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SEC. 203. INTEGRATED CONSORTIUM OF LABORATORY NET-
WORKS. 
(a) IN GENERAL.—The Secretary of Homeland Secu-
rity, in coordination with the Secretary of Health and 
Human Services, the Secretary of Agriculture, the Secretary 
of Commerce, and the Administrator of the Environmental 
Protection Agency, shall maintain an agreement through 
which relevant laboratory network members, as determined 
by the Secretary of Homeland Security, shall— 
(1) agree on common laboratory methods in 
order to reduce the time required to detect and re-
spond to foodborne illness outbreaks and facilitate the 
sharing of knowledge and information relating to ani-
mal health, agriculture, and human health; 
(2) identify means by which laboratory network 
members 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
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† HR 2751 EAS 
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. 204. ENHANCING TRACKING AND TRACING OF FOOD 
AND RECORDKEEPING. 
(a) PILOT PROJECTS.— 
(1) IN GENERAL.—Not later than 270 days after 
the date of enactment of this Act, the Secretary of 
Health and Human Services (referred to in this sec-
tion as the ‘‘Secretary’’), taking into account rec-
ommendations from the Secretary of Agriculture and 
representatives of State departments of health and ag-
riculture, shall establish pilot projects in coordination 
with the food industry to explore and evaluate meth-
ods to rapidly and effectively identify recipients of 
food to prevent or mitigate a foodborne illness out-
break and to address credible threats of serious ad-
verse health consequences or death to humans or ani-
mals as a result of such food being adulterated under 
section 402 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 342) or misbranded under section 
403(w) of such Act (21 U.S.C. 343(w)). 
(2) CONTENT.—The Secretary shall conduct 1 or 
more pilot projects under paragraph (1) in coordina-
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† HR 2751 EAS 
tion with the processed food sector and 1 or more such 
pilot projects in coordination with processors or dis-
tributors of fruits and vegetables that are raw agricul-
tural commodities. The Secretary shall ensure that the 
pilot projects under paragraph (1) reflect the diver-
sity of the food supply and include at least 3 different 
types of foods that have been the subject of significant 
outbreaks during the 5-year period preceding the date 
of enactment of this Act, and are selected in order 
to— 
(A) develop and demonstrate methods for 
rapid and effective tracking and tracing of foods 
in a manner that is practicable for facilities of 
varying sizes, including small businesses; 
(B) develop and demonstrate appropriate 
technologies, including technologies existing on 
the date of enactment of this Act, that enhance 
the tracking and tracing of food; and 
(C) inform the promulgation of regulations 
under subsection (d). 
(3) REPORT.—Not later than 18 months after the 
date of enactment of this Act, the Secretary shall re-
port to Congress on the findings of the pilot projects 
under this subsection together with recommendations 
for improving the tracking and tracing of food.
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† HR 2751 EAS 
(b) ADDITIONAL DATA GATHERING.— 
(1) IN GENERAL.—The Secretary, in coordina-
tion with the Secretary of Agriculture and multiple 
representatives of State departments of health and ag-
riculture, shall assess— 
(A) the costs and benefits associated with 
the adoption and use of several product tracing 
technologies, including technologies used in the 
pilot projects under subsection (a); 
(B) the feasibility of such technologies for 
different sectors of the food industry, including 
small businesses; and 
(C) whether such technologies are compat-
ible with the requirements of this subsection. 
(2) REQUIREMENTS.—To the extent practicable, 
in carrying out paragraph (1), the Secretary shall— 
(A) evaluate domestic and international 
product tracing practices in commercial use; 
(B) consider international efforts, including 
an assessment of whether product tracing re-
quirements developed under this section are com-
patible with global tracing systems, as appro-
priate; and 
(C) consult with a diverse and broad range 
of experts and stakeholders, including representa-
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† HR 2751 EAS 
tives of the food industry, agricultural producers, 
and nongovernmental organizations that rep-
resent the interests of consumers. 
(c) PRODUCT TRACING SYSTEM.—The Secretary, in 
consultation with the Secretary of Agriculture, shall, as ap-
propriate, establish within the Food and Drug Administra-
tion a product tracing system to receive information that 
improves the capacity of the Secretary to effectively and 
rapidly track and trace food that is in the United States 
or offered for import into the United States. Prior to the 
establishment of such product tracing system, the Secretary 
shall examine the results of applicable pilot projects and 
shall ensure that the activities of such system are adequately 
supported by the results of such pilot projects. 
(d) ADDITIONAL
RECORDKEEPING
REQUIREMENTS 
FOR HIGH RISK FOODS.— 
(1) IN GENERAL.—In order to rapidly and effec-
tively identify recipients of a food to prevent or miti-
gate a foodborne illness outbreak and to address cred-
ible threats of serious adverse health consequences or 
death to humans or animals as a result of such food 
being adulterated under section 402 of the Federal 
Food, Drug, and Cosmetic Act or misbranded under 
section 403(w) of such Act, not later than 2 years 
after the date of enactment of this Act, the Secretary
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† HR 2751 EAS 
shall publish a notice of proposed rulemaking to es-
tablish recordkeeping requirements, in addition to the 
requirements under section 414 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 350c) and sub-
part J of part 1 of title 21, Code of Federal Regula-
tions (or any successor regulations), for facilities that 
manufacture, process, pack, or hold foods that the Sec-
retary designates under paragraph (2) as high-risk 
foods. The Secretary shall set an appropriate effective 
date of such additional requirements for foods des-
ignated as high risk that takes into account the length 
of time necessary to comply with such requirements. 
Such requirements shall— 
(A) relate only to information that is rea-
sonably available and appropriate; 
(B) be science-based; 
(C) not prescribe specific technologies for the 
maintenance of records; 
(D) ensure that the public health benefits of 
imposing additional recordkeeping requirements 
outweigh the cost of compliance with such re-
quirements; 
(E) be scale-appropriate and practicable for 
facilities of varying sizes and capabilities with 
respect to costs and recordkeeping burdens, and
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† HR 2751 EAS 
not require the creation and maintenance of du-
plicate records where the information is con-
tained in other company records kept in the nor-
mal course of business; 
(F) minimize the number of different rec-
ordkeeping requirements for facilities that handle 
more than 1 type of food; 
(G) to the extent practicable, not require a 
facility to change business systems to comply 
with such requirements; 
(H) allow any person subject to this sub-
section to maintain records required under this 
subsection at a central or reasonably accessible 
location provided that such records can be made 
available to the Secretary not later than 24 
hours after the Secretary requests such records; 
and 
(I) include a process by which the Secretary 
may issue a waiver of the requirements under 
this subsection if the Secretary determines that 
such requirements would result in an economic 
hardship for an individual facility or a type of 
facility; 
(J) be commensurate with the known safety 
risks of the designated food;
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† HR 2751 EAS 
(K) take into account international trade 
obligations; 
(L) not require— 
(i) a full pedigree, or a record of the 
complete previous distribution history of the 
food from the point of origin of such food; 
(ii) records of recipients of a food be-
yond the immediate subsequent recipient of 
such food; or 
(iii) product tracking to the case level 
by persons subject to such requirements; and 
(M) include a process by which the Sec-
retary may remove a high-risk food designation 
developed under paragraph (2) for a food or type 
of food. 
(2) DESIGNATION OF HIGH-RISK FOODS.— 
(A) IN GENERAL.—Not later than 1 year 
after the date of enactment of this Act, and there-
after as the Secretary determines necessary, the 
Secretary shall designate high-risk foods for 
which the additional recordkeeping requirements 
described in paragraph (1) are appropriate and 
necessary to protect the public health. Each such 
designation shall be based on—
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† HR 2751 EAS 
(i) the known safety risks of a par-
ticular food, including the history and se-
verity of foodborne illness outbreaks attrib-
uted to such food, taking into consideration 
foodborne illness data collected by the Cen-
ters for Disease Control and Prevention; 
(ii) the likelihood that a particular 
food has a high potential risk for micro-
biological or chemical contamination or 
would support the growth of pathogenic 
microorganisms due to the nature of the 
food or the processes used to produce such 
food; 
(iii) the point in the manufacturing 
process of the food where contamination is 
most likely to occur; 
(iv) the likelihood of contamination 
and steps taken during the manufacturing 
process to reduce the possibility of contami-
nation; 
(v) the likelihood that consuming a 
particular food will result in a foodborne 
illness due to contamination of the food; 
and
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† HR 2751 EAS 
(vi) the likely or known severity, in-
cluding health and economic impacts, of a 
foodborne illness attributed to a particular 
food. 
(B) LIST
OF
HIGH-RISK
FOODS.—At the 
time the Secretary promulgates the final rules 
under paragraph (1), the Secretary shall publish 
the list of the foods designated under subpara-
graph (A) as high-risk foods on the Internet 
website of the Food and Drug Administration. 
