I 

111TH CONGRESS 

1ST SESSION H. R. 1332 

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

safety of the food supply. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 5, 2009 

Mr. COSTA (for himself, Mr. PUTNAM, Mr. PETERSON, Mr. DEAL of Georgia, 

Mr. CARDOZA, Mr. BARTON of Texas, Mr. FARR, Mr. SHIMKUS, Mr. 

ENGEL, Mr. RADANOVICH, Mr. THOMPSON of California, Mr. TERRY, Mr. 

SALAZAR, Mr. BOSWELL, Ms. HERSETH SANDLIN, Mr. WALDEN, Mr. 

CUELLAR, Mr. KAGEN, Mr. SCOTT of Georgia, Ms. ROS-LEHTINEN, Mr. 

BURGESS, and Mr. BACA) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to 

the Committee on Agriculture, for a period to be subsequently determined 

by the Speaker, in each case for consideration of such provisions as fall 

within the jurisdiction of the committee concerned 

A BILL 

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

respect to the safety of the food supply. 

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 ‘‘Safe Food Enforcement, Assessment, Standards, and 


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1 Targeting Act of 2009’’ or as the ‘‘Safe FEAST Act of 

2 2009’’. 

3 (b) REFERENCES.—Except as otherwise specified, 

4 whenever in this Act an amendment is expressed in terms 

5 of an amendment to a section or other provision, the ref6 erence shall be construed to be made to a section or other 

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

8 (21 U.S.C. 301 et seq.). 

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

10 this Act is as follows: 

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

TITLE I—GENERAL FOOD PROVISIONS 

Sec. 101. Inspection of records during food-related emergencies. 

Sec. 102. Registration of food facilities. 

Sec. 103. Mandatory recall authority. 

Sec. 104. Hazard analysis and risk-based preventive controls. 

Sec. 105. Performance standards. 

Sec. 106. Standards for the safety of fruits and vegetables. 

Sec. 107. Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report. 

Sec. 108. Administrative detention of food. 

Sec. 109. National agriculture and food defense strategy. 

Sec. 110. Food and Agriculture Coordinating Councils. 

Sec. 111. Authority to collect fees. 

TITLE II—DETECTION AND SURVEILLANCE 

Sec. 201. Recognition of laboratory accreditation for analyses of foods. 

Sec. 202. Integrated consortium of laboratory networks. 

Sec. 203. Building domestic capacity. 

Sec. 204. Enhancing traceback and recordkeeping. 

Sec. 205. Surveillance. 

TITLE III—SPECIFIC PROVISIONS FOR IMPORTED FOOD 

Sec. 301. Foreign supplier verification program. 

Sec. 302. Voluntary qualified importer program. 

Sec. 303. Authority to require import certifications for food. 

Sec. 304. Prior notice of imported food shipments. 

Sec. 305. Review of a regulatory authority of a foreign country. 

Sec. 306. Building capacity of foreign governments with respect to food. 

Sec. 307. Inspection of foreign food facilities. 


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Sec. 308. Third-party accreditation of qualified auditors and audit agents. 

Sec. 309. Jurisdiction; authorities. 

1 TITLE I—GENERAL FOOD 

2 PROVISIONS 

3 SEC. 101. INSPECTION OF RECORDS DURING FOOD-RE4 LATED EMERGENCIES. 

5 (a) IN GENERAL.—Section 414 (21 U.S.C. 350c) is 

6 amended— 

7 (1) by redesignating subsections (b), (c), and 

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

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

11 ‘‘(b) RECORDS INSPECTIONS DURING FOOD-RE12 LATED EMERGENCIES.—If the Secretary has a reasonable 

13 belief that an article of food presents a threat of serious 

14 adverse health consequences or death to humans or ani15 mals, during a food-related emergency, the Secretary— 

16 ‘‘(1) may have access to and copy all records 

17 relating to such article of food in the same manner 

18 and for the same purpose as described in subsection 

19 (a); and 

20 ‘‘(2) shall, from each person (excluding farms 

21 and restaurants) who manufactures, processes, 

22 packs, distributes, receives, holds, or imports an ar23 ticle of food related to the article of food referred to 

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1 duced on the same manufacturing line or any other 

2 article of food that the Secretary reasonably believes 

3 is likely to be affected in a similar manner) at the 

4 request of an officer or employee duly designated by 

5 the Secretary, have permission for such officer or 

6 employee, upon presentation of appropriate creden7 tials and a written notice to such person, at reason8 able times and within reasonable limits and in a rea9 sonable manner, to have access to and copy all 

10 records relating to such article that are needed to 

11 assist the Secretary in determining whether the food 

12 presents a threat of serious adverse health con13 sequences or death to humans or animals.’’. 

14 (b) CONFORMING AMENDMENTS.— 

15 (1) Section 301(e) (21 U.S.C. 331(e)) is 

16 amended by striking ‘‘414(b)’’ and inserting 

17 ‘‘414(c)’’. 

18 (2) Section 704(a)(1) (21 U.S.C. 374(a)(1)) is 

19 amended by striking ‘‘414(d)’’ and inserting 

20 ‘‘414(e)’’. 

21 SEC. 102. REGISTRATION OF FOOD FACILITIES. 

22 (a) UPDATING OF FOOD CATEGORY REGULATIONS; 

23 BIENNIAL REGISTRATION RENEWAL.—Section 415(a) (21 

24 U.S.C. 350d(a)) is amended— 

25 (1) in paragraph (2), by— 


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1 (A) striking ‘‘conducts business and’’ and 

2 inserting ‘‘conducts business, the e-mail address 

3 for the contact person of the facility, and’’; and 

4 (B) inserting ‘‘, or any other food cat5 egories as determined appropriate by the Sec6 retary, including by guidance)’’ after ‘‘Code of 

7 Federal Regulations’’; 

8 (2) by redesignating paragraphs (3) and (4) as 

9 paragraphs (4) and (5), respectively; and 

10 (3) by inserting after paragraph (2) the fol11 lowing: 

12 ‘‘(3) BIENNIAL REGISTRATION RENEWAL.— 

13 During the period beginning on October 1 and end14 ing on December 31 of each even-numbered year, a 

15 registrant that has submitted a registration under 

16 paragraph (1) shall submit to the Secretary a re17 newal registration containing the information de18 scribed in paragraph (2). The Secretary shall pro19 vide for an abbreviated registration renewal process 

20 for any registrant that has not had any changes to 

21 such information since the registrant submitted the 

22 preceding registration or registration renewal for the 

23 facility involved.’’. 

24 (b) SUSPENSION OF REGISTRATION.— 


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

2 350d) is amended— 

3 (A) in subsection (a)(2), by inserting after 

4 the first sentence the following: ‘‘The registra5 tion shall contain a consent to permit the Sec6 retary to inspect such facility.’’; 

7 (B) by redesignating subsections (b) and 

8 (c) as subsections (c) and (d), respectively; and 

9 (C) by inserting after subsection (a) the 

10 following: 

11 ‘‘(b) SUSPENSION OF REGISTRATION.— 

12 ‘‘(1) IN GENERAL.—If the Secretary determines 

13 that food manufactured, processed, packed, or held 

14 by a facility registered under this section has a rea15 sonable probability of causing serious adverse health 

16 consequences or death to humans or animals, the 

17 Secretary may by order suspend the registration of 

18 the facility under this section in accordance with this 

19 subsection. 

20 ‘‘(2) HEARING ON SUSPENSION.—The Secretary 

21 shall provide the registrant subject to an order 

22 under paragraph (1) with an opportunity for an in23 formal hearing, to be held as soon as possible but 

24 not later than 2 days after the issuance of the order, 

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1 tion and why the registration that is subject to sus2 pension should be reinstated. The Secretary shall re3 instate a registration if the Secretary determines, 

4 based on evidence presented, that adequate grounds 

5 do not exist to continue the suspension of the reg6 istration. 

7 ‘‘(3) POST-HEARING CORRECTIVE ACTION PLAN; 

8 VACATING OF ORDER.— 

9 ‘‘(A) CORRECTIVE ACTION PLAN.—If, after 

10 providing opportunity for an informal hearing 

11 under paragraph (2), the Secretary determines 

12 that the suspension of registration remains nec13 essary, the Secretary shall require the reg14 istrant to submit a corrective action plan to 

15 demonstrate how the registrant plans to correct 

16 the conditions found by the Secretary. The Sec17 retary shall review such plan in a timely man18 ner. 

19 ‘‘(B) VACATING OF ORDER.—Upon a de20 termination by the Secretary that adequate 

21 grounds do not exist to continue the suspension 

22 actions required by the order, or that such ac23 tions should be modified, the Secretary shall va24 cate the order or modify the order. 


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1 ‘‘(4) EFFECT OF SUSPENSION.—If the registra2 tion of a facility is suspended under this subsection, 

3 such facility shall not import food or offer to import 

4 food into the United States, or otherwise introduce 

5 food into interstate commerce in the United States. 

6 ‘‘(5) REGULATIONS.—The Secretary shall pro7 mulgate regulations that describe the standards offi8 cials will use in making a determination to suspend 

9 a registration, and the format such officials will use 

10 to explain to the registrant the conditions found at 

11 the facility. 

12 ‘‘(6) NO DELEGATION.—The authority con13 ferred by this subsection to issue an order to sus14 pend a registration or vacate an order of suspension 

15 shall not be delegated to any officer or employee 

16 other than the Commissioner.’’. 

17 (2) IMPORTED FOOD.—Section 801(l) (21 

18 U.S.C. 381(l)) is amended by inserting ‘‘(or for 

19 which a registration has been suspended under such 

20 section)’’ after ‘‘section 415’’. 

21 (c) CONFORMING AMENDMENTS.— 

22 (1) Section 301(d) (21 U.S.C. 331(d)) is 

23 amended by inserting ‘‘415,’’ after ‘‘404,’’. 

24 (2) Section 415(d), as redesignated by sub25 section (b), is amended by adding at the end before 


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1 the period ‘‘for a facility to be registered, except 

2 with respect to the reinstatement of a registration 

3 that is suspended under subsection (b)’’. 

4 SEC. 103. MANDATORY RECALL AUTHORITY. 

5 (a) IN GENERAL.—Chapter IV (21 U.S.C. 341 et 

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

7 ‘‘SEC. 418. MANDATORY RECALL AUTHORITY. 

8 ‘‘(a) VOLUNTARY PROCEDURES.—If the Secretary 

9 determines, based on information gathered through the re10 portable food registry under section 417 or through any 

11 other means, that there is a reasonable probability that 

12 an article of food (other than infant formula) is adulter13 ated under section 402 or misbranded under section 

14 403(w) and the use of or exposure to such article will 

15 cause serious adverse health consequences or death to hu16 mans or animals, the Secretary shall provide the respon17 sible party (as defined in section 417) with an opportunity 

18 to cease distribution and recall such article. 

19 ‘‘(b) PREHEARING ORDER TO CEASE DISTRIBUTION

20 AND GIVE NOTICE.—If the responsible party refuses to 

21 or does not voluntarily cease distribution or recall such 

22 article within the time and in the manner prescribed by 

23 the Secretary (if so prescribed), the Secretary may, by 

24 order require, as the Secretary deems necessary, such per25 son to— 


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1 ‘‘(1) immediately cease distribution of such arti2 cle; or 

3 ‘‘(2) immediately notify all persons— 

4 ‘‘(A) manufacturing, processing, packing, 

5 transporting, distributing, receiving, holding, or 

6 importing and selling such article; and 

7 ‘‘(B) to which such article has been dis8 tributed, transported, or sold, to immediately 

9 cease distribution of such article. 

10 ‘‘(c) HEARING ON ORDER.—The Secretary shall pro11 vide the responsible party subject to an order under sub12 section (b) with an opportunity for an informal hearing, 

13 to be held as soon as possible but not later than 2 days 

14 after the issuance of the order, on the actions required 

15 by the order and on why the article that is the subject 

16 of the order should not be recalled. 

17 ‘‘(d) POST-HEARING RECALL ORDER AND MODIFICA18 TION OF ORDER.— 

19 ‘‘(1) AMENDMENT OF ORDER.—If, after pro20 viding opportunity for an informal hearing under 

21 subsection (c), the Secretary determines that re22 moval of the article from commerce is necessary, the 

23 Secretary shall, as appropriate— 

24 ‘‘(A) amend the order to require recall of 

25 such article or other appropriate action; 


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1 ‘‘(B) specify a timetable in which the recall 

2 shall occur; 

3 ‘‘(C) require periodic reports to the Sec4 retary describing the progress of the recall; and 

5 ‘‘(D) provide notice to consumers to whom 

6 such article was, or may have been, distributed. 

7 ‘‘(2) VACATING OF ORDER.—If, after such hear8 ing, the Secretary determines that adequate grounds 

9 do not exist to continue the actions required by the 

10 order, or that such actions should be modified, the 

11 Secretary shall vacate the order or modify the order. 

12 ‘‘(e) COOPERATION AND CONSULTATION.—The Sec13 retary shall work with State and local public health offi14 cials in carrying out this section, as appropriate. 

