IIB 

111TH CONGRESS 

1ST SESSION H. R. 2749 

IN THE SENATE OF THE UNITED STATES 

AUGUST 3, 2009 

Received; read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

AN ACT 

To amend the Federal Food, Drug, and Cosmetic Act to 

improve the safety of food in the global market, and 

for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Food Safety Enhance3 ment Act of 2009’’. 

4 SEC. 2. TABLE OF CONTENTS. 

5 The table of contents of this Act is as follows: 

Sec. 1. Short title. 

Sec. 2. Table of contents. 

Sec. 3. References. 

Sec. 4. Rules of construction. 

Sec. 5. USDA exemptions. 

Sec. 6. Alcohol-related facilities. 

TITLE I—FOOD SAFETY 

Subtitle A—Prevention 

Sec. 101. Changes in registration of food facilities. 

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

Sec. 103. Performance standards. 

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

Sec. 105. Risk-based inspection schedule. 

Sec. 106. Access to records. 

Sec. 107. Traceability of food. 

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

Sec. 109. Certification and accreditation. 

Sec. 110. Testing by accredited laboratories. 

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

food. 

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

Sec. 113. Safe and secure food importation program. 

Sec. 114. Infant formula. 

Subtitle B—Intervention 

Sec. 121. Surveillance. 

Sec. 122. Public education and advisory system. 

Sec. 123. Research. 

Subtitle C—Response 

Sec. 131. Procedures for seizure. 

Sec. 132. Administrative detention. 

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

Sec. 134. Criminal penalties. 

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

Sec. 136. Improper import entry filings. 

TITLE II—MISCELLANEOUS 

Sec. 201. Food substances generally recognized as safe. 


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Sec. 202. Country of origin labeling. 

Sec. 203. Exportation certificate program. 

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

Sec. 205. Registration for customs brokers. 

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

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

Sec. 208. Dedicated foreign inspectorate. 

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

Sec. 210. False or misleading reporting to FDA. 

Sec. 211. Subpoena authority. 

Sec. 212. Whistleblower protections. 

Sec. 213. Extraterritorial jurisdiction. 

Sec. 214. Support for training institutes. 

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

Sec. 216. Lead content labeling requirement for ceramic tableware and 

cookware. 

1 SEC. 3. REFERENCES. 

2 Except as otherwise specified, whenever in this Act 

3 an amendment is expressed in terms of an amendment to 

4 a section or other provision, the reference shall be consid5 ered to be made to a section or other provision of the Fed6 eral Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 

7 seq.). 

8 SEC. 4. RULES OF CONSTRUCTION. 

9 (a) Nothing in this Act or the amendments made by 

10 this Act shall be construed to prohibit or limit— 

11 (1) any cause of action under State law; or 

12 (2) the introduction of evidence of compliance 

13 or noncompliance with the requirements of the Fed14 eral Food, Drug, and Cosmetic Act (21 U.S.C. 301 

15 et seq.). 

16 (b) Nothing in this Act or any amendment made by 

17 this Act shall be construed to— 


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1 (1) alter the jurisdiction between the Secretary 

2 of Agriculture and the Secretary of Health and 

3 Human Services, under applicable statutes and regu4 lations; 

5 (2) limit the authority of the Secretary of 

6 Health and Human Services to issue regulations re7 lated to the safety of food under— 

8 (A) the Federal Food, Drug, and Cosmetic 

9 Act (21 U.S.C. 301 et seq.) as in effect on the 

10 day before the date of the enactment of this 

11 Act; or 

12 (B) the Public Health Service Act (42 

13 U.S.C. 301 et seq.) as in effect on the day be14 fore the date of the enactment of this Act; or 

15 (3) impede, minimize, or affect the authority of 

16 the Secretary of Agriculture to prevent, control, or 

17 mitigate a plant or animal health emergency, or a 

18 food emergency involving products regulated under 

19 the Federal Meat Inspection Act (21 U.S.C. 601 et 

20 seq.), the Poultry Products Inspection Act (21 

21 U.S.C. 451 et seq.), or the Egg Products Inspection 

22 Act (21 U.S.C. 1031 et seq.). 

23 SEC. 5. USDA EXEMPTIONS. 

24 (a) USDA-REGULATED PRODUCTS.—Food is exempt 

25 from the requirements of this Act to the extent that such 


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1 food is regulated by the Secretary of Agriculture under 

2 the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), 

3 the Poultry Products Inspection Act (21 U.S.C. 451 et 

4 seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 

5 et seq.). 

6 (b) LIVESTOCK AND POULTRY.—Livestock and poul7 try that are intended to be presented for slaughter pursu8 ant to the regulations by the Secretary of Agriculture 

9 under the Federal Meat Inspection Act or the Poultry 

10 Products Inspection Act are exempt from the require11 ments of this Act. A cow, sheep, or goat that is used for 

12 the production of milk is exempt from the requirements 

13 of this Act. 

14 (c) USDA-REGULATED FACILITIES.—A facility is ex15 empt from the requirements of this Act to the extent such 

16 facility is regulated as an official establishment by the Sec17 retary of Agriculture under the Federal Meat Inspection 

18 Act, the Poultry Products Inspection Act, or the Egg 

19 Products Inspection Act or under a program recognized 

20 by the Secretary of Agriculture as at least equal to Fed21 eral regulation under the Federal Meat Inspection Act, the 

22 Poultry Products Inspection Act, or the Egg Products In23 spection Act. 

24 (d) FARMS.—A farm is exempt from the require25 ments of this Act to the extent such farm raises animals 


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1 from which food is derived that is regulated under the 

2 Federal Meat Inspection Act, the Poultry Products In3 spection Act, or the Egg Products Inspection Act. 

4 SEC. 6. ALCOHOL-RELATED FACILITIES. 

5 (a) IN GENERAL.—With the exception of the amend6 ments made by section 101(a) and (b) and section 113 

7 of this Act, nothing in this Act, or the amendments made 

8 by this Act, shall be construed to apply to a facility that— 

9 (1) under the Federal Alcohol Administration 

10 Act (27 U.S.C. 201 et seq.) or chapter 51 of subtitle 

11 E of the Internal Revenue Code of 1986 (26 U.S.C. 

12 5291 et seq.) is required to obtain a permit or to 

13 register with the Secretary of the Treasury as a con14 dition of doing business in the United States; and 

15 (2) under section 415 of the Federal Food, 

16 Drug, and Cosmetic Act (21 U.S.C. 350d), as 

17 amended by this Act, is required to register as a fa18 cility because such facility is engaged in manufac19 turing, processing, packing, or holding 1 or more al20 coholic beverages. 

21 (b) LIMITED RECEIPT AND DISTRIBUTION OF NON22 ALCOHOL FOOD.—Subsection (a) shall not apply to a fa23 cility engaged in the distributing of any non-alcohol food, 

24 except that subsection (a) shall apply to a facility de25 scribed in paragraphs (1) and (2) of subsection (a) that 


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1 receives and distributes non-alcohol food provided such 

2 food is received and distributed— 

3 (1) in a prepackaged form that prevents any di4 rect human contact with such food; and 

5 (2) in amounts that constitute not more than 5 

6 percent of the overall sales of such facility, as deter7 mined by the Secretary of the Treasury. 

8 (c) RULE OF CONSTRUCTION.—This section shall not 

9 be construed to exempt any food, apart from distilled spir10 its, wine, and malt beverages, as defined in section 211 

11 of the Federal Alcohol Administration Act (27 U.S.C. 

12 211), from the requirements of this Act and the amend13 ments made by this Act. 

14 TITLE I—FOOD SAFETY 

15 Subtitle A—Prevention 

16 SEC. 101. CHANGES IN REGISTRATION OF FOOD FACILI17 TIES. 

18 (a) MISBRANDING.—Section 403 (21 U.S.C. 343) is 

19 amended by adding at the end the following: 

20 ‘‘(z) If it was manufactured, processed, packed, or 

21 held in a facility that is not duly registered under section 

22 415, including a facility whose registration is canceled or 

23 suspended under such section.’’. 

24 (b) ANNUAL REGISTRATION.— 


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1 (1) DEFINITION OF FACILITY.—Paragraph (1) 

2 of section 415(b) (21 U.S.C. 350d(b)) is amended to 

3 read as follows: 

4 ‘‘(1)(A) The term ‘facility’ means any factory, 

5 warehouse, or establishment (including a factory, 

6 warehouse, or establishment of an importer) that 

7 manufactures, processes, packs, or holds food. 

8 ‘‘(B) Such term does not include farms; private 

9 residences of individuals; restaurants; other retail 

10 food establishments; nonprofit food establishments 

11 in which food is prepared for or served directly to 

12 the consumer; or fishing vessels (except such vessels 

13 engaged in processing as defined in section 123.3(k) 

14 of title 21, Code of Federal Regulations, or any suc15 cessor regulations). 

16 ‘‘(C)(i) The term ‘retail food establishment’ 

17 means an establishment that, as its primary func18 tion, sells food products (including those food prod19 ucts that it manufactures, processes, packs, or 

20 holds) directly to consumers (including by Internet 

21 or mail order). 

22 ‘‘(ii) Such term includes— 

23 ‘‘(I) grocery stores; 

24 ‘‘(II) convenience stores; 

25 ‘‘(III) vending machine locations; and 


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1 ‘‘(IV) stores that sell bagged feed, pet 

2 food, and feed ingredients or additives 

3 over-the-counter directly to consumers and 

4 final purchasers for their own personal ani5 mals. 

6 ‘‘(iii) A retail food establishment’s primary 

7 function is to sell food directly to consumers if 

8 the annual monetary value of sales of food 

9 products directly to consumers exceeds the an10 nual monetary value of sales of food products to 

11 all other buyers. 

12 ‘‘(D)(i) The term ‘farm’ means an operation in 

13 one general physical location devoted to the growing 

14 and harvesting of crops, the raising of animals (in15 cluding seafood), or both. 

16 ‘‘(ii) Such term includes— 

17 ‘‘(I) such an operation that packs or holds 

18 food, provided that all food used in such activi19 ties is grown, raised, or consumed on such farm 

20 or another farm under the same ownership; 

21 ‘‘(II) such an operation that manufactures 

22 or processes food, provided that all food used in 

23 such activities is consumed on such farm or an24 other farm under the same ownership; 


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1 ‘‘(III) such an operation that sells food di2 rectly to consumers if the annual monetary 

3 value of sales of the food products from the 

4 farm or by an agent of the farm to consumers 

5 exceeds the annual monetary value of sales of 

6 the food products to all other buyers; 

7 ‘‘(IV) such an operation that manufactures 

8 grains or other feed stuffs that are grown and 

9 harvested on such farm or another farm under 

10 the same ownership and are distributed directly 

11 to 1 or more farms for consumption as food by 

12 humans or animals on such farm; and 

13 ‘‘(V) a fishery, including a wild fishery, an 

14 aquaculture operation or bed, a fresh water 

15 fishery, and a saltwater fishery. 

16 ‘‘(iii) Such term does not include such an oper17 ation that receives manufactured feed from another 

18 farm as described in clause (ii)(IV) if the receiving 

19 farm releases the feed to another farm or facility 

20 under different ownership. 

21 ‘‘(iv) The term ‘harvesting’ includes washing, 

22 trimming of outer leaves of, and cooling produce. 

23 ‘‘(E) The term ‘consumer’ does not include a 

24 business.’’. 


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1 (2) REGISTRATION.—Section 415(a) (21 U.S.C. 

2 350d(a)) is amended— 

3 (A) in the first sentence of paragraph 

4 (1)— 

5 (i) by striking ‘‘require that’’ and in6 serting ‘‘require that, on or before Decem7 ber 31 of each year,’’; and 

8 (ii) by striking ‘‘food for consumption 

9 in the United States’’ and inserting ‘‘food 

10 for consumption in the United States or 

11 for export from the United States’’; 

12 (B) in subparagraphs (A) and (B) of para13 graph (1), by inserting ‘‘and pay the registra14 tion fee required under section 743’’ after ‘‘sub15 mit a registration to the Secretary’’ each place 

16 it appears; 

17 (C) in the first sentence of paragraph (2), 

18 by inserting ‘‘in electronic format’’ after ‘‘sub19 mit’’; and 

20 (D) in paragraph (4), by inserting after 

21 the first sentence the following: ‘‘The Secretary 

22 shall remove from such list the name of any fa23 cility that fails to reregister in accordance with 

24 this section, that fails to pay the registration 

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1 istration is canceled by the registrant, canceled 

2 by the Secretary in accordance with this sec3 tion, or suspended by the Secretary in accord4 ance with this section.’’. 

5 (3) CONTENTS OF REGISTRATION.—Paragraph 

6 (2) of section 415(a) (21 U.S.C. 350d(a)), as 

7 amended by paragraph (1), is amended by striking 

8 ‘‘containing information’’ and all that follows and in9 serting the following: ‘‘containing information that 

10 identifies the following: 

11 ‘‘(A) The name, address, and emergency 

12 contact information of the facility being reg13 istered. 

14 ‘‘(B) The primary purpose and business 

15 activity of the facility, including the dates of op16 eration if the facility is seasonal. 

17 ‘‘(C) The general food category (as defined 

18 by the Secretary by guidance) of each food 

19 manufactured, processed, packed, or held at the 

20 facility. 

21 ‘‘(D) All trade names under which the fa22 cility conducts business related to food. 

23 ‘‘(E) The name, address, and 24-hour 

24 emergency contact information of the United 

25 States distribution agent for the facility, which 


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1 agent shall have access to the information re2 quired to be maintained under section 414(d) 

3 for food that is manufactured, processed, 

4 packed, or held at the facility. 

5 ‘‘(F) If the facility is located outside of the 

6 United States, the name, address, and emer7 gency contact information for a United States 

8 agent. 

9 ‘‘(G) The unique facility identifier of the 

10 facility, as specified under section 1011. 

11 ‘‘(H) Such additional information per12 taining to the facility as the Secretary may re13 quire by regulation. 

14 The registrant shall notify the Secretary of any 

15 change in the submitted information not later than 

16 30 days after the date of such change, unless other17 wise specified by the Secretary.’’. 

18 (4) SUSPENSION AND CANCELLATION AUTHOR19 ITY.—Section 415(a) (21 U.S.C. 350d(a)), as 

20 amended by paragraphs (1) and (2), is further 

21 amended by adding at the end the following: 

22 ‘‘(5) SUSPENSION OF REGISTRATION.— 

23 ‘‘(A) IN GENERAL.—The Secretary may 

24 suspend the registration of any facility reg25 istered under this section for a violation of this 


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1 Act that could result in serious adverse health 

2 consequences or death to humans or animals. 

3 ‘‘(B) NOTICE OF SUSPENSION.—Suspen4 sion of a registration shall be preceded by— 

5 ‘‘(i) notice to the facility of the intent 

6 to suspend the registration; and 

7 ‘‘(ii) an opportunity for an informal 

8 hearing, as defined in guidance or regula9 tions issued by the Secretary, concerning 

10 the suspension of such registration for 

11 such facility. 

12 ‘‘(C) REQUEST.—The owner, operator, or 

13 agent in charge of a facility whose registration 

14 is suspended may request that the Secretary va15 cate the suspension of registration when such 

16 owner, operator, or agent has corrected the vio17 lation that is the basis for such suspension. 

18 ‘‘(D) VACATING OF SUSPENSION.—If, 

19 based on an inspection of the facility or other 

20 information, the Secretary determines that ade21 quate reasons do not exist to continue the sus22 pension of a registration, the Secretary shall va23 cate such suspension. 

24 ‘‘(6) CANCELLATION OF REGISTRATION.— 


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1 ‘‘(A) IN GENERAL.—Not earlier than 10 

2 days after providing the notice under subpara3 graph (B), the Secretary may cancel a registra4 tion if the Secretary determines that— 

5 ‘‘(i) the registration was not updated 

6 in accordance with this section or other7 wise contains false, incomplete, or inac8 curate information; or 

9 ‘‘(ii) the required registration fee has 

10 not been paid within 30 days after the date 

11 due. 

12 ‘‘(B) NOTICE OF CANCELLATION.—Can13 cellation shall be preceded by notice to the facil14 ity of the intent to cancel the registration and 

15 the basis for such cancellation. 

16 ‘‘(C) TIMELY UPDATE OR CORRECTION.— 

17 If the registration for the facility is updated or 

18 corrected no later than 7 days after notice is 

19 provided under subparagraph (B), the Sec20 retary shall not cancel such registration. 

21 ‘‘(7) REPORT TO CONGRESS.—Not later than 

22 March 30th of each year, the Secretary shall submit 

23 to the Congress a report, based on the registrations 

24 on or before December 31 of the previous year, on 

25 the following: 


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1 ‘‘(A) The number of facilities registered 

2 under this section. 

3 ‘‘(B) The number of such facilities that are 

4 domestic. 

5 ‘‘(C) The number of such facilities that are 

6 foreign. 

7 ‘‘(D) The number of such facilities that 

8 are high-risk. 

9 ‘‘(E) The number of such facilities that are 

10 low-risk. 

11 ‘‘(F) The number of such facilities that 

12 hold food. 

13 ‘‘(8) LIMITATION ON DELEGATION.—The au14 thority conferred by this subsection to issue an order 

15 to suspend a registration or cancel a registration 

16 shall not be delegated to any officer or employee 

17 other than the Commissioner of Food and Drugs, 

18 the Principal Deputy Commissioner, the Associate 

19 Commissioner for Regulatory Affairs, or the Direc20 tor for the Center for Food Safety and Applied Nu21 trition, of the Food and Drug Administration.’’. 

22 (c) REGISTRATION FEE.—Chapter VII (21 U.S.C. 

23 371 et seq.) is amended by adding at the end of sub24 chapter C the following: 


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1 ‘‘PART 6—FEES RELATING TO FOOD 

2 ‘‘SEC. 743. FACILITY REGISTRATION FEE. 

3 ‘‘(a) IN GENERAL.— 

4 ‘‘(1) ASSESSMENT AND COLLECTION.—Begin5 ning in fiscal year 2010, the Secretary shall assess 

6 and collect an annual fee for the registration of a fa7 cility under section 415. 

8 ‘‘(2) PAYABLE DATE.—A fee under this section 

9 shall be payable— 

10 ‘‘(A) for a facility that was not registered 

11 under section 415 for the preceding fiscal year, 

12 on the date of registration; and 

13 ‘‘(B) for any other facility— 

14 ‘‘(i) for fiscal year 2010, not later 

15 than the sooner of 90 days after the date 

16 of the enactment of this part or December 

17 31, 2009; and 

18 ‘‘(ii) for a subsequent fiscal year, not 

19 later than December 31 of such fiscal year. 

20 ‘‘(b) FEE AMOUNTS.— 

21 ‘‘(1) IN GENERAL.—The registration fee under 

22 subsection (a) shall be— 

23 ‘‘(A) for fiscal year 2010, $500; and 

24 ‘‘(B) for fiscal year 2011 and each subse25 quent fiscal year, the fee for fiscal year 2010 as 

26 adjusted under subsection (c). 


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1 ‘‘(2) ANNUAL FEE SETTING.—The Secretary 

2 shall, not later than 60 days before the start of fis3 cal year 2011 and each subsequent fiscal year, es4 tablish, for the next fiscal year, registration fees 

5 under subsection (a), as described in paragraph (1). 

6 ‘‘(3) MAXIMUM AMOUNT.—Notwithstanding 

7 paragraph (1), a person who owns or operates mul8 tiple facilities for which a fee must be paid under 

9 this section for a fiscal year shall be liable for not 

10 more than $175,000 in aggregate fees under this 

11 section for such fiscal year. 

12 ‘‘(c) INFLATION ADJUSTMENT.—For fiscal year 2011 

13 and each subsequent fiscal year, the fee amount under 

14 subsection (b)(1) shall be adjusted by the Secretary by no15 tice, published in the Federal Register, to reflect the 

16 greater of— 

17 ‘‘(1) the total percentage change that occurred 

18 in the Consumer Price Index for all urban con19 sumers (all items; U.S. city average) for the 12- 

20 month period ending June 30 preceding the fiscal 

21 year for which fees are being established; 

22 ‘‘(2) the total percentage change for the pre23 vious fiscal year in basic pay under the General 

24 Schedule in accordance with section 5332 of title 5, 

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1 based comparability payment pursuant to section 

2 5304 of such title for Federal employees stationed in 

3 the District of Columbia; or 

4 ‘‘(3) the average annual change in the cost, per 

5 full-time equivalent position of the Food and Drug 

6 Administration, of all personnel compensation and 

7 benefits paid with respect to such positions for the 

8 first 5 years of the preceding 6 fiscal years. 

9 The adjustment made each fiscal year under this sub10 section shall be added on a compounded basis to the sum 

11 of all adjustments made each fiscal year after fiscal year 

12 2010 under this subsection. 

13 ‘‘(d) LIMITATIONS.— 

14 ‘‘(1) IN GENERAL.—Fees under subsection (a) 

15 shall be refunded for a fiscal year beginning after 

16 fiscal year 2010 unless appropriations for salaries 

17 and expenses of the Food and Drug Administration 

18 for such fiscal year (excluding the amount of fees 

19 appropriated for such fiscal year) are equal to or 

20 greater than the amount of appropriations for the 

21 salaries and expenses of the Food and Drug Admin22 istration for fiscal year 2010 (excluding the amount 

23 of fees appropriated for such fiscal year) multiplied 

24 by the adjustment factor applicable to the fiscal year 

25 involved. 


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1 ‘‘(2) AUTHORITY.—If the Secretary does not 

2 assess fees under subsection (a) during any portion 

3 of a fiscal year because of paragraph (1) and if at 

4 a later date in such fiscal year the Secretary may as5 sess such fees, the Secretary may assess and collect 

6 such fees, without any modification in the rate, for 

7 registration under section 415 at any time in such 

8 fiscal year. 

9 ‘‘(3) ADJUSTMENT FACTOR.—In this sub10 section, the term ‘adjustment factor’ applicable to a 

11 fiscal year is the Consumer Price Index for all urban 

12 consumers (all items; United States city average) for 

13 October of the preceding fiscal year divided by such 

14 Index for October 2009. 

15 ‘‘(e) CREDITING AND AVAILABILITY OF FEES.— 

16 ‘‘(1) IN GENERAL.—Fees authorized under sub17 section (a) shall be collected and available for obliga18 tion only to the extent and in the amount provided 

19 in advance in appropriations Acts. Such fees are au20 thorized to remain available until expended. Such 

21 sums as may be necessary may be transferred from 

22 the Food and Drug Administration salaries and ex23 penses appropriation account without fiscal year lim24 itation to such appropriation account for salaries 

25 and expenses with such fiscal year limitation. 