The Secretary may update the list to designate 
new high-risk foods and to remove foods that are 
no longer deemed to be high-risk foods, provided 
that each such update to the list is consistent 
with the requirements of this subsection and no-
tice of such update is published in the Federal 
Register. 
(3) PROTECTION OF SENSITIVE INFORMATION.— 
In promulgating regulations under this subsection, 
the Secretary shall take appropriate measures to en-
sure that there are effective procedures to prevent the 
unauthorized disclosure of any trade secret or con-
fidential information that is obtained by the Sec-
retary pursuant to this section, including periodic
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† HR 2751 EAS 
risk assessment and planning to prevent unauthorized 
release and controls to— 
(A) prevent unauthorized reproduction of 
trade secret or confidential information; 
(B) prevent unauthorized access to trade se-
cret or confidential information; and 
(C) maintain records with respect to access 
by any person to trade secret or confidential in-
formation maintained by the agency. 
(4) PUBLIC INPUT.—During the comment period 
in the notice of proposed rulemaking under para-
graph (1), the Secretary shall conduct not less than 
3 public meetings in diverse geographical areas of the 
United States to provide persons in different regions 
an opportunity to comment. 
(5) RETENTION OF RECORDS.—Except as other-
wise provided in this subsection, the Secretary may 
require that a facility retain records under this sub-
section for not more than 2 years, taking into consid-
eration the risk of spoilage, loss of value, or loss of 
palatability of the applicable food when determining 
the appropriate timeframes. 
(6) LIMITATIONS.— 
(A) FARM TO SCHOOL PROGRAMS.—In es-
tablishing requirements under this subsection,
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† HR 2751 EAS 
the Secretary shall, in consultation with the Sec-
retary of Agriculture, consider the impact of re-
quirements on farm to school or farm to institu-
tion programs of the Department of Agriculture 
and other farm to school and farm to institution 
programs outside such agency, and shall modify 
the requirements under this subsection, as appro-
priate, with respect to such programs so that the 
requirements do not place undue burdens on 
farm to school or farm to institution programs. 
(B) IDENTITY-PRESERVED
LABELS
WITH 
RESPECT TO FARM SALES OF FOOD THAT IS PRO-
DUCED
AND
PACKAGED
ON
A
FARM.—The re-
quirements under this subsection shall not apply 
to a food that is produced and packaged on a 
farm if— 
(i) the packaging of the food maintains 
the integrity of the product and prevents 
subsequent contamination or alteration of 
the product; and 
(ii) the labeling of the food includes the 
name, complete address (street address, 
town, State, country, and zip or other post-
al code), and business phone number of the 
farm, unless the Secretary waives the re-
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† HR 2751 EAS 
quirement to include a business phone num-
ber of the farm, as appropriate, in order to 
accommodate a religious belief of the indi-
vidual in charge of such farm. 
(C) FISHING
VESSELS.—The requirements 
under this subsection with respect to a food that 
is produced through the use of a fishing vessel (as 
defined in section 3(18) of the Magnuson-Stevens 
Fishery Conservation and Management Act (16 
U.S.C. 1802(18))) shall be limited to the require-
ments under subparagraph (F) until such time 
as the food is sold by the owner, operator, or 
agent in charge of such fishing vessel. 
(D) COMMINGLED RAW AGRICULTURAL COM-
MODITIES.— 
(i) LIMITATION ON EXTENT OF TRAC-
ING.—Recordkeeping 
requirements 
under 
this subsection with regard to any commin-
gled raw agricultural commodity shall be 
limited to the requirements under subpara-
graph (F). 
(ii) DEFINITIONS.—For the purposes of 
this subparagraph— 
(I) the term ‘‘commingled raw ag-
ricultural 
commodity’’ 
means 
any
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† HR 2751 EAS 
commodity that is combined or mixed 
after harvesting, but before processing; 
(II) the term ‘‘commingled raw 
agricultural commodity’’ shall not in-
clude types of fruits and vegetables that 
are raw agricultural commodities for 
which the Secretary has determined 
that standards promulgated under sec-
tion 419 of the Federal Food, Drug, 
and Cosmetic Act (as added by section 
105) would minimize the risk of seri-
ous adverse health consequences or 
death; and 
(III) the term ‘‘processing’’ means 
operations that alter the general state 
of the commodity, such as canning, 
cooking, freezing, dehydration, milling, 
grinding, pasteurization, or homogeni-
zation. 
(E) EXEMPTION
OF
OTHER
FOODS.—The 
Secretary may, by notice in the Federal Register, 
modify the requirements under this subsection 
with respect to, or exempt a food or a type of fa-
cility from, the requirements of this subsection 
(other than the requirements under subpara-
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† HR 2751 EAS 
graph (F), if applicable) if the Secretary deter-
mines that product tracing requirements for such 
food (such as bulk or commingled ingredients 
that are intended to be processed to destroy 
pathogens) or type of facility is not necessary to 
protect the public health. 
(F) RECORDKEEPING REGARDING PREVIOUS 
SOURCES AND SUBSEQUENT RECIPIENTS.—In the 
case of a person or food to which a limitation or 
exemption under subparagraph (C), (D), or (E) 
applies, if such person, or a person who manu-
factures, processes, packs, or holds such food, is 
required to register with the Secretary under sec-
tion 415 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 350d) with respect to the 
manufacturing, processing, packing, or holding 
of the applicable food, the Secretary shall require 
such person to maintain records that identify the 
immediate previous source of such food and the 
immediate subsequent recipient of such food. 
(G) GROCERY STORES.—With respect to a 
sale of a food described in subparagraph (H) to 
a grocery store, the Secretary shall not require 
such grocery store to maintain records under this 
subsection other than records documenting the
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† HR 2751 EAS 
farm that was the source of such food. The Sec-
retary shall not require that such records be kept 
for more than 180 days. 
(H) FARM
SALES
TO
CONSUMERS.—The 
Secretary shall not require a farm to maintain 
any distribution records under this subsection 
with respect to a sale of a food described in sub-
paragraph (I) (including a sale of a food that is 
produced and packaged on such farm), if such 
sale is made by the farm directly to a consumer. 
(I) SALE OF A FOOD.—A sale of a food de-
scribed in this subparagraph is a sale of a food 
in which— 
(i) the food is produced on a farm; and 
(ii) the sale is made by the owner, op-
erator, or agent in charge of such farm di-
rectly to a consumer or grocery store. 
(7) NO IMPACT ON NON-HIGH-RISK FOODS.—The 
recordkeeping requirements established under para-
graph (1) shall have no effect on foods that are not 
designated by the Secretary under paragraph (2) as 
high-risk foods. Foods described in the preceding sen-
tence shall be subject solely to the recordkeeping re-
quirements under section 414 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 350c) and sub-
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† HR 2751 EAS 
part J of part 1 of title 21, Code of Federal Regula-
tions (or any successor regulations). 
(e) EVALUATION AND RECOMMENDATIONS.— 
(1) REPORT.—Not later than 1 year after the ef-
fective date of the final rule promulgated under sub-
section (d)(1), the Comptroller General of the United 
States shall submit to Congress a report, taking into 
consideration the costs of compliance and other regu-
latory burdens on small businesses and Federal, 
State, and local food safety practices and require-
ments, that evaluates the public health benefits and 
risks, if any, of limiting— 
(A) the product tracing requirements under 
subsection (d) to foods identified under para-
graph (2) of such subsection, including whether 
such requirements provide adequate assurance of 
traceability in the event of intentional adultera-
tion, including by acts of terrorism; and 
(B) the participation of restaurants in the 
recordkeeping requirements. 
(2) DETERMINATION AND RECOMMENDATIONS.— 
In conducting the evaluation and report under para-
graph (1), if the Comptroller General of the United 
States determines that the limitations described in 
such paragraph do not adequately protect the public
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† HR 2751 EAS 
health, the Comptroller General shall submit to Con-
gress recommendations, if appropriate, regarding rec-
ordkeeping requirements for restaurants and addi-
tional foods, in order to protect the public health. 
(f) FARMS.— 
(1) 
REQUEST
FOR
INFORMATION.—Notwith-
standing subsection (d), during an active investiga-
tion of a foodborne illness outbreak, or if the Sec-
retary determines it is necessary to protect the public 
health and prevent or mitigate a foodborne illness 
outbreak, the Secretary, in consultation and coordina-
tion with State and local agencies responsible for food 
safety, as appropriate, may request that the owner, 
operator, or agent of a farm identify potential imme-
diate recipients, other than consumers, of an article 
of the food that is the subject of such investigation if 
the Secretary reasonably believes such article of 
food— 
(A) is adulterated under section 402 of the 
Federal Food, Drug, and Cosmetic Act; 
(B) presents a threat of serious adverse 
health consequences or death to humans or ani-
mals; and 
(C) was adulterated as described in sub-
paragraph (A) on a particular farm (as defined
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† HR 2751 EAS 
in section 1.227 of chapter 21, Code of Federal 
Regulations (or any successor regulation)). 