15 ‘‘(f) PUBLIC NOTIFICATION.—In conducting a recall 

16 under this section, the Secretary shall ensure that a press 

17 release is published regarding the recall, as well as alerts 

18 and public notices, as appropriate, in order to provide noti19 fication of the recall to consumers and retailers to whom 

20 such article was, or may have been, distributed. The notifi21 cation shall include, at a minimum— 

22 ‘‘(1) the name of the article of food subject to 

23 the recall; and 

24 ‘‘(2) a description of the risk associated with 

25 such article. 


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1 ‘‘(g) NO DELEGATION.—The authority conferred by 

2 this section to order a recall or vacate a recall order shall 

3 not be delegated to any officer or employee other than the 

4 Commissioner. 

5 ‘‘(h) EFFECT.—Nothing in this section shall affect 

6 the authority of the Secretary to request or participate 

7 in a voluntary recall.’’. 

8 (b) PROHIBITED ACTS.—Section 301 (21 U.S.C. 331 

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

10 ‘‘(oo) The refusal or failure to follow an order under 

11 section 418.’’. 

12 SEC. 104. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE 

13 CONTROLS. 

14 (a) IN GENERAL.—Chapter IV (21 U.S.C. 341 et 

15 seq.), as amended by section 103, is amended by adding 

16 at the end the following: 

17 ‘‘SEC. 419. HAZARD ANALYSIS AND RISK-BASED PREVEN18 TIVE CONTROLS. 

19 ‘‘(a) IN GENERAL.—Each owner, operator, or agent 

20 in charge of a facility shall, in accordance with this sec21 tion, evaluate the hazards that could affect food manufac22 tured, processed, packed, or held by such facility, identify 

23 and implement preventive controls to significantly mini24 mize or prevent their occurrence and provide assurances 

25 that such food is not adulterated under section 402 or 


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1 misbranded under section 403(w), monitor the perform2 ance of those controls, and maintain records of this moni3 toring as a matter of routine practice. 

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

5 agent in charge of a facility shall— 

6 ‘‘(1) identify and evaluate known or reasonably 

7 foreseeable hazards that may be associated with the 

8 facility, including— 

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

11 drug residues, decomposition, parasites, aller12 gens, and unapproved food and color additives; 

13 and 

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

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

18 ‘‘(2) develop a written analysis of the hazards. 

19 ‘‘(c) PREVENTIVE CONTROLS.—The owner, operator, 

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

22 points, if any, to provide assurances that— 

23 ‘‘(1) hazards identified in the hazard analysis 

24 conducted under subsection (b) will be significantly 

25 minimized or prevented; and 


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1 ‘‘(2) the food manufactured, processed, packed, 

2 or held by such facility will not be adulterated under 

3 section 402 or misbranded under section 403(w). 

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

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

6 effectiveness of the preventive controls implemented under 

7 subsection (c) to provide assurances that the outcomes de8 scribed in subsection (c) shall be achieved. 

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

10 or agent in charge of a facility shall establish procedures 

11 that a facility will implement if the preventive controls im12 plemented under subsection (c) are found to be ineffective 

13 through monitoring under subsection (d). 

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

15 in charge of a facility shall verify that— 

16 ‘‘(1) the preventive controls implemented under 

17 subsection (c) are adequate to control the hazards 

18 identified under subsection (b); 

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

20 monitoring in accordance with subsection (d); 

21 ‘‘(3) the owner, operator, or agent is making 

22 appropriate decisions about corrective actions taken 

23 under subsection (e); and 

24 ‘‘(4) there is documented, periodic reanalysis of 

25 the plan under subsection (i) to ensure that the plan 


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1 is still relevant to the raw materials, as well as to 

2 conditions and processes in the facility, and to new 

3 and emerging threats. 

4 ‘‘(g) RECORDKEEPING.—The owner, operator, or 

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

6 than 2 years, records documenting the monitoring of the 

7 preventive controls implemented under subsection (c), in8 stances of nonconformance material to food safety, in9 stances when corrective actions were implemented, and the 

10 efficacy of preventive controls and corrective actions. 

11 ‘‘(h) WRITTEN PLAN AND DOCUMENTATION.—Each 

12 owner, operator, or agent in charge of a facility shall pre13 pare a written plan that documents and describes the pro14 cedures used by the facility to comply with the require15 ments of this section, including analyzing the hazards 

16 under subsection (b) and identifying the preventive con17 trols adopted to address those hazards under subsection 

18 (c). High-risk facilities, as determined by the Secretary, 

19 shall submit such written plan to the Food and Drug Ad20 ministration’s Center for Food Safety and Applied Nutri21 tion. The Secretary or a duly authorized representative of 

22 the Secretary may review the plan and may make rec23 ommendations regarding the effectiveness of the plan in 

24 preventing or minimizing the threat of serious adverse 

25 health consequences or death to humans or animals. All 


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1 facilities shall promptly make available such written plan, 

2 together with documentation that the plan is being imple3 mented, to a duly authorized representative of the Sec4 retary upon oral or written request. 

5 ‘‘(i) REQUIREMENT TO REANALYZE.—Each owner, 

6 operator, or agent in charge of a facility shall conduct a 

7 reanalysis under subsection (b) whenever a significant 

8 change is made in the activities conducted at a facility 

9 operated by such owner, operator, or agent if the change 

10 creates a reasonable potential for a new hazard or a sig11 nificant increase in a previously identified hazard or not 

12 less frequently than once every 3 years, whichever is ear13 lier. Such reanalysis shall be completed and additional pre14 ventive controls needed to address the hazard identified, 

15 if any, shall be implemented before the change in activities 

16 at the facility is commenced. Such owner, operator, or 

17 agent shall revise the written plan required under sub18 section (h) if such a significant change is made or docu19 ment the basis for the conclusion that no additional or 

20 revised preventive controls are needed. The Secretary may 

21 require a reanalysis under this section to respond to new 

22 hazards and developments in scientific understanding. 

23 ‘‘(j) DEEMED COMPLIANCE OF SEAFOOD, JUICE, 

24 AND LOW-ACID CANNED FOOD FACILITIES IN COMPLI25 ANCE WITH HACCP.—An owner, operator, or agent in 


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1 charge of a facility required to comply with 1 of the fol2 lowing standards and regulations with respect to such fa3 cility shall be deemed to be in compliance with this section, 

4 with respect to such facility: 

5 ‘‘(1) The Seafood Hazard Analysis Critical 

6 Control Points Program of the Food and Drug Ad7 ministration. 

8 ‘‘(2) The Juice Hazard Analysis Critical Con9 trol Points Program of the Food and Drug Adminis10 tration. 

11 ‘‘(3) The Thermally Processed Low-Acid Foods 

12 Packaged in Hermetically Sealed Containers stand13 ards of the Food and Drug Administration (or any 

14 successor standards). 

15 ‘‘(k) EXCEPTION FOR FACILITIES IN COMPLIANCE

16 WITH SECTION 420.—This section shall not apply to a 

17 facility that is subject to section 420. 

18 ‘‘(l) AUTHORITY WITH RESPECT TO CERTAIN FA19 CILITIES.—The Secretary may, by regulation, exempt or 

20 modify the requirements for compliance under this section 

21 with respect to facilities that are solely engaged in the 

22 storage of packaged foods that are not exposed to the envi23 ronment. 

24 ‘‘(m) DEFINITIONS.—For purposes of this section: 


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

2 ‘critical control point’ means a point, step, or proce3 dure in a food process at which control can be ap4 plied and is essential to prevent or eliminate a food 

5 safety hazard or reduce it to an acceptable level. 

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

7 domestic facility or a foreign facility that is required 

8 to register under section 415. 

9 ‘‘(3) PREVENTIVE CONTROLS.—The term ‘pre10 ventive controls’ means those risk-based, reasonably 

11 appropriate procedures, practices, and processes that 

12 a person knowledgeable about the safe manufac13 turing, processing, packing, or holding of food would 

14 have employed to significantly minimize or prevent 

15 the hazards identified under the hazard analysis con16 ducted under subsection (a) and that are consistent 

17 with the current scientific understanding of safe 

18 food manufacturing, processing, packing, or holding 

19 at the time of the analysis. Those procedures, prac20 tices, and processes shall include the following: 

21 ‘‘(A) Sanitation procedures for food con22 tact surfaces and utensils and food-contact sur23 faces of equipment. 

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

25 hygiene training. 


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1 ‘‘(C) An environmental monitoring pro2 gram to verify the effectiveness of pathogen 

3 controls. 

4 ‘‘(D) An allergen control program. 

5 ‘‘(E) A recall contingency plan. 

6 ‘‘(F) Good Manufacturing Practices 

7 (GMPs). 

8 ‘‘(G) Supplier verification activities.’’. 

9 (b) REGULATIONS.— 

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

11 Human Services (referred to in this Act as the ‘‘Sec12 retary’’) shall promulgate regulations to establish 

13 science-based minimum standards for conducting a 

14 hazard analysis, documenting hazards, implementing 

15 preventive controls, and documenting the implemen16 tation of the preventive controls under section 419 

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

18 added by subsection (a)). 

19 (2) CONTENT.—The regulations promulgated 

20 under paragraph (1) shall provide sufficient flexi21 bility to be applicable in all situations, including in 

22 the operations of small businesses. 

23 (3) RULE OF CONSTRUCTION.—Nothing in this 

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1 nologies, practices, or critical controls to an indi2 vidual facility. 

3 (4) REVIEW.—In promulgating the regulations 

4 under paragraph (1), the Secretary shall review reg5 ulatory hazard analysis and preventive control pro6 grams in existence on the date of enactment of this 

7 Act to ensure that the program under such section 

8 419 is consistent, to the extent practicable, with ap9 plicable internationally recognized standards in exist10 ence on such date. 

11 (c) GUIDANCE DOCUMENT.—The Secretary shall 

12 issue a guidance document related to hazard analysis and 

13 preventive controls required under section 419 of the Fed14 eral Food, Drug, and Cosmetic Act (as added by sub15 section (a)). 

16 (d) PROHIBITED ACTS.—Section 301 (21 U.S.C. 

17 331), as amended by section 103, is amended by adding 

18 at the end the following: 

19 ‘‘(pp) The operation of a facility that manufacturers, 

20 processes, packs, or holds food for sale in the United 

21 States if the owner, operator, or agent in charge of such 

22 facility is not in compliance with section 419.’’. 

23 (e) NO EFFECT ON HACCP AUTHORITIES.—Noth24 ing in the amendments made by this section limits the au25 thority of the Secretary under the Federal Food, Drug, 


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

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

3 or enforce product and category-specific regulations, such 

4 as the Seafood Hazard Analysis Critical Controls Points 

5 Program, the Juice Hazard Analysis Critical Control Pro6 gram, and the Thermally Processed Low-Acid Foods 

7 Packaged in Hermetically Sealed Containers standards. 

8 (f) EFFECTIVE DATE.— 

9 (1) GENERAL RULE.—The amendments made 

10 by this section shall take effect 18 months after the 

11 date of enactment of this Act. 

12 (2) EXCEPTIONS.—Notwithstanding paragraph 

13 (1)— 

14 (A) the amendments made by this section 

15 shall apply to a small business (as defined by 

16 the Secretary) after the date that is 2 years 

17 after the date of enactment of this Act; and 

18 (B) the amendments made by this section 

19 shall apply to a very small business (as defined 

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

21 after the date of enactment of this Act. 

22 SEC. 105. PERFORMANCE STANDARDS. 

23 The Secretary shall, not less frequently than every 

24 2 years, review and evaluate relevant health data and 

25 other relevant information, including from toxicological 


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1 and epidemiological studies and analyses, to determine the 

2 most significant food-borne contaminants and, when ap3 propriate to reduce the risk of serious illness or death to 

4 humans or animals, to prevent the adulteration of the food 

5 under section 402 of the Federal Food, Drug, or Cosmetic 

6 Act (21 U.S.C. 342), or to prevent the spread of commu7 nicable disease under the Public Health Service Act (42 

8 U.S.C. 201 et seq.), shall issue contaminant-specific, 

9 science-based guidance documents, actions levels, or regu10 lations. Such guidance documents, action levels, or regula11 tions shall apply to products or product classes, take into 

12 account naturally occurring substances in the case of raw 

13 agricultural products, and shall not be written to be facil14 ity-specific. 

15 SEC. 106. STANDARDS FOR THE SAFETY OF FRUITS AND 

16 VEGETABLES. 

17 (a) IN GENERAL.—Chapter IV (21 U.S.C. 341 et 

18 seq.), as amended by section 104, is amended by adding 

19 at the end the following: 

20 ‘‘SEC. 420. STANDARDS FOR THE SAFETY OF FRUITS AND 

21 VEGETABLES. 

22 ‘‘(a) DEFINITION.—For purposes of this section, the 

23 term ‘fruits and vegetables’ means raw agricultural prod24 ucts as defined in section 201(r). 


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1 ‘‘(b) IN GENERAL.—Not later than 1 year after en2 actment of this section, the Secretary, in consultation with 

3 the Secretary of Agriculture and representatives of State 

4 departments of agriculture, shall publish a notice of pro5 posed rulemaking to establish regulations for the safe pro6 duction, harvesting, handling, and packing of those types 

7 of fruits and vegetables for which the Secretary has deter8 mined that such regulations are necessary to minimize the 

9 risk of serious adverse health consequences. 

