FDA Food Safety Modernization Act
PL 111-353 (H.R.2751), enacted 01/04/2011

124 STAT. 3885 
PUBLIC LAW 111–353—JAN. 4, 2011 
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 oys-
ters. 
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 per-
son (excluding farms and restaurants) who manufactures, proc-
esses, 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 presen-
tation 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 importa-
tion of such article maintained by or on behalf of such person 
Notice. 
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124 STAT. 3887 
PUBLIC LAW 111–353—JAN. 4, 2011 
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 REG-
ISTRATION
RENEWAL.—Section 415(a) (21 U.S.C. 350d(a)) is 
amended— 
(1) in paragraph (2), by— 
(A) striking ‘‘conducts business and’’ and inserting ‘‘con-
ducts 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 deter-
mined 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 registra-
tion 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 sub-
mitted 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 sub-
sections (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 registra-
tion 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 con-
tinue 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 sub-
section 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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124 STAT. 3889 
PUBLIC LAW 111–353—JAN. 4, 2011 
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 lan-
guage 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 pro-
gram’’ 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 regu-
lation); 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 CON-
TROLS. 
(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 CON-
TROLS. 
‘‘(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 moni-
toring 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 haz-
ards, natural toxins, pesticides, drug residues, decomposi-
tion, parasites, allergens, and unapproved food and color 
additives; and 
‘‘(B) hazards that occur naturally, or may be uninten-
tionally 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 pre-
vented; 
‘‘(2) any hazards identified in the hazard analysis conducted 
under subsection (b)(2) will be significantly minimized or pre-
vented 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 mis-
branded 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 com-
merce 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 sub-
section (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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124 STAT. 3891 
PUBLIC LAW 111–353—JAN. 4, 2011 
‘‘(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, oper-
ator, 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 sub-
section (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 imple-
mented 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, chem-
ical, 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 Pack-
aged in Hermetically Sealed Containers standards of the 
Food and Drug Administration (or any successor stand-
ards). 
‘‘(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 SEC-
TION 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 condi-
tions 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 affil-
iate of the facility, is, collectively, a very small business 
(as defined in the regulations promulgated under sub-
section (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, collec-
tively, of any entity of which the facility is a sub-
sidiary 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, proc-
essed, packed, or held at such facility (or the collec-
tive 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, proc-
essed, packed, or held at such facility (or the collec-
tive average annual monetary value of such food 
at any subsidiary or affiliate, as so described) sold 
by such facility (or collectively by any such sub-
sidiary 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 aver-
age 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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124 STAT. 3893 
PUBLIC LAW 111–353—JAN. 4, 2011 
‘‘(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 preven-
tive 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 over-
sight), 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 investiga-
tion 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 nec-
essary 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 sub-
section 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 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— 
‘‘(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 deter-
mine— 
‘‘(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 co- 
located 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 Mod-
ernization 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 pack-
aging 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 manufac-
tured or processed; or 
‘‘(ii) with respect to a food for which a food pack-
aging 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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124 STAT. 3895 
PUBLIC LAW 111–353—JAN. 4, 2011 
food was manufactured or processed, on a label, poster, 
sign, placard, or documents delivered contempora-
neously 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 proc-
essing, 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, imple-
menting 
preventive 
controls, 
and 
documenting 
the 
implementation of the preventive controls under this sec-
tion; 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 para-
graph (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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124 STAT. 3896 
PUBLIC LAW 111–353—JAN. 4, 2011 
‘‘(5) REVIEW.—In promulgating the regulations under para-
graph (1)(A), the Secretary shall review regulatory hazard anal-
ysis 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 stand-
ards 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 sub-
section (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, prac-
tices, 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 environ-
ment. 
‘‘(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 guid-
ance document related to the regulations promulgated under sub-
section (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 rule-
making 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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124 STAT. 3897 
PUBLIC LAW 111–353—JAN. 4, 2011 
on such farm or another farm under the same owner-
ship 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 manufac-
turing 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 activi-
ties 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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124 STAT. 3898 
PUBLIC LAW 111–353—JAN. 4, 2011 
(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 pur-
poses of section 415 of the Federal Food, Drug, and Cos-
metic 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 Cos-
metic Act (as added by subsection (a)), the Secretary shall issue 
a small entity compliance policy guide setting forth in plain lan-
guage 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 Sec-
retary 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 manu-
facturing, 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 promul-
gated 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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124 STAT. 3899 
PUBLIC LAW 111–353—JAN. 4, 2011 
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 rel-
evant 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 guid-
ance 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 ani-
mals other than humans; and 
(3) shall not be written to be facility-specific. 
