—I 

111TH CONGRESS 

1ST SESSION H. R. 759 

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

of food, drugs, devices, and cosmetics in the global market, and for 

other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JANUARY 28, 2009 

Mr. DINGELL (for himself, Mr. STUPAK, and Mr. PALLONE) 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, drugs, devices, and cosmetics 

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; REFERENCES; TABLE OF CON4 TENTS. 

5 (a) SHORT TITLE.—This Act may be cited as the 

6 ‘‘Food and Drug Administration Globalization Act of 

7 2009’’. 

8 (b) REFERENCES TO THE FEDERAL FOOD, DRUG, 

9 AND COSMETIC ACT.—Except as otherwise specified, 


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1 whenever in this Act an amendment is expressed in terms 

2 of an amendment to a section or other provision, the ref3 erence shall be considered to be made to a section or other 

4 provision of the Federal Food, Drug, and Cosmetic Act 

5 (21 U.S.C. 301 et seq.). 

6 (c) TABLE OF CONTENTS.—The table of contents of 

7 this Act is as follows: 

Sec. 1. Short title; references; table of contents. 

Sec. 2. Relationship to State law. 

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. 

Sec. 105. Risk-based inspection. 

Sec. 106. Access to records. 

Sec. 107. Traceability of food. 

Sec. 108. Reinspection fee applicable to facilities. 

Sec. 109. Certification of food facilities. 

Sec. 110. Safe and secure food importation program. 

Subtitle B—Intervention 

Sec. 111. Public health assessment system. 

Sec. 112. Public education and advisory system. 

Sec. 113. Research. 

Sec. 114. Notification, nondistribution, and recall of adulterated or misbranded 

articles of food. 

Subtitle C—Response 

Sec. 121. Administrative detention. 

Sec. 122. Civil penalties relating to food. 

Sec. 123. Failure to consent to investigation. 

Subtitle D—Miscellaneous 

Sec. 131. Labeling requirement for meat, poultry products, and seafood that 

contain carbon monoxide. 

Sec. 132. Food substances generally recognized as safe. 

Sec. 133. Country of origin labeling; disclosure of source of ingredients. 

Sec. 134. New food and animal feed export certification fee to improve the ability of United States firms to export their products. 

TITLE II—DRUG AND DEVICE SAFETY 


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Sec. 201. Registration of producers of drugs and devices; applicable fee. 

Sec. 202. Inspection of producers of drugs and active pharmaceutical ingredients. 

Sec. 203. Documentation for admissibility of drug imports. 

Sec. 204. Drug supply quality and safety. 

Sec. 205. Delay, limitation, or denial of inspection. 

Sec. 206. Country of origin labeling. 

Sec. 207. Nondistribution and recall of adulterated or misbranded drugs. 

Sec. 208. Destruction of adulterated, misbranded or counterfeit articles offered 

for import. 

Sec. 209. Administrative detention of drugs that appear to violate the law. 

Sec. 210. Penalties regarding counterfeit drugs. 

Sec. 211. Civil money penalties for violative drugs and devices and improper 

import entry filings. 

Sec. 212. Human generic drug application and supplement fees to cover preapproval inspection costs. 

TITLE III—COSMETIC SAFETY 

Sec. 301. Registration of cosmetic establishments. 

Sec. 302. Cosmetic and ingredient statements. 

Sec. 303. Serious and unexpected adverse event reports for cosmetics. 

Sec. 304. Good manufacturing practices for cosmetics. 

Sec. 305. Authorization of appropriations. 

Sec. 306. Effective date. 

TITLE IV—MISCELLANEOUS 

Sec. 401. Registration for commercial importers of food, drugs, devices, and 

cosmetics; fee. 

Sec. 402. Unique identification number for food, drug, and device facilities and 

establishments. 

Sec. 403. Prohibition against delaying or limiting inspection. 

Sec. 404. Dedicated foreign inspectorate. 

Sec. 405. Continued operation of field laboratories. 

Sec. 406. False or misleading reporting to FDA. 

Sec. 407. Subpoena authority. 

Sec. 408. Whistleblower protections. 

1 SEC. 2. RELATIONSHIP TO STATE LAW. 

2 This Act and the amendments made by this Act may 

3 not be construed as modifying or otherwise affecting any 

4 action or the liability of any person (as defined in section 

5 201 of the Federal Food, Drug, and Cosmetic Act) under 

6 the law of any State. 


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1 TITLE I—FOOD SAFETY 

2 Subtitle A—Prevention 

3 SEC. 101. CHANGES IN REGISTRATION OF FOOD FACILI4 TIES. 

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

6 amended by adding at the end the following: 

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

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

9 415 or is in violation of section 741 (requiring payment 

10 of a fee for such registration).’’. 

11 (b) ANNUAL REGISTRATION AND PAYMENT OF REG12 ISTRATION FEE.— 

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

14 350d(a)) is amended— 

15 (A) in the first sentence of paragraph (1), 

16 by inserting ‘‘annually’’ after ‘‘be registered’’; 

17 (B) in paragraph (1), by inserting ‘‘and 

18 pay the registration fee required under section 

19 741’’ after ‘‘submit a registration to the Sec20 retary’’ each place it appears in subparagraphs 

21 (A) and (B); and 

22 (C) in paragraph (4), by inserting after the 

23 first sentence the following: ‘‘The Secretary 

24 shall remove from such list the name of any fa25 cility that fails to reregister in accordance with 


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1 this section and shall treat such removal as a 

2 suspension of the facility’s registration.’’. 

3 (2) REGISTRATION FEE.—Chapter VII (21 

4 U.S.C. 371 et seq.) is amended— 

5 (A) by redesignating sections 741 and 742 

6 as sections 744 and 745, respectively; and 

7 (B) by adding at the end of subchapter C 

8 the following: 

9 ‘‘PART 5—FEES RELATING TO FOOD 

10 ‘‘SEC. 741. FACILITY REGISTRATION FEE. 

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

12 collect a fee for a facility registration under section 415 

13 to defray increases (as described in subsection 

14 (f)(2)(A)(ii)) in the costs of inspecting establishments reg15 istered under section 415 and for related activities to en16 sure compliance by such establishments with the require17 ments of this Act relating to food (including increases in 

18 such costs for management of information, and the acqui19 sition, maintenance, and repair of information technology 

20 resources). 

21 ‘‘(b) FEE REVENUE AMOUNTS.— 

22 ‘‘(1) IN GENERAL.—For each of fiscal years 

23 2010 through 2014, fees under subsection (a) shall, 

24 except as provided in subsections (c), (e), and (f), be 


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1 established to generate a total revenue amount 

2 under subsection (a). 

3 ‘‘(2) TOTAL REVENUE AMOUNT.—Not later 

4 than September 1, 2009, the Secretary shall trans5 mit to the Congress the total revenue amount under 

6 paragraph (1) and how such amount was calculated. 

7 ‘‘(3) ANNUAL FEE SETTING.—The Secretary 

8 shall, not later than 60 days before the start of each 

9 fiscal year that begins after September 30, 2009, es10 tablish, for the next fiscal year, registration fees 

11 under subsection (a) based on the total revenue 

12 amount applicable under paragraph (1). 

13 ‘‘(c) ADJUSTMENTS.— 

14 ‘‘(1) INFLATION ADJUSTMENT.—For fiscal year 

15 2011 and subsequent fiscal years, the revenues es16 tablished under subsection (b)(1) shall be adjusted 

17 by the Secretary by notice, published in the Federal 

18 Register, for a fiscal year to reflect the greater of— 

19 ‘‘(A) the total percentage change that oc20 curred in the Consumer Price Index for all 

21 urban consumers (all items; U.S. city average) 

22 for the 12-month period ending June 30 pre23 ceding the fiscal year for which fees are being 

24 established; 


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1 ‘‘(B) the total percentage change for the 

2 previous fiscal year in basic pay under the Gen3 eral Schedule in accordance with section 5332 

4 of title 5, United States Code, as adjusted by 

5 any locality-based comparability payment pur6 suant to section 5304 of such title for Federal 

7 employees stationed in the District of Columbia; 

8 or 

9 ‘‘(C) the average annual change in the 

10 cost, per full-time equivalent position of the 

11 Food and Drug Administration, of all personnel 

12 compensation and benefits paid with respect to 

13 such positions for the first 5 years of the pre14 ceding 6 fiscal years. 

15 The adjustment made each fiscal year under this 

16 subsection shall be added on a compounded basis to 

17 the sum of all adjustments made each fiscal year 

18 after fiscal year 2009 under this subsection. 

19 ‘‘(2) WORKLOAD ADJUSTMENT.—For fiscal 

20 year 2011 and subsequent fiscal years, after the fee 

21 revenues established under subsection (b)(1) are ad22 justed for a fiscal year for inflation in accordance 

23 with paragraph (1), the fee revenues shall be ad24 justed further for such fiscal year to reflect changes 

25 in the workload of the Secretary for inspections and 


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1 related activities described in subsection (a). With 

2 respect to such adjustment: 

3 ‘‘(A) The adjustment shall be determined 

4 by the Secretary based on a weighted average 

5 of the change in the total amount of inspections 

6 and related activities described in subsection 

7 (a). The Secretary shall publish in the Federal 

8 Register the fee revenues and fees resulting 

9 from the adjustment and the supporting meth10 odologies. 

11 ‘‘(B) Under no circumstances shall the ad12 justment result in fee revenues for a fiscal year 

13 that are less than the fee revenues for the fiscal 

14 year established under subsection (b)(1), as ad15 justed for inflation under paragraph (1). Any 

16 adjustment for changes in inspections and re17 lated activities described in subsection (a) made 

18 in setting fees and revenue amounts for fiscal 

19 year 2011 or any subsequent year may not re20 sult in the total workload adjustment being 

21 more than 2 percentage points higher than it 

22 would have been in the absence of the adjust23 ment for changes in inspections and related ac24 tivities. 


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1 ‘‘(C) The Secretary shall contract with an 

2 independent accounting firm to study the ad3 justment for changes in inspections and related 

4 activities described in subsection (a) applied in 

5 setting fees and revenue amounts for fiscal year 

6 2011 and to make recommendations, if war7 ranted, for future changes in the methodology 

8 for calculating the adjustment. After review of 

9 the recommendations, the Secretary shall, if 

10 warranted, make appropriate changes to the 

11 methodology, and the changes shall be effective 

12 for each of fiscal years 2012 through 2014. The 

13 Secretary shall not make any adjustment for 

14 changes in inspections and related activities de15 scribed in subsection (a) for any fiscal year 

16 after 2011 unless such study has been com17 pleted. 

18 ‘‘(3) RENT AND RENT-RELATED COST ADJUST19 MENT.—For fiscal year 2012 and each subsequent 

20 fiscal year, the Secretary shall, before making ad21 justments under paragraphs (1) and (2), decrease 

22 the fee revenue amount established under subsection 

23 (b)(1) if actual costs paid for rent and rent-related 

24 expenses for the preceding fiscal year are less than 

25 estimates made for such year in fiscal year 2008. 


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1 Any reduction made under this paragraph shall not 

2 exceed the amount by which such costs fall below the 

3 estimates made in fiscal year 2008 for such fiscal 

4 year, and shall not exceed $11,721,000 for any fiscal 

5 year. 

6 ‘‘(4) FINAL YEAR ADJUSTMENT.—For fiscal 

7 year 2014, the Secretary may, in addition to adjust8 ments under paragraphs (1), (2), (3), and (5), fur9 ther increase the fee revenues and fees established in 

10 subsection (b) if such an adjustment is necessary to 

11 provide for not more than 3 months of operating re12 serves of carryover user fees for inspections de13 scribed in subsection (a) for the first 3 months of 

14 fiscal year 2015. If such an adjustment is necessary, 

15 the rationale for the amount of the increase shall be 

16 contained in the annual notice establishing fee reve17 nues and fees for fiscal year 2014. If the Secretary 

18 has carryover balances for such inspections in excess 

19 of 3 months of such operating reserves, the adjust20 ment under this paragraph shall not be made. 

21 ‘‘(5) COST ESTIMATE ADJUSTMENT.—For fiscal 

22 year 2011 and subsequent fiscal years, the Secretary 

23 by notice, published in the Federal Register, shall— 


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1 ‘‘(A) provide an estimate of the amount of 

2 the total increases described in subsection (a) 

3 for such fiscal year; and 

4 ‘‘(B) after making adjustments under 

5 paragraphs (1), (2), and (3), adjust the reve6 nues established under subsection (b)(1) to be 

7 equal to such amount. 

8 ‘‘(6) LIMIT.—The total amount of fees charged, 

9 as adjusted under this subsection, for a fiscal year 

10 may not exceed the total increases described in sub11 section (a) for such fiscal year. 

12 ‘‘(d) WAIVERS.—The Secretary shall waive the fee 

13 under this section with respect to any facility that is a 

14 small business, as defined by the Secretary. 

15 ‘‘(e) LIMITATIONS.— 

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

17 shall be refunded for a fiscal year beginning after 

18 fiscal year 2010 unless appropriations for salaries 

19 and expenses of the Food and Drug Administration 

20 for such fiscal year (excluding the amount of fees 

21 appropriated for such fiscal year) are equal to or 

22 greater than the amount of appropriations for the 

23 salaries and expenses of the Food and Drug Admin24 istration for the fiscal year 2010 (excluding the 

25 amount of fees appropriated for such fiscal year) 


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1 multiplied by the adjustment factor applicable to the 

2 fiscal year involved. 

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

4 assess fees under subsection (a) during any portion 

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

6 a later date in such fiscal year the Secretary may as7 sess such fees, the Secretary may assess and collect 

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

9 registration under section 415 at any time in such 

10 fiscal year. 

11 ‘‘(f) CREDITING AND AVAILABILITY OF FEES.— 

12 ‘‘(1) IN GENERAL.—Fees authorized under sub13 section (a) shall be collected and available for obliga14 tion only to the extent and in the amount provided 

15 in advance in appropriations Acts. Such fees are au16 thorized to remain available until expended. Such 

17 sums as may be necessary may be transferred from 

18 the Food and Drug Administration salaries and ex19 penses appropriation account without fiscal year lim20 itation to such appropriation account for salaries 

21 and expenses with such fiscal year limitation. 

22 ‘‘(2) COLLECTIONS AND APPROPRIATION

23 ACTS.— 

24 ‘‘(A) IN GENERAL.—The fees authorized 

25 by this section— 


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1 ‘‘(i) shall be retained in each fiscal 

2 year in an amount not to exceed the 

3 amount specified in appropriation Acts, or 

4 otherwise made available for obligation, for 

5 such fiscal year; and 

6 ‘‘(ii) shall only be collected and avail7 able to defray increases in the costs of in8 specting establishments registered under 

9 section 415 and related activities to ensure 

10 compliance by such establishments with the 

11 requirements of this Act relating to food 

12 (including increases in such costs for an 

13 additional number of full-time equivalent 

14 positions in the Department of Health and 

15 Human Services to be engaged in such in16 spections and for management of informa17 tion, and the acquisition, maintenance, and 

18 repair of information technology resources) 

19 over such costs, excluding costs paid from 

20 fees collected under this section, for fiscal 

21 year 2009 multiplied by the adjustment 

22 factor. 

23 ‘‘(B) COMPLIANCE.—The Secretary shall 

24 be considered to have met the requirements of 

25 subparagraph (A)(ii) in any fiscal year if the 


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1 costs funded by appropriations and allocated for 

2 inspections described in subsection (a)— 

3 ‘‘(i) are not more than 3 percent 

4 below the level specified in subparagraph 

5 (A)(ii); or 

6 ‘‘(ii)(I) are more than 3 percent below 

7 the level specified in subparagraph (A)(ii), 

8 and fees assessed for the fiscal year fol9 lowing the subsequent fiscal year are de10 creased by the amount in excess of 3 per11 cent by which such costs fell below the 

12 level specified in such subparagraph; and 

13 ‘‘(II) such costs are not more than 5 

14 percent below the level specified in such 

15 subparagraph. 

16 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

17 For each of the fiscal years 2010 through 2014, 

18 there is authorized to be appropriated for fees under 

19 this section an amount equal to the total revenue 

20 amount determined under subsection (b)(1) for the 

21 fiscal year, as adjusted or otherwise affected under 

22 subsection (c) and paragraph (4) of this subsection. 

23 ‘‘(4) OFFSET.—If the sum of the cumulative 

24 amount of fees collected under this section for the 

25 fiscal years 2010 through 2013 and the amount of 


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1 fees estimated to be collected under this section for 

2 fiscal year 2014 exceeds the cumulative amount ap3 propriated under paragraph (3) for the fiscal years 

4 2010 through 2013, the excess shall be credited to 

5 the appropriation account of the Food and Drug Ad6 ministration as provided in paragraph (1), and shall 

7 be subtracted from the amount of fees that would 

8 otherwise be authorized to be collected under this 

9 section for fiscal year 2014. 

10 ‘‘(g) COLLECTION OF UNPAID FEES.—In any case 

11 where the Secretary does not receive payment of a fee as12 sessed under subsection (a) within 30 days after it is due, 

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

14 Government subject to subchapter II of chapter 37 of title 

15 31, United States Code. 

16 ‘‘(h) CONSTRUCTION.—This section may not be con17 strued to require that the number of full-time equivalent 

18 positions in the Department of Health and Human Serv19 ices, for officers, employers, and advisory committees not 

20 engaged in inspections described in subsection (a), be re21 duced to offset the number of officers, employees, and ad22 visory committees so engaged. 

23 ‘‘(i) ANNUAL FISCAL REPORTS.—Beginning with fis24 cal year 2011, not later than 120 days after the end of 

25 each fiscal year for which fees are collected under this secVerDate Nov 24 2008 03:16 Jan 30, 2009 Jkt 079200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6201 E:\BILLS\H759.IH H759

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1 tion, the Secretary shall prepare and submit to the Com2 mittee on Energy and Commerce of the House of Rep3 resentatives and the Committee on Health, Education, 

4 Labor, and Pensions of the Senate a report on the imple5 mentation of the authority for such fees during such fiscal 

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

7 of the fees collected for such fiscal year. 

8 ‘‘(j) DEFINITION.—In this section, the term ‘adjust9 ment factor’ applicable to a fiscal year is the Consumer 

10 Price Index for all urban consumers (all items; United 

11 States city average) for October of the preceding fiscal 

12 year divided by such Index for October 2009.’’. 

13 (c) CONTENTS OF REGISTRATION.—Paragraph (2) of 

14 section 415(a) (21 U.S.C. 350d(a)) is amended by striking 

15 ‘‘containing information’’ and all that follows and insert16 ing the following: ‘‘containing information that identifies 

17 the following: 

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

19 contact information of each facility engaged in 

20 manufacturing, processing, packing, or holding 

21 food for consumption in the United States that 

22 the registrant operates. 

23 ‘‘(B) The primary purpose and business 

24 activity of each such facility, including the dates 

25 of operation if the facility is seasonal. 


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1 ‘‘(C) The general food category (as listed 

2 under section 170.3(n) of title 21, Code of Fed3 eral Regulations, or as the Secretary may other4 wise designate for purposes of evaluating poten5 tial threats to food protection) of any food man6 ufactured, processed, packed, or held at each 

7 such facility. 

8 ‘‘(D) All trade names under which each 

9 such facility conducts business related to food. 

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

11 emergency contact information of the United 

12 States distribution agent for each such facility, 

13 which agent shall maintain information on the 

14 wholesale and retail distribution of food. 

15 The registrant shall notify the Secretary of any 

16 change in the products, function, or legal status of 

17 each such facility (including cessation of business ac18 tivities) not later than 30 days after the date of such 

19 change.’’. 

