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

Federal law — U.S. Code and appendices · legal_authorities

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

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Source file: Laws/federal/codes/united-states-code/title-21/section-399-grants-to-enhance-food-safety--ff6ce42669.md
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Source location: Title 21, Chapter 9, § 399; chapter-009-federal-food-drug-and-cosmetic-act.md

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**(a) In general** The Secretary is authorized to make grants to eligible entities to— (1) undertake examinations, inspections, and investigations, and related food safety activities under [section 372 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section372&num=0&edition=prelim); (2) train to the standards of the Secretary for the examination, inspection, and investigation of food manufacturing, processing, packing, holding, distribution, and importation, including as such examination, inspection, and investigation relate to retail food establishments; (3) build the food safety capacity of the laboratories of such eligible entity, including the detection of zoonotic diseases; (4) build the infrastructure and capacity of the food safety programs of such eligible entity 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section398&num=0&edition=prelim), including planning and otherwise preparing 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title25-section5304/e&num=0&edition=prelim)); or (v) a nonprofit food safety training entity that collaborates with 1 or more institutions of higher education; and (B) that submits an application to the Secretary at such time, in such manner, and including 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 received 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 Secretary to conduct evaluations under this section. **(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 directly or through donations from public or private entities and may be in cash or in-kind, fairly 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 fiscal year for which the requirement of subsection (c) has not been met only if such requirement was not met because such funding was diverted for response to 1 or more natural disasters or in other extenuating circumstances that the Secretary may determine appropriate. **(e) Duration of awards** The Secretary may award grants to an individual grant recipient under this section for periods of not more than 3 years. In the event the Secretary conducts a program evaluation, funding in the second year or third year of the grant, where applicable, shall be contingent on a successful 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), including the grant program under this section. A recipient of a grant described in the preceding 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 determining 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 require measurement and review of the activities of grant recipients under either this chapter 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 available 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.

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 372 — Examinations and investigations

**(a) Authority to conduct** (1) (A) The Secretary is authorized to conduct examinations and investigations for the purposes of this chapter through officers and employees of the Department or through any health, food, or drug officer or employee of any State, Territory, or political subdivision thereof, duly commissioned by the Secretary as an officer of the Department. (B) (i) For a tobacco product, to the extent feasible, the Secretary shall contract with the States in accordance with this paragraph to carry out inspections of retailers within that State in connection with the enforcement of this chapter. (ii) The Secretary shall not enter into any contract under clause (i) with the government of any of the several States to exercise enforcement authority under this chapter on Indian country without the express written consent of the Indian tribe involved. (2) (A) In addition to the authority established in paragraph (1), the Secretary, pursuant to a memorandum of understanding between the Secretary and the head of another Federal department or agency, is authorized to conduct examinations and investigations for the purposes of this chapter through the officers and employees of such other department or agency, subject to subparagraph (B). Such a memorandum shall include provisions to ensure adequate training of such officers and employees to conduct the examinations and investigations. The memorandum of understanding shall contain provisions regarding reimbursement. Such provisions may, at the sole discretion of the head of the other department or agency, require reimbursement, in whole or in part, from the Secretary for the examinations or investigations performed under this section by the officers or employees of the other department or agency.

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 372

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 2201 — Performance standards

**(a) In general** The Secretary shall, in coordination with the Secretary of Agriculture, not less frequently than every 2 years, review and evaluate relevant health data and other relevant information, including from toxicological and epidemiological studies and analyses, current Good Manufacturing Practices issued by the Secretary relating to food, and relevant recommendations of relevant advisory committees, including the Food Advisory Committee, to determine the most significant foodborne contaminants. **(b) Guidance documents and regulations** Based on the review and evaluation conducted under subsection (a), and when appropriate to reduce the risk of serious illness or death to humans or animals or to prevent adulteration of the food under [section 342 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342&num=0&edition=prelim) or to prevent the spread by food of communicable disease under [section 264 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section264&num=0&edition=prelim), the Secretary shall issue contaminant-specific and science-based guidance documents, including guidance documents regarding action levels, or regulations. Such guidance, including guidance regarding action levels, or regulations— (1) shall apply to products or product classes; (2) shall, where appropriate, differentiate between food for human consumption and food intended for consumption by animals other than humans; and (3) shall not be written to be facility-specific. **(c) No duplication of efforts** The Secretary shall coordinate with the Secretary of Agriculture to avoid issuing duplicative guidance on the same contaminants. **(d) Review** The Secretary shall periodically review and revise, as appropr

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 2201

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 398 — Notices to States regarding imported food

**(a) In general** If the Secretary has credible evidence or information indicating that a shipment of imported food or portion thereof presents a threat of serious adverse health consequences or death to humans or animals, the Secretary shall provide notice 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 appropriate, if any, to protect the public health regarding the food involved. **(b) Rule of construction** Subsection (a) may not be construed as limiting the authority of the Secretary with respect to food under any other provision of this chapter.

