IB 

Union Calendar No. 130 

111TH CONGRESS 

1ST SESSION H. R. 2749 

[Report No. 111–234] 

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

of food in the global market, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 8, 2009 

Mr. DINGELL (for himself, Mr. WAXMAN, Mr. PALLONE, Mr. STUPAK, Ms. 

DEGETTE, and Ms. SUTTON) introduced the following bill; which was referred to the Committee on Energy and Commerce 

JULY 29, 2009 

Reported with an amendment, committed to the Committee of the Whole 

House on the State of the Union, and ordered to be printed 

[Strike out all after the enacting clause and insert the part printed in italic] 

[For text of introduced bill, see copy of bill as introduced on June 8, 2009] 


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A BILL 

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

improve the safety of food in the global market, and 

for other purposes. 


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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Food Safety Enhance5 ment Act of 2009’’. 

6 SEC. 2. TABLE OF CONTENTS. 

7 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. Quarantine authority for foods. 

Sec. 134. Criminal penalties. 


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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. 

Sec. 202. Country of origin labeling; disclosure of source of ingredients. 

Sec. 203. Exportation certificate program. 

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

Sec. 205. Registration for customs brokers and filers; fee. 

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

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. 

1 SEC. 3. REFERENCES. 

2 Except as otherwise specified, whenever in this Act an 

3 amendment is expressed in terms of an amendment to a 

4 section or other provision, the reference shall be considered 

5 to be made to a section or other provision of the Federal 

6 Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). 

7 SEC. 4. RULES OF CONSTRUCTION. 

8 (a) Nothing in this Act or any amendment made by 

9 this Act shall be construed to prohibit or limit— 

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

11 (2) the introduction of evidence of compliance or 

12 noncompliance with the requirements of the Federal 

13 Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). 

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

15 this Act shall be construed to— 


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1 (1) alter the jurisdiction between the Secretary of 

2 Agriculture and the Secretary of Health and Human 

3 Services, under applicable statutes and regulations; 

4 (2) limit the authority of the Secretary of Health 

5 and Human Services to issue regulations related to 

6 the safety of food under— 

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

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

9 day before the date of the enactment of this Act; 

10 or 

11 (B) the Public Health Service Act (42 

12 U.S.C. 301 et seq.) as in effect on the day before 

13 the date of the enactment of this Act; or 

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

15 the Secretary of Agriculture to prevent, control, or 

16 mitigate a plant or animal health emergency, or a 

17 food emergency involving products regulated under 

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

19 seq.), the Poultry Products Inspection Act (21 U.S.C. 

20 451 et seq.), or the Egg Products Inspection Act (21 

21 U.S.C. 1031 et seq.). 

22 SEC. 5. USDA EXEMPTIONS. 

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

24 from the requirements of this Act if such food is regulated 

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1 spection Act, the Poultry Products Inspection Act, or the 

2 Egg Products Inspection Act. 

3 (b) USDA-REGULATED FACILITIES.—A facility is ex4 empt from the requirements of this Act if such facility is 

5 regulated exclusively as an official establishment by the Sec6 retary of Agriculture under the Federal Meat Inspection 

7 Act, the Poultry Products Inspection Act, or the Egg Prod8 ucts Inspection Act. 

9 (c) FARMS.—A farm is exempt from the requirements 

10 of this Act to the extent such farm raises animals from 

11 which food is derived that is regulated under the Federal 

12 Meat Inspection Act, the Poultry Products Inspection Act, 

13 or the Egg Products Inspection Act. 

14 SEC. 6. ALCOHOL-RELATED FACILITIES. 

15 (a) IN GENERAL.—With the exception of the amend16 ments made by section 101(a) and (b) and section 113 of 

17 this Act, nothing in this Act, or the amendments made by 

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

19 (1) under the Federal Alcohol Administration 

20 Act or chapter 51 of subtitle E of the Internal Rev21 enue Code, is required to obtain a permit or to reg22 ister with the Secretary of the Treasury as a condi23 tion of doing business in the United States; and 

24 (2) under section 415 of the Federal Food, Drug, 

25 and Cosmetic Act, as amended by this Act, is required 


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1 to register as a facility solely because such facility is 

2 engaged in manufacturing, processing, packing, or 

3 holding 1 or more alcoholic beverages. 

4 (b) RULE OF CONSTRUCTION.—This section shall not 

5 be construed to exempt any food, apart from distilled spir6 its, wine, and malt beverages, as defined in section 211 of 

7 the Federal Alcohol Administration Act, from the require8 ments of this Act and the amendments made by this Act. 

9 TITLE I—FOOD SAFETY 

10 Subtitle A—Prevention 

11 SEC. 101. CHANGES IN REGISTRATION OF FOOD FACILITIES. 

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

13 amended by adding at the end the following: 

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

15 in a facility that is not duly registered under section 415, 

16 including a facility whose registration is canceled or sus17 pended under such section.’’. 

18 (b) ANNUAL REGISTRATION.— 

19 (1) IN GENERAL.—Section 415(a) (21 U.S.C. 

20 350d(a)) is amended— 

21 (A) in the first sentence of paragraph (1)— 

22 (i) by striking ‘‘require that’’ and in23 serting ‘‘require that, on or before December 

24 31 of each year,’’; and 


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1 (ii) by striking ‘‘food for consumption 

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

3 for consumption in the United States or for 

4 export from the United States’’; 

5 (B) in subparagraphs (A) and (B) of para6 graph (1), by inserting ‘‘and pay the registration 

7 fee required under section 743’’ after ‘‘submit a 

8 registration to the Secretary’’ each place it ap9 pears; 

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

11 by inserting ‘‘in electronic format’’ after ‘‘sub12 mit’’; and 

13 (D) in paragraph (4), by inserting after the 

14 first sentence the following: ‘‘The Secretary shall 

15 remove from such list the name of any facility 

16 that fails to reregister in accordance with this 

17 section, that fails to pay the registration fee re18 quired under section 743, or whose registration 

19 is canceled by the registrant, canceled by the Sec20 retary in accordance with this section, or sus21 pended by the Secretary in accordance with this 

22 section.’’. 

23 (2) CONTENTS OF REGISTRATION.—Paragraph 

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

25 by paragraph (1), is amended by striking ‘‘containing 


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1 information’’ and all that follows and inserting the 

2 following: ‘‘containing information that identifies the 

3 following: 

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

5 contact information of the facility being reg6 istered. 

7 ‘‘(B) The primary purpose and business ac8 tivity of the facility, including the dates of oper9 ation if the facility is seasonal. 

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

11 by the Secretary by guidance) of each food man12 ufactured, processed, packed, or held at the facil13 ity. 

14 ‘‘(D) All trade names under which the facil15 ity conducts business related to food. 

16 ‘‘(E) The name, address, and 24-hour emer17 gency contact information of the United States 

18 distribution agent for the facility, which agent 

19 shall have access to the information required to 

20 be maintained under section 414(d) for food that 

21 is manufactured, processed, packed, or held at 

22 the facility. 

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

24 United States, the name, address, and emergency 

25 contact information for a United States agent. 


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1 ‘‘(G) The unique facility identifier of the fa2 cility, as specified under section 911. 

3 ‘‘(H) Such additional information per4 taining to the facility as the Secretary may re5 quire by regulation. 

6 The registrant shall notify the Secretary of any 

7 change in the submitted information not later than 

8 30 days after the date of such change, unless otherwise 

9 specified by the Secretary.’’. 

10 (3) SUSPENSION AND CANCELLATION AUTHOR11 ITY.—Section 415(a) (21 U.S.C. 350d(a)), as amend12 ed by paragraphs (1) and (2), is further amended by 

13 adding at the end the following: 

14 ‘‘(5) SUSPENSION OF REGISTRATION.— 

15 ‘‘(A) IN GENERAL.—The Secretary may sus16 pend the registration of any facility registered 

17 under this section for a violation of this Act that 

18 could result in serious adverse health con19 sequences or death to humans or animals. 

20 ‘‘(B) NOTICE OF SUSPENSION.—Suspension 

21 of a registration shall be preceded by— 

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

23 to suspend the registration; and 

24 ‘‘(ii) an opportunity for an informal 

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1 tions issued by the Secretary, concerning the 

2 suspension of such registration for such fa3 cility. 

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

5 agent in charge of a facility whose registration 

6 is suspended may request that the Secretary va7 cate the suspension of registration when such 

8 owner, operator, or agent has corrected the viola9 tion that is the basis for such suspension. 

10 ‘‘(D) VACATING OF SUSPENSION.—If, based 

11 on an inspection of the facility or other informa12 tion, the Secretary determines that adequate rea13 sons do not exist to continue the suspension of a 

14 registration, the Secretary shall vacate such sus15 pension. 

16 ‘‘(6) CANCELLATION OF REGISTRATION.— 

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

18 days after providing the notice under subpara19 graph (B), the Secretary may cancel a registra20 tion if the Secretary determines that— 

21 ‘‘(i) the registration was not updated 

22 in accordance with this section or otherwise 

23 contains false, incomplete, or inaccurate in24 formation; or 


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1 ‘‘(ii) the required registration fee has 

2 not been paid within 30 days after the date 

3 due. 

4 ‘‘(B) NOTICE OF CANCELLATION.—Cancella5 tion shall be preceded by notice to the facility of 

6 the intent to cancel the registration and the basis 

7 for such cancellation. 

8 ‘‘(C) TIMELY UPDATE OR CORRECTION.—If 

9 the registration for the facility is updated or cor10 rected no later than 7 days after notice is pro11 vided under subparagraph (B), the Secretary 

12 shall not cancel such registration. 

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

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

15 to the Congress a report, based on the registrations on 

16 or before December 31 of the previous year, on the fol17 lowing: 

18 ‘‘(A) The number of facilities registered 

19 under this section. 

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

21 domestic. 

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

23 foreign. 

24 ‘‘(D) The number of such facilities that are 

25 high-risk. 


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

2 low-risk. 

3 ‘‘(F) The number of such facilities that hold 

4 food. 

5 ‘‘(8) LIMITATION ON DELEGATION.—The author6 ity conferred by this subsection to issue an order to 

7 suspend a registration or cancel a registration shall 

8 not be delegated to any officer or employee other than 

9 the Commissioner of Food and Drugs, the Principal 

10 Deputy Commissioner, the Associate Commissioner 

11 for Regulatory Affairs, or the Director for the Center 

12 for Food Safety and Applied Nutrition, of the Food 

13 and Drug Administration.’’. 

14 (c) REGISTRATION FEE.—Chapter VII (21 U.S.C. 371 

15 et seq.) is amended by adding at the end of subchapter C 

16 the following: 

17 ‘‘PART 6—FEES RELATING TO FOOD 

18 ‘‘SEC. 743. FACILITY REGISTRATION FEE. 

19 ‘‘(a) IN GENERAL.— 

20 ‘‘(1) ASSESSMENT AND COLLECTION.—Beginning 

21 in fiscal year 2010, the Secretary shall assess and col22 lect an annual fee for the registration of a facility 

23 under section 415. 

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

25 shall be payable— 


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

2 under section 415 for the preceding fiscal year, 

3 on the date of registration; and 

4 ‘‘(B) for any other facility— 

5 ‘‘(i) for fiscal year 2010, not later than 

6 the sooner of 90 days after the date of the 

7 enactment of this part or December 31, 

8 2009; and 

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

10 later than December 31 of such fiscal year. 

11 ‘‘(b) FEE AMOUNTS.— 

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

13 subsection (a) shall be— 

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

15 ‘‘(B) for fiscal year 2011 and each subse16 quent fiscal year, the fee for fiscal year 2010 as 

17 adjusted under subsection (c). 

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

19 shall, not later than 60 days before the start of fiscal 

20 year 2011 and each subsequent fiscal year, establish, 

21 for the next fiscal year, registration fees under sub22 section (a), as described in paragraph (1). 

23 ‘‘(3) MAXIMUM AMOUNT.—Notwithstanding 

24 paragraph (1), a person who owns or operates mul25 tiple facilities for which a fee must be paid under this 


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1 section for a fiscal year shall be liable for not more 

2 than $175,000 in aggregate fees under this section for 

3 such fiscal year. 

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

5 and each subsequent fiscal year, the fee amount under sub6 section (b)(1) shall be adjusted by the Secretary by notice, 

7 published in the Federal Register, to reflect the greater of— 

8 ‘‘(1) the total percentage change that occurred in 

9 the Consumer Price Index for all urban consumers 

10 (all items; U.S. city average) for the 12-month period 

11 ending June 30 preceding the fiscal year for which 

12 fees are being established; 

13 ‘‘(2) the total percentage change for the previous 

14 fiscal year in basic pay under the General Schedule 

15 in accordance with section 5332 of title 5, United 

16 States Code, as adjusted by any locality-based com17 parability payment pursuant to section 5304 of such 

18 title for Federal employees stationed in the District of 

19 Columbia; or 

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

21 full-time equivalent position of the Food and Drug 

22 Administration, of all personnel compensation and 

23 benefits paid with respect to such positions for the 

24 first 5 years of the preceding 6 fiscal years. 


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1 The adjustment made each fiscal year under this subsection 

2 shall be added on a compounded basis to the sum of all 

3 adjustments made each fiscal year after fiscal year 2010 

4 under this subsection. 

5 ‘‘(d) LIMITATIONS.— 

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

7 shall be refunded for a fiscal year beginning after fis8 cal year 2010 unless appropriations for salaries and 

9 expenses of the Food and Drug Administration for 

10 such fiscal year (excluding the amount of fees appro11 priated for such fiscal year) are equal to or greater 

12 than the amount of appropriations for the salaries 

13 and expenses of the Food and Drug Administration 

14 for fiscal year 2010 (excluding the amount of fees ap15 propriated for such fiscal year) multiplied by the ad16 justment factor applicable to the fiscal year involved. 

17 ‘‘(2) AUTHORITY.—If the Secretary does not as18 sess fees under subsection (a) during any portion of 

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

20 later date in such fiscal year the Secretary may assess 

21 such fees, the Secretary may assess and collect such 

22 fees, without any modification in the rate, for reg23 istration under section 415 at any time in such fiscal 

24 year. 


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1 ‘‘(3) ADJUSTMENT FACTOR.—In this subsection, 

2 the term ‘adjustment factor’ applicable to a fiscal 

3 year is the Consumer Price Index for all urban con4 sumers (all items; United States city average) for Oc5 tober of the preceding fiscal year divided by such 

6 Index for October 2009. 

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

8 ‘‘(1) IN GENERAL.—Fees authorized under sub9 section (a) shall be collected and available for obliga10 tion only to the extent and in the amount provided 

11 in advance in appropriations Acts. Such fees are au12 thorized to remain available until expended. Such 

13 sums as may be necessary may be transferred from 

14 the Food and Drug Administration salaries and ex15 penses appropriation account without fiscal year lim16 itation to such appropriation account for salaries and 

17 expenses with such fiscal year limitation. 

18 ‘‘(2) COLLECTIONS AND APPROPRIATIONS

19 ACTS.—The fees authorized by this section— 

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

21 an amount not to exceed the amount specified in 

22 appropriation Acts, or otherwise made available 

23 for obligation, for such fiscal year; and 

24 ‘‘(B) shall only be collected and available to 

25 defray the costs of food safety activities. 


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1 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For 

2 each of fiscal years 2010 through 2014, there are au3 thorized to be appropriated for fees under this section 

4 such sums as may be necessary. 

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

6 the Secretary shall hold a public meeting on how fees 

7 collected under this section will be used to defray the 

8 costs of food safety activities in order to solicit the 

9 views of the regulated industry, consumers, and other 

10 interested stakeholders. 

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

12 where the Secretary does not receive payment of a fee as13 sessed under subsection (a) within 30 days after it is due, 

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

15 Government subject to subchapter II of chapter 37 of title 

16 31, United States Code. 

17 ‘‘(g) CONSTRUCTION.—This section may not be con18 strued to require that the number of full-time equivalent 

19 positions in the Department of Health and Human Serv20 ices, for officers, employees, and advisory committees not 

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

22 number of officers, employees, and advisory committees so 

23 engaged. 

24 ‘‘(h) ANNUAL FISCAL REPORTS.—Beginning with fis25 cal year 2011, not later than 120 days after the end of each 


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1 fiscal year for which fees are collected under this section, 

2 the Secretary shall prepare and submit to the Committee 

3 on Energy and Commerce of the House of Representatives 

4 and the Committee on Health, Education, Labor, and Pen5 sions of the Senate a report on the implementation of the 

6 authority for such fees during such fiscal year and the use, 

7 by the Food and Drug Administration, of the fees collected 

8 for such fiscal year. 

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

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

11 means the expenses incurred in connection with food 

12 safety activities for— 

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

14 Drug Administration, contractors of the Food 

15 and Drug Administration, advisory committees, 

16 and costs related to such officers, employees, and 

17 committees and to contracts with such contrac18 tors; 

19 ‘‘(B) laboratory capacity; 

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

21 acquisition, maintenance, and repair of tech22 nology resources; 

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

24 repair of facilities and acquisition, maintenance, 

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1 ment, and other necessary materials and sup2 plies; and 

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

4 accounting for resources allocated for food safety 

5 activities. 

6 ‘‘(2) The term ‘food safety activities’ means ac7 tivities related to compliance by facilities registered 

8 under section 415 with the requirements of this Act 

9 relating to food (including research related to and the 

10 development of standards (such as performance stand11 ards and preventive controls), risk assessments, haz12 ard analyses, inspection planning and inspections, 

13 third-party inspections, compliance review and en14 forcement, import review, information technology sup15 port, test development, product sampling, risk com16 munication, and administrative detention).’’. 

