21 U.S.C. § 399c — Improving the training of State, local, ter-

Page 710 TITLE 21—FOOD AND DRUGS § 399c tion as the ‘‘Office’’). The Office shall be headed by a director who shall be appointed by the Commissioner of Food and Drugs. (b) Purpose The Director of the Office shall— (1) report to the Commissioner of Food and Drugs on current Food and Drug Administra- tion (referred to in this section as the ‘‘Ad- ministration’’) levels of activity regarding women’s participation in clinical trials and the analysis of data by sex in the testing of drugs, medical devices, and biological products across, where appropriate, age, biological, and sociocultural contexts; (2) establish short-range and long-range goals and objectives within the Administra- tion for issues of particular concern to wom- en’s health within the jurisdiction of the Ad- ministration, including, where relevant and appropriate, adequate inclusion of women and analysis of data by sex in Administration pro- tocols and policies; (3) provide information to women and health care providers on those areas in which dif- ferences between men and women exist; (4) consult with pharmaceutical, biologics, and device manufacturers, health profes- sionals with expertise in women’s issues, con- sumer organizations, and women’s health pro- fessionals on Administration policy with re- gard to women; (5) make annual estimates of funds needed to monitor clinical trials and analysis of data by sex in accordance with needs that are identi- fied; and (6) serve as a member of the Department of Health and Human Services Coordinating Committee on Women’s Health (established under section 237a(b)(4) of title 42). (c) Authorization of appropriations For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2010 through 2014. (June 25, 1938, ch. 675, § 1011, as added Pub. L. 111–148, title III, § 3509(g), Mar. 23, 2010, 124 Stat. 536.) Editorial Notes CODIFICATION Another section 1011 of act June 25, 1938, ch. 675, was enacted by Pub. L. 111–353, title II, § 209(a), Jan. 4, 2011, 124 Stat. 3945, and subsequently renumbered section 1012 by Pub. L. 114–255, div. A, title III, § 3073(b)(2), Dec. 13, 2016, 130 Stat. 1137, and is classified to section 399c of this title. § 399c. Improving the training of State, local, ter- ritorial, and tribal food safety officials (a) Training The Secretary shall set standards and admin- ister training and education programs for the employees of State, local, territorial, and tribal food safety officials relating to the regulatory responsibilities and policies established by this chapter, including programs for— (1) scientific training; (2) training to improve the skill of officers and employees authorized to conduct inspec- tions under sections 372 and 374 of this title; (3) training to achieve advanced product or process specialization in such inspections; (4) training that addresses best practices; (5) training in administrative process and procedure and integrity issues; (6) training in appropriate sampling and lab- oratory analysis methodology; and (7) training in building enforcement actions following inspections, examinations, testing, and investigations. (b) Partnerships with State and local officials (1) In general The Secretary, pursuant to a contract or memorandum of understanding between the Secretary and the head of a State, local, terri- torial, or tribal department or agency, is au- thorized and encouraged to conduct examina- tions, testing, and investigations for the pur- poses of determining compliance with the food safety provisions of this chapter through the officers and employees of such State, local, territorial, or tribal department or agency. (2) Content A contract or memorandum described under paragraph (1) shall include provisions to en- sure adequate training of such officers and em- ployees to conduct such examinations, testing, and investigations. The contract or memo- randum shall contain provisions regarding re- imbursement. Such provisions may, at the sole discretion of the head of the other depart- ment or agency, require reimbursement, in whole or in part, from the Secretary for the examinations, testing, or investigations per- formed pursuant to this section by the officers or employees of the State, territorial, or tribal department or agency. (3) Effect Nothing in this subsection shall be con- strued to limit the authority of the Secretary under section 372 of this title. (c) Extension service The Secretary shall ensure coordination with the extension activities of the National Insti- tute of Food and Agriculture of the Department of Agriculture in advising producers and small processors transitioning into new practices re- quired as a result of the enactment of the FDA Food Safety Modernization Act and assisting regulated industry with compliance with such Act. (d) National Food Safety Training, Education, Extension, Outreach and Technical Assist- ance Program (1) In general In order to improve food safety and reduce the incidence of foodborne illness, the Sec- retary shall, not later than 180 days after Jan- uary 4, 2011, enter into one or more memo- randa of understanding, or enter into other co- operative agreements, with the Secretary of Agriculture to establish a competitive grant program within the National Institute for Food and Agriculture to provide food safety training, education, extension, outreach, and technical assistance to— (A) owners and operators of farms; 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.