(c) NO DUPLICATION OF EFFORTS.—The Secretary shall coordi-
nate 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 docu-
ments 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 rule-
making 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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124 STAT. 3900 
PUBLIC LAW 111–353—JAN. 4, 2011 
and vegetables, including specific mixes or categories of 
fruits and vegetables, that are raw agricultural commod-
ities for which the Secretary has determined that such 
standards minimize the risk of serious adverse health con-
sequences 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 subpara-
graph (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 produc-
tion 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 Sec-
retary 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 agricul-
tural 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 min-
imum standards related to soil amendments, hygiene, pack-
aging, temperature controls, animals in the growing area, 
and water; 
‘‘(C) consider hazards that occur naturally, may be 
unintentionally introduced, or may be intentionally intro-
duced, 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 conserva-
tion, 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 estab-
lished 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 regula-
tions 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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124 STAT. 3901 
PUBLIC LAW 111–353—JAN. 4, 2011 
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 sub-
section (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 enforce-
ment 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 sub-
section (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 cat-
egories 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 collec-
tion of information (as defined in section 3502(3) of such 
Act), associated with such regulations; 
Applicability. 
Effective dates. 
Deadline. 
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124 STAT. 3902 
PUBLIC LAW 111–353—JAN. 4, 2011 
‘‘(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 regu-
lations, 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, proc-
esses, and practices to be followed under the variance are 
reasonably likely to ensure that the produce is not adulter-
ated under section 402 and to provide the same level of 
public health protection as the requirements of the regula-
tions 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 regula-
tions 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 sub-
section (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 regu-
lations 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 Gov-
ernor of each State to perform activities to ensure compliance 
with this section. 
‘‘(e) GUIDANCE.— 
Contracts. 
Notification. 
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124 STAT. 3903 
PUBLIC LAW 111–353—JAN. 4, 2011 
‘‘(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 agri-
culture, 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 guid-
ance 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 require-
ments 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 pack-
aging 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 pack-
aging 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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124 STAT. 3904 
PUBLIC LAW 111–353—JAN. 4, 2011 
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 investiga-
tion 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 ill-
ness 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 sub-
section 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 pro-
duced 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 SEC-
TION 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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124 STAT. 3905 
PUBLIC LAW 111–353—JAN. 4, 2011 
‘‘(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 Sec-
retary 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 regula-
tions, 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 vulner-
able 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 Sec-
retary, in coordination with the Secretary of Homeland Security 
and in consultation with the Secretary of Agriculture, shall promul-
gate 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 con-
sultation 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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124 STAT. 3906 
PUBLIC LAW 111–353—JAN. 4, 2011 
‘‘(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 Secu-
rity 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 para-
graph (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 meas-
ures described in subsection (b)(2) of such section; and 
(C) specify situations in which the examples of mitiga-
tion strategies or measures described in subsection (b)(2) 
of such section are appropriate. 
(3) LIMITED DISTRIBUTION.—In the interest of national secu-
rity, the Secretary of Health and Human Services, in consulta-
tion 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 docu-
ments 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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124 STAT. 3907 
PUBLIC LAW 111–353—JAN. 4, 2011 
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 activi-
ties 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 quali-
fied 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 con-
ducted under such provision which identified non-
compliance materially related to a food safety require-
ment of this Act, specifically to determine whether 
compliance has been achieved to the Secretary’s satis-
faction; and 
‘‘(ii) with respect to importers, 1 or more examina-
tions 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 Sec-
retary’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 reinspection- 
related activities (including by type or level of reinspec-
tion activity, as the Secretary determines applicable) 
described in such subparagraph (A) for such year; 
Federal Register, 
publication. 
Notice. 
Deadline. 
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124 STAT. 3908 
PUBLIC LAW 111–353—JAN. 4, 2011 
‘‘(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 partici-
pate 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 pro-
vide 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 para-
graph (2)(A) available solely to pay for the costs referred to 
in such clause (i), (ii), (iii), and (iv) of paragraph (2)(A), respec-
tively. 
‘‘(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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124 STAT. 3909 
PUBLIC LAW 111–353—JAN. 4, 2011 
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, notwith-
standing 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 con-
sumers (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 provi-
sion 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 with-
out 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 con-
tractors performing activities associated with these food safety fees. 
