In the Senate of the United States, 

December 19, 2010. 

Resolved, That the bill from the House of Representatives (H.R. 2751) entitled ‘‘An Act to accelerate motor fuel 

savings nationwide and provide incentives to registered owners of high polluting automobiles to replace such automobiles 

with new fuel efficient and less polluting automobiles.’’, do 

pass with the following 

AMENDMENTS: 

Strike all after the enacting clause and insert the 

following: 

1 SECTION 1. SHORT TITLE; REFERENCES; TABLE OF CON2 TENTS. 

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

4 ‘‘FDA Food Safety Modernization Act’’. 

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

6 whenever in this Act an amendment is expressed in terms 

7 of an amendment to a section or other provision, the ref8 erence shall be considered to be made to a section or other 
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1 provision of the Federal Food, Drug, and Cosmetic Act (21 

2 U.S.C. 301 et seq.). 

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

4 this Act is as follows: 

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

TITLE I—IMPROVING CAPACITY TO PREVENT FOOD SAFETY 

PROBLEMS 

Sec. 101. Inspections of records. 

Sec. 102. Registration of food facilities. 

Sec. 103. Hazard analysis and risk-based preventive controls. 

Sec. 104. Performance standards. 

Sec. 105. Standards for produce safety. 

Sec. 106. Protection against intentional adulteration. 

Sec. 107. Authority to collect fees. 

Sec. 108. National agriculture and food defense strategy. 

Sec. 109. Food and Agriculture Coordinating Councils. 

Sec. 110. Building domestic capacity. 

Sec. 111. Sanitary transportation of food. 

Sec. 112. Food allergy and anaphylaxis management. 

Sec. 113. New dietary ingredients. 

Sec. 114. Requirement for guidance relating to post harvest processing of raw oysters. 

Sec. 115. Port shopping. 

Sec. 116. Alcohol-related facilities. 

TITLE II—IMPROVING CAPACITY TO DETECT AND RESPOND TO 

FOOD SAFETY PROBLEMS 

Sec. 201. Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report. 

Sec. 202. Laboratory accreditation for analyses of foods. 

Sec. 203. Integrated consortium of laboratory networks. 

Sec. 204. Enhancing tracking and tracing of food and recordkeeping. 

Sec. 205. Surveillance. 

Sec. 206. Mandatory recall authority. 

Sec. 207. Administrative detention of food. 

Sec. 208. Decontamination and disposal standards and plans. 

Sec. 209. Improving the training of State, local, territorial, and tribal food safety 

officials. 

Sec. 210. Enhancing food safety. 

Sec. 211. Improving the reportable food registry. 

TITLE III—IMPROVING THE SAFETY OF 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. Building capacity of foreign governments with respect to food safety. 

Sec. 306. Inspection of foreign food facilities. 
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Sec. 307. Accreditation of third-party auditors. 

Sec. 308. Foreign offices of the Food and Drug Administration. 

Sec. 309. Smuggled food. 

TITLE IV—MISCELLANEOUS PROVISIONS 

Sec. 401. Funding for food safety. 

Sec. 402. Employee protections. 

Sec. 403. Jurisdiction; authorities. 

Sec. 404. Compliance with international agreements. 

Sec. 405. Determination of budgetary effects. 

1 TITLE I—IMPROVING CAPACITY 

2 TO PREVENT FOOD SAFETY 

3 PROBLEMS 

4 SEC. 101. INSPECTIONS OF RECORDS. 

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

6 is amended— 

7 (1) by striking the heading and all that follows 

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

9 ‘‘RECORDS INSPECTION.— 

10 ‘‘(1) ADULTERATED FOOD.—If the Secretary has 

11 a reasonable belief that an article of food, and any 

12 other article of food that the Secretary reasonably be13 lieves is likely to be affected in a similar manner, is’’; 

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

15 food that the Secretary reasonably believes is likely to 

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

17 such article’’; 

18 (3) by striking the last sentence; and 

19 (4) by inserting at the end the following: 
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1 ‘‘(2) USE OF OR EXPOSURE TO FOOD OF CON2 CERN.—If the Secretary believes that there is a rea3 sonable probability that the use of or exposure to an 

4 article of food, and any other article of food that the 

5 Secretary reasonably believes is likely to be affected in 

6 a similar manner, will cause serious adverse health 

7 consequences or death to humans or animals, each 

8 person (excluding farms and restaurants) who manu9 factures, processes, packs, distributes, receives, holds, 

10 or imports such article shall, at the request of an offi11 cer or employee duly designated by the Secretary, per12 mit such officer or employee, upon presentation of ap13 propriate credentials and a written notice to such 

14 person, at reasonable times and within reasonable 

15 limits and in a reasonable manner, to have access to 

16 and copy all records relating to such article and to 

17 any other article of food that the Secretary reasonably 

18 believes is likely to be affected in a similar manner, 

19 that are needed to assist the Secretary in determining 

20 whether there is a reasonable probability that the use 

21 of or exposure to the food will cause serious adverse 

22 health consequences or death to humans or animals. 

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

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

25 to the manufacture, processing, packing, distribution, 
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1 receipt, holding, or importation of such article main2 tained by or on behalf of such person in any format 

3 (including paper and electronic formats) and at any 

4 location.’’. 

5 (b) CONFORMING AMENDMENT.—Section 704(a)(1)(B) 

6 (21 U.S.C. 374(a)(1)(B)) is amended by striking ‘‘section 

7 414 when’’ and all that follows through ‘‘subject to’’ and 

8 inserting ‘‘section 414, when the standard for records in9 spection under paragraph (1) or (2) of section 414(a) ap10 plies, subject to’’. 

11 SEC. 102. REGISTRATION OF FOOD FACILITIES. 

12 (a) UPDATING OF FOOD CATEGORY REGULATIONS; BI13 ENNIAL REGISTRATION RENEWAL.—Section 415(a) (21 

14 U.S.C. 350d(a)) is amended— 

15 (1) in paragraph (2), by— 

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

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

18 for the contact person of the facility or, in the 

19 case of a foreign facility, the United States agent 

20 for the facility, and’’; and 

21 (B) inserting ‘‘, or any other food categories 

22 as determined appropriate by the Secretary, in23 cluding by guidance’’ after ‘‘Code of Federal 

24 Regulations’’; 
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1 (2) by redesignating paragraphs (3) and (4) as 

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

3 (3) by inserting after paragraph (2) the fol4 lowing: 

5 ‘‘(3) BIENNIAL REGISTRATION RENEWAL.—Dur6 ing the period beginning on October 1 and ending on 

7 December 31 of each even-numbered year, a registrant 

8 that has submitted a registration under paragraph 

9 (1) shall submit to the Secretary a renewal registra10 tion containing the information described in para11 graph (2). The Secretary shall provide for an abbre12 viated registration renewal process for any registrant 

13 that has not had any changes to such information 

14 since the registrant submitted the preceding registra15 tion or registration renewal for the facility involved.’’. 

16 (b) SUSPENSION OF REGISTRATION.— 

17 (1) IN GENERAL.—Section 415 (21 U.S.C. 350d) 

18 is amended— 

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

20 the first sentence the following: ‘‘The registration 

21 shall contain an assurance that the Secretary 

22 will be permitted to inspect such facility at the 

23 times and in the manner permitted by this 

24 Act.’’; 
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1 (B) by redesignating subsections (b) and (c) 

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

3 (C) by inserting after subsection (a) the fol4 lowing: 

5 ‘‘(b) SUSPENSION OF REGISTRATION.— 

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

7 that food manufactured, processed, packed, received, 

8 or held by a facility registered under this section has 

9 a reasonable probability of causing serious adverse 

10 health consequences or death to humans or animals, 

11 the Secretary may by order suspend the registration 

12 of a facility— 

13 ‘‘(A) that created, caused, or was otherwise 

14 responsible for such reasonable probability; or 

15 ‘‘(B)(i) that knew of, or had reason to know 

16 of, such reasonable probability; and 

17 ‘‘(ii) packed, received, or held such food. 

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

19 shall provide the registrant subject to an order under 

20 paragraph (1) with an opportunity for an informal 

21 hearing, to be held as soon as possible but not later 

22 than 2 business days after the issuance of the order 

23 or such other time period, as agreed upon by the Sec24 retary and the registrant, on the actions required for 

25 reinstatement of registration and why the registration 
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1 that is subject to suspension should be reinstated. The 

2 Secretary shall reinstate a registration if the Sec3 retary determines, based on evidence presented, that 

4 adequate grounds do not exist to continue the suspen5 sion of the registration. 

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

7 VACATING OF ORDER.— 

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

9 providing opportunity for an informal hearing 

10 under paragraph (2), the Secretary determines 

11 that the suspension of registration remains nec12 essary, the Secretary shall require the registrant 

13 to submit a corrective action plan to demonstrate 

14 how the registrant plans to correct the conditions 

15 found by the Secretary. The Secretary shall re16 view such plan not later than 14 days after the 

17 submission of the corrective action plan or such 

18 other time period as determined by the Sec19 retary. 

20 ‘‘(B) VACATING OF ORDER.—Upon a deter21 mination by the Secretary that adequate grounds 

22 do not exist to continue the suspension actions 

23 required by the order, or that such actions should 

24 be modified, the Secretary shall promptly vacate 

25 the order and reinstate the registration of the fa-
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1 cility subject to the order or modify the order, as 

2 appropriate. 

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

5 no person shall import or export food into the United 

6 States from such facility, offer to import or export 

7 food into the United States from such facility, or oth8 erwise introduce food from such facility into inter9 state or intrastate commerce in the United States. 

10 ‘‘(5) REGULATIONS.— 

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

12 promulgate regulations to implement this sub13 section. The Secretary may promulgate such reg14 ulations on an interim final basis. 

15 ‘‘(B) REGISTRATION REQUIREMENT.—The 

16 Secretary may require that registration under 

17 this section be submitted in an electronic format. 

18 Such requirement may not take effect before the 

19 date that is 5 years after the date of enactment 

20 of the FDA Food Safety Modernization Act. 

21 ‘‘(6) APPLICATION DATE.—Facilities shall be 

22 subject to the requirements of this subsection begin23 ning on the earlier of— 

24 ‘‘(A) the date on which the Secretary issues 

25 regulations under paragraph (5); or 
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1 ‘‘(B) 180 days after the date of enactment 

2 of the FDA Food Safety Modernization Act. 

3 ‘‘(7) NO DELEGATION.—The authority conferred 

4 by this subsection to issue an order to suspend a reg5 istration or vacate an order of suspension shall not 

6 be delegated to any officer or employee other than the 

7 Commissioner.’’. 

8 (2) SMALL ENTITY COMPLIANCE POLICY

9 GUIDE.—Not later than 180 days after the issuance of 

10 the regulations promulgated under section 415(b)(5) 

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

12 added by this section), the Secretary shall issue a 

13 small entity compliance policy guide setting forth in 

14 plain language the requirements of such regulations to 

15 assist small entities in complying with registration 

16 requirements and other activities required under such 

17 section. 

18 (3) IMPORTED FOOD.—Section 801(l) (21 U.S.C. 

19 381(l)) is amended by inserting ‘‘(or for which a reg20 istration has been suspended under such section)’’ 

21 after ‘‘section 415’’. 

22 (c) CLARIFICATION OF INTENT.— 

23 (1) RETAIL FOOD ESTABLISHMENT.—The Sec24 retary shall amend the definition of the term ‘‘retail 

25 food establishment’’ in section in 1.227(b)(11) of title 
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1 21, Code of Federal Regulations to clarify that, in de2 termining the primary function of an establishment 

3 or a retail food establishment under such section, the 

4 sale of food products directly to consumers by such es5 tablishment and the sale of food directly to consumers 

6 by such retail food establishment include— 

7 (A) the sale of such food products or food di8 rectly to consumers by such establishment at a 

9 roadside stand or farmers’ market where such 

10 stand or market is located other than where the 

11 food was manufactured or processed; 

12 (B) the sale and distribution of such food 

13 through a community supported agriculture pro14 gram; and 

15 (C) the sale and distribution of such food at 

16 any other such direct sales platform as deter17 mined by the Secretary. 

18 (2) DEFINITIONS.—For purposes of paragraph 

19 (1)— 

20 (A) the term ‘‘community supported agri21 culture program’’ has the same meaning given 

22 the term ‘‘community supported agriculture 

23 (CSA) program’’ in section 249.2 of title 7, Code 

24 of Federal Regulations (or any successor regula25 tion); and 
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1 (B) the term ‘‘consumer’’ does not include a 

2 business. 

3 (d) CONFORMING AMENDMENTS.— 

4 (1) Section 301(d) (21 U.S.C. 331(d)) is amend5 ed by inserting ‘‘415,’’ after ‘‘404,’’. 

6 (2) Section 415(d), as redesignated by subsection 

7 (b), is amended by adding at the end before the period 

8 ‘‘for a facility to be registered, except with respect to 

9 the reinstatement of a registration that is suspended 

10 under subsection (b)’’. 

11 SEC. 103. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE 

12 CONTROLS. 

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

14 is amended by adding at the end the following: 

15 ‘‘SEC. 418. HAZARD ANALYSIS AND RISK-BASED PREVEN16 TIVE CONTROLS. 

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

18 charge of a facility shall, in accordance with this section, 

19 evaluate the hazards that could affect food manufactured, 

20 processed, packed, or held by such facility, identify and im21 plement preventive controls to significantly minimize or 

22 prevent the occurrence of such hazards and provide assur23 ances that such food is not adulterated under section 402 

24 or misbranded under section 403(w), monitor the perform-
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1 ance of those controls, and maintain records of this moni2 toring as a matter of routine practice. 

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

4 agent in charge of a facility shall— 

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

6 foreseeable hazards that may be associated with the 

7 facility, including— 

8 ‘‘(A) biological, chemical, physical, and ra9 diological hazards, natural toxins, pesticides, 

10 drug residues, decomposition, parasites, aller11 gens, and unapproved food and color additives; 

12 and 

13 ‘‘(B) hazards that occur naturally, or may 

14 be unintentionally introduced; and 

15 ‘‘(2) identify and evaluate hazards that may be 

16 intentionally introduced, including by acts of ter17 rorism; and 

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

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

20 agent in charge of a facility shall identify and implement 

21 preventive controls, including at critical control points, if 

22 any, to provide assurances that— 

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

24 conducted under subsection (b)(1) will be significantly 

25 minimized or prevented; 
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1 ‘‘(2) any hazards identified in the hazard anal2 ysis conducted under subsection (b)(2) will be signifi3 cantly minimized or prevented and addressed, con4 sistent with section 420, as applicable; and 

5 ‘‘(3) the food manufactured, processed, packed, or 

6 held by such facility will not be adulterated under 

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

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

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

10 effectiveness of the preventive controls implemented under 

11 subsection (c) to provide assurances that the outcomes de12 scribed in subsection (c) shall be achieved. 

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

14 agent in charge of a facility shall establish procedures to 

15 ensure that, if the preventive controls implemented under 

16 subsection (c) are not properly implemented or are found 

17 to be ineffective— 

18 ‘‘(1) appropriate action is taken to reduce the 

19 likelihood of recurrence of the implementation failure; 

20 ‘‘(2) all affected food is evaluated for safety; and 

21 ‘‘(3) all affected food is prevented from entering 

22 into commerce if the owner, operator or agent in 

23 charge of such facility cannot ensure that the affected 

24 food is not adulterated under section 402 or mis25 branded under section 403(w). 
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1 ‘‘(f) VERIFICATION.—The owner, operator, or agent in 

2 charge of a facility shall verify that— 

3 ‘‘(1) the preventive controls implemented under 

4 subsection (c) are adequate to control the hazards 

5 identified under subsection (b); 

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

7 monitoring in accordance with subsection (d); 

8 ‘‘(3) the owner, operator, or agent is making ap9 propriate decisions about corrective actions taken 

10 under subsection (e); 

11 ‘‘(4) the preventive controls implemented under 

12 subsection (c) are effectively and significantly mini13 mizing or preventing the occurrence of identified haz14 ards, including through the use of environmental and 

15 product testing programs and other appropriate 

16 means; and 

17 ‘‘(5) there is documented, periodic reanalysis of 

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

19 is still relevant to the raw materials, conditions and 

20 processes in the facility, and new and emerging 

21 threats. 

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

23 in charge of a facility shall maintain, for not less than 2 

24 years, records documenting the monitoring of the preventive 

25 controls implemented under subsection (c), instances of non-
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1 conformance material to food safety, the results of testing 

2 and other appropriate means of verification under sub3 section (f)(4), instances when corrective actions were imple4 mented, and the efficacy of preventive controls and correc5 tive actions. 

6 ‘‘(h) WRITTEN PLAN AND DOCUMENTATION.—The 

7 owner, operator, or agent in charge of a facility shall pre8 pare a written plan that documents and describes the proce9 dures used by the facility to comply with the requirements 

10 of this section, including analyzing the hazards under sub11 section (b) and identifying the preventive controls adopted 

12 under subsection (c) to address those hazards. Such written 

13 plan, together with the documentation described in sub14 section (g), shall be made promptly available to a duly au15 thorized representative of the Secretary upon oral or written 

16 request. 

17 ‘‘(i) REQUIREMENT TO REANALYZE.—The owner, op18 erator, or agent in charge of a facility shall conduct a rea19 nalysis under subsection (b) whenever a significant change 

20 is made in the activities conducted at a facility operated 

21 by such owner, operator, or agent if the change creates a 

22 reasonable potential for a new hazard or a significant in23 crease in a previously identified hazard or not less fre24 quently than once every 3 years, whichever is earlier. Such 

25 reanalysis shall be completed and additional preventive 
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1 controls needed to address the hazard identified, if any, 

2 shall be implemented before the change in activities at the 

3 facility is operative. Such owner, operator, or agent shall 

4 revise the written plan required under subsection (h) if such 

5 a significant change is made or document the basis for the 

6 conclusion that no additional or revised preventive controls 

7 are needed. The Secretary may require a reanalysis under 

8 this section to respond to new hazards and developments 

9 in scientific understanding, including, as appropriate, re10 sults from the Department of Homeland Security biological, 

11 chemical, radiological, or other terrorism risk assessment. 

12 ‘‘(j) EXEMPTION FOR SEAFOOD, JUICE, AND LOW-ACID

13 CANNED FOOD FACILITIES SUBJECT TO HACCP.— 

14 ‘‘(1) IN GENERAL.—This section shall not apply 

15 to a facility if the owner, operator, or agent in charge 

16 of such facility is required to comply with, and is in 

17 compliance with, 1 of the following standards and 

18 regulations with respect to such facility: 

19 ‘‘(A) The Seafood Hazard Analysis Critical 

20 Control Points Program of the Food and Drug 

21 Administration. 

22 ‘‘(B) The Juice Hazard Analysis Critical 

23 Control Points Program of the Food and Drug 

24 Administration. 
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† HR 2751 EAS 

1 ‘‘(C) The Thermally Processed Low-Acid 

2 Foods Packaged in Hermetically Sealed Con3 tainers standards of the Food and Drug Admin4 istration (or any successor standards). 

5 ‘‘(2) APPLICABILITY.—The exemption under 

6 paragraph (1)(C) shall apply only with respect to 

7 microbiological hazards that are regulated under the 

8 standards for Thermally Processed Low-Acid Foods 

9 Packaged in Hermetically Sealed Containers under 

10 part 113 of chapter 21, Code of Federal Regulations 

11 (or any successor regulations). 

12 ‘‘(k) EXCEPTION FOR ACTIVITIES OF FACILITIES SUB13 JECT TO SECTION 419.—This section shall not apply to ac14 tivities of a facility that are subject to section 419. 

15 ‘‘(l) MODIFIED REQUIREMENTS FOR QUALIFIED FA16 CILITIES.— 

17 ‘‘(1) QUALIFIED FACILITIES.— 

18 ‘‘(A) IN GENERAL.—A facility is a qualified 

19 facility for purposes of this subsection if the fa20 cility meets the conditions under subparagraph 

21 (B) or (C). 

22 ‘‘(B) VERY SMALL BUSINESS.—A facility is 

23 a qualified facility under this subparagraph— 

24 ‘‘(i) if the facility, including any sub25 sidiary or affiliate of the facility, is, collec-
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1 tively, a very small business (as defined in 

2 the regulations promulgated under sub3 section (n)); and 

4 ‘‘(ii) in the case where the facility is a 

5 subsidiary or affiliate of an entity, if such 

6 subsidiaries or affiliates, are, collectively, a 

7 very small business (as so defined). 

8 ‘‘(C) LIMITED ANNUAL MONETARY VALUE OF

9 SALES.— 

10 ‘‘(i) IN GENERAL.—A facility is a 

11 qualified facility under this subparagraph 

12 if clause (ii) applies— 

13 ‘‘(I) to the facility, including any 

14 subsidiary or affiliate of the facility, 

15 collectively; and 

16 ‘‘(II) to the subsidiaries or affili17 ates, collectively, of any entity of which 

18 the facility is a subsidiary or affiliate. 

19 ‘‘(ii) AVERAGE ANNUAL MONETARY

20 VALUE.—This clause applies if— 

21 ‘‘(I) during the 3-year period pre22 ceding the applicable calendar year, 

23 the average annual monetary value of 

24 the food manufactured, processed, 

25 packed, or held at such facility (or the 
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† HR 2751 EAS 

1 collective average annual monetary 

2 value of such food at any subsidiary or 

3 affiliate, as described in clause (i)) 

4 that is sold directly to qualified end5 users during such period exceeded the 

6 average annual monetary value of the 

7 food manufactured, processed, packed, 

8 or held at such facility (or the collec9 tive average annual monetary value of 

10 such food at any subsidiary or affil11 iate, as so described) sold by such facil12 ity (or collectively by any such sub13 sidiary or affiliate) to all other pur14 chasers during such period; and 

15 ‘‘(II) the average annual mone16 tary value of all food sold by such fa17 cility (or the collective average annual 

18 monetary value of such food sold by 

19 any subsidiary or affiliate, as de20 scribed in clause (i)) during such pe21 riod was less than $500,000, adjusted 

22 for inflation. 

23 ‘‘(2) EXEMPTION.—A qualified facility— 
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† HR 2751 EAS 

1 ‘‘(A) shall not be subject to the requirements 

2 under subsections (a) through (i) and subsection 

3 (n) in an applicable calendar year; and 

4 ‘‘(B) shall submit to the Secretary— 

5 ‘‘(i)(I) documentation that dem6 onstrates that the owner, operator, or agent 

7 in charge of the facility has identified po8 tential hazards associated with the food 

9 being produced, is implementing preventive 

10 controls to address the hazards, and is mon11 itoring the preventive controls to ensure 

12 that such controls are effective; or 

13 ‘‘(II) documentation (which may in14 clude licenses, inspection reports, certifi15 cates, permits, credentials, certification by 

16 an appropriate agency (such as a State de17 partment of agriculture), or other evidence 

18 of oversight), as specified by the Secretary, 

19 that the facility is in compliance with 

20 State, local, county, or other applicable 

21 non-Federal food safety law; and 

22 ‘‘(ii) documentation, as specified by the 

23 Secretary in a guidance document issued 

24 not later than 1 year after the date of enact25 ment of this section, that the facility is a 
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† HR 2751 EAS 

1 qualified facility under paragraph (1)(B) or 

2 (1)(C). 

3 ‘‘(3) WITHDRAWAL; RULE OF CONSTRUCTION.— 

4 ‘‘(A) IN GENERAL.—In the event of an ac5 tive investigation of a foodborne illness outbreak 

6 that is directly linked to a qualified facility sub7 ject to an exemption under this subsection, or if 

8 the Secretary determines that it is necessary to 

9 protect the public health and prevent or mitigate 

10 a foodborne illness outbreak based on conduct or 

11 conditions associated with a qualified facility 

12 that are material to the safety of the food manu13 factured, processed, packed, or held at such facil14 ity, the Secretary may withdraw the exemption 

15 provided to such facility under this subsection. 

16 ‘‘(B) RULE OF CONSTRUCTION.—Nothing in 

17 this subsection shall be construed to expand or 

18 limit the inspection authority of the Secretary. 

19 ‘‘(4) DEFINITIONS.—In this subsection: 

20 ‘‘(A) AFFILIATE.—The term ‘affiliate’ 

21 means any facility that controls, is controlled by, 

22 or is under common control with another facil23 ity. 
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† HR 2751 EAS 

1 ‘‘(B) QUALIFIED END-USER.—The term 

2 ‘qualified end-user’, with respect to a food, 

3 means— 

4 ‘‘(i) the consumer of the food; or 

5 ‘‘(ii) a restaurant or retail food estab6 lishment (as those terms are defined by the 

7 Secretary for purposes of section 415) 

8 that— 

9 ‘‘(I) is located— 

10 ‘‘(aa) in the same State as 

11 the qualified facility that sold the 

12 food to such restaurant or estab13 lishment; or 

14 ‘‘(bb) not more than 275 

15 miles from such facility; and 

16 ‘‘(II) is purchasing the food for 

17 sale directly to consumers at such res18 taurant or retail food establishment. 

19 ‘‘(C) CONSUMER.—For purposes of subpara20 graph (B), the term ‘consumer’ does not include 

21 a business. 

22 ‘‘(D) SUBSIDIARY.—The term ‘subsidiary’ 

23 means any company which is owned or con24 trolled directly or indirectly by another com25 pany. 
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† HR 2751 EAS 

1 ‘‘(5) STUDY.— 

2 ‘‘(A) IN GENERAL.—The Secretary, in con3 sultation with the Secretary of Agriculture, shall 

4 conduct a study of the food processing sector reg5 ulated by the Secretary to determine— 

6 ‘‘(i) the distribution of food production 

7 by type and size of operation, including 

8 monetary value of food sold; 

9 ‘‘(ii) the proportion of food produced 

10 by each type and size of operation; 

11 ‘‘(iii) the number and types of food fa12 cilities co-located on farms, including the 

13 number and proportion by commodity and 

14 by manufacturing or processing activity; 

15 ‘‘(iv) the incidence of foodborne illness 

16 originating from each size and type of oper17 ation and the type of food facilities for 

18 which no reported or known hazard exists; 

19 and 

20 ‘‘(v) the effect on foodborne illness risk 

21 associated with commingling, processing, 

22 transporting, and storing food and raw ag23 ricultural commodities, including dif24 ferences in risk based on the scale and dura25 tion of such activities. 
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1 ‘‘(B) SIZE.—The results of the study con2 ducted under subparagraph (A) shall include the 

3 information necessary to enable the Secretary to 

4 define the terms ‘small business’ and ‘very small 

5 business’, for purposes of promulgating the regu6 lation under subsection (n). In defining such 

7 terms, the Secretary shall include consideration 

8 of harvestable acres, income, the number of em9 ployees, and the volume of food harvested. 

10 ‘‘(C) SUBMISSION OF REPORT.—Not later 

11 than 18 months after the date of enactment the 

12 FDA Food Safety Modernization Act, the Sec13 retary shall submit to Congress a report that de14 scribes the results of the study conducted under 

15 subparagraph (A). 

16 ‘‘(6) NO PREEMPTION.—Nothing in this sub17 section preempts State, local, county, or other non18 Federal law regarding the safe production of food. 

19 Compliance with this subsection shall not relieve any 

20 person from liability at common law or under State 

21 statutory law. 

22 ‘‘(7) NOTIFICATION TO CONSUMERS.— 

23 ‘‘(A) IN GENERAL.—A qualified facility that 

24 is exempt from the requirements under sub25 sections (a) through (i) and subsection (n) and 
26 

† HR 2751 EAS 

1 does not prepare documentation under para2 graph (2)(B)(i)(I) shall— 

3 ‘‘(i) with respect to a food for which a 

4 food packaging label is required by the Sec5 retary under any other provision of this 

6 Act, include prominently and conspicuously 

7 on such label the name and business address 

8 of the facility where the food was manufac9 tured or processed; or 

10 ‘‘(ii) with respect to a food for which 

11 a food packaging label is not required by 

12 the Secretary under any other provisions of 

13 this Act, prominently and conspicuously 

14 display, at the point of purchase, the name 

15 and business address of the facility where 

16 the food was manufactured or processed, on 

17 a label, poster, sign, placard, or documents 

18 delivered contemporaneously with the food 

19 in the normal course of business, or, in the 

20 case of Internet sales, in an electronic no21 tice. 

22 ‘‘(B) NO ADDITIONAL LABEL.—Subpara23 graph (A) does not provide authority to the Sec24 retary to require a label that is in addition to 
27 

† HR 2751 EAS 

1 any label required under any other provision of 

2 this Act. 

3 ‘‘(m) AUTHORITY WITH RESPECT TO CERTAIN FACILI4 TIES.—The Secretary may, by regulation, exempt or modify 

5 the requirements for compliance under this section with re6 spect to facilities that are solely engaged in the production 

7 of food for animals other than man, the storage of raw agri8 cultural commodities (other than fruits and vegetables) in9 tended for further distribution or processing, or the storage 

10 of packaged foods that are not exposed to the environment. 

11 ‘‘(n) REGULATIONS.— 

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

13 after the date of enactment of the FDA Food Safety 

14 Modernization Act, the Secretary shall promulgate 

15 regulations— 

16 ‘‘(A) to establish science-based minimum 

17 standards for conducting a hazard analysis, doc18 umenting hazards, implementing preventive con19 trols, and documenting the implementation of 

20 the preventive controls under this section; and 

21 ‘‘(B) to define, for purposes of this section, 

22 the terms ‘small business’ and ‘very small busi23 ness’, taking into consideration the study de24 scribed in subsection (l)(5). 
28 

† HR 2751 EAS 

1 ‘‘(2) COORDINATION.—In promulgating the regu2 lations under paragraph (1)(A), with regard to haz3 ards that may be intentionally introduced, including 

4 by acts of terrorism, the Secretary shall coordinate 

5 with the Secretary of Homeland Security, as appro6 priate. 

7 ‘‘(3) CONTENT.—The regulations promulgated 

8 under paragraph (1)(A) shall— 

9 ‘‘(A) provide sufficient flexibility to be prac10 ticable for all sizes and types of facilities, includ11 ing small businesses such as a small food proc12 essing facility co-located on a farm; 

13 ‘‘(B) comply with chapter 35 of title 44, 

14 United States Code (commonly known as the 

15 ‘Paperwork Reduction Act’), with special atten16 tion to minimizing the burden (as defined in sec17 tion 3502(2) of such Act) on the facility, and col18 lection of information (as defined in section 

19 3502(3) of such Act), associated with such regu20 lations; 

21 ‘‘(C) acknowledge differences in risk and 

22 minimize, as appropriate, the number of sepa23 rate standards that apply to separate foods; and 

24 ‘‘(D) not require a facility to hire a consult25 ant or other third party to identify, implement, 
29 

† HR 2751 EAS 

1 certify, or audit preventative controls, except in 

2 the case of negotiated enforcement resolutions 

3 that may require such a consultant or third 

4 party. 

5 ‘‘(4) RULE OF CONSTRUCTION.—Nothing in this 

6 subsection shall be construed to provide the Secretary 

7 with the authority to prescribe specific technologies, 

8 practices, or critical controls for an individual facil9 ity. 

10 ‘‘(5) REVIEW.—In promulgating the regulations 

11 under paragraph (1)(A), the Secretary shall review 

12 regulatory hazard analysis and preventive control 

13 programs in existence on the date of enactment of the 

14 FDA Food Safety Modernization Act, including the 

15 Grade ‘A’ Pasteurized Milk Ordinance to ensure that 

16 such regulations are consistent, to the extent prac17 ticable, with applicable domestic and internationally18 recognized standards in existence on such date. 

