303 
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 
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-
304 
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 
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;
305 
(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; 
(I) include a process by which the Secretary 
may issue a waiver of the requirements under 
this subsection if the Secretary determines that 
such requirements would result in an economic 
hardship for an individual facility or a type of 
facility; 
(J) be commensurate with the known safety 
risks of the designated food; 
(K) take into account international trade 
obligations; 
(L) not require—
306 
(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— 
(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
307 
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 
(vi) the likely or known severity, in-
cluding health and economic impacts, of a 
foodborne illness attributed to a particular 
food.
308 
(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 
risk assessment and planning to prevent unauthorized 
release and controls to— 
(A) prevent unauthorized reproduction of 
trade secret or confidential information;
309 
(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, 
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
310 
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-
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.
311 
(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 
commodity that is combined or mixed 
after harvesting, but before processing; 
(II) the term ‘‘commingled raw 
agricultural commodity’’ shall not in-
312 
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 
6105) 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-
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
313 
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 
farm that was the source of such food. The Sec-
retary shall not require that such records be kept 
for more than 180 days.
314 
(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-
part J of part 1 of title 21, Code of Federal Regula-
tions (or any successor regulations). 
(e) EVALUATION AND RECOMMENDATIONS.—
315 
(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 
health, the Comptroller General shall submit to Con-
gress recommendations, if appropriate, regarding rec-
316 
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 
in section 1.227 of chapter 21, Code of Federal 
Regulations (or any successor regulation)).
317 
(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 nonelectronic 
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 
from the farm to which the article of food has been 
traced, other than information necessary to identify
318 
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 
complying with the recordkeeping requirements under such 
subsection.
319 
(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 6103, not later than 90 days after 
the date of enactment of this Act) beginning on the 
date that is 1 year after the effective date of the final 
regulations promulgated under subsection (d); and 
(2) to very small businesses (as defined by the 
Secretary in section 6103, 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 
6204 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 6204 of the FDA 
Food Safety Modernization Act (other than the re-
quirements under subsection (f) of such section) have
320 
not been complied with regarding such article,’’ in the 
third sentence before ‘‘then such article shall be re-
fused admission’’. 
SEC. 6205. 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 
Administration, the Department of Agriculture,
321 
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; 
(I) integrating foodborne illness surveillance 
systems and data with other biosurveillance and
322 
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; 
(B) opportunities to improve the effective-
ness of initiatives at the Federal, State, and
323 
local levels, including coordination and integra-
tion of activities among Federal agencies, and 
among the Federal, State, and local levels of gov-
ernment; 
(C) improvement in the timeliness and 
depth of access by regulatory and health agen-
cies, the food industry, academic researchers, and 
consumers to foodborne illness aggregated, de- 
identified surveillance data collected by govern-
ment agencies at all levels, including data com-
piled by the Centers for Disease Control and Pre-
vention; 
(D) key barriers at Federal, State, and local 
levels to improving foodborne illness surveillance 
and the utility of such surveillance for pre-
venting foodborne illness; 
(E) the capabilities needed for establishing 
automatic electronic searches of surveillance 
data; and 
(F) specific actions to reduce barriers to im-
provement, implement the working group’s rec-
ommendations, and achieve the purposes of this 
section, with measurable objectives and timelines, 
and identification of resource and staffing needs.
324 
(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 
safety and defense resources and reduce the inci-
dence of foodborne illness.
325 
(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 6108. 
(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-
cies and with counterparts at the Federal level; 
and
326 
(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. 6206. MANDATORY RECALL AUTHORITY. 
(a) IN GENERAL.—Chapter IV (21 U.S.C. 341 et seq.), 
as amended by section 6202, 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-
retary shall provide the responsible party (as defined in sec-
327 
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 
(1)(B) has been distributed to a warehouse-based
328 
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 re-
quirements of this Act, including the re-
quirements 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
329 
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.
330 
‘‘(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—
331 
‘‘(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 paragraph (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
332 
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 foodborne 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;
333 
‘‘(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-
334 
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 6106, is amended by adding 
at the end the following: 
‘‘(xx) The refusal or failure to follow an order under 
section 423.’’. 
(e) GAO REVIEW.—
335 
(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;
336 
(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-
337 
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
338 
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).
339 
SEC. 6207. 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. 6208. 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.
340 
(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-
341 
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.
342 
SEC. 6209. 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. 1012. 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
343 
‘‘(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
344 
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 
PROGRAM.— 
‘‘(1) IN
GENERAL.—In order to improve food 
safety and reduce the incidence of foodborne illness, 
the Secretary shall, not later than 180 days after the 
date of enactment of the FDA Food Safety 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-
345 
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-
346 
gram established under section 1012(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, conservation, and environmental prac-
tices. 
‘‘(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
347 
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
348 
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 nongovern-
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 or more eligible 
entities described in this subsection; or 
‘‘(E) such other appropriate entity, as de-
termined by the Secretary.
349 
‘‘(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.’’.
350 
SEC. 6210. ENHANCING FOOD SAFETY. 
(a) GRANTS TO ENHANCE FOOD SAFETY.—Section 
1009 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 399) is amended to read as follows: 
‘‘SEC. 1009. GRANTS TO ENHANCE FOOD SAFETY. 
‘‘(a) IN GENERAL.—The Secretary is authorized to 
make grants to eligible entities to— 
‘‘(1) undertake examinations, inspections, inves-
tigations, and related food safety activities under sec-
tion 702; 
‘‘(2) train to the standards of the Secretary for 
the examination, inspection, and investigation of food 
manufacturing, processing, packing, holding, dis-
tribution, and importation, including as such exam-
ination, inspection, and investigation relate to retail 
food establishments; 
‘‘(3) build the food safety capacity of the labora-
tories of such eligible entity, including the detection 
of zoonotic diseases; 
‘‘(4) build the infrastructure and capacity of the 
food safety programs of such eligible entity to meet 
the standards as outlined in the grant application; 
and 
‘‘(5) take appropriate action to protect the public 
health in response to—
351 
‘‘(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—
352 
‘‘(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—
353 
‘‘(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
354 
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.’’.
355 
(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,
356 
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-
357 
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.
358 
‘‘(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. 6211. 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
359 
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
360 
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-
361 
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 6206, 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)’’.