‘‘(e) COLLECTION OF FEES.— 
‘‘(1) IN GENERAL.—The Secretary shall specify in the Fed-
eral Register notice described in subsection (b)(1) the time 
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124 STAT. 3910 
PUBLIC LAW 111–353—JAN. 4, 2011 
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 appro-
priated 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.—Para-
graph (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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124 STAT. 3911 
PUBLIC LAW 111–353—JAN. 4, 2011 
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 con-
sequence 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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124 STAT. 3912 
PUBLIC LAW 111–353—JAN. 4, 2011 
(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 out-
breaks 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 commu-
nication 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 busi-
ness 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 prod-
ucts; 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 Secu-
rity, shall— 
(A) develop metrics to measure progress for the evalua-
tion 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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124 STAT. 3913 
PUBLIC LAW 111–353—JAN. 4, 2011 
and make publicly available on the Internet Web site of the Depart-
ment 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 informa-
tion); 
(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 enact-
ment 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 con-
cerning 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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124 STAT. 3914 
PUBLIC LAW 111–353—JAN. 4, 2011 
(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 prac-
tices; 
(B) outlines the success of those programs and prac-
tices; 
(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 sub-
section (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 inspec-
tion resources. The Secretary shall promptly undertake those risk- 
based 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 sam-
ples 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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124 STAT. 3915 
PUBLIC LAW 111–353—JAN. 4, 2011 
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, out-
break response, and traceability. Such findings and recommenda-
tions 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 Sec-
retary 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 descrip-
tion 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 Serv-
ices 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, develop-
ment 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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124 STAT. 3916 
PUBLIC LAW 111–353—JAN. 4, 2011 
of such a system, and make recommendations about what new 
authorities, if any, would be necessary to develop and imple-
ment 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 examina-
tion 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 chil-
dren 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 edu-
cational 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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124 STAT. 3917 
PUBLIC LAW 111–353—JAN. 4, 2011 
(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 fol-
lowing and may be updated as the Secretary determines nec-
essary: 
(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 his-
tory 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 reac-
tion; and 
(VII) assessing the child’s readiness for self- 
administration 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 pro-
viders 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 life- 
threatening food allergies to school or early childhood edu-
cation 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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124 STAT. 3918 
PUBLIC LAW 111–353—JAN. 4, 2011 
(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 appro-
priate 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 after- 
school 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 Sec-
retary 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, administra-
tors, 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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124 STAT. 3919 
PUBLIC LAW 111–353—JAN. 4, 2011 
(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 mon-
itored; and 
(v) an agreement by the local educational agency 
to report information required by the Secretary to con-
duct 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 lim-
ited medical supplies such as epinephrine and disposable 
wet wipes, to support carrying out the food allergy and 
anaphylaxis management guidelines described in sub-
section (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 evalua-
tion 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 enti-
ties) 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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124 STAT. 3920 
PUBLIC LAW 111–353—JAN. 4, 2011 
(B) DETERMINATION OF AMOUNT OF NON-FEDERAL CON-
TRIBUTION.—Non-Federal funds required under subpara-
graph (A) may be cash or in kind, including plant, equip-
ment, or services. Amounts provided by the Federal Govern-
ment, 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 avail-
able to carry out the activities described in this subsection. 
(12) AUTHORIZATION OF APPROPRIATIONS.—There is author-
ized 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 sub-
section (b) are voluntary. Nothing in this section or the guide-
lines 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 Sec-
retary may enforce an agreement by a local educational agency 
to implement food allergy and anaphylaxis management guide-
lines 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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124 STAT. 3921 
PUBLIC LAW 111–353—JAN. 4, 2011 
the submission of information regarding the article to the Sec-
retary 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 enact-
ment 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 Pro-
gram’s Model Ordinance, or the issuance of any guidance or regula-
tion 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 proc-
essing 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, elimi-
nate, 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 meas-
ures. 
(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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124 STAT. 3922 
PUBLIC LAW 111–353—JAN. 4, 2011 
(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 associ-
ated 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 Inter-
state 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 Cos-
metic 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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124 STAT. 3923 
PUBLIC LAW 111–353—JAN. 4, 2011 
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 Sec-
retary 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 DE-
TECT 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 high- 
risk 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 manufac-
tured, 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 appro-
priate 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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124 STAT. 3924 
PUBLIC LAW 111–353—JAN. 4, 2011 
‘‘(B) DOMESTIC HIGH-RISK FACILITIES.—The Secretary 
shall increase the frequency of inspection of domestic facili-
ties 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 there-
after. 
‘‘(C) DOMESTIC
NON-HIGH-RISK
FACILITIES.—The Sec-
retary 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 there-
after. 