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 398

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 280g–16 — Food Safety Integrated Centers of Excellence

**(a) In general** Not later than 1 year after January 4, 2011, the Secretary, acting through the Director of the Centers for Disease Control and Prevention and in consultation with the working group described in subsection (b)(2), shall designate 5 Integrated Food Safety Centers of Excellence (referred to in this section as the “Centers of Excellence”) to serve as resources for Federal, State, and local public health professionals to respond to foodborne illness outbreaks. The Centers of Excellence shall be headquartered at selected State health departments. **(b) Selection of Centers of Excellence** (1) **Eligible entities** — To be eligible to be designated as a Center of Excellence under subsection (a), an entity shall— (A) be a State health department; (B) partner with 1 or more institutions of higher education that have demonstrated knowledge, expertise, and meaningful experience with regional or national food production, processing, and distribution, as well as leadership in the laboratory, epidemiological, and environmental detection and investigation of foodborne illness; and (C) provide to the Secretary such information, at such time, and in such manner, as the Secretary may require. (2) **Working group** — Not later than 180 days after January 4, 2011, the Secretary shall establish a diverse working group of experts and stakeholders from Federal, State, and local food safety and health agencies, the food industry, including food retailers and food manufacturers, consumer organizations, and academia to make recommendations to the Secretary regarding designations of the Centers of Excellence. (3) **Additional Centers of Excellence** — The Secretary may designate eligible entities to be regional Food Safety Centers of Excellence, in addition to the

Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 280g–16

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Federal law — U.S. Code and appendices · legal_authorities

7 U.S.C. § 7625 — Biobased products

**(a) “Biobased product” defined** In this section, the term “biobased product” means a product suitable for food or nonfood use that is derived in whole or in part from renewable agricultural and forestry materials. **(b) Coordination of biobased product activities** The Secretary of Agriculture shall— (1) coordinate the research, technical expertise, economic information, and market information resources and activities of the Department to develop, commercialize, and promote the use of biobased products; (2) solicit input from private sector persons who produce, or are interested in producing, biobased products; (3) provide a centralized contact point for advice and technical assistance for promising and innovative biobased products; and (4) submit an annual report to Congress describing the coordinated research, marketing, and commercialization activities of the Department relating to biobased products. **(c) Cooperative agreements for biobased products** (1) **Agreements authorized** — The Secretary may enter into cooperative agreements with private entities described in subsection (d), under which the facilities and technical expertise of the Agricultural Research Service and the Forest Service may be made available to operate pilot plants and other large-scale preparation facilities for the purpose of bringing technologies necessary for the development and commercialization of new biobased products to the point of practical application. (2) **Description of cooperative activities** — Cooperative activities may include— (A) research on potential environmental impacts of a biobased product; (B) methods to reduce the cost of manufacturing a biobased product; and (C) other appropriate research. (3) **Authority of Secretary** — To carry out a cooperat

Source: Supplied U.S. Code snapshot — release unconfirmed · 7 U.S.C. § 7625

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 247b–20 — Food safety grants

**(a) In general** The Secretary may award grants to States and Indian tribes (as defined in [section 5304(e) of title 25](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title25-section5304/e&num=0&edition=prelim)) to expand participation in networks to enhance Federal, State, and local food safety efforts, including meeting the costs of establishing and maintaining the food safety surveillance, technical, and laboratory capacity needed for such participation. **(b) Authorization of appropriations** For the purpose of carrying out this section, there are authorized to be appropriated $19,500,000 for fiscal year 2010, and such sums as may be necessary for each of the fiscal years 2011 through 2015.

Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 247b–20

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 387i — Records and reports on tobacco products

**(a) In general** Every person who is a tobacco product manufacturer or importer of a tobacco product shall establish and maintain such records, make such reports, and provide such information, as the Secretary may by regulation reasonably require to assure that such tobacco product is not adulterated or misbranded and to otherwise protect public health. Regulations prescribed under the preceding sentence— (1) may require a tobacco product manufacturer or importer to report to the Secretary whenever the manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its marketed tobacco products may have caused or contributed to a serious unexpected adverse experience associated with the use of the product or any significant increase in the frequency of a serious, expected adverse product experience; (2) shall require reporting of other significant adverse tobacco product experiences as determined by the Secretary to be necessary to be reported; (3) shall not impose requirements unduly burdensome to a tobacco product manufacturer or importer, taking into account the cost of complying with such requirements and the need for the protection of the public health and the implementation of this subchapter; (4) when prescribing the procedure for making requests for reports or information, shall require that each request made under such regulations for submission of a report or information to the Secretary state the reason or purpose for such request and identify to the fullest extent practicable such report or information; (5) when requiring submission of a report or information to the Secretary, shall state the reason or purpose for the submission of such report or information and identify to the fullest extent practicabl

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 387i

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Federal law — U.S. Code and appendices · legal_authorities

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 St

Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 399

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