Title 21 USC reference

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 27 - FOOD SAFETY MODERNIZATION SUBCHAPTER I - IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS Sec. 2201 - Performance standards From the U.S. Government Publishing Office, www.gpo.gov §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 or to prevent the spread by food of communicable disease under section 264 of title 42, the…

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 27 - FOOD SAFETY MODERNIZATION SUBCHAPTER I - IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS Sec. 2202 - National Agriculture and Food Defense Strategy From the U.S. Government Publishing Office, www.gpo.gov §2202. National Agriculture and Food Defense Strategy (a) Development and submission of strategy (1) In general Not later than 1 year after January 4, 2011, the Secretary of Health and Human Services and the Secretary of Agriculture, in coordination with the Secretary of Homeland Security, shall prepare and transmit to the relevant committees of Congress, and make publicly available on the Internet Web sites of the Department of Health and Human Services and the Department of Agriculture, the National Agriculture and Food Defense Strategy. (2) Implementation plan The strategy shall include an implementation plan for use by the Secretaries described under paragraph (1) in carrying out the strategy. (3) Research The strategy shall include a coordinated research agenda for use by the Secretaries described under paragraph (1) in conducting research to support the…

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 27 - FOOD SAFETY MODERNIZATION SUBCHAPTER I - IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS Sec. 2203 - Food and Agriculture Coordinating Councils From the U.S. Government Publishing Office, www.gpo.gov §2203. Food and Agriculture Coordinating Councils The Secretary of Homeland Security, in coordination with the Secretary of Health and Human Services and the Secretary of Agriculture, shall within 180 days of January 4, 2011, and annually thereafter, submit to the relevant committees of Congress, and make publicly available on the Internet Web site of the Department of Homeland Security, a report on the activities of the Food and Agriculture Government Coordinating Council and the Food and Agriculture Sector Coordinating Council, including the progress of such Councils on— (1) facilitating partnerships between public and private entities to help coordinate and enhance the protection of the agriculture and food system of the United States; (2) providing for the regular and timely interchange of information between each council relating to the security of the…

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 27 - FOOD SAFETY MODERNIZATION SUBCHAPTER I - IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS Sec. 2204 - Building domestic capacity From the U.S. Government Publishing Office, www.gpo.gov §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, to identify potential sources of emerging threats to the safety and security of the food supply and…

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 27 - FOOD SAFETY MODERNIZATION SUBCHAPTER I - IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS Sec. 2205 - Food allergy and anaphylaxis management From the U.S. Government Publishing Office, www.gpo.gov §2205. Food allergy and anaphylaxis management (a) Definitions In this section: (1) Early childhood education program The term "early childhood education program" means— (A) a Head Start program or an Early Head Start program carried out under the Head Start Act (42 U.S.C. 9831 et seq.); (B) a State licensed or regulated child care program or school; or (C) a State prekindergarten program that serves children from birth through kindergarten. (2) ESEA definitions The terms "local educational agency", "secondary school", "elementary school", and "parent" have the meanings given the terms in section 7801 of title 20. (3) School The term "school" includes public— (A) kindergartens; (B) elementary schools; and (C) secondary schools. (4) Secretary The term "Secretary" means the Secretary of Health and Human Services. (b) Establishment of voluntary food allergy…

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 27 - FOOD SAFETY MODERNIZATION SUBCHAPTER I - IMPROVING CAPACITY TO PREVENT FOOD SAFETY PROBLEMS Sec. 2206 - Alcohol-related facilities From the U.S. Government Publishing Office, www.gpo.gov §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 et seq.) or chapter 51 of subtitle E of the Internal Revenue Code of 1986 (26 U.S.C. 5001 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 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…

