Most commented sections:

• Paragraph 1,388 (1 comments)

HR 2751 PCS

Received and read the first time

Read the second time and placed on the calendar

Resolved, That the bill from the House of Representatives (H.R. 2751) entitled ‘An Act to accelerate motor fuel savings nationwide and provide incentives to registered owners of high polluting automobiles to replace such automobiles with new fuel efficient and less polluting automobiles.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.; REFERENCES; TABLE OF CONTENTS.

(a) Short Title- This Act may be cited as the ‘Consumer Assistance to Recycle and Save FDA Food Safety Modernization Act’. CommentsClose CommentsPermalink





SEC. 2. TEMPORARY VEHICLE TRADE-IN PROGRAM.(a) Establishment- There is established in the (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 et seq.). CommentsClose CommentsPermalink





(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

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 Highway Traffic Safety Administration a voluntary program to be known as the ‘Consumer Assistance to Recycle and Save Program’ through which the Secretary of Transportation (hereinafter in this section referred to as the ‘Secretary’), in accordance with this Act and the regulations promulgated under subsection (d), shall--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

(a) Updating of Food Category Regulations; Biennial Registration Renewal- Section 415(a) (21 U.S.C. 350d(a)) is amended-- CommentsClose CommentsPermalink





(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’; and CommentsClose 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; and CommentsClose 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)authorize the issuance of 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 (21 U.S.C. 350d) is amended-- CommentsClose CommentsPermalink





(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; and CommentsClose 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 a facility-- CommentsClose CommentsPermalink





‘(A) that created, caused, or was otherwise responsible for such reasonable probability; or CommentsClose CommentsPermalink





‘(B)(i) that knew of, or had reason to know of, such reasonable probability; and CommentsClose 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 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 promptly 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, no person shall import or export food into the United States from such facility, offer to import or 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 to implement this subsection. The Secretary may promulgate such regulations on an interim final basis. CommentsClose CommentsPermalink





‘(B) REGISTRATION REQUIREMENT- The Secretary may require that registration under this section be submitted in an electronic voucher, subject to the specifications setformat. 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); or CommentsClose 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) (21 U.S.C. 381(l)) is amended by inserting ‘(or for which a registration has been suspended under such section)’ after ‘section 415’. CommentsClose CommentsPermalink





(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; and CommentsClose 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); and CommentsClose CommentsPermalink





(B) the term ‘consumer’ does not include a business. CommentsClose CommentsPermalink





(d) Conforming Amendments- CommentsClose CommentsPermalink





(1) Section 301(d) (21 U.S.C. 331(d)) is amended by inserting ‘415,’ after ‘404,’. CommentsClose CommentsPermalink





(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. 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; and CommentsClose CommentsPermalink





‘(B) hazards that occur naturally, or may be unintentionally introduced; and CommentsClose CommentsPermalink





‘(2) identify and evaluate hazards that may be intentionally introduced, including by acts of terrorism; and CommentsClose CommentsPermalink





‘(3) 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 (c), to offset the purchase price or lease price for a qualifying lease of a new fuel efficient automobile upon the surrender of an eligible trade-in vehicle to a dealer participating in the Program;

(2) register dealers for participation in the Program and require all registered dealers--

(A) to accept vouchers as provided in this section as partial payment or down payment for the purchase or qualifying lease of any new fuel efficient automobile offered for sale or lease by that dealer; and

(B) in accordance withb)(1) will be significantly minimized or prevented; CommentsClose CommentsPermalink




‘(2) any hazards identified in the hazard analysis conducted under subsection (c)(2), to transfer each eligible trade-in vehicle surrendered to the dealer under the Program to an entity for disposal;(3) in consultation with the Secretary of the Treasury, make electronic payments to dealers for eligible transactions accepted by such dealers, in accordance with the regulations issub)(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 to ensure that, if the preventive controls implemented under subsection (c) are not properly implemented or are found to be ineffective-- 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; and CommentsClose 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 (d); and

(4) in consultation with the Secretary of Treasury and the Inspector General of the Department of Transportation, establish and provide for the enforcement of measures to prevent and penalize fraud under the Program.