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

20 ‘‘(1) CRITICAL CONTROL POINT.—The term ‘crit21 ical control point’ means a point, step, or procedure 

22 in a food process at which control can be applied and 

23 is essential to prevent or eliminate a food safety haz24 ard or reduce such hazard to an acceptable level. 
30 

† HR 2751 EAS 

1 ‘‘(2) FACILITY.—The term ‘facility’ means a do2 mestic facility or a foreign facility that is required to 

3 register under section 415. 

4 ‘‘(3) PREVENTIVE CONTROLS.—The term ‘preven5 tive controls’ means those risk-based, reasonably ap6 propriate procedures, practices, and processes that a 

7 person knowledgeable about the safe manufacturing, 

8 processing, packing, or holding of food would employ 

9 to significantly minimize or prevent the hazards iden10 tified under the hazard analysis conducted under sub11 section (b) and that are consistent with the current 

12 scientific understanding of safe food manufacturing, 

13 processing, packing, or holding at the time of the 

14 analysis. Those procedures, practices, and processes 

15 may include the following: 

16 ‘‘(A) Sanitation procedures for food contact 

17 surfaces and utensils and food-contact surfaces of 

18 equipment. 

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

20 hygiene training. 

21 ‘‘(C) An environmental monitoring pro22 gram to verify the effectiveness of pathogen con23 trols in processes where a food is exposed to a po24 tential contaminant in the environment. 

25 ‘‘(D) A food allergen control program. 
31 

† HR 2751 EAS 

1 ‘‘(E) A recall plan. 

2 ‘‘(F) Current Good Manufacturing Practices 

3 (cGMPs) under part 110 of title 21, Code of Fed4 eral Regulations (or any successor regulations). 

5 ‘‘(G) Supplier verification activities that re6 late to the safety of food.’’. 

7 (b) GUIDANCE DOCUMENT.—The Secretary shall issue 

8 a guidance document related to the regulations promulgated 

9 under subsection (b)(1) with respect to the hazard analysis 

10 and preventive controls under section 418 of the Federal 

11 Food, Drug, and Cosmetic Act (as added by subsection (a)). 

12 (c) RULEMAKING.— 

13 (1) PROPOSED RULEMAKING.— 

14 (A) IN GENERAL.—Not later than 9 months 

15 after the date of enactment of this Act, the Sec16 retary of Health and Human Services (referred 

17 to in this subsection as the ‘‘Secretary’’) shall 

18 publish a notice of proposed rulemaking in the 

19 Federal Register to promulgate regulations with 

20 respect to— 

21 (i) activities that constitute on-farm 

22 packing or holding of food that is not 

23 grown, raised, or consumed on such farm or 

24 another farm under the same ownership for 

25 purposes of section 415 of the Federal Food, 
32 

† HR 2751 EAS 

1 Drug, and Cosmetic Act (21 U.S.C. 350d), 

2 as amended by this Act; and 

3 (ii) activities that constitute on-farm 

4 manufacturing or processing of food that is 

5 not consumed on that farm or on another 

6 farm under common ownership for purposes 

7 of such section 415. 

8 (B) CLARIFICATION.—The rulemaking de9 scribed under subparagraph (A) shall enhance 

10 the implementation of such section 415 and clar11 ify the activities that are included as part of the 

12 definition of the term ‘‘facility’’ under such sec13 tion 415. Nothing in this Act authorizes the Sec14 retary to modify the definition of the term ‘‘facil15 ity’’ under such section. 

16 (C) SCIENCE-BASED RISK ANALYSIS.—In 

17 promulgating regulations under subparagraph 

18 (A), the Secretary shall conduct a science-based 

19 risk analysis of— 

20 (i) specific types of on-farm packing or 

21 holding of food that is not grown, raised, or 

22 consumed on such farm or another farm 

23 under the same ownership, as such packing 

24 and holding relates to specific foods; and 
33 

† HR 2751 EAS 

1 (ii) specific on-farm manufacturing 

2 and processing activities as such activities 

3 relate to specific foods that are not con4 sumed on that farm or on another farm 

5 under common ownership. 

6 (D) AUTHORITY WITH RESPECT TO CERTAIN

7 FACILITIES.— 

8 (i) IN GENERAL.—In promulgating the 

9 regulations under subparagraph (A), the 

10 Secretary shall consider the results of the 

11 science-based risk analysis conducted under 

12 subparagraph (C), and shall exempt certain 

13 facilities from the requirements in section 

14 418 of the Federal Food, Drug, and Cos15 metic Act (as added by this section), includ16 ing hazard analysis and preventive controls, 

17 and the mandatory inspection frequency in 

18 section 421 of such Act (as added by section 

19 201), or modify the requirements in such 

20 sections 418 or 421, as the Secretary deter21 mines appropriate, if such facilities are en22 gaged only in specific types of on-farm 

23 manufacturing, processing, packing, or 

24 holding activities that the Secretary deter-
34 

† HR 2751 EAS 

1 mines to be low risk involving specific foods 

2 the Secretary determines to be low risk. 

3 (ii) LIMITATION.—The exemptions or 

4 modifications under clause (i) shall not in5 clude an exemption from the requirement to 

6 register under section 415 of the Federal 

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

8 350d), as amended by this Act, if applica9 ble, and shall apply only to small businesses 

10 and very small businesses, as defined in the 

11 regulation promulgated under section 

12 418(n) of the Federal Food, Drug, and Cos13 metic Act (as added under subsection (a)). 

14 (2) FINAL REGULATIONS.—Not later than 9 

15 months after the close of the comment period for the 

16 proposed rulemaking under paragraph (1), the Sec17 retary shall adopt final rules with respect to— 

18 (A) activities that constitute on-farm pack19 ing or holding of food that is not grown, raised, 

20 or consumed on such farm or another farm 

21 under the same ownership for purposes of section 

22 415 of the Federal Food, Drug, and Cosmetic Act 

23 (21 U.S.C. 350d), as amended by this Act; 

24 (B) activities that constitute on-farm manu25 facturing or processing of food that is not con-
35 

† HR 2751 EAS 

1 sumed on that farm or on another farm under 

2 common ownership for purposes of such section 

3 415; and 

4 (C) the requirements under sections 418 and 

5 421 of the Federal Food, Drug, and Cosmetic 

6 Act, as added by this Act, from which the Sec7 retary may issue exemptions or modifications of 

8 the requirements for certain types of facilities. 

9 (d) SMALL ENTITY COMPLIANCE POLICY GUIDE.—Not 

10 later than 180 days after the issuance of the regulations 

11 promulgated under subsection (n) of section 418 of the Fed12 eral Food, Drug, and Cosmetic Act (as added by subsection 

13 (a)), the Secretary shall issue a small entity compliance 

14 policy guide setting forth in plain language the require15 ments of such section 418 and this section to assist small 

16 entities in complying with the hazard analysis and other 

17 activities required under such section 418 and this section. 

18 (e) PROHIBITED ACTS.—Section 301 (21 U.S.C. 331) 

19 is amended by adding at the end the following: 

20 ‘‘(uu) The operation of a facility that manufactures, 

21 processes, packs, or holds food for sale in the United States 

22 if the owner, operator, or agent in charge of such facility 

23 is not in compliance with section 418.’’. 

24 (f) NO EFFECT ON HACCP AUTHORITIES.—Nothing 

25 in the amendments made by this section limits the author-
36 

† HR 2751 EAS 

1 ity of the Secretary under the Federal Food, Drug, and Cos2 metic Act (21 U.S.C. 301 et seq.) or the Public Health Serv3 ice Act (42 U.S.C. 201 et seq.) to revise, issue, or enforce 

4 Hazard Analysis Critical Control programs and the Ther5 mally Processed Low-Acid Foods Packaged in Hermetically 

6 Sealed Containers standards. 

7 (g) DIETARY SUPPLEMENTS.—Nothing in the amend8 ments made by this section shall apply to any facility with 

9 regard to the manufacturing, processing, packing, or hold10 ing of a dietary supplement that is in compliance with the 

11 requirements of sections 402(g)(2) and 761 of the Federal 

12 Food, Drug, and Cosmetic Act (21 U.S.C. 342(g)(2), 379aa– 

13 1). 

14 (h) UPDATING GUIDANCE RELATING TO FISH AND

15 FISHERIES PRODUCTS HAZARDS AND CONTROLS.—The 

16 Secretary shall, not later than 180 days after the date of 

17 enactment of this Act, update the Fish and Fisheries Prod18 ucts Hazards and Control Guidance to take into account 

19 advances in technology that have occurred since the pre20 vious publication of such Guidance by the Secretary. 

21 (i) EFFECTIVE DATES.— 

22 (1) GENERAL RULE.—The amendments made by 

23 this section shall take effect 18 months after the date 

24 of enactment of this Act. 
37 

† HR 2751 EAS 

1 (2) FLEXIBILITY FOR SMALL BUSINESSES.—Not2 withstanding paragraph (1)— 

3 (A) the amendments made by this section 

4 shall apply to a small business (as defined in the 

5 regulations promulgated under section 418(n) of 

6 the Federal Food, Drug, and Cosmetic Act (as 

7 added by this section)) beginning on the date 

8 that is 6 months after the effective date of such 

9 regulations; and 

10 (B) the amendments made by this section 

11 shall apply to a very small business (as defined 

12 in such regulations) beginning on the date that 

13 is 18 months after the effective date of such regu14 lations. 

15 SEC. 104. PERFORMANCE STANDARDS. 

16 (a) IN GENERAL.—The Secretary shall, in coordina17 tion with the Secretary of Agriculture, not less frequently 

18 than every 2 years, review and evaluate relevant health data 

19 and other relevant information, including from toxi20 cological and epidemiological studies and analyses, current 

21 Good Manufacturing Practices issued by the Secretary re22 lating to food, and relevant recommendations of relevant 

23 advisory committees, including the Food Advisory Com24 mittee, to determine the most significant foodborne contami25 nants. 
38 

† HR 2751 EAS 

1 (b) GUIDANCE DOCUMENTS AND REGULATIONS.— 

2 Based on the review and evaluation conducted under sub3 section (a), and when appropriate to reduce the risk of seri4 ous illness or death to humans or animals or to prevent 

5 adulteration of the food under section 402 of the Federal 

6 Food, Drug, or Cosmetic Act (21 U.S.C. 342) or to prevent 

7 the spread by food of communicable disease under section 

8 361 of the Public Health Service Act (42 U.S.C. 264), the 

9 Secretary shall issue contaminant-specific and science10 based guidance documents, including guidance documents 

11 regarding action levels, or regulations. Such guidance, in12 cluding guidance regarding action levels, or regulations— 

13 (1) shall apply to products or product classes; 

14 (2) shall, where appropriate, differentiate be15 tween food for human consumption and food intended 

16 for consumption by animals other than humans; and 

17 (3) shall not be written to be facility-specific. 

18 (c) NO DUPLICATION OF EFFORTS.—The Secretary 

19 shall coordinate with the Secretary of Agriculture to avoid 

20 issuing duplicative guidance on the same contaminants. 

21 (d) REVIEW.—The Secretary shall periodically review 

22 and revise, as appropriate, the guidance documents, includ23 ing guidance documents regarding action levels, or regula24 tions promulgated under this section. 
39 

† HR 2751 EAS 

1 SEC. 105. STANDARDS FOR PRODUCE SAFETY. 

2 (a) IN GENERAL.—Chapter IV (21 U.S.C. 341 et seq.), 

3 as amended by section 103, is amended by adding at the 

4 end the following: 

5 ‘‘SEC. 419. STANDARDS FOR PRODUCE SAFETY. 

6 ‘‘(a) PROPOSED RULEMAKING.— 

7 ‘‘(1) IN GENERAL.— 

8 ‘‘(A) RULEMAKING.—Not later than 1 year 

9 after the date of enactment of the FDA Food 

10 Safety Modernization Act, the Secretary, in co11 ordination with the Secretary of Agriculture and 

12 representatives of State departments of agri13 culture (including with regard to the national 

14 organic program established under the Organic 

15 Foods Production Act of 1990), and in consulta16 tion with the Secretary of Homeland Security, 

17 shall publish a notice of proposed rulemaking to 

18 establish science-based minimum standards for 

19 the safe production and harvesting of those types 

20 of fruits and vegetables, including specific mixes 

21 or categories of fruits and vegetables, that are 

22 raw agricultural commodities for which the Sec23 retary has determined that such standards mini24 mize the risk of serious adverse health con25 sequences or death. 
40 

† HR 2751 EAS 

1 ‘‘(B) DETERMINATION BY SECRETARY.— 

2 With respect to small businesses and very small 

3 businesses (as such terms are defined in the regu4 lation promulgated under subparagraph (A)) 

5 that produce and harvest those types of fruits 

6 and vegetables that are raw agricultural com7 modities that the Secretary has determined are 

8 low risk and do not present a risk of serious ad9 verse health consequences or death, the Secretary 

10 may determine not to include production and 

11 harvesting of such fruits and vegetables in such 

12 rulemaking, or may modify the applicable re13 quirements of regulations promulgated pursuant 

14 to this section. 

15 ‘‘(2) PUBLIC INPUT.—During the comment pe16 riod on the notice of proposed rulemaking under 

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

18 than 3 public meetings in diverse geographical areas 

19 of the United States to provide persons in different 

20 regions an opportunity to comment. 

21 ‘‘(3) CONTENT.—The proposed rulemaking under 

22 paragraph (1) shall— 

23 ‘‘(A) provide sufficient flexibility to be ap24 plicable to various types of entities engaged in 

25 the production and harvesting of fruits and vege-
41 

† HR 2751 EAS 

1 tables that are raw agricultural commodities, in2 cluding small businesses and entities that sell di3 rectly to consumers, and be appropriate to the 

4 scale and diversity of the production and har5 vesting of such commodities; 

6 ‘‘(B) include, with respect to growing, har7 vesting, sorting, packing, and storage operations, 

8 science-based minimum standards related to soil 

9 amendments, hygiene, packaging, temperature 

10 controls, animals in the growing area, and 

11 water; 

12 ‘‘(C) consider hazards that occur naturally, 

13 may be unintentionally introduced, or may be 

14 intentionally introduced, including by acts of 

15 terrorism; 

16 ‘‘(D) take into consideration, consistent 

17 with ensuring enforceable public health protec18 tion, conservation and environmental practice 

19 standards and policies established by Federal 

20 natural resource conservation, wildlife conserva21 tion, and environmental agencies; 

22 ‘‘(E) in the case of production that is cer23 tified organic, not include any requirements that 

24 conflict with or duplicate the requirements of the 

25 national organic program established under the 
42 

† HR 2751 EAS 

1 Organic Foods Production Act of 1990, while 

2 providing the same level of public health protec3 tion as the requirements under guidance docu4 ments, including guidance documents regarding 

5 action levels, and regulations under the FDA 

6 Food Safety Modernization Act; and 

7 ‘‘(F) define, for purposes of this section, the 

8 terms ‘small business’ and ‘very small business’ 

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

10 prioritize the implementation of the regulations under 

11 this section for specific fruits and vegetables that are 

12 raw agricultural commodities based on known risks 

13 which may include a history and severity of 

14 foodborne illness outbreaks. 

15 ‘‘(b) FINAL REGULATION.— 

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

17 the close of the comment period for the proposed rule18 making under subsection (a), the Secretary shall 

19 adopt a final regulation to provide for minimum 

20 science-based standards for those types of fruits and 

21 vegetables, including specific mixes or categories of 

22 fruits or vegetables, that are raw agricultural com23 modities, based on known safety risks, which may in24 clude a history of foodborne illness outbreaks. 
43 

† HR 2751 EAS 

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

2 shall— 

3 ‘‘(A) provide for coordination of education 

4 and enforcement activities by State and local of5 ficials, as designated by the Governors of the re6 spective States or the appropriate elected State 

7 official as recognized by State statute; and 

8 ‘‘(B) include a description of the variance 

9 process under subsection (c) and the types of per10 missible variances the Secretary may grant. 

11 ‘‘(3) FLEXIBILITY FOR SMALL BUSINESSES.— 

12 Notwithstanding paragraph (1)— 

13 ‘‘(A) the regulations promulgated under this 

14 section shall apply to a small business (as de15 fined in the regulation promulgated under sub16 section (a)(1)) after the date that is 1 year after 

17 the effective date of the final regulation under 

18 paragraph (1); and 

19 ‘‘(B) the regulations promulgated under this 

20 section shall apply to a very small business (as 

21 defined in the regulation promulgated under sub22 section (a)(1)) after the date that is 2 years after 

23 the effective date of the final regulation under 

24 paragraph (1). 

25 ‘‘(c) CRITERIA.— 
44 

† HR 2751 EAS 

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

2 under subsection (b) shall— 

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

4 and practices that the Secretary determines to 

5 minimize the risk of serious adverse health con6 sequences or death, including procedures, proc7 esses, and practices that the Secretary determines 

8 to be reasonably necessary to prevent the intro9 duction of known or reasonably foreseeable bio10 logical, chemical, and physical hazards, includ11 ing hazards that occur naturally, may be unin12 tentionally introduced, or may be intentionally 

13 introduced, including by acts of terrorism, into 

14 fruits and vegetables, including specific mixes or 

15 categories of fruits and vegetables, that are raw 

16 agricultural commodities and to provide reason17 able assurances that the produce is not adulter18 ated under section 402; 

19 ‘‘(B) provide sufficient flexibility to be 

20 practicable for all sizes and types of businesses, 

21 including small businesses such as a small food 

22 processing facility co-located on a farm; 

23 ‘‘(C) comply with chapter 35 of title 44, 

24 United States Code (commonly known as the 

25 ‘Paperwork Reduction Act’), with special atten-
45 

† HR 2751 EAS 

1 tion to minimizing the burden (as defined in sec2 tion 3502(2) of such Act) on the business, and 

3 collection of information (as defined in section 

4 3502(3) of such Act), associated with such regu5 lations; 

6 ‘‘(D) acknowledge differences in risk and 

7 minimize, as appropriate, the number of sepa8 rate standards that apply to separate foods; and 

9 ‘‘(E) not require a business to hire a con10 sultant or other third party to identify, imple11 ment, certify, compliance with these procedures, 

12 processes, and practices, except in the case of ne13 gotiated enforcement resolutions that may re14 quire such a consultant or third party; and 

15 ‘‘(F) permit States and foreign countries 

16 from which food is imported into the United 

17 States to request from the Secretary variances 

18 from the requirements of the regulations, subject 

19 to paragraph (2), where the State or foreign 

20 country determines that the variance is necessary 

21 in light of local growing conditions and that the 

22 procedures, processes, and practices to be fol23 lowed under the variance are reasonably likely to 

24 ensure that the produce is not adulterated under 

25 section 402 and to provide the same level of pub-
46 

† HR 2751 EAS 

1 lic health protection as the requirements of the 

2 regulations adopted under subsection (b). 

3 ‘‘(2) VARIANCES.— 

4 ‘‘(A) REQUESTS FOR VARIANCES.—A State 

5 or foreign country from which food is imported 

6 into the United States may in writing request a 

7 variance from the Secretary. Such request shall 

8 describe the variance requested and present in9 formation demonstrating that the variance does 

10 not increase the likelihood that the food for which 

11 the variance is requested will be adulterated 

12 under section 402, and that the variance pro13 vides the same level of public health protection as 

14 the requirements of the regulations adopted 

15 under subsection (b). The Secretary shall review 

16 such requests in a reasonable timeframe. 

17 ‘‘(B) APPROVAL OF VARIANCES.—The Sec18 retary may approve a variance in whole or in 

19 part, as appropriate, and may specify the scope 

20 of applicability of a variance to other similarly 

21 situated persons. 

22 ‘‘(C) DENIAL OF VARIANCES.—The Sec23 retary may deny a variance request if the Sec24 retary determines that such variance is not rea25 sonably likely to ensure that the food is not adul-
47 

† HR 2751 EAS 

1 terated under section 402 and is not reasonably 

2 likely to provide the same level of public health 

3 protection as the requirements of the regulation 

4 adopted under subsection (b). The Secretary shall 

5 notify the person requesting such variance of the 

6 reasons for the denial. 

7 ‘‘(D) MODIFICATION OR REVOCATION OF A

8 VARIANCE.—The Secretary, after notice and an 

9 opportunity for a hearing, may modify or revoke 

10 a variance if the Secretary determines that such 

11 variance is not reasonably likely to ensure that 

12 the food is not adulterated under section 402 and 

13 is not reasonably likely to provide the same level 

14 of public health protection as the requirements of 

15 the regulations adopted under subsection (b). 

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

17 with the Secretary of Agriculture and, as appropriate, shall 

18 contract and coordinate with the agency or department des19 ignated by the Governor of each State to perform activities 

20 to ensure compliance with this section. 

21 ‘‘(e) GUIDANCE.— 

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

23 the date of enactment of the FDA Food Safety Mod24 ernization Act, the Secretary shall publish, after con25 sultation with the Secretary of Agriculture, represent-
48 

† HR 2751 EAS 

1 atives of State departments of agriculture, farmer 

2 representatives, and various types of entities engaged 

3 in the production and harvesting or importing of 

4 fruits and vegetables that are raw agricultural com5 modities, including small businesses, updated good 

6 agricultural practices and guidance for the safe pro7 duction and harvesting of specific types of fresh 

8 produce under this section. 

9 ‘‘(2) PUBLIC MEETINGS.—The Secretary shall 

10 conduct not fewer than 3 public meetings in diverse 

11 geographical areas of the United States as part of an 

12 effort to conduct education and outreach regarding 

13 the guidance described in paragraph (1) for persons 

14 in different regions who are involved in the produc15 tion and harvesting of fruits and vegetables that are 

16 raw agricultural commodities, including persons that 

17 sell directly to consumers and farmer representatives, 

18 and for importers of fruits and vegetables that are 

19 raw agricultural commodities. 

20 ‘‘(3) PAPERWORK REDUCTION.—The Secretary 

21 shall ensure that any updated guidance under this 

22 section will— 

23 ‘‘(A) provide sufficient flexibility to be prac24 ticable for all sizes and types of facilities, includ-
49 

† HR 2751 EAS 

1 ing small businesses such as a small food proc2 essing facility co-located on a farm; and 

3 ‘‘(B) acknowledge differences in risk and 

4 minimize, as appropriate, the number of sepa5 rate standards that apply to separate foods. 

6 ‘‘(f) EXEMPTION FOR DIRECT FARM MARKETING.— 

7 ‘‘(1) IN GENERAL.—A farm shall be exempt from 

8 the requirements under this section in a calendar 

9 year if— 

10 ‘‘(A) during the previous 3-year period, the 

11 average annual monetary value of the food sold 

12 by such farm directly to qualified end-users dur13 ing such period exceeded the average annual 

14 monetary value of the food sold by such farm to 

15 all other buyers during such period; and 

16 ‘‘(B) the average annual monetary value of 

17 all food sold during such period was less than 

18 $500,000, adjusted for inflation. 

19 ‘‘(2) NOTIFICATION TO CONSUMERS.— 

20 ‘‘(A) IN GENERAL.—A farm that is exempt 

21 from the requirements under this section shall— 

22 ‘‘(i) with respect to a food for which a 

23 food packaging label is required by the Sec24 retary under any other provision of this 

25 Act, include prominently and conspicuously 
50 

† HR 2751 EAS 

1 on such label the name and business address 

2 of the farm where the produce was grown; 

3 or 

4 ‘‘(ii) with respect to a food for which 

5 a food packaging label is not required by 

6 the Secretary under any other provision of 

7 this Act, prominently and conspicuously 

8 display, at the point of purchase, the name 

9 and business address of the farm where the 

10 produce was grown, on a label, poster, sign, 

11 placard, or documents delivered contem12 poraneously with the food in the normal 

13 course of business, or, in the case of Internet 

14 sales, in an electronic notice. 

15 ‘‘(B) NO ADDITIONAL LABEL.—Subpara16 graph (A) does not provide authority to the Sec17 retary to require a label that is in addition to 

18 any label required under any other provision of 

19 this Act. 

20 ‘‘(3) WITHDRAWAL; RULE OF CONSTRUCTION.— 

21 ‘‘(A) IN GENERAL.—In the event of an ac22 tive investigation of a foodborne illness outbreak 

23 that is directly linked to a farm subject to an ex24 emption under this subsection, or if the Sec25 retary determines that it is necessary to protect 
51 

† HR 2751 EAS 

1 the public health and prevent or mitigate a 

2 foodborne illness outbreak based on conduct or 

3 conditions associated with a farm that are mate4 rial to the safety of the food produced or har5 vested at such farm, the Secretary may withdraw 

6 the exemption provided to such farm under this 

7 subsection. 

8 ‘‘(B) RULE OF CONSTRUCTION.—Nothing in 

9 this subsection shall be construed to expand or 

10 limit the inspection authority of the Secretary. 

11 ‘‘(4) DEFINITIONS.— 

12 ‘‘(A) QUALIFIED END-USER.—In this sub13 section, the term ‘qualified end-user’, with re14 spect to a food means— 

15 ‘‘(i) the consumer of the food; or 

16 ‘‘(ii) a restaurant or retail food estab17 lishment (as those terms are defined by the 

18 Secretary for purposes of section 415) that 

19 is located— 

20 ‘‘(I) in the same State as the farm 

21 that produced the food; or 

22 ‘‘(II) not more than 275 miles 

23 from such farm. 
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1 ‘‘(B) CONSUMER.—For purposes of subpara2 graph (A), the term ‘consumer’ does not include 

3 a business. 

4 ‘‘(5) NO PREEMPTION.—Nothing in this sub5 section preempts State, local, county, or other non6 Federal law regarding the safe production, harvesting, 

7 holding, transportation, and sale of fresh fruits and 

8 vegetables. Compliance with this subsection shall not 

9 relieve any person from liability at common law or 

10 under State statutory law. 

11 ‘‘(6) LIMITATION OF EFFECT.—Nothing in this 

12 subsection shall prevent the Secretary from exercising 

13 any authority granted in the other sections of this 

14 Act. 

15 ‘‘(g) CLARIFICATION.—This section shall not apply to 

16 produce that is produced by an individual for personal con17 sumption. 

18 ‘‘(h) EXCEPTION FOR ACTIVITIES OF FACILITIES SUB19 JECT TO SECTION 418.—This section shall not apply to ac20 tivities of a facility that are subject to section 418.’’. 

21 (b) SMALL ENTITY COMPLIANCE POLICY GUIDE.—Not 

22 later than 180 days after the issuance of regulations under 

23 section 419 of the Federal Food, Drug, and Cosmetic Act 

24 (as added by subsection (a)), the Secretary of Health and 

25 Human Services shall issue a small entity compliance pol-
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1 icy guide setting forth in plain language the requirements 

2 of such section 419 and to assist small entities in complying 

3 with standards for safe production and harvesting and 

4 other activities required under such section. 

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

6 as amended by section 103, is amended by adding at the 

7 end the following: 

8 ‘‘(vv) The failure to comply with the requirements 

9 under section 419.’’. 

10 (d) NO EFFECT ON HACCP AUTHORITIES.—Nothing 

11 in the amendments made by this section limits the author12 ity of the Secretary under the Federal Food, Drug, and Cos13 metic Act (21 U.S.C. 301 et seq.) or the Public Health Serv14 ice Act (42 U.S.C. 201 et seq.) to revise, issue, or enforce 

15 product and category-specific regulations, such as the Sea16 food Hazard Analysis Critical Controls Points Program, 

17 the Juice Hazard Analysis Critical Control Program, and 

18 the Thermally Processed Low-Acid Foods Packaged in Her19 metically Sealed Containers standards. 

20 SEC. 106. PROTECTION AGAINST INTENTIONAL ADULTERA21 TION. 

22 (a) IN GENERAL.—Chapter IV (21 U.S.C. 341 et seq.), 

23 as amended by section 105, is amended by adding at the 

24 end the following: 
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1 ‘‘SEC. 420. PROTECTION AGAINST INTENTIONAL ADULTERA2 TION. 

3 ‘‘(a) DETERMINATIONS.— 

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

5 ‘‘(A) conduct a vulnerability assessment of 

6 the food system, including by consideration of 

7 the Department of Homeland Security biological, 

8 chemical, radiological, or other terrorism risk as9 sessments; 

10 ‘‘(B) consider the best available under11 standing of uncertainties, risks, costs, and bene12 fits associated with guarding against intentional 

13 adulteration of food at vulnerable points; and 

14 ‘‘(C) determine the types of science-based 

15 mitigation strategies or measures that are nec16 essary to protect against the intentional adulter17 ation of food. 

18 ‘‘(2) LIMITED DISTRIBUTION.—In the interest of 

19 national security, the Secretary, in consultation with 

20 the Secretary of Homeland Security, may determine 

21 the time, manner, and form in which determinations 

22 made under paragraph (1) are made publicly avail23 able. 

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

25 the date of enactment of the FDA Food Safety Moderniza26 tion Act, the Secretary, in coordination with the Secretary 
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1 of Homeland Security and in consultation with the Sec2 retary of Agriculture, shall promulgate regulations to pro3 tect against the intentional adulteration of food subject to 

4 this Act. Such regulations shall— 

5 ‘‘(1) specify how a person shall assess whether 

6 the person is required to implement mitigation strate7 gies or measures intended to protect against the in8 tentional adulteration of food; and 

9 ‘‘(2) specify appropriate science-based mitigation 

10 strategies or measures to prepare and protect the food 

11 supply chain at specific vulnerable points, as appro12 priate. 

13 ‘‘(c) APPLICABILITY.—Regulations promulgated under 

14 subsection (b) shall apply only to food for which there is 

15 a high risk of intentional contamination, as determined by 

16 the Secretary, in consultation with the Secretary of Home17 land Security, under subsection (a), that could cause serious 

18 adverse health consequences or death to humans or animals 

19 and shall include those foods— 

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

21 vulnerabilities (including short shelf-life or suscepti22 bility to intentional contamination at critical control 

23 points); and 

24 ‘‘(2) in bulk or batch form, prior to being pack25 aged for the final consumer. 
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1 ‘‘(d) EXCEPTION.—This section shall not apply to 

2 farms, except for those that produce milk. 

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

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

5 1.227 of title 21, Code of Federal Regulations (or any suc6 cessor regulation).’’. 

7 (b) GUIDANCE DOCUMENTS.— 

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

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

10 Health and Human Services, in consultation with the 

11 Secretary of Homeland Security and the Secretary of 

12 Agriculture, shall issue guidance documents related to 

13 protection against the intentional adulteration of 

14 food, including mitigation strategies or measures to 

15 guard against such adulteration as required under 

16 section 420 of the Federal Food, Drug, and Cosmetic 

17 Act, as added by subsection (a). 

18 (2) CONTENT.—The guidance documents issued 

19 under paragraph (1) shall— 

20 (A) include a model assessment for a person 

21 to use under subsection (b)(1) of section 420 of 

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

23 added by subsection (a); 
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1 (B) include examples of mitigation strate2 gies or measures described in subsection (b)(2) of 

3 such section; and 

4 (C) specify situations in which the examples 

5 of mitigation strategies or measures described in 

6 subsection (b)(2) of such section are appropriate. 

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

8 national security, the Secretary of Health and 

9 Human Services, in consultation with the Secretary 

10 of Homeland Security, may determine the time, man11 ner, and form in which the guidance documents 

12 issued under paragraph (1) are made public, includ13 ing by releasing such documents to targeted audi14 ences. 

15 (c) PERIODIC REVIEW.—The Secretary of Health and 

16 Human Services shall periodically review and, as appro17 priate, update the regulations under section 420(b) of the 

18 Federal Food, Drug, and Cosmetic Act, as added by sub19 section (a), and the guidance documents under subsection 

20 (b). 

