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21 U.S.C. § 399c — Improving the training of State, local, territorial, and tribal food safety officials
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,
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Source file: Laws/federal/codes/united-states-code/title-21/section-399c-improving-the-training-of-state-local-territorial-and-tribal-food-safety--ce5b4d139e.md
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Source location: Title 21, Chapter 9, § 399c; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(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, from the Secretary for the examinations, testing, or investigations performed pursuant to this section by the officers or employees of the State, territorial, or tribal department or agency.
(3) **Effect** — Nothing in this subsection shall be construed to limit the authority of the Secretary under [section 372 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section372&num=0&edition=prelim).
**(c) Extension service** The Secretary shall ensure coordination with the extension activities of the National Institute of Food and Agriculture of the Department of Agriculture in advising producers and small processors transitioning into new practices required as a result of the enactment of the FDA Food Safety Modernization Act and assisting regulated industry with compliance with such Act.
**(d) National Food Safety Training, Education, Extension, Outreach and Technical Assistance Program**
(1) **In general** — In order to improve food safety and reduce the incidence of foodborne illness, the Secretary shall, not later than 180 days after January 4, 2011, enter into one or more memoranda of understanding, or enter into other cooperative agreements, with the Secretary of Agriculture to establish a competitive grant program within the National Institute for Food and Agriculture to provide food safety training, education, extension, outreach, and technical assistance to—
(A) owners and operators of farms;
(B) small food processors; and
(C) small fruit and vegetable merchant wholesalers.
(2) **Implementation** — The competitive grant program established under paragraph (1) shall be carried out in accordance with [section 7625 of title 7](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title7-section7625&num=0&edition=prelim).
**(e) Authorization of appropriations** There are authorized to be appropriated such sums as may be necessary to carry out this section for fiscal years 2011 through 2015.
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Authority to conduct**
(1)
(A) The Secretary is authorized to conduct examinations and investigations for the purposes of this chapter through officers and employees of the Department or through any health, food, or drug officer or employee of any State, Territory, or political subdivision thereof, duly commissioned by the Secretary as an officer of the Department.
(B)
(i) For a tobacco product, to the extent feasible, the Secretary shall contract with the States in accordance with this paragraph to carry out inspections of retailers within that State in connection with the enforcement of this chapter.
(ii) The Secretary shall not enter into any contract under clause (i) with the government of any of the several States to exercise enforcement authority under this chapter on Indian country without the express written consent of the Indian tribe involved.
(2)
(A) In addition to the authority established in paragraph (1), the Secretary, pursuant to a memorandum of understanding between the Secretary and the head of another Federal department or agency, is authorized to conduct examinations and investigations for the purposes of this chapter through the officers and employees of such other department or agency, subject to subparagraph (B). Such a memorandum shall include provisions to ensure adequate training of such officers and employees to conduct the examinations and investigations. The memorandum of understanding 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, from the Secretary for the examinations or investigations performed under this section by the officers or employees of the other department or agency.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 372
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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** No entity engaged in the manufacture, processing, packing, transporting, distribution, reception, holding, or importation of food may discharge an employee or otherwise discriminate against an employee with respect to compensation, terms, conditions, or privileges of employment because the employee, whether at the employee’s initiative or in the ordinary course of the employee’s duties (or any person acting pursuant to a request of the employee)—
(1) provided, caused to be provided, or is about to provide or cause to be provided to the employer, the Federal Government, or the attorney general of a State information relating to any violation of, or any act or omission the employee reasonably believes to be a violation of any provision of this chapter or any order, rule, regulation, standard, or ban under this chapter, or any order, rule, regulation, standard, or ban under this chapter; 11 So in original.
(2) testified or is about to testify in a proceeding concerning such violation;
(3) assisted or participated or is about to assist or participate in such a proceeding; or
(4) objected to, or refused to participate in, any activity, policy, practice, or assigned task that the employee (or other such person) reasonably believed to be in violation of any provision of this chapter, or any order, rule, regulation, standard, or ban under this chapter.
**(b) Process**
(1) **In general** — A person who believes that he or she has been discharged or otherwise discriminated against by any person in violation of subsection (a) may, not later than 180 days after the date on which such violation occurs, file (or have any person file on his or her behalf) a complaint with the Secretary of Labor (referred to in this section as the “Secretary”) alleging such dis
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 399d
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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
**(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
**(a) Establishment** There is established within the Office of the Commissioner, an office to be known as the Office of Women’s Health (referred to in this section as the “Office”). The Office shall be headed by a director who shall be appointed by the Commissioner of Food and Drugs.
