ance has been achieved to the Secretary’s 
satisfaction; and 
‘‘(B) the term ‘reinspection-related costs’ 
means all expenses, including administrative ex-
penses, incurred in connection with— 
‘‘(i) arranging, conducting, and evalu-
ating the results of reinspections; and 
‘‘(ii) assessing and collecting reinspec-
tion fees under this section. 
‘‘(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 speci-
fied 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 sub-
section (a)(1) for a fiscal year shall be 
based on the Secretary’s estimate of 100 
percent of the costs of the reinspection-re-
lated activities (including by type or level 
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of reinspection activity, as the Secretary 
determines applicable) described in such 
subparagraph (A) for such year; 
‘‘(ii) under subparagraph (B) of sub-
section (a)(1) for a fiscal year shall be 
based on the Secretary’s estimate of 100 
percent of the costs of the activities de-
scribed in such subparagraph (B) for such 
year; 
‘‘(iii) under subparagraph (C) of sub-
section (a)(1) for a fiscal year shall be 
based on the Secretary’s estimate of 100 
percent of the costs of the activities de-
scribed in such subparagraph (C) for such 
year; and 
‘‘(iv) under subparagraph (D) of sub-
section (a)(1) for a fiscal year shall be 
based on the Secretary’s estimate of 100 
percent of the costs of the activities de-
scribed in such subparagraph (D) for such 
year. 
‘‘(B) OTHER CONSIDERATIONS.— 
‘‘(i) 
VOLUNTARY
QUALIFIED
IM-
PORTER PROGRAM.— 
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‘‘(I) PARTICIPATION.—In estab-
lishing the fee amounts under sub-
paragraph (A)(iii) for a fiscal year, 
the Secretary shall provide for the 
number of importers who have sub-
mitted to the Secretary a notice under 
section 806 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 estab-
lishing the fee amounts under sub-
paragraph (A)(iii) for the first 5 fiscal 
years after the date of enactment of 
this section, the Secretary shall in-
clude in such fee a reasonable sur-
charge 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 estab-
lishing the fee amounts under subpara-
graph (A) for a fiscal year, the Secretary 
shall provide for the crediting of fees from 
the previous year to the next year if the 
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Secretary overestimated the amount of fees 
needed to carry out such activities, and 
consider the need to account for any ad-
justment of fees and such other factors as 
the Secretary determines appropriate. 
‘‘(3) USE OF FEES.—The Secretary shall make 
all of the fees collected pursuant to clause (i), (ii), 
(iii), and (iv) of paragraph (2)(A) available solely to 
pay for the costs referred to in such clause (i), (ii), 
(iii), and (iv) of paragraph (2)(A), respectively. 
‘‘(4) 
COMPLIANCE
WITH
INTERNATIONAL 
AGREEMENTS.—Nothing in this section shall be con-
strued to authorize the assessment of any fee incon-
sistent with the agreement establishing the World 
Trade Organization or any other treaty or inter-
national agreement to which the United States is a 
party. 
‘‘(c) LIMITATIONS.— 
‘‘(1) IN GENERAL.—Fees under subsection (a) 
shall be refunded for a fiscal year beginning after 
fiscal year 2010 unless appropriations for the Center 
for Food Safety and Applied Nutrition and the Cen-
ter for Veterinary Medicine and related activities of 
the Office of Regulatory Affairs at the Food and 
Drug Administration for such fiscal year (excluding 
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the amount of fees appropriated for such fiscal year) 
are equal to or greater than the amount of appro-
priations for the Center for Food Safety and Applied 
Nutrition and the Center for Veterinary Medicine 
and related activities of the Office of Regulatory Af-
fairs at the Food and Drug Administration for the 
preceding fiscal year (excluding the amount of fees 
appropriated for such fiscal year) multiplied by 1 
plus 4.5 percent. 
‘‘(2) AUTHORITY.—If the Secretary does not 
assess fees under subsection (a) during any portion 
of a fiscal year because of paragraph (1) and if at 
a later date in such fiscal year the Secretary may as-
sess such fees, the Secretary may assess and collect 
such fees, without any modification in the rate, 
under subsection (a), notwithstanding the provisions 
of subsection (a) relating to the date fees are to be 
paid. 
