PUBLIC LAW 111–353—JAN. 4, 2011 124 STAT. 3885 

Public Law 111–353 

111th Congress 

An Act 

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

of the food supply. 

Be it enacted by the Senate and House of Representatives of 

the United States of America in Congress assembled, 

SECTION 1. SHORT TITLE; REFERENCES; TABLE OF CONTENTS. 

(a) SHORT TITLE.—This Act may be cited as the ‘‘FDA Food 

Safety Modernization Act’’. 

(b) REFERENCES.—Except as otherwise specified, whenever in 

this Act an amendment is expressed in terms of an amendment 

to a section or other provision, the reference shall be considered 

to be made to a section or other provision of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). 

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

21 USC 2201 

note. 

FDA Food Safety 

Modernization 

Act. 

Jan. 4, 2011 

[H.R. 2751] 


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124 STAT. 3886 PUBLIC LAW 111–353—JAN. 4, 2011 

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. 

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. 

TITLE I—IMPROVING CAPACITY TO 

PREVENT FOOD SAFETY PROBLEMS 

SEC. 101. INSPECTIONS OF RECORDS. 

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

amended— 

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

‘‘of food is’’ and inserting the following: ‘‘RECORDS INSPECTION.— 

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

belief that an article of food, and any other article of food 

that the Secretary reasonably believes is likely to be affected 

in a similar manner, is’’; 

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

the Secretary reasonably believes is likely to be affected in 

a similar manner,’’ after ‘‘relating to such article’’; 

(3) by striking the last sentence; and 

(4) by inserting at the end the following: 

‘‘(2) USE OF OR EXPOSURE TO FOOD OF CONCERN.—If the 

Secretary believes that there is a reasonable probability that 

the use of or exposure to an article of food, and any other 

article of food that the Secretary reasonably believes is likely 

to be affected in a similar manner, will cause serious adverse 

health consequences or death to humans or animals, each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports such article 

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

by the Secretary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such 

person, at reasonable times and within reasonable limits and 

in a reasonable manner, to have access to and copy all records 

relating to such article and to any other article of food that 

the Secretary reasonably believes is likely to be affected in 

a similar manner, that are needed to assist the Secretary 

in determining whether there is a reasonable probability that 

the use of or exposure to the food will cause serious adverse 

health consequences or death to humans or animals. 

‘‘(3) APPLICATION.—The requirement under paragraphs (1) 

and (2) applies to all records relating to the manufacture, 

processing, packing, distribution, receipt, holding, or importation of such article maintained by or on behalf of such person 

Notice. 


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PUBLIC LAW 111–353—JAN. 4, 2011 124 STAT. 3887 

in any format (including paper and electronic formats) and 

at any location.’’. 

(b) CONFORMING AMENDMENT.—Section 704(a)(1)(B) (21 U.S.C. 

374(a)(1)(B)) is amended by striking ‘‘section 414 when’’ and all 

that follows through ‘‘subject to’’ and inserting ‘‘section 414, when 

the standard for records inspection under paragraph (1) or (2) 

of section 414(a) applies, subject to’’. 

SEC. 102. REGISTRATION OF FOOD FACILITIES. 

(a) UPDATING OF FOOD CATEGORY REGULATIONS; BIENNIAL REGISTRATION RENEWAL.—Section 415(a) (21 U.S.C. 350d(a)) is 

amended— 

(1) in paragraph (2), by— 

(A) striking ‘‘conducts business and’’ and inserting ‘‘conducts business, the e-mail address for the contact person 

of the facility or, in the case of a foreign facility, the 

United States agent for the facility, and’’; and 

(B) inserting ‘‘, or any other food categories as determined appropriate by the Secretary, including by guidance’’ 

after ‘‘Code of Federal Regulations’’; 

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

(4) and (5), respectively; and 

(3) by inserting after paragraph (2) the following: 

‘‘(3) BIENNIAL REGISTRATION RENEWAL.—During the period 

beginning on October 1 and ending on December 31 of each 

even-numbered year, a registrant that has submitted a registration under paragraph (1) shall submit to the Secretary a 

renewal registration containing the information described in 

paragraph (2). The Secretary shall provide for an abbreviated 

registration renewal process for any registrant that has not 

had any changes to such information since the registrant submitted the preceding registration or registration renewal for 

the facility involved.’’. 

(b) SUSPENSION OF REGISTRATION.— 

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

amended— 

(A) in subsection (a)(2), by inserting after the first 

sentence the following: ‘‘The registration shall contain an 

assurance that the Secretary will be permitted to inspect 

such facility at the times and in the manner permitted 

by this Act.’’; 

(B) by redesignating subsections (b) and (c) as subsections (c) and (d), respectively; and 

(C) by inserting after subsection (a) the following: 

‘‘(b) SUSPENSION OF REGISTRATION.— 

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

manufactured, processed, packed, received, or held by a facility 

registered under this section has a reasonable probability of 

causing serious adverse health consequences or death to 

humans or animals, the Secretary may by order suspend the 

registration of a facility— 

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

for such reasonable probability; or 

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

reasonable probability; and 

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

Time period. 


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124 STAT. 3888 PUBLIC LAW 111–353—JAN. 4, 2011 

‘‘(2) HEARING ON SUSPENSION.—The Secretary shall provide 

the registrant subject to an order under paragraph (1) with 

an opportunity for an informal hearing, to be held as soon 

as possible but not later than 2 business days after the issuance 

of the order or such other time period, as agreed upon by 

the Secretary and the registrant, on the actions required for 

reinstatement of registration and why the registration that 

is subject to suspension should be reinstated. The Secretary 

shall reinstate a registration if the Secretary determines, based 

on evidence presented, that adequate grounds do not exist 

to continue the suspension of the registration. 

‘‘(3) POST-HEARING CORRECTIVE ACTION PLAN; VACATING OF

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

opportunity for an informal hearing under paragraph (2), 

the Secretary determines that the suspension of registration remains necessary, the Secretary shall require the 

registrant to submit a corrective action plan to demonstrate 

how the registrant plans to correct the conditions found 

by the Secretary. The Secretary shall review such plan 

not later than 14 days after the submission of the corrective 

action plan or such other time period as determined by 

the Secretary. 

‘‘(B) VACATING OF ORDER.—Upon a determination by 

the Secretary that adequate grounds do not exist to continue the suspension actions required by the order, or 

that such actions should be modified, the Secretary shall 

promptly vacate the order and reinstate the registration 

of the facility subject to the order or modify the order, 

as appropriate. 

‘‘(4) EFFECT OF SUSPENSION.—If the registration of a facility 

is suspended under this subsection, no person shall import 

or export food into the United States from such facility, offer 

to import or export food into the United States from such 

facility, or otherwise introduce food from such facility into 

interstate or intrastate commerce in the United States. 

‘‘(5) REGULATIONS.— 

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

regulations to implement this subsection. The Secretary 

may promulgate such regulations on an interim final basis. 

‘‘(B) REGISTRATION REQUIREMENT.—The Secretary may 

require that registration under this section be submitted 

in an electronic format. Such requirement may not take 

effect before the date that is 5 years after the date of 

enactment of the FDA Food Safety Modernization Act. 

‘‘(6) APPLICATION DATE.—Facilities shall be subject to the 

requirements of this subsection beginning on the earlier of— 

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

under paragraph (5); or 

‘‘(B) 180 days after the date of enactment of the FDA 

Food Safety Modernization Act. 

‘‘(7) NO DELEGATION.—The authority conferred by this subsection to issue an order to suspend a registration or vacate 

an order of suspension shall not be delegated to any officer 

or employee other than the Commissioner.’’. 

(2) SMALL ENTITY COMPLIANCE POLICY GUIDE.—Not later 

than 180 days after the issuance of the regulations promulgated 

Deadline. 

21 USC 350d 

note. 

Effective dates. 

Deadline. 

Deadline. 


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PUBLIC LAW 111–353—JAN. 4, 2011 124 STAT. 3889 

under section 415(b)(5) of the Federal Food, Drug, and Cosmetic 

Act (as added by this section), the Secretary shall issue a 

small entity compliance policy guide setting forth in plain language the requirements of such regulations to assist small 

entities in complying with registration requirements and other 

activities required under such section. 

(3) IMPORTED FOOD.—Section 801(l) (21 U.S.C. 381(l)) is 

amended by inserting ‘‘(or for which a registration has been 

suspended under such section)’’ after ‘‘section 415’’. 

(c) CLARIFICATION OF INTENT.— (1) RETAIL FOOD ESTABLISHMENT.—The Secretary shall 

amend the definition of the term ‘‘retail food establishment’’ 

in section in 1.227(b)(11) of title 21, Code of Federal Regulations 

to clarify that, in determining the primary function of an 

establishment or a retail food establishment under such section, 

the sale of food products directly to consumers by such 

establishment and the sale of food directly to consumers by 

such retail food establishment include— 

(A) the sale of such food products or food directly 

to consumers by such establishment at a roadside stand 

or farmers’ market where such stand or market is located 

other than where the food was manufactured or processed; 

(B) the sale and distribution of such food through a 

community supported agriculture program; and 

(C) the sale and distribution of such food at any other 

such direct sales platform as determined by the Secretary. 

(2) DEFINITIONS.—For purposes of paragraph (1)— 

(A) the term ‘‘community supported agriculture program’’ has the same meaning given the term ‘‘community 

supported agriculture (CSA) program’’ in section 249.2 of 

title 7, Code of Federal Regulations (or any successor regulation); and 

(B) the term ‘‘consumer’’ does not include a business. 

(d) CONFORMING AMENDMENTS.— 

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

inserting ‘‘415,’’ after ‘‘404,’’. 

(2) Section 415(d), as redesignated by subsection (b), is 

amended by adding at the end before the period ‘‘for a facility 

to be registered, except with respect to the reinstatement of 

a registration that is suspended under subsection (b)’’. 

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

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

by adding at the end the following: 

‘‘SEC. 418. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS. 

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

of a facility shall, in accordance with this section, evaluate the 

hazards that could affect food manufactured, processed, packed, 

or held by such facility, identify and implement preventive controls 

to significantly minimize or prevent the occurrence of such hazards 

and provide assurances that such food is not adulterated under 

section 402 or misbranded under section 403(w), monitor the 

performance of those controls, and maintain records of this monitoring as a matter of routine practice. 

21 USC 350g. 

21 USC 350d. 

21 USC 350d 

note. 


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124 STAT. 3890 PUBLIC LAW 111–353—JAN. 4, 2011 

‘‘(b) HAZARD ANALYSIS.—The owner, operator, or agent in charge 

of a facility shall— 

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

hazards that may be associated with the facility, including— 

‘‘(A) biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, and unapproved food and color 

additives; and 

‘‘(B) hazards that occur naturally, or may be unintentionally introduced; and 

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

introduced, including by acts of terrorism; and 

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

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

charge of a facility shall identify and implement preventive controls, 

including at critical control points, if any, to provide assurances 

that— 

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

under subsection (b)(1) will be significantly minimized or prevented; 

‘‘(2) any hazards identified in the hazard analysis conducted 

under subsection (b)(2) will be significantly minimized or prevented and addressed, consistent with section 420, as 

applicable; and 

‘‘(3) the food manufactured, processed, packed, or held by 

such facility will not be adulterated under section 402 or misbranded under section 403(w). 

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

agent in charge of a facility shall monitor the effectiveness of 

the preventive controls implemented under subsection (c) to provide 

assurances that the outcomes described in subsection (c) shall be 

achieved. 

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

charge of a facility shall establish procedures to ensure that, if 

the preventive controls implemented under subsection (c) are not 

properly implemented or are found to be ineffective— 

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

of recurrence of the implementation failure; 

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

‘‘(3) all affected food is prevented from entering into commerce if the owner, operator or agent in charge of such facility 

cannot ensure that the affected food is not adulterated under 

section 402 or misbranded under section 403(w). 

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

of a facility shall verify that— 

‘‘(1) the preventive controls implemented under subsection 

(c) are adequate to control the hazards identified under subsection (b); 

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

in accordance with subsection (d); 

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

decisions about corrective actions taken under subsection (e); 

‘‘(4) the preventive controls implemented under subsection 

(c) are effectively and significantly minimizing or preventing 

the occurrence of identified hazards, including through the 

use of environmental and product testing programs and other 

appropriate means; and 

Procedures. 


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PUBLIC LAW 111–353—JAN. 4, 2011 124 STAT. 3891 

‘‘(5) there is documented, periodic reanalysis of the plan 

under subsection (i) to ensure that the plan is still relevant 

to the raw materials, conditions and processes in the facility, 

and new and emerging threats. 

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

of a facility shall maintain, for not less than 2 years, records 

documenting the monitoring of the preventive controls implemented 

under subsection (c), instances of nonconformance material to food 

safety, the results of testing and other appropriate means of 

verification under subsection (f)(4), instances when corrective 

actions were implemented, and the efficacy of preventive controls 

and corrective actions. 

‘‘(h) WRITTEN PLAN AND DOCUMENTATION.—The owner, operator, or agent in charge of a facility shall prepare a written plan 

that documents and describes the procedures used by the facility 

to comply with the requirements of this section, including analyzing 

the hazards under subsection (b) and identifying the preventive 

controls adopted under subsection (c) to address those hazards. 

Such written plan, together with the documentation described in 

subsection (g), shall be made promptly available to a duly authorized 

representative of the Secretary upon oral or written request. 

‘‘(i) REQUIREMENT TO REANALYZE.—The owner, operator, or 

agent in charge of a facility shall conduct a reanalysis under subsection (b) whenever a significant change is made in the activities 

conducted at a facility operated by such owner, operator, or agent 

if the change creates a reasonable potential for a new hazard 

or a significant increase in a previously identified hazard or not 

less frequently than once every 3 years, whichever is earlier. Such 

reanalysis shall be completed and additional preventive controls 

needed to address the hazard identified, if any, shall be implemented before the change in activities at the facility is operative. 

Such owner, operator, or agent shall revise the written plan 

required under subsection (h) if such a significant change is made 

or document the basis for the conclusion that no additional or 

revised preventive controls are needed. The Secretary may require 

a reanalysis under this section to respond to new hazards and 

developments in scientific understanding, including, as appropriate, 

results from the Department of Homeland Security biological, chemical, radiological, or other terrorism risk assessment. 

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

FOOD FACILITIES SUBJECT TO HACCP.— 

‘‘(1) IN GENERAL.—This section shall not apply to a facility 

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

required to comply with, and is in compliance with, 1 of the 

following standards and regulations with respect to such 

facility: 

‘‘(A) The Seafood Hazard Analysis Critical Control 

Points Program of the Food and Drug Administration. 

‘‘(B) The Juice Hazard Analysis Critical Control Points 

Program of the Food and Drug Administration. 

‘‘(C) The Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards of the 

Food and Drug Administration (or any successor standards). 

‘‘(2) APPLICABILITY.—The exemption under paragraph (1)(C) 

shall apply only with respect to microbiological hazards that 

are regulated under the standards for Thermally Processed 

Deadline. 

Time period. 


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124 STAT. 3892 PUBLIC LAW 111–353—JAN. 4, 2011 

Low-Acid Foods Packaged in Hermetically Sealed Containers 

under part 113 of chapter 21, Code of Federal Regulations 

(or any successor regulations). 

‘‘(k) EXCEPTION FOR ACTIVITIES OF FACILITIES SUBJECT TO SECTION 419.—This section shall not apply to activities of a facility 

that are subject to section 419. 

‘‘(l) MODIFIED REQUIREMENTS FOR QUALIFIED FACILITIES.— 

‘‘(1) QUALIFIED FACILITIES.— 

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

purposes of this subsection if the facility meets the conditions under subparagraph (B) or (C). 

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

facility under this subparagraph— 

‘‘(i) if the facility, including any subsidiary or affiliate of the facility, is, collectively, a very small business 

(as defined in the regulations promulgated under subsection (n)); and 

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

or affiliate of an entity, if such subsidiaries or affiliates, 

are, collectively, a very small business (as so defined). 

‘‘(C) LIMITED ANNUAL MONETARY VALUE OF SALES.— 

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

under this subparagraph if clause (ii) applies— 

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

or affiliate of the facility, collectively; and 

‘‘(II) to the subsidiaries or affiliates, collectively, of any entity of which the facility is a subsidiary or affiliate. 

‘‘(ii) AVERAGE ANNUAL MONETARY VALUE.—This 

clause applies if— 

‘‘(I) during the 3-year period preceding the 

applicable calendar year, the average annual 

monetary value of the food manufactured, processed, packed, or held at such facility (or the collective average annual monetary value of such food 

at any subsidiary or affiliate, as described in clause 

(i)) that is sold directly to qualified end-users 

during such period exceeded the average annual 

monetary value of the food manufactured, processed, packed, or held at such facility (or the collective average annual monetary value of such food 

at any subsidiary or affiliate, as so described) sold 

by such facility (or collectively by any such subsidiary or affiliate) to all other purchasers during 

such period; and 

‘‘(II) the average annual monetary value of 

all food sold by such facility (or the collective average annual monetary value of such food sold by 

any subsidiary or affiliate, as described in clause 

(i)) during such period was less than $500,000, 

adjusted for inflation. 

‘‘(2) EXEMPTION.—A qualified facility— 

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

subsections (a) through (i) and subsection (n) in an 

applicable calendar year; and 

‘‘(B) shall submit to the Secretary— 

Applicability. 


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PUBLIC LAW 111–353—JAN. 4, 2011 124 STAT. 3893 

‘‘(i)(I) documentation that demonstrates that the 

owner, operator, or agent in charge of the facility has 

identified potential hazards associated with the food 

being produced, is implementing preventive controls 

to address the hazards, and is monitoring the preventive controls to ensure that such controls are effective; 

or 

‘‘(II) documentation (which may include licenses, 

inspection reports, certificates, permits, credentials, 

certification by an appropriate agency (such as a State 

department of agriculture), or other evidence of oversight), as specified by the Secretary, that the facility 

is in compliance with State, local, county, or other 

applicable non-Federal food safety law; and 

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

in a guidance document issued not later than 1 year 

after the date of enactment of this section, that the 

facility is a qualified facility under paragraph (1)(B) 

or (1)(C). 

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

‘‘(A) IN GENERAL.—In the event of an active investigation of a foodborne illness outbreak that is directly linked 

to a qualified facility subject to an exemption under this 

subsection, or if the Secretary determines that it is necessary to protect the public health and prevent or mitigate 

a foodborne illness outbreak based on conduct or conditions 

associated with a qualified facility that are material to 

the safety of the food manufactured, processed, packed, 

or held at such facility, the Secretary may withdraw the 

exemption provided to such facility under this subsection. 

‘‘(B) RULE OF CONSTRUCTION.—Nothing in this subsection shall be construed to expand or limit the inspection 

authority of the Secretary. 

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

‘‘(A) AFFILIATE.—The term ‘affiliate’ means any facility 

that controls, is controlled by, or is under common control 

with another facility. 

‘‘(B) QUALIFIED END-USER.—The term ‘qualified enduser’, with respect to a food, means— 

‘‘(i) the consumer of the food; or 

‘‘(ii) a restaurant or retail food establishment (as 

those terms are defined by the Secretary for purposes 

of section 415) that— 

‘‘(I) is located— 

‘‘(aa) in the same State as the qualified 

facility that sold the food to such restaurant 

or establishment; or 

‘‘(bb) not more than 275 miles from such 

facility; and 

‘‘(II) is purchasing the food for sale directly 

to consumers at such restaurant or retail food 

establishment. 

‘‘(C) CONSUMER.—For purposes of subparagraph (B), 

the term ‘consumer’ does not include a business. 

‘‘(D) SUBSIDIARY.—The term ‘subsidiary’ means any 

company which is owned or controlled directly or indirectly 

by another company. 

Deadline. 


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124 STAT. 3894 PUBLIC LAW 111–353—JAN. 4, 2011 

‘‘(5) STUDY.— ‘‘(A) IN GENERAL.—The Secretary, in consultation with 

the Secretary of Agriculture, shall conduct a study of the 

food processing sector regulated by the Secretary to determine— 

‘‘(i) the distribution of food production by type and 

size of operation, including monetary value of food 

sold; 

‘‘(ii) the proportion of food produced by each type 

and size of operation; 

‘‘(iii) the number and types of food facilities colocated on farms, including the number and proportion 

by commodity and by manufacturing or processing 

activity; 

‘‘(iv) the incidence of foodborne illness originating 

from each size and type of operation and the type 

of food facilities for which no reported or known hazard 

exists; and 

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

with commingling, processing, transporting, and 

storing food and raw agricultural commodities, 

including differences in risk based on the scale and 

duration of such activities. 

‘‘(B) SIZE.—The results of the study conducted under 

subparagraph (A) shall include the information necessary 

to enable the Secretary to define the terms ‘small business’ 

and ‘very small business’, for purposes of promulgating 

the regulation under subsection (n). In defining such terms, 

the Secretary shall include consideration of harvestable 

acres, income, the number of employees, and the volume 

of food harvested. 

‘‘(C) SUBMISSION OF REPORT.—Not later than 18 months 

after the date of enactment the FDA Food Safety Modernization Act, the Secretary shall submit to Congress a 

report that describes the results of the study conducted 

under subparagraph (A). 

‘‘(6) NO PREEMPTION.—Nothing in this subsection preempts 

State, local, county, or other non-Federal law regarding the 

safe production of food. Compliance with this subsection shall 

not relieve any person from liability at common law or under 

State statutory law. 

‘‘(7) NOTIFICATION TO CONSUMERS.— 

‘‘(A) IN GENERAL.—A qualified facility that is exempt 

from the requirements under subsections (a) through (i) 

and subsection (n) and does not prepare documentation 

under paragraph (2)(B)(i)(I) shall— 

‘‘(i) with respect to a food for which a food packaging label is required by the Secretary under any 

other provision of this Act, include prominently and 

conspicuously on such label the name and business 

address of the facility where the food was manufactured or processed; or 

‘‘(ii) with respect to a food for which a food packaging label is not required by the Secretary under 

any other provisions of this Act, prominently and 

conspicuously display, at the point of purchase, the 

name and business address of the facility where the 


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PUBLIC LAW 111–353—JAN. 4, 2011 124 STAT. 3895 

food was manufactured or processed, on a label, poster, 

sign, placard, or documents delivered contemporaneously with the food in the normal course of business, 

or, in the case of Internet sales, in an electronic notice. 

‘‘(B) NO ADDITIONAL LABEL.—Subparagraph (A) does 

not provide authority to the Secretary to require a label 

that is in addition to any label required under any other 

provision of this Act. 

‘‘(m) AUTHORITY WITH RESPECT TO CERTAIN FACILITIES.—The 

Secretary may, by regulation, exempt or modify the requirements 

for compliance under this section with respect to facilities that 

are solely engaged in the production of food for animals other 

than man, the storage of raw agricultural commodities (other than 

fruits and vegetables) intended for further distribution or processing, or the storage of packaged foods that are not exposed to 

the environment. 

‘‘(n) REGULATIONS.— 

‘‘(1) IN GENERAL.—Not later than 18 months after the date 

of enactment of the FDA Food Safety Modernization Act, the 

Secretary shall promulgate regulations— 

‘‘(A) to establish science-based minimum standards for 

conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting the 

implementation of the preventive controls under this section; and 

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

‘small business’ and ‘very small business’, taking into 

consideration the study described in subsection (l)(5). 

‘‘(2) COORDINATION.—In promulgating the regulations 

under paragraph (1)(A), with regard to hazards that may be 

intentionally introduced, including by acts of terrorism, the 

Secretary shall coordinate with the Secretary of Homeland 

Security, as appropriate. 

‘‘(3) CONTENT.—The regulations promulgated under paragraph (1)(A) shall— 

‘‘(A) provide sufficient flexibility to be practicable for 

all sizes and types of facilities, including small businesses 

such as a small food processing facility co-located on a 

farm; 

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

Code (commonly known as the ‘Paperwork Reduction Act’), 

with special attention to minimizing the burden (as defined 

in section 3502(2) of such Act) on the facility, and collection 

of information (as defined in section 3502(3) of such Act), 

associated with such regulations; 

‘‘(C) acknowledge differences in risk and minimize, as 

appropriate, the number of separate standards that apply 

to separate foods; and 

‘‘(D) not require a facility to hire a consultant or other 

third party to identify, implement, certify, or audit 

preventative controls, except in the case of negotiated 

enforcement resolutions that may require such a consultant 

or third party. 

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

shall be construed to provide the Secretary with the authority 

to prescribe specific technologies, practices, or critical controls 

for an individual facility. 

Deadline. 


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‘‘(5) REVIEW.—In promulgating the regulations under paragraph (1)(A), the Secretary shall review regulatory hazard analysis and preventive control programs in existence on the date 

of enactment of the FDA Food Safety Modernization Act, 

including the Grade ‘A’ Pasteurized Milk Ordinance to ensure 

that such regulations are consistent, to the extent practicable, 

with applicable domestic and internationally-recognized standards in existence on such date. 

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

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

point’ means a point, step, or procedure in a food process 

at which control can be applied and is essential to prevent 

or eliminate a food safety hazard or reduce such hazard to 

an acceptable level. 

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

or a foreign facility that is required to register under section 

415. 

‘‘(3) PREVENTIVE CONTROLS.—The term ‘preventive controls’ 

means those risk-based, reasonably appropriate procedures, 

practices, and processes that a person knowledgeable about 

the safe manufacturing, processing, packing, or holding of food 

would employ to significantly minimize or prevent the hazards 

identified under the hazard analysis conducted under subsection (b) and that are consistent with the current scientific 

understanding of safe food manufacturing, processing, packing, 

or holding at the time of the analysis. Those procedures, practices, and processes may include the following: 

‘‘(A) Sanitation procedures for food contact surfaces 

and utensils and food-contact surfaces of equipment. 

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

training. 

‘‘(C) An environmental monitoring program to verify 

the effectiveness of pathogen controls in processes where 

a food is exposed to a potential contaminant in the environment. 

‘‘(D) A food allergen control program. 

‘‘(E) A recall plan. 

‘‘(F) Current Good Manufacturing Practices (cGMPs) 

under part 110 of title 21, Code of Federal Regulations 

(or any successor regulations). 

‘‘(G) Supplier verification activities that relate to the 

safety of food.’’. 

(b) GUIDANCE DOCUMENT.—The Secretary shall issue a guidance document related to the regulations promulgated under subsection (b)(1) with respect to the hazard analysis and preventive 

controls under section 418 of the Federal Food, Drug, and Cosmetic 

Act (as added by subsection (a)). 

(c) RULEMAKING.— 

(1) PROPOSED RULEMAKING.— 

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

date of enactment of this Act, the Secretary of Health 

and Human Services (referred to in this subsection as 

the ‘‘Secretary’’) shall publish a notice of proposed rulemaking in the Federal Register to promulgate regulations 

with respect to— 

(i) activities that constitute on-farm packing or 

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

Deadline. 

Federal Register, 

publication. 

Notice. 

21 USC 350d 

note. 

21 USC 350g 

note. 


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on such farm or another farm under the same ownership for purposes of section 415 of the Federal Food, 

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

by this Act; and 

(ii) activities that constitute on-farm manufacturing or processing of food that is not consumed on 

that farm or on another farm under common ownership 

for purposes of such section 415. 

(B) CLARIFICATION.—The rulemaking described under 

subparagraph (A) shall enhance the implementation of such 

section 415 and clarify the activities that are included 

as part of the definition of the term ‘‘facility’’ under such 

section 415. Nothing in this Act authorizes the Secretary 

to modify the definition of the term ‘‘facility’’ under such 

section. 