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

22 et seq.), as amended by section 105, is amended by adding 

23 at the end the following: 

24 ‘‘(ww) The failure to comply with section 420.’’. 
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1 SEC. 107. AUTHORITY TO COLLECT FEES. 

2 (a) FEES FOR REINSPECTION, RECALL, AND IMPORTA3 TION ACTIVITIES.—Subchapter C of chapter VII (21 U.S.C. 

4 379f et seq.) is amended by adding at the end the following: 

5 ‘‘PART 6—FEES RELATED TO FOOD 

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

7 ‘‘(a) IN GENERAL.— 

8 ‘‘(1) PURPOSE AND AUTHORITY.—For fiscal year 

9 2010 and each subsequent fiscal year, the Secretary 

10 shall, in accordance with this section, assess and col11 lect fees from— 

12 ‘‘(A) the responsible party for each domestic 

13 facility (as defined in section 415(b)) and the 

14 United States agent for each foreign facility sub15 ject to a reinspection in such fiscal year, to cover 

16 reinspection-related costs for such year; 

17 ‘‘(B) the responsible party for a domestic 

18 facility (as defined in section 415(b)) and an 

19 importer who does not comply with a recall 

20 order under section 423 or under section 412(f) 

21 in such fiscal year, to cover food recall activities 

22 associated with such order performed by the Sec23 retary, including technical assistance, follow-up 

24 effectiveness checks, and public notifications, for 

25 such year; 
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1 ‘‘(C) each importer participating in the vol2 untary qualified importer program under section 

3 806 in such year, to cover the administrative 

4 costs of such program for such year; and 

5 ‘‘(D) each importer subject to a reinspection 

6 in such fiscal year, to cover reinspection-related 

7 costs for such year. 

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

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

11 ‘‘(i) with respect to domestic facilities 

12 (as defined in section 415(b)), 1 or more in13 spections conducted under section 704 subse14 quent to an inspection conducted under 

15 such provision which identified noncompli16 ance materially related to a food safety re17 quirement of this Act, specifically to deter18 mine whether compliance has been achieved 

19 to the Secretary’s satisfaction; and 

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

21 more examinations conducted under section 

22 801 subsequent to an examination con23 ducted under such provision which identi24 fied noncompliance materially related to a 

25 food safety requirement of this Act, specifi-
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1 cally to determine whether compliance has 

2 been achieved to the Secretary’s satisfaction; 

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

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

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

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

10 ‘‘(C) the term ‘responsible party’ has the 

11 meaning given such term in section 417(a)(1). 

12 ‘‘(b) ESTABLISHMENT OF FEES.— 

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

14 and (d), the Secretary shall establish the fees to be col15 lected under this section for each fiscal year specified 

16 in subsection (a)(1), based on the methodology de17 scribed under paragraph (2), and shall publish such 

18 fees in a Federal Register notice not later than 60 

19 days before the start of each such year. 

20 ‘‘(2) FEE METHODOLOGY.— 

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

22 collection— 

23 ‘‘(i) under subparagraph (A) of sub24 section (a)(1) for a fiscal year shall be based 

25 on the Secretary’s estimate of 100 percent of 
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1 the costs of the reinspection-related activi2 ties (including by type or level of reinspec3 tion activity, as the Secretary determines 

4 applicable) described in such subparagraph 

5 (A) for such year; 

6 ‘‘(ii) under subparagraph (B) of sub7 section (a)(1) for a fiscal year shall be based 

8 on the Secretary’s estimate of 100 percent of 

9 the costs of the activities described in such 

10 subparagraph (B) for such year; 

11 ‘‘(iii) under subparagraph (C) of sub12 section (a)(1) for a fiscal year shall be based 

13 on the Secretary’s estimate of 100 percent of 

14 the costs of the activities described in such 

15 subparagraph (C) for such year; and 

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

18 on the Secretary’s estimate of 100 percent of 

19 the costs of the activities described in such 

20 subparagraph (D) for such year. 

21 ‘‘(B) OTHER CONSIDERATIONS.— 

22 ‘‘(i) VOLUNTARY QUALIFIED IMPORTER

23 PROGRAM.—In establishing the fee amounts 

24 under subparagraph (A)(iii) for a fiscal 

25 year, the Secretary shall provide for the 
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1 number of importers who have submitted to 

2 the Secretary a notice under section 806(c) 

3 informing the Secretary of the intent of 

4 such importer to participate in the program 

5 under section 806 in such fiscal year. 

6 ‘‘(II) RECOUPMENT.—In estab7 lishing the fee amounts under subpara8 graph (A)(iii) for the first 5 fiscal 

9 years after the date of enactment of 

10 this section, the Secretary shall include 

11 in such fee a reasonable surcharge that 

12 provides a recoupment of the costs ex13 pended by the Secretary to establish 

14 and implement the first year of the 

15 program under section 806. 

16 ‘‘(ii) CREDITING OF FEES.—In estab17 lishing the fee amounts under subparagraph 

18 (A) for a fiscal year, the Secretary shall 

19 provide for the crediting of fees from the 

20 previous year to the next year if the Sec21 retary overestimated the amount of fees 

22 needed to carry out such activities, and con23 sider the need to account for any adjust24 ment of fees and such other factors as the 

25 Secretary determines appropriate. 
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1 ‘‘(iii) PUBLISHED GUIDELINES.—Not 

2 later than 180 days after the date of enact3 ment of the FDA Food Safety Moderniza4 tion Act, the Secretary shall publish in the 

5 Federal Register a proposed set of guidelines 

6 in consideration of the burden of fee 

7 amounts on small business. Such consider8 ation may include reduced fee amounts for 

9 small businesses. The Secretary shall pro10 vide for a period of public comment on such 

11 guidelines. The Secretary shall adjust the fee 

12 schedule for small businesses subject to such 

13 fees only through notice and comment rule14 making. 

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

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

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

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

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

20 ‘‘(c) LIMITATIONS.— 

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

22 shall be refunded for a fiscal year beginning after fis23 cal year 2010 unless the amount of the total appro24 priations for food safety activities at the Food and 

25 Drug Administration for such fiscal year (excluding 
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1 the amount of fees appropriated for such fiscal year) 

2 is equal to or greater than the amount of appropria3 tions for food safety activities at the Food and Drug 

4 Administration for fiscal year 2009 (excluding the 

5 amount of fees appropriated for such fiscal year), 

6 multiplied by the adjustment factor under paragraph 

7 (3). 

8 ‘‘(2) AUTHORITY.—If— 

9 ‘‘(A) the Secretary does not assess fees under 

10 subsection (a) for a portion of a fiscal year be11 cause paragraph (1) applies; and 

12 ‘‘(B) at a later date in such fiscal year, 

13 such paragraph (1) ceases to apply, 

14 the Secretary may assess and collect such fees under 

15 subsection (a), without any modification to the rate 

16 of such fees, notwithstanding the provisions of sub17 section (a) relating to the date fees are to be paid. 

18 ‘‘(3) ADJUSTMENT FACTOR.— 

19 ‘‘(A) IN GENERAL.—The adjustment factor 

20 described in paragraph (1) shall be the total per21 centage change that occurred in the Consumer 

22 Price Index for all urban consumers (all items; 

23 United States city average) for the 12-month pe24 riod ending June 30 preceding the fiscal year, 
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1 but in no case shall such adjustment factor be 

2 negative. 

3 ‘‘(B) COMPOUNDED BASIS.—The adjustment 

4 under subparagraph (A) made each fiscal year 

5 shall be added on a compounded basis to the sum 

6 of all adjustments made each fiscal year after fis7 cal year 2009. 

8 ‘‘(4) LIMITATION ON AMOUNT OF CERTAIN

9 FEES.— 

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

11 other provision of this section and subject to sub12 paragraph (B), the Secretary may not collect fees 

13 in a fiscal year such that the amount collected— 

14 ‘‘(i) under subparagraph (B) of sub15 section (a)(1) exceeds $20,000,000; and 

16 ‘‘(ii) under subparagraphs (A) and (D) 

17 of subsection (a)(1) exceeds $25,000,000 

18 combined. 

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

20 (as defined in section 415(b)) or an importer be21 comes subject to a fee described in subparagraph 

22 (A), (B), or (D) of subsection (a)(1) after the 

23 maximum amount of fees has been collected by 

24 the Secretary under subparagraph (A), the Sec-
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1 retary may collect a fee from such facility or im2 porter. 

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

4 authorized under subsection (a) shall be collected and avail5 able for obligation only to the extent and in the amount 

6 provided in appropriations Acts. Such fees are authorized 

7 to remain available until expended. Such sums as may be 

8 necessary may be transferred from the Food and Drug Ad9 ministration salaries and expenses account without fiscal 

10 year limitation to such appropriation account for salaries 

11 and expenses with such fiscal year limitation. The sums 

12 transferred shall be available solely for the purpose of pay13 ing the operating expenses of the Food and Drug Adminis14 tration employees and contractors performing activities as15 sociated with these food safety fees. 

16 ‘‘(e) COLLECTION OF FEES.— 

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

18 in the Federal Register notice described in subsection 

19 (b)(1) the time and manner in which fees assessed 

20 under this section shall be collected. 

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

22 case where the Secretary does not receive payment of 

23 a fee assessed under this section within 30 days after 

24 it is due, such fee shall be treated as a claim of the 

25 United States Government subject to provisions of 
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1 subchapter II of chapter 37 of title 31, United States 

2 Code. 

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

4 120 days after each fiscal year for which fees are assessed 

5 under this section, the Secretary shall submit a report to 

6 the Committee on Health, Education, Labor, and Pensions 

7 of the Senate and the Committee on Energy and Commerce 

8 of the House of Representatives, to include a description 

9 of fees assessed and collected for each such year and a sum10 mary description of the entities paying such fees and the 

11 types of business in which such entities engage. 

12 ‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—For fis13 cal year 2010 and each fiscal year thereafter, there is au14 thorized to be appropriated for fees under this section an 

15 amount equal to the total revenue amount determined under 

16 subsection (b) for the fiscal year, as adjusted or otherwise 

17 affected under the other provisions of this section.’’. 

18 (b) EXPORT CERTIFICATION FEES FOR FOODS AND

19 ANIMAL FEED.— 

20 (1) AUTHORITY FOR EXPORT CERTIFICATIONS

21 FOR FOOD, INCLUDING ANIMAL FEED.—Section 

22 801(e)(4)(A) (21 U.S.C. 381(e)(4)(A)) is amended— 

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

24 striking ‘‘a drug’’ and inserting ‘‘a food, drug’’; 
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1 (B) in clause (i) by striking ‘‘exported 

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

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

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

5 drug’’. 

6 (2) CLARIFICATION OF CERTIFICATION.—Section 

7 801(e)(4) (21 U.S.C. 381(e)(4)) is amended by insert8 ing after subparagraph (B) the following new sub9 paragraph: 

10 ‘‘(C) For purposes of this paragraph, a cer11 tification by the Secretary shall be made on such 

12 basis, and in such form (including a publicly 

13 available listing) as the Secretary determines ap14 propriate.’’. 

15 (3) LIMITATIONS ON THE USE AND AMOUNT OF

16 FEES.—Paragraph (4) of section 801(e) (21 U.S.C. 

17 381(e)) is amended by adding at the end the fol18 lowing: 

19 ‘‘(D) With regard to fees pursuant to sub20 paragraph (B) in connection with written export 

21 certifications for food: 

22 ‘‘(i) Such fees shall be collected and 

23 available solely for the costs of the Food and 

24 Drug Administration associated with 

25 issuing such certifications. 
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1 ‘‘(ii) Such fees may not be retained in 

2 an amount that exceeds such costs for the 

3 respective fiscal year.’’ 

4 SEC. 108. NATIONAL AGRICULTURE AND FOOD DEFENSE 

5 STRATEGY. 

6 (a) DEVELOPMENT AND SUBMISSION OF STRATEGY.— 

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

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

9 Health and Human Services and the Secretary of Ag10 riculture, in coordination with the Secretary of 

11 Homeland Security, shall prepare and transmit to the 

12 relevant committees of Congress, and make publicly 

13 available on the Internet Web sites of the Department 

14 of Health and Human Services and the Department 

15 of Agriculture, the National Agriculture and Food De16 fense Strategy. 

17 (2) IMPLEMENTATION PLAN.—The strategy shall 

18 include an implementation plan for use by the Secre19 taries described under paragraph (1) in carrying out 

20 the strategy. 

21 (3) RESEARCH.—The strategy shall include a co22 ordinated research agenda for use by the Secretaries 

23 described under paragraph (1) in conducting research 

24 to support the goals and activities described in para25 graphs (1) and (2) of subsection (b). 
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1 (4) REVISIONS.—Not later than 4 years after the 

2 date on which the strategy is submitted to the relevant 

3 committees of Congress under paragraph (1), and not 

4 less frequently than every 4 years thereafter, the Sec5 retary of Health and Human Services and the Sec6 retary of Agriculture, in coordination with the Sec7 retary of Homeland Security, shall revise and submit 

8 to the relevant committees of Congress the strategy. 

9 (5) CONSISTENCY WITH EXISTING PLANS.—The 

10 strategy described in paragraph (1) shall be consistent 

11 with— 

12 (A) the National Incident Management Sys13 tem; 

14 (B) the National Response Framework; 

15 (C) the National Infrastructure Protection 

16 Plan; 

17 (D) the National Preparedness Goals; and 

18 (E) other relevant national strategies. 

19 (b) COMPONENTS.— 

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

21 description of the process to be used by the Depart22 ment of Health and Human Services, the Department 

23 of Agriculture, and the Department of Homeland Se24 curity— 
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1 (A) to achieve each goal described in para2 graph (2); and 

3 (B) to evaluate the progress made by Fed4 eral, State, local, and tribal governments to5 wards the achievement of each goal described in 

6 paragraph (2). 

7 (2) GOALS.—The strategy shall include a de8 scription of the process to be used by the Department 

9 of Health and Human Services, the Department of 

10 Agriculture, and the Department of Homeland Secu11 rity to achieve the following goals: 

12 (A) PREPAREDNESS GOAL.—Enhance the 

13 preparedness of the agriculture and food system 

14 by— 

15 (i) conducting vulnerability assess16 ments of the agriculture and food system; 

17 (ii) mitigating vulnerabilities of the 

18 system; 

19 (iii) improving communication and 

20 training relating to the system; 

21 (iv) developing and conducting exer22 cises to test decontamination and disposal 

23 plans; 
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1 (v) developing modeling tools to im2 prove event consequence assessment and de3 cision support; and 

4 (vi) preparing risk communication 

5 tools and enhancing public awareness 

6 through outreach. 

7 (B) DETECTION GOAL.—Improve agri8 culture and food system detection capabilities 

9 by— 

10 (i) identifying contamination in food 

11 products at the earliest possible time; and 

12 (ii) conducting surveillance to prevent 

13 the spread of diseases. 

14 (C) EMERGENCY RESPONSE GOAL.—Ensure 

15 an efficient response to agriculture and food 

16 emergencies by— 

17 (i) immediately investigating animal 

18 disease outbreaks and suspected food con19 tamination; 

20 (ii) preventing additional human ill21 nesses; 

22 (iii) organizing, training, and equip23 ping animal, plant, and food emergency re24 sponse teams of— 

25 (I) the Federal Government; and 
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1 (II) State, local, and tribal gov2 ernments; 

3 (iv) designing, developing, and evalu4 ating training and exercises carried out 

5 under agriculture and food defense plans; 

6 and 

7 (v) ensuring consistent and organized 

8 risk communication to the public by— 

9 (I) the Federal Government; 

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

12 (III) the private sector. 

13 (D) RECOVERY GOAL.—Secure agriculture 

14 and food production after an agriculture or food 

15 emergency by— 

16 (i) working with the private sector to 

17 develop business recovery plans to rapidly 

18 resume agriculture, food production, and 

19 international trade; 

20 (ii) conducting exercises of the plans 

21 described in subparagraph (C) with the goal 

22 of long-term recovery results; 

23 (iii) rapidly removing, and effectively 

24 disposing of— 
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1 (I) contaminated agriculture and 

2 food products; and 

3 (II) infected plants and animals; 

4 and 

5 (iv) decontaminating and restoring 

6 areas affected by an agriculture or food 

7 emergency. 

8 (3) EVALUATION.—The Secretary, in coordina9 tion with the Secretary of Agriculture and the Sec10 retary of Homeland Security, shall— 

11 (A) develop metrics to measure progress for 

12 the evaluation process described in paragraph 

13 (1)(B); and 

14 (B) report on the progress measured in sub15 paragraph (A) as part of the National Agri16 culture and Food Defense strategy described in 

17 subsection (a)(1). 

18 (c) LIMITED DISTRIBUTION.—In the interest of na19 tional security, the Secretary of Health and Human Serv20 ices and the Secretary of Agriculture, in coordination with 

21 the Secretary of Homeland Security, may determine the 

22 manner and format in which the National Agriculture and 

23 Food Defense strategy established under this section is made 

24 publicly available on the Internet Web sites of the Depart25 ment of Health and Human Services, the Department of 
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1 Homeland Security, and the Department of Agriculture, as 

2 described in subsection (a)(1). 

3 SEC. 109. FOOD AND AGRICULTURE COORDINATING COUN4 CILS. 

5 The Secretary of Homeland Security, in coordination 

6 with the Secretary of Health and Human Services and the 

7 Secretary of Agriculture, shall within 180 days of enact8 ment of this Act, and annually thereafter, submit to the 

9 relevant committees of Congress, and make publicly avail10 able on the Internet Web site of the Department of Home11 land Security, a report on the activities of the Food and 

12 Agriculture Government Coordinating Council and the 

13 Food and Agriculture Sector Coordinating Council, includ14 ing the progress of such Councils on— 

15 (1) facilitating partnerships between public and 

16 private entities to help coordinate and enhance the 

17 protection of the agriculture and food system of the 

18 United States; 

19 (2) providing for the regular and timely inter20 change of information between each council relating 

21 to the security of the agriculture and food system (in22 cluding intelligence information); 

23 (3) identifying best practices and methods for 

24 improving the coordination among Federal, State, 
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1 local, and private sector preparedness and response 

2 plans for agriculture and food defense; and 

3 (4) recommending methods by which to protect 

4 the economy and the public health of the United 

5 States from the effects of— 

6 (A) animal or plant disease outbreaks; 

7 (B) food contamination; and 

8 (C) natural disasters affecting agriculture 

9 and food. 

10 SEC. 110. BUILDING DOMESTIC CAPACITY. 

11 (a) IN GENERAL.— 

12 (1) INITIAL REPORT.—The Secretary, in coordi13 nation with the Secretary of Agriculture and the Sec14 retary of Homeland Security, shall, not later than 2 

15 years after the date of enactment of this Act, submit 

16 to Congress a comprehensive report that identifies 

17 programs and practices that are intended to promote 

18 the safety and supply chain security of food and to 

19 prevent outbreaks of foodborne illness and other food20 related hazards that can be addressed through preven21 tive activities. Such report shall include a description 

22 of the following: 

23 (A) Analysis of the need for further regula24 tions or guidance to industry. 
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1 (B) Outreach to food industry sectors, in2 cluding through the Food and Agriculture Co3 ordinating Councils referred to in section 109, to 

4 identify potential sources of emerging threats to 

5 the safety and security of the food supply and 

6 preventive strategies to address those threats. 

7 (C) Systems to ensure the prompt distribu8 tion to the food industry of information and 

9 technical assistance concerning preventive strate10 gies. 

11 (D) Communication systems to ensure that 

12 information about specific threats to the safety 

13 and security of the food supply are rapidly and 

14 effectively disseminated. 

15 (E) Surveillance systems and laboratory 

16 networks to rapidly detect and respond to 

17 foodborne illness outbreaks and other food-related 

18 hazards, including how such systems and net19 works are integrated. 

20 (F) Outreach, education, and training pro21 vided to States and local governments to build 

22 State and local food safety and food defense ca23 pabilities, including progress implementing 

24 strategies developed under sections 108 and 205. 
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1 (G) The estimated resources needed to effec2 tively implement the programs and practices 

3 identified in the report developed in this section 

4 over a 5-year period. 

5 (H) The impact of requirements under this 

6 Act (including amendments made by this Act) 

7 on certified organic farms and facilities (as de8 fined in section 415 (21 U.S.C. 350d). 

9 (I) Specific efforts taken pursuant to the 

10 agreements authorized under section 421(c) of 

11 the Federal Food, Drug, and Cosmetic Act (as 

12 added by section 201), together with, as nec13 essary, a description of any additional authori14 ties necessary to improve seafood safety. 

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

16 following the submission of the report under para17 graph (1), the Secretary shall submit to Congress a 

18 report that— 

19 (A) reviews previous food safety programs 

20 and practices; 

21 (B) outlines the success of those programs 

22 and practices; 

23 (C) identifies future programs and prac24 tices; and 
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1 (D) includes information related to any 

2 matter described in subparagraphs (A) through 

3 (H) of paragraph (1), as necessary. 

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

5 under subsection (a)(1) shall describe methods that seek to 

6 ensure that resources available to the Secretary for food 

7 safety-related activities are directed at those actions most 

8 likely to reduce risks from food, including the use of preven9 tive strategies and allocation of inspection resources. The 

10 Secretary shall promptly undertake those risk-based actions 

11 that are identified during the development of the report as 

12 likely to contribute to the safety and security of the food 

13 supply. 

14 (c) CAPABILITY FOR LABORATORY ANALYSES; RE15 SEARCH.—The report developed under subsection (a)(1) 

16 shall provide a description of methods to increase capacity 

17 to undertake analyses of food samples promptly after collec18 tion, to identify new and rapid analytical techniques, in19 cluding commercially-available techniques that can be em20 ployed at ports of entry and by Food Emergency Response 

21 Network laboratories, and to provide for well-equipped and 

22 staffed laboratory facilities and progress toward laboratory 

23 accreditation under section 422 of the Federal Food, Drug, 

24 and Cosmetic Act (as added by section 202). 
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1 (d) INFORMATION TECHNOLOGY.—The report devel2 oped under subsection (a)(1) shall include a description of 

3 such information technology systems as may be needed to 

4 identify risks and receive data from multiple sources, in5 cluding foreign governments, State, local, and tribal govern6 ments, other Federal agencies, the food industry, labora7 tories, laboratory networks, and consumers. The informa8 tion technology systems that the Secretary describes shall 

9 also provide for the integration of the facility registration 

10 system under section 415 of the Federal Food, Drug, and 

11 Cosmetic Act (21 U.S.C. 350d), and the prior notice system 

12 under section 801(m) of such Act (21 U.S.C. 381(m)) with 

13 other information technology systems that are used by the 

14 Federal Government for the processing of food offered for 

15 import into the United States. 

16 (e) AUTOMATED RISK ASSESSMENT.—The report de17 veloped under subsection (a)(1) shall include a description 

18 of progress toward developing and improving an automated 

19 risk assessment system for food safety surveillance and allo20 cation of resources. 

21 (f) TRACEBACK AND SURVEILLANCE REPORT.—The 

22 Secretary shall include in the report developed under sub23 section (a)(1) an analysis of the Food and Drug Adminis24 tration’s performance in foodborne illness outbreaks during 

25 the 5-year period preceding the date of enactment of this 
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1 Act involving fruits and vegetables that are raw agricul2 tural commodities (as defined in section 201(r) (21 U.S.C. 

3 321(r)) and recommendations for enhanced surveillance, 

4 outbreak response, and traceability. Such findings and rec5 ommendations shall address communication and coordina6 tion with the public, industry, and State and local govern7 ments, as such communication and coordination relates to 

8 outbreak identification and traceback. 

9 (g) BIENNIAL FOOD SAFETY AND FOOD DEFENSE RE10 SEARCH PLAN.—The Secretary, the Secretary of Agri11 culture, and the Secretary of Homeland Security shall, on 

12 a biennial basis, submit to Congress a joint food safety and 

13 food defense research plan which may include studying the 

14 long-term health effects of foodborne illness. Such biennial 

15 plan shall include a list and description of projects con16 ducted during the previous 2-year period and the plan for 

17 projects to be conducted during the subsequent 2-year pe18 riod. 

19 (h) EFFECTIVENESS OF PROGRAMS ADMINISTERED BY

20 THE DEPARTMENT OF HEALTH AND HUMAN SERVICES.— 

21 (1) IN GENERAL.—To determine whether existing 

22 Federal programs administered by the Department of 

23 Health and Human Services are effective in achieving 

24 the stated goals of such programs, the Secretary shall, 
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1 beginning not later than 1 year after the date of en2 actment of this Act— 

3 (A) conduct an annual evaluation of each 

4 program of such Department to determine the ef5 fectiveness of each such program in achieving 

6 legislated intent, purposes, and objectives; and 

7 (B) submit to Congress a report concerning 

8 such evaluation. 

9 (2) CONTENT.—The report described under para10 graph (1)(B) shall— 

11 (A) include conclusions concerning the rea12 sons that such existing programs have proven 

13 successful or not successful and what factors con14 tributed to such conclusions; 

15 (B) include recommendations for consolida16 tion and elimination to reduce duplication and 

17 inefficiencies in such programs at such Depart18 ment as identified during the evaluation conduct 

19 under this subsection; and 

20 (C) be made publicly available in a publi21 cation entitled ‘‘Guide to the U.S. Department of 

22 Health and Human Services Programs’’. 

23 (i) UNIQUE IDENTIFICATION NUMBERS.— 

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

25 the date of enactment of this Act, the Secretary, act-
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1 ing through the Commissioner of Food and Drugs, 

2 shall conduct a study regarding the need for, and 

3 challenges associated with, development and imple4 mentation of a program that requires a unique iden5 tification number for each food facility registered 

6 with the Secretary and, as appropriate, each broker 

7 that imports food into the United States. Such study 

8 shall include an evaluation of the costs associated 

9 with development and implementation of such a sys10 tem, and make recommendations about what new au11 thorities, if any, would be necessary to develop and 

12 implement such a system. 

13 (2) REPORT.—Not later than 15 months after the 

14 date of enactment of this Act, the Secretary shall sub15 mit to Congress a report that describes the findings 

16 of the study conducted under paragraph (1) and that 

17 includes any recommendations determined appro18 priate by the Secretary. 

19 SEC. 111. SANITARY TRANSPORTATION OF FOOD. 

20 (a) IN GENERAL.—Not later than 18 months after the 

21 date of enactment of this Act, the Secretary shall promul22 gate regulations described in section 416(b) of the Federal 

23 Food, Drug, and Cosmetic Act (21 U.S.C. 350e(b)). 

24 (b) FOOD TRANSPORTATION STUDY.—The Secretary, 

25 acting through the Commissioner of Food and Drugs, shall 
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1 conduct a study of the transportation of food for consump2 tion in the United States, including transportation by air, 

3 that includes an examination of the unique needs of rural 

4 and frontier areas with regard to the delivery of safe food. 

5 SEC. 112. FOOD ALLERGY AND ANAPHYLAXIS MANAGE6 MENT. 

7 (a) DEFINITIONS.—In this section: 

8 (1) EARLY CHILDHOOD EDUCATION PROGRAM.— 

9 The term ‘‘early childhood education program’’ 

10 means— 

11 (A) a Head Start program or an Early 

12 Head Start program carried out under the Head 

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

14 (B) a State licensed or regulated child care 

15 program or school; or 

16 (C) a State prekindergarten program that 

17 serves children from birth through kindergarten. 

18 (2) ESEA DEFINITIONS.—The terms ‘‘local edu19 cational agency’’, ‘‘secondary school’’, ‘‘elementary 

20 school’’, and ‘‘parent’’ have the meanings given the 

21 terms in section 9101 of the Elementary and Sec22 ondary Education Act of 1965 (20 U.S.C. 7801). 

23 (3) SCHOOL.—The term ‘‘school’’ includes pub24 lic— 

25 (A) kindergartens; 
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1 (B) elementary schools; and 

2 (C) secondary schools. 

3 (4) SECRETARY.—The term ‘‘Secretary’’ means 

4 the Secretary of Health and Human Services. 

5 (b) ESTABLISHMENT OF VOLUNTARY FOOD ALLERGY

6 AND ANAPHYLAXIS MANAGEMENT GUIDELINES.— 

7 (1) ESTABLISHMENT.— 

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

9 after the date of enactment of this Act, the Sec10 retary, in consultation with the Secretary of 

11 Education, shall— 

12 (i) develop guidelines to be used on a 

13 voluntary basis to develop plans for indi14 viduals to manage the risk of food allergy 

15 and anaphylaxis in schools and early child16 hood education programs; and 

17 (ii) make such guidelines available to 

18 local educational agencies, schools, early 

19 childhood education programs, and other 

20 interested entities and individuals to be im21 plemented on a voluntary basis only. 

22 (B) APPLICABILITY OF FERPA.—Each plan 

23 described in subparagraph (A) that is developed 

24 for an individual shall be considered an edu25 cation record for the purpose of section 444 of the 
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1 General Education Provisions Act (commonly re2 ferred to as the ‘‘Family Educational Rights and 

3 Privacy Act of 1974’’) (20 U.S.C. 1232g). 

4 (2) CONTENTS.—The voluntary guidelines devel5 oped by the Secretary under paragraph (1) shall ad6 dress each of the following and may be updated as the 

7 Secretary determines necessary: 

8 (A) Parental obligation to provide the 

9 school or early childhood education program, 

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

11 (i) documentation from their child’s 

12 physician or nurse— 

13 (I) supporting a diagnosis of food 

14 allergy, and any risk of anaphylaxis, if 

15 applicable; 

16 (II) identifying any food to which 

17 the child is allergic; 

18 (III) describing, if appropriate, 

19 any prior history of anaphylaxis; 

20 (IV) listing any medication pre21 scribed for the child for the treatment 

22 of anaphylaxis; 

23 (V) detailing emergency treatment 

24 procedures in the event of a reaction; 
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1 (VI) listing the signs and symp2 toms of a reaction; and 

3 (VII) assessing the child’s readi4 ness for self-administration of prescrip5 tion medication; and 

6 (ii) a list of substitute meals that may 

7 be offered to the child by school or early 

8 childhood education program food service 

9 personnel. 

10 (B) The creation and maintenance of an in11 dividual plan for food allergy management, in 

12 consultation with the parent, tailored to the 

13 needs of each child with a documented risk for 

14 anaphylaxis, including any procedures for the 

15 self-administration of medication by such chil16 dren in instances where— 

17 (i) the children are capable of self-ad18 ministering medication; and 

19 (ii) such administration is not prohib20 ited by State law. 

21 (C) Communication strategies between indi22 vidual schools or early childhood education pro23 grams and providers of emergency medical serv24 ices, including appropriate instructions for 

25 emergency medical response. 
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1 (D) Strategies to reduce the risk of exposure 

2 to anaphylactic causative agents in classrooms 

3 and common school or early childhood education 

4 program areas such as cafeterias. 

5 (E) The dissemination of general informa6 tion on life-threatening food allergies to school or 

7 early childhood education program staff, parents, 

8 and children. 

9 (F) Food allergy management training of 

10 school or early childhood education program per11 sonnel who regularly come into contact with chil12 dren with life-threatening food allergies. 

13 (G) The authorization and training of 

14 school or early childhood education program per15 sonnel to administer epinephrine when the nurse 

16 is not immediately available. 

17 (H) The timely accessibility of epinephrine 

18 by school or early childhood education program 

19 personnel when the nurse is not immediately 

20 available. 

21 (I) The creation of a plan contained in each 

22 individual plan for food allergy management 

23 that addresses the appropriate response to an in24 cident of anaphylaxis of a child while such child 

25 is engaged in extracurricular programs of a 
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1 school or early childhood education program, 

2 such as non-academic outings and field trips, 

3 before- and after-school programs or before- and 

4 after-early child education program programs, 

5 and school-sponsored or early childhood edu6 cation program-sponsored programs held on 

7 weekends. 