‘‘(D) FOREIGN FACILITIES.— 
‘‘(i) YEAR 1.—In the 1-year period following the 
date of enactment of the FDA Food Safety Moderniza-
tion 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 INSPEC-
TIONS.—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, memo-
randa 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 viola-
tions of food safety standards. 
‘‘(4) The rigor and effectiveness of the activities conducted 
by the importer of such article of food to satisfy the require-
ments 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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124 STAT. 3925 
PUBLIC LAW 111–353—JAN. 4, 2011 
‘‘(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 para-
graph (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, inspec-
tion 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 Con-
sumer 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 require-
ments. 
‘‘(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 Feb-
ruary 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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124 STAT. 3926 
PUBLIC LAW 111–353—JAN. 4, 2011 
‘‘(A) the appropriations used to inspect facilities reg-
istered 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 pursu-
ant to section 421 that the Secretary inspected in the 
previous fiscal year; and 
‘‘(F) the number of high-risk facilities identified pursu-
ant 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 sam-
pling 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 Sec-
retary shall make the reports required under subsection (h) avail-
able to the public on the Internet Web site of the Food and Drug 
Administration.’’. 
(c) ADVISORY COMMITTEE CONSULTATION.—In allocating inspec-
tion 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 accredita-
tion bodies recognized by the Secretary and laboratories 
Establishment. 
Deadline. 
21 USC 350k. 
21 USC 350j 
note. 
Web posting. 
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124 STAT. 3927 
PUBLIC LAW 111–353—JAN. 4, 2011 
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 accredita-
tion, as appropriate, that recognized accreditation bodies 
and accredited laboratories report to the Secretary any 
changes that would affect the recognition of such accredita-
tion 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 oper-
ated by a Federal agency (including the Department of Com-
merce), State, or locality with a demonstrated capability to 
conduct 1 or more sampling and analytical testing methodolo-
gies for food. 
‘‘(3) INCREASING
THE
NUMBER
OF
QUALIFIED
LABORA-
TORIES.—The Secretary shall work with the laboratory accredi-
tation 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 recog-
nized by the Secretary under paragraph (1) may accredit labora-
tories 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 stand-
ards for guidance. The model standards shall include— 
‘‘(A) methods to ensure that— 
‘‘(i) appropriate sampling, analytical procedures 
(including rapid analytical procedures), and commer-
cially 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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124 STAT. 3928 
PUBLIC LAW 111–353—JAN. 4, 2011 
‘‘(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 accred-
ited 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-Fed-
eral 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 sus-
pected 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 emer-
gency or foodborne illness outbreak. 
‘‘(c) REVIEW BY SECRETARY.—If food sampling and testing per-
formed 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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124 STAT. 3929 
PUBLIC LAW 111–353—JAN. 4, 2011 
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 main-
tain an agreement through which relevant laboratory network mem-
bers, 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 informa-
tion 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 commit-
tees 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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124 STAT. 3930 
PUBLIC LAW 111–353—JAN. 4, 2011 
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 agri-
culture, 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 sub-
section (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— 
Recommenda- 
tions. 
21 USC 2223. 
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124 STAT. 3931 
PUBLIC LAW 111–353—JAN. 4, 2011 
(A) evaluate domestic and international product tracing 
practices in commercial use; 
(B) consider international efforts, including an assess-
ment of whether product tracing requirements developed 
under this section are compatible with global tracing sys-
tems, 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 require-
ments, 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 avail-
able and appropriate; 
(B) be science-based; 
(C) not prescribe specific technologies for the mainte-
nance 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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124 STAT. 3932 
PUBLIC LAW 111–353—JAN. 4, 2011 
(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 require-
ments; 
(H) allow any person subject to this subsection to main-
tain 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 imme-
diate 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 para-
graph (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 high- 
risk foods for which the additional recordkeeping require-
ments described in paragraph (1) are appropriate and nec-
essary 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 consider-
ation 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 patho-
genic 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 possi-
bility 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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124 STAT. 3933 
PUBLIC LAW 111–353—JAN. 4, 2011 
(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 Sec-
retary 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 Sec-
retary 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 promul-
gating 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 Sec-
retary pursuant to this section, including periodic risk assess-
ment 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 con-
fidential information; and 
(C) maintain records with respect to access by any 
person to trade secret or confidential information main-
tained by the agency. 
