Version	Word Count	Changes From Previous Version	Percent Change
Introduced in House	19,919	n/a	n/a
Reported in House	24,326	355	34%
Engrossed in House	29,002	326	27%
Referred in Senate	28,851	5 Show Changes Hide Changes	0%

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• Paragraph 109 (1 comments)
• Paragraph 118 (1 comments)

HR 2749 EHRFSCommentsClose CommentsPermalink

111th CONGRESSCommentsClose CommentsPermalink

1st SessionCommentsClose CommentsPermalink

H. R. 2749CommentsClose CommentsPermalink

AN ACTCommentsClose CommentsPermalink

To amend the Federal Food, Drug, and Cosmetic Act to improve the safety of food in the global market, and for other purposes.CommentsClose CommentsPermalink

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

SECTION 1. SHORT TITLE.

This Act may be cited as the ‘Food Safety Enhancement Act of 2009’.CommentsClose CommentsPermalink

SEC. 2. TABLE OF CONTENTS.

The table of contents of this Act is as follows:CommentsClose CommentsPermalink





Sec. 1. Short title.CommentsClose CommentsPermalink





Sec. 2. Table of contents.CommentsClose CommentsPermalink





Sec. 3. References.CommentsClose CommentsPermalink





Sec. 4. Rules of construction.CommentsClose CommentsPermalink





Sec. 5. USDA exemptions.CommentsClose CommentsPermalink





Sec. 6. Alcohol-related facilities.CommentsClose CommentsPermalink

TITLE I--FOOD SAFETY

Subtitle A--Prevention

Sec. 101. Changes in registration of food facilities.CommentsClose CommentsPermalink





Sec. 102. Hazard analysis, risk-based preventive controls, food safety plan, finished product test results from category 1 facilities.CommentsClose CommentsPermalink





Sec. 103. Performance standards.CommentsClose CommentsPermalink





Sec. 104. Safety standards for produce and certain other raw agricultural commodities.CommentsClose CommentsPermalink





Sec. 105. Risk-based inspection schedule.CommentsClose CommentsPermalink





Sec. 106. Access to records.CommentsClose CommentsPermalink





Sec. 107. Traceability of food.CommentsClose CommentsPermalink





Sec. 108. Reinspection and food recall fees applicable to facilities.CommentsClose CommentsPermalink





Sec. 109. Certification and accreditation.CommentsClose CommentsPermalink





Sec. 110. Testing by accredited laboratories.CommentsClose CommentsPermalink





Sec. 111. Notification, nondistribution, and recall of adulterated or misbranded food.CommentsClose CommentsPermalink





Sec. 112. Reportable food registry; exchange of information.CommentsClose CommentsPermalink





Sec. 113. Safe and secure food importation program.CommentsClose CommentsPermalink





Sec. 114. Infant formula.CommentsClose CommentsPermalink

Subtitle B--Intervention

Sec. 121. Surveillance.CommentsClose CommentsPermalink





Sec. 122. Public education and advisory system.CommentsClose CommentsPermalink





Sec. 123. Research.CommentsClose CommentsPermalink

Subtitle C--Response

Sec. 131. Procedures for seizure.CommentsClose CommentsPermalink





Sec. 132. Administrative detention.CommentsClose CommentsPermalink





Sec. 133. Authority to prohibit or restrict the movement of food.CommentsClose CommentsPermalink





Sec. 134. Criminal penalties.CommentsClose CommentsPermalink





Sec. 135. Civil penalties for violations relating to food.CommentsClose CommentsPermalink





Sec. 136. Improper import entry filings.CommentsClose CommentsPermalink

TITLE II--MISCELLANEOUS

Sec. 201. Food substances generally recognized as safe.CommentsClose CommentsPermalink





Sec. 202. Country of origin labeling.CommentsClose CommentsPermalink





Sec. 203. Exportation certificate program.CommentsClose CommentsPermalink





Sec. 204. Registration for commercial importers of food; fee.CommentsClose CommentsPermalink





Sec. 205. Registration for customs brokers.CommentsClose CommentsPermalink





Sec. 206. Unique identification number for food facilities, importers, and custom brokers.CommentsClose CommentsPermalink





Sec. 207. Prohibition against delaying, limiting, or refusing inspection.CommentsClose CommentsPermalink





Sec. 208. Dedicated foreign inspectorate.CommentsClose CommentsPermalink





Sec. 209. Plan and review of continued operation of field laboratories.CommentsClose CommentsPermalink





Sec. 210. False or misleading reporting to FDA.CommentsClose CommentsPermalink





Sec. 211. Subpoena authority.CommentsClose CommentsPermalink





Sec. 212. Whistleblower protections.CommentsClose CommentsPermalink





Sec. 213. Extraterritorial jurisdiction.CommentsClose CommentsPermalink





Sec. 214. Support for training institutes.CommentsClose CommentsPermalink





Sec. 215. Bisphenol A in food and beverage containers.CommentsClose CommentsPermalink





Sec. 216. Lead content labeling requirement for ceramic tableware and cookware.CommentsClose CommentsPermalink

SEC. 3. 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

SEC. 4. RULES OF CONSTRUCTION.

(a) Nothing in this Act or the amendments made by this Act shall be construed to prohibit or limit--CommentsClose CommentsPermalink





(1) any cause of action under State law; orCommentsClose CommentsPermalink





(2) the introduction of evidence of compliance or noncompliance with the requirements of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).CommentsClose CommentsPermalink





(b) Nothing in this Act or any amendment made by this Act shall be construed to--CommentsClose CommentsPermalink





(1) alter the jurisdiction between the Secretary of Agriculture and the Secretary of Health and Human Services, under applicable statutes and regulations;CommentsClose CommentsPermalink





(2) limit the authority of the Secretary of Health and Human Services to issue regulations related to the safety of food under--CommentsClose CommentsPermalink





(A) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) as in effect on the day before the date of the enactment of this Act; orCommentsClose CommentsPermalink





(B) the Public Health Service Act (42 U.S.C. 301 et seq.) as in effect on the day before the date of the enactment of this Act; orCommentsClose CommentsPermalink





(3) impede, minimize, or affect the authority of the Secretary of Agriculture to prevent, control, or mitigate a plant or animal health emergency, or a food emergency involving products regulated under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.).CommentsClose CommentsPermalink

SEC. 5. USDA EXEMPTIONS.

(a) USDA-regulated Products- Food is exempt from the requirements of this Act to the extent that such food is regulated by the Secretary of Agriculture under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.).CommentsClose CommentsPermalink





(b) Livestock and Poultry- Livestock and poultry that are intended to be presented for slaughter pursuant to the regulations by the Secretary of Agriculture under the Federal Meat Inspection Act or the Poultry Products Inspection Act are exempt from the requirements of this Act. A cow, sheep, or goat that is used for the production of milk is exempt from the requirements of this Act.CommentsClose CommentsPermalink





(c) USDA-regulated Facilities- A facility is exempt from the requirements of this Act to the extent such facility is regulated as an official establishment by the Secretary of Agriculture under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act or under a program recognized by the Secretary of Agriculture as at least equal to Federal regulation under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act.CommentsClose CommentsPermalink





(d) Farms- A farm is exempt from the requirements of this Act to the extent such farm raises animals from which food is derived that is regulated under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act.CommentsClose CommentsPermalink

SEC. 6. ALCOHOL-RELATED FACILITIES.

(a) In General- With the exception of the amendments made by section 101(a) and (b) and section 113 of this Act, nothing in this Act, or the amendments made by this Act, shall be construed to apply to a facility that--CommentsClose CommentsPermalink





(1) under the Federal Alcohol Administration Act (27 U.S.C. 201 et seq.) or chapter 51 of subtitle E of the Internal Revenue Code of 1986 (26 U.S.C. 5291 et seq.) is required to obtain a permit or to register with the Secretary of the Treasury as a condition of doing business in the United States; andCommentsClose CommentsPermalink





(2) under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d), as amended by this Act, is required to register as a facility because such facility is engaged in manufacturing, processing, packing, or holding 1 or more alcoholic beverages.CommentsClose CommentsPermalink





(b) Limited Receipt and Distribution of Non-alcohol Food- Subsection (a) shall not apply to a facility engaged in the distributing of any non-alcohol food, except that subsection (a) shall apply to a facility described in paragraphs (1) and (2) of subsection (a) that receives and distributes non-alcohol food provided such food is received and distributed--CommentsClose CommentsPermalink





(1) in a prepackaged form that prevents any direct human contact with such food; andCommentsClose CommentsPermalink





(2) in amounts that constitute not more than 5 percent of the overall sales of such facility, as determined by the Secretary of the Treasury.CommentsClose CommentsPermalink





(c) Rule of Construction- This section shall not be construed to exempt any food, apart from distilled spirits, wine, and malt beverages, as defined in section 211 of the Federal Alcohol Administration Act (27 U.S.C. 211), from the requirements of this Act and the amendments made by this Act.CommentsClose CommentsPermalink

TITLE I--FOOD SAFETYCommentsClose CommentsPermalink

Subtitle A--PreventionCommentsClose CommentsPermalink

SEC. 101. CHANGES IN REGISTRATION OF FOOD FACILITIES.

(a) Misbranding- Section 403 (21 U.S.C. 343) is amended by adding at the end the following:CommentsClose CommentsPermalink





‘(z) If it was manufactured, processed, packed, or held in a facility that is not duly registered under section 415, including a facility whose registration is canceled or suspended under such section.’.CommentsClose CommentsPermalink





(b) Annual Registration-CommentsClose CommentsPermalink





(1) DEFINITION OF FACILITY- Paragraph (1) of section 415(b) (21 U.S.C. 350d(b)) is amended to read as follows:CommentsClose CommentsPermalink





‘(1)(A) The term ‘facility’ means any factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food.CommentsClose CommentsPermalink





‘(B) Such term does not include farms; private residences of individuals; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer; or fishing vessels (except such vessels engaged in processing as defined in section 123.3(k) of title 21, Code of Federal Regulations, or any successor regulations).CommentsClose CommentsPermalink





‘(C)(i) The term ‘retail food establishment’ means an establishment that, as its primary function, sells food products (including those food products that it manufactures, processes, packs, or holds) directly to consumers (including by Internet or mail order).CommentsClose CommentsPermalink





‘(ii) Such term includes--CommentsClose CommentsPermalink





‘(I) grocery stores;CommentsClose CommentsPermalink





‘(II) convenience stores;CommentsClose CommentsPermalink





‘(III) vending machine locations; andCommentsClose CommentsPermalink





‘(IV) stores that sell bagged feed, pet food, and feed ingredients or additives over-the-counter directly to consumers and final purchasers for their own personal animals.CommentsClose CommentsPermalink





‘(iii) A retail food establishment’s primary function is to sell food directly to consumers if the annual monetary value of sales of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers.CommentsClose CommentsPermalink





‘(D)(i) The term ‘farm’ means an operation in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both.CommentsClose CommentsPermalink





‘(ii) Such term includes--CommentsClose CommentsPermalink





‘(I) such an operation that packs or holds food, provided that all food used in such activities is grown, raised, or consumed on such farm or another farm under the same ownership;CommentsClose CommentsPermalink





‘(II) such an operation that manufactures or processes food, provided that all food used in such activities is consumed on such farm or another farm under the same ownership;CommentsClose CommentsPermalink





‘(III) such an operation that sells food directly to consumers if the annual monetary value of sales of the food products from the farm or by an agent of the farm to consumers exceeds the annual monetary value of sales of the food products to all other buyers;CommentsClose CommentsPermalink





‘(IV) such an operation that manufactures grains or other feed stuffs that are grown and harvested on such farm or another farm under the same ownership and are distributed directly to 1 or more farms for consumption as food by humans or animals on such farm; andCommentsClose CommentsPermalink





‘(V) a fishery, including a wild fishery, an aquaculture operation or bed, a fresh water fishery, and a saltwater fishery.CommentsClose CommentsPermalink





‘(iii) Such term does not include such an operation that receives manufactured feed from another farm as described in clause (ii)(IV) if the receiving farm releases the feed to another farm or facility under different ownership.CommentsClose CommentsPermalink





‘(iv) The term ‘harvesting’ includes washing, trimming of outer leaves of, and cooling produce.CommentsClose CommentsPermalink





‘(E) The term ‘consumer’ does not include a business.’.CommentsClose CommentsPermalink





(2) REGISTRATION- Section 415(a) (21 U.S.C. 350d(a)) is amended--CommentsClose CommentsPermalink





(A) in the first sentence of paragraph (1)--CommentsClose CommentsPermalink





(i) by striking ‘require that’ and inserting ‘require that, on or before December 31 of each year,’; andCommentsClose CommentsPermalink





(ii) by striking ‘food for consumption in the United States’ and inserting ‘food for consumption in the United States or for export from the United States’;CommentsClose CommentsPermalink





(B) in subparagraphs (A) and (B) of paragraph (1), by inserting ‘and pay the registration fee required under section 743’ after ‘submit a registration to the Secretary’ each place it appears;CommentsClose CommentsPermalink





(C) in the first sentence of paragraph (2), by inserting ‘in electronic format’ after ‘submit’; andCommentsClose CommentsPermalink





(D) in paragraph (4), by inserting after the first sentence the following: ‘The Secretary shall remove from such list the name of any facility that fails to reregister in accordance with this section, that fails to pay the registration fee required under section 743, or whose registration is canceled by the registrant, canceled by the Secretary in accordance with this section, or suspended by the Secretary in accordance with this section.’.CommentsClose CommentsPermalink





(3) CONTENTS OF REGISTRATION- Paragraph (2) of section 415(a) (21 U.S.C. 350d(a)), as amended by paragraph (1), is amended by striking ‘containing information’ and all that follows and inserting the following: ‘containing information that identifies the following:CommentsClose CommentsPermalink





‘(A) The name, address, and emergency contact information of the facility being registered.CommentsClose CommentsPermalink





‘(B) The primary purpose and business activity of the facility, including the dates of operation if the facility is seasonal.CommentsClose CommentsPermalink





‘(C) The general food category (as defined by the Secretary by guidance) of each food manufactured, processed, packed, or held at the facility.CommentsClose CommentsPermalink





‘(D) All trade names under which the facility conducts business related to food.CommentsClose CommentsPermalink





‘(E) The name, address, and 24-hour emergency contact information of the United States distribution agent for the facility, which agent shall have access to the information required to be maintained under section 414(d) for food that is manufactured, processed, packed, or held at the facility.CommentsClose CommentsPermalink





‘(F) If the facility is located outside of the United States, the name, address, and emergency contact information for a United States agent.CommentsClose CommentsPermalink





‘(G) The unique facility identifier of the facility, as specified under section 1011.CommentsClose CommentsPermalink





‘(H) Such additional information pertaining to the facility as the Secretary may require by regulation.CommentsClose CommentsPermalink





The registrant shall notify the Secretary of any change in the submitted information not later than 30 days after the date of such change, unless otherwise specified by the Secretary.’.CommentsClose CommentsPermalink





(4) SUSPENSION AND CANCELLATION AUTHORITY- Section 415(a) (21 U.S.C. 350d(a)), as amended by paragraphs (1) and (2), is further amended by adding at the end the following:CommentsClose CommentsPermalink





‘(5) SUSPENSION OF REGISTRATION-CommentsClose CommentsPermalink





‘(A) IN GENERAL- The Secretary may suspend the registration of any facility registered under this section for a violation of this Act that could result in serious adverse health consequences or death to humans or animals.CommentsClose CommentsPermalink





‘(B) NOTICE OF SUSPENSION- Suspension of a registration shall be preceded by--CommentsClose CommentsPermalink





‘(i) notice to the facility of the intent to suspend the registration; andCommentsClose CommentsPermalink





‘(ii) an opportunity for an informal hearing, as defined in guidance or regulations issued by the Secretary, concerning the suspension of such registration for such facility.CommentsClose CommentsPermalink





‘(C) REQUEST- The owner, operator, or agent in charge of a facility whose registration is suspended may request that the Secretary vacate the suspension of registration when such owner, operator, or agent has corrected the violation that is the basis for such suspension.CommentsClose CommentsPermalink





‘(D) VACATING OF SUSPENSION- If, based on an inspection of the facility or other information, the Secretary determines that adequate reasons do not exist to continue the suspension of a registration, the Secretary shall vacate such suspension.CommentsClose CommentsPermalink





‘(6) CANCELLATION OF REGISTRATION-CommentsClose CommentsPermalink





‘(A) IN GENERAL- Not earlier than 10 days after providing the notice under subparagraph (B), the Secretary may cancel a registration if the Secretary determines that--CommentsClose CommentsPermalink





‘(i) the registration was not updated in accordance with this section or otherwise contains false, incomplete, or inaccurate information; orCommentsClose CommentsPermalink





‘(ii) the required registration fee has not been paid within 30 days after the date due.CommentsClose CommentsPermalink





‘(B) NOTICE OF CANCELLATION- Cancellation shall be preceded by notice to the facility of the intent to cancel the registration and the basis for such cancellation.CommentsClose CommentsPermalink





‘(C) TIMELY UPDATE OR CORRECTION- If the registration for the facility is updated or corrected no later than 7 days after notice is provided under subparagraph (B), the Secretary shall not cancel such registration.CommentsClose CommentsPermalink





‘(7) REPORT TO CONGRESS- Not later than March 30th of each year, the Secretary shall submit to the Congress a report, based on the registrations on or before December 31 of the previous year, on the following:CommentsClose CommentsPermalink





‘(A) The number of facilities registered under this section.CommentsClose CommentsPermalink





‘(B) The number of such facilities that are domestic.CommentsClose CommentsPermalink





‘(C) The number of such facilities that are foreign.CommentsClose CommentsPermalink





‘(D) The number of such facilities that are high-risk.CommentsClose CommentsPermalink





‘(E) The number of such facilities that are low-risk.CommentsClose CommentsPermalink





‘(F) The number of such facilities that hold food.CommentsClose CommentsPermalink





‘(8) LIMITATION ON DELEGATION- The authority conferred by this subsection to issue an order to suspend a registration or cancel a registration shall not be delegated to any officer or employee other than the Commissioner of Food and Drugs, the Principal Deputy Commissioner, the Associate Commissioner for Regulatory Affairs, or the Director for the Center for Food Safety and Applied Nutrition, of the Food and Drug Administration.’.CommentsClose CommentsPermalink





(c) Registration Fee- Chapter VII (21 U.S.C. 371 et seq.) is amended by adding at the end of subchapter C the following:CommentsClose CommentsPermalink

‘PART 6--FEES RELATING TO FOOD

‘SEC. 743. FACILITY REGISTRATION FEE.

