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

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

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Source file: Laws/federal/codes/united-states-code/title-21/section-2201-performance-standards--c62e60f067.md
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Source location: Title 21, Chapter 27, § 2201; chapter-027-food-safety-modernization.md

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

42 U.S.C. § 264 — Regulations to control communicable diseases

**(a) Promulgation and enforcement by Surgeon General** The Surgeon General, with the approval of the Secretary, is authorized to make and enforce such regulations as in his judgment are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession. For purposes of carrying out and enforcing such regulations, the Surgeon General may provide for such inspection, fumigation, disinfection, sanitation, pest extermination, destruction of animals or articles found to be so infected or contaminated as to be sources of dangerous infection to human beings, and other measures, as in his judgment may be necessary. **(b) Apprehension, detention, or conditional release of individuals** Regulations prescribed under this section shall not provide for the apprehension, detention, or conditional release of individuals except for the purpose of preventing the introduction, transmission, or spread of such communicable diseases as may be specified from time to time in Executive orders of the President upon the recommendation of the Secretary, in consultation with the Surgeon General,11 So in original. The comma probably should not appear.. **(c) Application of regulations to persons entering from foreign countries** Except as provided in subsection (d), regulations prescribed under this section, insofar as they provide for the apprehension, detention, examination, or conditional release of individuals, shall be applicable only to individuals coming into a State or possession from a foreign country or a possession. **(d) Apprehension and examination of persons reasonably believed to be infected** (1) Regulations prescribed under this section

Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 264

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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. § 342 — Adulterated food

A food shall be deemed to be adulterated— **(a) Poisonous, insanitary, etc., ingredients** (1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health.11 So in original. The period probably should be “; or”. (2)(A) if it bears or contains any added poisonous or added deleterious substance (other than a substance that is a pesticide chemical residue in or on a raw agricultural commodity or processed food, a food additive, a color additive, or a new animal drug) that is unsafe within the meaning of [section 346 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section346&num=0&edition=prelim); or (B) if it bears or contains a pesticide chemical residue that is unsafe within the meaning of [section 346a(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section346a/a&num=0&edition=prelim); or (C) if it is or if it bears or contains (i) any food additive that is unsafe within the meaning of [section 348 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section348&num=0&edition=prelim); or (ii) a new animal drug (or conversion product thereof) that is unsafe within the meaning of [section 360b of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360b&num=0&edition=prelim); or (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or (4) if it has been prepared, packed, or held under insanitary conditions wher

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 342

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

21 U.S.C. § 2204 — Building domestic capacity

**(a) In general** (1) **Initial report** — The Secretary, in coordination with the Secretary of Agriculture and the Secretary of Homeland Security, shall, not later than 2 years after January 4, 2011, submit to Congress a comprehensive report that identifies programs and practices that are intended to promote the safety and supply chain security of food and to prevent outbreaks of foodborne illness and other food-related hazards that can be addressed through preventive activities. Such report shall include a description of the following: (A) Analysis of the need for further regulations or guidance to industry. (B) Outreach to food industry sectors, including through the Food and Agriculture Coordinating Councils referred to in [section 2203 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section2203&num=0&edition=prelim), to identify potential sources of emerging threats to the safety and security of the food supply and preventive strategies to address those threats. (C) Systems to ensure the prompt distribution to the food industry of information and technical assistance concerning preventive strategies. (D) Communication systems to ensure that information about specific threats to the safety and security of the food supply are rapidly and effectively disseminated. (E) Surveillance systems and laboratory networks to rapidly detect and respond to foodborne illness outbreaks and other food-related hazards, including how such systems and networks are integrated. (F) Outreach, education, and training provided to States and local governments to build State and local food safety and food defense capabilities, including progress implementing strategies developed under sections 2202 and 2224 of this title. (G) The esti