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1 ‘‘(2) COLLECTIONS AND APPROPRIATIONS

2 ACTS.—The fees authorized by this section— 

3 ‘‘(A) shall be retained in each fiscal year in 

4 an amount not to exceed the amount specified 

5 in appropriation Acts, or otherwise made avail6 able for obligation, for such fiscal year; and 

7 ‘‘(B) shall only be collected and available 

8 to defray the costs of food safety activities. 

9 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

10 For each of fiscal years 2010 through 2014, there 

11 are authorized to be appropriated for fees under this 

12 section such sums as may be necessary. 

13 ‘‘(4) PUBLIC MEETINGS.—For each fiscal year, 

14 the Secretary shall hold a public meeting on how 

15 fees collected under this section will be used to de16 fray the costs of food safety activities in order to so17 licit the views of the regulated industry, consumers, 

18 and other interested stakeholders. 

19 ‘‘(f) COLLECTION OF UNPAID FEES.—In any case 

20 where the Secretary does not receive payment of a fee as21 sessed under subsection (a) within 30 days after it is due, 

22 such fee shall be treated as a claim of the United States 

23 Government subject to subchapter II of chapter 37 of title 

24 31, United States Code. 


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1 ‘‘(g) CONSTRUCTION.—This section may not be con2 strued to require that the number of full-time equivalent 

3 positions in the Department of Health and Human Serv4 ices, for officers, employees, and advisory committees not 

5 engaged in food safety activities, be reduced to offset the 

6 number of officers, employees, and advisory committees so 

7 engaged. 

8 ‘‘(h) ANNUAL FISCAL REPORTS.—Beginning with 

9 fiscal year 2011, not later than 120 days after the end 

10 of each fiscal year for which fees are collected under this 

11 section, the Secretary shall prepare and submit to the 

12 Committee on Energy and Commerce of the House of 

13 Representatives and the Committee on Health, Education, 

14 Labor, and Pensions of the Senate a report on the imple15 mentation of the authority for such fees during such fiscal 

16 year and the use, by the Food and Drug Administration, 

17 of the fees collected for such fiscal year. 

18 ‘‘(i) DEFINITIONS.—In this section: 

19 ‘‘(1) The term ‘costs of food safety activities’ 

20 means the expenses incurred in connection with food 

21 safety activities for— 

22 ‘‘(A) officers and employees of the Food 

23 and Drug Administration, contractors of the 

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1 ployees, and committees and to contracts with 

2 such contractors; 

3 ‘‘(B) laboratory capacity; 

4 ‘‘(C) management of information, and the 

5 acquisition, maintenance, and repair of tech6 nology resources; 

7 ‘‘(D) leasing, maintenance, renovation, and 

8 repair of facilities and acquisition, maintenance, 

9 and repair of fixtures, furniture, scientific 

10 equipment, and other necessary materials and 

11 supplies; and 

12 ‘‘(E) collecting fees under this section and 

13 accounting for resources allocated for food safe14 ty activities. 

15 ‘‘(2) The term ‘food safety activities’ means ac16 tivities related to compliance by facilities registered 

17 under section 415 with the requirements of this Act 

18 relating to food (including research related to and 

19 the development of standards (such as performance 

20 standards and preventive controls), risk assessments, 

21 hazard analyses, inspection planning and inspec22 tions, third-party inspections, compliance review and 

23 enforcement, import review, information technology 

24 support, test development, product sampling, risk 

25 communication, and administrative detention).’’. 


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1 (d) TRANSITIONAL PROVISIONS.— 

2 (1) FEES.—The Secretary of Health and 

3 Human Services shall first impose the fee estab4 lished under section 743 of the Federal Food, Drug, 

5 and Cosmetic Act, as added by subsection (c), for 

6 fiscal years beginning with fiscal year 2010. 

7 (2) MODIFICATION OF REGISTRATION FORM.— 

8 Not later than 180 days after the date of the enact9 ment of this Act, the Secretary of Health and 

10 Human Services shall modify the registration form 

11 under section 415 of the Federal Food, Drug, and 

12 Cosmetic Act (21 U.S.C. 350d) to comply with the 

13 amendments made by this section. 

14 (3) APPLICATION.—The amendments made by 

15 this section, other than subsections (b)(2) and (c), 

16 shall take effect on the date that is 30 days after 

17 the date on which such modified registration form 

18 takes effect, but not later than 210 days after the 

19 date of the enactment of this Act. 

20 (4) SUNSET DATE.—Section 743 of the Federal 

21 Food, Drug, and Cosmetic Act, as added by sub22 section (c), does not authorize the assessment or col23 lection of a fee for registration under section 415 of 

24 such Act (21 U.S.C. 360) occurring after fiscal year 

25 2014. 


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1 SEC. 102. HAZARD ANALYSIS, RISK-BASED PREVENTIVE 

2 CONTROLS, FOOD SAFETY PLAN, FINISHED 

3 PRODUCT TEST RESULTS FROM CATEGORY 1 

4 FACILITIES. 

5 (a) HAZARD ANALYSIS, RISK-BASED PREVENTIVE

6 CONTROLS, FOOD SAFETY PLAN.— 

7 (1) ADULTERATED FOOD.—Section 402 (21 

8 U.S.C. 342) is amended by adding at the end the 

9 following: 

10 ‘‘(j) If it has been manufactured, processed, packed, 

11 transported, or held under conditions that do not meet the 

12 requirements of sections 418 and 418A.’’. 

13 (2) REQUIREMENTS.—Chapter IV (21 U.S.C. 

14 341 et seq.) is amended by adding at the end the 

15 following: 

16 ‘‘SEC. 418. HAZARD ANALYSIS AND RISK-BASED PREVEN17 TIVE CONTROLS. 

18 ‘‘(a) IN GENERAL.—The owner, operator, or agent 

19 of a facility shall, in accordance with this section— 

20 ‘‘(1) conduct a hazard analysis (or more than 

21 one if appropriate); 

22 ‘‘(2) identify and implement effective preventive 

23 controls; 

24 ‘‘(3) monitor preventive controls; 

25 ‘‘(4) institute corrective actions when— 


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1 ‘‘(A) monitoring shows that preventive con2 trols have not been properly implemented; or 

3 ‘‘(B) monitoring and verification show that 

4 such controls were ineffective; 

5 ‘‘(5) conduct verification activities; 

6 ‘‘(6) maintain records of monitoring, corrective 

7 action, and verification; and 

8 ‘‘(7) reanalyze for hazards. 

9 ‘‘(b) IDENTIFICATION OF HAZARDS.— 

10 ‘‘(1) IN GENERAL.—The owner, operator, or 

11 agent of a facility shall evaluate whether there are 

12 any hazards, including hazards due to the source of 

13 the ingredients, that are reasonably likely to occur 

14 in the absence of preventive controls that may affect 

15 the safety, wholesomeness, or sanitation of the food 

16 manufactured, processed, packed, transported, or 

17 held by the facility, including— 

18 ‘‘(A) biological, chemical, physical, and ra19 diological hazards, natural toxins, pesticides, 

20 drug residues, filth, decomposition, parasites, 

21 allergens, and unapproved food and color addi22 tives; and 

23 ‘‘(B) hazards that occur naturally or that 

24 may be unintentionally introduced. 


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1 ‘‘(2) IDENTIFIED BY THE SECRETARY.—The 

2 Secretary may, by regulation or guidance, identify 

3 hazards that are reasonably likely to occur in the ab4 sence of preventive controls. 

5 ‘‘(3) HAZARD ANALYSIS.—The owner, operator, 

6 or agent of a facility shall identify and describe the 

7 hazards evaluated under paragraph (1) or identified 

8 under paragraph (2), to the extent applicable to the 

9 facility, in a hazard analysis. 

10 ‘‘(c) PREVENTIVE CONTROLS.— 

11 ‘‘(1) IN GENERAL.—The owner, operator, or 

12 agent of a facility shall identify and implement effec13 tive preventive controls to prevent, eliminate, or re14 duce to acceptable levels the occurrence of any haz15 ards identified in the hazard analysis under sub16 section (b)(3). 

17 ‘‘(2) IDENTIFIED BY THE SECRETARY.— 

18 ‘‘(A) ESTABLISHMENT.—The Secretary 

19 may establish by regulation or guidance preven20 tive controls for specific product types to pre21 vent unintentional contamination throughout 

22 the supply chain. The owner, operator, or agent 

23 of a facility shall implement any preventive con24 trols identified by the Secretary under this 

25 paragraph. 


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1 ‘‘(B) ALTERNATIVE CONTROLS.—Such reg2 ulation or guidance shall allow the owner, oper3 ator, or agent of a facility to implement an al4 ternative preventive control to one established 

5 by the Secretary, provided that, in response to 

6 a request by the Secretary, the owner, operator, 

7 or agent can present to the Secretary data or 

8 other information sufficient to demonstrate that 

9 the alternative control effectively addresses the 

10 hazard, including meeting any applicable per11 formance standard. 

12 ‘‘(C) LIMITATION.—Subparagraph (B) 

13 shall not apply to any preventive control de14 scribed in subparagraph (A), (B), or (E) of 

15 subsection (i)(2). 

16 ‘‘(d) MONITORING.—The owner, operator, or agent of 

17 a facility shall monitor the implementation of preventive 

18 controls under subsection (c) to identify any circumstances 

19 in which the preventive controls are not fully implemented 

20 or verification shows that such controls were ineffective. 

21 ‘‘(e) CORRECTIVE ACTIONS.—The owner, operator, 

22 or agent of a facility shall establish and implement proce23 dures to ensure that, if the preventive controls under sub24 section (c) are not fully implemented or are not found ef25 fective— 


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1 ‘‘(1) no affected product from such facility en2 ters commerce; and 

3 ‘‘(2) appropriate action is taken to reduce the 

4 likelihood of recurrence of the implementation fail5 ure. 

6 ‘‘(f) VERIFICATION.—The owner, operator, or agent 

7 of a facility shall ensure that— 

8 ‘‘(1) the system of preventive controls identified 

9 under subsection (c) has been validated as scientif10 ically and technically sound so that, if such system 

11 is implemented, the hazards identified in the hazard 

12 analysis under subsection (b)(3) will be prevented, 

13 eliminated, or reduced to an acceptable level; 

14 ‘‘(2) the facility is conducting monitoring in ac15 cordance with subsection (d); 

16 ‘‘(3) the facility is taking effective corrective ac17 tions under subsection (e); and 

18 ‘‘(4) the preventive controls are effectively pre19 venting, eliminating, or reducing to an acceptable 

20 level the occurrence of identified hazards, including 

21 through the use of environmental and product test22 ing programs and other appropriate means. 

23 ‘‘(g) REQUIREMENT TO REANALYZE AND REVISE.— 

24 ‘‘(1) REQUIREMENT.—The owner, operator, or 

25 agent of a facility shall— 


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1 ‘‘(A) review the evaluation under sub2 section (b) for the facility and, as necessary, re3 vise the hazard analysis under subsection (b)(3) 

4 for the facility— 

5 ‘‘(i) not less than every 2 years; 

6 ‘‘(ii) if there is a change in the proc7 ess or product that could affect the hazard 

8 analysis; and 

9 ‘‘(iii) if the Secretary determines that 

10 it is appropriate to protect public health; 

11 and 

12 ‘‘(B) whenever there is a change in the 

13 hazard analysis, revise the preventive controls 

14 under subsection (c) for the facility as nec15 essary to ensure that all hazards that are rea16 sonably likely to occur are prevented, elimi17 nated, or reduced to an acceptable level, or doc18 ument the basis for the conclusion that no such 

19 revision is needed. 

20 ‘‘(2) NONDELEGATION.—Any revisions ordered 

21 by the Secretary under this subsection shall be or22 dered by the Secretary or an official designated by 

23 the Secretary. An official may not be so designated 

24 unless the official is the director of the district 


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1 under this Act in which the facility involved is lo2 cated, or is an official senior to such director. 

3 ‘‘(h) RECORDKEEPING.—The owner, operator, or 

4 agent of a facility shall maintain, for not less than 2 years, 

5 records documenting the activities described in subsections 

6 (a) through (g). 

7 ‘‘(i) DEFINITIONS.—For purposes of this section: 

8 ‘‘(1) FACILITY.—The term ‘facility’ means a 

9 domestic facility or a foreign facility that is required 

10 to be registered under section 415. 

11 ‘‘(2) PREVENTIVE CONTROLS.—The term ‘pre12 ventive controls’ means those risk-based procedures, 

13 practices, and processes that a person knowledgeable 

14 about the safe manufacturing, processing, packing, 

15 transporting, or holding of food would employ to 

16 prevent, eliminate, or reduce to an acceptable level 

17 the hazards identified in the hazard analysis under 

18 subsection (b)(3) and that are consistent with the 

19 current scientific understanding of safe food manu20 facturing, processing, packing, transporting, or hold21 ing at the time of the analysis. Those procedures, 

22 practices, and processes shall include the following, 

23 as appropriate to the type of facility or food: 

24 ‘‘(A) Sanitation procedures and practices. 


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1 ‘‘(B) Supervisor, manager, and employee 

2 hygiene training. 

3 ‘‘(C) Process controls. 

4 ‘‘(D) An allergen control program to mini5 mize potential allergic reactions in humans 

6 from ingestion of, or contact with, human and 

7 animal food. 

8 ‘‘(E) Good manufacturing practices. 

9 ‘‘(F) Verification procedures, practices, 

10 and processes for suppliers and incoming ingre11 dients, which may include onsite auditing of 

12 suppliers and testing of incoming ingredients. 

13 ‘‘(G) Other procedures, practices, and 

14 processes established by the Secretary under 

15 subsection (c)(2). 

16 ‘‘(3) HAZARD THAT IS REASONABLY LIKELY TO

17 OCCUR.—A food safety hazard that is reasonably 

18 likely to occur is one for which a prudent person 

19 who, as applicable, manufactures, processes, packs, 

20 transports, or holds food, would establish controls 

21 because experience, illness data, scientific reports, or 

22 other information provides a basis to conclude that 

23 there is a reasonable possibility that the hazard will 

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1 essed, packed, transported, or held in the absence of 

2 those controls. 

3 ‘‘SEC. 418A. FOOD SAFETY PLAN. 

4 ‘‘(a) IN GENERAL.—Before a facility (as defined in 

5 section 418(i)) introduces or delivers for introduction into 

6 interstate commerce any shipment of food, the owner, op7 erator, or agent of the facility shall develop and implement 

8 a written food safety plan (in this section referred to as 

9 a ‘food safety plan’). 

10 ‘‘(b) CONTENTS.—The food safety plan shall include 

11 each of the following elements: 

12 ‘‘(1) The hazard analysis and any reanalysis 

13 conducted under section 418. 

14 ‘‘(2) A description of the preventive controls 

15 being implemented under subsection 418(c), includ16 ing those to address hazards identified by the Sec17 retary under subsection 418(b)(2). 

18 ‘‘(3) A description of the procedures for moni19 toring preventive controls. 

20 ‘‘(4) A description of the procedures for taking 

21 corrective actions. 

22 ‘‘(5) A description of verification activities for 

23 the preventive controls, including validation that the 

24 system of controls, if implemented, will prevent, 

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1 fied hazards, review of monitoring and corrective ac2 tion records, and procedures for determining wheth3 er the system of controls as implemented is effec4 tively preventing, eliminating, or reducing to an ac5 ceptable level the occurrence of identified hazards, 

6 including the use of environmental and product test7 ing programs. 

8 ‘‘(6) A description of the facility’s record9 keeping procedures. 

10 ‘‘(7) A description of the facility’s procedures 

11 for the recall of articles of food, whether voluntarily 

12 or when required under section 422. 

13 ‘‘(8) A description of the facility’s procedures 

14 for tracing the distribution history of articles of 

15 food, whether voluntarily or when required under 

16 section 414. 

17 ‘‘(9) A description of the facility’s procedures to 

18 ensure a safe and secure supply chain for the ingre19 dients or components used in making the food man20 ufactured, processed, packed, transported, or held by 

21 such facility. 

22 ‘‘(10) A description of the facility’s procedures 

23 to implement the science-based performance stand24 ards issued under section 419.’’. 

25 (3) GUIDANCE OR REGULATIONS.— 


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1 (A) IN GENERAL.—The Secretary of 

2 Health and Human Services (referred to in this 

3 subsection as the ‘‘Secretary’’) shall issue guid4 ance or promulgate regulations to establish 

5 science-based standards for conducting a haz6 ard analysis, documenting hazards, identifying 

7 and implementing preventive controls, and doc8 umenting the implementation of the preventive 

9 controls, including verification and corrective 

10 actions under sections 418 and 418A of the 

11 Federal Food, Drug, and Cosmetic Act (as 

12 added by paragraph (2)). 

13 (B) INTERNATIONAL STANDARDS.—In 

14 issuing guidance or regulations under subpara15 graph (A), the Secretary shall review inter16 national hazard analysis and preventive control 

17 standards that are in existence on the date of 

18 the enactment of this Act and relevant to such 

19 guidelines or regulations to ensure that the pro20 grams under sections 418 and 418A of the Fed21 eral Food, Drug, and Cosmetic Act (as added 

22 by paragraph (2) are consistent, to the extent 

23 the Secretary determines practicable and appro24 priate, with such standards. 


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1 (C) AUTHORITY WITH RESPECT TO CER2 TAIN FACILITIES.—The Secretary may, by regu3 lation, exempt or modify the requirements for 

4 compliance under this section and the amend5 ments made by this section with respect to fa6 cilities that are solely engaged in— 

7 (i) the production of food for animals 

8 other than man or the storage of packaged 

9 foods that are not exposed to the environ10 ment; or 

11 (ii) the storage of raw agricultural 

12 commodities for further distribution or 

13 processing. 

14 (D) SMALL BUSINESSES.—The Sec15 retary— 

16 (i) shall consider the impact of any 

17 guidance or regulations under this section 

18 on small businesses; and 

19 (ii) shall issue guidance to assist small 

20 businesses in complying with the require21 ments of this section and the amendments 

22 made by this section. 

23 (4) NO EFFECT ON EXISTING HACCP AUTHORI24 TIES.—Nothing in this section or the amendments 

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1 retary under the Federal Food, Drug, and Cosmetic 

2 Act (21 U.S.C. 301 et seq.) or the Public Health 

3 Service Act (42 U.S.C. 201 et seq.), as in effect on 

4 the day before the date of the enactment of this Act, 

5 to revise, issue, or enforce product- and category6 specific regulations, such as the Seafood Hazard 

7 Analysis Critical Controls Points Program, the Juice 

8 Hazard Analysis Critical Control Program, and the 

9 Thermally Processed Low-Acid Foods Packaged in 

10 Hermetically Sealed Containers standards. 

11 (5) CONSIDERATION.—When implementing sec12 tions 418 and 418A of the Federal Food, Drug, and 

13 Cosmetic Act, as added by paragraph (2), the Sec14 retary may take into account differences between 

15 food intended for human consumption and food in16 tended for consumption by animals other than man. 

17 (6) EFFECTIVE DATE.— 

18 (A) GENERAL RULE.—The amendments 

19 made by subsection (a) and this subsection 

20 shall take effect 18 months after the date of the 

21 enactment of this Act. 

22 (B) EXCEPTIONS.—Notwithstanding sub23 paragraph (A)— 

24 (i) the amendments made by sub25 section (a) and this subsection shall apply 


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1 to a small business (as defined by the Sec2 retary) after the date that is 2 years after 

3 the date of the enactment of this Act; and 

4 (ii) the amendments made by sub5 section (a) and this subsection shall apply 

6 to a very small business (as defined by the 

7 Secretary) after the date that is 3 years 

8 after the date of the enactment of this Act. 

9 (b) FINISHED PRODUCT TEST RESULTS FROM CAT10 EGORY 1 FACILITIES.— 

11 (1) ADULTERATION.—Section 402 (21 U.S.C. 

12 342), as amended by subsection (a), is amended by 

13 adding at the end the following: 

14 ‘‘(k) If it is manufactured or processed in a facility 

15 that is in violation of section 418B.’’. 

16 (2) REQUIREMENTS.—Chapter IV (21 U.S.C. 

17 341 et seq.), as amended, is further amended by 

18 adding at the end the following: 

19 ‘‘SEC. 418B. FINISHED PRODUCT TEST RESULTS FROM CAT20 EGORY 1 FACILITIES. 

21 ‘‘(a) AUTHORITY.—Beginning on the date specified 

22 in subsection (c), the Secretary shall require, after public 

23 notice and an opportunity for comment, the submission 

24 to the Secretary of finished product test results by the 

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1 ject to good manufacturing practices regulations docu2 menting the presence of contaminants in food in the pos3 session or control of such facility posing a risk of severe 

4 adverse health consequences or death. 

5 ‘‘(b) CONSIDERATIONS.—The Secretary shall require 

6 submissions under subsection (a)— 

7 ‘‘(1) as the Secretary determines feasible and 

8 appropriate; and 

9 ‘‘(2) taking into consideration available data 

10 and information on the potential risks posed by the 

11 facility. 

12 ‘‘(c) BEGINNING DATE.—The date specified in this 

13 subsection is the sooner of— 

14 ‘‘(1) the date of completion of the pilot projects 

15 and feasibility study under subsections (d) and (e); 

16 and 

17 ‘‘(2) the date that is 2 years after the date of 

18 the enactment of this section. 

19 ‘‘(d) PILOT PROJECTS.—The Secretary shall conduct 

20 2 or more pilot projects to evaluate the feasibility of col21 lecting positive finished product testing results from cat22 egory 1 facilities, including the value and feasibility of re23 porting corrective actions taken when positive finished 

24 product test results are reported to the Secretary. 


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1 ‘‘(e) FEASIBILITY STUDY.—The Secretary shall as2 sess the feasibility and benefits of the reporting by facili3 ties subject to good manufacturing practices regulations 

4 of appropriate finished product testing results from cat5 egory 1 facilities to the Secretary, including the extent to 

6 which the collection of such finished product testing re7 sults will help the Secretary assess the risk presented by 

8 a facility or product category. 

9 ‘‘(f) LIMITATIONS.—Nothing in this section shall be 

10 construed— 

11 ‘‘(1) to require the Secretary to mandate test12 ing or submission of test results that the Secretary 

13 determines would not provide useful information in 

14 assessing the potential risk presented by a facility or 

15 product category; or 

16 ‘‘(2) to limit the Secretary’s authority under 

17 any other provisions of law to require any person to 

18 provide access, or to submit information or test re19 sults, to the Secretary, including the ability of the 

20 Secretary to require field or other testing and to ob21 tain test results in the course of an investigation of 

22 a potential food-borne illness or contamination inci23 dent. 


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1 ‘‘(g) DEFINITION.—In this section, the term ‘cat2 egory 1 facility’ means a category 1 facility within the 

3 meaning of section 704(h).’’. 

