II 

110TH CONGRESS 

2D SESSION S. 3385 

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

safety of the food supply. 

IN THE SENATE OF THE UNITED STATES 

JULY 31, 2008 

Mr. DURBIN (for himself, Mr. GREGG, Mr. DODD, Mr. BURR, Mr. HARKIN, 

and Mr. ALEXANDER) introduced the following bill; which was read twice 

and referred to the Committee on Health, Education, Labor, and Pensions 

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 ‘‘FDA Food Safety Modernization Act’’. 

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

8 whenever in this Act an amendment is expressed in terms 

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1 erence shall be considered to be made to a section or other 

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

3 (21 U.S.C. 301 et seq.). 

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

5 this Act is as follows: 

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

TITLE I—GENERAL FOOD PROVISIONS 

Sec. 101. Inspections of records. 

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 produce safety. 

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. Protection against intentional adulteration. 

Sec. 110. National agriculture and food defense strategy. 

Sec. 111. Food and Agriculture Coordinating Councils. 

Sec. 112. Decontamination and disposal standards and plans. 

Sec. 113. Authority to collect fees. 

Sec. 114. Final rule for prevention of Salmonella Enteritidis in shell eggs during production. 

Sec. 115. Sanitary transportation of food. 

Sec. 116. Food allergy and anaphylaxis management. 

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. 

Sec. 308. Accreditation of qualified third-party auditors. 

Sec. 309. Foreign offices of the Food and Drug Administration. 

Sec. 310. Funding for food safety. 

Sec. 311. Jurisdiction; authorities. 


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1 TITLE I—GENERAL FOOD 

2 PROVISIONS 

3 SEC. 101. INSPECTIONS OF RECORDS. 

4 Section 414(a) (21 U.S.C. 350c(a)) is amended— 

5 (1) by striking the heading and all follows 

6 through ‘‘of food is’’ and inserting the following: 

7 ‘‘RECORDS INSPECTION.— 

8 ‘‘(1) ADULTERATED FOOD.—If the Secretary 

9 has a reasonable belief that an article of food, and 

10 any other article of food that the Secretary reason11 ably believes is likely to be affected in a similar man12 ner, is’’; 

13 (2) by inserting ‘‘, and to any other article of 

14 food that the Secretary reasonably believes is likely 

15 to be affected in a similar manner,’’ after ‘‘relating 

16 to such article’’; 

17 (3) by striking the last sentence; and 

18 (4) by inserting at the end the following: 

19 ‘‘(2) SERIOUS ADVERSE HEALTH CON20 SEQUENCES.—If the Secretary believes that there is 

21 a reasonable probability that the use of or exposure 

22 to an article of food, and any other article of food 

23 that the Secretary reasonably believes is likely to be 

24 affected in a similar manner, will cause serious ad25 verse health consequences or death to humans or 


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1 animals, each person (excluding farms and res2 taurants) who manufactures, processes, packs, dis3 tributes, receives, holds, or imports such article 

4 shall, at the request of an officer or employee duly 

5 designated by the Secretary, permit 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 and to any other ar11 ticle of food that the Secretary reasonably believes is 

12 likely to be affected in a similar manner, that are 

13 needed to assist the Secretary in determining wheth14 er there is a reasonable probability that the use of 

15 or exposure to the food will cause serious adverse 

16 health consequences or death to humans or animals. 

17 ‘‘(3) APPLICATION.—The requirement under 

18 paragraphs (1) and (2) applies to all records relating 

19 to the manufacture, processing, packing, distribu20 tion, receipt, holding, or importation of such article 

21 maintained by or on behalf of such person in any 

22 format (including paper and electronic formats) and 

23 at any location.’’. 


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1 SEC. 102. REGISTRATION OF FOOD FACILITIES. 

2 (a) UPDATING OF FOOD CATEGORY REGULATIONS; 

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

4 U.S.C. 350d(a)) is amended— 

5 (1) in paragraph (2), by— 

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

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

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

9 (B) inserting ‘‘, or any other food cat10 egories as determined appropriate by the Sec11 retary, including by guidance)’’ after ‘‘Code of 

12 Federal Regulations’’; 

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

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

15 (3) by inserting after paragraph (2) the fol16 lowing: 

17 ‘‘(3) BIENNIAL REGISTRATION RENEWAL.— 

18 During the period beginning on October 1 and end19 ing on December 31 of each even-numbered year, a 

20 registrant that has submitted a registration under 

21 paragraph (1) shall submit to the Secretary a re22 newal registration containing the information de23 scribed in paragraph (2). The Secretary shall pro24 vide for an abbreviated registration renewal process 

25 for any registrant that has not had any changes to 

26 such information since the registrant submitted the 


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1 preceding registration or registration renewal for the 

2 facility involved.’’. 

3 (b) SUSPENSION OF REGISTRATION.— 

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

5 350d) is amended— 

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

7 the first sentence the following: ‘‘The registra8 tion shall contain a consent to permit the Sec9 retary to inspect such facility.’’; 

10 (B) by redesignating subsections (b) and 

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

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

13 following: 

14 ‘‘(b) SUSPENSION OF REGISTRATION.— 

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

16 that food manufactured, processed, packed, or held 

17 by a facility registered under this section has a rea18 sonable probability of causing serious adverse health 

19 consequences or death to humans or animals, the 

20 Secretary may by order suspend the registration of 

21 the facility under this section in accordance with this 

22 subsection. 

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

24 shall provide the registrant subject to an order 

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1 formal hearing, to be held as soon as possible but 

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

3 on the actions required for reinstatement of registra4 tion and why the registration that is subject to sus5 pension should be reinstated. The Secretary may re6 instate a registration if the Secretary determines, 

7 based on evidence presented, that adequate grounds 

8 do not exist to continue the suspension of the reg9 istration. 

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

11 VACATING OF ORDER.— 

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

13 providing opportunity for an informal hearing 

14 under paragraph (2), the Secretary determines 

15 that the suspension of registration remains nec16 essary, the Secretary shall require the reg17 istrant to submit a corrective action plan to 

18 demonstrate how the registrant plans to correct 

19 the conditions found by the Secretary. The Sec20 retary shall review such plan in a timely man21 ner. 

22 ‘‘(B) VACATING OF ORDER.—Upon a de23 termination by the Secretary that adequate 

24 grounds do not exist to continue the suspension 

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1 tions should be modified, the Secretary shall va2 cate the order or modify the order. 

3 ‘‘(4) EFFECT OF SUSPENSION.—If the registra4 tion of a facility is suspended under this subsection, 

5 such facility shall not import food or offer to import 

6 food into the United States, or otherwise introduce 

7 food into interstate commerce in the United States. 

8 ‘‘(5) REGULATIONS.—The Secretary shall pro9 mulgate regulations that describe the standards offi10 cials will use in making a determination to suspend 

11 a registration, and the format such officials will use 

12 to explain to the registrant the conditions found at 

13 the facility. 

14 ‘‘(6) NO DELEGATION.—The authority con15 ferred by this subsection to issue an order to sus16 pend a registration or vacate an order of suspension 

17 shall not be delegated to any officer or employee 

18 other than the Commissioner.’’. 

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

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

21 which a registration has been suspended under such 

22 section)’’ after ‘‘section 415’’. 

23 (c) CONFORMING AMENDMENTS.— 

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

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


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1 (2) Section 415(d), as redesignated by sub2 section (b), is amended by adding at the end before 

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

4 with respect to the reinstatement of a registration 

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

6 SEC. 103. MANDATORY RECALL AUTHORITY. 

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

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

9 ‘‘SEC. 418. MANDATORY RECALL AUTHORITY. 

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

11 determines, based on information gathered through the re12 portable food registry under section 417 or through any 

13 other means, that there is a reasonable probability that 

14 an article of food (other than infant formula) is adulter15 ated under section 402 or misbranded under section 

16 403(w) and the use of or exposure to such article will 

17 cause serious adverse health consequences or death to hu18 mans or animals, the Secretary shall provide the respon19 sible party (as defined in section 417) with an opportunity 

20 to cease distribution and recall such article. 

21 ‘‘(b) PREHEARING ORDER TO CEASE DISTRIBUTION

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

23 or does not voluntarily cease distribution or recall such 

24 article within the time and in the manner prescribed by 

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


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1 order require, as the Secretary deems necessary, such per2 son to— 

3 ‘‘(1) immediately cease distribution of such arti4 cle; or 

5 ‘‘(2) immediately notify all persons— 

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

7 transporting, distributing, receiving, holding, or 

8 importing and selling such article; and 

9 ‘‘(B) to which such article has been dis10 tributed, transported, or sold, to immediately 

11 cease distribution of such article. 

12 ‘‘(c) HEARING ON ORDER.—The Secretary shall pro13 vide the responsible party subject to an order under sub14 section (b) with an opportunity for an informal hearing, 

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

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

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

18 of the order should not be recalled. 

19 ‘‘(d) POST-HEARING RECALL ORDER AND MODIFICA20 TION OF ORDER.— 

21 ‘‘(1) AMENDMENT OF ORDER.—If, after pro22 viding opportunity for an informal hearing under 

23 subsection (c), the Secretary determines that re24 moval of the article from commerce is necessary, the 

25 Secretary shall, as appropriate— 


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

2 such article or other appropriate action; 

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

4 shall occur; 

5 ‘‘(C) require periodic reports to the Sec6 retary describing the progress of the recall; and 

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

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

9 ‘‘(2) VACATING OF ORDER.—If, after such hear10 ing, the Secretary determines that adequate grounds 

11 do not exist to continue the actions required by the 

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

13 Secretary shall vacate the order or modify the order. 

14 ‘‘(e) COOPERATION AND CONSULTATION.—The Sec15 retary shall work with State and local public health offi16 cials in carrying out this section, as appropriate. 

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

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

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

20 and public notices, as appropriate, in order to provide noti21 fication of the recall to consumers and retailers to whom 

22 such article was, or may have been, distributed. The notifi23 cation shall include, at a minimum— 

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

25 the recall; and 


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

2 such article. 

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

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

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

6 Commissioner. 

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

8 the authority of the Secretary to request or participate 

9 in a voluntary recall.’’. 

10 (b) CIVIL PENALTY.—Section 303(f)(2)(A) (21 

11 U.S.C. 333(f)(2)(A)) is amended by inserting ‘‘or any per12 son who does not comply with a recall order under section 

13 418’’ after ‘‘section 402(a)(2)(B)’’. 

14 (c) PROHIBITED ACTS.—Section 301 (21 U.S.C. 331 

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

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

17 section 418.’’. 

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

19 CONTROLS. 

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

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

22 at the end the following: 


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1 ‘‘SEC. 419. HAZARD ANALYSIS AND RISK-BASED PREVEN2 TIVE CONTROLS. 

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

4 in charge of a facility shall, in accordance with this sec5 tion, evaluate the hazards that could affect food manufac6 tured, processed, packed, or held by such facility, identify 

7 and implement preventive controls to significantly mini8 mize or prevent their occurrence and provide assurances 

9 that such food is not adulterated under section 402 or 

10 misbranded under section 403(w), monitor the perform11 ance of those controls, and maintain records of this moni12 toring as a matter of routine practice. 

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

14 agent in charge of a facility shall— 

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

16 foreseeable hazards that may be associated with the 

17 facility, including— 

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

20 drug residues, decomposition, parasites, aller21 gens, and unapproved food and color additives; 

22 and 

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

24 unintentionally introduced, or may be inten25 tionally introduced, including by acts of ter26 rorism; and 


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

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

3 or agent in charge of a facility shall identify and imple4 ment preventive controls, including at critical control 

5 points, if any, to provide assurances that— 

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

7 conducted under subsection (b) will be significantly 

8 minimized or prevented; and 

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

10 or held by such facility will not be adulterated under 

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

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

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

14 effectiveness of the preventive controls implemented under 

15 subsection (c) to provide assurances that the outcomes de16 scribed in subsection (c) shall be achieved. 

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

18 or agent in charge of a facility shall establish procedures 

19 that a facility will implement if the preventive controls im20 plemented under subsection (c) are found to be ineffective 

21 through monitoring under subsection (d). 

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

23 in charge of a facility shall verify that— 


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1 ‘‘(1) the preventive controls implemented under 

2 subsection (c) are adequate to control the hazards 

3 identified under subsection (b); 

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

5 monitoring in accordance with subsection (d); 

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

7 appropriate decisions about corrective actions taken 

8 under subsection (e); and 

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

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

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

12 conditions and processes in the facility, and to new 

13 and emerging threats. 

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

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

16 than 2 years, records documenting the monitoring of the 

17 preventive controls implemented under subsection (c), in18 stances of nonconformance material to food safety, in19 stances when corrective actions were implemented, and the 

20 efficacy of preventive controls and corrective actions. 

