I 

111TH CONGRESS 

1ST SESSION H. R. 2749 

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 

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. 

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. Rule of construction. 


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TITLE I—FOOD SAFETY 

Subtitle A—Prevention 

Sec. 101. Changes in registration of food facilities. 

Sec. 102. Hazard analysis, risk-based preventive controls, and food safety plan. 

Sec. 103. Performance standards. 

Sec. 104. Safety standards for fresh 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. Public health assessment system. 

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. 

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

Sec. 136. Improper import entry filings. 

TITLE II—MISCELLANEOUS 

Sec. 201. Treatment of carbon monoxide used to preserve color of meat, poultry 

products, or seafood as color additive. 

Sec. 202. Food substances generally recognized as safe. 

Sec. 203. Country of origin labeling; disclosure of source of ingredients. 

Sec. 204. Exportation certificate program. 

Sec. 205. Registration for commercial importers of food; 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. 


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1 SEC. 3. REFERENCES. 

2 Except as otherwise specified, whenever in this Act 

3 an amendment is expressed in terms of an amendment to 

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

7 seq.). 

8 SEC. 4. RULE OF CONSTRUCTION. 

9 Nothing in this Act or the amendments made by this 

10 Act shall be construed to prohibit or limit— 

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

12 (2) the introduction of evidence of compliance 

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

15 et seq.). 

16 TITLE I—FOOD SAFETY 

17 Subtitle A—Prevention 

18 SEC. 101. CHANGES IN REGISTRATION OF FOOD FACILI19 TIES. 

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

21 amended by adding at the end the following: 

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

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

24 415, including a facility whose registration is canceled or 

25 suspended under such section.’’. 

26 (b) ANNUAL REGISTRATION.— 


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

2 350d(a)) is amended— 

3 (A) in the first sentence of paragraph 

4 (1)— 

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

8 (ii) by striking ‘‘food for consumption 

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

10 for consumption in the United States or 

11 for export from the United States’’; 

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

16 it appears; 

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

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

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

21 the first sentence the following: ‘‘The Secretary 

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

24 this section, that fails to pay the registration 

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1 istration is canceled by the registrant, canceled 

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

5 (2) CONTENTS OF REGISTRATION.—Paragraph 

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

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

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

10 identifies the following: 

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

12 contact information of the facility being reg13 istered. 

14 ‘‘(B) The primary purpose and business 

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

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

18 by the Secretary by guidance) of each food 

19 manufactured, processed, packed, or held at the 

20 facility. 

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

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

24 emergency contact information of the United 

25 States distribution agent for the facility, which 


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

3 for food that is manufactured, processed, 

4 packed, or held at the facility. 

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

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

8 agent. 

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

10 facility, as specified under section 911. 

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

14 The registrant shall notify the Secretary of any 

15 change in the submitted information not later than 

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

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

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

21 amended by adding at the end the following: 

22 ‘‘(5) SUSPENSION OF REGISTRATION.— 

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

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


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1 Act that could result in serious adverse health 

2 consequences or death to humans or animals. 

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

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

6 to suspend the registration; and 

7 ‘‘(ii) an opportunity for an informal 

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

10 the suspension of such registration for 

11 such facility. 

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

13 agent in charge of a facility whose registration 

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

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

18 ‘‘(D) VACATING OF SUSPENSION.—If, 

19 based on an inspection of the facility or other 

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

24 ‘‘(6) CANCELLATION OF REGISTRATION.— 


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

2 days after providing the notice under subpara3 graph (B), the Secretary may cancel a registra4 tion that the Secretary determines was not up5 dated in accordance with this section or other6 wise contains false, incomplete, or inaccurate 

7 information. 

8 ‘‘(B) NOTICE OF CANCELLATION.—Can9 cellation shall be preceded by notice to the facil10 ity of the intent to cancel the registration and 

11 the basis for such cancellation. 

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

13 If the registration for the facility is updated or 

14 corrected no later than 7 days after notice is 

15 provided under subparagraph (B), the Sec16 retary shall not cancel such registration. 

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

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

19 to the Congress a report, based on the registrations 

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

21 the following: 

22 ‘‘(A) The number of facilities registered 

23 under this section. 

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

25 domestic. 


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

2 foreign. 

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

4 are high-risk. 

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

6 low-risk. 

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

8 hold food.’’. 

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

10 371 et seq.) is amended by adding at the end of sub11 chapter C the following: 

12 ‘‘PART 6—FEES RELATING TO FOOD 

13 ‘‘SEC. 743. FACILITY REGISTRATION FEE. 

14 ‘‘(a) IN GENERAL.— 

15 ‘‘(1) ASSESSMENT AND COLLECTION.—Begin16 ning in fiscal year 2010, the Secretary shall assess 

17 and collect an annual fee for the registration of a fa18 cility under section 415. 

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

20 shall be payable— 

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

22 under section 415 for the preceding fiscal year, 

23 on the date of registration; and 

24 ‘‘(B) for any other facility— 


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

2 than the sooner of 90 days after the date 

3 of the enactment of this part or December 

4 31, 2009; and 

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

6 later than December 31 of such fiscal year. 

7 ‘‘(b) FEE AMOUNTS.— 

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

9 subsection (a) shall be— 

10 ‘‘(A) for fiscal year 2010, $1,000; and 

11 ‘‘(B) for fiscal year 2011 and each subse12 quent fiscal year, the fee for fiscal year 2010 as 

13 adjusted under subsection (c). 

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

15 shall, not later than 60 days before the start of fis16 cal year 2011 and each subsequent fiscal year, es17 tablish, for the next fiscal year, registration fees 

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

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

20 and each subsequent fiscal year, the fee amount under 

21 subsection (b) shall be adjusted by the Secretary by notice, 

22 published in the Federal Register, to reflect the greater 

23 of— 

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

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1 sumers (all items; U.S. city average) for the 12- 

2 month period ending June 30 preceding the fiscal 

3 year for which fees are being established; 

4 ‘‘(2) the total percentage change for the pre5 vious fiscal year in basic pay under the General 

6 Schedule in accordance with section 5332 of title 5, 

7 United States Code, as adjusted by any locality8 based comparability payment pursuant to section 

9 5304 of such title for Federal employees stationed in 

10 the District of Columbia; or 

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

12 full-time equivalent position of the Food and Drug 

13 Administration, of all personnel compensation and 

14 benefits paid with respect to such positions for the 

15 first 5 years of the preceding 6 fiscal years. 

16 The adjustment made each fiscal year under this sub17 section shall be added on a compounded basis to the sum 

18 of all adjustments made each fiscal year after fiscal year 

19 2010 under this subsection. 

20 ‘‘(d) LIMITATIONS.— 

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

22 shall be refunded for a fiscal year beginning after 

23 fiscal year 2010 unless appropriations for salaries 

24 and expenses of the Food and Drug Administration 

25 for such fiscal year (excluding the amount of fees 


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1 appropriated for such fiscal year) are equal to or 

2 greater than the amount of appropriations for the 

3 salaries and expenses of the Food and Drug Admin4 istration for fiscal year 2010 (excluding the amount 

5 of fees appropriated for such fiscal year) multiplied 

6 by the adjustment factor applicable to the fiscal year 

7 involved. 

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

9 assess fees under subsection (a) during any portion 

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

11 a later date in such fiscal year the Secretary may as12 sess such fees, the Secretary may assess and collect 

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

14 registration under section 415 at any time in such 

15 fiscal year. 

16 ‘‘(3) ADJUSTMENT FACTOR.—In this sub17 section, the term ‘adjustment factor’ applicable to a 

18 fiscal year is the Consumer Price Index for all urban 

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

20 October of the preceding fiscal year divided by such 

21 Index for October 2009. 

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

23 ‘‘(1) IN GENERAL.—Fees authorized under sub24 section (a) shall be collected and available for obliga25 tion only to the extent and in the amount provided 


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1 in advance in appropriations Acts. Such fees are au2 thorized to remain available until expended. Such 

3 sums as may be necessary may be transferred from 

4 the Food and Drug Administration salaries and ex5 penses appropriation account without fiscal year lim6 itation to such appropriation account for salaries 

7 and expenses with such fiscal year limitation. 

8 ‘‘(2) COLLECTIONS AND APPROPRIATIONS

9 ACTS.—The fees authorized by this section— 

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

11 an amount not to exceed the amount specified 

12 in appropriation Acts, or otherwise made avail13 able for obligation, for such fiscal year; and 

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

15 to defray the costs of food safety activities. 

16 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

17 For each of fiscal years 2010 through 2014, there 

18 are authorized to be appropriated for fees under this 

19 section such sums as may be necessary. 

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

21 where the Secretary does not receive payment of a fee as22 sessed under subsection (a) within 30 days after it is due, 

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

24 Government subject to subchapter II of chapter 37 of title 

25 31, United States Code. 


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

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

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

6 number of officers, employees, and advisory committees so 

7 engaged. 

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

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

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

11 section, the Secretary shall prepare and submit to the 

12 Committee on Energy and Commerce of the House of 

13 Representatives and the Committee on Health, Education, 

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

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

17 of the fees collected for such fiscal year. 

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

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

20 means the expenses incurred in connection with food 

21 safety activities for— 

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

23 and Drug Administration, contractors of the 

24 Food and Drug Administration, advisory com25 mittees, and costs related to such officers, emVerDate Nov 24 2008 21:58 Jun 09, 2009 Jkt 079200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\H2749.IH H2749

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1 ployees, and committees and to contracts with 

2 such contractors; 

3 ‘‘(B) laboratory capacity; 

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

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

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

8 repair of facilities and acquisition, maintenance, 

9 and repair of fixtures, furniture, scientific 

10 equipment, and other necessary materials and 

11 supplies; and 

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

13 accounting for resources allocated for food safe14 ty activities. 

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

17 under section 415 with the requirements of this Act 

18 relating to food (including research related to and 

19 the development of standards (such as performance 

20 standards and preventive controls), risk assessments, 

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

23 enforcement, import review, information technology 

24 support, test development, product sampling, risk 

25 communication, and administrative detention).’’. 


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1 (d) TRANSITIONAL PROVISIONS.— 

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

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

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

6 fiscal years beginning with fiscal year 2010. 

7 (2) MODIFICATION OF REGISTRATION FORM.— 

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

10 Human Services shall modify the registration form 

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

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

13 amendments made by this section. 

14 (3) APPLICATION.—The amendments made by 

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

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

17 the date on which such modified registration form 

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

19 date of the enactment of this Act. 

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

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

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

25 2014. 


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

2 CONTROLS, AND FOOD SAFETY PLAN. 

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

4 342) is amended by adding at the end the following: 

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

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

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

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

9 seq.) is amended by adding at the end the following: 

10 ‘‘SEC. 418. HAZARD ANALYSIS AND RISK-BASED PREVEN11 TIVE CONTROLS. 

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

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

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

15 one if appropriate); 

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

17 preventive controls; 

18 ‘‘(3) monitor preventive controls; 

19 ‘‘(4) institute corrective actions when moni20 toring shows that preventive controls have not been 

21 properly implemented or were ineffective; 

22 ‘‘(5) conduct verification activities; 

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

24 action, and verification; and 

25 ‘‘(7) reanalyze for hazards. 

26 ‘‘(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 

5 in the absence of preventive controls that may affect 

6 the safety, wholesomeness, or sanitation of the food 

7 manufactured, processed, packed, transported, or 

8 held by the facility, including— 

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

11 drug residues, filth, decomposition, parasites, 

12 allergens, 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 

19 Secretary may, by regulation or guidance, identify 

20 hazards that are reasonably likely to occur in the ab21 sence 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, elimi7 nate, or reduce to acceptable levels the occurrence of 

8 any hazards identified in the hazard analysis under 

9 subsection (b)(3). 

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

11 Secretary may establish by regulation or guidance 

12 preventive controls for specific product types to pre13 vent intentional or unintentional contamination 

14 throughout the supply chain. The owner, operator, 

15 or agent of a facility shall implement any preventive 

16 controls identified by the Secretary under this para17 graph. 

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

19 a facility shall monitor the implementation of preventive 

20 controls under subsection (c) to identify any circumstances 

21 in which the preventive controls are not fully implemented 

22 or were ineffective, including through the use of environ23 mental and product testing programs, as appropriate. 

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

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1 dures to ensure that, if the preventive controls under sub2 section (c) are not fully implemented or are not effective— 

3 ‘‘(1) no product from such facility enters com4 merce; and 

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

6 likelihood of recurrence of the implementation fail7 ure. 

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

9 of a facility shall ensure that— 

10 ‘‘(1) the preventive controls identified under 

11 subsection (c) have been validated as adequate to 

12 control the hazards identified in the hazard analysis 

13 under subsection (b)(3); 

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

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

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

20 level the occurrence of identified hazards, including 

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

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

24 ‘‘(1) HAZARD ANALYSIS.—The owner, operator, 

25 or agent of a facility shall review the evaluation 


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1 under subsection (b) for the facility and, as nec2 essary, revise the hazard analysis under subsection 

3 (b)(3) for the facility not less than every 2 years. 