4 (c) FOOD DEFENSE.— 

5 (1) ADULTERATION.—Section 402(j), as added 

6 by subsection (a), is amended by striking ‘‘and 

7 418A’’ and inserting ‘‘, 418A, or 418C’’. 

8 (2) REQUIREMENTS.—Chapter IV (21 U.S.C. 

9 341 et seq.), as amended, is further amended by 

10 adding at the end the following: 

11 ‘‘SEC. 418C. FOOD DEFENSE. 

12 ‘‘(a) IN GENERAL.—Before a facility (as defined in 

13 section 418(i)) introduces or delivers for introduction into 

14 interstate commerce any shipment of food, the owner, op15 erator, or agent of the facility shall develop and implement 

16 a written food defense plan (in this section referred to as 

17 a ‘food defense plan’). 

18 ‘‘(b) CONTENTS.—The food defense plan shall in19 clude each of the following elements: 

20 ‘‘(1) A food defense assessment to identify con21 ditions and practices that may permit a hazard that 

22 may be intentionally introduced, including by an act 

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1 aging), personnel security, storage security, shipping 

2 and receiving security, and utility security. 

3 ‘‘(2) A description of the preventive measures 

4 being implemented as a result of such assessment to 

5 minimize the risk of intentional contamination. 

6 ‘‘(3) A description of the procedures to check 

7 for and identify any circumstances in which the pre8 ventive measures are not fully implemented or were 

9 ineffective. 

10 ‘‘(4) A description of the procedures for taking 

11 corrective actions to ensure that when preventive 

12 measures have not been properly implemented or 

13 have been ineffective, appropriate action is taken— 

14 ‘‘(A) to reduce the likelihood of recurrence 

15 of the failure; and 

16 ‘‘(B) to assess the consequences of the fail17 ure. 

18 ‘‘(5) A description of evaluation activities for 

19 the preventive measures, including a review of 

20 records provided for under paragraph (6) and proce21 dures to periodically test the effectiveness of the 

22 plan. 

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1 plementation of the procedures under paragraphs 

2 (3), (4), and (5). 

3 ‘‘(c) HAZARD.—For purposes of this section, the 

4 term ‘hazard that may be intentionally introduced, includ5 ing by an act of terrorism’ means a hazard for which a 

6 prudent person who, as applicable, manufactures, proc7 esses, packs, transports, or holds food, would establish 

8 preventive measures because the hazard has been identi9 fied by a food defense assessment by application of— 

10 ‘‘(1) a targeting assessment tool recommended 

11 by the Secretary by guidance; or 

12 ‘‘(2) a comparable targeting assessment tool. 

13 ‘‘(d) FOOD DEFENSE HAZARDS IDENTIFIED BY THE

14 SECRETARY.— 

15 ‘‘(1) ESTABLISHMENT.—The Secretary may es16 tablish by regulation or guidance preventive meas17 ures for specific product types to prevent intentional 

18 contamination throughout the supply chain. The 

19 owner, operator, or agent of a facility shall imple20 ment any preventive measures identified by the Sec21 retary under this paragraph. 

22 ‘‘(2) ALTERNATIVE MEASURES.—Such regula23 tion or guidance shall allow the owner, operator, or 

24 agent of a facility to implement an alternative pre25 ventive measure to one established by the Secretary, 


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1 provided that, in response to a request by the Sec2 retary, the owner, operator, or agent can present to 

3 the Secretary data or other information sufficient to 

4 demonstrate that the alternative measure effectively 

5 addresses the hazard. 

6 ‘‘(e) REQUIREMENT TO REASSESS AND REVISE.— 

7 ‘‘(1) REQUIREMENT.—The owner, operator, or 

8 agent of a facility shall— 

9 ‘‘(A) review the food defense assessment 

10 under subsection (b)(1) for the facility and, as 

11 necessary, revise the food defense assessment 

12 under subsection (b)(1) for the facility— 

13 ‘‘(i) not less than every 2 years; 

14 ‘‘(ii) if there is a change in the proc15 ess or product that could affect the food 

16 defense assessment; and 

17 ‘‘(iii) if the Secretary determines that 

18 it is appropriate to protect public health; 

19 and 

20 ‘‘(B) whenever there is a change in the 

21 food defense assessment, revise the preventive 

22 measures under subsection (b)(2) for the facil23 ity as necessary to ensure that for all hazards 

24 identified, the risk is minimized, or document 


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1 the basis for the conclusion that no such revi2 sion is needed. 

3 ‘‘(2) NONDELEGATION.—Any revisions ordered 

4 by the Secretary under this subsection shall be or5 dered by the Secretary or an official designated by 

6 the Secretary. An official may not be so designated 

7 unless the official is the director of the district 

8 under this Act in which the facility involved is lo9 cated, or is an official senior to such director. 

10 ‘‘(f) RECORDKEEPING.—The owner, operator, or 

11 agent of a facility shall maintain, for not less than 2 years, 

12 records documenting the activities described in subsections 

13 (b) and (e). 

14 ‘‘(g) ACCESS TO PLAN.— 

15 ‘‘(1) ON INSPECTION.—An officer or employee 

16 of the Secretary shall have access to the food de17 fense plan of a facility under section 414(a) only if 

18 the Secretary, through an official who is the director 

19 of the district under this Act in which the facility is 

20 located or an official who is senior to such a direc21 tor, provides notice under section 414(a)(1)(C). 

22 ‘‘(2) NONDISCLOSURE.—A food defense plan, 

23 and any information derived from such a plan, shall 

24 be exempt from disclosure under section 552 of title 

25 5, United States Code.’’. 


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1 (3) PROHIBITION.—Section 301(j) (21 U.S.C. 

2 331(j)) is amended by inserting after ‘‘entitled to 

3 protection’’ the following: ‘‘or a food defense plan, or 

4 any information derived from such a plan, under 

5 section 418C’’. 

6 SEC. 103. PERFORMANCE STANDARDS. 

7 (a) ADULTERATED FOOD.—Section 402 (21 U.S.C. 

8 342), as amended by section 102, is amended by adding 

9 at the end the following: 

10 ‘‘(l) If it has been manufactured, processed, packed, 

11 transported, or held under conditions that do not meet the 

12 standards issued under section 419.’’. 

13 (b) REQUIREMENTS.—Chapter IV (21 U.S.C. 341 et 

14 seq.), as amended by section 102(b), is further amended 

15 by adding at the end the following: 

16 ‘‘SEC. 419. PERFORMANCE STANDARDS. 

17 ‘‘(a) PERFORMANCE STANDARDS.—The Secretary 

18 shall, not less frequently than every 2 years, review and 

19 evaluate epidemiological data and other appropriate 

20 sources of information, including research under section 

21 123 of the Food Safety Enhancement Act of 2009, to 

22 identify the most significant food-borne contaminants and 

23 the most significant resulting hazards. The Secretary shall 

24 issue, as soon as practicable, through guidance or by regu25 lation, science-based performance standards (which may 


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1 include action levels) applicable to foods or food classes, 

2 as appropriate, to minimize to an acceptable level, prevent, 

3 or eliminate the occurrence of such hazards. Such stand4 ards shall be applicable to foods and food classes. Notwith5 standing the timelines set forth in this paragraph, the Sec6 retary shall as appropriate establish such science-based 

7 performance standards for identified contaminants as nec8 essary to protect the public health. 

9 ‘‘(b) LIST OF CONTAMINANTS.—Following each re10 view under subsection (a), the Secretary shall publish in 

11 the Federal Register a list of food-borne contaminants 

12 that have the greatest adverse impact on public health. 

13 In determining whether a particular food-borne contami14 nant should be added to such list, the Secretary shall con15 sider the number and severity of illnesses and the number 

16 of deaths associated with the foods associated with such 

17 contaminants. 

18 ‘‘(c) SAMPLING PROGRAM.—In conjunction with the 

19 establishment of a performance standard under this sec20 tion, the Secretary may make recommendations to indus21 try for conducting product sampling. 

22 ‘‘(d) REVOCATION BY SECRETARY.—All performance 

23 standards of the Food and Drug Administration applicable 

24 to foods or food classes in effect on the date of the enact25 ment of this section, or issued under this section, shall 


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1 remain in effect until revised or revoked by the Sec2 retary.’’. 

3 (c) REPORT TO CONGRESS.—The Secretary of Health 

4 and Human Services shall submit to the Congress by 

5 March 30th of the year following each review under sec6 tion 419 of the Federal Food, Drug, and Cosmetic Act, 

7 as added by subsection (b), a report on the results of such 

8 review and the Secretary’s plans to address the significant 

9 food-borne hazards identified, or the basis for not address10 ing any significant food-borne hazards identified, includ11 ing any resource limitations or limitations in data that 

12 preclude further action at that time. 

13 SEC. 104. SAFETY STANDARDS FOR PRODUCE AND CERTAIN 

14 OTHER RAW AGRICULTURAL COMMODITIES. 

15 (a) ADULTERATED FOOD.—Section 402 (21 U.S.C. 

16 342), as amended by sections 102 and 103(a), is amended 

17 by adding at the end the following: 

18 ‘‘(m) If it has been grown, harvested, processed, 

19 packed, sorted, transported, or held under conditions that 

20 do not meet the standards established under section 

21 419A.’’. 

22 (b) STANDARDS.—Chapter IV (21 U.S.C. 341 et 

23 seq.), as amended by sections 102(b) and 103(b), is 

24 amended by adding at the end the following: 


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1 ‘‘SEC. 419A. SAFETY STANDARDS FOR PRODUCE AND CER2 TAIN OTHER RAW AGRICULTURAL COMMOD3 ITIES. 

4 ‘‘(a) STANDARDS.—The Secretary, in coordination 

5 with the Secretary of Agriculture, shall establish by regu6 lation scientific and risk-based food safety standards for 

7 the growing, harvesting, processing, packing, sorting, 

8 transporting, and holding of those types of raw agricul9 tural commodities— 

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

11 and 

12 ‘‘(2) for which the Secretary has determined 

13 that such standards are reasonably necessary to 

14 minimize the risk of serious adverse health con15 sequences or death to humans or animals. 

16 ‘‘(b) CONTENTS.—The regulations under subsection 

17 (a)— 

18 ‘‘(1) may set forth such procedures, processes, 

19 and practices as the Secretary determines to be rea20 sonably necessary— 

21 ‘‘(A) to prevent the introduction of known 

22 or reasonably foreseeable biological, chemical, 

23 and physical hazards, including hazards that 

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1 tural commodities that are a fruit, vegetable, 

2 nut, or fungus; and 

3 ‘‘(B) to provide reasonable assurances that 

4 such commodity is not adulterated under sec5 tion 402; 

6 ‘‘(2) may include, with respect to growing, har7 vesting, processing, packing, sorting, transporting, 

8 and storage operations, standards for safety as the 

9 Secretary determines to be reasonably necessary; 

10 ‘‘(3) may include standards addressing manure 

11 use, water quality, employee hygiene, sanitation and 

12 animal control, and temperature controls, as the 

13 Secretary determines to be reasonably necessary; 

14 ‘‘(4) may include standards for such other ele15 ments as the Secretary determines necessary to 

16 carry out subsection (a); 

17 ‘‘(5) shall provide a reasonable period of time 

18 for compliance, taking into account the needs of 

19 small businesses for additional time to comply; 

20 ‘‘(6) may provide for coordination of education 

21 and enforcement activities; 

22 ‘‘(7) shall take into consideration, consistent 

23 with ensuring enforceable public health protection, 

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1 shed-protection efforts, and organic production 

2 methods; 

3 ‘‘(8) may provide for coordination of education 

4 and training with other government agencies, univer5 sities, private entities, and others with experience 

6 working directly with farmers; and 

7 ‘‘(9) may provide for recognition through guid8 ance of other existing publicly available procedures, 

9 processes, and practices that the Secretary deter10 mines to be equivalent to those established under 

11 paragraph (1). 

12 ‘‘(c) EDUCATION AND COMPLIANCE.—The Secretary 

13 shall coordinate with the Secretary of Agriculture to pro14 vide for effective implementation of education and compli15 ance activities. The Secretary may contract and coordinate 

16 with the agency or department designated by the Governor 

17 of each State to perform activities to ensure compliance 

18 with this section.’’. 

19 (c) TIMING.— 

20 (1) PROPOSED RULE.—Not later than 18 

21 months after the date of enactment of this Act, the 

22 Secretary of Health and Human Services shall issue 

23 a proposed rule to carry out section 419A of the 

24 Federal Food, Drug, and Cosmetic Act, as added by 

25 subsection (b). 


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1 (2) FINAL RULE.—Not later than 3 years after 

2 such date, the Secretary of Health and Human 

3 Services shall issue a final rule under such section. 

4 (d) NO EFFECT ON EXISTING HACCP AUTHORI5 TIES.—Nothing in this section or the amendments made 

6 by this section limits the authority of the Secretary under 

7 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 

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

9 et seq.), as in effect on the day before the date of the 

10 enactment of this Act, to revise, issue, or enforce product11 and category-specific regulations, such as the Seafood 

12 Hazard Analysis Critical Controls Points Program, the 

13 Juice Hazard Analysis Critical Control Program, and the 

14 Thermally Processed Low-Acid Foods Packaged in Her15 metically Sealed Containers standards. 

16 (e) UPDATE EXISTING GUIDANCE.—Not later than 

17 1 year after the date of the enactment of this Act, the 

18 Secretary of Health and Human Services shall update the 

19 guidance document entitled ‘‘Guidance For Industry: 

20 Guide To Minimize Microbial Food Safety Hazards For 

21 Fresh Fruits And Vegetables’’ (issued on October 26, 

22 1998) in accordance with this section and the amendments 

23 made by this section. 


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1 SEC. 105. RISK-BASED INSPECTION SCHEDULE. 

2 (a) IN GENERAL.—Section 704 (21 U.S.C. 374) is 

3 amended by adding at the end the following: 

4 ‘‘(h)(1) Each facility registered under section 415 

5 shall be inspected— 

6 ‘‘(A)(i) by one or more officers duly designated 

7 under section 702 or other statutory authority by 

8 the Secretary; 

9 ‘‘(ii) for domestic facilities, by a Federal, State, 

10 or local official recognized by the Secretary under 

11 paragraph (2); or 

12 ‘‘(iii) for foreign facilities, by an agency or a 

13 representative of a country that is recognized by the 

14 Secretary under paragraph (2); and 

15 ‘‘(B) at a frequency determined pursuant to a 

16 risk-based schedule. 

17 ‘‘(2) For purposes of paragraph (1)(A), the Sec18 retary— 

19 ‘‘(A) may recognize Federal, State, and local of20 ficials and agencies and representatives of foreign 

21 countries as meeting standards established by the 

22 Secretary for conducting inspections under this Act; 

23 and 

24 ‘‘(B) may limit such recognition to inspections 

25 of specific commodities or food types. 


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1 ‘‘(3) The risk-based schedule under paragraph (1)(B) 

2 shall be implemented beginning not later than 18 months 

3 after the date of the enactment of this subsection. 

4 ‘‘(4) Such risk-based schedule shall provide for a fre5 quency of inspections commensurate with the risk pre6 sented by the facility and shall be based on the following 

7 categories and inspection frequencies: 

8 ‘‘(A) CATEGORY 1.—A category 1 food facility 

9 is a high-risk facility that manufactures or processes 

10 food. The Secretary shall randomly inspect a cat11 egory 1 food facility at least every 6 to 12 months. 

12 ‘‘(B) CATEGORY 2.—A category 2 food facility 

13 is a low-risk facility that manufactures or processes 

14 food or a facility that packs or labels food. The Sec15 retary shall randomly inspect a category 2 facility at 

16 least every 18 months to 3 years. 

17 ‘‘(C) CATEGORY 3.—A category 3 food facility 

18 is a facility that holds food. The Secretary shall ran19 domly inspect a category 3 facility at least every 5 

20 years. 

21 ‘‘(5) The Secretary— 

22 ‘‘(A) may, by guidance, modify the types of 

23 food facilities within a category under paragraph 

24 (4); 


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1 ‘‘(B) may alter the inspection frequencies speci2 fied in paragraph (4) based on the need to respond 

3 to food-borne illness outbreaks and food recalls; and 

4 ‘‘(C) may inspect a facility more frequently 

5 than the inspection frequency provided by paragraph 

6 (4); 

7 ‘‘(D) beginning 6 months after submitting the 

8 report required by section 105(b)(2) of the Food 

9 Safety Enhancement Act of 2009, may— 

10 ‘‘(i) publish in the Federal Register adjust11 ments to the inspection frequencies specified in 

12 subparagraphs (B) and (C) of paragraph (4) 

13 for category 2 and category 3 food facilities, 

14 which adjustments shall be in accordance with 

15 the Secretary’s recommendations in such re16 port; and 

17 ‘‘(ii) after such publication, implement the 

18 adjustments; and 

19 ‘‘(E) except as provided in subparagraphs (B) 

20 and (C), may not alter the inspection frequency 

21 specified in paragraph (4)(A) for category 1 food fa22 cilities. 

23 ‘‘(6) In determining the appropriate frequency of in24 spection, the Secretary shall consider— 


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1 ‘‘(A) the type of food manufactured, processed, 

2 packed, or held at the facility; 

3 ‘‘(B) the compliance history of the facility; 

4 ‘‘(C) whether the facility importing or offering 

5 for import into the United States food is certified by 

6 a qualified certifying entity in accordance with sec7 tion 801(q); and 

8 ‘‘(D) such other factors as the Secretary deter9 mines by guidance to be relevant to assessing the 

10 risk presented by the facility. 

11 ‘‘(7) Before establishing or modifying the categoriza12 tion under paragraph (4) of any food facility or type of 

13 food facility, the Secretary shall publish a notice of the 

14 proposed categorization in the Federal Register and pro15 vide a period of not less than 60 days for public comment 

16 on the proposed categorization.’’. 

17 (b) REPORTS ON RISK-BASED INSPECTIONS OF FOOD

18 FACILITIES.— 

19 (1) ANNUAL REPORT.—Not later than Decem20 ber 31 of each year, the Secretary of Health and 

21 Human Services shall submit a report to the Com22 mittee on Energy and Commerce of the House of 

23 Representatives and the Committee on Health, Edu24 cation, Labor, and Pensions of the Senate describ25 ing— 


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1 (A) the number of foreign and domestic fa2 cilities, by risk category, inspected under the 

3 risk-based inspection schedule established under 

4 section 704(h) of the Federal Food, Drug, and 

5 Cosmetic Act, as added by subsection (a), in 

6 the preceding fiscal year; and 

7 (B) the costs of implementing the risk8 based inspection schedule for the preceding 12 

9 months. 

10 (2) THIRD-YEAR REPORT.—Not later than 3 

11 years after the date of the enactment of this Act, the 

12 Secretary of Health and Human Services shall sub13 mit a report to the Committee on Energy and Com14 merce of the House of Representatives and the Com15 mittee on Health, Education, Labor, and Pensions 

16 of the Senate describing recommendations on the 

17 risk-based inspection schedule under section 704(h) 

18 of the Federal Food, Drug, and Cosmetic Act, as 

19 added by subsection (a), including recommendations 

20 for adjustments to the timing of the schedule and 

21 other ways to improve the risk-based allocation of 

22 resources by the Food and Drug Administration. In 

23 making such recommendations, the Secretary shall 

24 consider— 


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1 (A) the nature of the food products being 

2 processed, stored, or transported; 

3 (B) the manner in which food products are 

4 processed, stored, or transported; 

5 (C) the inherent likelihood that the prod6 ucts will contribute to the risk of food-borne ill7 ness; 

8 (D) the best available evidence concerning 

9 reported illnesses associated with the foods 

10 processed, stored, held, or transported in the 

11 category of facilities; and 

12 (E) the overall record of compliance with 

13 food safety law among facilities in the category, 

14 including compliance with applicable perform15 ance standards and the frequency of recalls. 

16 SEC. 106. ACCESS TO RECORDS. 

17 (a) RECORDS ACCESS.—Subsection (a) of section 414 

18 (21 U.S.C. 350c) is amended to read as follows: 

19 ‘‘(a) RECORDS ACCESS.— 

20 ‘‘(1) RECORDS ACCESS DURING AN INSPEC21 TION.— 

22 ‘‘(A) IN GENERAL.—Except as provided in 

23 paragraph (3), each person who manufactures, 

24 processes, packs, transports, distributes, re25 ceives, or holds an article of food in the United 


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1 States or for import into the United States 

2 shall, at the request of an officer or employee 

3 duly designated by the Secretary, permit such 

4 officer or employee, upon presentation of appro5 priate credentials, at reasonable times and with6 in reasonable limits and in a reasonable man7 ner, to have access to and copy all records re8 lating to such article bearing on whether the 

9 food may be adulterated, misbranded, or other10 wise in violation of this Act, including all 

11 records collected or developed to comply with 

12 section 418 or 418A. 

13 ‘‘(B) SCOPE OF RECORDS.—The require14 ment under subparagraph (A) applies to all 

15 records relating to the manufacture, processing, 

16 packing, transporting, distribution, receipt, 

17 holding, or importation of such article main18 tained by or on behalf of such person in any 

19 format (including paper and electronic formats) 

20 and at any location. 

21 ‘‘(C) IMMEDIATE AVAILABILITY WITH NO22 TICE.—Records not required to be made avail23 able immediately on commencement of an in24 spection under subparagraph (A) shall nonethe25 less be made available immediately on comVerDate Nov 24 2008 02:11 Aug 04, 2009 Jkt 079200 PO 00000 Frm 00059 Fmt 6652 Sfmt 6201 E:\BILLS\H2749.RFS H2749

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1 mencement of such an inspection if, by a rea2 sonable time before such inspection, the Sec3 retary by letter to the person identifies the 

4 records to be made available during such in5 spection. Nothing in this subparagraph shall 

6 be construed as permitting a person to refuse to 

7 produce records required under and in accord8 ance with subparagraph (A) due to failure of 

9 the Secretary to provide notice under this 

10 paragraph. 

11 ‘‘(2) ADDITIONAL AUTHORITIES TO ACCESS

12 RECORDS REMOTELY; SUBMISSION OF RECORDS TO

13 THE SECRETARY.— 

14 ‘‘(A) REMOTE ACCESS IN EMERGENCIES.— 

15 If the Secretary has a reasonable belief that an 

16 article of food presents a threat of serious ad17 verse health consequences or death to humans 

18 or animals, the Secretary may require each per19 son who manufactures, processes, packs, trans20 ports, distributes, receives, holds, or imports 

21 such article of food, or any article of food that 

22 the Secretary determines may be affected in a 

23 similar manner, to submit to the Secretary all 

24 records reasonably related to such article of 

25 food as soon as is reasonably practicable, after 


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1 receiving written notice (including by notice 

2 served personally and outside normal business 

3 hours to an agent identified under subpara4 graph (E) or (F) of section 415(a)(2)) of such 

5 requirement. 

