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•AMDT. NO. 4805 
(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 mecha-
nisms described in such paragraph do not exist or 
are inadequate, then, not later than 90 days after 
the conclusion of such review, the Secretary of Agri-
culture shall conduct a study of the feasibility of im-
plementing a farmer indemnification program to 
provide restitution to agricultural producers for 
losses sustained as a result of a mandatory recall of 
an agricultural commodity by a Federal or State 
regulatory agency that is subsequently determined to 
be in error. The Secretary of Agriculture shall sub-
mit to the Committee on Agriculture of the House 
of Representatives and the Committee on Agri-
culture, Nutrition, and Forestry of the Senate a re-
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•AMDT. NO. 4805 
port that describes the results of the study, includ-
ing 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 
thereafter, the Secretary of Health and Human 
Services (referred to in this subsection as the ‘‘Sec-
retary’’) shall submit a report to the Committee on 
Health, Education, Labor, and Pensions of the Sen-
ate and the Committee on Energy and Commerce of 
the House of Representatives on the use of recall au-
thority 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, 
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•AMDT. NO. 4805 
and Cosmetic Act, or a mandatory recall order 
under subsection (b) of such section; 
(B) the number of responsible parties, as 
defined in section 417 of the Federal Food, 
Drug, and Cosmetic Act, formally given the op-
portunity to cease distribution of an article of 
food and recall such article, as described in sec-
tion 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 
recall 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 adultera-
tion of an article of food that was the subject 
of a recall under section 423(b) of the Federal 
Food, Drug, and Cosmetic Act or a public 
health advisory described in paragraph (1). 
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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 
indicating’’ and inserting ‘‘reason to believe’’; and 
(2) striking ‘‘presents a threat of serious ad-
verse health consequences or death to humans or 
animals’’ and inserting ‘‘is adulterated or mis-
branded’’. 
(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 Envi-
ronmental Protection Agency (referred to in this section 
as the ‘‘Administrator’’), in coordination with the Sec-
retary of Health and Human Services, Secretary of Home-
land Security, and Secretary of Agriculture, shall provide 
support for, and technical assistance to, State, local, and 
tribal governments in preparing for, assessing, decontami-
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•AMDT. NO. 4805 
nating, and recovering from an agriculture or food emer-
gency. 
(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 dissemi-
nate 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 
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•AMDT. NO. 4805 
under subsection (b), shall conduct exercises at least annu-
ally to evaluate and identify weaknesses in the decon-
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 
Emergency Management Reform Act of 2006 (6 U.S.C. 
748(b)(1)). 
(e) MODIFICATIONS.—Based on the exercises de-
scribed in subsection (d), the Administrator, in coordina-
tion with the entities described in subsection (b), shall re-
view and modify as necessary the plans described in sub-
section (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 eco-
nomic devastation to the agriculture and food sys-
tem; and 
(3) agents that are most difficult to clean or re-
mediate. 
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•AMDT. NO. 4805 
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 fol-
lowing: 
‘‘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 
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•AMDT. NO. 4805 
‘‘(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 be-
tween the Secretary and the head of a State, local, 
territorial, or tribal department or agency, is author-
ized and encouraged to conduct examinations, test-
ing, and investigations for the purposes of deter-
mining compliance with the food safety provisions of 
this Act through the officers and employees of such 
State, local, territorial, or tribal department or agen-
cy. 
‘‘(2) CONTENT.—A contract or memorandum 
described under paragraph (1) shall include provi-
sions to ensure adequate training of such officers 
and employees to conduct such examinations, test-
ing, and investigations. The contract or memo-
randum shall contain provisions regarding reim-
bursement. Such provisions may, at the sole discre-
tion of the head of the other department or agency, 
require reimbursement, in whole or in part, from the 
Secretary for the examinations, testing, or investiga-
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•AMDT. NO. 4805 
tions performed pursuant to this section by the offi-
cers 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 en-
sure coordination with the extension activities of the Na-
tional Institute of Food and Agriculture of the Depart-
ment of Agriculture in advising producers and small proc-
essors 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, EDU-
CATION, EXTENSION, OUTREACH, AND TECHNICAL AS-
SISTANCE 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 Mod-
ernization Act, enter into one or more memoranda of 
understanding, or enter into other cooperative agree-
ments, with the Secretary of Agriculture to establish 
a competitive grant program within the National In-
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•AMDT. NO. 4805 
stitute for Food and Agriculture to provide food 
safety training, education, extension, outreach, and 
technical assistance 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 
Agricultural Research, Extension, and Education 
Reform Act of 1998. 
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated such sums as may be 
necessary to carry out this section for fiscal years 2011 
through 2015.’’. 