17 (d) TRANSITIONAL PROVISIONS.— 

18 (1) FEES.—The Secretary of Health and Human 

19 Services shall first impose the fee established under 

20 section 743 of the Federal Food, Drug, and Cosmetic 

21 Act, as added by subsection (c), for fiscal years begin22 ning with fiscal year 2010. 

23 (2) MODIFICATION OF REGISTRATION FORM.— 

24 Not later than 180 days after the date of the enact25 ment of this Act, the Secretary of Health and Human 


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1 Services shall modify the registration form under sec2 tion 415 of the Federal Food, Drug, and Cosmetic Act 

3 (21 U.S.C. 350d) to comply with the amendments 

4 made by this section. 

5 (3) APPLICATION.—The amendments made by 

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

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

8 date on which such modified registration form takes 

9 effect, but not later than 210 days after the date of 

10 the enactment of this Act. 

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

12 Food, Drug, and Cosmetic Act, as added by subsection 

13 (c), does not authorize the assessment or collection of 

14 a fee for registration under section 415 of such Act 

15 (21 U.S.C. 360) occurring after fiscal year 2014. 

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

17 CONTROLS, FOOD SAFETY PLAN, FINISHED 

18 PRODUCT TEST RESULTS FROM CATEGORY 1 

19 FACILITIES. 

20 (a) HAZARD ANALYSIS, RISK-BASED PREVENTIVE

21 CONTROLS, FOOD SAFETY PLAN.— 

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

23 U.S.C. 342) is amended by adding at the end the fol24 lowing: 


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

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

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

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

5 341 et seq.) is amended by adding at the end the fol6 lowing: 

7 ‘‘SEC. 418. HAZARD ANALYSIS AND RISK-BASED PREVEN8 TIVE CONTROLS. 

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

10 a facility shall, in accordance with this section— 

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

12 one if appropriate); 

13 ‘‘(2) identify, implement, and validate effective 

14 preventive controls; 

15 ‘‘(3) monitor preventive controls; 

16 ‘‘(4) institute corrective actions when— 

17 ‘‘(A) monitoring shows that preventive con18 trols have not been properly implemented; or 

19 ‘‘(B) monitoring and verification show that 

20 such controls were ineffective; 

21 ‘‘(5) conduct verification activities; 

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

23 action, and verification; and 

24 ‘‘(7) reanalyze for hazards. 

25 ‘‘(b) IDENTIFICATION OF HAZARDS.— 


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

2 agent of a facility shall evaluate whether there are 

3 any hazards, including hazards due to the source of 

4 the ingredients, that are reasonably likely to occur in 

5 the absence of preventive controls that may affect the 

6 safety, wholesomeness, or sanitation of the food manu7 factured, processed, packed, transported, or held by 

8 the facility, including— 

9 ‘‘(A) biological, chemical, physical, and ra10 diological hazards, natural toxins, pesticides, 

11 drug residues, filth, decomposition, parasites, al12 lergens, and unapproved food and color addi13 tives; and 

14 ‘‘(B) hazards that occur naturally, may be 

15 unintentionally introduced, or may be inten16 tionally introduced, including by acts of ter17 rorism. 

18 ‘‘(2) IDENTIFIED BY THE SECRETARY.—The Sec19 retary may, by regulation or guidance, identify haz20 ards that are reasonably likely to occur in the absence 

21 of preventive controls. 

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

23 or agent of a facility shall identify and describe the 

24 hazards evaluated under paragraph (1) or identified 


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

2 facility, in a hazard analysis. 

3 ‘‘(c) PREVENTIVE CONTROLS.— 

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

5 agent of a facility shall identify, implement, and vali6 date effective preventive controls to prevent, eliminate, 

7 or reduce to acceptable levels the occurrence of any 

8 hazards identified in the hazard analysis under sub9 section (b)(3). 

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

11 ‘‘(A) ESTABLISHMENT.—The Secretary may 

12 establish by regulation or guidance preventive 

13 controls for specific product types to prevent in14 tentional or unintentional contamination 

15 throughout the supply chain. The owner, oper16 ator, or agent of a facility shall implement any 

17 preventive controls identified by the Secretary 

18 under this paragraph. 

19 ‘‘(B) ALTERNATIVE CONTROLS.—Such regu20 lation or guidance shall allow the owner, oper21 ator, or agent of a facility to implement an al22 ternative preventive control to one established by 

23 the Secretary, provided that, in response to a re24 quest by the Secretary, the owner, operator, or 

25 agent can present to the Secretary data or other 


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1 information sufficient to demonstrate that the al2 ternative control effectively addresses the hazard, 

3 including meeting any applicable performance 

4 standard. 

5 ‘‘(C) LIMITATION.—Subparagraph (B) shall 

6 not apply to any preventive control described in 

7 subparagraph (A), (B), or (E) of subsection 

8 (i)(2). 

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

10 a facility shall monitor the implementation of preventive 

11 controls under subsection (c) to identify any circumstances 

12 in which the preventive controls are not fully implemented 

13 or verification shows that such controls were ineffective. 

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

15 agent of a facility shall establish and implement procedures 

16 to ensure that, if the preventive controls under subsection 

17 (c) are not fully implemented or are not effective— 

18 ‘‘(1) no product from such facility enters com19 merce; and 

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

21 likelihood of recurrence of the implementation failure. 

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

23 a facility shall ensure that— 

24 ‘‘(1) the preventive controls identified under sub25 section (c) have been validated as adequate to control 


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1 the hazards identified in the hazard analysis under 

2 subsection (b)(3); 

3 ‘‘(2) the facility is conducting monitoring in ac4 cordance with subsection (d); 

5 ‘‘(3) the facility is taking effective corrective ac6 tions under subsection (e); and 

7 ‘‘(4) the preventive controls are effectively pre8 venting, eliminating, or reducing to an acceptable 

9 level the occurrence of identified hazards, including 

10 through the use of environmental and product testing 

11 programs and other appropriate means. 

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

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

14 agent of a facility shall— 

15 ‘‘(A) review the evaluation under subsection 

16 (b) for the facility and, as necessary, revise the 

17 hazard analysis under subsection (b)(3) for the 

18 facility— 

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

20 ‘‘(ii) if there is a change in the process 

21 or product that could affect the hazard 

22 analysis; and 

23 ‘‘(iii) if the Secretary determines that 

24 it is appropriate to protect public health; 

25 and 


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1 ‘‘(B) whenever there is a change in the haz2 ard analysis, revise the preventive controls under 

3 subsection (c) for the facility as necessary to en4 sure that all hazards that are reasonably likely 

5 to occur are prevented, eliminated, or reduced to 

6 an acceptable level, or document the basis for the 

7 conclusion that no such revision is needed. 

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

9 by the Secretary under this subsection shall be ordered 

10 by the Secretary or an official designated by the Sec11 retary. An official may not be so designated unless the 

12 official is the director of the district under this Act 

13 in which the article involved is located, or is an offi14 cial senior to such director. 

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

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

17 records documenting the activities described in subsections 

18 (a) through (g). 

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

20 ‘‘(1) FACILITY.—The term ‘facility’ means a do21 mestic facility or a foreign facility that is required to 

22 be registered under section 415. 

23 ‘‘(2) PREVENTIVE CONTROLS.—The term ‘preven24 tive controls’ means those risk-based procedures, prac25 tices, and processes that a person knowledgeable about 


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1 the safe manufacturing, processing, packing, trans2 porting, or holding of food would employ to prevent, 

3 eliminate, or reduce to an acceptable level the hazards 

4 identified in the hazard analysis under subsection 

5 (b)(3) and that are consistent with the current sci6 entific understanding of safe food manufacturing, 

7 processing, packing, transporting, or holding at the 

8 time of the analysis. Those procedures, practices, and 

9 processes shall include the following, as appropriate: 

10 ‘‘(A) Sanitation procedures and practices. 

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

12 hygiene training. 

13 ‘‘(C) Process controls. 

14 ‘‘(D) An allergen control program to mini15 mize potential allergic reactions in humans from 

16 ingestion of, or contact with, human and animal 

17 food. 

18 ‘‘(E) Good manufacturing practices. 

19 ‘‘(F) Verification procedures, practices, and 

20 processes for suppliers and incoming ingredients, 

21 which may include onsite auditing of suppliers 

22 and testing of incoming ingredients. 

23 ‘‘(G) Other procedures, practices, and proc24 esses established by the Secretary under sub25 section (c)(2). 


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

2 OCCUR.—A food safety hazard that is reasonably like3 ly to occur is one for which a prudent person who, 

4 as applicable, manufactures, processes, packs, trans5 ports, or holds food, would establish controls because 

6 experience, illness data, scientific reports, or other in7 formation provides a basis to conclude that there is 

8 a reasonable possibility that the hazard will occur in 

9 the type of food being manufactured, processed, 

10 packed, transported, or held in the absence of those 

11 controls. 

12 ‘‘SEC. 418A. FOOD SAFETY PLAN. 

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

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

15 interstate commerce any shipment of food, the owner, oper16 ator, or agent of the facility shall develop and implement 

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

18 a ‘food safety plan’). 

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

20 each of the following elements: 

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

22 conducted under section 418. 

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

24 being implemented under subsection 418(c), including 


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1 those to address hazards or conditions identified by 

2 the Secretary under subsection 418(b)(2). 

3 ‘‘(3) A description of the procedures for moni4 toring preventive controls. 

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

6 corrective actions. 

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

8 the preventive controls, including validation, review 

9 of monitoring and corrective action records, and pro10 cedures for determining whether the preventive con11 trols are effectively preventing, eliminating, or reduc12 ing to an acceptable level the occurrence of identified 

13 hazards or conditions, including the use of environ14 mental and product testing programs. 

15 ‘‘(6) A description of the facility’s recordkeeping 

16 procedures. 

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

18 the recall of articles of food, whether voluntarily or 

19 when required under section 422. 

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

21 tracing the distribution history of articles of food, 

22 whether voluntarily or when required under section 

23 414. 

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

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1 ents or components used in making the food manufac2 tured, processed, packed, transported, or held by such 

3 facility. 

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

5 implement the science-based performance standards 

6 issued under section 419.’’. 

7 (3) GUIDANCE OR REGULATIONS.— 

8 (A) IN GENERAL.—The Secretary of Health 

9 and Human Services (referred to in this sub10 section as the ‘‘Secretary’’) shall issue guidance 

11 or promulgate regulations to establish science12 based standards for conducting a hazard anal13 ysis, documenting hazards, identifying and im14 plementing preventive controls, and documenting 

15 the implementation of the preventive controls, in16 cluding verification and corrective actions under 

17 sections 418 and 418A of the Federal Food, 

18 Drug, and Cosmetic Act (as added by paragraph 

19 (2)). 

20 (B) INTERNATIONAL STANDARDS.—In 

21 issuing guidance or regulations under subpara22 graph (A), the Secretary shall review inter23 national hazard analysis and preventive control 

24 standards that are in existence on the date of the 

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1 lines or regulations to ensure that the programs 

2 under sections 418 and 418A of the Federal 

3 Food, Drug, and Cosmetic Act (as added by 

4 paragraph (2)) are consistent, to the extent the 

5 Secretary determines practicable and appro6 priate, with such standards. 

7 (C) AUTHORITY WITH RESPECT TO CERTAIN

8 FACILITIES.—The Secretary may, by regulation, 

9 exempt or modify the requirements for compli10 ance under this section and the amendments 

11 made by this section with respect to facilities 

12 that are solely engaged in— 

13 (i) the production of food for animals 

14 other than man or the storage of packaged 

15 foods that are not exposed to the environ16 ment; or 

17 (ii) the storage of raw agricultural 

18 commodities for further processing. 

19 (D) SMALL BUSINESSES.—The Secretary— 

20 (i) shall consider the impact of any 

21 guidance or regulations under this section 

22 on small businesses; and 

23 (ii) shall issue guidance to assist small 

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1 ments of this section and the amendments 

2 made by this section. 

3 (4) NO EFFECT ON EXISTING HACCP AUTHORI4 TIES.—Nothing in this section or the amendments 

5 made by this section limits the authority of the Sec6 retary under the Federal Food, Drug, and Cosmetic 

7 Act (21 U.S.C. 301 et seq.) or the Public Health Serv8 ice Act (42 U.S.C. 201 et seq.), as in effect on the day 

9 before the date of the enactment of this Act, to revise, 

10 issue, or enforce product- and category-specific regula11 tions, such as the Seafood Hazard Analysis Critical 

12 Controls Points Program, the Juice Hazard Analysis 

13 Critical Control Program, and the Thermally Proc14 essed Low-Acid Foods Packaged in Hermetically 

15 Sealed Containers standards. 

16 (5) CONSIDERATION.—When implementing sec17 tions 418 and 418A of the Federal Food, Drug, and 

18 Cosmetic Act, as added by paragraph (2), the Sec19 retary may take into account differences between food 

20 intended for human consumption and food intended 

21 for consumption by animals other than man. 

22 (6) EFFECTIVE DATE.— 

23 (A) GENERAL RULE.—The amendments 

24 made by subsection (a) and this subsection shall 


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1 take effect 18 months after the date of the enact2 ment of this Act. 

3 (B) EXCEPTIONS.—Notwithstanding sub4 paragraph (A)— 

5 (i) the amendments made by subsection 

6 (a) and this subsection shall apply to a 

7 small business (as defined by the Secretary) 

8 after the date that is 2 years after the date 

9 of the enactment of this Act; and 

10 (ii) the amendments made by sub11 section (a) and this subsection shall apply 

12 to a very small business (as defined by the 

13 Secretary) after the date that is 3 years 

14 after the date of the enactment of this Act. 

15 (b) FINISHED PRODUCT TEST RESULTS FROM CAT16 EGORY 1 FACILITIES.— 

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

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

19 adding at the end the following: 

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

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

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

23 341 et seq.) is amended by adding at the end the fol24 lowing: 


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1 ‘‘SEC. 418B. FINISHED PRODUCT TEST RESULTS FROM CAT2 EGORY 1 FACILITIES. 

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

4 subsection (c), the Secretary shall require, after public no5 tice and an opportunity for comment, the submission to the 

6 Secretary of finished product test results by the owner, oper7 ator, or agent of each category 1 facility subject to good 

8 manufacturing practices regulations documenting the pres9 ence of contaminants in food in the possession or control 

10 of such facility posing a risk of severe adverse health con11 sequences or death. 

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

13 submissions under subsection (a)— 

14 ‘‘(1) as the Secretary determines feasible and ap15 propriate; and 

16 ‘‘(2) taking into consideration available data 

17 and information on the potential risks posed by the 

18 facility. 

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

20 subsection is the sooner of— 

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

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

23 and 

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

25 enactment of this section. 


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

2 2 or more pilot projects to evaluate the feasibility of col3 lecting positive finished product testing results from cat4 egory 1 facilities, including the value and feasibility of re5 porting corrective actions taken when positive finished 

6 product test results are reported to the Secretary. 

7 ‘‘(e) FEASIBILITY STUDY.—The Secretary shall assess 

8 the feasibility and benefits of the reporting by facilities sub9 ject to good manufacturing practices regulations of appro10 priate finished product testing results from category 1 fa11 cilities to the Secretary, including the extent to which the 

12 collection of such finished product testing results will help 

13 the Secretary assess the risk presented by a facility or prod14 uct category. 

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

16 construed— 

17 ‘‘(1) to require the Secretary to mandate testing 

18 or submission of test results that the Secretary deter19 mines would not provide useful information in assess20 ing the potential risk presented by a facility or prod21 uct category; or 

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

23 other provisions of law to require any person to pro24 vide access, or to submit information or test results, 

25 to the Secretary, including the ability of the Secretary 


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1 to require field or other testing and to obtain test re2 sults in the course of an investigation of a potential 

3 food-borne illness or contamination incident. 

4 ‘‘(g) DEFINITION.—In this section, the term ‘category 

5 1 facility’ means a category 1 facility within the meaning 

6 of section 704(h).’’. 

7 SEC. 103. PERFORMANCE STANDARDS. 

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

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

10 at the end the following: 

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

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

13 standards issued under section 419.’’. 

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

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

16 adding at the end the following: 

17 ‘‘SEC. 419. PERFORMANCE STANDARDS. 

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

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

20 evaluate epidemiological data and other appropriate 

21 sources of information, including research under section 

22 123 of the Food Safety Enhancement Act of 2009, to iden23 tify the most significant food-borne contaminants and the 

24 most significant resulting hazards. The Secretary shall 

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1 tion, science-based performance standards (which may in2 clude action levels) applicable to foods or food classes, as 

3 appropriate, to minimize to an acceptable level, prevent, 

4 or eliminate the occurrence of such hazards. Such standards 

5 shall be applicable to foods and food classes. 

6 ‘‘(b) LIST OF CONTAMINANTS.—Following each review 

7 under subsection (a), the Secretary shall publish in the Fed8 eral Register a list of food-borne contaminants that have 

9 the greatest adverse impact on public health. In deter10 mining whether a particular food-borne contaminant 

11 should be added to such list, the Secretary shall consider 

12 the number and severity of illnesses and the number of 

13 deaths associated with the foods associated with such con14 taminants. 

15 ‘‘(c) REVOCATION BY SECRETARY.—All performance 

16 standards of the Food and Drug Administration applicable 

17 to foods or food classes in effect on the date of the enactment 

18 of this section, or issued under this section, shall remain 

19 in effect until revised or revoked by the Secretary.’’. 