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

21 U.S.C. § 2206 — Alcohol-related facilities

**(a) In general** Except as provided by sections 102, 206, 207, 302, 304, 402, 403, and 404 of this Act, and the amendments made by such sections, nothing in this Act, or the amendments made by this Act, shall be construed to apply to a facility that— (1) under the Federal Alcohol Administration Act ([27 U.S.C. 201](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title27-section201&num=0&edition=prelim) et seq.) or chapter 51 of subtitle E of the Internal Revenue Code of 1986 ([26 U.S.C. 5001](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title26-section5001&num=0&edition=prelim) et seq.) is required to obtain a permit or to register with the Secretary of the Treasury as a condition of doing business in the United States; and (2) under [section 350d of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350d&num=0&edition=prelim) is required to register as a facility because such facility is engaged in manufacturing, processing, packing, or holding 1 or more alcoholic beverages, with respect to the activities of such facility that relate to the manufacturing, processing, packing, or holding of alcoholic beverages. **(b) Limited receipt and distribution of non-alcohol food** Subsection (a) shall not apply to a facility engaged in the receipt and distribution of any non-alcohol food, except that such paragraph shall apply to a facility described in such paragraph that receives and distributes non-alcohol food, provided such food is received and distributed— (1) in a prepackaged form that prevents any direct human contact with such food; and (2) in amounts that constitute not more than 5 percent of the overall sales of such facility, as determined by the Secretary of the Treasury. **(c) Rule of construc

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 2206

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

21 U.S.C. § 2224 — Surveillance

**(a) Definition of foodborne illness outbreak** In this Act, the term “foodborne illness outbreak” means the occurrence of 2 or more cases of a similar illness resulting from the ingestion of a certain food. **(b) Foodborne illness surveillance systems** (1) **In general** — The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall enhance foodborne illness surveillance systems to improve the collection, analysis, reporting, and usefulness of data on foodborne illnesses by— (A) coordinating Federal, State and local foodborne illness surveillance systems, including complaint systems, and increasing participation in national networks of public health and food regulatory agencies and laboratories; (B) facilitating sharing of surveillance information on a more timely basis among governmental agencies, including the Food and Drug Administration, the Department of Agriculture, the Department of Homeland Security, and State and local agencies, and with the public; (C) developing improved epidemiological tools for obtaining quality exposure data and microbiological methods for classifying cases; (D) augmenting such systems to improve attribution of a foodborne illness outbreak to a specific food; (E) expanding capacity of such systems, including working toward automatic electronic searches, for implementation of identification practices, including fingerprinting strategies, for foodborne infectious agents, in order to identify new or rarely documented causes of foodborne illness and submit standardized information to a centralized database; (F) allowing timely public access to aggregated, de-identified surveillance data; (G) at least annually, publishing current reports on findings from such systems; (H) estab

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 2224

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

21 U.S.C. § 2251 — Jurisdiction; authorities

Nothing in this Act, or an amendment made by this Act, shall be construed to— (1) alter the jurisdiction between the Secretary of Agriculture and the Secretary of Health and Human Services, under applicable statutes, regulations, or agreements regarding voluntary inspection of non-amenable species under the Agricultural Marketing Act of 1946 ([7 U.S.C. 1621](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title7-section1621&num=0&edition=prelim) et seq.); (2) alter the jurisdiction between the Alcohol and Tobacco Tax and Trade Bureau and the Secretary of Health and Human Services, under applicable statutes and regulations; (3) limit the authority of the Secretary of Health and Human Services under— (A) the Federal Food, Drug, and Cosmetic Act ([21 U.S.C. 301](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section301&num=0&edition=prelim) et seq.) as in effect on the day before January 4, 2011; or (B) the Public Health Service Act [[42 U.S.C. 201](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section201&num=0&edition=prelim) et seq.] as in effect on the day before January 4, 2011; (4) alter or limit the authority of the Secretary of Agriculture under the laws administered by such Secretary, including— (A) the Federal Meat Inspection Act ([21 U.S.C. 601](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section601&num=0&edition=prelim) et seq.); (B) the Poultry Products Inspection Act ([21 U.S.C. 451](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section451&num=0&edition=prelim) et seq.); (C) the Egg Products Inspection Act ([21 U.S.C. 1031](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section1031&num=0&edition=prelim) et seq.);

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 2251

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

21 U.S.C. § 2252 — Compliance with international agreements

Nothing in this Act (or an amendment made by this Act) shall be construed in a manner inconsistent with the agreement establishing the World Trade Organization or any other treaty or international agreement to which the United States is a party.

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