10 ‘‘(c) FINAL REGULATION.—Not later than 1 year 

11 after the close of the comment period on the notice of pro12 posed rulemaking under subsection (a), the Secretary shall 

13 adopt a final regulation covering those types of fruits and 

14 vegetables for which the Secretary has determined that 

15 such regulations are necessary to minimize the risk of seri16 ous adverse health consequences. The final regulation 

17 shall provide a reasonable period of time for implementa18 tion, taking into account the needs of small businesses for 

19 additional time to comply. The final regulation shall pro20 vide for coordination of education and enforcement activi21 ties by the Secretary of Agriculture, appropriate State and 

22 local agencies, and appropriate agencies of foreign govern23 ments. 

24 ‘‘(d) COOPERATION.—The Secretary shall work with 

25 State and local public health officials in carrying out this 


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1 section. The Secretary shall coordinate activities with the 

2 Secretary of Agriculture related to on-farm requirements 

3 for growers including the development of food safety 

4 standards and enforcement mechanisms that will address 

5 regulations adopted under subsection (c). 

6 ‘‘(e) CRITERIA.—The regulations adopted under sub7 section (b) shall— 

8 ‘‘(1) set forth such procedures, processes, and 

9 practices as the Secretary determines to be reason10 ably necessary to minimize the introduction of 

11 known or reasonably foreseeable biological, chemical, 

12 and physical hazards into fruits and vegetables and 

13 to provide reasonable assurance that the fruits and 

14 vegetables are not adulterated under section 402; 

15 ‘‘(2) permit States and foreign governments to 

16 seek variances from the requirements of the regula17 tions, where the State or foreign government deter18 mines that the variance is necessary in light of local 

19 growing conditions and that the procedures, proc20 esses, and practices to be followed under the vari21 ance are reasonably likely to ensure that the fruits 

22 or vegetables are not adulterated within the meaning 

23 of section 402 to the same extent as the require24 ments of the regulation adopted under subsection 

25 (b); 


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1 ‘‘(3) require that any State or foreign govern2 ment seeking a variance under paragraph (2) shall 

3 first notify the Secretary of the intended variance 

4 and the basis for it, and the Secretary may grant 

5 the variance after 90 days of such notification if 

6 Secretary does not communicate objections or modi7 fications to the intended variance to the respective 

8 State or foreign government prior to the conclusion 

9 of the 90-day period; and 

10 ‘‘(4) provide for publication of notices of re11 quests for variances under paragraph (2) at the time 

12 they are received. 

13 ‘‘(f) ENFORCEMENT.—The Secretary shall coordinate 

14 enforcement under this section with appropriate State and 

15 local agencies and with appropriate agencies of foreign 

16 governments. In enforcing any standards for the safety of 

17 fruits and vegetables, the Secretary shall, to the maximum 

18 extent practicable, use the Department of Agriculture and 

19 state agricultural agencies. Such enforcement may be in 

20 the form of audit-based verification systems or other 

21 methods of inspection. 

22 ‘‘(g) GUIDANCE FOR GOOD AGRICULTURAL PRAC23 TICES.—Not later than 1 year after the date of the enact24 ment of this section, the Secretary shall publish updated 

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1 culture and representatives of State departments of agri2 culture, based on the most currently available scientific 

3 evidence, for the safe production, harvesting, handling, 

4 packing, and traceability of fruits and vegetables. The Sec5 retary shall publish subsequently updated guidance, as 

6 necessary. 

7 ‘‘(h) SCOPE.—This section shall apply to the produc8 tion, harvesting, packaging, and traceability of fruits and 

9 vegetables intended for human consumption, but not to— 

10 ‘‘(1) activities involving the further processing 

11 of fruits and vegetables which shall be subject to 

12 section 419; or 

13 ‘‘(2) those activities that occur in a retail food 

14 establishment (as such term is defined in regulations 

15 to carry out section 415(b)(1)).’’. 

16 (b) PROHIBITED.—Section 301 (21 U.S.C. 331), as 

17 amended by section 104, is further amended by adding 

18 at the end the following: 

19 ‘‘(qq) Production, harvesting, handling, and packing 

20 of fruits or vegetables not in accordance with the regula21 tions under section 419 or a variance issued under section 

22 419(e)(2).’’. 


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1 SEC. 107. TARGETING OF INSPECTION RESOURCES FOR DO2 MESTIC FACILITIES, FOREIGN FACILITIES, 

3 AND PORTS OF ENTRY; ANNUAL REPORT. 

4 (a) TARGETING OF INSPECTION RESOURCES FOR

5 DOMESTIC FACILITIES, FOREIGN FACILITIES, AND PORTS

6 OF ENTRY.—Chapter IV (21 U.S.C. 341 et seq.), as 

7 amended by section 106, is amended by adding at the end 

8 the following: 

9 ‘‘SEC. 421. TARGETING OF INSPECTION RESOURCES FOR 

10 DOMESTIC FACILITIES, FOREIGN FACILITIES, 

11 AND PORTS OF ENTRY; ANNUAL REPORT. 

12 ‘‘(a) IDENTIFICATION AND INSPECTION OF FACILI13 TIES.— 

14 ‘‘(1) IDENTIFICATION.—The Secretary shall al15 locate resources to inspect facilities according to the 

16 risk profile of the facilities, which shall be based on 

17 the following factors: 

18 ‘‘(A) The risk profile of the food manufac19 tured, processed, packed, or held at the facility. 

20 ‘‘(B) The facility’s history of food recalls, 

21 outbreaks, and violations of food safety stand22 ards. 

23 ‘‘(C) The rigor of the facility’s hazard 

24 analysis and risk-based preventive controls. 

25 ‘‘(D) Whether the food manufactured, 

26 processed, packed, handled, prepared, treated, 


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1 distributed, or stored at the facility meets the 

2 criteria for priority under section 801(h)(1). 

3 ‘‘(E) Whether the facility has received a 

4 certificate as described in section 809(b). 

5 ‘‘(F) Any other criteria deemed necessary 

6 and appropriate by the Secretary for purposes 

7 of allocating inspection resources. 

8 ‘‘(2) INSPECTIONS.—The Secretary shall in9 crease the frequency of inspections of all facilities 

10 such that— 

11 ‘‘(A) all facilities registered under section 

12 415 are inspected not less than once every 4 

13 years; and 

14 ‘‘(B) all facilities identified under para15 graph (1) as a high-risk facility are inspected— 

16 ‘‘(i) not less than once within a 2-year 

17 period after the date of enactment of this 

18 section; and 

19 ‘‘(ii) for each succeeding year, each 

20 high-risk facility is inspected not less than 

21 once each year. 

22 ‘‘(b) IDENTIFICATION AND INSPECTION AT PORTS OF

23 ENTRY.—The Secretary, in consultation with the Sec24 retary of Homeland Security, shall allocate resources to 

25 inspect articles of food imported into the United States 


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1 according to the risk profile of the article of food, which 

2 shall be based on the following factors: 

3 ‘‘(1) The risk profile of the food imported. 

4 ‘‘(2) The risk profile of the countries of origin 

5 and countries of transport of the food imported. 

6 ‘‘(3) The history of food recalls, outbreaks, and 

7 violations of food safety standards of the food im8 porter. 

9 ‘‘(4) The rigor of the foreign supplier verifica10 tion program under section 805. 

11 ‘‘(5) Whether the food importer participates in 

12 the Voluntary Qualified Importer Program under 

13 section 806. 

14 ‘‘(6) Whether the food meets the criteria for 

15 priority under section 801(h)(1). 

16 ‘‘(7) Whether the food is from a facility that 

17 has received a certificate as described in section 

18 809(b). 

19 ‘‘(8) Any other criteria deemed appropriate by 

20 the Secretary for purposes of allocating inspection 

21 resources. 

22 ‘‘(c) COORDINATION.—The Secretary shall improve 

23 coordination and cooperation with the Secretary of Agri24 culture to target food inspection resources. 


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1 ‘‘(d) FACILITY.—For purposes of this section, the 

2 term ‘facility’ means a domestic facility or a foreign facil3 ity that is required to register under section 415.’’. 

4 (b) ANNUAL REPORT.—Section 903 (21 U.S.C. 393) 

5 is amended by adding at the end the following: 

6 ‘‘(h) ANNUAL REPORT REGARDING FOOD.—Not 

7 later than February 1 of each year, the Secretary shall 

8 submit to Congress a report regarding— 

9 ‘‘(1) information about food facilities includ10 ing— 

11 ‘‘(A) the appropriations used to inspect fa12 cilities registered pursuant to section 415 in the 

13 previous fiscal year; 

14 ‘‘(B) the average cost of both a non-high15 risk food facility inspection and a high-risk food 

16 facility inspection, if such a difference exists, in 

17 the previous fiscal year; 

18 ‘‘(C) the number of domestic facilities and 

19 the number of foreign facilities registered pur20 suant to section 415 that the Secretary in21 spected in the previous fiscal year; 

22 ‘‘(D) the number of domestic facilities and 

23 the number of foreign facilities registered pur24 suant to section 415 that the Secretary did not 

25 inspect in the previous fiscal year; 


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1 ‘‘(E) the number of high-risk facilities 

2 identified pursuant to section 421 that the Sec3 retary inspected in the previous fiscal year; and 

4 ‘‘(F) the number of high-risk facilities 

5 identified pursuant to section 421 that the Sec6 retary did not inspect in the previous fiscal 

7 year; and 

8 ‘‘(2) information about food imports includ9 ing— 

10 ‘‘(A) the number of lines of food imported 

11 into the United States that the Secretary phys12 ically inspected or sampled in the previous fiscal 

13 year; 

14 ‘‘(B) the number of lines of food imported 

15 into the United States that the Secretary did 

16 not physically inspect or sample in the previous 

17 fiscal year; and 

18 ‘‘(C) the average cost of physically inspect19 ing or sampling a food line subject to this Act 

20 that is imported or offered for import into the 

21 United States. 

22 ‘‘(i) PUBLIC AVAILABILITY OF ANNUAL FOOD RE23 PORTS.—The Secretary shall make the reports required 

24 under subsection (h) available to the public on the Internet 

25 Web site of the Food and Drug Administration.’’. 


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1 SEC. 108. ADMINISTRATIVE DETENTION OF FOOD. 

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

3 334(h)(1)(A)) is amended by— 

4 (1) striking ‘‘credible evidence or information 

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

6 (2) striking ‘‘presents a threat of serious ad7 verse health consequences or death to humans or 

8 animals’’ and inserting ‘‘is adulterated or mis9 branded under section 403(w)’’. 

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

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

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

13 21, Code of Federal Regulations, to implement the amend14 ment made by this section. 

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

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

17 enactment of this Act. 

18 SEC. 109. NATIONAL AGRICULTURE AND FOOD DEFENSE 

19 STRATEGY. 

20 (a) DEVELOPMENT AND SUBMISSION OF STRAT21 EGY.— 

22 (1) IN GENERAL.—Not later than 1 year after 

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

24 Health and Human Services and the Secretary of 

25 Agriculture, in coordination with the Secretary of 

26 Homeland Security, shall prepare and submit to the 


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1 relevant committees of Congress, and make publicly 

2 available on the Internet Web site of the Depart3 ment of Health and Human Services and the De4 partment of Agriculture, the National Agriculture 

5 and Food Defense Strategy. 

6 (2) IMPLEMENTATION PLAN.—The strategy 

7 shall include an implementation plan for use by the 

8 Secretaries described under paragraph (1) in car9 rying out the strategy. 

10 (3) RESEARCH.—The strategy shall include a 

11 coordinated research agenda for use by the Secre12 taries described under paragraph (1) in conducting 

13 research to support the goals and activities described 

14 in paragraphs (1) and (2) of subsection (b). 

15 (4) REVISIONS.—Not later than 4 years after 

16 the date on which the strategy is submitted to the 

17 relevant committees of Congress under paragraph 

18 (1), and not less frequently than every 4 years there19 after, the Secretary of Health and Human Services 

20 and the Secretary of Agriculture, in coordination 

21 with the Secretary of Homeland Security, shall re22 vise and submit to the relevant committees of Con23 gress the strategy. 


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1 (5) CONSISTENCY WITH EXISTING PLANS.—The 

2 strategy described in paragraph (1) shall be con3 sistent with— 

4 (A) the National Incident Management 

5 System; 

6 (B) the National Response Framework; 

7 (C) the National Infrastructure Protection 

8 Plan; 

9 (D) the National Preparedness Goals; and 

10 (E) other relevant national strategies. 

11 (b) COMPONENTS.— 

12 (1) IN GENERAL.—The strategy shall include a 

13 description of the process to be used by the Depart14 ment of Health and Human Services, the Depart15 ment of Agriculture, and the Department of Home16 land Security— 

17 (A) to achieve each goal described in para18 graph (2); and 

19 (B) to evaluate the progress made by Fed20 eral, State, local, and tribal governments to21 wards the achievement of each goal described in 

22 paragraph (2). 