(2) MANNER OF REQUEST.—In making a request 
under paragraph (1), the Secretary, in consultation 
and coordination with State and local agencies re-
sponsible for food safety, as appropriate, shall issue a 
written notice to the owner, operator, or agent of the 
farm to which the article of food has been traced. The 
individual providing such notice shall present to such 
owner, operator, or agent appropriate credentials and 
shall deliver such notice at reasonable times and with-
in reasonable limits and in a reasonable manner. 
(3) DELIVERY OF INFORMATION REQUESTED.— 
The owner, operator, or agent of a farm shall deliver 
the information requested under paragraph (1) in a 
prompt and reasonable manner. Such information 
may consist of records kept in the normal course of 
business, and may be in electronic or non-electronic 
format. 
(4) LIMITATION.—A request made under para-
graph (1) shall not include a request for information 
relating to the finances, pricing of commodities pro-
duced, personnel, research, sales (other than informa-
tion relating to shipping), or other disclosures that 
may reveal trade secrets or confidential information
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† HR 2751 EAS 
from the farm to which the article of food has been 
traced, other than information necessary to identify 
potential immediate recipients of such food. Section 
301(j) of the Federal Food, Drug, and Cosmetic Act 
and the Freedom of Information Act shall apply with 
respect to any confidential commercial information 
that is disclosed to the Food and Drug Administra-
tion in the course of responding to a request under 
paragraph (1). 
(5) RECORDS.—Except with respect to identi-
fying potential immediate recipients in response to a 
request under this subsection, nothing in this sub-
section shall require the establishment or maintenance 
by farms of new records. 
(g) NO LIMITATION ON COMMINGLING OF FOOD.— 
Nothing in this section shall be construed to authorize the 
Secretary to impose any limitation on the commingling of 
food. 
(h) SMALL ENTITY COMPLIANCE GUIDE.—Not later 
than 180 days after promulgation of a final rule under sub-
section (d), the Secretary shall issue a small entity compli-
ance guide setting forth in plain language the requirements 
of the regulations under such subsection in order to assist 
small entities, including farms and small businesses, in
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† HR 2751 EAS 
complying with the recordkeeping requirements under such 
subsection. 
(i) FLEXIBILITY FOR SMALL BUSINESSES.—Notwith-
standing any other provision of law, the regulations pro-
mulgated under subsection (d) shall apply— 
(1) to small businesses (as defined by the Sec-
retary in section 103, not later than 90 days after the 
date of enactment of this Act) beginning on the date 
that is 1 year after the effective date of the final regu-
lations promulgated under subsection (d); and 
(2) to very small businesses (as defined by the 
Secretary in section 103, not later than 90 days after 
the date of enactment of this Act) beginning on the 
date that is 2 years after the effective date of the final 
regulations promulgated under subsection (d). 
(j) ENFORCEMENT.— 
(1) PROHIBITED
ACTS.—Section 301(e) (21 
U.S.C. 331(e)) is amended by inserting ‘‘; or the vio-
lation of any recordkeeping requirement under section 
204 of the FDA Food Safety Modernization Act (ex-
cept when such violation is committed by a farm)’’ 
before the period at the end. 
(2) 
IMPORTS.—Section 
801(a) 
(21 
U.S.C. 
381(a)) is amended by inserting ‘‘or (4) the record-
keeping requirements under section 204 of the FDA
140 
† HR 2751 EAS 
Food Safety Modernization Act (other than the re-
quirements under subsection (f) of such section) have 
not been complied with regarding such article,’’ in the 
third sentence before ‘‘then such article shall be re-
fused admission’’. 
SEC. 205. SURVEILLANCE. 
(a) DEFINITION
OF
FOODBORNE
ILLNESS
OUT-
BREAK.—In this Act, the term ‘‘foodborne illness outbreak’’ 
means the occurrence of 2 or more cases of a similar illness 
resulting from the ingestion of a certain food. 
(b) FOODBORNE ILLNESS SURVEILLANCE SYSTEMS.— 
(1) IN GENERAL.—The Secretary, acting through 
the Director of the Centers for Disease Control and 
Prevention, shall enhance foodborne illness surveil-
lance systems to improve the collection, analysis, re-
porting, and usefulness of data on foodborne illnesses 
by— 
(A) coordinating Federal, State and local 
foodborne illness surveillance systems, including 
complaint systems, and increasing participation 
in national networks of public health and food 
regulatory agencies and laboratories; 
(B) facilitating sharing of surveillance in-
formation on a more timely basis among govern-
mental agencies, including the Food and Drug
141 
† HR 2751 EAS 
Administration, the Department of Agriculture, 
the Department of Homeland Security, and 
State and local agencies, and with the public; 
(C) developing improved epidemiological 
tools for obtaining quality exposure data and 
microbiological methods for classifying cases; 
(D) augmenting such systems to improve at-
tribution of a foodborne illness outbreak to a spe-
cific food; 
(E) expanding capacity of such systems, in-
cluding working toward automatic electronic 
searches, for implementation of identification 
practices, including fingerprinting strategies, for 
foodborne infectious agents, in order to identify 
new or rarely documented causes of foodborne ill-
ness and submit standardized information to a 
centralized database; 
(F) allowing timely public access to aggre-
gated, de-identified surveillance data; 
(G) at least annually, publishing current 
reports on findings from such systems; 
(H) establishing a flexible mechanism for 
rapidly initiating scientific research by aca-
demic institutions;
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† HR 2751 EAS 
(I) integrating foodborne illness surveillance 
systems and data with other biosurveillance and 
public health situational awareness capabilities 
at the Federal, State, and local levels, including 
by sharing foodborne illness surveillance data 
with the National Biosurveillance Integration 
Center; and 
(J) other activities as determined appro-
priate by the Secretary. 
(2) WORKING GROUP.—The Secretary shall sup-
port and maintain a diverse working group of experts 
and stakeholders from Federal, State, and local food 
safety and health agencies, the food and food testing 
industries, consumer organizations, and academia. 
Such working group shall provide the Secretary, 
through at least annual meetings of the working 
group and an annual public report, advice and rec-
ommendations on an ongoing and regular basis re-
garding the improvement of foodborne illness surveil-
lance and implementation of this section, including 
advice and recommendations on— 
(A) the priority needs of regulatory agen-
cies, the food industry, and consumers for infor-
mation and analysis on foodborne illness and its 
causes;
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† HR 2751 EAS 
section, with measurable objectives and timelines, 
and identification of resource and staffing needs. 
(3) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out the activities described in paragraph (1), 
there is authorized to be appropriated $24,000,000 for 
each fiscal years 2011 through 2015. 
(c) IMPROVING FOOD SAFETY AND DEFENSE CAPACITY 
AT THE STATE AND LOCAL LEVEL.— 
(1) IN GENERAL.—The Secretary shall develop 
and implement strategies to leverage and enhance the 
food safety and defense capacities of State and local 
agencies in order to achieve the following goals: 
(A) Improve foodborne illness outbreak re-
sponse and containment. 
(B) Accelerate foodborne illness surveillance 
and outbreak investigation, including rapid 
shipment of clinical isolates from clinical labora-
tories to appropriate State laboratories, and con-
ducting more standardized illness outbreak inter-
views. 
(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, and local partnerships to coordinate food
145 
† HR 2751 EAS 
safety and defense resources and reduce the inci-
dence of foodborne 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 108. 
(2) REVIEW.—In developing of the strategies re-
quired by paragraph (1), the Secretary shall, not 
later than 1 year after the date of enactment of the 
FDA Food Safety Modernization Act, complete a re-
view of State and local capacities, and needs for en-
hancement, 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 enforce-
ment activities; 
(C) information systems to support data 
management and sharing of food safety and de-
fense information among State and local agen-
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† HR 2751 EAS 
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.—Sec-
tion 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 insert-
ing ‘‘2011 through 2015’’. 
SEC. 206. MANDATORY RECALL AUTHORITY. 
(a) IN GENERAL.—Chapter IV (21 U.S.C. 341 et seq.), 
as amended by section 202, is amended by adding at the 
end the following: 
‘‘SEC. 423. MANDATORY RECALL AUTHORITY. 
‘‘(a) VOLUNTARY PROCEDURES.—If the Secretary de-
termines, based on information gathered through the report-
able food registry under section 417 or through any other 
means, that there is a reasonable probability that an article 
of food (other than infant formula) is adulterated under sec-
tion 402 or misbranded under section 403(w) and the use 
of or exposure to such article will cause serious adverse 
health consequences or death to humans or animals, the Sec-
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† HR 2751 EAS 
retary shall provide the responsible party (as defined in sec-
tion 417) with an opportunity to cease distribution and re-
call such article. 