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

regulations under subparagraph (A), the Secretary shall 

conduct a science-based risk analysis of— 

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

of food that is not grown, raised, or consumed on 

such farm or another farm under the same ownership, 

as such packing and holding relates to specific foods; 

and 

(ii) specific on-farm manufacturing and processing 

activities as such activities relate to specific foods that 

are not consumed on that farm or on another farm 

under common ownership. 

(D) AUTHORITY WITH RESPECT TO CERTAIN FACILITIES.— 

(i) IN GENERAL.—In promulgating the regulations 

under subparagraph (A), the Secretary shall consider 

the results of the science-based risk analysis conducted 

under subparagraph (C), and shall exempt certain 

facilities from the requirements in section 418 of the 

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

this section), including hazard analysis and preventive 

controls, and the mandatory inspection frequency in 

section 421 of such Act (as added by section 201), 

or modify the requirements in such sections 418 or 

421, as the Secretary determines appropriate, if such 

facilities are engaged only in specific types of on-farm 

manufacturing, processing, packing, or holding activities that the Secretary determines to be low risk 

involving specific foods the Secretary determines to 

be low risk. 

(ii) LIMITATION.—The exemptions or modifications 

under clause (i) shall not include an exemption from 

the requirement to register under section 415 of the 

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

as amended by this Act, if applicable, and shall apply 

only to small businesses and very small businesses, 

as defined in the regulation promulgated under section 

418(n) of the Federal Food, Drug, and Cosmetic Act 

(as added under subsection (a)). 

(2) FINAL REGULATIONS.—Not later than 9 months after 

the close of the comment period for the proposed rulemaking 

under paragraph (1), the Secretary shall adopt final rules with 

respect to— 

Applicability. 


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(A) activities that constitute on-farm packing or holding 

of food that is not grown, raised, or consumed on such 

farm or another farm under the same ownership for purposes of section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d), as amended by this Act; 

(B) activities that constitute on-farm manufacturing 

or processing of food that is not consumed on that farm 

or on another farm under common ownership for purposes 

of such section 415; and 

(C) the requirements under sections 418 and 421 of 

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

this Act, from which the Secretary may issue exemptions 

or modifications of the requirements for certain types of 

facilities. 

(d) SMALL ENTITY COMPLIANCE POLICY GUIDE.—Not later than 

180 days after the issuance of the regulations promulgated under 

subsection (n) of section 418 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)), the Secretary shall issue 

a small entity compliance policy guide setting forth in plain language the requirements of such section 418 and this section to 

assist small entities in complying with the hazard analysis and 

other activities required under such section 418 and this section. 

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

by adding at the end the following: 

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

packs, or holds food for sale in the United States if the owner, 

operator, or agent in charge of such facility is not in compliance 

with section 418.’’. 

(f) NO EFFECT ON HACCP AUTHORITIES.—Nothing in the 

amendments made by this section limits the authority of the Secretary under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

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

seq.) to revise, issue, or enforce Hazard Analysis Critical Control 

programs and the Thermally Processed Low-Acid Foods Packaged 

in Hermetically Sealed Containers standards. 

(g) DIETARY SUPPLEMENTS.—Nothing in the amendments made 

by this section shall apply to any facility with regard to the manufacturing, processing, packing, or holding of a dietary supplement 

that is in compliance with the requirements of sections 402(g)(2) 

and 761 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

342(g)(2), 379aa–1). 

(h) UPDATING GUIDANCE RELATING TO FISH AND FISHERIES

PRODUCTS HAZARDS AND CONTROLS.—The Secretary shall, not later 

than 180 days after the date of enactment of this Act, update 

the Fish and Fisheries Products Hazards and Control Guidance 

to take into account advances in technology that have occurred 

since the previous publication of such Guidance by the Secretary. 

(i) EFFECTIVE DATES.— 

(1) GENERAL RULE.—The amendments made by this section 

shall take effect 18 months after the date of enactment of 

this Act. 

(2) FLEXIBILITY FOR SMALL BUSINESSES.—Notwithstanding 

paragraph (1)— 

(A) the amendments made by this section shall apply 

to a small business (as defined in the regulations promulgated under section 418(n) of the Federal Food, Drug, and 

Cosmetic Act (as added by this section)) beginning on the 

Applicability. 

Effective dates. 

21 USC 350g. 

Deadline. 

21 USC 342 note. 

Applicability. 

21 USC 350g 

note. 

21 USC 350g 

note. 

Deadline. 

21 USC 350g 

note. 


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date that is 6 months after the effective date of such 

regulations; and 

(B) the amendments made by this section shall apply 

to a very small business (as defined in such regulations) 

beginning on the date that is 18 months after the effective 

date of such regulations. 

SEC. 104. PERFORMANCE STANDARDS. 

(a) IN GENERAL.—The Secretary shall, in coordination with 

the Secretary of Agriculture, not less frequently than every 2 years, 

review and evaluate relevant health data and other relevant 

information, including from toxicological and epidemiological studies 

and analyses, current Good Manufacturing Practices issued by the 

Secretary relating to food, and relevant recommendations of relevant advisory committees, including the Food Advisory Committee, 

to determine the most significant foodborne contaminants. 

(b) GUIDANCE DOCUMENTS AND REGULATIONS.—Based on the 

review and evaluation conducted under subsection (a), and when 

appropriate to reduce the risk of serious illness or death to humans 

or animals or to prevent adulteration of the food under section 

402 of the Federal Food, Drug, or Cosmetic Act (21 U.S.C. 342) 

or to prevent the spread by food of communicable disease under 

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

Secretary shall issue contaminant-specific and science-based guidance documents, including guidance documents regarding action 

levels, or regulations. Such guidance, including guidance regarding 

action levels, or regulations— 

(1) shall apply to products or product classes; 

(2) shall, where appropriate, differentiate between food for 

human consumption and food intended for consumption by animals other than humans; and 

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

(c) NO DUPLICATION OF EFFORTS.—The Secretary shall coordinate with the Secretary of Agriculture to avoid issuing duplicative 

guidance on the same contaminants. 

(d) REVIEW.—The Secretary shall periodically review and revise, 

as appropriate, the guidance documents, including guidance documents regarding action levels, or regulations promulgated under 

this section. 

SEC. 105. STANDARDS FOR PRODUCE SAFETY. 

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

amended by section 103, is amended by adding at the end the 

following: 

‘‘SEC. 419. STANDARDS FOR PRODUCE SAFETY. 

‘‘(a) PROPOSED RULEMAKING.— 

‘‘(1) IN GENERAL.— 

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

date of enactment of the FDA Food Safety Modernization 

Act, the Secretary, in coordination with the Secretary of 

Agriculture and representatives of State departments of 

agriculture (including with regard to the national organic 

program established under the Organic Foods Production 

Act of 1990), and in consultation with the Secretary of 

Homeland Security, shall publish a notice of proposed rulemaking to establish science-based minimum standards for 

the safe production and harvesting of those types of fruits 

Deadline. 

Publication. 

Notice. 

21 USC 350h. 

Applicability. 

Deadline. 

21 USC 2201. 


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and vegetables, including specific mixes or categories of 

fruits and vegetables, that are raw agricultural commodities for which the Secretary has determined that such 

standards minimize the risk of serious adverse health consequences or death. 

‘‘(B) DETERMINATION BY SECRETARY.—With respect to 

small businesses and very small businesses (as such terms 

are defined in the regulation promulgated under subparagraph (A)) that produce and harvest those types of fruits 

and vegetables that are raw agricultural commodities that 

the Secretary has determined are low risk and do not 

present a risk of serious adverse health consequences or 

death, the Secretary may determine not to include production and harvesting of such fruits and vegetables in such 

rulemaking, or may modify the applicable requirements 

of regulations promulgated pursuant to this section. 

‘‘(2) PUBLIC INPUT.—During the comment period on the 

notice of proposed rulemaking under paragraph (1), the Secretary shall conduct not less than 3 public meetings in diverse 

geographical areas of the United States to provide persons 

in different regions an opportunity to comment. 

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

(1) shall— 

‘‘(A) provide sufficient flexibility to be applicable to 

various types of entities engaged in the production and 

harvesting of fruits and vegetables that are raw agricultural commodities, including small businesses and entities 

that sell directly to consumers, and be appropriate to the 

scale and diversity of the production and harvesting of 

such commodities; 

‘‘(B) include, with respect to growing, harvesting, 

sorting, packing, and storage operations, science-based minimum standards related to soil amendments, hygiene, packaging, temperature controls, animals in the growing area, 

and water; 

‘‘(C) consider hazards that occur naturally, may be 

unintentionally introduced, or may be intentionally introduced, including by acts of terrorism; 

‘‘(D) take into consideration, consistent with ensuring 

enforceable public health protection, conservation and 

environmental practice standards and policies established 

by Federal natural resource conservation, wildlife conservation, and environmental agencies; 

‘‘(E) in the case of production that is certified organic, 

not include any requirements that conflict with or duplicate 

the requirements of the national organic program established under the Organic Foods Production Act of 1990, 

while providing the same level of public health protection 

as the requirements under guidance documents, including 

guidance documents regarding action levels, and regulations under the FDA Food Safety Modernization Act; and 

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

‘small business’ and ‘very small business’. 

‘‘(4) PRIORITIZATION.—The Secretary shall prioritize the 

implementation of the regulations under this section for specific 

fruits and vegetables that are raw agricultural commodities 


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based on known risks which may include a history and severity 

of foodborne illness outbreaks. 

‘‘(b) FINAL REGULATION.— 

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

of the comment period for the proposed rulemaking under subsection (a), the Secretary shall adopt a final regulation to 

provide for minimum science-based standards for those types 

of fruits and vegetables, including specific mixes or categories 

of fruits or vegetables, that are raw agricultural commodities, 

based on known safety risks, which may include a history 

of foodborne illness outbreaks. 

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

‘‘(A) provide for coordination of education and enforcement activities by State and local officials, as designated 

by the Governors of the respective States or the appropriate 

elected State official as recognized by State statute; and 

‘‘(B) include a description of the variance process under 

subsection (c) and the types of permissible variances the 

Secretary may grant. 

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

paragraph (1)— 

‘‘(A) the regulations promulgated under this section 

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

promulgated under subsection (a)(1)) after the date that 

is 1 year after the effective date of the final regulation 

under paragraph (1); and 

‘‘(B) the regulations promulgated under this section 

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

regulation promulgated under subsection (a)(1)) after the 

date that is 2 years after the effective date of the final 

regulation under paragraph (1). 

‘‘(c) CRITERIA.— 

‘‘(1) IN GENERAL.—The regulations adopted under subsection (b) shall— 

‘‘(A) set forth those procedures, processes, and practices 

that the Secretary determines to minimize the risk of 

serious adverse health consequences or death, including 

procedures, processes, and practices that the Secretary 

determines to be reasonably necessary to prevent the 

introduction of known or reasonably foreseeable biological, 

chemical, and physical hazards, including hazards that 

occur naturally, may be unintentionally introduced, or may 

be intentionally introduced, including by acts of terrorism, 

into fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural 

commodities and to provide reasonable assurances that 

the produce is not adulterated under section 402; 

‘‘(B) provide sufficient flexibility to be practicable for 

all sizes and types of businesses, including small businesses 

such as a small food processing facility co-located on a 

farm; 

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

Code (commonly known as the ‘Paperwork Reduction Act’), 

with special attention to minimizing the burden (as defined 

in section 3502(2) of such Act) on the business, and collection of information (as defined in section 3502(3) of such 

Act), associated with such regulations; 

Applicability. 

Effective dates. 

Deadline. 


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‘‘(D) acknowledge differences in risk and minimize, 

as appropriate, the number of separate standards that 

apply to separate foods; and 

‘‘(E) not require a business to hire a consultant or 

other third party to identify, implement, certify, compliance 

with these procedures, processes, and practices, except in 

the case of negotiated enforcement resolutions that may 

require such a consultant or third party; and 

‘‘(F) permit States and foreign countries from which 

food is imported into the United States to request from 

the Secretary variances from the requirements of the regulations, subject to paragraph (2), where the State or foreign 

country determines that the variance is necessary in light 

of local growing conditions and that the procedures, processes, and practices to be followed under the variance are 

reasonably likely to ensure that the produce is not adulterated under section 402 and to provide the same level of 

public health protection as the requirements of the regulations adopted under subsection (b). 

‘‘(2) VARIANCES.— 

‘‘(A) REQUESTS FOR VARIANCES.—A State or foreign 

country from which food is imported into the United States 

may in writing request a variance from the Secretary. 

Such request shall describe the variance requested and 

present information demonstrating that the variance does 

not increase the likelihood that the food for which the 

variance is requested will be adulterated under section 

402, and that the variance provides the same level of 

public health protection as the requirements of the regulations adopted under subsection (b). The Secretary shall 

review such requests in a reasonable timeframe. 

‘‘(B) APPROVAL OF VARIANCES.—The Secretary may 

approve a variance in whole or in part, as appropriate, 

and may specify the scope of applicability of a variance 

to other similarly situated persons. 

‘‘(C) DENIAL OF VARIANCES.—The Secretary may deny 

a variance request if the Secretary determines that such 

variance is not reasonably likely to ensure that the food 

is not adulterated under section 402 and is not reasonably 

likely to provide the same level of public health protection 

as the requirements of the regulation adopted under subsection (b). The Secretary shall notify the person requesting 

such variance of the reasons for the denial. 

‘‘(D) MODIFICATION OR REVOCATION OF A VARIANCE.— 

The Secretary, after notice and an opportunity for a 

hearing, may modify or revoke a variance if the Secretary 

determines that such variance is not reasonably likely to 

ensure that the food is not adulterated under section 402 

and is not reasonably likely to provide the same level 

of public health protection as the requirements of the regulations adopted under subsection (b). 

‘‘(d) ENFORCEMENT.—The Secretary may coordinate with the 

Secretary of Agriculture and, as appropriate, shall contract and 

coordinate with the agency or department designated by the Governor of each State to perform activities to ensure compliance 

with this section. 

‘‘(e) GUIDANCE.— 

Contracts. 

Notification. 


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

of enactment of the FDA Food Safety Modernization Act, the 

Secretary shall publish, after consultation with the Secretary 

of Agriculture, representatives of State departments of agriculture, farmer representatives, and various types of entities 

engaged in the production and harvesting or importing of fruits 

and vegetables that are raw agricultural commodities, including 

small businesses, updated good agricultural practices and guidance for the safe production and harvesting of specific types 

of fresh produce under this section. 

‘‘(2) PUBLIC MEETINGS.—The Secretary shall conduct not 

fewer than 3 public meetings in diverse geographical areas 

of the United States as part of an effort to conduct education 

and outreach regarding the guidance described in paragraph 

(1) for persons in different regions who are involved in the 

production and harvesting of fruits and vegetables that are 

raw agricultural commodities, including persons that sell 

directly to consumers and farmer representatives, and for 

importers of fruits and vegetables that are raw agricultural 

commodities. 

‘‘(3) PAPERWORK REDUCTION.—The Secretary shall ensure 

that any updated guidance under this section will— 

‘‘(A) provide sufficient flexibility to be practicable for 

all sizes and types of facilities, including small businesses 

such as a small food processing facility co-located on a 

farm; and 

‘‘(B) acknowledge differences in risk and minimize, as 

appropriate, the number of separate standards that apply 

to separate foods. 

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

‘‘(1) IN GENERAL.—A farm shall be exempt from the requirements under this section in a calendar year if— 

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

annual monetary value of the food sold by such farm 

directly to qualified end-users during such period exceeded 

the average annual monetary value of the food sold by 

such farm to all other buyers during such period; and 

‘‘(B) the average annual monetary value of all food 

sold during such period was less than $500,000, adjusted 

for inflation. 

‘‘(2) NOTIFICATION TO CONSUMERS.— 

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

requirements under this section shall— 

‘‘(i) with respect to a food for which a food packaging label is required by the Secretary under any 

other provision of this Act, include prominently and 

conspicuously on such label the name and business 

address of the farm where the produce was grown; 

or 

‘‘(ii) with respect to a food for which a food packaging label is not required by the Secretary under 

any other provision of this Act, prominently and 

conspicuously display, at the point of purchase, the 

name and business address of the farm where the 

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

or documents delivered contemporaneously with the 

Deadline. 

Publication. 

Consultation. 


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food in the normal course of business, or, in the case 

of Internet sales, in an electronic notice. 

‘‘(B) NO ADDITIONAL LABEL.—Subparagraph (A) does 

not provide authority to the Secretary to require a label 

that is in addition to any label required under any other 

provision of this Act. 

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

‘‘(A) IN GENERAL.—In the event of an active investigation of a foodborne illness outbreak that is directly linked 

to a farm subject to an exemption under this subsection, 

or if the Secretary determines that it is necessary to protect 

the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated 

with a farm that are material to the safety of the food 

produced or harvested at such farm, the Secretary may 

withdraw the exemption provided to such farm under this 

subsection. 

‘‘(B) RULE OF CONSTRUCTION.—Nothing in this subsection shall be construed to expand or limit the inspection 

authority of the Secretary. 

‘‘(4) DEFINITIONS.— 

‘‘(A) QUALIFIED END-USER.—In this subsection, the term 

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

‘‘(i) the consumer of the food; or 

‘‘(ii) a restaurant or retail food establishment (as 

those terms are defined by the Secretary for purposes 

of section 415) that is located— 

‘‘(I) in the same State as the farm that produced the food; or 

‘‘(II) not more than 275 miles from such farm. 

‘‘(B) CONSUMER.—For purposes of subparagraph (A), 

the term ‘consumer’ does not include a business. 

‘‘(5) NO PREEMPTION.—Nothing in this subsection preempts 

State, local, county, or other non-Federal law regarding the 

safe production, harvesting, holding, transportation, and sale 

of fresh fruits and vegetables. Compliance with this subsection 

shall not relieve any person from liability at common law 

or under State statutory law. 

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

shall prevent the Secretary from exercising any authority 

granted in the other sections of this Act. 

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

that is produced by an individual for personal consumption. 

‘‘(h) EXCEPTION FOR ACTIVITIES OF FACILITIES SUBJECT TO SECTION 418.—This section shall not apply to activities of a facility 

that are subject to section 418.’’. 

(b) SMALL ENTITY COMPLIANCE POLICY GUIDE.—Not later than 

180 days after the issuance of regulations under section 419 of 

the Federal Food, Drug, and Cosmetic Act (as added by subsection 

(a)), the Secretary of Health and Human Services shall issue a 

small entity compliance policy guide setting forth in plain language 

the requirements of such section 419 and to assist small entities 

in complying with standards for safe production and harvesting 

and other activities required under such section. 

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

by section 103, is amended by adding at the end the following: 

Deadline. 

21 USC 350h 

note. 


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‘‘(vv) The failure to comply with the requirements under section 

419.’’. 

(d) NO EFFECT ON HACCP AUTHORITIES.—Nothing in the 

amendments made by this section limits the authority of the Secretary under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

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

seq.) to revise, issue, or enforce product and category-specific regulations, such as the Seafood Hazard Analysis Critical Controls Points 

Program, the Juice Hazard Analysis Critical Control Program, and 

the Thermally Processed Low-Acid Foods Packaged in Hermetically 

Sealed Containers standards. 

SEC. 106. PROTECTION AGAINST INTENTIONAL ADULTERATION. 

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

amended by section 105, is amended by adding at the end the 

following: 

‘‘SEC. 420. PROTECTION AGAINST INTENTIONAL ADULTERATION. 

‘‘(a) DETERMINATIONS.— ‘‘(1) IN GENERAL.—The Secretary shall— 

‘‘(A) conduct a vulnerability assessment of the food 

system, including by consideration of the Department of 

Homeland Security biological, chemical, radiological, or 

other terrorism risk assessments; 

‘‘(B) consider the best available understanding of 

uncertainties, risks, costs, and benefits associated with 

guarding against intentional adulteration of food at vulnerable points; and 

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

strategies or measures that are necessary to protect against 

the intentional adulteration of food. 

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

security, the Secretary, in consultation with the Secretary of 

Homeland Security, may determine the time, manner, and form 

in which determinations made under paragraph (1) are made 

publicly available. 

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

of enactment of the FDA Food Safety Modernization Act, the Secretary, in coordination with the Secretary of Homeland Security 

and in consultation with the Secretary of Agriculture, shall promulgate regulations to protect against the intentional adulteration of 

food subject to this Act. Such regulations shall— 

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

is required to implement mitigation strategies or measures 

intended to protect against the intentional adulteration of food; 

and 

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

or measures to prepare and protect the food supply chain at 

specific vulnerable points, as appropriate. 

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

(b) shall apply only to food for which there is a high risk of 

intentional contamination, as determined by the Secretary, in consultation with the Secretary of Homeland Security, under subsection 

(a), that could cause serious adverse health consequences or death 

to humans or animals and shall include those foods— 

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

vulnerabilities (including short shelf-life or susceptibility to 

intentional contamination at critical control points); and 

Deadline. 

Determination. 

21 USC 350i. 

21 USC 350h 

note. 


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‘‘(2) in bulk or batch form, prior to being packaged for 

the final consumer. 

‘‘(d) EXCEPTION.—This section shall not apply to farms, except 

for those that produce milk. 

‘‘(e) DEFINITION.—For purposes of this section, the term ‘farm’ 

has the meaning given that term in section 1.227 of title 21, 

Code of Federal Regulations (or any successor regulation).’’. 

(b) GUIDANCE DOCUMENTS.— (1) IN GENERAL.—Not later than 1 year after the date 

of enactment of this Act, the Secretary of Health and Human 

Services, in consultation with the Secretary of Homeland Security and the Secretary of Agriculture, shall issue guidance 

documents related to protection against the intentional 

adulteration of food, including mitigation strategies or measures 

to guard against such adulteration as required under section 

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

by subsection (a). 

(2) CONTENT.—The guidance documents issued under paragraph (1) shall— 

(A) include a model assessment for a person to use 

under subsection (b)(1) of section 420 of the Federal Food, 

Drug, and Cosmetic Act, as added by subsection (a); 

(B) include examples of mitigation strategies or measures described in subsection (b)(2) of such section; and 

(C) specify situations in which the examples of mitigation strategies or measures described in subsection (b)(2) 

of such section are appropriate. 

(3) LIMITED DISTRIBUTION.—In the interest of national security, the Secretary of Health and Human Services, in consultation with the Secretary of Homeland Security, may determine 

the time, manner, and form in which the guidance documents 

issued under paragraph (1) are made public, including by 

releasing such documents to targeted audiences. 

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

Services shall periodically review and, as appropriate, update the 

regulations under section 420(b) of the Federal Food, Drug, and 

Cosmetic Act, as added by subsection (a), and the guidance documents under subsection (b). 

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

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

the following: 

‘‘(ww) The failure to comply with section 420.’’. 

SEC. 107. AUTHORITY TO COLLECT FEES. 

(a) FEES FOR REINSPECTION, RECALL, AND IMPORTATION ACTIVI- TIES.—Subchapter C of chapter VII (21 U.S.C. 379f et seq.) is 

amended by adding at the end the following: 

‘‘PART 6—FEES RELATED TO FOOD 

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

‘‘(a) IN GENERAL.— 

‘‘(1) PURPOSE AND AUTHORITY.—For fiscal year 2010 and 

each subsequent fiscal year, the Secretary shall, in accordance 

with this section, assess and collect fees from— 

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

(as defined in section 415(b)) and the United States agent 

21 USC 379j–31. 

21 USC 350i 

note. 

Deadline. 


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for each foreign facility subject to a reinspection in such 

fiscal year, to cover reinspection-related costs for such year; 

‘‘(B) the responsible party for a domestic facility (as 

defined in section 415(b)) and an importer who does not 

comply with a recall order under section 423 or under 

section 412(f) in such fiscal year, to cover food recall activities associated with such order performed by the Secretary, 

including technical assistance, follow-up effectiveness 

checks, and public notifications, for such year; 

‘‘(C) each importer participating in the voluntary qualified importer program under section 806 in such year, 

to cover the administrative costs of such program for such 

year; and 

‘‘(D) each importer subject to a reinspection in such 

fiscal year, to cover reinspection-related costs for such year. 

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

‘‘(A) the term ‘reinspection’ means— 

‘‘(i) with respect to domestic facilities (as defined 

in section 415(b)), 1 or more inspections conducted 

under section 704 subsequent to an inspection conducted under such provision which identified noncompliance materially related to a food safety requirement of this Act, specifically to determine whether 

compliance has been achieved to the Secretary’s satisfaction; and 

‘‘(ii) with respect to importers, 1 or more examinations conducted under section 801 subsequent to an 

examination conducted under such provision which 

identified noncompliance materially related to a food 

safety requirement of this Act, specifically to determine 

whether compliance has been achieved to the Secretary’s satisfaction; 

‘‘(B) the term ‘reinspection-related costs’ means all 

expenses, including administrative expenses, incurred in 

connection with— 

‘‘(i) arranging, conducting, and evaluating the 

results of reinspections; and 

‘‘(ii) assessing and collecting reinspection fees 

under this section; and 

‘‘(C) the term ‘responsible party’ has the meaning given 

such term in section 417(a)(1). 

‘‘(b) ESTABLISHMENT OF FEES.— 

‘‘(1) IN GENERAL.—Subject to subsections (c) and (d), the 

Secretary shall establish the fees to be collected under this 

section for each fiscal year specified in subsection (a)(1), based 

on the methodology described under paragraph (2), and shall 

publish such fees in a Federal Register notice not later than 

60 days before the start of each such year. 

‘‘(2) FEE METHODOLOGY.— 

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

‘‘(i) under subparagraph (A) of subsection (a)(1) 

for a fiscal year shall be based on the Secretary’s 

estimate of 100 percent of the costs of the reinspectionrelated activities (including by type or level of reinspection activity, as the Secretary determines applicable) 

described in such subparagraph (A) for such year; 

Federal Register, 

publication. 

Notice. 

Deadline. 


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‘‘(ii) under subparagraph (B) of subsection (a)(1) 

for a fiscal year shall be based on the Secretary’s 

estimate of 100 percent of the costs of the activities 

described in such subparagraph (B) for such year; 

‘‘(iii) under subparagraph (C) of subsection (a)(1) 

for a fiscal year shall be based on the Secretary’s 

estimate of 100 percent of the costs of the activities 

described in such subparagraph (C) for such year; and 

‘‘(iv) under subparagraph (D) of subsection (a)(1) 

for a fiscal year shall be based on the Secretary’s 

estimate of 100 percent of the costs of the activities 

described in such subparagraph (D) for such year. 

‘‘(B) OTHER CONSIDERATIONS.— ‘‘(i) VOLUNTARY QUALIFIED IMPORTER PROGRAM.— In establishing the fee amounts under subparagraph 

(A)(iii) for a fiscal year, the Secretary shall provide 

for the number of importers who have submitted to 

the Secretary a notice under section 806(c) informing 

the Secretary of the intent of such importer to participate in the program under section 806 in such fiscal 

year. 

‘‘(II) RECOUPMENT.—In establishing the fee 

amounts under subparagraph (A)(iii) for the first 

5 fiscal years after the date of enactment of this 

section, the Secretary shall include in such fee 

a reasonable surcharge that provides a recoupment 

of the costs expended by the Secretary to establish 

and implement the first year of the program under 

section 806. 

‘‘(ii) CREDITING OF FEES.—In establishing the fee 

amounts under subparagraph (A) for a fiscal year, 

the Secretary shall provide for the crediting of fees 

from the previous year to the next year if the Secretary 

overestimated the amount of fees needed to carry out 

such activities, and consider the need to account for 

any adjustment of fees and such other factors as the 

Secretary determines appropriate. 

‘‘(iii) PUBLISHED GUIDELINES.—Not later than 180 

days after the date of enactment of the FDA Food 

Safety Modernization Act, the Secretary shall publish 

in the Federal Register a proposed set of guidelines 

in consideration of the burden of fee amounts on small 

business. Such consideration may include reduced fee 

amounts for small businesses. The Secretary shall provide for a period of public comment on such guidelines. 