‘‘(3) LIMITATION
ON
AMOUNT
OF
CERTAIN 
FEES.— 
‘‘(A) IN GENERAL.—Notwithstanding any 
other provision of this section and subject to 
subparagraph (B), the Secretary may not col-
lect fees in a fiscal year such that the amount 
collected— 
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‘‘(i) under subparagraph (B) of sub-
section (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 subpara-
graph (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 au-
thorized to remain available until expended. Such sums 
as may be necessary may be transferred from the Food 
and Drug Administration salaries and expenses account 
without fiscal year limitation to such appropriation ac-
count for salaries and expenses with such fiscal year limi-
tation. The sums transferred shall be available solely for 
the purpose of paying the operating expenses of the Food 
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and Drug Administration employees and contractors per-
forming activities associated with these food safety fees. 
‘‘(e) COLLECTION OF FEES.— 
‘‘(1) IN GENERAL.—The Secretary shall specify 
in the Federal Register notice described in sub-
section (b)(1) the time and manner in which fees as-
sessed 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 provi-
sions 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 United States Senate and the Committee 
on Energy and Commerce of the United States House of 
Representatives, to include a description of fees assessed 
and collected for each such year and a summary descrip-
tion of the entities paying such fees and the types of busi-
ness in which such entities engage. 
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‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—For fis-
cal year 2010 and each fiscal year thereafter, there is au-
thorized to be appropriated for fees under this section an 
amount equal to the total revenue amount determined 
under subsection (b) for the fiscal year, as adjusted or 
otherwise affected under the other provisions of this sec-
tion.’’. 
(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 amend-
ed— 
(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.—Sec-
tion 801(e)(4) (21 U.S.C. 381(e)(4)) is amended by 
inserting after subparagraph (B) the following new 
subparagraph: 
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‘‘(C) For purposes of this paragraph, a 
certification by the Secretary shall be made on 
such basis, and in such form (including a pub-
licly available listing) as the Secretary deter-
mines appropriate.’’. 
TITLE II—DETECTION AND 
SURVEILLANCE 
SEC. 201. RECOGNITION OF LABORATORY ACCREDITATION 
FOR ANALYSES OF FOODS. 
(a) IN GENERAL.—Chapter IV (21 U.S.C. 341 et 
seq.), as amended by section 107, is amended by adding 
at the end the following: 
‘‘SEC. 422. RECOGNITION OF LABORATORY ACCREDITATION 
FOR ANALYSES OF FOODS. 
‘‘(a) RECOGNITION
OF LABORATORY ACCREDITA-
TION.— 
‘‘(1) IN
GENERAL.—Not later than 2 years 
after the date of enactment of this section, the Sec-
retary shall— 
‘‘(A) provide for the recognition of accredi-
tation bodies that accredit laboratories, includ-
ing laboratories run and operated by a State or 
locality, with a demonstrated capability to con-
duct analytical testing of food products; and 
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‘‘(B) establish a publicly available registry 
of accreditation bodies, including the name of, 
contact information for, and other information 
deemed necessary by the Secretary about such 
bodies. 
‘‘(2) MODEL
ACCREDITATION
STANDARDS.— 
The Secretary shall develop model standards that an 
accreditation body shall require laboratories to meet 
in order to be included in the registry provided for 
under paragraph (1). In developing the model stand-
ards, the Secretary shall look to existing standards 
for guidance. The model standards shall include 
methods to ensure that— 
‘‘(A) appropriate sampling and analytical 
procedures are followed and reports of analyses 
are certified as true and accurate; 
‘‘(B) internal quality systems are estab-
lished and maintained; 
‘‘(C) procedures exist to evaluate and re-
spond promptly to complaints regarding anal-
yses and other activities for which the labora-
tory is recognized; 
‘‘(D) individuals who conduct the analyses 
are qualified by training and experience to do 
so; and 
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‘‘(E) any other criteria determined appro-
priate by the Secretary. 
‘‘(3) REVIEW OF ACCREDITATION.—To assure 
compliance with the requirements of this section, the 
Secretary shall— 
‘‘(A) periodically, or at least every 5 years, 
reevaluate accreditation bodies recognized under 
paragraph (1); and 
‘‘(B) promptly revoke the recognition of 
any accreditation body found not to be in com-
pliance with the requirements of this section. 