(4) PUBLIC
INPUT.—During the comment period in the 
notice of proposed rulemaking under paragraph (1), the Sec-
retary 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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124 STAT. 3934 
PUBLIC LAW 111–353—JAN. 4, 2011 
(i) the packaging of the food maintains the integ-
rity of the product and prevents subsequent contamina-
tion 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.—Record-
keeping requirements under this subsection with 
regard to any commingled raw agricultural commodity 
shall be limited to the requirements under subpara-
graph (F). 
(ii) 
DEFINITIONS.—For 
the 
purposes 
of 
this 
subparagraph— 
(I) the term ‘‘commingled raw agricultural 
commodity’’ means any commodity that is com-
bined or mixed after harvesting, but before proc-
essing; 
(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 stand-
ards 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 sub-
section (other than the requirements under subparagraph 
(F), if applicable) if the Secretary determines that product 
tracing requirements for such food (such as bulk or commin-
gled 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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124 STAT. 3935 
PUBLIC LAW 111–353—JAN. 4, 2011 
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 imme-
diate 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 main-
tain records under this subsection other than records docu-
menting 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 record-
keeping 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 record-
keeping 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 Comp-
troller 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 lim-
iting— 
(A) the product tracing requirements under subsection 
(d) to foods identified under paragraph (2) of such sub-
section, including whether such requirements provide ade-
quate assurance of traceability in the event of intentional 
adulteration, including by acts of terrorism; and 
(B) the participation of restaurants in the record-
keeping requirements. 
(2) DETERMINATION
AND
RECOMMENDATIONS.—In con-
ducting 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 pro-
tect the public health, the Comptroller General shall submit 
Time period. 
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124 STAT. 3936 
PUBLIC LAW 111–353—JAN. 4, 2011 
to Congress recommendations, if appropriate, regarding record-
keeping requirements for restaurants and additional foods, in 
order to protect the public health. 
(f) FARMS.— 
(1) REQUEST
FOR
INFORMATION.—Notwithstanding sub-
section (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 con-
sequences 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 regula-
tion)). 
(2) MANNER OF REQUEST.—In making a request under para-
graph (1), the Secretary, in consultation and coordination with 
State and local agencies responsible for food safety, as appro-
priate, 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 reason-
able 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 non- 
electronic 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 disclo-
sures 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 imme-
diate 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 Administra-
tion 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 sub-
section, nothing in this subsection shall require the establish-
ment or maintenance by farms of new records. 
Applicability. 
Notice. 
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124 STAT. 3937 
PUBLIC LAW 111–353—JAN. 4, 2011 
(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 sub-
section (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 sub-
section (d); and 
(2) to very small businesses (as defined by the Secretary 
in section 103, not later than 90 days after the date of enact-
ment 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 Mod-
ernization 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 sec-
tion 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 admis-
sion’’. 
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 Depart-
ment 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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124 STAT. 3938 
PUBLIC LAW 111–353—JAN. 4, 2011 
(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, de- 
identified surveillance data; 
(G) at least annually, publishing current reports on 
findings from such systems; 
(H) establishing a flexible mechanism for rapidly initi-
ating scientific research by academic institutions; 
(I) integrating foodborne illness surveillance systems 
and data with other biosurveillance and public health situa-
tional awareness capabilities at the Federal, State, and 
local levels, including by sharing foodborne illness surveil-
lance 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 sec-
tion, 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 initia-
tives 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, aca-
demic 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. 
Recommenda- 
tions. 
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124 STAT. 3939 
PUBLIC LAW 111–353—JAN. 4, 2011 
achieve the purposes of this section, with measurable objec-
tives 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 imple-
ment 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 out-
break investigation, including rapid shipment of clinical 
isolates from clinical laboratories to appropriate State lab-
oratories, and conducting more standardized illness out-
break 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, out-
break 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 Fed-
eral level; and 
(D) other State and local activities and needs as deter-
mined 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, trans-
porting, 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 distrib-
uted 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 warehouse- 
based third party logistics provider to identify the food. 
‘‘(B) RULES OF CONSTRUCTION.—Nothing in this para-
graph shall be construed— 
‘‘(i) to exempt a warehouse-based third party logis-
tics 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 logis-
tics provider from being the subject of a mandatory 
recall order. 
‘‘(3) DETERMINATION TO LIMIT AREAS AFFECTED.—If the Sec-
retary 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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124 STAT. 3941 
PUBLIC LAW 111–353—JAN. 4, 2011 
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 nec-
essary, 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 Sec-
retary determines that adequate grounds do not exist to con-
tinue 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 con-
sumers 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 require-
ments 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 organiza-
tions 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 Depart-
ment 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 Sec-
retary 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 mul-
tiple 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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124 STAT. 3943 
PUBLIC LAW 111–353—JAN. 4, 2011 
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 Depart-
ment 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 imple-
mented 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 para-
graph (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 rec-
ommendations. 