8 (J) Maintenance of information for each 

9 administration of epinephrine to a child at risk 

10 for anaphylaxis and prompt notification to par11 ents. 

12 (K) Other elements the Secretary determines 

13 necessary for the management of food allergies 

14 and anaphylaxis in schools and early childhood 

15 education programs. 

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

17 section or the guidelines developed by the Secretary 

18 under paragraph (1) shall be construed to preempt 

19 State law, including any State law regarding whether 

20 students at risk for anaphylaxis may self-administer 

21 medication. 

22 (c) SCHOOL-BASED FOOD ALLERGY MANAGEMENT

23 GRANTS.— 

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

25 grants to local educational agencies to assist such 
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1 agencies with implementing voluntary food allergy 

2 and anaphylaxis management guidelines described in 

3 subsection (b). 

4 (2) APPLICATION.— 

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

6 a grant under this subsection, a local edu7 cational agency shall submit an application to 

8 the Secretary at such time, in such manner, and 

9 including such information as the Secretary may 

10 reasonably require. 

11 (B) CONTENTS.—Each application sub12 mitted under subparagraph (A) shall include— 

13 (i) an assurance that the local edu14 cational agency has developed plans in ac15 cordance with the food allergy and anaphy16 laxis management guidelines described in 

17 subsection (b); 

18 (ii) a description of the activities to be 

19 funded by the grant in carrying out the 

20 food allergy and anaphylaxis management 

21 guidelines, including— 

22 (I) how the guidelines will be car23 ried out at individual schools served by 

24 the local educational agency; 
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1 (II) how the local educational 

2 agency will inform parents and stu3 dents of the guidelines in place; 

4 (III) how school nurses, teachers, 

5 administrators, and other school-based 

6 staff will be made aware of, and given 

7 training on, when applicable, the 

8 guidelines in place; and 

9 (IV) any other activities that the 

10 Secretary determines appropriate; 

11 (iii) an itemization of how grant funds 

12 received under this subsection will be ex13 pended; 

14 (iv) a description of how adoption of 

15 the guidelines and implementation of grant 

16 activities will be monitored; and 

17 (v) an agreement by the local edu18 cational agency to report information re19 quired by the Secretary to conduct evalua20 tions under this subsection. 

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

22 agency that receives a grant under this subsection 

23 may use the grant funds for the following: 

24 (A) Purchase of materials and supplies, in25 cluding limited medical supplies such as epi-
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1 nephrine and disposable wet wipes, to support 

2 carrying out the food allergy and anaphylaxis 

3 management guidelines described in subsection 

4 (b). 

5 (B) In partnership with local health depart6 ments, school nurse, teacher, and personnel 

7 training for food allergy management. 

8 (C) Programs that educate students as to 

9 the presence of, and policies and procedures in 

10 place related to, food allergies and anaphylactic 

11 shock. 

12 (D) Outreach to parents. 

13 (E) Any other activities consistent with the 

14 guidelines described in subsection (b). 

15 (4) DURATION OF AWARDS.—The Secretary may 

16 award grants under this subsection for a period of not 

17 more than 2 years. In the event the Secretary con18 ducts a program evaluation under this subsection, 

19 funding in the second year of the grant, where appli20 cable, shall be contingent on a successful program 

21 evaluation by the Secretary after the first year. 

22 (5) LIMITATION ON GRANT FUNDING.—The Sec23 retary may not provide grant funding to a local edu24 cational agency under this subsection after such local 
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1 educational agency has received 2 years of grant 

2 funding under this subsection. 

3 (6) MAXIMUM AMOUNT OF ANNUAL AWARDS.—A 

4 grant awarded under this subsection may not be 

5 made in an amount that is more than $50,000 annu6 ally. 

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

8 subsection, the Secretary shall give priority to local 

9 educational agencies with the highest percentages of 

10 children who are counted under section 1124(c) of the 

11 Elementary and Secondary Education Act of 1965 

12 (20 U.S.C. 6333(c)). 

13 (8) MATCHING FUNDS.— 

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

15 award a grant under this subsection unless the 

16 local educational agency agrees that, with respect 

17 to the costs to be incurred by such local edu18 cational agency in carrying out the grant activi19 ties, the local educational agency shall make 

20 available (directly or through donations from 

21 public or private entities) non-Federal funds to22 ward such costs in an amount equal to not less 

23 than 25 percent of the amount of the grant. 

24 (B) DETERMINATION OF AMOUNT OF NON25 FEDERAL CONTRIBUTION.—Non-Federal funds 
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1 required under subparagraph (A) may be cash or 

2 in kind, including plant, equipment, or services. 

3 Amounts provided by the Federal Government, 

4 and any portion of any service subsidized by the 

5 Federal Government, may not be included in de6 termining the amount of such non-Federal funds. 

7 (9) ADMINISTRATIVE FUNDS.—A local edu8 cational agency that receives a grant under this sub9 section may use not more than 2 percent of the grant 

10 amount for administrative costs related to carrying 

11 out this subsection. 

12 (10) PROGRESS AND EVALUATIONS.—At the com13 pletion of the grant period referred to in paragraph 

14 (4), a local educational agency shall provide the Sec15 retary with information on how grant funds were 

16 spent and the status of implementation of the food al17 lergy and anaphylaxis management guidelines de18 scribed in subsection (b). 

19 (11) SUPPLEMENT, NOT SUPPLANT.—Grant 

20 funds received under this subsection shall be used to 

21 supplement, and not supplant, non-Federal funds and 

22 any other Federal funds available to carry out the ac23 tivities described in this subsection. 

24 (12) AUTHORIZATION OF APPROPRIATIONS.— 

25 There is authorized to be appropriated to carry out 
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1 this subsection $30,000,000 for fiscal year 2011 and 

2 such sums as may be necessary for each of the 4 suc3 ceeding fiscal years. 

4 (d) VOLUNTARY NATURE OF GUIDELINES.— 

5 (1) IN GENERAL.—The food allergy and anaphy6 laxis management guidelines developed by the Sec7 retary under subsection (b) are voluntary. Nothing in 

8 this section or the guidelines developed by the Sec9 retary under subsection (b) shall be construed to re10 quire a local educational agency to implement such 

11 guidelines. 

12 (2) EXCEPTION.—Notwithstanding paragraph 

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

14 local educational agency to implement food allergy 

15 and anaphylaxis management guidelines as a condi16 tion of the receipt of a grant under subsection (c). 

17 SEC. 113. NEW DIETARY INGREDIENTS. 

18 (a) IN GENERAL.—Section 413 of the Federal Food, 

19 Drug, and Cosmetic Act (21 U.S.C. 350b) is amended— 

20 (1) by redesignating subsection (c) as subsection 

21 (d); and 

22 (2) by inserting after subsection (b) the fol23 lowing: 

24 ‘‘(c) NOTIFICATION.— 
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1 ‘‘(1) IN GENERAL.—If the Secretary determines 

2 that the information in a new dietary ingredient no3 tification submitted under this section for an article 

4 purported to be a new dietary ingredient is inad5 equate to establish that a dietary supplement con6 taining such article will reasonably be expected to be 

7 safe because the article may be, or may contain, an 

8 anabolic steroid or an analogue of an anabolic ster9 oid, the Secretary shall notify the Drug Enforcement 

10 Administration of such determination. Such notifica11 tion by the Secretary shall include, at a minimum, 

12 the name of the dietary supplement or article, the 

13 name of the person or persons who marketed the prod14 uct or made the submission of information regarding 

15 the article to the Secretary under this section, and 

16 any contact information for such person or persons 

17 that the Secretary has. 

18 ‘‘(2) DEFINITIONS.—For purposes of this sub19 section— 

20 ‘‘(A) the term ‘anabolic steroid’ has the 

21 meaning given such term in section 102(41) of 

22 the Controlled Substances Act; and 

23 ‘‘(B) the term ‘analogue of an anabolic ster24 oid’ means a substance whose chemical structure 
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1 is substantially similar to the chemical structure 

2 of an anabolic steroid.’’. 

3 (b) GUIDANCE.—Not later than 180 days after the date 

4 of enactment of this Act, the Secretary shall publish guid5 ance that clarifies when a dietary supplement ingredient 

6 is a new dietary ingredient, when the manufacturer or dis7 tributor of a dietary ingredient or dietary supplement 

8 should provide the Secretary with information as described 

9 in section 413(a)(2) of the Federal Food, Drug, and Cos10 metic Act, the evidence needed to document the safety of new 

11 dietary ingredients, and appropriate methods for estab12 lishing the identify of a new dietary ingredient. 

13 SEC. 114. REQUIREMENT FOR GUIDANCE RELATING TO 

14 POST HARVEST PROCESSING OF RAW OYS15 TERS. 

16 (a) IN GENERAL.—Not later than 90 days prior to the 

17 issuance of any guidance, regulation, or suggested amend18 ment by the Food and Drug Administration to the National 

19 Shellfish Sanitation Program’s Model Ordinance, or the 

20 issuance of any guidance or regulation by the Food and 

21 Drug Administration relating to the Seafood Hazard Anal22 ysis Critical Control Points Program of the Food and Drug 

23 Administration (parts 123 and 1240 of title 21, Code of 

24 Federal Regulations (or any successor regulations), where 

25 such guidance, regulation or suggested amendment relates 
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1 to post harvest processing for raw oysters, the Secretary 

2 shall prepare and submit to the Committee on Health, Edu3 cation, Labor, and Pensions of the Senate and the Com4 mittee on Energy and Commerce of the House of Represent5 atives a report which shall include— 

6 (1) an assessment of how post harvest processing 

7 or other equivalent controls feasibly may be imple8 mented in the fastest, safest, and most economical 

9 manner; 

10 (2) the projected public health benefits of any 

11 proposed post harvest processing; 

12 (3) the projected costs of compliance with such 

13 post harvest processing measures; 

14 (4) the impact post harvest processing is expected 

15 to have on the sales, cost, and availability of raw oys16 ters; 

17 (5) criteria for ensuring post harvest processing 

18 standards will be applied equally to shellfish imported 

19 from all nations of origin; 

20 (6) an evaluation of alternative measures to pre21 vent, eliminate, or reduce to an acceptable level the 

22 occurrence of foodborne illness; and 

23 (7) the extent to which the Food and Drug Ad24 ministration has consulted with the States and other 
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1 regulatory agencies, as appropriate, with regard to 

2 post harvest processing measures. 

3 (b) LIMITATION.—Subsection (a) shall not apply to the 

4 guidance described in section 103(h). 

5 (c) REVIEW AND EVALUATION.—Not later than 30 

6 days after the Secretary issues a proposed regulation or 

7 guidance described in subsection (a), the Comptroller Gen8 eral of the United States shall— 

9 (1) review and evaluate the report described in 

10 (a) and report to Congress on the findings of the esti11 mates and analysis in the report; 

12 (2) compare such proposed regulation or guid13 ance to similar regulations or guidance with respect 

14 to other regulated foods, including a comparison of 

15 risks the Secretary may find associated with seafood 

16 and the instances of those risks in such other regu17 lated foods; and 

18 (3) evaluate the impact of post harvest proc19 essing on the competitiveness of the domestic oyster 

20 industry in the United States and in international 

21 markets. 

22 (d) WAIVER.—The requirement of preparing a report 

23 under subsection (a) shall be waived if the Secretary issues 

24 a guidance that is adopted as a consensus agreement be25 tween Federal and State regulators and the oyster industry, 
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1 acting through the Interstate Shellfish Sanitation Con2 ference. 

3 (e) PUBLIC ACCESS.—Any report prepared under this 

4 section shall be made available to the public. 

5 SEC. 115. PORT SHOPPING. 

6 Until the date on which the Secretary promulgates a 

7 final rule that implements the amendments made by section 

8 308 of the Public Health Security and Bioterrorism Pre9 paredness and Response Act of 2002, (Public Law 107– 

10 188), the Secretary shall notify the Secretary of Homeland 

11 Security of all instances in which the Secretary refuses to 

12 admit a food into the United States under section 801(a) 

13 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

14 381(a)) so that the Secretary of Homeland Security, acting 

15 through the Commissioner of Customs and Border Protec16 tion, may prevent food refused admittance into the United 

17 States by a United States port of entry from being admitted 

18 by another United States port of entry, through the notifica19 tion of other such United States ports of entry. 

20 SEC. 116. ALCOHOL-RELATED FACILITIES. 

21 (a) IN GENERAL.—Except as provided by sections 102, 

22 206, 207, 302, 304, 402, 403, and 404 of this Act, and the 

23 amendments made by such sections, nothing in this Act, 

24 or the amendments made by this Act, shall be construed 

25 to apply to a facility that— 
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1 (1) under the Federal Alcohol Administration 

2 Act (27 U.S.C. 201 et seq.) or chapter 51 of subtitle 

3 E of the Internal Revenue Code of 1986 (26 U.S.C. 

4 5001 et seq.) is required to obtain a permit or to reg5 ister with the Secretary of the Treasury as a condi6 tion of doing business in the United States; and 

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

8 and Cosmetic Act (21 U.S.C. 350d) is required to reg9 ister as a facility because such facility is engaged in 

10 manufacturing, processing, packing, or holding 1 or 

11 more alcoholic beverages, with respect to the activities 

12 of such facility that relate to the manufacturing, 

13 processing, packing, or holding of alcoholic beverages. 

14 (b) LIMITED RECEIPT AND DISTRIBUTION OF NON-AL15 COHOL FOOD.—Subsection (a) shall not apply to a facility 

16 engaged in the receipt and distribution of any non-alcohol 

17 food, except that such paragraph shall apply to a facility 

18 described in such paragraph that receives and distributes 

19 non-alcohol food, provided such food is received and distrib20 uted— 

21 (1) in a prepackaged form that prevents any di22 rect human contact with such food; and 

23 (2) in amounts that constitute not more than 5 

24 percent of the overall sales of such facility, as deter25 mined by the Secretary of the Treasury. 
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1 (c) RULE OF CONSTRUCTION.—Except as provided in 

2 subsections (a) and (b), this section shall not be construed 

3 to exempt any food, other than alcoholic beverages, as de4 fined in section 214 of the Federal Alcohol Administration 

5 Act (27 U.S.C. 214), from the requirements of this Act (in6 cluding the amendments made by this Act). 

7 TITLE II—IMPROVING CAPACITY 

8 TO DETECT AND RESPOND TO 

9 FOOD SAFETY PROBLEMS 

10 SEC. 201. TARGETING OF INSPECTION RESOURCES FOR DO11 MESTIC FACILITIES, FOREIGN FACILITIES, 

12 AND PORTS OF ENTRY; ANNUAL REPORT. 

13 (a) TARGETING OF INSPECTION RESOURCES FOR DO14 MESTIC FACILITIES, FOREIGN FACILITIES, AND PORTS OF

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

16 by section 106, is amended by adding at the end the fol17 lowing: 

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

19 DOMESTIC FACILITIES, FOREIGN FACILITIES, 

20 AND PORTS OF ENTRY; ANNUAL REPORT. 

21 ‘‘(a) IDENTIFICATION AND INSPECTION OF FACILI22 TIES.— 

23 ‘‘(1) IDENTIFICATION.—The Secretary shall iden24 tify high-risk facilities and shall allocate resources to 

25 inspect facilities according to the known safety risks 
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1 of the facilities, which shall be based on the following 

2 factors: 

3 ‘‘(A) The known safety risks of the food 

4 manufactured, processed, packed, or held at the 

5 facility. 

6 ‘‘(B) The compliance history of a facility, 

7 including with regard to food recalls, outbreaks 

8 of foodborne illness, and violations of food safety 

9 standards. 

10 ‘‘(C) The rigor and effectiveness of the fa11 cility’s hazard analysis and risk-based preven12 tive controls. 

13 ‘‘(D) Whether the food manufactured, proc14 essed, packed, or held at the facility meets the 

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

16 ‘‘(E) Whether the food or the facility that 

17 manufactured, processed, packed, or held such 

18 food has received a certification as described in 

19 section 801(q) or 806, as appropriate. 

20 ‘‘(F) Any other criteria deemed necessary 

21 and appropriate by the Secretary for purposes of 

22 allocating inspection resources. 

23 ‘‘(2) INSPECTIONS.— 

24 ‘‘(A) IN GENERAL.—Beginning on the date 

25 of enactment of the FDA Food Safety Moderniza-
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1 tion Act, the Secretary shall increase the fre2 quency of inspection of all facilities. 

3 ‘‘(B) DOMESTIC HIGH-RISK FACILITIES.— 

4 The Secretary shall increase the frequency of in5 spection of domestic facilities identified under 

6 paragraph (1) as high-risk facilities such that 

7 each such facility is inspected— 

8 ‘‘(i) not less often than once in the 5- 

9 year period following the date of enactment 

10 of the FDA Food Safety Modernization Act; 

11 and 

12 ‘‘(ii) not less often than once every 3 

13 years thereafter. 

14 ‘‘(C) DOMESTIC NON-HIGH-RISK FACILI15 TIES.—The Secretary shall ensure that each do16 mestic facility that is not identified under para17 graph (1) as a high-risk facility is inspected— 

18 ‘‘(i) not less often than once in the 7- 

19 year period following the date of enactment 

20 of the FDA Food Safety Modernization Act; 

21 and 

22 ‘‘(ii) not less often than once every 5 

23 years thereafter. 

24 ‘‘(D) FOREIGN FACILITIES.— 
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1 ‘‘(i) YEAR 1.—In the 1-year period fol2 lowing the date of enactment of the FDA 

3 Food Safety Modernization Act, the Sec4 retary shall inspect not fewer than 600 for5 eign facilities. 

6 ‘‘(ii) SUBSEQUENT YEARS.—In each of 

7 the 5 years following the 1-year period de8 scribed in clause (i), the Secretary shall in9 spect not fewer than twice the number of 

10 foreign facilities inspected by the Secretary 

11 during the previous year. 

12 ‘‘(E) RELIANCE ON FEDERAL, STATE, OR

13 LOCAL INSPECTIONS.—In meeting the inspection 

14 requirements under this subsection for domestic 

15 facilities, the Secretary may rely on inspections 

16 conducted by other Federal, State, or local agen17 cies under interagency agreement, contract, 

18 memoranda of understanding, or other obliga19 tion. 

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

21 ENTRY.—The Secretary, in consultation with the Secretary 

22 of Homeland Security, shall allocate resources to inspect 

23 any article of food imported into the United States accord24 ing to the known safety risks of the article of food, which 

25 shall be based on the following factors: 
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1 ‘‘(1) The known safety risks of the food imported. 

2 ‘‘(2) The known safety risks of the countries or 

3 regions of origin and countries through which such 

4 article of food is transported. 

5 ‘‘(3) The compliance history of the importer, in6 cluding with regard to food recalls, outbreaks of 

7 foodborne illness, and violations of food safety stand8 ards. 

9 ‘‘(4) The rigor and effectiveness of the activities 

10 conducted by the importer of such article of food to 

11 satisfy the requirements of the foreign supplier 

12 verification program under section 805. 

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

14 the voluntary qualified importer program under sec15 tion 806. 

16 ‘‘(6) Whether the food meets the criteria for pri17 ority under section 801(h)(1). 

18 ‘‘(7) Whether the food or the facility that manu19 factured, processed, packed, or held such food received 

20 a certification as described in section 801(q) or 806. 

21 ‘‘(8) Any other criteria deemed necessary and 

22 appropriate by the Secretary for purposes of allo23 cating inspection resources. 

24 ‘‘(c) INTERAGENCY AGREEMENTS WITH RESPECT TO

25 SEAFOOD.— 
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1 ‘‘(1) IN GENERAL.—The Secretary of Health and 

2 Human Services, the Secretary of Commerce, the Sec3 retary of Homeland Security, the Chairman of the 

4 Federal Trade Commission, and the heads of other 

5 appropriate agencies may enter into such agreements 

6 as may be necessary or appropriate to improve sea7 food safety. 

8 ‘‘(2) SCOPE OF AGREEMENTS.—The agreements 

9 under paragraph (1) may include— 

10 ‘‘(A) cooperative arrangements for exam11 ining and testing seafood imports that leverage 

12 the resources, capabilities, and authorities of 

13 each party to the agreement; 

14 ‘‘(B) coordination of inspections of foreign 

15 facilities to increase the percentage of imported 

16 seafood and seafood facilities inspected; 

17 ‘‘(C) standardization of data on seafood 

18 names, inspection records, and laboratory testing 

19 to improve interagency coordination; 

20 ‘‘(D) coordination to detect and investigate 

21 violations under applicable Federal law; 

22 ‘‘(E) a process, including the use or modi23 fication of existing processes, by which officers 

24 and employees of the National Oceanic and At25 mospheric Administration may be duly des-
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1 ignated by the Secretary to carry out seafood ex2 aminations and investigations under section 801 

3 of this Act or section 203 of the Food Allergen 

4 Labeling and Consumer Protection Act of 2004; 

5 ‘‘(F) the sharing of information concerning 

6 observed non-compliance with United States food 

7 requirements domestically and in foreign nations 

8 and new regulatory decisions and policies that 

9 may affect the safety of food imported into the 

10 United States; 

11 ‘‘(G) conducting joint training on subjects 

12 that affect and strengthen seafood inspection ef13 fectiveness by Federal authorities; and 

14 ‘‘(H) outreach on Federal efforts to enhance 

15 seafood safety and compliance with Federal food 

16 safety requirements. 

17 ‘‘(d) COORDINATION.—The Secretary shall improve co18 ordination and cooperation with the Secretary of Agri19 culture and the Secretary of Homeland Security to target 

20 food inspection resources. 

21 ‘‘(e) FACILITY.—For purposes of this section, the term 

22 ‘facility’ means a domestic facility or a foreign facility that 

23 is required to register under section 415.’’. 

24 (b) ANNUAL REPORT.—Section 1003 (21 U.S.C. 393) 

25 is amended by adding at the end the following: 
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1 ‘‘(h) ANNUAL REPORT REGARDING FOOD.—Not later 

2 than February 1 of each year, the Secretary shall submit 

3 to Congress a report, including efforts to coordinate and 

4 cooperate with other Federal agencies with responsibilities 

5 for food inspections, 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 pursu17 ant to section 415 that the Secretary inspected in 

18 the previous fiscal year; 

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

20 the number of foreign facilities registered pursu21 ant to section 415 that were scheduled for inspec22 tion in the previous fiscal year and which the 

23 Secretary did not inspect in such year; 
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1 ‘‘(E) the number of high-risk facilities iden2 tified pursuant to section 421 that the Secretary 

3 inspected in the previous fiscal year; and 

4 ‘‘(F) the number of high-risk facilities iden5 tified pursuant to section 421 that were sched6 uled for inspection in the previous fiscal year 

7 and which the Secretary did not inspect in such 

8 year. 

9 ‘‘(2) information about food imports including— 

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

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

13 year; 

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

15 into the United States that the Secretary did not 

16 physically inspect or sample in the previous fis17 cal year; and 

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

20 that is imported or offered for import into the 

21 United States; and 

22 ‘‘(3) information on the foreign offices of the 

23 Food and Drug Administration including— 

24 ‘‘(A) the number of foreign offices estab25 lished; and 
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1 ‘‘(B) the number of personnel permanently 

2 stationed in each foreign office. 

3 ‘‘(i) PUBLIC AVAILABILITY OF ANNUAL FOOD RE4 PORTS.—The Secretary shall make the reports required 

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

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

7 (c) ADVISORY COMMITTEE CONSULTATION.—In allo8 cating inspection resources as described in section 421 of 

9 the Federal Food, Drug, and Cosmetic Act (as added by 

10 subsection (a)), the Secretary may, as appropriate, consult 

11 with any relevant advisory committee within the Depart12 ment of Health and Human Services. 

13 SEC. 202. LABORATORY ACCREDITATION FOR ANALYSES OF 

14 FOODS. 

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

16 as amended by section 201, is amended by adding at the 

17 end the following: 

18 ‘‘SEC. 422. LABORATORY ACCREDITATION FOR ANALYSES 

19 OF FOODS. 

20 ‘‘(a) RECOGNITION OF LABORATORY ACCREDITA21 TION.— 

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

23 the date of enactment of the FDA Food Safety Mod24 ernization Act, the Secretary shall— 
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1 ‘‘(A) establish a program for the testing of 

2 food by accredited laboratories; 

3 ‘‘(B) establish a publicly available registry 

4 of accreditation bodies recognized by the Sec5 retary and laboratories accredited by a recog6 nized accreditation body, including the name of, 

7 contact information for, and other information 

8 deemed appropriate by the Secretary about such 

9 bodies and laboratories; and 

10 ‘‘(C) require, as a condition of recognition 

11 or accreditation, as appropriate, that recognized 

12 accreditation bodies and accredited laboratories 

13 report to the Secretary any changes that would 

14 affect the recognition of such accreditation body 

15 or the accreditation of such laboratory. 

16 ‘‘(2) PROGRAM REQUIREMENTS.—The program 

17 established under paragraph (1)(A) shall provide for 

18 the recognition of laboratory accreditation bodies that 

19 meet criteria established by the Secretary for accredi20 tation of laboratories, including independent private 

21 laboratories and laboratories run and operated by a 

22 Federal agency (including the Department of Com23 merce), State, or locality with a demonstrated capa24 bility to conduct 1 or more sampling and analytical 

25 testing methodologies for food. 
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1 ‘‘(3) INCREASING THE NUMBER OF QUALIFIED

2 LABORATORIES.—The Secretary shall work with the 

3 laboratory accreditation bodies recognized under 

4 paragraph (1), as appropriate, to increase the num5 ber of qualified laboratories that are eligible to per6 form testing under subparagraph (b) beyond the num7 ber so qualified on the date of enactment of the FDA 

8 Food Safety Modernization Act. 

9 ‘‘(4) LIMITED DISTRIBUTION.—In the interest of 

10 national security, the Secretary, in coordination with 

11 the Secretary of Homeland Security, may determine 

12 the time, manner, and form in which the registry es13 tablished under paragraph (1)(B) is made publicly 

14 available. 

15 ‘‘(5) FOREIGN LABORATORIES.—Accreditation 

16 bodies recognized by the Secretary under paragraph 

17 (1) may accredit laboratories that operate outside the 

18 United States, so long as such laboratories meet the 

19 accreditation standards applicable to domestic labora20 tories accredited under this section. 

21 ‘‘(6) MODEL LABORATORY STANDARDS.—The 

22 Secretary shall develop model standards that a lab23 oratory shall meet to be accredited by a recognized ac24 creditation body for a specified sampling or analyt25 ical testing methodology and included in the registry 
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1 provided for under paragraph (1). In developing the 

2 model standards, the Secretary shall consult existing 

3 standards for guidance. The model standards shall in4 clude— 

5 ‘‘(A) methods to ensure that— 

6 ‘‘(i) appropriate sampling, analytical 

7 procedures (including rapid analytical pro8 cedures), and commercially available tech9 niques are followed and reports of analyses 

10 are certified as true and accurate; 

11 ‘‘(ii) internal quality systems are es12 tablished and maintained; 

13 ‘‘(iii) procedures exist to evaluate and 

14 respond promptly to complaints regarding 

15 analyses and other activities for which the 

16 laboratory is accredited; and 

17 ‘‘(iv) individuals who conduct the sam18 pling and analyses are qualified by train19 ing and experience to do so; and 

20 ‘‘(B) any other criteria determined appro21 priate by the Secretary. 

22 ‘‘(7) REVIEW OF RECOGNITION.—To ensure com23 pliance with the requirements of this section, the Sec24 retary— 
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1 ‘‘(A) shall periodically, and in no case less 

2 than once every 5 years, reevaluate accreditation 

3 bodies recognized under paragraph (1) and may 

4 accompany auditors from an accreditation body 

5 to assess whether the accreditation body meets 

6 the criteria for recognition; and 

7 ‘‘(B) shall promptly revoke the recognition 

8 of any accreditation body found not to be in 

9 compliance with the requirements of this section, 

10 specifying, as appropriate, any terms and condi11 tions necessary for laboratories accredited by 

12 such body to continue to perform testing as de13 scribed in this section. 

14 ‘‘(b) TESTING PROCEDURES.— 

15 ‘‘(1) IN GENERAL.—Not later than 30 months 

16 after the date of enactment of the FDA Food Safety 

17 Modernization Act, food testing shall be conducted by 

18 Federal laboratories or non-Federal laboratories that 

19 have been accredited for the appropriate sampling or 

20 analytical testing methodology or methodologies by a 

21 recognized accreditation body on the registry estab22 lished by the Secretary under subsection (a)(1)(B) 

23 whenever such testing is conducted— 

24 ‘‘(A) by or on behalf of an owner or con25 signee— 
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1 ‘‘(i) in response to a specific testing re2 quirement under this Act or implementing 

3 regulations, when applied to address an 

4 identified or suspected food safety problem; 

5 and 

6 ‘‘(ii) as required by the Secretary, as 

7 the Secretary deems appropriate, to address 

8 an identified or suspected food safety prob9 lem; or 

10 ‘‘(B) on behalf of an owner or consignee— 

11 ‘‘(i) in support of admission of an ar12 ticle of food under section 801(a); and 

13 ‘‘(ii) under an Import Alert that re14 quires successful consecutive tests. 

15 ‘‘(2) RESULTS OF TESTING.—The results of any 

16 such testing shall be sent directly to the Food and 

17 Drug Administration, except the Secretary may by 

18 regulation exempt test results from such submission 

19 requirement if the Secretary determines that such re20 sults do not contribute to the protection of public 

21 health. Test results required to be submitted may be 

22 submitted to the Food and Drug Administration 

23 through electronic means. 

24 ‘‘(3) EXCEPTION.—The Secretary may waive re25 quirements under this subsection if— 
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1 ‘‘(A) a new methodology or methodologies 

2 have been developed and validated but a labora3 tory has not yet been accredited to perform such 

4 methodology or methodologies; and 

5 ‘‘(B) the use of such methodology or meth6 odologies are necessary to prevent, control, or 

7 mitigate a food emergency or foodborne illness 

8 outbreak. 

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

10 testing performed by a laboratory run and operated by a 

11 State or locality that is accredited by a recognized accredi12 tation body on the registry established by the Secretary 

13 under subsection (a) result in a State recalling a food, the 

14 Secretary shall review the sampling and testing results for 

15 the purpose of determining the need for a national recall 

16 or other compliance and enforcement activities. 

17 ‘‘(d) NO LIMIT ON SECRETARIAL AUTHORITY.—Noth18 ing in this section shall be construed to limit the ability 

19 of the Secretary to review and act upon information from 

20 food testing, including determining the sufficiency of such 

21 information and testing.’’. 

22 (b) FOOD EMERGENCY RESPONSE NETWORK.—The 

23 Secretary, in coordination with the Secretary of Agri24 culture, the Secretary of Homeland Security, and State, 

25 local, and tribal governments shall, not later than 180 days 
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1 after the date of enactment of this Act, and biennially there2 after, submit to the relevant committees of Congress, and 

3 make publicly available on the Internet Web site of the De4 partment of Health and Human Services, a report on the 

5 progress in implementing a national food emergency re6 sponse laboratory network that— 

7 (1) provides ongoing surveillance, rapid detec8 tion, and surge capacity for large-scale food-related 

9 emergencies, including intentional adulteration of the 

10 food supply; 

11 (2) coordinates the food laboratory capacities of 

12 State, local, and tribal food laboratories, including 

13 the adoption of novel surveillance and identification 

14 technologies and the sharing of data between Federal 

15 agencies and State laboratories to develop national 

16 situational awareness; 

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

18 consistent food laboratory services throughout the 

19 United States; 

20 (4) develops and implements a methods reposi21 tory for use by Federal, State, and local officials; 

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

23 (6) is integrated with relevant laboratory net24 works administered by other Federal agencies. 
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1 SEC. 203. INTEGRATED CONSORTIUM OF LABORATORY NET2 WORKS. 