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

22 owner, operator, or agent in charge of a facility shall pre23 pare a written plan that documents and describes the pro24 cedures used by the facility to comply with the require25 ments of this section, including analyzing the hazards 


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1 under subsection (b) and identifying the preventive con2 trols adopted to address those hazards under subsection 

3 (c). Such written plan, together with documentation that 

4 the plan is being implemented, shall be made promptly 

5 available to a duly authorized representative of the Sec6 retary upon oral or written request. 

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

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

9 reanalysis under subsection (b) whenever a significant 

10 change is made in the activities conducted at a facility 

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

12 creates a reasonable potential for a new hazard or a sig13 nificant increase in a previously identified hazard or not 

14 less frequently than once every 3 years, whichever is ear15 lier. Such reanalysis shall be completed and additional pre16 ventive controls needed to address the hazard identified, 

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

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

19 agent shall revise the written plan required under sub20 section (h) if such a significant change is made or docu21 ment the basis for the conclusion that no additional or 

22 revised preventive controls are needed. The Secretary may 

23 require a reanalysis under this section to respond to new 

24 hazards and developments in scientific understanding. 


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

2 AND LOW-ACID CANNED FOOD FACILITIES IN COMPLI3 ANCE WITH HACCP.—An owner, operator, or agent in 

4 charge of a facility required to comply with 1 of the fol5 lowing standards and regulations with respect to such fa6 cility shall be deemed to be in compliance with this section, 

7 with respect to such facility: 

8 ‘‘(1) The Seafood Hazard Analysis Critical 

9 Control Points Program of the Food and Drug Ad10 ministration. 

11 ‘‘(2) The Juice Hazard Analysis Critical Con12 trol Points Program of the Food and Drug Adminis13 tration. 

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

15 Packaged in Hermetically Sealed Containers stand16 ards of the Food and Drug Administration (or any 

17 successor standards). 

18 ‘‘(k) EXCEPTION FOR FACILITIES IN COMPLIANCE

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

20 facility that is subject to section 420. 

21 ‘‘(l) AUTHORITY WITH RESPECT TO CERTAIN FA22 CILITIES.—The Secretary may, by regulation, exempt or 

23 modify the requirements for compliance under this section 

24 with respect to facilities that are solely engaged in the 


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1 storage of packaged foods that are not exposed to the envi2 ronment. 

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

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

5 ‘critical control point’ means a point, step, or proce6 dure in a food process at which control can be ap7 plied and is essential to prevent or eliminate a food 

8 safety hazard or reduce it to an acceptable level. 

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

10 domestic facility or a foreign facility that is required 

11 to register under section 415. 

12 ‘‘(3) PREVENTIVE CONTROLS.—The term ‘pre13 ventive controls’ means those risk-based, reasonably 

14 appropriate procedures, practices, and processes that 

15 a person knowledgeable about the safe manufac16 turing, processing, packing, or holding of food would 

17 have employed to significantly minimize or prevent 

18 the hazards identified under the hazard analysis con19 ducted under subsection (a) and that are consistent 

20 with the current scientific understanding of safe 

21 food manufacturing, processing, packing, or holding 

22 at the time of the analysis. Those procedures, prac23 tices, and processes may include the following: 


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1 ‘‘(A) Sanitation procedures for food con2 tact surfaces and utensils and food-contact sur3 faces of equipment. 

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

5 hygiene training. 

6 ‘‘(C) An environmental monitoring pro7 gram to verify the effectiveness of pathogen 

8 controls. 

9 ‘‘(D) An allergen control program. 

10 ‘‘(E) A recall contingency plan. 

11 ‘‘(F) Good Manufacturing Practices 

12 (GMPs). 

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

14 (b) REGULATIONS.— 

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

16 Human Services (referred to in this Act as the ‘‘Sec17 retary’’) shall promulgate regulations to establish 

18 science-based minimum standards for conducting a 

19 hazard analysis, documenting hazards, implementing 

20 preventive controls, and documenting the implemen21 tation of the preventive controls under section 419 

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

23 added by subsection (a)). 

24 (2) CONTENT.—The regulations promulgated 

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1 bility to be applicable in all situations, including in 

2 the operations of small businesses. 

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

4 subsection shall be construed to provide the Sec5 retary with the authority to apply specific tech6 nologies, practices, or critical controls to an indi7 vidual facility. 

8 (4) REVIEW.—In promulgating the regulations 

9 under paragraph (1), the Secretary shall review reg10 ulatory hazard analysis and preventive control pro11 grams in existence on the date of enactment of this 

12 Act to ensure that the program under such section 

13 419 is consistent, to the extent practicable, with ap14 plicable internationally recognized standards in exist15 ence on such date. 

16 (c) GUIDANCE DOCUMENT.—The Secretary shall 

17 issue a guidance document related to hazard analysis and 

18 preventive controls required under section 419 of the Fed19 eral Food, Drug, and Cosmetic Act (as added by sub20 section (a)). 

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

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

23 at the end the following: 

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

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


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

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

3 (e) NO EFFECT ON HACCP AUTHORITIES.—Noth4 ing in the amendments made by this section limits the au5 thority of the Secretary under the Federal Food, Drug, 

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

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

8 or enforce product and category-specific regulations, such 

9 as the Seafood Hazard Analysis Critical Controls Points 

10 Program, the Juice Hazard Analysis Critical Control Pro11 gram, and the Thermally Processed Low-Acid Foods 

12 Packaged in Hermetically Sealed Containers standards. 

13 (f) EFFECTIVE DATE.— 

14 (1) GENERAL RULE.—The amendments made 

15 by this section shall take effect 18 months after the 

16 date of enactment of this Act. 

17 (2) EXCEPTIONS.—Notwithstanding paragraph 

18 (1)— 

19 (A) the amendments made by this section 

20 shall apply to a small business (as defined by 

21 the Secretary) after the date that is 2 years 

22 after the date of enactment of this Act; and 

23 (B) the amendments made by this section 

24 shall apply to a very small business (as defined 


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

2 after the date of enactment of this Act. 

3 SEC. 105. PERFORMANCE STANDARDS. 

4 The Secretary shall, not less frequently than every 

5 2 years, review and evaluate epidemiological data and 

6 other appropriate sources of information to determine the 

7 most significant food-borne contaminants and the most 

8 significant resulting hazards, and may issue science-based 

9 guidance documents, action levels, and regulations to help 

10 prevent adulteration under section 402 of the Federal 

11 Food, Drug, and Cosmetic Act (21 U.S.C. 342). Such 

12 standards shall be applicable to products and product 

13 classes and shall not be written to be facility-specific. 

14 SEC. 106. STANDARDS FOR PRODUCE SAFETY. 

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

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

17 at the end the following: 

18 ‘‘SEC. 420. STANDARDS FOR PRODUCE SAFETY. 

19 ‘‘(a) PROPOSED RULEMAKING.— 

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

21 the date of enactment of the FDA Food Safety Mod22 ernization Act, the Secretary, in consultation with 

23 the Secretary of Agriculture and representatives of 

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1 based minimum standards for the safe production 

2 and harvesting of those types of fruits and vegeta3 bles that are raw agricultural commodities for which 

4 the Secretary has determined that such standards 

5 minimize the risk of serious adverse health con6 sequences or death. 

7 ‘‘(2) PUBLIC INPUT.—During the comment pe8 riod on the notice of proposed rulemaking under 

9 paragraph (1), the Secretary shall conduct not less 

10 than 3 public meetings in diverse geographical areas 

11 of the United States to provide persons in different 

12 regions an opportunity to comment. 

13 ‘‘(3) CONTENT.—The proposed rulemaking 

14 under paragraph (1) shall— 

15 ‘‘(A) include, with respect to growing, har16 vesting, sorting, and storage operations, min17 imum standards related to fertilizer use, nutri18 ents, hygiene, packaging, temperature controls, 

19 animal encroachment, and water; and 

20 ‘‘(B) consider hazards that occur naturally, 

21 may be unintentionally introduced, or may be 

22 intentionally introduced, including by acts of 

23 terrorism. 

24 ‘‘(4) PRIORITIZATION.—The Secretary shall 

25 prioritize the implementation of the regulations for 


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1 specific fruits and vegetables that are raw agricul2 tural commodities that have been associated with 

3 food-borne illness outbreaks. 

4 ‘‘(b) FINAL REGULATION.— 

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

6 the close of the comment period for the proposed 

7 rulemaking under subsection (a), the Secretary shall 

8 adopt a final regulation to provide for minimum 

9 standards for those types of fruits and vegetables 

10 that are raw agricultural commodities for which the 

11 Secretary has determined that such standards mini12 mize the risk of serious adverse health consequences 

13 or death. 

14 ‘‘(2) FINAL REGULATION.—The final regulation 

15 shall— 

16 ‘‘(A) provide a reasonable period of time 

17 for compliance, taking into account the needs of 

18 small businesses for additional time to comply; 

19 ‘‘(B) provide for coordination of education 

20 and enforcement activities by State and local 

21 officials, as designated by the Governors of the 

22 respective States; and 

23 ‘‘(C) include a description of the variance 

24 process under subsection (c) and the types of 

25 permissible variances the Secretary may grant. 


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1 ‘‘(c) CRITERIA.— 

2 ‘‘(1) IN GENERAL.—The regulations adopted 

3 under subsection (b) shall— 

4 ‘‘(A) set forth those procedures, processes, 

5 and practices as the Secretary determines to be 

6 reasonably necessary to prevent the introduc7 tion of known or reasonably foreseeable biologi8 cal, chemical, and physical hazards, including 

9 hazards that occur naturally, may be uninten10 tionally introduced, or may be intentionally in11 troduced, including by acts of terrorism, into 

12 fruits and vegetables that are raw agricultural 

13 commodities and to provide reasonable assur14 ances that the produce is not adulterated under 

15 section 402; and 

16 ‘‘(B) permit States and foreign countries 

17 from which food is imported into the United 

18 States, subject to paragraph (2), to request 

19 from the Secretary variances from the require20 ments of the regulations, where upon approval 

21 of the Secretary, the variance is considered per22 missible under the requirements of the regula23 tions adopted under subsection (b)(1)(C) and 

24 where the State or foreign country determines 

25 that the variance is necessary in light of local 


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1 growing conditions and that the procedures, 

2 processes, and practices to be followed under 

3 the variance are reasonably likely to ensure that 

4 the produce is not adulterated under section 

5 402 to the same extent as the requirements of 

6 the regulation adopted under subsection (b). 

7 ‘‘(2) APPROVAL OF VARIANCES.—A State or 

8 foreign country from which food is imported into the 

9 United States shall request a variance from the Sec10 retary in writing. The Secretary may deny such a re11 quest as not reasonably likely to ensure that the 

12 produce is not adulterated under section 402 to the 

13 same extent as the requirements of the regulation 

14 adopted under subsection (b). 

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

16 with the Secretary of Agriculture and shall contract and 

17 coordinate with the agency or department designated by 

18 the Governor of each State to perform activities to ensure 

19 compliance with this section. 

20 ‘‘(e) GUIDANCE.—Not later than 1 year after the 

21 date of enactment of the FDA Food Safety Modernization 

22 Act, the Secretary shall publish, after consultation with 

23 the Secretary of Agriculture and representatives of State 

24 departments of agriculture, updated good agricultural 


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1 practices and guidance for the safe production and har2 vesting of specific types of fresh produce. 

3 ‘‘(f) EXCEPTION FOR FACILITIES IN COMPLIANCE

4 WITH SECTION 419.—This section shall not apply to a 

5 facility that is subject to section 419.’’. 

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

7 331), as amended by section 104, is amended by adding 

8 at the end the following: 

9 ‘‘(qq) The production or harvesting of produce not 

10 in accordance with minimum standards as provided by 

11 regulation under section 420(b) or a variance issued under 

12 section 420(c).’’. 

13 (c) NO EFFECT ON HACCP AUTHORITIES.—Nothing 

14 in the amendments made by this section limits the author15 ity of the Secretary under the Federal Food, Drug, and 

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

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

18 enforce product and category-specific regulations, such as 

19 the Seafood Hazard Analysis Critical Controls Points Pro20 gram, the Juice Hazard Analysis Critical Control Pro21 gram, and the Thermally Processed Low-Acid Foods 

22 Packaged in Hermetically Sealed Containers standards. 


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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 inspection of all facilities, 

10 and shall increase the frequency of inspection of fa11 cilities identified under paragraph (1) as high-risk 

12 facilities such that— 

13 ‘‘(A) for the first 2 years after the date of 

14 enactment of the FDA Food Safety Moderniza15 tion Act, each high-risk facility is inspected not 

16 less often than once every 2 years; and 

17 ‘‘(B) for each succeeding year, each high18 risk facility is inspected not less often than once 

19 each year. 

