21 U.S.C. § 1532 (2024) — Title 21: FOOD AND DRUGS / Chapter 20: NATIONAL DRUG CONTROL PROGRAM / Subchapter II: DRUG-FREE COMMUNITIES / Section 1532: Program authorization
Program authorization
Status: in_force

(a) Grant eligibility

To be eligible to receive an initial grant or a renewal grant under this part, a coalition shall meet each of the following criteria:

(1) Application

The coalition shall submit an application to the Administrator in accordance with section 1533(a)(2) of this title.

(2) Major sector involvement

(A) In general

The coalition shall consist of 1 or more representatives of each of the following categories:

(i) Youth.

(ii) Parents.

(iii) Businesses.

(iv) The media.

(v) Schools.

(vi) Organizations serving youth.

(vii) Law enforcement.

(viii) Religious or fraternal organizations.

(ix) Civic and volunteer groups.

(x) Health care professionals.

(xi) State, local, or tribal governmental agencies with expertise in the field of substance use and misuse (including, if applicable, the State authority with primary authority for substance use and misuse).

(xii) Other organizations involved in reducing substance use and misuse.

(B) Elected officials

If feasible, in addition to representatives from the categories listed in subparagraph (A), the coalition shall have an elected official (or a representative of an elected official) from—

(i) the Federal Government; and

(ii) the government of the appropriate State and political subdivision thereof or the governing body or an Indian tribe (as that term is defined in section 5304(e) of title 25).

(C) Representation

An individual who is a member of the coalition may serve on the coalition as a representative of not more than 1 category listed under subparagraph (A).

(3) Commitment

The coalition shall demonstrate, to the satisfaction of the Administrator—

(A) that the representatives of the coalition have worked together on substance use and misuse reduction initiatives, which, at a minimum, includes initiatives that target drugs referenced in section 1523(9)(A) of this title, for a period of not less than 6 months, acting through entities such as task forces, subcommittees, or community boards; and

(B) substantial participation from volunteer leaders in the community involved (especially in cooperation with individuals involved with youth such as parents, teachers, coaches, youth workers, and members of the clergy).

(4) Mission and strategies

The coalition shall, with respect to the community involved—

(A) have as its principal mission the reduction of substance use and misuse, which, at a minimum, includes the use and abuse of drugs referenced in section 1523(9)(A) of this title, in a comprehensive and long-term manner, with a primary focus on youth in the community;

(B) describe and document the nature and extent of the substance use and misuse problem, which, at a minimum, includes the use and abuse of drugs referenced in section 1523(9)(A) of this title, in the community;

(C)(i) provide a description of substance use and misuse prevention and treatment programs and activities, which, at a minimum, includes programs and activities relating to the use and abuse of drugs referenced in section 1523(9)(A) of this title, in existence at the time of the grant application; and

(ii) identify substance use and misuse programs and service gaps, which, at a minimum, includes programs and gaps relating to the use and abuse of drugs referenced in section 1523(9)(A) of this title, in the community;

(D) develop a strategic plan to reduce substance use and misuse among youth, which, at a minimum, includes the use and abuse of drugs referenced in section 1523(9)(A) of this title, in a comprehensive and long-term fashion; and

(E) work to develop a consensus regarding the priorities of the community to combat substance use and misuse among youth, which, at a minimum, includes the use and abuse of drugs referenced in section 1523(9)(A) of this title.

(5) Sustainability

The coalition shall demonstrate that the coalition is an ongoing concern by demonstrating that the coalition—

(A) is—

(i)(I) a nonprofit organization; or

(II) an entity that the Administrator determines to be appropriate; or

(ii) part of, or is associated with, an established legal entity;

(B) receives financial support (including, in the discretion of the Administrator, in-kind contributions) from non-Federal sources; and

(C) has a strategy to solicit substantial financial support from non-Federal sources to ensure that the coalition and the programs operated by the coalition are self-sustaining.

(6) Accountability

The coalition shall—

(A) establish a system to measure and report outcomes—

(i) consistent with common indicators and evaluation protocols established by the Administrator; and

(ii) approved by the Administrator;

(B) conduct—

(i) for an initial grant under this part, an initial benchmark survey of drug use among youth (or use local surveys or performance measures available or accessible in the community at the time of the grant application); and

(ii) biennial surveys (or incorporate local surveys in existence at the time of the evaluation) to measure the progress and effectiveness of the coalition; and

(C) provide assurances that the entity conducting an evaluation under this paragraph, or from which the coalition receives information, has experience—

(i) in gathering data related to substance use and misuse among youth; or

(ii) in evaluating the effectiveness of community anti-drug coalitions.