‘‘(b) PREHEARING ORDER TO CEASE DISTRIBUTION 
AND GIVE NOTICE.— 
‘‘(1) IN GENERAL.—If the responsible party re-
fuses to or does not voluntarily cease distribution or 
recall such article within the time and in the manner 
prescribed by the Secretary (if so prescribed), the Sec-
retary may, by order require, as the Secretary deems 
necessary, such person to— 
‘‘(A) immediately cease distribution of such 
article; and 
‘‘(B) as applicable, immediately notify all 
persons— 
‘‘(i) manufacturing, processing, pack-
ing, transporting, distributing, receiving, 
holding, or importing and selling such arti-
cle; and 
‘‘(ii) to which such article has been 
distributed, transported, or sold, to imme-
diately cease distribution of such article. 
‘‘(2) REQUIRED ADDITIONAL INFORMATION.— 
‘‘(A) IN GENERAL.—If an article of food 
covered by a recall order issued under paragraph
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† HR 2751 EAS 
(1)(B) has been distributed to a warehouse-based 
third party logistics provider without providing 
such provider sufficient information to know or 
reasonably determine the precise identity of the 
article of food covered by a recall order that is 
in its possession, the notice provided by the re-
sponsible party subject to the order issued under 
paragraph (1)(B) shall include such information 
as is necessary for the warehouse-based third 
party logistics provider to identify the food. 
‘‘(B) RULES
OF
CONSTRUCTION.—Nothing 
in this paragraph shall be construed— 
‘‘(i) to exempt a warehouse-based third 
party logistics provider from the require-
ments of this Act, including the require-
ments in this section and section 414; or 
‘‘(ii) to exempt a warehouse-based 
third party logistics provider from being the 
subject of a mandatory recall order. 
‘‘(3) DETERMINATION
TO
LIMIT
AREAS
AF-
FECTED.—If the Secretary requires a responsible 
party to cease distribution under paragraph (1)(A) of 
an article of food identified in subsection (a), the Sec-
retary may limit the size of the geographic area and
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† HR 2751 EAS 
the markets affected by such cessation if such limita-
tion would not compromise the public health. 
‘‘(c) HEARING ON ORDER.—The Secretary shall pro-
vide the responsible party subject to an order under sub-
section (b) with an opportunity for an informal hearing, 
to be held as soon as possible, but not later than 2 days 
after the issuance of the order, on the actions required by 
the order and on why the article that is the subject of the 
order should not be recalled. 
‘‘(d) POST-HEARING RECALL ORDER AND MODIFICA-
TION OF ORDER.— 
‘‘(1) AMENDMENT
OF
ORDER.—If, after pro-
viding opportunity for an informal hearing under 
subsection (c), the Secretary determines that removal 
of the article from commerce is necessary, the Sec-
retary shall, as appropriate— 
‘‘(A) amend the order to require recall of 
such article or other appropriate action; 
‘‘(B) specify a timetable in which the recall 
shall occur; 
‘‘(C) require periodic reports to the Sec-
retary describing the progress of the recall; and 
‘‘(D) provide notice to consumers to whom 
such article was, or may have been, distributed.
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‘‘(2) VACATING OF ORDER.—If, after such hear-
ing, the Secretary determines that adequate grounds 
do not exist to continue the actions required by the 
order, or that such actions should be modified, the 
Secretary shall vacate the order or modify the order. 
‘‘(e) RULE REGARDING ALCOHOLIC BEVERAGES.—The 
Secretary shall not initiate a mandatory recall or take any 
other action under this section with respect to any alcohol 
beverage until the Secretary has provided the Alcohol and 
Tobacco Tax and Trade Bureau with a reasonable oppor-
tunity to cease distribution and recall such article under 
the Alcohol and Tobacco Tax and Trade Bureau authority. 
‘‘(f) COOPERATION
AND CONSULTATION.—The Sec-
retary shall work with State and local public health officials 
in carrying out this section, as appropriate. 
‘‘(g) PUBLIC NOTIFICATION.—In conducting a recall 
under this section, the Secretary shall— 
‘‘(1) ensure that a press release is published re-
garding the recall, as well as alerts and public no-
tices, as appropriate, in order to provide notifica-
tion— 
‘‘(A) of the recall to consumers and retailers 
to whom such article was, or may have been, dis-
tributed; and 
‘‘(B) that includes, at a minimum—
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† HR 2751 EAS 
‘‘(i) the name of the article of food sub-
ject to the recall; 
‘‘(ii) a description of the risk associ-
ated with such article; and 
‘‘(iii) to the extent practicable, infor-
mation for consumers about similar articles 
of food that are not affected by the recall; 
‘‘(2) consult the policies of the Department of Ag-
riculture regarding providing to the public a list of 
retail consignees receiving products involved in a 
Class I recall and shall consider providing such a list 
to the public, as determined appropriate by the Sec-
retary; and 
‘‘(3) if available, publish on the Internet Web 
site of the Food and Drug Administration an image 
of the article that is the subject of the press release de-
scribed in (1). 
‘‘(h) NO DELEGATION.—The authority conferred by 
this section to order a recall or vacate a recall order shall 
not be delegated to any officer or employee other than the 
Commissioner. 
‘‘(i) EFFECT.—Nothing in this section shall affect the 
authority of the Secretary to request or participate in a 
voluntary recall, or to issue an order to cease distribution
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† HR 2751 EAS 
or to recall under any other provision of this Act or under 
the Public Health Service Act. 
‘‘(j) COORDINATED COMMUNICATION.— 
‘‘(1) IN GENERAL.—To assist in carrying out the 
requirements of this subsection, the Secretary shall es-
tablish an incident command operation or a similar 
operation within the Department of Health and 
Human Services that will operate not later than 24 
hours after the initiation of a mandatory recall or the 
recall of an article of food for which the use of, or ex-
posure to, such article will cause serious adverse 
health consequences or death to humans or animals. 
‘‘(2) REQUIREMENTS.—To reduce the potential 
for miscommunication during recalls or regarding in-
vestigations of a food borne illness outbreak associated 
with a food that is subject to a recall, each incident 
command operation or similar operation under para-
graph (1) shall use regular staff and resources of the 
Department of Health and Human Services to— 
‘‘(A) ensure timely and coordinated commu-
nication within the Department, including en-
hanced communication and coordination between 
different agencies and organizations within the 
Department;
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† HR 2751 EAS 
‘‘(B) ensure timely and coordinated commu-
nication from the Department, including public 
statements, throughout the duration of the inves-
tigation and related foodborne illness outbreak; 
‘‘(C) identify a single point of contact with-
in the Department for public inquiries regarding 
any actions by the Secretary related to a recall; 
‘‘(D) coordinate with Federal, State, local, 
and tribal authorities, as appropriate, that have 
responsibilities related to the recall of a food or 
a foodborne illness outbreak associated with a 
food that is subject to the recall, including notifi-
cation of the Secretary of Agriculture and the 
Secretary of Education in the event such recalled 
food is a commodity intended for use in a child 
nutrition program (as identified in section 25(b) 
of the Richard B. Russell National School Lunch 
Act (42 U.S.C. 1769f(b)); and 
‘‘(E) conclude operations at such time as 
the Secretary determines appropriate. 
‘‘(3) MULTIPLE RECALLS.—The Secretary may 
establish multiple or concurrent incident command 
operations or similar operations in the event of mul-
tiple recalls or foodborne illness outbreaks necessi-
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† HR 2751 EAS 
tating such action by the Department of Health and 
Human Services.’’. 
(b) SEARCH ENGINE.—Not later than 90 days after 
the date of enactment of this Act, the Secretary shall modify 
the Internet Web site of the Food and Drug Administration 
to include a search engine that— 
(1) is consumer-friendly, as determined by the 
Secretary; and 
(2) provides a means by which an individual 
may locate relevant information regarding each arti-
cle of food subject to a recall under section 423 of the 
Federal Food, Drug, and Cosmetic Act and the status 
of such recall (such as whether a recall is ongoing or 
has been completed). 
(c) CIVIL PENALTY.—Section 303(f)(2)(A) (21 U.S.C. 
333(f)(2)(A)) is amended by inserting ‘‘or any person who 
does not comply with a recall order under section 423’’ after 
‘‘section 402(a)(2)(B)’’. 
(d) PROHIBITED ACTS.—Section 301 (21 U.S.C. 331 
et seq.), as amended by section 106, is amended by adding 
at the end the following: 
‘‘(xx) The refusal or failure to follow an order under 
section 423.’’. 