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; and CommentsClose 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)Qualifications for and Value of Vouchers- A voucher issued under the Program shall have a value that may be applied to offset the purchase price or lease price for a qualifying lease of a new fuel efficient automobile as follows:(1) $3,500 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) Exemption for Seafood, Juice, and Low-acid Canned Food Facilities Subject to HACCP- CommentsClose CommentsPermalink





‘(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: CommentsClose CommentsPermalink





‘(A) The Seafood Hazard Analysis Critical Control Points Program of the Food and Drug Administration. CommentsClose CommentsPermalink





‘(B) The Juice Hazard Analysis Critical Control Points Program of the Food and Drug Administration. CommentsClose CommentsPermalink





‘(C) 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 activities 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)); and CommentsClose 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; and CommentsClose 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- The voucher may be used to offset the purchase price or lease price of the new fuel efficient automobile by $3,500 if--

(A) the new fuel efficient automobile is a passenger automobile and the combined fuel economy value of such automobile is at least 4 miles per gallon higher than the combined fuel economy value of the eligible trade-in vehicle;

(B) the new fuel efficient automobile is a category 1 truck and the combined fuel economy value of such truck is at least 2 miles per gallon higher than the combined fuel economy value of the eligible trade-is 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; and CommentsClose 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; and CommentsClose 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; or CommentsClose 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; and CommentsClose 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; or CommentsClose 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; or CommentsClose CommentsPermalink

‘(bb) not more than 275 miles from such facility; and CommentsClose 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 vehicle;

(C) the new fuel efficient automobile is a category 2 truck that has a combined fuel economy value of at least 15 miles per gallon and--

(i) the eligible trade-in vehicle is a category 2 truck and the combined fuel economy value of the new fuel efficient automobileconsultation 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; and CommentsClose 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; or CommentsClose 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





‘(n) 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; and CommentsClose 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; and CommentsClose 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 (b) 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 (cGMPs) 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) Guidance 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 9 months after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this subsection as the ‘Secretary’) shall publish 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 (21 U.S.C. 350d), as amended by this Act; and CommentsClose CommentsPermalink





(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 risk 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; and CommentsClose 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 (21 U.S.C. 350d), 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





(2) FINAL REGULATIONS- Not later than 9 months after the close of the comment period for the proposed rulemaking under paragraph (1), the Secretary shall 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 (21 U.S.C. 350d), as amended by this Act; CommentsClose CommentsPermalink





(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 415; and CommentsClose 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)), 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 (21 U.S.C. 331) is amended by adding at the end the following: CommentsClose CommentsPermalink





‘(uu) The operation of a facility that manufactures, 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





(f) 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 et seq.) or the Public Health Service Act (42 U.S.C. 201 et seq.) to revise, issue, or enforce Hazard Analysis Critical Control programs and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards. CommentsClose CommentsPermalink





(g) 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 (21 U.S.C. 342(g)(2), 379aa-1). CommentsClose CommentsPermalink





(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





(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) FLEXIBILITY FOR SMALL BUSINESSES- Notwithstanding paragraph (1)-- CommentsClose CommentsPermalink





(A) the amendments made by this section shall apply to a small business (as defined in 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 at least 1 mile per gallon higher than the combined fuel economy value of the eligible trade-in vehicle; or

(ii) the eligible trade-in vehicle is a category 3 truck of model year 2001 or earlier; or

(D) the new fuel efficient automobile is a category 3 truck and the eligible trade-in vehicle is a category 3 truck of model year of 2001 or earlier and is of similar size or larger than the new fuel efficient automobile as determined in a manner prescribed by the Secretary.

(2) $4,500 VALUE- The voucher may be used to offset the purchase price or lease price of the new fuel efficient automobile by $4,500 if--

(A) the new fuel efficient automobile is a passenger automobile and the combined fuel economy value of such automobile6 months after the effective date of such regulations; and CommentsClose CommentsPermalink




(B) the amendments made by this section shall apply to a very small business (as defined in such regulations) beginning on the date that is at least 10 miles per gallon higher than the combined fuel economy value of the eligible trade-in vehicle;

(B) the new fuel efficient automobile is a category 1 truck and the combined fuel economy value of such truck is at least 5 miles per gallon higher than the combined fuel economy value of the eligible trade-in vehicle; or

(C) the new fuel efficient automobile is a category 2 truck that has a combined fuel economy value of at least 15 miles per gallon and the combined fuel economy value of such truck is at least 2 miles per gallon higher than the combined fuel economy value of the eligible trade-in vehicle and the eligible trade-in vehicle is a category 2 truck.