4 ‘‘(2) PREVENTIVE CONTROLS.—If there is a 

5 change that could affect the hazard analysis for a 

6 facility under subsection (b)(3) or if the Secretary 

7 determines that it is appropriate to protect public 

8 health, the owner, operator, or agent of the facility 

9 shall revise the preventive controls under subsection 

10 (c) for the facility to ensure that all hazards that are 

11 reasonably likely to occur are prevented, eliminated, 

12 or reduced to an acceptable level, or document the 

13 basis for the conclusion that no such revision is 

14 needed. 

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

16 agent 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 

21 domestic facility or a foreign facility that is required 

22 to be registered under section 415. 

23 ‘‘(2) PREVENTIVE CONTROLS.—The term ‘pre24 ventive controls’ means those risk-based procedures, 

25 practices, and processes that a person knowledgeable 


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1 about the safe manufacturing, processing, packing, 

2 transporting, or holding of food would employ to 

3 prevent, eliminate, or reduce to an acceptable level 

4 the hazards identified in the hazard analysis under 

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

6 current scientific understanding of safe food manu7 facturing, processing, packing, transporting, or hold8 ing at the time of the analysis. Those procedures, 

9 practices, and processes shall include the following, 

10 as appropriate: 

11 ‘‘(A) Sanitation procedures and practices. 

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

13 hygiene training. 

14 ‘‘(C) Process controls. 

15 ‘‘(D) An allergen control program to mini16 mize potential allergic reactions in humans 

17 from ingestion of, or contact with, human and 

18 animal food. 

19 ‘‘(E) Good manufacturing practices. 

20 ‘‘(F) Verification procedures, practices, 

21 and processes for suppliers and incoming ingre22 dients, which may include onsite auditing of 

23 suppliers and testing of incoming ingredients. 


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

2 processes established by the Secretary under 

3 subsection (c)(2). 

4 ‘‘(3) REASONABLY LIKELY TO OCCUR.—The 

5 term ‘reasonably likely to occur’ means a hazard for 

6 which a prudent person who, as applicable, manufac7 tures, processes, packs, transports, or holds food 

8 would establish controls because experience, illness 

9 data, scientific reports, or other information provide 

10 a basis to conclude that there is a reasonable possi11 bility that, in the absence of those controls, the haz12 ard will occur in the type of food being manufac13 tured, processed, packed, transported, or held. 

14 ‘‘SEC. 418A. FOOD SAFETY PLAN. 

15 ‘‘(a) IMPLEMENTATION OF FOOD SAFETY PLAN.— 

16 ‘‘(1) IN GENERAL.—Before a facility (as de17 fined in section 418(i)) introduces or delivers for in18 troduction into interstate commerce any shipment of 

19 food, the owner, operator, or agent of the facility 

20 shall develop and implement a written food safety 

21 plan (in this section referred to as a ‘food safety 

22 plan’). 

23 ‘‘(2) CONTENTS.—The food safety plan shall in24 clude each of the following elements: 


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1 ‘‘(A) The hazard analysis and any reanaly2 sis conducted under section 418. 

3 ‘‘(B) A description of the preventive con4 trols being implemented under subsection 

5 418(c), including those to address hazards or 

6 conditions identified by the Secretary under 

7 subsection 418(b)(2). 

8 ‘‘(C) A description of the procedures for 

9 monitoring preventive controls. 

10 ‘‘(D) A description of the procedures for 

11 taking corrective actions. 

12 ‘‘(E) A description of verification activities 

13 for the preventive controls, including validation, 

14 review of monitoring and corrective action 

15 records, and procedures for determining wheth16 er the preventive controls are effectively pre17 venting, eliminating, or reducing to an accept18 able level the occurrence of identified hazards 

19 or conditions. 

20 ‘‘(F) A description of the facility’s record21 keeping procedures. 

22 ‘‘(G) A description of the facility’s proce23 dures for the recall of articles of food, whether 

24 voluntarily or when required under section 422. 


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1 ‘‘(H) A description of the facility’s proce2 dures for tracing the distribution history of ar3 ticles of food, whether voluntarily or when re4 quired under section 414. 

5 ‘‘(I) A description of the facility’s proce6 dures to ensure a safe and secure supply chain 

7 for the ingredients or components used in mak8 ing the food manufactured, processed, packed, 

9 transported, or held by such facility. 

10 ‘‘(J) A description of the facility’s proce11 dures to implement the science-based perform12 ance standards issued under section 419.’’. 

13 (c) GUIDANCE OR REGULATIONS.— 

14 (1) IN GENERAL.—The Secretary of Health and 

15 Human Services (referred to in this subsection as 

16 the ‘‘Secretary’’) shall issue guidance or promulgate 

17 regulations to establish science-based standards for 

18 conducting a hazard analysis, documenting hazards, 

19 identifying and implementing preventive controls, 

20 and documenting the implementation of the preven21 tive controls, including verification and corrective ac22 tions under sections 418 and 418A of the Federal 

23 Food, Drug, and Cosmetic Act (as added by sub24 section (b)). 


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1 (2) CONSIDERATION.—In issuing guidance or 

2 promulgating regulations under this section, the Sec3 retary shall consider the impact of such guidance or 

4 regulations on small businesses. 

5 (d) NO EFFECT ON EXISTING HACCP AUTHORI6 TIES.—Nothing in this section or the amendments made 

7 by this section limits the authority of the Secretary under 

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

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

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

11 enactment of this Act, to revise, issue, or enforce product12 and category-specific regulations, such as the Seafood 

13 Hazard Analysis Critical Controls Points Program, the 

14 Juice Hazard Analysis Critical Control Program, and the 

15 Thermally Processed Low-Acid Foods Packaged in Her16 metically Sealed Containers standards. 

17 (e) EFFECTIVE DATE.— 

18 (1) GENERAL RULE.—The amendments made 

19 by this section shall take effect 18 months after the 

20 date of the enactment of this Act. 

21 (2) EXCEPTIONS.—Notwithstanding paragraph 

22 (1)— 

23 (A) the amendments made by this section 

24 shall apply to a small business (as defined by 


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1 the Secretary) after the date that is 2 years 

2 after the date of the enactment of this Act; and 

3 (B) the amendments made by this section 

4 shall apply to a very small business (as defined 

5 by the Secretary) after the date that is 3 years 

6 after the date of the enactment of this Act. 

7 SEC. 103. PERFORMANCE STANDARDS. 

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

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

10 at the end the following: 

11 ‘‘(k) 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 

16 by adding at the end the following: 

17 ‘‘SEC. 419. PERFORMANCE STANDARDS. 

18 ‘‘The Secretary shall, not less frequently than every 

19 2 years, review and evaluate epidemiological data and 

20 other appropriate sources of information, including re21 search under section 123 of the Food Safety Enhancement 

22 Act of 2009, to identify the most significant food-borne 

23 contaminants and the most significant resulting hazards. 

24 The Secretary shall issue, as soon as practicable, through 

25 guidance or by regulation, science-based performance 


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1 standards (which may include action levels) applicable to 

2 foods or food classes, as appropriate to minimize to an 

3 acceptable level, prevent, or eliminate the occurrence of 

4 such hazards. Such standards shall be applicable to foods 

5 and food classes.’’. 

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

7 and Human Services shall submit to the Congress by 

8 March 30th of the year following each review under sec9 tion 419 of the Federal Food, Drug, and Cosmetic Act, 

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

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

12 food-borne hazards identified, or the basis for not address13 ing any significant food-borne hazards identified, includ14 ing any resource limitations or limitations in data that 

15 preclude further action at that time. 

16 SEC. 104. SAFETY STANDARDS FOR FRESH PRODUCE AND 

17 CERTAIN OTHER RAW AGRICULTURAL COM18 MODITIES. 

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

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

21 amended by adding at the end the following: 

22 ‘‘(l) If it has been grown, harvested, packed, sorted, 

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

24 standards established under section 419A.’’. 


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

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

3 amended by adding at the end the following: 

4 ‘‘SEC. 419A. SAFETY STANDARDS FOR PRODUCE AND CER5 TAIN OTHER RAW AGRICULTURAL COMMOD6 ITIES. 

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

8 regulation science-based standards for the safe growing, 

9 harvesting, packing, sorting, transporting, and holding of 

10 raw agricultural commodities that— 

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

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

13 that such standards minimize the risk of serious ad14 verse health consequences or death to humans or 

15 animals. 

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

17 (a)— 

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

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

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

22 or reasonably foreseeable biological, chemical, 

23 and physical hazards, including hazards that 

24 occur naturally, may be unintentionally intro25 duced, or may be intentionally introduced, inVerDate Nov 24 2008 21:58 Jun 09, 2009 Jkt 079200 PO 00000 Frm 00029 Fmt 6652 Sfmt 6201 E:\BILLS\H2749.IH H2749

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1 cluding by acts of terrorism, into raw agricul2 tural commodities that are from a plant or a 

3 fungus; and 

4 ‘‘(B) to provide reasonable assurances that 

5 such commodity is not adulterated under sec6 tion 402; 

7 ‘‘(2) may include, with respect to growing, har8 vesting, packing, sorting, transporting, and storage 

9 operations, minimum standards for safety as the 

10 Secretary determines to be reasonably necessary; 

11 ‘‘(3) may include standards addressing manure 

12 use, water quality, employee hygiene, sanitation and 

13 animal control, and temperature controls, as the 

14 Secretary determines to be reasonably necessary; 

15 ‘‘(4) may include standards for such other ele16 ments as the Secretary determines necessary to 

17 carry out subsection (a); 

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

19 for compliance, taking into account the needs of 

20 small businesses for additional time to comply; and 

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

22 and enforcement activities. 

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

24 with the Secretary of Agriculture and may contract and 

25 coordinate with the agency or department designated by 


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1 the Governor of each State to perform activities to ensure 

2 compliance with this section.’’. 

3 (c) TIMING.— 

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

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

6 Secretary of Health and Human Services shall issue 

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

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

9 subsection (a). 

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

11 such date, the Secretary of Health and Human 

12 Services shall issue a final rule under such section. 

13 (d) NO EFFECT ON EXISTING HACCP AUTHORI14 TIES.—Nothing in this section or the amendments made 

15 by this section limits the authority of the Secretary under 

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

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

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

19 enactment of this Act, to revise, issue, or enforce product20 and category-specific regulations, such as the Seafood 

21 Hazard Analysis Critical Controls Points Program, the 

22 Juice Hazard Analysis Critical Control Program, and the 

23 Thermally Processed Low-Acid Foods Packaged in Her24 metically Sealed Containers standards. 


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

2 one year after the date of the enactment of this Act, the 

3 Secretary of Health and Human Services shall update the 

4 guidance document entitled ‘‘Guidance For Industry: 

5 Guide To Minimize Microbial Food Safety Hazards For 

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

7 1998) in accordance with this section and the amendments 

8 made by this section. 

9 SEC. 105. RISK-BASED INSPECTION SCHEDULE. 

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

11 amended by adding at the end the following: 

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

13 shall be inspected— 

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

15 under section 702 or other statutory authority by 

16 the Secretary; 

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

18 or local official recognized by the Secretary under 

19 paragraph (2); or 

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

21 representative of a country that is recognized by the 

22 Secretary under paragraph (2); and 

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

24 risk-based schedule. 


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1 ‘‘(2) For purposes of paragraph (1)(A), the Sec2 retary— 

3 ‘‘(A) may recognize Federal, State, and local of4 ficials and agencies and representatives of foreign 

5 countries as meeting standards established by the 

6 Secretary for conducting inspections under this Act; 

7 and 

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

9 of specific commodities or food types. 

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

11 shall be implemented beginning not later than 18 months 

12 after the date of the enactment of this subsection. 

13 ‘‘(4) Such risk-based schedule shall provide for a fre14 quency of inspections commensurate with the risk pre15 sented by the facility and shall be based on the following 

16 categories and inspection frequencies: 

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

18 is a high-risk facility that manufactures or processes 

19 food, including any facility that manufactures or 

20 processes raw products of animal origin (including 

21 fish and fisheries products) or other foods as des22 ignated by the Secretary. The Secretary shall ran23 domly inspect a category 1 food facility at least 

24 every 6 to 18 months. 


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

2 is a low-risk facility that manufactures or processes 

3 food or a facility that packs or labels food. The Sec4 retary shall randomly inspect a category 2 facility at 

5 least every 18 months to 3 years. 

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

7 is a facility that holds food. The Secretary shall ran8 domly inspect a category 3 facility at least every 3 

9 to 4 years. 

10 ‘‘(5) The Secretary— 

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

12 food facilities within a category under paragraph 

13 (4); 

14 ‘‘(B) may alter the inspection frequencies speci15 fied in paragraph (4) based on the need to respond 

16 to foodborne illness outbreaks and food recalls; and 

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

18 than the inspection frequency provided by paragraph 

19 (4). 