362 
TITLE III—IMPROVING THE 
SAFETY OF IMPORTED FOOD 
SEC. 6301. 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
363 
‘‘(B) in the case when there is no United 
States owner or consignee as described in sub-
paragraph (A), the United States agent or rep-
resentative of a foreign owner or consignee of the 
article of food at the time of entry of such article 
into the United States. 
‘‘(b) GUIDANCE.—Not later than 1 year after the date 
of enactment of the FDA Food Safety Modernization Act, 
the Secretary shall issue guidance to assist importers in de-
veloping foreign supplier verification programs. 
‘‘(c) REGULATIONS.— 
‘‘(1) IN GENERAL.—Not later than 1 year after 
the date of enactment of the FDA Food Safety Mod-
ernization Act, the Secretary shall promulgate regula-
tions to provide for the content of the foreign supplier 
verification program established under subsection (a). 
‘‘(2) REQUIREMENTS.—The regulations promul-
gated under paragraph (1)— 
‘‘(A) shall require that the foreign supplier 
verification program of each importer be ade-
quate to provide assurances that each foreign 
supplier to the importer produces the imported 
food in compliance with— 
‘‘(i) processes and procedures, includ-
ing reasonably appropriate risk-based pre-
364 
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-
365 
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
366 
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 6211, 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
367 
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. 6302. VOLUNTARY QUALIFIED IMPORTER PROGRAM. 
Chapter VIII (21 U.S.C. 381 et seq.), as amended by 
section 6301, 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
368 
‘‘(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
369 
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.’’.
370 
SEC. 6303. AUTHORITY TO REQUIRE IMPORT CERTIFI-
CATIONS FOR FOOD. 
(a) IN GENERAL.—Section 801(a) (21 U.S.C. 381(a)) 
is amended by inserting after the third sentence the fol-
lowing: ‘‘With respect to an article of food, if importation 
of such food is subject to, but not compliant with, the re-
quirement under subsection (q) that such food be accom-
panied by a certification or other assurance that the food 
meets applicable requirements of this Act, then such article 
shall be refused admission.’’. 
(b) ADDITION OF CERTIFICATION REQUIREMENT.— 
Section 801 (21 U.S.C. 381) is amended by adding at the 
end the following new subsection: 
‘‘(q) 
CERTIFICATIONS
CONCERNING
IMPORTED 
FOODS.— 
‘‘(1) IN GENERAL.—The Secretary may require, 
as a condition of granting admission to an article of 
food imported or offered for import into the United 
States, that an entity described in paragraph (3) pro-
vide a certification, or such other assurances as the 
Secretary determines appropriate, that the article of 
food complies with applicable requirements of this 
Act. Such certification or assurances may be provided 
in the form of shipment-specific certificates, a listing 
of certified facilities that manufacture, process, pack,
371 
or hold such food, or in such other form as the Sec-
retary may specify. 
‘‘(2) FACTORS TO BE CONSIDERED IN REQUIRING 
CERTIFICATION.—The Secretary shall base the deter-
mination that an article of food is required to have 
a certification described in paragraph (1) on the risk 
of the food, including— 
‘‘(A) known safety risks associated with the 
food; 
‘‘(B) known food safety risks associated 
with the country, territory, or region of origin of 
the food; 
‘‘(C) a finding by the Secretary, supported 
by scientific, risk-based evidence, that— 
‘‘(i) the food safety programs, systems, 
and standards in the country, territory, or 
region of origin of the food are inadequate 
to ensure that the article of food is as safe 
as a similar article of food that is manufac-
tured, processed, packed, or held in the 
United States in accordance with the re-
quirements of this Act; and 
‘‘(ii) the certification would assist the 
Secretary in determining whether to refuse
372 
or admit the article of food under subsection 
(a); and 
‘‘(D) information submitted to the Secretary 
in accordance with the process established in 
paragraph (7). 
‘‘(3) CERTIFYING
ENTITIES.—For purposes of 
paragraph (1), entities that shall provide the certifi-
cation or assurances described in such paragraph 
are— 
‘‘(A) an agency or a representative of the 
government of the country from which the article 
of food at issue originated, as designated by the 
Secretary; or 
‘‘(B) such other persons or entities accred-
ited pursuant to section 808 to provide such cer-
tification or assurance. 
‘‘(4) RENEWAL
AND
REFUSAL
OF
CERTIFI-
CATIONS.—The Secretary may— 
‘‘(A) require that any certification or other 
assurance provided by an entity specified in 
paragraph (2) be renewed by such entity at such 
times as the Secretary determines appropriate; 
and
373 
‘‘(B) refuse to accept any certification or 
assurance if the Secretary determines that such 
certification or assurance is not valid or reliable. 
‘‘(5) ELECTRONIC SUBMISSION.—The Secretary 
shall provide for the electronic submission of certifi-
cations under this subsection. 
‘‘(6) FALSE
STATEMENTS.—Any statement or 
representation made by an entity described in para-
graph (2) to the Secretary shall be subject to section 
1001 of title 18, United States Code. 
‘‘(7) ASSESSMENT OF FOOD SAFETY PROGRAMS, 
SYSTEMS, AND STANDARDS.—If the Secretary deter-
mines that the food safety programs, systems, and 
standards in a foreign region, country, or territory 
are inadequate to ensure that an article of food is as 
safe as a similar article of food that is manufactured, 
processed, packed, or held in the United States in ac-
cordance with the requirements of this Act, the Sec-
retary shall, to the extent practicable, identify such 
inadequacies and establish a process by which the for-
eign region, country, or territory may inform the Sec-
retary of improvements made to such food safety pro-
gram, system, or standard and demonstrate that those 
controls are adequate to ensure that an article of food 
is as safe as a similar article of food that is manufac-
374 
tured, processed, packed, or held in the United States 
in accordance with the requirements of this Act.’’. 
(c) CONFORMING TECHNICAL AMENDMENT.—Section 
801(b) (21 U.S.C. 381(b)) is amended in the second sentence 
by striking ‘‘with respect to an article included within the 
provision of the fourth sentence of subsection (a)’’ and in-
serting ‘‘with respect to an article described in subsection 
(a) relating to the requirements of sections 760 or 761,’’. 
(d) NO LIMIT ON AUTHORITY.—Nothing in the amend-
ments made by this section shall limit the authority of the 
Secretary to conduct inspections of imported food or to take 
such other steps as the Secretary deems appropriate to de-
termine the admissibility of imported food. 
SEC. 6304. PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS. 
(a) IN GENERAL.—Section 801(m)(1) (21 U.S.C. 