(e) GAO REVIEW.—
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† HR 2751 EAS 
(1) IN GENERAL.—Not later than 90 days after 
the date of enactment of this Act, the Comptroller 
General of the United States shall submit to Congress 
a report that— 
(A) identifies State and local agencies with 
the authority to require the mandatory recall of 
food, and evaluates use of such authority with re-
gard to frequency, effectiveness, and appropriate-
ness, including consideration of any new or ex-
isting mechanisms available to compensate per-
sons for general and specific recall-related costs 
when a recall is subsequently determined by the 
relevant authority to have been an error; 
(B) identifies Federal agencies, other than 
the Department of Health and Human Services, 
with mandatory recall authority and examines 
use of that authority with regard to frequency, 
effectiveness, and appropriateness, including any 
new or existing mechanisms available to com-
pensate persons for general and specific recall-re-
lated costs when a recall is subsequently deter-
mined by the relevant agency to have been an 
error;
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† HR 2751 EAS 
(C) considers models for farmer restitution 
implemented in other nations in cases of erro-
neous recalls; and 
(D) makes recommendations to the Sec-
retary regarding use of the authority under sec-
tion 423 of the Federal Food, Drug, and Cos-
metic Act (as added by this section) to protect 
the public health while seeking to minimize un-
necessary economic costs. 
(2) EFFECT
OF
REVIEW.—If the Comptroller 
General of the United States finds, after the review 
conducted under paragraph (1), that the mechanisms 
described in such paragraph do not exist or are inad-
equate, then, not later than 90 days after the conclu-
sion of such review, the Secretary of Agriculture shall 
conduct a study of the feasibility of implementing a 
farmer indemnification program to provide restitu-
tion to agricultural producers for losses sustained as 
a result of a mandatory recall of an agricultural com-
modity by a Federal or State regulatory agency that 
is subsequently determined to be in error. The Sec-
retary of Agriculture shall submit to the Committee 
on Agriculture of the House of Representatives and 
the Committee on Agriculture, Nutrition, and For-
157 
† HR 2751 EAS 
estry of the Senate a report that describes the results 
of the study, including any recommendations. 
(f) ANNUAL REPORT TO CONGRESS.— 
(1) IN GENERAL.—Not later than 2 years after 
the date of enactment of this Act and annually there-
after, the Secretary of Health and Human Services 
(referred to in this subsection as 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 on the use of recall authority under 
section 423 of the Federal Food, Drug, and Cosmetic 
Act (as added by subsection (a)) and any public 
health advisories issued by the Secretary that advise 
against the consumption of an article of food on the 
ground that the article of food is adulterated and 
poses an imminent danger to health. 
(2) CONTENT.—The report under paragraph (1) 
shall include, with respect to the report year— 
(A) the identity of each article of food that 
was the subject of a public health advisory de-
scribed in paragraph (1), an opportunity to 
cease distribution and recall under subsection (a) 
of section 423 of the Federal Food, Drug, and
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† HR 2751 EAS 
Cosmetic Act, or a mandatory recall order under 
subsection (b) of such section; 
(B) the number of responsible parties, as de-
fined in section 417 of the Federal Food, Drug, 
and Cosmetic Act, formally given the oppor-
tunity to cease distribution of an article of food 
and recall such article, as described in section 
423(a) of such Act; 
(C) the number of responsible parties de-
scribed in subparagraph (B) who did not cease 
distribution of or recall an article of food after 
given the opportunity to cease distribution or re-
call under section 423(a) of the Federal Food, 
Drug, and Cosmetic Act; 
(D) the number of recall orders issued under 
section 423(b) of the Federal Food, Drug, and 
Cosmetic Act; and 
(E) a description of any instances in which 
there was no testing that confirmed adulteration 
of an article of food that was the subject of a re-
call under section 423(b) of the Federal Food, 
Drug, and Cosmetic Act or a public health advi-
sory described in paragraph (1).
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† HR 2751 EAS 
SEC. 207. ADMINISTRATIVE DETENTION OF FOOD. 
(a) IN GENERAL.—Section 304(h)(1)(A) (21 U.S.C. 
334(h)(1)(A)) is amended by— 
(1) striking ‘‘credible evidence or information in-
dicating’’ and inserting ‘‘reason to believe’’; and 
(2) striking ‘‘presents a threat of serious adverse 
health consequences or death to humans or animals’’ 
and inserting ‘‘is adulterated or misbranded’’. 
(b) REGULATIONS.—Not later than 120 days after the 
date of enactment of this Act, the Secretary shall issue an 
interim final rule amending subpart K of part 1 of title 
21, Code of Federal Regulations, to implement the 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. 208. DECONTAMINATION AND DISPOSAL STANDARDS 
AND PLANS. 
(a) IN GENERAL.—The Administrator of the Environ-
mental Protection Agency (referred to in this section as the 
‘‘Administrator’’), in coordination with the Secretary of 
Health and Human Services, Secretary of Homeland Secu-
rity, and Secretary of Agriculture, shall provide support 
for, and technical assistance to, State, local, and tribal gov-
ernments in preparing for, assessing, decontaminating, and 
recovering from an agriculture or food emergency.
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† HR 2751 EAS 
(b) DEVELOPMENT OF STANDARDS.—In carrying out 
subsection (a), the Administrator, in coordination with the 
Secretary of Health and Human Services, Secretary of 
Homeland Security, Secretary of Agriculture, and State, 
local, and tribal governments, shall develop and disseminate 
specific standards and protocols to undertake clean-up, 
clearance, and recovery activities following the decon-
tamination and disposal of specific threat agents and for-
eign animal diseases. 
(c) DEVELOPMENT OF MODEL PLANS.—In carrying 
out subsection (a), the Administrator, the Secretary of 
Health and Human Services, and the Secretary of Agri-
culture shall jointly develop and disseminate model plans 
for— 
(1) the decontamination of individuals, equip-
ment, and facilities following an intentional contami-
nation of agriculture or food; and 
(2) the disposal of large quantities of animals, 
plants, or food products that have been infected or 
contaminated by specific threat agents and foreign 
animal diseases. 
(d) EXERCISES.—In carrying out subsection (a), the 
Administrator, in coordination with the entities described 
under subsection (b), shall conduct exercises at least annu-
ally to evaluate and identify weaknesses in the decon-
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† HR 2751 EAS 
tamination and disposal model plans described in sub-
section (c). Such exercises shall be carried out, to the max-
imum extent practicable, as part of the national exercise 
program under section 648(b)(1) of the Post-Katrina Emer-
gency Management Reform Act of 2006 (6 U.S.C. 
748(b)(1)). 
(e) MODIFICATIONS.—Based on the exercises described 
in subsection (d), the Administrator, in coordination with 
the entities described in subsection (b), shall review and 
modify as necessary the plans described in subsection (c) 
not less frequently than biennially. 
(f) PRIORITIZATION.—The Administrator, in coordi-
nation with the entities described in subsection (b), shall 
develop standards and plans under subsections (b) and (c) 
in an identified order of priority that takes into account— 
(1) highest-risk biological, chemical, and radio-
logical threat agents; 
(2) agents that could cause the greatest economic 
devastation to the agriculture and food system; and 
(3) agents that are most difficult to clean or re-
mediate.
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† HR 2751 EAS 
SEC. 209. IMPROVING THE TRAINING OF STATE, LOCAL, 
TERRITORIAL, AND TRIBAL FOOD SAFETY OF-
FICIALS. 
(a) IMPROVING TRAINING.—Chapter X (21 U.S.C. 391 
et seq.) is amended by adding at the end the following: 
‘‘SEC. 1011. IMPROVING THE TRAINING OF STATE, LOCAL, 
TERRITORIAL, AND TRIBAL FOOD SAFETY OF-
FICIALS. 
‘‘(a) TRAINING.—The Secretary shall set standards 
and administer training and education programs for the 
employees of State, local, territorial, and tribal food safety 
officials relating to the regulatory responsibilities and poli-
cies established by this Act, including programs for— 
‘‘(1) scientific training; 
‘‘(2) training to improve the skill of officers and 
employees authorized to conduct inspections under 
sections 702 and 704; 
‘‘(3) training to achieve advanced product or 
process specialization in such inspections; 
‘‘(4) training that addresses best practices; 
‘‘(5) training in administrative process and pro-
cedure and integrity issues; 
‘‘(6) training in appropriate sampling and lab-
oratory analysis methodology; and
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† HR 2751 EAS 
‘‘(7) training in building enforcement actions 
following inspections, examinations, testing, and in-
vestigations. 
‘‘(b) PARTNERSHIPS WITH STATE AND LOCAL OFFI-
CIALS.— 
‘‘(1) IN GENERAL.—The Secretary, pursuant to a 
contract or memorandum of understanding between 
the Secretary and the head of a State, local, terri-
torial, or tribal department or agency, is authorized 
and encouraged to conduct examinations, testing, and 
investigations for the purposes of determining compli-
ance with the food safety provisions of this Act 
through the officers and employees of such State, local, 
territorial, or tribal department or agency. 