‘‘(b) TESTING PROCEDURES.—Food testing shall be 
conducted by either Federal laboratories or non-Federal 
laboratories that have been accredited by an accreditation 
body on the registry established by the Secretary under 
subsection (a) whenever such testing— 
‘‘(1) is either conducted by or on behalf of an 
owner or consignee— 
‘‘(A) in support of admission of an article 
of food under section 801(a); or 
‘‘(B) under an Import Alert that requires 
successful consecutive tests; or 
‘‘(2) is required by the Secretary as the Sec-
retary deems appropriate to identify or address a 
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threat of serious adverse health consequences or 
death to humans or animals. 
The results of any such testing shall be sent directly to 
the Food and Drug Administration. 
‘‘(c) REVIEW BY SECRETARY.—If food testing per-
formed by a laboratory run and operated by a State or 
locality that is accredited by an accreditation body on the 
registry established by the Secretary under subsection (a) 
result in a State recalling a food, the Secretary shall re-
view the testing results for the purpose of determining the 
need for a national recall or other compliance and enforce-
ment activities.’’. 
(b) FOOD EMERGENCY RESPONSE NETWORK.—The 
Secretary, in coordination with the Secretary of Agri-
culture, 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 emer-
gency response laboratory network that— 
(1) provides ongoing surveillance, rapid detec-
tion, and surge capacity for large-scale food-related 
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emergencies, including intentional adulteration of 
the food supply; 
(2) coordinates the food laboratory capacities of 
State food laboratories, including the sharing of data 
between State laboratories to develop national situa-
tional awareness; 
(3) provides accessible, timely, accurate, and 
consistent food laboratory services throughout the 
United States; 
(4) develops and implements a methods reposi-
tory for use by Federal, State, and local officials; 
(5) responds to food-related emergencies; and 
(6) is integrated with relevant laboratory net-
works administered by other Federal agencies. 
SEC. 202. INTEGRATED CONSORTIUM OF LABORATORY 
NETWORKS. 
(a) IN GENERAL.—The Secretary of Homeland Secu-
rity, in consultation with the Secretary of Health and 
Human Services, the Secretary of Agriculture, and the 
Administrator of the Environmental Protection Agency, 
shall maintain an agreement through which relevant lab-
oratory network members, as determined by the Secretary 
of Homeland Security, shall— 
(1) agree on common laboratory methods in 
order to facilitate the sharing of knowledge and in-
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formation relating to animal health, agriculture, and 
human health; 
(2) identify the means by which each laboratory 
network member could work cooperatively— 
(A) to optimize national laboratory pre-
paredness; and 
(B) to provide surge capacity during emer-
gencies; and 
(3) engage in ongoing dialogue and build rela-
tionships that will support a more effective and inte-
grated response during emergencies. 
(b) REPORTING REQUIREMENT.—The Secretary of 
Homeland Security shall, on a biennial basis, submit to 
the relevant committees of Congress, and make publicly 
available on the Internet Web site of the Department of 
Homeland Security, a report on the progress of the inte-
grated consortium of laboratory networks, as established 
under subsection (a), in carrying out this section. 
SEC. 203. BUILDING DOMESTIC CAPACITY. 
(a) IN GENERAL.— 
(1) INITIAL REPORT.—The Secretary shall, not 
later than 2 years after the date of enactment of 
this Act, submit to Congress a comprehensive report 
that identifies programs and practices that are in-
tended to promote the safety and security of food 
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and to prevent outbreaks of food-borne illness and 
other food-related hazards that can be addressed 
through preventive activities. Such report shall in-
clude a description of the following: 
(A) Analysis of the need for regulations or 
guidance to industry. 
(B) Outreach to food industry sectors, in-
cluding through the Food and Agriculture Co-
ordinating Councils referred to in section 111, 
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 distribu-
tion to the food industry of information and 
technical assistance concerning preventive strat-
egies. 
(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 food- 
borne illness outbreaks and other food-related 
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hazards, including how such systems and net-
works are integrated. 
(F) Outreach, education, and training pro-
vided to States to build State food safety and 
food defense capabilities, including progress im-
plementing strategies developed under sections 
109 and 205. 
(G) The estimated resources needed to ef-
fectively implement the programs and practices 
identified in the report developed in this section 
over a 5-year period. 