381(m)(1)) is amended by inserting ‘‘any country to which 
the article has been refused entry;’’ after ‘‘the country from 
which the article is shipped;’’. 
(b) REGULATIONS.—Not later than 120 days after the 
date of enactment of this Act, the Secretary shall issue an 
interim final rule amending subpart I of part 1 of title 
21, Code of Federal Regulations, to implement the amend-
ment made by this section.
375 
(c) EFFECTIVE DATE.—The amendment made by this 
section shall take effect 180 days after the date of enactment 
of this Act. 
SEC. 6305. BUILDING CAPACITY OF FOREIGN GOVERN-
MENTS WITH RESPECT TO FOOD SAFETY. 
(a) IN GENERAL.—The Secretary shall, not later than 
2 years of the date of enactment of this Act, develop a com-
prehensive plan to expand the technical, scientific, and reg-
ulatory food safety capacity of foreign governments, and 
their respective food industries, from which foods are ex-
ported to the United States. 
(b) CONSULTATION.—In developing the plan under 
subsection (a), the Secretary shall consult with the Sec-
retary of Agriculture, Secretary of State, Secretary of the 
Treasury, the Secretary of Homeland Security, the United 
States Trade Representative, and the Secretary of Com-
merce, representatives of the food industry, appropriate for-
eign government officials, nongovernmental organizations 
that represent the interests of consumers, and other stake-
holders. 
(c) PLAN.—The plan developed under subsection (a) 
shall include, as appropriate, the following: 
(1) Recommendations for bilateral and multilat-
eral arrangements and agreements, including provi-
376 
sions to provide for responsibility of exporting coun-
tries to ensure the safety of food. 
(2) Provisions for secure electronic data sharing. 
(3) Provisions for mutual recognition of inspec-
tion reports. 
(4) Training of foreign governments and food 
producers on United States requirements for safe food. 
(5) Recommendations on whether and how to 
harmonize 
requirements 
under 
the 
Codex 
Alimentarius. 
(6) Provisions for the multilateral acceptance of 
laboratory methods and testing and detection tech-
niques. 
(d) RULE OF CONSTRUCTION.—Nothing in this section 
shall be construed to affect the regulation of dietary supple-
ments under the Dietary Supplement Health and Edu-
cation Act of 1994 (Public Law 103–417). 
SEC. 6306. INSPECTION OF FOREIGN FOOD FACILITIES. 
(a) IN GENERAL.—Chapter VIII (21 U.S.C. 381 et 
seq.), as amended by section 6302, is amended by inserting 
at the end the following: 
‘‘SEC. 807. INSPECTION OF FOREIGN FOOD FACILITIES. 
‘‘(a) INSPECTION.—The Secretary— 
‘‘(1) may enter into arrangements and agree-
ments with foreign governments to facilitate the in-
377 
spection of foreign facilities registered under section 
415; and 
‘‘(2) shall direct resources to inspections of for-
eign facilities, suppliers, and food types, especially 
such facilities, suppliers, and food types that present 
a high risk (as identified by the Secretary), to help 
ensure the safety and security of the food supply of 
the United States. 
‘‘(b) EFFECT OF INABILITY TO INSPECT.—Notwith-
standing any other provision of law, food shall be refused 
admission into the United States if it is from a foreign 
factory, warehouse, or other establishment of which the 
owner, operator, or agent in charge, or the government of 
the foreign country, refuses to permit entry of United States 
inspectors or other individuals duly designated by the Sec-
retary, upon request, to inspect such factory, warehouse, or 
other establishment. For purposes of this subsection, such 
an owner, operator, or agent in charge shall be considered 
to have refused an inspection if such owner, operator, or 
agent in charge does not permit an inspection of a factory, 
warehouse, or other establishment during the 24-hour period 
after such request is submitted, or after such other time pe-
riod, as agreed upon by the Secretary and the foreign fac-
tory, warehouse, or other establishment.’’. 
(b) INSPECTION BY THE SECRETARY OF COMMERCE.—
378 
(1) IN GENERAL.—The Secretary of Commerce, 
in coordination with the Secretary of Health and 
Human Services, may send 1 or more inspectors to 
a country or facility of an exporter from which sea-
food imported into the United States originates. The 
inspectors shall assess practices and processes used in 
connection with the farming, cultivation, harvesting, 
preparation for market, or transportation of such sea-
food and may provide technical assistance related to 
such activities. 
(2) INSPECTION REPORT.— 
(A) IN GENERAL.—The Secretary of Health 
and Human Services, in coordination with the 
Secretary of Commerce, shall— 
(i) prepare an inspection report for 
each inspection conducted under paragraph 
(1); 
(ii) provide the report to the country 
or exporter that is the subject of the report; 
and 
(iii) provide a 30-day period during 
which the country or exporter may provide 
a rebuttal or other comments on the find-
ings of the report to the Secretary of Health 
and Human Services.
379 
(B) DISTRIBUTION AND USE OF REPORT.— 
The Secretary of Health and Human Services 
shall consider the inspection reports described in 
subparagraph (A) in distributing inspection re-
sources under section 421 of the Federal Food, 
Drug, and Cosmetic Act, as added by section 
6201. 
SEC. 6307. ACCREDITATION OF THIRD-PARTY AUDITORS. 
Chapter VIII (21 U.S.C. 381 et seq.), as amended by 
section 6306, is amended by adding at the end the following: 
‘‘SEC. 808. ACCREDITATION OF THIRD-PARTY AUDITORS. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) AUDIT
AGENT.—The term ‘audit agent’ 
means an individual who is an employee or agent of 
an accredited third-party auditor and, although not 
individually accredited, is qualified to conduct food 
safety audits on behalf of an accredited third-party 
auditor. 
‘‘(2) ACCREDITATION BODY.—The term ‘accredi-
tation body’ means an authority that performs ac-
creditation of third-party auditors. 
‘‘(3) THIRD-PARTY AUDITOR.—The term ‘third- 
party auditor’ means a foreign government, agency of 
a foreign government, foreign cooperative, or any 
other thirdparty, as the Secretary determines appro-
382 
FDA Food Safety Modernization Act, the 
Secretary shall establish a system for the 
recognition of accreditation bodies that ac-
credit third-party auditors to certify that 
eligible entities meet the applicable require-
ments of this section. 