‘‘(2) CONTENT.—A contract or memorandum de-
scribed under paragraph (1) shall include provisions 
to ensure adequate training of such officers and em-
ployees to conduct such examinations, testing, and in-
vestigations. The contract or memorandum shall con-
tain provisions regarding reimbursement. Such provi-
sions may, at the sole discretion of the head of the 
other department or agency, require reimbursement, 
in whole or in part, from the Secretary for the exami-
nations, testing, or investigations performed pursuant
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† HR 2751 EAS 
to this section by the officers or employees of the 
State, territorial, or tribal department or agency. 
‘‘(3) EFFECT.—Nothing in this subsection shall 
be construed to limit the authority of the Secretary 
under section 702. 
‘‘(c) EXTENSION SERVICE.—The Secretary shall ensure 
coordination with the extension activities of the National 
Institute of Food and Agriculture of the Department of Ag-
riculture in advising producers and small processors 
transitioning into new practices required as a result of the 
enactment of the FDA Food Safety Modernization Act and 
assisting regulated industry with compliance with such Act. 
‘‘(d) NATIONAL FOOD SAFETY TRAINING, EDUCATION, 
EXTENSION, OUTREACH AND TECHNICAL ASSISTANCE PRO-
GRAM.— 
‘‘(1) IN
GENERAL.—In order to improve food 
safety and reduce the incidence of foodborne illness, 
the Secretary shall, not later than 180 days after the 
date of enactment of the FDA Food Safety Moderniza-
tion Act, enter into one or more memoranda of under-
standing, or enter into other cooperative agreements, 
with the Secretary of Agriculture to establish a com-
petitive grant program within the National Institute 
for Food and Agriculture to provide food safety train-
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† HR 2751 EAS 
ing, education, extension, outreach, and technical as-
sistance to— 
‘‘(A) owners and operators of farms; 
‘‘(B) small food processors; and 
‘‘(C) small fruit and vegetable merchant 
wholesalers. 
‘‘(2) IMPLEMENTATION.—The competitive grant 
program established under paragraph (1) shall be 
carried out in accordance with section 405 of the Ag-
ricultural Research, Extension, and Education Re-
form Act of 1998. 
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There are 
authorized to be appropriated such sums as may be nec-
essary to carry out this section for fiscal years 2011 through 
2015.’’. 
(b) NATIONAL FOOD SAFETY TRAINING, EDUCATION, 
EXTENSION, OUTREACH, AND
TECHNICAL
ASSISTANCE 
PROGRAM.—Title IV of the Agricultural Research, Exten-
sion, and Education Reform Act of 1998 is amended by 
inserting after section 404 (7 U.S.C. 7624) the following: 
‘‘SEC. 405. NATIONAL FOOD SAFETY TRAINING, EDUCATION, 
EXTENSION, OUTREACH, AND TECHNICAL AS-
SISTANCE PROGRAM. 
‘‘(a) IN GENERAL.—The Secretary shall award grants 
under this section to carry out the competitive grant pro-
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† HR 2751 EAS 
gram established under section 1011(d) of the Federal Food, 
Drug, and Cosmetic Act, pursuant to any memoranda of 
understanding entered into under such section. 
‘‘(b) INTEGRATED APPROACH.—The grant program 
described under subsection (a) shall be carried out under 
this section in a manner that facilitates the integration of 
food safety standards and guidance with the variety of agri-
cultural production systems, encompassing conventional, 
sustainable, organic, and conservation and environmental 
practices. 
‘‘(c) PRIORITY.—In awarding grants under this sec-
tion, the Secretary shall give priority to projects that target 
small and medium-sized farms, beginning farmers, socially 
disadvantaged farmers, small processors, or small fresh 
fruit and vegetable merchant wholesalers. 
‘‘(d) PROGRAM COORDINATION.— 
‘‘(1) IN GENERAL.—The Secretary shall coordi-
nate implementation of the grant program under this 
section with the National Integrated Food Safety Ini-
tiative. 
‘‘(2) INTERACTION.—The Secretary shall— 
‘‘(A) in carrying out the grant program 
under this section, take into consideration ap-
plied research, education, and extension results
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† HR 2751 EAS 
obtained from the National Integrated Food 
Safety Initiative; and 
‘‘(B) in determining the applied research 
agenda for the National Integrated Food Safety 
Initiative, take into consideration the needs ar-
ticulated by participants in projects funded by 
the program under this section. 
‘‘(e) GRANTS.— 
‘‘(1) IN GENERAL.—In carrying out this section, 
the Secretary shall make competitive grants to sup-
port training, education, extension, outreach, and 
technical assistance projects that will help improve 
public health by increasing the understanding and 
adoption of established food safety standards, guid-
ance, and protocols. 
‘‘(2) ENCOURAGED
FEATURES.—The Secretary 
shall encourage projects carried out using grant funds 
under this section to include co-management of food 
safety, conservation systems, and ecological health. 
‘‘(3) MAXIMUM TERM AND SIZE OF GRANT.— 
‘‘(A) IN GENERAL.—A grant under this sec-
tion shall have a term that is not more than 3 
years. 
‘‘(B) LIMITATION ON GRANT FUNDING.—The 
Secretary may not provide grant funding to an
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† HR 2751 EAS 
entity under this section after such entity has re-
ceived 3 years of grant funding under this sec-
tion. 
‘‘(f) GRANT ELIGIBILITY.— 
‘‘(1) IN GENERAL.—To be eligible for a grant 
under this section, an entity shall be— 
‘‘(A) a State cooperative extension service; 
‘‘(B) a Federal, State, local, or tribal agen-
cy, a nonprofit community-based or non-govern-
mental organization, or an organization rep-
resenting owners and operators of farms, small 
food processors, or small fruit and vegetable mer-
chant wholesalers that has a commitment to pub-
lic health and expertise in administering pro-
grams that contribute to food safety; 
‘‘(C) an institution of higher education (as 
defined in section 101(a) of the Higher Edu-
cation Act of 1965 (20 U.S.C. 1001(a))) or a 
foundation maintained by an institution of 
higher education; 
‘‘(D) a collaboration of 2 of more eligible 
entities described in this subsection; or 
‘‘(E) such other appropriate entity, as de-
termined by the Secretary.
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† HR 2751 EAS 
‘‘(2) 
MULTISTATE
PARTNERSHIPS.—Grants 
under this section may be made for projects involving 
more than 1 State. 
‘‘(g) REGIONAL BALANCE.—In making grants under 
this section, the Secretary shall, to the maximum extent 
practicable, ensure— 
‘‘(1) geographic diversity; and 
‘‘(2) diversity of types of agricultural produc-
tion. 
‘‘(h) TECHNICAL ASSISTANCE.—The Secretary may 
use funds made available under this section to provide tech-
nical assistance to grant recipients to further the purposes 
of this section. 
‘‘(i) BEST PRACTICES
AND MODEL PROGRAMS.— 
Based on evaluations of, and responses arising from, 
projects funded under this section, the Secretary may issue 
a set of recommended best practices and models for food 
safety training programs for agricultural producers, small 
food processors, and small fresh fruit and vegetable mer-
chant wholesalers. 
‘‘(j) AUTHORIZATION OF APPROPRIATIONS.—For the 
purposes of making grants under this section, there are au-
thorized to be appropriated such sums as may be necessary 
for fiscal years 2011 through 2015.’’.
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† HR 2751 EAS 
‘‘(A) a notification under section 1008, in-
cluding planning and otherwise preparing to 
take such action; or 
‘‘(B) a recall of food under this Act. 
‘‘(b) ELIGIBLE ENTITIES; APPLICATION.— 
‘‘(1) IN GENERAL.—In this section, the term ‘eli-
gible entity’ means an entity— 
‘‘(A) that is— 
‘‘(i) a State; 
‘‘(ii) a locality; 
‘‘(iii) a territory; 
‘‘(iv) an Indian tribe (as defined in 
section 4(e) of the Indian Self-Determina-
tion and Education Assistance Act); or 
‘‘(v) a nonprofit food safety training 
entity that collaborates with 1 or more in-
stitutions of higher education; and 
‘‘(B) that submits an application to the 
Secretary at such time, in such manner, and in-
cluding such information as the Secretary may 
reasonably require. 
‘‘(2) CONTENTS.—Each application submitted 
under paragraph (1) shall include—
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† HR 2751 EAS 
‘‘(A) an assurance that the eligible entity 
has developed plans to engage in the types of ac-
tivities described in subsection (a); 
‘‘(B) a description of the types of activities 
to be funded by the grant; 
‘‘(C) an itemization of how grant funds re-
ceived under this section will be expended; 
‘‘(D) a description of how grant activities 
will be monitored; and 
‘‘(E) an agreement by the eligible entity to 
report information required by the Secretary to 
conduct evaluations under this section. 