6 ‘‘(B) REMOTE ACCESS TO RECORDS RE7 LATED TO FOOD SAFETY PLANS.—With respect 

8 to a facility subject to section 418 and 418A, 

9 the Secretary may require the owner, operator, 

10 or agent of such facility to submit to the Sec11 retary, as soon as reasonably practicable after 

12 receiving written notice of such requirement, 

13 the food safety plan, supporting information re14 lied on by the facility to select the preventive 

15 controls to include in its food safety plan, and 

16 documentation of corrective actions, if any, 

17 taken under section 418(e) within the preceding 

18 2 years 

19 ‘‘(C) ELECTRONIC SUBMISSION.—If the 

20 records required to be submitted to the Sec21 retary under subparagraph (A) or (B) are avail22 able in electronic format, such records shall be 

23 submitted electronically unless the Secretary 

24 specifies otherwise in the notice under such sub25 paragraph. 


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1 ‘‘(3) LIMITED RECORDS ACCESS ON FARMS.— 

2 ‘‘(A) APPLICATION.—Paragraphs (1) and 

3 (2) do not apply with respect to farms, except 

4 as provided in this paragraph. 

5 ‘‘(B) IN GENERAL.—A person who is the 

6 owner, operator, or agent of a farm (as defined 

7 in section 415) shall, at the request of an offi8 cer or employee duly designated by the Sec9 retary, permit such officer or employee, at rea10 sonable times and within reasonable limits and 

11 in a reasonable manner, to have access to and 

12 copy all records relating to an article of food 

13 produced, manufactured, processed, packed, or 

14 held on such farm as specified in paragraphs 

15 (1) and (2) if— 

16 ‘‘(i) such article of food is a fruit, veg17 etable, nut, or fungus that is the subject of 

18 a standard issued under section 419A; or 

19 ‘‘(ii) such article of food is the subject 

20 of an active investigation by the Secretary 

21 of a food borne illness outbreak and is not 

22 a grain or similarly handled commodity as 

23 defined in subsection (c)(4)(C)(ii). 

24 ‘‘(C) RECORDS ACCESS ON FARMS PRIOR

25 TO RULEMAKING.— 


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1 ‘‘(i) IN GENERAL.—As soon as prac2 ticable after the enactment of this para3 graph, the Secretary shall, in coordination 

4 with the Secretary of Agriculture, identify 

5 1 or more fruits, vegetables, nuts, or fungi 

6 for which the Secretary shall have access 

7 to records on farms. Such identification 

8 shall be made by guidance, following notice 

9 and public comment. 

10 ‘‘(ii) IDENTIFICATION OF RAW AGRI11 CULTURAL COMMODITIES.—The Secretary, 

12 in coordination with the Secretary of Agri13 culture, shall make the identification in 

14 clause (i), based on any past food borne ill15 ness outbreak attributed to the fruit, vege16 table, nut, or fungus— 

17 ‘‘(I) in the United States and the 

18 risk that a similar outbreak could 

19 occur again in the United States; or 

20 ‘‘(II) in a foreign country and 

21 the risk that a similar outbreak could 

22 occur in the United States. 

23 ‘‘(iii) DURATION OF AUTHORITY.— 

24 The authority to have access to records for 

25 a fruit, vegetable, nut, or fungus under 


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1 this subparagraph shall begin on the date 

2 on which the Secretary identifies such 

3 fruit, vegetable, nut, or fungus under 

4 clause (i) and shall terminate on the effec5 tive date of a final rule issued by the Sec6 retary under section 419A. 

7 ‘‘(iv) SCOPE OF RECORDS ACCESS.— 

8 In the guidance under clause (i), and for 

9 the period specified in clause (iii), the Sec10 retary, in coordination with the Secretary 

11 of Agriculture, shall determine the scope of 

12 the records to which the Secretary shall 

13 have access under this subparagraph. 

14 ‘‘(D) RULE OF CONSTRUCTION.—This 

15 paragraph shall not be construed as limiting ac16 cess to any records authorized under— 

17 ‘‘(i) this Act or the Public Health 

18 Service Act, as in effect on the day before 

19 the date of the enactment of this para20 graph; or 

21 ‘‘(ii) regulations issued under such 

22 Acts on any date before the date of the en23 actment of this paragraph.’’. 

24 (b) REGULATIONS CONCERNING RECORDKEEPING.— 


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1 (1) AMENDMENT.—Subsection (b) of section 

2 414 (21 U.S.C. 350c) is amended to read as follows: 

3 ‘‘(b) REGULATIONS CONCERNING RECORD4 KEEPING.—The Secretary, in consultation and coordina5 tion, as appropriate, with other Federal departments and 

6 agencies with responsibilities for regulating food safety, 

7 shall by regulation establish requirements regarding the 

8 establishment and maintenance, for not longer than 3 

9 years, of records by persons who manufacture, process, 

10 pack, transport, distribute, receive, or hold food in the 

11 United States or for import into the United States. The 

12 Secretary shall take into account the size of a business 

13 in promulgating regulations under this subsection. The 

14 Secretary shall consult with the Secretary of Agriculture 

15 in promulgating regulations with respect to farms under 

16 this subsection and shall take into account the nature of 

17 and impact on farms in promulgating such regulations. 

18 The only distribution records which may be required of 

19 restaurants under this subsection are those showing the 

20 restaurant’s suppliers and subsequent distribution other 

21 than to consumers.’’. 

22 (2) APPLICATION.—The Secretary of Health 

23 and Human Services shall promulgate revised regu24 lations to implement section 414(b) of the Federal 

25 Food, Drug, and Cosmetic Act, as amended by this 


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1 subsection. Section 414(b) of the Federal Food, 

2 Drug, and Cosmetic Act and regulations thereunder, 

3 as in effect on the day before the date of the enact4 ment of this Act, shall apply to acts and omissions 

5 occurring before the effective date of such revised 

6 regulations. 

7 (c) CONFORMING AMENDMENTS.—Section 704(a)(1) 

8 (21 U.S.C. 374(a)(1)) is amended— 

9 (1) in the second sentence— 

10 (A) by striking ‘‘(excluding farms or res11 taurants)’’ and inserting ‘‘(excluding farms, ex12 cept as provided in section 414(a)(3))’’; 

13 (B) by inserting ‘‘receives,’’ before 

14 ‘‘holds’’; 

15 (C) by striking ‘‘described in section 414’’ 

16 and inserting ‘‘described in or required under 

17 section 414’’; and 

18 (D) by striking ‘‘when the Secretary has a 

19 reasonable belief that an article of food is adul20 terated and presents a threat of serious adverse 

21 health consequences or death to humans or ani22 mals’’ and inserting ‘‘bearing on whether such 

23 food is adulterated, misbranded, or otherwise in 

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1 lected or developed to comply with section 418 

2 or 418A’’; and 

3 (2) in the fourth sentence— 

4 (A) by striking ‘‘the preceding sentence’’ 

5 and inserting ‘‘either of the preceding two sen6 tences’’; and 

7 (B) by inserting ‘‘recipes for food,’’ before 

8 ‘‘financial data,’’. 

9 SEC. 107. TRACEABILITY OF FOOD. 

10 (a) PROHIBITED ACT.—Section 301(e) (21 U.S.C. 

11 331(e)) is amended by inserting ‘‘, the violation of any 

12 requirement of the food tracing system under section 

13 414(c);’’ before ‘‘or the refusal to permit access to or 

14 verification or copying of any such required record’’. 

15 (b) IMPORTS.—Section 801(a) (21 U.S.C. 381(a)) is 

16 amended by inserting ‘‘or (4) the requirements of section 

17 414 have not been complied with regarding such article,’’ 

18 before ‘‘then such article shall be refused admission’’. 

19 (c) PRODUCT TRACING FOR FOOD.—Section 414 (21 

20 U.S.C. 350c), as amended by section 106, is amended— 

21 (1) by redesignating subsections (c) and (d) as 

22 subsections (d) and (e), respectively; and 

23 (2) by inserting after subsection (b) the fol24 lowing: 

25 ‘‘(c) TRACING SYSTEM FOR FOOD.— 


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1 ‘‘(1) IN GENERAL.—The Secretary shall by reg2 ulation establish a tracing system for food that is lo3 cated in the United States or is for import into the 

4 United States. 

5 ‘‘(2) INFORMATION GATHERING.— 

6 ‘‘(A) TRACING TECHNOLOGIES.—Before 

7 issuing a proposed regulation under this sub8 section, the Secretary shall— 

9 ‘‘(i) identify technologies and meth10 odologies for tracing the distribution his11 tory of a food that are, or may be, used by 

12 members of different sectors of the food in13 dustry, including technologies and meth14 odologies to enable each person who pro15 duces, manufactures, processes, pack, 

16 transports, or holds a food to— 

17 ‘‘(I) maintain the full pedigree of 

18 the origin and previous distribution 

19 history of the food; 

20 ‘‘(II) link that history with the 

21 subsequent distribution of the food; 

22 ‘‘(III) establish and maintain a 

23 system for tracing the food that is 

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1 lished and maintained by other such 

2 persons; and 

3 ‘‘(IV) use a unique identifier for 

4 each facility owned or operated by 

5 such person for such purpose, as spec6 ified under section 1011; and 

7 ‘‘(ii) to the extent practicable, as8 sess— 

9 ‘‘(I) the costs and benefits associ10 ated with the adoption and use of 

11 such technologies; 

12 ‘‘(II) the feasibility of such tech13 nologies for different sectors of the 

14 food industry; and 

15 ‘‘(III) whether such technologies 

16 are compatible with the requirements 

17 of this subsection. 

18 ‘‘(B) PUBLIC MEETINGS.—Before issuing a 

19 proposed regulation under this subsection, the 

20 Secretary shall conduct not less than 2 public 

21 meetings in diverse geographical areas of the 

22 United States to provide persons in different re23 gions an opportunity to provide input and infor24 mation to the Secretary. 


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1 ‘‘(C) PILOT PROJECTS.—Before issuing a 

2 proposed regulation under this subsection, the 

3 Secretary shall conduct 1 or more pilot projects 

4 in coordination with 1 or more sectors of the 

5 food industry to explore and evaluate tracing 

6 systems for food. The Secretary shall coordinate 

7 with the Secretary of Agriculture in conducting 

8 pilot projects with respect to farms under this 

9 subsection. 

10 ‘‘(3) REGULATION.— 

11 ‘‘(A) IN GENERAL.—Taking into account 

12 information obtained through information gath13 ering under paragraph (2), the Secretary shall 

14 issue regulations establishing a tracing system 

15 that enables the Secretary to identify each per16 son who grows, produces, manufactures, proc17 esses, packs, transports, holds, or sells such 

18 food in as short a timeframe as practicable but 

19 no longer than 2 business days. 

20 ‘‘(B) SCOPE OF REGULATION.—The Sec21 retary may include in the regulations estab22 lishing a tracing system— 

23 ‘‘(i) the establishment and mainte24 nance of lot numbers; 


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1 ‘‘(ii) a standardized format for pedi2 gree information; and 

3 ‘‘(iii) the use of a common nomen4 clature for food. 

5 ‘‘(C) COORDINATION REGARDING FARM IM6 PACT.—In issuing regulations under this para7 graph that will impact farms, the Secretary— 

8 ‘‘(i) shall coordinate with the Sec9 retary of Agriculture; and 

10 ‘‘(ii) take into account the nature of 

11 the impact of the regulations on farms. 

12 ‘‘(4) EXEMPTIONS AND LIMITATIONS.— 

13 ‘‘(A) DIRECT SALES BY FARMS.—Food is 

14 exempt from the requirements of this sub15 section if such food is— 

16 ‘‘(i) produced on a farm; and 

17 ‘‘(ii) sold by the owner, operator, or 

18 agent in charge of such farm directly to a 

19 consumer or to a restaurant or grocery 

20 store. 

21 ‘‘(B) FISHING VESSELS.—Food is exempt 

22 from the requirements of this subsection if such 

23 food is produced through the use of a fishing 

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1 ment Act until such time as the food is sold by 

2 the owner, operator, or agent in charge of such 

3 fishing vessel. 

4 ‘‘(C) GRAINS AND SIMILARLY HANDLED

5 COMMODITIES.— 

6 ‘‘(i) LIMITATION ON EXTENT OF

7 TRACING.—In addition to the exemption 

8 under subparagraph (A), any tracing sys9 tem established under this subsection with 

10 regard to any grain or similarly handled 

11 commodity shall be limited to enabling the 

12 Secretary to identify persons who received, 

13 processed, packed, transported, distributed, 

14 held, or sold the grain or similarly handled 

15 commodity from the initial warehouse op16 erator that held the grain or similarly han17 dled commodity for any period of time to 

18 the ultimate consumer. 

19 ‘‘(ii) DEFINITIONS.—In this subpara20 graph: 

21 ‘‘(I) The term ‘grain or similarly 

22 handled commodity’ means wheat, 

23 corn, grain sorghum, barley, oats, 

24 rice, wild rice, rye, soybeans, legumes, 

25 sugar cane, sugar beets, sunflower 


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1 seed, rapeseed, canola, safflower, 

2 flaxseed, mustard seed, crambe, ses3 ame seed, camelina, cottonseed, cocoa 

4 beans, grass hay, and honey. The 

5 term may include any other com6 modity as determined by the Sec7 retary in coordination with the Sec8 retary of Agriculture. 

9 ‘‘(II) The term ‘warehouse oper10 ator’ has the meaning given that term 

11 in section 2 of the United States 

12 Warehouse Act (7 U.S.C. 241), except 

13 that the term also includes any person 

14 or entity that handles or stores agri15 cultural products for other persons or 

16 entities or, in the case of a coopera17 tive, handles or stores agricultural 

18 products for its members, as deter19 mined by the Secretary in coordina20 tion with the Secretary of Agriculture. 

21 ‘‘(D) EXEMPTION OF OTHER FOODS.—The 

22 Secretary may by notice in the Federal Register 

23 exempt a food or a type of facility, farm, or res24 taurant from, or modify the requirements with 

25 respect to, the requirements of this subsection 


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1 if the Secretary determines that a tracing sys2 tem for such food or type of facility, farm, or 

3 restaurant is not necessary to protect the public 

4 health. 

5 ‘‘(E) RECORDKEEPING REGARDING PRE6 VIOUS SOURCES AND SUBSEQUENT RECIPI7 ENTS.—For a food or person covered by a limi8 tation or exemption under subparagraph (B), 

9 (C), or (D), the Secretary shall require each 

10 person who produces, receives, manufactures, 

11 processes, packs, transports, distributes, or 

12 holds such food to maintain records to identify 

13 the immediate previous sources of such food 

14 and its ingredients and the immediate subse15 quent recipients of such food. 

16 ‘‘(F) RECORDKEEPING BY RESTAURANTS

17 AND GROCERY STORES.—For a food covered by 

18 an exemption under subparagraph (A), res19 taurants and grocery stores shall keep records 

20 documenting the farm that was the source of 

21 the food. 

22 ‘‘(G) RECORDKEEPING BY FARMS.—For a 

23 food covered by an exemption under subpara24 graph (A), farms shall keep records, in elec25 tronic or non-electronic format, for at least 6 


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1 months documenting the restaurant or grocery 

2 store to which the food was sold.’’. 

3 SEC. 108. REINSPECTION AND FOOD RECALL FEES APPLI4 CABLE TO FACILITIES. 

5 (a) IN GENERAL.—Part 6 of subchapter C of chapter 

6 VII (21 U.S.C. 371 et seq.), as added by section 101(c), 

7 is amended by adding at the end the following: 

8 ‘‘SEC. 743A. REINSPECTION AND FOOD RECALL FEES APPLI9 CABLE TO FACILITIES. 

10 ‘‘(a) IN GENERAL.—The Secretary shall assess and 

11 collect fees from each entity in a fiscal year— 

12 ‘‘(1) that— 

13 ‘‘(A) during such fiscal year commits a vio14 lation of any requirement of this Act relating to 

15 food, including any such requirement relating to 

16 good manufacturing practices; and 

17 ‘‘(B) because of such violation, undergoes 

18 additional inspection by the Food and Drug Ad19 ministration; or 

20 ‘‘(2) during such fiscal year is subject to a food 

21 recall. 

22 ‘‘(b) AMOUNT OF FEES.—The Secretary shall set the 

23 amount of the fees under this section to fully cover the 

24 costs of— 


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1 ‘‘(1) in the case of fees collected under sub2 section (a)(1), conducting the additional inspections 

3 referred to in such subsection; and 

4 ‘‘(2) in the case of fees collected under sub5 section (a)(2), conducting food recall activities, in6 cluding technical assistance, follow-up effectiveness 

7 checks, and public notifications, during the fiscal 

8 year involved. 

9 ‘‘(c) CREDITING AND AVAILABILITY OF FEES.— 

10 ‘‘(1) IN GENERAL.—Fees authorized under sub11 section (a) shall be collected and available for obliga12 tion only to the extent and in the amount provided 

13 in advance in appropriations Acts. Such fees are au14 thorized to remain available until expended. Such 

15 sums as may be necessary may be transferred from 

16 the Food and Drug Administration salaries and ex17 penses appropriation account without fiscal year lim18 itation to such appropriation account for salaries 

19 and expenses with such fiscal year limitation. 

20 ‘‘(2) COLLECTIONS AND APPROPRIATIONS

21 ACTS.—The fees authorized by this section— 

22 ‘‘(A) shall be retained in each fiscal year in 

23 an amount not to exceed the amount specified 

24 in appropriation Acts, or otherwise made avail25 able for obligation, for such fiscal year; and 


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1 ‘‘(B) shall only be collected and available 

2 to defray the costs referred to in subsection (b). 

3 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

4 For each of fiscal years 2010 through 2014, there 

5 are authorized to be appropriated for fees under this 

6 section such sums as may be necessary. 

7 ‘‘(d) WAIVER.—The Secretary shall waive and, if ap8 plicable, refund the amount of any fee collected under this 

9 section from an entity as a result of a food recall that 

10 the Secretary determines was inappropriately ordered.’’. 

11 (b) EFFECTIVE DATE.—The amendment made by 

12 subsection (a) shall apply to additional inspections and 

13 food recall activities occurring after the date of the enact14 ment of this Act. 

15 SEC. 109. CERTIFICATION AND ACCREDITATION. 

16 (a) MISBRANDING.— 

17 (1) IN GENERAL.—Section 403 (21 U.S.C. 

18 343), as amended by section 101(a), is amended by 

19 adding at the end the following: 

20 ‘‘(aa) If it is part of a shipment offered for import 

21 into the United States and such shipment is in violation 

22 of section 801(q) (requiring a certification of compliance 

23 for certain food shipments).’’. 

24 (2) EFFECTIVE DATE.—The amendment made 

25 by paragraph (1) shall apply to shipments offered 


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1 for import on or after the date that is 3 years after 

2 the date of the enactment of this Act. 

3 (b) CERTIFICATION OF COMPLIANCE FOR IM4 PORTS.—Chapter VIII (21 U.S.C. 381 et seq.) is amend5 ed— 

6 (1) in section 801(a), as amended by section 

7 107(b), by inserting after the third sentence the fol8 lowing: ‘‘If such article is food being imported or of9 fered for import into the United States and is not 

10 in compliance with the requirement of subsection (q) 

11 (relating to certifications of compliance with this 

12 Act), then such article shall be refused admission.’’; 

13 (2) in the second sentence of section 801(b), by 

14 striking ‘‘the fourth sentence’’ and inserting ‘‘the 

15 fifth sentence’’; and 

16 (3) by adding at the end of section 801 the fol17 lowing: 

18 ‘‘(q) CERTIFICATIONS CONCERNING IMPORTED ARTI19 CLES.— 

20 ‘‘(1) IN GENERAL.— 

21 ‘‘(A) REQUIREMENT.—The Secretary may 

22 require, as an additional condition of granting 

23 admission to an article of food being imported 

24 or offered for import into the United States, 

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1 tification that the article complies with require2 ments of this Act as specified by the Secretary 

3 if— 

4 ‘‘(i) for food imported from a par5 ticular country, territory, or region, the 

6 Secretary finds, based on scientific, risk7 based evidence, that the government con8 trols in such country, territory, or region 

9 are inadequate to ensure that the article is 

10 safe and that certification would assist the 

11 Secretary in determining whether to refuse 

12 to admit such article under subsection (a); 

13 ‘‘(ii) for a type of food for which there 

14 is scientific evidence that there is a par15 ticular risk associated with the food that 

16 presents a threat of serious adverse health 

17 consequences or death, the Secretary finds 

18 that certification would assist the Sec19 retary in determining whether to refuse to 

20 admit such article under subsection (a); or 

21 ‘‘(iii) for an article imported from a 

22 particular country or territory, there is an 

23 agreement between the Secretary and the 

24 government of such country or territory 

25 providing for such certification. 


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1 ‘‘(B) FORM OF CERTIFICATION.—A certifi2 cation under subparagraph (A) may take the 

3 form of a statement that the article or the facil4 ity or farm that manufactured, processed, 

5 packed, held, grew, harvested, sorted, or trans6 ported the article, as the case may be, complies 

7 with requirements of this Act as specified by 

8 the Secretary, or any other form as the Sec9 retary may specify, including a listing of cer10 tified facilities or other entities. The Secretary 

11 may require that the certification include addi12 tional information regarding compliance. 

13 ‘‘(C) ADEQUATE GOVERNMENT CON14 TROLS.— 

15 ‘‘(i) PROCESS.—Before requiring a 

16 certification under clause (ii) of subpara17 graph (A) with respect to a food, the Sec18 retary shall establish a process by which a 

19 country or territory may demonstrate that 

20 its government controls are adequate to 

21 ensure that such food exported from its 

22 territory to the United States is safe. 

23 ‘‘(ii) DEMONSTRATION.—The Sec24 retary shall not require a certification 

25 under clause (ii) of subparagraph (A) for 


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1 a food exported from a country or terri2 tory, if that country or territory has dem3 onstrated, pursuant to the process estab4 lished by the Secretary under clause (i), 

5 that its government controls are adequate 

6 to ensure that such food exported from its 

7 territory to the United States is safe. 

8 ‘‘(D) NOTICE OF CANCELLATION OR SUS9 PENSION OF CERTIFICATION.—As a condition 

10 on acceptance of certifications from a qualified 

11 certifying entity, the Secretary shall require the 

12 qualified certifying entity to notify the Sec13 retary whenever the qualified certifying entity 

14 cancels or suspends the certification of any fa15 cility or other entity included in a listing under 

16 subparagraph (B). 