‘‘(ii) DIRECT ACCREDITATION.—If, by 
the date that is 2 years after the date of es-
tablishment of the system described in 
clause (i), the Secretary has not identified 
and recognized an accreditation body to 
meet the requirements of this section, the 
Secretary may directly accredit third-party 
auditors. 
‘‘(B) NOTIFICATION.—Each accreditation 
body recognized by the Secretary shall submit to 
the Secretary a list of all accredited third-party 
auditors accredited by such body and the audit 
agents of such auditors. 
‘‘(C) REVOCATION OF RECOGNITION AS AN 
ACCREDITATION
BODY.—The 
Secretary 
shall 
promptly revoke the recognition of any accredita-
tion body found not to be in compliance with the 
requirements of this section.
383 
‘‘(D) 
REINSTATEMENT.—The 
Secretary 
shall establish procedures to reinstate recognition 
of an accreditation body if the Secretary deter-
mines, based on evidence presented by such ac-
creditation body, that revocation was inappro-
priate or that the body meets the requirements 
for recognition under this section. 
‘‘(2) MODEL ACCREDITATION STANDARDS.—Not 
later than 18 months after the date of enactment of 
the FDA Food Safety Modernization Act, the Sec-
retary shall develop model standards, including re-
quirements for regulatory audit reports, and each rec-
ognized accreditation body shall ensure that third- 
party auditors and audit agents of such auditors meet 
such standards in order to qualify such third-party 
auditors as accredited third-party auditors under this 
section. In developing the model standards, the Sec-
retary shall look to standards in place on the date of 
the enactment of this section for guidance, to avoid 
unnecessary duplication of efforts and costs. 
‘‘(c) THIRD-PARTY AUDITORS.— 
‘‘(1) REQUIREMENTS FOR ACCREDITATION AS A 
THIRD-PARTY AUDITOR.— 
‘‘(A) FOREIGN GOVERNMENTS.—Prior to ac-
crediting a foreign government or an agency of
384 
a foreign government as an accredited third- 
party auditor, the accreditation body (or, in the 
case of direct accreditation under subsection 
(b)(1)(A)(ii), the Secretary) shall perform such 
reviews and audits of food safety programs, sys-
tems, and standards of the government or agency 
of the government as the Secretary deems nec-
essary, including requirements under the model 
standards developed under subsection (b)(2), to 
determine that the foreign government or agency 
of the foreign government is capable of ade-
quately ensuring that eligible entities or foods 
certified by such government or agency meet the 
requirements of this Act with respect to food 
manufactured, processed, packed, or held for im-
port into the United States. 
‘‘(B) FOREIGN COOPERATIVES AND OTHER 
THIRD PARTIES.—Prior to accrediting a foreign 
cooperative that aggregates the products of grow-
ers or processors, or any other third party to be 
an accredited third-party auditor, the accredita-
tion body (or, in the case of direct accreditation 
under subsection (b)(1)(A)(ii), the Secretary) 
shall perform such reviews and audits of the 
training and qualifications of audit agents used
385 
by that cooperative or party and conduct such 
reviews of internal systems and such other inves-
tigation of the cooperative or party as the Sec-
retary deems necessary, including requirements 
under the model standards developed under sub-
section (b)(2), to determine that each eligible en-
tity certified by the cooperative or party has sys-
tems and standards in use to ensure that such 
entity or food meets the requirements of this Act. 
‘‘(2) REQUIREMENT TO ISSUE CERTIFICATION OF 
ELIGIBLE ENTITIES OR FOODS.— 
‘‘(A) IN GENERAL.—An accreditation body 
(or, in the case of direct accreditation under sub-
section (b)(1)(A)(ii), the Secretary) may not ac-
credit a third-party auditor unless such third- 
party auditor agrees to issue a written and, as 
appropriate, electronic food certification, de-
scribed in section 801(q), or facility certification 
under section 806(a), as appropriate, to accom-
pany each food shipment for import into the 
United States from an eligible entity, subject to 
requirements set forth by the Secretary. Such 
written or electronic certification may be in-
cluded with other documentation regarding such 
food shipment. The Secretary shall consider cer-
386 
tifications under section 801(q) and participa-
tion in the voluntary qualified importer pro-
gram described in section 806 when targeting in-
spection resources under section 421. 
‘‘(B) PURPOSE
OF
CERTIFICATION.—The 
Secretary shall use certification provided by ac-
credited third-party auditors to— 
‘‘(i) determine, in conjunction with 
any other assurances the Secretary may re-
quire under section 801(q), whether a food 
satisfies the requirements of such section; 
and 
‘‘(ii) determine whether a facility is el-
igible to be a facility from which food may 
be offered for import under the voluntary 
qualified importer program under section 
806. 
‘‘(C) REQUIREMENTS FOR ISSUING CERTIFI-
CATION.— 
‘‘(i) 
IN
GENERAL.—An 
accredited 
third-party auditor shall issue a food cer-
tification under section 801(q) or a facility 
certification described under subparagraph 
(B) only after conducting a regulatory 
audit and such other activities that may be
387 
necessary to establish compliance with the 
requirements of such sections. 
‘‘(ii) PROVISION OF CERTIFICATION.— 
Only an accredited third-party auditor or 
the Secretary may provide a facility certifi-
cation under section 806(a). Only those 
parties described in 801(q)(3) or the Sec-
retary may provide a food certification 
under 301(g). 
‘‘(3) AUDIT
REPORT
SUBMISSION
REQUIRE-
MENTS.— 
‘‘(A) REQUIREMENTS IN GENERAL.—As a 
condition of accreditation, not later than 45 
days after conducting an audit, an accredited 
third-party auditor or audit agent of such audi-
tor shall prepare, and, in the case of a regu-
latory audit, submit, the audit report for each 
audit conducted, in a form and manner des-
ignated by the Secretary, which shall include— 
‘‘(i) the identity of the persons at the 
audited eligible entity responsible for com-
pliance with food safety requirements; 
‘‘(ii) the dates of the audit; 
‘‘(iii) the scope of the audit; and
388 
‘‘(iv) any other information required 
by the Secretary that relates to or may in-
fluence an assessment of compliance with 
this Act. 
‘‘(B) RECORDS.—Following any accredita-
tion of a third-party auditor, the Secretary may, 
at any time, require the accredited third-party 
auditor to submit to the Secretary an onsite 
audit report and such other reports or documents 
required as part of the audit process, for any eli-
gible entity certified by the third-party auditor 
or audit agent of such auditor. Such report may 
include documentation that the eligible entity is 
in compliance with any applicable registration 
requirements. 