‘(a) In General-CommentsClose CommentsPermalink





‘(1) ASSESSMENT AND COLLECTION- Beginning in fiscal year 2010, the Secretary shall assess and collect an annual fee for the registration of a facility under section 415.CommentsClose CommentsPermalink





‘(2) PAYABLE DATE- A fee under this section shall be payable--CommentsClose CommentsPermalink





‘(A) for a facility that was not registered under section 415 for the preceding fiscal year, on the date of registration; andCommentsClose CommentsPermalink





‘(B) for any other facility--CommentsClose CommentsPermalink





‘(i) for fiscal year 2010, not later than the sooner of 90 days after the date of the enactment of this part or December 31, 2009; andCommentsClose CommentsPermalink





‘(ii) for a subsequent fiscal year, not later than December 31 of such fiscal year.CommentsClose CommentsPermalink





‘(b) Fee Amounts-CommentsClose CommentsPermalink





‘(1) IN GENERAL- The registration fee under subsection (a) shall be--CommentsClose CommentsPermalink





‘(A) for fiscal year 2010, $500; andCommentsClose CommentsPermalink





‘(B) for fiscal year 2011 and each subsequent fiscal year, the fee for fiscal year 2010 as adjusted under subsection (c).CommentsClose CommentsPermalink





‘(2) ANNUAL FEE SETTING- The Secretary shall, not later than 60 days before the start of fiscal year 2011 and each subsequent fiscal year, establish, for the next fiscal year, registration fees under subsection (a), as described in paragraph (1).CommentsClose CommentsPermalink





‘(3) MAXIMUM AMOUNT- Notwithstanding paragraph (1), a person who owns or operates multiple facilities for which a fee must be paid under this section for a fiscal year shall be liable for not more than $175,000 in aggregate fees under this section for such fiscal year.CommentsClose CommentsPermalink





‘(c) Inflation Adjustment- For fiscal year 2011 and each subsequent fiscal year, the fee amount under subsection (b)(1) shall be adjusted by the Secretary by notice, published in the Federal Register, to reflect the greater of--CommentsClose CommentsPermalink





‘(1) the total percentage change that occurred in the Consumer Price Index for all urban consumers (all items; U.S. city average) for the 12-month period ending June 30 preceding the fiscal year for which fees are being established;CommentsClose CommentsPermalink





‘(2) the total percentage change for the previous fiscal year in basic pay under the General Schedule in accordance with section 5332 of title 5, United States Code, as adjusted by any locality-based comparability payment pursuant to section 5304 of such title for Federal employees stationed in the District of Columbia; orCommentsClose CommentsPermalink





‘(3) the average annual change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 5 years of the preceding 6 fiscal years.CommentsClose CommentsPermalink





The adjustment made each fiscal year under this subsection shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2010 under this subsection.CommentsClose CommentsPermalink





‘(d) Limitations-CommentsClose CommentsPermalink





‘(1) IN GENERAL- Fees under subsection (a) shall be refunded for a fiscal year beginning after fiscal year 2010 unless appropriations for salaries and expenses of the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) are equal to or greater than the amount of appropriations for the salaries and expenses of the Food and Drug Administration for fiscal year 2010 (excluding the amount of fees appropriated for such fiscal year) multiplied by the adjustment factor applicable to the fiscal year involved.CommentsClose CommentsPermalink





‘(2) AUTHORITY- If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate, for registration under section 415 at any time in such fiscal year.CommentsClose CommentsPermalink





‘(3) ADJUSTMENT FACTOR- In this subsection, the term ‘adjustment factor’ applicable to a fiscal year is the Consumer Price Index for all urban consumers (all items; United States city average) for October of the preceding fiscal year divided by such Index for October 2009.CommentsClose CommentsPermalink





‘(e) Crediting and Availability of Fees-CommentsClose CommentsPermalink





‘(1) IN GENERAL- Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance 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 appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation.CommentsClose CommentsPermalink





‘(2) COLLECTIONS AND APPROPRIATIONS ACTS- The fees authorized by this section--CommentsClose CommentsPermalink





‘(A) shall be retained in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation, for such fiscal year; andCommentsClose CommentsPermalink





‘(B) shall only be collected and available to defray the costs of food safety activities.CommentsClose CommentsPermalink





‘(3) AUTHORIZATION OF APPROPRIATIONS- For each of fiscal years 2010 through 2014, there are authorized to be appropriated for fees under this section such sums as may be necessary.CommentsClose CommentsPermalink





‘(4) PUBLIC MEETINGS- For each fiscal year, the Secretary shall hold a public meeting on how fees collected under this section will be used to defray the costs of food safety activities in order to solicit the views of the regulated industry, consumers, and other interested stakeholders.CommentsClose CommentsPermalink





‘(f) Collection of Unpaid Fees- In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31, United States Code.CommentsClose CommentsPermalink





‘(g) Construction- This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employees, and advisory committees not engaged in food safety activities, be reduced to offset the number of officers, employees, and advisory committees so engaged.CommentsClose CommentsPermalink





‘(h) Annual Fiscal Reports- Beginning with fiscal year 2011, not later than 120 days after the end of each fiscal year for which fees are collected under this section, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected for such fiscal year.CommentsClose CommentsPermalink





‘(i) Definitions- In this section:CommentsClose CommentsPermalink





‘(1) The term ‘costs of food safety activities’ means the expenses incurred in connection with food safety activities for--CommentsClose CommentsPermalink





‘(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees and to contracts with such contractors;CommentsClose CommentsPermalink





‘(B) laboratory capacity;CommentsClose CommentsPermalink





‘(C) management of information, and the acquisition, maintenance, and repair of technology resources;CommentsClose CommentsPermalink





‘(D) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; andCommentsClose CommentsPermalink





‘(E) collecting fees under this section and accounting for resources allocated for food safety activities.CommentsClose CommentsPermalink





‘(2) The term ‘food safety activities’ means activities related to compliance by facilities registered under section 415 with the requirements of this Act relating to food (including research related to and the development of standards (such as performance standards and preventive controls), risk assessments, hazard analyses, inspection planning and inspections, third-party inspections, compliance review and enforcement, import review, information technology support, test development, product sampling, risk communication, and administrative detention).’.CommentsClose CommentsPermalink





(d) Transitional Provisions-CommentsClose CommentsPermalink





(1) FEES- The Secretary of Health and Human Services shall first impose the fee established under section 743 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (c), for fiscal years beginning with fiscal year 2010.CommentsClose CommentsPermalink





(2) MODIFICATION OF REGISTRATION FORM- Not later than 180 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall modify the registration form under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d) to comply with the amendments made by this section.CommentsClose CommentsPermalink





(3) APPLICATION- The amendments made by this section, other than subsections (b)(2) and (c), shall take effect on the date that is 30 days after the date on which such modified registration form takes effect, but not later than 210 days after the date of the enactment of this Act.CommentsClose CommentsPermalink





(4) SUNSET DATE- Section 743 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (c), does not authorize the assessment or collection of a fee for registration under section 415 of such Act (21 U.S.C. 360) occurring after fiscal year 2014.CommentsClose CommentsPermalink

SEC. 102. HAZARD ANALYSIS, RISK-BASED PREVENTIVE CONTROLS, FOOD SAFETY PLAN, FINISHED PRODUCT TEST RESULTS FROM CATEGORY 1 FACILITIES.

(a) Hazard Analysis, Risk-based Preventive Controls, Food Safety Plan-CommentsClose CommentsPermalink





(1) ADULTERATED FOOD- Section 402 (21 U.S.C. 342) is amended by adding at the end the following:CommentsClose CommentsPermalink





‘(j) If it has been manufactured, processed, packed, transported, or held under conditions that do not meet the requirements of sections 418 and 418A.’.CommentsClose CommentsPermalink





(2) REQUIREMENTS- Chapter IV (21 U.S.C. 341 et seq.) is amended by adding at the end the following:CommentsClose CommentsPermalink

‘SEC. 418. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS.

‘(a) In General- The owner, operator, or agent of a facility shall, in accordance with this section--CommentsClose CommentsPermalink





‘(1) conduct a hazard analysis (or more than one if appropriate);CommentsClose CommentsPermalink





‘(2) identify and implement effective preventive controls;CommentsClose CommentsPermalink





‘(3) monitor preventive controls;CommentsClose CommentsPermalink





‘(4) institute corrective actions when--CommentsClose CommentsPermalink





‘(A) monitoring shows that preventive controls have not been properly implemented; orCommentsClose CommentsPermalink





‘(B) monitoring and verification show that such controls were ineffective;CommentsClose CommentsPermalink





‘(5) conduct verification activities;CommentsClose CommentsPermalink





‘(6) maintain records of monitoring, corrective action, and verification; andCommentsClose CommentsPermalink





‘(7) reanalyze for hazards.CommentsClose CommentsPermalink





‘(b) Identification of Hazards-CommentsClose CommentsPermalink





‘(1) IN GENERAL- The owner, operator, or agent of a facility shall evaluate whether there are any hazards, including hazards due to the source of the ingredients, that are reasonably likely to occur in the absence of preventive controls that may affect the safety, wholesomeness, or sanitation of the food manufactured, processed, packed, transported, or held by the facility, including--CommentsClose CommentsPermalink





‘(A) biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, filth, decomposition, parasites, allergens, and unapproved food and color additives; andCommentsClose CommentsPermalink





‘(B) hazards that occur naturally or that may be unintentionally introduced.CommentsClose CommentsPermalink





‘(2) IDENTIFIED BY THE SECRETARY- The Secretary may, by regulation or guidance, identify hazards that are reasonably likely to occur in the absence of preventive controls.CommentsClose CommentsPermalink





‘(3) HAZARD ANALYSIS- The owner, operator, or agent of a facility shall identify and describe the hazards evaluated under paragraph (1) or identified under paragraph (2), to the extent applicable to the facility, in a hazard analysis.CommentsClose CommentsPermalink





‘(c) Preventive Controls-CommentsClose CommentsPermalink





‘(1) IN GENERAL- The owner, operator, or agent of a facility shall identify and implement effective preventive controls to prevent, eliminate, or reduce to acceptable levels the occurrence of any hazards identified in the hazard analysis under subsection (b)(3).CommentsClose CommentsPermalink





‘(2) IDENTIFIED BY THE SECRETARY-CommentsClose CommentsPermalink





‘(A) ESTABLISHMENT- The Secretary may establish by regulation or guidance preventive controls for specific product types to prevent unintentional contamination throughout the supply chain. The owner, operator, or agent of a facility shall implement any preventive controls identified by the Secretary under this paragraph.CommentsClose CommentsPermalink





‘(B) ALTERNATIVE CONTROLS- Such regulation or guidance shall allow the owner, operator, or agent of a facility to implement an alternative preventive control to one established by the Secretary, provided that, in response to a request by the Secretary, the owner, operator, or agent can present to the Secretary data or other information sufficient to demonstrate that the alternative control effectively addresses the hazard, including meeting any applicable performance standard.CommentsClose CommentsPermalink





‘(C) LIMITATION- Subparagraph (B) shall not apply to any preventive control described in subparagraph (A), (B), or (E) of subsection (i)(2).CommentsClose CommentsPermalink





‘(d) Monitoring- The owner, operator, or agent of a facility shall monitor the implementation of preventive controls under subsection (c) to identify any circumstances in which the preventive controls are not fully implemented or verification shows that such controls were ineffective.CommentsClose CommentsPermalink





‘(e) Corrective Actions- The owner, operator, or agent of a facility shall establish and implement procedures to ensure that, if the preventive controls under subsection (c) are not fully implemented or are not found effective--CommentsClose CommentsPermalink





‘(1) no affected product from such facility enters commerce; andCommentsClose CommentsPermalink





‘(2) appropriate action is taken to reduce the likelihood of recurrence of the implementation failure.CommentsClose CommentsPermalink





‘(f) Verification- The owner, operator, or agent of a facility shall ensure that--CommentsClose CommentsPermalink





‘(1) the system of preventive controls identified under subsection (c) has been validated as scientifically and technically sound so that, if such system is implemented, the hazards identified in the hazard analysis under subsection (b)(3) will be prevented, eliminated, or reduced to an acceptable level;CommentsClose CommentsPermalink





‘(2) the facility is conducting monitoring in accordance with subsection (d);CommentsClose CommentsPermalink





‘(3) the facility is taking effective corrective actions under subsection (e); andCommentsClose CommentsPermalink





‘(4) the preventive controls are effectively preventing, eliminating, or reducing to an acceptable level the occurrence of identified hazards, including through the use of environmental and product testing programs and other appropriate means.CommentsClose CommentsPermalink





‘(g) Requirement to Reanalyze and Revise-CommentsClose CommentsPermalink





‘(1) REQUIREMENT- The owner, operator, or agent of a facility shall--CommentsClose CommentsPermalink





‘(A) review the evaluation under subsection (b) for the facility and, as necessary, revise the hazard analysis under subsection (b)(3) for the facility--CommentsClose CommentsPermalink





‘(i) not less than every 2 years;CommentsClose CommentsPermalink





‘(ii) if there is a change in the process or product that could affect the hazard analysis; andCommentsClose CommentsPermalink





‘(iii) if the Secretary determines that it is appropriate to protect public health; andCommentsClose CommentsPermalink





‘(B) whenever there is a change in the hazard analysis, revise the preventive controls under subsection (c) for the facility as necessary to ensure that all hazards that are reasonably likely to occur are prevented, eliminated, or reduced to an acceptable level, or document the basis for the conclusion that no such revision is needed.CommentsClose CommentsPermalink





‘(2) NONDELEGATION- Any revisions ordered by the Secretary under this subsection shall be ordered by the Secretary or an official designated by the Secretary. An official may not be so designated unless the official is the director of the district under this Act in which the facility involved is located, or is an official senior to such director.CommentsClose CommentsPermalink





‘(h) Recordkeeping- The owner, operator, or agent of a facility shall maintain, for not less than 2 years, records documenting the activities described in subsections (a) through (g).CommentsClose CommentsPermalink





‘(i) Definitions- For purposes of this section:CommentsClose CommentsPermalink





‘(1) FACILITY- The term ‘facility’ means a domestic facility or a foreign facility that is required to be registered under section 415.CommentsClose CommentsPermalink





‘(2) PREVENTIVE CONTROLS- The term ‘preventive controls’ means those risk-based procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, transporting, or holding of food would employ to prevent, eliminate, or reduce to an acceptable level the hazards identified in the hazard analysis under subsection (b)(3) and that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, transporting, or holding at the time of the analysis. Those procedures, practices, and processes shall include the following, as appropriate to the type of facility or food:CommentsClose CommentsPermalink





‘(A) Sanitation procedures and practices.CommentsClose CommentsPermalink





‘(B) Supervisor, manager, and employee hygiene training.CommentsClose CommentsPermalink





‘(C) Process controls.CommentsClose CommentsPermalink





‘(D) An allergen control program to minimize potential allergic reactions in humans from ingestion of, or contact with, human and animal food.CommentsClose CommentsPermalink





‘(E) Good manufacturing practices.CommentsClose CommentsPermalink





‘(F) Verification procedures, practices, and processes for suppliers and incoming ingredients, which may include onsite auditing of suppliers and testing of incoming ingredients.CommentsClose CommentsPermalink





‘(G) Other procedures, practices, and processes established by the Secretary under subsection (c)(2).CommentsClose CommentsPermalink





‘(3) HAZARD THAT IS REASONABLY LIKELY TO OCCUR- A food safety hazard that is reasonably likely to occur is one for which a prudent person who, as applicable, manufactures, processes, packs, transports, or holds food, would establish controls because experience, illness data, scientific reports, or other information provides a basis to conclude that there is a reasonable possibility that the hazard will occur in the type of food being manufactured, processed, packed, transported, or held in the absence of those controls.CommentsClose CommentsPermalink

‘SEC. 418A. FOOD SAFETY PLAN.