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

21 and Human Services shall submit to the Congress by March 

22 30th of the year following each review under section 419 

23 of the Federal Food, Drug, and Cosmetic Act, as added by 

24 subsection (b), a report on the results of such review and 

25 the Secretary’s plans to address the significant food-borne 


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1 hazards identified, or the basis for not addressing any sig2 nificant food-borne hazards identified, including any re3 source limitations or limitations in data that preclude fur4 ther action at that time. 

5 SEC. 104. SAFETY STANDARDS FOR PRODUCE AND CERTAIN 

6 OTHER RAW AGRICULTURAL COMMODITIES. 

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

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

9 by adding at the end the following: 

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

11 sorted, transported, or held under conditions that do not 

12 meet the standards established under section 419A.’’. 

13 (b) STANDARDS.—Chapter IV (21 U.S.C. 341 et seq.), 

14 as amended by sections 102(b) and 103(b), is amended by 

15 adding at the end the following: 

16 ‘‘SEC. 419A. SAFETY STANDARDS FOR PRODUCE AND CER17 TAIN OTHER RAW AGRICULTURAL COMMOD18 ITIES. 

19 ‘‘(a) STANDARDS.—The Secretary shall establish by 

20 regulation scientific and risk-based standards for the safe 

21 growing, harvesting, processing, packing, sorting, trans22 porting, and holding of those types of raw agricultural com23 modities— 

24 ‘‘(1) that are from a plant or a fungus; and 


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1 ‘‘(2) for which the Secretary has determined that 

2 such standards are reasonably necessary to minimize 

3 the risk of serious adverse health consequences or 

4 death to humans or animals. 

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

6 (a)— 

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

8 and practices as the Secretary determines to be rea9 sonably necessary— 

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

11 or reasonably foreseeable biological, chemical, 

12 and physical hazards, including hazards that 

13 occur naturally, may be unintentionally intro14 duced, or may be intentionally introduced, in15 cluding by acts of terrorism, into raw agricul16 tural commodities that are from a plant or a 

17 fungus; and 

18 ‘‘(B) to provide reasonable assurances that 

19 such commodity is not adulterated under section 

20 402; 

21 ‘‘(2) may include, with respect to growing, har22 vesting, processing, packing, sorting, transporting, 

23 and storage operations, standards for safety as the 

24 Secretary determines to be reasonably necessary; 


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1 ‘‘(3) may include standards addressing manure 

2 use, water quality, employee hygiene, sanitation and 

3 animal control, and temperature controls, as the Sec4 retary determines to be reasonably necessary; 

5 ‘‘(4) may include standards for such other ele6 ments as the Secretary determines necessary to carry 

7 out subsection (a); 

8 ‘‘(5) shall provide a reasonable period of time for 

9 compliance, taking into account the needs of small 

10 businesses for additional time to comply; 

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

12 and enforcement activities; 

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

14 with ensuring enforceable public health protection, the 

15 impact on small-scale and diversified farms, and on 

16 wildlife habitat, conservation practices, watershed17 protection efforts, and organic production methods; 

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

19 and training with other government agencies, univer20 sities, private entities, and others with experience 

21 working directly with farmers; and 

22 ‘‘(9) may provide for recognition through guid23 ance of other existing publicly available procedures, 

24 processes, and practices that the Secretary determines 


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1 to be equivalent to those established under paragraph 

2 (1). 

3 ‘‘(c) ENFORCEMENT.—The Secretary may coordinate 

4 with the Secretary of Agriculture and may contract and 

5 coordinate with the agency or department designated by the 

6 Governor of each State to perform activities to ensure com7 pliance with this section.’’. 

8 (c) TIMING.— 

9 (1) PROPOSED RULE.—Not later than 18 months 

10 after the date of enactment of this Act, the Secretary 

11 of Health and Human Services shall issue a proposed 

12 rule to carry out section 419A of the Federal Food, 

13 Drug, and Cosmetic Act, as added by subsection (b). 

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

15 such date, the Secretary of Health and Human Serv16 ices shall issue a final rule under such section. 

17 (d) NO EFFECT ON EXISTING HACCP AUTHORI18 TIES.—Nothing in this section or the amendments made by 

19 this section limits the authority of the Secretary under the 

20 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 

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

22 seq.), as in effect on the day before the date of the enactment 

23 of this Act, to revise, issue, or enforce product- and category24 specific regulations, such as the Seafood Hazard Analysis 

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1 ysis Critical Control Program, and the Thermally Processed 

2 Low-Acid Foods Packaged in Hermetically Sealed Con3 tainers standards. 

4 (e) UPDATE EXISTING GUIDANCE.—Not later than 1 

5 year after the date of the enactment of this Act, the Sec6 retary of Health and Human Services shall update the 

7 guidance document entitled ‘‘Guidance For Industry: Guide 

8 To Minimize Microbial Food Safety Hazards For Fresh 

9 Fruits And Vegetables’’ (issued on October 26, 1998) in ac10 cordance with this section and the amendments made by 

11 this section. 

12 SEC. 105. RISK-BASED INSPECTION SCHEDULE. 

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

14 amended by adding at the end the following: 

15 ‘‘(h)(1) Each facility registered under section 415 shall 

16 be inspected— 

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

18 under section 702 or other statutory authority by the 

19 Secretary; 

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

21 or local official recognized by the Secretary under 

22 paragraph (2); or 

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

24 representative of a country that is recognized by the 

25 Secretary under paragraph (2); and 


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

2 risk-based schedule. 

3 ‘‘(2) For purposes of paragraph (1)(A), the Sec4 retary— 

5 ‘‘(A) may recognize Federal, State, and local of6 ficials and agencies and representatives of foreign 

7 countries as meeting standards established by the Sec8 retary for conducting inspections under this Act; and 

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

10 of specific commodities or food types. 

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

12 shall be implemented beginning not later than 18 months 

13 after the date of the enactment of this subsection. 

14 ‘‘(4) Such risk-based schedule shall provide for a fre15 quency of inspections commensurate with the risk presented 

16 by the facility and shall be based on the following categories 

17 and inspection frequencies: 

18 ‘‘(A) CATEGORY 1.—A category 1 food facility is 

19 a high-risk facility that manufactures or processes 

20 food. The Secretary shall randomly inspect a category 

21 1 food facility at least every 6 to 12 months. 

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

23 a low-risk facility that manufactures or processes food 

24 or a facility that packs or labels food. The Secretary 


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1 shall randomly inspect a category 2 facility at least 

2 every 18 months to 3 years. 

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

4 a facility that holds food. The Secretary shall ran5 domly inspect a category 3 facility at least every 5 

6 years. 

7 ‘‘(5) The Secretary— 

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

9 facilities within a category under paragraph (4); 

10 ‘‘(B) may alter the inspection frequencies speci11 fied in paragraph (4) based on the need to respond 

12 to food-borne illness outbreaks and food recalls; 

13 ‘‘(C) may inspect a facility more frequently than 

14 the inspection frequency provided by paragraph (4); 

15 ‘‘(D) beginning 6 months after submitting the re16 port required by section 105(b)(2) of the Food Safety 

17 Enhancement Act of 2009, may— 

18 ‘‘(i) publish in the Federal Register adjust19 ments to the inspection frequencies specified in 

20 subparagraphs (B) and (C) of paragraph (4) for 

21 category 2 and category 3 food facilities, which 

22 adjustments shall be in accordance with the Sec23 retary’s recommendations in such report; and 

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

25 adjustments; and 


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

2 and (C), may not alter the inspection frequency speci3 fied in paragraph (4)(A) for category 1 food facilities. 

4 ‘‘(6) In determining the appropriate frequency of in5 spection, the Secretary shall consider— 

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

7 packed, or held at the facility; 

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

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

10 for import into the United States food is certified by 

11 a qualified certifying entity in accordance with sec12 tion 801(p); and 

13 ‘‘(D) such other factors as the Secretary deter14 mines by guidance to be relevant to assessing the risk 

15 presented by the facility.’’. 

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

17 FACILITIES.— 

18 (1) ANNUAL REPORT.—Not later than December 

19 31 of each year, the Secretary of Health and Human 

20 Services shall submit a report to the Committee on 

21 Energy and Commerce of the House of Representa22 tives and the Committee on Health, Education, 

23 Labor, and Pensions of the Senate describing— 

24 (A) the number of foreign and domestic fa25 cilities, by risk category, inspected under the 


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1 risk-based inspection schedule established under 

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

3 Cosmetic Act, as added by subsection (a), in the 

4 preceding fiscal year; and 

5 (B) the costs of implementing the risk-based 

6 inspection schedule for the preceding 12 months. 

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

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

9 Secretary of Health and Human Services shall sub10 mit a report to the Committee on Energy and Com11 merce of the House of Representatives and the Com12 mittee on Health, Education, Labor, and Pensions of 

13 the Senate describing recommendations on the risk14 based inspection schedule under section 704(h) of the 

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

16 subsection (a), including recommendations for adjust17 ments to the timing of the schedule and other ways 

18 to improve the risk-based allocation of resources by 

19 the Food and Drug Administration. In making such 

20 recommendations, the Secretary shall consider the fol21 lowing— 

22 (A) the nature of the food products being 

23 processed, stored, or transported; 

24 (B) the manner in which food products are 

25 processed, stored, or transported; 


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1 (C) the inherent likelihood that the products 

2 will contribute to the risk of food-borne illness; 

3 (D) the best available evidence concerning 

4 reported illnesses associated with the foods proc5 essed, stored, held, or transported in the category 

6 of facilities; and 

7 (E) the overall record of compliance with 

8 food safety law among facilities in the category, 

9 including compliance with applicable perform10 ance standards and the frequency of recalls. 

11 SEC. 106. ACCESS TO RECORDS. 

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

13 (21 U.S.C. 350c) is amended to read as follows: 

14 ‘‘(a) RECORDS ACCESS.— 

15 ‘‘(1) RECORDS ACCESS DURING AN INSPEC16 TION.— 

17 ‘‘(A) IN GENERAL.—Each person who pro18 duces, manufactures, processes, packs, transports, 

19 distributes, receives, or holds an article of food in 

20 the United States or for import into the United 

21 States shall, at the request of an officer or em22 ployee duly designated by the Secretary, permit 

23 such officer or employee, upon presentation of 

24 appropriate credentials, at reasonable times and 

25 within reasonable limits and in a reasonable 


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1 manner, to have access to and copy all records 

2 relating to such article bearing on whether the 

3 food may be adulterated, misbranded, or other4 wise in violation of this Act, including all 

5 records collected or developed to comply with sec6 tion 418 or 418A. 

7 ‘‘(B) SCOPE OF RECORDS.—The require8 ment under subparagraph (A) applies to all 

9 records relating to the production, manufacture, 

10 processing, packing, transporting, distribution, 

11 receipt, holding, or importation of such article 

12 maintained by or on behalf of such person in 

13 any format (including paper and electronic for14 mats) and at any location. 

15 ‘‘(C) IMMEDIATE AVAILABILITY WITH NO16 TICE.—Records not required to be made avail17 able immediately on commencement of an in18 spection under subparagraph (A) shall nonethe19 less be made available immediately on com20 mencement of such an inspection if, by a reason21 able time before such inspection, the Secretary by 

22 letter to the person identifies the records to be 

23 made available during such inspection. 


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1 ‘‘(2) ADDITIONAL AUTHORITIES TO ACCESS

2 RECORDS REMOTELY; SUBMISSION OF RECORDS TO

3 THE SECRETARY.— 

4 ‘‘(A) REMOTE ACCESS IN EMERGENCIES.—If 

5 the Secretary has a reasonable belief that an ar6 ticle of food presents a threat of serious adverse 

7 health consequences or death to humans or ani8 mals, the Secretary may require each person who 

9 manufactures, processes, packs, transports, dis10 tributes, receives, holds, or imports such article 

11 of food, or any article of food that the Secretary 

12 determines may be affected in a similar manner, 

13 to submit to the Secretary all records reasonably 

14 related to such article of food as soon as is rea15 sonably practicable, after receiving written no16 tice (including by notice served personally and 

17 outside normal business hours to an agent iden18 tified under subparagraph (E) or (F) of section 

19 415(a)(2)) of such requirement. 

20 ‘‘(B) REMOTE ACCESS TO RECORDS RE21 LATED TO FOOD SAFETY PLANS.—With respect to 

22 a facility subject to section 418 and 418A, the 

23 Secretary may require the owner, operator, or 

24 agent of such facility to submit to the Secretary, 

25 as soon as reasonably practicable after receiving 


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1 written notice of such requirement, the food safe2 ty plan, supporting information relied on by the 

3 facility to select the preventive controls to in4 clude in its food safety plan, and documentation 

5 of corrective actions, if any, taken under section 

6 418(e) within the preceding 2 years. 

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

8 records required to be submitted to the Secretary 

9 under subparagraph (A) or (B) are available in 

10 electronic format, such records shall be submitted 

11 electronically unless the Secretary specifies other12 wise in the notice under such subparagraph.’’. 

13 (b) REGULATIONS CONCERNING RECORDKEEPING.— 

14 (1) AMENDMENT.—Subsection (b) of section 414 

15 (21 U.S.C. 350c) is amended to read as follows: 

16 ‘‘(b) REGULATIONS CONCERNING RECORDKEEPING.— 

17 The Secretary, in consultation and coordination, as appro18 priate, with other Federal departments and agencies with 

19 responsibilities for regulating food safety, may by regula20 tion establish requirements regarding the establishment and 

21 maintenance, for not longer than 3 years, of records by per22 sons who produce, manufacture, process, pack, transport, 

23 distribute, receive, or hold food in the United States or for 

24 import into the United States. The Secretary shall take into 

25 account the size of a business in promulgating regulations 


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1 under this section. The only distribution records which may 

2 be required of restaurants under this subsection are those 

3 showing the restaurant’s suppliers and subsequent distribu4 tion other than to consumers.’’. 

5 (2) APPLICATION.—The Secretary of Health and 

6 Human Services shall promulgate revised regulations 

7 to implement section 414(b) of the Federal Food, 

8 Drug, and Cosmetic Act, as amended by this sub9 section. Section 414(b) of the Federal Food, Drug, 

10 and Cosmetic Act and regulations thereunder, as in 

11 effect on the day before the date of the enactment of 

12 this Act, shall apply to acts and omissions occurring 

13 before the effective date of such revised regulations. 

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

15 (21 U.S.C. 374(a)(1)) is amended— 

16 (1) in the first sentence— 

17 (A) by inserting ‘‘farm,’’ before ‘‘factory’’ 

18 each place it appears; and 

19 (B) by inserting ‘‘produced,’’ before ‘‘manu20 factured’’; 

21 (2) in the second sentence— 

22 (A) by striking ‘‘(excluding farms and res23 taurants)’’; 

24 (B) by inserting ‘‘produces,’’ before ‘‘manu25 factures’’; 


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1 (C) by inserting ‘‘receives,’’ before ‘‘holds’’; 

2 (D) by striking ‘‘described in section 414’’ 

3 and inserting ‘‘described in or required under 

4 section 414’’; and 

5 (E) by striking ‘‘when the Secretary has a 

6 reasonable belief that an article of food is adul7 terated and presents a threat of serious adverse 

8 health consequences or death to humans or ani9 mals’’ and inserting ‘‘bearing on whether such 

10 food is adulterated, misbranded, or otherwise in 

11 violation of this Act, including all records col12 lected or developed to comply with section 418 or 

13 418A’’; and 

14 (3) in the fourth sentence— 

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

16 and inserting ‘‘either of the preceding two sen17 tences’’; and 

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

19 ‘‘financial data,’’. 

20 SEC. 107. TRACEABILITY OF FOOD. 

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

22 331(e)) is amended by inserting ‘‘, the violation of any re23 quirement of the food tracing system under section 414(c);’’ 

24 before ‘‘or the refusal to permit access to or verification or 

25 copying of any such required record’’. 


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

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

3 414 have not been complied with regarding such article,’’ 

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

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

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

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

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

9 (2) by inserting after subsection (b) the fol10 lowing: 

11 ‘‘(c) TRACING SYSTEM FOR FOOD.— 

12 ‘‘(1) IN GENERAL.—The Secretary shall by regu13 lation establish a tracing system for food that is lo14 cated in the United States or is for import into the 

15 United States. 

16 ‘‘(2) INFORMATION GATHERING.— 

17 ‘‘(A) TRACING TECHNOLOGIES.—Before 

18 issuing a proposed regulation under this sub19 section, the Secretary shall— 

20 ‘‘(i) identify technologies and meth21 odologies for tracing the distribution history 

22 of a food that are, or may be, used by mem23 bers of different sectors of the food industry, 

24 including technologies and methodologies to 

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1 tures, processes, pack, transports, or holds a 

2 food to— 

3 ‘‘(I) maintain the full pedigree of 

4 the origin and previous distribution 

5 history of the food; 

6 ‘‘(II) link that history with the 

7 subsequent distribution of the food; 

8 ‘‘(III) establish and maintain a 

9 system for tracing the food that is 

10 interoperable with the systems estab11 lished and maintained by other such 

12 persons; and 

13 ‘‘(IV) use a unique identifier for 

14 each facility owned or operated by such 

15 person for such purpose, as specified 

16 under section 911; and 

17 ‘‘(ii) to the extent practicable, assess— 

18 ‘‘(I) the costs and benefits associ19 ated with the adoption and use of such 

20 technologies; 

21 ‘‘(II) the feasibility of such tech22 nologies for different sectors of the food 

23 industry; and 


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1 ‘‘(III) whether such technologies 

2 are compatible with the requirements 

3 of this subsection. 

