H. R. 2751—21 
‘‘(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
H. R. 2751—22 
‘‘(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
H. R. 2751—23 
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;
H. R. 2751—24 
‘‘(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
H. R. 2751—25 
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
H. R. 2751—26 
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
H. R. 2751—27 
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
H. R. 2751—28 
(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,
H. R. 2751—29 
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.
H. R. 2751—30 
(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
H. R. 2751—31 
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
H. R. 2751—32 
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.
H. R. 2751—33 
(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.
H. R. 2751—34 
(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