The Secretary shall adjust the fee schedule for small 

businesses subject to such fees only through notice 

and comment rulemaking. 

‘‘(3) USE OF FEES.—The Secretary shall make all of the 

fees collected pursuant to clause (i), (ii), (iii), and (iv) of paragraph (2)(A) available solely to pay for the costs referred to 

in such clause (i), (ii), (iii), and (iv) of paragraph (2)(A), respectively. 

‘‘(c) LIMITATIONS.— 

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

refunded for a fiscal year beginning after fiscal year 2010 

unless the amount of the total appropriations for food safety 

Deadline. 

Federal Register, 

publication. 

Comment period. 


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activities at the Food and Drug Administration for such fiscal 

year (excluding the amount of fees appropriated for such fiscal 

year) is equal to or greater than the amount of appropriations 

for food safety activities at the Food and Drug Administration 

for fiscal year 2009 (excluding the amount of fees appropriated 

for such fiscal year), multiplied by the adjustment factor under 

paragraph (3). 

‘‘(2) AUTHORITY.—If— 

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

(a) for a portion of a fiscal year because paragraph (1) 

applies; and 

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

(1) ceases to apply, 

the Secretary may assess and collect such fees under subsection 

(a), without any modification to the rate of such fees, notwithstanding the provisions of subsection (a) relating to the date 

fees are to be paid. 

‘‘(3) ADJUSTMENT FACTOR.— 

‘‘(A) IN GENERAL.—The adjustment factor described in 

paragraph (1) shall be the total percentage change that 

occurred in the Consumer Price Index for all urban consumers (all items; United States city average) for the 12- 

month period ending June 30 preceding the fiscal year, 

but in no case shall such adjustment factor be negative. 

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

subparagraph (A) made each fiscal year shall be added 

on a compounded basis to the sum of all adjustments 

made each fiscal year after fiscal year 2009. 

‘‘(4) LIMITATION ON AMOUNT OF CERTAIN FEES.— 

‘‘(A) IN GENERAL.—Notwithstanding any other provision of this section and subject to subparagraph (B), the 

Secretary may not collect fees in a fiscal year such that 

the amount collected— 

‘‘(i) under subparagraph (B) of subsection (a)(1) 

exceeds $20,000,000; and 

‘‘(ii) under subparagraphs (A) and (D) of subsection 

(a)(1) exceeds $25,000,000 combined. 

‘‘(B) EXCEPTION.—If a domestic facility (as defined in 

section 415(b)) or an importer becomes subject to a fee 

described in subparagraph (A), (B), or (D) of subsection 

(a)(1) after the maximum amount of fees has been collected 

by the Secretary under subparagraph (A), the Secretary 

may collect a fee from such facility or importer. 

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

under subsection (a) shall be collected and available for obligation 

only to the extent and in the amount provided in appropriations 

Acts. Such fees are authorized to remain available until expended. 

Such sums as may be necessary may be transferred from the 

Food and Drug Administration salaries and expenses account without fiscal year limitation to such appropriation account for salaries 

and expenses with such fiscal year limitation. The sums transferred 

shall be available solely for the purpose of paying the operating 

expenses of the Food and Drug Administration employees and contractors performing activities associated with these food safety fees. 

‘‘(e) COLLECTION OF FEES.— ‘‘(1) IN GENERAL.—The Secretary shall specify in the Federal Register notice described in subsection (b)(1) the time 


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and manner in which fees assessed under this section shall 

be collected. 

‘‘(2) COLLECTION OF UNPAID FEES.—In any case where the 

Secretary does not receive payment of a fee assessed under 

this section within 30 days after it is due, such fee shall 

be treated as a claim of the United States Government subject 

to provisions of subchapter II of chapter 37 of title 31, United 

States Code. 

‘‘(f) ANNUAL REPORT TO CONGRESS.—Not later than 120 days 

after each fiscal year for which fees are assessed under this section, 

the Secretary shall submit a report to the Committee on Health, 

Education, Labor, and Pensions of the Senate and the Committee 

on Energy and Commerce of the House of Representatives, to 

include a description of fees assessed and collected for each such 

year and a summary description of the entities paying such fees 

and the types of business in which such entities engage. 

‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—For fiscal year 2010 

and each fiscal year thereafter, there is authorized to be appropriated for fees under this section an amount equal to the total 

revenue amount determined under subsection (b) for the fiscal 

year, as adjusted or otherwise affected under the other provisions 

of this section.’’. 

(b) EXPORT CERTIFICATION FEES FOR FOODS AND ANIMAL

FEED.— 

(1) AUTHORITY FOR EXPORT CERTIFICATIONS FOR FOOD, 

INCLUDING ANIMAL FEED.—Section 801(e)(4)(A) (21 U.S.C. 

381(e)(4)(A)) is amended— 

(A) in the matter preceding clause (i), by striking ‘‘a 

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

(B) in clause (i) by striking ‘‘exported drug’’ and 

inserting ‘‘exported food, drug’’; and 

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

it appears and inserting ‘‘the food, drug’’. 

(2) CLARIFICATION OF CERTIFICATION.—Section 801(e)(4) (21 

U.S.C. 381(e)(4)) is amended by inserting after subparagraph 

(B) the following new subparagraph: 

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

by the Secretary shall be made on such basis, and in 

such form (including a publicly available listing) as the 

Secretary determines appropriate.’’. 

(3) LIMITATIONS ON THE USE AND AMOUNT OF FEES.—Paragraph (4) of section 801(e) (21 U.S.C. 381(e)) is amended by 

adding at the end the following: 

‘‘(D) With regard to fees pursuant to subparagraph 

(B) in connection with written export certifications for food: 

‘‘(i) Such fees shall be collected and available solely 

for the costs of the Food and Drug Administration 

associated with issuing such certifications. 

‘‘(ii) Such fees may not be retained in an amount 

that exceeds such costs for the respective fiscal year.’’ 

SEC. 108. NATIONAL AGRICULTURE AND FOOD DEFENSE STRATEGY. 

(a) DEVELOPMENT AND SUBMISSION OF STRATEGY.— 

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

of enactment of this Act, the Secretary of Health and Human 

Services and the Secretary of Agriculture, in coordination with 

the Secretary of Homeland Security, shall prepare and transmit 

Deadline. 

Web posting. 

21 USC 2202. 

Deadline. 


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to the relevant committees of Congress, and make publicly 

available on the Internet Web sites of the Department of Health 

and Human Services and the Department of Agriculture, the 

National Agriculture and Food Defense Strategy. 

(2) IMPLEMENTATION PLAN.—The strategy shall include an 

implementation plan for use by the Secretaries described under 

paragraph (1) in carrying out the strategy. 

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

research agenda for use by the Secretaries described under 

paragraph (1) in conducting research to support the goals and 

activities described in paragraphs (1) and (2) of subsection 

(b). 

(4) REVISIONS.—Not later than 4 years after the date on 

which the strategy is submitted to the relevant committees 

of Congress under paragraph (1), and not less frequently than 

every 4 years thereafter, the Secretary of Health and Human 

Services and the Secretary of Agriculture, in coordination with 

the Secretary of Homeland Security, shall revise and submit 

to the relevant committees of Congress the strategy. 

(5) CONSISTENCY WITH EXISTING PLANS.—The strategy 

described in paragraph (1) shall be consistent with— 

(A) the National Incident Management System; 

(B) the National Response Framework; 

(C) the National Infrastructure Protection Plan; 

(D) the National Preparedness Goals; and 

(E) other relevant national strategies. 

(b) COMPONENTS.— 

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

of the process to be used by the Department of Health and 

Human Services, the Department of Agriculture, and the 

Department of Homeland Security— 

(A) to achieve each goal described in paragraph (2); 

and 

(B) to evaluate the progress made by Federal, State, 

local, and tribal governments towards the achievement of 

each goal described in paragraph (2). 

(2) GOALS.—The strategy shall include a description of 

the process to be used by the Department of Health and Human 

Services, the Department of Agriculture, and the Department 

of Homeland Security to achieve the following goals: 

(A) PREPAREDNESS GOAL.—Enhance the preparedness 

of the agriculture and food system by— 

(i) conducting vulnerability assessments of the 

agriculture and food system; 

(ii) mitigating vulnerabilities of the system; 

(iii) improving communication and training 

relating to the system; 

(iv) developing and conducting exercises to test 

decontamination and disposal plans; 

(v) developing modeling tools to improve event consequence assessment and decision support; and 

(vi) preparing risk communication tools and 

enhancing public awareness through outreach. 

(B) DETECTION GOAL.—Improve agriculture and food 

system detection capabilities by— 

(i) identifying contamination in food products at 

the earliest possible time; and 

Deadlines. 


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(ii) conducting surveillance to prevent the spread 

of diseases. 

(C) EMERGENCY RESPONSE GOAL.—Ensure an efficient 

response to agriculture and food emergencies by— 

(i) immediately investigating animal disease outbreaks and suspected food contamination; 

(ii) preventing additional human illnesses; 

(iii) organizing, training, and equipping animal, 

plant, and food emergency response teams of— 

(I) the Federal Government; and 

(II) State, local, and tribal governments; 

(iv) designing, developing, and evaluating training 

and exercises carried out under agriculture and food 

defense plans; and 

(v) ensuring consistent and organized risk communication to the public by— 

(I) the Federal Government; 

(II) State, local, and tribal governments; and 

(III) the private sector. 

(D) RECOVERY GOAL.—Secure agriculture and food 

production after an agriculture or food emergency by— 

(i) working with the private sector to develop business recovery plans to rapidly resume agriculture, food 

production, and international trade; 

(ii) conducting exercises of the plans described in 

subparagraph (C) with the goal of long-term recovery 

results; 

(iii) rapidly removing, and effectively disposing 

of— 

(I) contaminated agriculture and food products; and 

(II) infected plants and animals; and 

(iv) decontaminating and restoring areas affected 

by an agriculture or food emergency. 

(3) EVALUATION.—The Secretary, in coordination with the 

Secretary of Agriculture and the Secretary of Homeland Security, shall— 

(A) develop metrics to measure progress for the evaluation process described in paragraph (1)(B); and 

(B) report on the progress measured in subparagraph 

(A) as part of the National Agriculture and Food Defense 

strategy described in subsection (a)(1). 

(c) LIMITED DISTRIBUTION.—In the interest of national security, 

the Secretary of Health and Human Services and the Secretary 

of Agriculture, in coordination with the Secretary of Homeland 

Security, may determine the manner and format in which the 

National Agriculture and Food Defense strategy established under 

this section is made publicly available on the Internet Web sites 

of the Department of Health and Human Services, the Department 

of Homeland Security, and the Department of Agriculture, as 

described in subsection (a)(1). 

SEC. 109. FOOD AND AGRICULTURE COORDINATING COUNCILS. 

The Secretary of Homeland Security, in coordination with the 

Secretary of Health and Human Services and the Secretary of 

Agriculture, shall within 180 days of enactment of this Act, and 

annually thereafter, submit to the relevant committees of Congress, 

Deadlines. 

Web posting. 

Reports. 

21 USC 2203. 

Reports. 


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and make publicly available on the Internet Web site of the Department of Homeland Security, a report on the activities of the Food 

and Agriculture Government Coordinating Council and the Food 

and Agriculture Sector Coordinating Council, including the progress 

of such Councils on— 

(1) facilitating partnerships between public and private 

entities to help coordinate and enhance the protection of the 

agriculture and food system of the United States; 

(2) providing for the regular and timely interchange of 

information between each council relating to the security of 

the agriculture and food system (including intelligence information); 

(3) identifying best practices and methods for improving 

the coordination among Federal, State, local, and private sector 

preparedness and response plans for agriculture and food 

defense; and 

(4) recommending methods by which to protect the economy 

and the public health of the United States from the effects 

of— 

(A) animal or plant disease outbreaks; 

(B) food contamination; and 

(C) natural disasters affecting agriculture and food. 

SEC. 110. BUILDING DOMESTIC CAPACITY. 

(a) IN GENERAL.— 

(1) INITIAL REPORT.—The Secretary, in coordination with 

the Secretary of Agriculture and the Secretary of Homeland 

Security, shall, not later than 2 years after the date of enactment of this Act, submit to Congress a comprehensive report 

that identifies programs and practices that are intended to 

promote the safety and supply chain security of food and to 

prevent outbreaks of foodborne illness and other food-related 

hazards that can be addressed through preventive activities. 

Such report shall include a description of the following: 

(A) Analysis of the need for further regulations or 

guidance to industry. 

(B) Outreach to food industry sectors, including 

through the Food and Agriculture Coordinating Councils 

referred to in section 109, to identify potential sources 

of emerging threats to the safety and security of the food 

supply and preventive strategies to address those threats. 

(C) Systems to ensure the prompt distribution to the 

food industry of information and technical assistance concerning preventive strategies. 

(D) Communication systems to ensure that information 

about specific threats to the safety and security of the 

food supply are rapidly and effectively disseminated. 

(E) Surveillance systems and laboratory networks to 

rapidly detect and respond to foodborne illness outbreaks 

and other food-related hazards, including how such systems 

and networks are integrated. 

(F) Outreach, education, and training provided to 

States and local governments to build State and local food 

safety and food defense capabilities, including progress 

implementing strategies developed under sections 108 and 

205. 

21 USC 2204. 


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(G) The estimated resources needed to effectively 

implement the programs and practices identified in the 

report developed in this section over a 5-year period. 

(H) The impact of requirements under this Act 

(including amendments made by this Act) on certified 

organic farms and facilities (as defined in section 415 (21 

U.S.C. 350d). 

(I) Specific efforts taken pursuant to the agreements 

authorized under section 421(c) of the Federal Food, Drug, 

and Cosmetic Act (as added by section 201), together with, 

as necessary, a description of any additional authorities 

necessary to improve seafood safety. 

(2) BIENNIAL REPORTS.—On a biennial basis following the 

submission of the report under paragraph (1), the Secretary 

shall submit to Congress a report that— 

(A) reviews previous food safety programs and practices; 

(B) outlines the success of those programs and practices; 

(C) identifies future programs and practices; and 

(D) includes information related to any matter 

described in subparagraphs (A) through (H) of paragraph 

(1), as necessary. 

(b) RISK-BASED ACTIVITIES.—The report developed under subsection (a)(1) shall describe methods that seek to ensure that 

resources available to the Secretary for food safety-related activities 

are directed at those actions most likely to reduce risks from food, 

including the use of preventive strategies and allocation of inspection resources. The Secretary shall promptly undertake those riskbased actions that are identified during the development of the 

report as likely to contribute to the safety and security of the 

food supply. 

(c) CAPABILITY FOR LABORATORY ANALYSES; RESEARCH.—The 

report developed under subsection (a)(1) shall provide a description 

of methods to increase capacity to undertake analyses of food samples promptly after collection, to identify new and rapid analytical 

techniques, including commercially-available techniques that can 

be employed at ports of entry and by Food Emergency Response 

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

laboratory facilities and progress toward laboratory accreditation 

under section 422 of the Federal Food, Drug, and Cosmetic Act 

(as added by section 202). 

(d) INFORMATION TECHNOLOGY.—The report developed under 

subsection (a)(1) shall include a description of such information 

technology systems as may be needed to identify risks and receive 

data from multiple sources, including foreign governments, State, 

local, and tribal governments, other Federal agencies, the food 

industry, laboratories, laboratory networks, and consumers. The 

information technology systems that the Secretary describes shall 

also provide for the integration of the facility registration system 

under section 415 of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 350d), and the prior notice system under section 801(m) 

of such Act (21 U.S.C. 381(m)) with other information technology 

systems that are used by the Federal Government for the processing 

of food offered for import into the United States. 

(e) AUTOMATED RISK ASSESSMENT.—The report developed under 

subsection (a)(1) shall include a description of progress toward 


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developing and improving an automated risk assessment system 

for food safety surveillance and allocation of resources. 

(f) TRACEBACK AND SURVEILLANCE REPORT.—The Secretary 

shall include in the report developed under subsection (a)(1) an 

analysis of the Food and Drug Administration’s performance in 

foodborne illness outbreaks during the 5-year period preceding the 

date of enactment of this Act involving fruits and vegetables that 

are raw agricultural commodities (as defined in section 201(r) (21 

U.S.C. 321(r)) and recommendations for enhanced surveillance, outbreak response, and traceability. Such findings and recommendations shall address communication and coordination with the public, 

industry, and State and local governments, as such communication 

and coordination relates to outbreak identification and traceback. 

(g) BIENNIAL FOOD SAFETY AND FOOD DEFENSE RESEARCH

PLAN.—The Secretary, the Secretary of Agriculture, and the Secretary of Homeland Security shall, on a biennial basis, submit 

to Congress a joint food safety and food defense research plan 

which may include studying the long-term health effects of 

foodborne illness. Such biennial plan shall include a list and description of projects conducted during the previous 2-year period and 

the plan for projects to be conducted during the subsequent 2- 

year period. 

(h) EFFECTIVENESS OF PROGRAMS ADMINISTERED BY THE

DEPARTMENT OF HEALTH AND HUMAN SERVICES.— 

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

programs administered by the Department of Health and 

Human Services are effective in achieving the stated goals 

of such programs, the Secretary shall, beginning not later than 

1 year after the date of enactment of this Act— 

(A) conduct an annual evaluation of each program of 

such Department to determine the effectiveness of each 

such program in achieving legislated intent, purposes, and 

objectives; and 

(B) submit to Congress a report concerning such 

evaluation. 

(2) CONTENT.—The report described under paragraph (1)(B) 

shall— 

(A) include conclusions concerning the reasons that 

such existing programs have proven successful or not 

successful and what factors contributed to such conclusions; 

(B) include recommendations for consolidation and 

elimination to reduce duplication and inefficiencies in such 

programs at such Department as identified during the 

evaluation conduct under this subsection; and 

(C) be made publicly available in a publication entitled 

‘‘Guide to the U.S. Department of Health and Human Services Programs’’. 

(i) UNIQUE IDENTIFICATION NUMBERS.— 

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

of enactment of this Act, the Secretary, acting through the 

Commissioner of Food and Drugs, shall conduct a study 

regarding the need for, and challenges associated with, development and implementation of a program that requires a unique 

identification number for each food facility registered with the 

Secretary and, as appropriate, each broker that imports food 

into the United States. Such study shall include an evaluation 

of the costs associated with development and implementation 

Deadline. 

Study. 

Publication. 

Reports. 

Deadline. 


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of such a system, and make recommendations about what new 

authorities, if any, would be necessary to develop and implement such a system. 

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

enactment of this Act, the Secretary shall submit to Congress 

a report that describes the findings of the study conducted 

under paragraph (1) and that includes any recommendations 

determined appropriate by the Secretary. 

SEC. 111. SANITARY TRANSPORTATION OF FOOD. 

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

of enactment of this Act, the Secretary shall promulgate regulations 

described in section 416(b) of the Federal Food, Drug, and Cosmetic 

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

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

through the Commissioner of Food and Drugs, shall conduct a 

study of the transportation of food for consumption in the United 

States, including transportation by air, that includes an examination of the unique needs of rural and frontier areas with regard 

to the delivery of safe food. 

SEC. 112. FOOD ALLERGY AND ANAPHYLAXIS MANAGEMENT. 

(a) DEFINITIONS.—In this section: 

(1) EARLY CHILDHOOD EDUCATION PROGRAM.—The term 

‘‘early childhood education program’’ means— 

(A) a Head Start program or an Early Head Start 

program carried out under the Head Start Act (42 U.S.C. 

9831 et seq.); 

(B) a State licensed or regulated child care program 

or school; or 

(C) a State prekindergarten program that serves children from birth through kindergarten. 

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

agency’’, ‘‘secondary school’’, ‘‘elementary school’’, and ‘‘parent’’ 

have the meanings given the terms in section 9101 of the 

Elementary and Secondary Education Act of 1965 (20 U.S.C. 

7801). 

(3) SCHOOL.—The term ‘‘school’’ includes public— 

(A) kindergartens; 

(B) elementary schools; and 

(C) secondary schools. 

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

of Health and Human Services. 

(b) ESTABLISHMENT OF VOLUNTARY FOOD ALLERGY AND

ANAPHYLAXIS MANAGEMENT GUIDELINES.— 

(1) ESTABLISHMENT.— 

(A) IN GENERAL.—Not later than 1 year after the date 

of enactment of this Act, the Secretary, in consultation 

with the Secretary of Education, shall— 

(i) develop guidelines to be used on a voluntary 

basis to develop plans for individuals to manage the 

risk of food allergy and anaphylaxis in schools and 

early childhood education programs; and 

(ii) make such guidelines available to local educational agencies, schools, early childhood education 

programs, and other interested entities and individuals 

to be implemented on a voluntary basis only. 

Deadline. 

21 USC 2205. 

Deadline. 

Regulations. 

21 USC 350e 

note. 


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(B) APPLICABILITY OF FERPA.—Each plan described in 

subparagraph (A) that is developed for an individual shall 

be considered an education record for the purpose of section 

444 of the General Education Provisions Act (commonly 

referred to as the ‘‘Family Educational Rights and Privacy 

Act of 1974’’) (20 U.S.C. 1232g). 

(2) CONTENTS.—The voluntary guidelines developed by the 

Secretary under paragraph (1) shall address each of the following and may be updated as the Secretary determines necessary: 

(A) Parental obligation to provide the school or early 

childhood education program, prior to the start of every 

school year, with— 

(i) documentation from their child’s physician or 

nurse— 

(I) supporting a diagnosis of food allergy, and 

any risk of anaphylaxis, if applicable; 

(II) identifying any food to which the child 

is allergic; 

(III) describing, if appropriate, any prior history of anaphylaxis; 

(IV) listing any medication prescribed for the 

child for the treatment of anaphylaxis; 

(V) detailing emergency treatment procedures 

in the event of a reaction; 

(VI) listing the signs and symptoms of a reaction; and 

(VII) assessing the child’s readiness for selfadministration of prescription medication; and 

(ii) a list of substitute meals that may be offered 

to the child by school or early childhood education 

program food service personnel. 

(B) The creation and maintenance of an individual 

plan for food allergy management, in consultation with 

the parent, tailored to the needs of each child with a 

documented risk for anaphylaxis, including any procedures 

for the self-administration of medication by such children 

in instances where— 

(i) the children are capable of self-administering 

medication; and 

(ii) such administration is not prohibited by State 

law. 

(C) Communication strategies between individual 

schools or early childhood education programs and providers of emergency medical services, including appropriate 

instructions for emergency medical response. 

(D) Strategies to reduce the risk of exposure to 

anaphylactic causative agents in classrooms and common 

school or early childhood education program areas such 

as cafeterias. 

(E) The dissemination of general information on lifethreatening food allergies to school or early childhood education program staff, parents, and children. 

(F) Food allergy management training of school or 

early childhood education program personnel who regularly 

come into contact with children with life-threatening food 

allergies. 


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(G) The authorization and training of school or early 

childhood education program personnel to administer 

epinephrine when the nurse is not immediately available. 

(H) The timely accessibility of epinephrine by school 

or early childhood education program personnel when the 

nurse is not immediately available. 

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

plan for food allergy management that addresses the appropriate response to an incident of anaphylaxis of a child 

while such child is engaged in extracurricular programs 

of a school or early childhood education program, such 

as non-academic outings and field trips, before- and afterschool programs or before- and after-early child education 

program programs, and school-sponsored or early childhood 

education program-sponsored programs held on weekends. 

(J) Maintenance of information for each administration 

of epinephrine to a child at risk for anaphylaxis and prompt 

notification to parents. 

(K) Other elements the Secretary determines necessary 

for the management of food allergies and anaphylaxis in 

schools and early childhood education programs. 

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

the guidelines developed by the Secretary under paragraph 

(1) shall be construed to preempt State law, including any 

State law regarding whether students at risk for anaphylaxis 

may self-administer medication. 

(c) SCHOOL-BASED FOOD ALLERGY MANAGEMENT GRANTS.— 

(1) IN GENERAL.—The Secretary may award grants to local 

educational agencies to assist such agencies with implementing 

voluntary food allergy and anaphylaxis management guidelines 

described in subsection (b). 

(2) APPLICATION.— 

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

under this subsection, a local educational agency shall 

submit an application to the Secretary at such time, in 

such manner, and including such information as the Secretary may reasonably require. 

(B) CONTENTS.—Each application submitted under 

subparagraph (A) shall include— 

(i) an assurance that the local educational agency 

has developed plans in accordance with the food allergy 

and anaphylaxis management guidelines described in 

subsection (b); 

(ii) a description of the activities to be funded 

by the grant in carrying out the food allergy and 

anaphylaxis management guidelines, including— 

(I) how the guidelines will be carried out at 

individual schools served by the local educational 

agency; 

(II) how the local educational agency will 

inform parents and students of the guidelines in 

place; 

(III) how school nurses, teachers, administrators, and other school-based staff will be made 

aware of, and given training on, when applicable, 

the guidelines in place; and 


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(IV) any other activities that the Secretary 

determines appropriate; 

(iii) an itemization of how grant funds received 

under this subsection will be expended; 

(iv) a description of how adoption of the guidelines 

and implementation of grant activities will be monitored; and 

(v) an agreement by the local educational agency 

to report information required by the Secretary to conduct evaluations under this subsection. 

(3) USE OF FUNDS.—Each local educational agency that 

receives a grant under this subsection may use the grant funds 

for the following: 

(A) Purchase of materials and supplies, including limited medical supplies such as epinephrine and disposable 

wet wipes, to support carrying out the food allergy and 

anaphylaxis management guidelines described in subsection (b). 

(B) In partnership with local health departments, 

school nurse, teacher, and personnel training for food 

allergy management. 

(C) Programs that educate students as to the presence 

of, and policies and procedures in place related to, food 

allergies and anaphylactic shock. 

(D) Outreach to parents. 

(E) Any other activities consistent with the guidelines 

described in subsection (b). 

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

grants under this subsection for a period of not more than 

2 years. In the event the Secretary conducts a program evaluation under this subsection, funding in the second year of the 

grant, where applicable, shall be contingent on a successful 

program evaluation by the Secretary after the first year. 

(5) LIMITATION ON GRANT FUNDING.—The Secretary may 

not provide grant funding to a local educational agency under 

this subsection after such local educational agency has received 

2 years of grant funding under this subsection. 

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

awarded under this subsection may not be made in an amount 

that is more than $50,000 annually. 

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

the Secretary shall give priority to local educational agencies 

with the highest percentages of children who are counted under 

section 1124(c) of the Elementary and Secondary Education 

Act of 1965 (20 U.S.C. 6333(c)). 

(8) MATCHING FUNDS.— 

(A) IN GENERAL.—The Secretary may not award a grant 

under this subsection unless the local educational agency 

agrees that, with respect to the costs to be incurred by 

such local educational agency in carrying out the grant 

activities, the local educational agency shall make available 

(directly or through donations from public or private entities) non-Federal funds toward such costs in an amount 

equal to not less than 25 percent of the amount of the 

grant. 


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(B) DETERMINATION OF AMOUNT OF NON-FEDERAL CONTRIBUTION.—Non-Federal funds required under subparagraph (A) may be cash or in kind, including plant, equipment, or services. Amounts provided by the Federal Government, and any portion of any service subsidized by the 

Federal Government, may not be included in determining 

the amount of such non-Federal funds. 

(9) ADMINISTRATIVE FUNDS.—A local educational agency 

that receives a grant under this subsection may use not more 

than 2 percent of the grant amount for administrative costs 

related to carrying out this subsection. 

(10) PROGRESS AND EVALUATIONS.—At the completion of 

the grant period referred to in paragraph (4), a local educational 

agency shall provide the Secretary with information on how 

grant funds were spent and the status of implementation of 

the food allergy and anaphylaxis management guidelines 

described in subsection (b). 