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

5 proposed regulation under this subsection, the 

6 Secretary shall conduct not less than 2 public 

7 meetings in diverse geographical areas of the 

8 United States to provide persons in different re9 gions an opportunity to provide input and infor10 mation to the Secretary. 

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

12 proposed regulation under this subsection, the 

13 Secretary shall conduct 1 or more pilot projects 

14 in coordination with 1 or more sectors of the 

15 food industry to explore and evaluate tracing 

16 systems for food. 

17 ‘‘(3) REGULATION.—Taking into account infor18 mation obtained through information gathering under 

19 paragraph (2), the Secretary shall issue regulations 

20 establishing a tracing system that enables the Sec21 retary to identify each person who grows, produces, 

22 manufactures, processes, packs, transports, holds, or 

23 sells such food in as short a timeframe as practicable 

24 but no longer than 2 business days. The Secretary 

25 may include in such regulation— 


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1 ‘‘(A) the establishment and maintenance of 

2 lot numbers; 

3 ‘‘(B) a standardized format for pedigree in4 formation; and 

5 ‘‘(C) the use of a common nomenclature for 

6 food. 

7 ‘‘(4) EXEMPTIONS.— 

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

9 exempt from the requirements of this subsection 

10 if such food is— 

11 ‘‘(i) produced on a farm or fishery (in12 cluding an oyster bed, a wild fishery, an 

13 aquaculture facility, a fresh water fishery, 

14 and a saltwater fishery); and 

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

16 agent in charge of such farm or fishery di17 rectly to a consumer or to a restaurant or 

18 grocery store. 

19 ‘‘(B) OTHER FOODS.—The Secretary may 

20 by notice in the Federal Register exempt a food 

21 or a type of facility, farm, or restaurant from, 

22 or modify the requirements with respect to, the 

23 requirements of this subsection if the Secretary 

24 determines that a tracing system for such food or 


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1 type of facility, farm, or restaurant is not nec2 essary to protect the public health. 

3 ‘‘(C) PREVIOUS SOURCES AND SUBSEQUENT

4 RECIPIENTS.—For a food covered by an exemp5 tion under subparagraph (B), the Secretary shall 

6 require each person who produces, manufactures, 

7 processes, packs, transports, or holds such food to 

8 maintain records to identify the immediate pre9 vious sources of such food and its ingredients 

10 and the immediate subsequent recipients of such 

11 food. 

12 ‘‘(D) RESTAURANTS AND GROCERY

13 STORES.—For a food covered by an exemption 

14 under subparagraph (A), restaurants and gro15 cery stores shall keep records documenting the 

16 farm that was the source of the food. 

17 ‘‘(E) FARMS AND FISHERIES.—For a food 

18 covered by an exemption under subparagraph 

19 (A), farms and fisheries shall keep records, in 

20 electronic or non-electronic format, for at least 6 

21 months documenting the restaurant or grocery 

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


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1 SEC. 108. REINSPECTION AND FOOD RECALL FEES APPLICA2 BLE TO FACILITIES. 

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

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

5 amended by adding at the end the following: 

6 ‘‘SEC. 743A. REINSPECTION AND FOOD RECALL FEES APPLI7 CABLE TO FACILITIES. 

8 ‘‘(a) IN GENERAL.—The Secretary shall assess and col9 lect fees from each entity in a fiscal year— 

10 ‘‘(1) that— 

11 ‘‘(A) during such fiscal year commits a vio12 lation of any requirement of this Act relating to 

13 food, including any such requirement relating to 

14 good manufacturing practices; and 

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

16 additional inspection by the Food and Drug Ad17 ministration; or 

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

19 recall. 

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

21 amount of the fees under this section to fully cover the costs 

22 of— 

23 ‘‘(1) in the case of fees collected under subsection 

24 (a)(1), conducting the additional inspections referred 

25 to in such subsection; and 


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1 ‘‘(2) in the case of fees collected under subsection 

2 (a)(2), conducting food recall activities, including 

3 technical assistance, follow-up effectiveness checks, 

4 and public notifications, during the fiscal year in5 volved. 

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

7 ‘‘(1) IN GENERAL.—Fees authorized under sub8 section (a) shall be collected and available for obliga9 tion only to the extent and in the amount provided 

10 in advance in appropriations Acts. Such fees are au11 thorized to remain available until expended. Such 

12 sums as may be necessary may be transferred from 

13 the Food and Drug Administration salaries and ex14 penses appropriation account without fiscal year lim15 itation to such appropriation account for salaries and 

16 expenses with such fiscal year limitation. 

17 ‘‘(2) COLLECTIONS AND APPROPRIATIONS

18 ACTS.—The fees authorized by this section— 

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

20 an amount not to exceed the amount specified in 

21 appropriation Acts, or otherwise made available 

22 for obligation, for such fiscal year; and 

23 ‘‘(B) shall only be collected and available to 

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


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1 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For 

2 each of fiscal years 2010 through 2014, there are au3 thorized to be appropriated for fees under this section 

4 such sums as may be necessary. 

5 ‘‘(d) WAIVER.—The Secretary shall waive and, if ap6 plicable, refund the amount of any fee collected under this 

7 section from an entity as a result of a food recall that the 

8 Secretary determines was inappropriately ordered.’’. 

9 (b) EFFECTIVE DATE.—The amendment made by sub10 section (a) shall apply to additional inspections and food 

11 recall activities occurring after the date of the enactment 

12 of this Act. 

13 SEC. 109. CERTIFICATION AND ACCREDITATION. 

14 (a) MISBRANDING.— 

15 (1) IN GENERAL.—Section 403 (21 U.S.C. 343), 

16 as amended by section 101(a), is amended by adding 

17 at the end the following: 

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

19 into the United States and such shipment is in violation 

20 of section 801(p) (requiring a certification to accompany 

21 certain food shipments).’’. 

22 (2) EFFECTIVE DATE.—The amendment made by 

23 paragraph (1) shall apply to shipments offered for 

24 import on or after the date that is 3 years after the 

25 date of the enactment of this Act. 


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1 (b) CERTIFICATION OF COMPLIANCE FOR IMPORTS.— 

2 Chapter VIII (21 U.S.C. 381 et seq.) is amended— 

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

4 107(b), by inserting after the third sentence the fol5 lowing: ‘‘If an article of food being imported or of6 fered for import into the United States is not in com7 pliance with the requirement of subsection (p) (relat8 ing to certifications of compliance with this Act), then 

9 such article shall be refused admission.’’; 

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

11 striking ‘‘the fourth sentence’’ and inserting ‘‘the fifth 

12 sentence’’; and 

13 (3) by adding at the end of section 801 the fol14 lowing: 

15 ‘‘(p) CERTIFICATIONS CONCERNING IMPORTED ARTI16 CLES.— 

17 ‘‘(1) IN GENERAL.— 

18 ‘‘(A) REQUIREMENT.—The Secretary shall 

19 require, as an additional condition of granting 

20 admission to an article of food being imported or 

21 offered for import into the United States, that a 

22 qualified certifying entity provide a certification 

23 that the article complies with specified require24 ments of this Act if— 


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1 ‘‘(i) for food imported from a par2 ticular country or region, based on the ade3 quacy of government controls in such coun4 try or region or other information relevant 

5 to such food, certification would assist the 

6 Secretary in determining whether to refuse 

7 to admit such article under subsection (a); 

8 ‘‘(ii) for a type of food that could pose 

9 a significant risk to health, certification 

10 would assist the Secretary in determining 

11 whether such article poses such risk; or 

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

13 particular country, there is an agreement 

14 between the Secretary and the government 

15 of such country providing for such certifi16 cation. 

17 ‘‘(B) CONTENTS OF CERTIFICATION.—Such 

18 certification shall include such information re19 garding compliance as the Secretary may speci20 fy, and may be provided in the form of ship21 ment-specific certificates, a listing of certified fa22 cilities or other entities, or in such other form as 

23 the Secretary may specify. 

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1 ceptance of certifications from a qualified certi2 fying entity, the Secretary shall require the 

3 qualified certifying entity to notify the Secretary 

4 whenever the qualified certifying entity cancels 

5 or suspends the certification of any facility or 

6 other entity included in a listing under subpara7 graph (B). 

8 ‘‘(2) QUALIFIED CERTIFYING ENTITY.—For pur9 poses of this subsection, the term ‘qualified certifying 

10 entity’ means— 

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

12 government of the country from which the article 

13 originated, as designated by such government or 

14 the Secretary; or 

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

16 the Secretary or an accredited body recognized 

17 by the Secretary to be qualified to provide a cer18 tification under paragraph (1). 

19 ‘‘(3) NO CONFLICTS OF INTEREST.— 

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

21 issue regulations to ensure that any qualified 

22 certifying entity and its auditors are free from 

23 conflicts of interest. 

24 ‘‘(B) REGULATIONS.—Such regulations 

25 shall require that— 


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1 ‘‘(i) the qualified certifying entity shall 

2 have a committee or management structure 

3 for safeguarding impartiality; 

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

5 qualified certifying entity and auditors act6 ing for the qualified certifying entity shall 

7 be written; 

8 ‘‘(iii) the qualified certifying entity 

9 shall not be owned, operated, or controlled 

10 by a producer, manufacturer, processor, 

11 packer, holder, supplier, or vendor of any 

12 article of the type it certifies; 

13 ‘‘(iv) the qualified certifying entity 

14 shall not have any ownership or financial 

15 interest in any product, producer, manufac16 turer, processor, packer, holder, supplier or 

17 vendor of the type it certifies; 

18 ‘‘(v) no auditor acting for the qualified 

19 certifying entity (or spouse or minor chil20 dren) shall have any significant ownership 

21 or other financial interest regarding any 

22 product of the type it certifies; 

23 ‘‘(vi) the qualified certifying entity 

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1 nancial interests of the personnel involved 

2 in audits; 

3 ‘‘(vii) neither the qualified certifying 

4 entity nor any of its auditors acting for the 

5 qualified certifying entity shall participate 

6 in the production, manufacture, processing, 

7 packing, holding, promotion, or sale of any 

8 product of the type it certifies; 

9 ‘‘(viii) neither the qualified certifying 

10 entity nor any of its auditors shall provide 

11 consultative services to any facility certified 

12 by the qualified certifying entity, or the 

13 owner, operator, or agent in charge of such 

14 a facility, unless the qualified certifying en15 tity has procedures in place, approved by 

16 the Secretary, to ensure separation of func17 tions between auditors providing consult18 ative services and auditors providing cer19 tification services under this subsection; 

20 ‘‘(ix) no auditors acting for the quali21 fied certifying entity shall participate in an 

22 audit of a facility they were employed by 

23 within the last 12 months; 

24 ‘‘(x) fees charged or accepted shall not 

25 be contingent or based upon the report made 


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1 by the qualified certifying entity or any 

2 personnel involved in the audit process; 

3 ‘‘(xi) neither the qualified certifying 

4 entity nor any of its auditors shall accept 

5 anything of value from anyone in connec6 tion with the facility being audited other 

7 than the audit fee; 

8 ‘‘(xii) the qualified certifying entity 

9 shall not be owned, operated, or controlled 

10 by a trade association whose member com11 panies operate facilities that it certifies; 

12 ‘‘(xiii) the qualified certifying entity 

13 and its auditors shall be free from any other 

14 conflicts of interest that threaten impar15 tiality; 

16 ‘‘(xiv) the qualified certifying entity 

17 and its auditors shall sign a statement at18 testing to compliance with the conflict of in19 terests requirements under this paragraph; 

20 and 

21 ‘‘(xv) the qualified certifying entity 

22 shall ensure that any subcontractors that 

23 might be used (such as laboratories and 

24 sampling services) provide similar assur25 ances, except that it shall not be a violation 


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1 of this subsection to the extent such sub2 contractors perform additional nutritional 

3 testing services unrelated to the testing 

4 under this subsection. 

5 ‘‘(C) ANYTHING OF VALUE.—In this para6 graph, the term ‘anything of value’ includes 

7 gifts, gratuities, reimbursement of expenses, en8 tertainment, loans, or any other form of com9 pensation in cash or in kind. 

10 ‘‘(4) RENEWAL AND REFUSAL OF CERTIFI11 CATIONS.—The Secretary shall— 

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

13 any certification provided by a qualified certi14 fying entity be renewed by such entity at such 

15 times as the Secretary determines appropriate; 

16 and 

17 ‘‘(B) refuse to accept any certification if the 

18 Secretary determines that such certification is no 

19 longer valid or reliable. 

20 ‘‘(5) ELECTRONIC SUBMISSION.—The Secretary 

21 shall provide for the electronic submission of certifi22 cations under this subsection. 

23 ‘‘(6) NO LIMIT ON AUTHORITY.—This subsection 

24 shall not be construed to limit the authority of the 

25 Secretary to conduct random inspections of imported 


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1 articles or facilities of importers, issue import alerts 

2 for detention without physical examination, require 

3 submission to the Secretary of documentation or other 

4 information about an article imported or offered for 

5 import, or to take such other steps as the Secretary 

6 deems appropriate to determine the admissibility of 

7 imported articles.’’. 

8 SEC. 110. TESTING BY ACCREDITED LABORATORIES. 

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

10 is amended by adding at the end the following: 

11 ‘‘(oo) The violation of any requirement of section 714 

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

13 (b) LABORATORY ACCREDITATION.—Subchapter A of 

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

15 at the end the following: 

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

17 ‘‘(a) IN GENERAL.— 

18 ‘‘(1) REQUIREMENT.—Whenever analytical test19 ing of an article of food is conducted as part of testi20 mony for the purposes of section 801(a), or for such 

21 other purposes as the Secretary deems appropriate 

22 through regulation or guidance, such testing shall be 

23 conducted by a laboratory that— 


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1 ‘‘(A) is accredited, for the analytical method 

2 used, by a laboratory accreditation body that has 

3 been recognized by the Secretary; and 

4 ‘‘(B) samples such article with adequate 

5 controls for ensuring the integrity of the samples 

6 analyzed. 

7 ‘‘(2) INDEPENDENCE OF LABORATORY.— 

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

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

10 finding of noncompliance by the Secretary shall 

11 be conducted by a laboratory independent of the 

12 person on whose behalf such testing is conducted 

13 and analyzed. 

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

15 may require that testing for certain products 

16 under paragraph (1) be conducted by a labora17 tory independent of the person on whose behalf 

18 such testing is conducted. 

19 ‘‘(b) RECOGNITION OF LABORATORY ACCREDITATION

20 BODIES.—The Secretary shall establish and implement a 

21 program for the recognition, based on standards the Sec22 retary deems appropriate, of laboratory accreditation bod23 ies that accredit laboratories to perform analytical testing 

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

25 regulations or guidance to implement this program. 


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1 ‘‘(c) ONSITE AUDITS.—In evaluating whether an ac2 creditation body meets, or continues to meet, the standards 

3 for recognition under subsection (b), the Secretary may— 

4 ‘‘(1) observe onsite audits of laboratories by such 

5 accreditation bodies; or 

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

7 such accreditation body under this section, upon re8 quest of an officer or employee designated by the Sec9 retary and upon presentation of appropriate creden10 tials, at reasonable times and within reasonable lim11 its and in a reasonable manner, conduct an onsite 

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

13 and copying and verification of, any related records. 

14 ‘‘(d) PUBLICATION OF LIST OF RECOGNIZED ACCREDI15 TATION BODIES.—The Secretary shall publish and main16 tain on the public Web site of the Food and Drug Adminis17 tration a list of accreditation bodies recognized by the Sec18 retary under subsection (b). 

19 ‘‘(e) NOTIFICATION OF ACCREDITATION OF LABORA20 TORY.—An accreditation body that has been recognized 

21 pursuant to this section shall promptly notify the Secretary 

22 whenever it accredits a laboratory for the purposes of this 

23 section and whenever it withdraws or suspends such accred24 itation. 


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

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

3 behalf the testing is conducted shall notify the Secretary be4 fore any sample of the article is collected. Such notice shall 

5 contain information the Secretary determines is appro6 priate to identify the article, the location of the article, and 

7 each laboratory that will analyze the sample on the person’s 

8 behalf. 

9 ‘‘(g) CONTENTS OF LABORATORY PACKAGES.—When10 ever analytical testing is conducted pursuant to subsection 

11 (a), the laboratory conducting such testing shall submit, di12 rectly to the Secretary— 

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

14 laboratory on each sample of such article; and 

15 ‘‘(2) all information the Secretary deems appro16 priate to— 

17 ‘‘(A) determine whether the laboratory is ac18 credited by a recognized laboratory accreditation 

19 body; 

20 ‘‘(B) identify the article tested; 

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

22 ‘‘(D) determine whether the requirements of 

23 this section have been met. 

24 ‘‘(h) EXIGENT CIRCUMSTANCES.—The Secretary may 

25 waive the requirement of subsection (a)(1)(A) (relating to 


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1 analytical methods) on a laboratory or method basis due 

2 to exigent or other circumstances. 

3 ‘‘(i) NO LIMIT ON AUTHORITY.—Nothing in this sec4 tion shall be construed to limit— 

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

6 act upon information from the analytical testing of 

7 food (including under this section), including deter8 mining the sufficiency of such information and test9 ing; or 

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

11 require, or consider the results of analytical testing 

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

13 SEC. 111. NOTIFICATION, NONDISTRIBUTION, AND RECALL 

14 OF ADULTERATED OR MISBRANDED FOOD. 

15 (a) PROHIBITED ACTS.—Section 301 (21 U.S.C. 331), 

16 as amended by section 110, is amended by adding at the 

17 end the following: 

18 ‘‘(pp)(1) The failure to notify the Secretary in viola19 tion of section 420(a). 