23 (2) GOALS.—The strategy shall include a de24 scription of the process to be used by the Depart25 ment of Health and Human Services, the DepartVerDate Nov 24 2008 01:02 Mar 07, 2009 Jkt 079200 PO 00000 Frm 00034 Fmt 6652 Sfmt 6201 E:\BILLS\H1332.IH H1332

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1 ment of Agriculture, and the Department of Home2 land Security to achieve the following goals: 

3 (A) PREPAREDNESS GOAL.—Enhance the 

4 preparedness of the agriculture and food system 

5 by— 

6 (i) conducting vulnerability assess7 ments of the agriculture and food system; 

8 (ii) mitigating vulnerabilities of the 

9 system; 

10 (iii) improving communication and 

11 training relating to the system; 

12 (iv) developing and conducting exer13 cises to test decontamination and disposal 

14 plans; 

15 (v) developing modeling tools to im16 prove event consequence assessment and 

17 decision support; and 

18 (vi) preparing risk communication 

19 tools and enhancing public awareness 

20 through outreach. 

21 (B) DETECTION GOAL.—Improve agri22 culture and food system detection capabilities 

23 by— 

24 (i) identifying contamination in food 

25 products at the earliest possible time; and 


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1 (ii) conducting surveillance to prevent 

2 the spread of diseases. 

3 (C) EMERGENCY RESPONSE GOAL.—En4 sure an efficient response to agriculture and 

5 food emergencies by— 

6 (i) immediately investigating animal 

7 disease outbreaks and suspected food con8 tamination; 

9 (ii) preventing additional human ill10 nesses; 

11 (iii) organizing, training, and equip12 ping animal, plant, and food emergency re13 sponse teams of— 

14 (I) the Federal Government; and 

15 (II) State, local, and tribal gov16 ernments; 

17 (iv) designing, developing, and evalu18 ating training and exercises carried out 

19 under agriculture and food defense plans; 

20 and 

21 (v) ensuring consistent and organized 

22 risk communication to the public by— 

23 (I) the Federal Government; 

24 (II) State, local, and tribal gov25 ernments; and 


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1 (III) the private sector. 

2 (D) RECOVERY GOAL.—Secure agriculture 

3 and food production after an agriculture or food 

4 emergency by— 

5 (i) working with the private sector to 

6 develop business recovery plans to rapidly 

7 resume agriculture and food production; 

8 (ii) conducting exercises of the plans 

9 described in subparagraph (C) with the 

10 goal of long-term recovery results; 

11 (iii) rapidly removing, and effectively 

12 disposing of— 

13 (I) contaminated agriculture and 

14 food products; and 

15 (II) infected plants and animals; 

16 and 

17 (iv) decontaminating and restoring 

18 areas affected by an agriculture or food 

19 emergency. 

20 SEC. 110. FOOD AND AGRICULTURE COORDINATING COUN21 CILS. 

22 The Secretary of Homeland Security, in consultation 

23 with the Secretary of Health and Human Services and the 

24 Secretary of Agriculture, shall within 180 days of enact25 ment of this Act, and annually thereafter, submit to the 


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1 relevant committees of Congress, and make publicly avail2 able on the Internet Web site of the Department of Home3 land Security, a report on the activities of the Food and 

4 Agriculture Government Coordinating Council and the 

5 Food and Agriculture Sector Coordinating Council, includ6 ing the progress of such Councils on— 

7 (1) facilitating partnerships between public and 

8 private entities to help unify and enhance the protec9 tion of the agriculture and food system of the 

10 United States; 

11 (2) providing for the regular and timely inter12 change of information between each council relating 

13 to the security of the agriculture and food system 

14 (including intelligence information); 

15 (3) identifying best practices and methods for 

16 improving the coordination among Federal, State, 

17 local, and private sector preparedness and response 

18 plans for agriculture and food defense; and 

19 (4) recommending methods by which to protect 

20 the economy and the public health of the United 

21 States from the effects of— 

22 (A) animal or plant disease outbreaks; 

23 (B) food contamination; and 

24 (C) natural disasters affecting agriculture 

25 and food. 


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1 SEC. 111. AUTHORITY TO COLLECT FEES. 

2 (a) FEES FOR REINSPECTION, RECALL, AND IMPOR3 TATION ACTIVITIES.—Subchapter C of chapter VII (21 

4 U.S.C. 379f et seq.) is amended by inserting after section 

5 742 the following: 

6 ‘‘PART 6—FEES RELATED TO FOOD 

7 ‘‘SEC. 743. AUTHORITY TO COLLECT AND USE FEES. 

8 ‘‘(a) IN GENERAL.— 

9 ‘‘(1) PURPOSE AND AUTHORITY.—For fiscal 

10 year 2010 and each subsequent fiscal year, the Sec11 retary shall, in accordance with this section, assess 

12 and collect fees from— 

13 ‘‘(A) each domestic facility (as defined in 

14 section 415(b)) subject to a reinspection in such 

15 fiscal year, to cover reinspection-related costs 

16 for such year; 

17 ‘‘(B) each domestic facility (as defined in 

18 section 415(b)) and importer subject to a food 

19 recall in such fiscal year, to cover food recall ac20 tivities performed by the Secretary, including 

21 technical assistance, follow-up effectiveness 

22 checks, and public notifications, for such year; 

23 ‘‘(C) each importer participating in the 

24 voluntary qualified importer program under sec25 tion 806 in such year, to cover the administra26 tive costs such program for such year; and 


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1 ‘‘(D) each importer subject to a reinspec2 tion in such fiscal year at a port of entry, to 

3 cover reinspection-related costs at ports of entry 

4 for such year. 

5 ‘‘(2) DEFINITIONS.—For purposes of this sec6 tion— 

7 ‘‘(A) the term ‘reinspection’ means— 

8 ‘‘(i) with respect to domestic facilities 

9 (as defined in section 415(b)), 1 or more 

10 inspections conducted under section 704 

11 subsequent to an inspection conducted 

12 under such provision which identified non13 compliance materially related to a food 

14 safety requirement of this Act, specifically 

15 to determine whether compliance has been 

16 achieved to the Secretary’s satisfaction; 

17 and 

18 ‘‘(ii) with respect to importers, 1 or 

19 more examinations conducted under sec20 tion 801 subsequent to an examination 

21 conducted under such provision which 

22 identified noncompliance materially related 

23 to a food safety requirement of this Act, 

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1 ance has been achieved to the Secretary’s 

2 satisfaction; and 

3 ‘‘(B) the term ‘reinspection-related costs’ 

4 means all expenses, including administrative ex5 penses, incurred in connection with— 

6 ‘‘(i) arranging, conducting, and evalu7 ating the results of reinspections; and 

8 ‘‘(ii) assessing and collecting reinspec9 tion fees under this section. 

10 ‘‘(b) ESTABLISHMENT OF FEES.— 

11 ‘‘(1) IN GENERAL.—Subject to subsections (c) 

12 and (d), the Secretary shall establish the fees to be 

13 collected under this section for each fiscal year speci14 fied in subsection (a)(1), based on the methodology 

15 described under paragraph (2), and shall publish 

16 such fees in a Federal Register notice not later than 

17 60 days before the start of each such year. 

18 ‘‘(2) FEE METHODOLOGY.— 

19 ‘‘(A) FEES.—Fees amounts established for 

20 collection— 

21 ‘‘(i) under subparagraph (A) of sub22 section (a)(1) for a fiscal year shall be 

23 based on the Secretary’s estimate of 100 

24 percent of the costs of the reinspection-re25 lated activities (including by type or level 


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1 of reinspection activity, as the Secretary 

2 determines applicable) described in such 

3 subparagraph (A) for such year; 

4 ‘‘(ii) under subparagraph (B) of sub5 section (a)(1) for a fiscal year shall be 

6 based on the Secretary’s estimate of 100 

7 percent of the costs of the activities de8 scribed in such subparagraph (B) for such 

9 year; 

10 ‘‘(iii) under subparagraph (C) of sub11 section (a)(1) for a fiscal year shall be 

12 based on the Secretary’s estimate of 100 

13 percent of the costs of the activities de14 scribed in such subparagraph (C) for such 

15 year; and 

16 ‘‘(iv) under subparagraph (D) of sub17 section (a)(1) for a fiscal year shall be 

18 based on the Secretary’s estimate of 100 

19 percent of the costs of the activities de20 scribed in such subparagraph (D) for such 

21 year. 

22 ‘‘(B) OTHER CONSIDERATIONS.— 

23 ‘‘(i) VOLUNTARY QUALIFIED IM24 PORTER PROGRAM.— 


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1 ‘‘(I) PARTICIPATION.—In estab2 lishing the fee amounts under sub3 paragraph (A)(iii) for a fiscal year, 

4 the Secretary shall provide for the 

5 number of importers who have sub6 mitted to the Secretary a notice under 

7 section 806 informing the Secretary of 

8 the intent of such importer to partici9 pate in the program under section 

10 806 in such fiscal year. 

11 ‘‘(II) RECOUPMENT.—In estab12 lishing the fee amounts under sub13 paragraph (A)(iii) for the first 5 fiscal 

14 years after the date of enactment of 

15 this section, the Secretary shall in16 clude in such fee a reasonable sur17 charge that provides a recoupment of 

18 the costs expended by the Secretary to 

19 establish and implement the first year 

20 of the program under section 806. 

21 ‘‘(ii) CREDITING OF FEES.—In estab22 lishing the fee amounts under subpara23 graph (A) for a fiscal year, the Secretary 

24 shall provide for the crediting of fees from 

25 the previous year to the next year if the 


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1 Secretary overestimated the amount of fees 

2 needed to carry out such activities, and 

3 consider the need to account for any ad4 justment of fees and such other factors as 

5 the Secretary determines appropriate. 

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

7 all of the fees collected pursuant to clause (i), (ii), 

8 (iii), and (iv) of paragraph (2)(A) available solely to 

9 pay for the costs referred to in such clause (i), (ii), 

10 (iii), and (iv) of paragraph (2)(A), respectively. 

11 ‘‘(4) COMPLIANCE WITH INTERNATIONAL

12 AGREEMENTS.—Nothing in this section shall be con13 strued to authorize the assessment of any fee incon14 sistent with the agreement establishing the World 

15 Trade Organization or any other treaty or inter16 national agreement to which the United States is a 

17 party. 

18 ‘‘(c) LIMITATIONS.— 

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

20 shall be refunded for a fiscal year beginning after 

21 fiscal year 2010 unless appropriations for the Center 

22 for Food Safety and Applied Nutrition and the Cen23 ter for Veterinary Medicine and related activities of 

24 the Office of Regulatory Affairs at the Food and 

25 Drug Administration for such fiscal year (excluding 


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1 the amount of fees appropriated for such fiscal year) 

2 are equal to or greater than the amount of appro3 priations for the Center for Food Safety and Applied 

4 Nutrition and the Center for Veterinary Medicine 

5 and related activities of the Office of Regulatory Af6 fairs at the Food and Drug Administration for the 

7 preceding fiscal year (excluding the amount of fees 

8 appropriated for such fiscal year) multiplied by 1 

9 plus 4.5 percent. 

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

11 assess fees under subsection (a) during any portion 

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

13 a later date in such fiscal year the Secretary may as14 sess such fees, the Secretary may assess and collect 

15 such fees, without any modification in the rate, 

16 under subsection (a), notwithstanding the provisions 

17 of subsection (a) relating to the date fees are to be 

18 paid. 

19 ‘‘(3) LIMITATION ON AMOUNT OF CERTAIN

20 FEES.— 

21 ‘‘(A) IN GENERAL.—Notwithstanding any 

22 other provision of this section and subject to 

23 subparagraph (B), the Secretary may not col24 lect fees in a fiscal year such that the amount 

25 collected— 


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1 ‘‘(i) under subparagraph (B) of sub2 section (a)(1) exceeds $20,000,000; and 

3 ‘‘(ii) under subparagraphs (A) and 

4 (D) of subsection (a)(1) exceeds 

5 $25,000,000 combined. 

6 ‘‘(B) EXCEPTION.—If a domestic facility 

7 (as defined in section 415(b)) or an importer 

8 becomes subject to a fee described in subpara9 graph (A), (B), or (D) of subsection (a)(1) 

10 after the maximum amount of fees has been 

11 collected by the Secretary under subparagraph 

12 (A), the Secretary may collect a fee from such 

13 facility or importer. 

14 ‘‘(d) CREDITING AND AVAILABILITY OF FEES.—Fees 

15 authorized under subsection (a) shall be collected and 

16 available for obligation only to the extent and in the 

17 amount provided in appropriations Acts. Such fees are au18 thorized to remain available until expended. Such sums 

19 as may be necessary may be transferred from the Food 

20 and Drug Administration salaries and expenses account 

21 without fiscal year limitation to such appropriation ac22 count for salaries and expenses with such fiscal year limi23 tation. The sums transferred shall be available solely for 

24 the purpose of paying the operating expenses of the Food 


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1 and Drug Administration employees and contractors per2 forming activities associated with these food safety fees. 

3 ‘‘(e) COLLECTION OF FEES.— 

4 ‘‘(1) IN GENERAL.—The Secretary shall specify 

5 in the Federal Register notice described in sub6 section (b)(1) the time and manner in which fees as7 sessed under this section shall be collected. 