(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. 
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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 Rep-
resentatives 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 sub-
section (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 ‘‘Adminis-
trator’’), in coordination with the Secretary of Health and Human 
Services, Secretary of Homeland Security, and Secretary of Agri-
culture, shall provide support for, and technical assistance to, State, 
local, and tribal governments in preparing for, assessing, decontami-
nating, and recovering from an agriculture or food emergency. 
21 USC 2225. 
21 USC 334 note. 
Deadline. 
21 USC 334 note. 
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124 STAT. 3945 
PUBLIC LAW 111–353—JAN. 4, 2011 
(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 under-
take clean-up, clearance, and recovery activities following the decon-
tamination 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 dissemi-
nate 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 spe-
cific threat agents and foreign animal diseases. 
(d) EXERCISES.—In carrying out subsection (a), the Adminis-
trator, 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 sub-
section (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 bienni-
ally. 
(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 devasta-
tion 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, TERRI-
TORIAL, AND TRIBAL FOOD SAFETY OFFICIALS. 
‘‘(a) TRAINING.—The Secretary shall set standards and admin-
ister 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 spe-
cialization in such inspections; 
21 USC 399c. 
Deadline. 
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124 STAT. 3946 
PUBLIC LAW 111–353—JAN. 4, 2011 
‘‘(4) training that addresses best practices; 
‘‘(5) training in administrative process and procedure and 
integrity issues; 
‘‘(6) training in appropriate sampling and laboratory anal-
ysis 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 examina-
tions, testing, and investigations for the purposes of deter-
mining compliance with the food safety provisions of this Act 
through the officers and employees of such State, local, terri-
torial, 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 reimburse-
ment. 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 coordina-
tion with the extension activities of the National Institute of Food 
and Agriculture of the Department of Agriculture in advising pro-
ducers 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 accord-
ance 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. 
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124 STAT. 3947 
PUBLIC LAW 111–353—JAN. 4, 2011 
(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, EXTEN-
SION, OUTREACH, AND TECHNICAL ASSISTANCE PRO-
GRAM. 
‘‘(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 Sec-
retary shall give priority to projects that target small and medium- 
sized farms, beginning farmers, socially disadvantaged farmers, 
small processors, or small fresh fruit and vegetable merchant whole-
salers. 
‘‘(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 Sec-
retary shall make competitive grants to support training, edu-
cation, extension, outreach, and technical assistance projects 
that will help improve public health by increasing the under-
standing and adoption of established food safety standards, 
guidance, and protocols. 
‘‘(2) ENCOURAGED FEATURES.—The Secretary shall encour-
age 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 mer-
chant 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 institu-
tion 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 evalua-
tions 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 pro-
ducers, 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 appro-
priated 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 investiga-
tions, and related food safety activities under section 702; 
‘‘(2) train to the standards of the Secretary for the examina-
tion, inspection, and investigation of food manufacturing, proc-
essing, 
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 out-
lined in the grant application; and 
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124 STAT. 3949 
PUBLIC LAW 111–353—JAN. 4, 2011 
‘‘(5) take appropriate action to protect the public health 
in response to— 
‘‘(A) a notification under section 1008, including plan-
ning 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 Assist-
ance Act); or 
‘‘(v) a nonprofit food safety training entity that 
collaborates with 1 or more institutions of higher edu-
cation; 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 para-
graph (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 mon-
itored; and 
‘‘(E) an agreement by the eligible entity to report 
information required by the Secretary to conduct evalua-
tions 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, equip-
ment, 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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124 STAT. 3950 
PUBLIC LAW 111–353—JAN. 4, 2011 
‘‘(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 Moderniza-
tion 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, non- 
Federal 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 appro-
priated 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 Sec-
retary, acting through the Director of the Centers for Disease Con-
trol 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 edu-
cation that have demonstrated knowledge, expertise, and 
meaningful experience with regional or national food 
production, processing, and distribution, as well as leader-
ship in the laboratory, epidemiological, and environmental 
detection and investigation of foodborne illness; and 
Deadline. 
Designation. 
42 USC 280g–16. 
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124 STAT. 3951 
PUBLIC LAW 111–353—JAN. 4, 2011 
‘‘(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 designa-
tions of the Centers of Excellence. 