(c) Program Specifications-

18 months after the effective date of such regulations. CommentsClose CommentsPermalink

‘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), 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





‘(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)LIMITATIONS-(A) GENERAL PERIOD OF ELIGIBILITY- A voucher issued under the Program shall be used only in connection with the purchase or qualifying lease of new fuel efficient automobile shall-- CommentsClose CommentsPermalink





‘(A) provide sufficient flexibility to be applicable to various types of entities engaged in the production and harvesting of fruits 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, animals in the growing area, and water; CommentsClose CommentsPermalink





‘(C) consider hazards that occur between--(i) the date of enactment of this 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





‘(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, while providing 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; and CommentsClose CommentsPermalink





(ii) the date that is 1 ‘(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 under this section for specific fruits and vegetables that are raw agricultural commodities 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, 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 for coordination of education and enforcement activities by State and local officials, as designated by the Governors of the respective States or the appropriate elected State official as recognized by State statute; and CommentsClose CommentsPermalink





‘(B) include a description of the variance process under subsection (c) and the types of permissible variances the Secretary may grant. CommentsClose CommentsPermalink





‘(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); and CommentsClose 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 that 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





‘(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; and CommentsClose 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; and CommentsClose CommentsPermalink





‘(F) permit States and foreign countries from which food is imported into the United States to request from the Secretary variances from the requirements of the regulations, subject 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 and to provide the same level of public health protection as the requirements of the regulations adopted under subsection (b). CommentsClose CommentsPermalink





‘(2) VARIANCES- CommentsClose CommentsPermalink





‘(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. 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 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 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 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; and CommentsClose 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 after the date on which the regulations promulgated under 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; and CommentsClose 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; or CommentsClose 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; or CommentsClose 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; or CommentsClose 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 activities 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 (21 U.S.C. 331), as amended by section 103, is amended by adding at the end the following: CommentsClose CommentsPermalink





‘(vv) The failure to comply with the requirements under section 419.’. CommentsClose CommentsPermalink





(d) are implemented.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 et seq.) or the Public Health Service Act (42 U.S.C. 201 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

‘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; and CommentsClose 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; and CommentsClose 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; and CommentsClose CommentsPermalink





‘(ii) assessing and collecting reinspection fees under this section; and CommentsClose 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)NUMBER OF VOUCHERS PER PERSON AND PER TRADE-IN VEHICLE- Not more than 1 voucher may be issued for a single person and not more than 1 voucher may be issued for the joint registered owners of a single eligible trade-in vehicle. 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)NO COMBINATION OF VOUCHERS- Only 1 voucher issued under the Program may be applied toward the purchase or qualifying lease of a single new fuel efficient automobile. 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 CommentsClose CommentsPermalink





‘(iv) under subparagraph (D)CAP 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- 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(c) 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 180 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; and CommentsClose 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 FUNDS FOR CATEGORY 3 TRUCKS- Not more than 7.5 percent ofAMOUNT 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; and CommentsClose 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 funds made available for the Programrevenue 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) (21 U.S.C. 381(e)(4)(A)) is amended-- CommentsClose CommentsPermalink





(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’; and CommentsClose 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) (21 U.S.C. 381(e)(4)) is amended by inserting after subparagraph (B) the following new subparagraph: CommentsClose CommentsPermalink





‘(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





(3) LIMITATIONS ON THE USE AND AMOUNT OF FEES- Paragraph (4) of section 801(e) (21 U.S.C. 381(e)) is amended by adding at the end the following: CommentsClose CommentsPermalink





‘(D) With regard to fees pursuant to subparagraph (B) in connection with written export certifications for food: CommentsClose CommentsPermalink





‘(i) Such fees shall be collected and available solely for the costs of the Food and Drug Administration associated with issuing such certifications. CommentsClose CommentsPermalink





‘(ii) Such fees may not be retained in an amount that exceeds such costs for the respective fiscal year.’ CommentsClose CommentsPermalink

(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 transmit 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 used for vouchers for the purchase or qualifying lease of category 3 trucksconsistent 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; and CommentsClose 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); and CommentsClose 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; and CommentsClose 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; and CommentsClose 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; and CommentsClose 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; and CommentsClose 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; and CommentsClose 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; and CommentsClose CommentsPermalink