(2) BIENNIAL REPORTS.—On a biennial basis 
following the submission of the report under para-
graph (1), the Secretary shall submit to Congress a 
report that— 
(A) reviews previous food safety programs 
and practices; 
(B) outlines the success of those programs 
and practices; 
(C) identifies future programs and prac-
tices; and 
(D) includes information related to any 
matter described in subparagraphs (A) through 
(G) of paragraph (1), as necessary. 
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(b) RISK-BASED ACTIVITIES.—The report developed 
under subsection (a)(1) shall describe methods that seek 
to ensure that resources available to the Secretary for food 
safety-related activities are directed at those actions most 
likely to reduce risks from food, including the use of pre-
ventive strategies and allocation of inspection 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; RE-
SEARCH.—The report developed under subsection (a)(1) 
shall provide a description of methods to increase capacity 
to undertake analyses of food samples promptly after col-
lection, to identify new and rapid analytical techniques, 
including techniques that can be employed at ports of 
entry and through Food Emergency Response Network 
laboratories, and to provide for well-equipped and staffed 
laboratory facilities. 
(d) INFORMATION TECHNOLOGY.—The report devel-
oped 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 gov-
ernments, other Federal agencies, the food industry, lab-
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oratories, laboratory networks, and consumers. The infor-
mation technology systems that the Secretary describes 
shall also provide for the integration of the facility reg-
istration 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 proc-
essing of food offered for import into the United States. 
(e) AUTOMATED RISK ASSESSMENT.—The report de-
veloped under subsection (a)(1) shall include a description 
of progress toward developing and improving an auto-
mated 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 sub-
section (a)(1) an analysis of the Food and Drug Adminis-
tration’s performance in food-borne illness outbreaks dur-
ing the 5-year period preceding the date of enactment of 
this Act involving fruits and vegetables that are raw agri-
cultural commodities (as defined in section 201(r) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321(r))) and recommendations for enhanced surveillance, 
outbreak response, and traceability. Such findings and 
recommendations shall address communication and coordi-
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nation with the public and industry, outbreak identifica-
tion, and traceback. 
(g) BIENNIAL FOOD SAFETY AND FOOD DEFENSE 
RESEARCH PLAN.—The Secretary and the Secretary of 
Agriculture 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 food- 
borne illness. Such biennial plan shall include a list and 
description of projects conducted during the previous 2- 
year period and the plan for projects to be conducted dur-
ing the following 2-year period. 
SEC. 204. ENHANCING TRACEBACK AND RECORDKEEPING. 
(a) IN GENERAL.—The Secretary, in consultation 
with the Secretary of Agriculture and representatives of 
State departments of health and agriculture, shall improve 
the capacity of the Secretary to effectively and rapidly 
track and trace, in the event of an outbreak, fruits and 
vegetables that are raw agricultural commodities. 
(b) PILOT PROJECT.— 
(1) IN GENERAL.—Not later than 12 months 
after the date of enactment of this Act, the Sec-
retary shall establish a pilot project in coordination 
with the produce industry to explore and evaluate 
new methods for rapidly and effectively tracking and 
tracing fruits and vegetables that are raw agricul-
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tural commodities so that, if an outbreak occurs in-
volving such a fruit or vegetable, the Secretary may 
quickly identify the source of the outbreak and the 
recipients of the contaminated food. 
(2) CONTENT.—The Secretary shall select par-
ticipants from the produce industry to run projects 
which overall shall include at least 3 different types 
of fruits or vegetables that have been the subject of 
outbreaks during the 10-year period preceding the 
date of enactment of this Act, and shall be selected 
in order to develop and demonstrate— 
(A) methods that are applicable and appro-
priate for small businesses; and 
(B) technologies, including existing tech-
nologies, that enhance traceback and trace for-
ward. 
(c) 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 project under sub-
section (b) together with recommendations for establishing 
more effective traceback and trace forward procedures for 
fruits and vegetables that are raw agricultural commod-
ities. 