17 ‘‘(E) CONSISTENCY WITH INTERNATIONAL

18 OBLIGATIONS.—The Secretary shall apply this 

19 paragraph consistently with United States obli20 gations under international agreements. 

21 ‘‘(2) QUALIFIED CERTIFYING ENTITY.—For 

22 purposes of this subsection, the term ‘qualified certi23 fying entity’ means— 

24 ‘‘(A) an agency or a representative of the 

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1 cle originated, as designated by such govern2 ment or the Secretary; or 

3 ‘‘(B) an individual or entity determined by 

4 the Secretary or an accredited body recognized 

5 by the Secretary to be qualified to provide a 

6 certification under paragraph (1). 

7 ‘‘(3) NO CONFLICTS OF INTEREST.— 

8 ‘‘(A) IN GENERAL.—The Secretary shall 

9 issue regulations to ensure that any qualified 

10 certifying entity and its auditors are free from 

11 conflicts of interest. In issuing these regula12 tions, the Secretary may rely on or incorporate 

13 international certification standards. 

14 ‘‘(B) REGULATIONS.—Such regulations 

15 shall require that— 

16 ‘‘(i) the qualified certifying entity 

17 shall have a committee or management 

18 structure for safeguarding impartiality; 

19 ‘‘(ii) conflict of interest policies for a 

20 qualified certifying entity and auditors act21 ing for the qualified certifying entity shall 

22 be written; 

23 ‘‘(iii) the qualified certifying entity 

24 shall not be owned, operated, or controlled 

25 by a producer, manufacturer, processor, 


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1 packer, holder, supplier, or vendor of any 

2 article of the type it certifies; 

3 ‘‘(iv) the qualified certifying entity 

4 shall not have any ownership or financial 

5 interest in any product, producer, manu6 facturer, processor, packer, holder, supplier 

7 or vendor of the type it certifies; 

8 ‘‘(v) no auditor acting for the quali9 fied certifying entity (or spouse or minor 

10 children) shall have any significant owner11 ship or other financial interest regarding 

12 any product of the type it certifies; 

13 ‘‘(vi) the qualified certifying entity 

14 shall— 

15 ‘‘(I) obtain and maintain annual 

16 declarations from all personnel who 

17 may be directly involved in the per18 formance of audits as to whether they 

19 do or do not have direct financial in20 terests in any producer, manufacturer, 

21 processor, packer, holder, supplier, or 

22 vendor of foods, and a list of any such 

23 companies in which they do have fi24 nancial interests or by which they 

25 were employed in the past year; and 


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1 ‘‘(II) when an auditor is assigned 

2 to audit a facility, require that indi3 vidual to affirm that he or she has no 

4 financial interest in the company that 

5 owns or operates that facility and was 

6 not employed by that facility in the 

7 previous year; 

8 ‘‘(vii) neither the qualified certifying 

9 entity nor any of its auditors acting for the 

10 qualified certifying entity shall participate 

11 in the production, manufacture, processing, 

12 packing, holding, promotion, or sale of any 

13 product of the type it certifies; 

14 ‘‘(viii) neither the qualified certifying 

15 entity nor any of its auditors shall provide 

16 consultative services to any facility cer17 tified by the qualified certifying entity, or 

18 the owner, operator, or agent in charge of 

19 such a facility, unless the qualified certi20 fying entity has procedures in place, ap21 proved by the Secretary, to ensure separa22 tion of functions between auditors pro23 viding consultative services and auditors 

24 providing certification services under this 

25 subsection; 


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1 ‘‘(ix) no auditors acting for the quali2 fied certifying entity shall participate in an 

3 audit of a facility they were employed by 

4 within the last 12 months; 

5 ‘‘(x) fees charged or accepted shall 

6 not be contingent or based upon the report 

7 made by the qualified certifying entity or 

8 any personnel involved in the audit proc9 ess; 

10 ‘‘(xi) neither the qualified certifying 

11 entity nor any of its auditors shall accept 

12 anything of value from anyone in connec13 tion with the facility being audited other 

14 than the audit fee; 

15 ‘‘(xii) the qualified certifying entity 

16 shall not be owned, operated, or controlled 

17 by a trade association whose member com18 panies operate facilities that it certifies; 

19 ‘‘(xiii) the qualified certifying entity 

20 and its auditors shall be free from any 

21 other conflicts of interest that threaten im22 partiality; 

23 ‘‘(xiv) the qualified certifying entity 

24 and its auditors shall sign a statement at25 testing to compliance with the conflict of 


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1 interests requirements under this para2 graph; and 

3 ‘‘(xv) the qualified certifying entity 

4 shall ensure that any subcontractors that 

5 might be used (such as laboratories and 

6 sampling services) provide similar assur7 ances, except that it shall not be a viola8 tion of this subsection to the extent such 

9 subcontractors perform additional nutri10 tional testing services unrelated to the test11 ing under this subsection. 

12 ‘‘(C) DEFINITIONS.—In this paragraph: 

13 ‘‘(i) The term ‘anything of value’ in14 cludes gifts, gratuities, reimbursement of 

15 non-audit-related expenses, entertainment, 

16 loans, or any other form of compensation 

17 in cash or in kind. 

18 ‘‘(ii) The term ‘direct financial inter19 est’ does not include any ownership of mu20 tual funds that have a financial interest in 

21 a company. 

22 ‘‘(4) RENEWAL AND REFUSAL OF CERTIFI23 CATIONS.—The Secretary shall— 

24 ‘‘(A) require that, to the extent applicable, 

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1 fying entity be renewed by such entity at such 

2 times as the Secretary determines appropriate; 

3 and 

4 ‘‘(B) refuse to accept any certification if 

5 the Secretary determines that such certification 

6 is no longer valid or reliable. 

7 ‘‘(5) ON-SITE AUDITS.—In evaluating whether 

8 an accreditation body meets, or continues to meet, 

9 the standards for recognition under this subsection, 

10 or whether to accept certifications from a qualified 

11 certifying entity, the Secretary may— 

12 ‘‘(A) observe on-site audits of qualified cer13 tifying entities by such accreditation body; or 

14 ‘‘(B) for any facility that is certified by a 

15 qualified certifying entity, upon request of an 

16 officer or employee designated by the Secretary 

17 and upon presentation of appropriate creden18 tials, at reasonable times and within reasonable 

19 limits and in a reasonable manner, conduct an 

20 on-site audit of the facility, which shall include 

21 access to, and copying and verification of, any 

22 related records. 

23 ‘‘(6) ELECTRONIC SUBMISSION.—The Secretary 

24 shall provide, in coordination with the Commissioner 

25 responsible for Customs and Border Protection, for 


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1 the electronic submission of certifications under this 

2 subsection. 

3 ‘‘(7) NO LIMIT ON AUTHORITY.—This sub4 section shall not be construed to limit the authority 

5 of the Secretary to conduct random inspections of 

6 imported articles or facilities of importers, issue im7 port alerts for detention without physical examina8 tion, require submission to the Secretary of docu9 mentation or other information about an article im10 ported or offered for import, or to take such other 

11 steps as the Secretary deems appropriate to deter12 mine the admissibility of imported articles.’’. 

13 SEC. 110. TESTING BY ACCREDITED LABORATORIES. 

14 (a) PROHIBITED ACT.—Section 301 (21 U.S.C. 331) 

15 is amended by adding at the end the following: 

16 ‘‘(uu) The violation of any requirement of section 714 

17 (relating to testing by accredited laboratories).’’. 

18 (b) LABORATORY ACCREDITATION.—Subchapter A of 

19 chapter VII (21 U.S.C. 371 et seq.) is amended by adding 

20 at the end the following: 

21 ‘‘SEC. 714. TESTING BY ACCREDITED LABORATORIES. 

22 ‘‘(a) IN GENERAL.— 

23 ‘‘(1) REQUIREMENT.—Whenever analytical test24 ing of an article of food is conducted as part of testi25 mony for the purposes of section 801(a), or for such 


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1 other purposes as the Secretary deems appropriate 

2 through regulation or guidance, such testing shall be 

3 conducted by a laboratory that— 

4 ‘‘(A) is accredited, for the analytical meth5 od used, by a laboratory accreditation body that 

6 has been recognized by the Secretary; and 

7 ‘‘(B) samples such article with adequate 

8 controls for ensuring the integrity of the sam9 ples analyzed. 

10 ‘‘(2) INDEPENDENCE OF LABORATORY.— 

11 ‘‘(A) CERTAIN TESTS.—Tests required for 

12 purposes of section 801(a) or in response to a 

13 finding of noncompliance by the Secretary shall 

14 be conducted by a laboratory independent of the 

15 person on whose behalf such testing is con16 ducted and analyzed. 

17 ‘‘(B) CERTAIN PRODUCTS.—The Secretary 

18 may require that testing for certain products 

19 under paragraph (1) be conducted by a labora20 tory independent of the person on whose behalf 

21 such testing is conducted. 

22 ‘‘(b) RECOGNITION OF LABORATORY ACCREDITATION

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1 ies that accredit laboratories to perform analytical testing 

2 for the purposes of this section. The Secretary shall issue 

3 regulations or guidance to implement this program. 

4 ‘‘(c) ONSITE AUDITS.—In evaluating whether an ac5 creditation body meets, or continues to meet, the stand6 ards for recognition under subsection (b), the Secretary 

7 may— 

8 ‘‘(1) observe onsite audits of laboratories by 

9 such accreditation bodies; or 

10 ‘‘(2) for any laboratory that is accredited by 

11 such accreditation body under this section, upon re12 quest of an officer or employee designated by the 

13 Secretary and upon presentation of appropriate cre14 dentials, at reasonable times and within reasonable 

15 limits and in a reasonable manner, conduct an onsite 

16 audit of the laboratory, which shall include access to, 

17 and copying and verification of, any related records. 

18 ‘‘(d) PUBLICATION OF LIST OF RECOGNIZED AC19 CREDITATION BODIES.—The Secretary shall publish and 

20 maintain on the public Web site of the Food and Drug 

21 Administration a list of accreditation bodies recognized by 

22 the Secretary under subsection (b). 

23 ‘‘(e) NOTIFICATION OF ACCREDITATION OF LABORA24 TORY.—An accreditation body that has been recognized 

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1 retary whenever it accredits a laboratory for the purposes 

2 of this section and whenever it withdraws or suspends 

3 such accreditation. 

4 ‘‘(f) ADVANCE NOTICE.—Whenever analytical testing 

5 is conducted pursuant to subsection (a), the person on 

6 whose behalf the testing is conducted shall notify the Sec7 retary before any sample of the article is collected. Such 

8 notice shall contain information the Secretary determines 

9 is appropriate to identify the article, the location of the 

10 article, and each laboratory that will analyze the sample 

11 on the person’s behalf. 

12 ‘‘(g) CONTENTS OF LABORATORY PACKAGES.— 

13 Whenever analytical testing is conducted pursuant to sub14 section (a), the laboratory conducting such testing shall 

15 submit, directly to the Secretary— 

16 ‘‘(1) the results of all analyses conducted by the 

17 laboratory on each sample of such article; and 

18 ‘‘(2) all information the Secretary deems appro19 priate to— 

20 ‘‘(A) determine whether the laboratory is 

21 accredited by a recognized laboratory accredita22 tion body; 

23 ‘‘(B) identify the article tested; 

24 ‘‘(C) evaluate the analytical results; and 


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1 ‘‘(D) determine whether the requirements 

2 of this section have been met. 

3 ‘‘(h) EXIGENT CIRCUMSTANCES.—The Secretary 

4 may waive the requirement of subsection (a)(1)(A) (relat5 ing to analytical methods) on a laboratory or method basis 

6 due to exigent or other circumstances. 

7 ‘‘(i) FEDERAL LABORATORY TESTING.—If Customs 

8 and Border Protection laboratory testing concludes that 

9 an article of food is adulterated or misbranded, the Sec10 retary shall consider and utilize as appropriate the testing 

11 results issued by the Customs and Border Protection lab12 oratories in making a decision about the admissibility of 

13 the product. 

14 ‘‘(j) NO LIMIT ON AUTHORITY.—Nothing in this sec15 tion shall be construed to limit— 

16 ‘‘(1) the ability of the Secretary to review and 

17 act upon information from the analytical testing of 

18 food (including under this section), including deter19 mining the sufficiency of such information and test20 ing; or 

21 ‘‘(2) the authority of the Secretary to conduct, 

22 require, or consider the results of analytical testing 

23 pursuant to any other provision of law.’’. 


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1 SEC. 111. NOTIFICATION, NONDISTRIBUTION, AND RECALL 

2 OF ADULTERATED OR MISBRANDED FOOD. 

3 (a) PROHIBITED ACTS.—Section 301 (21 U.S.C. 

4 331), as amended by section 110, is amended by adding 

5 at the end the following: 

6 ‘‘(vv)(1) The failure to notify the Secretary in viola7 tion of section 420(a). 

8 ‘‘(2) The failure to comply with any order issued 

9 under section 420.’’. 

10 (b) NOTIFICATION, NONDISTRIBUTION, AND RECALL

11 OF ADULTERATED OR MISBRANDED FOOD.—Chapter IV 

12 (21 U.S.C. 341 et seq.), as amended by sections 102, 103, 

13 and 104, is amended by adding at the end the following: 

14 ‘‘SEC. 420. NOTIFICATION, NONDISTRIBUTION, AND RECALL 

15 OF ADULTERATED OR MISBRANDED FOOD. 

16 ‘‘(a) NOTIFICATION, NONDISTRIBUTION, AND RE17 CALL OF ADULTERATED OR MISBRANDED FOOD.— 

18 ‘‘(1) IN GENERAL.—A responsible party as that 

19 term is defined in section 417(a)(1) or a person re20 quired to register under section 801(s) that has rea21 son to believe that an article of food when intro22 duced into or while in interstate commerce, or while 

23 held for sale (regardless of whether the first sale) 

24 after shipment in interstate commerce, is adulter25 ated or misbranded in a manner that presents a rea26 sonable probability that the use or consumption of, 


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1 or exposure to, the article (or an ingredient or com2 ponent used in any such article) will cause a threat 

3 of serious adverse health consequences or death to 

4 humans or animals shall, as soon as practicable, no5 tify the Secretary of the identity and location of the 

6 article. 

7 ‘‘(2) MANNER OF NOTIFICATION.—Notification 

8 under paragraph (1) shall be made in such manner 

9 and by such means as the Secretary may require by 

10 regulation or guidance. 

11 ‘‘(b) VOLUNTARY RECALL.—The Secretary may re12 quest that any person who distributes an article of food 

13 that the Secretary has reason to believe is adulterated, 

14 misbranded, or otherwise in violation of this Act volun15 tarily— 

16 ‘‘(1) recall such article; and 

17 ‘‘(2) provide for notice, including to individuals 

18 as appropriate, to persons who may be affected by 

19 the recall. 

20 ‘‘(c) ORDER TO CEASE DISTRIBUTION.—If the Sec21 retary has reason to believe that the use or consumption 

22 of, or exposure to, an article of food may cause serious 

23 adverse health consequences or death to humans or ani24 mals, the Secretary shall have the authority to issue an 


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1 order requiring any person who distributes such article to 

2 immediately cease distribution of such article. 

3 ‘‘(d) ACTION FOLLOWING ORDER.—Any person who 

4 is subject to an order under subsection (c) shall imme5 diately cease distribution of such article and provide notifi6 cation as required by such order, and may appeal within 

7 24 hours of issuance such order to the Secretary. Such 

8 appeal may include a request for an informal hearing and 

9 a description of any efforts to recall such article under10 taken voluntarily by the person, including after a request 

11 under subsection (b). Except as provided in subsection (f), 

12 an informal hearing shall be held as soon as practicable, 

13 but not later than 5 calendar days, or less as determined 

14 by the Secretary, after such an appeal is filed, unless the 

15 parties jointly agree to an extension. After affording an 

16 opportunity for an informal hearing, the Secretary shall 

17 determine whether the order should be amended to require 

18 a recall of such article. If, after providing an opportunity 

19 for such a hearing, the Secretary determines that inad20 equate grounds exist to support the actions required by 

21 the order, the Secretary shall vacate the order. 

22 ‘‘(e) ORDER TO RECALL.— 

23 ‘‘(1) AMENDMENT.—Except as provided under 

24 subsection (f), if after providing an opportunity for 

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1 retary determines that the order should be amended 

2 to include a recall of the article with respect to 

3 which the order was issued, the Secretary shall 

4 amend the order to require a recall. 

5 ‘‘(2) CONTENTS.—An amended order under 

6 paragraph (1) shall— 

7 ‘‘(A) specify a timetable in which the recall 

8 will occur; 

9 ‘‘(B) require periodic reports to the Sec10 retary describing the progress of the recall; and 

11 ‘‘(C) provide for notice, including to indi12 viduals as appropriate, to persons who may be 

13 affected by the recall. 

14 In providing for such notice, the Secretary may 

15 allow for the assistance of health professionals, State 

16 or local officials, or other individuals designated by 

17 the Secretary. 

18 ‘‘(3) NONDELEGATION.—An amended order 

19 under this subsection shall be ordered by the Sec20 retary or an official designated by the Secretary. An 

21 official may not be so designated unless the official 

22 is the director of the district under this Act in which 

23 the article involved is located, or is an official senior 

24 to such director. 

25 ‘‘(f) EMERGENCY RECALL ORDER.— 


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1 ‘‘(1) IN GENERAL.—If the Secretary has cred2 ible evidence or information that an article of food 

3 subject to an order under subsection (c) presents an 

4 imminent threat of serious adverse health con5 sequences or death to humans or animals, the Sec6 retary may issue an order requiring any person who 

7 distributes such article— 

8 ‘‘(A) to immediately recall such article; and 

9 ‘‘(B) to provide for notice, including to in10 dividuals as appropriate, to persons who may be 

11 affected by the recall. 

12 ‘‘(2) ACTION FOLLOWING ORDER.—Any person 

13 who is subject to an emergency recall order under 

14 this subsection shall immediately recall such article 

15 and provide notification as required by such order, 

16 and may appeal within 24 hours after issuance such 

17 order to the Secretary. An informal hearing shall be 

18 held within as soon as practicable but not later than 

19 5 calendar days, or less as determined by the Sec20 retary, after such an appeal is filed, unless the par21 ties jointly agree to an extension. After affording an 

22 opportunity for an informal hearing, the Secretary 

23 shall determine whether the order should be amend24 ed pursuant to subsection (e)(1). If, after providing 

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1 termines that inadequate grounds exist to support 

2 the actions required by the order, the Secretary shall 

3 vacate the order. 

4 ‘‘(3) NONDELEGATION.—An order under this 

5 subsection shall be issued by the Commissioner of 

6 Food and Drugs, the Principal Deputy Commis7 sioner, or the Associate Commissioner for Regu8 latory Affairs of the Food and Drug Administration. 

9 ‘‘(g) NOTICE TO CONSUMERS AND HEALTH OFFI10 CIALS.—The Secretary shall, as the Secretary determines 

11 to be necessary, provide notice of a recall order under this 

12 section to consumers to whom the article was, or may have 

13 been, distributed and to appropriate State and local health 

14 officials. 

15 ‘‘(h) SAVINGS CLAUSE.—Nothing contained in this 

16 section shall be construed as limiting— 

17 ‘‘(1) the authority of the Secretary to issue an 

18 order to cease distribution of, or to recall, an article 

19 under any other provision of this Act or the Public 

20 Health Service Act; or 

21 ‘‘(2) the ability of the Secretary to request any 

22 person to perform a voluntary activity related to any 

23 article subject to this Act or the Public Health Serv24 ice Act.’’. 


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1 (c) ARTICLES SUBJECT TO REFUSAL.—The third 

2 sentence of subsection (a) of section 801 (21 U.S.C. 381), 

3 as amended by section 107(b), is amended by inserting 

4 ‘‘or (5) such article is subject to an order under section 

5 420 to cease distribution of or recall the article,’’ before 

6 ‘‘then such article shall be refused admission’’. 

7 (d) EFFECTIVE DATE.—Sections 301(vv)(1) and 420 

8 of the Federal Food, Drug, and Cosmetic Act, as added 

9 by subsections (a) and (b), shall apply with respect to arti10 cles of food as of such date, not later than 1 year after 

11 the date of the enactment of this Act, as the Secretary 

12 of Health and Human Services shall specify. 

13 SEC. 112. REPORTABLE FOOD REGISTRY; EXCHANGE OF IN14 FORMATION. 

15 (a) REPORTABLE FOOD REGISTRY.—Section 417 (21 

16 U.S.C. 350f) is amended— 

17 (1) in subsection (a)(1), by striking ‘‘means a 

18 person’’ and all that follows through the end of 

19 paragraph (1) and inserting the following: ‘‘means— 

20 ‘‘(A) a person who submits the registration 

21 under section 415(a) for a food facility that is 

22 required to be registered under section 415(a), 

23 at which such food is manufactured, processed, 

24 packed, or held; 


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1 ‘‘(B) a person who owns, operates, is an 

2 agent of, or is otherwise responsible for such 

3 food on a farm (as such term is defined in sec4 tion 1.227(b)(3) of title 21, Code of Federal 

5 Regulations, or successor regulations) at which 

6 such food is produced for sale or distribution in 

7 interstate commerce; 

8 ‘‘(C) a person who owns, operates, or is an 

9 agent of a restaurant or other retail food estab10 lishment (as such terms are defined in section 

11 1.227(b)(11) and (12), respectively, of title 21, 

12 Code of Federal Regulations, or successor regu13 lations) at which such food is offered for sale; 

14 or 

15 ‘‘(D) a person that is required to register 

16 pursuant to section 801(s) with respect to im17 portation of such food.’’; 

18 (2) in subsection (b), by adding at the end the 

19 following: 

20 ‘‘(3) REPORTING BY FARMS, RESTAURANTS, 

21 AND RETAIL FOOD ESTABLISHMENTS.—In addition 

22 to the electronic portal described in paragraph (1), 

23 the Secretary shall make available alternative means 

24 of reporting under this section with respect to farms, 


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1 restaurants, and other retail food establishments 

2 with limited ability for such reporting.’’; 

3 (3) in subsection (d)(1)— 

4 (A) in the matter preceding subparagraph 

5 (A), by inserting ‘‘following a timely review of 

6 any reasonably available data and information,’’ 

7 after ‘‘reportable food,’’; 

8 (B) in subparagraph (A), by striking 

9 ‘‘and’’ at the end; 

10 (C) by redesignating subparagraph (B) as 

11 subparagraph (C); and 

12 (D) by inserting after subparagraph (A) 

13 the following: 

14 ‘‘(B) submit, with such report, through the 

15 electronic portal, documentation of results from 

16 any sampling and testing of such article, includ17 ing— 

18 ‘‘(i) analytical results from testing of 

19 such article conducted by or on behalf of 

20 the responsible party under section 418, 

21 418A, 419, 419A, or 714; 

22 ‘‘(ii) analytical results from testing 

23 conducted by or on behalf of such respon24 sible party of a component of such article; 


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1 ‘‘(iii) analytical results of environ2 mental testing of any facility at which such 

3 article, or a component of such article, is 

4 manufactured, processed, packed, or held; 

5 and 

6 ‘‘(iv) any other information the Sec7 retary determines is necessary to evaluate 

8 the adulteration of such article, any com9 ponent of such article, any other article of 

10 food manufactured, processed, packed or 

11 held in the same manner as, or at the 

12 same facility as, such article, or any other 

13 article containing a component from the 

14 same source as a component of such arti15 cle; and’’; and 

16 (4) in subsection (e)— 

17 (A) in paragraph (1), by inserting ‘‘if the 

18 responsible party is required to register’’ after 

19 ‘‘415(a)(3)’’; and 

20 (B) by adding at the end the following: 

21 ‘‘(12) Such additional information as the Sec22 retary deems appropriate.’’. 