(11) SUPPLEMENT, NOT SUPPLANT.—Grant funds received 

under this subsection shall be used to supplement, and not 

supplant, non-Federal funds and any other Federal funds available to carry out the activities described in this subsection. 

(12) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out this subsection $30,000,000 

for fiscal year 2011 and such sums as may be necessary for 

each of the 4 succeeding fiscal years. 

(d) VOLUNTARY NATURE OF GUIDELINES.— 

(1) IN GENERAL.—The food allergy and anaphylaxis 

management guidelines developed by the Secretary under subsection (b) are voluntary. Nothing in this section or the guidelines developed by the Secretary under subsection (b) shall 

be construed to require a local educational agency to implement 

such guidelines. 

(2) EXCEPTION.—Notwithstanding paragraph (1), the Secretary may enforce an agreement by a local educational agency 

to implement food allergy and anaphylaxis management guidelines as a condition of the receipt of a grant under subsection 

(c). 

SEC. 113. NEW DIETARY INGREDIENTS. 

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

Cosmetic Act (21 U.S.C. 350b) is amended— 

(1) by redesignating subsection (c) as subsection (d); and 

(2) by inserting after subsection (b) the following: 

‘‘(c) NOTIFICATION.— 

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

information in a new dietary ingredient notification submitted 

under this section for an article purported to be a new dietary 

ingredient is inadequate to establish that a dietary supplement 

containing such article will reasonably be expected to be safe 

because the article may be, or may contain, an anabolic steroid 

or an analogue of an anabolic steroid, the Secretary shall notify 

the Drug Enforcement Administration of such determination. 

Such notification by the Secretary shall include, at a minimum, 

the name of the dietary supplement or article, the name of 

the person or persons who marketed the product or made 


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the submission of information regarding the article to the Secretary under this section, and any contact information for such 

person or persons that the Secretary has. 

‘‘(2) DEFINITIONS.—For purposes of this subsection— 

‘‘(A) the term ‘anabolic steroid’ has the meaning given 

such term in section 102(41) of the Controlled Substances 

Act; and 

‘‘(B) the term ‘analogue of an anabolic steroid’ means 

a substance whose chemical structure is substantially 

similar to the chemical structure of an anabolic steroid.’’. 

(b) GUIDANCE.—Not later than 180 days after the date of enactment of this Act, the Secretary shall publish guidance that clarifies 

when a dietary supplement ingredient is a new dietary ingredient, 

when the manufacturer or distributor of a dietary ingredient or 

dietary supplement should provide the Secretary with information 

as described in section 413(a)(2) of the Federal Food, Drug, and 

Cosmetic Act, the evidence needed to document the safety of new 

dietary ingredients, and appropriate methods for establishing the 

identify of a new dietary ingredient. 

SEC. 114. REQUIREMENT FOR GUIDANCE RELATING TO POST HARVEST 

PROCESSING OF RAW OYSTERS. 

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

of any guidance, regulation, or suggested amendment by the Food 

and Drug Administration to the National Shellfish Sanitation Program’s Model Ordinance, or the issuance of any guidance or regulation by the Food and Drug Administration relating to the Seafood 

Hazard Analysis Critical Control Points Program of the Food and 

Drug Administration (parts 123 and 1240 of title 21, Code of Federal 

Regulations (or any successor regulations), where such guidance, 

regulation or suggested amendment relates to post harvest processing for raw oysters, the Secretary shall prepare and submit 

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

the Senate and the Committee on Energy and Commerce of the 

House of Representatives a report which shall include— 

(1) an assessment of how post harvest processing or other 

equivalent controls feasibly may be implemented in the fastest, 

safest, and most economical manner; 

(2) the projected public health benefits of any proposed 

post harvest processing; 

(3) the projected costs of compliance with such post harvest 

processing measures; 

(4) the impact post harvest processing is expected to have 

on the sales, cost, and availability of raw oysters; 

(5) criteria for ensuring post harvest processing standards 

will be applied equally to shellfish imported from all nations 

of origin; 

(6) an evaluation of alternative measures to prevent, eliminate, or reduce to an acceptable level the occurrence of 

foodborne illness; and 

(7) the extent to which the Food and Drug Administration 

has consulted with the States and other regulatory agencies, 

as appropriate, with regard to post harvest processing measures. 

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

described in section 103(h). 

Deadline. 

Reports. 

21 USC 342 note. 

Deadline. 

Publication. 

21 USC 350b 

note. 


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

the Secretary issues a proposed regulation or guidance described 

in subsection (a), the Comptroller General of the United States 

shall— 

(1) review and evaluate the report described in (a) and 

report to Congress on the findings of the estimates and analysis 

in the report; 

(2) compare such proposed regulation or guidance to similar 

regulations or guidance with respect to other regulated foods, 

including a comparison of risks the Secretary may find associated with seafood and the instances of those risks in such 

other regulated foods; and 

(3) evaluate the impact of post harvest processing on the 

competitiveness of the domestic oyster industry in the United 

States and in international markets. 

(d) WAIVER.—The requirement of preparing a report under 

subsection (a) shall be waived if the Secretary issues a guidance 

that is adopted as a consensus agreement between Federal and 

State regulators and the oyster industry, acting through the Interstate Shellfish Sanitation Conference. 

(e) PUBLIC ACCESS.—Any report prepared under this section 

shall be made available to the public. 

SEC. 115. PORT SHOPPING. 

Until the date on which the Secretary promulgates a final 

rule that implements the amendments made by section 308 of 

the Public Health Security and Bioterrorism Preparedness and 

Response Act of 2002, (Public Law 107–188), the Secretary shall 

notify the Secretary of Homeland Security of all instances in which 

the Secretary refuses to admit a food into the United States under 

section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 381(a)) so that the Secretary of Homeland Security, acting 

through the Commissioner of Customs and Border Protection, may 

prevent food refused admittance into the United States by a United 

States port of entry from being admitted by another United States 

port of entry, through the notification of other such United States 

ports of entry. 

SEC. 116. ALCOHOL-RELATED FACILITIES. 

(a) IN GENERAL.—Except as provided by sections 102, 206, 

207, 302, 304, 402, 403, and 404 of this Act, and the amendments 

made by such sections, nothing in this Act, or the amendments 

made by this Act, shall be construed to apply to a facility that— 

(1) under the Federal Alcohol Administration Act (27 U.S.C. 

201 et seq.) or chapter 51 of subtitle E of the Internal Revenue 

Code of 1986 (26 U.S.C. 5001 et seq.) is required to obtain 

a permit or to register with the Secretary of the Treasury 

as a condition of doing business in the United States; and 

(2) under section 415 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350d) is required to register as a facility 

because such facility is engaged in manufacturing, processing, 

packing, or holding 1 or more alcoholic beverages, with respect 

to the activities of such facility that relate to the manufacturing, 

processing, packing, or holding of alcoholic beverages. 

(b) LIMITED RECEIPT AND DISTRIBUTION OF NON-ALCOHOL

FOOD.—Subsection (a) shall not apply to a facility engaged in the 

receipt and distribution of any non-alcohol food, except that such 

paragraph shall apply to a facility described in such paragraph 

Applicability. 

21 USC 2206. 

Notification. 

21 USC 381 note. 


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that receives and distributes non-alcohol food, provided such food 

is received and distributed— 

(1) in a prepackaged form that prevents any direct human 

contact with such food; and 

(2) in amounts that constitute not more than 5 percent 

of the overall sales of such facility, as determined by the Secretary of the Treasury. 

(c) RULE OF CONSTRUCTION.—Except as provided in subsections 

(a) and (b), this section shall not be construed to exempt any 

food, other than alcoholic beverages, as defined in section 214 

of the Federal Alcohol Administration Act (27 U.S.C. 214), from 

the requirements of this Act (including the amendments made 

by this Act). 

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. 

(a) TARGETING OF INSPECTION RESOURCES FOR DOMESTIC

FACILITIES, FOREIGN FACILITIES, AND PORTS OF ENTRY.—Chapter 

IV (21 U.S.C. 341 et seq.), as amended by section 106, is amended 

by adding at the end the following: 

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

FACILITIES, FOREIGN FACILITIES, AND PORTS OF ENTRY; 

ANNUAL REPORT. 

‘‘(a) IDENTIFICATION AND INSPECTION OF FACILITIES.— 

‘‘(1) IDENTIFICATION.—The Secretary shall identify highrisk facilities and shall allocate resources to inspect facilities 

according to the known safety risks of the facilities, which 

shall be based on the following factors: 

‘‘(A) The known safety risks of the food manufactured, 

processed, packed, or held at the facility. 

‘‘(B) The compliance history of a facility, including 

with regard to food recalls, outbreaks of foodborne illness, 

and violations of food safety standards. 

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

analysis and risk-based preventive controls. 

‘‘(D) Whether the food manufactured, processed, 

packed, or held at the facility meets the criteria for priority 

under section 801(h)(1). 

‘‘(E) Whether the food or the facility that manufactured, processed, packed, or held such food has received 

a certification as described in section 801(q) or 806, as 

appropriate. 

‘‘(F) Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection 

resources. 

‘‘(2) INSPECTIONS.— 

‘‘(A) IN GENERAL.—Beginning on the date of enactment 

of the FDA Food Safety Modernization Act, the Secretary 

shall increase the frequency of inspection of all facilities. 

Effective date. 

21 USC 350j. 


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‘‘(B) DOMESTIC HIGH-RISK FACILITIES.—The Secretary 

shall increase the frequency of inspection of domestic facilities identified under paragraph (1) as high-risk facilities 

such that each such facility is inspected— 

‘‘(i) not less often than once in the 5-year period 

following the date of enactment of the FDA Food Safety 

Modernization Act; and 

‘‘(ii) not less often than once every 3 years thereafter. 

‘‘(C) DOMESTIC NON-HIGH-RISK FACILITIES.—The Secretary shall ensure that each domestic facility that is not 

identified under paragraph (1) as a high-risk facility is 

inspected— 

‘‘(i) not less often than once in the 7-year period 

following the date of enactment of the FDA Food Safety 

Modernization Act; and 

‘‘(ii) not less often than once every 5 years thereafter. 

‘‘(D) FOREIGN FACILITIES.— 

‘‘(i) YEAR 1.—In the 1-year period following the 

date of enactment of the FDA Food Safety Modernization Act, the Secretary shall inspect not fewer than 

600 foreign facilities. 

‘‘(ii) SUBSEQUENT YEARS.—In each of the 5 years 

following the 1-year period described in clause (i), the 

Secretary shall inspect not fewer than twice the 

number of foreign facilities inspected by the Secretary 

during the previous year. 

‘‘(E) RELIANCE ON FEDERAL, STATE, OR LOCAL INSPECTIONS.—In meeting the inspection requirements under this 

subsection for domestic facilities, the Secretary may rely 

on inspections conducted by other Federal, State, or local 

agencies under interagency agreement, contract, memoranda of understanding, or other obligation. 

‘‘(b) IDENTIFICATION AND INSPECTION AT PORTS OF ENTRY.— 

The Secretary, in consultation with the Secretary of Homeland 

Security, shall allocate resources to inspect any article of food 

imported into the United States according to the known safety 

risks of the article of food, which shall be based on the following 

factors: 

‘‘(1) The known safety risks of the food imported. 

‘‘(2) The known safety risks of the countries or regions 

of origin and countries through which such article of food is 

transported. 

‘‘(3) The compliance history of the importer, including with 

regard to food recalls, outbreaks of foodborne illness, and violations of food safety standards. 

‘‘(4) The rigor and effectiveness of the activities conducted 

by the importer of such article of food to satisfy the requirements of the foreign supplier verification program under section 

805. 

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

qualified importer program under section 806. 

‘‘(6) Whether the food meets the criteria for priority under 

section 801(h)(1). 

Time period. 

Deadlines. 

Deadlines. 


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‘‘(7) Whether the food or the facility that manufactured, 

processed, packed, or held such food received a certification 

as described in section 801(q) or 806. 

‘‘(8) Any other criteria deemed necessary and appropriate 

by the Secretary for purposes of allocating inspection resources. 

‘‘(c) INTERAGENCY AGREEMENTS WITH RESPECT TO SEAFOOD.— ‘‘(1) IN GENERAL.—The Secretary of Health and Human 

Services, the Secretary of Commerce, the Secretary of Homeland 

Security, the Chairman of the Federal Trade Commission, and 

the heads of other appropriate agencies may enter into such 

agreements as may be necessary or appropriate to improve 

seafood safety. 

‘‘(2) SCOPE OF AGREEMENTS.—The agreements under paragraph (1) may include— 

‘‘(A) cooperative arrangements for examining and 

testing seafood imports that leverage the resources, 

capabilities, and authorities of each party to the agreement; 

‘‘(B) coordination of inspections of foreign facilities to 

increase the percentage of imported seafood and seafood 

facilities inspected; 

‘‘(C) standardization of data on seafood names, inspection records, and laboratory testing to improve interagency 

coordination; 

‘‘(D) coordination to detect and investigate violations 

under applicable Federal law; 

‘‘(E) a process, including the use or modification of 

existing processes, by which officers and employees of the 

National Oceanic and Atmospheric Administration may be 

duly designated by the Secretary to carry out seafood 

examinations and investigations under section 801 of this 

Act or section 203 of the Food Allergen Labeling and Consumer Protection Act of 2004; 

‘‘(F) the sharing of information concerning observed 

non-compliance with United States food requirements 

domestically and in foreign nations and new regulatory 

decisions and policies that may affect the safety of food 

imported into the United States; 

‘‘(G) conducting joint training on subjects that affect 

and strengthen seafood inspection effectiveness by Federal 

authorities; and 

‘‘(H) outreach on Federal efforts to enhance seafood 

safety and compliance with Federal food safety requirements. 

‘‘(d) COORDINATION.—The Secretary shall improve coordination 

and cooperation with the Secretary of Agriculture and the Secretary 

of Homeland Security to target food inspection resources. 

‘‘(e) FACILITY.—For purposes of this section, the term ‘facility’ 

means a domestic facility or a foreign facility that is required 

to register under section 415.’’. 

(b) ANNUAL REPORT.—Section 1003 (21 U.S.C. 393) is amended 

by adding at the end the following: 

‘‘(h) ANNUAL REPORT REGARDING FOOD.—Not later than February 1 of each year, the Secretary shall submit to Congress a 

report, including efforts to coordinate and cooperate with other 

Federal agencies with responsibilities for food inspections, 

regarding— 

‘‘(1) information about food facilities including— 

Definition. 


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‘‘(A) the appropriations used to inspect facilities registered pursuant to section 415 in the previous fiscal year; 

‘‘(B) the average cost of both a non-high-risk food 

facility inspection and a high-risk food facility inspection, 

if such a difference exists, in the previous fiscal year; 

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

of foreign facilities registered pursuant to section 415 that 

the Secretary inspected in the previous fiscal year; 

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

of foreign facilities registered pursuant to section 415 that 

were scheduled for inspection in the previous fiscal year 

and which the Secretary did not inspect in such year; 

‘‘(E) the number of high-risk facilities identified pursuant to section 421 that the Secretary inspected in the 

previous fiscal year; and 

‘‘(F) the number of high-risk facilities identified pursuant to section 421 that were scheduled for inspection in 

the previous fiscal year and which the Secretary did not 

inspect in such year. 

‘‘(2) information about food imports including— 

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

United States that the Secretary physically inspected or 

sampled in the previous fiscal year; 

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

United States that the Secretary did not physically inspect 

or sample in the previous fiscal year; and 

‘‘(C) the average cost of physically inspecting or sampling a line of food subject to this Act that is imported 

or offered for import into the United States; and 

‘‘(3) information on the foreign offices of the Food and 

Drug Administration including— 

‘‘(A) the number of foreign offices established; and 

‘‘(B) the number of personnel permanently stationed 

in each foreign office. 

‘‘(i) PUBLIC AVAILABILITY OF ANNUAL FOOD REPORTS.—The Secretary shall make the reports required under subsection (h) available to the public on the Internet Web site of the Food and Drug 

Administration.’’. 

(c) ADVISORY COMMITTEE CONSULTATION.—In allocating inspection resources as described in section 421 of the Federal Food, 

Drug, and Cosmetic Act (as added by subsection (a)), the Secretary 

may, as appropriate, consult with any relevant advisory committee 

within the Department of Health and Human Services. 

SEC. 202. LABORATORY ACCREDITATION FOR ANALYSES OF FOODS. 

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

amended by section 201, is amended by adding at the end the 

following: 

‘‘SEC. 422. LABORATORY ACCREDITATION FOR ANALYSES OF FOODS. 

‘‘(a) RECOGNITION OF LABORATORY ACCREDITATION.— 

‘‘(1) IN GENERAL.—Not later than 2 years after the date 

of enactment of the FDA Food Safety Modernization Act, the 

Secretary shall— 

‘‘(A) establish a program for the testing of food by 

accredited laboratories; 

‘‘(B) establish a publicly available registry of accreditation bodies recognized by the Secretary and laboratories 

Establishment. 

Deadline. 

21 USC 350k. 

21 USC 350j 

note. 

Web posting. 


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accredited by a recognized accreditation body, including 

the name of, contact information for, and other information 

deemed appropriate by the Secretary about such bodies 

and laboratories; and 

‘‘(C) require, as a condition of recognition or accreditation, as appropriate, that recognized accreditation bodies 

and accredited laboratories report to the Secretary any 

changes that would affect the recognition of such accreditation body or the accreditation of such laboratory. 

‘‘(2) PROGRAM REQUIREMENTS.—The program established 

under paragraph (1)(A) shall provide for the recognition of 

laboratory accreditation bodies that meet criteria established 

by the Secretary for accreditation of laboratories, including 

independent private laboratories and laboratories run and operated by a Federal agency (including the Department of Commerce), State, or locality with a demonstrated capability to 

conduct 1 or more sampling and analytical testing methodologies for food. 

‘‘(3) INCREASING THE NUMBER OF QUALIFIED LABORATORIES.—The Secretary shall work with the laboratory accreditation bodies recognized under paragraph (1), as appropriate, 

to increase the number of qualified laboratories that are eligible 

to perform testing under subparagraph (b) beyond the number 

so qualified on the date of enactment of the FDA Food Safety 

Modernization Act. 

‘‘(4) LIMITED DISTRIBUTION.—In the interest of national 

security, the Secretary, in coordination with the Secretary of 

Homeland Security, may determine the time, manner, and form 

in which the registry established under paragraph (1)(B) is 

made publicly available. 

‘‘(5) FOREIGN LABORATORIES.—Accreditation bodies recognized by the Secretary under paragraph (1) may accredit laboratories that operate outside the United States, so long as such 

laboratories meet the accreditation standards applicable to 

domestic laboratories accredited under this section. 

‘‘(6) MODEL LABORATORY STANDARDS.—The Secretary shall 

develop model standards that a laboratory shall meet to be 

accredited by a recognized accreditation body for a specified 

sampling or analytical testing methodology and included in 

the registry provided for under paragraph (1). In developing 

the model standards, the Secretary shall consult existing standards for guidance. The model standards shall include— 

‘‘(A) methods to ensure that— 

‘‘(i) appropriate sampling, analytical procedures 

(including rapid analytical procedures), and commercially available techniques are followed and reports 

of analyses are certified as true and accurate; 

‘‘(ii) internal quality systems are established and 

maintained; 

‘‘(iii) procedures exist to evaluate and respond 

promptly to complaints regarding analyses and other 

activities for which the laboratory is accredited; and 

‘‘(iv) individuals who conduct the sampling and 

analyses are qualified by training and experience to 

do so; and 

‘‘(B) any other criteria determined appropriate by the 

Secretary. 


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‘‘(7) REVIEW OF RECOGNITION.—To ensure compliance with 

the requirements of this section, the Secretary— 

‘‘(A) shall periodically, and in no case less than once 

every 5 years, reevaluate accreditation bodies recognized 

under paragraph (1) and may accompany auditors from 

an accreditation body to assess whether the accreditation 

body meets the criteria for recognition; and 

‘‘(B) shall promptly revoke the recognition of any 

accreditation body found not to be in compliance with the 

requirements of this section, specifying, as appropriate, 

any terms and conditions necessary for laboratories accredited by such body to continue to perform testing as 

described in this section. 

‘‘(b) TESTING PROCEDURES.— 

‘‘(1) IN GENERAL.—Not later than 30 months after the date 

of enactment of the FDA Food Safety Modernization Act, food 

testing shall be conducted by Federal laboratories or non-Federal laboratories that have been accredited for the appropriate 

sampling or analytical testing methodology or methodologies 

by a recognized accreditation body on the registry established 

by the Secretary under subsection (a)(1)(B) whenever such 

testing is conducted— 

‘‘(A) by or on behalf of an owner or consignee— 

‘‘(i) in response to a specific testing requirement 

under this Act or implementing regulations, when 

applied to address an identified or suspected food safety 

problem; and 

‘‘(ii) as required by the Secretary, as the Secretary 

deems appropriate, to address an identified or suspected food safety problem; or 

‘‘(B) on behalf of an owner or consignee— 

‘‘(i) in support of admission of an article of food 

under section 801(a); and 

‘‘(ii) under an Import Alert that requires successful 

consecutive tests. 

‘‘(2) RESULTS OF TESTING.—The results of any such testing 

shall be sent directly to the Food and Drug Administration, 

except the Secretary may by regulation exempt test results 

from such submission requirement if the Secretary determines 

that such results do not contribute to the protection of public 

health. Test results required to be submitted may be submitted 

to the Food and Drug Administration through electronic means. 

‘‘(3) EXCEPTION.—The Secretary may waive requirements 

under this subsection if— 

‘‘(A) a new methodology or methodologies have been 

developed and validated but a laboratory has not yet been 

accredited to perform such methodology or methodologies; 

and 

‘‘(B) the use of such methodology or methodologies 

are necessary to prevent, control, or mitigate a food emergency or foodborne illness outbreak. 

‘‘(c) REVIEW BY SECRETARY.—If food sampling and testing performed by a laboratory run and operated by a State or locality 

that is accredited by a recognized accreditation body on the registry 

established by the Secretary under subsection (a) result in a State 

recalling a food, the Secretary shall review the sampling and testing 

Waiver authority. 


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results for the purpose of determining the need for a national 

recall or other compliance and enforcement activities. 

‘‘(d) NO LIMIT ON SECRETARIAL AUTHORITY.—Nothing in this 

section shall be construed to limit the ability of the Secretary 

to review and act upon information from food testing, including 

determining the sufficiency of such information and testing.’’. 

(b) FOOD EMERGENCY RESPONSE NETWORK.—The Secretary, in 

coordination with the Secretary of Agriculture, the Secretary of 

Homeland Security, and State, local, and tribal governments shall, 

not later than 180 days after the date of enactment of this Act, 

and biennially thereafter, submit to the relevant committees of 

Congress, and make publicly available on the Internet Web site 

of the Department of Health and Human Services, a report on 

the progress in implementing a national food emergency response 

laboratory network that— 

(1) provides ongoing surveillance, rapid detection, and surge 

capacity for large-scale food-related emergencies, including 

intentional adulteration of the food supply; 

(2) coordinates the food laboratory capacities of State, local, 

and tribal food laboratories, including the adoption of novel 

surveillance and identification technologies and the sharing 

of data between Federal agencies and State laboratories to 

develop national situational awareness; 

(3) provides accessible, timely, accurate, and consistent food 

laboratory services throughout the United States; 

(4) develops and implements a methods repository for use 

by Federal, State, and local officials; 

(5) responds to food-related emergencies; and 

(6) is integrated with relevant laboratory networks 

administered by other Federal agencies. 

SEC. 203. INTEGRATED CONSORTIUM OF LABORATORY NETWORKS. 

(a) IN GENERAL.—The Secretary of Homeland Security, in 

coordination with the Secretary of Health and Human Services, 

the Secretary of Agriculture, the Secretary of Commerce, and the 

Administrator of the Environmental Protection Agency, shall maintain an agreement through which relevant laboratory network members, as determined by the Secretary of Homeland Security, shall— 

(1) agree on common laboratory methods in order to reduce 

the time required to detect and respond to foodborne illness 

outbreaks and facilitate the sharing of knowledge and information relating to animal health, agriculture, and human health; 

(2) identify means by which laboratory network members 

could work cooperatively— 

(A) to optimize national laboratory preparedness; and 

(B) to provide surge capacity during emergencies; and 

(3) engage in ongoing dialogue and build relationships that 

will support a more effective and integrated response during 

emergencies. 

(b) REPORTING REQUIREMENT.—The Secretary of Homeland 

Security shall, on a biennial basis, submit to the relevant committees of Congress, and make publicly available on the Internet Web 

site of the Department of Homeland Security, a report on the 

progress of the integrated consortium of laboratory networks, as 

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

Web posting. 

Contracts. 

21 USC 2222. 

Deadlines. 

Web posting. 

Reports. 

21 USC 2221. 


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SEC. 204. ENHANCING TRACKING AND TRACING OF FOOD AND 

RECORDKEEPING. 

(a) PILOT PROJECTS.— (1) IN GENERAL.—Not later than 270 days after the date 

of enactment of this Act, the Secretary of Health and Human 

Services (referred to in this section as the ‘‘Secretary’’), taking 

into account recommendations from the Secretary of Agriculture 

and representatives of State departments of health and agriculture, shall establish pilot projects in coordination with the 

food industry to explore and evaluate methods to rapidly and 

effectively identify recipients of food to prevent or mitigate 

a foodborne illness outbreak and to address credible threats 

of serious adverse health consequences or death to humans 

or animals as a result of such food being adulterated under 

section 402 of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 342) or misbranded under section 403(w) of such Act 

(21 U.S.C. 343(w)). 

(2) CONTENT.—The Secretary shall conduct 1 or more pilot 

projects under paragraph (1) in coordination with the processed 

food sector and 1 or more such pilot projects in coordination 

with processors or distributors of fruits and vegetables that 

are raw agricultural commodities. The Secretary shall ensure 

that the pilot projects under paragraph (1) reflect the diversity 

of the food supply and include at least 3 different types of 

foods that have been the subject of significant outbreaks during 

the 5-year period preceding the date of enactment of this Act, 

and are selected in order to— 

(A) develop and demonstrate methods for rapid and 

effective tracking and tracing of foods in a manner that 

is practicable for facilities of varying sizes, including small 

businesses; 

(B) develop and demonstrate appropriate technologies, 

including technologies existing on the date of enactment 

of this Act, that enhance the tracking and tracing of food; 

and 

(C) inform the promulgation of regulations under subsection (d). 

(3) REPORT.—Not later than 18 months after the date of 

enactment of this Act, the Secretary shall report to Congress 

on the findings of the pilot projects under this subsection 

together with recommendations for improving the tracking and 

tracing of food. 

(b) ADDITIONAL DATA GATHERING.— 

(1) IN GENERAL.—The Secretary, in coordination with the 

Secretary of Agriculture and multiple representatives of State 

departments of health and agriculture, shall assess— 

(A) the costs and benefits associated with the adoption 

and use of several product tracing technologies, including 

technologies used in the pilot projects under subsection 

(a); 

(B) the feasibility of such technologies for different 

sectors of the food industry, including small businesses; 

and 

(C) whether such technologies are compatible with the 

requirements of this subsection. 

(2) REQUIREMENTS.—To the extent practicable, in carrying 

out paragraph (1), the Secretary shall— 

Recommendations. 

21 USC 2223. 


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(A) evaluate domestic and international product tracing 

practices in commercial use; 

(B) consider international efforts, including an assessment of whether product tracing requirements developed 

under this section are compatible with global tracing systems, as appropriate; and 

(C) consult with a diverse and broad range of experts 

and stakeholders, including representatives of the food 

industry, agricultural producers, and nongovernmental 

organizations that represent the interests of consumers. 