20 ‘‘(2) The failure to comply with any order issued under 

21 section 420.’’. 

22 (b) NOTIFICATION, NONDISTRIBUTION, AND RECALL OF

23 ADULTERATED OR MISBRANDED FOOD.—Chapter IV (21 

24 U.S.C. 341 et seq.), as amended by sections 102, 103, and 

25 104, is amended by adding at the end the following: 


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1 ‘‘SEC. 420. NOTIFICATION, NONDISTRIBUTION, AND RECALL 

2 OF ADULTERATED OR MISBRANDED FOOD. 

3 ‘‘(a) NOTIFICATION, NONDISTRIBUTION, AND RECALL

4 OF ADULTERATED OR MISBRANDED FOOD.— 

5 ‘‘(1) IN GENERAL.—A responsible party as that 

6 term is defined in section 417(a)(1) or a person re7 quired to register under section 801(r) that has reason 

8 to believe that an article of food when introduced into 

9 or while in interstate commerce, or while held for sale 

10 (regardless of whether the first sale) after shipment in 

11 interstate commerce, is adulterated or misbranded in 

12 a manner that presents a reasonable probability that 

13 the use or consumption of, or exposure to, the article 

14 (or an ingredient or component used in any such ar15 ticle) will cause a threat of serious adverse health con16 sequences or death to humans or animals shall, as 

17 soon as practicable, notify the Secretary of the iden18 tity and location of the article. 

19 ‘‘(2) MANNER OF NOTIFICATION.—Notification 

20 under paragraph (1) shall be made in such manner 

21 and by such means as the Secretary may require by 

22 regulation or guidance. 

23 ‘‘(b) VOLUNTARY RECALL.—The Secretary may request 

24 that any person who distributes an article of food that the 

25 Secretary has reason to believe is adulterated, misbranded, 

26 or otherwise in violation of this Act voluntarily— 


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1 ‘‘(1) recall such article; and 

2 ‘‘(2) provide for notice, including to individuals 

3 as appropriate, to persons who may be affected by the 

4 recall. 

5 ‘‘(c) ORDER TO CEASE DISTRIBUTION.—If the Sec6 retary has reason to believe that the use or consumption 

7 of, or exposure to, an article of food may cause serious ad8 verse health consequences or death to humans or animals, 

9 the Secretary shall have the authority to issue an order re10 quiring any person who distributes such article to imme11 diately cease distribution of such article. 

12 ‘‘(d) ACTION FOLLOWING ORDER.—Any person who is 

13 subject to an order under subsection (c) shall immediately 

14 cease distribution of such article and provide notification 

15 as required by such order, and may appeal within 24 hours 

16 of issuance such order to the Secretary. Such appeal may 

17 include a request for an informal hearing and a description 

18 of any efforts to recall such article undertaken voluntarily 

19 by the person, including after a request under subsection 

20 (b). Except as provided in subsection (f), an informal hear21 ing shall be held within as soon as practicable, but not later 

22 than 5 calendar days, or less as determined by the Sec23 retary, after such an appeal is filed, unless the parties joint24 ly agree to an extension. After affording an opportunity for 

25 an informal hearing, the Secretary shall determine whether 


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1 the order should be amended to require a recall of such arti2 cle. If, after providing an opportunity for such a hearing, 

3 the Secretary determines that inadequate grounds exist to 

4 support the actions required by the order, the Secretary 

5 shall vacate the order. 

6 ‘‘(e) ORDER TO RECALL.— 

7 ‘‘(1) AMENDMENT.—Except as provided under 

8 subsection (f), if after providing an opportunity for 

9 an informal hearing under subsection (d), the Sec10 retary determines that the order should be amended to 

11 include a recall of the article with respect to which 

12 the order was issued, the Secretary shall amend the 

13 order to require a recall. 

14 ‘‘(2) CONTENTS.—An amended order under 

15 paragraph (1) shall— 

16 ‘‘(A) specify a timetable in which the recall 

17 will occur; 

18 ‘‘(B) require periodic reports to the Sec19 retary describing the progress of the recall; and 

20 ‘‘(C) provide for notice, including to indi21 viduals as appropriate, to persons who may be 

22 affected by the recall. 

23 In providing for such notice, the Secretary may allow 

24 for the assistance of health professionals, State or 


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1 local officials, or other individuals designated by the 

2 Secretary. 

3 ‘‘(3) NONDELEGATION.—An amended order 

4 under this subsection shall be ordered by the Secretary 

5 or an official designated by the Secretary. An official 

6 may not be so designated unless the official is the di7 rector of the district under this Act in which the arti8 cle involved is located, or is an official senior to such 

9 director. 

10 ‘‘(f) EMERGENCY RECALL ORDER.— 

11 ‘‘(1) IN GENERAL.—If the Secretary has a rea12 sonable belief that an article of food subject to an 

13 order under subsection (c) presents an imminent 

14 threat of serious adverse health consequences or death 

15 to humans or animals, the Secretary may issue an 

16 order requiring any person who distributes such arti17 cle— 

18 ‘‘(A) to immediately recall such article; and 

19 ‘‘(B) to provide for notice, including to in20 dividuals as appropriate, to persons who may be 

21 affected by the recall. 

22 ‘‘(2) ACTION FOLLOWING ORDER.—Any person 

23 who is subject to an emergency recall order under this 

24 subsection shall immediately recall such article and 

25 provide notification as required by such order, and 


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1 may appeal within 24 hours after issuance such order 

2 to the Secretary. An informal hearing shall be held 

3 within as soon as practicable but not later than 5 cal4 endar days, or less as determined by the Secretary, 

5 after such an appeal is filed, unless the parties jointly 

6 agree to an extension. After affording an opportunity 

7 for an informal hearing, the Secretary shall deter8 mine whether the order should be amended pursuant 

9 to subsection (e)(1). If, after providing an oppor10 tunity for such a hearing, the Secretary determines 

11 that inadequate grounds exist to support the actions 

12 required by the order, the Secretary shall vacate the 

13 order. 

14 ‘‘(3) NONDELEGATION.—An order under this 

15 subsection shall be issued by the Commissioner of 

16 Food and Drugs, the Principal Deputy Commis17 sioner, or the Associate Commissioner for Regulatory 

18 Affairs of the Food and Drug Administration. 

19 ‘‘(g) NOTICE TO CONSUMERS AND HEALTH OFFI20 CIALS.—The Secretary shall, as the Secretary determines to 

21 be necessary, provide notice of a recall order under this sec22 tion to consumers to whom the article was, or may have 

23 been, distributed and to appropriate State and local health 

24 officials. 


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1 ‘‘(h) SAVINGS CLAUSE.—Nothing contained in this sec2 tion shall be construed as limiting— 

3 ‘‘(1) the authority of the Secretary to issue an 

4 order to cease distribution of, or to recall, an article 

5 under any other provision of this Act or the Public 

6 Health Service Act; or 

7 ‘‘(2) the ability of the Secretary to request any 

8 person to perform a voluntary activity related to any 

9 article subject to this Act or the Public Health Service 

10 Act.’’. 

11 (c) ARTICLES SUBJECT TO REFUSAL.—The third sen12 tence of subsection (a) of section 801 (21 U.S.C. 381), as 

13 amended by section 107(b), is amended by inserting ‘‘or (5) 

14 such article is subject to an order under section 420 to cease 

15 distribution of or recall the article,’’ before ‘‘then such arti16 cle shall be refused admission’’. 

17 (d) EFFECTIVE DATE.—Sections 301(pp)(1) and 420 

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

19 subsections (a) and (b), shall apply with respect to articles 

20 of food as of such date, not later than 1 year after the date 

21 of the enactment of this Act, as the Secretary of Health and 

22 Human Services shall specify. 


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1 SEC. 112. REPORTABLE FOOD REGISTRY; EXCHANGE OF IN2 FORMATION. 

3 (a) REPORTABLE FOOD REGISTRY.—Section 417 (21 

4 U.S.C. 350f) is amended— 

5 (1) in subsection (a)(1), by striking ‘‘means a 

6 person’’ and all that follows through the end of para7 graph (1) and inserting the following: ‘‘means— 

8 ‘‘(A) a person who submits the registration 

9 under section 415(a) for a food facility that is 

10 required to be registered under section 415(a), at 

11 which such food is manufactured, processed, 

12 packed, or held; 

13 ‘‘(B) a person who owns, operates, is an 

14 agent of, or is otherwise responsible for such food 

15 on a farm (as such term is defined in section 

16 1.227(b)(3) of title 21, Code of Federal Regula17 tions, or successor regulations) at which such 

18 food is produced for sale or distribution in inter19 state commerce; 

20 ‘‘(C) a person who owns, operates, or is an 

21 agent of a restaurant or other retail food estab22 lishment (as such terms are defined in section 

23 1.227(b) (11) and (12), respectively, of title 21, 

24 Code of Federal Regulations, or successor regula25 tions) at which such food is offered for sale; or 


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1 ‘‘(D) a person that is required to register 

2 pursuant to section 801(r) with respect to impor3 tation of such food.’’; 

4 (2) in subsection (b), by adding at the end the 

5 following: 

6 ‘‘(3) REPORTING BY RESTAURANTS AND RETAIL

7 FOOD ESTABLISHMENTS.—In addition to the elec8 tronic portal described in paragraph (1), the Sec9 retary shall make available alternative means of re10 porting under this section with respect to restaurants 

11 and other retail food establishments with limited abil12 ity for such reporting.’’; 

13 (3) in subsection (d)(1)— 

14 (A) in the matter preceding subparagraph 

15 (A), by inserting ‘‘following a timely review of 

16 any reasonably available data and information,’’ 

17 after ‘‘reportable food,’’; 

18 (B) in subparagraph (A), by striking ‘‘and’’ 

19 at the end; 

20 (C) by redesignating subparagraph (B) as 

21 subparagraph (C); and 

22 (D) by inserting after subparagraph (A) the 

23 following: 

24 ‘‘(B) submit, with such report, through the 

25 electronic portal, documentation of results from 


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1 any sampling and testing of such article, includ2 ing— 

3 ‘‘(i) analytical results from testing of 

4 such article conducted by or on behalf of the 

5 responsible party under section 418, 418A, 

6 419, 419A, or 714; 

7 ‘‘(ii) analytical results from testing 

8 conducted by or on behalf of such respon9 sible party of a component of such article; 

10 ‘‘(iii) analytical results of environ11 mental testing of any facility at which such 

12 article, or a component of such article, is 

13 manufactured, processed, packed, or held; 

14 and 

15 ‘‘(iv) any other information the Sec16 retary determines is necessary to evaluate 

17 the adulteration of such article, any compo18 nent of such article, any other article of 

19 food manufactured, processed, packed or 

20 held in the same manner as, or at the same 

21 facility as, such article, or any other article 

22 containing a component from the same 

23 source as a component of such article; and’’; 

24 and 

25 (4) in subsection (e)— 


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1 (A) in paragraph (1), by inserting ‘‘if the 

2 responsible party is required to register’’ after 

3 ‘‘415(a)(3)’’; and 

4 (B) by adding at the end the following: 

5 ‘‘(12) Such additional information as the Sec6 retary deems appropriate.’’. 

7 (b) EXCHANGE OF INFORMATION.—Section 708 (21 

8 U.S.C. 379) is amended— 

9 (1) by striking ‘‘The Secretary’’ and inserting 

10 ‘‘(a) The Secretary’’; and 

11 (2) by adding at the end the following: 

12 ‘‘(b)(1)(A) The Secretary may provide to any Federal 

13 agency acting within the scope of its jurisdiction any infor14 mation relating to food that is exempt from disclosure pur15 suant to subsection (a) of section 552 of title 5, United 

16 States Code, by reason of subsection (b)(4) of such section, 

17 or that is referred to in section 301(j) or 415(a)(4). 

18 ‘‘(B) Any such information provided to another Fed19 eral agency shall not be disclosed by such agency except in 

20 any action or proceeding under the laws of the United 

21 States to which the receiving agency or the United States 

22 is a party. 

23 ‘‘(2)(A) In carrying out this Act, the Secretary may 

24 provide to a State or local government agency any informa25 tion relating to food that is exempt from disclosure pursuVerDate Nov 24 2008 21:46 Jul 29, 2009 Jkt 079200 PO 00000 Frm 00083 Fmt 6652 Sfmt 6203 E:\BILLS\H2749.RH H2749

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1 ant to section 552(a) of title 5, United States Code, by rea2 son of subsection (b)(4) of such section, or that is referred 

3 to in section 301(j) or 415(a)(4). 

4 ‘‘(B) Any such information provided to a State or local 

5 government agency shall not be disclosed by such agency. 

6 ‘‘(3) In carrying out this Act, the Secretary may pro7 vide to any person any information relating to food that 

8 is exempt from disclosure pursuant to section 552(a) of title 

9 5, United States Code, by reason of subsection (b)(4) of such 

10 section, if the Secretary determines that providing the infor11 mation to the person is appropriate under the cir12 cumstances and the recipient provides adequate assurances 

13 to the Secretary that the recipient will preserve the con14 fidentiality of the information. 

15 ‘‘(4) In carrying out this Act, the Secretary may pro16 vide any information relating to food that is exempt from 

17 disclosure pursuant to section 552(a) of title 5, United 

18 States Code, by reason of subsection (b)(4) of such section, 

19 or that is referred to in section 301(j)— 

20 ‘‘(A) to any foreign government agency; or 

21 ‘‘(B) any international organization established 

22 by law, treaty, or other governmental action and hav23 ing responsibility— 

24 ‘‘(i) to facilitate global or regional harmoni25 zation of standards and requirements in an area 


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1 of responsibility of the Food and Drug Adminis2 tration; or 

3 ‘‘(ii) to promote and coordinate public 

4 health efforts, 

5 if the agency or organization provides adequate assur6 ances to the Secretary that the agency or organization 

7 will preserve the confidentiality of the information. 

8 ‘‘(c) Except where specifically prohibited by statute, 

9 the Secretary may disclose to the public any information 

10 relating to food that is exempt from disclosure pursuant to 

11 section 552(a) of title 5, United States Code, by reason of 

12 subsection (b)(4) of such section, if the Secretary determines 

13 that such disclosure is necessary to protect the public health. 

14 ‘‘(d) Except as provided in subsection (e), the Sec15 retary shall not be required to disclose under section 552 

16 of title 5, United States Code, or any other provision of 

17 law any information relating to food obtained from a Fed18 eral, State, or local government agency, or from a foreign 

19 government agency, or from an international organization 

20 described in subsection (b)(4), if the agency or organization 

21 has requested that the information be kept confidential, or 

22 has precluded such disclosure under other use limitations, 

23 as a condition of providing the information. 

24 ‘‘(e) Nothing in subsection (d) authorizes the Secretary 

25 to withhold information from the Congress or prevents the 


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1 Secretary from complying with an order of a court of the 

2 United States. 

3 ‘‘(f) This section shall not affect the authority of the 

4 Secretary to provide or disclose information under any 

5 other provision of law.’’. 

6 (c) CONFORMING AMENDMENT.—Section 301(j) (21 

7 U.S.C. 331(j)) is amended by striking ‘‘or to the courts 

8 when relevant in any judicial proceeding under this Act,’’ 

9 and inserting ‘‘to the courts when relevant in any judicial 

10 proceeding under this Act, or as specified in section 708,’’. 

11 SEC. 113. SAFE AND SECURE FOOD IMPORTATION PRO12 GRAM. 

13 Chapter VIII (21 U.S.C. 381 et seq.) is amended by 

14 adding at the end the following: 

15 ‘‘SEC. 805. SAFE AND SECURE FOOD IMPORTATION PRO16 GRAM. 

17 ‘‘(a) IN GENERAL.—The Secretary may establish by 

18 regulation or guidance a program that facilitates the move19 ment of food through the importation process under this Act 

20 if the importer of such 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 security 

2 controls are in place throughout the supply chain for 

3 such food; and 

4 ‘‘(3) provides supporting information to the Sec5 retary. 

6 ‘‘(b) GUIDELINES.— 

7 ‘‘(1) DEVELOPMENT.—For purposes of the pro8 gram established under subsection (a), the Secretary 

9 shall develop safety and security guidelines applicable 

10 to the importation of food. 

11 ‘‘(2) FACTORS.—Such guidelines shall take into 

12 account the following factors: 

13 ‘‘(A) The personnel of the person importing 

14 the food. 

15 ‘‘(B) The physical and procedural safety 

16 and security of such person’s food supply chain. 

17 ‘‘(C) The sufficiency of preventive controls 

18 for food and ingredients purchased by such per19 son. 

20 ‘‘(D) Vendor and supplier information. 

21 ‘‘(E) Other programs for certification or 

22 verification by a qualified certifying entity used 

23 by the importer. 

24 ‘‘(F) Such other factors as the Secretary de25 termines necessary.’’. 


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1 SEC. 114. INFANT FORMULA. 

2 (a) MISBRANDING.—Section 403 of the Federal Food, 

3 Drug, and Cosmetic Act (21 U.S.C. 343) as amended by 

4 sections 101(a) and 109(a), is amended by adding at the 

5 end the following: 

6 ‘‘(bb) If it is a new infant formula and it is not the 

7 subject of a letter from the Secretary provided pursuant to 

8 section 412(c)(1)(C).’’. 

