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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.
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† HR 2751 EAS 
‘‘(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
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† HR 2751 EAS 
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
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† HR 2751 EAS 
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-
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† HR 2751 EAS 
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
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† HR 2751 EAS 
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
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† HR 2751 EAS 
‘‘(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.—
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† HR 2751 EAS 
‘‘(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 regu-
latory 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.
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† HR 2751 EAS 
‘‘(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
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† HR 2751 EAS 
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
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† HR 2751 EAS 
‘‘(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
213 
† HR 2751 EAS 
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.
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† HR 2751 EAS 
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
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† HR 2751 EAS 
‘‘(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
217 
† HR 2751 EAS 
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. 308. 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
218 
† HR 2751 EAS 
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. 309. 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,
219 
† HR 2751 EAS 
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.
220 
† HR 2751 EAS 
TITLE IV—MISCELLANEOUS 
PROVISIONS 
SEC. 401. 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.
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† HR 2751 EAS 
(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 309) from commerce. 
SEC. 402. EMPLOYEE PROTECTIONS. 
Chapter X of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 391 et seq.), as amended by section 209, 
is further amended by adding at the end the following: 
‘‘SEC. 1012. 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
222 
† HR 2751 EAS 
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.
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† HR 2751 EAS 
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-
224 
† HR 2751 EAS 
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-
225 
† HR 2751 EAS 
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
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† HR 2751 EAS 
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
227 
† HR 2751 EAS 
‘‘(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
228 
† HR 2751 EAS 
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-
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† HR 2751 EAS 
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
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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,
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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. 403. JURISDICTION; AUTHORITIES. 
Nothing in this Act, or an amendment made by this 
Act, shall be construed to—
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(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.);
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agreement establishing the World Trade Organization or 
any other treaty or international agreement to which the 
United States is a party. 
SEC. 405. 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, 
submitted for printing in the Congressional Record by the 
Chairman of the Senate Budget Committee, provided that 
such statement has been submitted prior to the vote on pas-
sage. 
Amend the title so as to read: ‘‘An Act to amend the 
Federal Food, Drug, and Cosmetic Act with respect to 
the safety of the food supply.’’. 
Attest: 
Secretary.