‘‘(c) LIMITATIONS.—The funds provided under sub-
section (a) shall be available to an eligible entity that re-
ceives a grant under this section only to the extent such 
entity funds the food safety programs of such entity inde-
pendently of any grant under this section in each year of 
the grant at a level equal to the level of such funding in 
the previous year, increased by the Consumer Price Index. 
Such non-Federal matching funds may be provided directly 
or through donations from public or private entities and 
may be in cash or in-kind, fairly evaluated, including 
plant, equipment, or services. 
‘‘(d) ADDITIONAL AUTHORITY.—The Secretary may—
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† HR 2751 EAS 
‘‘(1) award a grant under this section in each 
subsequent fiscal year without reapplication for a pe-
riod of not more than 3 years, provided the require-
ments of subsection (c) are met for the previous fiscal 
year; and 
‘‘(2) award a grant under this section in a fiscal 
year for which the requirement of subsection (c) has 
not been met only if such requirement was not met 
because such funding was diverted for response to 1 
or more natural disasters or in other extenuating cir-
cumstances that the Secretary may determine appro-
priate. 
‘‘(e) DURATION
OF AWARDS.—The Secretary may 
award grants to an individual grant recipient under this 
section for periods of not more than 3 years. In the event 
the Secretary conducts a program evaluation, funding in 
the second year or third year of the grant, where applicable, 
shall be contingent on a successful program evaluation by 
the Secretary after the first year. 
‘‘(f) PROGRESS AND EVALUATION.— 
‘‘(1) IN GENERAL.—The Secretary shall measure 
the status and success of each grant program author-
ized under the FDA Food Safety Modernization Act 
(and any amendment made by such Act), including 
the grant program under this section. A recipient of
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a grant described in the preceding sentence shall, at 
the end of each grant year, provide the Secretary with 
information on how grant funds were spent and the 
status of the efforts by such recipient to enhance food 
safety. To the extent practicable, the Secretary shall 
take the performance of such a grant recipient into 
account when determining whether to continue fund-
ing for such recipient. 
‘‘(2) NO DUPLICATION.—In carrying out para-
graph (1), the Secretary shall not duplicate the efforts 
of the Secretary under other provisions of this Act or 
the FDA Food Safety Modernization Act that require 
measurement and review of the activities of grant re-
cipients under either such Act. 
‘‘(g) SUPPLEMENT NOT SUPPLANT.—Grant funds re-
ceived under this section shall be used to supplement, and 
not supplant, non-Federal funds and any other Federal 
funds available to carry out the activities described in this 
section. 
‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—For the 
purpose of making grants under this section, there are au-
thorized to be appropriated such sums as may be necessary 
for fiscal years 2011 through 2015.’’.
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(b) CENTERS OF EXCELLENCE.—Part P of the Public 
Health Service Act (42 U.S.C. 280g et seq.) is amended by 
adding at the end the following: 
‘‘SEC. 399V–5. FOOD SAFETY INTEGRATED CENTERS OF EX-
CELLENCE. 
‘‘(a) IN GENERAL.—Not later than 1 year after the 
date of enactment of the FDA Food Safety Modernization 
Act, the Secretary, acting through the Director of the Cen-
ters for Disease Control and Prevention and in consultation 
with the working group described in subsection (b)(2), shall 
designate 5 Integrated Food Safety Centers of Excellence 
(referred to in this section as the ‘Centers of Excellence’) 
to serve as resources for Federal, State, and local public 
health professionals to respond to foodborne illness out-
breaks. The Centers of Excellence shall be headquartered at 
selected State health departments. 
‘‘(b) SELECTION OF CENTERS OF EXCELLENCE.— 
‘‘(1) ELIGIBLE ENTITIES.—To be eligible to be 
designated as a Center of Excellence under subsection 
(a), an entity shall— 
‘‘(A) be a State health department; 
‘‘(B) partner with 1 or more institutions of 
higher education that have demonstrated knowl-
edge, expertise, and meaningful experience with 
regional or national food production, processing,
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and distribution, as well as leadership in the 
laboratory, epidemiological, and environmental 
detection and investigation of foodborne illness; 
and 
‘‘(C) provide to the Secretary such informa-
tion, at such time, and in such manner, as the 
Secretary may require. 
‘‘(2) WORKING GROUP.—Not later than 180 days 
after the date of enactment of the FDA Food Safety 
Modernization Act, the Secretary shall establish a di-
verse working group of experts and stakeholders from 
Federal, State, and local food safety and health agen-
cies, the food industry, including food retailers and 
food manufacturers, consumer organizations, and aca-
demia to make recommendations to the Secretary re-
garding designations of the Centers of Excellence. 
‘‘(3) ADDITIONAL CENTERS OF EXCELLENCE.— 
The Secretary may designate eligible entities to be re-
gional Food Safety Centers of Excellence, in addition 
to the 5 Centers designated under subsection (a). 
‘‘(c) ACTIVITIES.—Under the leadership of the Director 
of the Centers for Disease Control and Prevention, each Cen-
ter of Excellence shall be based out of a selected State health 
department, which shall provide assistance to other re-
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gional, State, and local departments of health through ac-
tivities that include— 
‘‘(1) providing resources, including timely infor-
mation concerning symptoms and tests, for frontline 
health professionals interviewing individuals as part 
of routine surveillance and outbreak investigations; 
‘‘(2) providing analysis of the timeliness and ef-
fectiveness of foodborne disease surveillance and out-
break response activities; 
‘‘(3) providing training for epidemiological and 
environmental investigation of foodborne illness, in-
cluding suggestions for streamlining and standard-
izing the investigation process; 
‘‘(4) establishing fellowships, stipends, and schol-
arships to train future epidemiological and food-safe-
ty leaders and to address critical workforce shortages; 
‘‘(5) training and coordinating State and local 
personnel; 
‘‘(6) strengthening capacity to participate in ex-
isting or new foodborne illness surveillance and envi-
ronmental assessment information systems; and 
‘‘(7) conducting research and outreach activities 
focused on increasing prevention, communication, 
and education regarding food safety.
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‘‘(d) REPORT TO CONGRESS.—Not later than 2 years 
after the date of enactment of the FDA Food Safety Mod-
ernization Act, the Secretary shall submit to Congress a re-
port that— 
‘‘(1) describes the effectiveness of the Centers of 
Excellence; and 
‘‘(2) provides legislative recommendations or de-
scribes additional resources required by the Centers of 
Excellence. 
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There is 
authorized to be appropriated such sums as may be nec-
essary to carry out this section. 
‘‘(f) NO DUPLICATION OF EFFORT.—In carrying out 
activities of the Centers of Excellence or other programs 
under this section, the Secretary shall not duplicate other 
Federal foodborne illness response efforts.’’. 
SEC. 211. IMPROVING THE REPORTABLE FOOD REGISTRY. 
(a) IN GENERAL.—Section 417 (21 U.S.C. 350f) is 
amended— 
(1) by redesignating subsections (f) through (k) 
as subsections (i) through (n), respectively; and 
(2) by inserting after subsection (e) the following: 
‘‘(f) CRITICAL INFORMATION.—Except with respect to 
fruits and vegetables that are raw agricultural commodities, 
not more than 18 months after the date of enactment of
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the FDA Food Safety Modernization Act, the Secretary may 
require a responsible party to submit to the Secretary con-
sumer-oriented information regarding a reportable food, 
which shall include— 
‘‘(1) a description of the article of food as pro-
vided in subsection (e)(3); 
‘‘(2) as provided in subsection (e)(7), affected 
product identification codes, such as UPC, SKU, or 
lot or batch numbers sufficient for the consumer to 
identify the article of food; 
‘‘(3) contact information for the responsible 
party as provided in subsection (e)(8); and 
‘‘(4) any other information the Secretary deter-
mines is necessary to enable a consumer to accurately 
identify whether such consumer is in possession of the 
reportable food. 
‘‘(g) GROCERY STORE NOTIFICATION.— 
‘‘(1) ACTION
BY
SECRETARY.—The Secretary 
shall— 
‘‘(A) prepare the critical information de-
scribed under subsection (f) for a reportable food 
as a standardized one-page summary; 
‘‘(B) publish such one-page summary on the 
Internet website of the Food and Drug Adminis-
tration in a format that can be easily printed by
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a grocery store for purposes of consumer notifica-
tion. 
‘‘(2) ACTION BY GROCERY STORE.—A notifica-
tion described under paragraph (1)(B) shall include 
the date and time such summary was posted on the 
Internet website of the Food and Drug Administra-
tion. 