9 (b) REQUIREMENTS.—Section 412 of the Federal Food, 

10 Drug, and Cosmetic Act (21 U.S.C. 350a) is amended— 

11 (1) in subsection (b)(1), by adding at the end the 

12 following: ‘‘The quality factor requirements estab13 lished under this paragraph may include require14 ments for one or more clinical studies to demonstrate 

15 that the new infant formula supports normal physical 

16 growth of infants.’’; 

17 (2) in subsection (b)(4), by amending subpara18 graph (B) to read as follows: 

19 ‘‘(B) Records required under subparagraph (A) with 

20 respect to an infant formula shall be retained for at least 

21 one year after the expiration of the shelf life of such infant 

22 formula. Such records shall be made available to the Sec23 retary for review and duplication upon request of the Sec24 retary.’’; 

25 (3) in subsection (c)(1)— 


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1 (A) in subparagraph (A), by striking ‘‘and’’ 

2 at the end; 

3 (B) in subparagraph (B), by striking 

4 ‘‘(c)(1).’’ at the end and inserting ‘‘(d)(1), and’’; 

5 and 

6 (C) by adding at the end the following: 

7 ‘‘(C) the Secretary has by letter informed such 

8 person that the registration requirements and the re9 quirements in subsection (d)(1) have been satisfied.’’; 

10 and 

11 (4) in subsection (d)(1), by striking subpara12 graphs (C) and (D) and inserting the following: 

13 ‘‘(C) scientific evidence and other evidence, as 

14 identified in regulations promulgated by the Sec15 retary, that demonstrates that the infant formula sat16 isfies the requirements of subsection (b)(1), and, as 

17 demonstrated by the testing required under subsection 

18 (b)(3), that it satisfies the requirements of subsection 

19 (i), and 

20 ‘‘(D) scientific evidence and other evidence, as 

21 identified in regulations promulgated by the Sec22 retary, that demonstrate that the processing of the in23 fant formula complies with the requirements of sub24 section (b)(2).’’. 


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1 Subtitle B—Intervention 

2 SEC. 121. SURVEILLANCE. 

3 (a) DEFINITION OF FOOD-BORNE ILLNESS OUT4 BREAK.—In this section, the term ‘‘food-borne illness out5 break’’ means the occurrence of 2 or more cases of a similar 

6 illness resulting from the ingestion of a food. 

7 (b) FOOD-BORNE ILLNESS SURVEILLANCE SYS8 TEMS.—The Secretary, acting through the Director of the 

9 Centers for Disease Control and Prevention, shall enhance 

10 food-borne illness surveillance systems to improve the collec11 tion, analysis, reporting, and usefulness of data on food12 borne illnesses by— 

13 (1) coordinating Federal, State, and local food14 borne illness surveillance systems, including com15 plaint systems, and increasing participation in na16 tional networks of public health and food regulatory 

17 agencies and laboratories; 

18 (2) facilitating sharing of findings on a more 

19 timely basis among governmental agencies, including 

20 the Food and Drug Administration, the Department 

21 of Agriculture, and State and local agencies, and with 

22 the public; 

23 (3) developing improved epidemiological tools for 

24 obtaining quality exposure data, and microbiological 

25 methods for classifying cases; 


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1 (4) augmenting such systems to improve attribu2 tion of a food-borne illness outbreak to a specific food; 

3 (5) expanding capacity of such systems, includ4 ing fingerprinting and other detection strategies for 

5 food-borne infectious agents, in order to identify new 

6 or rarely documented causes of food-borne illness; 

7 (6) allowing timely public access to aggregated, 

8 de-identified surveillance data; 

9 (7) at least annually, publishing current reports 

10 on findings from such systems; 

11 (8) establishing a flexible mechanism for rapidly 

12 initiating scientific research by academic institutions; 

13 (9) integrating food-borne illness surveillance 

14 systems and data with other biosurveillance and pub15 lic health situational awareness capabilities at the 

16 Federal, State, and local levels; and 

17 (10) other activities as determined appropriate 

18 by the Secretary. 

19 (c) IMPROVING FOOD SAFETY AND DEFENSE CAPACITY

20 AT THE STATE AND LOCAL LEVEL.— 

21 (1) IN GENERAL.—The Secretary shall develop 

22 and implement strategies to leverage and enhance the 

23 food safety and defense capacities of State and local 

24 agencies in order to achieve the following goals: 


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1 (A) Improve food-borne illness outbreak re2 sponse and containment. 

3 (B) Accelerate food-borne illness surveillance 

4 and outbreak investigation, including rapid 

5 shipment of clinical isolates from clinical labora6 tories to appropriate State laboratories, and con7 ducting more standardized illness outbreak inter8 views. 

9 (C) Strengthen the capacity of State and 

10 local agencies to carry out inspections and en11 force safety standards. 

12 (D) Improve the effectiveness of Federal, 

13 State, and local partnerships to coordinate food 

14 safety and defense resources and reduce the inci15 dence of food-borne illness. 

16 (E) Share information on a timely basis 

17 among public health and food regulatory agen18 cies, with the food industry, with health care 

19 providers, and with the public. 

20 (2) REVIEW.—In developing of the strategies re21 quired by paragraph (1), the Secretary shall, not 

22 later than 1 year after the date of enactment of this 

23 Act, complete a review of State and local capacities, 

24 and needs for enhancement, which may include a sur25 vey with respect to— 


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1 (A) staffing levels and expertise available to 

2 perform food safety and defense functions; 

3 (B) laboratory capacity to support surveil4 lance, outbreak response, inspection, and enforce5 ment activities; 

6 (C) information systems to support data 

7 management and sharing of food safety and de8 fense information among State and local agen9 cies and with counterparts at the Federal level; 

10 and 

11 (D) other State and local activities and 

12 needs as determined appropriate by the Sec13 retary. 

14 SEC. 122. PUBLIC EDUCATION AND ADVISORY SYSTEM. 

15 (a) PUBLIC EDUCATION.—The Secretary, in coopera16 tion with private and public organizations, including the 

17 appropriate State entities, shall design and implement a 

18 national public education program on food safety. The pro19 gram shall provide— 

20 (1) information to the public so that individuals 

21 can understand the potential impact and risk of food22 borne illness, take action to reduce their risk of food23 borne illness and injury, and make healthy dietary 

24 choices; 


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1 (2) information to health professionals so that 

2 they may improve diagnosis and treatment of food-re3 lated illness and advise individuals whose health con4 ditions place them in particular risk; and 

5 (3) such other information or advice to con6 sumers and other persons as the Secretary determines 

7 will promote the purposes of this Act. 

8 (b) HEALTH ADVISORIES.—The Secretary shall work 

9 with the States and other appropriate entities to— 

10 (1) develop and distribute regional and national 

11 advisories concerning food safety; 

12 (2) develop standardized formats for written and 

13 broadcast advisories; and 

14 (3) incorporate State and local advisories into 

15 the national public education program required under 

16 subsection (a). 

17 SEC. 123. RESEARCH. 

18 The Secretary shall conduct research to assist in the 

19 implementation of this Act, including studies to— 

20 (1) improve sanitation and food safety practices 

21 in the production, harvesting, and processing of food 

22 products; 

23 (2) develop improved techniques for the moni24 toring of food and inspection of food products; 


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1 (3) develop efficient, rapid, and sensitive meth2 ods for determining and detecting the presence of con3 taminants in food products; 

4 (4) determine the sources of contamination of 

5 food and food products, including critical points of 

6 risk for fresh produce and other raw agricultural 

7 commodities; 

8 (5) develop consumption data with respect to 

9 food products; 

10 (6) draw upon research and educational pro11 grams that exist at the State and local level; 

12 (7) utilize the DNA matching system and other 

13 processes to identify and control pathogens; 

14 (8) address common and emerging zoonotic dis15 eases; 

16 (9) develop methods to reduce or destroy patho17 gens before, during, and after processing; 

18 (10) analyze the incidence of antibiotic resist19 ance as it pertains to the food supply and evaluate 

20 methods to reduce the transfer of antibiotic resistance 

21 to humans; and 

22 (11) conduct other research that supports the 

23 purposes of this Act. 


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1 Subtitle C—Response 

2 SEC. 131. PROCEDURES FOR SEIZURE. 

3 Section 304(b) (21 U.S.C. 334(b)) is amended by in4 serting ‘‘and except that, with respect to proceedings relat5 ing to food, Rule G of the Supplemental Rules of Admiralty 

6 or Maritime Claims and Asset Forfeiture Actions shall not 

7 apply in any such case, exigent circumstances shall be 

8 deemed to exist for all seizures brought under this section, 

9 and the summons and arrest warrant shall be issued by 

10 the clerk of the court without court review in any such case’’ 

11 after ‘‘in any such case shall be tried by jury’’. 

12 SEC. 132. ADMINISTRATIVE DETENTION. 

13 (a) AMENDMENTS.—Section 304(h) (21 U.S.C. 334(h)) 

14 is amended— 

15 (1) in paragraph (1)(A), by striking ‘‘credible 

16 evidence or information indicating’’ and inserting 

17 ‘‘reason to believe’’; 

18 (2) in paragraph (1)(A), by striking ‘‘presents a 

19 threat of serious adverse health consequences or death 

20 to humans or animals’’ and inserting ‘‘is adulterated, 

21 misbranded, or otherwise in violation of this Act’’; 

22 (3) in paragraph (2), by striking ‘‘30’’ and in23 serting ‘‘60’’; 

24 (4) in paragraph (3), by striking the third sen25 tence; and 


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1 (5) in paragraph (4)(A) by striking the terms 

2 ‘‘five’’ and ‘‘five-day’’ and inserting ‘‘fifteen’’ and 

3 ‘‘fifteen-day’’, respectively. 

4 (b) REGULATIONS.—The Secretary shall issue regula5 tions or guidance to implement the amendments made by 

6 this section. 

7 (c) EFFECTIVE DATE.—The amendments made by this 

8 section shall take effect 180 days after the date of the enact9 ment of this Act. 

10 SEC. 133. QUARANTINE AUTHORITY FOR FOODS. 

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

12 as amended by sections 110 and 111, is amended by adding 

13 at the end by adding the following: 

14 ‘‘(qq) The violation of a quarantine under section 

15 304(i).’’. 

16 (b) IN GENERAL.—Section 304 (21 U.S.C. 334) is 

17 amended by adding at the end the following: 

18 ‘‘(i) QUARANTINE OF GEOGRAPHIC LOCATION.— 

19 ‘‘(1) AUTHORITY TO QUARANTINE.—If the Sec20 retary determines that there is credible evidence or in21 formation that an article of food presents an immi22 nent threat of serious adverse health consequences or 

23 death to humans or animals, the Secretary may quar24 antine any geographic area within the United States 

25 where the Secretary reasonably believes such food is 


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1 located or from which such food originated. The au2 thority to quarantine includes prohibiting or restrict3 ing the movement of food or of any vehicle being used 

4 or that has been used to transport or hold such food 

5 within the geographic area. Any quarantine under 

6 this paragraph shall be no greater than is appro7 priate, as determined by the Secretary, to protect the 

8 public health. 

9 ‘‘(2) NOTIFICATION PROCEDURES.—Before any 

10 quarantine action is taken in any State under this 

11 subsection, the Secretary shall notify an appropriate 

12 official of the State affected and shall issue a public 

13 announcement of— 

14 ‘‘(A) the Secretary’s findings that support 

15 the quarantine action; 

16 ‘‘(B) the area affected by the intended quar17 antine action; 

18 ‘‘(C) the reasons for the intended quar19 antine action; and 

20 ‘‘(D) where practicable, an estimate of the 

21 anticipated duration of the quarantine. 

22 The Secretary is not required to make such announce23 ment by publication in the Federal Register, but may 

24 use a newspaper, radio or television, the Internet, or 

25 any reasonable means to make such announcement. 


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1 ‘‘(3) NONDELEGATION.—The authority to quar2 antine under this subsection is limited to the Com3 missioner of Food and Drugs, the Principal Deputy 

4 Commissioner, and the Associate Commissioner for 

5 Regulatory Affairs of the Food and Drug Administra6 tion.’’. 

7 SEC. 134. CRIMINAL PENALTIES. 

8 Section 303(a) (21 U.S.C. 333) is amended— 

9 (1) in paragraph (1), by striking ‘‘Any’’ and in10 serting ‘‘Except as provided in paragraph (2) or (3), 

11 any’’; and 

12 (2) by adding at the end the following: 

13 ‘‘(3) Notwithstanding paragraph (1), any person who 

14 knowingly violates paragraph (a), (b), (c), (k), or (v) of sec15 tion 301 with respect to any food that is misbranded or 

16 adulterated shall be imprisoned for not more than 10 years 

17 or fined in accordance with title 18, United States Code, 

18 or both.’’. 

19 SEC. 135. CIVIL PENALTIES FOR VIOLATIONS RELATING TO 

20 FOOD. 

21 (a) IN GENERAL.—Paragraph (2) of section 303(f) (21 

22 U.S.C. 331 et seq.) is amended to read as follows: 

23 ‘‘(2)(A) Any person who violates a provision of section 

24 301 relating to food shall be subject to a civil penalty for 

25 each such violation of not more than— 


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1 ‘‘(i) $20,000 in the case of an individual, not to 

2 exceed $50,000 in a single proceeding; and 

3 ‘‘(ii) $250,000 in the case of any other person, 

4 not to exceed $1,000,000 in a single proceeding. 

5 ‘‘(B) Any person who knowingly violates a provision 

6 of section 301 relating to food shall be subject to a civil 

7 penalty for each such violation of not more than— 

8 ‘‘(i) $50,000 in the case of an individual, not to 

9 exceed $100,000 in a single proceeding; and 

10 ‘‘(ii) $500,000 in the case of any other person, 

11 not to exceed $7,500,000 in a single proceeding. 

12 ‘‘(C) Each violation described in subparagraph (A) or 

13 (B) and each day during which the violation continues shall 

14 be considered to be a separate offense.’’. 

15 (b) EFFECTIVE DATE.—The amendment made by sub16 section (a) applies to violations committed on or after the 

17 date of the enactment of this Act. 

18 SEC. 136. IMPROPER IMPORT ENTRY FILINGS. 

19 (a) PROHIBITED ACTS.—Section 301 (21 U.S.C. 331), 

20 as amended by sections 110, 111, and 133, is amended by 

21 adding at the end the following: 

22 ‘‘(rr) The submission of information relating to food 

23 that is required by or under section 801 that is inaccurate 

24 or incomplete. 


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1 ‘‘(ss) The failure to submit information relating to food 

2 that is required by or under section 801.’’. 

3 (b) DOCUMENTATION FOR IMPORTS.—Section 801 (21 

4 U.S.C. 381), as amended by section 109, is amended by 

5 adding at the end the following: 

6 ‘‘(q) DOCUMENTATION.— 

7 ‘‘(1) SUBMISSION.—The Secretary may require 

8 by regulation or guidance the submission of docu9 mentation or other information for articles of food 

10 that are imported or offered for import into the 

11 United States. 

12 ‘‘(2) FORMAT.—A regulation or guidance under 

13 paragraph (1) may specify the format for submission 

14 of the documentation or other information.’’. 

15 TITLE II—MISCELLANEOUS 

16 SEC. 201. FOOD SUBSTANCES GENERALLY RECOGNIZED AS 

17 SAFE. 

18 Section 409 (21 U.S.C. 348) is amended by adding 

19 at the end the following: 

20 ‘‘Substances Generally Recognized as Safe 

21 ‘‘(k)(1) Not later than 60 days after the date of receipt 

22 by the Secretary, after the date of the enactment of this sub23 section, of a determination that a substance is a GRAS food 

24 substance, the Secretary shall post notice of such determinaVerDate Nov 24 2008 21:46 Jul 29, 2009 Jkt 079200 PO 00000 Frm 00101 Fmt 6652 Sfmt 6203 E:\BILLS\H2749.RH H2749

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1 tion and the supporting scientific justifications on the Food 

2 and Drug Administration’s public Web site. 

3 ‘‘(2) Not later than 60 days after the date of receipt 

4 of a request under paragraph (1), the Secretary shall ac5 knowledge receipt of such request by informing the requester 

6 in writing of the date on which the request was received. 

7 ‘‘(3) In this subsection, the term ‘GRAS food substance’ 

8 means a substance excluded from the definition of the term 

9 ‘food additive’ in section 201(s) because such substance is 

10 generally recognized, among experts qualified by scientific 

11 training and experience to evaluate its safety, as having 

12 been adequately shown through scientific procedures (or, in 

13 the case of a substance used in food prior to January 1, 

14 1958, through either scientific procedures or experience 

15 based on common use in food) to be safe under the condi16 tions of its intended use.’’. 

17 SEC. 202. COUNTRY OF ORIGIN LABELING; DISCLOSURE OF 

18 SOURCE OF INGREDIENTS. 

19 (a) MISBRANDING.—Section 403 (21 U.S.C. 343), as 

20 amended by sections 101(a), 109(a), and 114(a), is amend21 ed by adding at the end the following: 

22 ‘‘(cc) In the case of a processed food, if the labeling 

23 of the food fails to identify the country in which the final 

24 processing of the food occurs. 


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1 ‘‘(dd) In the case of nonprocessed food, if the labeling 

2 of the food fails to identify the country of origin of the 

3 food.’’. 

4 (b) REGULATIONS.— 

5 (1) PROMULGATION.—Not later than 180 days 

6 after the date of the enactment of this Act, the Sec7 retary of Health and Human Services shall promul8 gate final regulations to carry out paragraphs (cc) 

9 and (dd) of section 403 of the Federal Food, Drug, 

10 and Cosmetic Act, as added by subsection (a). 