20 ‘‘(6) In determining the appropriate frequency of in21 spection, the Secretary shall consider— 

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

23 packed, or held at the facility; 

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


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1 ‘‘(C) whether the facility importing food is cer2 tified by a qualified certifying entity in accordance 

3 with section 801(p); and 

4 ‘‘(D) such other factors as the Secretary deter5 mines by guidance to be relevant to assessing the 

6 risk presented by the facility.’’. 

7 (b) REPORTS ON RISK-BASED INSPECTIONS OF

8 FOOD FACILITIES.— 

9 (1) ANNUAL REPORT.—Not later than Decem10 ber 31 of each year, the Secretary of Health and 

11 Human Services shall submit a report to the Com12 mittee on Energy and Commerce of the House of 

13 Representatives and the Committee on Health, Edu14 cation, Labor, and Pensions of the Senate describ15 ing— 

16 (A) the number of foreign and domestic fa17 cilities, by risk category, inspected under the 

18 risk-based inspection schedule established under 

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

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

21 the preceding 12 months; and 

22 (B) the costs of implementing the risk23 based inspection schedule for the preceding 12 

24 months. 


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

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

3 Secretary of Health and Human Services shall sub4 mit a report to the Committee on Energy and Com5 merce of the House of Representatives and the Com6 mittee on Health, Education, Labor, and Pensions 

7 of the Senate describing recommendations on the 

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

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

10 added by subsection (a), including recommendations 

11 for— 

12 (A) adjustments to the timing of the 

13 schedule and other ways to increase the effi14 ciency of inspections in order to enable the 

15 Food and Drug Administration to conduct more 

16 inspections; and 

17 (B) other methods to contribute to assur18 ing the safety of food. 

19 SEC. 106. ACCESS TO RECORDS. 

20 (a) RECORDS INSPECTION.—Subsection (a) of section 

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

22 ‘‘(a) RECORDS INSPECTION.—Each person who pro23 duces, manufactures, processes, packs, transports, distrib24 utes, receives, or holds an article of food in the United 

25 States or for import into the United States shall, at the 


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1 request of an officer or employee duly designated by the 

2 Secretary, permit such officer or employee, upon presen3 tation of appropriate credentials, at reasonable times and 

4 within reasonable limits and in a reasonable manner, to 

5 have access to and copy all records relating to such article 

6 bearing on whether the food is adulterated, misbranded, 

7 or otherwise in violation of this Act, including all records 

8 collected or developed to comply with section 418 or 418A. 

9 The requirement under the preceding sentence applies to 

10 all records relating to the production, manufacture, proc11 essing, packing, transporting, distribution, receipt, hold12 ing, or importation of such article maintained by or on 

13 behalf of such person in any format (including paper and 

14 electronic formats) and at any location.’’. 

15 (b) REGULATIONS CONCERNING RECORDKEEPING.— 

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

17 414 (21 U.S.C. 350c) is amended to read as follows: 

18 ‘‘(b) REGULATIONS CONCERNING RECORD19 KEEPING.—The Secretary, in consultation and coordina20 tion, as appropriate, with other Federal departments and 

21 agencies with responsibilities for regulating food safety, 

22 may by regulation establish requirements regarding the es23 tablishment and maintenance, for not longer than 3 years, 

24 of records by persons who produce, manufacture, process, 

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


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

2 Secretary shall take into account the size of a business 

3 in promulgating regulations under this section. The Sec4 retary may require such persons to maintain such records 

5 in a standardized electronic format.’’. 

6 (2) APPLICATION.—The Secretary of Health 

7 and Human Services shall promulgate revised regu8 lations to implement section 414(b) of the Federal 

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

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

11 Drug, and Cosmetic Act and regulations thereunder, 

12 as in effect on the day before the date of the enact13 ment of this Act, shall apply to acts and omissions 

14 occurring before the effective date of such revised 

15 regulations. 

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

17 (21 U.S.C. 374(a)(1)) is amended— 

18 (1) in the first sentence— 

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

20 each place it appears; and 

21 (B) by inserting ‘‘produced,’’ before ‘‘man22 ufactured’’; 

23 (2) in the second sentence— 

24 (A) by striking ‘‘(excluding farms or res25 taurants)’’; 


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1 (B) by inserting ‘‘produces,’’ before ‘‘man2 ufactures’’; 

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

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

5 and inserting ‘‘described in or required under 

6 section 414’’; and 

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

8 reasonable belief that an article of food is adul9 terated and presents a threat of serious adverse 

10 health consequences or death to humans or ani11 mals’’ and inserting ‘‘bearing on whether such 

12 food is adulterated, misbranded, or otherwise in 

13 violation of this Act, including all records col14 lected or developed to comply with section 418 

15 or 418A’’; and 

16 (3) in the fourth sentence— 

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

18 and inserting ‘‘either of the preceding two sen19 tences’’; and 

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

21 ‘‘financial data,’’. 

22 SEC. 107. TRACEABILITY OF FOOD. 

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

24 331(e)) is amended by inserting ‘‘, the violation of any 

25 requirement of the food tracing system under section 


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1 414(c);’’ before ‘‘or the refusal to permit access to or 

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

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

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

5 414 have not been complied with regarding such article,’’ 

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

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

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

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

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

11 (2) by inserting after subsection (b) the fol12 lowing: 

13 ‘‘(c) TRACING SYSTEM FOR FOOD.— 

14 ‘‘(1) IN GENERAL.—The Secretary shall by reg15 ulation establish a tracing system for food that is lo16 cated in the United States or is for import into the 

17 United States. Such regulations shall require each 

18 person who produces, manufactures, processes, 

19 packs, transports, or holds such food— 

20 ‘‘(A) to maintain the full pedigree of the 

21 origin and previous distribution history of the 

22 food; 

23 ‘‘(B) to link that history with the subse24 quent distribution history of the food; 


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1 ‘‘(C) to establish and maintain a system 

2 for tracing the food that is interoperable with 

3 the systems established and maintained by 

4 other such persons; and 

5 ‘‘(D) to use a unique identifier for each fa6 cility owned or operated by such person for 

7 such purpose, as specified under section 911. 

8 ‘‘(2) INFORMATION GATHERING.— 

9 ‘‘(A) TRACING TECHNOLOGIES.—Before 

10 issuing a proposed regulation under this sub11 section, the Secretary shall— 

12 ‘‘(i) identify technologies for tracing 

13 the distribution history of a food that are, 

14 or may be, used by members of different 

15 sectors of the food industry; and 

16 ‘‘(ii) to the extent practicable, as17 sess— 

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

20 such technologies; 

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

23 food 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.—The Secretary 

12 shall conduct 1 or more pilot projects in coordi13 nation with 1 or more sectors of the food indus14 try to explore and evaluate tracing systems for 

15 food. 

16 ‘‘(3) ADDITIONAL AUTHORITY.—In establishing 

17 a tracing system for food, the Secretary shall re18 quire— 

19 ‘‘(A) the establishment and maintenance of 

20 such additional information, including lot num21 bers, as the Secretary deems appropriate; 

22 ‘‘(B) a standardized format for pedigree 

23 information; and 

24 ‘‘(C) the use of a common nomenclature 

25 for food. 


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1 ‘‘(4) EXEMPTIONS.— 

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

3 exempt from the requirements of this sub4 section if such food is— 

5 ‘‘(i) produced on a farm; and 

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

7 agent in charge of such farm directly to a 

8 consumer or restaurant. 

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

10 by notice in the Federal Register exempt a food 

11 from the requirements of this subsection if the 

12 Secretary determines that a tracing system for 

13 such food is not necessary to protect the public 

14 health. 

15 ‘‘(C) PREVIOUS SOURCES AND SUBSE16 QUENT RECIPIENTS.—For a food covered by an 

17 exemption under subparagraph (B), the Sec18 retary shall require each person who produces, 

19 manufactures, processes, packs, transports, or 

20 holds such food to maintain records to identify 

21 the immediate previous sources of such food 

22 and its ingredients and the immediate subse23 quent recipients of such food.’’. 


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1 SEC. 108. REINSPECTION AND FOOD RECALL FEES APPLI2 CABLE 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), 

5 is 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 

9 collect fees from each facility (as defined in section 

10 415(b)) in a fiscal year— 

11 ‘‘(1) that— 

12 ‘‘(A) during such fiscal year commits a vio13 lation of any requirement of this Act relating to 

14 food, including any such requirement relating to 

15 good manufacturing practices; and 

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

17 additional inspection by the Food and Drug Ad18 ministration; or 

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

20 recall. 

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

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

23 costs of— 

24 ‘‘(1) in the case of fees collected under sub25 section (a)(1), conducting the additional inspections 

26 referred to in such subsection; and 


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•HR 2749 IH

1 ‘‘(2) in the case of fees collected under sub2 section (a)(2), conducting food recall activities, in3 cluding technical assistance, follow-up effectiveness 

4 checks, and public notifications, during the fiscal 

5 year involved. 

6 ‘‘(c) USE OF FEES.—The Secretary shall make all 

7 fees collected pursuant to this section available solely to 

8 pay for the costs referred to in subsection (b).’’. 

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

10 subsection (a) shall apply to additional inspections and 

11 food recall activities occurring after the date of the enact12 ment of this Act. 

13 SEC. 109. CERTIFICATION AND ACCREDITATION. 

14 (a) MISBRANDING.— 

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

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

17 adding 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 

23 by paragraph (1) shall apply to shipments offered 

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

25 the date of the enactment of this Act. 


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1 (b) CERTIFICATION OF COMPLIANCE FOR IM2 PORTS.—Chapter VIII (21 U.S.C. 381 et seq.) is amend3 ed— 

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

5 107(b), by inserting after the third sentence the fol6 lowing: ‘‘If an article of food being imported or of7 fered for import into the United States is not in 

8 compliance with the requirement of subsection (p) 

9 (relating to certifications of compliance with this 

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

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

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

13 fifth sentence’’; and 

14 (3) by adding at the end of section 801 the fol15 lowing: 

16 ‘‘(p) CERTIFICATIONS CONCERNING IMPORTED ARTI17 CLES.— 

18 ‘‘(1) IN GENERAL.— 

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

20 require, as an additional condition of granting 

21 admission to an article of food being imported 

22 or offered for import into the United States, 

23 that a qualified certifying entity provide a cer24 tification that the article complies with specified 

25 requirements of this Act if— 


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•HR 2749 IH

1 ‘‘(i) for food imported from a par2 ticular country or region, based on the 

3 adequacy of government controls in such 

4 country or region or other information rel5 evant to such food, certification would as6 sist the Secretary in determining whether 

7 to refuse to admit such article under sub8 section (a); 

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

10 a significant risk to health, certification 

11 would assist the Secretary in determining 

12 whether such article poses such risk; or 

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

14 particular country, there is an agreement 

15 between the Secretary and the government 

16 of such country providing for such certifi17 cation. 

18 ‘‘(B) CONTENTS OF CERTIFICATION.— 

19 Such certification shall include such informa20 tion regarding compliance as the Secretary may 

21 specify, and may be provided in the form of 

22 shipment-specific certificates, a listing of cer23 tified facilities or other entities, or in such other 

24 form as the Secretary may specify. 


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1 ‘‘(C) NOTICE OF CANCELLATION OR SUS2 PENSION OF CERTIFICATION.—As a condition 

3 on acceptance of certifications from a qualified 

4 certifying entity, the Secretary shall require the 

5 qualified certifying entity to notify the Sec6 retary whenever the qualified certifying entity 

7 cancels or suspends the certification of any fa8 cility included in a listing under subparagraph 

9 (B). 

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

11 purposes of this subsection, the term ‘qualified certi12 fying entity’ means— 

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

14 government of the country from which the arti15 cle originated, as designated by such govern16 ment or the Secretary; or 

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

18 the Secretary to be qualified to provide a cer19 tification under paragraph (1). 

20 ‘‘(3) NO CONFLICTS OF INTEREST.— 

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

22 issue regulations to ensure that any qualified 

23 certifying entity and its auditors are free from 

24 conflicts of interest. 