(d) TRACEBACK PERFORMANCE REQUIREMENTS.— 
Not later than 24 months after the date of enactment of 
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this Act, the Secretary shall publish a notice of proposed 
rulemaking to establish standards for the type of informa-
tion, format, and timeframe for persons to submit records 
to aid the Secretary in effectively and rapidly tracking and 
tracing, in the event of an outbreak, fruits and vegetables 
that are raw agricultural commodities. Nothing in this sec-
tion shall be construed as giving the Secretary the author-
ity to prescribe specific technologies for the maintenance 
of records. 
(e) PUBLIC INPUT.—During the comment period in 
the notice of proposed rulemaking under subsection (d), 
the Secretary shall conduct not less than 3 public meetings 
in diverse geographical areas of the United States to pro-
vide persons in different regions an opportunity to com-
ment. 
(f) RAW AGRICULTURAL COMMODITY.—In this sec-
tion, the term ‘‘raw agricultural commodity’’ has the 
meaning given that term in section 201(r) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321(r)). 
SEC. 205. SURVEILLANCE. 
(a) DEFINITION
OF FOOD-BORNE ILLNESS OUT-
BREAK.—In this section, the term ‘‘food-borne illness out-
break’’ means the occurrence of 2 or more cases of a simi-
lar illness resulting from the ingestion of a food. 
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(b) FOOD-BORNE
ILLNESS
SURVEILLANCE
SYS-
TEMS.— 
(1) 
IN
GENERAL.—The 
Secretary, 
acting 
through the Director of the Centers for Disease 
Control and Prevention, shall enhance food-borne ill-
ness surveillance systems to improve the collection, 
analysis, reporting, and usefulness of data on food- 
borne illnesses by— 
(A) coordinating Federal, State and local 
food-borne illness surveillance systems, includ-
ing complaint systems, and increasing participa-
tion in national networks of public health and 
food regulatory agencies and laboratories; 
(B) facilitating sharing of findings on a 
more timely basis among governmental agen-
cies, including the Food and Drug Administra-
tion, the Department of Agriculture, and State 
and local agencies, and with the public; 
(C) ensuring early notification to the af-
fected food industry when a particular food may 
be suspected in the outbreak and sharing of all 
relevant data with the affected food industry 
during the course of the investigation; 
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(D) developing improved epidemiological 
tools for obtaining quality exposure data, and 
microbiological methods for classifying cases; 
(E) augmenting such systems to improve 
attribution of a food-borne illness outbreak to a 
specific food; 
(F) expanding capacity of such systems, 
including working toward automatic electronic 
searches, for implementation of fingerprinting 
strategies for food-borne infectious agents, in 
order to identify new or rarely documented 
causes of food-borne illness and submit stand-
ardized information to a centralized database; 
(G) allowing timely public access to aggre-
gated, de-identified surveillance data; 
(H) at least annually, publishing current 
reports on findings from such systems; 
(I) establishing a flexible mechanism for 
rapidly initiating scientific research by academic 
institutions; 
(J) integrating food-borne illness surveil-
lance systems and data with other biosurveil-
lance and public health situational awareness 
capabilities at the state and federal levels; and 
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(K) other activities as determined appro-
priate by the Secretary. 
(2) 
ADVISORY
GROUP
ON
IMPROVING 
FOODBORNE
ILLNESS
SURVEILLANCE
AND
OUT-
BREAK INVESTIGATIONS.— 
(A) IN
GENERAL.—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 industry, 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 
food-borne illness surveillance, outbreak inves-
tigation, and implementation of this section, in-
cluding advice and recommendations on— 
(i) the priority needs of regulatory 
agencies, the food industry, and consumers 
for information and analysis on food-borne 
illness and its causes; 
(ii) the priority needs of regulatory 
agencies, the food industry, and consumers 
for information and analysis on outbreak 
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investigations that can be used to improve 
the line of authority and accountability; 
(iii) opportunities to improve the ef-
fectiveness of initiatives at the Federal, 
State, and local levels, including coordina-
tion and integration of activities among 
Federal agencies, and between the Federal, 
State, and local levels of government; 
(iv) improvement in the timeliness and 
depth of access by regulatory and health 
agencies, the food industry, academic re-
searchers, and consumers to food-borne ill-
ness surveillance data and food recall sur-
vey data collected by government agencies 
at all levels, including data compiled by the 
Centers for Disease Control and Preven-
tion; 
(v) key barriers to improvement in 
food-borne illness surveillance and its util-
ity for preventing food-borne illness at 
Federal, State, and local levels; 
(vi) the capabilities needed for estab-
lishing automatic electronic searches of 
surveillance data; and 
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(vii) specific actions to reduce barriers 
to improvement, implement the working 
group’s recommendations, and achieve the 
purposes of this section, with measurable 
objectives and timelines, and identification 
of resource and staffing needs. 
