1751 
•AMDT. NO. 4805 
‘‘(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— 
‘‘(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 
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•AMDT. NO. 4805 
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 
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 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 
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•AMDT. NO. 4805 
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 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 
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•AMDT. NO. 4805 
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 Sec-
retary determines appropriate.’’. 
(3) LIMITATIONS
ON
USE
AND
AMOUNT
OF 
FEES.—Paragraph (4) of section 801(e) (21 U.S.C. 
381(e)) is amended by adding at the end the fol-
lowing: 
‘‘(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 Adminis-
tration associated with issuing such certifications. 
‘‘(ii) Such fees may not be retained in an 
amount that exceeds such costs.’’. 
SEC. 6108. NATIONAL AGRICULTURE AND FOOD DEFENSE 
STRATEGY. 
(a) DEVELOPMENT
AND SUBMISSION
OF STRAT-
EGY.— 
(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 
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•AMDT. NO. 4805 
Agriculture, in coordination with the Secretary of 
Homeland Security, shall prepare and transmit to 
the relevant committees of Congress, and make pub-
licly available on the Internet Web sites of the De-
partment 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 car-
rying out the strategy. 
(3) RESEARCH.—The strategy shall include a 
coordinated research agenda for use by the Secre-
taries 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 there-
after, the Secretary of Health and Human Services 
and the Secretary of Agriculture, in coordination 
with the Secretary of Homeland Security, shall re-
vise and submit to the relevant committees of Con-
gress the strategy. 
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•AMDT. NO. 4805 
(5) CONSISTENCY WITH EXISTING PLANS.—The 
strategy described in paragraph (1) shall be con-
sistent 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 Depart-
ment of Health and Human Services, the Depart-
ment of Agriculture, and the Department of Home-
land Security— 
(A) to achieve each goal described in para-
graph (2); and 
(B) to evaluate the progress made by Fed-
eral, State, local, and tribal governments to-
wards the achievement of each goal described in 
paragraph (2). 
(2) GOALS.—The strategy shall include a de-
scription of the process to be used by the Depart-
ment of Health and Human Services, the Depart-
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•AMDT. NO. 4805 
land Security, a report on the activities of the Food and 
Agriculture Government Coordinating Council and the 
Food and Agriculture Sector Coordinating Council, includ-
ing 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 inter-
change of information between each council relating 
to the security of the agriculture and food system 
(including intelligence information); 
(3) identifying best practices and methods for 
improving the coordination among Federal, State, 
local, and private sector preparedness and response 
plans for agriculture and food defense; and 
(4) recommending methods by which to protect 
the economy and the public health of the United 
States from the effects of— 
(A) animal or plant disease outbreaks; 
(B) food contamination; and 
(C) natural disasters affecting agriculture 
and food. 
SEC. 6110. BUILDING DOMESTIC CAPACITY. 
(a) IN GENERAL.— 
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•AMDT. NO. 4805 
(1) INITIAL REPORT.—The Secretary, in coordi-
nation with the Secretary of Agriculture and the 
Secretary of Homeland Security, shall, not later 
than 2 years after the date of enactment of this Act, 
submit to Congress a comprehensive report that 
identifies programs and practices that are intended 
to promote the safety and supply chain security of 
food and to prevent outbreaks of foodborne illness 
and other food-related hazards that can be ad-
dressed through preventive activities. Such report 
shall include a description of the following: 
(A) Analysis of the need for further regula-
tions or guidance to industry. 
(B) Outreach to food industry sectors, in-
cluding through the Food and Agriculture Co-
ordinating Councils referred to in section 6109, 
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. 
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•AMDT. NO. 4805 
(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-re-
lated hazards, including how such systems and 
networks are integrated. 
(F) Outreach, education, and training pro-
vided to States and local governments to build 
State and local food safety and food defense ca-
pabilities, 
including 
progress 
implementing 
strategies developed under sections 6108 and 
6205. 
(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. 
(H) The impact of requirements under this 
Act (including amendments made by this Act) 
on certified organic farms and facilities (as de-
fined in section 415 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 350d)). 
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1764 
•AMDT. NO. 4805 
(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 6201), together with, as nec-
essary, a description of any additional authori-
ties necessary to improve seafood safety. 
(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 
(H) of paragraph (1), as necessary. 
(b) RISK-BASED ACTIVITIES.—The report developed 
under subsection (a)(1) shall describe methods that seek 
to ensure that resources available to the Secretary for food 
safety-related activities are directed at those actions most 
likely to reduce risks from food, including the use of pre-
ventive strategies and allocation of inspection resources. 
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•AMDT. NO. 4805 
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 commercially available techniques that can be 
employed at ports of entry and by Food Emergency Re-
sponse Network laboratories, and to provide for well- 
equipped and staffed laboratory facilities and progress to-
ward laboratory accreditation under section 422 of the 
Federal Food, Drug, and Cosmetic Act (as added by sec-
tion 6202). 
(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-
oratories, laboratory networks, and consumers. The infor-
mation technology systems that the Secretary describes 
shall also provide for the integration of the facility reg-
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