‘‘(C) LIMITATION.—The requirement under 
subparagraph (B) shall not include any report 
or other documents resulting from a consultative 
audit by the accredited third-party auditor, ex-
cept that the Secretary may access the results of 
a consultative audit in accordance with section 
414. 
‘‘(4) REQUIREMENTS
OF
ACCREDITED
THIRD- 
PARTY AUDITORS AND AUDIT AGENTS OF SUCH AUDI-
TORS.—
389 
‘‘(A) RISKS
TO
PUBLIC
HEALTH.—If, at 
any time during an audit, an accredited third- 
party auditor or audit agent of such auditor dis-
covers a condition that could cause or contribute 
to a serious risk to the public health, such audi-
tor shall immediately notify the Secretary of— 
‘‘(i) the identification of the eligible en-
tity subject to the audit; and 
‘‘(ii) such condition. 
‘‘(B) TYPES
OF
AUDITS.—An accredited 
third-party auditor or audit agent of such audi-
tor may perform consultative and regulatory au-
dits of eligible entities. 
‘‘(C) LIMITATIONS.— 
‘‘(i) 
IN
GENERAL.—An 
accredited 
third-party auditor may not perform a reg-
ulatory audit of an eligible entity if such 
agent has performed a consultative audit or 
a regulatory audit of such eligible entity 
during the previous 13-month period. 
‘‘(ii) WAIVER.—The Secretary may 
waive the application of clause (i) if the 
Secretary determines that there is insuffi-
cient access to accredited third-party audi-
tors in a country or region.
390 
‘‘(5) CONFLICTS OF INTEREST.— 
‘‘(A) THIRD-PARTY AUDITORS.—An accred-
ited third-party auditor shall— 
‘‘(i) not be owned, managed, or con-
trolled by any person that owns or operates 
an eligible entity to be certified by such 
auditor; 
‘‘(ii) in carrying out audits of eligible 
entities under this section, have procedures 
to ensure against the use of any officer or 
employee of such auditor that has a finan-
cial conflict of interest regarding an eligible 
entity to be certified by such auditor; and 
‘‘(iii) annually make available to the 
Secretary disclosures of the extent to which 
such auditor and the officers and employees 
of such auditor have maintained compliance 
with clauses (i) and (ii) relating to finan-
cial conflicts of interest. 
‘‘(B) AUDIT
AGENTS.—An audit agent 
shall— 
‘‘(i) not own or operate an eligible en-
tity to be audited by such agent; 
‘‘(ii) in carrying out audits of eligible 
entities under this section, have procedures
391 
to ensure that such agent does not have a fi-
nancial conflict of interest regarding an eli-
gible entity to be audited by such agent; 
and 
‘‘(iii) annually make available to the 
Secretary disclosures of the extent to which 
such agent has maintained compliance with 
clauses (i) and (ii) relating to financial 
conflicts of interest. 
‘‘(C) REGULATIONS.—The Secretary shall 
promulgate regulations not later than 18 months 
after the date of enactment of the FDA Food 
Safety Modernization Act to implement this sec-
tion and to ensure that there are protections 
against conflicts of interest between an accred-
ited third-party auditor and the eligible entity to 
be certified by such auditor or audited by such 
audit agent. Such regulations shall include— 
‘‘(i) requiring that audits performed 
under this section be unannounced; 
‘‘(ii) a structure to decrease the poten-
tial for conflicts of interest, including tim-
ing and public disclosure, for fees paid by 
eligible entities to accredited third-party 
auditors; and
392 
‘‘(iii) appropriate limits on financial 
affiliations between an accredited third- 
party auditor or audit agents of such audi-
tor and any person that owns or operates 
an eligible entity to be certified by such 
auditor, as described in subparagraphs (A) 
and (B). 
‘‘(6) WITHDRAWAL OF ACCREDITATION.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
withdraw accreditation from an accredited 
third-party auditor— 
‘‘(i) if food certified under section 
801(q) or from a facility certified under 
paragraph (2)(B) by such third-party audi-
tor is linked to an outbreak of foodborne ill-
ness that has a reasonable probability of 
causing serious adverse health consequences 
or death in humans or animals; 
‘‘(ii) following an evaluation and find-
ing by the Secretary that the third-party 
auditor no longer meets the requirements for 
accreditation; or 
‘‘(iii) following a refusal to allow 
United States officials to conduct such au-
dits and investigations as may be necessary
393 
to ensure continued compliance with the re-
quirements set forth in this section. 
‘‘(B) ADDITIONAL BASIS FOR WITHDRAWAL 
OF ACCREDITATION.—The Secretary may with-
draw accreditation from an accredited third- 
party auditor in the case that such third-party 
auditor is accredited by an accreditation body 
for which recognition as an accreditation body 
under subsection (b)(1)(C) is revoked, if the Sec-
retary determines that there is good cause for the 
withdrawal. 
‘‘(C) 
EXCEPTION.—The 
Secretary 
may 
waive the application of subparagraph (A)(i) if 
the Secretary— 
‘‘(i) conducts an investigation of the 
material facts related to the outbreak of 
human or animal illness; and 
‘‘(ii) reviews the steps or actions taken 
by the third-party auditor to justify the cer-
tification and determines that the accredited 
third-party auditor satisfied the require-
ments under section 801(q) of certifying the 
food, or the requirements under paragraph 
(2)(B) of certifying the entity.
395 
which the Secretary assesses fees and requires accred-
ited third-party auditors and audit agents to reim-
burse the Food and Drug Administration for the work 
performed to establish and administer the accredita-
tion system under this section. The Secretary shall 
make operating this program revenue-neutral and 
shall not generate surplus revenue from such a reim-
bursement mechanism. Fees authorized under this 
paragraph shall be collected and available for obliga-
tion only to the extent and in the amount provided 
in advance in appropriation Acts. Such fees are au-
thorized to remain available until expended. 
‘‘(d) RECERTIFICATION OF ELIGIBLE ENTITIES.—An 
eligible entity shall apply for annual recertification by an 
accredited third-party auditor if such entity— 
‘‘(1) intends to participate in voluntary quali-
fied importer program under section 806; or 
‘‘(2) is required to provide to the Secretary a 
certification under section 801(q) for any food from 
such entity. 