3 (a) IN GENERAL.—The Secretary of Homeland Secu4 rity, in coordination with the Secretary of Health and 

5 Human Services, the Secretary of Agriculture, the Secretary 

6 of Commerce, and the Administrator of the Environmental 

7 Protection Agency, shall maintain an agreement through 

8 which relevant laboratory network members, as determined 

9 by the Secretary of Homeland Security, shall— 

10 (1) agree on common laboratory methods in 

11 order to reduce the time required to detect and re12 spond to foodborne illness outbreaks and facilitate the 

13 sharing of knowledge and information relating to ani14 mal health, agriculture, and human health; 

15 (2) identify means by which laboratory network 

16 members could work cooperatively— 

17 (A) to optimize national laboratory pre18 paredness; and 

19 (B) to provide surge capacity during emer20 gencies; and 

21 (3) engage in ongoing dialogue and build rela22 tionships that will support a more effective and inte23 grated response during emergencies. 

24 (b) REPORTING REQUIREMENT.—The Secretary of 

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

26 the relevant committees of Congress, and make publicly 
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1 available on the Internet Web site of the Department of 

2 Homeland Security, a report on the progress of the inte3 grated consortium of laboratory networks, as established 

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

5 SEC. 204. ENHANCING TRACKING AND TRACING OF FOOD 

6 AND RECORDKEEPING. 

7 (a) PILOT PROJECTS.— 

8 (1) IN GENERAL.—Not later than 270 days after 

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

10 Health and Human Services (referred to in this sec11 tion as the ‘‘Secretary’’), taking into account rec12 ommendations from the Secretary of Agriculture and 

13 representatives of State departments of health and ag14 riculture, shall establish pilot projects in coordination 

15 with the food industry to explore and evaluate meth16 ods to rapidly and effectively identify recipients of 

17 food to prevent or mitigate a foodborne illness out18 break and to address credible threats of serious ad19 verse health consequences or death to humans or ani20 mals as a result of such food being adulterated under 

21 section 402 of the Federal Food, Drug, and Cosmetic 

22 Act (21 U.S.C. 342) or misbranded under section 

23 403(w) of such Act (21 U.S.C. 343(w)). 

24 (2) CONTENT.—The Secretary shall conduct 1 or 

25 more pilot projects under paragraph (1) in coordina-
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1 tion with the processed food sector and 1 or more such 

2 pilot projects in coordination with processors or dis3 tributors of fruits and vegetables that are raw agricul4 tural commodities. The Secretary shall ensure that the 

5 pilot projects under paragraph (1) reflect the diver6 sity of the food supply and include at least 3 different 

7 types of foods that have been the subject of significant 

8 outbreaks during the 5-year period preceding the date 

9 of enactment of this Act, and are selected in order 

10 to— 

11 (A) develop and demonstrate methods for 

12 rapid and effective tracking and tracing of foods 

13 in a manner that is practicable for facilities of 

14 varying sizes, including small businesses; 

15 (B) develop and demonstrate appropriate 

16 technologies, including technologies existing on 

17 the date of enactment of this Act, that enhance 

18 the tracking and tracing of food; and 

19 (C) inform the promulgation of regulations 

20 under subsection (d). 

21 (3) REPORT.—Not later than 18 months after the 

22 date of enactment of this Act, the Secretary shall re23 port to Congress on the findings of the pilot projects 

24 under this subsection together with recommendations 

25 for improving the tracking and tracing of food. 
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1 (b) ADDITIONAL DATA GATHERING.— 

2 (1) IN GENERAL.—The Secretary, in coordina3 tion with the Secretary of Agriculture and multiple 

4 representatives of State departments of health and ag5 riculture, shall assess— 

6 (A) the costs and benefits associated with 

7 the adoption and use of several product tracing 

8 technologies, including technologies used in the 

9 pilot projects under subsection (a); 

10 (B) the feasibility of such technologies for 

11 different sectors of the food industry, including 

12 small businesses; and 

13 (C) whether such technologies are compat14 ible with the requirements of this subsection. 

15 (2) REQUIREMENTS.—To the extent practicable, 

16 in carrying out paragraph (1), the Secretary shall— 

17 (A) evaluate domestic and international 

18 product tracing practices in commercial use; 

19 (B) consider international efforts, including 

20 an assessment of whether product tracing re21 quirements developed under this section are com22 patible with global tracing systems, as appro23 priate; and 

24 (C) consult with a diverse and broad range 

25 of experts and stakeholders, including representa-
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1 tives of the food industry, agricultural producers, 

2 and nongovernmental organizations that rep3 resent the interests of consumers. 

4 (c) PRODUCT TRACING SYSTEM.—The Secretary, in 

5 consultation with the Secretary of Agriculture, shall, as ap6 propriate, establish within the Food and Drug Administra7 tion a product tracing system to receive information that 

8 improves the capacity of the Secretary to effectively and 

9 rapidly track and trace food that is in the United States 

10 or offered for import into the United States. Prior to the 

11 establishment of such product tracing system, the Secretary 

12 shall examine the results of applicable pilot projects and 

13 shall ensure that the activities of such system are adequately 

14 supported by the results of such pilot projects. 

15 (d) ADDITIONAL RECORDKEEPING REQUIREMENTS

16 FOR HIGH RISK FOODS.— 

17 (1) IN GENERAL.—In order to rapidly and effec18 tively identify recipients of a food to prevent or miti19 gate a foodborne illness outbreak and to address cred20 ible threats of serious adverse health consequences or 

21 death to humans or animals as a result of such food 

22 being adulterated under section 402 of the Federal 

23 Food, Drug, and Cosmetic Act or misbranded under 

24 section 403(w) of such Act, not later than 2 years 

25 after the date of enactment of this Act, the Secretary 
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1 shall publish a notice of proposed rulemaking to es2 tablish recordkeeping requirements, in addition to the 

3 requirements under section 414 of the Federal Food, 

4 Drug, and Cosmetic Act (21 U.S.C. 350c) and sub5 part J of part 1 of title 21, Code of Federal Regula6 tions (or any successor regulations), for facilities that 

7 manufacture, process, pack, or hold foods that the Sec8 retary designates under paragraph (2) as high-risk 

9 foods. The Secretary shall set an appropriate effective 

10 date of such additional requirements for foods des11 ignated as high risk that takes into account the length 

12 of time necessary to comply with such requirements. 

13 Such requirements shall— 

14 (A) relate only to information that is rea15 sonably available and appropriate; 

16 (B) be science-based; 

17 (C) not prescribe specific technologies for the 

18 maintenance of records; 

19 (D) ensure that the public health benefits of 

20 imposing additional recordkeeping requirements 

21 outweigh the cost of compliance with such re22 quirements; 

23 (E) be scale-appropriate and practicable for 

24 facilities of varying sizes and capabilities with 

25 respect to costs and recordkeeping burdens, and 
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1 not require the creation and maintenance of du2 plicate records where the information is con3 tained in other company records kept in the nor4 mal course of business; 

5 (F) minimize the number of different rec6 ordkeeping requirements for facilities that handle 

7 more than 1 type of food; 

8 (G) to the extent practicable, not require a 

9 facility to change business systems to comply 

10 with such requirements; 

11 (H) allow any person subject to this sub12 section to maintain records required under this 

13 subsection at a central or reasonably accessible 

14 location provided that such records can be made 

15 available to the Secretary not later than 24 

16 hours after the Secretary requests such records; 

17 and 

18 (I) include a process by which the Secretary 

19 may issue a waiver of the requirements under 

20 this subsection if the Secretary determines that 

21 such requirements would result in an economic 

22 hardship for an individual facility or a type of 

23 facility; 

24 (J) be commensurate with the known safety 

25 risks of the designated food; 
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1 (K) take into account international trade 

2 obligations; 

3 (L) not require— 

4 (i) a full pedigree, or a record of the 

5 complete previous distribution history of the 

6 food from the point of origin of such food; 

7 (ii) records of recipients of a food be8 yond the immediate subsequent recipient of 

9 such food; or 

10 (iii) product tracking to the case level 

11 by persons subject to such requirements; and 

12 (M) include a process by which the Sec13 retary may remove a high-risk food designation 

14 developed under paragraph (2) for a food or type 

15 of food. 

16 (2) DESIGNATION OF HIGH-RISK FOODS.— 

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

18 after the date of enactment of this Act, and there19 after as the Secretary determines necessary, the 

20 Secretary shall designate high-risk foods for 

21 which the additional recordkeeping requirements 

22 described in paragraph (1) are appropriate and 

23 necessary to protect the public health. Each such 

24 designation shall be based on— 
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1 (i) the known safety risks of a par2 ticular food, including the history and se3 verity of foodborne illness outbreaks attrib4 uted to such food, taking into consideration 

5 foodborne illness data collected by the Cen6 ters for Disease Control and Prevention; 

7 (ii) the likelihood that a particular 

8 food has a high potential risk for micro9 biological or chemical contamination or 

10 would support the growth of pathogenic 

11 microorganisms due to the nature of the 

12 food or the processes used to produce such 

13 food; 

14 (iii) the point in the manufacturing 

15 process of the food where contamination is 

16 most likely to occur; 

17 (iv) the likelihood of contamination 

18 and steps taken during the manufacturing 

19 process to reduce the possibility of contami20 nation; 

21 (v) the likelihood that consuming a 

22 particular food will result in a foodborne 

23 illness due to contamination of the food; 

24 and 
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1 (vi) the likely or known severity, in2 cluding health and economic impacts, of a 

3 foodborne illness attributed to a particular 

4 food. 

5 (B) LIST OF HIGH-RISK FOODS.—At the 

6 time the Secretary promulgates the final rules 

7 under paragraph (1), the Secretary shall publish 

8 the list of the foods designated under subpara9 graph (A) as high-risk foods on the Internet 

10 website of the Food and Drug Administration. 

11 The Secretary may update the list to designate 

12 new high-risk foods and to remove foods that are 

13 no longer deemed to be high-risk foods, provided 

14 that each such update to the list is consistent 

15 with the requirements of this subsection and no16 tice of such update is published in the Federal 

17 Register. 

18 (3) PROTECTION OF SENSITIVE INFORMATION.— 

19 In promulgating regulations under this subsection, 

20 the Secretary shall take appropriate measures to en21 sure that there are effective procedures to prevent the 

22 unauthorized disclosure of any trade secret or con23 fidential information that is obtained by the Sec24 retary pursuant to this section, including periodic 
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† HR 2751 EAS 

1 risk assessment and planning to prevent unauthorized 

2 release and controls to— 

3 (A) prevent unauthorized reproduction of 

4 trade secret or confidential information; 

5 (B) prevent unauthorized access to trade se6 cret or confidential information; and 

7 (C) maintain records with respect to access 

8 by any person to trade secret or confidential in9 formation maintained by the agency. 

10 (4) PUBLIC INPUT.—During the comment period 

11 in the notice of proposed rulemaking under para12 graph (1), the Secretary shall conduct not less than 

13 3 public meetings in diverse geographical areas of the 

14 United States to provide persons in different regions 

15 an opportunity to comment. 

16 (5) RETENTION OF RECORDS.—Except as other17 wise provided in this subsection, the Secretary may 

18 require that a facility retain records under this sub19 section for not more than 2 years, taking into consid20 eration the risk of spoilage, loss of value, or loss of 

21 palatability of the applicable food when determining 

22 the appropriate timeframes. 

23 (6) LIMITATIONS.— 

24 (A) FARM TO SCHOOL PROGRAMS.—In es25 tablishing requirements under this subsection, 
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1 the Secretary shall, in consultation with the Sec2 retary of Agriculture, consider the impact of re3 quirements on farm to school or farm to institu4 tion programs of the Department of Agriculture 

5 and other farm to school and farm to institution 

6 programs outside such agency, and shall modify 

7 the requirements under this subsection, as appro8 priate, with respect to such programs so that the 

9 requirements do not place undue burdens on 

10 farm to school or farm to institution programs. 

11 (B) IDENTITY-PRESERVED LABELS WITH

12 RESPECT TO FARM SALES OF FOOD THAT IS PRO13 DUCED AND PACKAGED ON A FARM.—The re14 quirements under this subsection shall not apply 

15 to a food that is produced and packaged on a 

16 farm if— 

17 (i) the packaging of the food maintains 

18 the integrity of the product and prevents 

19 subsequent contamination or alteration of 

20 the product; and 

21 (ii) the labeling of the food includes the 

22 name, complete address (street address, 

23 town, State, country, and zip or other post24 al code), and business phone number of the 

25 farm, unless the Secretary waives the re-
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1 quirement to include a business phone num2 ber of the farm, as appropriate, in order to 

3 accommodate a religious belief of the indi4 vidual in charge of such farm. 

5 (C) FISHING VESSELS.—The requirements 

6 under this subsection with respect to a food that 

7 is produced through the use of a fishing vessel (as 

8 defined in section 3(18) of the Magnuson-Stevens 

9 Fishery Conservation and Management Act (16 

10 U.S.C. 1802(18))) shall be limited to the require11 ments under subparagraph (F) until such time 

12 as the food is sold by the owner, operator, or 

13 agent in charge of such fishing vessel. 

14 (D) COMMINGLED RAW AGRICULTURAL COM15 MODITIES.— 

16 (i) LIMITATION ON EXTENT OF TRAC17 ING.—Recordkeeping requirements under 

18 this subsection with regard to any commin19 gled raw agricultural commodity shall be 

20 limited to the requirements under subpara21 graph (F). 

22 (ii) DEFINITIONS.—For the purposes of 

23 this subparagraph— 

24 (I) the term ‘‘commingled raw ag25 ricultural commodity’’ means any 
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1 commodity that is combined or mixed 

2 after harvesting, but before processing; 

3 (II) the term ‘‘commingled raw 

4 agricultural commodity’’ shall not in5 clude types of fruits and vegetables that 

6 are raw agricultural commodities for 

7 which the Secretary has determined 

8 that standards promulgated under sec9 tion 419 of the Federal Food, Drug, 

10 and Cosmetic Act (as added by section 

11 105) would minimize the risk of seri12 ous adverse health consequences or 

13 death; and 

14 (III) the term ‘‘processing’’ means 

15 operations that alter the general state 

16 of the commodity, such as canning, 

17 cooking, freezing, dehydration, milling, 

18 grinding, pasteurization, or homogeni19 zation. 

20 (E) EXEMPTION OF OTHER FOODS.—The 

21 Secretary may, by notice in the Federal Register, 

22 modify the requirements under this subsection 

23 with respect to, or exempt a food or a type of fa24 cility from, the requirements of this subsection 

25 (other than the requirements under subpara-
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1 graph (F), if applicable) if the Secretary deter2 mines that product tracing requirements for such 

3 food (such as bulk or commingled ingredients 

4 that are intended to be processed to destroy 

5 pathogens) or type of facility is not necessary to 

6 protect the public health. 

7 (F) RECORDKEEPING REGARDING PREVIOUS

8 SOURCES AND SUBSEQUENT RECIPIENTS.—In the 

9 case of a person or food to which a limitation or 

10 exemption under subparagraph (C), (D), or (E) 

11 applies, if such person, or a person who manu12 factures, processes, packs, or holds such food, is 

13 required to register with the Secretary under sec14 tion 415 of the Federal Food, Drug, and Cos15 metic Act (21 U.S.C. 350d) with respect to the 

16 manufacturing, processing, packing, or holding 

17 of the applicable food, the Secretary shall require 

18 such person to maintain records that identify the 

19 immediate previous source of such food and the 

20 immediate subsequent recipient of such food. 

21 (G) GROCERY STORES.—With respect to a 

22 sale of a food described in subparagraph (H) to 

23 a grocery store, the Secretary shall not require 

24 such grocery store to maintain records under this 

25 subsection other than records documenting the 
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1 farm that was the source of such food. The Sec2 retary shall not require that such records be kept 

3 for more than 180 days. 

4 (H) FARM SALES TO CONSUMERS.—The 

5 Secretary shall not require a farm to maintain 

6 any distribution records under this subsection 

7 with respect to a sale of a food described in sub8 paragraph (I) (including a sale of a food that is 

9 produced and packaged on such farm), if such 

10 sale is made by the farm directly to a consumer. 

11 (I) SALE OF A FOOD.—A sale of a food de12 scribed in this subparagraph is a sale of a food 

13 in which— 

14 (i) the food is produced on a farm; and 

15 (ii) the sale is made by the owner, op16 erator, or agent in charge of such farm di17 rectly to a consumer or grocery store. 

18 (7) NO IMPACT ON NON-HIGH-RISK FOODS.—The 

19 recordkeeping requirements established under para20 graph (1) shall have no effect on foods that are not 

21 designated by the Secretary under paragraph (2) as 

22 high-risk foods. Foods described in the preceding sen23 tence shall be subject solely to the recordkeeping re24 quirements under section 414 of the Federal Food, 

25 Drug, and Cosmetic Act (21 U.S.C. 350c) and sub-
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1 part J of part 1 of title 21, Code of Federal Regula2 tions (or any successor regulations). 

3 (e) EVALUATION AND RECOMMENDATIONS.— 

4 (1) REPORT.—Not later than 1 year after the ef5 fective date of the final rule promulgated under sub6 section (d)(1), the Comptroller General of the United 

7 States shall submit to Congress a report, taking into 

8 consideration the costs of compliance and other regu9 latory burdens on small businesses and Federal, 

10 State, and local food safety practices and require11 ments, that evaluates the public health benefits and 

12 risks, if any, of limiting— 

13 (A) the product tracing requirements under 

14 subsection (d) to foods identified under para15 graph (2) of such subsection, including whether 

16 such requirements provide adequate assurance of 

17 traceability in the event of intentional adultera18 tion, including by acts of terrorism; and 

19 (B) the participation of restaurants in the 

20 recordkeeping requirements. 

21 (2) DETERMINATION AND RECOMMENDATIONS.— 

22 In conducting the evaluation and report under para23 graph (1), if the Comptroller General of the United 

24 States determines that the limitations described in 

25 such paragraph do not adequately protect the public 
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1 health, the Comptroller General shall submit to Con2 gress recommendations, if appropriate, regarding rec3 ordkeeping requirements for restaurants and addi4 tional foods, in order to protect the public health. 

5 (f) FARMS.— 

6 (1) REQUEST FOR INFORMATION.—Notwith7 standing subsection (d), during an active investiga8 tion of a foodborne illness outbreak, or if the Sec9 retary determines it is necessary to protect the public 

10 health and prevent or mitigate a foodborne illness 

11 outbreak, the Secretary, in consultation and coordina12 tion with State and local agencies responsible for food 

13 safety, as appropriate, may request that the owner, 

14 operator, or agent of a farm identify potential imme15 diate recipients, other than consumers, of an article 

16 of the food that is the subject of such investigation if 

17 the Secretary reasonably believes such article of 

18 food— 

19 (A) is adulterated under section 402 of the 

20 Federal Food, Drug, and Cosmetic Act; 

21 (B) presents a threat of serious adverse 

22 health consequences or death to humans or ani23 mals; and 

24 (C) was adulterated as described in sub25 paragraph (A) on a particular farm (as defined 
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1 in section 1.227 of chapter 21, Code of Federal 

2 Regulations (or any successor regulation)). 

3 (2) MANNER OF REQUEST.—In making a request 

4 under paragraph (1), the Secretary, in consultation 

5 and coordination with State and local agencies re6 sponsible for food safety, as appropriate, shall issue a 

7 written notice to the owner, operator, or agent of the 

8 farm to which the article of food has been traced. The 

9 individual providing such notice shall present to such 

10 owner, operator, or agent appropriate credentials and 

11 shall deliver such notice at reasonable times and with12 in reasonable limits and in a reasonable manner. 

13 (3) DELIVERY OF INFORMATION REQUESTED.— 

14 The owner, operator, or agent of a farm shall deliver 

15 the information requested under paragraph (1) in a 

16 prompt and reasonable manner. Such information 

17 may consist of records kept in the normal course of 

18 business, and may be in electronic or non-electronic 

19 format. 

20 (4) LIMITATION.—A request made under para21 graph (1) shall not include a request for information 

22 relating to the finances, pricing of commodities pro23 duced, personnel, research, sales (other than informa24 tion relating to shipping), or other disclosures that 

25 may reveal trade secrets or confidential information 
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1 from the farm to which the article of food has been 

2 traced, other than information necessary to identify 

3 potential immediate recipients of such food. Section 

4 301(j) of the Federal Food, Drug, and Cosmetic Act 

5 and the Freedom of Information Act shall apply with 

6 respect to any confidential commercial information 

7 that is disclosed to the Food and Drug Administra8 tion in the course of responding to a request under 

9 paragraph (1). 

10 (5) RECORDS.—Except with respect to identi11 fying potential immediate recipients in response to a 

12 request under this subsection, nothing in this sub13 section shall require the establishment or maintenance 

14 by farms of new records. 

15 (g) NO LIMITATION ON COMMINGLING OF FOOD.— 

16 Nothing in this section shall be construed to authorize the 

17 Secretary to impose any limitation on the commingling of 

18 food. 

19 (h) SMALL ENTITY COMPLIANCE GUIDE.—Not later 

20 than 180 days after promulgation of a final rule under sub21 section (d), the Secretary shall issue a small entity compli22 ance guide setting forth in plain language the requirements 

23 of the regulations under such subsection in order to assist 

24 small entities, including farms and small businesses, in 
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1 complying with the recordkeeping requirements under such 

2 subsection. 

3 (i) FLEXIBILITY FOR SMALL BUSINESSES.—Notwith4 standing any other provision of law, the regulations pro5 mulgated under subsection (d) shall apply— 

6 (1) to small businesses (as defined by the Sec7 retary in section 103, not later than 90 days after the 

8 date of enactment of this Act) beginning on the date 

9 that is 1 year after the effective date of the final regu10 lations promulgated under subsection (d); and 

11 (2) to very small businesses (as defined by the 

12 Secretary in section 103, not later than 90 days after 

13 the date of enactment of this Act) beginning on the 

14 date that is 2 years after the effective date of the final 

15 regulations promulgated under subsection (d). 

16 (j) ENFORCEMENT.— 

17 (1) PROHIBITED ACTS.—Section 301(e) (21 

18 U.S.C. 331(e)) is amended by inserting ‘‘; or the vio19 lation of any recordkeeping requirement under section 

20 204 of the FDA Food Safety Modernization Act (ex21 cept when such violation is committed by a farm)’’ 

22 before the period at the end. 

23 (2) IMPORTS.—Section 801(a) (21 U.S.C. 

24 381(a)) is amended by inserting ‘‘or (4) the record25 keeping requirements under section 204 of the FDA 
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1 Food Safety Modernization Act (other than the re2 quirements under subsection (f) of such section) have 

3 not been complied with regarding such article,’’ in the 

4 third sentence before ‘‘then such article shall be re5 fused admission’’. 

6 SEC. 205. SURVEILLANCE. 

7 (a) DEFINITION OF FOODBORNE ILLNESS OUT8 BREAK.—In this Act, the term ‘‘foodborne illness outbreak’’ 

9 means the occurrence of 2 or more cases of a similar illness 

10 resulting from the ingestion of a certain food. 

11 (b) FOODBORNE ILLNESS SURVEILLANCE SYSTEMS.— 

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

13 the Director of the Centers for Disease Control and 

14 Prevention, shall enhance foodborne illness surveil15 lance systems to improve the collection, analysis, re16 porting, and usefulness of data on foodborne illnesses 

17 by— 

18 (A) coordinating Federal, State and local 

19 foodborne illness surveillance systems, including 

20 complaint systems, and increasing participation 

21 in national networks of public health and food 

22 regulatory agencies and laboratories; 

23 (B) facilitating sharing of surveillance in24 formation on a more timely basis among govern25 mental agencies, including the Food and Drug 
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1 Administration, the Department of Agriculture, 

2 the Department of Homeland Security, and 

3 State and local agencies, and with the public; 

4 (C) developing improved epidemiological 

5 tools for obtaining quality exposure data and 

6 microbiological methods for classifying cases; 

7 (D) augmenting such systems to improve at8 tribution of a foodborne illness outbreak to a spe9 cific food; 

10 (E) expanding capacity of such systems, in11 cluding working toward automatic electronic 

12 searches, for implementation of identification 

13 practices, including fingerprinting strategies, for 

14 foodborne infectious agents, in order to identify 

15 new or rarely documented causes of foodborne ill16 ness and submit standardized information to a 

17 centralized database; 

18 (F) allowing timely public access to aggre19 gated, de-identified surveillance data; 

20 (G) at least annually, publishing current 

21 reports on findings from such systems; 

22 (H) establishing a flexible mechanism for 

23 rapidly initiating scientific research by aca24 demic institutions; 
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1 (I) integrating foodborne illness surveillance 

2 systems and data with other biosurveillance and 

3 public health situational awareness capabilities 

4 at the Federal, State, and local levels, including 

5 by sharing foodborne illness surveillance data 

6 with the National Biosurveillance Integration 

7 Center; and 

8 (J) other activities as determined appro9 priate by the Secretary. 

10 (2) WORKING GROUP.—The Secretary shall sup11 port and maintain a diverse working group of experts 

12 and stakeholders from Federal, State, and local food 

13 safety and health agencies, the food and food testing 

14 industries, consumer organizations, and academia. 

15 Such working group shall provide the Secretary, 

16 through at least annual meetings of the working 

17 group and an annual public report, advice and rec18 ommendations on an ongoing and regular basis re19 garding the improvement of foodborne illness surveil20 lance and implementation of this section, including 

21 advice and recommendations on— 

22 (A) the priority needs of regulatory agen23 cies, the food industry, and consumers for infor24 mation and analysis on foodborne illness and its 

25 causes; 
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1 (B) opportunities to improve the effective2 ness of initiatives at the Federal, State, and 

3 local levels, including coordination and integra4 tion of activities among Federal agencies, and 

5 between the Federal, State, and local levels of 

6 government; 

7 (C) improvement in the timeliness and 

8 depth of access by regulatory and health agen9 cies, the food industry, academic researchers, and 

10 consumers to foodborne illness aggregated, de11 identified surveillance data collected by govern12 ment agencies at all levels, including data com13 piled by the Centers for Disease Control and Pre14 vention; 

15 (D) key barriers at Federal, State, and local 

16 levels to improving foodborne illness surveillance 

17 and the utility of such surveillance for pre18 venting foodborne illness; 

19 (E) the capabilities needed for establishing 

20 automatic electronic searches of surveillance 

21 data; and 

22 (F) specific actions to reduce barriers to im23 provement, implement the working group’s rec24 ommendations, and achieve the purposes of this 
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1 section, with measurable objectives and timelines, 

2 and identification of resource and staffing needs. 

3 (3) AUTHORIZATION OF APPROPRIATIONS.—To 

4 carry out the activities described in paragraph (1), 

5 there is authorized to be appropriated $24,000,000 for 

6 each fiscal years 2011 through 2015. 

7 (c) IMPROVING FOOD SAFETY AND DEFENSE CAPACITY

8 AT THE STATE AND LOCAL LEVEL.— 

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

10 and implement strategies to leverage and enhance the 

11 food safety and defense capacities of State and local 

12 agencies in order to achieve the following goals: 

13 (A) Improve foodborne illness outbreak re14 sponse and containment. 

15 (B) Accelerate foodborne illness surveillance 

16 and outbreak investigation, including rapid 

17 shipment of clinical isolates from clinical labora18 tories to appropriate State laboratories, and con19 ducting more standardized illness outbreak inter20 views. 

21 (C) Strengthen the capacity of State and 

22 local agencies to carry out inspections and en23 force safety standards. 

24 (D) Improve the effectiveness of Federal, 

25 State, and local partnerships to coordinate food 
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1 safety and defense resources and reduce the inci2 dence of foodborne illness. 

3 (E) Share information on a timely basis 

4 among public health and food regulatory agen5 cies, with the food industry, with health care 

6 providers, and with the public. 

7 (F) Strengthen the capacity of State and 

8 local agencies to achieve the goals described in 

9 section 108. 

10 (2) REVIEW.—In developing of the strategies re11 quired by paragraph (1), the Secretary shall, not 

12 later than 1 year after the date of enactment of the 

13 FDA Food Safety Modernization Act, complete a re14 view of State and local capacities, and needs for en15 hancement, which may include a survey with respect 

16 to— 

17 (A) staffing levels and expertise available to 

18 perform food safety and defense functions; 

19 (B) laboratory capacity to support surveil20 lance, outbreak response, inspection, and enforce21 ment activities; 

22 (C) information systems to support data 

23 management and sharing of food safety and de24 fense information among State and local agen-
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1 cies and with counterparts at the Federal level; 

2 and 

3 (D) other State and local activities and 

4 needs as determined appropriate by the Sec5 retary. 

6 (d) FOOD SAFETY CAPACITY BUILDING GRANTS.—Sec7 tion 317R(b) of the Public Health Service Act (42 U.S.C. 

8 247b–20(b)) is amended— 

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

10 and 

11 (2) by striking ‘‘2003 through 2006’’ and insert12 ing ‘‘2011 through 2015’’. 

13 SEC. 206. MANDATORY RECALL AUTHORITY. 

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

15 as amended by section 202, is amended by adding at the 

16 end the following: 

17 ‘‘SEC. 423. MANDATORY RECALL AUTHORITY. 

18 ‘‘(a) VOLUNTARY PROCEDURES.—If the Secretary de19 termines, based on information gathered through the report20 able food registry under section 417 or through any other 

21 means, that there is a reasonable probability that an article 

22 of food (other than infant formula) is adulterated under sec23 tion 402 or misbranded under section 403(w) and the use 

24 of or exposure to such article will cause serious adverse 

25 health consequences or death to humans or animals, the Sec-
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1 retary shall provide the responsible party (as defined in sec2 tion 417) with an opportunity to cease distribution and re3 call such article. 

4 ‘‘(b) PREHEARING ORDER TO CEASE DISTRIBUTION

5 AND GIVE NOTICE.— 

6 ‘‘(1) IN GENERAL.—If the responsible party re7 fuses to or does not voluntarily cease distribution or 

8 recall such article within the time and in the manner 

9 prescribed by the Secretary (if so prescribed), the Sec10 retary may, by order require, as the Secretary deems 

11 necessary, such person to— 

12 ‘‘(A) immediately cease distribution of such 

13 article; and 

14 ‘‘(B) as applicable, immediately notify all 

15 persons— 

16 ‘‘(i) manufacturing, processing, pack17 ing, transporting, distributing, receiving, 

18 holding, or importing and selling such arti19 cle; and 

20 ‘‘(ii) to which such article has been 

21 distributed, transported, or sold, to imme22 diately cease distribution of such article. 

23 ‘‘(2) REQUIRED ADDITIONAL INFORMATION.— 

24 ‘‘(A) IN GENERAL.—If an article of food 

25 covered by a recall order issued under paragraph 
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1 (1)(B) has been distributed to a warehouse-based 

2 third party logistics provider without providing 

3 such provider sufficient information to know or 

4 reasonably determine the precise identity of the 

5 article of food covered by a recall order that is 

6 in its possession, the notice provided by the re7 sponsible party subject to the order issued under 

8 paragraph (1)(B) shall include such information 

9 as is necessary for the warehouse-based third 

10 party logistics provider to identify the food. 