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1 ‘‘(B) REGULATIONS.—Such regulations 

2 shall require that— 

3 ‘‘(i) the qualified certifying entity 

4 shall have a committee or management 

5 structure for safeguarding impartiality; 

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

7 qualified certifying entity and auditors act8 ing for the qualified certifying entity shall 

9 be written; 

10 ‘‘(iii) the qualified certifying entity 

11 shall not be owned, operated, or controlled 

12 by a producer, manufacturer, processor, 

13 packer, holder, supplier, or vendor of any 

14 article of the type it certifies; 

15 ‘‘(iv) the qualified certifying entity 

16 shall not have any ownership or financial 

17 interest in any product, producer, manu18 facturer, processor, packer, holder, supplier 

19 or vendor of the type it certifies; 

20 ‘‘(v) no auditor acting for the quali21 fied certifying entity (or spouse or minor 

22 children) shall have any significant owner23 ship or other financial interest regarding 

24 any product of the type it certifies; 


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1 ‘‘(vi) the qualified certifying entity 

2 shall maintain records pertaining to the fi3 nancial interests of the personnel involved 

4 in audits; 

5 ‘‘(vii) neither the qualified certifying 

6 entity nor any of its auditors acting for the 

7 qualified certifying entity shall participate 

8 in the production, manufacture, processing, 

9 packing, holding, promotion, or sale of any 

10 product of the type it certifies; 

11 ‘‘(viii) neither the qualified certifying 

12 entity nor any of its auditors shall provide 

13 consultative services to any facility cer14 tified by the qualified certifying entity, or 

15 the owner, operator, or agent in charge of 

16 such a facility; 

17 ‘‘(ix) no auditors acting for the quali18 fied certifying entity shall participate in an 

19 audit of a facility they were employed by 

20 within the last 12 months; 

21 ‘‘(x) fees charged or accepted shall 

22 not be contingent or based upon the report 

23 made by the qualified certifying entity or 

24 any personnel involved in the audit proc25 ess; 


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1 ‘‘(xi) neither the qualified certifying 

2 entity nor any of its auditors shall accept 

3 anything of value from anyone in connec4 tion with the facility being audited other 

5 than the audit fee; 

6 ‘‘(xii) the qualified certifying entity 

7 shall not be owned, operated, or controlled 

8 by a trade association whose member com9 panies operate facilities that it certifies; 

10 ‘‘(xiii) the qualified certifying entity 

11 and its auditors shall be free from any 

12 other conflicts of interest that threaten im13 partiality; 

14 ‘‘(xiv) the qualified certifying entity 

15 and its auditors shall sign a statement at16 testing to compliance with the conflict of 

17 interests requirements under this para18 graph; and 

19 ‘‘(xv) the qualified certifying entity 

20 shall also ensure that any subcontractors 

21 that might be used (such as laboratories 

22 and sampling services) provide similar as23 surances. 

24 ‘‘(C) ANYTHING OF VALUE.—In this para25 graph, the term ‘anything of value’ includes 


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1 gifts, gratuities, reimbursement of expenses, en2 tertainment, loans, or any other form of com3 pensation in cash or in kind. 

4 ‘‘(4) RENEWAL AND REFUSAL OF CERTIFI5 CATIONS.—The Secretary shall— 

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

7 any certification provided by a qualified certi8 fying entity be renewed by such entity at such 

9 times as the Secretary determines appropriate; 

10 and 

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

12 the Secretary determines that such certification 

13 is no longer valid or reliable. 

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

15 shall provide for the electronic submission of certifi16 cations under this subsection. 

17 ‘‘(6) NO LIMIT ON AUTHORITY.—This sub18 section shall not be construed to limit the authority 

19 of the Secretary to conduct random inspections of 

20 imported articles or facilities of importers, issue im21 port alerts for detention without physical examina22 tion, require submission to the Secretary of docu23 mentation or other information about an article im24 ported or offered for import, or to take such other 


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1 steps as the Secretary deems appropriate to deter2 mine the admissibility of imported articles.’’. 

3 SEC. 110. TESTING BY ACCREDITED LABORATORIES. 

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

5 is amended by adding at the end the following: 

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

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

8 (b) LABORATORY ACCREDITATION.—Subchapter A of 

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

10 at the end the following: 

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

12 ‘‘(a) IN GENERAL.—Whenever analytical testing of 

13 an article of food is conducted as part of testimony for 

14 the purposes of section 801(a), or for other purposes as 

15 the Secretary deems appropriate, such testing shall be 

16 conducted by a laboratory that— 

17 ‘‘(1) is independent of the person on whose be18 half such testing is conducted; 

19 ‘‘(2) is accredited, for the analytical method 

20 used, by a laboratory accreditation body that has 

21 been recognized by the Secretary; and 

22 ‘‘(3) samples such article, itself or through an 

23 independent third party, with adequate controls for 

24 ensuring the integrity of the samples analyzed. 


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1 ‘‘(b) RECOGNITION OF LABORATORY ACCREDITATION

2 BODIES.—The Secretary shall establish and implement a 

3 program for the recognition, based on standards the Sec4 retary deems appropriate, of laboratory accreditation bod5 ies that accredit laboratories to perform analytical testing 

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

7 regulations or guidance to implement this program. 

8 ‘‘(c) ON-SITE AUDITS.—In evaluating whether an ac9 creditation body meets, or continues to meet, the stand10 ards for recognition under subsection (b), the Secretary 

11 may— 

12 ‘‘(1) observe on-site audits of laboratories by 

13 such accreditation bodies; or 

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

15 such accreditation body under this section, upon re16 quest of an officer or employee designated by the 

17 Secretary and upon presentation of appropriate cre18 dentials, at reasonable times and within reasonable 

19 limits and in a reasonable manner, conduct an on20 site audit of the laboratory, which shall include ac21 cess to, and copying and verification of, any related 

22 records. 

23 ‘‘(d) PUBLICATION OF LIST OF RECOGNIZED AC24 CREDITATION BODIES.—The Secretary shall publish and 

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


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1 Administration a list of accreditation bodies recognized by 

2 the Secretary under subsection (b). 

3 ‘‘(e) NOTIFICATION OF ACCREDITATION OF LABORA4 TORY.—An accreditation body that has been recognized 

5 pursuant to this section shall promptly notify the Sec6 retary whenever it accredits a laboratory for the purposes 

7 of this section and whenever it withdraws or suspends 

8 such accreditation. 

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

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

11 whose behalf the testing is conducted shall notify the Sec12 retary before any sample of the article is collected. Such 

13 notice shall contain information the Secretary determines 

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

15 article, and each laboratory that will analyze the sample 

16 on the person’s behalf. 

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

18 Whenever analytical testing is conducted pursuant to sub19 section (a), the laboratory conducting such testing shall 

20 submit, directly to the Secretary— 

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

22 laboratory on each sample of such article; 

23 ‘‘(2) all information the Secretary deems appro24 priate to— 


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1 ‘‘(A) determine whether the laboratory is 

2 accredited by a recognized laboratory accredita3 tion body; 

4 ‘‘(B) identify the article tested; 

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

6 ‘‘(D) determine whether the requirements 

7 of this section have been met. 

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

9 may waive the requirement of subsection (a)(2) (relating 

10 to analytical methods) on a laboratory- or method-basis 

11 due to exigent or other circumstances. 

12 ‘‘(i) NO LIMIT ON AUTHORITY.—Nothing in this sec13 tion shall be construed to limit— 

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

15 act upon information from the analytical testing of 

16 food (including under this section), including deter17 mining the sufficiency of such information and test18 ing; or 

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

20 require, or consider the results of analytical testing 

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


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1 SEC. 111. NOTIFICATION, NONDISTRIBUTION, AND RECALL 

2 OF ADULTERATED OR MISBRANDED FOOD. 

3 (a) PROHIBITED ACTS.—Section 301 (21 U.S.C. 

4 331), as amended by section 110, is amended by adding 

5 at the end the following: 

6 ‘‘(pp)(1) The failure to notify the Secretary in viola7 tion of section 420(a). 

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

9 under section 420.’’. 

10 (b) NOTIFICATION, NONDISTRIBUTION, AND RECALL

11 OF ADULTERATED OR MISBRANDED FOOD.—Chapter IV 

12 (21 U.S.C. 341 et seq.), as amended by sections 102, 103, 

13 and 104, is amended by adding at the end the following: 

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

15 OF ADULTERATED OR MISBRANDED FOOD. 

16 ‘‘(a) NOTIFICATION, NONDISTRIBUTION, AND RE17 CALL OF ADULTERATED OR MISBRANDED FOOD.— 

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

19 term is defined in section 417(a)(1) or a person re20 quired to register under section 801(r) that has rea21 son to believe that an article of food when intro22 duced into or while in interstate commerce, or while 

23 held for sale (regardless of whether the first sale) 

24 after shipment in interstate commerce, is adulter25 ated or misbranded in a manner that presents a rea26 sonable probability that the use or consumption of, 


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1 or exposure to, the article (or an ingredient or com2 ponent used in any such article) will cause a threat 

3 of serious adverse health consequences or death to 

4 humans or animals shall, as soon as practicable, no5 tify the Secretary of the identity and location of the 

6 article. 

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

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

9 and by such means as the Secretary may require by 

10 regulation or guidance. 

11 ‘‘(b) VOLUNTARY RECALL.—The Secretary may re12 quest that any person who distributes an article of food 

13 that the Secretary has reason to believe is adulterated, 

14 misbranded, or otherwise in violation of this Act volun15 tarily— 

16 ‘‘(1) recall such article, and 

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

18 as appropriate, to persons who may be affected by 

19 the recall. 

20 ‘‘(c) ORDER TO CEASE DISTRIBUTION.—If the Sec21 retary has reason to believe that the use or consumption 

22 of, or exposure to, an article of food may cause adverse 

23 health consequences or death to humans or animals, the 

24 Secretary shall have the authority to issue an order requir25 ing any person who distributes such article— 


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•HR 2749 IH

1 ‘‘(1) to immediately cease distribution of such 

2 article; and 

3 ‘‘(2) to immediately notify any person to whom 

4 the article was distributed of the order. 

5 In providing for notice under paragraph (2), the Secretary 

6 may, as appropriate, allow such notice to be provided with 

7 the assistance of health care professionals, State or local 

8 health officials, or other persons designated by the Sec9 retary. 

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

11 is subject to an order under subsection (c) shall imme12 diately cease distribution of such article and provide notifi13 cation as required by such order, and may appeal within 

14 24 hours of issuance such order to the Secretary. Such 

15 appeal may include a request for an informal hearing and 

16 a description of any efforts to recall such article under17 taken voluntarily by the person, including after a request 

18 under subsection (b). Except as provided in subsection (f), 

19 an informal hearing, if granted, shall be held within 10 

20 business days, or less as determined by the Secretary, 

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

22 agree to an extension. After affording an opportunity for 

23 an informal hearing, the Secretary shall determine wheth24 er the order should be amended to require a recall of such 

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1 ing, the Secretary determines that inadequate grounds 

2 exist to support the actions required by the order, the Sec3 retary shall vacate the order. 

4 ‘‘(e) ORDER TO RECALL.— 

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

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

7 an informal hearing under subsection (d), the Sec8 retary determines that the order should be amended 

9 to include a recall of the article with respect to 

10 which the order was issued, the Secretary shall 

11 amend the order to require a recall. 

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

13 paragraph (1) shall— 

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

15 will occur; 

16 ‘‘(B) require periodic reports to the Sec17 retary describing the progress of the recall; and 

18 ‘‘(C) provide for notice, including to indi19 viduals as appropriate, to persons who may be 

20 affected by the recall. 

21 In providing for such notice, the Secretary may 

22 allow for the assistance of health professionals, State 

23 or local officials, or other individuals designated by 

24 the Secretary. 

25 ‘‘(f) EMERGENCY RECALL ORDER.— 


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1 ‘‘(1) IN GENERAL.—If the Secretary has a rea2 sonable belief that an article of food subject to an 

3 order under subsection (c) presents a threat of seri4 ous adverse health consequences or death to humans 

5 or animals, the Secretary may issue an order requir6 ing any person who distributes such article— 

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

8 ‘‘(B) to provide for notice, including to in9 dividuals as appropriate, to persons who may be 

10 affected by the recall. 

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

12 who is subject to an emergency recall order under 

13 this subsection shall immediately recall such article 

14 and provide notification as required by such order, 

15 and may appeal within 24 hours after issuance such 

16 order to the Secretary. An informal hearing, if 

17 granted, shall be held within 10 business days, or 

18 less as determined by the Secretary, after such an 

19 appeal is filed, unless the parties jointly agree to an 

20 extension. After affording an opportunity for an in21 formal hearing, the Secretary shall determine wheth22 er the order should be amended pursuant to sub23 section (e)(1). If, after providing an opportunity for 

24 such a hearing, the Secretary determines that inadVerDate Nov 24 2008 21:58 Jun 09, 2009 Jkt 079200 PO 00000 Frm 00061 Fmt 6652 Sfmt 6201 E:\BILLS\H2749.IH H2749

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1 equate grounds exist to support the actions required 

2 by the order, the Secretary shall vacate the order. 

3 ‘‘(g) NOTICE TO CONSUMERS AND HEALTH OFFI4 CIALS.—The Secretary shall, as the Secretary determines 

5 to be necessary, provide notice of a recall order under this 

6 section to consumers to whom the article was, or may have 

7 been, distributed and to appropriate State and local health 

8 officials. 

9 ‘‘(h) SAVINGS CLAUSE.—Nothing contained in this 

10 section shall be construed as limiting— 

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

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

13 under any other provision of this Act or the Public 

14 Health Service Act; or 

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

16 person to perform a voluntary activity related to any 

17 article subject to this Act or the Public Health Serv18 ice Act.’’. 