20 (d) SUSPENSION AUTHORITY.—Section 415(a) (21 

21 U.S.C. 350d(a)), as amended by subsection (c), is further 

22 amended by adding at the end the following: 

23 ‘‘(5) SUSPENSION OF REGISTRATION.— 

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

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1 istered under this section, including the facility 

2 of an importer— 

3 ‘‘(i) for violation of this Act that could 

4 result in serious adverse health con5 sequences or death to humans or animals; 

6 or 

7 ‘‘(ii) if the facility, or an employee of 

8 the facility, delays or limits an inspection, 

9 or refuses to permit entry or inspection, by 

10 the Secretary under this Act. 

11 ‘‘(B) NOTICE AND OPPORTUNITY FOR

12 HEARING.—Before suspending the registration 

13 of a facility under this paragraph, the Secretary 

14 shall provide notice to a registrant of an intent 

15 to suspend the registration and provide the reg16 istrant with an opportunity for an informal 

17 hearing. The Secretary may issue a written 

18 order of suspension following the hearing, if the 

19 Secretary finds that a violation described in 

20 subparagraph (A) has occurred. 

21 ‘‘(C) REINSTATEMENT.—A registration 

22 that is suspended under this section may be re23 instated pursuant to criteria published by the 

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1 lic website of the Food and Drug Administra2 tion. 

3 ‘‘(D) APPEAL.—Any registrant whose reg4 istration is suspended under this section may 

5 appeal that action in any appropriate district 

6 court of the United States.’’. 

7 (e) EFFECTIVE DATES.— 

8 (1) FEES.— 

9 (A) EFFECTIVE DATE.—The Secretary of 

10 Health and Human Services shall first impose 

11 the fee established under section 741 of the 

12 Federal Food, Drug, and Cosmetic Act, as 

13 added by subsection (b)(2), for fiscal years be14 ginning with fiscal year 2010. 

15 (B) SUNSET DATE.—Section 741 of the 

16 Federal Food, Drug, and Cosmetic Act, as 

17 added by subsection (b)(2), does not authorize 

18 the assessment or collection of a fee for reg19 istration under section 415 of such Act (21 

20 U.S.C. 360) occurring after fiscal year 2014. 

21 (2) MODIFICATION OF REGISTRATION FORM.— 

22 Not later than 30 days after the date of the enact23 ment of this Act, the Secretary of Health and 

24 Human Services shall modify the registration form 

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


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

2 amendments made by subsection (c). 

3 (3) APPLICATION.—The amendments made by 

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

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

6 the date on which such modified registration form 

7 takes effect, but not later than 60 days after the 

8 date of the enactment of this Act. 

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

10 CONTROLS, AND FOOD SAFETY PLAN. 

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

12 is amended by adding at the end the following: 

13 ‘‘(oo) The operation of a facility that manufactures, 

14 processes, packs, transports, or holds food for consump15 tion in the United States if the owner, operator, or agent 

16 in charge of such facility is not in compliance with sections 

17 418 and 418A.’’. 

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

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

20 ‘‘SEC. 418. HAZARD ANALYSIS AND RISK-BASED PREVEN21 TIVE CONTROLS. 

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

23 in charge of a facility shall, in accordance with this sec24 tion, evaluate the hazards that could affect food manufac25 tured, processed, packed, transported, or held by such faVerDate Nov 24 2008 03:16 Jan 30, 2009 Jkt 079200 PO 00000 Frm 00020 Fmt 6652 Sfmt 6201 E:\BILLS\H759.IH H759

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1 cility, identify and implement preventive controls to sig2 nificantly minimize, prevent, or eliminate the occurrence 

3 of such hazards, monitor the performance of such controls, 

4 and maintain records of such monitoring. 

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

6 agent in charge of a facility shall identify and evaluate 

7 known or reasonably foreseeable hazards that may be as8 sociated with the facility, including— 

9 ‘‘(1) biological, chemical, physical, and radio10 logical hazards, natural toxins, pesticides, drug resi11 dues, decomposition, parasites, allergens, and unap12 proved food and color additives; 

13 ‘‘(2) hazards that occur naturally, may be unin14 tentionally introduced, or may be intentionally intro15 duced, including by acts of terrorism; and 

16 ‘‘(3) relevant hazards identified under section 

17 419. 

18 ‘‘(c) PREVENTIVE CONTROLS.— 

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

20 agent in charge of a facility shall identify, imple21 ment, and validate preventive controls, including at 

22 critical control points, if any, to significantly mini23 mize, prevent, or eliminate hazards identified in the 

24 hazard analysis conducted under subsection (b). 


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1 ‘‘(2) SPECIFIC PRODUCT TYPES.—The Sec2 retary may establish by regulation or guidance addi3 tional preventive controls under this section for spe4 cific product types to prevent intentional or uninten5 tional contamination throughout the supply chain. 

6 ‘‘(d) MONITORING OF EFFECTIVENESS.—The owner, 

7 operator, or agent in charge of a facility shall monitor the 

8 effectiveness of the preventive controls implemented under 

9 subsection (c). 

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

11 or agent in charge of a facility shall establish procedures 

12 that the facility will implement if the preventive controls 

13 implemented under subsection (c) are found to be ineffec14 tive through monitoring under subsection (d). 

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

16 in charge of a facility shall verify that— 

17 ‘‘(1) the preventive controls implemented under 

18 subsection (c) have been validated as adequate to 

19 control the hazards identified under subsection (b); 

20 ‘‘(2) the owner, operator, or agent is conducting 

21 monitoring in accordance with subsection (d); and 

22 ‘‘(3) the owner, operator, or agent is taking ef23 fective corrective actions under subsection (e). 

24 ‘‘(g) RECORD KEEPING.—The owner, operator, or 

25 agent in charge of a facility shall maintain, for not less 


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1 than 2 years, records documenting the monitoring and 

2 verification of the effectiveness of the actions described in 

3 subsections (a) through (f). 

4 ‘‘(h) REQUIREMENT TO REANALYZE.—Each owner, 

5 operator, or agent in charge of a facility shall— 

6 ‘‘(1) conduct a reanalysis under subsection 

7 (b)— 

8 ‘‘(A) whenever there is a reasonable poten9 tial for a new hazard or a significant increase 

10 in a previously identified hazard; 

11 ‘‘(B) not less frequently than once every 2 

12 years; and 

13 ‘‘(C) if the Secretary determines it to be 

14 appropriate for the protection of the public 

15 health; and 

16 ‘‘(2) revise the preventive controls under sub17 section (c) to significantly minimize, prevent, or 

18 eliminate such hazard or document the basis for the 

19 conclusion that no such revision is needed. 

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

21 ‘‘(1) CRITICAL CONTROL POINT.—The term 

22 ‘critical control point’ means a point, step, or proce23 dure in a food process at which control can be ap24 plied and is essential to prevent or eliminate a food 

25 safety hazard or reduce it to an acceptable level. 


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

2 domestic facility or a foreign facility that is required 

3 to register under section 415. 

4 ‘‘(3) PREVENTIVE CONTROLS.—The term ‘pre5 ventive controls’ means those risk-based procedures, 

6 practices, and processes that a person knowledgeable 

7 about the safe manufacturing, processing, packing, 

8 transporting, or holding of food would have em9 ployed to significantly minimize, prevent, or elimi10 nate the hazards identified under the hazard anal11 ysis conducted under subsection (a) and that are 

12 consistent with the current scientific understanding 

13 of safe food manufacturing, processing, packing, 

14 transporting, or holding at the time of the analysis. 

15 Those procedures, practices, and processes may in16 clude the following: 

17 ‘‘(A) Sanitation procedures for food con18 tact surfaces and utensils and food-contact sur19 faces of equipment. 

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

21 hygiene training. 

22 ‘‘(C) An environmental monitoring pro23 gram to verify the effectiveness of pathogen 

24 controls. 

25 ‘‘(D) An allergen control program. 


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1 ‘‘(E) A recall contingency plan. 

2 ‘‘(F) Good manufacturing practices. 

3 ‘‘(G) Supplier verification activities. 

4 ‘‘SEC. 418A. FOOD SAFETY PLAN. 

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

6 ‘‘(1) IN GENERAL.—Before a facility (as de7 fined in section 418(i)) introduces or delivers for in8 troduction into interstate commerce any shipment of 

9 food, the owner, operator, or agent in charge of the 

10 facility shall develop and implement a written food 

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

12 safety plan’). 

13 ‘‘(2) CONTENTS.—The food safety plan shall in14 clude each of the following elements: 

15 ‘‘(A) The hazard analysis conducted under 

16 section 418. 

17 ‘‘(B) A description of the preventive con18 trols being implemented under section 418(c), 

19 including any those for specific product types 

20 under section 418(c)(2). 

21 ‘‘(C) Validation that such preventive con22 trols are effective to reduce, control, or elimi23 nate such hazard. 

24 ‘‘(D) A description of monitoring of such 

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1 ing sampling and testing relating to the control 

2 of hazards where appropriate to verify that the 

3 controls are effective. 

4 ‘‘(E) A description of the record keeping 

5 being conducted, including evidence of correc6 tive actions, sampling and testing records, mon7 itoring and verification records, and validation 

8 records. 

9 ‘‘(F) A description of established proce10 dures for the recall of articles of food, whether 

11 voluntarily or when required under section 422. 

12 ‘‘(G) A description of established proce13 dures for the trace back of articles of food, 

14 whether voluntarily or when required under sec15 tion 403(g). 

16 ‘‘(H) A description of established proce17 dures to ensure a safe and secure supply chain 

18 for the ingredients or components used in mak19 ing the food produced, processed, packed, trans20 ported, or held by such facility. 

21 ‘‘(I) A description of established proce22 dures to implement the science-based perform23 ance standards issued under section 419. 

24 ‘‘(b) INSPECTION OF FOOD SAFETY PLAN IN COURSE

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1 spection under section 704, the Secretary shall conduct 

2 a review of the food safety plan to ensure the plan meets 

3 relevant requirements of section 418, this section, and sec4 tion 419 and is adequate to protect the public health.’’. 

5 (c) GUIDANCE OR REGULATIONS.— 

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

7 Human Services (referred to in this subsection as 

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

9 regulations to establish science-based minimum 

10 standards for conducting a hazard analysis, docu11 menting hazards, implementing preventive controls, 

12 and documenting the implementation of the preven13 tive controls under sections 418 and 418A of the 

14 Federal Food, Drug, and Cosmetic Act (as added by 

15 subsection (b)). 

16 (2) CONSIDERATION.—In issuing guidance or 

17 promulgating regulations under this section, the Sec18 retary shall consider the capacity of small busi19 nesses. 

20 (d) NO EFFECT ON HACCP AUTHORITIES.—Noth21 ing in the amendments made by this section limits the au22 thority of the Secretary under the Federal Food, Drug, 

23 and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public 

24 Health Service Act (42 U.S.C. 201 et seq.) to revise, issue, 

25 or enforce product and category-specific regulations, such 


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1 as the Seafood Hazard Analysis Critical Controls Points 

2 Program, the Juice Hazard Analysis Critical Control Pro3 gram, and the Thermally Processed Low-Acid Foods 

4 Packaged in Hermetically Sealed Containers standards. 

5 (e) EFFECTIVE DATE.— 

6 (1) GENERAL RULE.—The amendments made 

7 by this section shall take effect 18 months after the 

8 date of the enactment of this Act. 

9 (2) EXCEPTIONS.—Notwithstanding paragraph 

10 (1)— 

11 (A) the amendments made by this section 

12 shall apply to a small business (as defined by 

13 the Secretary) after the date that is 2 years 

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

15 (B) the amendments made by this section 

16 shall apply to a very small business (as defined 

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

18 after the date of the enactment of this Act. 

19 SEC. 103. PERFORMANCE STANDARDS. 

20 Chapter IV (21 U.S.C. 341 et seq.), as amended by 

21 section 102, is further amended by adding at the end the 

22 following: 

23 ‘‘SEC. 419. PERFORMANCE STANDARDS. 

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

25 2 years, review and evaluate epidemiological data and 


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1 other appropriate sources of information, including re2 search under section 113 of the Food and Drug Adminis3 tration Globalization Act of 2009, to identify the most sig4 nificant food-borne contaminants and the most significant 

5 resulting hazards, and shall issue, through guidance or by 

6 regulation, science-based performance standards (which 

7 may include action levels) to significantly minimize, pre8 vent, or eliminate the occurrence of such hazards. Such 

9 standards shall be applicable to products and product 

10 classes and shall not be specific to an individual facility.’’. 

11 SEC. 104. SAFETY STANDARDS FOR FRESH PRODUCE. 

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

13 as amended by sections 102 and 103, is amended by add14 ing at the end the following: 

15 ‘‘(pp) The production or harvesting of produce not 

16 in accordance with minimum standards as provided by 

17 regulation under section 419A(a) or a variance issued 

18 under section 419A(e).’’. 

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

20 seq.), as amended by sections 102 and 103, is amended 

21 by adding at the end the following: 

22 ‘‘SEC. 419A. STANDARDS FOR PRODUCE SAFETY. 

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

24 regulation science-based minimum standards for the safe 

25 production and harvesting of those types of fruits and 


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1 vegetables that are raw agricultural commodities for which 

2 the Secretary has determined that such standards mini3 mize the risk of serious adverse health consequences or 

4 death. 

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

6 (a)— 

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

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

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

11 or reasonably foreseeable biological, chemical, 

12 and physical hazards, including hazards that 

13 occur naturally, may be unintentionally intro14 duced, or may be intentionally introduced, in15 cluding by acts of terrorism, into fruits and 

16 vegetables that are raw agricultural commod17 ities; and 

18 ‘‘(B) to provide reasonable assurances that 

19 the produce is not adulterated under section 

20 402; 

21 ‘‘(2) shall include, with respect to growing, har22 vesting, packing, sorting, and storage operations, 

23 minimum standards for safety; 


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1 ‘‘(3) shall include standards addressing manure 

2 use, water quality, employee hygiene, sanitation and 

3 animal control, temperature controls, and nutrients; 

4 ‘‘(4) may include standards for such other ele5 ments as the Secretary determines necessary to 

6 carry out subsection (a); 

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

8 for compliance, taking into account the needs of 

9 small businesses for additional time to comply; and 

10 ‘‘(6) shall provide for coordination of education 

11 and enforcement activities by State and local offi12 cials, as designated by the Governors of the respec13 tive States. 

14 ‘‘(c) PRIORITIZATION.—The Secretary shall prioritize 

15 the implementation of the regulations under subsection (a) 

16 for specific fruits and vegetables that are raw agricultural 

17 commodities and have been associated with food-borne ill18 ness outbreaks. 

19 ‘‘(d) ENFORCEMENT.—The Secretary may coordinate 

20 with the Secretary of Agriculture and shall contract and 

21 coordinate with the agency or department designated by 

22 the Governor of each State to perform activities to ensure 

23 compliance with this section.’’. 

24 (c) GUIDANCE; RULEMAKING.— 


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1 (1) GUIDANCE.—Not later than 1 year after 

2 the date of enactment of this Act, the Secretary 

3 shall publish, after consultation with the Secretary 

4 of Agriculture and representatives of State depart5 ments of agriculture, updated good agricultural 

6 practices and guidance for the safe production and 

7 harvesting of specific types of fresh produce. 

8 (2) PROPOSED RULEMAKING.— 

9 (A) IN GENERAL.—Not later than 1 year 

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

11 Secretary, in consultation with the Secretary of 

12 Agriculture and representatives of State depart13 ments of agriculture, shall publish a notice of 

14 proposed rulemaking under section 419A of the 

15 Federal Food, Drug, and Cosmetic Act, as 

16 added by subsection (b). 

17 (B) PUBLIC INPUT.—During the comment 

18 period on the notice of proposed rulemaking 

19 under subparagraph (A), the Secretary shall 

20 conduct not less than 3 public meetings in di21 verse geographical areas of the United States to 

22 provide persons in different regions an oppor23 tunity to comment. 

24 (3) FINAL REGULATION.—Not later than 1 year 

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1 posed rulemaking under paragraph (2), the Sec2 retary shall adopt a final regulation under section 

3 419A of the Federal Food, Drug, and Cosmetic Act, 

4 as added by subsection (b). 

5 (d) NO EFFECT ON HACCP AUTHORITIES.—Noth6 ing in the amendments made by this section limits the au7 thority of the Secretary under the Federal Food, Drug, 

8 and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public 

9 Health Service Act (42 U.S.C. 201 et seq.) to revise, issue, 

10 or enforce product and category-specific regulations, such 

11 as the Seafood Hazard Analysis Critical Controls Points 

12 Program, the Juice Hazard Analysis Critical Control Pro13 gram, and the Thermally Processed Low-Acid Foods 

14 Packaged in Hermetically Sealed Containers standards. 

15 SEC. 105. RISK-BASED INSPECTION. 

16 (a) RISK-BASED INSPECTION SCHEDULE.— 

17 (1) IN GENERAL.—Section 704 (21 U.S.C. 374) 

18 is amended by adding at the end the following: 

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

20 shall be inspected by one or more officers duly designated 

21 by the Secretary at a frequency determined pursuant to 

22 a risk-based schedule. 

23 ‘‘(2) The Secretary shall establish such risk-based 

24 schedule not later than 18 months after the date of the 


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1 enactment of this subsection and may subsequently revise 

2 such schedule in accordance with this section. 

3 ‘‘(3) Such risk-based schedule shall provide for a fre4 quency of inspections commensurate with the risk pre5 sented by the facility, but in no case shall inspections of 

6 a facility occur less than once every 4 years beginning on 

7 the date of the facility’s initial registration pursuant to 

8 section 415. 

9 ‘‘(4) In determining the appropriate frequency of in10 spection, the Secretary shall consider— 

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

12 packed, or held at the facility; 

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

14 ‘‘(C) whether the facility is certified by a certi15 fying agent accredited pursuant to section 420(a); 

16 and 

17 ‘‘(D) such other factors as the Secretary deter18 mines by guidance to be relevant to assessing the 

19 risk presented by the facility.’’. 

20 (2) FACILITIES ALREADY REGISTERED.—In 

21 section 704(h)(3) of the Federal Food, Drug, and 

22 Cosmetic Act, as added by paragraph (1), the term 

23 ‘‘initial registration pursuant to section 415’’ means, 

24 with respect to a facility that is registered pursuant 

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1 actment of this Act, the first annual registration of 

2 the facility pursuant to such section 415 that occurs 

3 on or after such date of enactment. 

4 (3) REPORTS ON RISK-BASED INSPECTIONS OF

5 FOOD FACILITIES.— 

6 (A) INITIAL REPORT.—Not later than 18 

7 months after the date of the enactment of this 

8 Act, the Secretary of Health and Human Serv9 ices shall submit a report to the Committee on 

10 Energy and Commerce of the House of Rep11 resentatives and the Committee on Health, 

12 Education, Labor, and Pensions of the Senate 

13 describing the risk-based inspection schedule es14 tablished under section 704(h)(2) of the Fed15 eral Food, Drug, and Cosmetic Act, as added 

16 by paragraph (1). Such report shall include a 

17 description of the frequency of inspections for 

18 different classes of risk, the number of facilities 

19 in each class, and an estimate of the projected 

20 5-year costs of implementing such inspection 

21 schedule. 

22 (B) SUBSEQUENT REPORTS.—Annually 

23 after the submission of the report required by 

24 subparagraph (A), the Secretary shall submit a 

25 report to the Congress on— 


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1 (i) the number of foreign and domes2 tic facilities inspected under the risk-based 

3 inspection schedule established under sec4 tion 704(h)(2) of the Federal Food, Drug, 

5 and Cosmetic Act, as added by paragraph 

6 (1), in the preceding 12 months; and 

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

9 12 months. 