(b) NATIONAL
FOOD
SAFETY
TRAINING, EDU-
CATION, EXTENSION, OUTREACH, AND TECHNICAL AS-
SISTANCE PROGRAM.—Title IV of the Agricultural Re-
search, Extension, and Education Reform Act of 1998 is 
amended by inserting after section 404 (7 U.S.C. 7624) 
the following: 
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•AMDT. NO. 4805 
‘‘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 program established under section 1012(d) of the 
Federal Food, Drug, and Cosmetic Act, pursuant to any 
memoranda of understanding entered into under such sec-
tion. 
‘‘(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 
agricultural production systems, encompassing conven-
tional, sustainable, organic, conservation, and environ-
mental practices. 
‘‘(c) PRIORITY.—In awarding grants under this sec-
tion, the Secretary shall give priority to projects that tar-
get small- and medium-sized farms, beginning farmers, so-
cially 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 Safe-
ty Initiative. 
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•AMDT. NO. 4805 
‘‘(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 
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 sec-
tion, the Secretary shall make competitive grants to 
support 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.— 
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•AMDT. NO. 4805 
‘‘(A) IN
GENERAL.—A grant under this 
section 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 entity under this section after such entity 
has received 3 years of grant funding under 
this section. 
‘‘(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 
merchant wholesalers that has a commitment to 
public health and expertise in administering 
programs 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; 
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•AMDT. NO. 4805 
‘‘(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. 
‘‘(2) 
MULTISTATE
PARTNERSHIPS.—Grants 
under this section may be made for projects involv-
ing 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 
technical assistance to grant recipients to further the pur-
poses 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 
merchant wholesalers. 
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•AMDT. NO. 4805 
‘‘(j) AUTHORIZATION OF APPROPRIATIONS.—For the 
purposes of making grants under this section, there are 
authorized to be appropriated such sums as may be nec-
essary for fiscal years 2011 through 2015.’’. 
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 
section 702; 
‘‘(2) train to the standards of the Secretary for 
the examination, inspection, and investigation of 
food manufacturing, processing, packing, holding, 
distribution, and importation, including as such ex-
amination, inspection, and investigation relate to re-
tail food establishments; 
‘‘(3) build the food safety capacity of the lab-
oratories of such eligible entity, including the detec-
tion of zoonotic diseases; 
‘‘(4) build the infrastructure and capacity of 
the food safety programs of such eligible entity to 
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•AMDT. NO. 4805 
meet the standards as outlined in the grant applica-
tion; and 
‘‘(5) take appropriate action to protect the pub-
lic health in response to— 
‘‘(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 
‘eligible 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. 
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•AMDT. NO. 4805 
‘‘(d) 
ADDITIONAL
AUTHORITY.—The 
Secretary 
may— 
‘‘(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 fis-
cal year; and 
‘‘(2) award a grant under this section in a fis-
cal 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 extenu-
ating circumstances that the Secretary may deter-
mine appropriate. 
‘‘(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 applica-
ble, 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 meas-
ure the status and success of each grant program 
authorized under the FDA Food Safety Moderniza-
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•AMDT. NO. 4805 
tion Act (and any amendment made by such Act), 
including the grant program under this section. A 
recipient of a grant described in the preceding sen-
tence 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 re-
cipient to enhance food safety. To the extent prac-
ticable, the Secretary shall take the performance of 
such a grant recipient into account when deter-
mining whether to continue funding for such recipi-
ent. 
‘‘(2) NO DUPLICATION.—In carrying out para-
graph (1), the Secretary shall not duplicate the ef-
forts 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 recipients under either such Act. 
‘‘(g) SUPPLEMENT NOT SUPPLANT.—Grant funds 
received under this section shall be used to supplement, 
and not supplant, non-Federal funds and any other Fed-
eral 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-
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•AMDT. NO. 4805 
thorized to be appropriated such sums as may be nec-
essary for fiscal years 2011 through 2015.’’. 
(b) CENTERS OF EXCELLENCE.—Part P of the Pub-
lic 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 consulta-
tion with the working group described in subsection (b)(2), 
shall designate 5 Integrated Food Safety Centers of Excel-
lence (referred to in this section as the ‘Centers of Excel-
lence’) to serve as resources for Federal, State, and local 
public health professionals to respond to foodborne illness 
outbreaks. 
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 sub-
section (a), an entity shall— 
‘‘(A) be a State health department; 
‘‘(B) partner with 1 or more institutions of 
higher education that have demonstrated knowl-
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•AMDT. NO. 4805 
edge, expertise, and meaningful experience with 
regional or national food production, processing, 
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 infor-
mation, 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 estab-
lish a diverse working group of experts and stake-
holders from Federal, State, and local food safety 
and health agencies, the food industry, including 
food retailers and food manufacturers, consumer or-
ganizations, and academia to make recommendations 
to the Secretary regarding designations of the Cen-
ters of Excellence. 