‘(a) In General- Before a facility (as defined in section 418(i)) introduces or delivers for introduction into interstate commerce any shipment of food, the owner, operator, or agent of the facility shall develop and implement a written food safety plan (in this section referred to as a ‘food safety plan’).CommentsClose CommentsPermalink





‘(b) Contents- The food safety plan shall include each of the following elements:CommentsClose CommentsPermalink





‘(1) The hazard analysis and any reanalysis conducted under section 418.CommentsClose CommentsPermalink





‘(2) A description of the preventive controls being implemented under subsection 418(c), including those to address hazards identified by the Secretary under subsection 418(b)(2).CommentsClose CommentsPermalink





‘(3) A description of the procedures for monitoring preventive controls.CommentsClose CommentsPermalink





‘(4) A description of the procedures for taking corrective actions.CommentsClose CommentsPermalink





‘(5) A description of verification activities for the preventive controls, including validation that the system of controls, if implemented, will prevent, eliminate, or reduce to an acceptable level the identified hazards, review of monitoring and corrective action records, and procedures for determining whether the system of controls as implemented is effectively preventing, eliminating, or reducing to an acceptable level the occurrence of identified hazards, including the use of environmental and product testing programs.CommentsClose CommentsPermalink





‘(6) A description of the facility’s recordkeeping procedures.CommentsClose CommentsPermalink





‘(7) A description of the facility’s procedures for the recall of articles of food, whether voluntarily or when required under section 422.CommentsClose CommentsPermalink





‘(8) A description of the facility’s procedures for tracing the distribution history of articles of food, whether voluntarily or when required under section 414.CommentsClose CommentsPermalink





‘(9) A description of the facility’s procedures to ensure a safe and secure supply chain for the ingredients or components used in making the food manufactured, processed, packed, transported, or held by such facility.CommentsClose CommentsPermalink





‘(10) A description of the facility’s procedures to implement the science-based performance standards issued under section 419.’.CommentsClose CommentsPermalink





(3) GUIDANCE OR REGULATIONS-CommentsClose CommentsPermalink





(A) IN GENERAL- The Secretary of Health and Human Services (referred to in this subsection as the ‘Secretary’) shall issue guidance or promulgate regulations to establish science-based standards for conducting a hazard analysis, documenting hazards, identifying and implementing preventive controls, and documenting the implementation of the preventive controls, including verification and corrective actions under sections 418 and 418A of the Federal Food, Drug, and Cosmetic Act (as added by paragraph (2)).CommentsClose CommentsPermalink





(B) INTERNATIONAL STANDARDS- In issuing guidance or regulations under subparagraph (A), the Secretary shall review international hazard analysis and preventive control standards that are in existence on the date of the enactment of this Act and relevant to such guidelines or regulations to ensure that the programs under sections 418 and 418A of the Federal Food, Drug, and Cosmetic Act (as added by paragraph (2) are consistent, to the extent the Secretary determines practicable and appropriate, with such standards.CommentsClose CommentsPermalink





(C) AUTHORITY WITH RESPECT TO CERTAIN FACILITIES- The Secretary may, by regulation, exempt or modify the requirements for compliance under this section and the amendments made by this section with respect to facilities that are solely engaged in--CommentsClose CommentsPermalink





(i) the production of food for animals other than man or the storage of packaged foods that are not exposed to the environment; orCommentsClose CommentsPermalink





(ii) the storage of raw agricultural commodities for further distribution or processing.CommentsClose CommentsPermalink





(D) SMALL BUSINESSES- The Secretary--CommentsClose CommentsPermalink





(i) shall consider the impact of any guidance or regulations under this section on small businesses; andCommentsClose CommentsPermalink





(ii) shall issue guidance to assist small businesses in complying with the requirements of this section and the amendments made by this section.CommentsClose CommentsPermalink





(4) NO EFFECT ON EXISTING HACCP AUTHORITIES- Nothing in this section or 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.), as in effect on the day before the date of the enactment of this Act, 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





(5) CONSIDERATION- When implementing sections 418 and 418A of the Federal Food, Drug, and Cosmetic Act, as added by paragraph (2), the Secretary may take into account differences between food intended for human consumption and food intended for consumption by animals other than man.CommentsClose CommentsPermalink





(6) EFFECTIVE DATE-CommentsClose CommentsPermalink





(A) GENERAL RULE- The amendments made by subsection (a) and this subsection shall take effect 18 months after the date of the enactment of this Act.CommentsClose CommentsPermalink





(B) EXCEPTIONS- Notwithstanding subparagraph (A)--CommentsClose CommentsPermalink





(i) the amendments made by subsection (a) and this subsection shall apply to a small business (as defined by the Secretary) after the date that is 2 years after the date of the enactment of this Act; andCommentsClose CommentsPermalink





(ii) the amendments made by subsection (a) and this subsection shall apply to a very small business (as defined by the Secretary) after the date that is 3 years after the date of the enactment of this Act.CommentsClose CommentsPermalink





(b) Finished Product Test Results From Category 1 Facilities-CommentsClose CommentsPermalink





(1) ADULTERATION- Section 402 (21 U.S.C. 342), as amended by subsection (a), is amended by adding at the end the following:CommentsClose CommentsPermalink





‘(k) If it is manufactured or processed in a facility that is in violation of section 418B.’.CommentsClose CommentsPermalink





(2) REQUIREMENTS- Chapter IV (21 U.S.C. 341 et seq.), as amended, is further amended by adding at the end the following:CommentsClose CommentsPermalink

‘SEC. 418B. FINISHED PRODUCT TEST RESULTS FROM CATEGORY 1 FACILITIES.

‘(a) Authority- Beginning on the date specified in subsection (c), the Secretary shall require, after public notice and an opportunity for comment, the submission to the Secretary of finished product test results by the owner, operator, or agent of each category 1 facility subject to good manufacturing practices regulations documenting the presence of contaminants in food in the possession or control of such facility posing a risk of severe adverse health consequences or death.CommentsClose CommentsPermalink





‘(b) Considerations- The Secretary shall require submissions under subsection (a)--CommentsClose CommentsPermalink





‘(1) as the Secretary determines feasible and appropriate; andCommentsClose CommentsPermalink





‘(2) taking into consideration available data and information on the potential risks posed by the facility.CommentsClose CommentsPermalink





‘(c) Beginning Date- The date specified in this subsection is the sooner of--CommentsClose CommentsPermalink





‘(1) the date of completion of the pilot projects and feasibility study under subsections (d) and (e); andCommentsClose CommentsPermalink





‘(2) the date that is 2 years after the date of the enactment of this section.CommentsClose CommentsPermalink





‘(d) Pilot Projects- The Secretary shall conduct 2 or more pilot projects to evaluate the feasibility of collecting positive finished product testing results from category 1 facilities, including the value and feasibility of reporting corrective actions taken when positive finished product test results are reported to the Secretary.CommentsClose CommentsPermalink





‘(e) Feasibility Study- The Secretary shall assess the feasibility and benefits of the reporting by facilities subject to good manufacturing practices regulations of appropriate finished product testing results from category 1 facilities to the Secretary, including the extent to which the collection of such finished product testing results will help the Secretary assess the risk presented by a facility or product category.CommentsClose CommentsPermalink





‘(f) Limitations- Nothing in this section shall be construed--CommentsClose CommentsPermalink





‘(1) to require the Secretary to mandate testing or submission of test results that the Secretary determines would not provide useful information in assessing the potential risk presented by a facility or product category; orCommentsClose CommentsPermalink





‘(2) to limit the Secretary’s authority under any other provisions of law to require any person to provide access, or to submit information or test results, to the Secretary, including the ability of the Secretary to require field or other testing and to obtain test results in the course of an investigation of a potential food-borne illness or contamination incident.CommentsClose CommentsPermalink





‘(g) Definition- In this section, the term ‘category 1 facility’ means a category 1 facility within the meaning of section 704(h).’.CommentsClose CommentsPermalink





(c) Food Defense-CommentsClose CommentsPermalink





(1) ADULTERATION- Section 402(j), as added by subsection (a), is amended by striking ‘and 418A’ and inserting ‘, 418A, or 418C’.CommentsClose CommentsPermalink





(2) REQUIREMENTS- Chapter IV (21 U.S.C. 341 et seq.), as amended, is further amended by adding at the end the following:CommentsClose CommentsPermalink

‘SEC. 418C. FOOD DEFENSE.

‘(a) In General- Before a facility (as defined in section 418(i)) introduces or delivers for introduction into interstate commerce any shipment of food, the owner, operator, or agent of the facility shall develop and implement a written food defense plan (in this section referred to as a ‘food defense plan’).CommentsClose CommentsPermalink





‘(b) Contents- The food defense plan shall include each of the following elements:CommentsClose CommentsPermalink





‘(1) A food defense assessment to identify conditions and practices that may permit a hazard that may be intentionally introduced, including by an act of terrorism. This assessment shall evaluate processing security, cybersecurity, material security (including ingredients, finished product, and packaging), personnel security, storage security, shipping and receiving security, and utility security.CommentsClose CommentsPermalink





‘(2) A description of the preventive measures being implemented as a result of such assessment to minimize the risk of intentional contamination.CommentsClose CommentsPermalink





‘(3) A description of the procedures to check for and identify any circumstances in which the preventive measures are not fully implemented or were ineffective.CommentsClose CommentsPermalink





‘(4) A description of the procedures for taking corrective actions to ensure that when preventive measures have not been properly implemented or have been ineffective, appropriate action is taken--CommentsClose CommentsPermalink





‘(A) to reduce the likelihood of recurrence of the failure; andCommentsClose CommentsPermalink





‘(B) to assess the consequences of the failure.CommentsClose CommentsPermalink





‘(5) A description of evaluation activities for the preventive measures, including a review of records provided for under paragraph (6) and procedures to periodically test the effectiveness of the plan.CommentsClose CommentsPermalink





‘(6) A description of the facility’s record-keeping procedures, including records documenting implementation of the procedures under paragraphs (3), (4), and (5).CommentsClose CommentsPermalink





‘(c) Hazard- For purposes of this section, the term ‘hazard that may be intentionally introduced, including by an act of terrorism’ means a hazard for which a prudent person who, as applicable, manufactures, processes, packs, transports, or holds food, would establish preventive measures because the hazard has been identified by a food defense assessment by application of--CommentsClose CommentsPermalink





‘(1) a targeting assessment tool recommended by the Secretary by guidance; orCommentsClose CommentsPermalink





‘(2) a comparable targeting assessment tool.CommentsClose CommentsPermalink





‘(d) Food Defense Hazards Identified by the Secretary-CommentsClose CommentsPermalink





‘(1) ESTABLISHMENT- The Secretary may establish by regulation or guidance preventive measures for specific product types to prevent intentional contamination throughout the supply chain. The owner, operator, or agent of a facility shall implement any preventive measures identified by the Secretary under this paragraph.CommentsClose CommentsPermalink





‘(2) ALTERNATIVE MEASURES- Such regulation or guidance shall allow the owner, operator, or agent of a facility to implement an alternative preventive measure to one established by the Secretary, provided that, in response to a request by the Secretary, the owner, operator, or agent can present to the Secretary data or other information sufficient to demonstrate that the alternative measure effectively addresses the hazard.CommentsClose CommentsPermalink





‘(e) Requirement to Reassess and Revise-CommentsClose CommentsPermalink





‘(1) REQUIREMENT- The owner, operator, or agent of a facility shall--CommentsClose CommentsPermalink





‘(A) review the food defense assessment under subsection (b)(1) for the facility and, as necessary, revise the food defense assessment under subsection (b)(1) for the facility--CommentsClose CommentsPermalink





‘(i) not less than every 2 years;CommentsClose CommentsPermalink





‘(ii) if there is a change in the process or product that could affect the food defense assessment; andCommentsClose CommentsPermalink





‘(iii) if the Secretary determines that it is appropriate to protect public health; andCommentsClose CommentsPermalink





‘(B) whenever there is a change in the food defense assessment, revise the preventive measures under subsection (b)(2) for the facility as necessary to ensure that for all hazards identified, the risk is minimized, or document the basis for the conclusion that no such revision is needed.CommentsClose CommentsPermalink





‘(2) NONDELEGATION- Any revisions ordered by the Secretary under this subsection shall be ordered by the Secretary or an official designated by the Secretary. An official may not be so designated unless the official is the director of the district under this Act in which the facility involved is located, or is an official senior to such director.CommentsClose CommentsPermalink





‘(f) Recordkeeping- The owner, operator, or agent of a facility shall maintain, for not less than 2 years, records documenting the activities described in subsections (b) and (e).CommentsClose CommentsPermalink





‘(g) Access to Plan-CommentsClose CommentsPermalink





‘(1) ON INSPECTION- An officer or employee of the Secretary shall have access to the food defense plan of a facility under section 414(a) only if the Secretary, through an official who is the director of the district under this Act in which the facility is located or an official who is senior to such a director, provides notice under section 414(a)(1)(C).CommentsClose CommentsPermalink





‘(2) NONDISCLOSURE- A food defense plan, and any information derived from such a plan, shall be exempt from disclosure under section 552 of title 5, United States Code.’.CommentsClose CommentsPermalink





(3) PROHIBITION- Section 301(j) (21 U.S.C. 331(j)) is amended by inserting after ‘entitled to protection’ the following: ‘or a food defense plan, or any information derived from such a plan, under section 418C’.CommentsClose CommentsPermalink

SEC. 103. PERFORMANCE STANDARDS.

(a) Adulterated Food- Section 402 (21 U.S.C. 342), as amended by section 102, is amended by adding at the end the following:CommentsClose CommentsPermalink





‘(l) If it has been manufactured, processed, packed, transported, or held under conditions that do not meet the standards issued under section 419.’.CommentsClose CommentsPermalink





(b) Requirements- Chapter IV (21 U.S.C. 341 et seq.), as amended by section 102(b), is further amended by adding at the end the following:CommentsClose CommentsPermalink

‘SEC. 419. PERFORMANCE STANDARDS.

‘(a) Performance Standards- The Secretary shall, not less frequently than every 2 years, review and evaluate epidemiological data and other appropriate sources of information, including research under section 123 of the Food Safety Enhancement Act of 2009, to identify the most significant food-borne contaminants and the most significant resulting hazards. The Secretary shall issue, as soon as practicable, through guidance or by regulation, science-based performance standards (which may include action levels) applicable to foods or food classes, as appropriate, to minimize to an acceptable level, prevent, or eliminate the occurrence of such hazards. Such standards shall be applicable to foods and food classes. Notwithstanding the timelines set forth in this paragraph, the Secretary shall as appropriate establish such science-based performance standards for identified contaminants as necessary to protect the public health.CommentsClose CommentsPermalink





‘(b) List of Contaminants- Following each review under subsection (a), the Secretary shall publish in the Federal Register a list of food-borne contaminants that have the greatest adverse impact on public health. In determining whether a particular food-borne contaminant should be added to such list, the Secretary shall consider the number and severity of illnesses and the number of deaths associated with the foods associated with such contaminants.CommentsClose CommentsPermalink





‘(c) Sampling Program- In conjunction with the establishment of a performance standard under this section, the Secretary may make recommendations to industry for conducting product sampling.CommentsClose CommentsPermalink





‘(d) Revocation by Secretary- All performance standards of the Food and Drug Administration applicable to foods or food classes in effect on the date of the enactment of this section, or issued under this section, shall remain in effect until revised or revoked by the Secretary.’.CommentsClose CommentsPermalink





(c) Report to Congress- The Secretary of Health and Human Services shall submit to the Congress by March 30th of the year following each review under section 419 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (b), a report on the results of such review and the Secretary’s plans to address the significant food-borne hazards identified, or the basis for not addressing any significant food-borne hazards identified, including any resource limitations or limitations in data that preclude further action at that time.CommentsClose CommentsPermalink

SEC. 104. SAFETY STANDARDS FOR PRODUCE AND CERTAIN OTHER RAW AGRICULTURAL COMMODITIES.

(a) Adulterated Food- Section 402 (21 U.S.C. 342), as amended by sections 102 and 103(a), is amended by adding at the end the following:CommentsClose CommentsPermalink





‘(m) If it has been grown, harvested, processed, packed, sorted, transported, or held under conditions that do not meet the standards established under section 419A.’.CommentsClose CommentsPermalink





(b) Standards- Chapter IV (21 U.S.C. 341 et seq.), as amended by sections 102(b) and 103(b), is amended by adding at the end the following:CommentsClose CommentsPermalink

‘SEC. 419A. SAFETY STANDARDS FOR PRODUCE AND CERTAIN OTHER RAW AGRICULTURAL COMMODITIES.

‘(a) Standards- The Secretary, in coordination with the Secretary of Agriculture, shall establish by regulation scientific and risk-based food safety standards for the growing, harvesting, processing, packing, sorting, transporting, and holding of those types of raw agricultural commodities--CommentsClose CommentsPermalink





‘(1) that are a fruit, vegetable, nut, or fungus; andCommentsClose CommentsPermalink





‘(2) for which the Secretary has determined that such standards are reasonably necessary to minimize the risk of serious adverse health consequences or death to humans or animals.CommentsClose CommentsPermalink





‘(b) Contents- The regulations under subsection (a)--CommentsClose CommentsPermalink





‘(1) may set forth such procedures, processes, and practices as the Secretary determines to be reasonably necessary--CommentsClose CommentsPermalink





‘(A) 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 raw agricultural commodities that are a fruit, vegetable, nut, or fungus; andCommentsClose CommentsPermalink





‘(B) to provide reasonable assurances that such commodity is not adulterated under section 402;CommentsClose CommentsPermalink





‘(2) may include, with respect to growing, harvesting, processing, packing, sorting, transporting, and storage operations, standards for safety as the Secretary determines to be reasonably necessary;CommentsClose CommentsPermalink





‘(3) may include standards addressing manure use, water quality, employee hygiene, sanitation and animal control, and temperature controls, as the Secretary determines to be reasonably necessary;CommentsClose CommentsPermalink





‘(4) may include standards for such other elements as the Secretary determines necessary to carry out subsection (a);CommentsClose CommentsPermalink





‘(5) shall provide a reasonable period of time for compliance, taking into account the needs of small businesses for additional time to comply;CommentsClose CommentsPermalink





‘(6) may provide for coordination of education and enforcement activities;CommentsClose CommentsPermalink





‘(7) shall take into consideration, consistent with ensuring enforceable public health protection, the impact on small-scale and diversified farms, and on wildlife habitat, conservation practices, watershed-protection efforts, and organic production methods;CommentsClose CommentsPermalink





‘(8) may provide for coordination of education and training with other government agencies, universities, private entities, and others with experience working directly with farmers; andCommentsClose CommentsPermalink





‘(9) may provide for recognition through guidance of other existing publicly available procedures, processes, and practices that the Secretary determines to be equivalent to those established under paragraph (1).CommentsClose CommentsPermalink





‘(c) Education and Compliance- The Secretary shall coordinate with the Secretary of Agriculture to provide for effective implementation of education and compliance activities. The Secretary may 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





(c) Timing-CommentsClose CommentsPermalink





(1) PROPOSED RULE- Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services shall issue a proposed rule to carry out section 419A of the Federal Food, Drug, and Cosmetic Act, as added by subsection (b).CommentsClose CommentsPermalink





(2) FINAL RULE- Not later than 3 years after such date, the Secretary of Health and Human Services shall issue a final rule under such section.CommentsClose CommentsPermalink





(d) No Effect on Existing HACCP Authorities- Nothing in this section or 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.), as in effect on the day before the date of the enactment of this Act, 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





(e) Update Existing Guidance- Not later than 1 year after the date of the enactment of this Act, the Secretary of Health and Human Services shall update the guidance document entitled ‘Guidance For Industry: Guide To Minimize Microbial Food Safety Hazards For Fresh Fruits And Vegetables’ (issued on October 26, 1998) in accordance with this section and the amendments made by this section.CommentsClose CommentsPermalink

SEC. 105. RISK-BASED INSPECTION SCHEDULE.