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 27 - FOOD SAFETY MODERNIZATION SUBCHAPTER II - IMPROVING CAPACITY TO DETECT AND RESPOND TO FOOD SAFETY PROBLEMS Sec. 2221 - Food emergency response network From the U.S. Government Publishing Office, www.gpo.gov §2221. Food emergency response network The Secretary, in coordination with the Secretary of Agriculture, the Secretary of Homeland Security, and State, local, and tribal governments shall, not later than 180 days after January 4, 2011, and biennially thereafter, submit to the relevant committees of Congress, and make publicly available on the Internet Web site of the Department of Health and Human Services, a report on the progress in implementing a national food emergency response laboratory network that— (1) provides ongoing surveillance, rapid detection, and surge capacity for large-scale food-related emergencies, including intentional adulteration of the food supply; (2) coordinates the food laboratory capacities of State, local, and tribal food laboratories, including the adoption of novel surveillance and identification technologies and the sharing…

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 27 - FOOD SAFETY MODERNIZATION SUBCHAPTER II - IMPROVING CAPACITY TO DETECT AND RESPOND TO FOOD SAFETY PROBLEMS Sec. 2222 - Integrated consortium of laboratory networks From the U.S. Government Publishing Office, www.gpo.gov §2222. Integrated consortium of laboratory networks (a) In general The Secretary of Homeland Security, in coordination with the Secretary of Health and Human Services, the Secretary of Agriculture, the Secretary of Commerce, and the Administrator of the Environmental Protection Agency, shall maintain an agreement through which relevant laboratory network members, as determined by the Secretary of Homeland Security, shall— (1) agree on common laboratory methods in order to reduce the time required to detect and respond to foodborne illness outbreaks and facilitate the sharing of knowledge and information relating to animal health, agriculture, and human health; (2) identify means by which laboratory network members could work cooperatively— (A) to optimize national laboratory preparedness; and (B) to provide surge capacity during…

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 27 - FOOD SAFETY MODERNIZATION SUBCHAPTER II - IMPROVING CAPACITY TO DETECT AND RESPOND TO FOOD SAFETY PROBLEMS Sec. 2223 - Enhancing tracking and tracing of food and recordkeeping From the U.S. Government Publishing Office, www.gpo.gov §2223. Enhancing tracking and tracing of food and recordkeeping (a) Pilot projects (1) In general Not later than 270 days after January 4, 2011, the Secretary of Health and Human Services (referred to in this section as the "Secretary"), taking into account recommendations from the Secretary of Agriculture and representatives of State departments of health and agriculture, shall establish pilot projects in coordination with the food industry to explore and evaluate methods to rapidly and effectively identify recipients of food to prevent or mitigate a foodborne illness outbreak and to address credible threats of serious adverse health consequences or death to humans or animals as a result of such food being adulterated under section 342 of this title or misbranded under section 343(w) of this title. (2) Content The Secretary shall…

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 27 - FOOD SAFETY MODERNIZATION SUBCHAPTER II - IMPROVING CAPACITY TO DETECT AND RESPOND TO FOOD SAFETY PROBLEMS Sec. 2224 - Surveillance From the U.S. Government Publishing Office, www.gpo.gov §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…

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 27 - FOOD SAFETY MODERNIZATION SUBCHAPTER II - IMPROVING CAPACITY TO DETECT AND RESPOND TO FOOD SAFETY PROBLEMS Sec. 2225 - Decontamination and disposal standards and plans From the U.S. Government Publishing Office, www.gpo.gov §2225. Decontamination and disposal standards and plans (a) In general The Administrator of the Environmental Protection Agency (referred to in this section as the "Administrator"), in coordination with the Secretary of Health and Human Services, Secretary of Homeland Security, and Secretary of Agriculture, shall provide support for, and technical assistance to, State, local, and tribal governments in preparing for, assessing, decontaminating, and recovering from an agriculture or food emergency. (b) Development of standards In carrying out subsection (a), the Administrator, in coordination with the Secretary of Health and Human Services, Secretary of Homeland Security, Secretary of Agriculture, and State, local, and tribal governments, shall develop and disseminate specific standards and protocols to undertake clean-up, clearance, and…