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

21 ENTRY.—The Secretary, in consultation with the Sec22 retary of Homeland Security, shall allocate resources to 

23 inspect articles of food imported into the United States 

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

25 shall be based on the following factors: 


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

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

3 and countries of transport of the food imported. 

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

5 violations of food safety standards of the food im6 porter. 

7 ‘‘(4) The rigor of the foreign supplier 

8 verification program under section 805. 

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

10 the Voluntary Qualified Importer Program under 

11 section 806. 

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

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

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

15 has received a certificate as described in section 

16 809(b). 

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

18 the Secretary for purposes of allocating inspection 

19 resources. 

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

21 coordination and cooperation with the Secretary of Agri22 culture to target food inspection resources. 

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

24 term ‘facility’ means a domestic facility or a foreign facil25 ity that is required to register under section 415.’’. 


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

2 is amended by adding at the end the following: 

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

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

5 submit to Congress a report regarding— 

6 ‘‘(1) information about food facilities includ7 ing— 

8 ‘‘(A) the appropriations used to inspect fa9 cilities registered pursuant to section 415 in the 

10 previous fiscal year; 

11 ‘‘(B) the average cost of both a non-high12 risk food facility inspection and a high-risk food 

13 facility inspection, if such a difference exists, in 

14 the previous fiscal year; 

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

16 the number of foreign facilities registered pur17 suant to section 415 that the Secretary in18 spected in the previous fiscal year; 

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

20 the number of foreign facilities registered pur21 suant to section 415 that the Secretary did not 

22 inspect in the previous fiscal year; 

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

24 identified pursuant to section 421 that the Sec25 retary inspected in the previous fiscal year; and 


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

2 identified pursuant to section 421 that the Sec3 retary did not inspect in the previous fiscal 

4 year; 

5 ‘‘(2) information about food imports includ6 ing— 

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

8 into the United States that the Secretary phys9 ically inspected or sampled in the previous fiscal 

10 year; 

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

12 into the United States that the Secretary did 

13 not physically inspect or sample in the previous 

14 fiscal year; and 

15 ‘‘(C) the average cost of physically inspect16 ing or sampling a food line subject to this Act 

17 that is imported or offered for import into the 

18 United States; and 

19 ‘‘(3) information on the foreign offices estab20 lished under section 309 of the FDA Food Safety 

21 Modernization Act including— 

22 ‘‘(A) the number of foreign offices estab23 lished; and 

24 ‘‘(B) the number of personnel permanently 

25 stationed in each foreign office. 


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1 ‘‘(i) PUBLIC AVAILABILITY OF ANNUAL FOOD RE2 PORTS.—The Secretary shall make the reports required 

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

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

5 SEC. 108. ADMINISTRATIVE DETENTION OF FOOD. 

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

7 334(h)(1)(A)) is amended by— 

8 (1) striking ‘‘credible evidence or information 

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

10 (2) striking ‘‘presents a threat of serious ad11 verse health consequences or death to humans or 

12 animals’’ and inserting ‘‘is adulterated or mis13 branded’’. 

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

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

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

17 21, Code of Federal Regulations, to implement the amend18 ment made by this section. 

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

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

21 enactment of this Act. 


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1 SEC. 109. PROTECTION AGAINST INTENTIONAL ADULTERA2 TION. 

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

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

5 at the end the following: 

6 ‘‘SEC. 422. PROTECTION AGAINST INTENTIONAL ADULTERA7 TION. 

8 ‘‘(a) IN GENERAL.—Not later than 24 months after 

9 the date of enactment of the FDA Food Safety Moderniza10 tion Act, the Secretary, in consultation with the Secretary 

11 of Homeland Security and the Secretary of Agriculture, 

12 shall promulgate regulations to protect against the inten13 tional adulteration of food subject to this Act. 

14 ‘‘(b) CONTENT OF REGULATIONS.—Regulations 

15 under subsection (a) shall only apply to food— 

16 ‘‘(1) for which the Secretary has identified clear 

17 vulnerabilities (such as short shelf-life or suscepti18 bility to intentional contamination at critical control 

19 points); 

20 ‘‘(2) in bulk or batch form, prior to being pack21 aged for the final consumer; and 

22 ‘‘(3) for which there is a high risk of intentional 

23 contamination, as determined by the Secretary, that 

24 could cause serious adverse health consequences or 

25 death to humans or animals. 


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1 ‘‘(c) DETERMINATIONS.—In making the determina2 tion under subsection (b)(3), the Secretary shall— 

3 ‘‘(1) conduct vulnerability assessments of the 

4 food system; 

5 ‘‘(2) consider the best available understanding 

6 of uncertainties, risks, costs, and benefits associated 

7 with guarding against intentional adulteration at 

8 vulnerable points; and 

9 ‘‘(3) determine the types of science-based miti10 gation strategies or measures that are necessary to 

11 protect against the intentional adulteration of food. 

12 ‘‘(d) EXCEPTION.—This section shall not apply to 

13 food produced on farms, except for milk. 

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

15 term ‘farm’ has the meaning given that term in section 

16 1.227 of title 21, Code of Federal Regulations (or any suc17 cessor regulation).’’. 

18 (b) GUIDANCE DOCUMENTS.— 

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

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

21 consultation with the Secretary of Homeland Secu22 rity and the Secretary of Agriculture, shall issue 

23 guidance documents related to protection against the 

24 intentional adulteration of food, including mitigation 

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1 teration as required under section 422 of the Fed2 eral Food, Drug, and Cosmetic Act, as added by 

3 subsection (a). 

4 (2) CONTENT.—The guidance document issued 

5 under paragraph (1) shall— 

6 (A) specify how a person shall assess 

7 whether the person is required to implement 

8 mitigation strategies or measures intended to 

9 protect against the intentional adulteration of 

10 food; 

11 (B) specify appropriate science-based miti12 gation strategies or measures to prepare and 

13 protect the food supply chain at specific vulner14 able points, as appropriate; 

15 (C) include a model assessment for a per16 son to use under subparagraph (A); 

17 (D) include examples of mitigation strate18 gies or measures described in subparagraph 

19 (B); and 

20 (E) specify situations in which the exam21 ples of mitigation strategies or measures de22 scribed in subparagraph (D) are appropriate. 

23 (3) LIMITED DISTRIBUTION.—In the interest of 

24 national security, the Secretary, in consultation with 

25 the Secretary of Homeland Security, may determine 


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1 the time and manner in which the guidance docu2 ments issued under paragraph (1) are made public, 

3 including by releasing such documents to targeted 

4 audiences. 

5 (c) PERIODIC REVIEW.—The Secretary shall periodi6 cally review and, as appropriate, update the regulation 

7 under subsection (a) and the guidance documents under 

8 subsection (b). 

9 (d) PROHIBITED ACTS.—Section 301 (21 U.S.C. 331 

10 et seq.), as amended by section 106, is amended by adding 

11 at the end the following: 

12 ‘‘(rr) The failure to comply with section 422.’’. 

13 SEC. 110. NATIONAL AGRICULTURE AND FOOD DEFENSE 

14 STRATEGY. 

15 (a) DEVELOPMENT AND SUBMISSION OF STRAT16 EGY.— 

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

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

19 Health and Human Services and the Secretary of 

20 Agriculture, in coordination with the Secretary of 

21 Homeland Security, shall prepare and submit to the 

22 relevant committees of Congress, and make publicly 

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1 partment of Agriculture, the National Agriculture 

2 and Food Defense Strategy. 

3 (2) IMPLEMENTATION PLAN.—The strategy 

4 shall include an implementation plan for use by the 

5 Secretaries described under paragraph (1) in car6 rying out the strategy. 

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

8 coordinated research agenda for use by the Secre9 taries described under paragraph (1) in conducting 

10 research to support the goals and activities described 

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

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

13 the date on which the strategy is submitted to the 

14 relevant committees of Congress under paragraph 

15 (1), and not less frequently than every 4 years there16 after, the Secretary of Health and Human Services 

17 and the Secretary of Agriculture, in coordination 

18 with the Secretary of Homeland Security, shall re19 vise and submit to the relevant committees of Con20 gress the strategy. 

21 (5) CONSISTENCY WITH EXISTING PLANS.—The 

22 strategy described in paragraph (1) shall be con23 sistent with— 

24 (A) the National Incident Management 

25 System; 


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1 (B) the National Response Framework; 

2 (C) the National Infrastructure Protection 

3 Plan; 

4 (D) the National Preparedness Goals; and 

5 (E) other relevant national strategies. 

6 (b) COMPONENTS.— 

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

8 description of the process to be used by the Depart9 ment of Health and Human Services, the Depart10 ment of Agriculture, and the Department of Home11 land Security— 

12 (A) to achieve each goal described in para13 graph (2); and 

14 (B) to evaluate the progress made by Fed15 eral, State, local, and tribal governments to16 wards the achievement of each goal described in 

17 paragraph (2). 

18 (2) GOALS.—The strategy shall include a de19 scription of the process to be used by the Depart20 ment of Health and Human Services, the Depart21 ment of Agriculture, and the Department of Home22 land Security to achieve the following goals: 

23 (A) PREPAREDNESS GOAL.—Enhance the 

24 preparedness of the agriculture and food system 

25 by— 


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1 (i) conducting vulnerability assess2 ments of the agriculture and food system; 

3 (ii) mitigating vulnerabilities of the 

4 system; 

5 (iii) improving communication and 

6 training relating to the system; 

7 (iv) developing and conducting exer8 cises to test decontamination and disposal 

9 plans; 

10 (v) developing modeling tools to im11 prove event consequence assessment and 

12 decision support; and 

13 (vi) preparing risk communication 

14 tools and enhancing public awareness 

15 through outreach. 

16 (B) DETECTION GOAL.—Improve agri17 culture and food system detection capabilities 

18 by— 

19 (i) identifying contamination in food 

20 products at the earliest possible time; and 

21 (ii) conducting surveillance to prevent 

22 the spread of diseases. 

23 (C) EMERGENCY RESPONSE GOAL.—En24 sure an efficient response to agriculture and 

25 food emergencies by— 


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1 (i) immediately investigating animal 

2 disease outbreaks and suspected food con3 tamination; 

4 (ii) preventing additional human ill5 nesses; 

6 (iii) organizing, training, and equip7 ping animal, plant, and food emergency re8 sponse teams of— 

9 (I) the Federal Government; and 

10 (II) State, local, and tribal gov11 ernments; 

12 (iv) designing, developing, and evalu13 ating training and exercises carried out 

14 under agriculture and food defense plans; 

15 and 

16 (v) ensuring consistent and organized 

17 risk communication to the public by— 

18 (I) the Federal Government; 

19 (II) State, local, and tribal gov20 ernments; and 

21 (III) the private sector. 

22 (D) RECOVERY GOAL.—Secure agriculture 

23 and food production after an agriculture or food 

24 emergency by— 


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1 (i) working with the private sector to 

2 develop business recovery plans to rapidly 

3 resume agriculture and food production; 

4 (ii) conducting exercises of the plans 

5 described in subparagraph (C) with the 

6 goal of long-term recovery results; 

7 (iii) rapidly removing, and effectively 

8 disposing of— 

9 (I) contaminated agriculture and 

10 food products; and 

11 (II) infected plants and animals; 

12 and 

13 (iv) decontaminating and restoring 

14 areas affected by an agriculture or food 

15 emergency. 

16 SEC. 111. FOOD AND AGRICULTURE COORDINATING COUN17 CILS. 

18 The Secretary of Homeland Security, in consultation 

19 with the Secretary of Health and Human Services and the 

20 Secretary of Agriculture, shall within 180 days of enact21 ment of this Act, and annually thereafter, submit to the 

22 relevant committees of Congress, and make publicly avail23 able on the Internet Web site of the Department of Home24 land Security, a report on the activities of the Food and 

25 Agriculture Government Coordinating Council and the 


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1 Food and Agriculture Sector Coordinating Council, includ2 ing the progress of such Councils on— 

3 (1) facilitating partnerships between public and 

4 private entities to help unify and enhance the protec5 tion of the agriculture and food system of the 

6 United States; 

7 (2) providing for the regular and timely inter8 change of information between each council relating 

9 to the security of the agriculture and food system 

10 (including intelligence information); 

11 (3) identifying best practices and methods for 

12 improving the coordination among Federal, State, 

13 local, and private sector preparedness and response 

14 plans for agriculture and food defense; and 

15 (4) recommending methods by which to protect 

16 the economy and the public health of the United 

17 States from the effects of— 

18 (A) animal or plant disease outbreaks; 

19 (B) food contamination; and 

20 (C) natural disasters affecting agriculture 

21 and food. 