19 (c) ARTICLES SUBJECT TO REFUSAL.—The third 

20 sentence of subsection (a) of section 801 (21 U.S.C. 381), 

21 as amended by section 107(b), is amended by inserting 

22 ‘‘or (5) such article is subject to an order under section 

23 420 to cease distribution of or recall the article,’’ before 

24 ‘‘then such article shall be refused admission’’. 


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

2 of the Federal Food, Drug, and Cosmetic Act, as added 

3 by subsections (a) and (b), shall apply with respect to arti4 cles of food as of such date, not later than 1 year after 

5 the date of the enactment of this Act, as the Secretary 

6 of Health and Human Services shall specify. 

7 SEC. 112. REPORTABLE FOOD REGISTRY; EXCHANGE OF IN8 FORMATION. 

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

10 U.S.C. 350f) is amended— 

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

12 person’’ and all that follows through the end of 

13 paragraph (1) and inserting the following: ‘‘means— 

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

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

16 required to be registered under section 415(a), 

17 at which such food is manufactured, processed, 

18 packed, or held; 

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

20 agent of, or is otherwise responsible for such 

21 food on a farm (as such term is defined in sec22 tion 1.227(b)(3) of title 21, Code of Federal 

23 Regulations, or successor regulations) at which 

24 such food is produced for sale or distribution in 

25 interstate commerce; 


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

2 agent of a restaurant or other retail food estab3 lishment (as such terms are defined in section 

4 1.227(b)(11) and (12), respectively, of title 21, 

5 Code of Federal Regulations, or successor regu6 lations) at which such food is offered for sale; 

7 or 

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

9 pursuant to section 801(r) with respect to im10 portation of such food.’’; 

11 (2) in subsection (d)(1)— 

12 (A) in the matter preceding subparagraph 

13 (A)— 

14 (i) by inserting ‘‘information reason15 ably available to’’ after ‘‘after’’; and 

16 (ii) by striking ‘‘determines’’ and in17 serting ‘‘indicates’’; 

18 (B) in subparagraph (A), by striking 

19 ‘‘and’’ at the end; 

20 (C) by redesignating subparagraph (B) as 

21 subparagraph (C); and 

22 (D) by inserting after subparagraph (A) 

23 the 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 

5 the responsible party under section 418, 

6 418A, 419, 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 com18 ponent of such article, any other article of 

19 food manufactured, processed, packed or 

20 held in the same manner as, or at the 

21 same facility as, such article, or any other 

22 article containing a component from the 

23 same source as a component of such arti24 cle; and’’; and 

25 (3) 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 sec17 tion, 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 

20 in 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 infor25 mation relating to food that is exempt from disclosure purVerDate Nov 24 2008 21:58 Jun 09, 2009 Jkt 079200 PO 00000 Frm 00066 Fmt 6652 Sfmt 6201 E:\BILLS\H2749.IH H2749

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1 suant to section 552(a) of title 5, United States Code, by 

2 reason of subsection (b)(4) of such section, or that is re3 ferred to in section 301(j) or 415(a)(4). 

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

5 local government agency shall not be disclosed by such 

6 agency. 

7 ‘‘(3) In carrying out this Act, the Secretary may pro8 vide to any person any information relating to food that 

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

10 title 5, United States Code, by reason of subsection (b)(4) 

11 of such section, if the Secretary determines that providing 

12 the information to the person is appropriate under the cir13 cumstances and the recipient provides adequate assur14 ances to the Secretary that the recipient will preserve the 

15 confidentiality of the information. 

16 ‘‘(4) In carrying out this Act, the Secretary may pro17 vide any information relating to food that is exempt from 

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

19 States Code, by reason of subsection (b)(4) of such sec20 tion, or that is referred to in section 301(j)— 

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

22 ‘‘(B) any international organization established 

23 by law, treaty, or other governmental action and 

24 having responsibility— 


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1 ‘‘(i) to facilitate global or regional harmo2 nization of standards and requirements in an 

3 area of responsibility of the Food and Drug Ad4 ministration; or 

5 ‘‘(ii) to promote and coordinate public 

6 health efforts, 

7 if the agency or organization provides adequate as8 surances to the Secretary that the agency or organi9 zation will preserve the confidentiality of the infor10 mation. 

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

12 the Secretary may disclose to the public any information 

13 relating to food that is exempt from disclosure pursuant 

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

15 of subsection (b)(4) of such section, if the Secretary deter16 mines that such disclosure is necessary to protect the pub17 lic health. 

18 ‘‘(d) Except as provided in subsection (e), the Sec19 retary shall not be required to disclose under section 552 

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

21 law any information relating to food obtained from a Fed22 eral, State, or local government agency, or from a foreign 

23 government agency, or from an international organization 

24 described in subsection (b)(4), if the agency or organiza25 tion has requested that the information be kept confidenVerDate Nov 24 2008 21:58 Jun 09, 2009 Jkt 079200 PO 00000 Frm 00068 Fmt 6652 Sfmt 6201 E:\BILLS\H2749.IH H2749

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1 tial, or has precluded such disclosure under other use limi2 tations, as a condition of providing the information. 

3 ‘‘(e) Nothing in subsection (d) authorizes the Sec4 retary to withhold information from the Congress or pre5 vents the Secretary from complying with an order of a 

6 court of the United States. 

7 ‘‘(f) This section shall not affect the authority of the 

8 Secretary to provide or disclose information under any 

9 other provision of law.’’. 

10 (c) CONFORMING AMENDMENT.—Section 301(j) (21 

11 U.S.C. 331(j)) is amended by striking ‘‘or to the courts 

12 when relevant in any judicial proceeding under this Act,’’ 

13 and inserting ‘‘to the courts when relevant in any judicial 

14 proceeding under this Act, or as specified in section 708,’’. 

15 SEC. 113. SAFE AND SECURE FOOD IMPORTATION PRO16 GRAM. 

17 Chapter VIII (21 U.S.C. 381 et seq.) is amended by 

18 adding at the end the following: 

19 ‘‘SEC. 805. SAFE AND SECURE FOOD IMPORTATION PRO20 GRAM. 

21 ‘‘(a) IN GENERAL.—The Secretary may establish by 

22 regulation or guidance a program that facilitates the 

23 movement of food through the importation process under 

24 this Act if the importer of such food— 


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1 ‘‘(1) verifies that each facility involved in the 

2 production, manufacture, processing, packaging, and 

3 holding of the food is in compliance with the food 

4 safety and security guidelines developed under sub5 section (b) with respect to such food; 

6 ‘‘(2) ensures that appropriate safety and secu7 rity controls are in place throughout the supply 

8 chain for such food; and 

9 ‘‘(3) provides supporting information to the 

10 Secretary. 

11 ‘‘(b) GUIDELINES.— 

12 ‘‘(1) DEVELOPMENT.—For purposes of the pro13 gram established under subsection (a), the Secretary 

14 shall develop safety and security guidelines applica15 ble to the importation of food. 

16 ‘‘(2) FACTORS.—Such guidelines shall take into 

17 account the following factors: 

18 ‘‘(A) The personnel of the person import19 ing the food. 

20 ‘‘(B) The physical and procedural safety 

21 and security of such person’s food supply chain. 

22 ‘‘(C) The sufficiency of preventive controls 

23 for food and ingredients purchased by such per24 son. 

25 ‘‘(D) Vendor and supplier information. 


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1 ‘‘(E) Such other factors as the Secretary 

2 determines necessary.’’. 

3 SEC. 114. INFANT FORMULA. 

4 (a) MISBRANDING.—Section 403 of the Federal 

5 Food, Drug, and Cosmetic Act (21 U.S.C. 343) as amend6 ed by sections 101(a) and 109(a), is amended by adding 

7 at the end the following: 

8 ‘‘(bb) If it is a new infant formula and it is not the 

9 subject of a letter from the Secretary provided pursuant 

10 to section 412(c)(1)(C).’’. 

11 (b) REQUIREMENTS.—Section 412 of the Federal 

12 Food, Drug, and Cosmetic Act (21 U.S.C. 350a) is 

13 amended— 

14 (1) in subsection (b)(1), by adding at the end 

15 the following: ‘‘The quality factor requirements es16 tablished under this paragraph may include require17 ments for one or more clinical studies to dem18 onstrate that the new infant formula supports nor19 mal physical growth of infants.’’; 

20 (2) in subsection (b)(4), amend subparagraph 

21 (B) to read as follows: 

22 ‘‘(B) Records required under subparagraph (A) with 

23 respect to an infant formula shall be retained for at least 

24 one year after the expiration of the shelf life of such infant 

25 formula. Such records shall be made available to the SecVerDate Nov 24 2008 21:58 Jun 09, 2009 Jkt 079200 PO 00000 Frm 00071 Fmt 6652 Sfmt 6201 E:\BILLS\H2749.IH H2749

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1 retary for review and duplication upon request of the Sec2 retary.’’; 

3 (3) in subsection (c)(1)— 

4 (A) in subparagraph (A), by striking 

5 ‘‘and’’ at the end; 

6 (B) in subparagraph (B), by striking 

7 ‘‘(c)(1).’’ at the end and inserting ‘‘(d)(1), 

8 and’’; and 

9 (C) by adding at the end the following: 

10 ‘‘(C) the Secretary has by letter informed such 

11 person that the registration requirements and the 

12 requirements in subsection (d)(1) have been satis13 fied.’’; and 

14 (4) in subsection (d)(1), by striking subpara15 graphs (C) and (D) and inserting the following: 

16 ‘‘(C) scientific evidence and other evidence, as 

17 identified in regulations promulgated by the Sec18 retary, that demonstrates that the infant formula 

19 satisfies the requirements of subsection (b)(1), and, 

20 as demonstrated by the testing required under sub21 section (b)(3), that it satisfies the requirements of 

22 subsection (i), and 

23 ‘‘(D) scientific evidence and other evidence, as 

24 identified in regulations promulgated by the Sec25 retary, that demonstrates that the processing of the 


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1 infant formula complies with the requirements of 

2 subsection (b)(2).’’. 

3 Subtitle B—Intervention 

4 SEC. 121. PUBLIC HEALTH ASSESSMENT SYSTEM. 

5 (a) SURVEILLANCE SYSTEM.—The Secretary of 

6 Health and Human Services (in this subtitle referred to 

7 as the ‘‘Secretary’’) shall build upon the existing surveil8 lance system for food, based on a representative propor9 tion of the population of the United States, to assess the 

10 frequency and sources of human illness in the United 

11 States associated with the consumption of food. 

12 (b) SAMPLING AND ASSESSMENT.— 

13 (1) IN GENERAL.—The Secretary shall utilize, 

14 as appropriate, samples of food collected and ana15 lyzed by, or on behalf of, the Secretary in carrying 

16 out the Secretary’s duties under this Act and the 

17 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

18 301 et seq.) and may collect and analyze additional 

19 samples of food to assess the nature, frequency of 

20 occurrence, and amounts of contaminants in food. 

21 (2) REQUIREMENTS.—Assessment by the Sec22 retary under this section may employ, in the Sec23 retary’s discretion, statistically valid monitoring, in24 cluding market-basket studies, on the nature, fre25 quency of occurrence, and amounts of contaminants 


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1 in food available to consumers, and at the request of 

2 the Secretary such other information as the Sec3 retary determines may be useful. 

4 (c) PUBLIC AVAILABILITY OF ASSESSMENT.—To the 

5 extent it does not impede the ability of the United States 

6 to protect against terrorist threats and other intentional 

7 attacks against the food supply, the Secretary may make 

8 publicly available, by posting on the Web site of the De9 partment of Health and Human Services, the results of 

10 any assessment conducted under this section. To the ex11 tent feasible with the data and information available, the 

12 assessment may rank food categories based on their haz13 ard to human health and may address— 

14 (1) the safety of commercial harvesting and 

15 processing, as compared with the health hazards as16 sociated with food products that are harvested for 

17 recreational or subsistence purposes and prepared 

18 noncommercially; 

19 (2) the safety of food products that are domes20 tically harvested and processed, as compared with 

21 the health hazards associated with food products 

22 that are harvested or processed outside the United 

23 States; and 


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1 (3) contamination originating from handling 

2 practices that occur prior to or after sale of food 

3 products to consumers. 

4 SEC. 122. PUBLIC EDUCATION AND ADVISORY SYSTEM. 

5 (a) PUBLIC EDUCATION.—The Secretary, in coopera6 tion with private and public organizations, including the 

7 appropriate State entities, shall design and implement a 

8 national public education program on food safety. The 

9 program shall provide— 

10 (1) information to the public so that individuals 

11 can reduce their risk of foodborne illness and injury 

12 and make healthy dietary choices; 

13 (2) information to health professionals so that 

14 they may improve diagnosis and treatment of food15 related illness and advise individuals whose health 

16 conditions place them in particular risk; and 

17 (3) such other information or advice to con18 sumers and other persons as the Secretary deter19 mines will promote the purposes of this Act. 