‘‘(e) FALSE STATEMENTS.—Any statement or rep-
resentation made— 
‘‘(1) by an employee or agent of an eligible enti-
ty to an accredited third-party auditor or audit 
agent; or
396 
‘‘(2) by an accredited third-party auditor to the 
Secretary, 
shall be subject to section 1001 of title 18, United States 
Code. 
‘‘(f) MONITORING.—To ensure compliance with the re-
quirements of this section, the Secretary shall— 
‘‘(1) periodically, or at least once every 4 years, 
reevaluate the accreditation bodies described in sub-
section (b)(1); 
‘‘(2) periodically, or at least once every 4 years, 
evaluate the performance of each accredited third- 
party auditor, through the review of regulatory audit 
reports by such auditors, the compliance history as 
available of eligible entities certified by such auditors, 
and any other measures deemed necessary by the Sec-
retary; 
‘‘(3) at any time, conduct an onsite audit of any 
eligible entity certified by an accredited third-party 
auditor, with or without the auditor present; and 
‘‘(4) take any other measures deemed necessary 
by the Secretary. 
‘‘(g) PUBLICLY AVAILABLE REGISTRY.—The Secretary 
shall establish a publicly available registry of accreditation 
bodies and of accredited third-party auditors, including the 
name of, contact information for, and other information
397 
deemed necessary by the Secretary about such bodies and 
auditors. 
‘‘(h) LIMITATIONS.— 
‘‘(1) NO EFFECT ON SECTION 704 INSPECTIONS.— 
The audits performed under this section shall not be 
considered inspections under section 704. 
‘‘(2) NO EFFECT ON INSPECTION AUTHORITY.— 
Nothing in this section affects the authority of the 
Secretary to inspect any eligible entity pursuant to 
this Act.’’. 
SEC. 6308. FOREIGN OFFICES OF THE FOOD AND DRUG AD-
MINISTRATION. 
(a) IN GENERAL.—The Secretary shall establish offices 
of the Food and Drug Administration in foreign countries 
selected by the Secretary, to provide assistance to the appro-
priate governmental entities of such countries with respect 
to measures to provide for the safety of articles of food and 
other products regulated by the Food and Drug Administra-
tion exported by such country to the United States, includ-
ing by directly conducting risk-based inspections of such ar-
ticles and supporting such inspections by such govern-
mental entity. 
(b) CONSULTATION.—In establishing the foreign offices 
described in subsection (a), the Secretary shall consult with
398 
the Secretary of State, the Secretary of Homeland Security, 
and the United States Trade Representative. 
(c) REPORT.—Not later than October 1, 2011, the Sec-
retary shall submit to Congress a report on the basis for 
the selection by the Secretary of the foreign countries in 
which the Secretary established offices, the progress which 
such offices have made with respect to assisting the govern-
ments of such countries in providing for the safety of arti-
cles of food and other products regulated by the Food and 
Drug Administration exported to the United States, and 
the plans of the Secretary for establishing additional foreign 
offices of the Food and Drug Administration, as appro-
priate. 
SEC. 6309. SMUGGLED FOOD. 
(a) IN GENERAL.—Not later than 180 days after the 
enactment of this Act, the Secretary shall, in coordination 
with the Secretary of Homeland Security, develop and im-
plement a strategy to better identify smuggled food and pre-
vent entry of such food into the United States. 
(b) NOTIFICATION
TO HOMELAND SECURITY.—Not 
later than 10 days after the Secretary identifies a smuggled 
food that the Secretary believes would cause serious adverse 
health consequences or death to humans or animals, the Sec-
retary shall provide to the Secretary of Homeland Security 
a notification under section 417(n) of the Federal Food,
399 
Drug, and Cosmetic Act (21 U.S.C. 350f(k)) describing the 
smuggled food and, if available, the names of the individ-
uals or entities that attempted to import such food into the 
United States. 
(c) PUBLIC NOTIFICATION.—If the Secretary— 
(1) identifies a smuggled food; 
(2) reasonably believes exposure to the food 
would cause serious adverse health consequences or 
death to humans or animals; and 
(3) reasonably believes that the food has entered 
domestic commerce and is likely to be consumed, 
the Secretary shall promptly issue a press release describing 
that food and shall use other emergency communication or 
recall networks, as appropriate, to warn consumers and 
vendors about the potential threat. 
(d) EFFECT OF SECTION.—Nothing in this section 
shall affect the authority of the Secretary to issue public 
notifications under other circumstances. 
(e) DEFINITION.—In this subsection, the term ‘‘smug-
gled food’’ means any food that a person introduces into 
the United States through fraudulent means or with the in-
tent to defraud or mislead.
400 
TITLE IV—MISCELLANEOUS 
PROVISIONS 
SEC. 6401. FUNDING FOR FOOD SAFETY. 
(a) IN GENERAL.—There are authorized to be appro-
priated to carry out the activities of the Center for Food 
Safety and Applied Nutrition, the Center for Veterinary 
Medicine, and related field activities in the Office of Regu-
latory Affairs of the Food and Drug Administration such 
sums as may be necessary for fiscal years 2011 through 
2015. 
(b) INCREASED NUMBER OF FIELD STAFF.— 
(1) IN GENERAL.—To carry out the activities of 
the Center for Food Safety and Applied Nutrition, the 
Center for Veterinary Medicine, and related field ac-
tivities of the Office of Regulatory Affairs of the Food 
and Drug Administration, the Secretary of Health 
and Human Services shall increase the field staff of 
such Centers and Office with a goal of not fewer 
than— 
(A) 4,000 staff members in fiscal year 2011; 
(B) 4,200 staff members in fiscal year 2012; 
(C) 4,600 staff members in fiscal year 2013; 
and 
(D) 5,000 staff members in fiscal year 2014.
401 
(2) FIELD STAFF FOR FOOD DEFENSE.—The goal 
under paragraph (1) shall include an increase of 150 
employees by fiscal year 2011 to— 
(A) provide additional detection of and re-
sponse to food defense threats; and 
(B) detect, track, and remove smuggled food 
(as defined in section 6309) from commerce. 
SEC. 6402. EMPLOYEE PROTECTIONS. 
Chapter X of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 391 et seq.), as amended by section 6209, 
is further amended by adding at the end the following: 
‘‘SEC. 1013. EMPLOYEE PROTECTIONS. 