10 (b) FOOD OFFERED FOR IMPORT.—The third sen11 tence of subsection (a) of section 801 (21 U.S.C. 381) is 

12 amended by inserting ‘‘or (4) such article is food that has 

13 been processed, packed, or held at a facility that is in vio14 lation of section 301(f) (prohibiting the delay or limitation 

15 of an inspection, or the refusal to permit entry or inspec16 tion, under section 704),’’ before ‘‘then such article shall 

17 be refused admission’’. 

18 SEC. 106. ACCESS TO RECORDS. 

19 (a) RECORDS INSPECTION.—Section 414(a) (21 

20 U.S.C. 350c) is amended— 

21 (1) by striking ‘‘If the Secretary has a reason22 able belief that an article of food is adulterated and 

23 presents a threat of serious adverse health con24 sequences or death to humans or animals, each’’ and 

25 inserting ‘‘Each’’; 


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1 (2) by striking the term ‘‘such article’’ the first 

2 place such term appears and inserting ‘‘an article of 

3 food’’; 

4 (3) by striking ‘‘and a written notice to such 

5 person’’; and 

6 (4) by striking ‘‘and presents a threat of seri7 ous adverse health consequences or death to humans 

8 or animals’’ and inserting ‘‘, misbranded, or other9 wise in violation of this Act’’; and 

10 (b) CONFORMING AMENDMENT.—Section 704(a)(1) 

11 (21 U.S.C. 374(a)(1)) is amended by striking ‘‘when the 

12 Secretary has a reasonable belief that an article of food 

13 is adulterated and presents a threat of serious adverse 

14 health consequences or death to humans or animals’’ and 

15 inserting ‘‘bearing on whether such food is adulterated, 

16 misbranded, or otherwise in violation of this Act’’. 

17 SEC. 107. TRACEABILITY OF FOOD. 

18 (a) FARM AND RESTAURANT RECORDS.— 

19 (1) INSPECTION.—Section 414(a) of the Fed20 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

21 350c(a)), as amended by section 106, is amended by 

22 striking ‘‘(excluding farms and restaurants)’’. 

23 (2) MAINTENANCE OF RECORDS.—Section 

24 414(b) of the Federal Food, Drug, and Cosmetic Act 

25 (21 U.S.C. 350c(b)), as amended by section 106, is 


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1 amended by striking ‘‘(excluding farms and res2 taurants)’’. 

3 (b) STANDARDIZED ELECTRONIC FORMAT.—Section 

4 414 of the Federal Food, Drug, and Cosmetic Act (21 

5 U.S.C. 350c(a)), as amended by section 106 and sub6 section (a), is amended— 

7 (1) in subsection (a), by striking ‘‘in any for8 mat (including paper and electronic formats) and’’; 

9 and 

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

11 following: ‘‘The Secretary shall require such persons 

12 to maintain such records in a standardized electronic 

13 format.’’. 

14 (c) IDENTIFICATION OF SOURCE OF RAW AGRICUL15 TURAL PRODUCTS.—Section 403 of the Federal Food, 

16 Drug, and Cosmetic Act (21 U.S.C. 343) is amended by 

17 adding at the end the following: 

18 ‘‘(z) If it is a raw agricultural product, unless each 

19 commercial shipment of the product contains information 

20 enabling the Secretary to identify— 

21 ‘‘(1) the grower of the product; 

22 ‘‘(2) the lot on which the product was produced; 

23 ‘‘(3) the harvesting and packing dates of the 

24 product; and 


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1 ‘‘(4) any other information determined appro2 priate by the Secretary to facilitate identification of 

3 the source of raw agricultural products.’’. 

4 (d) STUDY.—Not later than 2 years after the date 

5 of the enactment of this Act, the Commissioner of Food 

6 and Drugs shall— 

7 (1) complete a study on the effectiveness of 

8 technologies for determining the source of raw agri9 cultural products; and 

10 (2) submit a report to the Congress on the re11 sults of such study. 

12 SEC. 108. REINSPECTION FEE APPLICABLE TO FACILITIES. 

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

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

15 101(b)(2), is further amended by adding at the end the 

16 following: 

17 ‘‘SEC. 741A. REINSPECTION FEE APPLICABLE TO FACILI18 TIES. 

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

20 collect fees from each facility (as defined in section 

21 415(b)) that— 

22 ‘‘(1) during such fiscal year, commits a viola23 tion of any requirement of this Act relating to food, 

24 including any such requirement relating to good 

25 manufacturing practices; and 


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1 ‘‘(2) because of such violation, undergoes addi2 tional inspection by the Food and Drug Administra3 tion. 

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

5 amount of the fees under this section to fully defray the 

6 costs of conducting the additional inspections referred to 

7 in subsection (a)(2). 

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

9 of the fees collected pursuant to this section available sole10 ly to pay for the costs of additional inspections referred 

11 to in subsection (a)(2).’’. 

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

13 subsection (a) shall apply to additional inspections occur14 ring after the date of the enactment of this Act. 

15 SEC. 109. CERTIFICATION OF FOOD FACILITIES. 

16 (a) MISBRANDING.— 

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

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

19 adding at the end the following: 

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

21 into the United States and such shipment is in violation 

22 of section 420(b)(5) (requiring a certification to accom23 pany certain food shipments).’’. 

24 (2) EFFECTIVE DATE.—The amendment made 

25 by paragraph (1) shall apply to shipments offered 


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

2 the date of the enactment of this Act. 

3 (b) ACCREDITATION OF CERTIFYING AGENTS; CER4 TIFICATION OF LABORATORIES AND ACCREDITATION OF

5 LABORATORY CERTIFYING AGENTS.—Chapter IV (21 

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

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

8 ‘‘SEC. 420. ACCREDITATION OF CERTIFYING AGENTS. 

9 ‘‘(a) ACCREDITATION AS CERTIFYING AGENT.— 

10 ‘‘(1) IN GENERAL.—Beginning not later than 2 

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

12 the Secretary shall establish and implement an ac13 creditation system under which a foreign govern14 ment, a State or regional food authority, a foreign 

15 or domestic cooperative that aggregates the products 

16 of growers or processors, and any other third party 

17 that the Secretary determines appropriate, may re18 quest to be accredited as a certifying agent to certify 

19 facilities as meeting the applicable requirements of 

20 this Act. 

21 ‘‘(2) QUALIFICATIONS OF CERTIFYING

22 AGENTS.—Prior to accrediting an third party as a 

23 certifying agent under paragraph (1), the Secretary 

24 shall perform such reviews and audits of the training 

25 and qualifications of auditors used by the third 


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1 party, and conduct such reviews of internal systems 

2 and such other investigation of the third party, as 

3 the Secretary deems necessary to determine whether 

4 the third party— 

5 ‘‘(A) meets the requirements of this sec6 tion; and 

7 ‘‘(B) is qualified to evaluate the compli8 ance of a facility with the applicable require9 ments of this Act. 

10 ‘‘(3) LIMITATION OF ACCREDITATION.—The 

11 Secretary may limit the accreditation under para12 graph (1) of a certifying agent to the certification of 

13 facilities that produce, manufacture, process, or hold 

14 only specified food products (or categories of food 

15 products). 

16 ‘‘(4) PERFORMANCE OF AUDITS AND RENEWAL

17 OF ACCREDITATION.—The Secretary shall audit the 

18 performance of certifying agents on a periodic basis, 

19 but not less than every 4 years, for the purpose of 

20 renewing the accreditation of such agents. 

21 ‘‘(5) WITHDRAWAL OF ACCREDITATION.—The 

22 Secretary— 

23 ‘‘(A) may withdraw accreditation under 

24 paragraph (1) from a certifying agent if— 


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1 ‘‘(i) a facility certified by the agent is 

2 linked to an outbreak of human or animal 

3 illness; or 

4 ‘‘(ii) the Secretary finds that the 

5 agent no longer meets the requirements for 

6 accreditation; and 

7 ‘‘(B) shall withdraw accreditation under 

8 paragraph (1) from a certifying agent if the 

9 Secretary finds that the certifying agent has re10 fused to allow the Secretary to conduct such 

11 audits and investigations as may be necessary 

12 to ensure continued compliance with the re13 quirements of this section. 

14 ‘‘(6) PUBLICATION OF LIST OF CERTIFYING

15 AGENTS.—The Secretary shall publish and maintain 

16 on the website of the Food and Drug Administration 

17 a current list of certifying agents accredited under 

18 this section, including— 

19 ‘‘(A) each such agent’s name and location; 

20 and 

21 ‘‘(B) any other information deemed nec22 essary by the Secretary. 

23 ‘‘(b) ADDITIONAL REQUIREMENTS APPLICABLE TO

24 CERTIFYING AGENTS.—As conditions of accreditation 


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1 under subsection (a), a certifying agent shall agree to the 

2 following: 

3 ‘‘(1) AUDIT REQUIREMENTS.—A certifying 

4 agent shall not certify a facility unless the certifying 

5 agent has— 

6 ‘‘(A) conducted an on-site audit of the fa7 cility, which shall be unannounced for a domes8 tic facility; 

9 ‘‘(B) reviewed the facility’s food safety 

10 plan under section 418A to ensure the plan 

11 meets applicable requirements of this Act and is 

12 adequate to protect the public health; 

13 ‘‘(C) prepared an audit report in a form 

14 and manner designated by the Secretary; and 

15 ‘‘(D) conducted any other review, analysis, 

16 or testing determined by the Secretary to be ap17 propriate for determining such facility’s compli18 ance with the applicable requirements of this 

19 Act. 

20 ‘‘(2) ACCESS TO REPORTS AND RECORDS.—A 

21 certifying agent shall provide to the Secretary, upon 

22 request— 

23 ‘‘(A) a copy of any audit report prepared 

24 under paragraph (1)(C); 


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1 ‘‘(B) any records relating to corrective ac2 tions planned or taken by the audited facility; 

3 and 

4 ‘‘(C) any other records related to— 

5 ‘‘(i) the certification or decertification 

6 of a facility; 

7 ‘‘(ii) compliance of a facility with the 

8 requirements of this Act; or 

9 ‘‘(iii) the accreditation of the certi10 fying agent. 

11 ‘‘(3) CONFLICTS OF INTEREST.— 

12 ‘‘(A) IN GENERAL.—A certifying agent 

13 shall— 

14 ‘‘(i) not have an ownership, manage15 ment, or other financial interest in any fa16 cility to be certified by the certifying agent 

17 or in such facility’s suppliers or vendors; 

18 ‘‘(ii) have procedures to ensure 

19 against the use, in carrying out audits of 

20 a facility under this section, of any officer 

21 or employee who has a financial conflict of 

22 interest regarding such facility; and 

23 ‘‘(iii) have written conflict of interest 

24 policies that include prompt disclosure to 


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1 the Secretary of all conflicts or potential 

2 conflicts of interest. 

3 ‘‘(B) REGULATIONS.—Not later than 18 

4 months after the date of the enactment of this 

5 section, the Secretary shall promulgate regula6 tions to implement the requirements of sub7 paragraph (A). Such regulations shall include a 

8 structure, including timing and public disclo9 sure, for fees paid by facilities to certifying 

10 agents. 

11 ‘‘(4) DECERTIFICATION OF FACILITIES.—A cer12 tifying agent shall decertify a facility if the certi13 fying agent, after providing a reasonable opportunity 

14 for corrective action, finds that the facility no longer 

15 meets the applicable requirements of this Act. 

16 ‘‘(5) REQUIRED CERTIFICATION OF IMPORTS.— 

17 A certifying agent shall issue a written and elec18 tronic certification to accompany each shipment of19 fered for import into the United States containing 

20 food that was manufactured, processed, packed, or 

21 held by a facility certified by the agent, subject to 

22 requirements set forth by the Secretary. 

23 ‘‘(6) RISKS TO PUBLIC HEALTH.—If, at any 

24 time during an audit, an auditor of a certifying 

25 agent finds a condition at a facility that could cause 


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1 or contribute to illness or injury to an individual 

2 consuming an article of food manufactured, proc3 essed, packed, or held by the facility, the certifying 

4 agent shall immediately notify the Secretary of the 

5 identity of the facility and such condition. 

6 ‘‘(c) FALSE OR MISLEADING STATEMENTS.—For 

7 purposes of section 301(q)(2), any statement or represen8 tation made by an employee or agent of a facility to an 

9 auditor of a certifying agent or a certifying agent is 

10 deemed to be a report required by or under this Act. 

11 ‘‘(d) DEFINITIONS.—In this section: 

12 ‘‘(1) The term ‘certifying agent’ means a third 

13 party accredited as a certifying agent pursuant to 

14 subsection (a)(1). 

15 ‘‘(2) The term ‘facility’ means a facility re16 quired to be registered under section 415. 

17 ‘‘SEC. 421. CERTIFICATION OF LABORATORIES; ACCREDITA18 TION OF LABORATORY CERTIFYING AGENTS. 

19 ‘‘(a) IN GENERAL.—Not later than 2 years after the 

20 date of the enactment of this section, the Secretary shall 

21 establish a program for the certification of laboratories for 

22 the purpose of conducting sampling and testing of food 

23 to ensure compliance with the requirements of this Act. 

24 ‘‘(b) STANDARDS.—Not later than 18 months after 

25 the date of the enactment of this section, the Secretary 


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1 shall develop standards to certify laboratories under this 

2 section. Such standards shall include— 

3 ‘‘(1) standards for sampling and analytical pro4 cedures; 

5 ‘‘(2) training and qualification levels for indi6 viduals who conduct the analyses; 

7 ‘‘(3) standards for internal quality systems; and 

8 ‘‘(4) any other standards determined appro9 priate by the Secretary. 

10 ‘‘(c) ACCREDITATION OF THIRD PARTIES AS LAB11 ORATORY CERTIFYING AGENTS.— 

12 ‘‘(1) IN GENERAL.—The Secretary may estab13 lish an accreditation system under which third par14 ties, as determined appropriate by the Secretary, 

15 may request to be accredited as a laboratory certi16 fying agent to certify laboratories as meeting the ap17 plicable requirements of this Act. 

18 ‘‘(2) APPLICATION OF REQUIREMENTS RELAT19 ING TO QUALIFICATIONS OF AGENTS, PERFORMANCE

20 OF AUDITS AND RENEWAL OF ACCREDITATION, AND

21 WITHDRAWAL OF ACCREDITATION.—The provisions 

22 of paragraphs (2), (4), and (5), other than para23 graph (5)(A)(i), of section 420(a) shall apply to the 

24 accreditation of laboratory certifying agents with re25 spect to laboratories in the same manner as such 


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1 provisions apply to the accreditation of certifying 

2 agents with respect to facilities. 

3 ‘‘(3) APPLICATION OF ADDITIONAL REQUIRE4 MENTS.—The provisions of paragraphs (1) (other 

5 than subparagraph (B) and other than the require6 ment under subparagraph (A) that an audit be un7 announced), (2), (3), and (4) of section 420(b) shall 

8 apply to laboratory certifying agents under this sub9 section with respect to laboratories in the same man10 ner as such provisions apply to the certifying agents 

11 with respect to facilities. 

12 ‘‘(4) LABORATORY CERTIFYING AGENT DE13 FINED.—In this section, the term ‘laboratory certi14 fying agent’ means a third party accredited as a lab15 oratory certifying agent under this subsection. 

16 ‘‘(d) PUBLICATION OF LIST OF CERTIFYING AGENTS

17 AND CERTIFIED LABORATORIES.—The provisions of para18 graph (6) of section 420(a) shall apply to third parties 

19 accredited as laboratory certifying agents under sub20 section (c) and to laboratories certified under subsection 

21 (a) in the same manner as such provisions apply to third 

22 parties accredited as certifying agents under such section. 

23 ‘‘(e) FOOD TESTING BY CERTIFIED LABORA24 TORIES.— 


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1 ‘‘(1) IN GENERAL.—Beginning 3 years after the 

2 date of the enactment of this section, testing of food 

3 described in paragraph (2) shall be conducted only 

4 by Federal laboratories or by laboratories certified 

5 under subsection (a). 

6 ‘‘(2) TESTING OF FOOD COVERED.—The testing 

7 of food described in this paragraph is testing of 

8 food— 

9 ‘‘(A) conducted in support of an admission 

10 of an article of food under section 801; 

11 ‘‘(B) conducted in support of a reoffer of 

12 food previously denied admission under section 

13 402(h); 

14 ‘‘(C) conducted under an import alert that 

15 requires successive consecutive tests; 

16 ‘‘(D) conducted to show compliance with 

17 an order of the Secretary; 

18 ‘‘(E) conducted in support of an appeal of 

19 an order of the Secretary; or 

20 ‘‘(F) as otherwise required to be conducted 

21 by the Secretary, as the Secretary deems appro22 priate. 

23 ‘‘(3) ACCESS TO TESTING RESULTS.—The re24 sults of any testing of food described in paragraph 

25 (2) by a laboratory certified under this section shall 


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1 be promptly transmitted by such laboratory in elec2 tronic format to the Secretary. 

3 ‘‘(f) FALSE OR MISLEADING STATEMENTS.—For 

4 purposes of section 301(q)(2), as amended by section 406, 

5 any statement or representation made by an employee or 

6 agent of a laboratory to a laboratory certifying agent is 

7 deemed to be a report required by or under this Act.’’. 

8 (c) FEES.—Part 5 of subchapter C of chapter VII, 

9 as added by section 101(b) and amended by section 

10 108(a), is amended by adding at the end the following: 

11 ‘‘SEC. 741B. CERTIFYING AGENT FEE. 

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

13 collect a fee for the accreditation of an entity as a certi14 fying agent under section 420(a) for the purpose of de15 fraying the costs of implementing the system established 

16 for such accreditation. 

17 ‘‘(b) AMOUNT OF FEE.—The amount of a fee under 

18 this section shall be as determined by the Secretary. 

19 ‘‘SEC. 741C. LABORATORY CERTIFYING AGENT ACCREDITA20 TION FEE. 

21 ‘‘The Secretary shall assess and collect an annual fee, 

22 specified by the Secretary, for accreditation of laboratory 

23 certifying agents under section 421 for the purpose of de24 fraying the costs of the accreditation activities under such 

25 section.’’. 


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1 SEC. 110. SAFE AND SECURE FOOD IMPORTATION PRO2 GRAM. 

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

4 adding at the end the following: 

5 ‘‘SEC. 805. SAFE AND SECURE FOOD IMPORTATION PRO6 GRAM. 

7 ‘‘(a) IN GENERAL.—Beginning not later than 2 years 

8 after the date of the enactment of this section, the Sec9 retary shall establish by regulation and carry out a pro10 gram under which the Secretary expedites the movement 

11 of food through the importation process under this Act 

12 if each facility involved in the production, manufacture, 

13 processing, packaging, and holding of the food— 

14 ‘‘(1) is certified by a certifying agent accredited 

15 pursuant to section 420(a)(1); and 

16 ‘‘(2) has agreed to abide by, and has been de17 termined by the Secretary to be in compliance with, 

18 the food safety and security guidelines developed 

19 under subsection (b) with respect to such food. 

20 ‘‘(b) GUIDELINES.— 

21 ‘‘(1) DEVELOPMENT.—For purposes of the pro22 gram established under subsection (a), the Secretary 

23 shall develop safety and security guidelines applica24 ble to the importation of food. 

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

26 account the following factors: 


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1 ‘‘(A) The personnel of the person import2 ing the food. 

3 ‘‘(B) The physical and procedural safety 

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

5 ‘‘(C) The sufficiency of access controls for 

6 food and ingredients purchased by such person. 