8 ‘‘(2) COLLECTION OF UNPAID FEES.—In any 

9 case where the Secretary does not receive payment 

10 of a fee assessed under this section within 30 days 

11 after it is due, such fee shall be treated as a claim 

12 of the United States Government subject to provi13 sions of subchapter II of chapter 37 of title 31, 

14 United States Code. 

15 ‘‘(f) ANNUAL REPORT TO CONGRESS.—Not later 

16 than 120 days after each fiscal year for which fees are 

17 assessed under this section, the Secretary shall submit a 

18 report to the Committee on Health, Education, Labor, and 

19 Pensions of the United States Senate and the Committee 

20 on Energy and Commerce of the United States House of 

21 Representatives, to include a description of fees assessed 

22 and collected for each such year and a summary descrip23 tion of the entities paying such fees and the types of busi24 ness in which such entities engage. 


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1 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—For fis2 cal year 2010 and each fiscal year thereafter, there is au3 thorized to be appropriated for fees under this section an 

4 amount equal to the total revenue amount determined 

5 under subsection (b) for the fiscal year, as adjusted or 

6 otherwise affected under the other provisions of this sec7 tion.’’. 

8 (b) EXPORT CERTIFICATION FEES FOR FOODS AND

9 ANIMAL FEED.— 

10 (1) AUTHORITY FOR EXPORT CERTIFICATIONS

11 FOR FOOD, INCLUDING ANIMAL FEED.—Section 

12 801(e)(4)(A) (21 U.S.C. 381(e)(4)(A)) is amend13 ed— 

14 (A) in the matter preceding clause (i), by 

15 striking ‘‘a drug’’ and inserting ‘‘a food, drug’’; 

16 (B) in clause (i), by striking ‘‘exported 

17 drug’’ and inserting ‘‘exported food, drug’’; and 

18 (C) in clause (ii), by striking ‘‘the drug’’ 

19 each place it appears and inserting ‘‘the food, 

20 drug’’. 

21 (2) CLARIFICATION OF CERTIFICATION.—Sec22 tion 801(e)(4) (21 U.S.C. 381(e)(4)) is amended by 

23 inserting after subparagraph (B) the following new 

24 subparagraph: 


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1 ‘‘(C) For purposes of this paragraph, a 

2 certification by the Secretary shall be made on 

3 such basis, and in such form (including a pub4 licly available listing) as the Secretary deter5 mines appropriate.’’. 

6 TITLE II—DETECTION AND 

7 SURVEILLANCE 

8 SEC. 201. RECOGNITION OF LABORATORY ACCREDITATION 

9 FOR ANALYSES OF FOODS. 

10 (a) IN GENERAL.—Chapter IV (21 U.S.C. 341 et 

11 seq.), as amended by section 107, is amended by adding 

12 at the end the following: 

13 ‘‘SEC. 422. RECOGNITION OF LABORATORY ACCREDITATION 

14 FOR ANALYSES OF FOODS. 

15 ‘‘(a) RECOGNITION OF LABORATORY ACCREDITA16 TION.— 

17 ‘‘(1) IN GENERAL.—Not later than 2 years 

18 after the date of enactment of this section, the Sec19 retary shall— 

20 ‘‘(A) provide for the recognition of accredi21 tation bodies that accredit laboratories, includ22 ing laboratories run and operated by a State or 

23 locality, with a demonstrated capability to con24 duct analytical testing of food products; and 


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1 ‘‘(B) establish a publicly available registry 

2 of accreditation bodies, including the name of, 

3 contact information for, and other information 

4 deemed necessary by the Secretary about such 

5 bodies. 

6 ‘‘(2) MODEL ACCREDITATION STANDARDS.— 

7 The Secretary shall develop model standards that an 

8 accreditation body shall require laboratories to meet 

9 in order to be included in the registry provided for 

10 under paragraph (1). In developing the model stand11 ards, the Secretary shall look to existing standards 

12 for guidance. The model standards shall include 

13 methods to ensure that— 

14 ‘‘(A) appropriate sampling and analytical 

15 procedures are followed and reports of analyses 

16 are certified as true and accurate; 

17 ‘‘(B) internal quality systems are estab18 lished and maintained; 

19 ‘‘(C) procedures exist to evaluate and re20 spond promptly to complaints regarding anal21 yses and other activities for which the labora22 tory is recognized; 

23 ‘‘(D) individuals who conduct the analyses 

24 are qualified by training and experience to do 

25 so; and 


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1 ‘‘(E) any other criteria determined appro2 priate by the Secretary. 

3 ‘‘(3) REVIEW OF ACCREDITATION.—To assure 

4 compliance with the requirements of this section, the 

5 Secretary shall— 

6 ‘‘(A) periodically, or at least every 5 years, 

7 reevaluate accreditation bodies recognized under 

8 paragraph (1); and 

9 ‘‘(B) promptly revoke the recognition of 

10 any accreditation body found not to be in com11 pliance with the requirements of this section. 

12 ‘‘(b) TESTING PROCEDURES.—Food testing shall be 

13 conducted by either Federal laboratories or non-Federal 

14 laboratories that have been accredited by an accreditation 

15 body on the registry established by the Secretary under 

16 subsection (a) whenever such testing— 

17 ‘‘(1) is either conducted by or on behalf of an 

18 owner or consignee— 

19 ‘‘(A) in support of admission of an article 

20 of food under section 801(a); or 

21 ‘‘(B) under an Import Alert that requires 

22 successful consecutive tests; or 

23 ‘‘(2) is required by the Secretary as the Sec24 retary deems appropriate to identify or address a 


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1 threat of serious adverse health consequences or 

2 death to humans or animals. 

3 The results of any such testing shall be sent directly to 

4 the Food and Drug Administration. 

5 ‘‘(c) REVIEW BY SECRETARY.—If food testing per6 formed by a laboratory run and operated by a State or 

7 locality that is accredited by an accreditation body on the 

8 registry established by the Secretary under subsection (a) 

9 result in a State recalling a food, the Secretary shall re10 view the testing results for the purpose of determining the 

11 need for a national recall or other compliance and enforce12 ment activities.’’. 

13 (b) FOOD EMERGENCY RESPONSE NETWORK.—The 

14 Secretary, in coordination with the Secretary of Agri15 culture, the Secretary of Homeland Security, and State, 

16 local, and tribal governments shall, not later than 180 

17 days after the date of enactment of this Act, and biennially 

18 thereafter, submit to the relevant committees of Congress, 

19 and make publicly available on the Internet Web site of 

20 the Department of Health and Human Services, a report 

21 on the progress in implementing a national food emer22 gency response laboratory network that— 

23 (1) provides ongoing surveillance, rapid detec24 tion, and surge capacity for large-scale food-related 


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1 emergencies, including intentional adulteration of 

2 the food supply; 

3 (2) coordinates the food laboratory capacities of 

4 State food laboratories, including the sharing of data 

5 between State laboratories to develop national situa6 tional awareness; 

7 (3) provides accessible, timely, accurate, and 

8 consistent food laboratory services throughout the 

9 United States; 

10 (4) develops and implements a methods reposi11 tory for use by Federal, State, and local officials; 

12 (5) responds to food-related emergencies; and 

13 (6) is integrated with relevant laboratory net14 works administered by other Federal agencies. 

15 SEC. 202. INTEGRATED CONSORTIUM OF LABORATORY 

16 NETWORKS. 

17 (a) IN GENERAL.—The Secretary of Homeland Secu18 rity, in consultation with the Secretary of Health and 

19 Human Services, the Secretary of Agriculture, and the 

20 Administrator of the Environmental Protection Agency, 

21 shall maintain an agreement through which relevant lab22 oratory network members, as determined by the Secretary 

23 of Homeland Security, shall— 

24 (1) agree on common laboratory methods in 

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1 formation relating to animal health, agriculture, and 

2 human health; 

3 (2) identify the means by which each laboratory 

4 network member could work cooperatively— 

5 (A) to optimize national laboratory pre6 paredness; and 

7 (B) to provide surge capacity during emer8 gencies; and 

9 (3) engage in ongoing dialogue and build rela10 tionships that will support a more effective and inte11 grated response during emergencies. 

12 (b) REPORTING REQUIREMENT.—The Secretary of 

13 Homeland Security shall, on a biennial basis, submit to 

14 the relevant committees of Congress, and make publicly 

15 available on the Internet Web site of the Department of 

16 Homeland Security, a report on the progress of the inte17 grated consortium of laboratory networks, as established 

18 under subsection (a), in carrying out this section. 

19 SEC. 203. BUILDING DOMESTIC CAPACITY. 

20 (a) IN GENERAL.— 

21 (1) INITIAL REPORT.—The Secretary shall, not 

22 later than 2 years after the date of enactment of 

23 this Act, submit to Congress a comprehensive report 

24 that identifies programs and practices that are in25 tended to promote the safety and security of food 


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1 and to prevent outbreaks of food-borne illness and 

2 other food-related hazards that can be addressed 

3 through preventive activities. Such report shall in4 clude a description of the following: 

5 (A) Analysis of the need for regulations or 

6 guidance to industry. 

7 (B) Outreach to food industry sectors, in8 cluding through the Food and Agriculture Co9 ordinating Councils referred to in section 111, 

10 to identify potential sources of emerging threats 

11 to the safety and security of the food supply 

12 and preventive strategies to address those 

13 threats. 

14 (C) Systems to ensure the prompt distribu15 tion to the food industry of information and 

16 technical assistance concerning preventive strat17 egies. 

18 (D) Communication systems to ensure that 

19 information about specific threats to the safety 

20 and security of the food supply are rapidly and 

21 effectively disseminated. 

22 (E) Surveillance systems and laboratory 

23 networks to rapidly detect and respond to food24 borne illness outbreaks and other food-related 


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1 hazards, including how such systems and net2 works are integrated. 

3 (F) Outreach, education, and training pro4 vided to States to build State food safety and 

5 food defense capabilities, including progress im6 plementing strategies developed under sections 

7 109 and 205. 

8 (G) The estimated resources needed to ef9 fectively implement the programs and practices 

10 identified in the report developed in this section 

11 over a 5-year period. 

12 (2) BIENNIAL REPORTS.—On a biennial basis 

13 following the submission of the report under para14 graph (1), the Secretary shall submit to Congress a 

15 report that— 

16 (A) reviews previous food safety programs 

17 and practices; 

18 (B) outlines the success of those programs 

19 and practices; 

20 (C) identifies future programs and prac21 tices; and 

22 (D) includes information related to any 

23 matter described in subparagraphs (A) through 

24 (G) of paragraph (1), as necessary. 


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1 (b) RISK-BASED ACTIVITIES.—The report developed 

2 under subsection (a)(1) shall describe methods that seek 

3 to ensure that resources available to the Secretary for food 

4 safety-related activities are directed at those actions most 

5 likely to reduce risks from food, including the use of pre6 ventive strategies and allocation of inspection resources. 

7 The Secretary shall promptly undertake those risk-based 

8 actions that are identified during the development of the 

9 report as likely to contribute to the safety and security 

10 of the food supply. 

11 (c) CAPABILITY FOR LABORATORY ANALYSES; RE12 SEARCH.—The report developed under subsection (a)(1) 

13 shall provide a description of methods to increase capacity 

14 to undertake analyses of food samples promptly after col15 lection, to identify new and rapid analytical techniques, 

16 including techniques that can be employed at ports of 

17 entry and through Food Emergency Response Network 

18 laboratories, and to provide for well-equipped and staffed 

19 laboratory facilities. 

20 (d) INFORMATION TECHNOLOGY.—The report devel21 oped under subsection (a)(1) shall include a description 

22 of such information technology systems as may be needed 

23 to identify risks and receive data from multiple sources, 

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1 oratories, laboratory networks, and consumers. The infor2 mation technology systems that the Secretary describes 

3 shall also provide for the integration of the facility reg4 istration system under section 415 of the Federal Food, 

5 Drug, and Cosmetic Act (21 U.S.C. 350d), and the prior 

6 notice system under section 801(m) of such Act (21 

7 U.S.C. 381(m)) with other information technology systems 

8 that are used by the Federal Government for the proc9 essing of food offered for import into the United States. 

10 (e) AUTOMATED RISK ASSESSMENT.—The report de11 veloped under subsection (a)(1) shall include a description 

12 of progress toward developing and improving an auto13 mated risk assessment system for food safety surveillance 

14 and allocation of resources. 

15 (f) TRACEBACK AND SURVEILLANCE REPORT.—The 

16 Secretary shall include in the report developed under sub17 section (a)(1) an analysis of the Food and Drug Adminis18 tration’s performance in food-borne illness outbreaks dur19 ing the 5-year period preceding the date of enactment of 

20 this Act involving fruits and vegetables that are raw agri21 cultural commodities (as defined in section 201(r) of the 

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

23 321(r))) and recommendations for enhanced surveillance, 

24 outbreak response, and traceability. Such findings and 

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1 nation with the public and industry, outbreak identifica2 tion, and traceback. 

3 (g) BIENNIAL FOOD SAFETY AND FOOD DEFENSE

4 RESEARCH PLAN.—The Secretary and the Secretary of 

5 Agriculture shall, on a biennial basis, submit to Congress 

6 a joint food safety and food defense research plan which 

7 may include studying the long-term health effects of food8 borne illness. Such biennial plan shall include a list and 

9 description of projects conducted during the previous 2- 

10 year period and the plan for projects to be conducted dur11 ing the following 2-year period. 

