21 U.S.C. § 399 — Grants to enhance food safety

Page 708 TITLE 21—FOOD AND DRUGS § 398 div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784.) Editorial Notes REFERENCES IN TEXT The Public Health Service Act, referred to in subsec. (b)(2), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§ 201 et seq.) of Title 42, The Public Health and Welfare. For complete classi- fication of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables. Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title. § 398. Notices to States regarding imported food (a) In general If the Secretary has credible evidence or infor- mation indicating that a shipment of imported food or portion thereof presents a threat of seri- ous adverse health consequences or death to hu- mans or animals, the Secretary shall provide no- tice regarding such threat to the States in which the food is held or will be held, and to the States in which the manufacturer, packer, or distributor of the food is located, to the extent that the Secretary has knowledge of which States are so involved. In providing notice to a State, the Secretary shall request the State to take such action as the State considers appro- priate, if any, to protect the public health re- garding the food involved. (b) Rule of construction Subsection (a) may not be construed as lim- iting the authority of the Secretary with respect to food under any other provision of this chap- ter. (June 25, 1938, ch. 675, § 1008, formerly § 908, as added Pub. L. 107–188, title III, § 310, June 12, 2002, 116 Stat. 673; renumbered § 1008, Pub. L. 111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784.) § 399. Grants to enhance food safety (a) In general The Secretary is authorized to make grants to eligible entities to— (1) undertake examinations, inspections, and investigations, and related food safety activi- ties under section 372 of this title; (2) train to the standards of the Secretary for the examination, inspection, and investiga- tion of food manufacturing, processing, pack- ing, holding, distribution, and importation, in- cluding as such examination, inspection, and investigation relate to retail food establish- ments; (3) build the food safety capacity of the lab- oratories of such eligible entity, including the detection of zoonotic diseases; (4) build the infrastructure and capacity of the food safety programs of such eligible enti- ty to meet the standards as outlined in the grant application; and (5) take appropriate action to protect the public health in response to— (A) a notification under section 398 of this title, including planning and otherwise pre- paring to take such action; or (B) a recall of food under this chapter. (b) Eligible entities; application (1) In general In this section, the term ‘‘eligible entity’’ means an entity— (A) that is— (i) a State; (ii) a locality; (iii) a territory; (iv) an Indian tribe (as defined in section 5304(e) of title 25); or (v) a nonprofit food safety training enti- ty that collaborates with 1 or more insti- tutions of higher education; and (B) that submits an application to the Sec- retary at such time, in such manner, and in- cluding such information as the Secretary may reasonably require. (2) Contents Each application submitted under paragraph (1) shall include— (A) an assurance that the eligible entity has developed plans to engage in the types of activities described in subsection (a); (B) a description of the types of activities to be funded by the grant; (C) an itemization of how grant funds re- ceived under this section will be expended; (D) a description of how grant activities will be monitored; and (E) an agreement by the eligible entity to report information required by the Sec- retary to conduct evaluations under this sec- tion. (c) Limitations The funds provided under subsection (a) shall be available to an eligible entity that receives a grant under this section only to the extent such entity funds the food safety programs of such entity independently of any grant under this section in each year of the grant at a level equal to the level of such funding in the previous year, increased by the Consumer Price Index. Such non-Federal matching funds may be provided di- rectly or through donations from public or pri- vate entities and may be in cash or in-kind, fair- ly evaluated, including plant, equipment, or services. (d) Additional authority The Secretary may— (1) award a grant under this section in each subsequent fiscal year without reapplication for a period of not more than 3 years, provided the requirements of subsection (c) are met for the previous fiscal year; and (2) award a grant under this section in a fis- cal year for which the requirement of sub- section (c) has not been met only if such re- quirement was not met because such funding was diverted for response to 1 or more natural disasters or in other extenuating