‘‘(a) IN GENERAL.—No entity engaged in the manu-
facture, processing, packing, transporting, distribution, re-
ception, holding, or importation of food may discharge an 
employee or otherwise discriminate against an employee 
with respect to compensation, terms, conditions, or privi-
leges of employment because the employee, whether at the 
employee’s initiative or in the ordinary course of the em-
ployee’s duties (or any person acting pursuant to a request 
of the employee)— 
‘‘(1) provided, caused to be provided, or is about 
to provide or cause to be provided to the employer, the 
Federal Government, or the attorney general of a 
State information relating to any violation of, or any
402 
act or omission the employee reasonably believes to be 
a violation of any provision of this Act or any order, 
rule, regulation, standard, or ban under this Act, or 
any order, rule, regulation, standard, or ban under 
this Act; 
‘‘(2) testified or is about to testify in a pro-
ceeding concerning such violation; 
‘‘(3) assisted or participated or is about to assist 
or participate in such a proceeding; or 
‘‘(4) objected to, or refused to participate in, any 
activity, policy, practice, or assigned task that the 
employee (or other such person) reasonably believed to 
be in violation of any provision of this Act, or any 
order, rule, regulation, standard, or ban under this 
Act. 
‘‘(b) PROCESS.— 
‘‘(1) IN GENERAL.—A person who believes that 
he or she has been discharged or otherwise discrimi-
nated against by any person in violation of sub-
section (a) may, not later than 180 days after the 
date on which such violation occurs, file (or have any 
person file on his or her behalf) a complaint with the 
Secretary of Labor (referred to in this section as the 
‘Secretary’) alleging such discharge or discrimination 
and identifying the person responsible for such act.
403 
Upon receipt of such a complaint, the Secretary shall 
notify, in writing, the person named in the complaint 
of the filing of the complaint, of the allegations con-
tained in the complaint, of the substance of evidence 
supporting the complaint, and of the opportunities 
that will be afforded to such person under paragraph 
(2). 
‘‘(2) INVESTIGATION.— 
‘‘(A) IN GENERAL.—Not later than 60 days 
after the date of receipt of a complaint filed 
under paragraph (1) and after affording the 
complainant and the person named in the com-
plaint an opportunity to submit to the Secretary 
a written response to the complaint and an op-
portunity to meet with a representative of the 
Secretary to present statements from witnesses, 
the Secretary shall initiate an investigation and 
determine whether there is reasonable cause to 
believe that the complaint has merit and notify, 
in writing, the complainant and the person al-
leged to have committed a violation of subsection 
(a) of the Secretary’s findings. 
‘‘(B) REASONABLE CAUSE FOUND; PRELIMI-
NARY ORDER.—If the Secretary concludes that 
there is reasonable cause to believe that a viola-
404 
tion of subsection (a) has occurred, the Secretary 
shall accompany the Secretary’s findings with a 
preliminary order providing the relief prescribed 
by paragraph (3)(B). Not later than 30 days 
after the date of notification of findings under 
this paragraph, the person alleged to have com-
mitted the violation or the complainant may file 
objections to the findings or preliminary order, 
or both, and request a hearing on the record. The 
filing of such objections shall not operate to stay 
any reinstatement remedy contained in the pre-
liminary order. Any such hearing shall be con-
ducted expeditiously. If a hearing is not re-
quested in such 30-day period, the preliminary 
order shall be deemed a final order that is not 
subject to judicial review. 
‘‘(C) DISMISSAL OF COMPLAINT.— 
‘‘(i) STANDARD FOR COMPLAINANT.— 
The Secretary shall dismiss a complaint 
filed under this subsection and shall not 
conduct an investigation otherwise required 
under subparagraph (A) unless the com-
plainant makes a prima facie showing that 
any behavior described in paragraphs (1) 
through (4) of subsection (a) was a contrib-
405 
uting factor in the unfavorable personnel 
action alleged in the complaint. 
‘‘(ii) STANDARD FOR EMPLOYER.—Not-
withstanding a finding by the Secretary 
that the complainant has made the showing 
required under clause (i), no investigation 
otherwise required under subparagraph (A) 
shall be conducted if the employer dem-
onstrates, by clear and convincing evidence, 
that the employer would have taken the 
same unfavorable personnel action in the 
absence of that behavior. 
‘‘(iii) VIOLATION STANDARD.—The Sec-
retary may determine that a violation of 
subsection (a) has occurred only if the com-
plainant demonstrates that any behavior 
described in paragraphs (1) through (4) of 
subsection (a) was a contributing factor in 
the unfavorable personnel action alleged in 
the complaint. 
‘‘(iv) RELIEF STANDARD.—Relief may 
not be ordered under subparagraph (A) if 
the employer demonstrates by clear and con-
vincing evidence that the employer would
406 
have taken the same unfavorable personnel 
action in the absence of that behavior. 
‘‘(3) FINAL ORDER.— 
‘‘(A) IN
GENERAL.—Not later than 120 
days after the date of conclusion of any hearing 
under paragraph (2), the Secretary shall issue a 
final order providing the relief prescribed by this 
paragraph or denying the complaint. At any 
time before issuance of a final order, a pro-
ceeding under this subsection may be terminated 
on the basis of a settlement agreement entered 
into by the Secretary, the complainant, and the 
person alleged to have committed the violation. 
‘‘(B) CONTENT OF ORDER.—If, in response 
to a complaint filed under paragraph (1), the 
Secretary determines that a violation of sub-
section (a) has occurred, the Secretary shall 
order the person who committed such violation— 
‘‘(i) to take affirmative action to abate 
the violation; 
‘‘(ii) to reinstate the complainant to 
his or her former position together with 
compensation (including back pay) and re-
store the terms, conditions, and privileges 
associated with his or her employment; and
407 
‘‘(iii) to provide compensatory dam-
ages to the complainant. 
‘‘(C) PENALTY.—If such an order is issued 
under this paragraph, the Secretary, at the re-
quest of the complainant, shall assess against the 
person against whom the order is issued a sum 
equal to the aggregate amount of all costs and 
expenses (including attorneys’ and expert witness 
fees) reasonably incurred, as determined by the 
Secretary, by the complainant for, or in connec-
tion with, the bringing of the complaint upon 
which the order was issued. 
‘‘(D) BAD FAITH CLAIM.—If the Secretary 
finds that a complaint under paragraph (1) is 
frivolous or has been brought in bad faith, the 
Secretary may award to the prevailing employer 
a reasonable attorneys’ fee, not exceeding $1,000, 
to be paid by the complainant. 