(3) ADDITIONAL DUTIES.—The Secretary shall 
also utilize the working group under paragraph (1) 
to assist in outbreak investigations as deemed appro-
priate. 
(c) IMPROVING FOOD SAFETY AND DEFENSE CAPAC-
ITY AT THE STATE AND LOCAL LEVEL.— 
(1) IN GENERAL.—The Secretary shall develop 
and implement strategies to leverage and enhance 
the food safety and defense capacities of State and 
local agencies in order to achieve the following goals: 
(A) Improve food-borne illness outbreak re-
sponse and containment. 
(B) Accelerate food-borne illness surveil-
lance and outbreak investigation, including 
rapid shipment of clinical isolates from clinical 
laboratories to appropriate State laboratories, 
and conducting more standardized illness out-
break interviews. 
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(C) Strengthen the capacity of State and 
local agencies to carry out inspections and en-
force safety standards. 
(D) Improve the effectiveness of Federal- 
State partnerships to coordinate food safety 
and defense resources and reduce the incidence 
of food-borne illness. 
(E) Share information on a timely basis 
among public health and food regulatory agen-
cies, 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 109. 
(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 this 
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 surveil-
lance, outbreak response, inspection, and en-
forcement activities; 
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(C) information systems to support data 
management and sharing of food safety and de-
fense information among State and local agen-
cies and with counterparts at the Federal level; 
and 
(D) other State and local activities and 
needs as determined appropriate by the Sec-
retary. 
(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 in-
serting ‘‘2011 through 2014’’. 
TITLE 
III—SPECIFIC 
PROVI-
SIONS FOR 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.—Each 
United States importer of record shall perform risk- 
based foreign supplier verification activities in ac-
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cordance with regulations promulgated under sub-
section (c) for the purpose of verifying that the food 
imported by the importer of record or its agent is— 
‘‘(A) produced in compliance with the re-
quirements of section 419 or 420, as appro-
priate; and 
‘‘(B) is not adulterated under section 402 
or misbranded under section 403(w). 
‘‘(2) IMPORTER EXCLUSION.—For purposes of 
this section, an ‘importer of record’ shall not include 
a person holding a valid license under section 641 of 
the Tariff Act of 1930 (19 U.S.C. 1641) (referred 
to as a ‘customs broker’) if the customs broker has 
executed a written agreement with another person 
who has agreed to comply with the requirements of 
this section with regard to food imported or offered 
for import by the customs broker. 
‘‘(b) GUIDANCE.—Not later than 270 days after the 
date of the enactment of this section, the Secretary shall 
issue guidance to assist United States importers of record 
in developing foreign supplier verification programs. 
‘‘(c) REGULATIONS.— 
‘‘(1) IN GENERAL.—Not later than 1 year after 
issuing guidance under subsection (b), the Secretary 
shall promulgate regulations to provide for the con-
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tent of the foreign supplier verification program es-
tablished under subsection (a). Such regulations 
shall, 
as 
appropriate, 
include 
a 
process 
for 
verification by a United States importer of record, 
with respect to each foreign supplier from which it 
obtains food, that the imported food is produced in 
compliance with the requirements of section 419 or 
420, as appropriate, and is not adulterated under 
section 402 or misbranded under section 403(w). 
‘‘(2) VERIFICATION.—The regulations under 
paragraph (1) shall require that the foreign supplier 
verification program of each importer of record be 
adequate to provide assurances that each foreign 
supplier to the importer of record produces the im-
ported food employing processes and procedures, in-
cluding risk-based reasonably appropriate preventive 
controls, that are documented in a written plan 
under subsection (d) and equivalent in preventing 
adulteration and reducing hazards as those required 
by section 419 or section 420, as appropriate. 
‘‘(3) ACTIVITIES.—Verification activities under 
a foreign supplier verification program under this 
section may include monitoring records for ship-
ments, lot-by-lot certification of compliance, annual 
on-site inspections, checking the hazard analysis and 
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risk-based preventive control plan of the foreign sup-
plier, and periodically testing and sampling ship-
ments. 