‘‘(3) ADDITIONAL CENTERS OF EXCELLENCE.— 
The Secretary may designate eligible entities to be 
regional Food Safety Centers of Excellence, in addi-
tion to the 5 Centers designated under subsection 
(a). 
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•AMDT. NO. 4805 
‘‘(c) ACTIVITIES.—Under the leadership of the Direc-
tor of the Centers for Disease Control and Prevention, 
each Center of Excellence shall be based out of a selected 
State health department, which shall provide assistance to 
other regional, State, and local departments of health 
through activities 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 
scholarships to train future epidemiological and 
food-safety leaders and to address critical workforce 
shortages; 
‘‘(5) training and coordinating State and local 
personnel; 
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•AMDT. NO. 4805 
‘‘(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. 
‘‘(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 
report that— 
‘‘(1) describes the effectiveness of the Centers 
of Excellence; and 
‘‘(2) provides legislative recommendations or 
describes additional resources required by the Cen-
ters 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— 
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•AMDT. NO. 4805 
(1) by redesignating subsections (f) through (k) 
as subsections (i) through (n), respectively; and 
(2) by inserting after subsection (e) the fol-
lowing: 
‘‘(f) CRITICAL INFORMATION.—Except with respect 
to fruits and vegetables that are raw agricultural commod-
ities, not more than 18 months after the date of enactment 
of the FDA Food Safety Modernization Act, the Secretary 
may require a responsible party to submit to the Secretary 
consumer-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 accu-
rately identify whether such consumer is in posses-
sion of the reportable food. 
‘‘(g) GROCERY STORE NOTIFICATION.— 
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•AMDT. NO. 4805 
‘‘(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 Ad-
ministration in a format that can be easily 
printed by a grocery store for purposes of con-
sumer notification. 
‘‘(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 
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•AMDT. NO. 4805 
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 no-
tification required in paragraph (1). Such list shall 
include— 
‘‘(A) posting the notification at or near the 
register; 
‘‘(B) providing the location of the report-
able food; 
‘‘(C) providing targeted recall information 
given to customers upon purchase of a food; 
and 
‘‘(D) other such prominent and con-
spicuous locations and manners utilized by gro-
cery 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 appropriate by the Secretary.’’. 
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•AMDT. NO. 4805 
(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 in-
serting ‘‘417(j)’’. 
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 im-
porter 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 
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•AMDT. NO. 4805 
‘‘(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 
‘‘(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 developing 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 regu-
lations to provide for the content of the foreign sup-
plier verification program established under sub-
section (a). 
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•AMDT. NO. 4805 
‘‘(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-
ventive controls, that provide the same 
level of public health protection as those 
required under section 418 or section 419 
(taking into consideration variances grant-
ed 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. 
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•AMDT. NO. 4805 
‘‘(4) ACTIVITIES.—Verification activities under 
a foreign supplier verification program under this 
section may include monitoring records for ship-
ments, lot-by-lot certification of compliance, annual 
on-site inspections, checking the hazard analysis and 
risk-based preventive control plan of the foreign sup-
plier, and periodically testing and sampling ship-
ments. 
‘‘(d) RECORD MAINTENANCE AND ACCESS.—Records 
of an importer related to a foreign supplier verification 
program shall be maintained for a period of not less than 
2 years and shall be made available promptly to a duly 
authorized 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 
facility: 
‘‘(1) The Seafood Hazard Analysis Critical 
Control Points Program of the Food and Drug Ad-
ministration. 
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•AMDT. NO. 4805 
‘‘(2) The Juice Hazard Analysis Critical Con-
trol Points Program of the Food and Drug Adminis-
tration. 
‘‘(3) The Thermally Processed Low-Acid Foods 
Packaged in Hermetically Sealed Containers stand-
ards of the Food and Drug Administration (or any 
successor standards). 
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 113 of chapter 21, Code of Federal Regulations (or 
any successor regulations). 
‘‘(f) ADDITIONAL EXEMPTIONS.—The Secretary, by 
notice published in the Federal Register, shall establish 
an exemption from the requirements of this section for ar-
ticles of food imported in small quantities for research and 
evaluation 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-
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•AMDT. NO. 4805 
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 
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 en-
actment 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 fol-
lowing: 
‘‘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— 
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•AMDT. NO. 4805 
‘‘(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 
participate in such program; and 
‘‘(B) consistent with section 808, establish 
a process for the issuance of a facility certifi-
cation to accompany food offered for importa-
tion by importers who have voluntarily agreed 
to participate in such program; and 
‘‘(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 appli-
cation to the Secretary of such intent at the time and in 
a manner established by the Secretary. 