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 27 - FOOD SAFETY MODERNIZATION SUBCHAPTER III - IMPROVING THE SAFETY OF IMPORTED FOOD Sec. 2241 - Inspection by the Secretary of Commerce From the U.S. Government Publishing Office, www.gpo.gov §2241. Inspection by the Secretary of Commerce (1) In general The Secretary of Commerce, in coordination with the Secretary of Health and Human Services, may send 1 or more inspectors to a country or facility of an exporter from which seafood imported into the United States originates. The inspectors shall assess practices and processes used in connection with the farming, cultivation, harvesting, preparation for market, or transportation of such seafood and may provide technical assistance related to such activities. (2) Inspection report (A) In general The Secretary of Health and Human Services, in coordination with the Secretary of Commerce, shall— (i) prepare an inspection report for each inspection conducted under paragraph (1); (ii) provide the report to the country or exporter that is the subject of the report; and (iii) provide a 30-day period during which the…

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 27 - FOOD SAFETY MODERNIZATION SUBCHAPTER III - IMPROVING THE SAFETY OF IMPORTED FOOD Sec. 2242 - Foreign offices of the Food and Drug Administration From the U.S. Government Publishing Office, www.gpo.gov §2242. Foreign offices of the Food and Drug Administration (a) In general The Secretary shall establish offices of the Food and Drug Administration in foreign countries selected by the Secretary, to provide assistance to the appropriate governmental entities of such countries with respect to measures to provide for the safety of articles of food and other products regulated by the Food and Drug Administration exported by such country to the United States, including by directly conducting risk-based inspections of such articles and supporting such inspections by such governmental entity. (b) Consultation In establishing the foreign offices described in subsection (a), the Secretary shall consult with the Secretary of State, the Secretary of Homeland Security, and the United States Trade Representative. (c) Report Not later than October 1, 2011, the Secretary shall…

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 27 - FOOD SAFETY MODERNIZATION SUBCHAPTER III - IMPROVING THE SAFETY OF IMPORTED FOOD Sec. 2243 - Smuggled food From the U.S. Government Publishing Office, www.gpo.gov §2243. Smuggled food (a) In general Not later than 180 days after January 4, 2011, the Secretary shall, in coordination with the Secretary of Homeland Security, develop and implement a strategy to better identify smuggled food and prevent entry of such food into the United States. (b) Notification to Homeland Security Not later than 10 days after the Secretary identifies a smuggled food that the Secretary believes would cause serious adverse health consequences or death to humans or animals, the Secretary shall provide to the Secretary of Homeland Security a notification under section 350f(n) of this title describing the smuggled food and, if available, the names of the individuals or entities that attempted to import such food into the United States. (c) Public notification If the Secretary— (1) identifies a smuggled food; (2) reasonably believes exposure to the food would cause serious adverse…

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 27 - FOOD SAFETY MODERNIZATION SUBCHAPTER IV - MISCELLANEOUS PROVISIONS Sec. 2251 - Jurisdiction; authorities From the U.S. Government Publishing Office, www.gpo.gov §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 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 et seq.) as in effect on the day before January 4, 2011; or (B) the Public Health Service Act [42 U.S.C. 201 et seq.] as in effect on the day before January 4, 2011; (4) alter or limit the…

U.S.C. Title 21 - FOOD AND DRUGS 21 U.S.C. United States Code, 2023 Edition Title 21 - FOOD AND DRUGS CHAPTER 27 - FOOD SAFETY MODERNIZATION SUBCHAPTER IV - MISCELLANEOUS PROVISIONS Sec. 2252 - Compliance with international agreements From the U.S. Government Publishing Office, www.gpo.gov §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. (Pub. L. 111–353, title IV, §404, Jan. 4, 2011, 124 Stat. 3972.) Editorial Notes References in Text This Act, referred to in text, is Pub. L. 111–353, Jan. 4, 2011, 124 Stat. 3885, known as the FDA Food Safety Modernization Act, which enacted this chapter and sections 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 Welfare, 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…