‘‘(d) RECORD MAINTENANCE AND ACCESS.—Each 
facility required to be registered under section 415 that 
is, as determined by the Secretary, a high-risk facility 
shall submit to the Secretary a written plan that docu-
ments and describes its hazard analysis and preventative 
control procedures. The Secretary or a duly authorized 
representative of the Secretary may review the plan and 
may make recommendations to improve the effectiveness 
of the plan in preventing or minimizing the threat of seri-
ous adverse health consequences or death to humans or 
animals. Records of all United States importers related 
to a foreign supplier verification program shall be main-
tained for a period of not less than 2 years and shall be 
made available promptly to a duly authorized representa-
tive of the Secretary upon request. 
‘‘(e) DEEMED COMPLIANCE
OF SEAFOOD, JUICE, 
AND LOW-ACID CANNED FOOD FACILITIES IN COMPLI-
ANCE WITH HACCP.—An owner, operator, or agent in 
charge of a facility required to comply with 1 of the fol-
lowing standards and regulations with respect to such fa-
cility shall be deemed to be in compliance with this section 
with respect to such facility: 
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‘‘(1) The Seafood Hazard Analysis Critical 
Control Points Program of the Food and Drug Ad-
ministration. 
‘‘(2) The Juice Hazard Analysis Critical Con-
trol Points Program of the Food and Drug Adminis-
tration. 
‘‘(3) The Thermally Processed Low-Acid Foods 
Packaged in Hermetically Sealed Containers stand-
ards of the Food and Drug Administration (or any 
successor standards). 
‘‘(f) 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 informa-
tion 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 106, is amended by adding at the 
end the following: 
‘‘(rr) The importation or offering for importation of 
a food if the importer of record does not have in place 
a foreign supplier verification program in compliance with 
section 805.’’. 
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(c) IMPORTS.—Section 801(a) (21 U.S.C. 381(a)) is 
amended by adding ‘‘or the importer of record is in viola-
tion of 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 en-
actment 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 fol-
lowing: 
‘‘SEC. 806. VOLUNTARY QUALIFIED IMPORTER PROGRAM. 
‘‘(a) IN GENERAL.—Beginning not later than 1 year 
after the date of enactment of this section, the Secretary 
shall— 
‘‘(1) establish a program, in consultation with 
the Department of Homeland Security, to provide 
for the expedited review and importation of food of-
fered for importation by United States importers 
who have voluntarily agreed to participate in such 
program; and 
‘‘(2) issue a guidance document related to par-
ticipation and compliance with such program. 
‘‘(b) VOLUNTARY PARTICIPATION.—An importer may 
request the Secretary to provide for the expedited review 
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and importation of designated foods in accordance with 
the program procedures established by the Secretary. 
‘‘(c) ELIGIBILITY.—In order to be eligible, an im-
porter shall be offering food for importation from a facility 
that has a certification described in section 809(b). In re-
viewing the applications and making determinations on 
such requests, the Secretary shall consider the risk of the 
food to be imported based on factors, such as the fol-
lowing: 
‘‘(1) The nature of the food to be imported. 
‘‘(2) The compliance history of the foreign sup-
plier. 
‘‘(3) The capability of the regulatory system of 
the country of export to ensure compliance with 
United States food safety standards. 
‘‘(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 adultera-
tion of the food. 
‘‘(7) Any other factor that the Secretary deter-
mines appropriate. 
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‘‘(d) 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 im-
porter found not to be in compliance with such criteria. 
‘‘(e) 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 CERTIFI-
CATIONS 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 impor-
tation of such food is subject to, but not compliant with, 
the requirement under subsection (p) that such food be 
accompanied by a certification or other assurance that the 
food meets some or all 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: 
‘‘(p) 
CERTIFICATIONS
CONCERNING
IMPORTED 
FOODS.— 
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‘‘(1) IN GENERAL.—The Secretary, based on 
public health considerations, including risks associ-
ated with the food or its place of origin, may require 
as a condition of granting admission to an article of 
food imported or offered for import into the United 
States, that an entity specified in paragraph (2) pro-
vide a certification or such other assurances as the 
Secretary determines appropriate that the article of 
food complies with some or all applicable require-
ments of this Act, as specified by the Secretary. 
