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42 U.S.C. § 280g–16 — Food Safety Integrated Centers of Excellence
Federal law — U.S. Code and appendices · legal_authorities
**(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
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Source location: Title 42, Chapter 6A, § 280g–16; chapter-6a-public-health-service.md
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**(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 5 Centers designated under subsection (a).
**(c) Activities** Under the leadership of the Director of the Centers for Disease Control and Prevention, each Center of Excellence shall be based out of a selected State health department, which shall provide assistance to other regional, State, and local departments of health through activities that include—
(1) providing resources, including timely information concerning symptoms and tests, for frontline health professionals interviewing individuals as part of routine surveillance and outbreak investigations;
(2) providing analysis of the timeliness and effectiveness of foodborne disease surveillance and outbreak response activities;
(3) providing training for epidemiological and environmental investigation of foodborne illness, including suggestions for streamlining and standardizing the investigation process;
(4) establishing fellowships, stipends, and scholarships to train future epidemiological and food-safety leaders and to address critical workforce shortages;
(5) training and coordinating State and local personnel;
(6) strengthening capacity to participate in existing or new foodborne illness surveillance and environmental assessment information systems; and
(7) conducting research and outreach activities focused on increasing prevention, communication, and education regarding food safety.
**(d) Report to Congress** Not later than 2 years after January 4, 2011, the Secretary shall submit to Congress a report that—
(1) describes the effectiveness of the Centers of Excellence; and
(2) provides legislative recommendations or describes additional resources required by the Centers of Excellence.
**(e) Authorization of appropriations** There is authorized to be appropriated such sums as may be necessary to carry out this section.
**(f) No duplication of effort** In carrying out activities of the Centers of Excellence or other programs under this section, the Secretary shall not duplicate other Federal foodborne illness response efforts.
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Federal law — U.S. Code and appendices · legal_authorities
**(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
**(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
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 2204
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Federal law — U.S. Code and appendices · legal_authorities
**(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
**(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
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
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.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 2252
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Proposed rulemaking**
(1) **In general**
(A) *Rulemaking* — Not later than 1 year after January 4, 2011, the Secretary, in coordination with the Secretary of Agriculture and representatives of State departments of agriculture (including with regard to the national organic program established under the Organic Foods Production Act of 1990 [[7 U.S.C. 6501](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title7-section6501&num=0&edition=prelim) et seq.]), and in consultation with the Secretary of Homeland Security, shall publish a notice of proposed rulemaking to establish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities for which the Secretary has determined that such standards minimize the risk of serious adverse health consequences or death.
(B) *Determination by Secretary* — With respect to small businesses and very small businesses (as such terms are defined in the regulation promulgated under subparagraph (A)) that produce and harvest those types of fruits and vegetables that are raw agricultural commodities that the Secretary has determined are low risk and do not present a risk of serious adverse health consequences or death, the Secretary may determine not to include production and harvesting of such fruits and vegetables in such rulemaking, or may modify the applicable requirements of regulations promulgated pursuant to this section.
(2) **Public input** — During the comment period on the notice of proposed rulemaking under paragraph (1), the Secretary shall conduct not less than 3 public meetings in diverse geographical areas of the United States to provide persons in diff
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 350h
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Federal law — U.S. Code and appendices · legal_authorities
**(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,
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 399
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Training** The Secretary shall set standards and administer 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 inspections 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 laboratory 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, territorial, or tribal department or agency, is authorized and encouraged to conduct examinations, testing, and investigations for the purposes 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 ensure adequate training of such officers and employees to conduct such examinations, testing, and investigations. The contract or memorandum 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,
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 399c
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