22 SEC. 112. DECONTAMINATION AND DISPOSAL STANDARDS 

23 AND PLANS. 

24 (a) IN GENERAL.—The Administrator of the Envi25 ronmental Protection Agency (referred to in this section 


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1 as the ‘‘Administrator’’), in coordination with the Sec2 retary of Health and Human Services, Secretary of Home3 land Security, and Secretary of Agriculture, shall provide 

4 support for, and technical assistance to, State, local, and 

5 tribal governments in preparing for, assessing, decontami6 nating, and recovering from an agriculture or food emer7 gency. 

8 (b) DEVELOPMENT OF STANDARDS.—In carrying out 

9 subsection (a), the Administrator, in coordination with the 

10 Secretary of Health and Human Services, Secretary of 

11 Homeland Security, Secretary of Agriculture, and State, 

12 local, and tribal governments, shall develop and dissemi13 nate specific standards and protocols to undertake clean14 up, clearance, and recovery activities following the decon15 tamination and disposal of specific threat agents and for16 eign animal diseases. 

17 (c) DEVELOPMENT OF MODEL PLANS.—In carrying 

18 out subsection (a), the Administrator, the Secretary of 

19 Health and Human Services, and the Secretary of Agri20 culture shall jointly develop and disseminate model plans 

21 for— 

22 (1) the decontamination of individuals, equip23 ment, and facilities following an intentional contami24 nation of agriculture or food; and 


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1 (2) the disposal of large quantities of animals, 

2 plants, or food products that have been infected or 

3 contaminated by specific threat agents and foreign 

4 animal diseases. 

5 (d) EXERCISES.—In carrying out subsection (a), the 

6 Administrator, in coordination with the entities described 

7 under subsection (b), shall conduct exercises at least annu8 ally to evaluate and identify weaknesses in the decon9 tamination and disposal model plans described in sub10 section (c). Such exercises shall be carried out, to the max11 imum extent practicable, as part of the national exercise 

12 program under section 648(b)(1) of the Post-Katrina 

13 Emergency Management Reform Act of 2006 (6 U.S.C. 

14 748(b)(1)). 

15 (e) MODIFICATIONS.—Based on the exercises de16 scribed in subsection (d), the Administrator, in coordina17 tion with the entities described in subsection (b), shall re18 view and modify as necessary the plans described in sub19 section (c) not less frequently than biennially. 

20 (f) PRIORITIZATION.—The Administrator, in coordi21 nation with the entities described in subsection (b), shall 

22 develop standards and plans under subsections (b) and (c) 

23 in an identified order of priority that takes into account— 

24 (1) highest-risk biological, chemical, and radio25 logical threat agents; 


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1 (2) agents that could cause the greatest eco2 nomic devastation to the agriculture and food sys3 tem; and 

4 (3) agents that are most difficult to clean or re5 mediate. 

6 SEC. 113. AUTHORITY TO COLLECT FEES. 

7 (a) FEES FOR REINSPECTION, RECALL, AND IMPOR8 TATION ACTIVITIES.—Subchapter C of chapter VII (21 

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

10 740 the following: 

11 ‘‘PART 5—FEES RELATED TO FOOD 

12 ‘‘SEC. 740A. AUTHORITY TO COLLECT AND USE FEES. 

13 ‘‘(a) IN GENERAL.— 

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

15 year 2009 and each subsequent fiscal year, the Sec16 retary shall, in accordance with this section, assess 

17 and collect fees from— 

18 ‘‘(A) domestic facilities required to register 

19 under section 415, to cover reinspection-related 

20 costs for each such year; 

21 ‘‘(B) domestic facilities required to register 

22 under section 415, to cover food recall activities 

23 performed by the Secretary, including technical 

24 assistance, follow-up effectiveness checks, and 

25 public notifications, for each such year; 


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1 ‘‘(C) importers required to register under 

2 section 415, to cover the administrative costs of 

3 participating in the voluntary qualified importer 

4 program under section 806 for each such year; 

5 and 

6 ‘‘(D) importers, to cover reinspection-re7 lated costs at ports of entry for each such year. 

8 ‘‘(2) DEFINITIONS.—For purposes of this sec9 tion— 

10 ‘‘(A) the term ‘reinspection’ means 1 or 

11 more inspections conducted under section 704 

12 of this Act subsequent to an inspection con13 ducted under such provision which identified 

14 noncompliance materially related to a food safe15 ty requirement of this Act, specifically to deter16 mine whether compliance has been achieved to 

17 the Secretary’s satisfaction; and 

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

19 means all expenses, including administrative ex20 penses, incurred in connection with— 

21 ‘‘(i) arranging, conducting, and evalu22 ating the results of reinspections; and 

23 ‘‘(ii) assessing and collecting reinspec24 tion fees under this section. 

25 ‘‘(b) ESTABLISHMENT OF FEES.— 


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

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

3 collected under this section for each fiscal year speci4 fied in subsection (a)(1), based on the methodology 

5 described under paragraph (2), and shall publish 

6 such fees in a Federal Register notice not later than 

7 60 days before the start of each such year. 

8 ‘‘(2) FEE METHODOLOGY.— 

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

10 collection— 

11 ‘‘(i) under subparagraph (A) of sub12 section (a)(1) for a fiscal year shall be 

13 based on the Secretary’s estimate of 100 

14 percent of the costs of the reinspection-re15 lated activities (including by type or level 

16 of reinspection activity, as the Secretary 

17 determines applicable) described in such 

18 subparagraph (A) for such year; 

19 ‘‘(ii) under subparagraph (B) of sub20 section (a)(1) for a fiscal year shall be 

21 based on the Secretary’s estimate of 100 

22 percent of the costs of the activities de23 scribed in such subparagraph (B) for such 

24 year; 


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1 ‘‘(iii) under subparagraph (C) of sub2 section (a)(1) for a fiscal year shall be 

3 based on the Secretary’s estimate of 100 

4 percent of the costs of the activities de5 scribed in such subparagraph (C) for such 

6 year; and 

7 ‘‘(iv) under subparagraph (D) of sub8 section (a)(1) for a fiscal year shall be 

9 based on the Secretary’s estimate of 100 

10 percent of the costs of the activities de11 scribed in such subparagraph (D) for such 

12 year. 

13 ‘‘(B) OTHER CONSIDERATIONS.—In estab14 lishing the fee amounts for a fiscal year, the 

15 Secretary shall provide for the crediting of fees 

16 from the previous year to the next year if the 

17 Secretary overestimated the amount of fees 

18 needed to carry out such activities, and consider 

19 the need to account for any adjustment of fees 

20 and such other factors as the Secretary deter21 mines appropriate. 

22 ‘‘(3) COMPLIANCE WITH INTERNATIONAL

23 AGREEMENTS.—Nothing in this section shall be con24 strued to authorize the assessment of any fee incon25 sistent with the agreement establishing the World 


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1 Trade Organization or any other treaty or inter2 national agreement to which the United States is a 

3 party. 

4 ‘‘(c) LIMITATIONS.— 

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

6 shall be refunded for a fiscal year beginning after 

7 fiscal year 2009 unless appropriations for the Center 

8 for Food Safety and Applied Nutrition and the Cen9 ter for Veterinary Medicine and related activities of 

10 the Office of Regulatory Affairs at the Food and 

11 Drug Administration for such fiscal year (excluding 

12 the amount of fees appropriated for such fiscal year) 

13 are equal to or greater than the amount of appro14 priations for the Center for Food Safety and Applied 

15 Nutrition and the Center for Veterinary Medicine 

16 and related activities of the Office of Regulatory Af17 fairs at the Food and Drug Administration for the 

18 preceding fiscal year (excluding the amount of fees 

19 appropriated for such fiscal year) multiplied by 1 

20 plus 4.5 percent. 

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

22 assess fees under subsection (a) during any portion 

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

24 a later date in such fiscal year the Secretary may as25 sess such fees, the Secretary may assess and collect 


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1 such fees, without any modification in the rate, 

2 under subsection (a), notwithstanding the provisions 

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

4 paid. 

5 ‘‘(3) LIMITATION ON AMOUNT OF CERTAIN

6 FEES.—Notwithstanding any other provision of this 

7 section, in no case may the amount of the fees col8 lected for a fiscal year— 

9 ‘‘(A) under subparagraph (B) of subsection 

10 (a)(1) exceed $20,000,000; and 

11 ‘‘(B) under subparagraphs (A) and (D) of 

12 subsection (a)(1) exceed $25,000,000 combined. 

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

14 authorized under subsection (a) shall be collected and 

15 available for obligation only to the extent and in the 

16 amount provided in appropriations Acts. Such fees are au17 thorized to remain available until expended. Such sums 

18 as may be necessary may be transferred from the Food 

19 and Drug Administration salaries and expenses account 

20 without fiscal year limitation to such appropriation ac21 count for salaries and expenses with such fiscal year limi22 tation. The sums transferred shall be available solely for 

23 the purpose of paying the operating expenses of the Food 

24 and Drug Administration employees and contractors per25 forming activities associated with these food safety fees. 


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1 ‘‘(e) COLLECTION OF FEES.— 

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

3 in the Federal Register notice described in sub4 section (b)(1) the time and manner in which fees as5 sessed under this section shall be collected. 

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

7 case where the Secretary does not receive payment 

8 of a fee assessed under this section within 30 days 

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

10 of the United States Government subject to provi11 sions of subchapter II of chapter 37 of title 31, 

12 United States Code. 

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

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

15 assessed under this section, the Secretary shall submit a 

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

17 Pensions of the United States Senate and the Committee 

18 on Energy and Commerce of the United States House of 

19 Representatives, to include a description of fees assessed 

20 and collected for each such year and a summary descrip21 tion of the entities paying such fees and the types of busi22 ness in which such entities engage. 

23 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—For fis24 cal year 2009 and each fiscal year thereafter, there is au25 thorized to be appropriated for fees under this section an 


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1 amount equal to the total revenue amount determined 

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

3 otherwise affected under the other provisions of this sec4 tion.’’. 

5 (b) EXPORT CERTIFICATION FEES FOR FOODS AND

6 ANIMAL FEED.— 

7 (1) AUTHORITY FOR EXPORT CERTIFICATIONS

8 FOR FOOD, INCLUDING ANIMAL FEED.—Section 

9 801(e)(4)(A) (21 U.S.C. 381(e)(4)(A)) is amend10 ed— 

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

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

13 (B) in clause (i) by striking ‘‘exported 

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

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

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

17 drug’’. 

18 (2) CLARIFICATION OF CERTIFICATION.—Sec19 tion 801(e)(4) (21 U.S.C. 381(e)(4)) is amended by 

20 inserting after subparagraph (B) the following new 

21 subparagraph: 

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

23 certification by the Secretary shall be made on 

24 such basis, and in such form (including a pubVerDate Aug 31 2005 05:02 Aug 02, 2008 Jkt 069002 PO 00000 Frm 00053 Fmt 6652 Sfmt 6201 E:\BILLS\S3385.IS S3385

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1 licly available listing) as the Secretary deter2 mines appropriate.’’. 

3 SEC. 114. FINAL RULE FOR PREVENTION OF SALMONELLA 

4 ENTERITIDIS IN SHELL EGGS DURING PRO5 DUCTION. 

6 Not later than 1 year after the date of enactment 

7 of this Act, the Secretary shall issue a final rule based 

8 on the proposed rule issued by the Commissioner of Food 

9 and Drugs entitled ‘‘Prevention of Salmonella Enteritidis 

10 in Shell Eggs During Production’’, 69 Fed. Reg. 56824, 

11 (September 22, 2004). 

12 SEC. 115. SANITARY TRANSPORTATION OF FOOD. 

13 Not later than 1 year after the date of enactment 

14 of this Act, the Secretary shall promulgate regulations de15 scribed in section 416(b) of the Federal Food, Drug, and 

16 Cosmetic Act (21 U.S.C. 350e(b)). 

17 SEC. 116. FOOD ALLERGY AND ANAPHYLAXIS MANAGE18 MENT. 

19 (a) DEFINITIONS.—In this section: 

20 (1) EARLY CHILDHOOD EDUCATION PRO21 GRAM.—The term ‘‘early childhood education pro22 gram’’ means— 

23 (A) a Head Start program or an Early 

24 Head Start program carried out under the 

25 Head Start Act (42 U.S.C. 9831 et seq.); 


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1 (B) a State licensed or regulated child care 

2 program or school; or 

3 (C) a State prekindergarten program that 

4 serves children from birth through kinder5 garten. 

6 (2) ESEA DEFINITIONS.—The terms ‘‘local 

7 educational agency’’, ‘‘secondary school’’, ‘‘elemen8 tary school’’, and ‘‘parent’’ have the meanings given 

9 the terms in section 9101 of the Elementary and 

10 Secondary Education Act of 1965 (20 U.S.C. 7801). 

11 (3) SCHOOL.—The term ‘‘school’’ includes pub12 lic— 

13 (A) kindergartens; 

14 (B) elementary schools; and 

15 (C) secondary schools. 