7 ‘‘(D) Vendor and supplier information. 

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

9 determines necessary.’’. 

10 Subtitle B—Intervention 

11 SEC. 111. PUBLIC HEALTH ASSESSMENT SYSTEM. 

12 (a) ACTIVE SURVEILLANCE SYSTEM.—The Secretary 

13 of Health and Human Services (in this subtitle referred 

14 to as the ‘‘Secretary’’), acting through the Centers for 

15 Disease Control and Prevention, shall establish and imple16 ment an active surveillance system for food, based on a 

17 representative proportion of the population of the United 

18 States, to assess more accurately the frequency and 

19 sources of human illness in the United States associated 

20 with the consumption of food. 

21 (b) SAMPLING SYSTEM.— 

22 (1) IN GENERAL.—The Secretary shall establish 

23 and implement a sampling system under which the 

24 Secretary takes and analyzes samples of food prod25 ucts— 


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1 (A) to assist the Secretary in carrying out 

2 this Act and the Federal Food, Drug, and Cos3 metic Act (21 U.S.C. 301 et seq.); and 

4 (B) to more accurately assess the nature, 

5 frequency of occurrence, and amounts of con6 taminants in food products. 

7 (2) REQUIREMENTS.—Such sampling system 

8 shall provide— 

9 (A) statistically valid monitoring, including 

10 market-basket studies, on the nature, frequency 

11 of occurrence, and amounts of contaminants in 

12 food products available to consumers; and 

13 (B) at the request of the Secretary, such 

14 other information, including analysis of moni15 toring and verification samples, as the Sec16 retary determines may be useful in assessing 

17 the occurrence of contaminants in food prod18 ucts. 

19 (3) GUIDELINES.—Within 12 months after the 

20 date of the enactment of this Act, the Secretary 

21 shall establish guidelines for the sampling system 

22 under this subsection. 

23 (c) ASSESSMENT OF HEALTH HAZARDS.—Through 

24 the surveillance system under subsection (a) and the sam25 pling system under subsection (b), the Secretary shall 


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1 rank food categories based on their hazard to human 

2 health and identify appropriate industry and regulatory 

3 approaches to minimize hazards in the food supply. Such 

4 analysis may include— 

5 (1) the safety of commercial harvesting and 

6 processing, as compared with the health hazards as7 sociated with food products that are harvested for 

8 recreational or subsistence purposes and prepared 

9 noncommercially; 

10 (2) the safety of food products that are domes11 tically harvested and processed, as compared with 

12 the health hazards associated with food products 

13 that are harvested or processed outside the United 

14 States; 

15 (3) contamination originating from handling 

16 practices that occur prior to or after sale of food 

17 products to consumers; and 

18 (4) use of comparative risk assessments. 

19 SEC. 112. PUBLIC EDUCATION AND ADVISORY SYSTEM. 

20 (a) PUBLIC EDUCATION.—The Secretary, in coopera21 tion with private and public organizations, including the 

22 appropriate State entities, shall design and implement a 

23 national public education program on food safety. The 

24 program shall provide— 


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1 (1) information to the public regarding Federal 

2 standards and good practice requirements and pro3 motion of public awareness, understanding, and ac4 ceptance of such standards and requirements; 

5 (2) information to health professionals so that 

6 they may improve diagnosis and treatment of food7 related illness and advise individuals whose health 

8 conditions place them in particular risk; and 

9 (3) such other information or advice to con10 sumers and other persons as the Secretary deter11 mines will promote the purposes of this Act. 

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

13 with the States and other appropriate entities to— 

14 (1) develop and distribute regional and national 

15 advisories concerning food safety; 

16 (2) develop standardized formats for written 

17 and broadcast advisories; and 

18 (3) incorporate State and local advisories into 

19 the national public education program required 

20 under subsection (a). 

21 SEC. 113. RESEARCH. 

22 (a) IN GENERAL.—The Secretary shall conduct re23 search to assist in the implementation of this Act, includ24 ing studies to— 


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1 (1) improve sanitation and food safety practices 

2 in the processing of food products; 

3 (2) develop improved techniques for the moni4 toring of food and inspection of food products; 

5 (3) develop efficient, rapid, and sensitive meth6 ods for determining and detecting the presence of 

7 contaminants in food products; 

8 (4) determine the sources of contamination of 

9 food and food products with contaminants; 

10 (5) develop consumption data with respect to 

11 food products; 

12 (6) draw upon research and educational pro13 grams that exist at the State and local level; 

14 (7) utilize the DNA matching system and other 

15 processes to identify and control pathogens; 

16 (8) address common and emerging zoonotic dis17 eases; 

18 (9) develop methods to reduce or destroy patho19 gens before, during, and after processing; 

20 (10) analyze the incidence of antibiotic resist21 ance as it pertains to the food supply and develop 

22 new methods to reduce the transfer of antibiotic re23 sistance to humans; and 

24 (11) conduct other research that supports the 

25 purposes of this Act. 


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1 (b) CONTRACT AUTHORITY.—The Secretary is au2 thorized to enter into contracts and agreements with any 

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

4 carry out this section. 

5 SEC. 114. NOTIFICATION, NONDISTRIBUTION, AND RECALL 

6 OF ADULTERATED OR MISBRANDED ARTI7 CLES OF FOOD. 

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

9 331), as amended by sections 102 and 104, is amended 

10 by adding at the end the following: 

11 ‘‘(qq)(1) The failure to notify the Secretary in viola12 tion of section 422(a). 

13 ‘‘(2) The failure to comply with— 

14 ‘‘(A) an order issued under section 422(b) fol15 lowing any hearing requested under section 422(c); 

16 or 

17 ‘‘(B) an amended order issued under section 

18 422(d)(1).’’. 

19 (b) NOTIFICATION, NONDISTRIBUTION, AND RECALL

20 OF ADULTERATED OR MISBRANDED ARTICLES OF

21 FOOD.—Chapter IV (21 U.S.C. 341 et seq.), as amended 

22 by sections 102(b), 104, and 108(c), is amended by adding 

23 at the end the following: 


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1 ‘‘SEC. 422. NOTIFICATION, NONDISTRIBUTION, AND RECALL 

2 OF ADULTERATED OR MISBRANDED ARTI3 CLES OF FOOD. 

4 ‘‘(a) NOTIFICATION TO SECRETARY OF VIOLATION.— 

5 ‘‘(1) IN GENERAL.—A person (other than a 

6 household consumer or other individual who is the 

7 intended consumer of an article of food) that has 

8 reason to believe that an article of food when intro9 duced into or while in interstate commerce, or while 

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

11 after shipment in interstate commerce, is adulter12 ated or misbranded in a manner that, if consumed, 

13 may result in illness or injury shall, as soon as prac14 ticable, notify the Secretary of the identity and loca15 tion of the article. 

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

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

18 and by such means as the Secretary may require by 

19 regulation. 

20 ‘‘(b) RECALL AND CONSUMER NOTIFICATION.— 

21 ‘‘(1) VOLUNTARY ACTIONS.—On receiving noti22 fication under subsection (a) or by other means of 

23 a suspected adulteration or misbranding of food, if 

24 the Secretary finds that an article of food when in25 troduced into or while in interstate commerce, or 

26 while held for sale (regardless of whether the first 


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1 sale) after shipment in interstate commerce, is adul2 terated or misbranded in a manner that, if con3 sumed, may result in illness or injury (as determined 

4 by the Secretary), the Secretary shall provide all ap5 propriate persons (including the manufacturer, im6 porter, distributor, or retailer of the article) with an 

7 opportunity (as determined by the Secretary)— 

8 ‘‘(A) to cease distribution of the article; 

9 ‘‘(B) to notify all persons— 

10 ‘‘(i) that produce, manufacture, pack, 

11 process, prepare, treat, package, distribute, 

12 or hold the article, to cease immediately 

13 those activities with respect to the article; 

14 or 

15 ‘‘(ii) to which the article has been dis16 tributed, transported, or sold, to cease im17 mediately distribution of the article; 

18 ‘‘(C) to recall the article; 

19 ‘‘(D) in consultation with the Secretary, to 

20 provide notice of the finding of the Secretary to 

21 all consumers to which the article was, or may 

22 have been, distributed and to appropriate State 

23 and local health officials; and 

24 ‘‘(E) to notify State and local public health 

25 officials. 


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1 ‘‘(2) MANDATORY ACTIONS.—If the appropriate 

2 person referred to in paragraph (1) does not carry 

3 out the actions described in that paragraph with re4 spect to an article within the time period and in the 

5 manner prescribed by the Secretary, the Secretary— 

6 ‘‘(A) shall issue an order requiring the per7 son— 

8 ‘‘(i) to immediately cease distribution 

9 of the article; and 

10 ‘‘(ii) to immediately make the notifica11 tion described in paragraph (1)(B); and 

12 ‘‘(B) may take control or possession of the 

13 article. 

14 ‘‘(3) NOTICE TO CONSUMERS AND HEALTH OF15 FICIALS.—The Secretary shall, as the Secretary de16 termines to be necessary, provide notice of the find17 ing of the Secretary under paragraph (1) to con18 sumers to which the article was, or may have been, 

19 distributed and to appropriate State and local health 

20 officials. 

21 ‘‘(c) HEARINGS ON ORDERS.— 

22 ‘‘(1) IN GENERAL.—The Secretary shall provide 

23 a person subject to an order under subsection (b)(2) 

24 with an opportunity for a hearing on— 

25 ‘‘(A) the actions required by the order; and 


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1 ‘‘(B) any reasons why the article of food 

2 that is the subject of the order should not be 

3 recalled. 

4 ‘‘(2) TIMING OF HEARINGS.—If a hearing is re5 quested under paragraph (1) with respect to an 

6 order, the Secretary shall hold the hearing as soon 

7 as practicable, but not later than 2 business days, 

8 after the date of issuance of the order. 

9 ‘‘(d) POST-HEARING RECALL ORDERS.— 

10 ‘‘(1) AMENDMENT OF ORDERS.—If, after pro11 viding an opportunity for a hearing (and a hearing 

12 if requested) under subsection (c), the Secretary de13 termines that an article of food when introduced into 

14 or while in interstate commerce, or while held for 

15 sale (regardless of whether the first sale) after ship16 ment in interstate commerce, is adulterated or mis17 branded in a manner that, if consumed, may result 

18 in illness or injury, the Secretary may, as the Sec19 retary determines to be necessary— 

20 ‘‘(A) amend the order under subsection 

21 (b)(2)— 

22 ‘‘(i) to require recall of the article or 

23 other appropriate action; and 

24 ‘‘(ii) to specify a timetable during 

25 which the recall shall occur; 


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•HR 759 IH

1 ‘‘(B) require periodic reports to the Sec2 retary describing the progress of any such re3 call; and 

4 ‘‘(C) provide notice of such a recall to con5 sumers to which the article was, or may have 

6 been, distributed. 

7 ‘‘(2) VACATION OF ORDERS.—If, after providing 

8 an opportunity for a hearing (and a hearing if re9 quested) under subsection (c), the Secretary deter10 mines that adequate grounds do not exist to con11 tinue the actions required by the order, the Sec12 retary shall vacate the order. 

13 ‘‘(e) REMEDIES NOT EXCLUSIVE.—The remedies au14 thorized by this section shall be in addition to any other 

15 remedies that may be available.’’. 

16 (c) EFFECTIVE DATE.—Sections 301(qq)(1) and 422 

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

18 by subsections (a) and (b), shall apply with respect to arti19 cles of food as of such date, not later than 1 year after 

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

21 of Health and Human Services shall specify. 

22 Subtitle C—Response 

23 SEC. 121. ADMINISTRATIVE DETENTION. 

24 (a) IN GENERAL.—Section 304(h)(1)(A) (21 U.S.C. 

25 334(h)(1)(A)) is amended by— 


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1 (1) striking ‘‘credible evidence or information 

2 indicating’’ and inserting ‘‘reason to believe’’; and 

3 (2) striking ‘‘presents a threat of serious ad4 verse health consequences or death to humans or 

5 animals’’ and inserting ‘‘is adulterated or mis6 branded’’. 

7 (b) REGULATIONS.—Not later than 120 days after 

8 the date of enactment of this Act, the Secretary shall issue 

9 an interim final rule amending subpart K of part 1 of title 

10 21, Code of Federal Regulations, to implement the amend11 ment made by this section. 

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

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

14 enactment of this Act. 

15 SEC. 122. CIVIL PENALTIES RELATING TO FOOD. 

16 (a) IN GENERAL.—Chapter III (21 U.S.C. 331 et 

17 seq.) is amended by adding after section 303 the following: 

18 ‘‘SEC. 303A. CIVIL PENALTIES RELATING TO FOODS. 

19 ‘‘(a) IN GENERAL.— 

20 ‘‘(1) ASSESSMENT.—The Secretary may assess 

21 against a person that commits an act prohibited by 

22 section 301 with respect to an article of food a civil 

23 penalty for each such act of not more than— 

24 ‘‘(A) $100,000, in the case of an indi25 vidual; and 


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1 ‘‘(B) $500,000, in the case of any other 

2 person. 

3 ‘‘(2) SEPARATE OFFENSES.—Each prohibited 

4 act described in paragraph (1) and each day during 

5 which the act continues shall be considered to be a 

6 separate offense. 

7 ‘‘(3) NOTICE AND OPPORTUNITY FOR HEAR8 ING.—The Secretary shall not assess a civil penalty 

9 under this section against a person unless the person 

10 is given notice and opportunity for a hearing on the 

11 record before the Secretary in accordance with sec12 tions 554 and 556 of title 5, United States Code. 

13 ‘‘(4) DETERMINATION OF CIVIL PENALTY

14 AMOUNT.—The amount of a civil penalty under this 

15 section— 

16 ‘‘(A) shall be assessed by the Secretary by 

17 written order, taking into account— 

18 ‘‘(i) the gravity of the violation; 

19 ‘‘(ii) the degree of culpability of the 

20 person; 

21 ‘‘(iii) the size and type of the business 

22 of the person; and 

23 ‘‘(iv) any history of prior offenses by 

24 the person; and 


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1 ‘‘(B) shall be reviewed only in accordance 

2 with subsection (b). 

3 ‘‘(b) JUDICIAL REVIEW.— 

4 ‘‘(1) IN GENERAL.—An order assessing a civil 

5 penalty against a person under subsection (a) shall 

6 be final unless the person— 

7 ‘‘(A) not later than 30 days after the effec8 tive date of the order, files a petition for judi9 cial review of the order in— 

10 ‘‘(i) the United States court of ap11 peals for the circuit in which the person re12 sides or has its principal place of business; 

13 or 

14 ‘‘(ii) the United States Court of Ap15 peals for the District of Columbia Circuit; 

16 and 

17 ‘‘(B) simultaneously sends a copy of the 

18 petition by certified mail to the Secretary. 

19 ‘‘(2) FILING OF COPY OF RECORD.—The Sec20 retary shall promptly file in the court a certified 

21 copy of the record on which the order was issued. 

22 ‘‘(3) STANDARD OF REVIEW.—The findings of 

23 the Secretary relating to the order shall be set aside 

24 only if the findings are found to be unsupported by 

25 substantial evidence on the record as a whole. 


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1 ‘‘(c) COLLECTION ACTIONS FOR FAILURE TO PAY

2 ASSESSMENT.— 

3 ‘‘(1) REFERRAL TO ATTORNEY GENERAL.—If a 

4 person fails to pay a civil penalty assessed under 

5 subsection (a) after the order assessing the civil pen6 alty has become a final order, or after the court of 

7 appeals has entered final judgment in favor of the 

8 Secretary, the Secretary may refer the matter to the 

9 Attorney General. 

10 ‘‘(2) ACTION BY ATTORNEY GENERAL.—The 

11 Attorney General shall bring a civil action to recover 

12 the amount of the civil penalty in United States dis13 trict court. 

14 ‘‘(3) SCOPE OF REVIEW.—In a civil action 

15 under paragraph (2), the validity and appropriate16 ness of the order of the Secretary assessing the civil 

17 penalty shall not be subject to review. 

18 ‘‘(d) PENALTIES DEPOSITED IN TREASURY.—All 

19 amounts collected as civil penalties under this section shall 

20 be deposited in the Treasury of the United States and 

21 shall be available to cover costs of the Administration in 

22 carrying out food safety activities under this Act. 

23 ‘‘(e) PENALTIES IN LIEU OF OTHER ACTIONS.— 

24 Nothing in this Act requires the Secretary to report for 

25 prosecution, or for the commencement of any libel or inVerDate Nov 24 2008 03:16 Jan 30, 2009 Jkt 079200 PO 00000 Frm 00067 Fmt 6652 Sfmt 6201 E:\BILLS\H759.IH H759

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1 junction proceeding, any violation of this Act in any case 

2 in which the Secretary believes that the public interest will 

3 be adequately served by the assessment of a civil penalty 

4 under this section. 

5 ‘‘(f) REMEDIES NOT EXCLUSIVE.—The remedies au6 thorized by this section shall be in addition to any other 

7 remedies that may be available.’’. 

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

9 subsection (a) shall apply to prohibited acts committed on 

10 or after the date of the enactment of this Act . 

11 SEC. 123. FAILURE TO CONSENT TO INVESTIGATION. 

12 Section 801 (21 U.S.C. 381) is amended by adding 

13 at the end the following: 

14 ‘‘(p) The Secretary may deny importation of food, 

15 other than only for personal use, from any foreign country, 

16 or which is manufactured, processed, packed, or held by 

17 a facility (as defined in section 415), if the government 

18 of such country, or such facility, respectively, does not 

19 timely consent to an investigation by the Administration 

20 when food from that country or facility is linked to a food21 borne illness outbreak or is otherwise found to be adulter22 ated or mislabeled.’’. 


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1 Subtitle D—Miscellaneous 

2 SEC. 131. LABELING REQUIREMENT FOR MEAT, POULTRY 

3 PRODUCTS, AND SEAFOOD THAT CONTAIN 

4 CARBON MONOXIDE. 

5 (a) LABELING REQUIREMENT.— 

6 (1) IN GENERAL.—Paragraph (t) of section 201 

7 (21 U.S.C. 321) is amended by adding at the end 

8 the following: 

9 ‘‘(4) In the case of food that is meat within the mean10 ing of the Federal Meat Inspection Act, a poultry product 

11 within the meaning of the Poultry Products Inspection 

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

13 molluscan shellfish, crustaceans, and other forms of 

14 aquatic animal life) intended for human consumption as 

15 food within the meaning of section 201(f) (referred to col16 lectively in this paragraph as ‘seafood’), the term ‘color 

17 additive’ shall include carbon monoxide under conditions 

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

19 or otherwise affect the color of fresh meat, poultry prod20 ucts, or seafood, unless the label of such food bears, 

21 prominently and conspicuously in such place and in such 

22 manner as to render it likely to be read and understood 

23 by the ordinary person, the following statement to prevent 

24 consumer deception and serious risks to the public health: 

25 ‘CONSUMER NOTICE: Carbon monoxide has been used 


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1 to preserve the color of this product. Do not rely on color 

2 or the ‘‘use or freeze by’’ date alone to judge the freshness 

3 of the product.’ ’’. 

4 (2) EFFECTIVE DATE.—The amendment made 

5 by this subsection shall apply to food labeled on or 

6 after the date that is 30 days after the date of the 

7 enactment of this Act. 