12 SEC. 204. ENHANCING TRACEBACK AND RECORDKEEPING. 

13 (a) IN GENERAL.—The Secretary, in consultation 

14 with the Secretary of Agriculture and representatives of 

15 State departments of health and agriculture, shall improve 

16 the capacity of the Secretary to effectively and rapidly 

17 track and trace, in the event of an outbreak, fruits and 

18 vegetables that are raw agricultural commodities. 

19 (b) PILOT PROJECT.— 

20 (1) IN GENERAL.—Not later than 12 months 

21 after the date of enactment of this Act, the Sec22 retary shall establish a pilot project in coordination 

23 with the produce industry to explore and evaluate 

24 new methods for rapidly and effectively tracking and 

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1 tural commodities so that, if an outbreak occurs in2 volving such a fruit or vegetable, the Secretary may 

3 quickly identify the source of the outbreak and the 

4 recipients of the contaminated food. 

5 (2) CONTENT.—The Secretary shall select par6 ticipants from the produce industry to run projects 

7 which overall shall include at least 3 different types 

8 of fruits or vegetables that have been the subject of 

9 outbreaks during the 10-year period preceding the 

10 date of enactment of this Act, and shall be selected 

11 in order to develop and demonstrate— 

12 (A) methods that are applicable and appro13 priate for small businesses; and 

14 (B) technologies, including existing tech15 nologies, that enhance traceback and trace for16 ward. 

17 (c) REPORT.—Not later than 18 months after the 

18 date of enactment of this Act, the Secretary shall report 

19 to Congress on the findings of the pilot project under sub20 section (b) together with recommendations for establishing 

21 more effective traceback and trace forward procedures for 

22 fruits and vegetables that are raw agricultural commod23 ities. 

24 (d) TRACEBACK PERFORMANCE REQUIREMENTS.— 

25 Not later than 24 months after the date of enactment of 


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1 this Act, the Secretary shall publish a notice of proposed 

2 rulemaking to establish standards for the type of informa3 tion, format, and timeframe for persons to submit records 

4 to aid the Secretary in effectively and rapidly tracking and 

5 tracing, in the event of an outbreak, fruits and vegetables 

6 that are raw agricultural commodities. Nothing in this sec7 tion shall be construed as giving the Secretary the author8 ity to prescribe specific technologies for the maintenance 

9 of records. 

10 (e) PUBLIC INPUT.—During the comment period in 

11 the notice of proposed rulemaking under subsection (d), 

12 the Secretary shall conduct not less than 3 public meetings 

13 in diverse geographical areas of the United States to pro14 vide persons in different regions an opportunity to com15 ment. 

16 (f) RAW AGRICULTURAL COMMODITY.—In this sec17 tion, the term ‘‘raw agricultural commodity’’ has the 

18 meaning given that term in section 201(r) of the Federal 

19 Food, Drug, and Cosmetic Act (21 U.S.C. 321(r)). 

20 SEC. 205. SURVEILLANCE. 

21 (a) DEFINITION OF FOOD-BORNE ILLNESS OUT22 BREAK.—In this section, the term ‘‘food-borne illness out23 break’’ means the occurrence of 2 or more cases of a simi24 lar illness resulting from the ingestion of a food. 


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1 (b) FOOD-BORNE ILLNESS SURVEILLANCE SYS2 TEMS.— 

3 (1) IN GENERAL.—The Secretary, acting 

4 through the Director of the Centers for Disease 

5 Control and Prevention, shall enhance food-borne ill6 ness surveillance systems to improve the collection, 

7 analysis, reporting, and usefulness of data on food8 borne illnesses by— 

9 (A) coordinating Federal, State and local 

10 food-borne illness surveillance systems, includ11 ing complaint systems, and increasing participa12 tion in national networks of public health and 

13 food regulatory agencies and laboratories; 

14 (B) facilitating sharing of findings on a 

15 more timely basis among governmental agen16 cies, including the Food and Drug Administra17 tion, the Department of Agriculture, and State 

18 and local agencies, and with the public; 

19 (C) ensuring early notification to the af20 fected food industry when a particular food may 

21 be suspected in the outbreak and sharing of all 

22 relevant data with the affected food industry 

23 during the course of the investigation; 


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1 (D) developing improved epidemiological 

2 tools for obtaining quality exposure data, and 

3 microbiological methods for classifying cases; 

4 (E) augmenting such systems to improve 

5 attribution of a food-borne illness outbreak to a 

6 specific food; 

7 (F) expanding capacity of such systems, 

8 including working toward automatic electronic 

9 searches, for implementation of fingerprinting 

10 strategies for food-borne infectious agents, in 

11 order to identify new or rarely documented 

12 causes of food-borne illness and submit stand13 ardized information to a centralized database; 

14 (G) allowing timely public access to aggre15 gated, de-identified surveillance data; 

16 (H) at least annually, publishing current 

17 reports on findings from such systems; 

18 (I) establishing a flexible mechanism for 

19 rapidly initiating scientific research by academic 

20 institutions; 

21 (J) integrating food-borne illness surveil22 lance systems and data with other biosurveil23 lance and public health situational awareness 

24 capabilities at the state and federal levels; and 


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1 (K) other activities as determined appro2 priate by the Secretary. 

3 (2) ADVISORY GROUP ON IMPROVING

4 FOODBORNE ILLNESS SURVEILLANCE AND OUT5 BREAK INVESTIGATIONS.— 

6 (A) IN GENERAL.—The Secretary shall 

7 support and maintain a diverse working group 

8 of experts and stakeholders from Federal, 

9 State, and local food safety and health agencies, 

10 the food industry, consumer organizations, and 

11 academia. Such working group shall provide the 

12 Secretary, through at least annual meetings of 

13 the working group and an annual public report, 

14 advice and recommendations on an ongoing and 

15 regular basis regarding the improvement of 

16 food-borne illness surveillance, outbreak inves17 tigation, and implementation of this section, in18 cluding advice and recommendations on— 

19 (i) the priority needs of regulatory 

20 agencies, the food industry, and consumers 

21 for information and analysis on food-borne 

22 illness and its causes; 

23 (ii) the priority needs of regulatory 

24 agencies, the food industry, and consumers 

25 for information and analysis on outbreak 


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1 investigations that can be used to improve 

2 the line of authority and accountability; 

3 (iii) opportunities to improve the ef4 fectiveness of initiatives at the Federal, 

5 State, and local levels, including coordina6 tion and integration of activities among 

7 Federal agencies, and between the Federal, 

8 State, and local levels of government; 

9 (iv) improvement in the timeliness and 

10 depth of access by regulatory and health 

11 agencies, the food industry, academic re12 searchers, and consumers to food-borne ill13 ness surveillance data and food recall sur14 vey data collected by government agencies 

15 at all levels, including data compiled by the 

16 Centers for Disease Control and Preven17 tion; 

18 (v) key barriers to improvement in 

19 food-borne illness surveillance and its util20 ity for preventing food-borne illness at 

21 Federal, State, and local levels; 

22 (vi) the capabilities needed for estab23 lishing automatic electronic searches of 

24 surveillance data; and 


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1 (vii) specific actions to reduce barriers 

2 to improvement, implement the working 

3 group’s recommendations, and achieve the 

4 purposes of this section, with measurable 

5 objectives and timelines, and identification 

6 of resource and staffing needs. 

7 (3) ADDITIONAL DUTIES.—The Secretary shall 

8 also utilize the working group under paragraph (1) 

9 to assist in outbreak investigations as deemed appro10 priate. 

11 (c) IMPROVING FOOD SAFETY AND DEFENSE CAPAC12 ITY AT THE STATE AND LOCAL LEVEL.— 

13 (1) IN GENERAL.—The Secretary shall develop 

14 and implement strategies to leverage and enhance 

15 the food safety and defense capacities of State and 

16 local agencies in order to achieve the following goals: 

17 (A) Improve food-borne illness outbreak re18 sponse and containment. 

19 (B) Accelerate food-borne illness surveil20 lance and outbreak investigation, including 

21 rapid shipment of clinical isolates from clinical 

22 laboratories to appropriate State laboratories, 

23 and conducting more standardized illness out24 break interviews. 


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1 (C) Strengthen the capacity of State and 

2 local agencies to carry out inspections and en3 force safety standards. 

4 (D) Improve the effectiveness of Federal5 State partnerships to coordinate food safety 

6 and defense resources and reduce the incidence 

7 of food-borne illness. 

8 (E) Share information on a timely basis 

9 among public health and food regulatory agen10 cies, with the food industry, with health care 

11 providers, and with the public. 

12 (F) Strengthen the capacity of State and 

13 local agencies to achieve the goals described in 

14 section 109. 

15 (2) REVIEW.—In developing of the strategies 

16 required by paragraph (1), the Secretary shall, not 

17 later than 1 year after the date of enactment of this 

18 Act, complete a review of State and local capacities, 

19 and needs for enhancement, which may include a 

20 survey with respect to— 

21 (A) staffing levels and expertise available 

22 to perform food safety and defense functions; 

23 (B) laboratory capacity to support surveil24 lance, outbreak response, inspection, and en25 forcement activities; 


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1 (C) information systems to support data 

2 management and sharing of food safety and de3 fense information among State and local agen4 cies and with counterparts at the Federal level; 

5 and 

6 (D) other State and local activities and 

7 needs as determined appropriate by the Sec8 retary. 

9 (d) FOOD SAFETY CAPACITY BUILDING GRANTS.— 

10 Section 317R(b) of the Public Health Service Act (42 

11 U.S.C. 247b–20(b)) is amended— 

12 (1) by striking ‘‘2002’’ and inserting ‘‘2010’’; 

13 and 

14 (2) by striking ‘‘2003 through 2006’’ and in15 serting ‘‘2011 through 2014’’. 

16 TITLE III—SPECIFIC PROVI17 SIONS FOR IMPORTED FOOD 

18 SEC. 301. FOREIGN SUPPLIER VERIFICATION PROGRAM. 

19 (a) IN GENERAL.—Chapter VIII (21 U.S.C. 381 et 

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

21 ‘‘SEC. 805. FOREIGN SUPPLIER VERIFICATION PROGRAM. 

22 ‘‘(a) IN GENERAL.— 

23 ‘‘(1) VERIFICATION REQUIREMENT.—Each 

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1 cordance with regulations promulgated under sub2 section (c) for the purpose of verifying that the food 

3 imported by the importer of record or its agent is— 

4 ‘‘(A) produced in compliance with the re5 quirements of section 419 or 420, as appro6 priate; and 

7 ‘‘(B) is not adulterated under section 402 

8 or misbranded under section 403(w). 

9 ‘‘(2) IMPORTER EXCLUSION.—For purposes of 

10 this section, an ‘importer of record’ shall not include 

11 a person holding a valid license under section 641 of 

12 the Tariff Act of 1930 (19 U.S.C. 1641) (referred 

13 to as a ‘customs broker’) if the customs broker has 

14 executed a written agreement with another person 

15 who has agreed to comply with the requirements of 

16 this section with regard to food imported or offered 

17 for import by the customs broker. 

18 ‘‘(b) GUIDANCE.—Not later than 270 days after the 

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

20 issue guidance to assist United States importers of record 

21 in developing foreign supplier verification programs. 

22 ‘‘(c) REGULATIONS.— 

23 ‘‘(1) IN GENERAL.—Not later than 1 year after 

24 issuing guidance under subsection (b), the Secretary 

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1 tent of the foreign supplier verification program es2 tablished under subsection (a). Such regulations 

3 shall, as appropriate, include a process for 

4 verification by a United States importer of record, 

5 with respect to each foreign supplier from which it 

6 obtains food, that the imported food is produced in 

7 compliance with the requirements of section 419 or 

8 420, as appropriate, and is not adulterated under 

9 section 402 or misbranded under section 403(w). 

10 ‘‘(2) VERIFICATION.—The regulations under 

11 paragraph (1) shall require that the foreign supplier 

12 verification program of each importer of record be 

13 adequate to provide assurances that each foreign 

14 supplier to the importer of record produces the im15 ported food employing processes and procedures, in16 cluding risk-based reasonably appropriate preventive 

17 controls, that are documented in a written plan 

18 under subsection (d) and equivalent in preventing 

19 adulteration and reducing hazards as those required 

20 by section 419 or section 420, as appropriate. 

21 ‘‘(3) ACTIVITIES.—Verification activities under 

22 a foreign supplier verification program under this 

23 section may include monitoring records for ship24 ments, lot-by-lot certification of compliance, annual 

25 on-site inspections, checking the hazard analysis and 


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1 risk-based preventive control plan of the foreign sup2 plier, and periodically testing and sampling ship3 ments. 

4 ‘‘(d) RECORD MAINTENANCE AND ACCESS.—Each 

5 facility required to be registered under section 415 that 

6 is, as determined by the Secretary, a high-risk facility 

7 shall submit to the Secretary a written plan that docu8 ments and describes its hazard analysis and preventative 

9 control procedures. The Secretary or a duly authorized 

10 representative of the Secretary may review the plan and 

11 may make recommendations to improve the effectiveness 

12 of the plan in preventing or minimizing the threat of seri13 ous adverse health consequences or death to humans or 

14 animals. Records of all United States importers related 

15 to a foreign supplier verification program shall be main16 tained for a period of not less than 2 years and shall be 

17 made available promptly to a duly authorized representa18 tive of the Secretary upon request. 