23 (b) EXCHANGE OF INFORMATION.—Section 708 (21 

24 U.S.C. 379) is amended— 


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1 (1) by striking ‘‘The Secretary’’ and inserting 

2 ‘‘(a) The Secretary’’; and 

3 (2) by adding at the end the following: 

4 ‘‘(b)(1)(A) The Secretary may provide to any Federal 

5 agency acting within the scope of its jurisdiction any infor6 mation relating to food that is exempt from disclosure pur7 suant to subsection (a) of section 552 of title 5, United 

8 States Code, by reason of subsection (b)(4) of such sec9 tion, or that is referred to in section 301(j) or 415(a)(4). 

10 ‘‘(B) Any such information provided to another Fed11 eral agency shall not be disclosed by such agency except 

12 in any action or proceeding under the laws of the United 

13 States to which the receiving agency or the United States 

14 is a party. 

15 ‘‘(2)(A) In carrying out this Act, the Secretary may 

16 provide to a State or local government agency any infor17 mation relating to food that is exempt from disclosure pur18 suant to section 552(a) of title 5, United States Code, by 

19 reason of subsection (b)(4) of such section, or that is re20 ferred to in section 301(j) or 415(a)(4). 

21 ‘‘(B) Any such information provided to a State or 

22 local government agency shall not be disclosed by such 

23 agency. 

24 ‘‘(3) In carrying out this Act, the Secretary may pro25 vide to any person any information relating to food that 


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1 is exempt from disclosure pursuant to section 552(a) of 

2 title 5, United States Code, by reason of subsection (b)(4) 

3 of such section, if the Secretary determines that providing 

4 the information to the person is appropriate under the cir5 cumstances and the recipient provides adequate assur6 ances to the Secretary that the recipient will preserve the 

7 confidentiality of the information. 

8 ‘‘(4) In carrying out this Act, the Secretary may pro9 vide any information relating to food that is exempt from 

10 disclosure pursuant to section 552(a) of title 5, United 

11 States Code, by reason of subsection (b)(4) of such sec12 tion, or that is referred to in section 301(j)— 

13 ‘‘(A) to any foreign government agency; or 

14 ‘‘(B) any international organization established 

15 by law, treaty, or other governmental action and 

16 having responsibility— 

17 ‘‘(i) to facilitate global or regional harmo18 nization of standards and requirements in an 

19 area of responsibility of the Food and Drug Ad20 ministration; or 

21 ‘‘(ii) to promote and coordinate public 

22 health efforts, 

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1 zation will preserve the confidentiality of the infor2 mation. 

3 ‘‘(c) Except where specifically prohibited by statute, 

4 the Secretary may disclose to the public any information 

5 relating to food that is exempt from disclosure pursuant 

6 to section 552(a) of title 5, United States Code, by reason 

7 of subsection (b)(4) of such section, if the Secretary deter8 mines that such disclosure is necessary to protect the pub9 lic health. 

10 ‘‘(d) Except as provided in subsection (e), the Sec11 retary shall not be required to disclose under section 552 

12 of title 5, United States Code, or any other provision of 

13 law any information relating to food obtained from a Fed14 eral, State, or local government agency, or from a foreign 

15 government agency, or from an international organization 

16 described in subsection (b)(4), if the agency or organiza17 tion has requested that the information be kept confiden18 tial, or has precluded such disclosure under other use limi19 tations, as a condition of providing the information. 

20 ‘‘(e) Nothing in subsection (d) authorizes the Sec21 retary to withhold information from the Congress or pre22 vents the Secretary from complying with an order of a 

23 court of the United States. 


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1 ‘‘(f) This section shall not affect the authority of the 

2 Secretary to provide or disclose information under any 

3 other provision of law.’’. 

4 (c) CONFORMING AMENDMENT.—Section 301(j) (21 

5 U.S.C. 331(j)) is amended by striking ‘‘or to the courts 

6 when relevant in any judicial proceeding under this Act,’’ 

7 and inserting ‘‘to the courts when relevant in any judicial 

8 proceeding under this Act, or as specified in section 708,’’. 

9 SEC. 113. SAFE AND SECURE FOOD IMPORTATION PRO10 GRAM. 

11 Chapter VIII (21 U.S.C. 381 et seq.) is amended by 

12 adding at the end the following: 

13 ‘‘SEC. 805. SAFE AND SECURE FOOD IMPORTATION PRO14 GRAM. 

15 ‘‘(a) IN GENERAL.—The Secretary may establish by 

16 regulation or guidance in coordination with the Commis17 sioner responsible for Customs and Border Protection a 

18 program that facilitates the movement of food through the 

19 importation process under this Act if the importer of such 

20 food— 

21 ‘‘(1) verifies that each facility involved in the 

22 production, manufacture, processing, packaging, and 

23 holding of the food is in compliance with the food 

24 safety and security guidelines developed under sub25 section (b) with respect to such food; 


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1 ‘‘(2) ensures that appropriate safety and secu2 rity controls are in place throughout the supply 

3 chain for such food; and 

4 ‘‘(3) provides supporting information to the 

5 Secretary. 

6 ‘‘(b) GUIDELINES.— 

7 ‘‘(1) DEVELOPMENT.—For purposes of the pro8 gram established under subsection (a), the Secretary 

9 shall develop in consultation with the Commissioner 

10 responsible for Customs and Border Protection safe11 ty and security guidelines applicable to the importa12 tion of food taking into account, to the extent appro13 priate, other relevant Federal programs, such as the 

14 Customs-Trade Partnership Against Terrorism (C15 TPAT) programs under section 211 of the Security 

16 and Accountability for Every Port Act of 2006. 

17 ‘‘(2) FACTORS.—Such guidelines shall take into 

18 account the following factors: 

19 ‘‘(A) The personnel of the person import20 ing the food. 

21 ‘‘(B) The physical and procedural safety 

22 and security of such person’s food supply chain. 

23 ‘‘(C) The sufficiency of preventive controls 

24 for food and ingredients purchased by such per25 son. 


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1 ‘‘(D) Vendor and supplier information. 

2 ‘‘(E) Other programs for certification or 

3 verification by a qualified certifying entity used 

4 by the importer. 

5 ‘‘(F) Such other factors as the Secretary 

6 determines necessary.’’. 

7 SEC. 114. INFANT FORMULA. 

8 (a) MISBRANDING.—Section 403 (21 U.S.C. 343), as 

9 amended by sections 101(a) and 109(a), is amended by 

10 adding at the end the following: 

11 ‘‘(bb) If it is a new infant formula and— 

12 ‘‘(1) it is not the subject of a registration made 

13 pursuant to section 412(c)(1)(A); 

14 ‘‘(2) it is not the subject of a submission made 

15 pursuant to section 412(c)(1)(B), or 

16 ‘‘(3) at least 90 days have not passed since the 

17 making of such registration or of such submission to 

18 the Secretary.’’. 

19 (b) REQUIREMENTS.—Section 412 (21 U.S.C. 350a) 

20 is amended— 

21 (1) in subsection (c)(1)(B), by striking ‘‘(c)(1)’’ 

22 at the end and inserting ‘‘(d)(1), subject to sub23 section (d)(2)(B)’’; 

24 (2) in subsection (d)(1)— 


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1 (A) by striking ‘‘and’’ at the end of sub2 paragraph (C); 

3 (B) by striking the period at the end of 

4 subparagraph (D) and inserting ‘‘, and’’; and 

5 (C) by adding at the end the following: 

6 ‘‘(E) information on any new ingredient in 

7 accordance with paragraph (2)(A).’’; 

8 (3) in subsection (d), by redesignating para9 graphs (2) and (3) as paragraphs (3) and (4), re10 spectively; and 

11 (4) by inserting after paragraph (1) of sub12 section (d) the following: 

13 ‘‘(2)(A) The description of any new infant formula 

14 required under paragraph (1) shall include, for any new 

15 ingredient for use in the formula— 

16 ‘‘(i) a citation to a prior approval by the Sec17 retary of the new ingredient for use in infant for18 mula under section 409; 

19 ‘‘(ii) a citation to or information showing a 

20 prior consideration of the new ingredient for use in 

21 infant formula under any program established by the 

22 Secretary for the review of ingredients used in food; 

23 or 

24 ‘‘(iii) for a new ingredient that is not a food ad25 ditive or a color additive, information equivalent to 


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1 that provided under any program established by the 

2 Secretary for the review of ingredients used in food. 

3 ‘‘(B) If the information submitted under subpara4 graph (A) is the information described in clause (iii) of 

5 such subparagraph, the 90 day period provided by sub6 section (c)(1)(B) shall not commence until the Secretary 

7 has completed review of the information submitted under 

8 such clause and has provided the submitter notice of the 

9 results of such review.’’. 

10 Subtitle B—Intervention 

11 SEC. 121. SURVEILLANCE. 

12 (a) DEFINITION OF FOOD-BORNE ILLNESS OUT13 BREAK.—In this section, the term ‘‘food-borne illness out14 break’’ means the occurrence of 2 or more cases of a simi15 lar illness resulting from the ingestion of a food. 

16 (b) FOOD-BORNE ILLNESS SURVEILLANCE SYS17 TEMS.—The Secretary of Health and Human Services (in 

18 this subtitle referred to as the ‘‘Secretary’’), acting 

19 through the Director of the Centers for Disease Control 

20 and Prevention, shall enhance food-borne illness surveil21 lance systems to improve the collection, analysis, report22 ing, and usefulness of data on food-borne illnesses by— 

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1 tional networks of public health and food regulatory 

2 agencies and laboratories; 

3 (2) facilitating sharing of findings on a more 

4 timely basis among governmental agencies, including 

5 the Food and Drug Administration, the Department 

6 of Agriculture, and State and local agencies, and 

7 with the public; 

8 (3) developing improved epidemiological tools 

9 for obtaining quality exposure data, and micro10 biological methods for classifying cases; 

11 (4) augmenting such systems to improve attri12 bution of a food-borne illness outbreak to a specific 

13 food; 

14 (5) expanding capacity of such systems, includ15 ing fingerprinting and other detection strategies for 

16 food-borne infectious agents, in order to identify new 

17 or rarely documented causes of food-borne illness; 

18 (6) allowing timely public access to aggregated, 

19 de-identified surveillance data; 

20 (7) at least annually, publishing current reports 

21 on findings from such systems; 

22 (8) establishing a flexible mechanism for rapidly 

23 initiating scientific research by academic institu24 tions; 


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1 (9) integrating food-borne illness surveillance 

2 systems and data with other biosurveillance and 

3 public health situational awareness capabilities at 

4 the Federal, State, and local levels; and 

5 (10) other activities as determined appropriate 

6 by the Secretary. 

7 (c) IMPROVING FOOD SAFETY AND DEFENSE CAPAC8 ITY AT THE STATE AND LOCAL LEVEL.— 

9 (1) IN GENERAL.—The Secretary shall develop 

10 and implement strategies to leverage and enhance 

11 the food safety and defense capacities of State and 

12 local agencies in order to achieve the following goals: 

13 (A) Improve food-borne illness outbreak re14 sponse and containment. 

15 (B) Accelerate food-borne illness surveil16 lance and outbreak investigation, including 

17 rapid shipment of clinical isolates from clinical 

18 laboratories to appropriate State laboratories, 

19 and conducting more standardized illness out20 break interviews. 

21 (C) Strengthen the capacity of State and 

22 local agencies to carry out inspections and en23 force safety standards. 

24 (D) Improve the effectiveness of Federal, 

25 State, and local partnerships to coordinate food 


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1 safety and defense resources and reduce the in2 cidence of food-borne illness. 

3 (E) Share information on a timely basis 

4 among public health and food regulatory agen5 cies, with the food industry, with health care 

6 providers, and with the public. 

7 (2) REVIEW.—In developing the strategies re8 quired by paragraph (1), the Secretary shall, not 

9 later than 1 year after the date of enactment of this 

10 Act, complete a review of State and local capacities, 

11 and needs for enhancement, which may include a 

12 survey with respect to— 

13 (A) staffing levels and expertise available 

14 to perform food safety and defense functions; 

15 (B) laboratory capacity to support surveil16 lance, outbreak response, inspection, and en17 forcement activities; 

18 (C) information systems to support data 

19 management and sharing of food safety and de20 fense information among State and local agen21 cies and with counterparts at the Federal level; 

22 and 

23 (D) other State and local activities and 

24 needs as determined appropriate by the Sec25 retary. 


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1 SEC. 122. PUBLIC EDUCATION AND ADVISORY SYSTEM. 

2 (a) PUBLIC EDUCATION.—The Secretary, in coopera3 tion with private and public organizations, including the 

4 appropriate State entities, shall design and implement a 

5 national public education program on food safety. The 

6 program shall provide— 

7 (1) information to the public so that individuals 

8 can understand the potential impact and risk of 

9 food-borne illness, take action to reduce their risk of 

10 food-borne illness and injury, and make healthy die11 tary choices; 

12 (2) information to health professionals so that 

13 they may improve diagnosis and treatment of food14 related illness and advise individuals whose health 

15 conditions place them in particular risk; and 

16 (3) such other information or advice to con17 sumers and other persons as the Secretary deter18 mines will promote the purposes of this Act. 

19 (b) HEALTH ADVISORIES.—The Secretary shall work 

20 with the States and other appropriate entities to— 

21 (1) develop and distribute regional and national 

22 advisories concerning food safety; 

23 (2) develop standardized formats for written 

24 and broadcast advisories; and 


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1 (3) incorporate State and local advisories into 

2 the national public education program required 

3 under subsection (a). 

4 SEC. 123. RESEARCH. 

5 The Secretary shall conduct research to assist in the 

6 implementation of this Act, including studies to— 

7 (1) improve sanitation and food safety practices 

8 in the production, harvesting, and processing of food 

9 products; 

10 (2) develop improved techniques for the moni11 toring of food and inspection of food products; 

12 (3) develop efficient, rapid, and sensitive meth13 ods for determining and detecting the presence of 

14 contaminants in food products; 

15 (4) determine the sources of contamination of 

16 food and food products, including critical points of 

17 risk for fresh produce and other raw agricultural 

18 commodities; 

19 (5) develop consumption data with respect to 

20 food products; 

21 (6) draw upon research and educational pro22 grams that exist at the State and local level; 

23 (7) utilize the DNA matching system and other 

24 processes to identify and control pathogens; 


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1 (8) address common and emerging zoonotic dis2 eases; 

3 (9) develop methods to reduce or destroy patho4 gens before, during, and after processing; 

5 (10) analyze the incidence of antibiotic resist6 ance as it pertains to the food supply and evaluate 

7 methods to reduce the transfer of antibiotic resist8 ance to humans; and 

9 (11) conduct other research that supports the 

10 purposes of this Act. 

11 Subtitle C—Response 

12 SEC. 131. PROCEDURES FOR SEIZURE. 

13 Section 304(b) (21 U.S.C. 334(b)) is amended by in14 serting ‘‘and except that, with respect to proceedings relat15 ing to food, Rule G of the Supplemental Rules of Admi16 ralty or Maritime Claims and Asset Forfeiture Actions 

17 shall not apply in any such case, exigent circumstances 

18 shall be deemed to exist for all seizures brought under this 

19 section, and the summons and arrest warrant shall be 

20 issued by the clerk of the court without court review in 

21 any such case’’ after ‘‘in any such case shall be tried by 

22 jury’’. 

23 SEC. 132. ADMINISTRATIVE DETENTION. 

24 (a) AMENDMENTS.—Section 304(h) (21 U.S.C. 

25 334(h)) is amended— 


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1 (1) in paragraph (1)(A), by striking ‘‘credible 

2 evidence or information indicating’’ and inserting 

3 ‘‘reason to believe’’; 

4 (2) in paragraph (1)(A), by striking ‘‘presents 

5 a threat of serious adverse health consequences or 

6 death to humans or animals’’ and inserting ‘‘is adul7 terated, misbranded, or otherwise in violation of this 

8 Act’’; 

9 (3) in paragraph (2), by striking ‘‘30’’ and in10 serting ‘‘60’’; 

11 (4) in paragraph (3), by striking the third sen12 tence; and 

13 (5) in paragraph (4)(A) by striking the terms 

14 ‘‘five’’ and ‘‘five-day’’ and inserting ‘‘fifteen’’ and 

15 ‘‘fifteen-day’’, respectively. 

16 (b) REGULATIONS.—The Secretary shall issue regula17 tions or guidance to implement the amendments made by 

18 this section. 

19 (c) EFFECTIVE DATE.—The amendments made by 

20 this section shall take effect 180 days after the date of 

21 the enactment of this Act. 


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1 SEC. 133. AUTHORITY TO PROHIBIT OR RESTRICT THE 

2 MOVEMENT OF FOOD. 

3 (a) PROHIBITED ACT.—Section 301 (21 U.S.C. 331), 

4 as amended by sections 110 and 111, is amended by add5 ing at the end by adding the following: 

6 ‘‘(ww) The violation of a prohibition or restriction 

7 under section 304(i).’’. 

8 (b) IN GENERAL.—Section 304 (21 U.S.C. 334) is 

9 amended by adding at the end the following: 

10 ‘‘(i) AUTHORITY TO PROHIBIT OR RESTRICT THE

11 MOVEMENT OF FOOD WITHIN A STATE OR PORTION OF

12 A STATE.— 

13 ‘‘(1) AUTHORITY TO PROHIBIT OR RESTRICT

14 THE MOVEMENT OF FOOD.— 

15 ‘‘(A) IN GENERAL.— 

16 ‘‘(i) After consultation with the Gov17 ernor or other appropriate official of an af18 fected State, if the Secretary determines 

19 that there is credible evidence that an arti20 cle of food presents an imminent threat of 

21 serious adverse health consequences or 

22 death to humans or animals, the Secretary 

23 may prohibit or restrict the movement of 

24 an article of food within a State or portion 

25 of a State for which the Secretary has 

26 credible evidence that such food is located 


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1 within, or originated from, such State or 

2 portion thereof. 

3 ‘‘(ii) In carrying out clause (i), the 

4 Secretary may prohibit or restrict the 

5 movement within a State or portion of a 

6 State of any article of food or means of 

7 conveyance of such article of food, if the 

8 Secretary determines that the prohibition 

9 or restriction is a necessary protection 

10 from an imminent threat of serious adverse 

11 health consequences or death to humans or 

12 animals. 

13 ‘‘(2) NOTIFICATION PROCEDURES.—Subject to 

14 paragraph (3), before any action is taken in a State 

15 under this subsection, the Secretary shall— 

16 ‘‘(A) notify the Governor or other appro17 priate official of the State affected by the pro18 posed action; 

19 ‘‘(B) issue a public announcement of the 

20 proposed action; and 

21 ‘‘(C) publish in the Federal Register— 

22 ‘‘(i) the findings of the Secretary that 

23 support the proposed action; 

24 ‘‘(ii) a statement of the reasons for 

25 the proposed action; and 


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1 ‘‘(iii) a description of the proposed ac2 tion, including— 

3 ‘‘(I) the area affected; and 

4 ‘‘(II) an estimate of the antici5 pated duration of the action. 

6 ‘‘(3) NOTICE AFTER ACTION.—If it is not prac7 ticable to publish in the Federal Register the infor8 mation required under paragraph (2)(C) before tak9 ing action under paragraph (1), the Secretary shall 

10 publish the information as soon as practicable, but 

11 not later than 10 business days, after commence12 ment of the action. 

13 ‘‘(4) APPLICATION OF LEAST DRASTIC AC14 TION.—No action shall be taken under paragraph 

15 (1) unless, in the opinion of the Secretary, there is 

16 no less drastic action that is feasible and that would 

17 be adequate to prevent the imminent threat of seri18 ous adverse health consequences or death to humans 

19 or animals. 

20 ‘‘(5) NONDELEGATION.—An action under para21 graph (1) may only be ordered by the Secretary or 

22 an official designated by the Secretary. An official 

23 may not be so designated unless the official is the 

24 Commissioner of Food and Drugs or the Principal 

25 Deputy Commissioner. 


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1 ‘‘(6) DURATION.—Fourteen days after the initi2 ation of an action under paragraph (1), and each 14 

3 days thereafter, if the Secretary determines that it 

4 is necessary to continue the action, the Secretary 

5 shall— 

6 ‘‘(A) notify the Governor or other appro7 priate official of the State affected of the con8 tinuation of the action; 

9 ‘‘(B) issue a public announcement of the 

10 continuation of the action; and 

11 ‘‘(C) publish in the Federal Register the 

12 findings of the Secretary that support the con13 tinuation of the action, including an estimate of 

14 the anticipated duration of the action. 

15 ‘‘(7) RULEMAKING.—The Secretary shall, con16 sistent with national security interests and as appro17 priate for known hazards, establish by regulation 

18 standards for conducting actions under paragraph 

19 (1), including, as appropriate, sanitation standards 

20 and procedures to restore any affected equipment or 

21 means of conveyance to its status prior to an action 

22 under paragraph (1).’’. 

23 SEC. 134. CRIMINAL PENALTIES. 

24 Section 303(a) (21 U.S.C. 333) is amended— 


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1 (1) in paragraph (1), by striking ‘‘Any’’ and in2 serting ‘‘Except as provided in paragraph (2) or (3), 

3 any’’; and 

4 (2) by adding at the end the following: 

5 ‘‘(3) Notwithstanding paragraph (1), any person who 

6 knowingly violates paragraph (a), (b), (c), (k), or (v) of 

7 section 301 with respect to any food that is misbranded 

8 or adulterated shall be imprisoned for not more than 10 

9 years or fined in accordance with title 18, United States 

10 Code, or both.’’. 

11 SEC. 135. CIVIL PENALTIES FOR VIOLATIONS RELATING TO 

12 FOOD. 

13 (a) IN GENERAL.—Paragraph (2) of section 303(f) 

14 (21 U.S.C. 331 et seq.) is amended to read as follows: 

15 ‘‘(2)(A) Any person who violates a provision of 

16 section 301 relating to food shall be subject to a civil 

17 penalty for each such violation of not more than— 

18 ‘‘(i) $20,000 in the case of an individual, 

19 not to exceed $50,000 in a single proceeding; 

20 and 

21 ‘‘(ii) $250,000 in the case of any other 

22 person, not to exceed $1,000,000 in a single 

23 proceeding. 