**(b) Purpose** The Director of the Office shall—
(1) report to the Commissioner of Food and Drugs on current Food and Drug Administration (referred to in this section as the “Administration”) levels of activity regarding women’s participation in clinical trials and the analysis of data by sex in the testing of drugs, medical devices, and biological products across, where appropriate, age, biological, and sociocultural contexts;
(2) establish short-range and long-range goals and objectives within the Administration for issues of particular concern to women’s health within the jurisdiction of the Administration, including, where relevant and appropriate, adequate inclusion of women and analysis of data by sex in Administration protocols and policies;
(3) provide information to women and health care providers on those areas in which differences between men and women exist;
(4) consult with pharmaceutical, biologics, and device manufacturers, health professionals with expertise in women’s issues, consumer organizations, and women’s health professionals on Administration policy with regard to women;
(5) make annual estimates of funds needed to monitor clinical trials and analysis of data by sex in accordance with needs that are identified; and
(6) serve as a member of the Department of Health and Human Services Coordinating Committee on Women’s Health (established under [section 237a(b)(4) of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section237a/b/4&
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 399b
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** The Secretary shall award grants under this section to carry out the competitive grant program established under section 399c(d) 11 See References in Text note below. of title 21, pursuant to any memoranda of understanding entered into under such section.
**(b) Integrated approach** The grant program described under subsection (a) shall be carried out under this section in a manner that facilitates the integration of food safety standards and guidance with the variety of agricultural production systems, encompassing conventional, sustainable, organic, and conservation and environmental practices.
**(c) Priority** In awarding grants under this section, the Secretary shall give priority to projects that target small and medium-sized farms, beginning farmers, socially disadvantaged farmers, veteran farmers or ranchers (as defined in [section 2279(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title7-section2279/a&num=0&edition=prelim)), small processors, or small fresh fruit and vegetable merchant wholesalers.
**(d) Program coordination**
(1) **In general** — The Secretary shall coordinate implementation of the grant program under this section with the National Integrated Food Safety Initiative.
(2) **Interaction** — The Secretary shall—
(A) in carrying out the grant program under this section, take into consideration applied research, education, and extension results obtained from the National Integrated Food Safety Initiative; and
(B) in determining the applied research agenda for the National Integrated Food Safety Initiative, take into consideration the needs articulated by participants in projects funded by the program under this section.
**(e) Grants**
(1) **In general** — In carrying out this section, t
Source: Supplied U.S. Code snapshot — release unconfirmed · 7 U.S.C. § 7626
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Federal law — U.S. Code and appendices · legal_authorities
Page 710
TITLE 21—FOOD AND DRUGS
§ 399c
tion as the ‘‘Office’’). The Office shall be headed
by a director who shall be appointed by the
Commissioner of Food and Drugs.
(b) Purpose
The Director of the Office shall—
(1) report to the Commissioner of Food and
Drugs on current Food and Drug Administra-
tion (referred to in this section as the ‘‘Ad-
ministration’’) levels of activity regarding
women’s participation in clinical trials and
the analysis of data by sex in the testing of
drugs, medical devices, and biological products
across, where appropriate, age, biological, and
sociocultural contexts;
(2) establish short-range and long-range
goals and objectives within the Administra-
tion for issues of particular concern to wom-
en’s health within the jurisdiction of the Ad-
ministration, including, where relevant and
appropriate, adequate inclusion of women and
analysis of data by sex in Administration pro-
tocols and policies;
(3) provide information to women and health
care providers on those areas in which dif-
ferences between men and women exist;
(4) consult with pharmaceutical, biologics,
and
device
manufacturers,
health
profes-
sionals with expertise in women’s issues, con-
sumer organizations, and women’s health pro-
fessionals on Administration policy with re-
gard to women;
(5) make annual estimates of funds needed to
monitor clinical trials and analysis of data by
sex in accordance with needs that are identi-
fied; and
(6) serve as a member of the Department of
Health and Human Services Coordinating
Committee on Women’s Health (established
under section 237a(b)(4) of title 42).
(c) Authorization of appropriations
For the purpose of carrying out this section,
there are authorized to be appropriated such
sums as may be necessary fo
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 399c
Stored review status: historical_2024_not_currentness_verified. Same stored citation; legal effect and authority still require review.