21 U.S.C. § 399d — Employee protections

Page 711 TITLE 21—FOOD AND DRUGS § 399d 1 So in original. (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 ac- cordance with section 7625 of title 7. (e) Authorization of appropriations There are authorized to be appropriated such sums as may be necessary to carry out this sec- tion for fiscal years 2011 through 2015. (June 25, 1938, ch. 675, § 1012, formerly § 1011, as added Pub. L. 111–353, title II, § 209(a), Jan. 4, 2011, 124 Stat. 3945; renumbered § 1012, Pub. L. 114–255, div. A, title III, § 3073(b)(2), Dec. 13, 2016, 130 Stat. 1137.) Editorial Notes REFERENCES IN TEXT The FDA Food Safety Modernization Act, referred to in subsec. (c), is Pub. L. 111–353, Jan. 4, 2011, 124 Stat. 3885, which enacted chapter 27 (§ 2201 et seq.) and sec- tions 350g to 350l–1, 379j–31, 384a to 384d, 399c, and 399d of this title, section 7625 of Title 7, Agriculture, and section 280g–16 of Title 42, The Public Health and Wel- fare, amended sections 331, 333, 334, 350b to 350d, 350f, 374, 381, 393, and 399 of this title and section 247b–20 of Title 42, and enacted provisions set out as notes under sections 331, 334, 342, 350b, 350d, 350e, 350g to 350j, 350l, and 381 of this title. For complete classification of this Act to the Code, see Short Title note set out under sec- tion 2201 of this title and Tables. PRIOR PROVISIONS A prior section 1012 of act June 25, 1938, was renum- bered section 1013 and is classified to section 399d of this title. Statutory Notes and Related Subsidiaries CONSTRUCTION Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agree- ments to which the United States is a party, see sec- tions 2206, 2251, and 2252 of this title. § 399d. Employee protections (a) In general No entity engaged in the manufacture, proc- essing, packing, transporting, distribution, re- ception, holding, or importation of food may dis- charge an employee or otherwise discriminate against an employee with respect to compensa- tion, terms, conditions, or privileges of employ- ment because the employee, whether at the em- ployee’s initiative or in the ordinary course of the employee’s duties (or any person acting pur- suant 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 at- torney 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 chapter or any order, rule, regulation, standard, or ban under this chapter, or any order, rule, regulation, stand- ard, or ban under this chapter; 1 (2) testified or is about to testify in a pro- ceeding concerning such violation; (3) assisted or participated or is about to as- sist 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) rea- sonably believed to be in violation of any pro- vision of this chapter, or any order, rule, regu- lation, standard, or ban under this chapter. (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 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 (re- ferred 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 Sec- retary 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 sup- porting the complaint, and of the opportuni- ties that will be afforded to such person under paragraph (2). (2) Investigation (A) In general Not later than 60 days after the date of re- ceipt of a complaint filed under paragraph (1) and after affording the complainant and the person named in the complaint an oppor- tunity to submit to the Secretary a written response to the complaint and an oppor- tunity to meet with a representative of the Secretary to present statements from wit- nesses, the Secretary shall initiate an inves- tigation and determine whether there is rea- sonable cause to believe that the complaint has merit and notify, in writing, the com- plainant and the person alleged to have com- mitted 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 al- leged to have committed the violation or the complainant may file objections to the find- ings or preliminary order, or both, and re- quest 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 conducted expeditiously. If a hearing is not requested in such 30-day period, the prelimi- nary order shall be deemed a final order that is not subject to judicial review. Page 712 TITLE 21—FOOD AND DRUGS § 399d (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 re- quired 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 con- tributing factor in the unfavorable per- sonnel action alleged in the complaint. (ii) Standard for employer Notwithstanding a finding by the Sec- retary that the complainant has made the showing required under clause (i), no in- vestigation otherwise required under sub- paragraph (A) shall be conducted if the employer demonstrates, by clear and con- vincing evidence, that the employer would have taken the same unfavorable per- sonnel action in the absence of that behav- ior. (iii) Violation standard The Secretary may determine that a vio- lation of subsection (a) has occurred only if the complainant demonstrates that any behavior described in paragraphs (1) through (4) of subsection (a) was a contrib- uting factor in the unfavorable personnel action alleged in the complaint. (iv) Relief