(a) In General- Section 704 (21 U.S.C. 374) is amended by adding at the end the following:CommentsClose CommentsPermalink





‘(h)(1) Each facility registered under section 415 shall be inspected--CommentsClose CommentsPermalink





‘(A)(i) by one or more officers duly designated under section 702 or other statutory authority by the Secretary;CommentsClose CommentsPermalink





‘(ii) for domestic facilities, by a Federal, State, or local official recognized by the Secretary under paragraph (2); orCommentsClose CommentsPermalink





‘(iii) for foreign facilities, by an agency or a representative of a country that is recognized by the Secretary under paragraph (2); andCommentsClose CommentsPermalink





‘(B) at a frequency determined pursuant to a risk-based schedule.CommentsClose CommentsPermalink





‘(2) For purposes of paragraph (1)(A), the Secretary--CommentsClose CommentsPermalink





‘(A) may recognize Federal, State, and local officials and agencies and representatives of foreign countries as meeting standards established by the Secretary for conducting inspections under this Act; andCommentsClose CommentsPermalink





‘(B) may limit such recognition to inspections of specific commodities or food types.CommentsClose CommentsPermalink





‘(3) The risk-based schedule under paragraph (1)(B) shall be implemented beginning not later than 18 months after the date of the enactment of this subsection.CommentsClose CommentsPermalink





‘(4) Such risk-based schedule shall provide for a frequency of inspections commensurate with the risk presented by the facility and shall be based on the following categories and inspection frequencies:CommentsClose CommentsPermalink





‘(A) CATEGORY 1- A category 1 food facility is a high-risk facility that manufactures or processes food. The Secretary shall randomly inspect a category 1 food facility at least every 6 to 12 months.CommentsClose CommentsPermalink





‘(B) CATEGORY 2- A category 2 food facility is a low-risk facility that manufactures or processes food or a facility that packs or labels food. The Secretary shall randomly inspect a category 2 facility at least every 18 months to 3 years.CommentsClose CommentsPermalink





‘(C) CATEGORY 3- A category 3 food facility is a facility that holds food. The Secretary shall randomly inspect a category 3 facility at least every 5 years.CommentsClose CommentsPermalink





‘(5) The Secretary--CommentsClose CommentsPermalink





‘(A) may, by guidance, modify the types of food facilities within a category under paragraph (4);CommentsClose CommentsPermalink





‘(B) may alter the inspection frequencies specified in paragraph (4) based on the need to respond to food-borne illness outbreaks and food recalls; andCommentsClose CommentsPermalink





‘(C) may inspect a facility more frequently than the inspection frequency provided by paragraph (4);CommentsClose CommentsPermalink





‘(D) beginning 6 months after submitting the report required by section 105(b)(2) of the Food Safety Enhancement Act of 2009, may--CommentsClose CommentsPermalink





‘(i) publish in the Federal Register adjustments to the inspection frequencies specified in subparagraphs (B) and (C) of paragraph (4) for category 2 and category 3 food facilities, which adjustments shall be in accordance with the Secretary’s recommendations in such report; andCommentsClose CommentsPermalink





‘(ii) after such publication, implement the adjustments; andCommentsClose CommentsPermalink





‘(E) except as provided in subparagraphs (B) and (C), may not alter the inspection frequency specified in paragraph (4)(A) for category 1 food facilities.CommentsClose CommentsPermalink





‘(6) In determining the appropriate frequency of inspection, the Secretary shall consider--CommentsClose CommentsPermalink





‘(A) the type of food manufactured, processed, packed, or held at the facility;CommentsClose CommentsPermalink





‘(B) the compliance history of the facility;CommentsClose CommentsPermalink





‘(C) whether the facility importing or offering for import into the United States food is certified by a qualified certifying entity in accordance with section 801(q); andCommentsClose CommentsPermalink





‘(D) such other factors as the Secretary determines by guidance to be relevant to assessing the risk presented by the facility.CommentsClose CommentsPermalink





‘(7) Before establishing or modifying the categorization under paragraph (4) of any food facility or type of food facility, the Secretary shall publish a notice of the proposed categorization in the Federal Register and provide a period of not less than 60 days for public comment on the proposed categorization.’.CommentsClose CommentsPermalink





(b) Reports on Risk-based Inspections of Food Facilities-CommentsClose CommentsPermalink





(1) ANNUAL REPORT- Not later than December 31 of each year, the Secretary of Health and Human Services shall submit a report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate describing--CommentsClose CommentsPermalink





(A) the number of foreign and domestic facilities, by risk category, inspected under the risk-based inspection schedule established under section 704(h) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), in the preceding fiscal year; andCommentsClose CommentsPermalink





(B) the costs of implementing the risk-based inspection schedule for the preceding 12 months.CommentsClose CommentsPermalink





(2) THIRD-YEAR REPORT- Not later than 3 years after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit a report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate describing recommendations on the risk-based inspection schedule under section 704(h) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), including recommendations for adjustments to the timing of the schedule and other ways to improve the risk-based allocation of resources by the Food and Drug Administration. In making such recommendations, the Secretary shall consider--CommentsClose CommentsPermalink





(A) the nature of the food products being processed, stored, or transported;CommentsClose CommentsPermalink





(B) the manner in which food products are processed, stored, or transported;CommentsClose CommentsPermalink





(C) the inherent likelihood that the products will contribute to the risk of food-borne illness;CommentsClose CommentsPermalink





(D) the best available evidence concerning reported illnesses associated with the foods processed, stored, held, or transported in the category of facilities; andCommentsClose CommentsPermalink





(E) the overall record of compliance with food safety law among facilities in the category, including compliance with applicable performance standards and the frequency of recalls.CommentsClose CommentsPermalink

SEC. 106. ACCESS TO RECORDS.

(a) Records Access- Subsection (a) of section 414 (21 U.S.C. 350c) is amended to read as follows:CommentsClose CommentsPermalink





‘(a) Records Access-CommentsClose CommentsPermalink





‘(1) RECORDS ACCESS DURING AN INSPECTION-CommentsClose CommentsPermalink





‘(A) IN GENERAL- Except as provided in paragraph (3), each person who manufactures, processes, packs, transports, distributes, receives, or holds an article of food in the United States or for import into the United States shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to such article bearing on whether the food may be adulterated, misbranded, or otherwise in violation of this Act, including all records collected or developed to comply with section 418 or 418A.CommentsClose CommentsPermalink





‘(B) SCOPE OF RECORDS- The requirement under subparagraph (A) applies to all records relating to the manufacture, processing, packing, transporting, distribution, receipt, holding, or importation of such article maintained by or on behalf of such person in any format (including paper and electronic formats) and at any location.CommentsClose CommentsPermalink





‘(C) IMMEDIATE AVAILABILITY WITH NOTICE- Records not required to be made available immediately on commencement of an inspection under subparagraph (A) shall nonetheless be made available immediately on commencement of such an inspection if, by a reasonable time before such inspection, the Secretary by letter to the person identifies the records to be made available during such inspection. Nothing in this subparagraph shall be construed as permitting a person to refuse to produce records required under and in accordance with subparagraph (A) due to failure of the Secretary to provide notice under this paragraph.CommentsClose CommentsPermalink





‘(2) ADDITIONAL AUTHORITIES TO ACCESS RECORDS REMOTELY; SUBMISSION OF RECORDS TO THE SECRETARY-CommentsClose CommentsPermalink





‘(A) REMOTE ACCESS IN EMERGENCIES- If the Secretary has a reasonable belief that an article of food presents a threat of serious adverse health consequences or death to humans or animals, the Secretary may require each person who manufactures, processes, packs, transports, distributes, receives, holds, or imports such article of food, or any article of food that the Secretary determines may be affected in a similar manner, to submit to the Secretary all records reasonably related to such article of food as soon as is reasonably practicable, after receiving written notice (including by notice served personally and outside normal business hours to an agent identified under subparagraph (E) or (F) of section 415(a)(2)) of such requirement.CommentsClose CommentsPermalink





‘(B) REMOTE ACCESS TO RECORDS RELATED TO FOOD SAFETY PLANS- With respect to a facility subject to section 418 and 418A, the Secretary may require the owner, operator, or agent of such facility to submit to the Secretary, as soon as reasonably practicable after receiving written notice of such requirement, the food safety plan, supporting information relied on by the facility to select the preventive controls to include in its food safety plan, and documentation of corrective actions, if any, taken under section 418(e) within the preceding 2 yearsCommentsClose CommentsPermalink





‘(C) ELECTRONIC SUBMISSION- If the records required to be submitted to the Secretary under subparagraph (A) or (B) are available in electronic format, such records shall be submitted electronically unless the Secretary specifies otherwise in the notice under such subparagraph.CommentsClose CommentsPermalink





‘(3) LIMITED RECORDS ACCESS ON FARMS-CommentsClose CommentsPermalink





‘(A) APPLICATION- Paragraphs (1) and (2) do not apply with respect to farms, except as provided in this paragraph.CommentsClose CommentsPermalink





‘(B) IN GENERAL- A person who is the owner, operator, or agent of a farm (as defined in section 415) shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to an article of food produced, manufactured, processed, packed, or held on such farm as specified in paragraphs (1) and (2) if--CommentsClose CommentsPermalink





‘(i) such article of food is a fruit, vegetable, nut, or fungus that is the subject of a standard issued under section 419A; orCommentsClose CommentsPermalink





‘(ii) such article of food is the subject of an active investigation by the Secretary of a food borne illness outbreak and is not a grain or similarly handled commodity as defined in subsection (c)(4)(C)(ii).CommentsClose CommentsPermalink





‘(C) RECORDS ACCESS ON FARMS PRIOR TO RULEMAKING-CommentsClose CommentsPermalink





‘(i) IN GENERAL- As soon as practicable after the enactment of this paragraph, the Secretary shall, in coordination with the Secretary of Agriculture, identify 1 or more fruits, vegetables, nuts, or fungi for which the Secretary shall have access to records on farms. Such identification shall be made by guidance, following notice and public comment.CommentsClose CommentsPermalink





‘(ii) IDENTIFICATION OF RAW AGRICULTURAL COMMODITIES- The Secretary, in coordination with the Secretary of Agriculture, shall make the identification in clause (i), based on any past food borne illness outbreak attributed to the fruit, vegetable, nut, or fungus--CommentsClose CommentsPermalink





‘(I) in the United States and the risk that a similar outbreak could occur again in the United States; orCommentsClose CommentsPermalink





‘(II) in a foreign country and the risk that a similar outbreak could occur in the United States.CommentsClose CommentsPermalink





‘(iii) DURATION OF AUTHORITY- The authority to have access to records for a fruit, vegetable, nut, or fungus under this subparagraph shall begin on the date on which the Secretary identifies such fruit, vegetable, nut, or fungus under clause (i) and shall terminate on the effective date of a final rule issued by the Secretary under section 419A.CommentsClose CommentsPermalink





‘(iv) SCOPE OF RECORDS ACCESS- In the guidance under clause (i), and for the period specified in clause (iii), the Secretary, in coordination with the Secretary of Agriculture, shall determine the scope of the records to which the Secretary shall have access under this subparagraph.CommentsClose CommentsPermalink





‘(D) RULE OF CONSTRUCTION- This paragraph shall not be construed as limiting access to any records authorized under--CommentsClose CommentsPermalink





‘(i) this Act or the Public Health Service Act, as in effect on the day before the date of the enactment of this paragraph; orCommentsClose CommentsPermalink





‘(ii) regulations issued under such Acts on any date before the date of the enactment of this paragraph.’.CommentsClose CommentsPermalink





(b) Regulations Concerning Recordkeeping-CommentsClose CommentsPermalink





(1) AMENDMENT- Subsection (b) of section 414 (21 U.S.C. 350c) is amended to read as follows:CommentsClose CommentsPermalink





‘(b) Regulations Concerning Recordkeeping- The Secretary, in consultation and coordination, as appropriate, with other Federal departments and agencies with responsibilities for regulating food safety, shall by regulation establish requirements regarding the establishment and maintenance, for not longer than 3 years, of records by persons who manufacture, process, pack, transport, distribute, receive, or hold food in the United States or for import into the United States. The Secretary shall take into account the size of a business in promulgating regulations under this subsection. The Secretary shall consult with the Secretary of Agriculture in promulgating regulations with respect to farms under this subsection and shall take into account the nature of and impact on farms in promulgating such regulations. The only distribution records which may be required of restaurants under this subsection are those showing the restaurant’s suppliers and subsequent distribution other than to consumers.’.CommentsClose CommentsPermalink





(2) APPLICATION- The Secretary of Health and Human Services shall promulgate revised regulations to implement section 414(b) of the Federal Food, Drug, and Cosmetic Act, as amended by this subsection. Section 414(b) of the Federal Food, Drug, and Cosmetic Act and regulations thereunder, as in effect on the day before the date of the enactment of this Act, shall apply to acts and omissions occurring before the effective date of such revised regulations.CommentsClose CommentsPermalink





(c) Conforming Amendments- Section 704(a)(1) (21 U.S.C. 374(a)(1)) is amended--CommentsClose CommentsPermalink





(1) in the second sentence--CommentsClose CommentsPermalink





(A) by striking ‘(excluding farms or restaurants)’ and inserting ‘(excluding farms, except as provided in section 414(a)(3))’;CommentsClose CommentsPermalink





(B) by inserting ‘receives,’ before ‘holds’;CommentsClose CommentsPermalink





(C) by striking ‘described in section 414’ and inserting ‘described in or required under section 414’; andCommentsClose CommentsPermalink





(D) by striking ‘when the Secretary has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals’ and inserting ‘bearing on whether such food is adulterated, misbranded, or otherwise in violation of this Act, including all records collected or developed to comply with section 418 or 418A’; andCommentsClose CommentsPermalink





(2) in the fourth sentence--CommentsClose CommentsPermalink





(A) by striking ‘the preceding sentence’ and inserting ‘either of the preceding two sentences’; andCommentsClose CommentsPermalink





(B) by inserting ‘recipes for food,’ before ‘financial data,’.CommentsClose CommentsPermalink

SEC. 107. TRACEABILITY OF FOOD.

(a) Prohibited Act- Section 301(e) (21 U.S.C. 331(e)) is amended by inserting ‘, the violation of any requirement of the food tracing system under section 414(c);’ before ‘or the refusal to permit access to or verification or copying of any such required record’.CommentsClose CommentsPermalink





(b) Imports- Section 801(a) (21 U.S.C. 381(a)) is amended by inserting ‘or (4) the requirements of section 414 have not been complied with regarding such article,’ before ‘then such article shall be refused admission’.CommentsClose CommentsPermalink





(c) Product Tracing for Food- Section 414 (21 U.S.C. 350c), as amended by section 106, is amended--CommentsClose CommentsPermalink





(1) by redesignating subsections (c) and (d) as subsections (d) and (e), respectively; andCommentsClose CommentsPermalink





(2) by inserting after subsection (b) the following:CommentsClose CommentsPermalink





‘(c) Tracing System for Food-CommentsClose CommentsPermalink





‘(1) IN GENERAL- The Secretary shall by regulation establish a tracing system for food that is located in the United States or is for import into the United States.CommentsClose CommentsPermalink





‘(2) INFORMATION GATHERING-CommentsClose CommentsPermalink





‘(A) TRACING TECHNOLOGIES- Before issuing a proposed regulation under this subsection, the Secretary shall--CommentsClose CommentsPermalink





‘(i) identify technologies and methodologies for tracing the distribution history of a food that are, or may be, used by members of different sectors of the food industry, including technologies and methodologies to enable each person who produces, manufactures, processes, pack, transports, or holds a food to--CommentsClose CommentsPermalink





‘(I) maintain the full pedigree of the origin and previous distribution history of the food;CommentsClose CommentsPermalink





‘(II) link that history with the subsequent distribution of the food;CommentsClose CommentsPermalink





‘(III) establish and maintain a system for tracing the food that is interoperable with the systems established and maintained by other such persons; andCommentsClose CommentsPermalink





‘(IV) use a unique identifier for each facility owned or operated by such person for such purpose, as specified under section 1011; andCommentsClose CommentsPermalink





‘(ii) to the extent practicable, assess--CommentsClose CommentsPermalink





‘(I) the costs and benefits associated with the adoption and use of such technologies;CommentsClose CommentsPermalink





‘(II) the feasibility of such technologies for different sectors of the food industry; andCommentsClose CommentsPermalink





‘(III) whether such technologies are compatible with the requirements of this subsection.CommentsClose CommentsPermalink





‘(B) PUBLIC MEETINGS- Before issuing a proposed regulation under this subsection, the Secretary shall conduct not less than 2 public meetings in diverse geographical areas of the United States to provide persons in different regions an opportunity to provide input and information to the Secretary.CommentsClose CommentsPermalink





‘(C) PILOT PROJECTS- Before issuing a proposed regulation under this subsection, the Secretary shall conduct 1 or more pilot projects in coordination with 1 or more sectors of the food industry to explore and evaluate tracing systems for food. The Secretary shall coordinate with the Secretary of Agriculture in conducting pilot projects with respect to farms under this subsection.CommentsClose CommentsPermalink





‘(3) REGULATION-CommentsClose CommentsPermalink





‘(A) IN GENERAL- Taking into account information obtained through information gathering under paragraph (2), the Secretary shall issue regulations establishing a tracing system that enables the Secretary to identify each person who grows, produces, manufactures, processes, packs, transports, holds, or sells such food in as short a timeframe as practicable but no longer than 2 business days.CommentsClose CommentsPermalink





‘(B) SCOPE OF REGULATION- The Secretary may include in the regulations establishing a tracing system--CommentsClose CommentsPermalink





‘(i) the establishment and maintenance of lot numbers;CommentsClose CommentsPermalink





‘(ii) a standardized format for pedigree information; andCommentsClose CommentsPermalink