20 (b) HEALTH ADVISORIES.—The Secretary shall work 

21 with the States and other appropriate entities to— 

22 (1) develop and distribute regional and national 

23 advisories concerning food safety; 

24 (2) develop standardized formats for written 

25 and broadcast advisories; and 


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1 (3) incorporate State and local advisories into 

2 the national public education program required 

3 under subsection (a). 

4 SEC. 123. RESEARCH. 

5 (a) IN GENERAL.—The Secretary shall conduct re6 search to assist in the implementation of this Act, includ7 ing studies to— 

8 (1) improve sanitation and food safety practices 

9 in the processing of food products; 

10 (2) develop improved techniques for the moni11 toring of food and inspection of food products; 

12 (3) develop efficient, rapid, and sensitive meth13 ods for determining and detecting the presence of 

14 contaminants in food products; 

15 (4) determine the sources of contamination of 

16 food and food products; 

17 (5) develop consumption data with respect to 

18 food products; 

19 (6) draw upon research and educational pro20 grams that exist at the State and local level; 

21 (7) utilize the DNA matching system and other 

22 processes to identify and control pathogens; 

23 (8) address common and emerging zoonotic dis24 eases; 


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1 (9) develop methods to reduce or destroy patho2 gens before, during, and after processing; 

3 (10) analyze the incidence of antibiotic resist4 ance as it pertains to the food supply and develop 

5 new methods to reduce the transfer of antibiotic re6 sistance to humans; and 

7 (11) conduct other research that supports the 

8 purposes of this Act. 

9 (b) CONTRACT AUTHORITY.—The Secretary is au10 thorized to enter into contracts and agreements with any 

11 State, university, government agency, or other person to 

12 carry out this section. 

13 Subtitle C—Response 

14 SEC. 131. PROCEDURES FOR SEIZURE. 

15 Section 304(b) (21 U.S.C. 334(b)) is amended by in16 serting ‘‘and except that, with respect to proceedings relat17 ing to food, Rule G of the Supplemental Rules of Admi18 ralty or Maritime Claims and Asset Forfeiture Actions 

19 shall not apply in any such case, exigent circumstances 

20 shall be deemed to exist for all seizures brought under this 

21 section, and the summons and arrest warrant shall be 

22 issued by the clerk of the court without court review in 

23 any such case’’ after ‘‘in any such case shall be tried by 

24 jury’’. 


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1 SEC. 132. ADMINISTRATIVE DETENTION. 

2 (a) AMENDMENTS.—Section 304(h) (21 U.S.C. 

3 334(h)) is amended— 

4 (1) in paragraph (1)(A), by striking ‘‘credible 

5 evidence or information indicating’’ and inserting 

6 ‘‘reason to believe’’; 

7 (2) in paragraph (1)(A), by striking ‘‘presents 

8 a threat of serious adverse health consequences or 

9 death to humans or animals’’ and inserting ‘‘is adul10 terated, misbranded, or otherwise in violation of this 

11 Act’’; 

12 (3) in paragraph (2), by striking ‘‘30’’ and in13 serting ‘‘60’’; 

14 (4) in paragraph (3), by striking the third sen15 tence; and 

16 (5) in paragraph (4)(A) by striking the terms 

17 ‘‘five’’ and ‘‘five-day’’ and inserting ‘‘fifteen’’ and 

18 ‘‘fifteen-day’’, respectively. 

19 (b) REGULATIONS.—The Secretary shall issue regula20 tions or guidance to implement the amendments made by 

21 this section. 

22 (c) EFFECTIVE DATE.—The amendments made by 

23 this section shall take effect 180 days after the date of 

24 the enactment of this Act. 


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1 SEC. 133. QUARANTINE AUTHORITY FOR FOODS. 

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

3 as amended by sections 110 and 111, is amended by add4 ing at the end by adding the following: 

5 ‘‘(qq) The violation of a quarantine under section 

6 304(i).’’. 

7 (b) IN GENERAL.—Section 304 (21 U.S.C. 334) is 

8 amended by adding at the end the following: 

9 ‘‘(i) QUARANTINE OF GEOGRAPHIC LOCATION.— 

10 ‘‘(1) AUTHORITY TO QUARANTINE.—If the Sec11 retary determines that there is credible evidence or 

12 information that an article of food presents a threat 

13 of serious adverse health consequences or death to 

14 humans or animals, the Secretary may quarantine 

15 any geographic area within the United States where 

16 the Secretary reasonably believes such food is lo17 cated or from which such food originated. The au18 thority to quarantine includes prohibiting or restrict19 ing the movement of food or of any vehicle being 

20 used or that has been used to transport or hold such 

21 food within the geographic area. 

22 ‘‘(2) NOTIFICATION PROCEDURES.—Before any 

23 quarantine action is taken in any State under this 

24 subsection, the Secretary shall notify an appropriate 

25 official of the State affected and shall issue a public 

26 announcement of— 


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1 ‘‘(A) the Secretary’s findings that support 

2 the quarantine action; 

3 ‘‘(B) the area affected by the intended 

4 quarantine action; 

5 ‘‘(C) the reasons for the intended quar6 antine action; and 

7 ‘‘(D) where practicable, an estimate of the 

8 anticipated duration of the quarantine. 

9 The Secretary is not required to make such announcement 

10 by publication in the Federal Register, but may use a 

11 newspaper, radio or television, the Internet, or any reason12 able means to make such announcement.’’ 

13 SEC. 134. CRIMINAL PENALTIES. 

14 Section 303(a) (21 U.S.C. 333) is amended— 

15 (1) in paragraph (1), by striking ‘‘Any’’ and in16 serting ‘‘Except as provided in paragraph (2) or (3), 

17 any’’; and 

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

19 ‘‘(3) Notwithstanding paragraph (1), any person who 

20 knowingly violates paragraph (a), (b), (c), (k), or (v) of 

21 section 301 with respect to any food that is misbranded 

22 or adulterated shall be imprisoned for not more than 10 

23 years or fined in accordance with title 18, United States 

24 Code, or both.’’. 


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1 SEC. 135. CIVIL PENALTIES FOR VIOLATIONS RELATING TO 

2 FOOD. 

3 (a) IN GENERAL.—Paragraph (2) of section 303(f) 

4 (21 U.S.C. 331 et seq.) is amended to read as follows: 

5 ‘‘(2)(A) Any person who violates a provision of 

6 section 301 relating to food shall be subject to a civil 

7 penalty for each such violation of not more than— 

8 ‘‘(i) $100,000, in the case of an individual; 

9 and 

10 ‘‘(ii) $500,000, in the case of any other 

11 person. 

12 ‘‘(B) Each violation described in subparagraph 

13 (A) and each day during which the violation con14 tinues shall be considered to be a separate offense.’’. 

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

16 subsection (a) applies to violations committed on or after 

17 the date of the enactment of this Act. 

18 SEC. 136. IMPROPER IMPORT ENTRY FILINGS. 

19 (a) PROHIBITED ACTS.—Section 301 (21 U.S.C. 

20 331), as amended by sections 110, 111, and 133, is 

21 amended by 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. 

25 ‘‘(ss) The failure to submit information relating to 

26 food that is required by or under section 801.’’. 


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1 (b) DOCUMENTATION FOR IMPORTS.—Section 801 

2 (21 U.S.C. 381), as amended by section 109, is amended 

3 by adding at the end the following: 

4 ‘‘(q) DOCUMENTATION.— 

5 ‘‘(1) SUBMISSION.—The Secretary may require 

6 by regulation or guidance the submission of docu7 mentation or other information for articles of food 

8 that are imported or offered for import into the 

9 United States. 

10 ‘‘(2) FORMAT.—A regulation or guidance under 

11 paragraph (1) may specify the format for submission 

12 of the documentation or other information.’’. 

13 TITLE II—MISCELLANEOUS 

14 SEC. 201. TREATMENT OF CARBON MONOXIDE USED TO 

15 PRESERVE COLOR OF MEAT, POULTRY PROD16 UCTS, OR SEAFOOD AS COLOR ADDITIVE. 

17 (a) IN GENERAL.—Paragraph (t) of section 201 (21 

18 U.S.C. 321) is amended by adding at the end the fol19 lowing: 

20 ‘‘(4) In the case of food that is meat within the mean21 ing of the Federal Meat Inspection Act, a poultry product 

22 within the meaning of the Poultry Products Inspection 

23 Act, or seafood (including all fresh or saltwater fish, 

24 molluscan shellfish, crustaceans, and other forms of 

25 aquatic animal life) intended for human consumption as 


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1 food within the meaning of paragraph (f) (referred to col2 lectively in this paragraph as ‘seafood’), the term ‘color 

3 additive’ shall include carbon monoxide under conditions 

4 of use that may impart, maintain, preserve, stabilize, fix, 

5 or otherwise affect the color of fresh meat, poultry prod6 ucts, or seafood.’’. 

7 (b) ACTION BY SECRETARY.—The Secretary of 

8 Health and Human Services shall— 

9 (1) promulgate a final regulation in accordance 

10 with section 721 of the Federal Food, Drug, and 

11 Cosmetic Act (21 U.S.C. 379e) for use of carbon 

12 monoxide in or on meat, poultry products, and sea13 food; or 

14 (2) publish in the Federal Register a decision 

15 against promulgating such a regulation. 

16 (c) APPLICATION.—Section 201(t)(4) of the Federal 

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

18 (a), applies to the use of carbon monoxide in or on meat, 

19 poultry products, and seafood beginning on the date on 

20 which the Secretary of Health and Human Services pro21 mulgates a final regulation under subsection (b)(1) or 

22 publishes a decision under subsection (b)(2). 


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1 SEC. 202. FOOD SUBSTANCES GENERALLY RECOGNIZED AS 

2 SAFE. 

3 Section 409 (21 U.S.C. 348) is amended by adding 

4 at the end the following: 

5 ‘‘Substances Generally Recognized as Safe 

6 ‘‘(k)(1) Not later than 60 days after the date of re7 ceipt by the Secretary, after the date of the enactment 

8 of this subsection, of a request for a substance to be deter9 mined by the Secretary to be a GRAS food substance, the 

10 Secretary shall post notice of such request and the sup11 porting scientific justifications on the Food and Drug Ad12 ministration’s public Web site. 

13 ‘‘(2) Not later than 60 days after the date of receipt 

14 of a request under paragraph (1), the Secretary shall ac15 knowledge receipt of such request by informing the re16 quester in writing of the date on which the request was 

17 received. 

18 ‘‘(3) In this subsection, the term ‘GRAS food sub19 stance’ means a substance excluded from the definition of 

20 the term ‘food additive’ in section 201(s) because such 

21 substance is generally recognized, among experts qualified 

22 by scientific training and experience to evaluate its safety, 

23 as having been adequately shown through scientific proce24 dures (or, in the case of a substances used in food prior 

25 to January 1, 1958, through either scientific procedures 


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1 or experience based on common use in food) to be safe 

2 under the conditions of its intended use.’’. 

3 SEC. 203. COUNTRY OF ORIGIN LABELING; DISCLOSURE OF 

4 SOURCE OF INGREDIENTS. 

5 (a) MISBRANDING.—Section 403 (21 U.S.C. 343), as 

6 amended by sections 101(a), 109(a), and 114(a), is 

7 amended by adding at the end the following: 

8 ‘‘(cc) In the case of a processed food if— 

9 ‘‘(1) the labeling of the food fails to identify the 

10 country in which the final processing of the food oc11 curs; and 

12 ‘‘(2) the Web site for the manufacturer of the 

13 food fails to identify the country (or countries) of or14 igin for each ingredient in the food. 

15 ‘‘(dd) In the case of non-processed food if— 

16 ‘‘(1) the labeling of the food fails to identify the 

17 country of origin of the food; and 

18 ‘‘(2) the Web site for the original packer of the 

19 food fails to identify the country of origin for the 

20 food.’’. 

21 (b) REGULATIONS.—Not later than 180 days after 

22 the date of the enactment of this Act, the Secretary of 

23 Health and Human Services shall promulgate final regula24 tions to carry out paragraphs (cc) and (dd) of section 403 


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1 of the Federal Food, Drug, and Cosmetic Act, as added 

2 by subsection (a). 

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 

7 enactment of this Act. 

8 SEC. 204. 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 

5 inserting ‘‘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 

11 certification by the Secretary shall be made on 

12 such basis and in such form (such as a publicly 

13 available listing) as the Secretary determines 

14 appropriate.’’; and 

15 (6) by adding at the end the following: 

16 ‘‘(D) Notwithstanding subparagraph (C), if the Sec17 retary issues an export certification within the 20 days 

18 prescribed by subparagraph (A) with respect to the export 

19 of food, a fee for such certification shall not exceed such 

20 amount as the Secretary determines is reasonably related 

21 to the cost of issuing certificates under subparagraph (A) 

22 with respect to the export of food. The Secretary may ad23 just this fee annually to account for inflation and other 

24 cost adjustments. Fees collected for a fiscal year pursuant 

25 to this subparagraph shall be credited to the appropriation 


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1 account for salaries and expenses of the Food and Drug 

2 Administration and shall be available in accordance with 

3 appropriations Acts until expended, without fiscal year 

4 limitation. Such fees shall be collected in each fiscal year 

5 in an amount equal to the amount specified in appropria6 tions Acts for such fiscal year and shall only be collected 

7 and available for the costs of the Food and Drug Adminis8 tration to cover the cost of issuing such certifications. 