16 (b) ESTABLISHMENT OF VOLUNTARY FOOD AL17 LERGY AND ANAPHYLAXIS MANAGEMENT GUIDELINES.— 

18 (1) ESTABLISHMENT.— 

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

20 after the date of enactment of this Act, the Sec21 retary, in consultation with the Secretary of 

22 Education, shall— 

23 (i) develop guidelines to be used on a 

24 voluntary basis to develop plans for indi25 viduals to manage the risk of food allergy 


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1 and anaphylaxis in schools and early child2 hood education programs; and 

3 (ii) make such guidelines available to 

4 local educational agencies, schools, early 

5 childhood education programs, and other 

6 interested entities and individuals to be im7 plemented on a voluntary basis only. 

8 (B) APPLICABILITY OF FERPA.—Each plan 

9 described in subparagraph (A) that is developed 

10 for an individual shall be considered an edu11 cation record for the purpose of the Family 

12 Educational Rights and Privacy Act of 1974 

13 (20 U.S.C. 1232g). 

14 (2) CONTENTS.—The voluntary guidelines de15 veloped by the Secretary under paragraph (1) shall 

16 address each of the following, and may be updated 

17 as the Secretary deems necessary: 

18 (A) Parental obligation to provide the 

19 school or early childhood education program, 

20 prior to the start of every school year, with— 

21 (i) documentation from their child’s 

22 physician or nurse— 

23 (I) supporting a diagnosis of food 

24 allergy and the risk of anaphylaxis; 


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1 (II) identifying any food to which 

2 the child is allergic; 

3 (III) describing, if appropriate, 

4 any prior history of anaphylaxis; 

5 (IV) listing any medication pre6 scribed for the child for the treatment 

7 of anaphylaxis; 

8 (V) detailing emergency treat9 ment procedures in the event of a re10 action; 

11 (VI) listing the signs and symp12 toms of a reaction; and 

13 (VII) assessing the child’s readi14 ness for self-administration of pre15 scription medication; and 

16 (ii) a list of substitute meals that may 

17 be offered to the child by school or early 

18 childhood education program food service 

19 personnel. 

20 (B) The creation and maintenance of an 

21 individual health care plan for food allergy 

22 management, in consultation with the parent, 

23 tailored to the needs of each child with a docu24 mented risk for anaphylaxis, including any proVerDate Aug 31 2005 05:02 Aug 02, 2008 Jkt 069002 PO 00000 Frm 00057 Fmt 6652 Sfmt 6201 E:\BILLS\S3385.IS S3385

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1 cedures for the self-administration of medica2 tion by such children in instances where— 

3 (i) the children are capable of self-ad4 ministering medication; and 

5 (ii) such administration is not prohib6 ited by State law. 

7 (C) Communication strategies between in8 dividual schools or early childhood education 

9 programs and local providers of emergency 

10 medical services, including appropriate instruc11 tions for emergency medical response. 

12 (D) Strategies to reduce the risk of expo13 sure to anaphylactic causative agents in class14 rooms and common school or early childhood 

15 education program areas such as cafeterias. 

16 (E) The dissemination of general informa17 tion on life-threatening food allergies to school 

18 or early childhood education program staff, par19 ents, and children. 

20 (F) Food allergy management training of 

21 school or early childhood education program 

22 personnel who regularly come into contact with 

23 children with life-threatening food allergies. 

24 (G) The authorization and training of 

25 school or early childhood education program 


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1 personnel to administer epinephrine when the 

2 nurse is not immediately available. 

3 (H) The timely accessibility of epinephrine 

4 by school or early childhood education program 

5 personnel when the nurse is not immediately 

6 available. 

7 (I) The creation of a plan contained in 

8 each individual health care plan for food allergy 

9 management that addresses the appropriate re10 sponse to an incident of anaphylaxis of a child 

11 while such child is engaged in extracurricular 

12 programs of a school or early childhood edu13 cation program, such as non-academic outings 

14 and field trips, before- and after-school pro15 grams or before- and after-early child education 

16 program programs, and school-sponsored or 

17 early childhood education program-sponsored 

18 programs held on weekends. 

19 (J) Maintenance of information for each 

20 administration of epinephrine to a child at risk 

21 for anaphylaxis and prompt notification to par22 ents. 

23 (K) Other elements the Secretary deems 

24 necessary for the management of food allergies 


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1 and anaphylaxis in schools and early childhood 

2 education programs. 

3 (3) RELATION TO STATE LAW.—Nothing in this 

4 section or the guidelines developed by the Secretary 

5 under paragraph (1) shall be construed to preempt 

6 State law, including any State law regarding wheth7 er students at risk for anaphylaxis may self-admin8 ister medication. 

9 (c) SCHOOL-BASED FOOD ALLERGY MANAGEMENT

10 GRANTS.— 

11 (1) IN GENERAL.—The Secretary may award 

12 grants to local educational agencies to assist such 

13 agencies with implementing voluntary food allergy 

14 and anaphylaxis management guidelines described in 

15 subsection (b). 

16 (2) APPLICATION.— 

17 (A) IN GENERAL.—To be eligible to receive 

18 a grant under this subsection, a local edu19 cational agency shall submit an application to 

20 the Secretary at such time, in such manner, 

21 and including such information as the Secretary 

22 may reasonably require. 

23 (B) CONTENTS.—Each application sub24 mitted under subparagraph (A) shall include— 


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1 (i) an assurance that the local edu2 cational agency has developed plans in ac3 cordance with the food allergy and anaphy4 laxis management guidelines described in 

5 subsection (b); 

6 (ii) a description of the activities to be 

7 funded by the grant in carrying out the 

8 food allergy and anaphylaxis management 

9 guidelines, including— 

10 (I) how the guidelines will be car11 ried out at individual schools served 

12 by the local educational agency; 

13 (II) how the local educational 

14 agency will inform parents and stu15 dents of the guidelines in place; 

16 (III) how school nurses, teachers, 

17 administrators, and other school-based 

18 staff will be made aware of, and given 

19 training on, when applicable, the 

20 guidelines in place; and 

21 (IV) any other activities that the 

22 Secretary determines appropriate; 

23 (iii) an itemization of how grant funds 

24 received under this subsection will be ex25 pended; 


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1 (iv) a description of how adoption of 

2 the guidelines and implementation of grant 

3 activities will be monitored; and 

4 (v) an agreement by the local edu5 cational agency to report information re6 quired by the Secretary to conduct evalua7 tions under this subsection. 

8 (3) USE OF FUNDS.—Each local educational 

9 agency that receives a grant under this subsection 

10 may use the grant funds for the following: 

11 (A) Purchase of materials and supplies, in12 cluding limited medical supplies such as epi13 nephrine and disposable wet wipes, to support 

14 carrying out the food allergy and anaphylaxis 

15 management guidelines described in subsection 

16 (b). 

17 (B) In partnership with local health de18 partments, school nurse, teacher, and personnel 

19 training for food allergy management. 

20 (C) Programs that educate students as to 

21 the presence of, and policies and procedures in 

22 place related to, food allergies and anaphylactic 

23 shock. 

24 (D) Outreach to parents. 


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1 (E) Any other activities consistent with the 

2 guidelines described in subsection (b). 

3 (4) DURATION OF AWARDS.—The Secretary 

4 may award grants under this subsection for a period 

5 of not more than 2 years. In the event the Secretary 

6 conducts a program evaluation under this sub7 section, funding in the second year of the grant, 

8 where applicable, shall be contingent on a successful 

9 program evaluation by the Secretary after the first 

10 year. 

11 (5) LIMITATION ON GRANT FUNDING.—The 

12 Secretary may not provide grant funding to a local 

13 educational agency under this subsection after such 

14 local educational agency has received 2 years of 

15 grant funding under this subsection. 

16 (6) MAXIMUM AMOUNT OF ANNUAL AWARDS.— 

17 A grant awarded under this subsection may not be 

18 made in an amount that is more than $50,000 an19 nually. 

20 (7) PRIORITY.—In awarding grants under this 

21 subsection, the Secretary shall give priority to local 

22 educational agencies with the highest percentages of 

23 children who are counted under section 1124(c) of 

24 the Elementary and Secondary Education Act of 

25 1965 (20 U.S.C. 6333(c)). 


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1 (8) MATCHING FUNDS.— 

2 (A) IN GENERAL.—The Secretary may not 

3 award a grant under this subsection unless the 

4 local educational agency agrees that, with re5 spect to the costs to be incurred by such local 

6 educational agency in carrying out the grant ac7 tivities, the local educational agency shall make 

8 available (directly or through donations from 

9 public or private entities) non-Federal funds to10 ward such costs in an amount equal to not less 

11 than 25 percent of the amount of the grant. 

12 (B) DETERMINATION OF AMOUNT OF NON13 FEDERAL CONTRIBUTION.—Non-Federal funds 

14 required under subparagraph (A) may be cash 

15 or in kind, including plant, equipment, or serv16 ices. Amounts provided by the Federal Govern17 ment, and any portion of any service subsidized 

18 by the Federal Government, may not be in19 cluded in determining the amount of such non20 Federal funds. 

21 (9) ADMINISTRATIVE FUNDS.—A local edu22 cational agency that receives a grant under this sub23 section may use not more than 2 percent of the 

24 grant amount for administrative costs related to car25 rying out this subsection. 


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1 (10) PROGRESS AND EVALUATIONS.—At the 

2 completion of the grant period referred to in para3 graph (4), a local educational agency shall provide 

4 the Secretary with information on how grant funds 

5 were spent and the status of implementation of the 

6 food allergy and anaphylaxis management guidelines 

7 described in subsection (b). 

8 (11) SUPPLEMENT, NOT SUPPLANT.—Grant 

9 funds received under this subsection shall be used to 

10 supplement, and not supplant, non-Federal funds 

11 and any other Federal funds available to carry out 

12 the activities described in this subsection. 

13 (12) AUTHORIZATION OF APPROPRIATIONS.— 

14 There is authorized to be appropriated to carry out 

15 this subsection $30,000,000 for fiscal year 2009 and 

16 such sums as may be necessary for each of the 4 

17 succeeding fiscal years. 

18 (d) VOLUNTARY NATURE OF GUIDELINES.— 

19 (1) IN GENERAL.—The food allergy and ana20 phylaxis management guidelines developed by the 

21 Secretary under subsection (b) are voluntary. Noth22 ing in this section or the guidelines developed by the 

23 Secretary under subsection (b) shall be construed to 

24 require a local educational agency to implement such 

25 guidelines. 


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1 (2) EXCEPTION.—Notwithstanding paragraph 

2 (1), the Secretary may enforce an agreement by a 

3 local educational agency to implement food allergy 

4 and anaphylaxis management guidelines as a condi5 tion of the receipt of a grant under subsection (c). 

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 109, is amended by adding 

12 at the end the following: 

13 ‘‘SEC. 423. 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 the FDA Food Safety 

19 Modernization Act, the Secretary 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 is either conducted 

17 by or on behalf of an owner or consignee— 

18 ‘‘(1) in support of admission of an article of 

19 food under section 801(a); 

20 ‘‘(2) due to a specific testing requirement in 

21 this Act or implementing regulations; 

22 ‘‘(3) under an Import Alert that requires suc23 cessful consecutive tests; or 

24 ‘‘(4) is so required by the Secretary as the Sec25 retary deems appropriate. 


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1 The results of any such sampling or testing shall be sent 

2 directly to the Food and Drug Administration. 

3 ‘‘(c) REVIEW BY SECRETARY.—If food sampling and 

4 testing performed by a laboratory run and operated by a 

5 State or locality that is accredited by an accreditation 

6 body on the registry established by the Secretary under 

7 subsection (a) result in a State recalling a food, the Sec8 retary shall review the sampling and testing results for 

9 the purpose of determining the need for a national recall 

10 or other compliance and enforcement activities.’’. 

11 (b) FOOD EMERGENCY RESPONSE NETWORK.—The 

12 Secretary, in coordination with the Secretary of Agri13 culture, the Secretary of Homeland Security, and State, 

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

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

16 thereafter, submit to the relevant committees of Congress, 

17 and make publicly available on the Internet Web site of 

18 the Department of Health and Human Services, a report 

19 on the progress in implementing a national food emer20 gency response laboratory network that— 

21 (1) provides ongoing surveillance, rapid detec22 tion, and surge capacity for large-scale food-related 

23 emergencies, including intentional adulteration of 

24 the food supply; 


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1 (2) coordinates the food laboratory capacities of 

2 State food laboratories, including the sharing of data 

3 between State laboratories to develop national situa4 tional awareness; 

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

6 consistent food laboratory services throughout the 

7 United States; 

8 (4) develops and implements a methods reposi9 tory for use by Federal, State, and local officials; 

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

11 (6) is integrated with relevant laboratory net12 works administered by other Federal agencies. 