‘‘(3) ADDITIONAL CENTERS OF EXCELLENCE.—The Secretary 
may designate eligible entities to be regional Food Safety Cen-
ters 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 Excel-
lence 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 con-
cerning 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 activi-
ties; 
‘‘(3) providing training for epidemiological and environ-
mental 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 assess-
ment 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 addi-
tional 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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124 STAT. 3952 
PUBLIC LAW 111–353—JAN. 4, 2011 
(1) by redesignating subsections (f) through (k) as sub-
sections (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 identi-
fication 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 pro-
vided in subsection (e)(8); and 
‘‘(4) any other information the Secretary determines is nec-
essary 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 one- 
page 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 loca-
tions, then such establishment shall, not later than 24 hours 
after a one page summary described in subsection (g) is pub-
lished, 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 Mod-
ernization 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 cus-
tomers 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 consid-
ered appropriate by the Secretary.’’. 
Publication. 
Time period. 
Deadlines. 
Publication. 
Web posting. 
Notification. 
Deadline. 
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124 STAT. 3953 
PUBLIC LAW 111–353—JAN. 4, 2011 
(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 risk- 
based 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 con-
signee 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 enact-
ment of the FDA Food Safety Modernization Act, the Secretary 
shall issue guidance to assist importers in developing foreign sup-
plier 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 con-
tent 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 assur-
ances 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 pro-
vide 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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124 STAT. 3954 
PUBLIC LAW 111–353—JAN. 4, 2011 
consideration variances granted under section 419), as 
appropriate; and 
‘‘(ii) section 402 and section 403(w). 
‘‘(B) shall include such other requirements as the Sec-
retary 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 sup-
plier verification program under this section may include moni-
toring records for shipments, lot-by-lot certification of compli-
ance, 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 pub-
lished 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 per-
sonal 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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124 STAT. 3955 
PUBLIC LAW 111–353—JAN. 4, 2011 
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 importa-
tion 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 volun-
tarily 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 Sec-
retary. 
‘‘(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 appro-
priate. 
Guidelines. 
Deadline. 
21 USC 384b. 
21 USC 331 note. 
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124 STAT. 3956 
PUBLIC LAW 111–353—JAN. 4, 2011 
‘‘(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 condi-
tion 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 facili-
ties 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
CERTIFI-
CATION.—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 stand-
ards 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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124 STAT. 3957 
PUBLIC LAW 111–353—JAN. 4, 2011 
‘‘(D) information submitted to the Secretary in accord-
ance 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 Sec-
retary 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 assur-
ance is not valid or reliable. 
‘‘(5) ELECTRONIC SUBMISSION.—The Secretary shall provide 
for the electronic submission of certifications under this sub-
section. 
‘‘(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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124 STAT. 3958 
PUBLIC LAW 111–353—JAN. 4, 2011 
(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 indus-
tries, 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 facili-
ties 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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124 STAT. 3959 
PUBLIC LAW 111–353—JAN. 4, 2011 
‘‘(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 sub-
mitted, or after such other time period, as agreed upon by the 
Secretary and the foreign factory, warehouse, or other establish-
ment.’’. 
(b) INSPECTION BY THE SECRETARY OF COMMERCE.— 
(1) IN GENERAL.—The Secretary of Commerce, in coordina-
tion 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, prepara-
tion 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 indi-
vidual who is an employee or agent of an accredited third- 
party auditor and, although not individually accredited, is quali-
fied 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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124 STAT. 3960 
PUBLIC LAW 111–353—JAN. 4, 2011 
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 sec-
tion. A third-party auditor may be a single individual. A third- 
party auditor may employ or use audit agents to help conduct 
consultative and regulatory audits. 
‘‘(4) ACCREDITED THIRD-PARTY AUDITOR.—The term ‘accred-
ited 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 require-
ments 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 sec-
tion 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, proc-
essed, 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 Mod-
ernization 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 recog-
nized by the Secretary shall submit to the Secretary a 
Deadline. 
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124 STAT. 3961 
PUBLIC LAW 111–353—JAN. 4, 2011 
list of all accredited third-party auditors accredited by such 
body and the audit agents of such auditors. 