8 (b) DISCRETIONARY AUTHORITY.—If, not earlier 

9 than 5 years after the effective date described in sub10 section (a)(2), the Secretary of Health and Human Serv11 ices finds, based on competent and reliable scientific evi12 dence, that the statement prescribed in section 201(t)(4) 

13 of the Federal Food, Drug, and Cosmetic Act is no longer 

14 required to prevent consumer deception and other harms, 

15 then the Secretary is authorized to issue regulations estab16 lishing alternative labeling requirements that are shown 

17 to be adequate and effective in preventing consumer de18 ception and other harms related to the conditions of use 

19 of carbon monoxide, including with respect to preventing 

20 any consumer deception or other harm that may result 

21 from the actual conditions of carbon monoxide use and 

22 its potential to impart a persistent color to meat, poultry 

23 products, or seafood described in such section through a 

24 reaction with natural pigment. 


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1 SEC. 132. 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 publish notice of such request in the Fed11 eral Register. 

12 ‘‘(2) Not later than 90 days after the date of publica13 tion of a notice under paragraph (1), the Secretary shall 

14 determine whether the substance is a GRAS food sub15 stance. 

16 ‘‘(3) A determination by the Secretary of whether a 

17 substance is a GRAS food substance shall be published 

18 in the Federal Register. 

19 ‘‘(4) In this subsection, the term ‘GRAS food sub20 stance’ means a substance excluded from the definition of 

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

22 substance is generally recognized, among experts qualified 

23 by scientific training and experience to evaluate its safety, 

24 as having been adequately shown through scientific proce25 dures (or, in the case of a substances used in food prior 

26 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. 133. COUNTRY OF ORIGIN LABELING; DISCLOSURE OF 

4 SOURCE OF INGREDIENTS. 

5 (a) FOOD.—Section 403 (21 U.S.C. 343), as amend6 ed by sections 101(a) and 108(b), is amended by adding 

7 at the end the following: 

8 ‘‘(bb) 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 website for the manufacturer of the 

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

15 ‘‘(cc) 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 website 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 (bb) and (cc) 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 (bb) and (cc) 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. 134. NEW FOOD AND ANIMAL FEED EXPORT CERTIFI9 CATION FEE TO IMPROVE THE ABILITY OF 

10 UNITED STATES FIRMS TO EXPORT THEIR 

11 PRODUCTS. 

12 Part 5 of subchapter C of chapter VII (21 U.S.C. 

13 371 et seq.), as added by section 101(b) and amended by 

14 sections 108 and 109, is further amended by adding at 

15 the end the following: 

16 ‘‘SEC. 741D. NEW FOOD AND ANIMAL FEED EXPORT CER17 TIFICATION FEE TO IMPROVE THE ABILITY 

18 OF UNITED STATES FIRMS TO EXPORT THEIR 

19 PRODUCTS. 

20 ‘‘(a) IN GENERAL.—If the Secretary provides for the 

21 issuance of export certificates for foods and animal feeds 

22 in cases where exportation is restricted without such a cer23 tificate, the Secretary may impose a fee for the issuance 

24 of such a certificate. 


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1 ‘‘(b) AMOUNT.—The amount of the fee under this 

2 section shall be an amount that is reasonably related to 

3 the cost of issuing such certificates. 

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

5 of the fees collected pursuant to this section available sole6 ly to pay for the costs of issuance of such certificates.’’. 

7 TITLE II—DRUG AND DEVICE 

8 SAFETY 

9 SEC. 201. REGISTRATION OF PRODUCERS OF DRUGS AND 

10 DEVICES; APPLICABLE FEE. 

11 (a) REGISTRATION.— 

12 (1) MISBRANDING.—Paragraph (o) of section 

13 502 (21 U.S.C. 352) is amended by striking ‘‘in any 

14 State’’. 

15 (2) EFFECTIVE DATE.—The amendment made 

16 by paragraph (1) applies only with respect to reg17 istration under section 510 of the Federal Food, 

18 Drug, and Cosmetic Act (21 U.S.C. 360) occurring 

19 on or after the date of the enactment of this Act. 

20 (b) REGISTRATION FEE.— 

21 (1) MISBRANDING.—Paragraph (o) of section 

22 502 (21 U.S.C. 352), as amended by subsection 

23 (a)(2), is further amended by inserting after ‘‘not 

24 duly registered under section 510’’ the following: ‘‘or 

25 in violation of section 736C for failure to pay a fee’’. 


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1 (2) ESTABLISHMENT.—Part 2 of subchapter C 

2 of chapter VII (21 U.S.C. 379g et seq.) is amended 

3 by adding at the end the following: 

4 ‘‘SEC. 736C. REGISTRATION FEE. 

5 ‘‘(a) IN GENERAL.—Except as provided in subsection 

6 (b) of this section, the Secretary shall assess and collect 

7 an annual fee for registration under subsection (b), (c), 

8 (d), or (i) of section 510 to defray increases (as described 

9 in subsection (g)(2)(A)(ii)) in the costs of inspecting es10 tablishments registered under subsection (b), (c), (d), or 

11 (i) of section 510 to ensure compliance by such establish12 ments with the requirements of this Act relating to drugs 

13 or devices. 

14 ‘‘(b) EXCEPTION.—The Secretary shall not assess or 

15 collect a fee under this section for registration of an estab16 lishment under section 510 on the basis of such establish17 ment’s manufacture, preparation, propagation, or proc18 essing of an excipient of a drug. 

19 ‘‘(c) FEE REVENUE AMOUNTS.— 

20 ‘‘(1) IN GENERAL.—For each of fiscal years 

21 2010 through 2014, fees under subsection (a) shall, 

22 except as provided in subsections (d), (f), and (g), 

23 be established to generate a total revenue amount 

24 under subsection (a). 


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1 ‘‘(2) TOTAL REVENUE AMOUNT.—Not later 

2 than September 1, 2010, the Secretary shall trans3 mit to the Congress the total revenue amount under 

4 paragraph (1) and how such amount was calculated. 

5 ‘‘(3) ANNUAL FEE SETTING.—The Secretary 

6 shall, not later than 60 days before the start of each 

7 fiscal year that begins after September 30, 2009, es8 tablish, for the next fiscal year, registration fees 

9 under subsection (a)— 

10 ‘‘(A) based on the total revenue amount 

11 applicable under paragraph (1); and 

12 ‘‘(B) taking into consideration the dif13 ference in costs of inspections between foreign 

14 and domestic establishments. 

15 ‘‘(d) ADJUSTMENTS.— 

16 ‘‘(1) INFLATION ADJUSTMENT.—For fiscal year 

17 2011 and subsequent fiscal years, the revenues es18 tablished in subsection (c)(1) shall be adjusted by 

19 the Secretary by notice, published in the Federal 

20 Register, for a fiscal year to reflect the greater of— 

21 ‘‘(A) the total percentage change that oc22 curred in the Consumer Price Index for all 

23 urban consumers (all items; U.S. city average) 

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1 ceding the fiscal year for which fees are being 

2 established; 

3 ‘‘(B) the total percentage change for the 

4 previous fiscal year in basic pay under the Gen5 eral Schedule in accordance with section 5332 

6 of title 5, United States Code, as adjusted by 

7 any locality-based comparability payment pur8 suant to section 5304 of such title for Federal 

9 employees stationed in the District of Columbia; 

10 or 

11 ‘‘(C) the average annual change in the 

12 cost, per full-time equivalent position of the 

13 Food and Drug Administration, of all personnel 

14 compensation and benefits paid with respect to 

15 such positions for the first 5 years of the pre16 ceding 6 fiscal years. 

17 The adjustment made each fiscal year by this sub18 section will be added on a compounded basis to the 

19 sum of all adjustments made each fiscal year after 

20 fiscal year 2009 under this subsection. 

21 ‘‘(2) WORKLOAD ADJUSTMENT.—For fiscal 

22 year 2011 and subsequent fiscal years, after the fee 

23 revenues established in subsection (c)(1) are ad24 justed for a fiscal year for inflation in accordance 

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1 justed further for such fiscal year to reflect changes 

2 in the workload of the Secretary for inspections de3 scribed in subsection (a). With respect to such ad4 justment: 

5 ‘‘(A) The adjustment shall be determined 

6 by the Secretary based on a weighted average 

7 of the change in the total amount of inspections 

8 described in subsection (a). The Secretary shall 

9 publish in the Federal Register the fee revenues 

10 and fees resulting from the adjustment and the 

11 supporting methodologies. 

12 ‘‘(B) Under no circumstances shall the ad13 justment result in fee revenues for a fiscal year 

14 that are less than the fee revenues for the fiscal 

15 year established in subsection (c)(1), as ad16 justed for inflation under paragraph (1). Any 

17 adjustment for changes in inspection activities 

18 made in setting fees and revenue amounts for 

19 fiscal year 2011 may not result in the total 

20 workload adjustment being more than 2 per21 centage points higher than it would have been 

22 in the absence of the adjustment for changes in 

23 inspection activities. 

24 ‘‘(C) The Secretary shall contract with an 

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1 justment for changes in inspection activities ap2 plied in setting fees and revenue amounts for 

3 fiscal year 2011 and to make recommendations, 

4 if warranted, for future changes in the method5 ology for calculating the adjustment. After re6 view of the recommendations, the Secretary 

7 shall, if warranted, make appropriate changes 

8 to the methodology, and the changes shall be ef9 fective for each of the fiscal years 2012 through 

10 2014. The Secretary shall not make any adjust11 ment for changes in inspection activities for any 

12 fiscal year after 2011 unless such study has 

13 been completed. 

14 ‘‘(3) RENT AND RENT-RELATED COST ADJUST15 MENT.—For fiscal year 2012 and each subsequent 

16 fiscal year, the Secretary shall, before making ad17 justments under paragraphs (1) and (2), decrease 

18 the fee revenue amount established in subsection 

19 (c)(1) if actual costs paid for rent and rent-related 

20 expenses for the preceding fiscal year are less than 

21 estimates made for such year in fiscal year 2008. 

22 Any reduction made under this paragraph shall not 

23 exceed the amount by which such costs fall below the 

24 estimates made in fiscal year 2008 for such fiscal 


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1 year, and shall not exceed $11,721,000 for any fiscal 

2 year. 

3 ‘‘(4) FINAL YEAR ADJUSTMENT.—For fiscal 

4 year 2014, the Secretary may, in addition to adjust5 ments under paragraphs (1), (2), (3), and (5), fur6 ther increase the fee revenues and fees established in 

7 subsection (c) if such an adjustment is necessary to 

8 provide for not more than 3 months of operating re9 serves of carryover user fees for inspections de10 scribed in subsection (a) for the first 3 months of 

11 fiscal year 2015. If such an adjustment is necessary, 

12 the rationale for the amount of the increase shall be 

13 contained in the annual notice establishing fee reve14 nues and fees for fiscal year 2014. If the Secretary 

15 has carryover balances for such inspections in excess 

16 of 3 months of such operating reserves, the adjust17 ment under this paragraph shall not be made. 

18 ‘‘(5) COST ESTIMATE ADJUSTMENT.—For fiscal 

19 year 2011 and subsequent fiscal years, the Secretary 

20 by notice, published in the Federal Register, shall— 

21 ‘‘(A) provide an estimate of the amount of 

22 the total increases described in subsection (a) 

23 for such fiscal year; and 

24 ‘‘(B) after making adjustments under 

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1 nues established in subsection (c)(1) to be equal 

2 to such amount. 

3 ‘‘(6) LIMIT.—The total amount of fees charged, 

4 as adjusted under this subsection, for a fiscal year 

5 may not exceed the total increases described in sub6 section (a) for such fiscal year. 

7 ‘‘(e) FEE WAIVER OR REDUCTION..— 

8 ‘‘(1) IN GENERAL.—The Secretary may grant 

9 to a person a waiver from, or a reduction of, one or 

10 more fees under this section if the Secretary finds 

11 that— 

12 ‘‘(A) such waiver or reduction is necessary 

13 to protect the public health; or 

14 ‘‘(B) the assessment of the fee would im15 pose significant financial hardship because of 

16 limited resources available to such person or 

17 other circumstances. 

18 ‘‘(2) SPECIAL RULES FOR POSITRON EMISSION

19 TOMOGRAPHY DRUGS.— 

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

21 subparagraph (B), each person who is named 

22 as the applicant in an approved human drug 

23 application for a positron emission tomography 

24 drug shall be subject under paragraph (a) to 

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1 spect to each establishment identified in the ap2 plication as producing positron emission tomog3 raphy drugs under the approved application. 

4 ‘‘(B) EXCEPTION FROM ANNUAL REG5 ISTRATION FEE.—Each person who is named as 

6 the applicant in an application described in sub7 paragraph (A) shall be granted a waiver under 

8 paragraph (1) from an annual registration fee 

9 under subsection (a) for a fiscal year if the per10 son certifies to the Secretary, at a time speci11 fied by the Secretary and using procedures 

12 specified by the Secretary, that— 

13 ‘‘(i) the person is a not-for-profit 

14 medical center that has only 1 establish15 ment for the production of positron emis16 sion tomography drugs; and 

17 ‘‘(ii) at least 95 percent of the total 

18 number of doses of each positron emission 

19 tomography drug produced by such estab20 lishment during such fiscal year will be 

21 used within the medical center. 

22 ‘‘(3) DESIGNATED ORPHAN DRUG.—An estab23 lishment registered under section 510 shall, with re24 spect to the manufacture, preparation, propagation, 

25 compounding, or processing of drugs, be granted a 


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1 waiver under paragraph (1) from a fee under sub2 section (a) if all drugs manufactured, prepared, 

3 propagated, compounded, or processed by the estab4 lishment are designated as a drug for a rare disease 

5 or condition pursuant to section 526. The preceding 

6 sentence shall not apply if the application approved 

7 under section 505 for any such drug includes an in8 dication for a disease or condition other than such 

9 a rare disease or condition. 

10 ‘‘(f) LIMITATIONS.— 

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

12 shall be refunded for a fiscal year beginning after 

13 fiscal year 2010 unless appropriations for salaries 

14 and expenses of the Food and Drug Administration 

15 for such fiscal year (excluding the amount of fees 

16 appropriated for such fiscal year) are equal to or 

17 greater than the amount of appropriations for the 

18 salaries and expenses of the Food and Drug Admin19 istration for the fiscal year 2010 (excluding the 

20 amount of fees appropriated for such fiscal year) 

21 multiplied by the adjustment factor applicable to the 

22 fiscal year involved. 

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

24 assess fees under subsection (a) during any portion 

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


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1 a later date in such fiscal year the Secretary may as2 sess such fees, the Secretary may assess and collect 

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

4 registration under subsection (b), (c), (d), or (i) of 

5 section 510 at any time in such fiscal year. 

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

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

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

12 sums as may be necessary may be transferred from 

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

16 and expenses with such fiscal year limitation. 

17 ‘‘(2) COLLECTIONS AND APPROPRIATION

18 ACTS.— 

19 ‘‘(A) IN GENERAL.—The fees authorized 

20 by this section— 

21 ‘‘(i) shall be retained in each fiscal 

22 year in an amount not to exceed the 

23 amount specified in appropriation Acts, or 

24 otherwise made available for obligation, for 

25 such fiscal year; and 


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1 ‘‘(ii) shall only be collected and avail2 able to defray increases in the costs of in3 specting establishments registered under 

4 subsection (b), (c), (d), or (i) of section 

5 510 to ensure compliance by such estab6 lishments with the requirements of this Act 

7 relating to drugs and devices (including in8 creases in such costs for an additional 

9 number of full-time equivalent positions in 

10 the Department of Health and Human 

11 Services to be engaged in such inspections) 

12 over such costs, excluding costs paid from 

13 fees collected under this section, for fiscal 

14 year 2009 multiplied by the adjustment 

15 factor. 

16 ‘‘(B) COMPLIANCE.—The Secretary shall 

17 be considered to have met the requirements of 

18 subparagraph (A)(ii) in any fiscal year if the 

19 costs funded by appropriations and allocated for 

20 inspections described in subsection (a)— 

21 ‘‘(i) are not more than 3 percent 

22 below the level specified in subparagraph 

23 (A)(ii); or 

24 ‘‘(ii)(I) are more than 3 percent below 

25 the level specified in subparagraph (A)(ii), 


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1 and fees assessed for the fiscal year fol2 lowing the subsequent fiscal year are de3 creased by the amount in excess of 3 per4 cent by which such costs fell below the 

5 level specified in such subparagraph; and 

6 ‘‘(II) such costs are not more than 5 

7 percent below the level specified in such 

8 subparagraph. 

9 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

10 For each of the fiscal years 2010 through 2014, 

11 there is authorized to be appropriated for fees under 

12 this section an amount equal to the total revenue 

13 amount determined under subsection (c)(1) for the 

14 fiscal year, as adjusted or otherwise affected under 

15 subsection (d) and paragraph (4) of this subsection. 

16 ‘‘(4) OFFSET.—If the sum of the cumulative 

17 amount of fees collected under this section for the 

18 fiscal years 2010 through 2013 and the amount of 

19 fees estimated to be collected under this section for 

20 fiscal year 2014 exceeds the cumulative amount ap21 propriated under paragraph (3) for the fiscal years 

22 2010 through 2014, the excess shall be credited to 

23 the appropriation account of the Food and Drug Ad24 ministration as provided in paragraph (1), and shall 

25 be subtracted from the amount of fees that would 


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1 otherwise be authorized to be collected under this 

2 section for fiscal year 2014. 

3 ‘‘(h) COLLECTION OF UNPAID FEES.—In any case 

4 where the Secretary does not receive payment of a fee as5 sessed under subsection (a) within 30 days after it is due, 

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

7 Government subject to subchapter II of chapter 37 of title 

8 31, United States Code. 

9 ‘‘(i) WRITTEN REQUESTS FOR WAIVERS, REDUC10 TIONS, AND REFUNDS.—To qualify for consideration for 

11 a waiver or reduction under subsection (e), or for a refund 

12 of any fee collected in accordance with subsection (a), a 

13 person shall submit to the Secretary a written request for 

14 such waiver, reduction, or refund not later than 180 days 

15 after such fee is due. 

16 ‘‘(j) CONSTRUCTION.—This section may not be con17 strued to require that the number of full-time equivalent 

18 positions in the Department of Health and Human Serv19 ices, for officers, employers, and advisory committees not 

20 engaged in inspections described in subsection (a), be re21 duced to offset the number of officers, employees, and ad22 visory committees so engaged. 

23 ‘‘(k) ANNUAL FISCAL REPORTS.—Beginning with fis24 cal year 2011, not later than 120 days after the end of 

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1 tion, the Secretary shall prepare and submit to the Com2 mittee on Energy and Commerce of the House of Rep3 resentatives and the Committee on Health, Education, 

4 Labor, and Pensions of the Senate a report on the imple5 mentation of the authority for such fees during such fiscal 

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

7 of the fees collected for such fiscal year. 

8 ‘‘(l) DEFINITION.—The term ‘costs of inspecting es9 tablishments registered under subsection (b), (c), (d), or 

10 (i) of section 510 to ensure compliance by such establish11 ments with the requirements of this Act relating to drugs 

12 and devices’ means the expenses incurred, in connection 

13 with inspecting establishments registered under subsection 

14 (b), (c), (d), or (i) of section 510 to ensure compliance 

15 by such establishments with the requirements of this Act 

16 relating to drugs and devices, for— 

17 ‘‘(1) officers and employees of the Food and 

18 Drug Administration, contractors of the Food and 

19 Drug Administration, and costs related to such offi20 cers and employees and to contracts with such con21 tractors; 

22 ‘‘(2) management of information, and the ac23 quisition, maintenance, and repair of information 

24 technology resources; 


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1 ‘‘(3) leasing, maintenance, renovation, and re2 pair of facilities and acquisition, maintenance, and 

3 repair of fixtures, furniture, scientific equipment, 

4 and other necessary materials and supplies; and 

5 ‘‘(4) collecting fees under this section and ac6 counting for resources allocated for such inspec7 tions.’’. 