13 SEC. 202. INTEGRATED CONSORTIUM OF LABORATORY 

14 NETWORKS. 

15 (a) IN GENERAL.—The Secretary of Homeland Secu16 rity, in consultation with the Secretary of Health and 

17 Human Services, the Secretary of Agriculture, and the 

18 Administrator of the Environmental Protection Agency, 

19 shall maintain an agreement through which relevant lab20 oratory network members, as determined by the Secretary 

21 of Homeland Security, shall— 

22 (1) agree on common laboratory methods in 

23 order to facilitate the sharing of knowledge and in24 formation relating to animal health, agriculture, and 

25 human health; 


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1 (2) identify the means by which each laboratory 

2 network member could work cooperatively— 

3 (A) to optimize national laboratory pre4 paredness; and 

5 (B) to provide surge capacity during emer6 gencies; and 

7 (3) engage in ongoing dialogue and build rela8 tionships that will support a more effective and inte9 grated response during emergencies. 

10 (b) REPORTING REQUIREMENT.—The Secretary of 

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

12 the relevant committees of Congress, and make publicly 

13 available on the Internet Web site of the Department of 

14 Homeland Security, a report on the progress of the inte15 grated consortium of laboratory networks, as established 

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

17 SEC. 203. BUILDING DOMESTIC CAPACITY. 

18 (a) IN GENERAL.— 

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

20 later than 2 years after the date of enactment of 

21 this Act, submit to Congress a comprehensive report 

22 that identifies programs and practices that are in23 tended to promote the safety and security of food 

24 and to prevent outbreaks of food-borne illness and 

25 other food-related hazards that can be addressed 


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1 through preventive activities. Such report shall in2 clude a description of the following: 

3 (A) Analysis of the need for regulations or 

4 guidance to industry. 

5 (B) Outreach to food industry sectors, in6 cluding through the Food and Agriculture Co7 ordinating Councils referred to in section 111, 

8 to identify potential sources of emerging threats 

9 to the safety and security of the food supply 

10 and preventive strategies to address those 

11 threats. 

12 (C) Systems to ensure the prompt distribu13 tion to the food industry of information and 

14 technical assistance concerning preventive strat15 egies. 

16 (D) Communication systems to ensure that 

17 information about specific threats to the safety 

18 and security of the food supply are rapidly and 

19 effectively disseminated. 

20 (E) Surveillance systems and laboratory 

21 networks to rapidly detect and respond to food22 borne illness outbreaks and other food-related 

23 hazards, including how such systems and net24 works are integrated. 


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1 (F) Outreach, education, and training pro2 vided to States to build State food safety and 

3 food defense capabilities, including progress im4 plementing strategies developed under sections 

5 110 and 205. 

6 (G) The estimated resources needed to ef7 fectively implement the programs and practices 

8 identified in the report developed in this section 

9 over a 5-year period. 

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

11 following the submission of the report under para12 graph (1), the Secretary shall submit to Congress a 

13 report that— 

14 (A) reviews previous food safety programs 

15 and practices; 

16 (B) outlines the success of those programs 

17 and practices; 

18 (C) identifies future programs and prac19 tices; and 

20 (D) includes information related to any 

21 matter described in subparagraphs (A) through 

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

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

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

25 to ensure that resources available to the Secretary for food 


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1 safety-related activities are directed at those actions most 

2 likely to reduce risks from food, including the use of pre3 ventive strategies and allocation of inspection resources. 

4 The Secretary shall promptly undertake those risk-based 

5 actions that are identified during the development of the 

6 report as likely to contribute to the safety and security 

7 of the food supply. 

8 (c) CAPABILITY FOR LABORATORY ANALYSES; RE9 SEARCH.—The report developed under subsection (a)(1) 

10 shall provide a description of methods to increase capacity 

11 to undertake analyses of food samples promptly after col12 lection, to identify new and rapid analytical techniques, 

13 including techniques that can be employed at ports of 

14 entry and through Food Emergency Response Network 

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

16 laboratory facilities. 

17 (d) INFORMATION TECHNOLOGY.—The report devel18 oped under subsection (a)(1) shall include a description 

19 of such information technology systems as may be needed 

20 to identify risks and receive data from multiple sources, 

21 including foreign governments, State, local, and tribal gov22 ernments, other Federal agencies, the food industry, lab23 oratories, laboratory networks, and consumers. The infor24 mation technology systems that the Secretary describes 

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1 istration system under section 415 of the Federal Food, 

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

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

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

5 that are used by the Federal Government for the proc6 essing of food offered for import into the United States. 

7 (e) AUTOMATED RISK ASSESSMENT.—The report de8 veloped under subsection (a)(1) shall include a description 

9 of progress toward developing and improving an auto10 mated risk assessment system for food safety surveillance 

11 and allocation of resources. 

12 (f) TRACEBACK AND SURVEILLANCE REPORT.—The 

13 Secretary shall include in the report developed under sub14 section (a)(1) an analysis of the Food and Drug Adminis15 tration’s performance in food-borne illness outbreaks dur16 ing the 5-year period preceding the date of enactment of 

17 this Act involving fruits and vegetables that are raw agri18 cultural commodities (as defined in section 201(r) of the 

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

20 and recommendations for enhanced surveillance, outbreak 

21 response, and traceability. Such findings and rec22 ommendations shall address communication and coordina23 tion with the public and industry, outbreak identification, 

24 and traceback. 


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1 (g) BIENNIAL FOOD SAFETY AND FOOD DEFENSE

2 RESEARCH PLAN.—The Secretary and the Secretary of 

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

4 a joint food safety and food defense research plan which 

5 may include studying the long-term health effects of food6 borne illness. Such biennial plan shall include a list and 

7 description of projects conducted during the previous 2- 

8 year period and the plan for projects to be conducted dur9 ing the following 2-year period. 

10 SEC. 204. ENHANCING TRACEBACK AND RECORDKEEPING. 

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

12 with the Secretary of Agriculture and representatives of 

13 State departments of health and agriculture, shall improve 

14 the capacity of the Secretary to effectively and rapidly 

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

16 vegetables that are raw agricultural commodities. 

17 (b) PILOT PROJECT.— 

18 (1) IN GENERAL.—Not later than 9 months 

19 after the date of enactment of this Act, the Sec20 retary shall establish a pilot project in coordination 

21 with the produce industry to explore and evaluate 

22 new methods for rapidly and effectively tracking and 

23 tracing fruits and vegetables that are raw agricul24 tural commodities so that, if an outbreak occurs in25 volving such a fruit or vegetable, the Secretary may 


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1 quickly identify the source of the outbreak and the 

2 recipients of the contaminated food. 

3 (2) CONTENT.—The Secretary shall select par4 ticipants from the produce industry to run projects 

5 which overall shall include at least 3 different types 

6 of fruits or vegetables that have been the subject of 

7 outbreaks during the 5-year period preceding the 

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

9 in order to develop and demonstrate— 

10 (A) methods that are applicable and appro11 priate for small businesses; and 

12 (B) technologies, including existing tech13 nologies, that enhance traceback and trace for14 ward. 

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

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

17 to Congress on the findings of the pilot project under sub18 section (b) together with recommendations for establishing 

19 more effective traceback and trace forward procedures for 

20 fruits and vegetables that are raw agricultural commod21 ities. 

22 (d) TRACEBACK PERFORMANCE REQUIREMENTS.— 

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

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

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1 tion, format, and timeframe for persons to submit records 

2 to aid the Secretary in effectively and rapidly tracking and 

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

4 that are raw agricultural commodities. Nothing in this sec5 tion shall be construed as giving the Secretary the author6 ity to prescribe specific technologies for the maintenance 

7 of records. 

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

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

10 the Secretary shall conduct not less than 3 public meetings 

11 in diverse geographical areas of the United States to pro12 vide persons in different regions an opportunity to com13 ment. 

14 (f) RAW AGRICULTURAL COMMODITY.—In this sec15 tion, the term ‘‘raw agricultural commodity’’ has the 

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

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

18 SEC. 205. SURVEILLANCE. 

19 (a) DEFINITION OF FOOD-BORNE ILLNESS OUT20 BREAK.—In this section, the term ‘‘food-borne illness out21 break’’ means the occurrence of 2 or more cases of a simi22 lar illness resulting from the ingestion of a food. 

23 (b) FOOD-BORNE ILLNESS SURVEILLANCE SYS24 TEMS.— 


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

2 through the Director of the Centers for Disease 

3 Control and Prevention, shall enhance food-borne ill4 ness surveillance systems to improve the collection, 

5 analysis, reporting, and usefulness of data on food6 borne illnesses by— 

7 (A) coordinating Federal, State and local 

8 food-borne illness surveillance systems, includ9 ing complaint systems, and increasing participa10 tion in national networks of public health and 

11 food regulatory agencies and laboratories; 

12 (B) facilitating sharing of findings on a 

13 more timely basis among governmental agen14 cies, including the Food and Drug Administra15 tion, the Department of Agriculture, and State 

16 and local agencies, and with the public; 

17 (C) developing improved epidemiological 

18 tools for obtaining quality exposure data, and 

19 microbiological methods for classifying cases; 

20 (D) augmenting such systems to improve 

21 attribution of a food-borne illness outbreak to a 

22 specific food; 

23 (E) expanding capacity of such systems, 

24 including working toward automatic electronic 

25 searches, for implementation of fingerprinting 


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1 strategies for food-borne infectious agents, in 

2 order to identify new or rarely documented 

3 causes of food-borne illness and submit stand4 ardized information to a centralized database; 

5 (F) allowing timely public access to aggre6 gated, de-identified surveillance data; 

7 (G) at least annually, publishing current 

8 reports on findings from such systems; 

9 (H) establishing a flexible mechanism for 

10 rapidly initiating scientific research by academic 

11 institutions; 

12 (I) integrating food-borne illness surveil13 lance systems and data with other biosurveil14 lance and public health situational awareness 

15 capabilities at the state and federal levels; and 

16 (J) other activities as determined appro17 priate by the Secretary. 

18 (2) PARTNERSHIPS.—The Secretary shall sup19 port and maintain a diverse working group of ex20 perts and stakeholders from Federal, State, and 

21 local food safety and health agencies, the food indus22 try, consumer organizations, and academia. Such 

23 working group shall provide the Secretary, through 

24 at least annual meetings of the working group and 

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1 tions on an ongoing and regular basis regarding the 

2 improvement of food-borne illness surveillance and 

3 implementation of this section, including advice and 

4 recommendations on— 

5 (A) the priority needs of regulatory agen6 cies, the food industry, and consumers for infor7 mation and analysis on food-borne illness and 

8 its causes; 

9 (B) opportunities to improve the effective10 ness of initiatives at the Federal, State, and 

11 local levels, including coordination and integra12 tion of activities among Federal agencies, and 

13 between the Federal, State, and local levels of 

14 government; 

15 (C) improvement in the timeliness and 

16 depth of access by regulatory and health agen17 cies, the food industry, academic researchers, 

18 and consumers to food-borne illness surveillance 

19 data collected by government agencies at all lev20 els, including data compiled by the Centers for 

21 Disease Control and Prevention; 

22 (D) key barriers to improvement in food23 borne illness surveillance and its utility for pre24 venting food-borne illness at Federal, State, and 

25 local levels; 


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1 (E) the capabilities needed for establishing 

2 automatic electronic searches of surveillance 

3 data; and 

4 (F) specific actions to reduce barriers to 

5 improvement, implement the working group’s 

6 recommendations, and achieve the purposes of 

7 this section, with measurable objectives and 

8 timelines, and identification of resource and 

9 staffing needs. 

10 (c) IMPROVING FOOD SAFETY AND DEFENSE CAPAC11 ITY AT THE STATE AND LOCAL LEVEL.— 

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

13 and implement strategies to leverage and enhance 

14 the food safety and defense capacities of State and 

15 local agencies in order to achieve the following goals: 

16 (A) Improve food-borne illness outbreak re17 sponse and containment. 

18 (B) Accelerate food-borne illness surveil19 lance and outbreak investigation, including 

20 rapid shipment of clinical isolates from clinical 

21 laboratories to appropriate State laboratories, 

22 and conducting more standardized illness out23 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 110. 

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 the 

18 FDA Food Safety Modernization Act, complete a re19 view of State and local capacities, and needs for en20 hancement, which may include a survey with respect 

21 to— 

22 (A) staffing levels and expertise available 

23 to perform food safety and defense functions; 


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1 (B) laboratory capacity to support surveil2 lance, outbreak response, inspection, and en3 forcement activities; 

4 (C) information systems to support data 

5 management and sharing of food safety and de6 fense information among State and local agen7 cies and with counterparts at the Federal level; 

8 and 

9 (D) other State and local activities and 

10 needs as determined appropriate by the Sec11 retary. 