‘(iii) the use of a common nomenclature for food.CommentsClose CommentsPermalink





‘(C) COORDINATION REGARDING FARM IMPACT- In issuing regulations under this paragraph that will impact farms, the Secretary--CommentsClose CommentsPermalink





‘(i) shall coordinate with the Secretary of Agriculture; andCommentsClose CommentsPermalink





‘(ii) take into account the nature of the impact of the regulations on farms.CommentsClose CommentsPermalink





‘(4) EXEMPTIONS AND LIMITATIONS-CommentsClose CommentsPermalink





‘(A) DIRECT SALES BY FARMS- Food is exempt from the requirements of this subsection if such food is--CommentsClose CommentsPermalink





‘(i) produced on a farm; andCommentsClose CommentsPermalink





‘(ii) sold by the owner, operator, or agent in charge of such farm directly to a consumer or to a restaurant or grocery store.CommentsClose CommentsPermalink





‘(B) FISHING VESSELS- Food is exempt from the requirements of this subsection if such food is produced through the use of a fishing vessel as defined in section 3(18) of the Magnuson-Stevens Fishery Conservation and Management Act until such time as the food is sold by the owner, operator, or agent in charge of such fishing vessel.CommentsClose CommentsPermalink





‘(C) GRAINS AND SIMILARLY HANDLED COMMODITIES-CommentsClose CommentsPermalink





‘(i) LIMITATION ON EXTENT OF TRACING- In addition to the exemption under subparagraph (A), any tracing system established under this subsection with regard to any grain or similarly handled commodity shall be limited to enabling the Secretary to identify persons who received, processed, packed, transported, distributed, held, or sold the grain or similarly handled commodity from the initial warehouse operator that held the grain or similarly handled commodity for any period of time to the ultimate consumer.CommentsClose CommentsPermalink





‘(ii) DEFINITIONS- In this subparagraph:CommentsClose CommentsPermalink





‘(I) The term ‘grain or similarly handled commodity’ means wheat, corn, grain sorghum, barley, oats, rice, wild rice, rye, soybeans, legumes, sugar cane, sugar beets, sunflower seed, rapeseed, canola, safflower, flaxseed, mustard seed, crambe, sesame seed, camelina, cottonseed, cocoa beans, grass hay, and honey. The term may include any other commodity as determined by the Secretary in coordination with the Secretary of Agriculture.CommentsClose CommentsPermalink





‘(II) The term ‘warehouse operator’ has the meaning given that term in section 2 of the United States Warehouse Act (7 U.S.C. 241), except that the term also includes any person or entity that handles or stores agricultural products for other persons or entities or, in the case of a cooperative, handles or stores agricultural products for its members, as determined by the Secretary in coordination with the Secretary of Agriculture.CommentsClose CommentsPermalink





‘(D) EXEMPTION OF OTHER FOODS- The Secretary may by notice in the Federal Register exempt a food or a type of facility, farm, or restaurant from, or modify the requirements with respect to, the requirements of this subsection if the Secretary determines that a tracing system for such food or type of facility, farm, or restaurant is not necessary to protect the public health.CommentsClose CommentsPermalink





‘(E) RECORDKEEPING REGARDING PREVIOUS SOURCES AND SUBSEQUENT RECIPIENTS- For a food or person covered by a limitation or exemption under subparagraph (B), (C), or (D), the Secretary shall require each person who produces, receives, manufactures, processes, packs, transports, distributes, or holds such food to maintain records to identify the immediate previous sources of such food and its ingredients and the immediate subsequent recipients of such food.CommentsClose CommentsPermalink





‘(F) RECORDKEEPING BY RESTAURANTS AND GROCERY STORES- For a food covered by an exemption under subparagraph (A), restaurants and grocery stores shall keep records documenting the farm that was the source of the food.CommentsClose CommentsPermalink





‘(G) RECORDKEEPING BY FARMS- For a food covered by an exemption under subparagraph (A), farms shall keep records, in electronic or non-electronic format, for at least 6 months documenting the restaurant or grocery store to which the food was sold.’.CommentsClose CommentsPermalink

SEC. 108. REINSPECTION AND FOOD RECALL FEES APPLICABLE TO FACILITIES.

(a) In General- Part 6 of subchapter C of chapter VII (21 U.S.C. 371 et seq.), as added by section 101(c), is amended by adding at the end the following:CommentsClose CommentsPermalink

‘SEC. 743A. REINSPECTION AND FOOD RECALL FEES APPLICABLE TO FACILITIES.

‘(a) In General- The Secretary shall assess and collect fees from each entity in a fiscal year--CommentsClose CommentsPermalink





‘(1) that--CommentsClose CommentsPermalink





‘(A) during such fiscal year commits a violation of any requirement of this Act relating to food, including any such requirement relating to good manufacturing practices; andCommentsClose CommentsPermalink





‘(B) because of such violation, undergoes additional inspection by the Food and Drug Administration; orCommentsClose CommentsPermalink





‘(2) during such fiscal year is subject to a food recall.CommentsClose CommentsPermalink





‘(b) Amount of Fees- The Secretary shall set the amount of the fees under this section to fully cover the costs of--CommentsClose CommentsPermalink





‘(1) in the case of fees collected under subsection (a)(1), conducting the additional inspections referred to in such subsection; andCommentsClose CommentsPermalink





‘(2) in the case of fees collected under subsection (a)(2), conducting food recall activities, including technical assistance, follow-up effectiveness checks, and public notifications, during the fiscal year involved.CommentsClose CommentsPermalink





‘(c) Crediting and Availability of Fees-CommentsClose CommentsPermalink





‘(1) IN GENERAL- Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance 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 appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation.CommentsClose CommentsPermalink





‘(2) COLLECTIONS AND APPROPRIATIONS ACTS- The fees authorized by this section--CommentsClose CommentsPermalink





‘(A) shall be retained in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation, for such fiscal year; andCommentsClose CommentsPermalink





‘(B) shall only be collected and available to defray the costs referred to in subsection (b).CommentsClose CommentsPermalink





‘(3) AUTHORIZATION OF APPROPRIATIONS- For each of fiscal years 2010 through 2014, there are authorized to be appropriated for fees under this section such sums as may be necessary.CommentsClose CommentsPermalink





‘(d) Waiver- The Secretary shall waive and, if applicable, refund the amount of any fee collected under this section from an entity as a result of a food recall that the Secretary determines was inappropriately ordered.’.CommentsClose CommentsPermalink





(b) Effective Date- The amendment made by subsection (a) shall apply to additional inspections and food recall activities occurring after the date of the enactment of this Act.CommentsClose CommentsPermalink

SEC. 109. CERTIFICATION AND ACCREDITATION.

(a) Misbranding-CommentsClose CommentsPermalink





(1) IN GENERAL- Section 403 (21 U.S.C. 343), as amended by section 101(a), is amended by adding at the end the following:CommentsClose CommentsPermalink





‘(aa) If it is part of a shipment offered for import into the United States and such shipment is in violation of section 801(q) (requiring a certification of compliance for certain food shipments).’.CommentsClose CommentsPermalink





(2) EFFECTIVE DATE- The amendment made by paragraph (1) shall apply to shipments offered for import on or after the date that is 3 years after the date of the enactment of this Act.CommentsClose CommentsPermalink





(b) Certification of Compliance for Imports- Chapter VIII (21 U.S.C. 381 et seq.) is amended--CommentsClose CommentsPermalink





(1) in section 801(a), as amended by section 107(b), by inserting after the third sentence the following: ‘If such article is food being imported or offered for import into the United States and is not in compliance with the requirement of subsection (q) (relating to certifications of compliance with this Act), then such article shall be refused admission.’;CommentsClose CommentsPermalink





(2) in the second sentence of section 801(b), by striking ‘the fourth sentence’ and inserting ‘the fifth sentence’; andCommentsClose CommentsPermalink





(3) by adding at the end of section 801 the following:CommentsClose CommentsPermalink





‘(q) Certifications Concerning Imported Articles-CommentsClose CommentsPermalink





‘(1) IN GENERAL-CommentsClose CommentsPermalink





‘(A) REQUIREMENT- The Secretary may require, as an additional condition of granting admission to an article of food being imported or offered for import into the United States, that a qualified certifying entity provide a certification that the article complies with requirements of this Act as specified by the Secretary if--CommentsClose CommentsPermalink





‘(i) for food imported from a particular country, territory, or region, the Secretary finds, based on scientific, risk-based evidence, that the government controls in such country, territory, or region are inadequate to ensure that the article is safe and that certification would assist the Secretary in determining whether to refuse to admit such article under subsection (a);CommentsClose CommentsPermalink





‘(ii) for a type of food for which there is scientific evidence that there is a particular risk associated with the food that presents a threat of serious adverse health consequences or death, the Secretary finds that certification would assist the Secretary in determining whether to refuse to admit such article under subsection (a); orCommentsClose CommentsPermalink





‘(iii) for an article imported from a particular country or territory, there is an agreement between the Secretary and the government of such country or territory providing for such certification.CommentsClose CommentsPermalink





‘(B) FORM OF CERTIFICATION- A certification under subparagraph (A) may take the form of a statement that the article or the facility or farm that manufactured, processed, packed, held, grew, harvested, sorted, or transported the article, as the case may be, complies with requirements of this Act as specified by the Secretary, or any other form as the Secretary may specify, including a listing of certified facilities or other entities. The Secretary may require that the certification include additional information regarding compliance.CommentsClose CommentsPermalink





‘(C) ADEQUATE GOVERNMENT CONTROLS-CommentsClose CommentsPermalink





‘(i) PROCESS- Before requiring a certification under clause (ii) of subparagraph (A) with respect to a food, the Secretary shall establish a process by which a country or territory may demonstrate that its government controls are adequate to ensure that such food exported from its territory to the United States is safe.CommentsClose CommentsPermalink





‘(ii) DEMONSTRATION- The Secretary shall not require a certification under clause (ii) of subparagraph (A) for a food exported from a country or territory, if that country or territory has demonstrated, pursuant to the process established by the Secretary under clause (i), that its government controls are adequate to ensure that such food exported from its territory to the United States is safe.CommentsClose CommentsPermalink





‘(D) NOTICE OF CANCELLATION OR SUSPENSION OF CERTIFICATION- As a condition on acceptance of certifications from a qualified certifying entity, the Secretary shall require the qualified certifying entity to notify the Secretary whenever the qualified certifying entity cancels or suspends the certification of any facility or other entity included in a listing under subparagraph (B).CommentsClose CommentsPermalink





‘(E) CONSISTENCY WITH INTERNATIONAL OBLIGATIONS- The Secretary shall apply this paragraph consistently with United States obligations under international agreements.CommentsClose CommentsPermalink





‘(2) QUALIFIED CERTIFYING ENTITY- For purposes of this subsection, the term ‘qualified certifying entity’ means--CommentsClose CommentsPermalink





‘(A) an agency or a representative of the government of the country from which the article originated, as designated by such government or the Secretary; orCommentsClose CommentsPermalink





‘(B) an individual or entity determined by the Secretary or an accredited body recognized by the Secretary to be qualified to provide a certification under paragraph (1).CommentsClose CommentsPermalink





‘(3) NO CONFLICTS OF INTEREST-CommentsClose CommentsPermalink





‘(A) IN GENERAL- The Secretary shall issue regulations to ensure that any qualified certifying entity and its auditors are free from conflicts of interest. In issuing these regulations, the Secretary may rely on or incorporate international certification standards.CommentsClose CommentsPermalink





‘(B) REGULATIONS- Such regulations shall require that--CommentsClose CommentsPermalink





‘(i) the qualified certifying entity shall have a committee or management structure for safeguarding impartiality;CommentsClose CommentsPermalink





‘(ii) conflict of interest policies for a qualified certifying entity and auditors acting for the qualified certifying entity shall be written;CommentsClose CommentsPermalink





‘(iii) the qualified certifying entity shall not be owned, operated, or controlled by a producer, manufacturer, processor, packer, holder, supplier, or vendor of any article of the type it certifies;CommentsClose CommentsPermalink





‘(iv) the qualified certifying entity shall not have any ownership or financial interest in any product, producer, manufacturer, processor, packer, holder, supplier or vendor of the type it certifies;CommentsClose CommentsPermalink





‘(v) no auditor acting for the qualified certifying entity (or spouse or minor children) shall have any significant ownership or other financial interest regarding any product of the type it certifies;CommentsClose CommentsPermalink





‘(vi) the qualified certifying entity shall--CommentsClose CommentsPermalink





‘(I) obtain and maintain annual declarations from all personnel who may be directly involved in the performance of audits as to whether they do or do not have direct financial interests in any producer, manufacturer, processor, packer, holder, supplier, or vendor of foods, and a list of any such companies in which they do have financial interests or by which they were employed in the past year; andCommentsClose CommentsPermalink





‘(II) when an auditor is assigned to audit a facility, require that individual to affirm that he or she has no financial interest in the company that owns or operates that facility and was not employed by that facility in the previous year;CommentsClose CommentsPermalink





‘(vii) neither the qualified certifying entity nor any of its auditors acting for the qualified certifying entity shall participate in the production, manufacture, processing, packing, holding, promotion, or sale of any product of the type it certifies;CommentsClose CommentsPermalink





‘(viii) neither the qualified certifying entity nor any of its auditors shall provide consultative services to any facility certified by the qualified certifying entity, or the owner, operator, or agent in charge of such a facility, unless the qualified certifying entity has procedures in place, approved by the Secretary, to ensure separation of functions between auditors providing consultative services and auditors providing certification services under this subsection;CommentsClose CommentsPermalink





‘(ix) no auditors acting for the qualified certifying entity shall participate in an audit of a facility they were employed by within the last 12 months;CommentsClose CommentsPermalink





‘(x) fees charged or accepted shall not be contingent or based upon the report made by the qualified certifying entity or any personnel involved in the audit process;CommentsClose CommentsPermalink





‘(xi) neither the qualified certifying entity nor any of its auditors shall accept anything of value from anyone in connection with the facility being audited other than the audit fee;CommentsClose CommentsPermalink





‘(xii) the qualified certifying entity shall not be owned, operated, or controlled by a trade association whose member companies operate facilities that it certifies;CommentsClose CommentsPermalink





‘(xiii) the qualified certifying entity and its auditors shall be free from any other conflicts of interest that threaten impartiality;CommentsClose CommentsPermalink





‘(xiv) the qualified certifying entity and its auditors shall sign a statement attesting to compliance with the conflict of interests requirements under this paragraph; andCommentsClose CommentsPermalink





‘(xv) the qualified certifying entity shall ensure that any subcontractors that might be used (such as laboratories and sampling services) provide similar assurances, except that it shall not be a violation of this subsection to the extent such subcontractors perform additional nutritional testing services unrelated to the testing under this subsection.CommentsClose CommentsPermalink





‘(C) DEFINITIONS- In this paragraph:CommentsClose CommentsPermalink





‘(i) The term ‘anything of value’ includes gifts, gratuities, reimbursement of non-audit-related expenses, entertainment, loans, or any other form of compensation in cash or in kind.CommentsClose CommentsPermalink





‘(ii) The term ‘direct financial interest’ does not include any ownership of mutual funds that have a financial interest in a company.CommentsClose CommentsPermalink





‘(4) RENEWAL AND REFUSAL OF CERTIFICATIONS- The Secretary shall--CommentsClose CommentsPermalink





‘(A) require that, to the extent applicable, any certification provided by a qualified certifying entity be renewed by such entity at such times as the Secretary determines appropriate; andCommentsClose CommentsPermalink





‘(B) refuse to accept any certification if the Secretary determines that such certification is no longer valid or reliable.CommentsClose CommentsPermalink





‘(5) ON-SITE AUDITS- In evaluating whether an accreditation body meets, or continues to meet, the standards for recognition under this subsection, or whether to accept certifications from a qualified certifying entity, the Secretary may--CommentsClose CommentsPermalink





‘(A) observe on-site audits of qualified certifying entities by such accreditation body; orCommentsClose CommentsPermalink





‘(B) for any facility that is certified by a qualified certifying entity, upon request of an officer or employee designated by the Secretary and upon presentation of appropriate credentials, at reasonable times and within reasonable limits and in a reasonable manner, conduct an on-site audit of the facility, which shall include access to, and copying and verification of, any related records.CommentsClose CommentsPermalink





‘(6) ELECTRONIC SUBMISSION- The Secretary shall provide, in coordination with the Commissioner responsible for Customs and Border Protection, for the electronic submission of certifications under this subsection.CommentsClose CommentsPermalink





‘(7) NO LIMIT ON AUTHORITY- This subsection shall not be construed to limit the authority of the Secretary to conduct random inspections of imported articles or facilities of importers, issue import alerts for detention without physical examination, require submission to the Secretary of documentation or other information about an article imported or offered for import, or to take such other steps as the Secretary deems appropriate to determine the admissibility of imported articles.’.CommentsClose CommentsPermalink

SEC. 110. TESTING BY ACCREDITED LABORATORIES.

(a) Prohibited Act- Section 301 (21 U.S.C. 331) is amended by adding at the end the following:CommentsClose CommentsPermalink





‘(uu) The violation of any requirement of section 714 (relating to testing by accredited laboratories).’.CommentsClose CommentsPermalink





(b) Laboratory Accreditation- Subchapter A of chapter VII (21 U.S.C. 371 et seq.) is amended by adding at the end the following:CommentsClose CommentsPermalink

‘SEC. 714. TESTING BY ACCREDITED LABORATORIES.