11 (2) RELATION TO OTHER REQUIREMENTS.—Reg12 ulations promulgated under paragraph (1) shall pro13 vide that labeling meets the requirements of para14 graphs (cc) and (dd) of section 403 of the Federal 

15 Food, Drug, and Cosmetic Act, as added by subsection 

16 (a), if— 

17 (A) in the case of a processed food, the label 

18 of the food informs the consumer of the country 

19 where the final processing of the food occurred in 

20 accordance with labeling requirements of the 

21 United States Customs and Border Protection; or 

22 (B) in the case of a nonprocessed food, the 

23 label of the food informs the consumer of the 

24 country of origin of the food in accordance with 


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1 labeling requirements of the Department of Agri2 culture. 

3 (c) EFFECTIVE DATE.—The requirements of para4 graphs (cc) and (dd) of section 403 of the Federal Food, 

5 Drug, and Cosmetic Act, as added by subsection (a), take 

6 effect on the date that is 2 years after the date of the enact7 ment of this Act. 

8 SEC. 203. EXPORTATION CERTIFICATE PROGRAM. 

9 Section 801(e)(4) (21 U.S.C. 381) is amended— 

10 (1) in the matter preceding clause (i) in sub11 paragraph (A)— 

12 (A) by inserting ‘‘from the United States’’ 

13 after ‘‘exports’’; and 

14 (B) by striking ‘‘a drug, animal drug, or 

15 device’’ and inserting ‘‘a food (including animal 

16 feed), drug, animal drug, or device’’; 

17 (2) in subparagraph (A)(i)— 

18 (A) by striking ‘‘in writing’’; and 

19 (B) by striking ‘‘exported drug, animal 

20 drug, or device’’ and inserting ‘‘exported food, 

21 drug, animal drug, or device’’; 

22 (3) in subparagraph (A)(ii)— 

23 (A) by striking ‘‘in writing’’; 


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1 (B) by striking ‘‘the drug, animal drug, or 

2 device’’ and inserting ‘‘the food, drug, animal 

3 drug, or device’’; and 

4 (C) by striking ‘‘the drug or device’’ and in5 serting ‘‘the food, drug, or device’’; 

6 (4) by redesignating subparagraph (B) as sub7 paragraph (C); 

8 (5) by inserting after subparagraph (A) the fol9 lowing: 

10 ‘‘(B) For purposes of this paragraph, a certification 

11 by the Secretary shall be made on such basis and in such 

12 form (such as a publicly available listing) as the Secretary 

13 determines appropriate.’’; and 

14 (6) by adding at the end the following: 

15 ‘‘(D) Notwithstanding subparagraph (C), if the Sec16 retary issues an export certification within the 20 days pre17 scribed by subparagraph (A) with respect to the export of 

18 food, a fee for such certification shall not exceed such 

19 amount as the Secretary determines is reasonably related 

20 to the cost of issuing certificates under subparagraph (A) 

21 with respect to the export of food. The Secretary may adjust 

22 this fee annually to account for inflation and other cost ad23 justments. Fees collected for a fiscal year pursuant to this 

24 subparagraph shall be credited to the appropriation account 

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1 tion and shall be available in accordance with appropria2 tions Acts until expended, without fiscal year limitation. 

3 Such fees shall be collected in each fiscal year in an amount 

4 equal to the amount specified in appropriations Acts for 

5 such fiscal year and shall only be collected and available 

6 for the costs of the Food and Drug Administration to cover 

7 the cost of issuing such certifications. Such sums as nec8 essary may be transferred from such appropriation account 

9 for salaries and expenses of the Food and Drug Administra10 tion without fiscal year limitation to such appropriation 

11 account for salaries and expenses with fiscal year limita12 tion.’’. 

13 SEC. 204. REGISTRATION FOR COMMERCIAL IMPORTERS OF 

14 FOOD; FEE. 

15 (a) REGISTRATION.— 

16 (1) PROHIBITIONS.—Section 301 (21 U.S.C. 

17 331), as amended by sections 110, 111, 133, and 136, 

18 is amended by adding at the end the following: 

19 ‘‘(tt) The failure to register in accordance with section 

20 801(r).’’. 

21 (2) MISBRANDING.—Section 403 (21 U.S.C. 343) 

22 as amended by sections 101(a), 109(a), 114(a), and 

23 202(a), is amended by adding at the end the fol24 lowing: 


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1 ‘‘(ee) If it is imported or offered for import by an im2 porter not duly registered under section 801(r).’’. 

3 (3) REGISTRATION.—Section 801, as amended by 

4 sections 109 and 136, is amended by adding at the 

5 end the following: 

6 ‘‘(r) REGISTRATION OF IMPORTERS.— 

7 ‘‘(1) REGISTRATION.—The Secretary shall re8 quire an importer of food— 

9 ‘‘(A) to be registered with the Secretary in 

10 a form and manner specified by the Secretary; 

11 and 

12 ‘‘(B) consistent with section 911, to submit 

13 appropriate unique facility identifiers as a con14 dition of registration. 

15 ‘‘(2) GOOD IMPORTER PRACTICES.—The mainte16 nance of registration under this subsection is condi17 tioned on compliance with good importer practices. 

18 Good importer practices shall include the verification 

19 of good manufacturing practices and preventive con20 trols of the importer’s foreign suppliers, as applicable. 

21 ‘‘(3) SUSPENSION OF REGISTRATION.— 

22 ‘‘(A) IN GENERAL.—Registration under this 

23 subsection is subject to suspension upon a find24 ing by the Secretary, after notice and an oppor25 tunity for an informal hearing, of— 


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1 ‘‘(i) a violation of this Act; or 

2 ‘‘(ii) the knowing or repeated making 

3 of an inaccurate or incomplete statement or 

4 submission of information relating to the 

5 importation of food. 

6 ‘‘(B) REQUEST.—The importer whose reg7 istration is suspended may request that the Sec8 retary vacate the suspension of registration when 

9 such importer has corrected the violation that is 

10 the basis for such suspension. 

11 ‘‘(C) VACATING OF SUSPENSION.—If the 

12 Secretary determines that adequate reasons do 

13 not exist to continue the suspension of a registra14 tion, the Secretary shall vacate such suspension. 

15 ‘‘(4) CANCELLATION OF REGISTRATION.— 

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

17 days after providing the notice under subpara18 graph (B), the Secretary may cancel a registra19 tion that the Secretary determines was not up20 dated in accordance with this section or other21 wise contains false, incomplete, or inaccurate in22 formation. 

23 ‘‘(B) NOTICE OF CANCELLATION.—Cancella24 tion shall be preceded by notice to the importer 


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1 of the intent to cancel the registration and the 

2 basis for such cancellation. 

3 ‘‘(C) TIMELY UPDATE OR CORRECTION.—If 

4 the registration for the importer is updated or 

5 corrected no later than 7 days after notice is pro6 vided under subparagraph (B), the Secretary 

7 shall not cancel such registration. 

8 ‘‘(5) EXEMPTIONS.—The Secretary, by notice 

9 published in the Federal Register— 

10 ‘‘(A) shall establish an exemption from the 

11 requirements of this subsection for importations 

12 for personal use; and 

13 ‘‘(B) may establish other exemptions from 

14 the requirements of this subsection.’’. 

15 (4) REGULATIONS.—Not later than 24 months 

16 after the date of the enactment of this Act, the Sec17 retary of Health and Human Services shall promul18 gate the regulations required to carry out section 

19 801(r) of the Federal Food, Drug, and Cosmetic Act, 

20 as added by paragraph (3). 

21 (5) EFFECTIVE DATE.—The amendments made 

22 by this subsection shall take effect on the date that is 

23 24 months after the date of enactment of this Act. 


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1 (b) FEE.—Subchapter C of chapter VII (21 U.S.C. 

2 379f et seq.) as added and amended by sections 101 and 

3 108, is amended by adding at the end the following: 

4 ‘‘PART 7—IMPORTERS OF FOOD 

5 ‘‘SEC. 744. IMPORTERS OF FOOD. 

6 ‘‘(a) IMPORTERS.—The Secretary shall assess and col7 lect an annual fee for the registration of an importer of 

8 food under section 801(r). 

9 ‘‘(b) AMOUNT OF FEE.— 

10 ‘‘(1) BASE AMOUNTS.—The registration fee under 

11 subsection (a) shall be— 

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

13 ‘‘(B) for fiscal year 2011 and each subse14 quent fiscal year, the fee for fiscal year 2010 as 

15 adjusted under paragraph (2). 

16 ‘‘(2) ADJUSTMENT.—For fiscal year 2011 and 

17 subsequent fiscal years, the fees established pursuant 

18 to paragraph (1) shall be adjusted by the Secretary 

19 by notice, published in the Federal Register, for a fis20 cal year to reflect the greater of— 

21 ‘‘(A) the total percentage change that oc22 curred in the Consumer Price Index for all 

23 urban consumers (all items; United States city 

24 average), for the 12-month period ending June 


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1 30 preceding the fiscal year for which fees are 

2 being established; 

3 ‘‘(B) the total percentage change for the pre4 vious fiscal year in basic pay under the General 

5 Schedule in accordance with section 5332 of title 

6 5, United States Code, as adjusted by any local7 ity-based comparability payment pursuant to 

8 section 5304 of such title for Federal employees 

9 stationed in the District of Columbia; or 

10 ‘‘(C) the average annual change in the cost, 

11 per full-time equivalent position of the Food and 

12 Drug Administration, of all personnel compensa13 tion and benefits paid with respect to such posi14 tions for the first 5 years of the preceding 6 fis15 cal years. 

16 ‘‘(3) COMPOUNDED BASIS.—The adjustment 

17 made each fiscal year pursuant this subsection shall 

18 be added on a compounded basis to the sum of all ad19 justments made each fiscal year after fiscal year 2010 

20 under this subsection. 

21 ‘‘(4) WAIVER FOR IMPORTERS REQUIRED TO PAY

22 REGISTRATION FEE.—In the case of a person who is 

23 required to pay both a fee under section 743 for reg24 istration of one or more facilities under section 415 

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1 porter of food under section 801(r), the Secretary 

2 shall waive the fees applicable to such person under 

3 section 743 or the fee applicable to such person under 

4 this section. 

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

6 ‘‘(1) IN GENERAL.—Fees authorized under sub7 section (a) shall be collected and available for obliga8 tion only to the extent and in the amount provided 

9 in advance in appropriations Acts. Such fees are au10 thorized to remain available until expended. Such 

11 sums as may be necessary may be transferred from 

12 the Food and Drug Administration salaries and ex13 penses appropriation account without fiscal year lim14 itation to such appropriation account for salaries and 

15 expenses with such fiscal year limitation. 

16 ‘‘(2) COLLECTIONS AND APPROPRIATIONS

17 ACTS.—The fees authorized by this section— 

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

19 an amount not to exceed the amount specified in 

20 appropriation Acts, or otherwise made available 

21 for obligation, for such fiscal year; and 

22 ‘‘(B) shall only be collected and available to 

23 cover the costs associated with registering im24 porters under section 801(r) and with ensuring 


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1 compliance with good importer practices respect2 ing food. 

3 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.—For 

4 each of fiscal years 2010 through 2014, there are au5 thorized to be appropriated for fees under this section 

6 such sums as may be necessary.’’. 

7 (c) INSPECTION.—Section 704 (21 U.S.C. 374), as 

8 amended by section 105, is amended by adding at the end 

9 the following: 

10 ‘‘(i) IMPORTERS.—Every person engaged in the im11 porting of any food shall, upon request of an officer or em12 ployee designated by the Secretary, permit such officer or 

13 employee at all reasonable times to inspect the facilities of 

14 such person and have access to, and to copy and verify, 

15 any related records.’’. 

16 SEC. 205. REGISTRATION FOR CUSTOMS BROKERS AND FIL17 ERS; FEE. 

18 (a) REGISTRATION.— 

19 (1) PROHIBITIONS.—Section 301(tt) (21 U.S.C. 

20 331), as added by section 204, is amended by insert21 ing ‘‘or 801(s)’’ after ‘‘801(r)’’. 

22 (2) MISBRANDING.—Section 403(ee) (21 U.S.C. 

23 343), as added by section 204, is amended— 

24 (A) by inserting ‘‘or a customs broker or 

25 filer’’ after ‘‘by an importer’’; and 


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1 (B) by inserting ‘‘or 801(s)’’ after ‘‘801(r)’’. 

2 (3) REGISTRATION.—Section 801, as amended by 

3 sections 109, 136, and 204, is amended by adding at 

4 the end the following: 

5 ‘‘(s) REGISTRATION OF CUSTOMS BROKERS AND FIL6 ERS.— 

7 ‘‘(1) REGISTRATION.—The Secretary shall re8 quire a customs broker or filer, with respect to the im9 portation of food— 

10 ‘‘(A) to be registered with the Secretary in 

11 a form and manner specified by the Secretary; 

12 and 

13 ‘‘(B) consistent with section 911, to submit 

14 appropriate unique facility identifiers as a con15 dition of registration. 

16 ‘‘(2) SUSPENSION OF REGISTRATION.— 

17 ‘‘(A) IN GENERAL.—Registration under this 

18 subsection is subject to suspension upon a find19 ing by the Secretary, after notice and an oppor20 tunity for an informal hearing, of— 

21 ‘‘(i) a violation of this Act; or 

22 ‘‘(ii) the knowing or repeated making 

23 of an inaccurate or incomplete statement or 

24 submission of information relating to the 

25 importation of food. 


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1 ‘‘(B) REQUEST.—The customs broker or 

2 filer whose registration is suspended may request 

3 that the Secretary vacate the suspension of reg4 istration when such customs broker or filer has 

5 corrected the violation that is the basis for such 

6 suspension. 

7 ‘‘(C) VACATING OF SUSPENSION.—If the 

8 Secretary determines that adequate reasons do 

9 not exist to continue the suspension of a registra10 tion, the Secretary shall vacate such suspension. 

11 ‘‘(3) 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 in18 formation. 

19 ‘‘(B) NOTICE OF CANCELLATION.—Cancella20 tion shall be preceded by notice to the customs 

21 broker or filer of the intent to cancel the registra22 tion and the basis for such cancellation. 

23 ‘‘(C) TIMELY UPDATE OR CORRECTION.—If 

24 the registration for the customs broker or filer is 

25 updated 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 ‘‘(4) EXEMPTIONS.—The Secretary, by notice 

4 published in the Federal Register— 

5 ‘‘(A) shall establish an exemption from the 

6 requirements of this subsection for importations 

7 for personal use; and 

8 ‘‘(B) may establish other exemptions from 

9 the requirements of this subsection.’’. 

10 (4) REGULATIONS.—Not later than 24 months 

11 after the date of the enactment of this Act, the Sec12 retary of Health and Human Services shall promul13 gate the regulations required to carry out section 

14 801(s) of the Federal Food, Drug, and Cosmetic Act, 

15 as added by paragraph (3). 

16 (5) EFFECTIVE DATE.—The amendments made 

17 by this subsection shall take effect on the date that is 

18 24 months after the date of enactment of this Act. 

19 (b) INSPECTION.—Section 704 (21 U.S.C. 374), as 

20 amended by sections 105 and 204, is amended by adding 

21 at the end the following: 

22 ‘‘(j) BROKERS AND FILERS.—Every person engaged in 

23 the brokering for import or filing for import of any food 

24 shall, upon request of an officer or employee designated by 

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1 able times to inspect the facilities of such person and have 

2 access to, and to copy and verify, any related records.’’. 

3 SEC. 206. UNIQUE IDENTIFICATION NUMBER FOR FOOD FA4 CILITIES, IMPORTERS, CUSTOM BROKERS, 

5 AND FILERS. 

6 Chapter IX (21 U.S.C. 391 et seq) is amended by add7 ing at the end the following: 

8 ‘‘SEC. 911. UNIQUE FACILITY IDENTIFIER. 

9 ‘‘(a) REGISTRATION OF FACILITY OR ESTABLISH10 MENT.—A person required to register a facility pursuant 

11 to section 415 shall submit, at the time of registration, a 

12 unique facility identifier for the facility or establishment. 

13 ‘‘(b) REGISTRATION OF IMPORTERS, CUSTOM BRO14 KERS, AND FILERS.—A person required to register pursu15 ant to section 801(r) or 801(s) shall submit, at the time 

16 of registration, a unique facility identifier for the principal 

17 place of business for which such person is required to reg18 ister under section 801(r) or 801(s). 

19 ‘‘(c) GUIDANCE.—The Secretary may, by guidance, 

20 specify the unique numerical identifier system to be used 

21 to meet the requirements of subsections (a) and (b) and the 

22 form, manner, and timing of a submission under such sub23 sections. 

24 ‘‘(d) IMPORTATION.—An article of food imported or of25 fered for import shall be refused admission unless the approVerDate Nov 24 2008 21:46 Jul 29, 2009 Jkt 079200 PO 00000 Frm 00117 Fmt 6652 Sfmt 6203 E:\BILLS\H2749.RH H2749

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1 priate unique facility identifiers, as specified by the Sec2 retary, are provided for such article.’’. 

3 SEC. 207. PROHIBITION AGAINST DELAYING, LIMITING, OR 

4 REFUSING INSPECTION. 

5 (a) ADULTERATION.—Section 402 (21 U.S.C. 342), as 

6 amended by sections 102, 103(a), and 104(a), is amended 

7 by adding at the end the following: 

8 ‘‘(n) If it has been produced, manufactured, processed, 

9 packed, or held in any farm, factory, warehouse, or estab10 lishment and the owner, operator, or agent of such farm, 

11 factory, warehouse, or establishment, or any agent of a gov12 ernmental authority in the foreign country within which 

13 such farm, factory, warehouse, or establishment is located, 

14 delays or limits an inspection, or refuses to permit entry 

15 or inspection, under section 414 or 704.’’. 