12 (d) FOOD SAFETY CAPACITY BUILDING GRANTS.— 

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

14 U.S.C. 247b–20(b)) is amended— 

15 (1) by striking ‘‘2002’’ and inserting ‘‘2009’’; 

16 and 

17 (2) by striking ‘‘2003 through 2006’’ and in18 serting ‘‘2010 through 2013’’. 

19 TITLE III—SPECIFIC PROVI20 SIONS FOR IMPORTED FOOD 

21 SEC. 301. FOREIGN SUPPLIER VERIFICATION PROGRAM. 

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

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

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

25 ‘‘(a) IN GENERAL.— 


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1 ‘‘(1) VERIFICATION REQUIREMENT.—Each 

2 United States importer of record shall perform risk3 based foreign supplier verification activities in ac4 cordance with regulations promulgated under sub5 section (c) for the purpose of verifying that the food 

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

7 ‘‘(A) produced in compliance with the re8 quirements of section 419 or 420, as appro9 priate; and 

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

11 or misbranded under section 403(w). 

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

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

14 a person holding a valid license under section 641 of 

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

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

17 executed a written agreement with another person 

18 who has agreed to comply with the requirements of 

19 this section with regard to food imported or offered 

20 for import by the customs broker. 

21 ‘‘(b) GUIDANCE.—Not later than 1 year after the 

22 date of enactment of the FDA Food Safety Modernization 

23 Act, the Secretary shall issue guidance to assist United 

24 States importers of record in developing foreign supplier 

25 verification programs. 


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1 ‘‘(c) REGULATIONS.— 

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

3 the date of enactment of the FDA Food Safety Mod4 ernization Act, the Secretary shall promulgate regu5 lations to provide for the content of the foreign sup6 plier verification program established under sub7 section (a). Such regulations shall, as appropriate, 

8 include a process for verification by a United States 

9 importer of record, with respect to each foreign sup10 plier from which it obtains food, that the imported 

11 food is produced in compliance with the require12 ments of section 419 or 420, as appropriate, and is 

13 not adulterated under section 402 or misbranded 

14 under section 403(w). 

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

16 paragraph (1) shall require that the foreign supplier 

17 verification program of each importer of record be 

18 adequate to provide assurances that each foreign 

19 supplier to the importer of record produces the im20 ported food employing processes and procedures, in21 cluding risk-based reasonably appropriate preventive 

22 controls, equivalent in preventing adulteration and 

23 reducing hazards as those required by section 419 or 

24 section 420, as appropriate. 


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

2 a foreign supplier verification program under this 

3 section may include monitoring records for ship4 ments, lot-by-lot certification of compliance, annual 

5 on-site inspections, checking the hazard analysis and 

6 risk-based preventive control plan of the foreign sup7 plier, and periodically testing and sampling ship8 ments. 

9 ‘‘(d) RECORD MAINTENANCE AND ACCESS.—Records 

10 of a United States importer of record related to a foreign 

11 supplier verification program shall be maintained for a pe12 riod of not less than 2 years and shall be made available 

13 promptly to a duly authorized representative of the Sec14 retary upon request. 

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

16 AND LOW-ACID CANNED FOOD FACILITIES IN COMPLI17 ANCE WITH HACCP.—An owner, operator, or agent in 

18 charge of a facility required to comply with 1 of the fol19 lowing standards and regulations with respect to such fa20 cility shall be deemed to be in compliance with this section 

21 with respect to such facility: 

22 ‘‘(1) The Seafood Hazard Analysis Critical 

23 Control Points Program of the Food and Drug Ad24 ministration. 


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1 ‘‘(2) The Juice Hazard Analysis Critical Con2 trol Points Program of the Food and Drug Adminis3 tration. 

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

5 Packaged in Hermetically Sealed Containers stand6 ards of the Food and Drug Administration (or any 

7 successor standards). 

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

9 Secretary shall publish and maintain on the Internet Web 

10 site of the Food and Drug Administration a current list 

11 that includes the name of, location of, and other informa12 tion deemed necessary by the Secretary about, importers 

13 participating under this section.’’. 

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

15 as amended by section 109, is amended by adding at the 

16 end the following: 

17 ‘‘(ss) The importation or offering for importation of 

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

19 a foreign supplier verification program in compliance with 

20 section 805.’’. 

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

22 amended by adding ‘‘or the importer of record is in viola23 tion of section 805’’ after ‘‘or in violation of section 505’’. 


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

2 this section shall take effect 2 years after the date of en3 actment of this Act. 

4 SEC. 302. VOLUNTARY QUALIFIED IMPORTER PROGRAM. 

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

6 by section 301, is amended by adding at the end the fol7 lowing: 

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

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

10 after the date of enactment of the FDA Food Safety Mod11 ernization Act, the Secretary shall— 

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

13 the Department of Homeland Security, to provide 

14 for the expedited review and importation of food of15 fered for importation by United States importers 

16 who have voluntarily agreed to participate in such 

17 program; and 

18 ‘‘(2) issue a guidance document related to par19 ticipation and compliance with such program. 

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

21 request the Secretary to provide for the expedited review 

22 and importation of designated foods in accordance with 

23 the program procedures established by the Secretary. 

24 ‘‘(c) ELIGIBILITY.—In order to be eligible, an im25 porter shall be offering food for importation from a facility 


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1 that has a certification described in section 809(b). In re2 viewing the applications and making determinations on 

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

4 food to be imported based on factors, such as the fol5 lowing: 

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

7 ‘‘(2) The compliance history of the foreign sup8 plier. 

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

10 the country of export to ensure compliance with 

11 United States food safety standards. 

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

13 requirements of section 805. 

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

15 and audits of facilities, traceability of articles of 

16 food, temperature controls, and sourcing practices of 

17 the importer. 

18 ‘‘(6) The potential risk for intentional adultera19 tion of the food. 

20 ‘‘(7) Any other factor that the Secretary deter21 mines appropriate. 

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

23 qualified by the Secretary in accordance with the eligibility 

24 criteria set forth in this section shall be reevaluated not 

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


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1 promptly revoke the qualified importer status of any im2 porter found not to be in compliance with such criteria. 

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

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

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

6 customs territory of the United States.’’. 

7 SEC. 303. AUTHORITY TO REQUIRE IMPORT CERTIFI8 CATIONS FOR FOOD. 

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

10 381(a)) is amended by inserting after the third sentence 

11 the following: ‘‘With respect to an article of food, if impor12 tation of such food is subject to, but not compliant with, 

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

14 accompanied by a certification or other assurance that the 

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

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

17 (b) ADDITION OF CERTIFICATION REQUIREMENT.— 

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

19 end the following new subsection: 

20 ‘‘(p) CERTIFICATIONS CONCERNING IMPORTED

21 FOODS.— 

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

23 public health considerations, including risks associ24 ated with the food or its place of origin, may require 

25 as a condition of granting admission to an article of 


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1 food imported or offered for import into the United 

2 States, that an entity specified in paragraph (2) pro3 vide a certification or such other assurances as the 

4 Secretary determines appropriate that the article of 

5 food complies with some or all applicable require6 ments of this Act, as specified by the Secretary. 

7 Such certification or assurances may be provided in 

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

9 certified entities, or in such other form as the Sec10 retary may specify. Such certification shall be used 

11 for designated food imported from countries with 

12 which the Food and Drug Administration has an 

13 agreement to establish a certification program. 

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

15 paragraph (1), entities that shall provide the certifi16 cation or assurances described in such paragraph 

17 are— 

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

19 government of the country from which the arti20 cle of food at issue originated, as designated by 

21 such government or the Secretary; or 

22 ‘‘(B) such other persons or entities accred23 ited pursuant to section 809 to provide such 

24 certification or assurance. 


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1 ‘‘(3) RENEWAL AND REFUSAL OF CERTIFI2 CATIONS.—The Secretary may— 

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

4 assurance provided by an entity specified in 

5 paragraph (2) be renewed by such entity at 

6 such times as the Secretary determines appro7 priate; and 

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

9 assurance if the Secretary determines that such 

10 certification or assurance is no longer valid or 

11 reliable. 

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

13 shall provide for the electronic submission of certifi14 cations under this subsection.’’. 

15 (c) CONFORMING TECHNICAL AMENDMENT.—Sec16 tion 801(b) (21 U.S.C. 381(b)) is amended in the second 

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

18 within the provision of the fourth sentence of subsection 

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

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

21 760 or 761,’’. 

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

23 amendments made by this section shall limit the authority 

24 of the Secretary to conduct random inspections of im25 ported food or to take such other steps as the Secretary 


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1 deems appropriate to determine the admissibility of im2 ported food. 

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

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

5 381(m)(1)) is amended by inserting ‘‘any country to which 

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

7 from which the article is shipped;’’. 

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

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

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

11 21, Code of Federal Regulations, to implement the amend12 ment made by this section. 

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

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

15 enactment of this Act. 

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

17 FOREIGN COUNTRY. 

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

19 by section 302, is amended by adding at the end the fol20 lowing: 

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

22 FOREIGN COUNTRY. 

23 ‘‘The Secretary may review information from a coun24 try outlining the statutes, regulations, standards, and con25 trols of such country, and conduct on-site audits in such 


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1 country to verify the implementation of those statutes, 

2 regulations, standards, and controls. Based on such re3 view, the Secretary shall determine whether such country 

4 can provide reasonable assurances that the food supply of 

5 the country is equivalent in safety to food manufactured, 

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

7 SEC. 306. BUILDING CAPACITY OF FOREIGN GOVERNMENTS 

8 WITH RESPECT TO FOOD. 

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

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

11 a comprehensive plan to expand the technical, scientific, 

12 and regulatory capacity of foreign governments, and their 

13 respective food industries, from which foods are exported 

14 to the United States. 

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

16 subsection (a), the Secretary shall consult with the Sec17 retary of Agriculture, Secretary of State, Secretary of the 

18 Treasury, and the Secretary of Commerce, representatives 

19 of the food industry, appropriate foreign government offi20 cials, and nongovernmental organizations that represent 

21 the interests of consumers, and other stakeholders. 

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

23 shall include, as appropriate, the following: 

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1 sions to provide for responsibility of exporting coun2 tries to ensure the safety of food. 

3 (2) Provisions for electronic data sharing. 

4 (3) Provisions for mutual recognition of inspec5 tion reports. 

6 (4) Training of foreign governments and food 

7 producers on United States requirements for safe 

8 food. 

9 (5) Recommendations to harmonize require10 ments under the Codex Alimentarius. 

11 (6) Provisions for the multilateral acceptance of 

12 laboratory methods and detection techniques. 

13 SEC. 307. INSPECTION OF FOREIGN FOOD FACILITIES. 

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

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

16 following: 

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

18 ‘‘(a) INSPECTION.—The Secretary— 

19 ‘‘(1) may enter into arrangements and agree20 ments with foreign governments to facilitate the in21 spection of foreign facilities registered under section 

22 415; and 

23 ‘‘(2) shall direct resources to inspections of for24 eign facilities, suppliers, and food types, especially 

25 such facilities, suppliers, and food types that present 


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

2 ensure the safety and security of the food supply of 

3 the United States. 

4 ‘‘(b) EFFECT OF INABILITY TO INSPECT.—Notwith5 standing any other provision of law, food shall be refused 

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

7 facility registered under section 415 of which the owner, 

8 operator, or agent in charge of the facility, or the govern9 ment of the foreign country, refuses to permit entry of 

10 United States inspectors, upon request, to inspect such fa11 cility. For purposes of this subsection, such an owner, op12 erator, or agent in charge shall be considered to have re13 fused an inspection if such owner, operator, or agent in 

14 charge refuses such a request to inspect a facility more 

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

16 SEC. 308. ACCREDITATION OF QUALIFIED THIRD-PARTY 

17 AUDITORS. 

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

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

20 the following: 

21 ‘‘SEC. 809. ACCREDITATION OF QUALIFIED THIRD-PARTY 

22 AUDITORS. 

23 ‘‘(a) ACCREDITATION OF CERTIFYING AGENTS.— 

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

25 years after the date of enactment of the FDA Food 


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1 Safety Modernization Act, the Secretary shall estab2 lish and implement an accreditation system under 

3 which a foreign government, a State or regional food 

4 authority, a foreign or domestic cooperative that ag5 gregates the products of growers or processors, or 

6 any other third party that the Secretary determines 

7 appropriate, may request to be accredited as a certi8 fying agent to certify that eligible entities meet the 

9 applicable requirements of this Act. 

10 ‘‘(2) REVIEW BY SECRETARY.—When estab11 lishing the accreditation system under paragraph 

12 (1), the Secretary shall review third-party accredita13 tion systems in existence on the date of enactment 

14 of the FDA Food Safety Modernization Act, to avoid 

15 unnecessary duplication of efforts and costs. 