11 ‘‘(B) RULES OF CONSTRUCTION.—Nothing 

12 in this paragraph shall be construed— 

13 ‘‘(i) to exempt a warehouse-based third 

14 party logistics provider from the require15 ments of this Act, including the require16 ments in this section and section 414; or 

17 ‘‘(ii) to exempt a warehouse-based 

18 third party logistics provider from being the 

19 subject of a mandatory recall order. 

20 ‘‘(3) DETERMINATION TO LIMIT AREAS AF21 FECTED.—If the Secretary requires a responsible 

22 party to cease distribution under paragraph (1)(A) of 

23 an article of food identified in subsection (a), the Sec24 retary may limit the size of the geographic area and 
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1 the markets affected by such cessation if such limita2 tion would not compromise the public health. 

3 ‘‘(c) HEARING ON ORDER.—The Secretary shall pro4 vide the responsible party subject to an order under sub5 section (b) with an opportunity for an informal hearing, 

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

7 after the issuance of the order, on the actions required by 

8 the order and on why the article that is the subject of the 

9 order should not be recalled. 

10 ‘‘(d) POST-HEARING RECALL ORDER AND MODIFICA11 TION OF ORDER.— 

12 ‘‘(1) AMENDMENT OF ORDER.—If, after pro13 viding opportunity for an informal hearing under 

14 subsection (c), the Secretary determines that removal 

15 of the article from commerce is necessary, the Sec16 retary shall, as appropriate— 

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

18 such article or other appropriate action; 

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

20 shall occur; 

21 ‘‘(C) require periodic reports to the Sec22 retary describing the progress of the recall; and 

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

24 such article was, or may have been, distributed. 
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1 ‘‘(2) VACATING OF ORDER.—If, after such hear2 ing, the Secretary determines that adequate grounds 

3 do not exist to continue the actions required by the 

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

5 Secretary shall vacate the order or modify the order. 

6 ‘‘(e) RULE REGARDING ALCOHOLIC BEVERAGES.—The 

7 Secretary shall not initiate a mandatory recall or take any 

8 other action under this section with respect to any alcohol 

9 beverage until the Secretary has provided the Alcohol and 

10 Tobacco Tax and Trade Bureau with a reasonable oppor11 tunity to cease distribution and recall such article under 

12 the Alcohol and Tobacco Tax and Trade Bureau authority. 

13 ‘‘(f) COOPERATION AND CONSULTATION.—The Sec14 retary shall work with State and local public health officials 

15 in carrying out this section, as appropriate. 

16 ‘‘(g) PUBLIC NOTIFICATION.—In conducting a recall 

17 under this section, the Secretary shall— 

18 ‘‘(1) ensure that a press release is published re19 garding the recall, as well as alerts and public no20 tices, as appropriate, in order to provide notifica21 tion— 

22 ‘‘(A) of the recall to consumers and retailers 

23 to whom such article was, or may have been, dis24 tributed; and 

25 ‘‘(B) that includes, at a minimum— 
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1 ‘‘(i) the name of the article of food sub2 ject to the recall; 

3 ‘‘(ii) a description of the risk associ4 ated with such article; and 

5 ‘‘(iii) to the extent practicable, infor6 mation for consumers about similar articles 

7 of food that are not affected by the recall; 

8 ‘‘(2) consult the policies of the Department of Ag9 riculture regarding providing to the public a list of 

10 retail consignees receiving products involved in a 

11 Class I recall and shall consider providing such a list 

12 to the public, as determined appropriate by the Sec13 retary; and 

14 ‘‘(3) if available, publish on the Internet Web 

15 site of the Food and Drug Administration an image 

16 of the article that is the subject of the press release de17 scribed in (1). 

18 ‘‘(h) NO DELEGATION.—The authority conferred by 

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

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

21 Commissioner. 

22 ‘‘(i) EFFECT.—Nothing in this section shall affect the 

23 authority of the Secretary to request or participate in a 

24 voluntary recall, or to issue an order to cease distribution 
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1 or to recall under any other provision of this Act or under 

2 the Public Health Service Act. 

3 ‘‘(j) COORDINATED COMMUNICATION.— 

4 ‘‘(1) IN GENERAL.—To assist in carrying out the 

5 requirements of this subsection, the Secretary shall es6 tablish an incident command operation or a similar 

7 operation within the Department of Health and 

8 Human Services that will operate not later than 24 

9 hours after the initiation of a mandatory recall or the 

10 recall of an article of food for which the use of, or ex11 posure to, such article will cause serious adverse 

12 health consequences or death to humans or animals. 

13 ‘‘(2) REQUIREMENTS.—To reduce the potential 

14 for miscommunication during recalls or regarding in15 vestigations of a food borne illness outbreak associated 

16 with a food that is subject to a recall, each incident 

17 command operation or similar operation under para18 graph (1) shall use regular staff and resources of the 

19 Department of Health and Human Services to— 

20 ‘‘(A) ensure timely and coordinated commu21 nication within the Department, including en22 hanced communication and coordination between 

23 different agencies and organizations within the 

24 Department; 
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1 ‘‘(B) ensure timely and coordinated commu2 nication from the Department, including public 

3 statements, throughout the duration of the inves4 tigation and related foodborne illness outbreak; 

5 ‘‘(C) identify a single point of contact with6 in the Department for public inquiries regarding 

7 any actions by the Secretary related to a recall; 

8 ‘‘(D) coordinate with Federal, State, local, 

9 and tribal authorities, as appropriate, that have 

10 responsibilities related to the recall of a food or 

11 a foodborne illness outbreak associated with a 

12 food that is subject to the recall, including notifi13 cation of the Secretary of Agriculture and the 

14 Secretary of Education in the event such recalled 

15 food is a commodity intended for use in a child 

16 nutrition program (as identified in section 25(b) 

17 of the Richard B. Russell National School Lunch 

18 Act (42 U.S.C. 1769f(b)); and 

19 ‘‘(E) conclude operations at such time as 

20 the Secretary determines appropriate. 

21 ‘‘(3) MULTIPLE RECALLS.—The Secretary may 

22 establish multiple or concurrent incident command 

23 operations or similar operations in the event of mul24 tiple recalls or foodborne illness outbreaks necessi-
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1 tating such action by the Department of Health and 

2 Human Services.’’. 

3 (b) SEARCH ENGINE.—Not later than 90 days after 

4 the date of enactment of this Act, the Secretary shall modify 

5 the Internet Web site of the Food and Drug Administration 

6 to include a search engine that— 

7 (1) is consumer-friendly, as determined by the 

8 Secretary; and 

9 (2) provides a means by which an individual 

10 may locate relevant information regarding each arti11 cle of food subject to a recall under section 423 of the 

12 Federal Food, Drug, and Cosmetic Act and the status 

13 of such recall (such as whether a recall is ongoing or 

14 has been completed). 

15 (c) CIVIL PENALTY.—Section 303(f)(2)(A) (21 U.S.C. 

16 333(f)(2)(A)) is amended by inserting ‘‘or any person who 

17 does not comply with a recall order under section 423’’ after 

18 ‘‘section 402(a)(2)(B)’’. 

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

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

21 at the end the following: 

22 ‘‘(xx) The refusal or failure to follow an order under 

23 section 423.’’. 

24 (e) GAO REVIEW.— 
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1 (1) IN GENERAL.—Not later than 90 days after 

2 the date of enactment of this Act, the Comptroller 

3 General of the United States shall submit to Congress 

4 a report that— 

5 (A) identifies State and local agencies with 

6 the authority to require the mandatory recall of 

7 food, and evaluates use of such authority with re8 gard to frequency, effectiveness, and appropriate9 ness, including consideration of any new or ex10 isting mechanisms available to compensate per11 sons for general and specific recall-related costs 

12 when a recall is subsequently determined by the 

13 relevant authority to have been an error; 

14 (B) identifies Federal agencies, other than 

15 the Department of Health and Human Services, 

16 with mandatory recall authority and examines 

17 use of that authority with regard to frequency, 

18 effectiveness, and appropriateness, including any 

19 new or existing mechanisms available to com20 pensate persons for general and specific recall-re21 lated costs when a recall is subsequently deter22 mined by the relevant agency to have been an 

23 error; 
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1 (C) considers models for farmer restitution 

2 implemented in other nations in cases of erro3 neous recalls; and 

4 (D) makes recommendations to the Sec5 retary regarding use of the authority under sec6 tion 423 of the Federal Food, Drug, and Cos7 metic Act (as added by this section) to protect 

8 the public health while seeking to minimize un9 necessary economic costs. 

10 (2) EFFECT OF REVIEW.—If the Comptroller 

11 General of the United States finds, after the review 

12 conducted under paragraph (1), that the mechanisms 

13 described in such paragraph do not exist or are inad14 equate, then, not later than 90 days after the conclu15 sion of such review, the Secretary of Agriculture shall 

16 conduct a study of the feasibility of implementing a 

17 farmer indemnification program to provide restitu18 tion to agricultural producers for losses sustained as 

19 a result of a mandatory recall of an agricultural com20 modity by a Federal or State regulatory agency that 

21 is subsequently determined to be in error. The Sec22 retary of Agriculture shall submit to the Committee 

23 on Agriculture of the House of Representatives and 

24 the Committee on Agriculture, Nutrition, and For-
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1 estry of the Senate a report that describes the results 

2 of the study, including any recommendations. 

3 (f) ANNUAL REPORT TO CONGRESS.— 

4 (1) IN GENERAL.—Not later than 2 years after 

5 the date of enactment of this Act and annually there6 after, the Secretary of Health and Human Services 

7 (referred to in this subsection as the ‘‘Secretary’’) 

8 shall submit a report to the Committee on Health, 

9 Education, Labor, and Pensions of the Senate and the 

10 Committee on Energy and Commerce of the House of 

11 Representatives on the use of recall authority under 

12 section 423 of the Federal Food, Drug, and Cosmetic 

13 Act (as added by subsection (a)) and any public 

14 health advisories issued by the Secretary that advise 

15 against the consumption of an article of food on the 

16 ground that the article of food is adulterated and 

17 poses an imminent danger to health. 

18 (2) CONTENT.—The report under paragraph (1) 

19 shall include, with respect to the report year— 

20 (A) the identity of each article of food that 

21 was the subject of a public health advisory de22 scribed in paragraph (1), an opportunity to 

23 cease distribution and recall under subsection (a) 

24 of section 423 of the Federal Food, Drug, and 
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1 Cosmetic Act, or a mandatory recall order under 

2 subsection (b) of such section; 

3 (B) the number of responsible parties, as de4 fined in section 417 of the Federal Food, Drug, 

5 and Cosmetic Act, formally given the oppor6 tunity to cease distribution of an article of food 

7 and recall such article, as described in section 

8 423(a) of such Act; 

9 (C) the number of responsible parties de10 scribed in subparagraph (B) who did not cease 

11 distribution of or recall an article of food after 

12 given the opportunity to cease distribution or re13 call under section 423(a) of the Federal Food, 

14 Drug, and Cosmetic Act; 

15 (D) the number of recall orders issued under 

16 section 423(b) of the Federal Food, Drug, and 

17 Cosmetic Act; and 

18 (E) a description of any instances in which 

19 there was no testing that confirmed adulteration 

20 of an article of food that was the subject of a re21 call under section 423(b) of the Federal Food, 

22 Drug, and Cosmetic Act or a public health advi23 sory described in paragraph (1). 
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1 SEC. 207. ADMINISTRATIVE DETENTION OF FOOD. 

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

3 334(h)(1)(A)) is amended by— 

4 (1) striking ‘‘credible evidence or information in5 dicating’’ and inserting ‘‘reason to believe’’; and 

6 (2) striking ‘‘presents a threat of serious adverse 

7 health consequences or death to humans or animals’’ 

8 and inserting ‘‘is adulterated or misbranded’’. 

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

10 date of enactment of this Act, the Secretary shall issue an 

11 interim final rule amending subpart K of part 1 of title 

12 21, Code of Federal Regulations, to implement the amend13 ment made by this section. 

14 (c) EFFECTIVE DATE.—The amendment made by this 

15 section shall take effect 180 days after the date of enactment 

16 of this Act. 

17 SEC. 208. DECONTAMINATION AND DISPOSAL STANDARDS 

18 AND PLANS. 

19 (a) IN GENERAL.—The Administrator of the Environ20 mental Protection Agency (referred to in this section as the 

21 ‘‘Administrator’’), in coordination with the Secretary of 

22 Health and Human Services, Secretary of Homeland Secu23 rity, and Secretary of Agriculture, shall provide support 

24 for, and technical assistance to, State, local, and tribal gov25 ernments in preparing for, assessing, decontaminating, and 

26 recovering from an agriculture or food emergency. 
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1 (b) DEVELOPMENT OF STANDARDS.—In carrying out 

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

3 Secretary of Health and Human Services, Secretary of 

4 Homeland Security, Secretary of Agriculture, and State, 

5 local, and tribal governments, shall develop and disseminate 

6 specific standards and protocols to undertake clean-up, 

7 clearance, and recovery activities following the decon8 tamination and disposal of specific threat agents and for9 eign animal diseases. 

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

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

12 Health and Human Services, and the Secretary of Agri13 culture shall jointly develop and disseminate model plans 

14 for— 

15 (1) the decontamination of individuals, equip16 ment, and facilities following an intentional contami17 nation of agriculture or food; and 

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

19 plants, or food products that have been infected or 

20 contaminated by specific threat agents and foreign 

21 animal diseases. 

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

23 Administrator, in coordination with the entities described 

24 under subsection (b), shall conduct exercises at least annu25 ally to evaluate and identify weaknesses in the decon-
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1 tamination and disposal model plans described in sub2 section (c). Such exercises shall be carried out, to the max3 imum extent practicable, as part of the national exercise 

4 program under section 648(b)(1) of the Post-Katrina Emer5 gency Management Reform Act of 2006 (6 U.S.C. 

6 748(b)(1)). 

7 (e) MODIFICATIONS.—Based on the exercises described 

8 in subsection (d), the Administrator, in coordination with 

9 the entities described in subsection (b), shall review and 

10 modify as necessary the plans described in subsection (c) 

11 not less frequently than biennially. 

12 (f) PRIORITIZATION.—The Administrator, in coordi13 nation with the entities described in subsection (b), shall 

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

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

16 (1) highest-risk biological, chemical, and radio17 logical threat agents; 

18 (2) agents that could cause the greatest economic 

19 devastation to the agriculture and food system; and 

20 (3) agents that are most difficult to clean or re21 mediate. 
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1 SEC. 209. IMPROVING THE TRAINING OF STATE, LOCAL, 

2 TERRITORIAL, AND TRIBAL FOOD SAFETY OF3 FICIALS. 

4 (a) IMPROVING TRAINING.—Chapter X (21 U.S.C. 391 

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

6 ‘‘SEC. 1011. IMPROVING THE TRAINING OF STATE, LOCAL, 

7 TERRITORIAL, AND TRIBAL FOOD SAFETY OF8 FICIALS. 

9 ‘‘(a) TRAINING.—The Secretary shall set standards 

10 and administer training and education programs for the 

11 employees of State, local, territorial, and tribal food safety 

12 officials relating to the regulatory responsibilities and poli13 cies established by this Act, including programs for— 

14 ‘‘(1) scientific training; 

15 ‘‘(2) training to improve the skill of officers and 

16 employees authorized to conduct inspections under 

17 sections 702 and 704; 

18 ‘‘(3) training to achieve advanced product or 

19 process specialization in such inspections; 

20 ‘‘(4) training that addresses best practices; 

21 ‘‘(5) training in administrative process and pro22 cedure and integrity issues; 

23 ‘‘(6) training in appropriate sampling and lab24 oratory analysis methodology; and 
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1 ‘‘(7) training in building enforcement actions 

2 following inspections, examinations, testing, and in3 vestigations. 

4 ‘‘(b) PARTNERSHIPS WITH STATE AND LOCAL OFFI5 CIALS.— 

6 ‘‘(1) IN GENERAL.—The Secretary, pursuant to a 

7 contract or memorandum of understanding between 

8 the Secretary and the head of a State, local, terri9 torial, or tribal department or agency, is authorized 

10 and encouraged to conduct examinations, testing, and 

11 investigations for the purposes of determining compli12 ance with the food safety provisions of this Act 

13 through the officers and employees of such State, local, 

14 territorial, or tribal department or agency. 

15 ‘‘(2) CONTENT.—A contract or memorandum de16 scribed under paragraph (1) shall include provisions 

17 to ensure adequate training of such officers and em18 ployees to conduct such examinations, testing, and in19 vestigations. The contract or memorandum shall con20 tain provisions regarding reimbursement. Such provi21 sions may, at the sole discretion of the head of the 

22 other department or agency, require reimbursement, 

23 in whole or in part, from the Secretary for the exami24 nations, testing, or investigations performed pursuant 
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1 to this section by the officers or employees of the 

2 State, territorial, or tribal department or agency. 

3 ‘‘(3) EFFECT.—Nothing in this subsection shall 

4 be construed to limit the authority of the Secretary 

5 under section 702. 

6 ‘‘(c) EXTENSION SERVICE.—The Secretary shall ensure 

7 coordination with the extension activities of the National 

8 Institute of Food and Agriculture of the Department of Ag9 riculture in advising producers and small processors 

10 transitioning into new practices required as a result of the 

11 enactment of the FDA Food Safety Modernization Act and 

12 assisting regulated industry with compliance with such Act. 

13 ‘‘(d) NATIONAL FOOD SAFETY TRAINING, EDUCATION, 

14 EXTENSION, OUTREACH AND TECHNICAL ASSISTANCE PRO15 GRAM.— 

16 ‘‘(1) IN GENERAL.—In order to improve food 

17 safety and reduce the incidence of foodborne illness, 

18 the Secretary shall, not later than 180 days after the 

19 date of enactment of the FDA Food Safety Moderniza20 tion Act, enter into one or more memoranda of under21 standing, or enter into other cooperative agreements, 

22 with the Secretary of Agriculture to establish a com23 petitive grant program within the National Institute 

24 for Food and Agriculture to provide food safety train-
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1 ing, education, extension, outreach, and technical as2 sistance to— 

3 ‘‘(A) owners and operators of farms; 

4 ‘‘(B) small food processors; and 

5 ‘‘(C) small fruit and vegetable merchant 

6 wholesalers. 

7 ‘‘(2) IMPLEMENTATION.—The competitive grant 

8 program established under paragraph (1) shall be 

9 carried out in accordance with section 405 of the Ag10 ricultural Research, Extension, and Education Re11 form Act of 1998. 

12 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There are 

13 authorized to be appropriated such sums as may be nec14 essary to carry out this section for fiscal years 2011 through 

15 2015.’’. 

16 (b) NATIONAL FOOD SAFETY TRAINING, EDUCATION, 

17 EXTENSION, OUTREACH, AND TECHNICAL ASSISTANCE

18 PROGRAM.—Title IV of the Agricultural Research, Exten19 sion, and Education Reform Act of 1998 is amended by 

20 inserting after section 404 (7 U.S.C. 7624) the following: 

21 ‘‘SEC. 405. NATIONAL FOOD SAFETY TRAINING, EDUCATION, 

22 EXTENSION, OUTREACH, AND TECHNICAL AS23 SISTANCE PROGRAM. 

24 ‘‘(a) IN GENERAL.—The Secretary shall award grants 

25 under this section to carry out the competitive grant pro-
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1 gram established under section 1011(d) of the Federal Food, 

2 Drug, and Cosmetic Act, pursuant to any memoranda of 

3 understanding entered into under such section. 

4 ‘‘(b) INTEGRATED APPROACH.—The grant program 

5 described under subsection (a) shall be carried out under 

6 this section in a manner that facilitates the integration of 

7 food safety standards and guidance with the variety of agri8 cultural production systems, encompassing conventional, 

9 sustainable, organic, and conservation and environmental 

10 practices. 

11 ‘‘(c) PRIORITY.—In awarding grants under this sec12 tion, the Secretary shall give priority to projects that target 

13 small and medium-sized farms, beginning farmers, socially 

14 disadvantaged farmers, small processors, or small fresh 

15 fruit and vegetable merchant wholesalers. 

16 ‘‘(d) PROGRAM COORDINATION.— 

17 ‘‘(1) IN GENERAL.—The Secretary shall coordi18 nate implementation of the grant program under this 

19 section with the National Integrated Food Safety Ini20 tiative. 

21 ‘‘(2) INTERACTION.—The Secretary shall— 

22 ‘‘(A) in carrying out the grant program 

23 under this section, take into consideration ap24 plied research, education, and extension results 
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1 obtained from the National Integrated Food 

2 Safety Initiative; and 

3 ‘‘(B) in determining the applied research 

4 agenda for the National Integrated Food Safety 

5 Initiative, take into consideration the needs ar6 ticulated by participants in projects funded by 

7 the program under this section. 

8 ‘‘(e) GRANTS.— 

9 ‘‘(1) IN GENERAL.—In carrying out this section, 

10 the Secretary shall make competitive grants to sup11 port training, education, extension, outreach, and 

12 technical assistance projects that will help improve 

13 public health by increasing the understanding and 

14 adoption of established food safety standards, guid15 ance, and protocols. 

16 ‘‘(2) ENCOURAGED FEATURES.—The Secretary 

17 shall encourage projects carried out using grant funds 

18 under this section to include co-management of food 

19 safety, conservation systems, and ecological health. 

20 ‘‘(3) MAXIMUM TERM AND SIZE OF GRANT.— 

21 ‘‘(A) IN GENERAL.—A grant under this sec22 tion shall have a term that is not more than 3 

23 years. 

24 ‘‘(B) LIMITATION ON GRANT FUNDING.—The 

25 Secretary may not provide grant funding to an 
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1 entity under this section after such entity has re2 ceived 3 years of grant funding under this sec3 tion. 

4 ‘‘(f) GRANT ELIGIBILITY.— 

5 ‘‘(1) IN GENERAL.—To be eligible for a grant 

6 under this section, an entity shall be— 

7 ‘‘(A) a State cooperative extension service; 

8 ‘‘(B) a Federal, State, local, or tribal agen9 cy, a nonprofit community-based or non-govern10 mental organization, or an organization rep11 resenting owners and operators of farms, small 

12 food processors, or small fruit and vegetable mer13 chant wholesalers that has a commitment to pub14 lic health and expertise in administering pro15 grams that contribute to food safety; 

16 ‘‘(C) an institution of higher education (as 

17 defined in section 101(a) of the Higher Edu18 cation Act of 1965 (20 U.S.C. 1001(a))) or a 

19 foundation maintained by an institution of 

20 higher education; 

21 ‘‘(D) a collaboration of 2 of more eligible 

22 entities described in this subsection; or 

23 ‘‘(E) such other appropriate entity, as de24 termined by the Secretary. 
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1 ‘‘(2) MULTISTATE PARTNERSHIPS.—Grants 

2 under this section may be made for projects involving 

3 more than 1 State. 

4 ‘‘(g) REGIONAL BALANCE.—In making grants under 

5 this section, the Secretary shall, to the maximum extent 

6 practicable, ensure— 

7 ‘‘(1) geographic diversity; and 

8 ‘‘(2) diversity of types of agricultural produc9 tion. 

10 ‘‘(h) TECHNICAL ASSISTANCE.—The Secretary may 

11 use funds made available under this section to provide tech12 nical assistance to grant recipients to further the purposes 

13 of this section. 

14 ‘‘(i) BEST PRACTICES AND MODEL PROGRAMS.— 

15 Based on evaluations of, and responses arising from, 

16 projects funded under this section, the Secretary may issue 

17 a set of recommended best practices and models for food 

18 safety training programs for agricultural producers, small 

19 food processors, and small fresh fruit and vegetable mer20 chant wholesalers. 

21 ‘‘(j) AUTHORIZATION OF APPROPRIATIONS.—For the 

22 purposes of making grants under this section, there are au23 thorized to be appropriated such sums as may be necessary 

24 for fiscal years 2011 through 2015.’’. 
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1 SEC. 210. ENHANCING FOOD SAFETY. 

2 (a) GRANTS TO ENHANCE FOOD SAFETY.—Section 

3 1009 of the Federal Food, Drug, and Cosmetic Act (21 

4 U.S.C. 399) is amended to read as follows: 

5 ‘‘SEC. 1009. GRANTS TO ENHANCE FOOD SAFETY. 

6 ‘‘(a) IN GENERAL.—The Secretary is authorized to 

7 make grants to eligible entities to— 

8 ‘‘(1) undertake examinations, inspections, and 

9 investigations, and related food safety activities under 

10 section 702; 

11 ‘‘(2) train to the standards of the Secretary for 

12 the examination, inspection, and investigation of food 

13 manufacturing, processing, packing, holding, dis14 tribution, and importation, including as such exam15 ination, inspection, and investigation relate to retail 

16 food establishments; 

17 ‘‘(3) build the food safety capacity of the labora18 tories of such eligible entity, including the detection 

19 of zoonotic diseases; 

20 ‘‘(4) build the infrastructure and capacity of the 

21 food safety programs of such eligible entity to meet 

22 the standards as outlined in the grant application; 

23 and 

24 ‘‘(5) take appropriate action to protect the public 

25 health in response to— 
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1 ‘‘(A) a notification under section 1008, in2 cluding planning and otherwise preparing to 

3 take such action; or 

4 ‘‘(B) a recall of food under this Act. 

5 ‘‘(b) ELIGIBLE ENTITIES; APPLICATION.— 

6 ‘‘(1) IN GENERAL.—In this section, the term ‘eli7 gible entity’ means an entity— 

8 ‘‘(A) that is— 

9 ‘‘(i) a State; 

10 ‘‘(ii) a locality; 

11 ‘‘(iii) a territory; 

12 ‘‘(iv) an Indian tribe (as defined in 

13 section 4(e) of the Indian Self-Determina14 tion and Education Assistance Act); or 

15 ‘‘(v) a nonprofit food safety training 

16 entity that collaborates with 1 or more in17 stitutions of higher education; and 

18 ‘‘(B) that submits an application to the 

19 Secretary at such time, in such manner, and in20 cluding such information as the Secretary may 

21 reasonably require. 

22 ‘‘(2) CONTENTS.—Each application submitted 

23 under paragraph (1) shall include— 
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1 ‘‘(A) an assurance that the eligible entity 

2 has developed plans to engage in the types of ac3 tivities described in subsection (a); 

4 ‘‘(B) a description of the types of activities 

5 to be funded by the grant; 

6 ‘‘(C) an itemization of how grant funds re7 ceived under this section will be expended; 

8 ‘‘(D) a description of how grant activities 

9 will be monitored; and 

10 ‘‘(E) an agreement by the eligible entity to 

11 report information required by the Secretary to 

12 conduct evaluations under this section. 

13 ‘‘(c) LIMITATIONS.—The funds provided under sub14 section (a) shall be available to an eligible entity that re15 ceives a grant under this section only to the extent such 

16 entity funds the food safety programs of such entity inde17 pendently of any grant under this section in each year of 

18 the grant at a level equal to the level of such funding in 

19 the previous year, increased by the Consumer Price Index. 

20 Such non-Federal matching funds may be provided directly 

21 or through donations from public or private entities and 

22 may be in cash or in-kind, fairly evaluated, including 

23 plant, equipment, or services. 

24 ‘‘(d) ADDITIONAL AUTHORITY.—The Secretary may— 
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1 ‘‘(1) award a grant under this section in each 

2 subsequent fiscal year without reapplication for a pe3 riod of not more than 3 years, provided the require4 ments of subsection (c) are met for the previous fiscal 

5 year; and 

6 ‘‘(2) award a grant under this section in a fiscal 

7 year for which the requirement of subsection (c) has 

8 not been met only if such requirement was not met 

9 because such funding was diverted for response to 1 

10 or more natural disasters or in other extenuating cir11 cumstances that the Secretary may determine appro12 priate. 

13 ‘‘(e) DURATION OF AWARDS.—The Secretary may 

14 award grants to an individual grant recipient under this 

15 section for periods of not more than 3 years. In the event 

16 the Secretary conducts a program evaluation, funding in 

17 the second year or third year of the grant, where applicable, 

18 shall be contingent on a successful program evaluation by 

19 the Secretary after the first year. 

20 ‘‘(f) PROGRESS AND EVALUATION.— 

21 ‘‘(1) IN GENERAL.—The Secretary shall measure 

22 the status and success of each grant program author23 ized under the FDA Food Safety Modernization Act 

24 (and any amendment made by such Act), including 

25 the grant program under this section. A recipient of 
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1 a grant described in the preceding sentence shall, at 

2 the end of each grant year, provide the Secretary with 

3 information on how grant funds were spent and the 

4 status of the efforts by such recipient to enhance food 

5 safety. To the extent practicable, the Secretary shall 

6 take the performance of such a grant recipient into 

7 account when determining whether to continue fund8 ing for such recipient. 

9 ‘‘(2) NO DUPLICATION.—In carrying out para10 graph (1), the Secretary shall not duplicate the efforts 

11 of the Secretary under other provisions of this Act or 

12 the FDA Food Safety Modernization Act that require 

13 measurement and review of the activities of grant re14 cipients under either such Act. 

15 ‘‘(g) SUPPLEMENT NOT SUPPLANT.—Grant funds re16 ceived under this section shall be used to supplement, and 

17 not supplant, non-Federal funds and any other Federal 

18 funds available to carry out the activities described in this 

19 section. 

20 ‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—For the 

21 purpose of making grants under this section, there are au22 thorized to be appropriated such sums as may be necessary 

23 for fiscal years 2011 through 2015.’’. 
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1 (b) CENTERS OF EXCELLENCE.—Part P of the Public 

2 Health Service Act (42 U.S.C. 280g et seq.) is amended by 

3 adding at the end the following: 

4 ‘‘SEC. 399V–5. FOOD SAFETY INTEGRATED CENTERS OF EX5 CELLENCE. 

6 ‘‘(a) IN GENERAL.—Not later than 1 year after the 

7 date of enactment of the FDA Food Safety Modernization 

8 Act, the Secretary, acting through the Director of the Cen9 ters for Disease Control and Prevention and in consultation 

10 with the working group described in subsection (b)(2), shall 

11 designate 5 Integrated Food Safety Centers of Excellence 

12 (referred to in this section as the ‘Centers of Excellence’) 

13 to serve as resources for Federal, State, and local public 

14 health professionals to respond to foodborne illness out15 breaks. The Centers of Excellence shall be headquartered at 

16 selected State health departments. 

17 ‘‘(b) SELECTION OF CENTERS OF EXCELLENCE.— 

18 ‘‘(1) ELIGIBLE ENTITIES.—To be eligible to be 

19 designated as a Center of Excellence under subsection 

20 (a), an entity shall— 

21 ‘‘(A) be a State health department; 

22 ‘‘(B) partner with 1 or more institutions of 

23 higher education that have demonstrated knowl24 edge, expertise, and meaningful experience with 

25 regional or national food production, processing, 
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1 and distribution, as well as leadership in the 

2 laboratory, epidemiological, and environmental 

3 detection and investigation of foodborne illness; 

4 and 

5 ‘‘(C) provide to the Secretary such informa6 tion, at such time, and in such manner, as the 

7 Secretary may require. 

8 ‘‘(2) WORKING GROUP.—Not later than 180 days 

9 after the date of enactment of the FDA Food Safety 

10 Modernization Act, the Secretary shall establish a di11 verse working group of experts and stakeholders from 

12 Federal, State, and local food safety and health agen13 cies, the food industry, including food retailers and 

14 food manufacturers, consumer organizations, and aca15 demia to make recommendations to the Secretary re16 garding designations of the Centers of Excellence. 

17 ‘‘(3) ADDITIONAL CENTERS OF EXCELLENCE.— 

18 The Secretary may designate eligible entities to be re19 gional Food Safety Centers of Excellence, in addition 

20 to the 5 Centers designated under subsection (a). 