8 (3) EFFECTIVE DATE.—The Secretary of 

9 Health and Human Services shall first impose the 

10 fee established under section 736C of the Federal 

11 Food, Drug, and Cosmetic Act, as added by para12 graph (2), for fiscal years beginning with fiscal year 

13 2010. 

14 (4) SUNSET DATE.—Section 736C of the Fed15 eral Food, Drug, and Cosmetic Act, as added by 

16 paragraph (2), does not authorize the assessment or 

17 collection of a fee for registration under section 510 

18 of such Act (21 U.S.C. 360) occurring after fiscal 

19 year 2014. 

20 SEC. 202. INSPECTION OF PRODUCERS OF DRUGS AND AC21 TIVE PHARMACEUTICAL INGREDIENTS. 

22 (a) INSPECTION.—Subsection (h) of section 510 (21 

23 U.S.C. 351) is amended— 

24 (1) by striking ‘‘(h)’’ and inserting ‘‘(h)(1)’’; 


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1 (2) by striking ‘‘Every establishment in any 

2 State registered with the Secretary pursuant to this 

3 section’’ and inserting ‘‘Every establishment reg4 istered with the Secretary pursuant to subsection 

5 (b), (c), (d), or (i)’’; 

6 (3) by striking ‘‘704(g), at least once’’ and all 

7 that follows and inserting the following: ‘‘704(g)— 

8 ‘‘(A) at least once in the 2-year period begin9 ning with the date of registration of such establish10 ment pursuant to this section and at least once in 

11 every successive 2-year period thereafter; or 

12 ‘‘(B) at least once in the 4-year period begin13 ning with the date of registration of such establish14 ment pursuant to this section and at least once in 

15 every successive 4-year period thereafter, if the Sec16 retary determines that sufficient information about 

17 the type of product produced in the establishment, 

18 inspection history, compliance history, and such ad19 ditional factors as the Secretary determines, by 

20 guidance, exists to assess risk and to establish a 

21 risk-based inspection schedule.’’; and 

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

23 ‘‘(2)(A) The Secretary shall conduct an inspection of 

24 a drug establishment when the establishment begins to 

25 manufacture, prepare, propagate, compound, or process a 


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1 drug or active pharmaceutical ingredient of a drug before 

2 its introduction into interstate commerce if the drug or 

3 ingredient is new or has undergone a major change requir4 ing prior approval by the Secretary of a supplement to 

5 an application submitted under section 505. Notwith6 standing the preceding sentence, the Secretary may opt 

7 against conducting such an inspection if the Secretary de8 termines, based on the inspection history of the establish9 ment, that such an inspection is not necessary to verify 

10 the data contained in the application (or supplement to 

11 the application) submitted under section 505, ensure com12 pliance with current good manufacturing practice, or oth13 erwise ensure the safety of the drug or ingredient. 

14 ‘‘(B) The Secretary shall annually submit a report 

15 to the Congress on each instance during the preceding 

16 year in which the Secretary determined under subpara17 graph (A) that an inspection was not necessary. 

18 ‘‘(3) The Secretary may, by regulation, provide for 

19 a risk-based inspection schedule for establishments en20 gaged in the manufacture, propagation, compounding, or 

21 processing of an excipient of a drug at a frequency dif22 ferent than the inspection schedule for an establishment 

23 under paragraph (1). 


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1 ‘‘(4) Nothing in this subsection shall be construed as 

2 limiting the authority of the Secretary to conduct inspec3 tions under any other provision of the Act. 

4 ‘‘(5) With respect to fiscal year 2010 and each subse5 quent fiscal year, the Secretary shall submit an annual 

6 report to the Congress on— 

7 ‘‘(A) funding dedicated to inspections under 

8 this subsection; and 

9 ‘‘(B) the number of establishments for which 

10 the frequency of such inspections has been modified 

11 pursuant to paragraph (1)(B). 

12 ‘‘(6) For purposes of determining inspection fre13 quency under subparagraphs (A) and (B) of paragraph 

14 (1), the Secretary shall establish information systems ca15 pacity sufficient to assess risk and shall develop and main16 tain a risk-based system for conducting surveillance of 

17 current good manufacturing practices by establishments 

18 registered with the Secretary pursuant to subsection (b), 

19 (c), (d), or (i). The Secretary shall have such capacity in 

20 place and begin implementation of such risk-based system 

21 not later than 3 years after the date of the enactment of 

22 the Food and Drug Administration Globalization Act of 

23 2009. Such risk-based system shall include consideration 

24 of the class of the establishment’s products and associated 

25 risks, the date the establishment was last inspected, the 


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1 establishment’s compliance and safety history, the estab2 lishment’s shipping volume and history, and such other 

3 factors as the Secretary determines relevant to assessing 

4 the risk presented by the establishment.’’. 

5 (b) GAO REPORT.—Not later than 3 years after the 

6 date of the enactment of this Act, the Comptroller General 

7 of the United States shall submit a report to the Congress 

8 on the risk-based process for conducting surveillance of 

9 current good manufacturing practices developed and im10 plemented under section 510(h)(6) of the Federal Food, 

11 Drug, and Cosmetic Act, as added by subsection (a)(4) 

12 of this section. 

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

14 this section shall apply to drugs introduced or delivered 

15 for introduction into interstate commerce on or after the 

16 date of the enactment of this Act. 

17 SEC. 203. DOCUMENTATION FOR ADMISSIBILITY OF DRUG 

18 IMPORTS. 

19 Section 801 (21 U.S.C. 381), as amended by section 

20 123, is further amended by adding at the end the fol21 lowing: 

22 ‘‘(q) Beginning 3 years after the date of the enact23 ment of this subsection, a drug shall not enter the United 

24 States unless the party offering the drug for import pro25 vides the Secretary, at the time of offering the drug for 


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1 import, information demonstrating compliance with appli2 cable requirements pertaining to identity, strength, qual3 ity, purity, approval, listing, labeling, registration, and 

4 such additional categories as the Secretary, by guidance, 

5 determines are necessary for protection of the public 

6 health. The Secretary may allow that such compliance be 

7 demonstrated through verification by an accredited third 

8 party or through such other means as determined, by 

9 guidance, by the Secretary.’’. 

10 SEC. 204. DRUG SUPPLY QUALITY AND SAFETY. 

11 (a) ADULTERATION.—Section 501 (21 U.S.C. 351) 

12 is amended by adding at the end the following: 

13 ‘‘(j) If it is drug that was manufactured, prepared, 

14 propagated, compounded, or processed by an establish15 ment that is or was at the time of such manufacture, prep16 aration, propagation, compounding, or processing in viola17 tion of section 505–2 because of— 

18 ‘‘(1) the failure to have in effect and implement 

19 a quality risk management plan in accordance with 

20 section 505–2; or 

21 ‘‘(2) the failure to transmit information in elec22 tronic form as requested by the Secretary under sec23 tion 505–2(f).’’. 


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1 (b) QUALITY RISK MANAGEMENT PLANS.—Chapter 

2 V (21 U.S.C. 351 et seq.) is amended by inserting after 

3 section 505–1 the following: 

4 ‘‘SEC. 505–2. DRUG SUPPLY QUALITY AND SAFETY. 

5 ‘‘(a) IMPLEMENTATION OF QUALITY RISK MANAGE6 MENT PLAN.—An establishment required to be registered 

7 with the Secretary pursuant to subsection (b), (c), (d), or 

8 (i) of section 510 for the manufacture, preparation, propa9 gation, compounding, or processing of a drug shall have 

10 in effect and implement an adequate quality risk manage11 ment plan that ensures the safety and quality of each such 

12 drug, including any ingredients produced, manufactured, 

13 processed, packed, or held by another person. 

14 ‘‘(b) PLAN PROVISIONS.—A quality risk management 

15 plan required by subsection (a) shall address risk assess16 ment, risk control, risk communication, and risk review 

17 and shall— 

18 ‘‘(1) provide for an assessment, prior to con19 tracting with a person to supply raw materials or in20 gredients or to undertake any aspect of the manu21 facturing of the drug, of the suitability and com22 petence of such person to carry out such activity, 

23 using audits, material evaluations, or qualification, 

24 as appropriate; 


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1 ‘‘(2) define responsibilities and communication 

2 processes for manufacturing, quality control, and 

3 quality assurance activities of any person referred to 

4 in paragraph (1); 

5 ‘‘(3) provide for the monitoring and review 

6 through periodic on-site audits of the facility condi7 tions, controls, and practices of any person referred 

8 to in paragraph (1) and ensure the implementation 

9 of appropriate measures to improve such conditions, 

10 controls, and practices; 

11 ‘‘(4) provide for the monitoring of incoming 

12 materials to ensure they are from a person that 

13 meets the requirements in paragraphs (1) through 

14 (3); 

15 ‘‘(5) provide for implementation of effective sys16 tems, including appropriate specifications and test 

17 methods and verification of the drug ingredients’ 

18 identity, quality, strength, and purity, to detect any 

19 hazard that has been, or is reasonably likely to be, 

20 present in or on the drug during production, manu21 facturing, processing, packing, holding, or trans22 porting; and 

23 ‘‘(6) be periodically reviewed and, as needed, 

24 updated. 


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1 ‘‘(c) ADDITIONAL PROVISIONS.—If the Secretary de2 termines that provisions in addition to those described in 

3 subsections (a) and (b) would be appropriate to include 

4 in a quality risk management plan for protection of the 

5 public health, including provisions for the prevention of 

6 intentional adulteration of a drug or class of drugs, the 

7 Secretary may by regulation require the inclusion of such 

8 provisions in a quality risk management plan. 

9 ‘‘(d) APPLICATION OF SPECIFICATIONS OR TEST

10 METHODS BY ORDER OF THE SECRETARY.—Upon a find11 ing that there is a significant threat to public health, the 

12 Secretary may order an establishment— 

13 ‘‘(1) to promptly revise its quality risk manage14 ment plan to include new or modified specifications 

15 or test methods for a drug; and 

16 ‘‘(2) to promptly implement such specifications 

17 or test methods. 

18 ‘‘(e) INSPECTION OF QUALITY RISK MANAGEMENT

19 PLAN.—The Secretary shall, in the course of an inspection 

20 of an establishment subject to this section or upon request 

21 by the Secretary, conduct a review of the establishment’s 

22 quality risk management plan. 

23 ‘‘(f) DOCUMENTATION OF SUPPLY CHAIN.— 

24 ‘‘(1) IN GENERAL.—Each establishment re25 quired to be registered with the Secretary pursuant 


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1 to subsection (b), (c), (d), or (i) of Section 510 for 

2 the manufacture, preparation, propagation, 

3 compounding, or processing of a drug, shall provide 

4 to the Secretary, upon request, adequate information 

5 transmitted in electronic form, establishing— 

6 ‘‘(A) where the drug, including its raw ma7 terials, were produced, including all preceding 

8 producers, manufacturers, distributors, and 

9 shippers; and 

10 ‘‘(B) that the drug, its ingredients and raw 

11 materials were manufactured, prepared, propa12 gated, compounded, processed, distributed, 

13 shipped, warehoused, brokered, imported, and 

14 conveyed under conditions that ensure the iden15 tity, strength, quality, and purity of the drug. 

16 ‘‘(2) REPACKAGERS.—For those establishments 

17 that are repackagers, paragraph (1)(A) requires only 

18 information regarding the immediately preceding es19 tablishment.’’. 

20 (c) EFFECTIVE DATE.— 

21 (1) IN GENERAL.—The requirements of sections 

22 501(j) and 505–2 of the Federal Food, Drug, and 

23 Cosmetic Act, as added by subsections (a) and (b), 

24 take effect 2 years after the date of the enactment 

25 of this Act. 


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1 (2) EXCEPTION.—Notwithstanding the effective 

2 date specified in paragraph (1)— 

3 (A) the authority of the Secretary to order 

4 an establishment to promptly implement new or 

5 modified specifications or test methods for a 

6 drug, as described in section 505–2(d)(2) of the 

7 Federal Food, Drug, and Cosmetic Act, as 

8 amended by subsection (b), shall take effect on 

9 the date of the enactment of this Act; 

10 (B) such authority shall apply irrespective 

11 of whether the establishment has in effect a 

12 quality risk management plan; and 

13 (C) a civil penalty under section 303(f)(5) 

14 of the Federal Food, Drug, and Cosmetic Act, 

15 as added by section 211 of this Act, shall apply 

16 to a violation of an order under this paragraph 

17 to the same extent and in the same manner as 

18 such a penalty applies to a violation of an order 

19 under such section 505–2(d)(2). 

20 SEC. 205. DELAY, LIMITATION, OR DENIAL OF INSPECTION. 

21 (a) REQUIREMENT.—Subsection (h) of section 510 

22 (21 U.S.C. 351), as amended by section 202(a), is further 

23 amended by adding at the end the following: 

24 ‘‘(7) The person who owns or operates an establish25 ment registered with the Secretary pursuant to subsection 


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1 (b), (c), (d), or (i), any agent or employee of such person, 

2 and any agent of a governmental authority in the foreign 

3 country within which such establishment is located shall 

4 not delay or limit an inspection, or refuse to permit entry 

5 or inspection, authorized by this subsection.’’. 

6 (b) REFERENCE TO PROHIBITED ACT.—For provi7 sion making delay, limiting, or denying an inspection 

8 under section 510(h) of the Federal Food, Drug, and Cos9 metic Act a prohibited act under section 301(f) of such 

10 Act, see the amendment made by section 403. 

11 (c) DRUGS OFFERED FOR IMPORT.—The third sen12 tence of subsection (a) of section 801 (21 U.S.C. 381), 

13 as amended by section 105(b), is amended by inserting 

14 ‘‘or (5) such article has been manufactured, prepared, 

15 propagated, compounded, or processed by an establish16 ment required to be registered with the Secretary pursu17 ant to subsection (b), (c), (d), or (i) of section 510 and 

18 such establishment is in violation of section 510(h)(7) 

19 (prohibiting the delay, limitation, or denial of an inspec20 tion under section 510(h)),’’ before ‘‘then such article 

21 shall be refused admission’’. 

22 SEC. 206. COUNTRY OF ORIGIN LABELING. 

23 (a) MISBRANDING.—Section 502 (21 U.S.C. 352) is 

24 amended by adding at the end the following: 


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1 ‘‘(aa) If it is a drug and the website of the manufac2 turer of the drug does not list the country of origin for 

3 each active pharmaceutical ingredient and finished dosage 

4 form of such drug.’’. 

5 (b) REGULATIONS.—Not later than 1 year after the 

6 date of the enactment of this Act, the Secretary shall pro7 mulgate final regulations to carry out section 502(aa) of 

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

9 subsection (a). 

10 (c) EFFECTIVE DATE.—The requirement of section 

11 502(aa) of the Federal Food, Drug, and Cosmetic Act, 

12 as added by subsection (a), takes effect 2 years after the 

13 date of the enactment of this Act. 

14 SEC. 207. NONDISTRIBUTION AND RECALL OF ADULTER15 ATED OR MISBRANDED DRUGS. 

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

17 331), as amended by sections 102, 104, and 112 of this 

18 Act, is amended by adding at the end the following: 

19 ‘‘(rr) The failure to comply with— 

20 ‘‘(1) an order issued under section 568(a) fol21 lowing any hearing requested under section 568(b); 

22 or 

23 ‘‘(2) an amended order issued under section 

24 568(c)(1).’’. 


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1 (b) NONDISTRIBUTION AND RECALL OF ADULTER2 ATED OR MISBRANDED DRUGS.—Subchapter E of chapter 

3 V (21 U.S.C. 360bb et seq.) is amended by adding at the 

4 end the following: 

5 ‘‘SEC. 568. NONDISTRIBUTION AND RECALL OF ADULTER6 ATED OR MISBRANDED DRUGS. 

7 ‘‘(a) RECALL AND CONSUMER NOTIFICATION.— 

8 ‘‘(1) VOLUNTARY ACTIONS.—On receiving infor9 mation of a suspected adulteration or misbranding 

10 of a drug, if the Secretary finds that there is a rea11 sonable probability that a drug intended for human 

12 use would cause serious, adverse health con13 sequences or death, the Secretary shall provide all 

14 persons (including the manufacturer, importer, dis15 tributor, or retailer of the drug) with an opportunity 

16 (as determined by the Secretary)— 

17 ‘‘(A) to cease distribution of the drug; 

18 ‘‘(B) to notify all entities— 

19 ‘‘(i) that produce, manufacture, pack, 

20 process, prepare, treat, package, distribute, 

21 or hold the drug, to cease immediately 

22 those activities with respect to the drug; or 

23 ‘‘(ii) to which the drug has been dis24 tributed, transported, or sold, to cease im25 mediately distribution of the drug; 


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1 ‘‘(C) to recall the drug; 

2 ‘‘(D) in consultation with the Secretary, to 

3 provide notice of the finding of the Secretary to 

4 all consumers to which the drug was, or may 

5 have been, distributed and to appropriate State 

6 and local health officials; and 

7 ‘‘(E) to notify State and local public health 

8 officials. 

9 ‘‘(2) MANDATORY ACTIONS.—If a person re10 ferred to in paragraph (1) does not carry out the ac11 tions described in that paragraph with respect to a 

12 drug within the time period and in the manner pre13 scribed by the Secretary, the Secretary shall issue an 

14 order requiring such person— 

15 ‘‘(A) to immediately cease distribution of 

16 the drug; and 

17 ‘‘(B) to immediately notify health profes18 sionals and drug user facilities of the order and 

19 to instruct such professionals and facilities to 

20 cease use of such drug. 

21 ‘‘(b) HEARINGS ON ORDERS.—The Secretary shall 

22 provide a person subject to an order under subsection 

23 (a)(2) with an opportunity for an informal hearing, to be 

24 held not later than 10 days after the date of the issuance 

25 of the order, on— 


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1 ‘‘(1) the actions required by the order; and 

2 ‘‘(2) any reasons why the drug that is the sub3 ject of the order should not be recalled. 

4 ‘‘(c) POST-HEARING RECALL ORDERS.— 

5 ‘‘(1) AMENDMENT OF ORDERS.—If, after pro6 viding an opportunity for an informal hearing under 

7 subsection (b), the Secretary determines that an 

8 order under subsection (a)(2) with respect to a drug 

9 should be amended to include a recall or other ap10 propriate action, the Secretary shall, except as pro11 vided in paragraph (2)— 

12 ‘‘(A) amend the order— 

13 ‘‘(i) to require recall of the drug or 

14 other appropriate action; and 

15 ‘‘(ii) to specify a timetable during 

16 which any such recall shall occur; and 

17 ‘‘(B) require periodic reports to the Sec18 retary describing the progress of any such re19 call. 

20 ‘‘(2) CONTENTS OF ORDER.— 

21 ‘‘(A) INDIVIDUALS AND DRUG USER FA22 CILITIES.—An amended order under paragraph 

23 (1) shall not include— 

24 ‘‘(i) a recall of a drug from individ25 uals; or 


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1 ‘‘(ii) a recall of a drug from drug user 

2 facilities if the Secretary determines that 

3 the risk of recalling such drug from the fa4 cilities presents a greater health risk than 

5 the health risk of not recalling the drug 

6 from use. 

7 ‘‘(B) NOTICE TO INDIVIDUALS SUBJECT TO

8 RISKS.—An amended order under paragraph 

9 (1) shall provide for notice to individuals sub10 ject to the risks associated with the use of such 

11 drug. In providing the notice required by this 

12 paragraph, the Secretary may use the assist13 ance of health professionals who prescribed or 

14 dispensed such a drug for individuals. If a sig15 nificant number of such individuals cannot be 

16 identified, the Secretary shall notify such indi17 viduals pursuant to section 705(b). 