16 (b) FOREIGN INSPECTIONS.—Section 704(a)(1) (21 

17 U.S.C. 374(a)(1)), as amended by section 106(c), is amend18 ed— 

19 (1) in the first sentence, by inserting ‘‘, includ20 ing any such food factory, warehouse, or establish21 ment whether foreign or domestic,’’ after ‘‘factory, 

22 warehouse, or establishment’’; and 

23 (2) in the third sentence, by inserting ‘‘, includ24 ing any food factory, warehouse, establishment, or 

25 consulting laboratory whether foreign or domestic,’’ 


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1 after ‘‘factory, warehouse, establishment, or consulting 

2 laboratory’’. 

3 SEC. 208. DEDICATED FOREIGN INSPECTORATE. 

4 Section 704 (21 U.S.C. 374), as amended by sections 

5 105, 204, and 205, is amended by adding at the end the 

6 following: 

7 ‘‘(k) DEDICATED FOREIGN INSPECTORATE.—The Sec8 retary shall establish and maintain a corps of inspectors 

9 dedicated to inspections of foreign food facilities. This corps 

10 shall be staffed and funded by the Secretary at a level suffi11 cient to enable it to assist the Secretary in achieving the 

12 frequency of inspections for food facilities as described in 

13 this Act.’’. 

14 SEC. 209. PLAN AND REVIEW OF CONTINUED OPERATION 

15 OF FIELD LABORATORIES. 

16 (a) SUBMISSION OF PLAN.—Not later than 90 days be17 fore the Secretary terminates or consolidates any labora18 tory, district office, or the functions (including the inspec19 tion and compliance functions) of any such laboratory or 

20 district office, specified in subsection (b), the Secretary shall 

21 submit a reorganization plan to the Comptroller General 

22 of the United States, the Committee on Energy and Com23 merce of the House of Representatives, and the Committee 

24 on Health, Education, Labor, and Pensions of the Senate. 


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1 (b) SPECIFIED LABORATORIES AND OFFICES.—The 

2 laboratories and offices specified in this subsection are the 

3 following: 

4 (1) Any of the 13 field laboratories responsible 

5 for analyzing food that were operated by the Office of 

6 Regulatory Affairs of the Food and Drug Administra7 tion as of January 1, 2007. 

8 (2) Any of the 20 district offices of the Food and 

9 Drug Administration with responsibility for food 

10 safety functioning as of January 1, 2007. 

11 (c) CONGRESSIONAL REVIEW.—A reorganization plan 

12 described in subsection (a) is deemed to be a major rule 

13 (as defined in section 804(2) of title 5, United States Code) 

14 for purposes of chapter 8 of such title. 

15 SEC. 210. FALSE OR MISLEADING REPORTING TO FDA. 

16 (a) IN GENERAL.—Section 301(q)(2) (21 U.S.C. 

17 331(q)(2)) is amended by inserting after ‘‘device’’ the fol18 lowing: ‘‘or food’’. 

19 (b) EFFECTIVE DATE.—The amendment made by sub20 section (a) shall apply to submissions made on or after the 

21 date of the enactment of this Act. 

22 SEC. 211. SUBPOENA AUTHORITY. 

23 (a) PROHIBITED ACT.—Section 301(f) is amended by 

24 inserting before the period the following: ‘‘or the failure or 

25 refusal to obey a subpoena issued pursuant to section 311’’. 


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1 (b) AMENDMENT.—Chapter III (21 U.S.C. 331 et seq.) 

2 is amended by adding at the end the following: 

3 ‘‘SEC. 311. EXERCISE OF SUBPOENA AUTHORITY. 

4 ‘‘(a) IN GENERAL.—For the purpose of— 

5 ‘‘(1) any hearing, investigation, or other pro6 ceeding respecting a violation of a provision of this 

7 Act, the Public Health Service Act, or the Federal 

8 Anti-Tampering Act, relating to food; or 

9 ‘‘(2) any hearing, investigation, or other pro10 ceeding to determine if a person is in violation of a 

11 specific provision of this Act, the Public Health Serv12 ice Act, or the Federal Anti-Tampering Act, relating 

13 to food, 

14 the Commissioner may issue subpoenas requiring the at15 tendance and testimony of witnesses and the production of 

16 records and other things. 

17 ‘‘(b) TIMING OF COMPLIANCE.—When the Commis18 sioner deems that immediate compliance with a subpoena 

19 issued under this section is necessary to address a threat 

20 of serious adverse health consequences or death, the sub21 poena may require immediate production. 

22 ‘‘(c) SERVICE OF SUBPOENA.— 

23 ‘‘(1) IN GENERAL.—Subpoenas of the Commis24 sioner shall be served by a person authorized by the 

25 Commissioner by delivering a copy thereof to the perVerDate Nov 24 2008 21:46 Jul 29, 2009 Jkt 079200 PO 00000 Frm 00121 Fmt 6652 Sfmt 6203 E:\BILLS\H2749.RH H2749

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1 son named therein or by certified mail addressed to 

2 such person at such person’s last known dwelling 

3 place or principal place of business. 

4 ‘‘(2) CORPORATIONS AND OTHER ENTITIES.— 

5 Service on a domestic or foreign corporation, partner6 ship, unincorporated association, or other entity that 

7 is subject to suit under a common name may be made 

8 by delivering the subpoena to an officer, a managing 

9 or general agent, or any other agent authorized by 

10 appointment or by law to receive service of process. 

11 ‘‘(3) PERSON OUTSIDE U.S. JURISDICTION.— 

12 Service on any person not found within the territorial 

13 jurisdiction of any court of the United States may be 

14 made in any manner as the Federal Rules of Civil 

15 Procedure prescribe for service in a foreign nation. 

16 ‘‘(4) PROOF OF SERVICE.—A verified return by 

17 the person so serving the subpoena setting forth the 

18 manner of service, or, in the case of service by cer19 tified mail, the return post office receipt therefor 

20 signed by the person so served, shall be proof of serv21 ice. 

22 ‘‘(d) PAYMENT OF WITNESSES.—Witnesses subpoenaed 

23 under subsection (a) shall be paid the same fees and mileage 

24 as are paid witnesses in the district courts of the United 

25 States. 


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1 ‘‘(e) ENFORCEMENT.—In the case of a refusal to obey 

2 a subpoena duly served upon any person under subsection 

3 (a), any district court of the United States for the judicial 

4 district in which such person charged with refusal to obey 

5 is found, resides, or transacts business, upon application 

6 by the Commissioner, shall have jurisdiction to issue an 

7 order compelling compliance with the subpoena and requir8 ing such person to appear and give testimony or to appear 

9 and produce records and other things, or both. The failure 

10 to obey such order of the court may be punished by the court 

11 as contempt thereof. If the person charged with failure or 

12 refusal to obey is not found within the territorial jurisdic13 tion of the United States, the United States District Court 

14 for the District of Columbia shall have the same jurisdic15 tion, consistent with due process, to take any action respect16 ing compliance with the subpoena by such person that such 

17 district court would have if such person were personally 

18 within the jurisdiction of such district court. 

19 ‘‘(f) NONDISCLOSURE.—A United States district court 

20 for the district in which the subpoena is or will be served, 

21 upon application of the Commissioner, may issue an ex 

22 parte order that no person or entity disclose to any other 

23 person or entity (other than to an attorney to obtain legal 

24 advice) the existence of such subpoena for a period of up 

25 to 90 days. Such order may be issued on a showing that 


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1 the records or things being sought may be relevant to the 

2 hearing, investigation, proceeding, or other matter and that 

3 there is reason to believe that such disclosure may result 

4 in— 

5 ‘‘(1) furtherance of a potential violation under 

6 investigation; 

7 ‘‘(2) endangerment to the life or physical safety 

8 of any person; 

9 ‘‘(3) flight or other action to avoid prosecution 

10 or other enforcement remedies; 

11 ‘‘(4) destruction of or tampering with evidence; 

12 or 

13 ‘‘(5) intimidation of potential witnesses. 

14 An order under this subsection may be renewed for addi15 tional periods of up to 90 days upon a showing that any 

16 of the circumstances described in paragraphs (1) through 

17 (5) continue to exist. 

18 ‘‘(g) RELATION TO OTHER PROVISIONS.—The sub19 poena authority vested in the Commissioner and the district 

20 courts of the United States by this section is in addition 

21 to any such authority vested in the Commissioner or such 

22 courts by other provisions of law. 

23 ‘‘(h) NONDELEGATION.—The authority to issue a sub24 poena under this section is limited to the Secretary or an 

25 official designated by the Secretary. An official may not 


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1 be so designated unless the official is the director of the dis2 trict under this Act in which the article involved is located, 

3 or is an official senior to such director.’’. 

4 SEC. 212. WHISTLEBLOWER PROTECTIONS. 

5 Chapter IX (21 U.S.C. 391 et seq.), as amended by 

6 section 206, is amended by adding at the end the following: 

7 ‘‘SEC. 912. PROTECTIONS FOR EMPLOYEES WHO REFUSE TO 

8 VIOLATE, OR WHO DISCLOSE VIOLATIONS OF, 

9 THIS ACT OR SECTION 351 OF THE PUBLIC 

10 HEALTH SERVICE ACT. 

11 ‘‘(a) IN GENERAL.—No person who submits or is re12 quired under this Act or the Public Health Service Act to 

13 submit any information related to a food, or any officer, 

14 employee, contractor, subcontractor, or agent of such person 

15 may discharge, demote, suspend, threaten, harass, or in any 

16 other manner discriminate against an employee in the 

17 terms and conditions of employment because of any lawful 

18 act done by the employee, including within the ordinary 

19 course of the job duties of such employee— 

20 ‘‘(1) to provide information, cause information 

21 to be provided, or otherwise assist in any investiga22 tion regarding any conduct which the employee rea23 sonably believes constitutes a violation of this Act, or 

24 any other provision of Federal law relating to the 

25 safety of a food, if the information or assistance is 


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1 provided to, or an investigation stemming from the 

2 provided information is conducted by— 

3 ‘‘(A) a Federal regulatory or law enforce4 ment agency; 

5 ‘‘(B) any Member of Congress or any com6 mittee of Congress; or 

7 ‘‘(C) a person with supervisory authority 

8 over the employee (or such other person working 

9 for the employer who has the authority to inves10 tigate, discover, or terminate the misconduct); 

11 ‘‘(2) to file, cause to be filed, testify, participate 

12 in, or otherwise assist in a proceeding filed, or about 

13 to be filed (with any knowledge of the employer), in 

14 any court or administrative forum relating to any 

15 such alleged violation; or 

16 ‘‘(3) to refuse to commit or assist in any such 

17 violation. 

18 ‘‘(b) ENFORCEMENT ACTION.— 

19 ‘‘(1) IN GENERAL.—An employee who alleges dis20 charge or other discrimination in violation of sub21 section (a) may seek relief in accordance with the pro22 visions of subsection (c) by— 

23 ‘‘(A) filing a complaint with the Secretary 

24 of Labor; or 


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1 ‘‘(B) if the Secretary of Labor has not 

2 issued a final decision within 210 days of the fil3 ing of the complaint and there is no showing 

4 that such delay is due to the bad faith of the 

5 claimant, or within 90 days after receiving a 

6 final decision or order from the Secretary, bring7 ing an action at law or equity for de novo re8 view in the appropriate district court of the 

9 United States, which court shall have jurisdic10 tion over such action without regard to the 

11 amount in controversy, and which action shall, 

12 at the request of either party to such action, be 

13 tried by the court with a jury. 

14 ‘‘(2) PROCEDURE.— 

15 ‘‘(A) IN GENERAL.—Any action under 

16 paragraph (1) shall be governed under the rules 

17 and procedures set forth in section 42121(b) of 

18 title 49, United States Code. 

19 ‘‘(B) EXCEPTION.—Notification in an ac20 tion under paragraph (1) shall be made in ac21 cordance with section 42121(b)(1) of title 49, 

22 United States Code, except that such notification 

23 shall be made to the person named in the com24 plaint and to the employer. 


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1 ‘‘(C) BURDENS OF PROOF.—An action 

2 brought under paragraph (1)(B) shall be gov3 erned by the legal burdens of proof set forth in 

4 section 42121(b) of title 49, United States Code. 

5 ‘‘(D) STATUTE OF LIMITATIONS.—An action 

6 under paragraph (1) shall be commenced not 

7 later than 180 days after the date on which the 

8 violation occurs. 

9 ‘‘(c) REMEDIES.— 

10 ‘‘(1) IN GENERAL.—An employee prevailing in 

11 any action under subsection (b)(1) shall be entitled to 

12 all relief necessary to make the employee whole. 

13 ‘‘(2) ISSUANCE OF ORDER.—If, in response to a 

14 complaint filed under subsection (b)(1), the Secretary 

15 of Labor or the district court, as applicable, deter16 mines that a violation of subsection (a) has occurred, 

17 the Secretary or the court shall order the person who 

18 committed such violation— 

19 ‘‘(A) to take affirmative action to abate the 

20 violation; 

21 ‘‘(B) to— 

22 ‘‘(i) reinstate the complainant to his or 

23 her former position together with compensa24 tion (including backpay); and 


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1 ‘‘(ii) restore the terms, conditions, and 

2 privileges associated with his or her employ3 ment; and 

4 ‘‘(C) to provide compensatory damages to 

5 the complainant. 

6 If such an order is issued under this paragraph, the 

7 Secretary or the court, at the request of the complain8 ant, shall assess against the person against whom the 

9 order is issued a sum equal to the aggregate amount 

10 of all costs and expenses (including attorney and ex11 pert witness fees) reasonably incurred, as determined 

12 by the Secretary, by the complainant for, or in con13 nection with, the bringing of the complaint upon 

14 which the order was issued. 

15 ‘‘(d) RIGHTS RETAINED BY EMPLOYEE.—Nothing in 

16 this section shall be deemed to diminish the rights, privi17 leges, or remedies of any employee under any Federal or 

18 State law or under any collective bargaining agreement. 

19 The rights and remedies in this section may not be waived 

20 by any agreement, policy, form, or condition of employ21 ment.’’. 

22 SEC. 213. EXTRATERRITORIAL JURISDICTION. 

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

24 as amended by sections 110, 111, 133, 136, and 204, is 

25 amended by adding at the end the following: 


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1 ‘‘(uu) The production, manufacture, processing, prepa2 ration, packing, holding, or distribution of an adulterated 

3 or misbranded food with the knowledge or intent that such 

4 article will be imported into the United States.’’. 

5 (b) JURISDICTION.—Chapter III (21 U.S.C. 331 et 

6 seq.), as amended by section 211, is amended by adding 

7 at the end the following: 

8 ‘‘SEC. 312. EXTRATERRITORIAL JURISDICTION. 

9 ‘‘There is extraterritorial Federal jurisdiction over any 

10 violation of this Act relating to any article of food if such 

11 article was intended for import into the United States or 

12 if any act in furtherance of the violation was committed 

13 in the United States.’’. 

14 SEC. 214. SUPPORT FOR TRAINING INSTITUTES. 

15 The Secretary of Health and Human Services, acting 

16 through the Commissioner of Food and Drugs, shall provide 

17 financial and other assistance to appropriate entities to es18 tablish and maintain one or more university-affiliated food 

19 protection training institutes that— 

20 (1) conduct training related to food protection 

21 activities for Federal, State, local, territorial, and 

22 tribal officials; and 

23 (2) meet standards developed by the Secretary. 


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1 SEC. 215. BISPHENOL A IN FOOD AND BEVERAGE CON2 TAINERS. 

3 (a) NOTICE OF DETERMINATION.—No later than De4 cember 31, 2009, the Secretary of Health and Human Serv5 ices shall notify the Congress whether the available scientific 

6 data support a determination that there is a reasonable cer7 tainty of no harm, for infants, young children, pregnant 

8 women, and adults, for approved uses of polycarbonate 

9 plastic and epoxy resin made with bisphenol A in food and 

10 beverage containers, including reusable food and beverage 

11 containers, under the conditions of use prescribed in current 

12 Food and Drug Administration regulations. 

13 (b) NOTICE OF ACTIONS TO BE TAKEN.—If the Sec14 retary concludes that such a determination cannot be made 

15 for any approved use, the Secretary shall notify the Con16 gress of the actions the Secretary intends to take under the 

17 Secretary’s authority to regulate food additives to protect 

18 the public health, which may include— 

19 (1) revoking or modifying any of the approved 

20 uses of bisphenol A in food and beverage containers, 

21 including reusable food and beverage containers; and 

22 (2) ensuring that the public is sufficiently in23 formed of such determination and the steps the public 

24 may take in response to such determination. 

25 (c) RULE OF CONSTRUCTION.—Nothing herein is in26 tended or shall be construed to modify existing Food and 


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1 Drug Administration authority, procedures, or policies for 

2 assessing scientific data, making safety determinations, or 

3 regulating the safe use of food additives. 


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Union Calendar No. 130 

111TH CONGRESS 

1ST SESSION H. R. 2749 

[Report No. 111–234] 

A BILL 

To amend the Federal Food, Drug, and Cosmetic 

market, and for other purposes. Act to improve the safety of food in the global 

JULY 29, 2009 

Reported with an amendment, committed to the Comand ordered to be printed mittee of the Whole House on the State of the Union, 


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