(II) infected plants and animals; and CommentsClose CommentsPermalink





(iv) decontaminating and restoring areas affected by an agriculture or food emergency. CommentsClose CommentsPermalink





(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); and CommentsClose 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

(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) COMBINATION WITH OTHER INCENTIVES PERMITTED- The availability or use of a Federal, State, or local incentive or a State-issued voucher for the purchase or lease of a new fuel efficient automobile shall not limit the value or issuance of a voucher under the Program to any person otherwise eligible to receive such a voucherSurveillance 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) NO ADDITIONAL FEES- A dealer participating in the program may not charge a person purchasing or leasing a new fuel efficient automobileOutreach, 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. 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 (21 U.S.C. 350d). CommentsClose CommentsPermalink





(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 fees associated with the use of a voucher under the Program.(G) NUMBER AND AMOUNT- The total number and value of vouchers issued under the Program may not exceed the amounts appropriated for such purposeauthorities necessary to improve seafood safety. CommentsClose CommentsPermalink





(2) DISPOSITION OF ELIGIBLE TRADE-IN VEHICLESBIENNIAL 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) IN GENERAL- For each eligible trade-in vehicle surrendered to a dealer under the Program, the dealer shall certify to the Secretary, in such manner as the Secretary shall prescribe by rule, that the dealer--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; and CommentsClose 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 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 (21 U.S.C. 350d), and the prior notice system under section 801(m) of such Act (21 U.S.C. 381(m)) with other information technology systems that are used by the Federal Government for the processing of food offered for import into the United States. CommentsClose CommentsPermalink





(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) (21 U.S.C. 321(r)) and recommendations for enhanced surveillance, outbreak response, and traceability. Such findings and recommendations shall address communication and coordination with the public, industry, and State and local governments, as such communication and coordination relates to outbreak identification and traceback. CommentsClose CommentsPermalink





(g) Biennial Food Safety and Food Defense Research Plan- The Secretary, 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; and CommentsClose 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; and CommentsClose 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) will arrange for the vehicle’s title to be transferred to the United States and will accept possession of the vehicle on behalf of the United States;(ii) has not and will not sell, lease, exchange, or otherwise dispose of the vehicle for use as an automobile in 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

(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 (42 U.S.C. 9831 et seq.); CommentsClose CommentsPermalink





(B) a State licensed or regulated child care program or school; or CommentsClose 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 (20 U.S.C. 7801). CommentsClose CommentsPermalink





(3) SCHOOL- The term ‘school’ includes public-- CommentsClose CommentsPermalink





(A) kindergartens; CommentsClose CommentsPermalink





(B) elementary schools; and CommentsClose 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; and CommentsClose 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’) (20 U.S.C. 1232g). CommentsClose CommentsPermalink





(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 United States or in any other country; and(iii) will transfer, on behalf of the United States, the vehicle (including the engine block) and the vehicle’s title, in such manner as the Secretary prescribes, to an entity that will ensure that the vehiclechild 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; and CommentsClose CommentsPermalink





(VII) assessing the child’s readiness for self-administration of prescription medication; and CommentsClose 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; and CommentsClose 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; and CommentsClose 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 crushed or shredded within such period and in such manner as the Secretary prescribes; and(II) has not been, and will not be, sold, leased, exchanged, or otherwise disposed of for use as an automobile in the United States or in any other countryexpended; CommentsClose CommentsPermalink





(iv) a description of how adoption of the guidelines and implementation of grant activities will be monitored; and CommentsClose 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 (20 U.S.C. 6333(c)). CommentsClose CommentsPermalink





(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) SAVINGS PROVISION- Nothing in subparagraph DETERMINATION OF AMOUNT OF NON-FEDERAL CONTRIBUTION- Non-Federal funds required under subparagraph (A) may be construed to preclude a person who is responsible for ensuring that the vehicle is crushed or shredded from--(i) selling any parts of the disposed vehicle other than the engine block and drive train (unless the transmission, drive shaft, or rear end ash 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 2011 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 sold as separate parts); or

(ii) retaining the proceeds from such sale.

(C) COORDINATION- The Secretary shall coordinate with the Attorney General to ensure that the 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