18 ‘‘(3) VACATION OF ORDERS.—If, after providing 

19 an opportunity for an informal hearing under sub20 section (b), the Secretary determines that adequate 

21 grounds do not exist to continue the actions required 

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

23 ‘‘(d) REMEDIES NOT EXCLUSIVE.—The remedies au24 thorized by this section shall be in addition to any other 

25 remedies that may be available.’’. 


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1 SEC. 208. DESTRUCTION OF ADULTERATED, MISBRANDED 

2 OR COUNTERFEIT ARTICLES OFFERED FOR 

3 IMPORT. 

4 (a) IN GENERAL.—The fifth sentence of subsection 

5 (a) of section 801 (21 U.S.C. 381), as amended by sec6 tions 105(b) and 205(c), is further amended by inserting 

7 before the period at the end of the following: ‘‘, except 

8 that any article that is refused admission may, at the dis9 cretion of the Secretary, be promptly (subject to the next 

10 sentence) destroyed and not exported if it appears to pose 

11 a risk of injury or death’’. 

12 (b) NOTICE.—Subsection (a) of section 801 (21 

13 U.S.C. 381), as amended by sections 105(b) and 205(c) 

14 and subsection (a) of this section, is amended by inserting 

15 after the fifth sentence the following: ‘‘Before causing the 

16 destruction of an article with a value greater than $2,000 

17 under the preceding sentence, the Secretary shall provide 

18 notice and an opportunity for an informal hearing to the 

19 owner or consignee.’’. 

20 (c) IMPROPER DESTRUCTION.—Section 801 (21 

21 U.S.C. 381), as amended by sections 123 and 203, is 

22 amended by adding at the end the following: 

23 ‘‘(r) Any person claiming any article which has been 

24 destroyed under subsection (a) may, at any time within 

25 3 months after the date of destruction, apply to the Sec26 retary for reimbursement of the value of the article as deVerDate Nov 24 2008 03:16 Jan 30, 2009 Jkt 079200 PO 00000 Frm 00106 Fmt 6652 Sfmt 6201 E:\BILLS\H759.IH H759

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1 termined by the Secretary. Upon the production of satis2 factory proof that the destruction of the article was not 

3 within the authority of the Secretary as provided in this 

4 section, the Secretary shall order the value of the article 

5 restored to the applicant.’’. 

6 (d) SAMPLES OF DESTROYED ARTICLES.—Section 

7 801 (21 U.S.C. 381), as amended by sections 123 and 

8 203 and subsection (c) of this section, is amended by add9 ing at the end the following: 

10 ‘‘(s) Where an article is caused to be destroyed under 

11 subsection (a) the Secretary shall, upon request, provide 

12 a sample of the article to the owner of the article, the 

13 owner’s attorney or agent, or if applicable any person 

14 named on the label of the article, except that the Secretary 

15 is authorized, by regulations, to make such reasonable ex16 ceptions from, and impose such reasonable terms and con17 ditions relating to, the operation of this subsection as the 

18 Secretary finds necessary for the proper administration of 

19 the provisions of this Act.’’. 

20 (e) EFFECTIVE DATE.—The amendments made by 

21 subsections (a), (b), (c), and (d) shall take effect 90 days 

22 after the date of the enactment of this Act. 


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1 SEC. 209. ADMINISTRATIVE DETENTION OF DRUGS THAT 

2 APPEAR TO VIOLATE THE LAW. 

3 (a) IN GENERAL.—Section 304(g) (21 U.S.C. 

4 334(g)) is amended— 

5 (1) by inserting ‘‘drug or’’ before ‘‘device’’ each 

6 place it appears; and 

7 (2) in paragraph (1), by inserting after ‘‘adul8 terated or misbranded’’ the following: ‘‘or, in the 

9 case of a drug, which in the determination of the of10 ficer or employee making the inspection appears to 

11 be in violation of section 505,’’. 

12 (b) EFFECTIVE DATE.—The amendments made by 

13 subsection (a) shall take effect on a date, specified by the 

14 Secretary of Health and Human Services, not later than 

15 1 year after the date of the enactment of this Act. 

16 SEC. 210. PENALTIES REGARDING COUNTERFEIT DRUGS. 

17 Section 303(a) (21 U.S.C. 333(a)) is amended by 

18 adding at the end the following paragraph: 

19 ‘‘(3) Notwithstanding paragraph (1) or (2), any per20 son who engages in any conduct described in section 

21 301(i)(2) knowing that the conduct concerns the rendering 

22 of a drug as a counterfeit drug, or who engages in conduct 

23 described in section 301(i)(3) knowing that the conduct 

24 will cause a drug to be a counterfeit drug or knowing that 

25 a drug held, sold, or dispensed is a counterfeit drug, shall 

26 be fined in accordance with title 18, United States Code, 


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1 or imprisoned not more than 20 years, or both, except that 

2 if the use of the counterfeit drug by a consumer is the 

3 proximate cause of the death of the consumer, the term 

4 of imprisonment shall be any term of years or for life.’’. 

5 SEC. 211. CIVIL MONEY PENALTIES FOR VIOLATIVE DRUGS 

6 AND DEVICES AND IMPROPER IMPORT 

7 ENTRY FILINGS. 

8 (a) IN GENERAL.—Section 303(f) (21 U.S.C. 333) 

9 is amended— 

10 (1) by redesignating paragraphs (5), (6), and 

11 (7) as paragraphs (6), (7), and (8), respectively; 

12 (2) by inserting after paragraph (4) the fol13 lowing: 

14 ‘‘(5)(A)(i) Any person that violates a require15 ment of this Act that relates to drugs for human use 

16 (except a requirement referred to in paragraph (4) 

17 or subsection (g)) shall be liable to the United 

18 States for a civil penalty not to exceed— 

19 ‘‘(I) $100,000 for an initial violation 

20 of such a requirement; or 

21 ‘‘(II) $200,000 for a subsequent viola22 tion of the same requirement. 

23 ‘‘(ii) In clause (i)(I), the term ‘initial violation’ 

24 means the first violation by a person of a require25 ment described in clause (i) that occurs on or after 


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1 the date of the enactment of the Food and Drug Ad2 ministration Globalization Act of 2009. 

3 ‘‘(iii) Each day during which a violation con4 tinues shall be considered a separate violation under 

5 clause (i), except that a continuing initial violation 

6 shall not be treated as a subsequent violation for 

7 purposes of clause (i)(II). 

8 ‘‘(B)(i) Any person that knowingly reports or 

9 enters false or misleading data on documents related 

10 to the importation of a drug shall be liable to the 

11 United States for a civil penalty not to exceed 

12 $200,000. 

13 ‘‘(ii) Each act of reporting or entering false 

14 data shall be considered a separate violation under 

15 clause (i). 

16 ‘‘(C) Any manufacturer, importer, distributer, 

17 or retailer who fails to comply with an order or an 

18 amended order issued under section 568(a) or 

19 568(c)(1), respectively, shall be liable to the United 

20 States for a civil penalty not to exceed $250,000 per 

21 day.’’. 

22 (3) in paragraph (6), as so redesignated, by 

23 striking ‘‘, or (4)’’ each place it appears and insert24 ing ‘‘(4), or (5)’’; 


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1 (4) in paragraph (7), as so redesignated, by 

2 striking ‘‘(5)(A)’’ and inserting ‘‘(6)(A)’’; and 

3 (5) in paragraph (8), as so redesignated, by 

4 striking ‘‘paragraph (6)’’ each place it appears and 

5 inserting ‘‘paragraph (7)’’. 

6 (b) APPLICABILITY.—Section 303(f)(5) (as amended 

7 by subsection (a)), shall apply to violations described in 

8 such section that occur after the date of the enactment 

9 of this Act. 

10 SEC. 212. HUMAN GENERIC DRUG APPLICATION AND SUP11 PLEMENT FEES TO COVER PRE-APPROVAL 

12 INSPECTION COSTS. 

13 (a) SENSE OF CONGRESS.—It is the sense of the Con14 gress that the amount of additional revenues generated 

15 from fees under this section should be used to support pre16 approval inspections of generic drug establishments, in ac17 cordance with performance goals to be developed by the 

18 Secretary of Health and Human Services in consultation 

19 with the entities listed in subparagraphs (A) through (F) 

20 of section 736B(d)(1) of the Federal Food, Drug, and 

21 Cosmetic Act (21 U.S.C. 379h–2(d)(1)). 

22 (b) FEE.— 

23 (1) MISBRANDING.—Paragraph (o) of section 

24 502 (21 U.S.C. 352), as amended by subsections (a) 


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1 and (b) of section 501, is further amended by strik2 ing ‘‘736C’’ and inserting ‘‘736C or 736D’’. 

3 (2) ESTABLISHMENT.—Part 2 of subchapter C 

4 of chapter VII (21 U.S.C. 379g et seq.), as amended 

5 by section 201(b), is amended by adding at the end 

6 the following: 

7 ‘‘SEC. 736D. HUMAN GENERIC DRUG APPLICATION AND 

8 SUPPLEMENT FEES TO COVER PRE-AP9 PROVAL INSPECTION COSTS. 

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

11 collect a fee upon submission of any human generic drug 

12 application or supplement to defray increases (as de13 scribed in subsection (c)(2)(B)) in the costs of resources 

14 allocated for conducting inspections in connection with the 

15 review of human generic drug applications and supple16 ments. 

17 ‘‘(b) FEE REVENUE AMOUNTS.—For each of fiscal 

18 years 2010 through 2014, fees under subsection (a) shall 

19 be established, subject to the provisions referred to in sub20 section (d), to generate a total revenue amount. 

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

22 ‘‘(1) IN GENERAL.—Fees authorized under sub23 section (a) shall be collected and available for obliga24 tion only to the extent and in the amount provided 

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1 thorized to remain available until expended. Such 

2 sums as may be necessary may be transferred from 

3 the Food and Drug Administration salaries and ex4 penses appropriation account without fiscal year lim5 itation to such appropriation account for salaries 

6 and expenses with such fiscal year limitation. 

7 ‘‘(2) COLLECTIONS AND APPROPRIATION

8 ACTS.—The fees authorized by this section— 

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

10 an amount not to exceed the amount specified 

11 in appropriation Acts, or otherwise made avail12 able for obligation, for such fiscal year; and 

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

14 to defray increases in the costs of resources al15 located for conducting inspections in connection 

16 with the review of human generic drug applica17 tions and supplements (including increases in 

18 such costs for an additional number of full-time 

19 equivalent positions in the Department of 

20 Health and Human Services to be engaged in 

21 such review) over such costs, excluding costs 

22 paid from fees collected under this section, for 

23 fiscal year 2009 multiplied by the adjustment 

24 factor. 


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1 ‘‘(d) APPLICABILITY OF CERTAIN PROVISIONS.—To 

2 the extent determined by the Secretary to be consistent 

3 with this section, the provisions of section 736 apply with 

4 respect to human generic drug application fees and sup5 plement fees under this section to the same extent and 

6 in the same manner as such provisions apply with respect 

7 to human drug application fees and supplement fees under 

8 section 736. 

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

10 ‘‘(1) The term ‘costs of resources allocated for 

11 conducting inspections in connection with the review 

12 of human generic drug applications and supple13 ments’ means the expenses that are— 

14 ‘‘(A) incurred in connection with inspec15 tions undertaken as part of the Secretary’s re16 view of pending human generic drug applica17 tions and supplements; and 

18 ‘‘(B) described in subparagraphs (A) 

19 through (D) of section 735(7), except that the 

20 reference in section 735(7)(D) to section 736 is 

21 deemed to be a reference to this section, and 

22 the reference is section 735(7)(D) to human 

23 drug applications and supplements (as defined 

24 in section 735(2)) is deemed to be a reference 


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1 to human generic drug applications and supple2 ments (as defined in this section). 

3 ‘‘(2) The term ‘human generic drug application’ 

4 means an application for approval of a new drug 

5 submitted under section 505(j). Such term does not 

6 include an application or a supplement to an appli7 cation described in section 735(1). 

8 ‘‘(3) Notwithstanding section 735(2), the term 

9 ‘supplement’ means a request to the Secretary to ap10 prove a change in a human generic drug application 

11 which has been approved.’’. 

12 (3) EFFECTIVE DATE.—The Secretary of 

13 Health and Human Services shall first impose the 

14 fee established under section 736D of the Federal 

15 Food, Drug, and Cosmetic Act, as added by para16 graph (2), for fiscal years beginning with fiscal year 

17 2010. 

18 (4) SUNSET DATE.—Section 736D, as added by 

19 paragraph (2), does not authorize the assessment or 

20 collection of a fee for submission of an application 

21 or supplement under section 505(j) of such Act (21 

22 U.S.C. 355(j)) occurring after fiscal year 2014. 


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1 TITLE III—COSMETIC SAFETY 

2 SEC. 301. REGISTRATION OF COSMETIC ESTABLISHMENTS. 

3 (a) MISBRANDING.—Section 602 is amended by add4 ing at the end the following: 

5 ‘‘(g) If it was manufactured or packaged in an estab6 lishment that is not duly registered under section 604.’’. 

7 (b) ANNUAL REGISTRATION.—Chapter VI is amend8 ed by adding at the end the following: 

9 ‘‘SEC. 604. REGISTRATION OF COSMETIC ESTABLISHMENTS. 

10 ‘‘(a) REGISTRATION.— 

11 ‘‘(1) IN GENERAL.—The Secretary shall by reg12 ulation require that any establishment engaged in 

13 manufacturing or packaging cosmetics for use in the 

14 United States be registered annually with the Sec15 retary. To be registered— 

16 ‘‘(A) for a domestic establishment, the 

17 owner, operator, or agent in charge of the es18 tablishment shall submit a registration to the 

19 Secretary; and 

20 ‘‘(B) for a foreign establishment, the 

21 owner, operator, or agent in charge of the es22 tablishment shall submit a registration to the 

23 Secretary and shall include with the registration 

24 the name of the United States agent for the es25 tablishment. 


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1 ‘‘(2) REGISTRATION.—An entity (referred to in 

2 this section as the ‘registrant’) shall submit a reg3 istration under paragraph (1) to the Secretary con4 taining information necessary to notify the Secretary 

5 of the name and address of each establishment at 

6 which, and all trade names under which, the reg7 istrant manufactures or packages cosmetics. The 

8 registrant shall notify the Secretary in a timely man9 ner of changes to such information. The registrant 

10 shall notify the Secretary of any change in the prod11 ucts, function, or legal status of each such establish12 ment (including cessation of business activities) not 

13 later than 30 days after the date of such change. 

14 ‘‘(3) PROCEDURE.—Upon receipt of a com15 pleted registration described in paragraph (1), the 

16 Secretary shall notify the registrant of the receipt of 

17 such registration and assign a registration number 

18 to each registered establishment. 

19 ‘‘(4) LIST.—The Secretary shall compile and 

20 maintain an up-to-date list of establishments that 

21 are registered under this section. The Secretary shall 

22 remove from such list the name of any establishment 

23 that fails to reregister in accordance with this sec24 tion and shall treat such removal as a suspension of 

25 the establishment’s registration. Such list and any 


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1 registration documents submitted pursuant to this 

2 subsection shall not be subject to disclosure under 

3 section 552 of title 5, United States Code. Informa4 tion derived from such list or registration documents 

5 shall not be subject to disclosure under section 552 

6 of title 5, United States Code, to the extent that 

7 such information discloses the identity or location of 

8 a specific registered person. 

9 ‘‘(b) ESTABLISHMENT.—For purposes of this section: 

10 ‘‘(1) The term ‘domestic establishment’ means 

11 an establishment located in any State (as defined in 

12 section 201). 

13 ‘‘(2)(A) The term ‘foreign establishment’ means 

14 an establishment that manufactures or packages cos15 metics that are exported to the United States with16 out further processing or packaging outside the 

17 United States. 

18 ‘‘(B) A cosmetic may not be considered to have 

19 undergone further processing or packaging for pur20 poses of subparagraph (A) solely on the basis that 

21 labeling was added or that any similar activity of a 

22 de minimis nature was carried out with respect to 

23 the cosmetic.’’. 


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1 SEC. 302. COSMETIC AND INGREDIENT STATEMENTS. 

2 (a) MISBRANDING.—Section 602, as amended by sec3 tion 301 of this Act, is amended by adding at the end 

4 the following: 

5 ‘‘(h) If its manufacturer is in violation of section 605 

6 for failure to submit a cosmetic and ingredient statement 

7 with respect to the cosmetic.’’. 

8 (b) STATEMENTS.—Chapter VI, as amended by sec9 tion 301 of this Act, is amended by adding at the end 

10 the following: 

11 ‘‘SEC. 605. COSMETIC AND INGREDIENT STATEMENTS. 

12 ‘‘(a) IN GENERAL.—The Secretary shall require by 

13 regulation that every establishment engaged in the manu14 facture of a cosmetic intended to be marketed in the 

15 United States submit to the Secretary for each cosmetic 

16 manufactured in the establishment, within 60 days after 

17 beginning manufacture of the product, a cosmetic and in18 gredient statement containing— 

19 ‘‘(1) the registration number of the manufac20 turing establishment where the cosmetic is manufac21 tured or, if the same cosmetic is manufactured in 

22 more than one establishment, the registration num23 ber of each establishment where it is manufactured; 

24 ‘‘(2) the brand name or names for the cosmetic; 

25 ‘‘(3) the applicable cosmetic category or cat26 egories for the cosmetic; 


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1 ‘‘(4) the ingredients in the cosmetic in descend2 ing order of predominance by weight, except that— 

3 ‘‘(A) flavors and fragrances may be des4 ignated as such; and 

5 ‘‘(B) all variations in color, flavor, or fra6 grance may be included in one statement; and 

7 ‘‘(5) the title and full contact information for 

8 the individual or individuals responsible for submit9 ting and maintaining the statement. 

10 The registrant shall notify the Secretary in a timely man11 ner of any change to the information required to be in 

12 such statement. 

13 ‘‘(b) PROCEDURE.—Upon receipt of a completed cos14 metic and ingredient statement described in paragraph 

15 (a), the Secretary shall notify the registrant of the receipt 

16 of such statement and assign a cosmetic and ingredient 

17 statement number. 

18 ‘‘(c) LIST.—The Secretary shall compile and main19 tain an up-to-date list of cosmetics and ingredients for 

20 which statements are submitted under this section.’’. 

21 SEC. 303. SERIOUS AND UNEXPECTED ADVERSE EVENT RE22 PORTS FOR COSMETICS. 

23 (a) PROHIBITED ACTS.—Section 301 is amended— 

24 (1) in paragraph (e), by striking ‘‘or 761’’ each 

25 place it appears and inserting ‘‘761, or 762’’; and 


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1 (2) in paragraph (ii)— 

2 (A) by striking ‘‘or the’’ and inserting ‘‘, 

3 the’’; and 

4 (B) by striking the period at the end and 

5 inserting ‘‘, or the falsification of a report sub6 mitted under section 762 to the Secretary.’’. 

7 (b) ADVERSE EVENT REPORTING.—Subchapter H of 

8 chapter VII is amended by adding at the end the following: 

9 ‘‘SEC. 762. SERIOUS AND UNEXPECTED ADVERSE EVENT RE10 PORTS FOR COSMETICS. 

11 ‘‘(a) IN GENERAL.—The Secretary shall require by 

12 regulation that the manufacturer, packager, or distributor 

13 whose name appears on the label of a cosmetic marketed 

14 in the United States pursuant to section 602(b)(1) submit 

15 to the Secretary under subsection (b) a report containing 

16 information received concerning any serious and unex17 pected adverse event in the United States associated with 

18 the use of the cosmetic. 