16 ‘‘(3) REQUEST BY FOREIGN GOVERNMENT.— 

17 Prior to accrediting a foreign government as a certi18 fying agent, the Secretary shall perform such re19 views and audits of food safety programs, systems, 

20 and standards of the government as the Secretary 

21 deems necessary to determine that they are adequate 

22 to ensure that eligible entities certified by such gov23 ernment meet the requirements of this Act with re24 spect to food manufactured, processed, packed, or 

25 held for import to the United States. 


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1 ‘‘(4) REQUEST BY STATE OR REGIONAL FOOD

2 AUTHORITY.—Prior to accrediting a State or re3 gional food authority as a certifying agent, the Sec4 retary shall perform such reviews and audits of the 

5 training and qualifications of auditors used by the 

6 authority and conduct such reviews of internal sys7 tems and such other investigation of the authority as 

8 the Secretary deems necessary to determine that 

9 each eligible entity certified by the authority has sys10 tems and standards in use to ensure that such entity 

11 meets the requirements of this Act. 

12 ‘‘(5) COOPERATIVES AND OTHER THIRD PAR13 TIES.—Prior to accrediting a foreign or domestic co14 operative that aggregates the products of growers or 

15 processors or any other third party that the Sec16 retary determines appropriate as a certifying agent, 

17 the Secretary shall perform such reviews and audits 

18 of the training and qualifications of auditors used by 

19 the cooperative or party and conduct such reviews of 

20 internal systems and such other investigation of the 

21 cooperative or party as the Secretary deems nec22 essary to determine that each eligible entity certified 

23 by the cooperative or party has systems and stand24 ards in use to ensure that such entity meets the re25 quirements of this Act. 


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1 ‘‘(6) LIMITATION ON THIRD PARTIES.—The 

2 Secretary may not accredit a third party that the 

3 Secretary determines appropriate as a certifying 

4 agent unless each auditor used by such party pre5 pares the audit report for an audit under this sec6 tion in a form and manner designated by the Sec7 retary. An audit report shall include— 

8 ‘‘(A) the identity of the persons at the au9 dited eligible entity responsible for compliance 

10 with food safety requirements; 

11 ‘‘(B) the dates of the audit; 

12 ‘‘(C) the scope of the audit; and 

13 ‘‘(D) any other information required by the 

14 Secretary that relate to or may influence an as15 sessment of compliance with this Act. 

16 ‘‘(b) IMPORTATION.—As a condition of accrediting a 

17 foreign government, a State or regional food authority, a 

18 foreign or domestic cooperative that aggregates the prod19 ucts of growers or processors, or any other third party 

20 that the Secretary determines appropriate as a certifying 

21 agent, such government, authority, cooperative, or party 

22 shall agree to issue a written and electronic certification 

23 to accompany each food shipment made for import from 

24 an eligible entity certified by the certifying agent, subject 

25 to requirements set forth by the Secretary. The Secretary 


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1 shall consider such certificates when targeting inspection 

2 resources under section 421. 

3 ‘‘(c) MONITORING.—Following any accreditation of a 

4 certifying agent, the Secretary may at any time— 

5 ‘‘(1) conduct an on-site audit of any eligible en6 tity certified by the agent, with or without the certi7 fying agent present; or 

8 ‘‘(2) require the agent to submit to the Sec9 retary, for any eligible entity certified by the agent, 

10 an onsite inspection report and such other reports or 

11 documents the agent requires as part of the audit 

12 process, including, for an eligible entity located out13 side the United States, documentation that the eligi14 ble is in compliance with any applicable registration 

15 requirements. 

16 ‘‘(d) DEFINITIONS.—For purposes of this section: 

17 ‘‘(1) AUDITOR.—The term ‘auditor’ means an 

18 individual who— 

19 ‘‘(A) is qualified to conduct food safety au20 dits; and 

21 ‘‘(B) has successfully completed any train22 ing requirements established by the Secretary 

23 for the conduct of food safety audits. 

24 ‘‘(2) CERTIFYING AGENT.—The term ‘certifying 

25 agent’ means a foreign government, a State or reVerDate Aug 31 2005 05:02 Aug 02, 2008 Jkt 069002 PO 00000 Frm 00101 Fmt 6652 Sfmt 6201 E:\BILLS\S3385.IS S3385

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1 gional food authority, a foreign or domestic coopera2 tive that aggregates the products of growers or proc3 essors, or any other third party that conducts audits 

4 of eligible entities and that is accredited by the Sec5 retary under this section. 

6 ‘‘(3) ELIGIBLE ENTITY.—The term ‘eligible en7 tity’ means any entity in the food supply chain that 

8 chooses to be audited by a certifying agent. 

9 ‘‘(e) AVOIDING CONFLICTS OF INTEREST WITH CER10 TIFYING AGENTS.— 

11 ‘‘(1) IN GENERAL.—A certifying agent shall— 

12 ‘‘(A) not be owned, managed, or controlled 

13 by any person that owns or operates an eligible 

14 entity to be certified by such agent; 

15 ‘‘(B) have procedures to ensure against the 

16 use, in carrying out audits of eligible entities 

17 under this section, of any officer or employee of 

18 such agent that has a financial conflict of inter19 est regarding an eligible entity to be certified by 

20 such agent; and 

21 ‘‘(C) annually make available to the Sec22 retary, disclosures of the extent to which such 

23 agent, and the officers and employees of such 

24 agent, have maintained compliance with subVerDate Aug 31 2005 05:02 Aug 02, 2008 Jkt 069002 PO 00000 Frm 00102 Fmt 6652 Sfmt 6201 E:\BILLS\S3385.IS S3385

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1 paragraphs (A) and (B) relating to financial 

2 conflicts of interest. 

3 ‘‘(2) REGULATIONS.—The Secretary shall pro4 mulgate regulations not later than 18 months after 

5 the date of enactment of the FDA Food Safety Mod6 ernization Act to ensure that there are protections 

7 against conflicts of interest between a certifying 

8 agent and the eligible entity to be certified by such 

9 agent. Such regulations shall include— 

10 ‘‘(A) requiring that domestic audits per11 formed under this section be unannounced; 

12 ‘‘(B) a structure, including timing and 

13 public disclosure, for fees paid by eligible enti14 ties to certifying agents to decrease the poten15 tial for conflicts of interest; and 

16 ‘‘(C) appropriate limits on financial affili17 ations between a certifying agent and any per18 son that owns or operates an eligible entity to 

19 be certified by such agent. 

20 ‘‘(f) FALSE STATEMENTS.—Any statement of rep21 resentation made by an employee or agent of an eligible 

22 entity to an auditor of a certifying agent or a certifying 

23 agent shall be subject to section 1001 of title 18, United 

24 States Code. 


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1 ‘‘(g) RISKS TO PUBLIC HEALTH.—If, at any time 

2 during an audit, an auditor of a certifying agent discovers 

3 a condition that could cause or contribute to a serious risk 

4 to the public health, the auditor shall immediately notify 

5 the Secretary of— 

6 ‘‘(1) the identification of the eligible entity sub7 ject to the audit; and 

8 ‘‘(2) such condition. 

9 ‘‘(h) WITHDRAWAL OF ACCREDITATION.—The Sec10 retary may withdraw accreditation from a certifying 

11 agent— 

12 ‘‘(1) if food from eligible entities certified by 

13 such agent is linked to an outbreak of human or ani14 mal illness; 

15 ‘‘(2) following a performance audit and finding 

16 by the Secretary that the agent no longer meets the 

17 requirements for accreditation; or 

18 ‘‘(3) following a refusal to allow United States 

19 officials to conduct such audits and investigations as 

20 may be necessary to ensure continued compliance 

21 with the requirements set forth in this section. 

22 ‘‘(i) PERFORMANCE AUDITS AND RENEWAL.—To en23 sure that accreditation of a certifying agent continues to 

24 meet the standards of this section and this Act and to 


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1 allow for the renewal of accreditation of such certifying 

2 agent, the Secretary shall— 

3 ‘‘(1) audit the performance of such certifying 

4 agent on a periodic basis, not less than every 4 

5 years, through the review of audit reports by such 

6 certifying agent and the compliance history, as avail7 able, of eligible entities certified by such certifying 

8 agent; and 

9 ‘‘(2) any other measures deemed necessary by 

10 the Secretary. 

11 ‘‘(j) PUBLICATION OF LIST OF CERTIFYING

12 AGENTS.—The Secretary shall publish and maintain on 

13 the Internet Web site of the Food and Drug Administra14 tion a current list, including, the name, location and other 

15 information deemed necessary by the Secretary, of certi16 fying agents under this section. 

17 ‘‘(k) NEUTRALIZING COSTS.—The Secretary shall es18 tablish a method, similar to the method used by the De19 partment of Agriculture, by which certifying agents reim20 burse the Food and Drug Administration for the work per21 formed to accredit such certifying agents. The Secretary 

22 shall make operating this program revenue-neutral and 

23 shall not generate surplus revenue from such a reimburse24 ment mechanism. 


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1 ‘‘(l) NO EFFECT ON SECTION 704 INSPECTIONS.— 

2 The audits performed under this section shall not be con3 sidered inspections under section 704. 

4 ‘‘(m) NO EFFECT ON INSPECTION AUTHORITY.— 

5 Nothing in this section affects the authority of the Sec6 retary to inspect any eligible entity pursuant to this Act.’’. 

7 SEC. 309. FOREIGN OFFICES OF THE FOOD AND DRUG AD8 MINISTRATION. 

9 (a) IN GENERAL.—The Secretary shall by October 1, 

10 2010, establish an office of the Food and Drug Adminis11 tration in not less than 5 foreign countries selected by the 

12 Secretary, to provide assistance to the appropriate govern13 mental entities of such countries with respect to measures 

14 to provide for the safety of articles of food and other prod15 ucts regulated by the Food and Drug Administration ex16 ported by such country to the United States, including by 

17 directly conducting risk-based inspections of such articles 

18 and supporting such inspections by such governmental en19 tity. 

20 (b) CONSULTATION.—In establishing the foreign of21 fices described in subsection (a), the Secretary shall con22 sult with the Secretary of State and the United States 

23 Trade Representative. 

24 (c) REPORT.—Not later than October 1, 2011, the 

25 Secretary shall submit to Congress a report on the basis 


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1 for the selection by the Secretary of the foreign countries 

2 in which the Secretary established offices under subsection 

3 (a), the progress which such offices have made with re4 spect to assisting the governments of such countries in 

5 providing for the safety of articles of food and other prod6 ucts regulated by the Food and Drug Administration ex7 ported to the United States, and the plans of the Secretary 

8 for establishing additional foreign offices of the Food and 

9 Drug Administration, as appropriate. 

10 SEC. 310. FUNDING FOR FOOD SAFETY. 

11 (a) IN GENERAL.—There are authorized to be appro12 priated to carry out the activities of the Center for Food 

13 Safety and Applied Nutrition, the Center for Veterinary 

14 Medicine, and related field activities in the Office of Regu15 latory Affairs of the Food and Drug Administration— 

16 (1) $775,000,000 for fiscal year 2009; and 

17 (2) such sums as may be necessary for fiscal 

18 years 2010 through 2013. 

19 (b) INCREASED NUMBER OF FIELD STAFF.—To 

20 carry out the activities of the Center for Food Safety and 

21 Applied Nutrition, the Center for Veterinary Medicine, 

22 and related field activities of the Office of Regulatory Af23 fairs of the Food and Drug Administration, the Secretary 

24 of Health and Human Services shall increase the field 


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1 staff of such Centers and Office with a goal of not fewer 

2 than— 

3 (1) 3,600 staff members in fiscal year 2009; 

4 (2) 3,800 staff members in fiscal year 2010; 

5 (3) 4,000 staff members in fiscal year 2011; 

6 (4) 4,200 staff members in fiscal year 2012; 

7 and 

8 (5) 4,600 staff members in fiscal year 2013. 

9 SEC. 311. JURISDICTION; AUTHORITIES. 

10 Nothing in this Act, or an amendment made by this 

11 Act, shall be construed to— 

12 (1) alter the jurisdiction between the Secretary 

13 of Agriculture and the Secretary of Health and 

14 Human Services, under applicable statutes and regu15 lations; 

16 (2) limit the authority of the Secretary of 

17 Health and Human Services to issue regulations re18 lated to the safety of food under— 

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

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

21 day before the date of enactment of this Act; or 

22 (B) the Public Health Service Act (42 

23 U.S.C. 301 et seq.) as in effect on the day be24 fore the date of enactment of this Act; or 


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

2 the Secretary of Agriculture to prevent, control, or 

3 mitigate a plant or animal health emergency, or a 

4 food emergency involving products regulated under 

5 the Federal Meat Inspection Act, the Poultry Prod6 ucts Inspection Act, or the Egg Products Inspection 

7 Act. 

Æ 


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