(c) PRODUCT TRACING SYSTEM.—The Secretary, in consultation 

with the Secretary of Agriculture, shall, as appropriate, establish 

within the Food and Drug Administration a product tracing system 

to receive information that improves the capacity of the Secretary 

to effectively and rapidly track and trace food that is in the United 

States or offered for import into the United States. Prior to the 

establishment of such product tracing system, the Secretary shall 

examine the results of applicable pilot projects and shall ensure 

that the activities of such system are adequately supported by 

the results of such pilot projects. 

(d) ADDITIONAL RECORDKEEPING REQUIREMENTS FOR HIGH RISK

FOODS.— 

(1) IN GENERAL.—In order to rapidly and effectively identify 

recipients of a food to prevent or mitigate a foodborne illness 

outbreak and to address credible threats of serious adverse 

health consequences or death to humans or animals as a result 

of such food being adulterated under section 402 of the Federal 

Food, Drug, and Cosmetic Act or misbranded under section 

403(w) of such Act, not later than 2 years after the date 

of enactment of this Act, the Secretary shall publish a notice 

of proposed rulemaking to establish recordkeeping requirements, in addition to the requirements under section 414 of 

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350c) 

and subpart J of part 1 of title 21, Code of Federal Regulations 

(or any successor regulations), for facilities that manufacture, 

process, pack, or hold foods that the Secretary designates under 

paragraph (2) as high-risk foods. The Secretary shall set an 

appropriate effective date of such additional requirements for 

foods designated as high risk that takes into account the length 

of time necessary to comply with such requirements. Such 

requirements shall— 

(A) relate only to information that is reasonably available and appropriate; 

(B) be science-based; 

(C) not prescribe specific technologies for the maintenance of records; 

(D) ensure that the public health benefits of imposing 

additional recordkeeping requirements outweigh the cost 

of compliance with such requirements; 

(E) be scale-appropriate and practicable for facilities 

of varying sizes and capabilities with respect to costs and 

recordkeeping burdens, and not require the creation and 

maintenance of duplicate records where the information 

is contained in other company records kept in the normal 

course of business; 

Deadline. 

Publication. 

Notice. 

Consultation. 


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(F) minimize the number of different recordkeeping 

requirements for facilities that handle more than 1 type 

of food; 

(G) to the extent practicable, not require a facility 

to change business systems to comply with such requirements; 

(H) allow any person subject to this subsection to maintain records required under this subsection at a central 

or reasonably accessible location provided that such records 

can be made available to the Secretary not later than 

24 hours after the Secretary requests such records; and 

(I) include a process by which the Secretary may issue 

a waiver of the requirements under this subsection if the 

Secretary determines that such requirements would result 

in an economic hardship for an individual facility or a 

type of facility; 

(J) be commensurate with the known safety risks of 

the designated food; 

(K) take into account international trade obligations; 

(L) not require— 

(i) a full pedigree, or a record of the complete 

previous distribution history of the food from the point 

of origin of such food; 

(ii) records of recipients of a food beyond the immediate subsequent recipient of such food; or 

(iii) product tracking to the case level by persons 

subject to such requirements; and 

(M) include a process by which the Secretary may 

remove a high-risk food designation developed under paragraph (2) for a food or type of food. 

(2) DESIGNATION OF HIGH-RISK FOODS.— 

(A) IN GENERAL.—Not later than 1 year after the date 

of enactment of this Act, and thereafter as the Secretary 

determines necessary, the Secretary shall designate highrisk foods for which the additional recordkeeping requirements described in paragraph (1) are appropriate and necessary to protect the public health. Each such designation 

shall be based on— 

(i) the known safety risks of a particular food, 

including the history and severity of foodborne illness 

outbreaks attributed to such food, taking into consideration foodborne illness data collected by the Centers 

for Disease Control and Prevention; 

(ii) the likelihood that a particular food has a 

high potential risk for microbiological or chemical 

contamination or would support the growth of pathogenic microorganisms due to the nature of the food 

or the processes used to produce such food; 

(iii) the point in the manufacturing process of the 

food where contamination is most likely to occur; 

(iv) the likelihood of contamination and steps taken 

during the manufacturing process to reduce the possibility of contamination; 

(v) the likelihood that consuming a particular food 

will result in a foodborne illness due to contamination 

of the food; and 

Deadline. 


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(vi) the likely or known severity, including health 

and economic impacts, of a foodborne illness attributed 

to a particular food. 

(B) LIST OF HIGH-RISK FOODS.—At the time the Secretary promulgates the final rules under paragraph (1), 

the Secretary shall publish the list of the foods designated 

under subparagraph (A) as high-risk foods on the Internet 

website of the Food and Drug Administration. The Secretary may update the list to designate new high-risk foods 

and to remove foods that are no longer deemed to be 

high-risk foods, provided that each such update to the 

list is consistent with the requirements of this subsection 

and notice of such update is published in the Federal 

Register. 

(3) PROTECTION OF SENSITIVE INFORMATION.—In promulgating regulations under this subsection, the Secretary shall 

take appropriate measures to ensure that there are effective 

procedures to prevent the unauthorized disclosure of any trade 

secret or confidential information that is obtained by the Secretary pursuant to this section, including periodic risk assessment and planning to prevent unauthorized release and controls 

to— 

(A) prevent unauthorized reproduction of trade secret 

or confidential information; 

(B) prevent unauthorized access to trade secret or confidential information; and 

(C) maintain records with respect to access by any 

person to trade secret or confidential information maintained by the agency. 

(4) PUBLIC INPUT.—During the comment period in the 

notice of proposed rulemaking under paragraph (1), the Secretary shall conduct not less than 3 public meetings in diverse 

geographical areas of the United States to provide persons 

in different regions an opportunity to comment. 

(5) RETENTION OF RECORDS.—Except as otherwise provided 

in this subsection, the Secretary may require that a facility 

retain records under this subsection for not more than 2 years, 

taking into consideration the risk of spoilage, loss of value, 

or loss of palatability of the applicable food when determining 

the appropriate timeframes. 

(6) LIMITATIONS.— 

(A) FARM TO SCHOOL PROGRAMS.—In establishing 

requirements under this subsection, the Secretary shall, 

in consultation with the Secretary of Agriculture, consider 

the impact of requirements on farm to school or farm 

to institution programs of the Department of Agriculture 

and other farm to school and farm to institution programs 

outside such agency, and shall modify the requirements 

under this subsection, as appropriate, with respect to such 

programs so that the requirements do not place undue 

burdens on farm to school or farm to institution programs. 

(B) IDENTITY-PRESERVED LABELS WITH RESPECT TO

FARM SALES OF FOOD THAT IS PRODUCED AND PACKAGED

ON A FARM.—The requirements under this subsection shall 

not apply to a food that is produced and packaged on 

a farm if— 

Federal Register, 

publication. 

Notice. 

List. 

Web posting. 


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(i) the packaging of the food maintains the integrity of the product and prevents subsequent contamination or alteration of the product; and 

(ii) the labeling of the food includes the name, 

complete address (street address, town, State, country, 

and zip or other postal code), and business phone 

number of the farm, unless the Secretary waives the 

requirement to include a business phone number of 

the farm, as appropriate, in order to accommodate 

a religious belief of the individual in charge of such 

farm. 

(C) FISHING VESSELS.—The requirements under this 

subsection with respect to a food that is produced through 

the use of a fishing vessel (as defined in section 3(18) 

of the Magnuson-Stevens Fishery Conservation and 

Management Act (16 U.S.C. 1802(18))) shall be limited 

to the requirements under subparagraph (F) until such 

time as the food is sold by the owner, operator, or agent 

in charge of such fishing vessel. 

(D) COMMINGLED RAW AGRICULTURAL COMMODITIES.— 

(i) LIMITATION ON EXTENT OF TRACING.—Recordkeeping requirements under this subsection with 

regard to any commingled raw agricultural commodity 

shall be limited to the requirements under subparagraph (F). 

(ii) DEFINITIONS.—For the purposes of this 

subparagraph— 

(I) the term ‘‘commingled raw agricultural 

commodity’’ means any commodity that is combined or mixed after harvesting, but before processing; 

(II) the term ‘‘commingled raw agricultural 

commodity’’ shall not include types of fruits and 

vegetables that are raw agricultural commodities 

for which the Secretary has determined that standards promulgated under section 419 of the Federal 

Food, Drug, and Cosmetic Act (as added by section 

105) would minimize the risk of serious adverse 

health consequences or death; and 

(III) the term ‘‘processing’’ means operations 

that alter the general state of the commodity, such 

as canning, cooking, freezing, dehydration, milling, 

grinding, pasteurization, or homogenization. 

(E) EXEMPTION OF OTHER FOODS.—The Secretary may, 

by notice in the Federal Register, modify the requirements 

under this subsection with respect to, or exempt a food 

or a type of facility from, the requirements of this subsection (other than the requirements under subparagraph 

(F), if applicable) if the Secretary determines that product 

tracing requirements for such food (such as bulk or commingled ingredients that are intended to be processed to 

destroy pathogens) or type of facility is not necessary to 

protect the public health. 

(F) RECORDKEEPING REGARDING PREVIOUS SOURCES AND

SUBSEQUENT RECIPIENTS.—In the case of a person or food 

to which a limitation or exemption under subparagraph 

(C), (D), or (E) applies, if such person, or a person who 


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manufactures, processes, packs, or holds such food, is 

required to register with the Secretary under section 415 

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

350d) with respect to the manufacturing, processing, 

packing, or holding of the applicable food, the Secretary 

shall require such person to maintain records that identify 

the immediate previous source of such food and the immediate subsequent recipient of such food. 

(G) GROCERY STORES.—With respect to a sale of a 

food described in subparagraph (H) to a grocery store, 

the Secretary shall not require such grocery store to maintain records under this subsection other than records documenting the farm that was the source of such food. The 

Secretary shall not require that such records be kept for 

more than 180 days. 

(H) FARM SALES TO CONSUMERS.—The Secretary shall 

not require a farm to maintain any distribution records 

under this subsection with respect to a sale of a food 

described in subparagraph (I) (including a sale of a food 

that is produced and packaged on such farm), if such 

sale is made by the farm directly to a consumer. 

(I) SALE OF A FOOD.—A sale of a food described in 

this subparagraph is a sale of a food in which— 

(i) the food is produced on a farm; and 

(ii) the sale is made by the owner, operator, or 

agent in charge of such farm directly to a consumer 

or grocery store. 

(7) NO IMPACT ON NON-HIGH-RISK FOODS.—The recordkeeping requirements established under paragraph (1) shall 

have no effect on foods that are not designated by the Secretary 

under paragraph (2) as high-risk foods. Foods described in 

the preceding sentence shall be subject solely to the recordkeeping requirements under section 414 of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 350c) and subpart J of 

part 1 of title 21, Code of Federal Regulations (or any successor 

regulations). 

(e) EVALUATION AND RECOMMENDATIONS.— 

(1) REPORT.—Not later than 1 year after the effective date 

of the final rule promulgated under subsection (d)(1), the Comptroller General of the United States shall submit to Congress 

a report, taking into consideration the costs of compliance and 

other regulatory burdens on small businesses and Federal, 

State, and local food safety practices and requirements, that 

evaluates the public health benefits and risks, if any, of limiting— 

(A) the product tracing requirements under subsection 

(d) to foods identified under paragraph (2) of such subsection, including whether such requirements provide adequate assurance of traceability in the event of intentional 

adulteration, including by acts of terrorism; and 

(B) the participation of restaurants in the recordkeeping requirements. 

(2) DETERMINATION AND RECOMMENDATIONS.—In conducting the evaluation and report under paragraph (1), if the 

Comptroller General of the United States determines that the 

limitations described in such paragraph do not adequately protect the public health, the Comptroller General shall submit 

Time period. 


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to Congress recommendations, if appropriate, regarding recordkeeping requirements for restaurants and additional foods, in 

order to protect the public health. 

(f) FARMS.— 

(1) REQUEST FOR INFORMATION.—Notwithstanding subsection (d), during an active investigation of a foodborne illness 

outbreak, or if the Secretary determines it is necessary to 

protect the public health and prevent or mitigate a foodborne 

illness outbreak, the Secretary, in consultation and coordination 

with State and local agencies responsible for food safety, as 

appropriate, may request that the owner, operator, or agent 

of a farm identify potential immediate recipients, other than 

consumers, of an article of the food that is the subject of 

such investigation if the Secretary reasonably believes such 

article of food— 

(A) is adulterated under section 402 of the Federal 

Food, Drug, and Cosmetic Act; 

(B) presents a threat of serious adverse health consequences or death to humans or animals; and 

(C) was adulterated as described in subparagraph (A) 

on a particular farm (as defined in section 1.227 of chapter 

21, Code of Federal Regulations (or any successor regulation)). 

(2) MANNER OF REQUEST.—In making a request under paragraph (1), the Secretary, in consultation and coordination with 

State and local agencies responsible for food safety, as appropriate, shall issue a written notice to the owner, operator, 

or agent of the farm to which the article of food has been 

traced. The individual providing such notice shall present to 

such owner, operator, or agent appropriate credentials and 

shall deliver such notice at reasonable times and within reasonable limits and in a reasonable manner. 

(3) DELIVERY OF INFORMATION REQUESTED.—The owner, 

operator, or agent of a farm shall deliver the information 

requested under paragraph (1) in a prompt and reasonable 

manner. Such information may consist of records kept in the 

normal course of business, and may be in electronic or nonelectronic format. 

(4) LIMITATION.—A request made under paragraph (1) shall 

not include a request for information relating to the finances, 

pricing of commodities produced, personnel, research, sales 

(other than information relating to shipping), or other disclosures that may reveal trade secrets or confidential information 

from the farm to which the article of food has been traced, 

other than information necessary to identify potential immediate recipients of such food. Section 301(j) of the Federal 

Food, Drug, and Cosmetic Act and the Freedom of Information 

Act shall apply with respect to any confidential commercial 

information that is disclosed to the Food and Drug Administration in the course of responding to a request under paragraph 

(1). 

(5) RECORDS.—Except with respect to identifying potential 

immediate recipients in response to a request under this subsection, nothing in this subsection shall require the establishment or maintenance by farms of new records. 

Applicability. 

Notice. 


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(g) NO LIMITATION ON COMMINGLING OF FOOD.—Nothing in 

this section shall be construed to authorize the Secretary to impose 

any limitation on the commingling of food. 

(h) SMALL ENTITY COMPLIANCE GUIDE.—Not later than 180 

days after promulgation of a final rule under subsection (d), the 

Secretary shall issue a small entity compliance guide setting forth 

in plain language the requirements of the regulations under such 

subsection in order to assist small entities, including farms and 

small businesses, in complying with the recordkeeping requirements 

under such subsection. 

(i) FLEXIBILITY FOR SMALL BUSINESSES.—Notwithstanding any 

other provision of law, the regulations promulgated under subsection (d) shall apply— 

(1) to small businesses (as defined by the Secretary in 

section 103, not later than 90 days after the date of enactment 

of this Act) beginning on the date that is 1 year after the 

effective date of the final regulations promulgated under subsection (d); and 

(2) to very small businesses (as defined by the Secretary 

in section 103, not later than 90 days after the date of enactment of this Act) beginning on the date that is 2 years after 

the effective date of the final regulations promulgated under 

subsection (d). 

(j) ENFORCEMENT.— 

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

is amended by inserting ‘‘; or the violation of any recordkeeping 

requirement under section 204 of the FDA Food Safety Modernization Act (except when such violation is committed by 

a farm)’’ before the period at the end. 

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

by inserting ‘‘or (4) the recordkeeping requirements under section 204 of the FDA Food Safety Modernization Act (other 

than the requirements under subsection (f) of such section) 

have not been complied with regarding such article,’’ in the 

third sentence before ‘‘then such article shall be refused admission’’. 

SEC. 205. SURVEILLANCE. 

(a) DEFINITION OF FOODBORNE ILLNESS OUTBREAK.—In this 

Act, the term ‘‘foodborne illness outbreak’’ means the occurrence 

of 2 or more cases of a similar illness resulting from the ingestion 

of a certain food. 

(b) FOODBORNE ILLNESS SURVEILLANCE SYSTEMS.— 

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

Director of the Centers for Disease Control and Prevention, 

shall enhance foodborne illness surveillance systems to improve 

the collection, analysis, reporting, and usefulness of data on 

foodborne illnesses by— 

(A) coordinating Federal, State and local foodborne 

illness surveillance systems, including complaint systems, 

and increasing participation in national networks of public 

health and food regulatory agencies and laboratories; 

(B) facilitating sharing of surveillance information on 

a more timely basis among governmental agencies, 

including the Food and Drug Administration, the Department of Agriculture, the Department of Homeland Security, 

and State and local agencies, and with the public; 

21 USC 2224. 

Applicability. 

Deadlines. 

Effective dates. 

Deadline. 


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(C) developing improved epidemiological tools for 

obtaining quality exposure data and microbiological 

methods for classifying cases; 

(D) augmenting such systems to improve attribution 

of a foodborne illness outbreak to a specific food; 

(E) expanding capacity of such systems, including 

working toward automatic electronic searches, for 

implementation of identification practices, including 

fingerprinting strategies, for foodborne infectious agents, 

in order to identify new or rarely documented causes of 

foodborne illness and submit standardized information to 

a centralized database; 

(F) allowing timely public access to aggregated, deidentified surveillance data; 

(G) at least annually, publishing current reports on 

findings from such systems; 

(H) establishing a flexible mechanism for rapidly initiating scientific research by academic institutions; 

(I) integrating foodborne illness surveillance systems 

and data with other biosurveillance and public health situational awareness capabilities at the Federal, State, and 

local levels, including by sharing foodborne illness surveillance data with the National Biosurveillance Integration 

Center; and 

(J) other activities as determined appropriate by the 

Secretary. 

(2) WORKING GROUP.—The Secretary shall support and 

maintain a diverse working group of experts and stakeholders 

from Federal, State, and local food safety and health agencies, 

the food and food testing industries, consumer organizations, 

and academia. Such working group shall provide the Secretary, 

through at least annual meetings of the working group and 

an annual public report, advice and recommendations on an 

ongoing and regular basis regarding the improvement of 

foodborne illness surveillance and implementation of this section, including advice and recommendations on— 

(A) the priority needs of regulatory agencies, the food 

industry, and consumers for information and analysis on 

foodborne illness and its causes; 

(B) opportunities to improve the effectiveness of initiatives at the Federal, State, and local levels, including 

coordination and integration of activities among Federal 

agencies, and between the Federal, State, and local levels 

of government; 

(C) improvement in the timeliness and depth of access 

by regulatory and health agencies, the food industry, academic researchers, and consumers to foodborne illness 

aggregated, de-identified surveillance data collected by 

government agencies at all levels, including data compiled 

by the Centers for Disease Control and Prevention; 

(D) key barriers at Federal, State, and local levels 

to improving foodborne illness surveillance and the utility 

of such surveillance for preventing foodborne illness; 

(E) the capabilities needed for establishing automatic 

electronic searches of surveillance data; and 

(F) specific actions to reduce barriers to improvement, 

implement the working group’s recommendations, and 

Deadline. 

Reports. 

Recommendations. 


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PUBLIC LAW 111–353—JAN. 4, 2011 124 STAT. 3939 

achieve the purposes of this section, with measurable objectives and timelines, and identification of resource and 

staffing needs. 

(3) AUTHORIZATION OF APPROPRIATIONS.—To carry out the 

activities described in paragraph (1), there is authorized to 

be appropriated $24,000,000 for each fiscal years 2011 through 

2015. 

(c) IMPROVING FOOD SAFETY AND DEFENSE CAPACITY AT THE

STATE AND LOCAL LEVEL.— (1) IN GENERAL.—The Secretary shall develop and implement strategies to leverage and enhance the food safety and 

defense capacities of State and local agencies in order to achieve 

the following goals: 

(A) Improve foodborne illness outbreak response and 

containment. 

(B) Accelerate foodborne illness surveillance and outbreak investigation, including rapid shipment of clinical 

isolates from clinical laboratories to appropriate State laboratories, and conducting more standardized illness outbreak interviews. 

(C) Strengthen the capacity of State and local agencies 

to carry out inspections and enforce safety standards. 

(D) Improve the effectiveness of Federal, State, and 

local partnerships to coordinate food safety and defense 

resources and reduce the incidence of foodborne illness. 

(E) Share information on a timely basis among public 

health and food regulatory agencies, with the food industry, 

with health care providers, and with the public. 

(F) Strengthen the capacity of State and local agencies 

to achieve the goals described in section 108. 

(2) REVIEW.—In developing of the strategies required by 

paragraph (1), the Secretary shall, not later than 1 year after 

the date of enactment of the FDA Food Safety Modernization 

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

for enhancement, which may include a survey with respect 

to— 

(A) staffing levels and expertise available to perform 

food safety and defense functions; 

(B) laboratory capacity to support surveillance, outbreak response, inspection, and enforcement activities; 

(C) information systems to support data management 

and sharing of food safety and defense information among 

State and local agencies and with counterparts at the Federal level; and 

(D) other State and local activities and needs as determined appropriate by the Secretary. 

(d) FOOD SAFETY CAPACITY BUILDING GRANTS.—Section 317R(b) 

of the Public Health Service Act (42 U.S.C. 247b–20(b)) is 

amended— 

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

(2) by striking ‘‘2003 through 2006’’ and inserting ‘‘2011 

through 2015’’. 

SEC. 206. MANDATORY RECALL AUTHORITY. 

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

amended by section 202, is amended by adding at the end the 

following: 

Deadline. 

Strategies. 


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124 STAT. 3940 PUBLIC LAW 111–353—JAN. 4, 2011 

‘‘SEC. 423. MANDATORY RECALL AUTHORITY. 

‘‘(a) VOLUNTARY PROCEDURES.—If the Secretary determines, 

based on information gathered through the reportable food registry 

under section 417 or through any other means, that there is a 

reasonable probability that an article of food (other than infant 

formula) is adulterated under section 402 or misbranded under 

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

cause serious adverse health consequences or death to humans 

or animals, the Secretary shall provide the responsible party (as 

defined in section 417) with an opportunity to cease distribution 

and recall such article. 

‘‘(b) PREHEARING ORDER TO CEASE DISTRIBUTION AND GIVE

NOTICE.— 

‘‘(1) IN GENERAL.—If the responsible party refuses to or 

does not voluntarily cease distribution or recall such article 

within the time and in the manner prescribed by the Secretary 

(if so prescribed), the Secretary may, by order require, as the 

Secretary deems necessary, such person to— 

‘‘(A) immediately cease distribution of such article; and 

‘‘(B) as applicable, immediately notify all persons— 

‘‘(i) manufacturing, processing, packing, transporting, distributing, receiving, holding, or importing 

and selling such article; and 

‘‘(ii) to which such article has been distributed, 

transported, or sold, to immediately cease distribution 

of such article. 

‘‘(2) REQUIRED ADDITIONAL INFORMATION.— 

‘‘(A) IN GENERAL.—If an article of food covered by a 

recall order issued under paragraph (1)(B) has been distributed to a warehouse-based third party logistics provider 

without providing such provider sufficient information to 

know or reasonably determine the precise identity of the 

article of food covered by a recall order that is in its 

possession, the notice provided by the responsible party 

subject to the order issued under paragraph (1)(B) shall 

include such information as is necessary for the warehousebased third party logistics provider to identify the food. 

‘‘(B) RULES OF CONSTRUCTION.—Nothing in this paragraph shall be construed— 

‘‘(i) to exempt a warehouse-based third party logistics provider from the requirements of this Act, 

including the requirements in this section and section 

414; or 

‘‘(ii) to exempt a warehouse-based third party logistics provider from being the subject of a mandatory 

recall order. 

‘‘(3) DETERMINATION TO LIMIT AREAS AFFECTED.—If the Secretary requires a responsible party to cease distribution under 

paragraph (1)(A) of an article of food identified in subsection 

(a), the Secretary may limit the size of the geographic area 

and the markets affected by such cessation if such limitation 

would not compromise the public health. 

‘‘(c) HEARING ON ORDER.—The Secretary shall provide the 

responsible party subject to an order under subsection (b) with 

an opportunity for an informal hearing, to be held as soon as 

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

Deadline. 

Determination. 

21 USC 350l. 


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PUBLIC LAW 111–353—JAN. 4, 2011 124 STAT. 3941 

on the actions required by the order and on why the article that 

is the subject of the order should not be recalled. 

‘‘(d) POST-HEARING RECALL ORDER AND MODIFICATION OF

ORDER.— 

‘‘(1) AMENDMENT OF ORDER.—If, after providing opportunity 

for an informal hearing under subsection (c), the Secretary 

determines that removal of the article from commerce is necessary, the Secretary shall, as appropriate— 

‘‘(A) amend the order to require recall of such article 

or other appropriate action; 

‘‘(B) specify a timetable in which the recall shall occur; 

‘‘(C) require periodic reports to the Secretary describing 

the progress of the recall; and 

‘‘(D) provide notice to consumers to whom such article 

was, or may have been, distributed. 

‘‘(2) VACATING OF ORDER.—If, after such hearing, the Secretary determines that adequate grounds do not exist to continue the actions required by the order, or that such actions 

should be modified, the Secretary shall vacate the order or 

modify the order. 

‘‘(e) RULE REGARDING ALCOHOLIC BEVERAGES.—The Secretary 

shall not initiate a mandatory recall or take any other action 

under this section with respect to any alcohol beverage until the 

Secretary has provided the Alcohol and Tobacco Tax and Trade 

Bureau with a reasonable opportunity to cease distribution and 

recall such article under the Alcohol and Tobacco Tax and Trade 

Bureau authority. 

‘‘(f) COOPERATION AND CONSULTATION.—The Secretary shall 

work with State and local public health officials in carrying out 

this section, as appropriate. 

‘‘(g) PUBLIC NOTIFICATION.—In conducting a recall under this 

section, the Secretary shall— 

‘‘(1) ensure that a press release is published regarding 

the recall, as well as alerts and public notices, as appropriate, 

in order to provide notification— 

‘‘(A) of the recall to consumers and retailers to whom 

such article was, or may have been, distributed; and 

‘‘(B) that includes, at a minimum— 

‘‘(i) the name of the article of food subject to the 

recall; 

‘‘(ii) a description of the risk associated with such 

article; and 

‘‘(iii) to the extent practicable, information for consumers about similar articles of food that are not 

affected by the recall; 

‘‘(2) consult the policies of the Department of Agriculture 

regarding providing to the public a list of retail consignees 

receiving products involved in a Class I recall and shall consider 

providing such a list to the public, as determined appropriate 

by the Secretary; and 

‘‘(3) if available, publish on the Internet Web site of the 

Food and Drug Administration an image of the article that 

is the subject of the press release described in (1). 

‘‘(h) NO DELEGATION.—The authority conferred by this section 

to order a recall or vacate a recall order shall not be delegated 

to any officer or employee other than the Commissioner. 

Web posting. 

Publication. 

Notices. 


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124 STAT. 3942 PUBLIC LAW 111–353—JAN. 4, 2011 

‘‘(i) EFFECT.—Nothing in this section shall affect the authority 

of the Secretary to request or participate in a voluntary recall, 

or to issue an order to cease distribution or to recall under any 

other provision of this Act or under the Public Health Service 

Act. 

‘‘(j) COORDINATED COMMUNICATION.— ‘‘(1) IN GENERAL.—To assist in carrying out the requirements of this subsection, the Secretary shall establish an 

incident command operation or a similar operation within the 

Department of Health and Human Services that will operate 

not later than 24 hours after the initiation of a mandatory 

recall or the recall of an article of food for which the use 

of, or exposure to, such article will cause serious adverse health 

consequences or death to humans or animals. 