‘(a) In General-CommentsClose CommentsPermalink





‘(1) REQUIREMENT- Whenever analytical testing of an article of food is conducted as part of testimony for the purposes of section 801(a), or for such other purposes as the Secretary deems appropriate through regulation or guidance, such testing shall be conducted by a laboratory that--CommentsClose CommentsPermalink





‘(A) is accredited, for the analytical method used, by a laboratory accreditation body that has been recognized by the Secretary; andCommentsClose CommentsPermalink





‘(B) samples such article with adequate controls for ensuring the integrity of the samples analyzed.CommentsClose CommentsPermalink





‘(2) INDEPENDENCE OF LABORATORY-CommentsClose CommentsPermalink





‘(A) CERTAIN TESTS- Tests required for purposes of section 801(a) or in response to a finding of noncompliance by the Secretary shall be conducted by a laboratory independent of the person on whose behalf such testing is conducted and analyzed.CommentsClose CommentsPermalink





‘(B) CERTAIN PRODUCTS- The Secretary may require that testing for certain products under paragraph (1) be conducted by a laboratory independent of the person on whose behalf such testing is conducted.CommentsClose CommentsPermalink





‘(b) Recognition of Laboratory Accreditation Bodies- The Secretary shall establish and implement a program for the recognition, based on standards the Secretary deems appropriate, of laboratory accreditation bodies that accredit laboratories to perform analytical testing for the purposes of this section. The Secretary shall issue regulations or guidance to implement this program.CommentsClose CommentsPermalink





‘(c) Onsite Audits- In evaluating whether an accreditation body meets, or continues to meet, the standards for recognition under subsection (b), the Secretary may--CommentsClose CommentsPermalink





‘(1) observe onsite audits of laboratories by such accreditation bodies; orCommentsClose CommentsPermalink





‘(2) for any laboratory that is accredited by such accreditation body under this section, upon request of an officer or employee designated by the Secretary and upon presentation of appropriate credentials, at reasonable times and within reasonable limits and in a reasonable manner, conduct an onsite audit of the laboratory, which shall include access to, and copying and verification of, any related records.CommentsClose CommentsPermalink





‘(d) Publication of List of Recognized Accreditation Bodies- The Secretary shall publish and maintain on the public Web site of the Food and Drug Administration a list of accreditation bodies recognized by the Secretary under subsection (b).CommentsClose CommentsPermalink





‘(e) Notification of Accreditation of Laboratory- An accreditation body that has been recognized pursuant to this section shall promptly notify the Secretary whenever it accredits a laboratory for the purposes of this section and whenever it withdraws or suspends such accreditation.CommentsClose CommentsPermalink





‘(f) Advance Notice- Whenever analytical testing is conducted pursuant to subsection (a), the person on whose behalf the testing is conducted shall notify the Secretary before any sample of the article is collected. Such notice shall contain information the Secretary determines is appropriate to identify the article, the location of the article, and each laboratory that will analyze the sample on the person’s behalf.CommentsClose CommentsPermalink





‘(g) Contents of Laboratory Packages- Whenever analytical testing is conducted pursuant to subsection (a), the laboratory conducting such testing shall submit, directly to the Secretary--CommentsClose CommentsPermalink





‘(1) the results of all analyses conducted by the laboratory on each sample of such article; andCommentsClose CommentsPermalink





‘(2) all information the Secretary deems appropriate to--CommentsClose CommentsPermalink





‘(A) determine whether the laboratory is accredited by a recognized laboratory accreditation body;CommentsClose CommentsPermalink





‘(B) identify the article tested;CommentsClose CommentsPermalink





‘(C) evaluate the analytical results; andCommentsClose CommentsPermalink





‘(D) determine whether the requirements of this section have been met.CommentsClose CommentsPermalink





‘(h) Exigent Circumstances- The Secretary may waive the requirement of subsection (a)(1)(A) (relating to analytical methods) on a laboratory or method basis due to exigent or other circumstances.CommentsClose CommentsPermalink





‘(i) Federal Laboratory Testing- If Customs and Border Protection laboratory testing concludes that an article of food is adulterated or misbranded, the Secretary shall consider and utilize as appropriate the testing results issued by the Customs and Border Protection laboratories in making a decision about the admissibility of the product.CommentsClose CommentsPermalink





‘(j) No Limit on Authority- Nothing in this section shall be construed to limit--CommentsClose CommentsPermalink





‘(1) the ability of the Secretary to review and act upon information from the analytical testing of food (including under this section), including determining the sufficiency of such information and testing; orCommentsClose CommentsPermalink





‘(2) the authority of the Secretary to conduct, require, or consider the results of analytical testing pursuant to any other provision of law.’.CommentsClose CommentsPermalink

SEC. 111. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED FOOD.

(a) Prohibited Acts- Section 301 (21 U.S.C. 331), as amended by section 110, is amended by adding at the end the following:CommentsClose CommentsPermalink





‘(vv)(1) The failure to notify the Secretary in violation of section 420(a).CommentsClose CommentsPermalink





‘(2) The failure to comply with any order issued under section 420.’.CommentsClose CommentsPermalink





(b) Notification, Nondistribution, and Recall of Adulterated or Misbranded Food- Chapter IV (21 U.S.C. 341 et seq.), as amended by sections 102, 103, and 104, is amended by adding at the end the following:CommentsClose CommentsPermalink

‘SEC. 420. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR MISBRANDED FOOD.

‘(a) Notification, Nondistribution, and Recall of Adulterated or Misbranded Food-CommentsClose CommentsPermalink





‘(1) IN GENERAL- A responsible party as that term is defined in section 417(a)(1) or a person required to register under section 801(s) that has reason to believe that an article of food when introduced into or while in interstate commerce, or while held for sale (regardless of whether the first sale) after shipment in interstate commerce, is adulterated or misbranded in a manner that presents a reasonable probability that the use or consumption of, or exposure to, the article (or an ingredient or component used in any such article) will cause a threat of serious adverse health consequences or death to humans or animals shall, as soon as practicable, notify the Secretary of the identity and location of the article.CommentsClose CommentsPermalink





‘(2) MANNER OF NOTIFICATION- Notification under paragraph (1) shall be made in such manner and by such means as the Secretary may require by regulation or guidance.CommentsClose CommentsPermalink





‘(b) Voluntary Recall- The Secretary may request that any person who distributes an article of food that the Secretary has reason to believe is adulterated, misbranded, or otherwise in violation of this Act voluntarily--CommentsClose CommentsPermalink





‘(1) recall such article; andCommentsClose CommentsPermalink





‘(2) provide for notice, including to individuals as appropriate, to persons who may be affected by the recall.CommentsClose CommentsPermalink





‘(c) Order to Cease Distribution- If the Secretary has reason to believe that the use or consumption of, or exposure to, an article of food may cause serious adverse health consequences or death to humans or animals, the Secretary shall have the authority to issue an order requiring any person who distributes such article to immediately cease distribution of such article.CommentsClose CommentsPermalink





‘(d) Action Following Order- Any person who is subject to an order under subsection (c) shall immediately cease distribution of such article and provide notification as required by such order, and may appeal within 24 hours of issuance such order to the Secretary. Such appeal may include a request for an informal hearing and a description of any efforts to recall such article undertaken voluntarily by the person, including after a request under subsection (b). Except as provided in subsection (f), an informal hearing shall be held as soon as practicable, but not later than 5 calendar days, or less as determined by the Secretary, after such an appeal is filed, unless the parties jointly agree to an extension. After affording an opportunity for an informal hearing, the Secretary shall determine whether the order should be amended to require a recall of such article. If, after providing an opportunity for such a hearing, the Secretary determines that inadequate grounds exist to support the actions required by the order, the Secretary shall vacate the order.CommentsClose CommentsPermalink





‘(e) Order to Recall-CommentsClose CommentsPermalink





‘(1) AMENDMENT- Except as provided under subsection (f), if after providing an opportunity for an informal hearing under subsection (d), the Secretary determines that the order should be amended to include a recall of the article with respect to which the order was issued, the Secretary shall amend the order to require a recall.CommentsClose CommentsPermalink





‘(2) CONTENTS- An amended order under paragraph (1) shall--CommentsClose CommentsPermalink





‘(A) specify a timetable in which the recall will occur;CommentsClose CommentsPermalink





‘(B) require periodic reports to the Secretary describing the progress of the recall; andCommentsClose CommentsPermalink





‘(C) provide for notice, including to individuals as appropriate, to persons who may be affected by the recall.CommentsClose CommentsPermalink





In providing for such notice, the Secretary may allow for the assistance of health professionals, State or local officials, or other individuals designated by the Secretary.CommentsClose CommentsPermalink





‘(3) NONDELEGATION- An amended order under this subsection shall be ordered by the Secretary or an official designated by the Secretary. An official may not be so designated unless the official is the director of the district under this Act in which the article involved is located, or is an official senior to such director.CommentsClose CommentsPermalink





‘(f) Emergency Recall Order-CommentsClose CommentsPermalink





‘(1) IN GENERAL- If the Secretary has credible evidence or information that an article of food subject to an order under subsection (c) presents an imminent threat of serious adverse health consequences or death to humans or animals, the Secretary may issue an order requiring any person who distributes such article--CommentsClose CommentsPermalink





‘(A) to immediately recall such article; andCommentsClose CommentsPermalink





‘(B) to provide for notice, including to individuals as appropriate, to persons who may be affected by the recall.CommentsClose CommentsPermalink





‘(2) ACTION FOLLOWING ORDER- Any person who is subject to an emergency recall order under this subsection shall immediately recall such article and provide notification as required by such order, and may appeal within 24 hours after issuance such order to the Secretary. An informal hearing shall be held within as soon as practicable but not later than 5 calendar days, or less as determined by the Secretary, after such an appeal is filed, unless the parties jointly agree to an extension. After affording an opportunity for an informal hearing, the Secretary shall determine whether the order should be amended pursuant to subsection (e)(1). If, after providing an opportunity for such a hearing, the Secretary determines that inadequate grounds exist to support the actions required by the order, the Secretary shall vacate the order.CommentsClose CommentsPermalink





‘(3) NONDELEGATION- An order under this subsection shall be issued by the Commissioner of Food and Drugs, the Principal Deputy Commissioner, or the Associate Commissioner for Regulatory Affairs of the Food and Drug Administration.CommentsClose CommentsPermalink





‘(g) Notice to Consumers and Health Officials- The Secretary shall, as the Secretary determines to be necessary, provide notice of a recall order under this section to consumers to whom the article was, or may have been, distributed and to appropriate State and local health officials.CommentsClose CommentsPermalink





‘(h) Savings Clause- Nothing contained in this section shall be construed as limiting--CommentsClose CommentsPermalink





‘(1) the authority of the Secretary to issue an order to cease distribution of, or to recall, an article under any other provision of this Act or the Public Health Service Act; orCommentsClose CommentsPermalink





‘(2) the ability of the Secretary to request any person to perform a voluntary activity related to any article subject to this Act or the Public Health Service Act.’.CommentsClose CommentsPermalink





(c) Articles Subject to Refusal- The third sentence of subsection (a) of section 801 (21 U.S.C. 381), as amended by section 107(b), is amended by inserting ‘or (5) such article is subject to an order under section 420 to cease distribution of or recall the article,’ before ‘then such article shall be refused admission’.CommentsClose CommentsPermalink





(d) Effective Date- Sections 301(vv)(1) and 420 of the Federal Food, Drug, and Cosmetic Act, as added by subsections (a) and (b), shall apply with respect to articles of food as of such date, not later than 1 year after the date of the enactment of this Act, as the Secretary of Health and Human Services shall specify.CommentsClose CommentsPermalink

SEC. 112. REPORTABLE FOOD REGISTRY; EXCHANGE OF INFORMATION.

(a) Reportable Food Registry- Section 417 (21 U.S.C. 350f) is amended--CommentsClose CommentsPermalink





(1) in subsection (a)(1), by striking ‘means a person’ and all that follows through the end of paragraph (1) and inserting the following: ‘means--CommentsClose CommentsPermalink





‘(A) a person who submits the registration under section 415(a) for a food facility that is required to be registered under section 415(a), at which such food is manufactured, processed, packed, or held;CommentsClose CommentsPermalink





‘(B) a person who owns, operates, is an agent of, or is otherwise responsible for such food on a farm (as such term is defined in section 1.227(b)(3) of title 21, Code of Federal Regulations, or successor regulations) at which such food is produced for sale or distribution in interstate commerce;CommentsClose CommentsPermalink





‘(C) a person who owns, operates, or is an agent of a restaurant or other retail food establishment (as such terms are defined in section 1.227(b)(11) and (12), respectively, of title 21, Code of Federal Regulations, or successor regulations) at which such food is offered for sale; orCommentsClose CommentsPermalink





‘(D) a person that is required to register pursuant to section 801(s) with respect to importation of such food.’;CommentsClose CommentsPermalink





(2) in subsection (b), by adding at the end the following:CommentsClose CommentsPermalink





‘(3) REPORTING BY FARMS, RESTAURANTS, AND RETAIL FOOD ESTABLISHMENTS- In addition to the electronic portal described in paragraph (1), the Secretary shall make available alternative means of reporting under this section with respect to farms, restaurants, and other retail food establishments with limited ability for such reporting.’;CommentsClose CommentsPermalink





(3) in subsection (d)(1)--CommentsClose CommentsPermalink





(A) in the matter preceding subparagraph (A), by inserting ‘following a timely review of any reasonably available data and information,’ after ‘reportable food,’;CommentsClose CommentsPermalink





(B) in subparagraph (A), by striking ‘and’ at the end;CommentsClose CommentsPermalink





(C) by redesignating subparagraph (B) as subparagraph (C); andCommentsClose CommentsPermalink





(D) by inserting after subparagraph (A) the following:CommentsClose CommentsPermalink





‘(B) submit, with such report, through the electronic portal, documentation of results from any sampling and testing of such article, including--CommentsClose CommentsPermalink





‘(i) analytical results from testing of such article conducted by or on behalf of the responsible party under section 418, 418A, 419, 419A, or 714;CommentsClose CommentsPermalink





‘(ii) analytical results from testing conducted by or on behalf of such responsible party of a component of such article;CommentsClose CommentsPermalink





‘(iii) analytical results of environmental testing of any facility at which such article, or a component of such article, is manufactured, processed, packed, or held; andCommentsClose CommentsPermalink





‘(iv) any other information the Secretary determines is necessary to evaluate the adulteration of such article, any component of such article, any other article of food manufactured, processed, packed or held in the same manner as, or at the same facility as, such article, or any other article containing a component from the same source as a component of such article; and’; andCommentsClose CommentsPermalink





(4) in subsection (e)--CommentsClose CommentsPermalink





(A) in paragraph (1), by inserting ‘if the responsible party is required to register’ after ‘415(a)(3)’; andCommentsClose CommentsPermalink





(B) by adding at the end the following:CommentsClose CommentsPermalink





‘(12) Such additional information as the Secretary deems appropriate.’.CommentsClose CommentsPermalink





(b) Exchange of Information- Section 708 (21 U.S.C. 379) is amended--CommentsClose CommentsPermalink





(1) by striking ‘The Secretary’ and inserting ‘(a) The Secretary’; andCommentsClose CommentsPermalink





(2) by adding at the end the following:CommentsClose CommentsPermalink





‘(b)(1)(A) The Secretary may provide to any Federal agency acting within the scope of its jurisdiction any information relating to food that is exempt from disclosure pursuant to subsection (a) of section 552 of title 5, United States Code, by reason of subsection (b)(4) of such section, or that is referred to in section 301(j) or 415(a)(4).CommentsClose CommentsPermalink





‘(B) Any such information provided to another Federal agency shall not be disclosed by such agency except in any action or proceeding under the laws of the United States to which the receiving agency or the United States is a party.CommentsClose CommentsPermalink





‘(2)(A) In carrying out this Act, the Secretary may provide to a State or local government agency any information relating to food that is exempt from disclosure pursuant to section 552(a) of title 5, United States Code, by reason of subsection (b)(4) of such section, or that is referred to in section 301(j) or 415(a)(4).CommentsClose CommentsPermalink





‘(B) Any such information provided to a State or local government agency shall not be disclosed by such agency.CommentsClose CommentsPermalink





‘(3) In carrying out this Act, the Secretary may provide to any person any information relating to food that is exempt from disclosure pursuant to section 552(a) of title 5, United States Code, by reason of subsection (b)(4) of such section, if the Secretary determines that providing the information to the person is appropriate under the circumstances and the recipient provides adequate assurances to the Secretary that the recipient will preserve the confidentiality of the information.CommentsClose CommentsPermalink





‘(4) In carrying out this Act, the Secretary may provide any information relating to food that is exempt from disclosure pursuant to section 552(a) of title 5, United States Code, by reason of subsection (b)(4) of such section, or that is referred to in section 301(j)--CommentsClose CommentsPermalink





‘(A) to any foreign government agency; orCommentsClose CommentsPermalink





‘(B) any international organization established by law, treaty, or other governmental action and having responsibility--CommentsClose CommentsPermalink





‘(i) to facilitate global or regional harmonization of standards and requirements in an area of responsibility of the Food and Drug Administration; orCommentsClose CommentsPermalink





‘(ii) to promote and coordinate public health efforts,CommentsClose CommentsPermalink





if the agency or organization provides adequate assurances to the Secretary that the agency or organization will preserve the confidentiality of the information.CommentsClose CommentsPermalink





‘(c) Except where specifically prohibited by statute, the Secretary may disclose to the public any information relating to food that is exempt from disclosure pursuant to section 552(a) of title 5, United States Code, by reason of subsection (b)(4) of such section, if the Secretary determines that such disclosure is necessary to protect the public health.CommentsClose CommentsPermalink





‘(d) Except as provided in subsection (e), the Secretary shall not be required to disclose under section 552 of title 5, United States Code, or any other provision of law any information relating to food obtained from a Federal, State, or local government agency, or from a foreign government agency, or from an international organization described in subsection (b)(4), if the agency or organization has requested that the information be kept confidential, or has precluded such disclosure under other use limitations, as a condition of providing the information.CommentsClose CommentsPermalink





‘(e) Nothing in subsection (d) authorizes the Secretary to withhold information from the Congress or prevents the Secretary from complying with an order of a court of the United States.CommentsClose CommentsPermalink





‘(f) This section shall not affect the authority of the Secretary to provide or disclose information under any other provision of law.’.CommentsClose CommentsPermalink





(c) Conforming Amendment- Section 301(j) (21 U.S.C. 331(j)) is amended by striking ‘or to the courts when relevant in any judicial proceeding under this Act,’ and inserting ‘to the courts when relevant in any judicial proceeding under this Act, or as specified in section 708,’.CommentsClose CommentsPermalink

SEC. 113. SAFE AND SECURE FOOD IMPORTATION PROGRAM.

