Section 402 of P.L. 111-353 (FSMA)

FDA Food Safety Modernization Act
P.L. 111-353
January 4, 2011
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 manufacture, processing, packing, transporting,
distribution, reception, holding, or importation of food may discharge an employee or otherwise
discriminate against an employee with respect to compensation, terms, conditions, or privileges
of employment because the employee, whether at the employee’s initiative or in the ordinary
course of the employee’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 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 proceeding 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
discriminated against by any person in violation of subsection (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. 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 contained 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 complaint an
opportunity to submit to the Secretary a written response to the complaint and an opportunity 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 alleged to have
committed a violation of subsection (a) of the Secretary’s findings.
‘‘(B) REASONABLE CAUSE FOUND; PRELIMINARY 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 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 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 objections shall not operate to stay any reinstatement
remedy contained in the preliminary order. Any such hearing shall be conducted expeditiously. If
a hearing is not requested 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 complainant makes a prima facie showing 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.
‘‘(ii) STANDARD FOR EMPLOYER.—Notwithstanding 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 demonstrates, 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 Secretary may determine that a violation of subsection
(a) has occurred only if the complainant 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 convincing evidence that the employer would 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 proceeding
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 subsection (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 restore the terms, conditions, and privileges associated with his or her
employment; and
‘‘(iii) to provide compensatory damages to the complainant.
‘‘(C) PENALTY.—If such an order is issued under this paragraph, the Secretary, at the request
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 connection
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 complainant
may bring an action at law or equity for de novo review in the appropriate district court of the

United States with jurisdiction, which shall have jurisdiction over such an action without regard
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 jurisdiction to grant all relief necessary to make the
employee whole, including injunctive relief and compensatory damages, including—
‘‘(i) reinstatement with the same seniority status that the employee would have had, but for the
discharge or discrimination;
‘‘(ii) the amount of back pay, with interest; and
‘‘(iii) compensation for any special damages sustained as a result of the discharge or
discrimination, including litigation costs, expert witness fees, and reasonable attorney’s fees.
‘‘(5) REVIEW.—
‘‘(A) IN GENERAL.—Unless the complainant brings an action under paragraph (4), any person
adversely affected or aggrieved by a final order issued under paragraph (3) may obtain review 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, allegedly occurred or the circuit in which the complainant 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 conform 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.—Whenever 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 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 behalf an order was issued under paragraph (3) may
commence a civil action against the person to whom such order was issued to require compliance
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 attorneys’ and expert witness fees) to any party whenever the
court determines such award is appropriate.
‘‘(c) EFFECT OF SECTION.—
‘‘(1) OTHER LAWS.—Nothing in this section preempts or diminishes any other safeguards
against discrimination, demotion, discharge, suspension, threats, 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 bargaining 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 imposed 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 manufacture, processing, packing, transporting, distribution, reception, holding,
or importation of food who, acting without direction from such entity (or such entity’s agent),
deliberately causes a violation of any requirement relating to any violation or alleged violation of
any order, rule, regulation, standard, or ban under this Act.’’.