‘‘(2) REQUIREMENTS.—To reduce the potential for 

miscommunication during recalls or regarding investigations 

of a food borne illness outbreak associated with a food that 

is subject to a recall, each incident command operation or 

similar operation under paragraph (1) shall use regular staff 

and resources of the Department of Health and Human Services 

to— 

‘‘(A) ensure timely and coordinated communication 

within the Department, including enhanced communication 

and coordination between different agencies and organizations within the Department; 

‘‘(B) ensure timely and coordinated communication 

from the Department, including public statements, 

throughout the duration of the investigation and related 

foodborne illness outbreak; 

‘‘(C) identify a single point of contact within the Department for public inquiries regarding any actions by the 

Secretary related to a recall; 

‘‘(D) coordinate with Federal, State, local, and tribal 

authorities, as appropriate, that have responsibilities 

related to the recall of a food or a foodborne illness outbreak 

associated with a food that is subject to the recall, including 

notification of the Secretary of Agriculture and the Secretary of Education in the event such recalled food is a 

commodity intended for use in a child nutrition program 

(as identified in section 25(b) of the Richard B. Russell 

National School Lunch Act (42 U.S.C. 1769f(b))); and 

‘‘(E) conclude operations at such time as the Secretary 

determines appropriate. 

‘‘(3) MULTIPLE RECALLS.—The Secretary may establish multiple or concurrent incident command operations or similar 

operations in the event of multiple recalls or foodborne illness 

outbreaks necessitating such action by the Department of 

Health and Human Services.’’. 

(b) SEARCH ENGINE.—Not later than 90 days after the date 

of enactment of this Act, the Secretary shall modify the Internet 

Web site of the Food and Drug Administration to include a search 

engine that— 

(1) is consumer-friendly, as determined by the Secretary; 

and 

(2) provides a means by which an individual may locate 

relevant information regarding each article of food subject to 

a recall under section 423 of the Federal Food, Drug, and 

Deadline. 

Web posting. 

21 USC 350l 

note. 


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PUBLIC LAW 111–353—JAN. 4, 2011 124 STAT. 3943 

Cosmetic Act and the status of such recall (such as whether 

a recall is ongoing or has been completed). 

(c) CIVIL PENALTY.—Section 303(f)(2)(A) (21 U.S.C. 333(f)(2)(A)) 

is amended by inserting ‘‘or any person who does not comply with 

a recall order under section 423’’ after ‘‘section 402(a)(2)(B)’’. 

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

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

the following: 

‘‘(xx) The refusal or failure to follow an order under section 

423.’’. 

(e) GAO REVIEW.— (1) IN GENERAL.—Not later than 90 days after the date 

of enactment of this Act, the Comptroller General of the United 

States shall submit to Congress a report that— 

(A) identifies State and local agencies with the 

authority to require the mandatory recall of food, and 

evaluates use of such authority with regard to frequency, 

effectiveness, and appropriateness, including consideration 

of any new or existing mechanisms available to compensate 

persons for general and specific recall-related costs when 

a recall is subsequently determined by the relevant 

authority to have been an error; 

(B) identifies Federal agencies, other than the Department of Health and Human Services, with mandatory recall 

authority and examines use of that authority with regard 

to frequency, effectiveness, and appropriateness, including 

any new or existing mechanisms available to compensate 

persons for general and specific recall-related costs when 

a recall is subsequently determined by the relevant agency 

to have been an error; 

(C) considers models for farmer restitution implemented in other nations in cases of erroneous recalls; and 

(D) makes recommendations to the Secretary regarding 

use of the authority under section 423 of the Federal Food, 

Drug, and Cosmetic Act (as added by this section) to protect 

the public health while seeking to minimize unnecessary 

economic costs. 

(2) EFFECT OF REVIEW.—If the Comptroller General of the 

United States finds, after the review conducted under paragraph (1), that the mechanisms described in such paragraph 

do not exist or are inadequate, then, not later than 90 days 

after the conclusion of such review, the Secretary of Agriculture 

shall conduct a study of the feasibility of implementing a farmer 

indemnification program to provide restitution to agricultural 

producers for losses sustained as a result of a mandatory recall 

of an agricultural commodity by a Federal or State regulatory 

agency that is subsequently determined to be in error. The 

Secretary of Agriculture shall submit to the Committee on 

Agriculture of the House of Representatives and the Committee 

on Agriculture, Nutrition, and Forestry of the Senate a report 

that describes the results of the study, including any recommendations. 

(f) ANNUAL REPORT TO CONGRESS.— 

(1) IN GENERAL.—Not later than 2 years after the date 

of enactment of this Act and annually thereafter, the Secretary 

of Health and Human Services (referred to in this subsection 

as the ‘‘Secretary’’) shall submit a report to the Committee 

21 USC 350l–1. 

Reports. 

Deadline. 

Study. 

Deadline. 

Reports. 


anorris on DSK5R6SHH1PROD with PUBLIC LAWS
124 STAT. 3944 PUBLIC LAW 111–353—JAN. 4, 2011 

on Health, Education, Labor, and Pensions of the Senate and 

the Committee on Energy and Commerce of the House of Representatives on the use of recall authority under section 423 

of the Federal Food, Drug, and Cosmetic Act (as added by 

subsection (a)) and any public health advisories issued by the 

Secretary that advise against the consumption of an article 

of food on the ground that the article of food is adulterated 

and poses an imminent danger to health. 

(2) CONTENT.—The report under paragraph (1) shall 

include, with respect to the report year— 

(A) the identity of each article of food that was the 

subject of a public health advisory described in paragraph 

(1), an opportunity to cease distribution and recall under 

subsection (a) of section 423 of the Federal Food, Drug, 

and Cosmetic Act, or a mandatory recall order under subsection (b) of such section; 

(B) the number of responsible parties, as defined in 

section 417 of the Federal Food, Drug, and Cosmetic Act, 

formally given the opportunity to cease distribution of an 

article of food and recall such article, as described in section 

423(a) of such Act; 

(C) the number of responsible parties described in 

subparagraph (B) who did not cease distribution of or recall 

an article of food after given the opportunity to cease 

distribution or recall under section 423(a) of the Federal 

Food, Drug, and Cosmetic Act; 

(D) the number of recall orders issued under section 

423(b) of the Federal Food, Drug, and Cosmetic Act; and 

(E) a description of any instances in which there was 

no testing that confirmed adulteration of an article of food 

that was the subject of a recall under section 423(b) of 

the Federal Food, Drug, and Cosmetic Act or a public 

health advisory described in paragraph (1). 

SEC. 207. ADMINISTRATIVE DETENTION OF FOOD. 

(a) IN GENERAL.—Section 304(h)(1)(A) (21 U.S.C. 334(h)(1)(A)) 

is amended by— 

(1) striking ‘‘credible evidence or information indicating’’ 

and inserting ‘‘reason to believe’’; and 

(2) striking ‘‘presents a threat of serious adverse health 

consequences or death to humans or animals’’ and inserting 

‘‘is adulterated or misbranded’’. 

(b) REGULATIONS.—Not later than 120 days after the date of 

enactment of this Act, the Secretary shall issue an interim final 

rule amending subpart K of part 1 of title 21, Code of Federal 

Regulations, to implement the amendment made by this section. 

(c) EFFECTIVE DATE.—The amendment made by this section 

shall take effect 180 days after the date of enactment of this 

Act. 

SEC. 208. DECONTAMINATION AND DISPOSAL STANDARDS AND PLANS. 

(a) IN GENERAL.—The Administrator of the Environmental 

Protection Agency (referred to in this section as the ‘‘Administrator’’), in coordination with the Secretary of Health and Human 

Services, Secretary of Homeland Security, and Secretary of Agriculture, shall provide support for, and technical assistance to, State, 

local, and tribal governments in preparing for, assessing, decontaminating, and recovering from an agriculture or food emergency. 

21 USC 2225. 

21 USC 334 note. 

Deadline. 

21 USC 334 note. 


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PUBLIC LAW 111–353—JAN. 4, 2011 124 STAT. 3945 

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

(a), the Administrator, in coordination with the Secretary of Health 

and Human Services, Secretary of Homeland Security, Secretary 

of Agriculture, and State, local, and tribal governments, shall 

develop and disseminate specific standards and protocols to undertake clean-up, clearance, and recovery activities following the decontamination and disposal of specific threat agents and foreign animal 

diseases. 

(c) DEVELOPMENT OF MODEL PLANS.—In carrying out subsection 

(a), the Administrator, the Secretary of Health and Human Services, 

and the Secretary of Agriculture shall jointly develop and disseminate model plans for— 

(1) the decontamination of individuals, equipment, and 

facilities following an intentional contamination of agriculture 

or food; and 

(2) the disposal of large quantities of animals, plants, or 

food products that have been infected or contaminated by specific threat agents and foreign animal diseases. 

(d) EXERCISES.—In carrying out subsection (a), the Administrator, in coordination with the entities described under subsection 

(b), shall conduct exercises at least annually to evaluate and identify 

weaknesses in the decontamination and disposal model plans 

described in subsection (c). Such exercises shall be carried out, 

to the maximum extent practicable, as part of the national exercise 

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

Management Reform Act of 2006 (6 U.S.C. 748(b)(1)). 

(e) MODIFICATIONS.—Based on the exercises described in subsection (d), the Administrator, in coordination with the entities 

described in subsection (b), shall review and modify as necessary 

the plans described in subsection (c) not less frequently than biennially. 

(f) PRIORITIZATION.—The Administrator, in coordination with 

the entities described in subsection (b), shall develop standards 

and plans under subsections (b) and (c) in an identified order 

of priority that takes into account— 

(1) highest-risk biological, chemical, and radiological threat 

agents; 

(2) agents that could cause the greatest economic devastation to the agriculture and food system; and 

(3) agents that are most difficult to clean or remediate. 

SEC. 209. IMPROVING THE TRAINING OF STATE, LOCAL, TERRITORIAL, 

AND TRIBAL FOOD SAFETY OFFICIALS. 

(a) IMPROVING TRAINING.—Chapter X (21 U.S.C. 391 et seq.) 

is amended by adding at the end the following: 

‘‘SEC. 1011. IMPROVING THE TRAINING OF STATE, LOCAL, TERRITORIAL, AND TRIBAL FOOD SAFETY OFFICIALS. 

‘‘(a) TRAINING.—The Secretary shall set standards and administer training and education programs for the employees of State, 

local, territorial, and tribal food safety officials relating to the 

regulatory responsibilities and policies established by this Act, 

including programs for— 

‘‘(1) scientific training; 

‘‘(2) training to improve the skill of officers and employees 

authorized to conduct inspections under sections 702 and 704; 

‘‘(3) training to achieve advanced product or process specialization in such inspections; 

21 USC 399c. 

Deadline. 


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‘‘(4) training that addresses best practices; 

‘‘(5) training in administrative process and procedure and 

integrity issues; 

‘‘(6) training in appropriate sampling and laboratory analysis methodology; and 

‘‘(7) training in building enforcement actions following 

inspections, examinations, testing, and investigations. 

‘‘(b) PARTNERSHIPS WITH STATE AND LOCAL OFFICIALS.— ‘‘(1) IN GENERAL.—The Secretary, pursuant to a contract 

or memorandum of understanding between the Secretary and 

the head of a State, local, territorial, or tribal department 

or agency, is authorized and encouraged to conduct examinations, testing, and investigations for the purposes of determining compliance with the food safety provisions of this Act 

through the officers and employees of such State, local, territorial, or tribal department or agency. 

‘‘(2) CONTENT.—A contract or memorandum described 

under paragraph (1) shall include provisions to ensure adequate 

training of such officers and employees to conduct such 

examinations, testing, and investigations. The contract or 

memorandum shall contain provisions regarding reimbursement. Such provisions may, at the sole discretion of the head 

of the other department or agency, require reimbursement, 

in whole or in part, from the Secretary for the examinations, 

testing, or investigations performed pursuant to this section 

by the officers or employees of the State, territorial, or tribal 

department or agency. 

‘‘(3) EFFECT.—Nothing in this subsection shall be construed 

to limit the authority of the Secretary under section 702. 

‘‘(c) EXTENSION SERVICE.—The Secretary shall ensure coordination with the extension activities of the National Institute of Food 

and Agriculture of the Department of Agriculture in advising producers and small processors transitioning into new practices 

required as a result of the enactment of the FDA Food Safety 

Modernization Act and assisting regulated industry with compliance 

with such Act. 

‘‘(d) NATIONAL FOOD SAFETY TRAINING, EDUCATION, EXTENSION, 

OUTREACH AND TECHNICAL ASSISTANCE PROGRAM.— 

‘‘(1) IN GENERAL.—In order to improve food safety and 

reduce the incidence of foodborne illness, the Secretary shall, 

not later than 180 days after the date of enactment of the 

FDA Food Safety Modernization Act, enter into one or more 

memoranda of understanding, or enter into other cooperative 

agreements, with the Secretary of Agriculture to establish a 

competitive grant program within the National Institute for 

Food and Agriculture to provide food safety training, education, 

extension, outreach, and technical assistance to— 

‘‘(A) owners and operators of farms; 

‘‘(B) small food processors; and 

‘‘(C) small fruit and vegetable merchant wholesalers. 

‘‘(2) IMPLEMENTATION.—The competitive grant program 

established under paragraph (1) shall be carried out in accordance with section 405 of the Agricultural Research, Extension, 

and Education Reform Act of 1998. 

‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There are authorized 

to be appropriated such sums as may be necessary to carry out 

this section for fiscal years 2011 through 2015.’’. 

Deadline. 

Contracts. 

Grants. 


anorris on DSK5R6SHH1PROD with PUBLIC LAWS
PUBLIC LAW 111–353—JAN. 4, 2011 124 STAT. 3947 

(b) NATIONAL FOOD SAFETY TRAINING, EDUCATION, EXTENSION, OUTREACH, AND TECHNICAL ASSISTANCE PROGRAM.—Title IV of the 

Agricultural Research, Extension, and Education Reform Act of 

1998 is amended by inserting after section 404 (7 U.S.C. 7624) 

the following: 

‘‘SEC. 405. NATIONAL FOOD SAFETY TRAINING, EDUCATION, EXTENSION, OUTREACH, AND TECHNICAL ASSISTANCE PROGRAM. 

‘‘(a) IN GENERAL.—The Secretary shall award grants under 

this section to carry out the competitive grant program established 

under section 1011(d) of the Federal Food, Drug, and Cosmetic 

Act, pursuant to any memoranda of understanding entered into 

under such section. 

‘‘(b) INTEGRATED APPROACH.—The grant program described 

under subsection (a) shall be carried out under this section in 

a manner that facilitates the integration of food safety standards 

and guidance with the variety of agricultural production systems, 

encompassing conventional, sustainable, organic, and conservation 

and environmental practices. 

‘‘(c) PRIORITY.—In awarding grants under this section, the Secretary shall give priority to projects that target small and mediumsized farms, beginning farmers, socially disadvantaged farmers, 

small processors, or small fresh fruit and vegetable merchant wholesalers. 

‘‘(d) PROGRAM COORDINATION.— 

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

implementation of the grant program under this section with 

the National Integrated Food Safety Initiative. 

‘‘(2) INTERACTION.—The Secretary shall— 

‘‘(A) in carrying out the grant program under this 

section, take into consideration applied research, education, 

and extension results obtained from the National 

Integrated Food Safety Initiative; and 

‘‘(B) in determining the applied research agenda for 

the National Integrated Food Safety Initiative, take into 

consideration the needs articulated by participants in 

projects funded by the program under this section. 

‘‘(e) GRANTS.— 

‘‘(1) IN GENERAL.—In carrying out this section, the Secretary shall make competitive grants to support training, education, extension, outreach, and technical assistance projects 

that will help improve public health by increasing the understanding and adoption of established food safety standards, 

guidance, and protocols. 

‘‘(2) ENCOURAGED FEATURES.—The Secretary shall encourage projects carried out using grant funds under this section 

to include co-management of food safety, conservation systems, 

and ecological health. 

‘‘(3) MAXIMUM TERM AND SIZE OF GRANT.— 

‘‘(A) IN GENERAL.—A grant under this section shall 

have a term that is not more than 3 years. 

‘‘(B) LIMITATION ON GRANT FUNDING.—The Secretary 

may not provide grant funding to an entity under this 

section after such entity has received 3 years of grant 

funding under this section. 

‘‘(f) GRANT ELIGIBILITY.— 

Grants. 

7 USC 7625. 


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124 STAT. 3948 PUBLIC LAW 111–353—JAN. 4, 2011 

‘‘(1) IN GENERAL.—To be eligible for a grant under this 

section, an entity shall be— 

‘‘(A) a State cooperative extension service; 

‘‘(B) a Federal, State, local, or tribal agency, a nonprofit 

community-based or non-governmental organization, or an 

organization representing owners and operators of farms, 

small food processors, or small fruit and vegetable merchant wholesalers that has a commitment to public health 

and expertise in administering programs that contribute 

to food safety; 

‘‘(C) an institution of higher education (as defined in 

section 101(a) of the Higher Education Act of 1965 (20 

U.S.C. 1001(a))) or a foundation maintained by an institution of higher education; 

‘‘(D) a collaboration of 2 of more eligible entities 

described in this subsection; or 

‘‘(E) such other appropriate entity, as determined by 

the Secretary. 

‘‘(2) MULTISTATE PARTNERSHIPS.—Grants under this section 

may be made for projects involving more than 1 State. 

‘‘(g) REGIONAL BALANCE.—In making grants under this section, 

the Secretary shall, to the maximum extent practicable, ensure— 

‘‘(1) geographic diversity; and 

‘‘(2) diversity of types of agricultural production. 

‘‘(h) TECHNICAL ASSISTANCE.—The Secretary may use funds 

made available under this section to provide technical assistance 

to grant recipients to further the purposes of this section. 

‘‘(i) BEST PRACTICES AND MODEL PROGRAMS.—Based on evaluations of, and responses arising from, projects funded under this 

section, the Secretary may issue a set of recommended best practices 

and models for food safety training programs for agricultural producers, small food processors, and small fresh fruit and vegetable 

merchant wholesalers. 

‘‘(j) AUTHORIZATION OF APPROPRIATIONS.—For the purposes of 

making grants under this section, there are authorized to be appropriated such sums as may be necessary for fiscal years 2011 through 

2015.’’. 

SEC. 210. ENHANCING FOOD SAFETY. 

(a) GRANTS TO ENHANCE FOOD SAFETY.—Section 1009 of the 

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 399) is amended 

to read as follows: 

‘‘SEC. 1009. GRANTS TO ENHANCE FOOD SAFETY. 

‘‘(a) IN GENERAL.—The Secretary is authorized to make grants 

to eligible entities to— 

‘‘(1) undertake examinations, inspections, and investigations, and related food safety activities under section 702; 

‘‘(2) train to the standards of the Secretary for the examination, inspection, and investigation of food manufacturing, processing, packing, holding, distribution, and importation, 

including as such examination, inspection, and investigation 

relate to retail food establishments; 

‘‘(3) build the food safety capacity of the laboratories of 

such eligible entity, including the detection of zoonotic diseases; 

‘‘(4) build the infrastructure and capacity of the food safety 

programs of such eligible entity to meet the standards as outlined in the grant application; and 


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‘‘(5) take appropriate action to protect the public health 

in response to— 

‘‘(A) a notification under section 1008, including planning and otherwise preparing to take such action; or 

‘‘(B) a recall of food under this Act. 

‘‘(b) ELIGIBLE ENTITIES; APPLICATION.— 

‘‘(1) IN GENERAL.—In this section, the term ‘eligible entity’ 

means an entity— 

‘‘(A) that is— 

‘‘(i) a State; 

‘‘(ii) a locality; 

‘‘(iii) a territory; 

‘‘(iv) an Indian tribe (as defined in section 4(e) 

of the Indian Self-Determination and Education Assistance Act); or 

‘‘(v) a nonprofit food safety training entity that 

collaborates with 1 or more institutions of higher education; and 

‘‘(B) that submits an application to the Secretary at 

such time, in such manner, and including such information 

as the Secretary may reasonably require. 

‘‘(2) CONTENTS.—Each application submitted under paragraph (1) shall include— 

‘‘(A) an assurance that the eligible entity has developed 

plans to engage in the types of activities described in 

subsection (a); 

‘‘(B) a description of the types of activities to be funded 

by the grant; 

‘‘(C) an itemization of how grant funds received under 

this section will be expended; 

‘‘(D) a description of how grant activities will be monitored; and 

‘‘(E) an agreement by the eligible entity to report 

information required by the Secretary to conduct evaluations under this section. 

‘‘(c) LIMITATIONS.—The funds provided under subsection (a) 

shall be available to an eligible entity that receives a grant under 

this section only to the extent such entity funds the food safety 

programs of such entity independently of any grant under this 

section in each year of the grant at a level equal to the level 

of such funding in the previous year, increased by the Consumer 

Price Index. Such non-Federal matching funds may be provided 

directly or through donations from public or private entities and 

may be in cash or in-kind, fairly evaluated, including plant, equipment, or services. 

‘‘(d) ADDITIONAL AUTHORITY.—The Secretary may— 

‘‘(1) award a grant under this section in each subsequent 

fiscal year without reapplication for a period of not more than 

3 years, provided the requirements of subsection (c) are met 

for the previous fiscal year; and 

‘‘(2) award a grant under this section in a fiscal year 

for which the requirement of subsection (c) has not been met 

only if such requirement was not met because such funding 

was diverted for response to 1 or more natural disasters or 

in other extenuating circumstances that the Secretary may 

determine appropriate. 

Definition. 


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‘‘(e) DURATION OF AWARDS.—The Secretary may award grants 

to an individual grant recipient under this section for periods of 

not more than 3 years. In the event the Secretary conducts a 

program evaluation, funding in the second year or third year of 

the grant, where applicable, shall be contingent on a successful 

program evaluation by the Secretary after the first year. 

‘‘(f) PROGRESS AND EVALUATION.— 

‘‘(1) IN GENERAL.—The Secretary shall measure the status 

and success of each grant program authorized under the FDA 

Food Safety Modernization Act (and any amendment made 

by such Act), including the grant program under this section. 

A recipient of a grant described in the preceding sentence 

shall, at the end of each grant year, provide the Secretary 

with information on how grant funds were spent and the status 

of the efforts by such recipient to enhance food safety. To 

the extent practicable, the Secretary shall take the performance 

of such a grant recipient into account when determining 

whether to continue funding for such recipient. 

‘‘(2) NO DUPLICATION.—In carrying out paragraph (1), the 

Secretary shall not duplicate the efforts of the Secretary under 

other provisions of this Act or the FDA Food Safety Modernization Act that require measurement and review of the activities 

of grant recipients under either such Act. 

‘‘(g) SUPPLEMENT NOT SUPPLANT.—Grant funds received under 

this section shall be used to supplement, and not supplant, nonFederal funds and any other Federal funds available to carry out 

the activities described in this section. 

‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—For the purpose of 

making grants under this section, there are authorized to be appropriated such sums as may be necessary for fiscal years 2011 through 

2015.’’. 

(b) CENTERS OF EXCELLENCE.—Part P of the Public Health 

Service Act (42 U.S.C. 280g et seq.) is amended by adding at 

the end the following: 

‘‘SEC. 399V–5. FOOD SAFETY INTEGRATED CENTERS OF EXCELLENCE. 

‘‘(a) IN GENERAL.—Not later than 1 year after the date of 

enactment of the FDA Food Safety Modernization Act, the Secretary, acting through the Director of the Centers for Disease Control and Prevention and in consultation with the working group 

described in subsection (b)(2), shall designate 5 Integrated Food 

Safety Centers of Excellence (referred to in this section as the 

‘Centers of Excellence’) to serve as resources for Federal, State, 

and local public health professionals to respond to foodborne illness 

outbreaks. The Centers of Excellence shall be headquartered at 

selected State health departments. 

‘‘(b) SELECTION OF CENTERS OF EXCELLENCE.— 

‘‘(1) ELIGIBLE ENTITIES.—To be eligible to be designated 

as a Center of Excellence under subsection (a), an entity shall— 

‘‘(A) be a State health department; 

‘‘(B) partner with 1 or more institutions of higher education that have demonstrated knowledge, expertise, and 

meaningful experience with regional or national food 

production, processing, and distribution, as well as leadership in the laboratory, epidemiological, and environmental 

detection and investigation of foodborne illness; and 

Deadline. 

Designation. 

42 USC 280g–16. 


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‘‘(C) provide to the Secretary such information, at such 

time, and in such manner, as the Secretary may require. 

‘‘(2) WORKING GROUP.—Not later than 180 days after the 

date of enactment of the FDA Food Safety Modernization Act, 

the Secretary shall establish a diverse working group of experts 

and stakeholders from Federal, State, and local food safety 

and health agencies, the food industry, including food retailers 

and food manufacturers, consumer organizations, and academia 

to make recommendations to the Secretary regarding designations of the Centers of Excellence. 

‘‘(3) ADDITIONAL CENTERS OF EXCELLENCE.—The Secretary 

may designate eligible entities to be regional Food Safety Centers of Excellence, in addition to the 5 Centers designated 

under subsection (a). 

‘‘(c) ACTIVITIES.—Under the leadership of the Director of the 

Centers for Disease Control and Prevention, each Center of Excellence shall be based out of a selected State health department, 

which shall provide assistance to other regional, State, and local 

departments of health through activities that include— 

‘‘(1) providing resources, including timely information concerning symptoms and tests, for frontline health professionals 

interviewing individuals as part of routine surveillance and 

outbreak investigations; 

‘‘(2) providing analysis of the timeliness and effectiveness 

of foodborne disease surveillance and outbreak response activities; 

‘‘(3) providing training for epidemiological and environmental investigation of foodborne illness, including suggestions 

for streamlining and standardizing the investigation process; 

‘‘(4) establishing fellowships, stipends, and scholarships to 

train future epidemiological and food-safety leaders and to 

address critical workforce shortages; 

‘‘(5) training and coordinating State and local personnel; 

‘‘(6) strengthening capacity to participate in existing or 

new foodborne illness surveillance and environmental assessment information systems; and 

‘‘(7) conducting research and outreach activities focused 

on increasing prevention, communication, and education 

regarding food safety. 

‘‘(d) REPORT TO CONGRESS.—Not later than 2 years after the 

date of enactment of the FDA Food Safety Modernization Act, 

the Secretary shall submit to Congress a report that— 

‘‘(1) describes the effectiveness of the Centers of Excellence; 

and 

‘‘(2) provides legislative recommendations or describes additional resources required by the Centers of Excellence. 

‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There is authorized 

to be appropriated such sums as may be necessary to carry out 

this section. 

‘‘(f) NO DUPLICATION OF EFFORT.—In carrying out activities 

of the Centers of Excellence or other programs under this section, 

the Secretary shall not duplicate other Federal foodborne illness 

response efforts.’’. 

SEC. 211. IMPROVING THE REPORTABLE FOOD REGISTRY. 

(a) IN GENERAL.—Section 417 (21 U.S.C. 350f) is amended— 

Deadline. 


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(1) by redesignating subsections (f) through (k) as subsections (i) through (n), respectively; and 

(2) by inserting after subsection (e) the following: 

‘‘(f) CRITICAL INFORMATION.—Except with respect to fruits and 

vegetables that are raw agricultural commodities, not more than 

18 months after the date of enactment of the FDA Food Safety 

Modernization Act, the Secretary may require a responsible party 

to submit to the Secretary consumer-oriented information regarding 

a reportable food, which shall include— 

‘‘(1) a description of the article of food as provided in 

subsection (e)(3); 

‘‘(2) as provided in subsection (e)(7), affected product identification codes, such as UPC, SKU, or lot or batch numbers 

sufficient for the consumer to identify the article of food; 

‘‘(3) contact information for the responsible party as provided in subsection (e)(8); and 

‘‘(4) any other information the Secretary determines is necessary to enable a consumer to accurately identify whether 

such consumer is in possession of the reportable food. 

