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21 U.S.C. § 2204 — Building domestic capacity
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
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Source location: Title 21, Chapter 27, § 2204; chapter-027-food-safety-modernization.md
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**(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 estimated resources needed to effectively implement the programs and practices identified in the report developed in this section over a 5-year period.
(H) The impact of requirements under this Act (including amendments made by this Act) on certified organic farms and facilities (as defined in [section 350d of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350d&num=0&edition=prelim).11 So in original. Probably should be “title).”
(I) Specific efforts taken pursuant to the agreements authorized under [section 350j(c) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350j/c&num=0&edition=prelim) (as added by section 201),22 See References in Text note below. together with, as necessary, a description of any additional authorities necessary to improve seafood safety.
(2) **Biennial reports** — On a biennial basis following the submission of the report under paragraph (1), the Secretary shall submit to Congress a report that—
(A) reviews previous food safety programs and practices;
(B) outlines the success of those programs and practices;
(C) identifies future programs and practices; and
(D) includes information related to any matter described in subparagraphs (A) through (H) of paragraph (1), as necessary.
**(b) Risk-based activities** The report developed under subsection (a)(1) shall describe methods that seek to ensure that resources available to the Secretary for food safety-related activities are directed at those actions most likely to reduce risks from food, including the use of preventive strategies and allocation of inspection resources. The Secretary shall promptly undertake those risk-based actions that are identified during the development of the report as likely to contribute to the safety and security of the food supply.
**(c) Capability for laboratory analyses; research** The report developed under subsection (a)(1) shall provide a description of methods to increase capacity to undertake analyses of food samples promptly after collection, to identify new and rapid analytical techniques, including commercially-available techniques that can be employed at ports of entry and by Food Emergency Response Network laboratories, and to provide for well-equipped and staffed laboratory facilities and progress toward laboratory accreditation under [section 350k of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350k&num=0&edition=prelim) (as added by section 202).2
**(d) Information technology** The report developed under subsection (a)(1) shall include a description of such information technology systems as may be needed to identify risks and receive data from multiple sources, including foreign governments, State, local, and tribal governments, other Federal agencies, the food industry, laboratories, laboratory networks, and consumers. The information technology systems that the Secretary describes shall also provide for the integration of the facility registration system under [section 350d of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350d&num=0&edition=prelim), and the prior notice system under [section 381(m) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section381/m&num=0&edition=prelim) with other information technology systems that are used by the Federal Government for the processing of food offered for import into the United States.
**(e) Automated risk assessment** The report developed under subsection (a)(1) shall include a description of progress toward developing and improving an automated risk assessment system for food safety surveillance and allocation of resources.
**(f) Traceback and surveillance report** The Secretary shall include in the report developed under subsection (a)(1) an analysis of the Food and Drug Administration’s performance in foodborne illness outbreaks during the 5-year period preceding January 4, 2011, involving fruits and vegetables that are raw agricultural commodities (as defined in [section 321(r) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section321/r&num=0&edition=prelim)) and recommendations for enhanced surveillance, outbreak response, and traceability. Such findings and recommendations shall address communication and coordination with the public, industry, and State and local governments, as such communication and coordination relates to outbreak identification and traceback.
**(g) Biennial food safety and food defense research plan** The Secretary, the Secretary of Agriculture, and the Secretary of Homeland Security shall, on a biennial basis, submit to Congress a joint food safety and food defense research plan which may include studying the long-term health effects of foodborne illness. Such biennial plan shall include a list and description of projects conducted during the previous 2-year period and the plan for projects to be conducted during the subsequent 2-year period.
**(h) Effectiveness of programs administered by the Department of Health and Human Services**
(1) **In general** — To determine whether existing Federal programs administered by the Department of Health and Human Services are effective in achieving the stated goals of such programs, the Secretary shall, beginning not later than 1 year after January 4, 2011—
(A) conduct an annual evaluation of each program of such Department to determine the effectiveness of each such program in achieving legislated intent, purposes, and objectives; and
(B) submit to Congress a report concerning such evaluation.
(2) **Content** — The report described under paragraph (1)(B) shall—
(A) include conclusions concerning the reasons that such existing programs have proven successful or not successful and what factors contributed to such conclusions;
(B) include recommendations for consolidation and elimination to reduce duplication and inefficiencies in such programs at such Department as identified during the evaluation conduct 33 So in original. Probably should be “conducted”. under this subsection; and
(C) be made publicly available in a publication entitled “Guide to the U.S. Department of Health and Human Services Programs”.
**(i) Unique identification numbers**
(1) **In general** — Not later than 1 year after January 4, 2011, the Secretary, acting through the Commissioner of Food and Drugs, shall conduct a study regarding the need for, and challenges associated with, development and implementation of a program that requires a unique identification number for each food facility registered with the Secretary and, as appropriate, each broker that imports food into the United States. Such study shall include an evaluation of the costs associated with development and implementation of such a system, and make recommendations about what new authorities, if any, would be necessary to develop and implement such a system.