‘‘(4) ACTION IN COURT.— 
‘‘(A) IN GENERAL.—If the Secretary has not 
issued a final decision within 210 days after the 
filing of the complaint, or within 90 days after 
receiving a written determination, the complain-
ant may bring an action at law or equity for de 
novo review in the appropriate district court of
408 
the United States with jurisdiction, which shall 
have jurisdiction over such an action without re-
gard to the amount in controversy, and which 
action shall, at the request of either party to such 
action, be tried by the court with a jury. The 
proceedings shall be governed by the same legal 
burdens of proof specified in paragraph (2)(C). 
‘‘(B) RELIEF.—The court shall have juris-
diction to grant all relief necessary to make the 
employee whole, including injunctive relief and 
compensatory damages, including— 
‘‘(i) reinstatement with the same se-
niority status that the employee would have 
had, but for the discharge or discrimina-
tion; 
‘‘(ii) the amount of back pay, with in-
terest; and 
‘‘(iii) compensation for any special 
damages sustained as a result of the dis-
charge or discrimination, including litiga-
tion costs, expert witness fees, and reason-
able attorney’s fees. 
‘‘(5) REVIEW.— 
‘‘(A) IN GENERAL.—Unless the complainant 
brings an action under paragraph (4), any per-
409 
son adversely affected or aggrieved by a final 
order issued under paragraph (3) may obtain re-
view of the order in the United States Court of 
Appeals for the circuit in which the violation, 
with respect to which the order was issued, alleg-
edly occurred or the circuit in which the com-
plainant resided on the date of such violation. 
The petition for review must be filed not later 
than 60 days after the date of the issuance of the 
final order of the Secretary. Review shall con-
form to chapter 7 of title 5, United States Code. 
The commencement of proceedings under this 
subparagraph shall not, unless ordered by the 
court, operate as a stay of the order. 
‘‘(B) NO JUDICIAL REVIEW.—An order of 
the Secretary with respect to which review could 
have been obtained under subparagraph (A) shall 
not be subject to judicial review in any criminal 
or other civil proceeding. 
‘‘(6) FAILURE TO COMPLY WITH ORDER.—When-
ever any person has failed to comply with an order 
issued under paragraph (3), the Secretary may file a 
civil action in the United States district court for the 
district in which the violation was found to occur, or 
in the United States district court for the District of
410 
Columbia, to enforce such order. In actions brought 
under this paragraph, the district courts shall have 
jurisdiction to grant all appropriate relief including, 
but not limited to, injunctive relief and compensatory 
damages. 
‘‘(7) CIVIL ACTION TO REQUIRE COMPLIANCE.— 
‘‘(A) IN GENERAL.—A person on whose be-
half an order was issued under paragraph (3) 
may commence a civil action against the person 
to whom such order was issued to require com-
pliance with such order. The appropriate United 
States district court shall have jurisdiction, 
without regard to the amount in controversy or 
the citizenship of the parties, to enforce such 
order. 
‘‘(B) AWARD.—The court, in issuing any 
final order under this paragraph, may award 
costs of litigation (including reasonable attor-
neys’ and expert witness fees) to any party 
whenever the court determines such award is ap-
propriate. 
‘‘(c) EFFECT OF SECTION.— 
‘‘(1) OTHER LAWS.—Nothing in this section pre-
empts or diminishes any other safeguards against dis-
crimination, demotion, discharge, suspension, threats,
411 
harassment, reprimand, retaliation, or any other 
manner of discrimination provided by Federal or 
State law. 
‘‘(2) RIGHTS OF EMPLOYEES.—Nothing in this 
section shall be construed to diminish the rights, 
privileges, or remedies of any employee under any 
Federal or State law or under any collective bar-
gaining agreement. The rights and remedies in this 
section may not be waived by any agreement, policy, 
form, or condition of employment. 
‘‘(d) ENFORCEMENT.—Any nondiscretionary duty im-
posed by this section shall be enforceable in a mandamus 
proceeding brought under section 1361 of title 28, United 
States Code. 
‘‘(e) LIMITATION.—Subsection (a) shall not apply with 
respect to an employee of an entity engaged in the manufac-
ture, processing, packing, transporting, distribution, recep-
tion, holding, or importation of food who, acting without 
direction from such entity (or such entity’s agent), delib-
erately causes a violation of any requirement relating to 
any violation or alleged violation of any order, rule, regula-
tion, standard, or ban under this Act.’’. 
SEC. 6403. JURISDICTION; AUTHORITIES. 
Nothing in this Act, or an amendment made by this 
Act, shall be construed to—
412 
(1) alter the jurisdiction between the Secretary of 
Agriculture and the Secretary of Health and Human 
Services, under applicable statutes, regulations, or 
agreements regarding voluntary inspection of non- 
amenable species under the Agricultural Marketing 
Act of 1946 (7 U.S.C. 1621 et seq.); 
(2) alter the jurisdiction between the Alcohol and 
Tobacco Tax and Trade Bureau and the Secretary of 
Health and Human Services, under applicable stat-
utes and regulations; 
(3) limit the authority of the Secretary of Health 
and Human Services under— 
(A) the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 301 et seq.) as in effect on the 
day before the date of enactment of this Act; or 
(B) the Public Health Service Act (42 
U.S.C. 301 et seq.) as in effect on the day before 
the date of enactment of this Act; 
(4) alter or limit the authority of the Secretary 
of Agriculture under the laws administered by such 
Secretary, including— 
(A) the Federal Meat Inspection Act (21 
U.S.C. 601 et seq.); 
(B) the Poultry Products Inspection Act (21 
U.S.C. 451 et seq.);
414 
agreement establishing the World Trade Organization or 
any other treaty or international agreement to which the 
United States is a party. 
SEC. 6405. DETERMINATION OF BUDGETARY EFFECTS. 
The budgetary effects of this Act, for the purpose of 
complying with the Statutory Pay-As-You-Go Act of 2010, 
shall be determined by reference to the latest statement titled 
‘‘Budgetary Effects of PAYGO Legislation’’ for this Act, 
jointly submitted for printing in the Congressional Record 
by the Chairmen of the House and Senate Budget Commit-
tees, provided that such statement has been submitted prior 
to the vote on passage in the House acting first on this con-
ference report or amendment between the Houses. 
Attest: 
Clerk.
111TH CONGRESS 
2D SESSION 
H.R. 3082 
HOUSE AMENDMENT TO 
SENATE AMENDMENT