19 ‘‘(e) DEEMED COMPLIANCE OF SEAFOOD, JUICE, 

20 AND LOW-ACID CANNED FOOD FACILITIES IN COMPLI21 ANCE WITH HACCP.—An owner, operator, or agent in 

22 charge of a facility required to comply with 1 of the fol23 lowing standards and regulations with respect to such fa24 cility shall be deemed to be in compliance with this section 

25 with respect to such facility: 


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1 ‘‘(1) The Seafood Hazard Analysis Critical 

2 Control Points Program of the Food and Drug Ad3 ministration. 

4 ‘‘(2) The Juice Hazard Analysis Critical Con5 trol Points Program of the Food and Drug Adminis6 tration. 

7 ‘‘(3) The Thermally Processed Low-Acid Foods 

8 Packaged in Hermetically Sealed Containers stand9 ards of the Food and Drug Administration (or any 

10 successor standards). 

11 ‘‘(f) PUBLICATION OF LIST OF PARTICIPANTS.—The 

12 Secretary shall publish and maintain on the Internet Web 

13 site of the Food and Drug Administration a current list 

14 that includes the name of, location of, and other informa15 tion deemed necessary by the Secretary about, importers 

16 participating under this section.’’. 

17 (b) PROHIBITED ACT.—Section 301 (21 U.S.C. 331), 

18 as amended by section 106, is amended by adding at the 

19 end the following: 

20 ‘‘(rr) The importation or offering for importation of 

21 a food if the importer of record does not have in place 

22 a foreign supplier verification program in compliance with 

23 section 805.’’. 


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

2 amended by adding ‘‘or the importer of record is in viola3 tion of section 805’’ after ‘‘or in violation of section 505’’. 

4 (d) EFFECTIVE DATE.—The amendments made by 

5 this section shall take effect 2 years after the date of en6 actment of this Act. 

7 SEC. 302. VOLUNTARY QUALIFIED IMPORTER PROGRAM. 

8 Chapter VIII (21 U.S.C. 381 et seq.), as amended 

9 by section 301, is amended by adding at the end the fol10 lowing: 

11 ‘‘SEC. 806. VOLUNTARY QUALIFIED IMPORTER PROGRAM. 

12 ‘‘(a) IN GENERAL.—Beginning not later than 1 year 

13 after the date of enactment of this section, the Secretary 

14 shall— 

15 ‘‘(1) establish a program, in consultation with 

16 the Department of Homeland Security, to provide 

17 for the expedited review and importation of food of18 fered for importation by United States importers 

19 who have voluntarily agreed to participate in such 

20 program; and 

21 ‘‘(2) issue a guidance document related to par22 ticipation and compliance with such program. 

23 ‘‘(b) VOLUNTARY PARTICIPATION.—An importer may 

24 request the Secretary to provide for the expedited review 


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1 and importation of designated foods in accordance with 

2 the program procedures established by the Secretary. 

3 ‘‘(c) ELIGIBILITY.—In order to be eligible, an im4 porter shall be offering food for importation from a facility 

5 that has a certification described in section 809(b). In re6 viewing the applications and making determinations on 

7 such requests, the Secretary shall consider the risk of the 

8 food to be imported based on factors, such as the fol9 lowing: 

10 ‘‘(1) The nature of the food to be imported. 

11 ‘‘(2) The compliance history of the foreign sup12 plier. 

13 ‘‘(3) The capability of the regulatory system of 

14 the country of export to ensure compliance with 

15 United States food safety standards. 

16 ‘‘(4) The compliance of the importer with the 

17 requirements of section 805. 

18 ‘‘(5) The recordkeeping, testing, inspections 

19 and audits of facilities, traceability of articles of 

20 food, temperature controls, and sourcing practices of 

21 the importer. 

22 ‘‘(6) The potential risk for intentional adultera23 tion of the food. 

24 ‘‘(7) Any other factor that the Secretary deter25 mines appropriate. 


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1 ‘‘(d) REVIEW AND REVOCATION.—Any importer 

2 qualified by the Secretary in accordance with the eligibility 

3 criteria set forth in this section shall be reevaluated not 

4 less often than once every 3 years and the Secretary shall 

5 promptly revoke the qualified importer status of any im6 porter found not to be in compliance with such criteria. 

7 ‘‘(e) DEFINITION.—For purposes of this section, the 

8 term ‘importer’ means the person that brings food, or 

9 causes food to be brought, from a foreign country into the 

10 customs territory of the United States.’’. 

11 SEC. 303. AUTHORITY TO REQUIRE IMPORT CERTIFI12 CATIONS FOR FOOD. 

13 (a) IN GENERAL.—Section 801(a) (21 U.S.C. 

14 381(a)) is amended by inserting after the third sentence 

15 the following: ‘‘With respect to an article of food, if impor16 tation of such food is subject to, but not compliant with, 

17 the requirement under subsection (p) that such food be 

18 accompanied by a certification or other assurance that the 

19 food meets some or all applicable requirements of this Act, 

20 then such article shall be refused admission.’’. 

21 (b) ADDITION OF CERTIFICATION REQUIREMENT.— 

22 Section 801 (21 U.S.C. 381) is amended by adding at the 

23 end the following new subsection: 

24 ‘‘(p) CERTIFICATIONS CONCERNING IMPORTED

25 FOODS.— 


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1 ‘‘(1) IN GENERAL.—The Secretary, based on 

2 public health considerations, including risks associ3 ated with the food or its place of origin, may require 

4 as a condition of granting admission to an article of 

5 food imported or offered for import into the United 

6 States, that an entity specified in paragraph (2) pro7 vide a certification or such other assurances as the 

8 Secretary determines appropriate that the article of 

9 food complies with some or all applicable require10 ments of this Act, as specified by the Secretary. 

11 Such certification or assurances may be provided in 

12 the form of shipment-specific certificates, a listing of 

13 certified entities, or in such other form as the Sec14 retary may specify. Such certification shall be used 

15 for designated food imported from countries with 

16 which the Food and Drug Administration has an 

17 agreement to establish a certification program. 

18 ‘‘(2) CERTIFYING ENTITIES.—For purposes of 

19 paragraph (1), entities that shall provide the certifi20 cation or assurances described in such paragraph 

21 are— 

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

23 government of the country from which the arti24 cle of food at issue originated, as designated by 

25 such government or the Secretary; or 


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1 ‘‘(B) such other persons or entities accred2 ited pursuant to section 809 to provide such 

3 certification or assurance. 

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

6 ‘‘(A) require that any certification or other 

7 assurance provided by an entity specified in 

8 paragraph (2) be renewed by such entity at 

9 such times as the Secretary determines appro10 priate; and 

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

12 assurance if the Secretary determines that such 

13 certification or assurance is no longer valid or 

14 reliable. 

15 ‘‘(4) ELECTRONIC SUBMISSION.—The Secretary 

16 shall provide for the electronic submission of certifi17 cations under this subsection.’’. 

18 (c) CONFORMING TECHNICAL AMENDMENT.—Sec19 tion 801(b) (21 U.S.C. 381(b)) is amended in the second 

20 sentence by striking ‘‘with respect to an article included 

21 within the provision of the fourth sentence of subsection 

22 (a)’’ and inserting ‘‘with respect to an article described 

23 in subsection (a) relating to the requirements of sections 

24 760 or 761,’’. 


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1 (d) NO LIMIT ON AUTHORITY.—Nothing in the 

2 amendments made by this section shall limit the authority 

3 of the Secretary to conduct random inspections of im4 ported food or to take such other steps as the Secretary 

5 deems appropriate to determine the admissibility of im6 ported food. 

7 SEC. 304. PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS. 

8 (a) IN GENERAL.—Section 801(m)(1) (21 U.S.C. 

9 381(m)(1)) is amended by inserting ‘‘any country to which 

10 the article has been refused entry;’’ after ‘‘the country 

11 from which the article is shipped;’’. 

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

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

14 an interim final rule amending subpart I of part 1 of title 

15 21, Code of Federal Regulations, to implement the amend16 ment made by this section. 

17 (c) EFFECTIVE DATE.—The amendment made by 

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

19 enactment of this Act. 

20 SEC. 305. REVIEW OF A REGULATORY AUTHORITY OF A 

21 FOREIGN COUNTRY. 

22 Chapter VIII (21 U.S.C. 381 et seq.), as amended 

23 by section 302, is amended by adding at the end the fol24 lowing: 


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1 ‘‘SEC. 807. REVIEW OF A REGULATORY AUTHORITY OF A 

2 FOREIGN COUNTRY. 

3 ‘‘The Secretary may review information from a coun4 try outlining the statutes, regulations, standards, and con5 trols of such country, and conduct on-site audits in such 

6 country to verify the implementation of those statutes, 

7 regulations, standards, and controls. Based on such re8 view, the Secretary shall determine whether such country 

9 can provide reasonable assurances that the food supply of 

10 the country is equivalent in safety to food manufactured, 

11 processed, packed, or held in the United States.’’. 

12 SEC. 306. BUILDING CAPACITY OF FOREIGN GOVERNMENTS 

13 WITH RESPECT TO FOOD. 

14 (a) IN GENERAL.—The Secretary shall, not later 

15 than 2 years of the date of enactment of this Act, develop 

16 a comprehensive plan to expand the technical, scientific, 

17 and regulatory capacity of foreign governments, and their 

18 respective food industries, from which foods are exported 

19 to the United States. 

20 (b) CONSULTATION.—In developing the plan under 

21 subsection (a), the Secretary shall consult with the Sec22 retary of Agriculture, Secretary of State, Secretary of the 

23 Treasury, and the Secretary of Commerce, representatives 

24 of the food industry, appropriate foreign government offi25 cials, and nongovernmental organizations that represent 

26 the interests of consumers, and other stakeholders. 


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1 (c) PLAN.—The plan developed under subsection (a) 

2 shall include, as appropriate, the following: 

3 (1) Recommendations for bilateral and multilat4 eral arrangements and agreements, including provi5 sions to provide for responsibility of exporting coun6 tries to ensure the safety of food. 

7 (2) Provisions for electronic data sharing. 

8 (3) Provisions for mutual recognition of inspec9 tion reports. 

10 (4) Training of foreign governments and food 

11 producers on United States requirements for safe 

12 food. 

13 (5) Recommendations to harmonize require14 ments under the Codex Alimentarius. 

15 (6) Provisions for the multilateral acceptance of 

16 laboratory methods and detection techniques. 

17 SEC. 307. INSPECTION OF FOREIGN FOOD FACILITIES. 

18 Chapter VIII (21 U.S.C. 381 et seq.), as amended 

19 by section 305, is amended by inserting at the end the 

20 following: 

21 ‘‘SEC. 808. INSPECTION OF FOREIGN FOOD FACILITIES. 

22 ‘‘(a) INSPECTION.—The Secretary— 

23 ‘‘(1) may enter into arrangements and agree24 ments with foreign governments to facilitate the inVerDate Nov 24 2008 01:02 Mar 07, 2009 Jkt 079200 PO 00000 Frm 00080 Fmt 6652 Sfmt 6201 E:\BILLS\H1332.IH H1332

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1 spection of foreign facilities registered under section 

2 415; and 

3 ‘‘(2) shall direct resources to inspections of for4 eign facilities, suppliers, and food types, especially 

5 such facilities, suppliers, and food types that present 

6 a high risk (as identified by the Secretary), to help 

7 ensure the safety and security of the food supply of 

8 the United States. 

9 ‘‘(b) EFFECT OF INABILITY TO INSPECT.—Notwith10 standing any other provision of law, food shall be refused 

11 admission into the United States if it is from a foreign 

12 facility registered under section 415 of which the owner, 

13 operator, or agent in charge of the facility, or the govern14 ment of the foreign country, refuses to permit entry of 

15 United States inspectors, upon request, to inspect such fa16 cility. For purposes of this subsection, such an owner, op17 erator, or agent in charge shall be considered to have re18 fused an inspection if such owner, operator, or agent in 

19 charge refuses such a request to inspect a facility more 

20 than 48 hours after such request is submitted.’’. 

21 SEC. 308. THIRD-PARTY ACCREDITATION OF QUALIFIED 

22 AUDITORS AND AUDIT AGENTS. 

23 Chapter VIII (21 U.S.C. 381 et seq.), as amended 

24 by section 307, is further amended by adding at the end 

25 the following: 


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1 ‘‘SEC. 809. THIRD-PARTY AUDITORS AND AUDIT AGENTS AC2 CREDITATION. 

3 ‘‘(a) DEFINITIONS.—In this section: 

4 ‘‘(1) ACCREDITATION BODY.—The term ‘ac5 creditation body’ means a recognized authority that 

6 performs accreditation of third-party auditors and 

7 audit agents. 

8 ‘‘(2) AUDIT AGENT.—The term ‘audit agent’ 

9 means an individual who is qualified to conduct food 

10 safety audits, and who may be an employee or an 

11 agent of a third-party auditor. 

12 ‘‘(3) ACCREDITED AUDIT AGENT.—The term 

13 ‘accredited audit agent’ means an audit agent ac14 credited by an accreditation body under this section. 

15 ‘‘(4) ACCREDITED THIRD-PARTY AUDITOR.— 

16 The term ‘accredited third-party auditor’ means a 

17 third-party auditor accredited by an accreditation 

18 body under this section. 