‘‘(g) GROCERY STORE NOTIFICATION.— 

‘‘(1) ACTION BY SECRETARY.—The Secretary shall— 

‘‘(A) prepare the critical information described under 

subsection (f) for a reportable food as a standardized onepage summary; 

‘‘(B) publish such one-page summary on the Internet 

website of the Food and Drug Administration in a format 

that can be easily printed by a grocery store for purposes 

of consumer notification. 

‘‘(2) ACTION BY GROCERY STORE.—A notification described 

under paragraph (1)(B) shall include the date and time such 

summary was posted on the Internet website of the Food and 

Drug Administration. 

‘‘(h) CONSUMER NOTIFICATION.— 

‘‘(1) IN GENERAL.—If a grocery store sold a reportable food 

that is the subject of the posting and such establishment is 

part of chain of establishments with 15 or more physical locations, then such establishment shall, not later than 24 hours 

after a one page summary described in subsection (g) is published, prominently display such summary or the information 

from such summary via at least one of the methods identified 

under paragraph (2) and maintain the display for 14 days. 

‘‘(2) LIST OF CONSPICUOUS LOCATIONS.—Not more than 1 

year after the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall develop and publish a list 

of acceptable conspicuous locations and manners, from which 

grocery stores shall select at least one, for providing the 

notification required in paragraph (1). Such list shall include— 

‘‘(A) posting the notification at or near the register; 

‘‘(B) providing the location of the reportable food; 

‘‘(C) providing targeted recall information given to customers upon purchase of a food; and 

‘‘(D) other such prominent and conspicuous locations 

and manners utilized by grocery stores as of the date 

of the enactment of the FDA Food Safety Modernization 

Act to provide notice of such recalls to consumers as considered appropriate by the Secretary.’’. 

Publication. 

Time period. 

Deadlines. 

Publication. 

Web posting. 

Notification. 

Deadline. 


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

by section 206, is amended by adding at the end the following: 

‘‘(yy) The knowing and willful failure to comply with the 

notification requirement under section 417(h).’’. 

(c) CONFORMING AMENDMENT.—Section 301(e) (21 U.S.C. 331(e)) 

is amended by striking ‘‘417(g)’’ and inserting ‘‘417(j)’’. 

TITLE III—IMPROVING THE SAFETY OF 

IMPORTED FOOD 

SEC. 301. FOREIGN SUPPLIER VERIFICATION PROGRAM. 

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

amended by adding at the end the following: 

‘‘SEC. 805. FOREIGN SUPPLIER VERIFICATION PROGRAM. 

‘‘(a) IN GENERAL.— 

‘‘(1) VERIFICATION REQUIREMENT.—Except as provided 

under subsections (e) and (f), each importer shall perform riskbased foreign supplier verification activities for the purpose 

of verifying that the food imported by the importer or agent 

of an importer is— 

‘‘(A) produced in compliance with the requirements 

of section 418 or section 419, as appropriate; and 

‘‘(B) is not adulterated under section 402 or misbranded 

under section 403(w). 

‘‘(2) IMPORTER DEFINED.—For purposes of this section, the 

term ‘importer’ means, with respect to an article of food— 

‘‘(A) the United States owner or consignee of the article 

of food at the time of entry of such article into the United 

States; or 

‘‘(B) in the case when there is no United States owner 

or consignee as described in subparagraph (A), the United 

States agent or representative of a foreign owner or consignee of the article of food at the time of entry of such 

article into the United States. 

‘‘(b) GUIDANCE.—Not later than 1 year after the date of enactment of the FDA Food Safety Modernization Act, the Secretary 

shall issue guidance to assist importers in developing foreign supplier verification programs. 

‘‘(c) REGULATIONS.— 

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

of enactment of the FDA Food Safety Modernization Act, the 

Secretary shall promulgate regulations to provide for the content of the foreign supplier verification program established 

under subsection (a). 

‘‘(2) REQUIREMENTS.—The regulations promulgated under 

paragraph (1)— 

‘‘(A) shall require that the foreign supplier verification 

program of each importer be adequate to provide assurances that each foreign supplier to the importer produces 

the imported food in compliance with— 

‘‘(i) processes and procedures, including reasonably 

appropriate risk-based preventive controls, that provide the same level of public health protection as those 

required under section 418 or section 419 (taking into 

21 USC 384a. 


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consideration variances granted under section 419), as 

appropriate; and 

‘‘(ii) section 402 and section 403(w). 

‘‘(B) shall include such other requirements as the Secretary deems necessary and appropriate to verify that food 

imported into the United States is as safe as food produced 

and sold within the United States. 

‘‘(3) CONSIDERATIONS.—In promulgating regulations under 

this subsection, the Secretary shall, as appropriate, take into 

account differences among importers and types of imported 

foods, including based on the level of risk posed by the imported 

food. 

‘‘(4) ACTIVITIES.—Verification activities under a foreign supplier verification program under this section may include monitoring records for shipments, lot-by-lot certification of compliance, annual on-site inspections, checking the hazard analysis 

and risk-based preventive control plan of the foreign supplier, 

and periodically testing and sampling shipments. 

‘‘(d) RECORD MAINTENANCE AND ACCESS.—Records of an 

importer related to a foreign supplier verification program shall 

be maintained for a period of not less than 2 years and shall 

be made available promptly to a duly authorized representative 

of the Secretary upon request. 

‘‘(e) EXEMPTION OF SEAFOOD, JUICE, AND LOW-ACID CANNED

FOOD FACILITIES IN COMPLIANCE WITH HACCP.—This section shall 

not apply to a facility if the owner, operator, or agent in charge 

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

with, 1 of the following standards and regulations with respect 

to such facility: 

‘‘(1) The Seafood Hazard Analysis Critical Control Points 

Program of the Food and Drug Administration. 

‘‘(2) The Juice Hazard Analysis Critical Control Points 

Program of the Food and Drug Administration. 

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

in Hermetically Sealed Containers standards of the Food and 

Drug Administration (or any successor standards). 

The exemption under paragraph (3) shall apply only with respect 

to microbiological hazards that are regulated under the standards 

for Thermally Processed Low-Acid Foods Packaged in Hermetically 

Sealed Containers under part 113 of chapter 21, Code of Federal 

Regulations (or any successor regulations). 

‘‘(f) ADDITIONAL EXEMPTIONS.—The Secretary, by notice published in the Federal Register, shall establish an exemption from 

the requirements of this section for articles of food imported in 

small quantities for research and evaluation purposes or for personal consumption, provided that such foods are not intended for 

retail sale and are not sold or distributed to the public. 

‘‘(g) PUBLICATION OF LIST OF PARTICIPANTS.—The Secretary 

shall publish and maintain on the Internet Web site of the Food 

and Drug Administration a current list that includes the name 

of, location of, and other information deemed necessary by the 

Secretary about, importers participating under this section.’’. 

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

by section 211, is amended by adding at the end the following: 

‘‘(zz) The importation or offering for importation of a food 

if the importer (as defined in section 805) does not have in place 

Web posting. 

Notice. 

Federal Register, 

publication. 

Applicability. 

Time period. 


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a foreign supplier verification program in compliance with such 

section 805.’’. 

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

by adding ‘‘or the importer (as defined in section 805) is in violation 

of such section 805’’ after ‘‘or in violation of section 505’’. 

(d) EFFECTIVE DATE.—The amendments made by this section 

shall take effect 2 years after the date of enactment of this Act. 

SEC. 302. VOLUNTARY QUALIFIED IMPORTER PROGRAM. 

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

301, is amended by adding at the end the following: 

‘‘SEC. 806. VOLUNTARY QUALIFIED IMPORTER PROGRAM. 

‘‘(a) IN GENERAL.—Beginning not later than 18 months after 

the date of enactment of the FDA Food Safety Modernization Act, 

the Secretary shall— 

‘‘(1) establish a program, in consultation with the Secretary 

of Homeland Security— 

‘‘(A) to provide for the expedited review and importation of food offered for importation by importers who have 

voluntarily agreed to participate in such program; and 

‘‘(B) consistent with section 808, establish a process 

for the issuance of a facility certification to accompany 

food offered for importation by importers who have voluntarily agreed to participate in such program; and 

‘‘(2) issue a guidance document related to participation 

in, revocation of such participation in, reinstatement in, and 

compliance with, such program. 

‘‘(b) VOLUNTARY PARTICIPATION.—An importer may request the 

Secretary to provide for the expedited review and importation of 

designated foods in accordance with the program established by 

the Secretary under subsection (a). 

‘‘(c) NOTICE OF INTENT TO PARTICIPATE.—An importer that 

intends to participate in the program under this section in a fiscal 

year shall submit a notice and application to the Secretary of 

such intent at the time and in a manner established by the Secretary. 

‘‘(d) ELIGIBILITY.—Eligibility shall be limited to an importer 

offering food for importation from a facility that has a certification 

described in subsection (a). In reviewing the applications and 

making determinations on such applications, the Secretary shall 

consider the risk of the food to be imported based on factors, 

such as the following: 

‘‘(1) The known safety risks of the food to be imported. 

‘‘(2) The compliance history of foreign suppliers used by 

the importer, as appropriate. 

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

of export to ensure compliance with United States food safety 

standards for a designated food. 

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

of section 805. 

‘‘(5) The recordkeeping, testing, inspections and audits of 

facilities, traceability of articles of food, temperature controls, 

and sourcing practices of the importer. 

‘‘(6) The potential risk for intentional adulteration of the 

food. 

‘‘(7) Any other factor that the Secretary determines appropriate. 

Guidelines. 

Deadline. 

21 USC 384b. 

21 USC 331 note. 


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‘‘(e) REVIEW AND REVOCATION.—Any importer qualified by the 

Secretary in accordance with the eligibility criteria set forth in 

this section shall be reevaluated not less often than once every 

3 years and the Secretary shall promptly revoke the qualified 

importer status of any importer found not to be in compliance 

with such criteria. 

‘‘(f) FALSE STATEMENTS.—Any statement or representation 

made by an importer to the Secretary shall be subject to section 

1001 of title 18, United States Code. 

‘‘(g) DEFINITION.—For purposes of this section, the term 

‘importer’ means the person that brings food, or causes food to 

be brought, from a foreign country into the customs territory of 

the United States.’’. 

SEC. 303. AUTHORITY TO REQUIRE IMPORT CERTIFICATIONS FOR 

FOOD. 

(a) IN GENERAL.—Section 801(a) (21 U.S.C. 381(a)) is amended 

by inserting after the third sentence the following: ‘‘With respect 

to an article of food, if importation of such food is subject to, 

but not compliant with, the requirement under subsection (q) that 

such food be accompanied by a certification or other assurance 

that the food meets applicable requirements of this Act, then such 

article shall be refused admission.’’. 

(b) ADDITION OF CERTIFICATION REQUIREMENT.—Section 801 

(21 U.S.C. 381) is amended by adding at the end the following 

new subsection: 

‘‘(q) CERTIFICATIONS CONCERNING IMPORTED FOODS.— 

‘‘(1) IN GENERAL.—The Secretary may require, as a condition of granting admission to an article of food imported or 

offered for import into the United States, that an entity 

described in paragraph (3) provide a certification, or such other 

assurances as the Secretary determines appropriate, that the 

article of food complies with applicable requirements of this 

Act. Such certification or assurances may be provided in the 

form of shipment-specific certificates, a listing of certified facilities that manufacture, process, pack, or hold such food, or 

in such other form as the Secretary may specify. 

‘‘(2) FACTORS TO BE CONSIDERED IN REQUIRING CERTIFICATION.—The Secretary shall base the determination that an 

article of food is required to have a certification described 

in paragraph (1) on the risk of the food, including— 

‘‘(A) known safety risks associated with the food; 

‘‘(B) known food safety risks associated with the 

country, territory, or region of origin of the food; 

‘‘(C) a finding by the Secretary, supported by scientific, 

risk-based evidence, that— 

‘‘(i) the food safety programs, systems, and standards in the country, territory, or region of origin of 

the food are inadequate to ensure that the article of 

food is as safe as a similar article of food that is 

manufactured, processed, packed, or held in the United 

States in accordance with the requirements of this 

Act; and 

‘‘(ii) the certification would assist the Secretary 

in determining whether to refuse or admit the article 

of food under subsection (a); and 

Deadline. 


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‘‘(D) information submitted to the Secretary in accordance with the process established in paragraph (7). 

‘‘(3) CERTIFYING ENTITIES.—For purposes of paragraph (1), 

entities that shall provide the certification or assurances 

described in such paragraph are— 

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

of the country from which the article of food at issue 

originated, as designated by the Secretary; or 

‘‘(B) such other persons or entities accredited pursuant 

to section 808 to provide such certification or assurance. 

‘‘(4) RENEWAL AND REFUSAL OF CERTIFICATIONS.—The Secretary may— 

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

provided by an entity specified in paragraph (2) be renewed 

by such entity at such times as the Secretary determines 

appropriate; and 

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

if the Secretary determines that such certification or assurance is not valid or reliable. 

‘‘(5) ELECTRONIC SUBMISSION.—The Secretary shall provide 

for the electronic submission of certifications under this subsection. 

‘‘(6) FALSE STATEMENTS.—Any statement or representation 

made by an entity described in paragraph (2) to the Secretary 

shall be subject to section 1001 of title 18, United States Code. 

‘‘(7) ASSESSMENT OF FOOD SAFETY PROGRAMS, SYSTEMS, AND

STANDARDS.—If the Secretary determines that the food safety 

programs, systems, and standards in a foreign region, country, 

or territory are inadequate to ensure that an article of food 

is as safe as a similar article of food that is manufactured, 

processed, packed, or held in the United States in accordance 

with the requirements of this Act, the Secretary shall, to the 

extent practicable, identify such inadequacies and establish 

a process by which the foreign region, country, or territory 

may inform the Secretary of improvements made to such food 

safety program, system, or standard and demonstrate that those 

controls are adequate to ensure that an article of food is as 

safe as a similar article of food that is manufactured, processed, 

packed, or held in the United States in accordance with the 

requirements of this Act.’’. 

(c) CONFORMING TECHNICAL AMENDMENT.—Section 801(b) (21 

U.S.C. 381(b)) is amended in the second sentence by striking ‘‘with 

respect to an article included within the provision of the fourth 

sentence of subsection (a)’’ and inserting ‘‘with respect to an article 

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

760 or 761,’’. 

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

made by this section shall limit the authority of the Secretary 

to conduct inspections of imported food or to take such other steps 

as the Secretary deems appropriate to determine the admissibility 

of imported food. 

SEC. 304. PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS. 

(a) IN GENERAL.—Section 801(m)(1) (21 U.S.C. 381(m)(1)) is 

amended by inserting ‘‘any country to which the article has been 

refused entry;’’ after ‘‘the country from which the article is shipped;’’. 

21 USC 381 note. 


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(b) REGULATIONS.—Not later than 120 days after the date of 

enactment of this Act, the Secretary shall issue an interim final 

rule amending subpart I of part 1 of title 21, Code of Federal 

Regulations, to implement the amendment made by this section. 

(c) EFFECTIVE DATE.—The amendment made by this section 

shall take effect 180 days after the date of enactment of this 

Act. 

SEC. 305. BUILDING CAPACITY OF FOREIGN GOVERNMENTS WITH 

RESPECT TO FOOD SAFETY. 

(a) IN GENERAL.—The Secretary shall, not later than 2 years 

of the date of enactment of this Act, develop a comprehensive 

plan to expand the technical, scientific, and regulatory food safety 

capacity of foreign governments, and their respective food industries, from which foods are exported to the United States. 

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

(a), the Secretary shall consult with the Secretary of Agriculture, 

Secretary of State, Secretary of the Treasury, the Secretary of 

Homeland Security, the United States Trade Representative, and 

the Secretary of Commerce, representatives of the food industry, 

appropriate foreign government officials, nongovernmental 

organizations that represent the interests of consumers, and other 

stakeholders. 

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

include, as appropriate, the following: 

(1) Recommendations for bilateral and multilateral 

arrangements and agreements, including provisions to provide 

for responsibility of exporting countries to ensure the safety 

of food. 

(2) Provisions for secure electronic data sharing. 

(3) Provisions for mutual recognition of inspection reports. 

(4) Training of foreign governments and food producers 

on United States requirements for safe food. 

(5) Recommendations on whether and how to harmonize 

requirements under the Codex Alimentarius. 

(6) Provisions for the multilateral acceptance of laboratory 

methods and testing and detection techniques. 

(d) RULE OF CONSTRUCTION.—Nothing in this section shall be 

construed to affect the regulation of dietary supplements under 

the Dietary Supplement Health and Education Act of 1994 (Public 

Law 103–417). 

SEC. 306. INSPECTION OF FOREIGN FOOD FACILITIES. 

(a) IN GENERAL.—Chapter VIII (21 U.S.C. 381 et seq.), as 

amended by section 302, is amended by inserting at the end the 

following: 

‘‘SEC. 807. INSPECTION OF FOREIGN FOOD FACILITIES. 

‘‘(a) INSPECTION.—The Secretary— 

‘‘(1) may enter into arrangements and agreements with 

foreign governments to facilitate the inspection of foreign facilities registered under section 415; and 

‘‘(2) shall direct resources to inspections of foreign facilities, 

suppliers, and food types, especially such facilities, suppliers, 

and food types that present a high risk (as identified by the 

Secretary), to help ensure the safety and security of the food 

supply of the United States. 

21 USC 384c. 

Plans. 

21 USC 381 note. 

Deadline. 

21 USC 381 note. 


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‘‘(b) EFFECT OF INABILITY TO INSPECT.—Notwithstanding any 

other provision of law, food shall be refused admission into the 

United States if it is from a foreign factory, warehouse, or other 

establishment of which the owner, operator, or agent in charge, 

or the government of the foreign country, refuses to permit entry 

of United States inspectors or other individuals duly designated 

by the Secretary, upon request, to inspect such factory, warehouse, 

or other establishment. For purposes of this subsection, such an 

owner, operator, or agent in charge shall be considered to have 

refused an inspection if such owner, operator, or agent in charge 

does not permit an inspection of a factory, warehouse, or other 

establishment during the 24-hour period after such request is submitted, or after such other time period, as agreed upon by the 

Secretary and the foreign factory, warehouse, or other establishment.’’. 

(b) INSPECTION BY THE SECRETARY OF COMMERCE.— (1) IN GENERAL.—The Secretary of Commerce, in coordination with the Secretary of Health and Human Services, may 

send 1 or more inspectors to a country or facility of an exporter 

from which seafood imported into the United States originates. 

The inspectors shall assess practices and processes used in 

connection with the farming, cultivation, harvesting, preparation for market, or transportation of such seafood and may 

provide technical assistance related to such activities. 

(2) INSPECTION REPORT.— (A) IN GENERAL.—The Secretary of Health and Human 

Services, in coordination with the Secretary of Commerce, 

shall— 

(i) prepare an inspection report for each inspection 

conducted under paragraph (1); 

(ii) provide the report to the country or exporter 

that is the subject of the report; and 

(iii) provide a 30-day period during which the 

country or exporter may provide a rebuttal or other 

comments on the findings of the report to the Secretary 

of Health and Human Services. 

(B) DISTRIBUTION AND USE OF REPORT.—The Secretary 

of Health and Human Services shall consider the inspection 

reports described in subparagraph (A) in distributing 

inspection resources under section 421 of the Federal Food, 

Drug, and Cosmetic Act, as added by section 201. 

SEC. 307. ACCREDITATION OF THIRD-PARTY AUDITORS. 

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

306, is amended by adding at the end the following: 

‘‘SEC. 808. ACCREDITATION OF THIRD-PARTY AUDITORS. 

‘‘(a) DEFINITIONS.—In this section: 

‘‘(1) AUDIT AGENT.—The term ‘audit agent’ means an individual who is an employee or agent of an accredited thirdparty auditor and, although not individually accredited, is qualified to conduct food safety audits on behalf of an accredited 

third-party auditor. 

‘‘(2) ACCREDITATION BODY.—The term ‘accreditation body’ 

means an authority that performs accreditation of third-party 

auditors. 

‘‘(3) THIRD-PARTY AUDITOR.—The term ‘third-party auditor’ 

means a foreign government, agency of a foreign government, 

21 USC 384d. 

Time period. 

21 USC 2241. 


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foreign cooperative, or any other third party, as the Secretary 

determines appropriate in accordance with the model standards 

described in subsection (b)(2), that is eligible to be considered 

for accreditation to conduct food safety audits to certify that 

eligible entities meet the applicable requirements of this section. A third-party auditor may be a single individual. A thirdparty auditor may employ or use audit agents to help conduct 

consultative and regulatory audits. 

‘‘(4) ACCREDITED THIRD-PARTY AUDITOR.—The term ‘accredited third-party auditor’ means a third-party auditor accredited 

by an accreditation body to conduct audits of eligible entities 

to certify that such eligible entities meet the applicable requirements of this section. An accredited third-party auditor may 

be an individual who conducts food safety audits to certify 

that eligible entities meet the applicable requirements of this 

section. 

‘‘(5) CONSULTATIVE AUDIT.—The term ‘consultative audit’ 

means an audit of an eligible entity— 

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

with the provisions of this Act and with applicable industry 

standards and practices; and 

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

only. 

‘‘(6) ELIGIBLE ENTITY.—The term ‘eligible entity’ means a 

foreign entity, including a foreign facility registered under section 415, in the food import supply chain that chooses to be 

audited by an accredited third-party auditor or the audit agent 

of such accredited third-party auditor. 

‘‘(7) REGULATORY AUDIT.—The term ‘regulatory audit’ 

means an audit of an eligible entity— 

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

with the provisions of this Act; and 

‘‘(B) the results of which determine— 

‘‘(i) whether an article of food manufactured, processed, packed, or held by such entity is eligible to 

receive a food certification under section 801(q); or 

‘‘(ii) whether a facility is eligible to receive a facility 

certification under section 806(a) for purposes of 

participating in the program under section 806. 

‘‘(b) ACCREDITATION SYSTEM.— 

‘‘(1) ACCREDITATION BODIES.— 

‘‘(A) RECOGNITION OF ACCREDITATION BODIES.— 

‘‘(i) IN GENERAL.—Not later than 2 years after 

the date of enactment of the FDA Food Safety Modernization Act, the Secretary shall establish a system 

for the recognition of accreditation bodies that accredit 

third-party auditors to certify that eligible entities 

meet the applicable requirements of this section. 

‘‘(ii) DIRECT ACCREDITATION.—If, by the date that 

is 2 years after the date of establishment of the system 

described in clause (i), the Secretary has not identified 

and recognized an accreditation body to meet the 

requirements of this section, the Secretary may directly 

accredit third-party auditors. 

‘‘(B) NOTIFICATION.—Each accreditation body recognized by the Secretary shall submit to the Secretary a 

Deadline. 


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list of all accredited third-party auditors accredited by such 

body and the audit agents of such auditors. 

‘‘(C) REVOCATION OF RECOGNITION AS AN ACCREDITATION BODY.—The Secretary shall promptly revoke the recognition of any accreditation body found not to be in compliance with the requirements of this section. 

‘‘(D) REINSTATEMENT.—The Secretary shall establish 

procedures to reinstate recognition of an accreditation body 

if the Secretary determines, based on evidence presented 

by such accreditation body, that revocation was inappropriate or that the body meets the requirements for recognition under this section. 

‘‘(2) MODEL ACCREDITATION STANDARDS.—Not later than 

18 months after the date of enactment of the FDA Food Safety 

Modernization Act, the Secretary shall develop model standards, including requirements for regulatory audit reports, and 

each recognized accreditation body shall ensure that thirdparty auditors and audit agents of such auditors meet such 

standards in order to qualify such third-party auditors as 

accredited third-party auditors under this section. In developing 

the model standards, the Secretary shall look to standards 

in place on the date of the enactment of this section for guidance, to avoid unnecessary duplication of efforts and costs. 

‘‘(c) THIRD-PARTY AUDITORS.— 

‘‘(1) REQUIREMENTS FOR ACCREDITATION AS A THIRD-PARTY

AUDITOR.— 

‘‘(A) FOREIGN GOVERNMENTS.—Prior to accrediting a 

foreign government or an agency of a foreign government 

as an accredited third-party auditor, the accreditation body 

(or, in the case of direct accreditation under subsection 

(b)(1)(A)(ii), the Secretary) shall perform such reviews and 

audits of food safety programs, systems, and standards 

of the government or agency of the government as the 

Secretary deems necessary, including requirements under 

the model standards developed under subsection (b)(2), to 

determine that the foreign government or agency of the 

foreign government is capable of adequately ensuring that 

eligible entities or foods certified by such government or 

agency meet the requirements of this Act with respect 

to food manufactured, processed, packed, or held for import 

into the United States. 

‘‘(B) FOREIGN COOPERATIVES AND OTHER THIRD PARTIES.—Prior to accrediting a foreign cooperative that aggregates the products of growers or processors, or any other 

third party to be an accredited third-party auditor, the 

accreditation body (or, in the case of direct accreditation 

under subsection (b)(1)(A)(ii), the Secretary) shall perform 

such reviews and audits of the training and qualifications 

of audit agents used by that cooperative or party and 

conduct such reviews of internal systems and such other 

investigation of the cooperative or party as the Secretary 

deems necessary, including requirements under the model 

standards developed under subsection (b)(2), to determine 

that each eligible entity certified by the cooperative or 

party has systems and standards in use to ensure that 

such entity or food meets the requirements of this Act. 

Deadline. 

Procedures. 


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124 STAT. 3962 PUBLIC LAW 111–353—JAN. 4, 2011 

‘‘(2) REQUIREMENT TO ISSUE CERTIFICATION OF ELIGIBLE

ENTITIES OR FOODS.— ‘‘(A) IN GENERAL.—An accreditation body (or, in the 

case of direct accreditation under subsection (b)(1)(A)(ii), 

the Secretary) may not accredit a third-party auditor unless 

such third-party auditor agrees to issue a written and, 

as appropriate, electronic food certification, described in 

section 801(q), or facility certification under section 806(a), 

as appropriate, to accompany each food shipment for import 

into the United States from an eligible entity, subject to 

requirements set forth by the Secretary. Such written or 

electronic certification may be included with other documentation regarding such food shipment. The Secretary 

shall consider certifications under section 801(q) and 

participation in the voluntary qualified importer program 

described in section 806 when targeting inspection 

resources under section 421. 

‘‘(B) PURPOSE OF CERTIFICATION.—The Secretary shall 

use certification provided by accredited third-party auditors 

to— 

‘‘(i) determine, in conjunction with any other assurances the Secretary may require under section 801(q), 

whether a food satisfies the requirements of such section; and 

‘‘(ii) determine whether a facility is eligible to be 

a facility from which food may be offered for import 

under the voluntary qualified importer program under 

section 806. 

‘‘(C) REQUIREMENTS FOR ISSUING CERTIFICATION.— 

‘‘(i) IN GENERAL.—An accredited third-party 

auditor shall issue a food certification under section 

801(q) or a facility certification described under 

subparagraph (B) only after conducting a regulatory 

audit and such other activities that may be necessary 

to establish compliance with the requirements of such 

sections. 

‘‘(ii) PROVISION OF CERTIFICATION.—Only an 

accredited third-party auditor or the Secretary may 

provide a facility certification under section 806(a). 

Only those parties described in 801(q)(3) or the Secretary may provide a food certification under 301(g). 