24 ‘‘(B) Any person who knowingly violates a pro25 vision of section 301 relating to food shall be subject 


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1 to a civil penalty for each such violation of not more 

2 than— 

3 ‘‘(i) $50,000 in the case of an individual, 

4 not to exceed $100,000 in a single proceeding; 

5 and 

6 ‘‘(ii) $500,000 in the case of any other 

7 person, not to exceed $7,500,000 in a single 

8 proceeding. 

9 ‘‘(C) Each violation described in subparagraph 

10 (A) or (B) and each day during which the violation 

11 continues shall be considered to be a separate of12 fense.’’. 

13 (b) EFFECTIVE DATE.—The amendment made by 

14 subsection (a) applies to violations committed on or after 

15 the date of the enactment of this Act. 

16 SEC. 136. IMPROPER IMPORT ENTRY FILINGS. 

17 (a) PROHIBITED ACTS.—Section 301 (21 U.S.C. 

18 331), as amended by sections 110, 111, and 133, is 

19 amended by adding at the end the following: 

20 ‘‘(xx) The submission of information relating to food 

21 that is required by or under section 801 that is inaccurate 

22 or incomplete. 

23 ‘‘(yy) The failure to submit information relating to 

24 food that is required by or under section 801.’’. 


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1 (b) DOCUMENTATION FOR IMPORTS.—Section 801 

2 (21 U.S.C. 381), as amended by section 109, is amended 

3 by adding at the end the following: 

4 ‘‘(r) DOCUMENTATION.— 

5 ‘‘(1) SUBMISSION.—The Secretary may require 

6 by regulation or guidance the submission of docu7 mentation or other information for articles of food 

8 that are imported or offered for import into the 

9 United States. When developing any regulation or 

10 guidance in accordance with this paragraph, to the 

11 extent that the collection of documentation or other 

12 information involves Customs and Border Protection 

13 efforts or resources, the Secretary shall consult with 

14 Customs and Border Protection. 

15 ‘‘(2) FORMAT.—A regulation or guidance under 

16 paragraph (1) may specify the format for submission 

17 of the documentation or other information.’’. 

18 TITLE II—MISCELLANEOUS 

19 SEC. 201. FOOD SUBSTANCES GENERALLY RECOGNIZED AS 

20 SAFE. 

21 Section 409 (21 U.S.C. 348) is amended by adding 

22 at the end the following: 

23 ‘‘Substances Generally Recognized as Safe 

24 ‘‘(k)(1) Not later than 60 days after the date of re25 ceipt by the Secretary, after the date of the enactment 


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1 of this subsection, of a determination that a substance is 

2 a GRAS food substance, the Secretary shall post notice 

3 of such determination and the supporting scientific jus4 tifications on the Food and Drug Administration’s public 

5 Web site. 

6 ‘‘(2) Not later than 60 days after the date of receipt 

7 of a request under paragraph (1), the Secretary shall ac8 knowledge receipt of such request by informing the re9 quester in writing of the date on which the request was 

10 received. 

11 ‘‘(3) In this subsection, the term ‘GRAS food sub12 stance’ means a substance excluded from the definition of 

13 the term ‘food additive’ in section 201(s) because such 

14 substance is generally recognized, among experts qualified 

15 by scientific training and experience to evaluate its safety, 

16 as having been adequately shown through scientific proce17 dures (or, in the case of a substance used in food prior 

18 to January 1, 1958, through either scientific procedures 

19 or experience based on common use in food) to be safe 

20 under the conditions of its intended use.’’. 

21 SEC. 202. COUNTRY OF ORIGIN LABELING. 

22 (a) MISBRANDING.—Section 403 (21 U.S.C. 343), as 

23 amended by sections 101(a), 109(a), and 114(a), is 

24 amended by adding at the end the following: 


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1 ‘‘(cc) In the case of a processed food, if the labeling 

2 of the food fails to identify the country in which the final 

3 processing of the food occurs. 

4 ‘‘(dd) In the case of nonprocessed food, if the labeling 

5 of the food fails to identify the country of origin of the 

6 food.’’. 

7 (b) REGULATIONS.— 

8 (1) PROMULGATION.—Not later than 180 days 

9 after the date of the enactment of this Act, the Sec10 retary of Health and Human Services shall promul11 gate final regulations to carry out paragraphs (cc) 

12 and (dd) of section 403 of the Federal Food, Drug, 

13 and Cosmetic Act, as added by subsection (a). 

14 (2) RELATION TO OTHER REQUIREMENTS.— 

15 Regulations promulgated under paragraph (1) shall 

16 provide that labeling meets the requirements of 

17 paragraphs (cc) and (dd) of section 403 of the Fed18 eral Food, Drug, and Cosmetic Act, as added by 

19 subsection (a), if— 

20 (A) in the case of a processed food, the 

21 label of the food informs the consumer of the 

22 country where the final processing of the food 

23 occurred in accordance with country of origin 

24 marking requirements of the United States 

25 Customs and Border Protection; or 


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1 (B) in the case of a nonprocessed food, the 

2 label of the food informs the consumer of the 

3 country of origin of the food in accordance with 

4 labeling requirements of the Department of Ag5 riculture. 

6 (c) EFFECTIVE DATE.—The requirements of para7 graphs (cc) and (dd) of section 403 of the Federal Food, 

8 Drug, and Cosmetic Act, as added by subsection (a), take 

9 effect on the date that is 2 years after the date of the 

10 enactment of this Act. 

11 SEC. 203. EXPORTATION CERTIFICATE PROGRAM. 

12 Section 801(e)(4) (21 U.S.C. 381) is amended— 

13 (1) in the matter preceding clause (i) in sub14 paragraph (A)— 

15 (A) by inserting ‘‘from the United States’’ 

16 after ‘‘exports’’; and 

17 (B) by striking ‘‘a drug, animal drug, or 

18 device’’ and inserting ‘‘a food (including animal 

19 feed), drug, animal drug, or device’’; 

20 (2) in subparagraph (A)(i)— 

21 (A) by striking ‘‘in writing’’; and 

22 (B) by striking ‘‘exported drug, animal 

23 drug, or device’’ and inserting ‘‘exported food, 

24 drug, animal drug, or device’’; 

25 (3) in subparagraph (A)(ii)— 


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1 (A) by striking ‘‘in writing’’; 

2 (B) by striking ‘‘the drug, animal drug, or 

3 device’’ and inserting ‘‘the food, drug, animal 

4 drug, or device’’; and 

5 (C) by striking ‘‘the drug or device’’ and 

6 inserting ‘‘the food, drug, or device’’; 

7 (4) by redesignating subparagraph (B) as sub8 paragraph (C); 

9 (5) by inserting after subparagraph (A) the fol10 lowing: 

11 ‘‘(B) For purposes of this paragraph, a 

12 certification by the Secretary shall be made on 

13 such basis and in such form (such as a publicly 

14 available listing) as the Secretary determines 

15 appropriate.’’; and 

16 (6) by adding at the end the following: 

17 ‘‘(D) Notwithstanding subparagraph (C), if the Sec18 retary issues an export certification within the 20 days 

19 prescribed by subparagraph (A) with respect to the export 

20 of food, a fee for such certification shall not exceed such 

21 amount as the Secretary determines is reasonably related 

22 to the cost of issuing certificates under subparagraph (A) 

23 with respect to the export of food. The Secretary may ad24 just this fee annually to account for inflation and other 

25 cost adjustments. Fees collected for a fiscal year pursuant 


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1 to this subparagraph shall be credited to the appropriation 

2 account for salaries and expenses of the Food and Drug 

3 Administration and shall be available in accordance with 

4 appropriations Acts until expended, without fiscal year 

5 limitation. Such fees shall be collected in each fiscal year 

6 in an amount equal to the amount specified in appropria7 tions Acts for such fiscal year and shall only be collected 

8 and available for the costs of the Food and Drug Adminis9 tration to cover the cost of issuing such certifications. 

10 Such sums as necessary may be transferred from such ap11 propriation account for salaries and expenses of the Food 

12 and Drug Administration without fiscal year limitation to 

13 such appropriation account for salaries and expenses with 

14 fiscal year limitation.’’. 

15 SEC. 204. REGISTRATION FOR COMMERCIAL IMPORTERS 

16 OF FOOD; FEE. 

17 (a) REGISTRATION.— 

18 (1) PROHIBITIONS.—Section 301 (21 U.S.C. 

19 331), as amended by sections 110, 111, 133, and 

20 136, is amended by adding at the end the following: 

21 ‘‘(zz) The failure to register in accordance with sec22 tion 801(s).’’. 

23 (2) MISBRANDING.—Section 403 (21 U.S.C. 

24 343) as amended by sections 101(a), 109(a), 114(a), 


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1 and 202, is amended by adding at the end the fol2 lowing: 

3 ‘‘(ee) If it is imported or offered for import by an 

4 importer not duly registered under section 801(s).’’. 

5 (3) REGISTRATION.—Section 801, as amended 

6 by sections 109 and 136, is amended by adding at 

7 the end the following: 

8 ‘‘(s) REGISTRATION OF IMPORTERS.— 

9 ‘‘(1) REGISTRATION.—The Secretary shall re10 quire an importer of food— 

11 ‘‘(A) to be registered with the Secretary in 

12 a form and manner specified by the Secretary; 

13 and 

14 ‘‘(B) consistent with section 1011, to sub15 mit appropriate unique facility identifiers as a 

16 condition of registration. 

17 ‘‘(2) GOOD IMPORTER PRACTICES.—The main18 tenance of registration under this subsection is con19 ditioned on compliance with good importer practices 

20 in accordance with the following: 

21 ‘‘(A) The Secretary, in consultation with 

22 Customs and Border Protection, shall promul23 gate regulations to establish good importer 

24 practices that specify the measures an importer 


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1 shall take to ensure imported food is in compli2 ance with the requirements of this Act. 

3 ‘‘(B) The measures under subparagraph 

4 (A) shall ensure that the importer of a food— 

5 ‘‘(i) has adequate information about 

6 the food, its hazards, and the requirements 

7 of this Act applicable to such food; 

8 ‘‘(ii) has adequate information or pro9 cedures in place to verify that both the 

10 food and each person that produced, man11 ufactured, processed, packed, transported, 

12 or held the food, including components of 

13 the food, are in compliance with the re14 quirements of this Act; and 

15 ‘‘(iii) has adequate procedures in 

16 place to take corrective action, such as the 

17 ability to appropriately trace, withhold, 

18 and recall articles of food, if a food im19 ported by the importer is not in compliance 

20 with the requirements of this Act. 

21 ‘‘(C) In promulgating good importer prac22 tices regulations, the Secretary may, as appro23 priate— 

24 ‘‘(i) incorporate certification of com25 pliance under section 801(q) and participaVerDate Nov 24 2008 02:11 Aug 04, 2009 Jkt 079200 PO 00000 Frm 00131 Fmt 6652 Sfmt 6201 E:\BILLS\H2749.RFS H2749

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1 tion in the safe and secure food importa2 tion program under section 805; and 

3 ‘‘(ii) take into account differences 

4 among importers and the types of imports, 

5 including based on the level of risk posed 

6 by the imported food. 

7 ‘‘(3) SUSPENSION OF REGISTRATION.— 

8 ‘‘(A) IN GENERAL.—Registration under 

9 this subsection is subject to suspension upon a 

10 finding by the Secretary, after notice and an 

11 opportunity for an informal hearing, of— 

12 ‘‘(i) a violation of this Act; or 

13 ‘‘(ii) the knowing or repeated making 

14 of an inaccurate or incomplete statement 

15 or submission of information relating to 

16 the importation of food. 

17 ‘‘(B) REQUEST.—The importer whose reg18 istration is suspended may request that the 

19 Secretary vacate the suspension of registration 

20 when such importer has corrected the violation 

21 that is the basis for such suspension. 

22 ‘‘(C) VACATING OF SUSPENSION.—If the 

23 Secretary determines that adequate reasons do 

24 not exist to continue the suspension of a regVerDate Nov 24 2008 02:11 Aug 04, 2009 Jkt 079200 PO 00000 Frm 00132 Fmt 6652 Sfmt 6201 E:\BILLS\H2749.RFS H2749

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1 istration, the Secretary shall vacate such sus2 pension. 

3 ‘‘(4) CANCELLATION OF REGISTRATION.— 

4 ‘‘(A) IN GENERAL.—Not earlier than 10 

5 days after providing the notice under subpara6 graph (B), the Secretary may cancel a registra7 tion that the Secretary determines was not up8 dated in accordance with this section or other9 wise contains false, incomplete, or inaccurate 

10 information. 

11 ‘‘(B) NOTICE OF CANCELLATION.—Can12 cellation shall be preceded by notice to the im13 porter of the intent to cancel the registration 

14 and the basis for such cancellation. 

15 ‘‘(C) TIMELY UPDATE OR CORRECTION.— 

16 If the registration for the importer is updated 

17 or corrected no later than 7 days after notice 

18 is provided under subparagraph (B), the Sec19 retary shall not cancel such registration. 

20 ‘‘(5) EXEMPTIONS.—The Secretary, by notice 

21 published in the Federal Register— 

22 ‘‘(A) shall establish an exemption from the 

23 requirements of this subsection for importations 

24 for personal use; and 


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1 ‘‘(B) may establish other exemptions from 

2 the requirements of this subsection.’’. 

3 (4) REGULATIONS.—Not later than 36 months 

4 after the date of the enactment of this Act, the Sec5 retary of Health and Human Services in consulta6 tion with the Commissioner responsible for Customs 

7 and Border Protection shall promulgate the regula8 tions required to carry out section 801(s) of the 

9 Federal Food, Drug, and Cosmetic Act, as added by 

10 paragraph (3). In establishing the effective date of 

11 a regulation promulgated under section 801(s), the 

12 Secretary shall, in consultation with the Commis13 sioner responsible for Customs and Border Protec14 tion, as appropriate, provide a reasonable period of 

15 time for importers of food to comply with good im16 porter practices, taking into account differences 

17 among importers and the types of imports, including 

18 based on the level of risk posed by the imported 

19 food. 

20 (5) EFFECTIVE DATE.—The amendments made 

21 by this subsection shall take effect on the date that 

22 is 24 months after the date of enactment of this Act. 

23 (b) FEE.—Subchapter C of chapter VII (21 U.S.C. 

24 379f et seq.) as added and amended by sections 101 and 

25 108, is amended by adding at the end the following: 


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1 ‘‘PART 7—IMPORTERS OF FOOD 

2 ‘‘SEC. 744. IMPORTERS OF FOOD. 

3 ‘‘(a) IMPORTERS.—The Secretary shall assess and 

4 collect an annual fee for the registration of an importer 

5 of food under section 801(s). 

6 ‘‘(b) AMOUNT OF FEE.— 

7 ‘‘(1) BASE AMOUNTS.—The registration fee 

8 under subsection (a) shall be— 

9 ‘‘(A) for fiscal year 2010, $500; and 

10 ‘‘(B) for fiscal year 2011 and each subse11 quent fiscal year, the fee for fiscal year 2010 as 

12 adjusted under paragraph (2). 

13 ‘‘(2) ADJUSTMENT.—For fiscal year 2011 and 

14 subsequent fiscal years, the fees established pursu15 ant to paragraph (1) shall be adjusted by the Sec16 retary by notice, published in the Federal Register, 

17 for a fiscal year to reflect the greater of— 

18 ‘‘(A) the total percentage change that oc19 curred in the Consumer Price Index for all 

20 urban consumers (all items; United States city 

21 average), for the 12-month period ending June 

22 30 preceding the fiscal year for which fees are 

23 being established; 

24 ‘‘(B) the total percentage change for the 

25 previous fiscal year in basic pay under the Gen26 eral Schedule in accordance with section 5332 


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1 of title 5, United States Code, as adjusted by 

2 any locality-based comparability payment pur3 suant to section 5304 of such title for Federal 

4 employees stationed in the District of Columbia; 

5 or 

6 ‘‘(C) the average annual change in the 

7 cost, per full-time equivalent position of the 

8 Food and Drug Administration, of all personnel 

9 compensation and benefits paid with respect to 

10 such positions for the first 5 years of the pre11 ceding 6 fiscal years. 

12 ‘‘(3) COMPOUNDED BASIS.—The adjustment 

13 made each fiscal year pursuant this subsection shall 

14 be added on a compounded basis to the sum of all 

15 adjustments made each fiscal year after fiscal year 

16 2010 under this subsection. 

17 ‘‘(4) WAIVER FOR IMPORTERS REQUIRED TO

18 PAY REGISTRATION FEE.—In the case of a person 

19 who is required to pay both a fee under section 743 

20 for registration of one or more facilities under sec21 tion 415 and a fee under this section for registration 

22 as an importer of food under section 801(s), the 

23 Secretary shall waive the fees applicable to such per24 son under section 743 or the fee applicable to such 

25 person under this section. 


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1 ‘‘(c) CREDITING AND AVAILABILITY OF FEES.— 

2 ‘‘(1) IN GENERAL.—Fees authorized under sub3 section (a) shall be collected and available for obliga4 tion only to the extent and in the amount provided 

5 in advance in appropriations Acts. Such fees are au6 thorized to remain available until expended. Such 

7 sums as may be necessary may be transferred from 

8 the Food and Drug Administration salaries and ex9 penses appropriation account without fiscal year lim10 itation to such appropriation account for salaries 

11 and expenses with such fiscal year limitation. 

12 ‘‘(2) COLLECTIONS AND APPROPRIATIONS

13 ACTS.—The fees authorized by this section— 

14 ‘‘(A) shall be retained in each fiscal year in 

15 an amount not to exceed the amount specified 

16 in appropriation Acts, or otherwise made avail17 able for obligation, for such fiscal year; and 

18 ‘‘(B) shall only be collected and available 

19 to cover the costs associated with registering 

20 importers under section 801(s) and with ensur21 ing compliance with good importer practices re22 specting food. 

23 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

24 For each of fiscal years 2010 through 2014, there 


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1 are authorized to be appropriated for fees under this 

2 section such sums as may be necessary.’’. 

3 (c) INSPECTION.—Section 704 (21 U.S.C. 374), as 

4 amended by section 105, is amended by adding at the end 

5 the following: 

6 ‘‘(i) IMPORTERS.—Every person engaged in the im7 porting of any food shall, upon request of an officer or 

8 employee designated by the Secretary, permit such officer 

9 or employee at all reasonable times to inspect the facilities 

10 of such person and have access to, and to copy and verify, 

11 any related records.’’. 

12 SEC. 205. REGISTRATION FOR CUSTOMS BROKERS. 

13 (a) REGISTRATION.— 

14 (1) PROHIBITIONS.—Section 301(zz) (21 

15 U.S.C. 331), as added by section 204, is amended 

16 by inserting ‘‘or 801(t)’’ after ‘‘801(s)’’. 

17 (2) MISBRANDING.—Section 403(ee) (21 U.S.C. 

18 343), as added by section 204, is amended— 

19 (A) by inserting ‘‘or a customs broker’’ 

20 after ‘‘by an importer’’; and 

21 (B) by inserting ‘‘or 801(t)’’ after 

22 ‘‘801(s)’’. 

23 (3) REGISTRATION.—Section 801, as amended 

24 by sections 109, 136, and 204, is amended by add25 ing at the end the following: 


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1 ‘‘(t) REGISTRATION OF CUSTOMS BROKER.— 

2 ‘‘(1) REGISTRATION.—The Secretary shall re3 quire a customs broker, with respect to the importa4 tion of food— 

5 ‘‘(A) to be registered with the Secretary in 

6 a form and manner specified by the Secretary; 

7 and 

8 ‘‘(B) consistent with section 1011, to sub9 mit appropriate unique facility identifiers as a 

10 condition of registration. 

11 ‘‘(2) CANCELLATION OF REGISTRATION.— 

12 ‘‘(A) IN GENERAL.—Not earlier than 10 

13 days after providing the notice under subpara14 graph (B), the Secretary may cancel a registra15 tion that the Secretary determines was not up16 dated in accordance with this section or other17 wise contains false, incomplete, or inaccurate 

18 information. 

19 ‘‘(B) NOTICE OF CANCELLATION.—Can20 cellation shall be preceded by notice to the cus21 toms broker of the intent to cancel the registra22 tion and the basis for such cancellation. 

23 ‘‘(C) TIMELY UPDATE OR CORRECTION.— 

24 If the registration for the customs broker is up25 dated or corrected no later than 7 days after 


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1 notice is provided under subparagraph (B), the 

2 Secretary shall not cancel such registration. 

3 ‘‘(3) NOTIFICATION.—The Secretary shall no4 tify the Commissioner responsible for Customs and 

5 Border Protection whenever the Secretary cancels a 

6 registration under this subsection. 

7 ‘‘(4) EXEMPTIONS.—In consultation with the 

8 Commissioner responsible for Customs and Border 

9 Protection, the Secretary, by notice published in the 

10 Federal Register— 

11 ‘‘(A) shall establish an exemption from the 

12 requirements of this subsection for importations 

13 for personal use; and 

14 ‘‘(B) may establish other exemptions from 

15 the requirements of this subsection. 

16 ‘‘(5) CIVIL PENALTIES.—Notwithstanding any 

17 other provision in this Act, a customs broker who 

18 violates section 301 because of a violation of section 

19 403(ee), or who violates section 301(xx), 301(yy), or 

20 301(zz), shall not be subject to a civil penalty under 

21 section 303(f)(2).’’. 

22 (4) REGULATIONS.—Not later than 24 months 

23 after the date of the enactment of this Act, the Sec24 retary of Health and Human Services, in consulta25 tion with the Commissioner responsible for Customs 


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1 and Border Protection, shall promulgate the regula2 tions required to carry out section 801(t) of the 

3 Federal Food, Drug, and Cosmetic Act, as added by 

4 paragraph (2). 

5 (5) EFFECTIVE DATE.—The amendments made 

6 by this subsection shall take effect on the date that 

7 is 24 months after the date of enactment of this Act. 