cir- cumstances that the Secretary may determine appropriate. Page 709 TITLE 21—FOOD AND DRUGS § 399b (e) Duration of awards The Secretary may award grants to an indi- vidual grant recipient under this section for pe- riods of not more than 3 years. In the event the Secretary conducts a program evaluation, fund- ing in the second year or third year of the grant, where applicable, shall be contingent on a suc- cessful program evaluation by the Secretary after the first year. (f) Progress and evaluation (1) In general The Secretary shall measure the status and success of each grant program authorized under the FDA Food Safety Modernization Act (and any amendment made by such Act), in- cluding the grant program under this section. A recipient of a grant described in the pre- ceding sentence shall, at the end of each grant year, provide the Secretary with information on how grant funds were spent and the status of the efforts by such recipient to enhance food safety. To the extent practicable, the Secretary shall take the performance of such a grant recipient into account when deter- mining whether to continue funding for such recipient. (2) No duplication In carrying out paragraph (1), the Secretary shall not duplicate the efforts of the Secretary under other provisions of this chapter or the FDA Food Safety Modernization Act that re- quire measurement and review of the activi- ties of grant recipients under either this chap- ter or such Act. (g) Supplement not supplant Grant funds received under this section shall be used to supplement, and not supplant, non- Federal funds and any other Federal funds avail- able to carry out the activities described in this section. (h) Authorization of appropriations For the purpose of making grants under this section, there are authorized to be appropriated such sums as may be necessary for fiscal years 2011 through 2015. (June 25, 1938, ch. 675, § 1009, formerly § 909, as added Pub. L. 107–188, title III, § 311, June 12, 2002, 116 Stat. 673; renumbered § 1009 and amend- ed Pub. L. 111–31, div. A, title I, §§ 101(b)(2), 103(n), June 22, 2009, 123 Stat. 1784, 1838; Pub. L. 111–353, title II, § 210(a), Jan. 4, 2011, 124 Stat. 3948.) Editorial Notes REFERENCES IN TEXT The FDA Food Safety Modernization Act, referred to in subsec. (f), 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. AMENDMENTS 2011—Pub. L. 111–353 amended section generally. Prior to amendment, section related to grants to States for inspections. 2009—Subsec. (b). Pub. L. 111–31, § 103(n), made tech- nical amendment to reference in original act which ap- pears in text as reference to section 398 of this title. Statutory Notes and Related Subsidiaries CONSTRUCTION OF 2011 AMENDMENT Nothing in amendment by Pub. L. 111–353 to be con- strued to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under cer- tain other Acts, or in a manner inconsistent with inter- national agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title. § 399a. Office of the Chief Scientist (a) Establishment; appointment The Secretary shall establish within the Office of the Commissioner an office to be known as the Office of the Chief Scientist. The Secretary shall appoint a Chief Scientist to lead such Of- fice. (b) Duties of the Office The Office of the Chief Scientist shall— (1) oversee, coordinate, and ensure quality and regulatory focus of the intramural re- search programs of the Food and Drug Admin- istration; (2) track and, to the extent necessary, co- ordinate intramural research awards made by each center of the Administration or science- based office within the Office of the Commis- sioner, and ensure that there is no duplication of research efforts supported by the Reagan- Udall Foundation for the Food and Drug Ad- ministration; (3) develop and advocate for a budget to sup- port intramural research; (4) develop a peer review process by which intramural research can be evaluated; (5) identify and solicit intramural research proposals from across the Food and Drug Ad- ministration through an advisory board com- posed of employees of the Administration that shall include— (A) representatives of each of the centers and the science-based offices within the Of- fice of the Commissioner; and (B) experts on trial design, epidemiology, demographics, pharmacovigilance, basic science, and public health; and (6) develop postmarket safety performance measures that are as measurable and rigorous as the ones already developed for premarket review. (June 25, 1938, ch. 675, § 1010, formerly § 910, as added Pub. L. 110–85, title VI, § 602, Sept. 27, 2007, 121 Stat. 898; renumbered § 1010, Pub. L. 111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784.) § 399b. Office of Women’s Health (a) Establishment There is established within the Office of the Commissioner, an office to be known as the Of- fice of Women’s Health (referred to in this sec-