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SEC. 303. 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,
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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
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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
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‘‘(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-
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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. 304. 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.
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(c) EFFECTIVE DATE.—The amendment made by this 
section shall take effect 180 days after the date of enactment 
of this Act. 
SEC. 305. BUILDING CAPACITY OF FOREIGN GOVERNMENTS 
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-
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† HR 2751 EAS 
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. 306. INSPECTION OF FOREIGN FOOD FACILITIES. 
(a) IN GENERAL.—Chapter VIII (21 U.S.C. 381 et 
seq.), as amended by section 302, 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-
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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.—
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(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.
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(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 
201. 
SEC. 307. ACCREDITATION OF THIRD-PARTY AUDITORS. 
Chapter VIII (21 U.S.C. 381 et seq.), as amended by 
section 306, 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 third party, as the Secretary determines appro-
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† HR 2751 EAS 
priate in accordance with the model standards de-
scribed in subsection (b)(2), that is eligible to be con-
sidered for accreditation to conduct food safety audits 
to certify that eligible entities meet the applicable re-
quirements of this section. A third-party auditor may 
be a single individual. A third-party auditor may 
employ or use audit agents to help conduct consult-
ative and regulatory audits. 
‘‘(4) ACCREDITED THIRD-PARTY AUDITOR.—The 
term ‘accredited third-party auditor’ means a third- 
party auditor accredited by an accreditation body to 
conduct audits of eligible entities to certify that such 
eligible entities meet the applicable requirements of 
this section. An accredited third-party auditor may 
be an individual who conducts food safety audits to 
certify that eligible entities meet the applicable re-
quirements of this section. 
‘‘(5) CONSULTATIVE AUDIT.—The term ‘consult-
ative audit’ means an audit of an eligible entity— 
‘‘(A) to determine whether such entity is in 
compliance with the provisions of this Act and 
with applicable industry standards and prac-
tices; and 
‘‘(B) the results of which are for internal 
purposes only.
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‘‘(6) ELIGIBLE ENTITY.—The term ‘eligible enti-
ty’ means a foreign entity, including a foreign facil-
ity registered under section 415, in the food import 
supply chain that chooses to be audited by an accred-
ited third-party auditor or the audit agent of such ac-
credited third-party auditor. 
‘‘(7) REGULATORY AUDIT.—The term ‘regulatory 
audit’ means an audit of an eligible entity— 
‘‘(A) to determine whether such entity is in 
compliance with the provisions of this Act; and 
‘‘(B) the results of which determine— 
‘‘(i) whether an article of food manu-
factured, processed, packed, or held by such 
entity is eligible to receive a food certifi-
cation under section 801(q); or 
‘‘(ii) whether a facility is eligible to re-
ceive a facility certification under section 
806(a) for purposes of participating in the 
program under section 806. 
‘‘(b) ACCREDITATION SYSTEM.— 
‘‘(1) ACCREDITATION BODIES.— 
‘‘(A) RECOGNITION OF ACCREDITATION BOD-
IES.— 
‘‘(i) IN GENERAL.—Not later than 2 
years after the date of enactment of the