‘‘(h) CONSUMER NOTIFICATION.— 
‘‘(1) IN GENERAL.—If a grocery store sold a re-
portable food that is the subject of the posting and 
such establishment is part of chain of establishments 
with 15 or more physical locations, then such estab-
lishment shall, not later than 24 hours after a one 
page summary described in subsection (g) is pub-
lished, prominently display such summary or the in-
formation from such summary via at least one of the 
methods identified under paragraph (2) and main-
tain the display for 14 days. 
‘‘(2) LIST
OF
CONSPICUOUS
LOCATIONS.—Not 
more than 1 year after the date of enactment of the 
FDA Food Safety Modernization Act, the Secretary 
shall develop and publish a list of acceptable con-
spicuous locations and manners, from which grocery 
stores shall select at least one, for providing the notifi-
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cation required in paragraph (1). Such list shall in-
clude— 
‘‘(A) posting the notification at or near the 
register; 
‘‘(B) providing the location of the reportable 
food; 
‘‘(C) providing targeted recall information 
given to customers upon purchase of a food; and 
‘‘(D) other such prominent and conspicuous 
locations and manners utilized by grocery stores 
as of the date of the enactment of the FDA Food 
Safety Modernization Act to provide notice of 
such recalls to consumers as considered appro-
priate by the Secretary.’’. 
(b) PROHIBITED ACT.—Section 301 (21 U.S.C. 331), 
as amended by section 206, is amended by adding at the 
end the following: 
‘‘(yy) The knowing and willful failure to comply with 
the notification requirement under section 417(h).’’. 
(c) CONFORMING AMENDMENT.—Section 301(e) (21 
U.S.C. 331(e)) is amended by striking ‘‘417(g)’’ and insert-
ing ‘‘417(j)’’.
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TITLE III—IMPROVING THE 
SAFETY OF IMPORTED FOOD 
SEC. 301. FOREIGN SUPPLIER VERIFICATION PROGRAM. 
(a) IN GENERAL.—Chapter VIII (21 U.S.C. 381 et 
seq.) is amended by adding at the end the following: 
‘‘SEC. 805. FOREIGN SUPPLIER VERIFICATION PROGRAM. 
‘‘(a) IN GENERAL.— 
‘‘(1) VERIFICATION
REQUIREMENT.—Except as 
provided under subsections (e) and (f), each importer 
shall perform risk-based foreign supplier verification 
activities for the purpose of verifying that the food 
imported by the importer or agent of an importer 
is— 
‘‘(A) produced in compliance with the re-
quirements of section 418 or section 419, as ap-
propriate; and 
‘‘(B) is not adulterated under section 402 or 
misbranded under section 403(w). 
‘‘(2) IMPORTER DEFINED.—For purposes of this 
section, the term ‘importer’ means, with respect to an 
article of food— 
‘‘(A) the United States owner or consignee 
of the article of food at the time of entry of such 
article into the United States; or
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ventive controls, that provide the same level 
of public health protection as those required 
under section 418 or section 419 (taking 
into consideration variances granted under 
section 419), as appropriate; and 
‘‘(ii) section 402 and section 403(w). 
‘‘(B) shall include such other requirements 
as the Secretary deems necessary and appro-
priate to verify that food imported into the 
United States is as safe as food produced and 
sold within the United States. 
‘‘(3) CONSIDERATIONS.—In promulgating regu-
lations under this subsection, the Secretary shall, as 
appropriate, take into account differences among im-
porters and types of imported foods, including based 
on the level of risk posed by the imported food. 
‘‘(4) ACTIVITIES.—Verification activities under a 
foreign supplier verification program under this sec-
tion may include monitoring records for shipments, 
lot-by-lot certification of compliance, annual on-site 
inspections, checking the hazard analysis and risk- 
based preventive control plan of the foreign supplier, 
and periodically testing and sampling shipments. 
‘‘(d) RECORD MAINTENANCE AND ACCESS.—Records of 
an importer related to a foreign supplier verification pro-
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gram shall be maintained for a period of not less than 2 
years and shall be made available promptly to a duly au-
thorized representative of the Secretary upon request. 
‘‘(e) EXEMPTION OF SEAFOOD, JUICE, AND LOW-ACID 
CANNED
FOOD
FACILITIES
IN
COMPLIANCE
WITH 
HACCP.—This section shall not apply to a facility if the 
owner, operator, or agent in charge of such facility is re-
quired to comply with, and is in compliance with, 1 of the 
following standards and regulations with respect to such fa-
cility: 
‘‘(1) The Seafood Hazard Analysis Critical Con-
trol Points Program of the Food and Drug Adminis-
tration. 
‘‘(2) The Juice Hazard Analysis Critical Control 
Points Program of the Food and Drug Administra-
tion. 
‘‘(3) The Thermally Processed Low-Acid Foods 
Packaged in Hermetically Sealed Containers stand-
ards of the Food and Drug Administration (or any 
successor standards). 
The exemption under paragraph (3) shall apply only with 
respect to microbiological hazards that are regulated under 
the standards for Thermally Processed Low-Acid Foods 
Packaged in Hermetically Sealed Containers under part
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113 of chapter 21, Code of Federal Regulations (or any suc-
cessor regulations). 
‘‘(f) ADDITIONAL EXEMPTIONS.—The Secretary, by no-
tice published in the Federal Register, shall establish an ex-
emption from the requirements of this section for articles 
of food imported in small quantities for research and eval-
uation purposes or for personal consumption, provided that 
such foods are not intended for retail sale and are not sold 
or distributed to the public. 
‘‘(g) PUBLICATION OF LIST OF PARTICIPANTS.—The 
Secretary shall publish and maintain on the Internet Web 
site of the Food and Drug Administration a current list 
that includes the name of, location of, and other 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 211, is amended by adding at the 
end the following: 
‘‘(zz) The importation or offering for importation of 
a food if the importer (as defined in section 805) does not 
have in place a foreign supplier verification program in 
compliance with such section 805.’’. 
(c) IMPORTS.—Section 801(a) (21 U.S.C. 381(a)) is 
amended by adding ‘‘or the importer (as defined in section
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† HR 2751 EAS 
805) is in violation of such section 805’’ after ‘‘or in viola-
tion of section 505’’. 
(d) EFFECTIVE DATE.—The amendments made by this 
section shall take effect 2 years after the date of enactment 
of this Act. 
SEC. 302. VOLUNTARY QUALIFIED IMPORTER PROGRAM. 
Chapter VIII (21 U.S.C. 381 et seq.), as amended by 
section 301, is amended by adding at the end the following: 
‘‘SEC. 806. VOLUNTARY QUALIFIED IMPORTER PROGRAM. 
‘‘(a) IN GENERAL.—Beginning not later than 18 
months after the date of enactment of the FDA Food Safety 
Modernization Act, the Secretary shall— 
‘‘(1) establish a program, in consultation with 
the Secretary of Homeland Security— 
‘‘(A) to provide for the expedited review and 
importation of food offered for importation by 
importers who have voluntarily agreed to par-
ticipate in such program; and 
‘‘(B) consistent with section 808, establish a 
process for the issuance of a facility certification 
to accompany food offered for importation by 
importers who have voluntarily agreed to par-
ticipate in such program; and
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‘‘(2) issue a guidance document related to par-
ticipation in, revocation of such participation in, re-
instatement in, and compliance with, such program. 
‘‘(b) VOLUNTARY PARTICIPATION.—An importer may 
request the Secretary to provide for the expedited review 
and importation of designated foods in accordance with the 
program established by the Secretary under subsection (a). 
‘‘(c) NOTICE OF INTENT TO PARTICIPATE.—An im-
porter that intends to participate in the program under this 
section in a fiscal year shall submit a notice and applica-
tion to the Secretary of such intent at the time and in a 
manner established by the Secretary. 
‘‘(d) ELIGIBILITY.—Eligibility shall be limited to an 
importer offering food for importation from a facility that 
has a certification described in subsection (a). In reviewing 
the applications and making determinations on such appli-
cations, the Secretary shall consider the risk of the food to 
be imported based on factors, such as the following: 
‘‘(1) The known safety risks of the food to be im-
ported. 
‘‘(2) The compliance history of foreign suppliers 
used by the importer, as appropriate. 
‘‘(3) The capability of the regulatory system of 
the country of export to ensure compliance with
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United States food safety standards for a designated 
food. 
‘‘(4) The compliance of the importer with the re-
quirements 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. 
‘‘(e) REVIEW AND REVOCATION.—Any importer quali-
fied by the Secretary in accordance with the eligibility cri-
teria 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. 
‘‘(f) FALSE STATEMENTS.—Any statement or represen-
tation made by an importer to the Secretary shall be subject 
to section 1001 of title 18, United States Code. 
‘‘(g) DEFINITION.—For purposes of this section, the 
term ‘importer’ means the person that brings food, or causes 
food to be brought, from a foreign country into the customs 
territory of the United States.’’.