standard Relief may not be ordered under subpara- graph (A) if the employer demonstrates by clear and convincing evidence that the em- ployer would have taken the same unfa- vorable 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 para- graph 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 com- pensation (including back pay) and restore the terms, conditions, and privileges asso- ciated with his or her employment; and (iii) to provide compensatory damages to the complainant. (C) Penalty If such an order is issued under this para- graph, 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 ex- pert witness fees) reasonably incurred, as de- termined by the Secretary, by the complain- ant 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 reason- able 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 deci- sion 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 con- troversy, and which action shall, at the re- quest 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 com- pensatory damages, including— (i) reinstatement with the same senior- ity status that the employee would have had, but for the discharge or discrimina- tion; (ii) the amount of back pay, with inter- est; and (iii) compensation for any special dam- ages 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 af- fected 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, alleg- edly occurred or the circuit in which the complainant resided on the date of such vio- lation. 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. 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 Page 713 TITLE 21—FOOD AND DRUGS § 399e 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 ap- propriate 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, with- out 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 litiga- tion (including reasonable attorneys’ and ex- pert 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 dimin- ishes any other safeguards against discrimina- tion, 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 pro- ceeding brought under section 1361 of title 28. (e) Limitation Subsection (a) shall not apply with respect to an employee of an entity engaged in the manu- facture, processing, packing, transporting, dis- tribution, 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 chapter. (June 25, 1938, ch. 675, § 1013, formerly § 1012, as added Pub. L. 111–353, title IV, § 402, Jan. 4, 2011, 124 Stat. 3968; renumbered § 1013, Pub. L. 114–255, div. A, title III, § 3073(b)(1), Dec. 13, 2016, 130 Stat. 1137.) Statutory Notes and Related Subsidiaries CONSTRUCTION Nothing in this section to be construed to alter juris- diction and authorities established under certain other Acts or in a manner inconsistent with international agreements to which the United States is a party, see sections 2251 and 2252 of this title. § 399e. Nanotechnology (a) In general The Secretary of Health and Human Services (referred to in this section as the ‘‘Secretary’’) shall intensify and expand activities related to enhancing scientific knowledge regarding nanomaterials included or intended for inclusion in products regulated under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or other statutes administered by the Food and Drug Administration, to address issues relevant to the regulation of those products, including the potential toxicology of such nanomaterials, the potential benefit of new therapies derived from nanotechnology, the effects of such nanomaterials on biological systems, and the interaction of such nanomaterials with biologi- cal systems. (b) Activities In conducting activities related to nanotechnology, the Secretary may— (1) assess scientific literature and data on general nanomaterials interactions with bio- logical systems and on specific nanomaterials of concern to the Food and Drug Administra- tion; (2) in cooperation with other Federal agen- cies, develop and organize information using databases and models that will facilitate the identification of generalized principles and characteristics regarding the behavior of classes of nanomaterials with biological sys- tems; (3) promote Food and Drug Administration programs and participate in collaborative ef- forts, to further the understanding of the science of novel properties of nanomaterials that might contribute to toxicity; (4) promote and participate in collaborative efforts to further the understanding of meas- urement and detection methods for nanomaterials; (5) collect, synthesize, interpret, and dis- seminate scientific information and data re- lated to the interactions of nanomaterials with biological systems; (6) build scientific expertise on nanomaterials within the Food and Drug Ad- ministration, including field and laboratory expertise, for monitoring the production and presence of nanomaterials in domestic and im- ported products regulated under this Act; (7) ensure ongoing training, as well as dis- semination of new information within the cen- ters of the Food and Drug Administration, and more broadly across the Food and Drug Ad- ministration, to ensure timely, informed con-