Chapter VIII (21 U.S.C. 381 et seq.) is amended by adding at the end the following:CommentsClose CommentsPermalink

‘SEC. 805. SAFE AND SECURE FOOD IMPORTATION PROGRAM.

‘(a) In General- The Secretary may establish by regulation or guidance in coordination with the Commissioner responsible for Customs and Border Protection a program that facilitates the movement of food through the importation process under this Act if the importer of such food--CommentsClose CommentsPermalink





‘(1) verifies that each facility involved in the production, manufacture, processing, packaging, and holding of the food is in compliance with the food safety and security guidelines developed under subsection (b) with respect to such food;CommentsClose CommentsPermalink





‘(2) ensures that appropriate safety and security controls are in place throughout the supply chain for such food; andCommentsClose CommentsPermalink





‘(3) provides supporting information to the Secretary.CommentsClose CommentsPermalink





‘(b) Guidelines-CommentsClose CommentsPermalink





‘(1) DEVELOPMENT- For purposes of the program established under subsection (a), the Secretary shall develop in consultation with the Commissioner responsible for Customs and Border Protection safety and security guidelines applicable to the importation of food taking into account, to the extent appropriate, other relevant Federal programs, such as the Customs-Trade Partnership Against Terrorism (C-TPAT) programs under section 211 of the Security and Accountability for Every Port Act of 2006.CommentsClose CommentsPermalink





‘(2) FACTORS- Such guidelines shall take into account the following factors:CommentsClose CommentsPermalink





‘(A) The personnel of the person importing the food.CommentsClose CommentsPermalink





‘(B) The physical and procedural safety and security of such person’s food supply chain.CommentsClose CommentsPermalink





‘(C) The sufficiency of preventive controls for food and ingredients purchased by such person.CommentsClose CommentsPermalink





‘(D) Vendor and supplier information.CommentsClose CommentsPermalink





‘(E) Other programs for certification or verification by a qualified certifying entity used by the importer.CommentsClose CommentsPermalink





‘(F) Such other factors as the Secretary determines necessary.’.CommentsClose CommentsPermalink

SEC. 114. INFANT FORMULA.

(a) Misbranding- Section 403 (21 U.S.C. 343), as amended by sections 101(a) and 109(a), is amended by adding at the end the following:CommentsClose CommentsPermalink





‘(bb) If it is a new infant formula and--CommentsClose CommentsPermalink





‘(1) it is not the subject of a registration made pursuant to section 412(c)(1)(A);CommentsClose CommentsPermalink





‘(2) it is not the subject of a submission made pursuant to section 412(c)(1)(B), orCommentsClose CommentsPermalink





‘(3) at least 90 days have not passed since the making of such registration or of such submission to the Secretary.’.CommentsClose CommentsPermalink





(b) Requirements- Section 412 (21 U.S.C. 350a) is amended--CommentsClose CommentsPermalink





(1) in subsection (c)(1)(B), by striking ‘(c)(1)’ at the end and inserting ‘(d)(1), subject to subsection (d)(2)(B)’;CommentsClose CommentsPermalink





(2) in subsection (d)(1)--CommentsClose CommentsPermalink





(A) by striking ‘and’ at the end of subparagraph (C);CommentsClose CommentsPermalink





(B) by striking the period at the end of subparagraph (D) and inserting ‘, and’; andCommentsClose CommentsPermalink





(C) by adding at the end the following:CommentsClose CommentsPermalink





‘(E) information on any new ingredient in accordance with paragraph (2)(A).’;CommentsClose CommentsPermalink





(3) in subsection (d), by redesignating paragraphs (2) and (3) as paragraphs (3) and (4), respectively; andCommentsClose CommentsPermalink





(4) by inserting after paragraph (1) of subsection (d) the following:CommentsClose CommentsPermalink





‘(2)(A) The description of any new infant formula required under paragraph (1) shall include, for any new ingredient for use in the formula--CommentsClose CommentsPermalink





‘(i) a citation to a prior approval by the Secretary of the new ingredient for use in infant formula under section 409;CommentsClose CommentsPermalink





‘(ii) a citation to or information showing a prior consideration of the new ingredient for use in infant formula under any program established by the Secretary for the review of ingredients used in food; orCommentsClose CommentsPermalink





‘(iii) for a new ingredient that is not a food additive or a color additive, information equivalent to that provided under any program established by the Secretary for the review of ingredients used in food.CommentsClose CommentsPermalink





‘(B) If the information submitted under subparagraph (A) is the information described in clause (iii) of such subparagraph, the 90 day period provided by subsection (c)(1)(B) shall not commence until the Secretary has completed review of the information submitted under such clause and has provided the submitter notice of the results of such review.’.CommentsClose CommentsPermalink

Subtitle B--InterventionCommentsClose CommentsPermalink

SEC. 121. SURVEILLANCE.

(a) Definition of Food-Borne Illness Outbreak- In this section, the term ‘food-borne illness outbreak’ means the occurrence of 2 or more cases of a similar illness resulting from the ingestion of a food.CommentsClose CommentsPermalink





(b) Food-Borne Illness Surveillance Systems- The Secretary of Health and Human Services (in this subtitle referred to as the ‘Secretary’), acting through the Director of the Centers for Disease Control and Prevention, shall enhance food-borne illness surveillance systems to improve the collection, analysis, reporting, and usefulness of data on food-borne illnesses by--CommentsClose CommentsPermalink





(1) coordinating Federal, State, and local food-borne illness surveillance systems, including complaint systems, and increasing participation in national networks of public health and food regulatory agencies and laboratories;CommentsClose CommentsPermalink





(2) facilitating sharing of findings on a more timely basis among governmental agencies, including the Food and Drug Administration, the Department of Agriculture, and State and local agencies, and with the public;CommentsClose CommentsPermalink





(3) developing improved epidemiological tools for obtaining quality exposure data, and microbiological methods for classifying cases;CommentsClose CommentsPermalink





(4) augmenting such systems to improve attribution of a food-borne illness outbreak to a specific food;CommentsClose CommentsPermalink





(5) expanding capacity of such systems, including fingerprinting and other detection strategies for food-borne infectious agents, in order to identify new or rarely documented causes of food-borne illness;CommentsClose CommentsPermalink





(6) allowing timely public access to aggregated, de-identified surveillance data;CommentsClose CommentsPermalink





(7) at least annually, publishing current reports on findings from such systems;CommentsClose CommentsPermalink





(8) establishing a flexible mechanism for rapidly initiating scientific research by academic institutions;CommentsClose CommentsPermalink





(9) integrating food-borne illness surveillance systems and data with other biosurveillance and public health situational awareness capabilities at the Federal, State, and local levels; andCommentsClose CommentsPermalink





(10) other activities as determined appropriate by the Secretary.CommentsClose CommentsPermalink





(c) Improving Food Safety and Defense Capacity at the State and Local Level-CommentsClose CommentsPermalink





(1) IN GENERAL- The Secretary shall develop and implement strategies to leverage and enhance the food safety and defense capacities of State and local agencies in order to achieve the following goals:CommentsClose CommentsPermalink





(A) Improve food-borne illness outbreak response and containment.CommentsClose CommentsPermalink





(B) Accelerate food-borne illness surveillance and outbreak investigation, including rapid shipment of clinical isolates from clinical laboratories to appropriate State laboratories, and conducting more standardized illness outbreak interviews.CommentsClose CommentsPermalink





(C) Strengthen the capacity of State and local agencies to carry out inspections and enforce safety standards.CommentsClose CommentsPermalink





(D) Improve the effectiveness of Federal, State, and local partnerships to coordinate food safety and defense resources and reduce the incidence of food-borne illness.CommentsClose CommentsPermalink





(E) Share information on a timely basis among public health and food regulatory agencies, with the food industry, with health care providers, and with the public.CommentsClose CommentsPermalink





(2) REVIEW- In developing the strategies required by paragraph (1), the Secretary shall, not later than 1 year after the date of enactment of this Act, complete a review of State and local capacities, and needs for enhancement, which may include a survey with respect to--CommentsClose CommentsPermalink





(A) staffing levels and expertise available to perform food safety and defense functions;CommentsClose CommentsPermalink





(B) laboratory capacity to support surveillance, outbreak response, inspection, and enforcement activities;CommentsClose CommentsPermalink





(C) information systems to support data management and sharing of food safety and defense information among State and local agencies and with counterparts at the Federal level; andCommentsClose CommentsPermalink





(D) other State and local activities and needs as determined appropriate by the Secretary.CommentsClose CommentsPermalink

SEC. 122. PUBLIC EDUCATION AND ADVISORY SYSTEM.

(a) Public Education- The Secretary, in cooperation with private and public organizations, including the appropriate State entities, shall design and implement a national public education program on food safety. The program shall provide--CommentsClose CommentsPermalink





(1) information to the public so that individuals can understand the potential impact and risk of food-borne illness, take action to reduce their risk of food-borne illness and injury, and make healthy dietary choices;CommentsClose CommentsPermalink





(2) information to health professionals so that they may improve diagnosis and treatment of food-related illness and advise individuals whose health conditions place them in particular risk; andCommentsClose CommentsPermalink





(3) such other information or advice to consumers and other persons as the Secretary determines will promote the purposes of this Act.CommentsClose CommentsPermalink





(b) Health Advisories- The Secretary shall work with the States and other appropriate entities to--CommentsClose CommentsPermalink





(1) develop and distribute regional and national advisories concerning food safety;CommentsClose CommentsPermalink





(2) develop standardized formats for written and broadcast advisories; andCommentsClose CommentsPermalink





(3) incorporate State and local advisories into the national public education program required under subsection (a).CommentsClose CommentsPermalink

SEC. 123. RESEARCH.

The Secretary shall conduct research to assist in the implementation of this Act, including studies to--CommentsClose CommentsPermalink





(1) improve sanitation and food safety practices in the production, harvesting, and processing of food products;CommentsClose CommentsPermalink





(2) develop improved techniques for the monitoring of food and inspection of food products;CommentsClose CommentsPermalink





(3) develop efficient, rapid, and sensitive methods for determining and detecting the presence of contaminants in food products;CommentsClose CommentsPermalink





(4) determine the sources of contamination of food and food products, including critical points of risk for fresh produce and other raw agricultural commodities;CommentsClose CommentsPermalink





(5) develop consumption data with respect to food products;CommentsClose CommentsPermalink





(6) draw upon research and educational programs that exist at the State and local level;CommentsClose CommentsPermalink





(7) utilize the DNA matching system and other processes to identify and control pathogens;CommentsClose CommentsPermalink





(8) address common and emerging zoonotic diseases;CommentsClose CommentsPermalink





(9) develop methods to reduce or destroy pathogens before, during, and after processing;CommentsClose CommentsPermalink





(10) analyze the incidence of antibiotic resistance as it pertains to the food supply and evaluate methods to reduce the transfer of antibiotic resistance to humans; andCommentsClose CommentsPermalink





(11) conduct other research that supports the purposes of this Act.CommentsClose CommentsPermalink

Subtitle C--ResponseCommentsClose CommentsPermalink

SEC. 131. PROCEDURES FOR SEIZURE.

Section 304(b) (21 U.S.C. 334(b)) is amended by inserting ‘and except that, with respect to proceedings relating to food, Rule G of the Supplemental Rules of Admiralty or Maritime Claims and Asset Forfeiture Actions shall not apply in any such case, exigent circumstances shall be deemed to exist for all seizures brought under this section, and the summons and arrest warrant shall be issued by the clerk of the court without court review in any such case’ after ‘in any such case shall be tried by jury’.CommentsClose CommentsPermalink

SEC. 132. ADMINISTRATIVE DETENTION.

(a) Amendments- Section 304(h) (21 U.S.C. 334(h)) is amended--CommentsClose CommentsPermalink





(1) in paragraph (1)(A), by striking ‘credible evidence or information indicating’ and inserting ‘reason to believe’;CommentsClose CommentsPermalink





(2) in paragraph (1)(A), by striking ‘presents a threat of serious adverse health consequences or death to humans or animals’ and inserting ‘is adulterated, misbranded, or otherwise in violation of this Act’;CommentsClose CommentsPermalink





(3) in paragraph (2), by striking ‘30’ and inserting ‘60’;CommentsClose CommentsPermalink





(4) in paragraph (3), by striking the third sentence; andCommentsClose CommentsPermalink





(5) in paragraph (4)(A) by striking the terms ‘five’ and ‘five-day’ and inserting ‘fifteen’ and ‘fifteen-day’, respectively.CommentsClose CommentsPermalink





(b) Regulations- The Secretary shall issue regulations or guidance to implement the amendments made by this section.CommentsClose CommentsPermalink





(c) Effective Date- The amendments made by this section shall take effect 180 days after the date of the enactment of this Act.CommentsClose CommentsPermalink

SEC. 133. AUTHORITY TO PROHIBIT OR RESTRICT THE MOVEMENT OF FOOD.

(a) Prohibited Act- Section 301 (21 U.S.C. 331), as amended by sections 110 and 111, is amended by adding at the end by adding the following:CommentsClose CommentsPermalink





‘(ww) The violation of a prohibition or restriction under section 304(i).’.CommentsClose CommentsPermalink





(b) In General- Section 304 (21 U.S.C. 334) is amended by adding at the end the following:CommentsClose CommentsPermalink





‘(i) Authority to Prohibit or Restrict the Movement of Food Within a State or Portion of a State-CommentsClose CommentsPermalink





‘(1) AUTHORITY TO PROHIBIT OR RESTRICT THE MOVEMENT OF FOOD-CommentsClose CommentsPermalink





‘(A) IN GENERAL-CommentsClose CommentsPermalink





‘(i) After consultation with the Governor or other appropriate official of an affected State, if the Secretary determines that there is credible evidence that an article of food presents an imminent threat of serious adverse health consequences or death to humans or animals, the Secretary may prohibit or restrict the movement of an article of food within a State or portion of a State for which the Secretary has credible evidence that such food is located within, or originated from, such State or portion thereof.CommentsClose CommentsPermalink





‘(ii) In carrying out clause (i), the Secretary may prohibit or restrict the movement within a State or portion of a State of any article of food or means of conveyance of such article of food, if the Secretary determines that the prohibition or restriction is a necessary protection from an imminent threat of serious adverse health consequences or death to humans or animals.CommentsClose CommentsPermalink





‘(2) NOTIFICATION PROCEDURES- Subject to paragraph (3), before any action is taken in a State under this subsection, the Secretary shall--CommentsClose CommentsPermalink





‘(A) notify the Governor or other appropriate official of the State affected by the proposed action;CommentsClose CommentsPermalink





‘(B) issue a public announcement of the proposed action; andCommentsClose CommentsPermalink





‘(C) publish in the Federal Register--CommentsClose CommentsPermalink





‘(i) the findings of the Secretary that support the proposed action;CommentsClose CommentsPermalink





‘(ii) a statement of the reasons for the proposed action; andCommentsClose CommentsPermalink





‘(iii) a description of the proposed action, including--CommentsClose CommentsPermalink





‘(I) the area affected; andCommentsClose CommentsPermalink





‘(II) an estimate of the anticipated duration of the action.CommentsClose CommentsPermalink





‘(3) NOTICE AFTER ACTION- If it is not practicable to publish in the Federal Register the information required under paragraph (2)(C) before taking action under paragraph (1), the Secretary shall publish the information as soon as practicable, but not later than 10 business days, after commencement of the action.CommentsClose CommentsPermalink





‘(4) APPLICATION OF LEAST DRASTIC ACTION- No action shall be taken under paragraph (1) unless, in the opinion of the Secretary, there is no less drastic action that is feasible and that would be adequate to prevent the imminent threat of serious adverse health consequences or death to humans or animals.CommentsClose CommentsPermalink





‘(5) NONDELEGATION- An action under paragraph (1) may only be ordered by the Secretary or an official designated by the Secretary. An official may not be so designated unless the official is the Commissioner of Food and Drugs or the Principal Deputy Commissioner.CommentsClose CommentsPermalink





‘(6) DURATION- Fourteen days after the initiation of an action under paragraph (1), and each 14 days thereafter, if the Secretary determines that it is necessary to continue the action, the Secretary shall--CommentsClose CommentsPermalink





‘(A) notify the Governor or other appropriate official of the State affected of the continuation of the action;CommentsClose CommentsPermalink





‘(B) issue a public announcement of the continuation of the action; andCommentsClose CommentsPermalink





‘(C) publish in the Federal Register the findings of the Secretary that support the continuation of the action, including an estimate of the anticipated duration of the action.CommentsClose CommentsPermalink





‘(7) RULEMAKING- The Secretary shall, consistent with national security interests and as appropriate for known hazards, establish by regulation standards for conducting actions under paragraph (1), including, as appropriate, sanitation standards and procedures to restore any affected equipment or means of conveyance to its status prior to an action under paragraph (1).’.CommentsClose CommentsPermalink

SEC. 134. CRIMINAL PENALTIES.

Section 303(a) (21 U.S.C. 333) is amended--CommentsClose CommentsPermalink





(1) in paragraph (1), by striking ‘Any’ and inserting ‘Except as provided in paragraph (2) or (3), any’; andCommentsClose CommentsPermalink





(2) by adding at the end the following:CommentsClose CommentsPermalink





‘(3) Notwithstanding paragraph (1), any person who knowingly violates paragraph (a), (b), (c), (k), or (v) of section 301 with respect to any food that is misbranded or adulterated shall be imprisoned for not more than 10 years or fined in accordance with title 18, United States Code, or both.’.CommentsClose CommentsPermalink

SEC. 135. CIVIL PENALTIES FOR VIOLATIONS RELATING TO FOOD.

