditation of such laboratory.CommentsClose CommentsPermalink
‘(2) PROGRAM REQUIREMENTS- The program established under paragraph (1)(A) shall provide for the recognition of laboratory accreditation bodies that meet criteria established by the Secretary for accreditation of laboratories, including independent private laboratories and laboratories run and operated by a Federal agency (including the Department of Commerce), State, or locality with a demonstrated capability to conduct 1 or more sampling and analytical testing methodologies for food.CommentsClose CommentsPermalink
‘(3) INCREASING THE NUMBER OF QUALIFIED LABORATORIES- The Secretary shall work with the laboratory accreditation bodies recognized under paragraph (1), as appropriate, to increase the number of qualified laboratories that are eligible to perform testing under subparagraph (b) beyond the number so qualified on the date of enactment of the FDA Food Safety Modernization Act.CommentsClose CommentsPermalink
‘(4) LIMITED DISTRIBUTION- In the interest of national security, the Secretary, in coordination with the Secretary of Homeland Security, may determine the time, manner, and form in which the registry established under paragraph (1)(B) is made publicly available.CommentsClose CommentsPermalink
‘(5) FOREIGN LABORATORIES- Accreditation bodies recognized by the Secretary under paragraph (1) may accredit laboratories that operate outside the United States, so long as such laboratories meet the accreditation standards applicable to domestic laboratories accredited under this section.CommentsClose CommentsPermalink
‘(36) MODEL ACCREDITATIONLABORATORY STANDARDS- The Secretary shall develop model standards that an accreditation body shall require laboratories to meet in order to be laboratory shall meet to be accredited by a recognized accreditation body for a specified sampling or analytical testing methodology and included in the registry provided for under paragraph (1). In developing the model standards, the Secretary shall look toconsult existing standards for guidance. The model standards shall include--CommentsClose CommentsPermalink
‘(A) methods to ensure that--CommentsClose CommentsPermalink
‘(A) appropriate sampling andi) appropriate sampling, analytical procedures (including rapid analytical procedures), and commercially available techniques are followed and reports of analyses are certified as true and accurate;CommentsClose CommentsPermalink
‘(Bii) internal quality systems are established and maintained;CommentsClose CommentsPermalink
‘(Ciii) procedures exist to evaluate and respond promptly to complaints regarding analyses and other activities for which the laboratory is recognized;‘(Daccredited; andCommentsClose CommentsPermalink
‘(iv) individuals who conduct the sampling and analyses are qualified by training and experience to do so; andCommentsClose CommentsPermalink
‘(EB) any other criteria determined appropriate by the Secretary.CommentsClose CommentsPermalink
‘(47) REVIEW OF ACCREDITARECOGNITION- To ensure compliance with the requirements of this section, the Secretary shall--‘(A) periodically, or at least--CommentsClose CommentsPermalink
‘(A) shall periodically, and in no case less than once every 5 years, reevaluate accreditation bodies recognized under paragraph (1); and‘(B) and may accompany auditors from an accreditation body to assess whether the accreditation body meets the criteria for recognition; andCommentsClose CommentsPermalink
‘(B) shall pr