‘‘(3) AUDIT REPORT SUBMISSION REQUIREMENTS.— 

‘‘(A) REQUIREMENTS IN GENERAL.—As a condition of 

accreditation, not later than 45 days after conducting an 

audit, an accredited third-party auditor or audit agent of 

such auditor shall prepare, and, in the case of a regulatory 

audit, submit, the audit report for each audit conducted, 

in a form and manner designated by the Secretary, which 

shall include— 

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

eligible entity responsible for compliance with food 

safety requirements; 

‘‘(ii) the dates of the audit; 

‘‘(iii) the scope of the audit; and 

‘‘(iv) any other information required by the Secretary that relates to or may influence an assessment 

of compliance with this Act. 

Audit. 


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‘‘(B) RECORDS.—Following any accreditation of a thirdparty auditor, the Secretary may, at any time, require 

the accredited third-party auditor to submit to the Secretary an onsite audit report and such other reports or 

documents required as part of the audit process, for any 

eligible entity certified by the third-party auditor or audit 

agent of such auditor. Such report may include documentation that the eligible entity is in compliance with any 

applicable registration requirements. 

‘‘(C) LIMITATION.—The requirement under subparagraph (B) shall not include any report or other documents 

resulting from a consultative audit by the accredited thirdparty auditor, except that the Secretary may access the 

results of a consultative audit in accordance with section 

414. 

‘‘(4) REQUIREMENTS OF ACCREDITED THIRD-PARTY AUDITORS

AND AUDIT AGENTS OF SUCH AUDITORS.— 

‘‘(A) RISKS TO PUBLIC HEALTH.—If, at any time during 

an audit, an accredited third-party auditor or audit agent 

of such auditor discovers a condition that could cause or 

contribute to a serious risk to the public health, such 

auditor shall immediately notify the Secretary of— 

‘‘(i) the identification of the eligible entity subject 

to the audit; and 

‘‘(ii) such condition. 

‘‘(B) TYPES OF AUDITS.—An accredited third-party 

auditor or audit agent of such auditor may perform consultative and regulatory audits of eligible entities. 

‘‘(C) LIMITATIONS.— 

‘‘(i) IN GENERAL.—An accredited third party auditor 

may not perform a regulatory audit of an eligible entity 

if such agent has performed a consultative audit or 

a regulatory audit of such eligible entity during the 

previous 13-month period. 

‘‘(ii) WAIVER.—The Secretary may waive the 

application of clause (i) if the Secretary determines 

that there is insufficient access to accredited thirdparty auditors in a country or region. 

‘‘(5) CONFLICTS OF INTEREST.— 

‘‘(A) THIRD-PARTY AUDITORS.—An accredited thirdparty auditor shall— 

‘‘(i) not be owned, managed, or controlled by any 

person that owns or operates an eligible entity to be 

certified by such auditor; 

‘‘(ii) in carrying out audits of eligible entities under 

this section, have procedures to ensure against the 

use of any officer or employee of such auditor that 

has a financial conflict of interest regarding an eligible 

entity to be certified by such auditor; and 

‘‘(iii) annually make available to the Secretary 

disclosures of the extent to which such auditor and 

the officers and employees of such auditor have maintained compliance with clauses (i) and (ii) relating 

to financial conflicts of interest. 

‘‘(B) AUDIT AGENTS.—An audit agent shall— 

‘‘(i) not own or operate an eligible entity to be 

audited by such agent; 

Deadline. 

Notification. 


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124 STAT. 3964 PUBLIC LAW 111–353—JAN. 4, 2011 

‘‘(ii) in carrying out audits of eligible entities under 

this section, have procedures to ensure that such agent 

does not have a financial conflict of interest regarding 

an eligible entity to be audited by such agent; and 

‘‘(iii) annually make available to the Secretary 

disclosures of the extent to which such agent has maintained compliance with clauses (i) and (ii) relating 

to financial conflicts of interest. 

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

regulations not later than 18 months after the date of 

enactment of the FDA Food Safety Modernization Act to 

implement this section and to ensure that there are protections against conflicts of interest between an accredited 

third-party auditor and the eligible entity to be certified 

by such auditor or audited by such audit agent. Such 

regulations shall include— 

‘‘(i) requiring that audits performed under this 

section be unannounced; 

‘‘(ii) a structure to decrease the potential for conflicts of interest, including timing and public disclosure, 

for fees paid by eligible entities to accredited thirdparty auditors; and 

‘‘(iii) appropriate limits on financial affiliations 

between an accredited third-party auditor or audit 

agents of such auditor and any person that owns or 

operates an eligible entity to be certified by such 

auditor, as described in subparagraphs (A) and (B). 

‘‘(6) WITHDRAWAL OF ACCREDITATION.— 

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

accreditation from an accredited third-party auditor— 

‘‘(i) if food certified under section 801(q) or from 

a facility certified under paragraph (2)(B) by such 

third-party auditor is linked to an outbreak of 

foodborne illness that has a reasonable probability of 

causing serious adverse health consequences or death 

in humans or animals; 

‘‘(ii) following an evaluation and finding by the 

Secretary that the third-party auditor no longer meets 

the requirements for accreditation; or 

‘‘(iii) following a refusal to allow United States 

officials to conduct such audits and investigations as 

may be necessary to ensure continued compliance with 

the requirements set forth in this section. 

‘‘(B) ADDITIONAL BASIS FOR WITHDRAWAL OF ACCREDITATION.—The Secretary may withdraw accreditation from an 

accredited third-party auditor in the case that such thirdparty auditor is accredited by an accreditation body for 

which recognition as an accreditation body under subsection (b)(1)(C) is revoked, if the Secretary determines 

that there is good cause for the withdrawal. 

‘‘(C) EXCEPTION.—The Secretary may waive the 

application of subparagraph (A)(i) if the Secretary— 

‘‘(i) conducts an investigation of the material facts 

related to the outbreak of human or animal illness; 

and 

Waiver authority. 

Deadline. 

Deadline. 


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‘‘(ii) reviews the steps or actions taken by the 

third party auditor to justify the certification and determines that the accredited third-party auditor satisfied 

the requirements under section 801(q) of certifying the 

food, or the requirements under paragraph (2)(B) of 

certifying the entity. 

‘‘(7) REACCREDITATION.—The Secretary shall establish 

procedures to reinstate the accreditation of a third-party auditor 

for which accreditation has been withdrawn under paragraph 

(6)— 

‘‘(A) if the Secretary determines, based on evidence 

presented, that the third-party auditor satisfies the requirements of this section and adequate grounds for revocation 

no longer exist; and 

‘‘(B) in the case of a third-party auditor accredited 

by an accreditation body for which recognition as an 

accreditation body under subsection (b)(1)(C) is revoked— 

‘‘(i) if the third-party auditor becomes accredited 

not later than 1 year after revocation of accreditation 

under paragraph (6)(A), through direct accreditation 

under subsection (b)(1)(A)(ii) or by an accreditation 

body in good standing; or 

‘‘(ii) under such conditions as the Secretary may 

require for a third-party auditor under paragraph 

(6)(B). 

‘‘(8) NEUTRALIZING COSTS.—The Secretary shall establish 

by regulation a reimbursement (user fee) program, similar to 

the method described in section 203(h) of the Agriculture Marketing Act of 1946, by which the Secretary assesses fees and 

requires accredited third-party auditors and audit agents to 

reimburse the Food and Drug Administration for the work 

performed to establish and administer the accreditation system 

under this section. The Secretary shall make operating this 

program revenue-neutral and shall not generate surplus revenue from such a reimbursement mechanism. Fees authorized 

under this paragraph shall be collected and available for obligation only to the extent and in the amount provided in advance 

in appropriation Acts. Such fees are authorized to remain available until expended. 

‘‘(d) RECERTIFICATION OF ELIGIBLE ENTITIES.—An eligible entity 

shall apply for annual recertification by an accredited third-party 

auditor if such entity— 

‘‘(1) intends to participate in voluntary qualified importer 

program under section 806; or 

‘‘(2) is required to provide to the Secretary a certification 

under section 801(q) for any food from such entity. 

‘‘(e) FALSE STATEMENTS.—Any statement or representation 

made— 

‘‘(1) by an employee or agent of an eligible entity to an 

accredited third-party auditor or audit agent; or 

‘‘(2) by an accredited third-party auditor to the Secretary, 

shall be subject to section 1001 of title 18, United States Code. 

‘‘(f) MONITORING.—To ensure compliance with the requirements 

of this section, the Secretary shall— 

‘‘(1) periodically, or at least once every 4 years, reevaluate 

the accreditation bodies described in subsection (b)(1); 

Deadlines. 

Applicability. 

Regulations. 

Deadline. 

Procedures. 


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‘‘(2) periodically, or at least once every 4 years, evaluate 

the performance of each accredited third-party auditor, through 

the review of regulatory audit reports by such auditors, the 

compliance history as available of eligible entities certified by 

such auditors, and any other measures deemed necessary by 

the Secretary; 

‘‘(3) at any time, conduct an onsite audit of any eligible 

entity certified by an accredited third-party auditor, with or 

without the auditor present; and 

‘‘(4) take any other measures deemed necessary by the 

Secretary. 

‘‘(g) PUBLICLY AVAILABLE REGISTRY.—The Secretary shall establish a publicly available registry of accreditation bodies and of 

accredited third-party auditors, including the name of, contact 

information for, and other information deemed necessary by the 

Secretary about such bodies and auditors. 

‘‘(h) LIMITATIONS.— ‘‘(1) NO EFFECT ON SECTION 704 INSPECTIONS.—The audits 

performed under this section shall not be considered inspections 

under section 704. 

‘‘(2) NO EFFECT ON INSPECTION AUTHORITY.—Nothing in 

this section affects the authority of the Secretary to inspect 

any eligible entity pursuant to this Act.’’. 

SEC. 308. FOREIGN OFFICES OF THE FOOD AND DRUG ADMINISTRATION. 

(a) IN GENERAL.—The Secretary shall establish offices of the 

Food and Drug Administration in foreign countries selected by 

the Secretary, to provide assistance to the appropriate governmental 

entities of such countries with respect to measures to provide for 

the safety of articles of food and other products regulated by the 

Food and Drug Administration exported by such country to the 

United States, including by directly conducting risk-based inspections of such articles and supporting such inspections by such 

governmental entity. 

(b) CONSULTATION.—In establishing the foreign offices described 

in subsection (a), the Secretary shall consult with the Secretary 

of State, the Secretary of Homeland Security, and the United States 

Trade Representative. 

(c) REPORT.—Not later than October 1, 2011, the Secretary 

shall submit to Congress a report on the basis for the selection 

by the Secretary of the foreign countries in which the Secretary 

established offices, the progress which such offices have made with 

respect to assisting the governments of such countries in providing 

for the safety of articles of food and other products regulated by 

the Food and Drug Administration exported to the United States, 

and the plans of the Secretary for establishing additional foreign 

offices of the Food and Drug Administration, as appropriate. 

SEC. 309. SMUGGLED FOOD. 

(a) IN GENERAL.—Not later than 180 days after the enactment 

of this Act, the Secretary shall, in coordination with the Secretary 

of Homeland Security, develop and implement a strategy to better 

identify smuggled food and prevent entry of such food into the 

United States. 

(b) NOTIFICATION TO HOMELAND SECURITY.—Not later than 10 

days after the Secretary identifies a smuggled food that the Secretary believes would cause serious adverse health consequences 

Deadline. 

Deadline. 

Strategy. 

21 USC 2243. 

Establishment. 

21 USC 2242. 

Deadlines. 


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or death to humans or animals, the Secretary shall provide to 

the Secretary of Homeland Security a notification under section 

417(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

350f(k)) describing the smuggled food and, if available, the names 

of the individuals or entities that attempted to import such food 

into the United States. 

(c) PUBLIC NOTIFICATION.—If the Secretary— 

(1) identifies a smuggled food; 

(2) reasonably believes exposure to the food would cause 

serious adverse health consequences or death to humans or 

animals; and 

(3) reasonably believes that the food has entered domestic 

commerce and is likely to be consumed, 

the Secretary shall promptly issue a press release describing that 

food and shall use other emergency communication or recall networks, as appropriate, to warn consumers and vendors about the 

potential threat. 

(d) EFFECT OF SECTION.—Nothing in this section shall affect 

the authority of the Secretary to issue public notifications under 

other circumstances. 

(e) DEFINITION.—In this subsection, the term ‘‘smuggled food’’ 

means any food that a person introduces into the United States 

through fraudulent means or with the intent to defraud or mislead. 

TITLE IV—MISCELLANEOUS 

PROVISIONS 

SEC. 401. FUNDING FOR FOOD SAFETY. 

(a) IN GENERAL.—There are authorized to be appropriated to 

carry out the activities of the Center for Food Safety and Applied 

Nutrition, the Center for Veterinary Medicine, and related field 

activities in the Office of Regulatory Affairs of the Food and Drug 

Administration such sums as may be necessary for fiscal years 

2011 through 2015. 

(b) INCREASED NUMBER OF FIELD STAFF.— 

(1) IN GENERAL.—To carry out the activities of the Center 

for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, and related field activities of the Office of Regulatory Affairs of the Food and Drug Administration, the Secretary of Health and Human Services shall increase the field 

staff of such Centers and Office with a goal of not fewer 

than— 

(A) 4,000 staff members in fiscal year 2011; 

(B) 4,200 staff members in fiscal year 2012; 

(C) 4,600 staff members in fiscal year 2013; and 

(D) 5,000 staff members in fiscal year 2014. 

(2) FIELD STAFF FOR FOOD DEFENSE.—The goal under paragraph (1) shall include an increase of 150 employees by fiscal 

year 2011 to— 

(A) provide additional detection of and response to 

food defense threats; and 

(B) detect, track, and remove smuggled food (as defined 

in section 309) from commerce. 


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124 STAT. 3968 PUBLIC LAW 111–353—JAN. 4, 2011 

SEC. 402. EMPLOYEE PROTECTIONS. 

Chapter X of the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 391 et seq.), as amended by section 209, is further amended 

by adding at the end the following: 

‘‘SEC. 1012. EMPLOYEE PROTECTIONS. 

‘‘(a) IN GENERAL.—No entity engaged in the manufacture, processing, packing, transporting, distribution, reception, holding, or 

importation of food may discharge an employee or otherwise 

discriminate against an employee with respect to compensation, 

terms, conditions, or privileges of employment because the 

employee, whether at the employee’s initiative or in the ordinary 

course of the employee’s duties (or any person acting pursuant 

to a request of the employee)— 

‘‘(1) provided, caused to be provided, or is about to provide 

or cause to be provided to the employer, the Federal Government, or the attorney general of a State information relating 

to any violation of, or any act or omission the employee reasonably believes to be a violation of any provision of this Act 

or any order, rule, regulation, standard, or ban under this 

Act, or any order, rule, regulation, standard, or ban under 

this Act; 

‘‘(2) testified or is about to testify in a proceeding concerning 

such violation; 

‘‘(3) assisted or participated or is about to assist or participate in such a proceeding; or 

‘‘(4) objected to, or refused to participate in, any activity, 

policy, practice, or assigned task that the employee (or other 

such person) reasonably believed to be in violation of any provision of this Act, or any order, rule, regulation, standard, or 

ban under this Act. 

‘‘(b) PROCESS.— 

‘‘(1) IN GENERAL.—A person who believes that he or she 

has been discharged or otherwise discriminated against by any 

person in violation of subsection (a) may, not later than 180 

days after the date on which such violation occurs, file (or 

have any person file on his or her behalf) a complaint with 

the Secretary of Labor (referred to in this section as the ‘Secretary’) alleging such discharge or discrimination and identifying the person responsible for such act. Upon receipt of such 

a complaint, the Secretary shall notify, in writing, the person 

named in the complaint of the filing of the complaint, of the 

allegations contained in the complaint, of the substance of 

evidence supporting the complaint, and of the opportunities 

that will be afforded to such person under paragraph (2). 

‘‘(2) INVESTIGATION.— 

‘‘(A) IN GENERAL.—Not later than 60 days after the 

date of receipt of a complaint filed under paragraph (1) 

and after affording the complainant and the person named 

in the complaint an opportunity to submit to the Secretary 

a written response to the complaint and an opportunity 

to meet with a representative of the Secretary to present 

statements from witnesses, the Secretary shall initiate an 

investigation and determine whether there is reasonable 

cause to believe that the complaint has merit and notify, 

in writing, the complainant and the person alleged to have 

Deadline. 

Notification. 

Notification. 

Deadline. 

21 USC 399d. 


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committed a violation of subsection (a) of the Secretary’s 

findings. 

‘‘(B) REASONABLE CAUSE FOUND; PRELIMINARY ORDER.— 

If the Secretary concludes that there is reasonable cause 

to believe that a violation of subsection (a) has occurred, 

the Secretary shall accompany the Secretary’s findings with 

a preliminary order providing the relief prescribed by paragraph (3)(B). Not later than 30 days after the date of 

notification of findings under this paragraph, the person 

alleged to have committed the violation or the complainant 

may file objections to the findings or preliminary order, 

or both, and request a hearing on the record. The filing 

of such objections shall not operate to stay any reinstatement remedy contained in the preliminary order. Any such 

hearing shall be conducted expeditiously. If a hearing is 

not requested in such 30-day period, the preliminary order 

shall be deemed a final order that is not subject to judicial 

review. 

‘‘(C) DISMISSAL OF COMPLAINT.— 

‘‘(i) STANDARD FOR COMPLAINANT.—The Secretary 

shall dismiss a complaint filed under this subsection 

and shall not conduct an investigation otherwise 

required under subparagraph (A) unless the complainant makes a prima facie showing that any behavior 

described in paragraphs (1) through (4) of subsection 

(a) was a contributing factor in the unfavorable personnel action alleged in the complaint. 

‘‘(ii) STANDARD FOR EMPLOYER.—Notwithstanding 

a finding by the Secretary that the complainant has 

made the showing required under clause (i), no investigation otherwise required under subparagraph (A) 

shall be conducted if the employer demonstrates, by 

clear and convincing evidence, that the employer would 

have taken the same unfavorable personnel action in 

the absence of that behavior. 

‘‘(iii) VIOLATION STANDARD.—The Secretary may 

determine that a violation of subsection (a) has 

occurred only if the complainant demonstrates that 

any behavior described in paragraphs (1) through (4) 

of subsection (a) was a contributing factor in the 

unfavorable personnel action alleged in the complaint. 

‘‘(iv) RELIEF STANDARD.—Relief may not be ordered 

under subparagraph (A) if the employer demonstrates 

by clear and convincing evidence that the employer 

would have taken the same unfavorable personnel 

action in the absence of that behavior. 

‘‘(3) FINAL ORDER.— 

‘‘(A) IN GENERAL.—Not later than 120 days after the 

date of conclusion of any hearing under paragraph (2), 

the Secretary shall issue a final order providing the relief 

prescribed by this paragraph or denying the complaint. 

At any time before issuance of a final order, a proceeding 

under this subsection may be terminated on the basis 

of a settlement agreement entered into by the Secretary, 

the complainant, and the person alleged to have committed 

the violation. 

Deadline. 

Deadline. 


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124 STAT. 3970 PUBLIC LAW 111–353—JAN. 4, 2011 

‘‘(B) CONTENT OF ORDER.—If, in response to a complaint 

filed under paragraph (1), the Secretary determines that 

a violation of subsection (a) has occurred, the Secretary 

shall order the person who committed such violation— 

‘‘(i) to take affirmative action to abate the violation; 

‘‘(ii) to reinstate the complainant to his or her 

former position together with compensation (including 

back pay) and restore the terms, conditions, and privileges associated with his or her employment; and 

‘‘(iii) to provide compensatory damages to the 

complainant. 

‘‘(C) PENALTY.—If such an order is issued under this 

paragraph, the Secretary, at the request of the complainant, shall assess against the person against whom the 

order is issued a sum equal to the aggregate amount of 

all costs and expenses (including attorneys’ and expert 

witness fees) reasonably incurred, as determined by the 

Secretary, by the complainant for, or in connection with, 

the bringing of the complaint upon which the order was 

issued. 

‘‘(D) BAD FAITH CLAIM.—If the Secretary finds that 

a complaint under paragraph (1) is frivolous or has been 

brought in bad faith, the Secretary may award to the 

prevailing employer a reasonable attorneys’ fee, not 

exceeding $1,000, to be paid by the complainant. 

‘‘(4) ACTION IN COURT.— 

‘‘(A) IN GENERAL.—If the Secretary has not issued a 

final decision within 210 days after the filing of the complaint, or within 90 days after receiving a written determination, the complainant may bring an action at law 

or equity for de novo review in the appropriate district 

court of the United States with jurisdiction, which shall 

have jurisdiction over such an action without regard to 

the amount in controversy, and which action shall, at the 

request of either party to such action, be tried by the 

court with a jury. The proceedings shall be governed by 

the same legal burdens of proof specified in paragraph 

(2)(C). 

‘‘(B) RELIEF.—The court shall have jurisdiction to grant 

all relief necessary to make the employee whole, including 

injunctive relief and compensatory damages, including— 

‘‘(i) reinstatement with the same seniority status 

that the employee would have had, but for the discharge or discrimination; 

‘‘(ii) the amount of back pay, with interest; and 

‘‘(iii) compensation for any special damages sustained as a result of the discharge or discrimination, 

including litigation costs, expert witness fees, and 

reasonable attorney’s fees. 

‘‘(5) REVIEW.— 

‘‘(A) IN GENERAL.—Unless the complainant brings an 

action under paragraph (4), any person adversely affected 

or aggrieved by a final order issued under paragraph (3) 

may obtain review of the order in the United States Court 

of Appeals for the circuit in which the violation, with 

respect to which the order was issued, allegedly occurred 

or the circuit in which the complainant resided on the 

Deadlines. 


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PUBLIC LAW 111–353—JAN. 4, 2011 124 STAT. 3971 

date of such violation. The petition for review must be 

filed not later than 60 days after the date of the issuance 

of the final order of the Secretary. Review shall conform 

to chapter 7 of title 5, United States Code. The commencement of proceedings under this subparagraph shall not, 

unless ordered by the court, operate as a stay of the order. 

‘‘(B) NO JUDICIAL REVIEW.—An order of the Secretary 

with respect to which review could have been obtained 

under subparagraph (A) shall not be subject to judicial 

review in any criminal or other civil proceeding. 

‘‘(6) FAILURE TO COMPLY WITH ORDER.—Whenever any person has failed to comply with an order issued under paragraph 

(3), the Secretary may file a civil action in the United States 

district court for the district in which the violation was found 

to occur, or in the United States district court for the District 

of Columbia, to enforce such order. In actions brought under 

this paragraph, the district courts shall have jurisdiction to 

grant all appropriate relief including, but not limited to, injunctive relief and compensatory damages. 

‘‘(7) CIVIL ACTION TO REQUIRE COMPLIANCE.— 

‘‘(A) IN GENERAL.—A person on whose behalf an order 

was issued under paragraph (3) may commence a civil 

action against the person to whom such order was issued 

to require compliance with such order. The appropriate 

United States district court shall have jurisdiction, without 

regard to the amount in controversy or the citizenship 

of the parties, to enforce such order. 

‘‘(B) AWARD.—The court, in issuing any final order 

under this paragraph, may award costs of litigation 

(including reasonable attorneys’ and expert witness fees) 

to any party whenever the court determines such award 

is appropriate. 

‘‘(c) EFFECT OF SECTION.— 

‘‘(1) OTHER LAWS.—Nothing in this section preempts or 

diminishes any other safeguards against discrimination, demotion, discharge, suspension, threats, harassment, reprimand, 

retaliation, or any other manner of discrimination provided 

by Federal or State law. 

‘‘(2) RIGHTS OF EMPLOYEES.—Nothing in this section shall 

be construed to diminish the rights, privileges, or remedies 

of any employee under any Federal or State law or under 

any collective bargaining agreement. The rights and remedies 

in this section may not be waived by any agreement, policy, 

form, or condition of employment. 

‘‘(d) ENFORCEMENT.—Any nondiscretionary duty imposed by 

this section shall be enforceable in a mandamus proceeding brought 

under section 1361 of title 28, United States Code. 

‘‘(e) LIMITATION.—Subsection (a) shall not apply with respect 

to an employee of an entity engaged in the manufacture, processing, 

packing, transporting, distribution, reception, holding, or importation of food who, acting without direction from such entity (or 

such entity’s agent), deliberately causes a violation of any requirement relating to any violation or alleged violation of any order, 

rule, regulation, standard, or ban under this Act.’’. 

Deadline. 


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124 STAT. 3972 PUBLIC LAW 111–353—JAN. 4, 2011 

SEC. 403. JURISDICTION; AUTHORITIES. 

Nothing in this Act, or an amendment made by this Act, shall 

be construed to— 

(1) alter the jurisdiction between the Secretary of Agriculture and the Secretary of Health and Human Services, under 

applicable statutes, regulations, or agreements regarding voluntary inspection of non-amenable species under the Agricultural Marketing Act of 1946 (7 U.S.C. 1621 et seq.); 

(2) alter the jurisdiction between the Alcohol and Tobacco 

Tax and Trade Bureau and the Secretary of Health and Human 

Services, under applicable statutes and regulations; 

(3) limit the authority of the Secretary of Health and 

Human Services under— 

(A) the Federal Food, Drug, and Cosmetic Act (21 

U.S.C. 301 et seq.) as in effect on the day before the 

date of enactment of this Act; or 

(B) the Public Health Service Act (42 U.S.C. 301 et 

seq.) as in effect on the day before the date of enactment 

of this Act; 

(4) alter or limit the authority of the Secretary of Agriculture under the laws administered by such Secretary, 

including— 

(A) the Federal Meat Inspection Act (21 U.S.C. 601 

et seq.); 

(B) the Poultry Products Inspection Act (21 U.S.C. 

451 et seq.); 

(C) the Egg Products Inspection Act (21 U.S.C. 1031 

et seq.); 

(D) the United States Grain Standards Act (7 U.S.C. 

71 et seq.); 

(E) the Packers and Stockyards Act, 1921 (7 U.S.C. 

181 et seq.); 

(F) the United States Warehouse Act (7 U.S.C. 241 

et seq.); 

(G) the Agricultural Marketing Act of 1946 (7 U.S.C. 

1621 et seq.); and 

(H) the Agricultural Adjustment Act (7 U.S.C. 601 

et seq.), reenacted with the amendments made by the Agricultural Marketing Agreement Act of 1937; or 

(5) alter, impede, or affect the authority of the Secretary 

of Homeland Security under the Homeland Security Act of 

2002 (6 U.S.C. 101 et seq.) or any other statute, including 

any authority related to securing the borders of the United 

States, managing ports of entry, or agricultural import and 

entry inspection activities. 

SEC. 404. COMPLIANCE WITH INTERNATIONAL AGREEMENTS. 

Nothing in this Act (or an amendment made by this Act) 

shall be construed in a manner inconsistent with the agreement 

establishing the World Trade Organization or any other treaty 

or international agreement to which the United States is a party. 

SEC. 405. DETERMINATION OF BUDGETARY EFFECTS. 

The budgetary effects of this Act, for the purpose of complying 

with the Statutory Pay-As-You-Go Act of 2010, shall be determined 

by reference to the latest statement titled ‘‘Budgetary Effects of 

PAYGO Legislation’’ for this Act, submitted for printing in the 

21 USC 2252. 

21 USC 2251. 


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PUBLIC LAW 111–353—JAN. 4, 2011 124 STAT. 3973 

LEGISLATIVE HISTORY—H.R. 2751: 

CONGRESSIONAL RECORD: 

Vol. 155 (2009): June 9, considered and passed House. 

Vol. 156 (2010): Dec. 19, considered and passed Senate, amended. 

Dec. 21, House concurred in Senate amendments. 

Æ 

Congressional Record by the Chairman of the Senate Budget Committee, provided that such statement has been submitted prior 

to the vote on passage. 

Approved January 4, 2011. 


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