dreamproit/uscode huggingface dataset:
21 U.S.C. § 2103 (FOOD AND DRUGS)
§ 2103. Ensuring efficient and effective communications during a recall
The Secretary shall, during an ongoing recall of human or pet food regulated by the Secretary—
(1) work with companies, relevant professional associations, and other organizations to collect and aggregate information pertaining to the recall;
(2) use existing networks of communication, including electronic forms of information dissemination, to enhance the quality and speed of communication with the public; and
(3) post information regarding recalled human and pet foods on the Internet Web site of the Food and Drug Administration in a single location, which shall include a searchable database of recalled human foods and a searchable database of recalled pet foods, that is easily accessed and understood by the public.
(Pub. L. 110–85, title X, § 1003, Sept. 27, 2007, 121 Stat. 963.)
21 U.S.C. § 2104 (FOOD AND DRUGS)
§ 2104. State and Federal cooperation
(a) In general
The Secretary shall work with the States in undertaking activities and programs that assist in improving the safety of food, including fresh and processed produce, so that State food safety programs and activities conducted by the Secretary function in a coordinated and cost-effective manner. With the assistance provided under subsection (b), the Secretary shall encourage States to—
(1) establish, continue, or strengthen State food safety programs, especially with respect to the regulation of retail commercial food establishments; and
(2) establish procedures and requirements for ensuring that processed produce under the jurisdiction of State food safety programs is not unsafe for human consumption.
(b) Assistance
The Secretary may provide to a State, for planning, developing, and implementing such a food safety program—
(1) advisory assistance;
(2) technical assistance, training, and laboratory assistance (including necessary materials and equipment); and
(3) financial and other assistance.
(c) Service agreements
The Secretary may, under an agreement entered into with a Federal, State, or local agency, use, on a reimbursable basis or otherwise, the personnel, services, and facilities of the agency to carry out the responsibilities of the agency under this section. An agreement entered into with a State agency under this subsection may provide for training of State employees.
(Pub. L. 110–85, title X, § 1004, Sept. 27, 2007, 121 Stat. 964.)
21 U.S.C. § 2105 (FOOD AND DRUGS)
§ 2105. Enhanced aquaculture and seafood inspection
(a) Findings
Congress finds the following:
(1) In 2007, there has been an overwhelming increase in the volume of aquaculture and seafood that has been found to contain substances that are not approved for use in food in the United States.
(2) As of May 2007, inspection programs are not able to satisfactorily accomplish the goals of ensuring the food safety of the United States.
(3) To protect the health and safety of consumers in the United States, the ability of the Secretary to perform inspection functions must be enhanced.
(b) Heightened inspections
The Secretary is authorized to enhance, as necessary, the inspection regime of the Food and Drug Administration for aquaculture and seafood, consistent with obligations of the United States under international agreements and United States law.
(c) Report to Congress
Not later than 180 days after September 27, 2007, the Secretary shall submit to Congress a report that—
(1) describes the specifics of the aquaculture and seafood inspection program;
(2) describes the feasibility of developing a traceability system for all catfish and seafood products, both domestic and imported, for the purpose of identifying the processing plant of origin of such products; and
(3) provides for an assessment of the risks associated with particular contaminants and banned substances.
(d) Partnerships with States
Upon the request by any State, the Secretary may enter into partnership agreements, as soon as practicable after the request is made, to implement inspection programs to Federal standards regarding the importation of aquaculture and seafood.
(Pub. L. 110–85, title X, § 1006, Sept. 27, 2007, 121 Stat. 969.)
21 U.S.C. § 2106 (FOOD AND DRUGS)
§ 2106. Consultation regarding genetically engineered seafood products
The Commissioner of Food and Drugs shall consult with the Assistant Administrator of the National Marine Fisheries Service of the National Oceanic and Atmospheric Administration to produce a report on any environmental risks associated with genetically engineered seafood products, including the impact on wild fish stocks.
(Pub. L. 110–85, title X, § 1007, Sept. 27, 2007, 121 Stat. 969.)
21 U.S.C. § 2107 (FOOD AND DRUGS)
§ 2107. Sense of Congress
It is the sense of Congress that—
(1) it is vital for Congress to provide the Food and Drug Administration with additional resources, authorities, and direction with respect to ensuring the safety of the food supply of the United States;
(2) additional inspectors are required to improve the Food and Drug Administration’s ability to safeguard the food supply of the United States;
(3) because of the increasing volume of international trade in food products the Secretary should make it a priority to enter into agreements with the trading partners of the United States with respect to food safety; and
(4) Congress should work to develop a comprehensive response to the issue of food safety.
(Pub. L. 110–85, title X, § 1008, Sept. 27, 2007, 121 Stat. 970.)