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•AMDT. NO. 4805 
‘‘(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 
imported. 
‘‘(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 
United States food safety standards for a designated 
food. 
‘‘(4) The compliance of the importer with the 
requirements of section 805. 
‘‘(5) The recordkeeping, testing, inspections 
and audits of facilities, traceability of articles of 
food, temperature controls, and sourcing practices of 
the importer. 
‘‘(6) The potential risk for intentional adultera-
tion of the food. 
‘‘(7) Any other factor that the Secretary deter-
mines appropriate. 
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•AMDT. NO. 4805 
‘‘(e) REVIEW
AND
REVOCATION.—Any importer 
qualified by the Secretary in accordance with the eligibility 
criteria set forth in this section shall be reevaluated not 
less often than once every 3 years and the Secretary shall 
promptly revoke the qualified importer status of any im-
porter found not to be in compliance with such criteria. 
‘‘(f) FALSE STATEMENTS.—Any statement or rep-
resentation 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.’’. 
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 following: ‘‘With respect to an article of food, if impor-
tation of such food is subject to, but not compliant with, 
the requirement under subsection (q) that such food be 
accompanied by a certification or other assurance that the 
food meets applicable requirements of this Act, then such 
article shall be refused admission.’’. 
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•AMDT. NO. 4805 
(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) 
provide a certification, or such other assurances as 
the Secretary determines appropriate, that the arti-
cle of food complies with applicable requirements of 
this Act. Such certification or assurances may be 
provided in the form of shipment-specific certifi-
cates, a listing of certified facilities that manufac-
ture, process, pack, or hold such food, or in such 
other form as the Secretary may specify. 
‘‘(2) FACTORS TO BE CONSIDERED IN REQUIR-
ING CERTIFICATION.—The Secretary shall base the 
determination 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; 
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•AMDT. NO. 4805 
‘‘(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, sys-
tems, and standards in the country, terri-
tory, or region of origin of the food are in-
adequate to ensure that the article of food 
is as safe as a similar article of food that 
is manufactured, processed, packed, or 
held in the United States in accordance 
with the requirements of this Act; and 
‘‘(ii) the certification would assist the 
Secretary in determining whether to refuse 
or admit the article of food under sub-
section (a); and 
‘‘(D) information submitted to the Sec-
retary in accordance with the process estab-
lished 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— 
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•AMDT. NO. 4805 
‘‘(A) an agency or a representative of the 
government of the country from which the arti-
cle of food at issue originated, as designated by 
the Secretary; or 
‘‘(B) such other persons or entities accred-
ited pursuant to section 808 to provide such 
certification 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 appro-
priate; and 
‘‘(B) refuse to accept any certification or 
assurance if the Secretary determines that such 
certification or assurance is not valid or reli-
able. 
‘‘(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. 
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•AMDT. NO. 4805 
‘‘(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 manufac-
tured, processed, packed, or held in the United 
States in accordance with the requirements of this 
Act, the Secretary shall, to the extent practicable, 
identify such inadequacies and establish a process by 
which the foreign region, country, or territory may 
inform the Secretary of improvements made to such 
food safety program, system, or standard and dem-
onstrate that those controls are adequate 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 accordance with the re-
quirements of this Act.’’. 
(c) CONFORMING TECHNICAL AMENDMENT.—Sec-
tion 801(b) (21 U.S.C. 381(b)) is amended in the second 
sentence by striking ‘‘with respect to an article included 
within the provision of the fourth sentence of subsection 
(a)’’ and inserting ‘‘with respect to an article described 
in subsection (a) relating to the requirements of sections 
760 or 761,’’. 
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•AMDT. NO. 4805 
complaint an opportunity to submit to the Sec-
retary a written response to the complaint and 
an opportunity to meet with a representative of 
the Secretary to present statements from wit-
nesses, the Secretary shall initiate an investiga-
tion and determine whether there is reasonable 
cause to believe that the complaint has merit 
and notify, in writing, the complainant and the 
person alleged to have committed a violation of 
subsection (a) of the Secretary’s findings. 
‘‘(B) REASONABLE
CAUSE
FOUND; PRE-
LIMINARY ORDER.—If the Secretary concludes 
that there is reasonable cause to believe that a 
violation of subsection (a) has occurred, the 
Secretary shall accompany the Secretary’s find-
ings with a preliminary order providing the re-
lief prescribed by paragraph (3)(B). Not later 
than 30 days after the date of notification of 
findings under this paragraph, the person al-
leged to have committed 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 objec-
tions shall not operate to stay any reinstate-
ment remedy contained in the preliminary 
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Amendment No. 4805 
H. R. 3082 
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