‘‘(C) REVOCATION OF RECOGNITION AS AN ACCREDITA-
TION BODY.—The Secretary shall promptly revoke the rec-
ognition of any accreditation body found not to be in compli-
ance 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 inappro-
priate or that the body meets the requirements for recogni-
tion 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 stand-
ards, including requirements for regulatory audit reports, and 
each recognized accreditation body shall ensure that third- 
party 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 guid-
ance, 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
PAR-
TIES.—Prior to accrediting a foreign cooperative that aggre-
gates 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 docu-
mentation 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 assur-
ances the Secretary may require under section 801(q), 
whether a food satisfies the requirements of such sec-
tion; 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 Sec-
retary 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 Sec-
retary that relates to or may influence an assessment 
of compliance with this Act. 
Audit. 
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124 STAT. 3963 
PUBLIC LAW 111–353—JAN. 4, 2011 
‘‘(B) RECORDS.—Following any accreditation of a third- 
party auditor, the Secretary may, at any time, require 
the accredited third-party auditor to submit to the Sec-
retary 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 documenta-
tion that the eligible entity is in compliance with any 
applicable registration requirements. 
‘‘(C) LIMITATION.—The requirement under subpara-
graph (B) shall not include any report or other documents 
resulting from a consultative audit by the accredited third- 
party 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 consult-
ative 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 third- 
party auditors in a country or region. 
‘‘(5) CONFLICTS OF INTEREST.— 
‘‘(A) THIRD-PARTY
AUDITORS.—An accredited third- 
party 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 main-
tained 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 main-
tained 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 protec-
tions 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 con-
flicts of interest, including timing and public disclosure, 
for fees paid by eligible entities to accredited third- 
party 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 ACCREDITA-
TION.—The Secretary may withdraw accreditation from an 
accredited third-party auditor in the case that such third- 
party auditor is accredited by an accreditation body for 
which recognition as an accreditation body under sub-
section (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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124 STAT. 3965 
PUBLIC LAW 111–353—JAN. 4, 2011 
‘‘(ii) reviews the steps or actions taken by the 
third party auditor to justify the certification and deter-
mines 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 require-
ments 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 Mar-
keting 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 rev-
enue from such a reimbursement mechanism. Fees authorized 
under this paragraph shall be collected and available for obliga-
tion only to the extent and in the amount provided in advance 
in appropriation Acts. Such fees are authorized to remain avail-
able 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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124 STAT. 3966 
PUBLIC LAW 111–353—JAN. 4, 2011 
‘‘(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 estab-
lish 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 ADMINISTRA-
TION. 
(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 inspec-
tions 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 Sec-
retary believes would cause serious adverse health consequences 
Deadline. 
Deadline. 
Strategy. 
21 USC 2243. 
Establishment. 
21 USC 2242. 
Deadlines. 
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124 STAT. 3967 
PUBLIC LAW 111–353—JAN. 4, 2011 
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 net-
works, 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 Veteri-
nary Medicine, and related field activities of the Office of Regu-
latory Affairs of the Food and Drug Administration, the Sec-
retary 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 para-
graph (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, proc-
essing, 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 Govern-
ment, or the attorney general of a State information relating 
to any violation of, or any act or omission the employee reason-
ably 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 partici-
pate 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 provi-
sion 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 ‘Sec-
retary’) alleging such discharge or discrimination and identi-
fying 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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124 STAT. 3969 
PUBLIC LAW 111–353—JAN. 4, 2011 
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 para-
graph (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 reinstate-
ment 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 complain-
ant makes a prima facie showing that any behavior 
described in paragraphs (1) through (4) of subsection 
(a) was a contributing factor in the unfavorable per-
sonnel 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 inves-
tigation 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 privi-
leges 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 complain-
ant, 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 com-
plaint, or within 90 days after receiving a written deter-
mination, 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 dis-
charge or discrimination; 
‘‘(ii) the amount of back pay, with interest; and 
‘‘(iii) compensation for any special damages sus-
tained 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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124 STAT. 3971 
PUBLIC LAW 111–353—JAN. 4, 2011 
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 commence-
ment 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 per-
son 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, injunc-
tive 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, demo-
tion, 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 importa-
tion of food who, acting without direction from such entity (or 
such entity’s agent), deliberately causes a violation of any require-
ment 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 Agri-
culture and the Secretary of Health and Human Services, under 
applicable statutes, regulations, or agreements regarding vol-
untary inspection of non-amenable species under the Agricul-
tural 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 Agri-
culture 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 Agri-
cultural 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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124 STAT. 3973 
PUBLIC LAW 111–353—JAN. 4, 2011 
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. 
Congressional Record by the Chairman of the Senate Budget Com-
mittee, provided that such statement has been submitted prior 
to the vote on passage. 
Approved January 4, 2011. 
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