21 U.S.C. § 2108 (FOOD AND DRUGS)
§ 2108. Annual report to Congress
The Secretary shall, on an annual basis, submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives a report that includes, with respect to the preceding 1-year period—
(1) the number and amount of food products regulated by the Food and Drug Administration imported into the United States, aggregated by country and type of food;
(2) a listing of the number of Food and Drug Administration inspectors of imported food products referenced in paragraph (1) and the number of Food and Drug Administration inspections performed on such products; and
(3) aggregated data on the findings of such inspections, including data related to violations of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], and enforcement actions used to follow-up on such findings and violations.
(Pub. L. 110–85, title X, § 1009, Sept. 27, 2007, 121 Stat. 970.)
heading: References in Text
text: The Federal Food, Drug, and Cosmetic Act, referred to in par. (3), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§ 301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.
21 U.S.C. § 2109 (FOOD AND DRUGS)
§ 2109. Publication of annual reports
(a) In general
The Commissioner of Food and Drugs shall annually submit to Congress and publish on the Internet Web site of the Food and Drug Administration, a report concerning the results of the Administration’s pesticide residue monitoring program, that includes—
(1) information and analysis similar to that contained in the report entitled “Food and Drug Administration Pesticide Program Residue Monitoring 2003” as released in June of 2005;
(2) based on an analysis of previous samples, an identification of products or countries (for imports) that require special attention and additional study based on a comparison with equivalent products manufactured, distributed, or sold in the United States (including details on the plans for such additional studies), including in the initial report (and subsequent reports as determined necessary) the results and analysis of the Ginseng Dietary Supplements Special Survey as described on page 13 of the report entitled “Food and Drug Administration Pesticide Program Residue Monitoring 2003”;
(3) information on the relative number of interstate and imported shipments of each tested commodity that were sampled, including recommendations on whether sampling is statistically significant, provides confidence intervals or other related statistical information, and whether the number of samples should be increased and the details of any plans to provide for such increase; and
(4) a description of whether certain commodities are being improperly imported as another commodity, including a description of additional steps that are being planned to prevent such smuggling.
(b) Initial reports
Annual reports under subsection (a) for fiscal years 2004 through 2006 may be combined into a single report, by not later than June 1, 2008, for purposes of publication under subsection (a). Thereafter such reports shall be completed by June 1 of each year for the data collected for the year that was 2-years prior to the year in which the report is published.
(c) Memorandum of understanding
The Commissioner of Food and Drugs, the Administrator of the Food Safety and Inspection Service, the Department of Commerce, and the head of the Agricultural Marketing Service shall enter into a memorandum of understanding to permit inclusion of data in the reports under subsection (a) relating to testing carried out by the Food Safety and Inspection Service and the Agricultural Marketing Service on meat, poultry, eggs, and certain raw agricultural products, respectively.
(Pub. L. 110–85, title X, § 1010, Sept. 27, 2007, 121 Stat. 970.)
21 U.S.C. § 2110 (FOOD AND DRUGS)
§ 2110. Rule of construction
Nothing in this chapter (or an amendment made by this chapter) shall be construed to affect—
(1) the regulation of dietary supplements under the Dietary Supplement Health and Education Act of 1994 (Public Law 103–417); or
(2) the adverse event reporting system for dietary supplements created under the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law 109–462).
(Pub. L. 110–85, title X, § 1011, Sept. 27, 2007, 121 Stat. 971.)
heading: References in Text
text: This chapter, referred to in text, was in the original “this title”, meaning title X of Pub. L. 110–85, Sept. 27, 2007, 121 Stat. 962, which enacted this chapter and section 350f of this title, amended sections 321 and 331 of this title, and enacted provisions set out as notes under this section and section 350f of this title. For complete classification of title X to the Code, see Tables.
The Dietary Supplement Health and Education Act of 1994, referred to in par. (1), is Pub. L. 103–417, Oct. 25, 1994, 108 Stat. 4325, which enacted sections 343–2 and 350b of this title and section 287c–11 of Title 42, The Public Health and Welfare, amended sections 321, 331, 342, 343, and 350 of this title and section 281 of Title 42, and enacted provisions set out as notes under sections 321 and 343 of this title. For complete classification of this Act to the Code, see Short Title of 1994 Amendments note set out under section 301 of this title and Tables.
The Dietary Supplement and Nonprescription Drug Consumer Protection Act, referred to in par. (2), is Pub. L. 109–462, Dec. 22, 2006, 120 Stat. 3469, which enacted sections 379aa and 379aa–1 of this title, amended sections 331, 343, 352, and 381 of this title, and enacted provisions set out as notes under sections 331, 343, 352, 379aa, and 381 of this title. For complete classification of this Act to the Code, see Short Title of 2006 Amendment note set out under section 301 of this title and Tables.
heading: Construction
text: Pub. L. 110–85, title X, § 1005(g), Sept. 27, 2007, 121 Stat. 969, provided that: “Nothing in this title [enacting this chapter and section 350f of this title, amending sections 321 and 331 of this title, and enacting provisions set out as notes under section 350f of this title], or an amendment made by this title, shall be construed to alter the jurisdiction between the Secretaries of Agriculture and of Health and Human Services, under applicable statutes and regulations.”