19 ‘‘(5) CONSULTATIVE AUDIT.—The term ‘con20 sultative audit’ means an audit of an eligible enti21 ty— 

22 ‘‘(A) to determine whether such entity is in 

23 compliance with the provisions of this Act and 

24 with applicable industry standards and prac25 tices; and 


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1 ‘‘(B) the results of which are for internal 

2 facility purposes only. 

3 ‘‘(6) ELIGIBLE ENTITY.—The term ‘eligible en4 tity’ means a foreign entity, including foreign facili5 ties registered under section 415, in the food import 

6 supply chain that chooses to be audited by an ac7 credited third-party auditor or audit agent. 

8 ‘‘(7) REGULATORY AUDIT.—The term ‘regu9 latory audit’ means an audit of an eligible entity— 

10 ‘‘(A) to determine whether such entity is in 

11 compliance with the provisions of this Act; and 

12 ‘‘(B) the results of which determine— 

13 ‘‘(i) whether an entity is eligible to re14 ceive a certification under section 801(p); 

15 and 

16 ‘‘(ii) whether the entity is eligible to 

17 participate in the voluntary qualified im18 porter program under section 806. 

19 ‘‘(8) THIRD-PARTY AUDITOR.—The term ‘third20 party auditor’ means a foreign government, foreign 

21 cooperative, or any other qualified third party, as 

22 the Secretary determines appropriate, that conducts 

23 audits of eligible entities to certify that such eligible 

24 entities meet the applicable requirements of this sec25 tion. 


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1 ‘‘(b) SYSTEM OF ACCREDITATION.— 

2 ‘‘(1) ACCREDITATION BODIES.— 

3 ‘‘(A) ACCREDITATION BODIES RECOGNI4 TION.—No later than 2 years after the date of 

5 enactment of the Safe Food Enforcement, As6 sessment, Standards and Targeting Act of 

7 2009, the Secretary shall establish a system for 

8 the recognition of accreditation bodies that ac9 credit third-party auditors and audit agents to 

10 certify that eligible entities meet the applicable 

11 requirements of this Act. 

12 ‘‘(B) NOTIFICATION.—Each accreditation 

13 body recognized by the Secretary under this 

14 section shall submit to the Secretary a list of all 

15 accredited third-party auditors and audit agents 

16 accredited by such body. 

17 ‘‘(C) REVOCATION OF ACCREDITATION

18 BODY RECOGNITION.—The Secretary shall 

19 promptly revoke the recognition of any accredi20 tation body found not to be in compliance with 

21 the requirements of this section. 

22 ‘‘(2) MODEL ACCREDITATION STANDARDS.— 

23 The Secretary shall develop model standards, includ24 ing audit report requirements, and each recognized 

25 accreditation body shall ensure that third-party 


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1 auditors and audit agents meet such standards in 

2 order to qualify as an accredited third-party auditor 

3 or audit agent under this section. In developing the 

4 model standards, the Secretary shall look to stand5 ards in place on the date of the enactment of this 

6 section for guidance, to avoid unnecessary duplica7 tion of efforts and costs. 

8 ‘‘(c) THIRD-PARTY AUDITORS AND AUDIT AGEN9 CIES.— 

10 ‘‘(1) THIRD-PARTY AUDITOR OR AUDIT AGENT

11 ACCREDITATION REQUIREMENTS.— 

12 ‘‘(A) FOREIGN GOVERNMENTS.—Prior to 

13 accrediting a foreign government as an accred14 ited third-party auditor, the accreditation body 

15 shall perform such reviews and audits of food 

16 safety programs, systems, and standards of the 

17 government as the Secretary deems necessary 

18 to determine that the foreign government is ca19 pable of adequately ensuring that eligible enti20 ties certified by such government meet the re21 quirements of this Act with respect to food 

22 manufactured, processed, packed, or held for 

23 import to the United States. 

24 ‘‘(B) FOREIGN COOPERATIVES AND OTHER

25 THIRD PARTIES.—Prior to accrediting a foreign 


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1 cooperative that aggregates the products of 

2 growers or processors, or any other third party 

3 that the Secretary determines appropriate to be 

4 an accredited third-party auditor or audit 

5 agent, the accreditation body shall perform such 

6 reviews and audits of the training and qualifica7 tions of auditors used by that cooperative or 

8 party and conduct such reviews of internal sys9 tems and such other investigation of the cooper10 ative or party as the Secretary deems necessary 

11 to determine that each eligible entity certified 

12 by the cooperative or party has systems and 

13 standards in use to ensure that such entity 

14 meets the requirements of this Act. 

15 ‘‘(2) REQUIREMENT TO ISSUE CERTIFICATION

16 OF ELIGIBLE ENTITIES.— 

17 ‘‘(A) IN GENERAL.—An accreditation body 

18 may not accredit a third-party auditor or audit 

19 agent unless such third-party auditor or audit 

20 agent agrees to issue a written and electronic 

21 certification to accompany each food shipment 

22 for import into the United States from an eligi23 ble entity certified by the third-party auditor or 

24 audit agent, subject to requirements set forth 

25 by the Secretary. The Secretary shall consider 


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1 such certificates when targeting inspection re2 sources under section 421. 

3 ‘‘(B) PURPOSE OF CERTIFICATION.—The 

4 Secretary shall use evidence of certification pro5 vided by accredited third-party auditors and 

6 audit agents— 

7 ‘‘(i) to determine the eligibility of an 

8 importer to receive a certification under 

9 section 801(p); and 

10 ‘‘(ii) to determine the eligibility of an 

11 importer to participate in the voluntary 

12 qualified importer program under section 

13 806. 

14 ‘‘(3) AUDIT REPORT REQUIREMENTS.— 

15 ‘‘(A) REQUIREMENTS IN GENERAL.—As a 

16 condition of accreditation, an accredited third17 party auditor or audit agent shall prepare the 

18 audit report for an audit, in a form and manner 

19 designated by the Secretary, which shall in20 clude— 

21 ‘‘(i) the identity of the persons at the 

22 audited eligible entity responsible for com23 pliance with food safety requirements; 

24 ‘‘(ii) the dates of the audit; 

25 ‘‘(iii) the scope of the audit; and 


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1 ‘‘(iv) any other information required 

2 by the Secretary that relates to or may in3 fluence an assessment of compliance with 

4 this Act. 

5 ‘‘(B) SUBMISSION OF REPORTS TO THE

6 SECRETARY.— 

7 ‘‘(i) IN GENERAL.—Following any ac8 creditation of a third-party auditor or 

9 audit agent, the Secretary may, at any 

10 time, require the accredited third-party 

11 auditor or audit agent to submit to the 

12 Secretary an onsite audit report and such 

13 other reports or documents required as 

14 part of the audit process, for any eligible 

15 entity certified by the third-party auditor 

16 or audit agent. Such report may include 

17 documentation that the eligible entity is in 

18 compliance with any applicable registration 

19 requirements. 

20 ‘‘(ii) LIMITATION.—The requirement 

21 under clause (i) shall not include any re22 port or other documents resulting from a 

23 consultative audit by the accredited third24 party auditor or audit agent, except that 

25 the Secretary may access the results of a 


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1 consultative audit in accordance with sec2 tion 414. 

3 ‘‘(4) AUDIT AGENT REQUIREMENTS.— 

4 ‘‘(A) PUBLIC HEALTH RISKS.—If, at any 

5 time during an audit, an accredited audit agent 

6 discovers a condition that could cause or con7 tribute to a serious risk to the public health, 

8 the audit agent shall immediately notify the 

9 Secretary of— 

10 ‘‘(i) the identification of the eligible 

11 entity subject to the audit; and 

12 ‘‘(ii) such condition. 

13 ‘‘(B) AUDIT TYPES.—An accredited audit 

14 agent may perform consultative and regulatory 

15 audits of eligible entities. 

16 ‘‘(C) LIMITATIONS.—An accredited audit 

17 agent may not perform a regulatory audit of an 

18 eligible entity if such agent has performed a 

19 consultative audit or a regulatory audit of such 

20 eligible entity during the previous 24-month pe21 riod. 

22 ‘‘(5) CONFLICTS OF INTEREST.— 

23 ‘‘(A) THIRD-PARTY AUDITORS.—An ac24 credited third-party auditor shall— 


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1 ‘‘(i) not be owned, managed, or con2 trolled by any person that owns or operates 

3 an eligible entity to be certified by such 

4 auditor; 

5 ‘‘(ii) in carrying out audits of eligible 

6 entities under this section, have procedures 

7 to ensure against the use of any officer or 

8 employee of such auditor that has a finan9 cial conflict of interest regarding an eligi10 ble entity to be certified by such auditor; 

11 and 

12 ‘‘(iii) annually make available to the 

13 Secretary disclosures of the extent to 

14 which such auditor and the officers and 

15 employees of such auditor have maintained 

16 compliance with clauses (i) and (ii) relat17 ing to financial conflicts of interest. 

18 ‘‘(B) AUDIT AGENTS.—An accredited audit 

19 agent shall— 

20 ‘‘(i) not own or operate an eligible en21 tity to be certified by such agent; 

22 ‘‘(ii) in carrying out audits of eligible 

23 entities under this section, have procedures 

24 to ensure that such agent does not have a 

25 financial conflict of interest regarding an 


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1 eligible entity to be certified by such agent; 

2 and 

3 ‘‘(iii) annually make available to the 

4 Secretary disclosures of the extent to 

5 which such agent has maintained compli6 ance with clauses (i) and (ii) relating to fi7 nancial conflicts of interest. 

8 ‘‘(C) REGULATIONS.—The Secretary shall 

9 promulgate regulations not later than 18 

10 months after the date of enactment of the Safe 

11 Food Enforcement, Assessment, Standards, and 

12 Targeting Act of 2009 to ensure that there are 

13 protections against conflicts of interest between 

14 an accredited third-party auditor or audit agent 

15 and the eligible entity to be certified by such 

16 auditor or audit agent. Such regulations shall 

17 include— 

18 ‘‘(i) requiring that audits performed 

19 under this section be unannounced; 

20 ‘‘(ii) a structure, including timing and 

21 public disclosure, for fees paid by eligible 

22 entities to accredited third-party auditors 

23 or audit agents to decrease the potential 

24 for conflicts of interest; and 


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1 ‘‘(iii) appropriate limits on financial 

2 affiliations between an accredited third3 party auditor or audit agent and any per4 son that owns or operates an eligible entity 

5 to be certified by such auditor or audit 

6 agent. 

7 ‘‘(6) WITHDRAWAL OF ACCREDITATION.—The 

8 Secretary shall withdraw accreditation from an ac9 credited third-party auditor or audit agent— 

10 ‘‘(A) if food from an eligible entity cer11 tified by such third-party auditor or audit agent 

12 is linked to an outbreak of human or animal ill13 ness; 

14 ‘‘(B) following a performance audit and 

15 finding by the Secretary that the third-party 

16 auditor or audit agent no longer meets the re17 quirements for accreditation; or 

18 ‘‘(C) following a refusal to allow United 

19 States officials to conduct such audits and in20 vestigations as may be necessary to ensure con21 tinued compliance with the requirements set 

22 forth in this section. 

23 ‘‘(7) NEUTRALIZING COSTS.—The Secretary 

24 shall establish a method, similar to the method used 

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1 ited third-party auditors and audit agents reimburse 

2 the Food and Drug Administration for the work per3 formed to establish and administer the accreditation 

4 system under this section. The Secretary shall make 

5 operating this program revenue-neutral and shall not 

6 generate surplus revenue from such a reimburse7 ment mechanism. 

8 ‘‘(d) ELIGIBLE ENTITIES RECERTIFICATION.—An el9 igible entity shall apply for annual recertification by an 

10 accredited third-party auditor or audit agent if such enti11 ty— 

12 ‘‘(1) intends to participate in voluntary quali13 fied importer program under section 806; or 

14 ‘‘(2) must provide to the Secretary a certifi15 cation under section 801(p) for any food from such 

16 entity. 

17 ‘‘(e) FALSE STATEMENTS.—Any statement or rep18 resentation made— 

19 ‘‘(1) by an employee or agent of an eligible enti20 ty to an accredited third-party auditor or audit 

21 agent; or 

22 ‘‘(2) by an accredited third-party auditor or an 

23 audit agent to the Secretary, 

24 shall be subject to section 1001 of title 18, United States 

25 Code.’’. 


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1 SEC. 309. JURISDICTION; AUTHORITIES. 

2 Nothing in this Act, or an amendment made by this 

3 Act, shall be construed to— 

4 (1) alter the jurisdiction between the Secretary 

5 of Agriculture and the Secretary of Health and 

6 Human Services, under applicable statutes and regu7 lations; 

8 (2) limit the authority of the Secretary of 

9 Health and Human Services to issue regulations re10 lated to the safety of food under— 

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

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

13 day before the date of enactment of this Act; or 

14 (B) the Public Health Service Act (42 

15 U.S.C. 301 et seq.) as in effect on the day be16 fore the date of enactment of this Act; or 

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

18 the Secretary of Agriculture to prevent, control, or 

19 mitigate a plant or animal health emergency, or a 

20 food emergency involving products regulated under 

21 the Federal Meat Inspection Act, the Poultry Prod22 ucts Inspection Act, or the Egg Products Inspection 

23 Act. 

Æ 


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