(2) **Report** — Not later than 15 months after January 4, 2011, the Secretary shall submit to Congress a report that describes the findings of the study conducted under paragraph (1) and that includes any recommendations determined appropriate by the Secretary.
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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) Recognition of laboratory accreditation**
(1) **In general** — Not later than 2 years after January 4, 2011, the Secretary shall—
(A) establish a program for the testing of food by accredited laboratories;
(B) establish a publicly available registry of accreditation bodies recognized by the Secretary and laboratories accredited by a recognized accreditation body, including the name of, contact information for, and other information deemed appropriate by the Secretary about such bodies and laboratories; and
(C) require, as a condition of recognition or accreditation, as appropriate, that recognized accreditation bodies and accredited laboratories report to the Secretary any changes that would affect the recognition of such accreditation body or the accreditation of such laboratory.
(2) **Program requirements** — The program established under paragraph (1)(A) shall provide for the recognition of laboratory accreditation bodies that meet criteria established by the Secretary for accreditation of laboratories, including independent private laboratories and laboratories run and operated by a Federal agency (including the Department of Commerce), State, or locality with a demonstrated capability to conduct 1 or more sampling and analytical testing methodologies for food.
(3) **Increasing the number of qualified laboratories** — The Secretary shall work with the laboratory accreditation bodies recognized under paragraph (1), as appropriate, to increase the number of qualified laboratories that are eligible to perform testing under subparagraph 11 So in original. Probably should be “subsection”. (b) beyond the number so qualified on January 4, 2011.
(4) **Limited distribution** — In the interest of national security, the Secretary, in coordination with the Se
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 350k
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Registration**
(1) **In general** — The Secretary shall by regulation require that any facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States be registered with the Secretary. To be registered—
(A) for a domestic facility, the owner, operator, or agent in charge of the facility shall submit a registration to the Secretary; and
(B) for a foreign facility, the owner, operator, or agent in charge of the facility shall submit a registration to the Secretary and shall include with the registration the name of the United States agent for the facility.
(2) **Registration** — An entity (referred to in this section as the “registrant”) shall submit a registration under paragraph (1) to the Secretary containing information necessary to notify the Secretary of the name and address of each facility at which, and all trade names under which, the registrant conducts business, the e-mail address for the contact person of the facility or, in the case of a foreign facility, the United States agent for the facility, and, when determined necessary by the Secretary through guidance, the general food category (as identified under section 170.3 of title 21, Code of Federal Regulations, or any other food categories as determined appropriate by the Secretary, including by guidance) of any food manufactured, processed, packed, or held at such facility. The registration shall contain an assurance that the Secretary will be permitted to inspect such facility at the times and in the manner permitted by this chapter. The registrant shall notify the Secretary in a timely manner of changes to such information.
(3) **Biennial registration renewal** — During the period beginning on October 1 and ending on December 31 of each even-numb
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 350d
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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
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
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.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 2203
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Federal law — U.S. Code and appendices · legal_authorities
**(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
**(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
Page 1008
TITLE 21—FOOD AND DRUGS
§ 2203
1 So in original. Probably should be ‘‘title).’’
2 See References in Text note below.
(3) Evaluation
The Secretary, in coordination with the Sec-
retary of Agriculture and the Secretary of
Homeland Security, shall—
(A) develop metrics to measure progress
for the evaluation process described in para-
graph (1)(B); and
(B) report on the progress measured in sub-
paragraph (A) as part of the National Agri-
culture and Food Defense strategy described
in subsection (a)(1).
(c) Limited distribution
In the interest of national security, the Sec-
retary of Health and Human Services and the
Secretary of Agriculture, in coordination with
the Secretary of Homeland Security, may deter-
mine the manner and format in which the Na-
tional Agriculture and Food Defense strategy
established under this section is made publicly
available on the Internet Web sites of the De-
partment of Health and Human Services, the De-
partment of Homeland Security, and the Depart-
ment of Agriculture, as described in subsection
(a)(1).
(Pub. L. 111–353, title I, § 108, Jan. 4, 2011, 124
Stat. 3910.)
Editorial Notes
REFERENCES IN TEXT
The Secretary, referred to in subsec. (b)(3), probably
means the Secretary of Health and Human Services.
§ 2203. Food and Agriculture Coordinating Coun-
cils
The Secretary of Homeland Security, in co-
ordination with the Secretary of Health and
Human Services and the Secretary of Agri-
culture, 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 Depart-
ment of Homeland Security, a report on the ac-
tivities of the Food and Agriculture Government
Coordinating Council and the Food and Agri-
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 2204
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