21 ‘‘(c) ACTIVITIES.—Under the leadership of the Director 

22 of the Centers for Disease Control and Prevention, each Cen23 ter of Excellence shall be based out of a selected State health 

24 department, which shall provide assistance to other re-
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1 gional, State, and local departments of health through ac2 tivities that include— 

3 ‘‘(1) providing resources, including timely infor4 mation concerning symptoms and tests, for frontline 

5 health professionals interviewing individuals as part 

6 of routine surveillance and outbreak investigations; 

7 ‘‘(2) providing analysis of the timeliness and ef8 fectiveness of foodborne disease surveillance and out9 break response activities; 

10 ‘‘(3) providing training for epidemiological and 

11 environmental investigation of foodborne illness, in12 cluding suggestions for streamlining and standard13 izing the investigation process; 

14 ‘‘(4) establishing fellowships, stipends, and schol15 arships to train future epidemiological and food-safe16 ty leaders and to address critical workforce shortages; 

17 ‘‘(5) training and coordinating State and local 

18 personnel; 

19 ‘‘(6) strengthening capacity to participate in ex20 isting or new foodborne illness surveillance and envi21 ronmental assessment information systems; and 

22 ‘‘(7) conducting research and outreach activities 

23 focused on increasing prevention, communication, 

24 and education regarding food safety. 
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1 ‘‘(d) REPORT TO CONGRESS.—Not later than 2 years 

2 after the date of enactment of the FDA Food Safety Mod3 ernization Act, the Secretary shall submit to Congress a re4 port that— 

5 ‘‘(1) describes the effectiveness of the Centers of 

6 Excellence; and 

7 ‘‘(2) provides legislative recommendations or de8 scribes additional resources required by the Centers of 

9 Excellence. 

10 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There is 

11 authorized to be appropriated such sums as may be nec12 essary to carry out this section. 

13 ‘‘(f) NO DUPLICATION OF EFFORT.—In carrying out 

14 activities of the Centers of Excellence or other programs 

15 under this section, the Secretary shall not duplicate other 

16 Federal foodborne illness response efforts.’’. 

17 SEC. 211. IMPROVING THE REPORTABLE FOOD REGISTRY. 

18 (a) IN GENERAL.—Section 417 (21 U.S.C. 350f) is 

19 amended— 

20 (1) by redesignating subsections (f) through (k) 

21 as subsections (i) through (n), respectively; and 

22 (2) by inserting after subsection (e) the following: 

23 ‘‘(f) CRITICAL INFORMATION.—Except with respect to 

24 fruits and vegetables that are raw agricultural commodities, 

25 not more than 18 months after the date of enactment of 
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1 the FDA Food Safety Modernization Act, the Secretary may 

2 require a responsible party to submit to the Secretary con3 sumer-oriented information regarding a reportable food, 

4 which shall include— 

5 ‘‘(1) a description of the article of food as pro6 vided in subsection (e)(3); 

7 ‘‘(2) as provided in subsection (e)(7), affected 

8 product identification codes, such as UPC, SKU, or 

9 lot or batch numbers sufficient for the consumer to 

10 identify the article of food; 

11 ‘‘(3) contact information for the responsible 

12 party as provided in subsection (e)(8); and 

13 ‘‘(4) any other information the Secretary deter14 mines is necessary to enable a consumer to accurately 

15 identify whether such consumer is in possession of the 

16 reportable food. 

17 ‘‘(g) GROCERY STORE NOTIFICATION.— 

18 ‘‘(1) ACTION BY SECRETARY.—The Secretary 

19 shall— 

20 ‘‘(A) prepare the critical information de21 scribed under subsection (f) for a reportable food 

22 as a standardized one-page summary; 

23 ‘‘(B) publish such one-page summary on the 

24 Internet website of the Food and Drug Adminis25 tration in a format that can be easily printed by 
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1 a grocery store for purposes of consumer notifica2 tion. 

3 ‘‘(2) ACTION BY GROCERY STORE.—A notifica4 tion described under paragraph (1)(B) shall include 

5 the date and time such summary was posted on the 

6 Internet website of the Food and Drug Administra7 tion. 

8 ‘‘(h) CONSUMER NOTIFICATION.— 

9 ‘‘(1) IN GENERAL.—If a grocery store sold a re10 portable food that is the subject of the posting and 

11 such establishment is part of chain of establishments 

12 with 15 or more physical locations, then such estab13 lishment shall, not later than 24 hours after a one 

14 page summary described in subsection (g) is pub15 lished, prominently display such summary or the in16 formation from such summary via at least one of the 

17 methods identified under paragraph (2) and main18 tain the display for 14 days. 

19 ‘‘(2) LIST OF CONSPICUOUS LOCATIONS.—Not 

20 more than 1 year after the date of enactment of the 

21 FDA Food Safety Modernization Act, the Secretary 

22 shall develop and publish a list of acceptable con23 spicuous locations and manners, from which grocery 

24 stores shall select at least one, for providing the notifi-
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† HR 2751 EAS 

1 cation required in paragraph (1). Such list shall in2 clude— 

3 ‘‘(A) posting the notification at or near the 

4 register; 

5 ‘‘(B) providing the location of the reportable 

6 food; 

7 ‘‘(C) providing targeted recall information 

8 given to customers upon purchase of a food; and 

9 ‘‘(D) other such prominent and conspicuous 

10 locations and manners utilized by grocery stores 

11 as of the date of the enactment of the FDA Food 

12 Safety Modernization Act to provide notice of 

13 such recalls to consumers as considered appro14 priate by the Secretary.’’. 

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

16 as amended by section 206, is amended by adding at the 

17 end the following: 

18 ‘‘(yy) The knowing and willful failure to comply with 

19 the notification requirement under section 417(h).’’. 

20 (c) CONFORMING AMENDMENT.—Section 301(e) (21 

21 U.S.C. 331(e)) is amended by striking ‘‘417(g)’’ and insert22 ing ‘‘417(j)’’. 
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1 TITLE III—IMPROVING THE 

2 SAFETY OF IMPORTED FOOD 

3 SEC. 301. FOREIGN SUPPLIER VERIFICATION PROGRAM. 

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

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

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

7 ‘‘(a) IN GENERAL.— 

8 ‘‘(1) VERIFICATION REQUIREMENT.—Except as 

9 provided under subsections (e) and (f), each importer 

10 shall perform risk-based foreign supplier verification 

11 activities for the purpose of verifying that the food 

12 imported by the importer or agent of an importer 

13 is— 

14 ‘‘(A) produced in compliance with the re15 quirements of section 418 or section 419, as ap16 propriate; and 

17 ‘‘(B) is not adulterated under section 402 or 

18 misbranded under section 403(w). 

19 ‘‘(2) IMPORTER DEFINED.—For purposes of this 

20 section, the term ‘importer’ means, with respect to an 

21 article of food— 

22 ‘‘(A) the United States owner or consignee 

23 of the article of food at the time of entry of such 

24 article into the United States; or 
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1 ‘‘(B) in the case when there is no United 

2 States owner or consignee as described in sub3 paragraph (A), the United States agent or rep4 resentative of a foreign owner or consignee of the 

5 article of food at the time of entry of such article 

6 into the United States. 

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

8 of enactment of the FDA Food Safety Modernization Act, 

9 the Secretary shall issue guidance to assist importers in de10 veloping foreign supplier verification programs. 

11 ‘‘(c) REGULATIONS.— 

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

13 the date of enactment of the FDA Food Safety Mod14 ernization Act, the Secretary shall promulgate regula15 tions to provide for the content of the foreign supplier 

16 verification program established under subsection (a). 

17 ‘‘(2) REQUIREMENTS.—The regulations promul18 gated under paragraph (1)— 

19 ‘‘(A) shall require that the foreign supplier 

20 verification program of each importer be ade21 quate to provide assurances that each foreign 

22 supplier to the importer produces the imported 

23 food in compliance with— 

24 ‘‘(i) processes and procedures, includ25 ing reasonably appropriate risk-based pre-
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1 ventive controls, that provide the same level 

2 of public health protection as those required 

3 under section 418 or section 419 (taking 

4 into consideration variances granted under 

5 section 419), as appropriate; and 

6 ‘‘(ii) section 402 and section 403(w). 

7 ‘‘(B) shall include such other requirements 

8 as the Secretary deems necessary and appro9 priate to verify that food imported into the 

10 United States is as safe as food produced and 

11 sold within the United States. 

12 ‘‘(3) CONSIDERATIONS.—In promulgating regu13 lations under this subsection, the Secretary shall, as 

14 appropriate, take into account differences among im15 porters and types of imported foods, including based 

16 on the level of risk posed by the imported food. 

17 ‘‘(4) ACTIVITIES.—Verification activities under a 

18 foreign supplier verification program under this sec19 tion may include monitoring records for shipments, 

20 lot-by-lot certification of compliance, annual on-site 

21 inspections, checking the hazard analysis and risk22 based preventive control plan of the foreign supplier, 

23 and periodically testing and sampling shipments. 

24 ‘‘(d) RECORD MAINTENANCE AND ACCESS.—Records of 

25 an importer related to a foreign supplier verification pro-
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1 gram shall be maintained for a period of not less than 2 

2 years and shall be made available promptly to a duly au3 thorized representative of the Secretary upon request. 

4 ‘‘(e) EXEMPTION OF SEAFOOD, JUICE, AND LOW-ACID

5 CANNED FOOD FACILITIES IN COMPLIANCE WITH

6 HACCP.—This section shall not apply to a facility if the 

7 owner, operator, or agent in charge of such facility is re8 quired to comply with, and is in compliance with, 1 of the 

9 following standards and regulations with respect to such fa10 cility: 

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

14 ‘‘(2) The Juice Hazard Analysis Critical Control 

15 Points Program of the Food and Drug Administra16 tion. 

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

18 Packaged in Hermetically Sealed Containers stand19 ards of the Food and Drug Administration (or any 

20 successor standards). 

21 The exemption under paragraph (3) shall apply only with 

22 respect to microbiological hazards that are regulated under 

23 the standards for Thermally Processed Low-Acid Foods 

24 Packaged in Hermetically Sealed Containers under part 
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1 113 of chapter 21, Code of Federal Regulations (or any suc2 cessor regulations). 

3 ‘‘(f) ADDITIONAL EXEMPTIONS.—The Secretary, by no4 tice published in the Federal Register, shall establish an ex5 emption from the requirements of this section for articles 

6 of food imported in small quantities for research and eval7 uation purposes or for personal consumption, provided that 

8 such foods are not intended for retail sale and are not sold 

9 or distributed to the public. 

10 ‘‘(g) PUBLICATION OF LIST OF PARTICIPANTS.—The 

11 Secretary shall publish and maintain on the Internet Web 

12 site of the Food and Drug Administration a current list 

13 that includes the name of, location of, and other informa14 tion deemed necessary by the Secretary about, importers 

15 participating under this section.’’. 

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

17 as amended by section 211, is amended by adding at the 

18 end the following: 

19 ‘‘(zz) The importation or offering for importation of 

20 a food if the importer (as defined in section 805) does not 

21 have in place a foreign supplier verification program in 

22 compliance with such section 805.’’. 

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

24 amended by adding ‘‘or the importer (as defined in section 
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1 805) is in violation of such section 805’’ after ‘‘or in viola2 tion of section 505’’. 

3 (d) EFFECTIVE DATE.—The amendments made by this 

4 section shall take effect 2 years after the date of enactment 

5 of this Act. 

6 SEC. 302. VOLUNTARY QUALIFIED IMPORTER PROGRAM. 

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

8 section 301, is amended by adding at the end the following: 

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

10 ‘‘(a) IN GENERAL.—Beginning not later than 18 

11 months after the date of enactment of the FDA Food Safety 

12 Modernization Act, the Secretary shall— 

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

14 the Secretary of Homeland Security— 

15 ‘‘(A) to provide for the expedited review and 

16 importation of food offered for importation by 

17 importers who have voluntarily agreed to par18 ticipate in such program; and 

19 ‘‘(B) consistent with section 808, establish a 

20 process for the issuance of a facility certification 

21 to accompany food offered for importation by 

22 importers who have voluntarily agreed to par23 ticipate in such program; and 
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1 ‘‘(2) issue a guidance document related to par2 ticipation in, revocation of such participation in, re3 instatement in, and compliance with, such program. 

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

5 request the Secretary to provide for the expedited review 

6 and importation of designated foods in accordance with the 

7 program established by the Secretary under subsection (a). 

8 ‘‘(c) NOTICE OF INTENT TO PARTICIPATE.—An im9 porter that intends to participate in the program under this 

10 section in a fiscal year shall submit a notice and applica11 tion to the Secretary of such intent at the time and in a 

12 manner established by the Secretary. 

13 ‘‘(d) ELIGIBILITY.—Eligibility shall be limited to an 

14 importer offering food for importation from a facility that 

15 has a certification described in subsection (a). In reviewing 

16 the applications and making determinations on such appli17 cations, the Secretary shall consider the risk of the food to 

18 be imported based on factors, such as the following: 

19 ‘‘(1) The known safety risks of the food to be im20 ported. 

21 ‘‘(2) The compliance history of foreign suppliers 

22 used by the importer, as appropriate. 

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

24 the country of export to ensure compliance with 
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1 United States food safety standards for a designated 

2 food. 

3 ‘‘(4) The compliance of the importer with the re4 quirements of section 805. 

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

6 audits of facilities, traceability of articles of food, 

7 temperature controls, and sourcing practices of the 

8 importer. 

9 ‘‘(6) The potential risk for intentional adultera10 tion of the food. 

11 ‘‘(7) Any other factor that the Secretary deter12 mines appropriate. 

13 ‘‘(e) REVIEW AND REVOCATION.—Any importer quali14 fied by the Secretary in accordance with the eligibility cri15 teria set forth in this section shall be reevaluated not less 

16 often than once every 3 years and the Secretary shall 

17 promptly revoke the qualified importer status of any im18 porter found not to be in compliance with such criteria. 

19 ‘‘(f) FALSE STATEMENTS.—Any statement or represen20 tation made by an importer to the Secretary shall be subject 

21 to section 1001 of title 18, United States Code. 

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

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

24 food to be brought, from a foreign country into the customs 

25 territory of the United States.’’. 
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1 SEC. 303. AUTHORITY TO REQUIRE IMPORT CERTIFI2 CATIONS FOR FOOD. 

3 (a) IN GENERAL.—Section 801(a) (21 U.S.C. 381(a)) 

4 is amended by inserting after the third sentence the fol5 lowing: ‘‘With respect to an article of food, if importation 

6 of such food is subject to, but not compliant with, the re7 quirement under subsection (q) that such food be accom8 panied by a certification or other assurance that the food 

9 meets applicable requirements of this Act, then such article 

10 shall be refused admission.’’. 

11 (b) ADDITION OF CERTIFICATION REQUIREMENT.— 

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

13 end the following new subsection: 

14 ‘‘(q) CERTIFICATIONS CONCERNING IMPORTED

15 FOODS.— 

16 ‘‘(1) IN GENERAL.—The Secretary may require, 

17 as a condition of granting admission to an article of 

18 food imported or offered for import into the United 

19 States, that an entity described in paragraph (3) pro20 vide a certification, or such other assurances as the 

21 Secretary determines appropriate, that the article of 

22 food complies with applicable requirements of this 

23 Act. Such certification or assurances may be provided 

24 in the form of shipment-specific certificates, a listing 

25 of certified facilities that manufacture, process, pack, 
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1 or hold such food, or in such other form as the Sec2 retary may specify. 

3 ‘‘(2) FACTORS TO BE CONSIDERED IN REQUIRING

4 CERTIFICATION.—The Secretary shall base the deter5 mination that an article of food is required to have 

6 a certification described in paragraph (1) on the risk 

7 of the food, including— 

8 ‘‘(A) known safety risks associated with the 

9 food; 

10 ‘‘(B) known food safety risks associated 

11 with the country, territory, or region of origin of 

12 the food; 

13 ‘‘(C) a finding by the Secretary, supported 

14 by scientific, risk-based evidence, that— 

15 ‘‘(i) the food safety programs, systems, 

16 and standards in the country, territory, or 

17 region of origin of the food are inadequate 

18 to ensure that the article of food is as safe 

19 as a similar article of food that is manufac20 tured, processed, packed, or held in the 

21 United States in accordance with the re22 quirements of this Act; and 

23 ‘‘(ii) the certification would assist the 

24 Secretary in determining whether to refuse 
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1 or admit the article of food under subsection 

2 (a); and 

3 ‘‘(D) information submitted to the Secretary 

4 in accordance with the process established in 

5 paragraph (7). 

6 ‘‘(3) CERTIFYING ENTITIES.—For purposes of 

7 paragraph (1), entities that shall provide the certifi8 cation or assurances described in such paragraph 

9 are— 

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

11 government of the country from which the article 

12 of food at issue originated, as designated by the 

13 Secretary; or 

14 ‘‘(B) such other persons or entities accred15 ited pursuant to section 808 to provide such cer16 tification or assurance. 

17 ‘‘(4) RENEWAL AND REFUSAL OF CERTIFI18 CATIONS.—The Secretary may— 

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

20 assurance provided by an entity specified in 

21 paragraph (2) be renewed by such entity at such 

22 times as the Secretary determines appropriate; 

23 and 
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1 ‘‘(B) refuse to accept any certification or 

2 assurance if the Secretary determines that such 

3 certification or assurance is not valid or reliable. 

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

5 shall provide for the electronic submission of certifi6 cations under this subsection. 

7 ‘‘(6) FALSE STATEMENTS.—Any statement or 

8 representation made by an entity described in para9 graph (2) to the Secretary shall be subject to section 

10 1001 of title 18, United States Code. 

11 ‘‘(7) ASSESSMENT OF FOOD SAFETY PROGRAMS, 

12 SYSTEMS, AND STANDARDS.—If the Secretary deter13 mines that the food safety programs, systems, and 

14 standards in a foreign region, country, or territory 

15 are inadequate to ensure that an article of food is as 

16 safe as a similar article of food that is manufactured, 

17 processed, packed, or held in the United States in ac18 cordance with the requirements of this Act, the Sec19 retary shall, to the extent practicable, identify such 

20 inadequacies and establish a process by which the for21 eign region, country, or territory may inform the Sec22 retary of improvements made to such food safety pro23 gram, system, or standard and demonstrate that those 

24 controls are adequate to ensure that an article of food 

25 is as safe as a similar article of food that is manufac-
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1 tured, processed, packed, or held in the United States 

2 in accordance with the requirements of this Act.’’. 

3 (c) CONFORMING TECHNICAL AMENDMENT.—Section 

4 801(b) (21 U.S.C. 381(b)) is amended in the second sentence 

5 by striking ‘‘with respect to an article included within the 

6 provision of the fourth sentence of subsection (a)’’ and in7 serting ‘‘with respect to an article described in subsection 

8 (a) relating to the requirements of sections 760 or 761,’’. 

9 (d) NO LIMIT ON AUTHORITY.—Nothing in the amend10 ments made by this section shall limit the authority of the 

11 Secretary to conduct inspections of imported food or to take 

12 such other steps as the Secretary deems appropriate to de13 termine the admissibility of imported food. 

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

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

16 381(m)(1)) is amended by inserting ‘‘any country to which 

17 the article has been refused entry;’’ after ‘‘the country from 

18 which the article is shipped;’’. 

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

20 date of enactment of this Act, the Secretary shall issue an 

21 interim final rule amending subpart I of part 1 of title 

22 21, Code of Federal Regulations, to implement the amend23 ment made by this section. 
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1 (c) EFFECTIVE DATE.—The amendment made by this 

2 section shall take effect 180 days after the date of enactment 

3 of this Act. 

4 SEC. 305. BUILDING CAPACITY OF FOREIGN GOVERNMENTS 

5 WITH RESPECT TO FOOD SAFETY. 

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

7 2 years of the date of enactment of this Act, develop a com8 prehensive plan to expand the technical, scientific, and reg9 ulatory food safety capacity of foreign governments, and 

10 their respective food industries, from which foods are ex11 ported to the United States. 

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

13 subsection (a), the Secretary shall consult with the Sec14 retary of Agriculture, Secretary of State, Secretary of the 

15 Treasury, the Secretary of Homeland Security, the United 

16 States Trade Representative, and the Secretary of Com17 merce, representatives of the food industry, appropriate for18 eign government officials, nongovernmental organizations 

19 that represent the interests of consumers, and other stake20 holders. 

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

22 shall include, as appropriate, the following: 

23 (1) Recommendations for bilateral and multilat24 eral arrangements and agreements, including provi-
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1 sions to provide for responsibility of exporting coun2 tries to ensure the safety of food. 

3 (2) Provisions for secure 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 food. 

8 (5) Recommendations on whether and how to 

9 harmonize requirements under the Codex 

10 Alimentarius. 

11 (6) Provisions for the multilateral acceptance of 

12 laboratory methods and testing and detection tech13 niques. 

14 (d) RULE OF CONSTRUCTION.—Nothing in this section 

15 shall be construed to affect the regulation of dietary supple16 ments under the Dietary Supplement Health and Edu17 cation Act of 1994 (Public Law 103–417). 

18 SEC. 306. INSPECTION OF FOREIGN FOOD FACILITIES. 

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

20 seq.), as amended by section 302, is amended by inserting 

21 at the end the following: 

22 ‘‘SEC. 807. INSPECTION OF FOREIGN FOOD FACILITIES. 

23 ‘‘(a) INSPECTION.—The Secretary— 

24 ‘‘(1) may enter into arrangements and agree25 ments with foreign governments to facilitate the in-
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1 spection of foreign facilities registered under section 

2 415; and 

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

5 such facilities, suppliers, and food types that present 

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

7 ensure the safety and security of the food supply of 

8 the United States. 

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

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

12 factory, warehouse, or other establishment of which the 

13 owner, operator, or agent in charge, or the government of 

14 the foreign country, refuses to permit entry of United States 

15 inspectors or other individuals duly designated by the Sec16 retary, upon request, to inspect such factory, warehouse, or 

17 other establishment. For purposes of this subsection, such 

18 an owner, operator, or agent in charge shall be considered 

19 to have refused an inspection if such owner, operator, or 

20 agent in charge does not permit an inspection of a factory, 

21 warehouse, or other establishment during the 24-hour period 

22 after such request is submitted, or after such other time pe23 riod, as agreed upon by the Secretary and the foreign fac24 tory, warehouse, or other establishment.’’. 

25 (b) INSPECTION BY THE SECRETARY OF COMMERCE.— 
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1 (1) IN GENERAL.—The Secretary of Commerce, 

2 in coordination with the Secretary of Health and 

3 Human Services, may send 1 or more inspectors to 

4 a country or facility of an exporter from which sea5 food imported into the United States originates. The 

6 inspectors shall assess practices and processes used in 

7 connection with the farming, cultivation, harvesting, 

8 preparation for market, or transportation of such sea9 food and may provide technical assistance related to 

10 such activities. 

11 (2) INSPECTION REPORT.— 

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

13 and Human Services, in coordination with the 

14 Secretary of Commerce, shall— 

15 (i) prepare an inspection report for 

16 each inspection conducted under paragraph 

17 (1); 

18 (ii) provide the report to the country 

19 or exporter that is the subject of the report; 

20 and 

21 (iii) provide a 30-day period during 

22 which the country or exporter may provide 

23 a rebuttal or other comments on the find24 ings of the report to the Secretary of Health 

25 and Human Services. 
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† HR 2751 EAS 

1 (B) DISTRIBUTION AND USE OF REPORT.— 

2 The Secretary of Health and Human Services 

3 shall consider the inspection reports described in 

4 subparagraph (A) in distributing inspection re5 sources under section 421 of the Federal Food, 

6 Drug, and Cosmetic Act, as added by section 

7 201. 

8 SEC. 307. ACCREDITATION OF THIRD-PARTY AUDITORS. 

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

10 section 306, is amended by adding at the end the following: 

11 ‘‘SEC. 808. ACCREDITATION OF THIRD-PARTY AUDITORS. 

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

13 ‘‘(1) AUDIT AGENT.—The term ‘audit agent’ 

14 means an individual who is an employee or agent of 

15 an accredited third-party auditor and, although not 

16 individually accredited, is qualified to conduct food 

17 safety audits on behalf of an accredited third-party 

18 auditor. 

19 ‘‘(2) ACCREDITATION BODY.—The term ‘accredi20 tation body’ means an authority that performs ac21 creditation of third-party auditors. 

22 ‘‘(3) THIRD-PARTY AUDITOR.—The term ‘third23 party auditor’ means a foreign government, agency of 

24 a foreign government, foreign cooperative, or any 

25 other third party, as the Secretary determines appro-
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1 priate in accordance with the model standards de2 scribed in subsection (b)(2), that is eligible to be con3 sidered for accreditation to conduct food safety audits 

4 to certify that eligible entities meet the applicable re5 quirements of this section. A third-party auditor may 

6 be a single individual. A third-party auditor may 

7 employ or use audit agents to help conduct consult8 ative and regulatory audits. 

9 ‘‘(4) ACCREDITED THIRD-PARTY AUDITOR.—The 

10 term ‘accredited third-party auditor’ means a third11 party auditor accredited by an accreditation body to 

12 conduct audits of eligible entities to certify that such 

13 eligible entities meet the applicable requirements of 

14 this section. An accredited third-party auditor may 

15 be an individual who conducts food safety audits to 

16 certify that eligible entities meet the applicable re17 quirements of this section. 

18 ‘‘(5) CONSULTATIVE AUDIT.—The term ‘consult19 ative audit’ means an audit of an eligible entity— 

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

21 compliance with the provisions of this Act and 

22 with applicable industry standards and prac23 tices; and 

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

25 purposes only. 
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1 ‘‘(6) ELIGIBLE ENTITY.—The term ‘eligible enti2 ty’ means a foreign entity, including a foreign facil3 ity registered under section 415, in the food import 

4 supply chain that chooses to be audited by an accred5 ited third-party auditor or the audit agent of such ac6 credited third-party auditor. 

7 ‘‘(7) REGULATORY AUDIT.—The term ‘regulatory 

8 audit’ means an audit of an eligible entity— 

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

10 compliance with the provisions of this Act; and 

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

12 ‘‘(i) whether an article of food manu13 factured, processed, packed, or held by such 

14 entity is eligible to receive a food certifi15 cation under section 801(q); or 

16 ‘‘(ii) whether a facility is eligible to re17 ceive a facility certification under section 

18 806(a) for purposes of participating in the 

19 program under section 806. 

20 ‘‘(b) ACCREDITATION SYSTEM.— 

21 ‘‘(1) ACCREDITATION BODIES.— 

22 ‘‘(A) RECOGNITION OF ACCREDITATION BOD23 IES.— 

24 ‘‘(i) IN GENERAL.—Not later than 2 

25 years after the date of enactment of the 
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1 FDA Food Safety Modernization Act, the 

2 Secretary shall establish a system for the 

3 recognition of accreditation bodies that ac4 credit third-party auditors to certify that 

5 eligible entities meet the applicable require6 ments of this section. 

7 ‘‘(ii) DIRECT ACCREDITATION.—If, by 

8 the date that is 2 years after the date of es9 tablishment of the system described in 

10 clause (i), the Secretary has not identified 

11 and recognized an accreditation body to 

12 meet the requirements of this section, the 

13 Secretary may directly accredit third-party 

14 auditors. 

15 ‘‘(B) NOTIFICATION.—Each accreditation 

16 body recognized by the Secretary shall submit to 

17 the Secretary a list of all accredited third-party 

18 auditors accredited by such body and the audit 

19 agents of such auditors. 

20 ‘‘(C) REVOCATION OF RECOGNITION AS AN

21 ACCREDITATION BODY.—The Secretary shall 

22 promptly revoke the recognition of any accredita23 tion body found not to be in compliance with the 

24 requirements of this section. 
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† HR 2751 EAS 

1 ‘‘(D) REINSTATEMENT.—The Secretary 

2 shall establish procedures to reinstate recognition 

3 of an accreditation body if the Secretary deter4 mines, based on evidence presented by such ac5 creditation body, that revocation was inappro6 priate or that the body meets the requirements 

7 for recognition under this section. 

8 ‘‘(2) MODEL ACCREDITATION STANDARDS.—Not 

9 later than 18 months after the date of enactment of 

10 the FDA Food Safety Modernization Act, the Sec11 retary shall develop model standards, including re12 quirements for regulatory audit reports, and each rec13 ognized accreditation body shall ensure that third14 party auditors and audit agents of such auditors meet 

15 such standards in order to qualify such third-party 

16 auditors as accredited third-party auditors under this 

17 section. In developing the model standards, the Sec18 retary shall look to standards in place on the date of 

19 the enactment of this section for guidance, to avoid 

20 unnecessary duplication of efforts and costs. 

21 ‘‘(c) THIRD-PARTY AUDITORS.— 

22 ‘‘(1) REQUIREMENTS FOR ACCREDITATION AS A

23 THIRD-PARTY AUDITOR.— 

24 ‘‘(A) FOREIGN GOVERNMENTS.—Prior to ac25 crediting a foreign government or an agency of 
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1 a foreign government as an accredited third2 party auditor, the accreditation body (or, in the 

3 case of direct accreditation under subsection 

4 (b)(1)(A)(ii), the Secretary) shall perform such 

5 reviews and audits of food safety programs, sys6 tems, and standards of the government or agency 

7 of the government as the Secretary deems nec8 essary, including requirements under the model 

9 standards developed under subsection (b)(2), to 

10 determine that the foreign government or agency 

11 of the foreign government is capable of ade12 quately ensuring that eligible entities or foods 

13 certified by such government or agency meet the 

14 requirements of this Act with respect to food 

15 manufactured, processed, packed, or held for im16 port into the United States. 

17 ‘‘(B) FOREIGN COOPERATIVES AND OTHER

18 THIRD PARTIES.—Prior to accrediting a foreign 

19 cooperative that aggregates the products of grow20 ers or processors, or any other third party to be 

21 an accredited third-party auditor, the accredita22 tion body (or, in the case of direct accreditation 

23 under subsection (b)(1)(A)(ii), the Secretary) 

24 shall perform such reviews and audits of the 

25 training and qualifications of audit agents used 
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† HR 2751 EAS 

1 by that cooperative or party and conduct such 

2 reviews of internal systems and such other inves3 tigation of the cooperative or party as the Sec4 retary deems necessary, including requirements 

5 under the model standards developed under sub6 section (b)(2), to determine that each eligible en7 tity certified by the cooperative or party has sys8 tems and standards in use to ensure that such 

9 entity or food meets the requirements of this Act. 

10 ‘‘(2) REQUIREMENT TO ISSUE CERTIFICATION OF

11 ELIGIBLE ENTITIES OR FOODS.— 

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

13 (or, in the case of direct accreditation under sub14 section (b)(1)(A)(ii), the Secretary) may not ac15 credit a third-party auditor unless such third16 party auditor agrees to issue a written and, as 

17 appropriate, electronic food certification, de18 scribed in section 801(q), or facility certification 

19 under section 806(a), as appropriate, to accom20 pany each food shipment for import into the 

21 United States from an eligible entity, subject to 

22 requirements set forth by the Secretary. Such 

23 written or electronic certification may be in24 cluded with other documentation regarding such 

25 food shipment. The Secretary shall consider cer-
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† HR 2751 EAS 

1 tifications under section 801(q) and participa2 tion in the voluntary qualified importer pro3 gram described in section 806 when targeting in4 spection resources under section 421. 

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

6 Secretary shall use certification provided by ac7 credited third-party auditors to— 

8 ‘‘(i) determine, in conjunction with 

9 any other assurances the Secretary may re10 quire under section 801(q), whether a food 

11 satisfies the requirements of such section; 

12 and 

13 ‘‘(ii) determine whether a facility is el14 igible to be a facility from which food may 

15 be offered for import under the voluntary 

16 qualified importer program under section 

17 806. 

