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 
facility registered under section 415 of which the owner, 
operator, or agent in charge of the facility, or the govern-
ment of the foreign country, refuses to permit entry of 
United States inspectors, upon request, to inspect such fa-
cility. For purposes of this subsection, such an owner, op-
erator, or agent in charge shall be considered to have re-
fused an inspection if such owner, operator, or agent in 
charge refuses such a request to inspect a facility more 
than 48 hours after such request is submitted.’’. 
SEC. 308. THIRD-PARTY ACCREDITATION OF QUALIFIED 
AUDITORS AND AUDIT AGENTS. 
Chapter VIII (21 U.S.C. 381 et seq.), as amended 
by section 307, is further amended by adding at the end 
the following: 
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‘‘SEC. 809. THIRD-PARTY AUDITORS AND AUDIT AGENTS AC-
CREDITATION. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) ACCREDITATION
BODY.—The term ‘ac-
creditation body’ means a recognized authority that 
performs accreditation of third-party auditors and 
audit agents. 
‘‘(2) AUDIT
AGENT.—The term ‘audit agent’ 
means an individual who is qualified to conduct food 
safety audits, and who may be an employee or an 
agent of a third-party auditor. 
‘‘(3) ACCREDITED
AUDIT
AGENT.—The term 
‘accredited audit agent’ means an audit agent ac-
credited by an accreditation body under this section. 
‘‘(4) ACCREDITED
THIRD-PARTY
AUDITOR.— 
The term ‘accredited third-party auditor’ means a 
third-party auditor accredited by an accreditation 
body under this section. 
‘‘(5) CONSULTATIVE
AUDIT.—The term ‘con-
sultative audit’ means an audit of an eligible enti-
ty— 
‘‘(A) to determine whether such entity is in 
compliance with the provisions of this Act and 
with applicable industry standards and prac-
tices; and 
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‘‘(B) the results of which are for internal 
facility purposes only. 
‘‘(6) ELIGIBLE ENTITY.—The term ‘eligible en-
tity’ means a foreign entity, including foreign facili-
ties registered under section 415, in the food import 
supply chain that chooses to be audited by an ac-
credited third-party auditor or audit agent. 
‘‘(7) REGULATORY
AUDIT.—The term ‘regu-
latory 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 entity is eligible to re-
ceive a certification under section 801(p); 
and 
‘‘(ii) whether the entity is eligible to 
participate in the voluntary qualified im-
porter program under section 806. 
‘‘(8) THIRD-PARTY AUDITOR.—The term ‘third- 
party auditor’ means a foreign government, foreign 
cooperative, or any other qualified third party, as 
the Secretary determines appropriate, that conducts 
audits of eligible entities to certify that such eligible 
entities meet the applicable requirements of this sec-
tion. 
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‘‘(b) SYSTEM OF ACCREDITATION.— 
‘‘(1) ACCREDITATION BODIES.— 
‘‘(A) ACCREDITATION
BODIES
RECOGNI-
TION.—No later than 2 years after the date of 
enactment of the Safe Food Enforcement, As-
sessment, Standards and Targeting Act of 
2009, the Secretary shall establish a system for 
the recognition of accreditation bodies that ac-
credit third-party auditors and audit agents to 
certify that eligible entities meet the applicable 
requirements of this Act. 
‘‘(B) NOTIFICATION.—Each accreditation 
body recognized by the Secretary under this 
section shall submit to the Secretary a list of all 
accredited third-party auditors and audit agents 
accredited by such body. 
‘‘(C) REVOCATION
OF
ACCREDITATION 
BODY
RECOGNITION.—The 
Secretary 
shall 
promptly revoke the recognition of any accredi-
tation body found not to be in compliance with 
the requirements of this section. 
‘‘(2) MODEL
ACCREDITATION
STANDARDS.— 
The Secretary shall develop model standards, includ-
ing audit report requirements, and each recognized 
accreditation body shall ensure that third-party 
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auditors and audit agents meet such standards in 
order to qualify as an accredited third-party auditor 
or audit agent under this section. In developing the 
model standards, the Secretary shall look to stand-
ards in place on the date of the enactment of this 
section for guidance, to avoid unnecessary duplica-
tion of efforts and costs. 
‘‘(c) THIRD-PARTY AUDITORS
AND AUDIT AGEN-
CIES.— 
‘‘(1) THIRD-PARTY AUDITOR OR AUDIT AGENT 
ACCREDITATION REQUIREMENTS.— 
‘‘(A) FOREIGN
GOVERNMENTS.—Prior to 
accrediting a foreign government as an accred-
ited third-party auditor, the accreditation body 
shall perform such reviews and audits of food 
safety programs, systems, and standards of the 
government as the Secretary deems necessary 
to determine that the foreign government is ca-
pable of adequately ensuring that eligible enti-
ties certified by such government meet the re-
quirements of this Act with respect to food 
manufactured, processed, packed, or held for 
import to the United States. 
‘‘(B) FOREIGN COOPERATIVES AND OTHER 
THIRD PARTIES.—Prior to accrediting a foreign 
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cooperative that aggregates the products of 
growers or processors, or any other third party 
that the Secretary determines appropriate to be 
an accredited third-party auditor or audit 
agent, the accreditation body shall perform such 
reviews and audits of the training and qualifica-
tions of auditors used by that cooperative or 
party and conduct such reviews of internal sys-
tems and such other investigation of the cooper-
ative or party as the Secretary deems necessary 
to determine that each eligible entity certified 
by the cooperative or party has systems and 
standards in use to ensure that such entity 
meets the requirements of this Act. 