9 Such sums as necessary may be transferred from such ap10 propriation account for salaries and expenses of the Food 

11 and Drug Administration without fiscal year limitation to 

12 such appropriation account for salaries and expenses with 

13 fiscal year limitation.’’. 

14 SEC. 205. REGISTRATION FOR COMMERCIAL IMPORTERS 

15 OF FOOD; FEE. 

16 (a) REGISTRATION.— 

17 (1) PROHIBITIONS.—Section 301 (21 U.S.C. 

18 331), as amended by sections 110, 111, 133, and 

19 136, is amended by adding at the end the following: 

20 ‘‘(tt) The failure to register in accordance with sec21 tion 801(r).’’. 

22 (2) MISBRANDING.—Section 403 (21 U.S.C. 

23 343) as amended by sections 101(a), 109(a), 114(a), 

24 and 203, is amended by adding at the end: 


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1 ‘‘(ee) If it is imported or offered for import by an 

2 importer or a customs broker or filer not duly registered 

3 under section 801(r).’’. 

4 (3) REGISTRATION.—Section 801, as amended 

5 by sections 109 and 136, is amended by adding at 

6 the end the following: 

7 ‘‘(r) REGISTRATION OF IMPORTERS AND CUSTOMS

8 BROKERS AND FILERS.— 

9 ‘‘(1) IMPORTERS.— 

10 ‘‘(A) REGISTRATION.—The Secretary shall 

11 require an importer of food— 

12 ‘‘(i) to be registered with the Sec13 retary in a form and manner specified by 

14 the Secretary; and 

15 ‘‘(ii) consistent with section 911, to 

16 submit appropriate unique facility identi17 fiers as a condition of registration. 

18 ‘‘(B) GOOD IMPORTER PRACTICES.—The 

19 maintenance of registration under this para20 graph is conditioned on compliance with good 

21 importer practices. Good importer practices 

22 shall include the verification of good manufac23 turing practices and preventive controls of the 

24 importer’s foreign suppliers, as applicable. 


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1 ‘‘(2) CUSTOMS BROKERS AND FILERS.—The 

2 Secretary shall require a customs broker or filer, 

3 with respect to the importation of food— 

4 ‘‘(A) to be registered with the Secretary in 

5 a form and manner specified by the Secretary; 

6 and 

7 ‘‘(B) consistent with section 911, to submit 

8 appropriate unique facility identifiers as a con9 dition of registration. 

10 ‘‘(3) SUSPENSION OF REGISTRATION.— 

11 ‘‘(A) IN GENERAL.—Registration under 

12 this subsection is subject to suspension upon a 

13 finding by the Secretary, after notice and an 

14 opportunity for an informal hearing, of— 

15 ‘‘(i) a violation of this Act; or 

16 ‘‘(ii) the making of an inaccurate or 

17 incomplete statement or submission of in18 formation relating to the importation of 

19 food, drugs, or devices. 

20 ‘‘(B) REQUEST.—The importer, customs 

21 broker, or filer whose registration is suspended 

22 may request that the Secretary vacate the sus23 pension of registration when such importer, 

24 customs broker, or filer has corrected the viola25 tion that is the basis for such suspension. 


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1 ‘‘(C) VACATING OF SUSPENSION.—If the 

2 Secretary determines that adequate reasons do 

3 not exist to continue the suspension of a reg4 istration, the Secretary shall vacate such sus5 pension. 

6 ‘‘(4) CANCELLATION OF REGISTRATION.— 

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

8 days after providing the notice under subpara9 graph (B), the Secretary may cancel a registra10 tion that the Secretary determines was not up11 dated in accordance with this section or other12 wise contains false, incomplete, or inaccurate 

13 information. 

14 ‘‘(B) NOTICE OF CANCELLATION.—Can15 cellation shall be preceded by notice to the im16 porter, customs broker, or filer of the intent to 

17 cancel the registration and the basis for such 

18 cancellation. 

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

20 If the registration for the importer, customs 

21 broker, or filer is updated or corrected no later 

22 than 7 days after notice is provided under sub23 paragraph (B), the Secretary shall not cancel 

24 such registration. 


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1 ‘‘(5) EXEMPTIONS.—The Secretary, by notice 

2 published in the Federal Register— 

3 ‘‘(A) shall establish an exemption from the 

4 requirements of this subsection for importations 

5 for personal use; and 

6 ‘‘(B) may establish other exemptions from 

7 the requirements of this subsection.’’. 

8 (4) REGULATIONS.—Not later than 24 months 

9 after the date of the enactment of this Act, the Sec10 retary of Health and Human Services shall promul11 gate the regulations required to carry out section 

12 801(r). 

13 (5) EFFECTIVE DATE.—The amendments made 

14 by this subsection shall take effect on the date that 

15 is 24 months after the date of enactment of this Act. 

16 (b) FEE.—Subchapter C of chapter VII (21 U.S.C. 

17 379f et seq.) as added and amended by sections 101 and 

18 108, is amended by adding at the end the following: 

19 ‘‘PART 7—IMPORTERS OF FOOD 

20 ‘‘SEC. 744. IMPORTERS OF FOOD. 

21 ‘‘(a) IMPORTERS.—The Secretary shall assess and 

22 collect an annual fee for the registration of an importer 

23 of food under section 801(r). 


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1 ‘‘(b) CUSTOMS BROKERS AND FILERS.—The Sec2 retary shall assess and collect an annual fee for the reg3 istration of a customs broker or filer under section 801(r). 

4 ‘‘(c) AMOUNT OF FEE.— 

5 ‘‘(1) BASE AMOUNTS.—For fiscal year 2010, 

6 the Secretary shall, subject to paragraph (4), deter7 mine the amount of the fees under this section for 

8 importers, customs brokers, and filers. 

9 ‘‘(2) ADJUSTMENT.—For fiscal year 2011 and 

10 subsequent fiscal years, the fees established pursu11 ant to paragraph (1) shall be adjusted by the Sec12 retary by notice, published in the Federal Register, 

13 for a fiscal year to reflect the greater of— 

14 ‘‘(A) the total percentage change that oc15 curred in the Consumer Price Index for all 

16 urban consumers (all items; United States city 

17 average), for the 12-month period ending June 

18 30 preceding the fiscal year for which fees are 

19 being established; 

20 ‘‘(B) the total percentage change for the 

21 previous fiscal year in basic pay under the Gen22 eral Schedule in accordance with section 5332 

23 of title 5, United States Code, as adjusted by 

24 any locality-based comparability payment pur25 suant to section 5304 of such title for Federal 


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1 employees stationed in the District of Columbia; 

2 or 

3 ‘‘(C) the average annual change in the 

4 cost, per full-time equivalent position of the 

5 Food and Drug Administration, of all personnel 

6 compensation and benefits paid with respect to 

7 such positions for the first 5 years of the pre8 ceding 6 fiscal years. 

9 ‘‘(3) COMPOUNDED BASIS.—The adjustment 

10 made each fiscal year pursuant this subsection shall 

11 be added on a compounded basis to the sum of all 

12 adjustments made each fiscal year after fiscal year 

13 2010 under this subsection. 

14 ‘‘(4) COLLECTIONS AND APPROPRIATIONS

15 ACTS.— 

16 ‘‘(A) IN GENERAL.—The fees authorized 

17 by this section— 

18 ‘‘(i) shall be retained in each fiscal 

19 year in an amount not to exceed the 

20 amount specified in appropriation Acts, or 

21 otherwise made available for obligation, for 

22 such fiscal year; and 

23 ‘‘(ii) shall only be collected and avail24 able to cover the costs associated with reg25 istering importers, customs brokers, and 


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1 filers under section 801(r) and with ensur2 ing compliance with good importer prac3 tices respecting food. 

4 ‘‘(B) LIMIT.—The total amount of fees 

5 charged, as adjusted under paragraphs (2) and 

6 (3), for a fiscal year may not exceed the total 

7 costs described in subparagraph (A)(ii) for such 

8 fiscal year.’’. 

9 (c) INSPECTION.—Section 704 (21 U.S.C. 374), as 

10 amended by sections 105, is amended by adding at the 

11 end the following: 

12 ‘‘(i) IMPORTERS, BROKERS, AND FILERS.—Every 

13 person engaged in the importing, brokering for import, or 

14 filing for import of any food shall, upon request of an offi15 cer or employee designated by the Secretary, permit such 

16 officer or employee at all reasonable times to inspect the 

17 facilities of such person and have access to, and to copy 

18 and verify, any related records.’’. 

19 SEC. 206. UNIQUE IDENTIFICATION NUMBER FOR FOOD FA20 CILITIES, IMPORTERS, CUSTOM BROKERS, 

21 AND FILERS. 

22 Chapter IX (21 U.S.C. 391 et seq) is amended by 

23 adding at the end the following: 


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1 ‘‘SEC. 911. UNIQUE FACILITY IDENTIFIER. 

2 ‘‘(a) REGISTRATION OF FACILITY OR ESTABLISH3 MENT.—A person required to register a facility pursuant 

4 to section 415 shall submit, at the time of registration, 

5 a unique facility identifier for the facility or establishment. 

6 ‘‘(b) REGISTRATION OF IMPORTERS, CUSTOM BRO7 KERS, AND FILERS.—A person required to register pursu8 ant to section 801(r) shall submit, at the time of registra9 tion, a unique facility identifier for the principal place of 

10 business for which such person is required to register 

11 under section 801(r). 

12 ‘‘(c) GUIDANCE.—The Secretary may, by guidance, 

13 specify the unique numerical identifier system to be used 

14 to meet the requirements of subsections (a) and (b) and 

15 the form, manner, and timing of a submission under such 

16 subsections. In the absence of a specification by the Sec17 retary, a Dunn & Bradstreet Universal Numbering System 

18 (DUNS) number shall be used as the required numerical 

19 identifier for purposes of such subsections. 

20 ‘‘(d) IMPORTATION.—An article of food imported or 

21 offered for import shall be refused admission unless the 

22 appropriate unique facility identifiers, as specified by the 

23 Secretary, are provided for such article.’’. 


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1 SEC. 207. PROHIBITION AGAINST DELAYING, LIMITING, OR 

2 REFUSING INSPECTION. 

3 (a) ADULTERATION.—Section 402 (21 U.S.C. 342), 

4 as amended by section 102(a), 103(a), and 104(a), is 

5 amended by adding at the end the following: 

6 ‘‘(m) If it has been produced manufactured, proc7 essed, packed, or held in any farm, factory, warehouse, 

8 or establishment and the owner, operator, or agent of such 

9 farm, factory, warehouse, or establishment, or any agent 

10 of a governmental authority in the foreign country within 

11 which such farm, factory, warehouse, or establishment is 

12 located, delays or limits an inspection, or refuses to permit 

13 entry or inspection, under section 414 or 704.’’. 

14 (b) FOREIGN INSPECTIONS.—Section 704(a)(1) (21 

15 U.S.C. 374(a)(1)), as amended by section 106(c), is 

16 amended— 

17 (1) in the first sentence, by inserting ‘‘, includ18 ing any such food factory, warehouse, or establish19 ment whether foreign or domestic,’’ after ‘‘factory, 

20 warehouse, or establishment’’. 

21 (2) in the third sentence, by inserting ‘‘, includ22 ing any food factory, warehouse, establishment, or 

23 consulting laboratory whether foreign or domestic,’’ 

24 after ‘‘factory, warehouse, establishment, or con25 sulting laboratory’’. 


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1 SEC. 208. DEDICATED FOREIGN INSPECTORATE. 

2 Section 704 (21 U.S.C. 374), as amended by sections 

3 105 and 205, is amended by adding at the end the fol4 lowing: 

5 ‘‘(j) DEDICATED FOREIGN INSPECTORATE.—The 

6 Secretary shall establish and maintain a corps of inspec7 tors dedicated to inspections of foreign food facilities. This 

8 corps shall be staffed and funded by the Secretary at a 

9 level sufficient to enable it to assist the Secretary in 

10 achieving the frequency of inspections for food facilities 

11 as described in this Act.’’. 