(a) In General- Paragraph (2) of section 303(f) (21 U.S.C. 331 et seq.) is amended to read as follows:CommentsClose CommentsPermalink





‘(2)(A) Any person who violates a provision of section 301 relating to food shall be subject to a civil penalty for each such violation of not more than--CommentsClose CommentsPermalink





‘(i) $20,000 in the case of an individual, not to exceed $50,000 in a single proceeding; andCommentsClose CommentsPermalink





‘(ii) $250,000 in the case of any other person, not to exceed $1,000,000 in a single proceeding.CommentsClose CommentsPermalink





‘(B) Any person who knowingly violates a provision of section 301 relating to food shall be subject to a civil penalty for each such violation of not more than--CommentsClose CommentsPermalink





‘(i) $50,000 in the case of an individual, not to exceed $100,000 in a single proceeding; andCommentsClose CommentsPermalink





‘(ii) $500,000 in the case of any other person, not to exceed $7,500,000 in a single proceeding.CommentsClose CommentsPermalink





‘(C) Each violation described in subparagraph (A) or (B) and each day during which the violation continues shall be considered to be a separate offense.’.CommentsClose CommentsPermalink





(b) Effective Date- The amendment made by subsection (a) applies to violations committed on or after the date of the enactment of this Act.CommentsClose CommentsPermalink

SEC. 136. IMPROPER IMPORT ENTRY FILINGS.

(a) Prohibited Acts- Section 301 (21 U.S.C. 331), as amended by sections 110, 111, and 133, is amended by adding at the end the following:CommentsClose CommentsPermalink





‘(xx) The submission of information relating to food that is required by or under section 801 that is inaccurate or incomplete.CommentsClose CommentsPermalink





‘(yy) The failure to submit information relating to food that is required by or under section 801.’.CommentsClose CommentsPermalink





(b) Documentation for Imports- Section 801 (21 U.S.C. 381), as amended by section 109, is amended by adding at the end the following:CommentsClose CommentsPermalink





‘(r) Documentation-CommentsClose CommentsPermalink





‘(1) SUBMISSION- The Secretary may require by regulation or guidance the submission of documentation or other information for articles of food that are imported or offered for import into the United States. When developing any regulation or guidance in accordance with this paragraph, to the extent that the collection of documentation or other information involves Customs and Border Protection efforts or resources, the Secretary shall consult with Customs and Border Protection.CommentsClose CommentsPermalink





‘(2) FORMAT- A regulation or guidance under paragraph (1) may specify the format for submission of the documentation or other information.’.CommentsClose CommentsPermalink

TITLE II--MISCELLANEOUSCommentsClose CommentsPermalink

SEC. 201. FOOD SUBSTANCES GENERALLY RECOGNIZED AS SAFE.

Section 409 (21 U.S.C. 348) is amended by adding at the end the following:CommentsClose CommentsPermalink

‘Substances Generally Recognized as Safe

‘(k)(1) Not later than 60 days after the date of receipt by the Secretary, after the date of the enactment of this subsection, of a determination that a substance is a GRAS food substance, the Secretary shall post notice of such determination and the supporting scientific justifications on the Food and Drug Administration’s public Web site.CommentsClose CommentsPermalink





‘(2) Not later than 60 days after the date of receipt of a request under paragraph (1), the Secretary shall acknowledge receipt of such request by informing the requester in writing of the date on which the request was received.CommentsClose CommentsPermalink





‘(3) In this subsection, the term ‘GRAS food substance’ means a substance excluded from the definition of the term ‘food additive’ in section 201(s) because such substance is generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use.’.CommentsClose CommentsPermalink

SEC. 202. COUNTRY OF ORIGIN LABELING.

(a) Misbranding- Section 403 (21 U.S.C. 343), as amended by sections 101(a), 109(a), and 114(a), is amended by adding at the end the following:CommentsClose CommentsPermalink





‘(cc) In the case of a processed food, if the labeling of the food fails to identify the country in which the final processing of the food occurs.CommentsClose CommentsPermalink





‘(dd) In the case of nonprocessed food, if the labeling of the food fails to identify the country of origin of the food.’.CommentsClose CommentsPermalink





(b) Regulations-CommentsClose CommentsPermalink





(1) PROMULGATION- Not later than 180 days after the date of the enactment of this Act, the Secretary of Health and Human Services shall promulgate final regulations to carry out paragraphs (cc) and (dd) of section 403 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a).CommentsClose CommentsPermalink





(2) RELATION TO OTHER REQUIREMENTS- Regulations promulgated under paragraph (1) shall provide that labeling meets the requirements of paragraphs (cc) and (dd) of section 403 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), if--CommentsClose CommentsPermalink





(A) in the case of a processed food, the label of the food informs the consumer of the country where the final processing of the food occurred in accordance with country of origin marking requirements of the United States Customs and Border Protection; orCommentsClose CommentsPermalink





(B) in the case of a nonprocessed food, the label of the food informs the consumer of the country of origin of the food in accordance with labeling requirements of the Department of Agriculture.CommentsClose CommentsPermalink





(c) Effective Date- The requirements of paragraphs (cc) and (dd) of section 403 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), take effect on the date that is 2 years after the date of the enactment of this Act.CommentsClose CommentsPermalink

SEC. 203. EXPORTATION CERTIFICATE PROGRAM.

Section 801(e)(4) (21 U.S.C. 381) is amended--CommentsClose CommentsPermalink





(1) in the matter preceding clause (i) in subparagraph (A)--CommentsClose CommentsPermalink





(A) by inserting ‘from the United States’ after ‘exports’; andCommentsClose CommentsPermalink





(B) by striking ‘a drug, animal drug, or device’ and inserting ‘a food (including animal feed), drug, animal drug, or device’;CommentsClose CommentsPermalink





(2) in subparagraph (A)(i)--CommentsClose CommentsPermalink





(A) by striking ‘in writing’; andCommentsClose CommentsPermalink





(B) by striking ‘exported drug, animal drug, or device’ and inserting ‘exported food, drug, animal drug, or device’;CommentsClose CommentsPermalink





(3) in subparagraph (A)(ii)--CommentsClose CommentsPermalink





(A) by striking ‘in writing’;CommentsClose CommentsPermalink





(B) by striking ‘the drug, animal drug, or device’ and inserting ‘the food, drug, animal drug, or device’; andCommentsClose CommentsPermalink





(C) by striking ‘the drug or device’ and inserting ‘the food, drug, or device’;CommentsClose CommentsPermalink





(4) by redesignating subparagraph (B) as subparagraph (C);CommentsClose CommentsPermalink





(5) by inserting after subparagraph (A) the following:CommentsClose CommentsPermalink





‘(B) For purposes of this paragraph, a certification by the Secretary shall be made on such basis and in such form (such as a publicly available listing) as the Secretary determines appropriate.’; andCommentsClose CommentsPermalink





(6) by adding at the end the following:CommentsClose CommentsPermalink





‘(D) Notwithstanding subparagraph (C), if the Secretary issues an export certification within the 20 days prescribed by subparagraph (A) with respect to the export of food, a fee for such certification shall not exceed such amount as the Secretary determines is reasonably related to the cost of issuing certificates under subparagraph (A) with respect to the export of food. The Secretary may adjust this fee annually to account for inflation and other cost adjustments. Fees collected for a fiscal year pursuant to this subparagraph shall be credited to the appropriation account for salaries and expenses of the Food and Drug Administration and shall be available in accordance with appropriations Acts until expended, without fiscal year limitation. Such fees shall be collected in each fiscal year in an amount equal to the amount specified in appropriations Acts for such fiscal year and shall only be collected and available for the costs of the Food and Drug Administration to cover the cost of issuing such certifications. Such sums as necessary may be transferred from such appropriation account for salaries and expenses of the Food and Drug Administration without fiscal year limitation to such appropriation account for salaries and expenses with fiscal year limitation.’.CommentsClose CommentsPermalink

SEC. 204. REGISTRATION FOR COMMERCIAL IMPORTERS OF FOOD; FEE.

(a) Registration-CommentsClose CommentsPermalink





(1) PROHIBITIONS- Section 301 (21 U.S.C. 331), as amended by sections 110, 111, 133, and 136, is amended by adding at the end the following:CommentsClose CommentsPermalink





‘(zz) The failure to register in accordance with section 801(s).’.CommentsClose CommentsPermalink





(2) MISBRANDING- Section 403 (21 U.S.C. 343) as amended by sections 101(a), 109(a), 114(a), and 202, is amended by adding at the end the following:CommentsClose CommentsPermalink





‘(ee) If it is imported or offered for import by an importer not duly registered under section 801(s).’.CommentsClose CommentsPermalink





(3) REGISTRATION- Section 801, as amended by sections 109 and 136, is amended by adding at the end the following:CommentsClose CommentsPermalink





‘(s) Registration of Importers-CommentsClose CommentsPermalink





‘(1) REGISTRATION- The Secretary shall require an importer of food--CommentsClose CommentsPermalink





‘(A) to be registered with the Secretary in a form and manner specified by the Secretary; andCommentsClose CommentsPermalink





‘(B) consistent with section 1011, to submit appropriate unique facility identifiers as a condition of registration.CommentsClose CommentsPermalink





‘(2) GOOD IMPORTER PRACTICES- The maintenance of registration under this subsection is conditioned on compliance with good importer practices in accordance with the following:CommentsClose CommentsPermalink





‘(A) The Secretary, in consultation with Customs and Border Protection, shall promulgate regulations to establish good importer practices that specify the measures an importer shall take to ensure imported food is in compliance with the requirements of this Act.CommentsClose CommentsPermalink





‘(B) The measures under subparagraph (A) shall ensure that the importer of a food--CommentsClose CommentsPermalink





‘(i) has adequate information about the food, its hazards, and the requirements of this Act applicable to such food;CommentsClose CommentsPermalink





‘(ii) has adequate information or procedures in place to verify that both the food and each person that produced, manufactured, processed, packed, transported, or held the food, including components of the food, are in compliance with the requirements of this Act; andCommentsClose CommentsPermalink





‘(iii) has adequate procedures in place to take corrective action, such as the ability to appropriately trace, withhold, and recall articles of food, if a food imported by the importer is not in compliance with the requirements of this Act.CommentsClose CommentsPermalink





‘(C) In promulgating good importer practices regulations, the Secretary may, as appropriate--CommentsClose CommentsPermalink





‘(i) incorporate certification of compliance under section 801(q) and participation in the safe and secure food importation program under section 805; andCommentsClose CommentsPermalink





‘(ii) take into account differences among importers and the types of imports, including based on the level of risk posed by the imported food.CommentsClose CommentsPermalink





‘(3) SUSPENSION OF REGISTRATION-CommentsClose CommentsPermalink





‘(A) IN GENERAL- Registration under this subsection is subject to suspension upon a finding by the Secretary, after notice and an opportunity for an informal hearing, of--CommentsClose CommentsPermalink





‘(i) a violation of this Act; orCommentsClose CommentsPermalink





‘(ii) the knowing or repeated making of an inaccurate or incomplete statement or submission of information relating to the importation of food.CommentsClose CommentsPermalink





‘(B) REQUEST- The importer whose registration is suspended may request that the Secretary vacate the suspension of registration when such importer has corrected the violation that is the basis for such suspension.CommentsClose CommentsPermalink





‘(C) VACATING OF SUSPENSION- If the Secretary determines that adequate reasons do not exist to continue the suspension of a registration, the Secretary shall vacate such suspension.CommentsClose CommentsPermalink





‘(4) CANCELLATION OF REGISTRATION-CommentsClose CommentsPermalink





‘(A) IN GENERAL- Not earlier than 10 days after providing the notice under subparagraph (B), the Secretary may cancel a registration that the Secretary determines was not updated in accordance with this section or otherwise contains false, incomplete, or inaccurate information.CommentsClose CommentsPermalink





‘(B) NOTICE OF CANCELLATION- Cancellation shall be preceded by notice to the importer of the intent to cancel the registration and the basis for such cancellation.CommentsClose CommentsPermalink





‘(C) TIMELY UPDATE OR CORRECTION- If the registration for the importer is updated or corrected no later than 7 days after notice is provided under subparagraph (B), the Secretary shall not cancel such registration.CommentsClose CommentsPermalink





‘(5) EXEMPTIONS- The Secretary, by notice published in the Federal Register--CommentsClose CommentsPermalink





‘(A) shall establish an exemption from the requirements of this subsection for importations for personal use; andCommentsClose CommentsPermalink





‘(B) may establish other exemptions from the requirements of this subsection.’.CommentsClose CommentsPermalink





(4) REGULATIONS- Not later than 36 months after the date of the enactment of this Act, the Secretary of Health and Human Services in consultation with the Commissioner responsible for Customs and Border Protection shall promulgate the regulations required to carry out section 801(s) of the Federal Food, Drug, and Cosmetic Act, as added by paragraph (3). In establishing the effective date of a regulation promulgated under section 801(s), the Secretary shall, in consultation with the Commissioner responsible for Customs and Border Protection, as appropriate, provide a reasonable period of time for importers of food to comply with good importer practices, taking into account differences among importers and the types of imports, including based on the level of risk posed by the imported food.CommentsClose CommentsPermalink





(5) EFFECTIVE DATE- The amendments made by this subsection shall take effect on the date that is 24 months after the date of enactment of this Act.CommentsClose CommentsPermalink





(b) Fee- Subchapter C of chapter VII (21 U.S.C. 379f et seq.) as added and amended by sections 101 and 108, is amended by adding at the end the following:CommentsClose CommentsPermalink

‘PART 7--IMPORTERS OF FOOD

‘SEC. 744. IMPORTERS OF FOOD.

‘(a) Importers- The Secretary shall assess and collect an annual fee for the registration of an importer of food under section 801(s).CommentsClose CommentsPermalink





‘(b) Amount of Fee-CommentsClose CommentsPermalink





‘(1) BASE AMOUNTS- The registration fee under subsection (a) shall be--CommentsClose CommentsPermalink





‘(A) for fiscal year 2010, $500; andCommentsClose CommentsPermalink





‘(B) for fiscal year 2011 and each subsequent fiscal year, the fee for fiscal year 2010 as adjusted under paragraph (2).CommentsClose CommentsPermalink





‘(2) ADJUSTMENT- For fiscal year 2011 and subsequent fiscal years, the fees established pursuant to paragraph (1) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year to reflect the greater of--CommentsClose CommentsPermalink





‘(A) 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 for which fees are being established;CommentsClose CommentsPermalink





‘(B) the total percentage change for the previous fiscal year in basic pay under the General Schedule in accordance with section 5332 of title 5, United States Code, as adjusted by any locality-based comparability payment pursuant to section 5304 of such title for Federal employees stationed in the District of Columbia; orCommentsClose CommentsPermalink





‘(C) the average annual change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 5 years of the preceding 6 fiscal years.CommentsClose CommentsPermalink





‘(3) COMPOUNDED BASIS- The adjustment made each fiscal year pursuant this subsection shall be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 2010 under this subsection.CommentsClose CommentsPermalink





‘(4) WAIVER FOR IMPORTERS REQUIRED TO PAY REGISTRATION FEE- In the case of a person who is required to pay both a fee under section 743 for registration of one or more facilities under section 415 and a fee under this section for registration as an importer of food under section 801(s), the Secretary shall waive the fees applicable to such person under section 743 or the fee applicable to such person under this section.CommentsClose CommentsPermalink





‘(c) Crediting and Availability of Fees-CommentsClose CommentsPermalink





‘(1) IN GENERAL- Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance 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 appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation.CommentsClose CommentsPermalink





‘(2) COLLECTIONS AND APPROPRIATIONS ACTS- The fees authorized by this section--CommentsClose CommentsPermalink





‘(A) shall be retained in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation, for such fiscal year; andCommentsClose CommentsPermalink





‘(B) shall only be collected and available to cover the costs associated with registering importers under section 801(s) and with ensuring compliance with good importer practices respecting food.CommentsClose CommentsPermalink





‘(3) AUTHORIZATION OF APPROPRIATIONS- For each of fiscal years 2010 through 2014, there are authorized to be appropriated for fees under this section such sums as may be necessary.’.CommentsClose CommentsPermalink





(c) Inspection- Section 704 (21 U.S.C. 374), as amended by section 105, is amended by adding at the end the following:CommentsClose CommentsPermalink





‘(i) Importers- Every person engaged in the importing of any food shall, upon request of an officer or employee designated by the Secretary, permit such officer or employee at all reasonable times to inspect the facilities of such person and have access to, and to copy and verify, any related records.’.CommentsClose CommentsPermalink

SEC. 205. REGISTRATION FOR CUSTOMS BROKERS.

(a) Registration-CommentsClose CommentsPermalink





(1) PROHIBITIONS- Section 301(zz) (21 U.S.C. 331), as added by section 204, is amended by inserting ‘or 801(t)’ after ‘801(s)’.CommentsClose CommentsPermalink





(2) MISBRANDING- Section 403(ee) (21 U.S.C. 343), as added by section 204, is amended--CommentsClose CommentsPermalink





(A) by inserting ‘or a customs broker’ after ‘by an importer’; andCommentsClose CommentsPermalink





(B) by inserting ‘or 801(t)’ after ‘801(s)’.CommentsClose CommentsPermalink





(3) REGISTRATION- Section 801, as amended by sections 109, 136, and 204, is amended by adding at the end the following:CommentsClose CommentsPermalink





‘(t) Registration of Customs Broker-CommentsClose CommentsPermalink





‘(1) REGISTRATION- The Secretary shall require a customs broker, with respect to the importation of food--CommentsClose CommentsPermalink





‘(A) to be registered with the Secretary in a form and manner specified by the Secretary; andCommentsClose CommentsPermalink





‘(B) consistent with section 1011, to submit appropriate unique facility identifiers as a condition of registration.CommentsClose CommentsPermalink





‘(2) CANCELLATION OF REGISTRATION-CommentsClose CommentsPermalink





‘(A) IN GENERAL- Not earlier than 10 days after providing the notice under subparagraph (B), the Secretary may cancel a registration that the Secretary determines was not updated in accordance with this section or otherwise contains false, incomplete, or inaccurate information.CommentsClose CommentsPermalink





‘(B) NOTICE OF CANCELLATION- Cancellation shall be preceded by notice to the customs broker of the intent to cancel the registration and the basis for such cancellation.CommentsClose Comments