Such certification or assurances may be provided in 
the form of shipment-specific certificates, a listing of 
certified entities, or in such other form as the Sec-
retary may specify. Such certification shall be used 
for designated food imported from countries with 
which the Food and Drug Administration has an 
agreement to establish a certification program. 
‘‘(2) CERTIFYING ENTITIES.—For purposes of 
paragraph (1), entities that shall provide the certifi-
cation or assurances described in such paragraph 
are— 
‘‘(A) an agency or a representative of the 
government of the country from which the arti-
cle of food at issue originated, as designated by 
such government or the Secretary; or 
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‘‘(B) such other persons or entities accred-
ited pursuant to section 809 to provide such 
certification or assurance. 
‘‘(3) RENEWAL
AND
REFUSAL
OF
CERTIFI-
CATIONS.—The Secretary may— 
‘‘(A) require that any certification or other 
assurance provided by an entity specified in 
paragraph (2) be renewed by such entity at 
such times as the Secretary determines appro-
priate; and 
‘‘(B) refuse to accept any certification or 
assurance if the Secretary determines that such 
certification or assurance is no longer valid or 
reliable. 
‘‘(4) ELECTRONIC SUBMISSION.—The Secretary 
shall provide for the electronic submission of certifi-
cations under this subsection.’’. 
(c) CONFORMING TECHNICAL AMENDMENT.—Sec-
tion 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,’’. 
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(d) NO LIMIT
ON AUTHORITY.—Nothing in the 
amendments made by this section shall limit the authority 
of the Secretary to conduct random inspections of im-
ported food or to take such other steps as the Secretary 
deems appropriate to determine the admissibility of im-
ported 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;’’. 
(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 amend-
ment 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. REVIEW OF A REGULATORY AUTHORITY OF A 
FOREIGN COUNTRY. 
Chapter VIII (21 U.S.C. 381 et seq.), as amended 
by section 302, is amended by adding at the end the fol-
lowing: 
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‘‘SEC. 807. REVIEW OF A REGULATORY AUTHORITY OF A 
FOREIGN COUNTRY. 
‘‘The Secretary may review information from a coun-
try outlining the statutes, regulations, standards, and con-
trols of such country, and conduct on-site audits in such 
country to verify the implementation of those statutes, 
regulations, standards, and controls. Based on such re-
view, the Secretary shall determine whether such country 
can provide reasonable assurances that the food supply of 
the country is equivalent in safety to food manufactured, 
processed, packed, or held in the United States.’’. 
SEC. 306. BUILDING CAPACITY OF FOREIGN GOVERNMENTS 
WITH RESPECT TO FOOD. 
(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 capacity of foreign governments, and their 
respective food industries, from which foods are exported 
to the United States. 
(b) CONSULTATION.—In developing the plan under 
subsection (a), the Secretary shall consult with the Sec-
retary of Agriculture, Secretary of State, Secretary of the 
Treasury, and the Secretary of Commerce, representatives 
of the food industry, appropriate foreign government offi-
cials, and nongovernmental organizations that represent 
the interests of consumers, and other stakeholders. 
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(c) PLAN.—The plan developed under subsection (a) 
shall include, as appropriate, the following: 
(1) Recommendations for bilateral and multilat-
eral arrangements and agreements, including provi-
sions to provide for responsibility of exporting coun-
tries to ensure the safety of food. 
(2) Provisions for electronic data sharing. 
(3) Provisions for mutual recognition of inspec-
tion reports. 
(4) Training of foreign governments and food 
producers on United States requirements for safe 
food. 
(5) Recommendations to harmonize require-
ments under the Codex Alimentarius. 
(6) Provisions for the multilateral acceptance of 
laboratory methods and detection techniques. 
SEC. 307. INSPECTION OF FOREIGN FOOD FACILITIES. 
Chapter VIII (21 U.S.C. 381 et seq.), as amended 
by section 305, is amended by inserting at the end the 
following: 
‘‘SEC. 808. INSPECTION OF FOREIGN FOOD FACILITIES. 
‘‘(a) INSPECTION.—The Secretary— 
‘‘(1) may enter into arrangements and agree-
ments with foreign governments to facilitate the in-
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