‘‘(2) REQUIREMENT TO ISSUE CERTIFICATION 
OF ELIGIBLE ENTITIES.— 
‘‘(A) IN GENERAL.—An accreditation body 
may not accredit a third-party auditor or audit 
agent unless such third-party auditor or audit 
agent agrees to issue a written and electronic 
certification to accompany each food shipment 
for import into the United States from an eligi-
ble entity certified by the third-party auditor or 
audit agent, subject to requirements set forth 
by the Secretary. The Secretary shall consider 
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such certificates when targeting inspection re-
sources under section 421. 
‘‘(B) PURPOSE
OF
CERTIFICATION.—The 
Secretary shall use evidence of certification pro-
vided by accredited third-party auditors and 
audit agents— 
‘‘(i) to determine the eligibility of an 
importer to receive a certification under 
section 801(p); and 
‘‘(ii) to determine the eligibility of an 
importer to participate in the voluntary 
qualified importer program under section 
806. 
‘‘(3) AUDIT REPORT REQUIREMENTS.— 
‘‘(A) REQUIREMENTS IN GENERAL.—As a 
condition of accreditation, an accredited third- 
party auditor or audit agent shall prepare the 
audit report for an audit, in a form and manner 
designated by the Secretary, which shall in-
clude— 
‘‘(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 
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‘‘(iv) any other information required 
by the Secretary that relates to or may in-
fluence an assessment of compliance with 
this Act. 
‘‘(B) SUBMISSION
OF
REPORTS
TO
THE 
SECRETARY.— 
‘‘(i) IN GENERAL.—Following any ac-
creditation of a third-party auditor or 
audit agent, the Secretary may, at any 
time, require the accredited third-party 
auditor or audit agent to submit to the 
Secretary an onsite audit report and such 
other reports or documents required as 
part of the audit process, for any eligible 
entity certified by the third-party auditor 
or audit agent. Such report may include 
documentation that the eligible entity is in 
compliance with any applicable registration 
requirements. 
‘‘(ii) LIMITATION.—The requirement 
under clause (i) shall not include any re-
port or other documents resulting from a 
consultative audit by the accredited third- 
party auditor or audit agent, except that 
the Secretary may access the results of a 
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consultative audit in accordance with sec-
tion 414. 
‘‘(4) AUDIT AGENT REQUIREMENTS.— 
‘‘(A) PUBLIC HEALTH RISKS.—If, at any 
time during an audit, an accredited audit agent 
discovers a condition that could cause or con-
tribute to a serious risk to the public health, 
the audit agent shall immediately notify the 
Secretary of— 
‘‘(i) the identification of the eligible 
entity subject to the audit; and 
‘‘(ii) such condition. 
‘‘(B) AUDIT TYPES.—An accredited audit 
agent may perform consultative and regulatory 
audits of eligible entities. 
‘‘(C) LIMITATIONS.—An accredited audit 
agent may not perform a regulatory audit of an 
eligible entity if such agent has performed a 
consultative audit or a regulatory audit of such 
eligible entity during the previous 24-month pe-
riod. 
‘‘(5) CONFLICTS OF INTEREST.— 
‘‘(A) THIRD-PARTY
AUDITORS.—An ac-
credited third-party auditor shall— 
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‘‘(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 eligi-
ble 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) relat-
ing to financial conflicts of interest. 
‘‘(B) AUDIT AGENTS.—An accredited audit 
agent shall— 
‘‘(i) not own or operate an eligible en-
tity to be certified by such agent; 
‘‘(ii) in carrying out audits of eligible 
entities under this section, have procedures 
to ensure that such agent does not have a 
financial conflict of interest regarding an 
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eligible entity to be certified by such agent; 
and 
‘‘(iii) annually make available to the 
Secretary disclosures of the extent to 
which such agent has maintained compli-
ance with clauses (i) and (ii) relating to fi-
nancial conflicts of interest. 
‘‘(C) REGULATIONS.—The Secretary shall 
promulgate regulations not later than 18 
months after the date of enactment of the Safe 
Food Enforcement, Assessment, Standards, and 
Targeting Act of 2009 to ensure that there are 
protections against conflicts of interest between 
an accredited third-party auditor or audit agent 
and the eligible entity to be certified by such 
auditor or audit agent. Such regulations shall 
include— 
‘‘(i) requiring that audits performed 
under this section be unannounced; 
‘‘(ii) a structure, including timing and 
public disclosure, for fees paid by eligible 
entities to accredited third-party auditors 
or audit agents to decrease the potential 
for conflicts of interest; and 
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‘‘(iii) appropriate limits on financial 
affiliations between an accredited third- 
party auditor or audit agent and any per-
son that owns or operates an eligible entity 
to be certified by such auditor or audit 
agent. 
‘‘(6) WITHDRAWAL
OF
ACCREDITATION.—The 
Secretary shall withdraw accreditation from an ac-
credited third-party auditor or audit agent— 
‘‘(A) if food from an eligible entity cer-
tified by such third-party auditor or audit agent 
is linked to an outbreak of human or animal ill-
ness; 
‘‘(B) following a performance audit and 
finding by the Secretary that the third-party 
auditor or audit agent no longer meets the re-
quirements for accreditation; or 
‘‘(C) following a refusal to allow United 
States officials to conduct such audits and in-
vestigations as may be necessary to ensure con-
tinued compliance with the requirements set 
forth in this section. 
‘‘(7) NEUTRALIZING
COSTS.—The Secretary 
shall establish a method, similar to the method used 
by the Department of Agriculture, by which accred-
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