8 (b) INSPECTION.—Section 704 (21 U.S.C. 374), as 

9 amended by sections 105 and 204, is amended by adding 

10 at the end the following: 

11 ‘‘(j) BROKERS.—Every customs broker required to be 

12 registered with the Secretary shall, upon request of an of13 ficer or employee designated by the Secretary, permit such 

14 officer or employee at all reasonable times to inspect the 

15 facilities of such person and have access to, and to copy 

16 and verify, any related records.’’. 

17 SEC. 206. UNIQUE IDENTIFICATION NUMBER FOR FOOD FA18 CILITIES, IMPORTERS, AND CUSTOM BRO19 KERS. 

20 Chapter X (21 U.S.C. 391 et seq) is amended by add21 ing at the end the following: 

22 ‘‘SEC. 1011. UNIQUE FACILITY IDENTIFIER. 

23 ‘‘(a) REGISTRATION OF FACILITY OR ESTABLISH24 MENT.—A person required to register a facility pursuant 


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1 to section 415 shall submit, at the time of registration, 

2 a unique facility identifier for the facility or establishment. 

3 ‘‘(b) REGISTRATION OF IMPORTERS AND CUSTOM

4 BROKERS.—A person required to register pursuant to sec5 tion 801(s) or 801(t) shall submit, at the time of registra6 tion, a unique facility identifier for the principal place of 

7 business for which such person is required to register 

8 under section 801(s) or 801(t). 

9 ‘‘(c) GUIDANCE.—The Secretary may, by guidance, 

10 and, with respect to importers and customs brokers, in 

11 consultation with the Commissioner responsible for Cus12 toms and Border Protection, specify the unique numerical 

13 identifier system to be used to meet the requirements of 

14 subsections (a) and (b) and the form, manner, and timing 

15 of a submission under such subsections. Development of 

16 such guidelines shall take into account the utilization of 

17 existing unique identification schemes and compatibility 

18 with customs automated systems, such as integration with 

19 the Automated Commercial Environment (ACE) and the 

20 International Trade Data System (ITDS), and any suc21 cessor systems. 

22 ‘‘(d) IMPORTATION.—An article of food imported or 

23 offered for import shall be refused admission unless the 

24 appropriate unique facility identifiers, as specified by the 

25 Secretary, are provided for such article.’’. 


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1 SEC. 207. PROHIBITION AGAINST DELAYING, LIMITING, OR 

2 REFUSING INSPECTION. 

3 (a) ADULTERATION.—Section 402 (21 U.S.C. 342), 

4 as amended by section 102, 103(a), and 104(a), is amend5 ed by adding at the end the following: 

6 ‘‘(n) If it has been produced, manufactured, proc7 essed, packed, or held in any farm, factory, warehouse, 

8 or establishment and the owner, operator, or agent of such 

9 farm, factory, warehouse, or establishment, or any agent 

10 of a governmental authority in the foreign country within 

11 which such farm, factory, warehouse, or establishment is 

12 located, delays or limits an inspection, or refuses to permit 

13 entry or inspection, under section 414 or 704.’’. 

14 (b) FOREIGN INSPECTIONS.—Section 704(a)(1) (21 

15 U.S.C. 374(a)(1)), as amended by section 106(c), is 

16 amended— 

17 (1) in the first sentence, by inserting ‘‘, includ18 ing any such food factory, warehouse, or establish19 ment whether foreign or domestic,’’ after ‘‘factory, 

20 warehouse, or establishment’’; and 

21 (2) in the third sentence, by inserting ‘‘, includ22 ing any food factory, warehouse, establishment, or 

23 consulting laboratory whether foreign or domestic,’’ 

24 after ‘‘factory, warehouse, establishment, or con25 sulting laboratory’’. 


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1 SEC. 208. DEDICATED FOREIGN INSPECTORATE. 

2 Section 704 (21 U.S.C. 374), as amended by sections 

3 105, 204, and 205, is amended by adding at the end the 

4 following: 

5 ‘‘(k) DEDICATED FOREIGN INSPECTORATE.—The 

6 Secretary shall establish and maintain a corps of inspec7 tors dedicated to inspections of foreign food facilities. This 

8 corps shall be staffed and funded by the Secretary at a 

9 level sufficient to enable it to assist the Secretary in 

10 achieving the frequency of inspections for food facilities 

11 as described in this Act.’’. 

12 SEC. 209. PLAN AND REVIEW OF CONTINUED OPERATION 

13 OF FIELD LABORATORIES. 

14 (a) SUBMISSION OF PLAN.—Not later than 90 days 

15 before the Secretary terminates or consolidates any lab16 oratory, district office, or the functions (including the in17 spection and compliance functions) of any such laboratory 

18 or district office, specified in subsection (b), the Secretary 

19 shall submit a reorganization plan to the Comptroller Gen20 eral of the United States, the Committee on Energy and 

21 Commerce of the House of Representatives, and the Com22 mittee on Health, Education, Labor, and Pensions of the 

23 Senate. 

24 (b) SPECIFIED LABORATORIES AND OFFICES.—The 

25 laboratories and offices specified in this subsection are the 

26 following: 


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1 (1) Any of the 13 field laboratories responsible 

2 for analyzing food that were operated by the Office 

3 of Regulatory Affairs of the Food and Drug Admin4 istration as of January 1, 2007. 

5 (2) Any of the 20 district offices of the Food 

6 and Drug Administration with responsibility for food 

7 safety functioning as of January 1, 2007. 

8 (c) CONGRESSIONAL REVIEW.—A reorganization 

9 plan described in subsection (a) is deemed to be a major 

10 rule (as defined in section 804(2) of title 5, United States 

11 Code) for purposes of chapter 8 of such title. 

12 SEC. 210. FALSE OR MISLEADING REPORTING TO FDA. 

13 (a) IN GENERAL.—Section 301(q)(2) (21 U.S.C. 

14 331(q)(2)) is amended by inserting after ‘‘device’’ the fol15 lowing: ‘‘, food,’’. 

16 (b) EFFECTIVE DATE.—The amendment made by 

17 subsection (a) shall apply to submissions made on or after 

18 the date of the enactment of this Act. 

19 SEC. 211. SUBPOENA AUTHORITY. 

20 (a) PROHIBITED ACT.—Section 301(f) is amended by 

21 inserting before the period ‘‘or the failure or refusal to 

22 obey a subpoena issued pursuant to section 311’’. 

23 (b) AMENDMENT.—Chapter III (21 U.S.C. 331 et 

24 seq.) is amended by adding at the end the following: 


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1 ‘‘SEC. 311. EXERCISE OF SUBPOENA AUTHORITY. 

2 ‘‘(a) IN GENERAL.—For the purpose of— 

3 ‘‘(1) any hearing, investigation, or other pro4 ceeding respecting a violation of a provision of this 

5 Act, the Public Health Service Act, or the Federal 

6 Anti-Tampering Act, relating to food; or 

7 ‘‘(2) any hearing, investigation, or other pro8 ceeding to determine if a person is in violation of a 

9 specific provision of this Act, the Public Health 

10 Service Act, or the Federal Anti-Tampering Act, re11 lating to food, 

12 the Commissioner may issue subpoenas requiring the at13 tendance and testimony of witnesses and the production 

14 of records and other things. 

15 ‘‘(b) TIMING OF COMPLIANCE.—When the Commis16 sioner deems that immediate compliance with a subpoena 

17 issued under this section is necessary to address a threat 

18 of serious adverse health consequences or death, the sub19 poena may require immediate production. 

20 ‘‘(c) SERVICE OF SUBPOENA.— 

21 ‘‘(1) IN GENERAL.—Subpoenas of the Commis22 sioner shall be served by a person authorized by the 

23 Commissioner by delivering a copy thereof to the 

24 person named therein or by certified mail addressed 

25 to such person at such person’s last known dwelling 

26 place or principal place of business. 


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1 ‘‘(2) CORPORATIONS AND OTHER ENTITIES.— 

2 Service on a domestic or foreign corporation, part3 nership, unincorporated association, or other entity 

4 that is subject to suit under a common name may 

5 be made by delivering the subpoena to an officer, a 

6 managing or general agent, or any other agent au7 thorized by appointment or by law to receive service 

8 of process. 

9 ‘‘(3) PERSON OUTSIDE U.S. JURISDICTION.— 

10 Service on any person not found within the terri11 torial jurisdiction of any court of the United States 

12 may be made in any manner as the Federal Rules 

13 of Civil Procedure prescribe for service in a foreign 

14 nation. 

15 ‘‘(4) PROOF OF SERVICE.—A verified return by 

16 the person so serving the subpoena setting forth the 

17 manner of service, or, in the case of service by cer18 tified mail, the return post office receipt therefor 

19 signed by the person so served, shall be proof of 

20 service. 

21 ‘‘(d) PAYMENT OF WITNESSES.—Witnesses subpoe22 naed under subsection (a) shall be paid the same fees and 

23 mileage as are paid witnesses in the district courts of the 

24 United States. 


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1 ‘‘(e) ENFORCEMENT.—In the case of a refusal to 

2 obey a subpoena duly served upon any person under sub3 section (a), any district court of the United States for the 

4 judicial district in which such person charged with refusal 

5 to obey is found, resides, or transacts business, upon ap6 plication by the Commissioner, shall have jurisdiction to 

7 issue an order compelling compliance with the subpoena 

8 and requiring such person to appear and give testimony 

9 or to appear and produce records and other things, or 

10 both. The failure to obey such order of the court may be 

11 punished by the court as contempt thereof. If the person 

12 charged with failure or refusal to obey is not found within 

13 the territorial jurisdiction of the United States, the United 

14 States District Court for the District of Columbia shall 

15 have the same jurisdiction, consistent with due process, 

16 to take any action respecting compliance with the sub17 poena by such person that such district court would have 

18 if such person were personally within the jurisdiction of 

19 such district court. 

20 ‘‘(f) NONDISCLOSURE.—A United States district 

21 court for the district in which the subpoena is or will be 

22 served, upon application of the Commissioner, may issue 

23 an ex parte order that no person or entity disclose to any 

24 other person or entity (other than to an attorney to obtain 

25 legal advice) the existence of such subpoena for a period 


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1 of up to 90 days. Such order may be issued on a showing 

2 that the records or things being sought may be relevant 

3 to the hearing, investigation, proceeding, or other matter 

4 and that there is reason to believe that such disclosure 

5 may result in— 

6 ‘‘(1) furtherance of a potential violation under 

7 investigation; 

8 ‘‘(2) endangerment to the life or physical safety 

9 of any person; 

10 ‘‘(3) flight or other action to avoid prosecution 

11 or other enforcement remedies; 

12 ‘‘(4) destruction of or tampering with evidence; 

13 or 

14 ‘‘(5) intimidation of potential witnesses. 

15 An order under this subsection may be renewed for addi16 tional periods of up to 90 days upon a showing that any 

17 of the circumstances described in paragraphs (1) through 

18 (5) continue to exist. 

19 ‘‘(g) RELATION TO OTHER PROVISIONS.—The sub20 poena authority vested in the Commissioner and the dis21 trict courts of the United States by this section is in addi22 tion to any such authority vested in the Commissioner or 

23 such courts by other provisions of law, or as is otherwise 

24 authorized by law. 


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1 ‘‘(h) NONDELEGATION.—The authority to issue a 

2 subpoena under this section is limited to the Secretary or 

3 an official designated by the Secretary. An official may 

4 not be so designated unless the official is the director of 

5 the district under this Act in which the article involved 

6 is located, or is an official senior to such director.’’. 

7 SEC. 212. WHISTLEBLOWER PROTECTIONS. 

8 Chapter X (21 U.S.C. 391 et seq.), as amended by 

9 section 206, is amended by adding at the end the fol10 lowing: 

11 ‘‘SEC. 1012 PROTECTIONS FOR EMPLOYEES WHO REFUSE 

12 TO VIOLATE, OR WHO DISCLOSE VIOLATIONS 

13 OF, THIS ACT. 

14 ‘‘(a) IN GENERAL.—No person who submits or is re15 quired under this Act or the Public Health Service Act 

16 to submit any information related to a food, or any officer, 

17 employee, contractor, subcontractor, or agent of such per18 son may discharge, demote, suspend, threaten, harass, or 

19 in any other manner discriminate against an employee in 

20 the terms and conditions of employment because of any 

21 lawful act done by the employee, including within the ordi22 nary course of the job duties of such employee— 

23 ‘‘(1) to provide information, cause information 

24 to be provided, or otherwise assist in any investiga25 tion regarding any conduct which the employee reaVerDate Nov 24 2008 02:11 Aug 04, 2009 Jkt 079200 PO 00000 Frm 00150 Fmt 6652 Sfmt 6201 E:\BILLS\H2749.RFS H2749

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1 sonably believes constitutes a violation of this Act, or 

2 any other provision of Federal law relating to the 

3 safety of a food, if the information or assistance is 

4 provided to, or an investigation stemming from the 

5 provided information is conducted by— 

6 ‘‘(A) a Federal regulatory or law enforce7 ment agency; 

8 ‘‘(B) any Member of Congress or any com9 mittee of Congress; or 

10 ‘‘(C) a person with supervisory authority 

11 over the employee (or such other person work12 ing for the employer who has the authority to 

13 investigate, discover, or terminate the mis14 conduct); 

15 ‘‘(2) to file, cause to be filed, testify, participate 

16 in, or otherwise assist in a proceeding filed, or about 

17 to be filed (with any knowledge of the employer), in 

18 any court or administrative forum relating to any 

19 such alleged violation; or 

20 ‘‘(3) to refuse to commit or assist in any such 

21 violation. 

22 ‘‘(b) ENFORCEMENT ACTION.— 

23 ‘‘(1) IN GENERAL.—An employee who alleges 

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1 section (a) may seek relief in accordance with the 

2 provisions of subsection (c) by— 

3 ‘‘(A) filing a complaint with the Secretary 

4 of Labor; or 

5 ‘‘(B) if the Secretary of Labor has not 

6 issued a final decision within 210 days of the 

7 filing of the complaint and there is no showing 

8 that such delay is due to the bad faith of the 

9 claimant, or within 90 days after receiving a 

10 final decision or order from the Secretary, 

11 bringing an action at law or equity for de novo 

12 review in the appropriate district court of the 

13 United States, which court shall have jurisdic14 tion over such action without regard to the 

15 amount in controversy, and which action shall, 

16 at the request of either party to such action, be 

17 tried by the court with a jury. 

18 ‘‘(2) PROCEDURE.— 

19 ‘‘(A) IN GENERAL.—Any action under 

20 paragraph (1) shall be governed under the rules 

21 and procedures set forth in section 42121(b) of 

22 title 49, United States Code. 

23 ‘‘(B) EXCEPTION.—Notification in an ac24 tion under paragraph (1) shall be made in ac25 cordance with section 42121(b)(1) of title 49, 


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1 United States Code, except that such notifica2 tion shall be made to the person named in the 

3 complaint, the employer, and the Commissioner 

4 of Food and Drugs. 

5 ‘‘(C) BURDENS OF PROOF.—An action 

6 brought under paragraph (1)(A) or (1)(B) shall 

7 be governed by the legal burdens of proof set 

8 forth in section 42121(b) of title 49, United 

9 States Code. 

10 ‘‘(D) STATUTE OF LIMITATIONS.—An ac11 tion under paragraph (1)(A) shall be com12 menced not later than 180 days after the date 

13 on which the violation occurs. 

14 ‘‘(c) REMEDIES.— 

15 ‘‘(1) IN GENERAL.—An employee prevailing in 

16 any action under subsection (b)(1) shall be entitled 

17 to all relief necessary to make the employee whole. 

18 ‘‘(2) ISSUANCE OF ORDER.—If, in response to 

19 a complaint filed under paragraph (b)(1), the Sec20 retary of Labor or the district court, as applicable, 

21 determines that a violation of subsection (a) has oc22 curred, the Secretary or the court shall order the 

23 person who committed such violation— 

24 ‘‘(A) to take affirmative action to abate 

25 the violation; 


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1 ‘‘(B) to— 

2 ‘‘(i) reinstate the complainant to his 

3 or her former position together with com4 pensation (including back pay); and 

5 ‘‘(ii) restore the terms, conditions, 

6 and privileges associated with his or her 

7 employment; and 

8 ‘‘(C) to provide compensatory damages to 

9 the complainant. 

10 If such an order is issued under this paragraph, the 

11 Secretary or the court, at the request of the com12 plainant, shall assess against the person against 

13 whom the order is issued a sum equal to the aggre14 gate amount of all costs and expenses (including at15 torney and expert witness fees) reasonably incurred, 

16 as determined by the Secretary, by the complainant 

17 for, or in connection with, the bringing of the com18 plaint upon which the order was issued. 

19 ‘‘(d) RIGHTS RETAINED BY EMPLOYEE.—Nothing in 

20 this section shall be deemed to diminish the rights, privi21 leges, or remedies of any employee under any Federal or 

22 State law or under any collective bargaining agreement. 

23 The rights and remedies in this section may not be waived 

24 by any agreement, policy, form, or condition of employ25 ment.’’. 


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1 SEC. 213. EXTRATERRITORIAL JURISDICTION. 

2 (a) PROHIBITED ACT.—Section 301 (21 U.S.C. 331), 

3 as amended by sections 110, 111, 133, 136, and 204, is 

4 amended by adding at the end the following: 

5 ‘‘(aaa) The production, manufacture, processing, 

6 preparation, packing, holding, or distribution of an adul7 terated or misbranded food with the knowledge or intent 

8 that such article will be imported into the United States.’’. 

9 (b) JURISDICTION.—Chapter III (21 U.S.C. 331 et 

10 seq.), as amended by section 211, is amended by adding 

11 at the end the following: 

12 ‘‘SEC. 312. EXTRATERRITORIAL JURISDICTION. 

13 ‘‘There is extraterritorial Federal jurisdiction over 

14 any violation of this Act relating to any article of food 

15 if such article was intended for import into the United 

16 States or if any act in furtherance of the violation was 

17 committed in the United States.’’. 

18 SEC. 214. SUPPORT FOR TRAINING INSTITUTES. 

19 The Secretary of Health and Human Services, acting 

20 through the Commissioner of Food and Drugs, shall pro21 vide financial and other assistance to appropriate entities 

22 to establish and maintain one or more university-affiliated 

23 food protection training institutes that— 

24 (1) conduct training related to food protection 

25 activities for Federal, State, local, territorial, and 

26 tribal officials; and 


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1 (2) meet standards developed by the Secretary. 

2 SEC. 215. BISPHENOL A IN FOOD AND BEVERAGE CON3 TAINERS. 

4 (a) NOTICE OF DETERMINATION.—No later than De5 cember 31, 2009, the Secretary of Health and Human 

6 Services shall notify the Congress whether the available 

7 scientific data support a determination that there is a rea8 sonable certainty of no harm, for infants, young children, 

9 pregnant women, and adults, for approved uses of 

10 polycarbonate plastic and epoxy resin made with bisphenol 

11 A in food and beverage containers, including reusable food 

12 and beverage containers, under the conditions of use pre13 scribed in current Food and Drug Administration regula14 tions. 

15 (b) NOTICE OF ACTIONS TO BE TAKEN.—If the Sec16 retary concludes that such a determination cannot be 

17 made for any approved use, the Secretary shall notify the 

18 Congress of the actions the Secretary intends to take 

19 under the Secretary’s authority to regulate food additives 

20 to protect the public health, which may include— 

21 (1) revoking or modifying any of the approved 

22 uses of bisphenol A in food and beverage containers, 

23 including reusable food and beverage containers; and 


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1 (2) ensuring that the public is sufficiently in2 formed of such determination and the steps the pub3 lic may take in response to such determination. 

4 (c) RULE OF CONSTRUCTION.—Nothing herein is in5 tended or shall be construed to modify existing Food and 

6 Drug Administration authority, procedures, or policies for 

7 assessing scientific data, making safety determinations, or 

8 regulating the safe use of food additives. 

9 SEC. 216. LEAD CONTENT LABELING REQUIREMENT FOR 

10 CERAMIC TABLEWARE AND COOKWARE. 

11 (a) IN GENERAL.—Section 403 (21 U.S.C. 343), as 

12 amended by sections 101(a), 109(a), 114(a), 202, and 

13 204, is amended by adding at the end the following: 

14 ‘‘(ff) If it is ceramic tableware or cookware and in15 cludes a glaze or decorations containing lead for an in16 tended functional purpose, unless— 

17 ‘‘(1) the product and its packaging bear the 

18 statement: ‘This product is made with lead-based 

19 glaze consistent with Food and Drug Administration 

20 guidelines for such lead.’; or 

21 ‘‘(2) the product is in compliance with the re22 quirements applicable to ornamental and decorative 

23 ceramicware in section 109.16 of title 21, Code of 

24 Federal Regulations (or any successor regulation).’’. 


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1 (b) EFFECTIVE DATE.—Section 403(ff) of the Fed2 eral Food, Drug, and Cosmetic Act, as added by sub3 section (a), shall apply only to ceramic tableware or 

4 cookware that is manufactured on or after the date that 

5 is 1 year after the date of the enactment of this Act. 

6 (c) CONSUMER EDUCATION.—Chapter IV (21 U.S.C. 

7 341 et seq.), as amended by sections 102, 103, 104, and 

8 111, is amended by adding at the end the following: 

9 ‘‘SEC. 421. CONSUMER EDUCATION ON THE CONTENT OF 

10 LEAD IN CERAMICWARE AND APPLICABLE 

11 LABELING REQUIREMENTS. 

12 ‘‘(a) IN GENERAL.—The Secretary shall educate con13 sumers on the safety of ceramicware for food use by post14 ing information on the Web site of the Food and Drug 

15 Administration with regard to— 

16 ‘‘(1) the content of lead in ceramicware and its 

17 glaze; 

18 ‘‘(2) existing Federal laws and regulations gov19 erning lead in ceramicware; 

20 ‘‘(3) as appropriate, existing industry practices 

21 and guidelines; and 

22 ‘‘(4) the labeling requirements applicable under 

23 this Act. 

24 ‘‘(b) TOPICS.—The education under this section shall 

25 address— 


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1 ‘‘(1) the broad range of ceramicware types, in2 cluding traditional pottery, ornamental and decora3 tive ceramicware, cookware, and everyday dinner4 ware; 

5 ‘‘(2) the safety of ceramicware that is aged or 

6 damaged; 

7 ‘‘(3) the use of ceramicware in microwave 

8 ovens; 

9 ‘‘(4) the storage of foods in ceramicware; 

10 ‘‘(5) the use of home lead test kits by con11 sumers; 

12 ‘‘(6) the use of ceramicware by children and 

13 women of childbearing age; and 

14 ‘‘(7) issues that are especially relevant to sub15 populations of consumers who may preferentially use 

16 certain types of ceramicware made with lead.’’. 

Passed the House of Representatives July 30, 2009. 

Attest: LORRAINE C. MILLER, 

Clerk. 


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