19 ‘‘(b) SUBMISSION OF REPORTS.— 

20 ‘‘(1) IN GENERAL.—A report under subsection 

21 (a) shall be submitted to the Secretary no later than 

22 15 business days after information concerning the 

23 adverse event is received at the place of business la24 beled on the cosmetic under section 602(b)(1). 


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1 ‘‘(2) CONTENTS.—A report under subsection 

2 (a) shall include the following information, to the ex3 tent to which the person submitting the report has 

4 been able to verify the information— 

5 ‘‘(A) an identifiable patient; 

6 ‘‘(B) an identifiable reporter; 

7 ‘‘(C) a suspect cosmetic; and 

8 ‘‘(D) a serious and unexpected adverse 

9 event. 

10 ‘‘(3) ADDITIONAL INFORMATION.—The person 

11 submitting a report under subsection (a) may in12 clude in the submission any additional pertinent in13 formation and may supplement the report with addi14 tional information at a later time. 

15 ‘‘(c) RELATION TO OTHER PROVISIONS.—A report 

16 under subsection (a) (including all information submitted 

17 in the initial report or added later) shall be considered 

18 to be— 

19 ‘‘(1) a safety report under section 756; 

20 ‘‘(2) a record about an individual under section 

21 552a of title 5, United States Code; and 

22 ‘‘(3) a medical or similar file the disclosure of 

23 which would constitute a violation of section 

24 552(b)(6) of such title 5, United States Codes, and 

25 shall not be disclosed under section 552 of such title. 


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1 ‘‘(d) DEFINITIONS.—In this section: 

2 ‘‘(1) The term ‘serious’, with respect to an ad3 verse event, means— 

4 ‘‘(A) resulting in— 

5 ‘‘(i) death; 

6 ‘‘(ii) a life-threatening experience; 

7 ‘‘(iii) inpatient hospitalization; 

8 ‘‘(iv) a persistent and significant dis9 ability or incapacity; or 

10 ‘‘(v) a congenital anomaly or birth de11 fect; or 

12 ‘‘(B) requiring, based on reasonable med13 ical judgment, a medical or surgical interven14 tion to prevent an outcome described in sub15 paragraph (A). 

16 ‘‘(2) The term ‘unexpected’, with respect to an 

17 adverse event, means not identified in the current la18 beling for the cosmetic.’’. 

19 SEC. 304. GOOD MANUFACTURING PRACTICES FOR COS20 METICS. 

21 Section 601 is amended by adding at the end the fol22 lowing: 

23 ‘‘(f) If the methods used in, or the facilities or con24 trols used for, its manufacture, processing, packaging, 

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1 facturing practice, as prescribed by the Secretary in regu2 lations, to ensure that the cosmetic is safe and otherwise 

3 in compliance with this Act.’’. 

4 SEC. 305. AUTHORIZATION OF APPROPRIATIONS. 

5 Chapter VI, as amended by sections 301 and 302, 

6 is amended by adding at the end the following: 

7 ‘‘SEC. 606. AUTHORIZATION OF APPROPRIATIONS. 

8 ‘‘To carry out this chapter and section 762, there is 

9 authorized to be appropriated $10,000,000 for each of fis10 cal years 2010 through 2014.’’. 

11 SEC. 306. EFFECTIVE DATE. 

12 The amendments made by sections 301, 302, 303, 

13 and 304 shall take effect 18 months after the date of the 

14 enactment of this Act. 

15 TITLE IV—MISCELLANEOUS 

16 SEC. 401. REGISTRATION FOR COMMERCIAL IMPORTERS 

17 OF FOOD, DRUGS, DEVICES, AND COSMETICS; 

18 FEE. 

19 (a) PROHIBITIONS.—Section 301 (21 U.S.C. 331), as 

20 amended by sections 102, 104, 112, and 207, is amended 

21 by adding at the end the following: 

22 ‘‘(ss) The importation of food, drugs, devices, or cos23 metics other than only for personal use by an importer 

24 that is not registered with respect to such food, drugs, 

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1 spectively, unless the importer is registered under section 

2 801(t).’’. 

3 (b) REGISTRATION.—Section 801, as amended by 

4 sections 123, 203, and 208, is amended by adding at the 

5 end the following: 

6 ‘‘(t) The Secretary shall by regulation require that 

7 an importer of food, drugs, devices, or cosmetics, other 

8 than only for personal use, that is not required to be reg9 istered with respect to such food, drugs, devices, or cos10 metics under section 415, 510, or 604, respectively, shall 

11 be registered with the Secretary in a form and manner 

12 specified by the Secretary. The Secretary shall assign a 

13 unique identification number to each importer so reg14 istered.’’. 

15 (c) FEE.—Subchapter C of chapter VII (21 U.S.C. 

16 379f et seq.) is amended by adding at the end the fol17 lowing: 

18 ‘‘PART 6—IMPORTERS OF FOOD, DRUGS, AND 

19 DEVICES 

20 ‘‘SEC. 742. IMPORTERS OF FOOD, DRUGS, AND DEVICES. 

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

22 collect an annual fee for the registration of an importer 

23 of food, drugs, or devices under section 801(t). 

24 ‘‘(b) AMOUNT OF FEE.—The amount of the fee under 

25 this section shall be $10,000. 


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1 ‘‘(c) RULE OF CONSTRUCTION.—This section shall 

2 not be construed to authorize the assessment or collection 

3 of any fee from an importer of food, drugs, or devices if, 

4 with respect to such food, drugs, or devices, the importer 

5 is registered under section 415 or 510 and required to 

6 pay a fee under section 736C or 741.’’. 

7 (d) EFFECTIVE DATE.— 

8 (1) REGISTRATION.—Not later than 1 year 

9 after the date of the enactment of this Act, the Sec10 retary of Health and Human Services shall establish 

11 procedures for the registration of importers under 

12 section 801(t) of the Federal Food, Drug, and Cos13 metic Act, as added by subsection (a). 

14 (2) REGISTRATION.—The amendments made by 

15 this section shall first apply not later than 1 year 

16 after the date of the enactment of this Act. 

17 SEC. 402. UNIQUE IDENTIFICATION NUMBER FOR FOOD, 

18 DRUG, AND DEVICE FACILITIES AND ESTAB19 LISHMENTS. 

20 (a) FOOD AND COSMETICS.—Section 415(a)(3) (21 

21 U.S.C. 350d(a)(3)) is amended by inserting ‘‘unique’’ be22 fore ‘‘registration number’’. 

23 (b) DRUGS AND DEVICES.—Section 510(e) (21 

24 U.S.C. 360(e)) is amended by adding after the first sen25 tence the following: ‘‘The registration number shall be the 


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1 unique identification number for each such establish2 ment.’’. 

3 (c) EFFECTIVE DATE.—The Secretary of Health and 

4 Human Services shall implement the amendments made 

5 by this section not later than 1 year after the date of the 

6 enactment of this Act. 

7 SEC. 403. PROHIBITION AGAINST DELAYING OR LIMITING 

8 INSPECTION. 

9 Section 301(f) (21 U.S.C. 331(e)) is amended to read 

10 as follows: 

11 ‘‘(f) The delay or limitation of an inspection, or the 

12 refusal to permit entry or inspection, as authorized by sec13 tion 510(h) or 704, including any such delay, limitation, 

14 or refusal by an agent of a governmental authority in a 

15 foreign country.’’. 

16 SEC. 404. DEDICATED FOREIGN INSPECTORATE. 

17 Section 704 (21 U.S.C. 374) is amended by adding 

18 at the end the following: 

19 ‘‘(i) The Secretary shall establish and maintain a 

20 corps of inspectors dedicated to inspections of foreign 

21 food, drug, device, and cosmetics facilities and establish22 ments. This corps shall be staffed and funded by the Sec23 retary at a level sufficient to allow it to conduct inspec24 tions of foreign food, drug, device, and cosmetic facilities 

25 and establishments at a frequency at least equivalent to 


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1 the inspection rate of domestic food, drug, device, and cos2 metic facilities and establishments.’’. 

3 SEC. 405. CONTINUED OPERATION OF FIELD LABORA4 TORIES. 

5 (a) IN GENERAL.—Subject to subsections (b) and 

6 (d), the Secretary of Health and Human Services (in this 

7 section referred to as the ‘‘Secretary’’) shall not— 

8 (1) terminate any of the 13 field laboratories 

9 that were operated by the Office of Regulatory Af10 fairs of the Food and Drug Administration as of 

11 January 1, 2007; 

12 (2) consolidate any such laboratory with any 

13 other laboratory; 

14 (3) terminate any of the 20 district offices or 

15 any of the inspection or compliance functions of any 

16 of the 20 district offices of the Food and Drug Ad17 ministration functioning as of January 1, 2007; or 

18 (4) consolidate— 

19 (A) any such district office with an office 

20 in any other district; or 

21 (B) transfer any of the compliance or in22 spection functions of any such district office to 

23 any other district. 

24 (b) REPORT BY SECRETARY.— 


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1 (1) SUBMISSION.—The Secretary shall submit a 

2 reorganization plan involving the termination or con3 solidation of the laboratories, the district offices, or 

4 the functions of such district offices specified in sub5 section (a) to the Comptroller General of the United 

6 States, the Committee on Energy and Commerce of 

7 the House of Representatives, and the Committee on 

8 Health, Education, Labor, and Pensions of the Sen9 ate. 

10 (2) CONSULTATION.—In preparing the reorga11 nization plan described in paragraph (1), the Sec12 retary shall consult with personnel and unions to be 

13 affected by the plan. 

14 (c) REPORT BY GAO.—The Comptroller General 

15 shall study the cost effectiveness of the reorganization 

16 plan described in subsection (b) and its impact on the 

17 safety of food, drug, and other products regulated under 

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

19 et seq.) and the Public Health Service Act (42 U.S.C. 201 

20 et seq.) and report to the Committee on Energy and Com21 merce of the House of Representatives and the Committee 

22 on Health, Education, Labor, and Pensions of the Senate. 

23 (d) REORGANIZATION.— 

24 (1) CONGRESSIONAL REVIEW.—The reorganiza25 tion plan described in subsection (b) is deemed to be 


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1 a major rule (as defined in section 804(2) of title 5, 

2 United States Code) for purposes of chapter 8 of 

3 such title. 

4 (2) EFFECTIVE DATE.—Notwithstanding sec5 tion 801(a)(3) of title 5, United States Code, the re6 organization plan described in subsection (b) shall 

7 take effect (unless disapproved under section 802 of 

8 such title) on the date that is specified in such plan, 

9 but not earlier than 180 days after the date on 

10 which the Comptroller General submits the report 

11 required by subsection (c). 

12 SEC. 406. FALSE OR MISLEADING REPORTING TO FDA. 

13 (a) IN GENERAL.—Section 301(q)(2) (21 U.S.C. 

14 331(q)(2)) is amended by inserting after ‘‘device’’ the fol15 lowing: ‘‘food, drug, or biological product’’. 

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. 407. SUBPOENA AUTHORITY. 

20 Chapter III (21 U.S.C. 331 et seq.) is amended by 

21 adding at the end the following: 

22 ‘‘SEC. 311. EXERCISE OF SUBPOENA AUTHORITY. 

23 ‘‘(a) IN GENERAL.—For the purpose of— 

24 ‘‘(1) any hearing, investigation, or other pro25 ceeding respecting a violation of the Act, or 


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1 ‘‘(2) any hearing, investigation, or other pro2 ceeding to determine if a person is in violation of a 

3 specific provision of the Act, 

4 the Commissioner may issue subpoenas requiring the at5 tendance and testimony of witnesses and the production 

6 of documentary evidence. Such attendance of witnesses 

7 and production of evidence at the designated place of such 

8 hearing, investigation, or other proceeding may be re9 quired from any place in the United States or in any terri10 tory or possession of the United States. Subpoenas of the 

11 Commissioner shall be served by a person authorized by 

12 the Commissioner by delivering a copy thereof to the per13 son named therein or by certified mail addressed to such 

14 person at such person’s last known dwelling place or prin15 cipal place of business. A verified return by the person 

16 so serving the subpoena setting forth the manner of serv17 ice, or, in the case of service by certified mail, the return 

18 post office receipt therefor signed by the person so served, 

19 shall be proof of service. Witnesses so subpoenaed shall 

20 be paid the same fees and mileage as are paid witnesses 

21 in the district courts of the United States. 

22 ‘‘(b) ENFORCEMENT.—In the case of a refusal to 

23 obey a subpoena duly served upon any person under sub24 section (a), any district court of the United States for the 

25 judicial district in which such person charged with refusal 


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1 to obey is found, resides, or transacts business, upon ap2 plication by the Commissioner, shall have jurisdiction to 

3 issue an order requiring such person to appear and give 

4 testimony or to appear and produce evidence, or both. The 

5 failure to obey such order of the court may be punished 

6 by the court as contempt thereof. Furthermore, the failure 

7 or refusal to obey such a subpoena shall be treated as a 

8 prohibited act under section 301(a). 

9 ‘‘(c) RELATION TO OTHER PROVISIONS.—The sub10 poena authority vested in the Commissioner and the dis11 trict courts of the United States by this section is in addi12 tion to any such authority vested in the Commissioner or 

13 such courts by other provisions of law.’’. 

14 SEC. 408. WHISTLEBLOWER PROTECTIONS. 

15 Chapter IX (21 U.S.C. 391 et seq.) is amended by 

16 adding at the end the following: 

17 ‘‘SEC. 911. PROTECTIONS FOR EMPLOYEES WHO REFUSE TO 

18 VIOLATE, OR WHO DISCLOSE VIOLATIONS OF, 

19 THIS ACT OR SECTION 351 OF THE PUBLIC 

20 HEALTH SERVICE ACT. 

21 ‘‘(a) IN GENERAL.—No person that submits or is re22 quired to submit to the Secretary, a registration under 

23 section 415, 510, or 604, a new drug application under 

24 section 505(b), an abbreviated new drug application under 

25 section 505(j), a biologics license application under section 


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1 351 of the Public Health Service Act, an application for 

2 an investigational new drug exemption under section 

3 505(i), a new animal drug application under section 

4 512(b), an abbreviated new animal drug application under 

5 section 512(b), an application under section 571, a request 

6 under section 572, an application or report for premarket 

7 approval under section 515, an application for an inves8 tigational device exemption under section 520(g), a report 

9 under section 510(k), an application for a humanitarian 

10 device exemption under section 520(m), an amendment, 

11 supplement, or other submission with respect to any such 

12 registration, application, or report, or a record or report 

13 related to an adverse event, a postapproval study, a post14 approval clinical trial, a report, or postmarket surveillance 

15 under section 505(k), 505(o), 519, 522, or 760, or any 

16 officer, employee, contractor, subcontractor, or agent of 

17 such a person, may discharge, demote, suspend, threaten, 

18 harass, or in any other manner discriminate against an 

19 employee in the terms and conditions of employment be20 cause of any lawful act done by the employee, including 

21 within the ordinary course of the job duties of such em22 ployee— 

23 ‘‘(1) to provide information, cause information 

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1 sonably believes constitutes a violation of this Act or 

2 section 351 of the Public Health Service Act, any 

3 other provision of Federal law relating to the safety 

4 or effectiveness of a drug, biological product, or de5 vice or to the safety of a food or cosmetic, or any 

6 provision of Federal law prohibiting fraud against 

7 the Food and Drug Administration, if the informa8 tion or assistance is provided to, or an investigation 

9 stemming from the provided information is con10 ducted by— 

11 ‘‘(A) a Federal regulatory or law enforce12 ment agency; 

13 ‘‘(B) any Member of Congress or any com14 mittee of Congress; or 

15 ‘‘(C) a person with supervisory authority 

16 over the employee (or such other person work17 ing for the employer who has the authority to 

18 investigate, discover, or terminate the mis19 conduct); 

20 ‘‘(2) to file, cause to be filed, testify, participate 

21 in, or otherwise assist in a proceeding filed or about 

22 to be filed (with any knowledge of the employer) re23 lating to any such alleged violation; or 

24 ‘‘(3) to refuse to commit or assist in any such 

25 violation. 


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1 ‘‘(b) ENFORCEMENT ACTION.— 

2 ‘‘(1) IN GENERAL.—An employee who alleges 

3 discharge, or other discrimination in violation of 

4 subsection (a), may seek relief in accordance with 

5 the provisions of subsection (c), by— 

6 ‘‘(A) filing a complaint with the Secretary 

7 of Labor; or 

8 ‘‘(B) if the Secretary of Labor has not 

9 issued a final decision within 210 days of the 

10 filing of the complaint, or within 90 days after 

11 receiving a final decision or order from the Sec12 retary, and there is no showing that such delay 

13 is due to the bad faith of the claimant, bringing 

14 an action at law or equity for de novo review in 

15 the appropriate district court of the United 

16 States, which court shall have jurisdiction over 

17 such action without regard to the amount in 

18 controversy, and which action shall, at the re19 quest of either party to such action, be tried by 

20 the court with a jury. 

21 ‘‘(2) PROCEDURE.— 

22 ‘‘(A) IN GENERAL.—Any action under 

23 paragraph (1) shall be governed under the rules 

24 and procedures set forth in section 42121(b) of 

25 title 49, United States Code. 


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1 ‘‘(B) EXCEPTION.—Notification in an ac2 tion under paragraph (1) shall be made in ac3 cordance with section 42121(b)(1) of title 49, 

4 United States Code, except that such notifica5 tion shall be made to the person named in the 

6 complaint and to the employer. 

7 ‘‘(C) BURDENS OF PROOF.—An action 

8 brought under paragraph (1)(B) shall be gov9 erned by the legal burdens of proof set forth in 

10 section 42121(b) of title 49, United States 

11 Code. 

12 ‘‘(D) STATUTE OF LIMITATIONS.—An ac13 tion under paragraph (1) shall be commenced 

14 not later than 180 days after the date on which 

15 the violation occurs. 

16 ‘‘(c) REMEDIES.— 

17 ‘‘(1) IN GENERAL.—An employee prevailing in 

18 any action under subsection (b)(1) shall be entitled 

19 to all relief necessary to make the employee whole. 

20 ‘‘(2) ISSUANCE OF ORDER.—If, in response to 

21 a complaint filed under paragraph (b)(1), the Sec22 retary of Labor or the district court, as applicable, 

23 determines that a violation of subsection (a) has oc24 curred, the Secretary or the court shall order the 

25 person who committed such violation— 


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1 ‘‘(A) to take affirmative action to abate 

2 the violation; 

3 ‘‘(B) to reinstate the complainant to his or 

4 her former position together with compensation 

5 (including back pay) and restore the terms, 

6 conditions, and privileges associated with his or 

7 her employment; and 

8 ‘‘(C) to provide compensatory damages to 

9 the complainant. 

10 If such an order is issued under this paragraph, the 

11 Secretary or the court, at the request of the com12 plainant, shall assess against the person against 

13 whom the order is issued a sum equal to the aggre14 gate amount of all costs and expenses (including at15 torney and expert witness fees) reasonably incurred, 

16 as determined by the Secretary, by the complainant 

17 for, or in connection with, the bringing of the com18 plaint upon which the order was issued. 

19 ‘‘(d) RIGHTS RETAINED BY EMPLOYEE.—Nothing in 

20 this section shall be deemed to diminish the rights, privi21 leges, or remedies of any employee under any Federal or 

22 State law or under any collective bargaining agreement. 

23 The rights and remedies in this section may not be waived 


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•HR 759 IH

1 by any agreement, policy, form, or condition of employ2 ment.’’. 

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wwoods2 on PRODPC68 with BILLS