12 SEC. 209. PLAN AND REVIEW OF CONTINUED OPERATION 

13 OF FIELD LABORATORIES. 

14 (a) SUBMISSION OF PLAN.—Not later than 90 days 

15 before the Secretary terminates or consolidates any lab16 oratory, district office, or the functions (including the in17 spection and compliance functions) of any such laboratory 

18 or district office, specified in subsection (b), the Secretary 

19 shall submit a reorganization plan to the Comptroller Gen20 eral of the United States, the Committee on Energy and 

21 Commerce of the House of Representatives, and the Com22 mittee on Health, Education, Labor, and Pensions of the 

23 Senate. 

24 (b) SPECIFIED LABORATORIES AND OFFICES.—The 

25 laboratories and offices specified in this subsection are the 

26 following: 


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1 (1) Any of the 13 field laboratories responsible 

2 for analyzing food that were operated by the Office 

3 of Regulatory Affairs of the Food and Drug Admin4 istration as of January 1, 2007. 

5 (2) Any of the 20 district offices of the Food 

6 and Drug Administration with responsibility for food 

7 safety functioning as of January 1, 2007. 

8 (c) CONGRESSIONAL REVIEW.—A reorganization 

9 plan described in subsection (a) is deemed to be a major 

10 rule (as defined in section 804(2) of title 5, United States 

11 Code) for purposes of chapter 8 of such title. 

12 SEC. 210. FALSE OR MISLEADING REPORTING TO FDA. 

13 (a) IN GENERAL.—Section 301(q)(2) (21 U.S.C. 

14 331(q)(2)) is amended by inserting after ‘‘device’’ the fol15 lowing: ‘‘or food’’. 

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

17 subsection (a) shall apply to submissions made on or after 

18 the date of the enactment of this Act. 

19 SEC. 211. SUBPOENA AUTHORITY. 

20 (a) PROHIBITED ACT.—Section 301(f) is amended by 

21 inserting before the period ‘‘or the failure or refusal to 

22 obey a subpoena issued pursuant to section 311’’. 

23 (b) AMENDMENT.—Chapter III (21 U.S.C. 331 et 

24 seq.) is amended by adding at the end the following: 


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1 ‘‘SEC. 311 EXERCISE OF SUBPOENA AUTHORITY. 

2 ‘‘(a) IN GENERAL.—For the purpose of— 

3 ‘‘(1) any hearing, investigation, or other pro4 ceeding respecting a violation of a provision of this 

5 Act relating to food; 

6 ‘‘(2) any hearing, investigation, or other pro7 ceeding to determine if a person is in violation of a 

8 specific provision of this Act relating to food; or 

9 ‘‘(3) any other matter relative to the Commis10 sioner’s jurisdiction over food under this Act, the 

11 Public Health Service Act, or the Federal Anti-Tam12 pering Act, 

13 the Commissioner may issue subpoenas requiring the at14 tendance and testimony of witnesses and the production 

15 of records and other things. 

16 ‘‘(b) TIMING OF COMPLIANCE.—When the Commis17 sioner deems that immediate compliance with a subpoena 

18 issued under this section is necessary to address a threat 

19 of serious adverse health consequences or death, the sub20 poena may require immediate production. 

21 ‘‘(c) SERVICE OF SUBPOENA.— 

22 ‘‘(1) IN GENERAL.—Subpoenas of the Commis23 sioner shall be served by a person authorized by the 

24 Commissioner by delivering a copy thereof to the 

25 person named therein or by certified mail addressed 


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1 to such person at such person’s last known dwelling 

2 place or principal place of business. 

3 ‘‘(2) CORPORATIONS AND OTHER ENTITIES.— 

4 Service on a domestic or foreign corporation, part5 nership, unincorporated association, or other entity 

6 that is subject to suit under a common name may 

7 be made by delivering the subpoena to an officer, a 

8 managing or general agent, or any other agent au9 thorized by appointment or by law to receive service 

10 of process. 

11 ‘‘(3) PERSON OUTSIDE U.S. JURISDICTION.— 

12 Service on any person not found within the terri13 torial jurisdiction of any court of the United States 

14 may be made in any manner as the Federal Rules 

15 of Civil Procedure prescribe for service in a foreign 

16 nation. 

17 ‘‘(4) PROOF OF SERVICE.—A verified return by 

18 the person so serving the subpoena setting forth the 

19 manner of service, or, in the case of service by cer20 tified mail, the return post office receipt therefor 

21 signed by the person so served, shall be proof of 

22 service. 

23 ‘‘(d) PAYMENT OF WITNESSES.—Witnesses subpoe24 naed under subsection (a) shall be paid the same fees and 


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1 mileage as are paid witnesses in the district courts of the 

2 United States. 

3 ‘‘(e) ENFORCEMENT.—In the case of a refusal to 

4 obey a subpoena duly served upon any person under sub5 section (a), any district court of the United States for the 

6 judicial district in which such person charged with refusal 

7 to obey is found, resides, or transacts business, upon ap8 plication by the Commissioner, shall have jurisdiction to 

9 issue an order compelling compliance with the subpoena 

10 and requiring such person to appear and give testimony 

11 or to appear and produce records and other things, or 

12 both. The failure to obey such order of the court may be 

13 punished by the court as contempt thereof. If the person 

14 charged with failure or refusal to obey is not found within 

15 the territorial jurisdiction of the United States, the United 

16 States District Court for the District of Columbia shall 

17 have the same jurisdiction, consistent with due process, 

18 to take any action respecting compliance with the sub19 poena by such person that such district court would have 

20 if such person were personally within the jurisdiction of 

21 such district court. 

22 ‘‘(f) NONDISCLOSURE.—A United States district 

23 court for the district in which the subpoena is or will be 

24 served, upon application of the Commissioner, may issue 

25 an ex parte order that no person or entity disclose to any 


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1 other person or entity (other than to an attorney to obtain 

2 legal advice) the existence of such subpoena for a period 

3 of up to 90 days. Such order may be issued on a showing 

4 that the records or things being sought may be relevant 

5 to the hearing, investigation, proceeding, or other matter 

6 and that there is reason to believe that such disclosure 

7 may result in— 

8 ‘‘(1) furtherance of a potential violation under 

9 investigation; 

10 ‘‘(2) endangerment to the life or physical safety 

11 of any person; 

12 ‘‘(3) flight or other action to avoid prosecution 

13 or other enforcement remedies; 

14 ‘‘(4) destruction of or tampering with evidence; 

15 or 

16 ‘‘(5) intimidation of potential witnesses. 

17 An order under this subsection may be renewed for addi18 tional periods of up to 90 days upon a showing that any 

19 of the circumstances described in paragraphs (1) through 

20 (5) continue to exist. 

21 ‘‘(g) RELATION TO OTHER PROVISIONS.—The sub22 poena authority vested in the Commissioner and the dis23 trict courts of the United States by this section is in addi24 tion to any such authority vested in the Commissioner or 

25 such courts by other provisions of law.’’. 


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1 SEC. 212. WHISTLEBLOWER PROTECTIONS. 

2 Chapter IX (21 U.S.C. 391 et seq.), as amended by 

3 section 206, is amended by adding at the end the fol4 lowing: 

5 ‘‘SEC. 912 PROTECTIONS FOR EMPLOYEES WHO REFUSE TO 

6 VIOLATE, OR WHO DISCLOSE VIOLATIONS OF, 

7 THIS ACT OR SECTION 351 OF THE PUBLIC 

8 HEALTH SERVICE ACT. 

9 ‘‘(a) IN GENERAL.—No person who submits or is re10 quired under this Act or the Public Health Service Act 

11 to submit any information related to a food, or any officer, 

12 employee, contractor, subcontractor, or agent of such per13 son may discharge, demote, suspend, threaten, harass, or 

14 in any other manner discriminate against an employee in 

15 the terms and conditions of employment because of any 

16 lawful act done by the employee, including within the ordi17 nary course of the job duties of such employee— 

18 ‘‘(1) to provide information, cause information 

19 to be provided, or otherwise assist in any investiga20 tion regarding any conduct which the employee rea21 sonably believes constitutes a violation of this Act, or 

22 any other provision of Federal law relating to the 

23 safety of a food, if the information or assistance is 

24 provided to, or an investigation stemming from the 

25 provided information is conducted by— 


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1 ‘‘(A) a Federal regulatory or law enforce2 ment agency; 

3 ‘‘(B) any Member of Congress or any com4 mittee of Congress; or 

5 ‘‘(C) a person with supervisory authority 

6 over the employee (or such other person work7 ing for the employer who has the authority to 

8 investigate, discover, or terminate the mis9 conduct); 

10 ‘‘(2) to file, cause to be filed, testify, participate 

11 in, or otherwise assist in a proceeding filed, or about 

12 to be filed (with any knowledge of the employer), in 

13 any court or administrative forum relating to any 

14 such alleged violation; or 

15 ‘‘(3) to refuse to commit or assist in any such 

16 violation. 

17 ‘‘(b) ENFORCEMENT ACTION.— 

18 ‘‘(1) IN GENERAL.—An employee who alleges 

19 discharge or other discrimination in violation of sub20 section (a) may seek relief in accordance with the 

21 provisions of subsection (c) by— 

22 ‘‘(A) filing a complaint with the Secretary 

23 of Labor; or 

24 ‘‘(B) if the Secretary of Labor has not 

25 issued a final decision within 210 days of the 


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1 filing of the complaint and there is no showing 

2 that such delay is due to the bad faith of the 

3 claimant, or within 90 days after receiving a 

4 final decision or order from the Secretary, 

5 bringing an action at law or equity for de novo 

6 review in the appropriate district court of the 

7 United States, which court shall have jurisdic8 tion over such action without regard to the 

9 amount in controversy, and which action shall, 

10 at the request of either party to such action, be 

11 tried by the court with a jury. 

12 ‘‘(2) PROCEDURE.— 

13 ‘‘(A) IN GENERAL.—Any action under 

14 paragraph (1) shall be governed under the rules 

15 and procedures set forth in section 42121(b) of 

16 title 49, United States Code. 

17 ‘‘(B) EXCEPTION.—Notification in an ac18 tion under paragraph (1) shall be made in ac19 cordance with section 42121(b)(1) of title 49, 

20 United States Code, except that such notifica21 tion shall be made to the person named in the 

22 complaint and to the employer. 

23 ‘‘(C) BURDENS OF PROOF.—An action 

24 brought under paragraph (1)(B) shall be gov25 erned by the legal burdens of proof set forth in 


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1 section 42121(b) of title 49, United States 

2 Code. 

3 ‘‘(D) STATUTE OF LIMITATIONS.—An ac4 tion under paragraph (1) shall be commenced 

5 not later than 180 days after the date on which 

6 the violation occurs. 

7 ‘‘(c) REMEDIES.— 

8 ‘‘(1) IN GENERAL.—An employee prevailing in 

9 any action under subsection (b)(1) shall be entitled 

10 to all relief necessary to make the employee whole. 

11 ‘‘(2) ISSUANCE OF ORDER.—If, in response to 

12 a complaint filed under paragraph (b)(1), the Sec13 retary of Labor or the district court, as applicable, 

14 determines that a violation of subsection (a) has oc15 curred, the Secretary or the court shall order the 

16 person who committed such violation— 

17 ‘‘(A) to take affirmative action to abate 

18 the violation; 

19 ‘‘(B) to— 

20 ‘‘(i) reinstate the complainant to his 

21 or her former position together with com22 pensation (including back pay); and 

23 ‘‘(ii) restore the terms, conditions, 

24 and privileges associated with his or her 

25 employment; and 


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1 ‘‘(C) to provide compensatory damages to 

2 the complainant. 

3 If such an order is issued under this paragraph, the 

4 Secretary or the court, at the request of the com5 plainant, shall assess against the person against 

6 whom the order is issued a sum equal to the aggre7 gate amount of all costs and expenses (including at8 torney and expert witness fees) reasonably incurred, 

9 as determined by the Secretary, by the complainant 

10 for, or in connection with, the bringing of the com11 plaint upon which the order was issued. 

12 ‘‘(d) RIGHTS RETAINED BY EMPLOYEE.—Nothing in 

13 this section shall be deemed to diminish the rights, privi14 leges, or remedies of any employee under any Federal or 

15 State law or under any collective bargaining agreement. 

16 The rights and remedies in this section may not be waived 

17 by any agreement, policy, form, or condition of employ18 ment.’’. 

19 SEC. 213. EXTRATERRITORIAL JURISDICTION. 

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

21 as amended by sections 110, 111, 133, 136, and 205, is 

22 amended by adding at the end the following: 

23 ‘‘(uu) The production, manufacture, processing, prep24 aration, packing, holding, or distribution of an adulterated 


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1 or misbranded food with the knowledge or intent that such 

2 article will be imported into the United States.’’. 

3 (b) JURISDICTION.—Chapter III (21 U.S.C. 331 et 

4 seq.), as amended by section 211, is amended by adding 

5 at the end the following: 

6 ‘‘SEC. 312. EXTRATERRITORIAL JURISDICTION. 

7 ‘‘There is extraterritorial Federal jurisdiction over 

8 any violation of this Act relating to any article of food 

9 if such article was intended for import into the United 

10 States or if any act in furtherance of the violation was 

11 committed in the United States.’’. 

Æ 


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