21 U.S.C. § 2201 (FOOD AND DRUGS)
§ 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 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 appropriate, the guidance documents, including guidance documents regarding action levels, or regulations promulgated under this section.
(Pub. L. 111–353, title I, § 104, Jan. 4, 2011, 124 Stat. 3899.)
heading: References in Text
text: The Secretary, referred to in text, probably means the Secretary of Health and Human Services.
heading: Short Title
text: Pub. L. 111–353, § 1(a), Jan. 4, 2011, 124 Stat. 3885, provided that: “This Act [enacting 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, amending sections 331, 333, 334, 350b to 350d, 350f, 374, 381, 393, and 399 of this title and section 247b–20 of Title 42, and enacting provisions set out as notes under sections 331, 334, 342, 350b, 350d, 350e, 350g to 350j, 350l, and 381 of this title] may be cited as the ‘FDA Food Safety Modernization Act’.”
21 U.S.C. § 2203 (FOOD AND DRUGS)
§ 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 agriculture and food system (including intelligence information);
(3) identifying best practices and methods for improving the coordination among Federal, State, local, and private sector preparedness and response plans for agriculture and food defense; and
(4) recommending methods by which to protect the economy and the public health of the United States from the effects of—
(A) animal or plant disease outbreaks;
(B) food contamination; and
(C) natural disasters affecting agriculture and food.
(Pub. L. 111–353, title I, § 109, Jan. 4, 2011, 124 Stat. 3912.)
21 U.S.C. § 2221 (FOOD AND DRUGS)
§ 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 of data between Federal agencies and State laboratories to develop national situational awareness;
(3) provides accessible, timely, accurate, and consistent food laboratory services throughout the United States;
(4) develops and implements a methods repository for use by Federal, State, and local officials;
(5) responds to food-related emergencies; and
(6) is integrated with relevant laboratory networks administered by other Federal agencies.
(Pub. L. 111–353, title II, § 202(b), Jan. 4, 2011, 124 Stat. 3929.)
heading: References in Text
text: The Secretary, referred to in text, probably means the Secretary of Health and Human Services.
21 U.S.C. § 2222 (FOOD AND DRUGS)
§ 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 emergencies; and
(3) engage in ongoing dialogue and build relationships that will support a more effective and integrated response during emergencies.
(b) Reporting requirement
The Secretary of Homeland Security shall, on a biennial basis, 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 progress of the integrated consortium of laboratory networks, as established under subsection (a), in carrying out this section.
(Pub. L. 111–353, title II, § 203, Jan. 4, 2011, 124 Stat. 3929.)
21 U.S.C. § 2225 (FOOD AND DRUGS)
§ 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 recovery activities following the decontamination and disposal of specific threat agents and foreign animal diseases.
(c) Development of model plans
In carrying out subsection (a), the Administrator, the Secretary of Health and Human Services, and the Secretary of Agriculture shall jointly develop and disseminate model plans for—
(1) the decontamination of individuals, equipment, and facilities following an intentional contamination of agriculture or food; and
(2) the disposal of large quantities of animals, plants, or food products that have been infected or contaminated by specific threat agents and foreign animal diseases.
(d) Exercises
In carrying out subsection (a), the Administrator, in coordination with the entities described under subsection (b), shall conduct exercises at least annually to evaluate and identify weaknesses in the decontamination and disposal model plans described in subsection (c). Such exercises shall be carried out, to the maximum extent practicable, as part of the national exercise program under section 748(b)(1) of title 6.
(e) Modifications
Based on the exercises described in subsection (d), the Administrator, in coordination with the entities described in subsection (b), shall review and modify as necessary the plans described in subsection (c) not less frequently than biennially.
(f) Prioritization
The Administrator, in coordination with the entities described in subsection (b), shall develop standards and plans under subsections (b) and (c) in an identified order of priority that takes into account—
(1) highest-risk biological, chemical, and radiological threat agents;
(2) agents that could cause the greatest economic devastation to the agriculture and food system; and
(3) agents that are most difficult to clean or remediate.
(Pub. L. 111–353, title II, § 208, Jan. 4, 2011, 124 Stat. 3944.)
21 U.S.C. § 2241 (FOOD AND DRUGS)
§ 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 country or exporter may provide a rebuttal or other comments on the findings of the report to the Secretary of Health and Human Services.
(B) Distribution and use of report
The Secretary of Health and Human Services shall consider the inspection reports described in subparagraph (A) in distributing inspection resources under section 350j of this title.
(Pub. L. 111–353, title III, § 306(b), Jan. 4, 2011, 124 Stat. 3959.)