18 ‘‘(C) REQUIREMENTS FOR ISSUING CERTIFI19 CATION.— 

20 ‘‘(i) IN GENERAL.—An accredited 

21 third-party auditor shall issue a food cer22 tification under section 801(q) or a facility 

23 certification described under subparagraph 

24 (B) only after conducting a regulatory 

25 audit and such other activities that may be 
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1 necessary to establish compliance with the 

2 requirements of such sections. 

3 ‘‘(ii) PROVISION OF CERTIFICATION.— 

4 Only an accredited third-party auditor or 

5 the Secretary may provide a facility certifi6 cation under section 806(a). Only those 

7 parties described in 801(q)(3) or the Sec8 retary may provide a food certification 

9 under 301(g). 

10 ‘‘(3) AUDIT REPORT SUBMISSION REQUIRE11 MENTS.— 

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

13 condition of accreditation, not later than 45 

14 days after conducting an audit, an accredited 

15 third-party auditor or audit agent of such audi16 tor shall prepare, and, in the case of a regu17 latory audit, submit, the audit report for each 

18 audit conducted, in a form and manner des19 ignated by the Secretary, which shall include— 

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

21 audited eligible entity responsible for com22 pliance with food safety requirements; 

23 ‘‘(ii) the dates of the audit; 

24 ‘‘(iii) the scope of the audit; and 
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1 ‘‘(iv) any other information required 

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

4 this Act. 

5 ‘‘(B) RECORDS.—Following any accredita6 tion of a third-party auditor, the Secretary may, 

7 at any time, require the accredited third-party 

8 auditor to submit to the Secretary an onsite 

9 audit report and such other reports or documents 

10 required as part of the audit process, for any eli11 gible entity certified by the third-party auditor 

12 or audit agent of such auditor. Such report may 

13 include documentation that the eligible entity is 

14 in compliance with any applicable registration 

15 requirements. 

16 ‘‘(C) LIMITATION.—The requirement under 

17 subparagraph (B) shall not include any report 

18 or other documents resulting from a consultative 

19 audit by the accredited third-party auditor, ex20 cept that the Secretary may access the results of 

21 a consultative audit in accordance with section 

22 414. 

23 ‘‘(4) REQUIREMENTS OF ACCREDITED THIRD24 PARTY AUDITORS AND AUDIT AGENTS OF SUCH AUDI25 TORS.— 
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1 ‘‘(A) RISKS TO PUBLIC HEALTH.—If, at 

2 any time during an audit, an accredited third3 party auditor or audit agent of such auditor dis4 covers a condition that could cause or contribute 

5 to a serious risk to the public health, such audi6 tor shall immediately notify the Secretary of— 

7 ‘‘(i) the identification of the eligible en8 tity subject to the audit; and 

9 ‘‘(ii) such condition. 

10 ‘‘(B) TYPES OF AUDITS.—An accredited 

11 third-party auditor or audit agent of such audi12 tor may perform consultative and regulatory au13 dits of eligible entities. 

14 ‘‘(C) LIMITATIONS.— 

15 ‘‘(i) IN GENERAL.—An accredited third 

16 party auditor may not perform a regu17 latory audit of an eligible entity if such 

18 agent has performed a consultative audit or 

19 a regulatory audit of such eligible entity 

20 during the previous 13-month period. 

21 ‘‘(ii) WAIVER.—The Secretary may 

22 waive the application of clause (i) if the 

23 Secretary determines that there is insuffi24 cient access to accredited third-party audi25 tors in a country or region. 
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1 ‘‘(5) CONFLICTS OF INTEREST.— 

2 ‘‘(A) THIRD-PARTY AUDITORS.—An accred3 ited third-party auditor shall— 

4 ‘‘(i) not be owned, managed, or con5 trolled by any person that owns or operates 

6 an eligible entity to be certified by such 

7 auditor; 

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

9 entities under this section, have procedures 

10 to ensure against the use of any officer or 

11 employee of such auditor that has a finan12 cial conflict of interest regarding an eligible 

13 entity to be certified by such auditor; and 

14 ‘‘(iii) annually make available to the 

15 Secretary disclosures of the extent to which 

16 such auditor and the officers and employees 

17 of such auditor have maintained compliance 

18 with clauses (i) and (ii) relating to finan19 cial conflicts of interest. 

20 ‘‘(B) AUDIT AGENTS.—An audit agent 

21 shall— 

22 ‘‘(i) not own or operate an eligible en23 tity to be audited by such agent; 

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

25 entities under this section, have procedures 
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1 to ensure that such agent does not have a fi2 nancial conflict of interest regarding an eli3 gible entity to be audited by such agent; 

4 and 

5 ‘‘(iii) annually make available to the 

6 Secretary disclosures of the extent to which 

7 such agent has maintained compliance with 

8 clauses (i) and (ii) relating to financial 

9 conflicts of interest. 

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

11 promulgate regulations not later than 18 months 

12 after the date of enactment of the FDA Food 

13 Safety Modernization Act to implement this sec14 tion and to ensure that there are protections 

15 against conflicts of interest between an accred16 ited third-party auditor and the eligible entity to 

17 be certified by such auditor or audited by such 

18 audit agent. Such regulations shall include— 

19 ‘‘(i) requiring that audits performed 

20 under this section be unannounced; 

21 ‘‘(ii) a structure to decrease the poten22 tial for conflicts of interest, including tim23 ing and public disclosure, for fees paid by 

24 eligible entities to accredited third-party 

25 auditors; and 
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1 ‘‘(iii) appropriate limits on financial 

2 affiliations between an accredited third3 party auditor or audit agents of such audi4 tor and any person that owns or operates 

5 an eligible entity to be certified by such 

6 auditor, as described in subparagraphs (A) 

7 and (B). 

8 ‘‘(6) WITHDRAWAL OF ACCREDITATION.— 

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

10 withdraw accreditation from an accredited 

11 third-party auditor— 

12 ‘‘(i) if food certified under section 

13 801(q) or from a facility certified under 

14 paragraph (2)(B) by such third-party audi15 tor is linked to an outbreak of foodborne ill16 ness that has a reasonable probability of 

17 causing serious adverse health consequences 

18 or death in humans or animals; 

19 ‘‘(ii) following an evaluation and find20 ing by the Secretary that the third-party 

21 auditor no longer meets the requirements for 

22 accreditation; or 

23 ‘‘(iii) following a refusal to allow 

24 United States officials to conduct such au25 dits and investigations as may be necessary 
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1 to ensure continued compliance with the re2 quirements set forth in this section. 

3 ‘‘(B) ADDITIONAL BASIS FOR WITHDRAWAL

4 OF ACCREDITATION.—The Secretary may with5 draw accreditation from an accredited third6 party auditor in the case that such third-party 

7 auditor is accredited by an accreditation body 

8 for which recognition as an accreditation body 

9 under subsection (b)(1)(C) is revoked, if the Sec10 retary determines that there is good cause for the 

11 withdrawal. 

12 ‘‘(C) EXCEPTION.—The Secretary may 

13 waive the application of subparagraph (A)(i) if 

14 the Secretary— 

15 ‘‘(i) conducts an investigation of the 

16 material facts related to the outbreak of 

17 human or animal illness; and 

18 ‘‘(ii) reviews the steps or actions taken 

19 by the third party auditor to justify the cer20 tification and determines that the accredited 

21 third-party auditor satisfied the require22 ments under section 801(q) of certifying the 

23 food, or the requirements under paragraph 

24 (2)(B) of certifying the entity. 
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1 ‘‘(7) REACCREDITATION.—The Secretary shall es2 tablish procedures to reinstate the accreditation of a 

3 third-party auditor for which accreditation has been 

4 withdrawn under paragraph (6)— 

5 ‘‘(A) if the Secretary determines, based on 

6 evidence presented, that the third-party auditor 

7 satisfies the requirements of this section and ade8 quate grounds for revocation no longer exist; and 

9 ‘‘(B) in the case of a third-party auditor 

10 accredited by an accreditation body for which 

11 recognition as an accreditation body under sub12 section (b)(1)(C) is revoked— 

13 ‘‘(i) if the third-party auditor becomes 

14 accredited not later than 1 year after rev15 ocation of accreditation under paragraph 

16 (6)(A), through direct accreditation under 

17 subsection (b)(1)(A)(ii) or by an accredita18 tion body in good standing; or 

19 ‘‘(ii) under such conditions as the Sec20 retary may require for a third-party audi21 tor under paragraph (6)(B). 

22 ‘‘(8) NEUTRALIZING COSTS.—The Secretary shall 

23 establish by regulation a reimbursement (user fee) 

24 program, similar to the method described in section 

25 203(h) of the Agriculture Marketing Act of 1946, by 
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1 which the Secretary assesses fees and requires accred2 ited third-party auditors and audit agents to reim3 burse the Food and Drug Administration for the work 

4 performed to establish and administer the accredita5 tion system under this section. The Secretary shall 

6 make operating this program revenue-neutral and 

7 shall not generate surplus revenue from such a reim8 bursement mechanism. Fees authorized under this 

9 paragraph shall be collected and available for obliga10 tion only to the extent and in the amount provided 

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

13 ‘‘(d) RECERTIFICATION OF ELIGIBLE ENTITIES.—An 

14 eligible entity shall apply for annual recertification by an 

15 accredited third-party auditor if such entity— 

16 ‘‘(1) intends to participate in voluntary quali17 fied importer program under section 806; or 

18 ‘‘(2) is required to provide to the Secretary a 

19 certification under section 801(q) for any food from 

20 such entity. 

21 ‘‘(e) FALSE STATEMENTS.—Any statement or rep22 resentation made— 

23 ‘‘(1) by an employee or agent of an eligible enti24 ty to an accredited third-party auditor or audit 

25 agent; or 
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† HR 2751 EAS 

1 ‘‘(2) by an accredited third-party auditor to the 

2 Secretary, 

3 shall be subject to section 1001 of title 18, United States 

4 Code. 

5 ‘‘(f) MONITORING.—To ensure compliance with the re6 quirements of this section, the Secretary shall— 

7 ‘‘(1) periodically, or at least once every 4 years, 

8 reevaluate the accreditation bodies described in sub9 section (b)(1); 

10 ‘‘(2) periodically, or at least once every 4 years, 

11 evaluate the performance of each accredited third12 party auditor, through the review of regulatory audit 

13 reports by such auditors, the compliance history as 

14 available of eligible entities certified by such auditors, 

15 and any other measures deemed necessary by the Sec16 retary; 

17 ‘‘(3) at any time, conduct an onsite audit of any 

18 eligible entity certified by an accredited third-party 

19 auditor, with or without the auditor present; and 

20 ‘‘(4) take any other measures deemed necessary 

21 by the Secretary. 

22 ‘‘(g) PUBLICLY AVAILABLE REGISTRY.—The Secretary 

23 shall establish a publicly available registry of accreditation 

24 bodies and of accredited third-party auditors, including the 

25 name of, contact information for, and other information 
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1 deemed necessary by the Secretary about such bodies and 

2 auditors. 

3 ‘‘(h) LIMITATIONS.— 

4 ‘‘(1) NO EFFECT ON SECTION 704 INSPECTIONS.— 

5 The audits performed under this section shall not be 

6 considered inspections under section 704. 

7 ‘‘(2) NO EFFECT ON INSPECTION AUTHORITY.— 

8 Nothing in this section affects the authority of the 

9 Secretary to inspect any eligible entity pursuant to 

10 this Act.’’. 

11 SEC. 308. FOREIGN OFFICES OF THE FOOD AND DRUG AD12 MINISTRATION. 

13 (a) IN GENERAL.—The Secretary shall establish offices 

14 of the Food and Drug Administration in foreign countries 

15 selected by the Secretary, to provide assistance to the appro16 priate governmental entities of such countries with respect 

17 to measures to provide for the safety of articles of food and 

18 other products regulated by the Food and Drug Administra19 tion exported by such country to the United States, includ20 ing by directly conducting risk-based inspections of such ar21 ticles and supporting such inspections by such govern22 mental entity. 

23 (b) CONSULTATION.—In establishing the foreign offices 

24 described in subsection (a), the Secretary shall consult with 
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1 the Secretary of State, the Secretary of Homeland Security, 

2 and the United States Trade Representative. 

3 (c) REPORT.—Not later than October 1, 2011, the Sec4 retary shall submit to Congress a report on the basis for 

5 the selection by the Secretary of the foreign countries in 

6 which the Secretary established offices, the progress which 

7 such offices have made with respect to assisting the govern8 ments of such countries in providing for the safety of arti9 cles of food and other products regulated by the Food and 

10 Drug Administration exported to the United States, and 

11 the plans of the Secretary for establishing additional foreign 

12 offices of the Food and Drug Administration, as appro13 priate. 

14 SEC. 309. SMUGGLED FOOD. 

15 (a) IN GENERAL.—Not later than 180 days after the 

16 enactment of this Act, the Secretary shall, in coordination 

17 with the Secretary of Homeland Security, develop and im18 plement a strategy to better identify smuggled food and pre19 vent entry of such food into the United States. 

20 (b) NOTIFICATION TO HOMELAND SECURITY.—Not 

21 later than 10 days after the Secretary identifies a smuggled 

22 food that the Secretary believes would cause serious adverse 

23 health consequences or death to humans or animals, the Sec24 retary shall provide to the Secretary of Homeland Security 

25 a notification under section 417(n) of the Federal Food, 
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† HR 2751 EAS 

1 Drug, and Cosmetic Act (21 U.S.C. 350f(k)) describing the 

2 smuggled food and, if available, the names of the individ3 uals or entities that attempted to import such food into the 

4 United States. 

5 (c) PUBLIC NOTIFICATION.—If the Secretary— 

6 (1) identifies a smuggled food; 

7 (2) reasonably believes exposure to the food 

8 would cause serious adverse health consequences or 

9 death to humans or animals; and 

10 (3) reasonably believes that the food has entered 

11 domestic commerce and is likely to be consumed, 

12 the Secretary shall promptly issue a press release describing 

13 that food and shall use other emergency communication or 

14 recall networks, as appropriate, to warn consumers and 

15 vendors about the potential threat. 

16 (d) EFFECT OF SECTION.—Nothing in this section 

17 shall affect the authority of the Secretary to issue public 

18 notifications under other circumstances. 

19 (e) DEFINITION.—In this subsection, the term ‘‘smug20 gled food’’ means any food that a person introduces into 

21 the United States through fraudulent means or with the in22 tent to defraud or mislead. 
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1 TITLE IV—MISCELLANEOUS 

2 PROVISIONS 

3 SEC. 401. FUNDING FOR FOOD SAFETY. 

4 (a) IN GENERAL.—There are authorized to be appro5 priated to carry out the activities of the Center for Food 

6 Safety and Applied Nutrition, the Center for Veterinary 

7 Medicine, and related field activities in the Office of Regu8 latory Affairs of the Food and Drug Administration such 

9 sums as may be necessary for fiscal years 2011 through 

10 2015. 

11 (b) INCREASED NUMBER OF FIELD STAFF.— 

12 (1) IN GENERAL.—To carry out the activities of 

13 the Center for Food Safety and Applied Nutrition, the 

14 Center for Veterinary Medicine, and related field ac15 tivities of the Office of Regulatory Affairs of the Food 

16 and Drug Administration, the Secretary of Health 

17 and Human Services shall increase the field staff of 

18 such Centers and Office with a goal of not fewer 

19 than— 

20 (A) 4,000 staff members in fiscal year 2011; 

21 (B) 4,200 staff members in fiscal year 2012; 

22 (C) 4,600 staff members in fiscal year 2013; 

23 and 

24 (D) 5,000 staff members in fiscal year 2014. 
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1 (2) FIELD STAFF FOR FOOD DEFENSE.—The goal 

2 under paragraph (1) shall include an increase of 150 

3 employees by fiscal year 2011 to— 

4 (A) provide additional detection of and re5 sponse to food defense threats; and 

6 (B) detect, track, and remove smuggled food 

7 (as defined in section 309) from commerce. 

8 SEC. 402. EMPLOYEE PROTECTIONS. 

9 Chapter X of the Federal Food, Drug, and Cosmetic 

10 Act (21 U.S.C. 391 et seq.), as amended by section 209, 

11 is further amended by adding at the end the following: 

12 ‘‘SEC. 1012. EMPLOYEE PROTECTIONS. 

13 ‘‘(a) IN GENERAL.—No entity engaged in the manu14 facture, processing, packing, transporting, distribution, re15 ception, holding, or importation of food may discharge an 

16 employee or otherwise discriminate against an employee 

17 with respect to compensation, terms, conditions, or privi18 leges of employment because the employee, whether at the 

19 employee’s initiative or in the ordinary course of the em20 ployee’s duties (or any person acting pursuant to a request 

21 of the employee)— 

22 ‘‘(1) provided, caused to be provided, or is about 

23 to provide or cause to be provided to the employer, the 

24 Federal Government, or the attorney general of a 

25 State information relating to any violation of, or any 
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† HR 2751 EAS 

1 act or omission the employee reasonably believes to be 

2 a violation of any provision of this Act or any order, 

3 rule, regulation, standard, or ban under this Act, or 

4 any order, rule, regulation, standard, or ban under 

5 this Act; 

6 ‘‘(2) testified or is about to testify in a pro7 ceeding concerning such violation; 

8 ‘‘(3) assisted or participated or is about to assist 

9 or participate in such a proceeding; or 

10 ‘‘(4) objected to, or refused to participate in, any 

11 activity, policy, practice, or assigned task that the 

12 employee (or other such person) reasonably believed to 

13 be in violation of any provision of this Act, or any 

14 order, rule, regulation, standard, or ban under this 

15 Act. 

16 ‘‘(b) PROCESS.— 

17 ‘‘(1) IN GENERAL.—A person who believes that 

18 he or she has been discharged or otherwise discrimi19 nated against by any person in violation of sub20 section (a) may, not later than 180 days after the 

21 date on which such violation occurs, file (or have any 

22 person file on his or her behalf) a complaint with the 

23 Secretary of Labor (referred to in this section as the 

24 ‘Secretary’) alleging such discharge or discrimination 

25 and identifying the person responsible for such act. 
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† HR 2751 EAS 

1 Upon receipt of such a complaint, the Secretary shall 

2 notify, in writing, the person named in the complaint 

3 of the filing of the complaint, of the allegations con4 tained in the complaint, of the substance of evidence 

5 supporting the complaint, and of the opportunities 

6 that will be afforded to such person under paragraph 

7 (2). 

8 ‘‘(2) INVESTIGATION.— 

9 ‘‘(A) IN GENERAL.—Not later than 60 days 

10 after the date of receipt of a complaint filed 

11 under paragraph (1) and after affording the 

12 complainant and the person named in the com13 plaint an opportunity to submit to the Secretary 

14 a written response to the complaint and an op15 portunity to meet with a representative of the 

16 Secretary to present statements from witnesses, 

17 the Secretary shall initiate an investigation and 

18 determine whether there is reasonable cause to 

19 believe that the complaint has merit and notify, 

20 in writing, the complainant and the person al21 leged to have committed a violation of subsection 

22 (a) of the Secretary’s findings. 

23 ‘‘(B) REASONABLE CAUSE FOUND; PRELIMI24 NARY ORDER.—If the Secretary concludes that 

25 there is reasonable cause to believe that a viola-
224 

† HR 2751 EAS 

1 tion of subsection (a) has occurred, the Secretary 

2 shall accompany the Secretary’s findings with a 

3 preliminary order providing the relief prescribed 

4 by paragraph (3)(B). Not later than 30 days 

5 after the date of notification of findings under 

6 this paragraph, the person alleged to have com7 mitted the violation or the complainant may file 

8 objections to the findings or preliminary order, 

9 or both, and request a hearing on the record. The 

10 filing of such objections shall not operate to stay 

11 any reinstatement remedy contained in the pre12 liminary order. Any such hearing shall be con13 ducted expeditiously. If a hearing is not re14 quested in such 30-day period, the preliminary 

15 order shall be deemed a final order that is not 

16 subject to judicial review. 

17 ‘‘(C) DISMISSAL OF COMPLAINT.— 

18 ‘‘(i) STANDARD FOR COMPLAINANT.— 

19 The Secretary shall dismiss a complaint 

20 filed under this subsection and shall not 

21 conduct an investigation otherwise required 

22 under subparagraph (A) unless the com23 plainant makes a prima facie showing that 

24 any behavior described in paragraphs (1) 

25 through (4) of subsection (a) was a contrib-
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† HR 2751 EAS 

1 uting factor in the unfavorable personnel 

2 action alleged in the complaint. 

3 ‘‘(ii) STANDARD FOR EMPLOYER.—Not4 withstanding a finding by the Secretary 

5 that the complainant has made the showing 

6 required under clause (i), no investigation 

7 otherwise required under subparagraph (A) 

8 shall be conducted if the employer dem9 onstrates, by clear and convincing evidence, 

10 that the employer would have taken the 

11 same unfavorable personnel action in the 

12 absence of that behavior. 

13 ‘‘(iii) VIOLATION STANDARD.—The Sec14 retary may determine that a violation of 

15 subsection (a) has occurred only if the com16 plainant demonstrates that any behavior 

17 described in paragraphs (1) through (4) of 

18 subsection (a) was a contributing factor in 

19 the unfavorable personnel action alleged in 

20 the complaint. 

21 ‘‘(iv) RELIEF STANDARD.—Relief may 

22 not be ordered under subparagraph (A) if 

23 the employer demonstrates by clear and con24 vincing evidence that the employer would 
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† HR 2751 EAS 

1 have taken the same unfavorable personnel 

2 action in the absence of that behavior. 

3 ‘‘(3) FINAL ORDER.— 

4 ‘‘(A) IN GENERAL.—Not later than 120 

5 days after the date of conclusion of any hearing 

6 under paragraph (2), the Secretary shall issue a 

7 final order providing the relief prescribed by this 

8 paragraph or denying the complaint. At any 

9 time before issuance of a final order, a pro10 ceeding under this subsection may be terminated 

11 on the basis of a settlement agreement entered 

12 into by the Secretary, the complainant, and the 

13 person alleged to have committed the violation. 

14 ‘‘(B) CONTENT OF ORDER.—If, in response 

15 to a complaint filed under paragraph (1), the 

16 Secretary determines that a violation of sub17 section (a) has occurred, the Secretary shall 

18 order the person who committed such violation— 

19 ‘‘(i) to take affirmative action to abate 

20 the violation; 

21 ‘‘(ii) to reinstate the complainant to 

22 his or her former position together with 

23 compensation (including back pay) and re24 store the terms, conditions, and privileges 

25 associated with his or her employment; and 
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1 ‘‘(iii) to provide compensatory dam2 ages to the complainant. 

3 ‘‘(C) PENALTY.—If such an order is issued 

4 under this paragraph, the Secretary, at the re5 quest of the complainant, shall assess against the 

6 person against whom the order is issued a sum 

7 equal to the aggregate amount of all costs and 

8 expenses (including attorneys’ and expert witness 

9 fees) reasonably incurred, as determined by the 

10 Secretary, by the complainant for, or in connec11 tion with, the bringing of the complaint upon 

12 which the order was issued. 

13 ‘‘(D) BAD FAITH CLAIM.—If the Secretary 

14 finds that a complaint under paragraph (1) is 

15 frivolous or has been brought in bad faith, the 

16 Secretary may award to the prevailing employer 

17 a reasonable attorneys’ fee, not exceeding $1,000, 

18 to be paid by the complainant. 

19 ‘‘(4) ACTION IN COURT.— 

20 ‘‘(A) IN GENERAL.—If the Secretary has not 

21 issued a final decision within 210 days after the 

22 filing of the complaint, or within 90 days after 

23 receiving a written determination, the complain24 ant may bring an action at law or equity for de 

25 novo review in the appropriate district court of 
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† HR 2751 EAS 

1 the United States with jurisdiction, which shall 

2 have jurisdiction over such an action without re3 gard to the amount in controversy, and which 

4 action shall, at the request of either party to such 

5 action, be tried by the court with a jury. The 

6 proceedings shall be governed by the same legal 

7 burdens of proof specified in paragraph (2)(C). 

8 ‘‘(B) RELIEF.—The court shall have juris9 diction to grant all relief necessary to make the 

10 employee whole, including injunctive relief and 

11 compensatory damages, including— 

12 ‘‘(i) reinstatement with the same se13 niority status that the employee would have 

14 had, but for the discharge or discrimina15 tion; 

16 ‘‘(ii) the amount of back pay, with in17 terest; and 

18 ‘‘(iii) compensation for any special 

19 damages sustained as a result of the dis20 charge or discrimination, including litiga21 tion costs, expert witness fees, and reason22 able attorney’s fees. 

23 ‘‘(5) REVIEW.— 

24 ‘‘(A) IN GENERAL.—Unless the complainant 

25 brings an action under paragraph (4), any per-
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† HR 2751 EAS 

1 son adversely affected or aggrieved by a final 

2 order issued under paragraph (3) may obtain re3 view of the order in the United States Court of 

4 Appeals for the circuit in which the violation, 

5 with respect to which the order was issued, alleg6 edly occurred or the circuit in which the com7 plainant resided on the date of such violation. 

8 The petition for review must be filed not later 

9 than 60 days after the date of the issuance of the 

10 final order of the Secretary. Review shall con11 form to chapter 7 of title 5, United States Code. 

12 The commencement of proceedings under this 

13 subparagraph shall not, unless ordered by the 

14 court, operate as a stay of the order. 

15 ‘‘(B) NO JUDICIAL REVIEW.—An order of 

16 the Secretary with respect to which review could 

17 have been obtained under subparagraph (A) shall 

18 not be subject to judicial review in any criminal 

19 or other civil proceeding. 

20 ‘‘(6) FAILURE TO COMPLY WITH ORDER.—When21 ever any person has failed to comply with an order 

22 issued under paragraph (3), the Secretary may file a 

23 civil action in the United States district court for the 

24 district in which the violation was found to occur, or 

25 in the United States district court for the District of 
230 

† HR 2751 EAS 

1 Columbia, to enforce such order. In actions brought 

2 under this paragraph, the district courts shall have 

3 jurisdiction to grant all appropriate relief including, 

4 but not limited to, injunctive relief and compensatory 

5 damages. 

6 ‘‘(7) CIVIL ACTION TO REQUIRE COMPLIANCE.— 

7 ‘‘(A) IN GENERAL.—A person on whose be8 half an order was issued under paragraph (3) 

9 may commence a civil action against the person 

10 to whom such order was issued to require com11 pliance with such order. The appropriate United 

12 States district court shall have jurisdiction, 

13 without regard to the amount in controversy or 

14 the citizenship of the parties, to enforce such 

15 order. 

16 ‘‘(B) AWARD.—The court, in issuing any 

17 final order under this paragraph, may award 

18 costs of litigation (including reasonable attor19 neys’ and expert witness fees) to any party 

20 whenever the court determines such award is ap21 propriate. 

22 ‘‘(c) EFFECT OF SECTION.— 

23 ‘‘(1) OTHER LAWS.—Nothing in this section pre24 empts or diminishes any other safeguards against dis25 crimination, demotion, discharge, suspension, threats, 
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† HR 2751 EAS 

1 harassment, reprimand, retaliation, or any other 

2 manner of discrimination provided by Federal or 

3 State law. 

4 ‘‘(2) RIGHTS OF EMPLOYEES.—Nothing in this 

5 section shall be construed to diminish the rights, 

6 privileges, or remedies of any employee under any 

7 Federal or State law or under any collective bar8 gaining agreement. The rights and remedies in this 

9 section may not be waived by any agreement, policy, 

10 form, or condition of employment. 

11 ‘‘(d) ENFORCEMENT.—Any nondiscretionary duty im12 posed by this section shall be enforceable in a mandamus 

13 proceeding brought under section 1361 of title 28, United 

14 States Code. 

15 ‘‘(e) LIMITATION.—Subsection (a) shall not apply with 

16 respect to an employee of an entity engaged in the manufac17 ture, processing, packing, transporting, distribution, recep18 tion, holding, or importation of food who, acting without 

19 direction from such entity (or such entity’s agent), delib20 erately causes a violation of any requirement relating to 

21 any violation or alleged violation of any order, rule, regula22 tion, standard, or ban under this Act.’’. 

23 SEC. 403. JURISDICTION; AUTHORITIES. 

24 Nothing in this Act, or an amendment made by this 

25 Act, shall be construed to— 
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1 (1) alter the jurisdiction between the Secretary of 

2 Agriculture and the Secretary of Health and Human 

3 Services, under applicable statutes, regulations, or 

4 agreements regarding voluntary inspection of non5 amenable species under the Agricultural Marketing 

6 Act of 1946 (7 U.S.C. 1621 et seq.); 

7 (2) alter the jurisdiction between the Alcohol and 

8 Tobacco Tax and Trade Bureau and the Secretary of 

9 Health and Human Services, under applicable stat10 utes and regulations; 

11 (3) limit the authority of the Secretary of Health 

12 and Human Services under— 

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

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

15 day before the date of enactment of this Act; or 

16 (B) the Public Health Service Act (42 

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

18 the date of enactment of this Act; 

19 (4) alter or limit the authority of the Secretary 

20 of Agriculture under the laws administered by such 

21 Secretary, including— 

22 (A) the Federal Meat Inspection Act (21 

23 U.S.C. 601 et seq.); 

24 (B) the Poultry Products Inspection Act (21 

25 U.S.C. 451 et seq.); 
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† HR 2751 EAS 

1 (C) the Egg Products Inspection Act (21 

2 U.S.C. 1031 et seq.); 

3 (D) the United States Grain Standards Act 

4 (7 U.S.C. 71 et seq.); 

5 (E) the Packers and Stockyards Act, 1921 

6 (7 U.S.C. 181 et seq.); 

7 (F) the United States Warehouse Act (7 

8 U.S.C. 241 et seq.); 

9 (G) the Agricultural Marketing Act of 1946 

10 (7 U.S.C. 1621 et seq.); and 

11 (H) the Agricultural Adjustment Act (7 

12 U.S.C. 601 et seq.), reenacted with the amend13 ments made by the Agricultural Marketing 

14 Agreement Act of 1937; or 

15 (5) alter, impede, or affect the authority of the 

16 Secretary of Homeland Security under the Homeland 

17 Security Act of 2002 (6 U.S.C. 101 et seq.) or any 

18 other statute, including any authority related to se19 curing the borders of the United States, managing 

20 ports of entry, or agricultural import and entry in21 spection activities. 

22 SEC. 404. COMPLIANCE WITH INTERNATIONAL AGREE23 MENTS. 

24 Nothing in this Act (or an amendment made by this 

25 Act) shall be construed in a manner inconsistent with the 
234 

† HR 2751 EAS 

1 agreement establishing the World Trade Organization or 

2 any other treaty or international agreement to which the 

3 United States is a party. 

4 SEC. 405. DETERMINATION OF BUDGETARY EFFECTS. 

5 The budgetary effects of this Act, for the purpose of 

6 complying with the Statutory Pay-As-You-Go-Act of 2010, 

7 shall be determined by reference to the latest statement titled 

8 ‘‘Budgetary Effects of PAYGO Legislation’’ for this Act, 

9 submitted for printing in the Congressional Record by the 

10 Chairman of the Senate Budget Committee, provided that 

11 such statement has been submitted prior to the vote on pas12 sage. 

Amend the title so as to read: ‘‘An Act to amend the 

Federal Food, Drug, and Cosmetic Act with respect to 

the safety of the food supply.’’. 

Attest: 

Secretary. 

111TH CONGRESS 

2D SESSION H.R. 2751 

AMENDMENTS