(7) Additional criteria

The Director shall not impose any eligibility criteria on new applicants or renewal grantees not provided in this subchapter.

(b) Grant amounts

(1) In general

(A) Grants

(i) In general

Subject to clause (iv), for a fiscal year, the Administrator may grant to an eligible coalition under this paragraph, an amount not to exceed the amount of non-Federal funds raised by the coalition, including in-kind contributions, for that fiscal year.

(ii) Suspension of grants

If such grant recipient fails to continue to meet the criteria specified in subsection (a), the Administrator may suspend the grant, after providing written notice to the grant recipient and an opportunity to appeal.

(iii) Renewal grants

Subject to clause (iv), the Administrator may award a renewal grant to a grant recipient under this subparagraph for each fiscal year following the fiscal year for which an initial grant is awarded, in an amount not to exceed the amount of non-Federal funds raised by the coalition, including in-kind contributions, for that fiscal year, during the 4-year period following the period of the initial grant.

(iv) Limitation

The amount of a grant award under this subparagraph may not exceed $125,000 for a fiscal year.

(B) Coalition awards

(i) In general

Except as provided in clause (ii), the Administrator may, with respect to a community, make a grant to 1 eligible coalition that represents that community.

(ii) Exception

The Administrator may make a grant to more than 1 eligible coalition that represents a community if—

(I) the eligible coalitions demonstrate that the coalitions are collaborating with one another; and

(II) each of the coalitions has independently met the requirements set forth in subsection (a).

(2) Rural coalition grants

(A) In general

(i) In general

In addition to awarding grants under paragraph (1), to stimulate the development of coalitions in sparsely populated and rural areas, the Administrator, in consultation with the Advisory Commission, may award a grant in accordance with this section to a coalition that represents a county with a population that does not exceed 30,000 individuals. In awarding a grant under this paragraph, the Administrator may waive any requirement under subsection (a) if the Administrator considers that waiver to be appropriate.

(ii) Matching requirement

Subject to subparagraph (C), for a fiscal year, the Administrator may grant to an eligible coalition under this paragraph, an amount not to exceed the amount of non-Federal funds raised by the coalition, including in-kind contributions, for that fiscal year.

(iii) Suspension of grants

If such grant recipient fails to continue to meet any criteria specified in subsection (a) that has not been waived by the Administrator pursuant to clause (i), the Administrator may suspend the grant, after providing written notice to the grant recipient and an opportunity to appeal.

(B) Renewal grants

The Administrator may award a renewal grant to an eligible coalition that is a grant recipient under this paragraph for each fiscal year following the fiscal year for which an initial grant is awarded, in an amount not to exceed the amount of non-Federal funds raised by the coalition, including in-kind contributions, during the 4-year period following the period of the initial grant.

(C) Limitations

(i) Amount

The amount of a grant award under this paragraph shall not exceed $125,000 for a fiscal year.

(ii) Awards

With respect to a county referred to in subparagraph (A), the Administrator may award a grant under this section to not more than 1 eligible coalition that represents the county.

(3) Additional grants

(A) In general

Subject to subparagraph (F), the Administrator may award an additional grant under this paragraph to an eligible coalition awarded a grant under paragraph (1) or (2) for any first fiscal year after the end of the 4-year period following the period of the initial grant under paragraph (1) or (2), as the case may be.

(B) Scope of grants

A coalition awarded a grant under paragraph (1) or (2), including a renewal grant under such paragraph, may not be awarded another grant under such paragraph, and is eligible for an additional grant under this section only under this paragraph.

(C) No priority for applications

The Administrator may not afford a higher priority in the award of an additional grant under this paragraph than the Administrator would afford the applicant for the grant if the applicant were submitting an application for an initial grant under paragraph (1) or (2) rather than an application for a grant under this paragraph.

(D) Renewal grants

Subject to clause (iv),1 the Administrator may award a renewal grant to a grant recipient under this subparagraph 2 for each fiscal year of the 4-fiscal-year period following the first fiscal year for which the initial additional grant is awarded in an amount not to exceed the following:

(i) For the first and second fiscal years of the 4-fiscal-year period, the amount of the non-Federal funds, including in-kind contributions, raised by the coalition for the applicable fiscal year is not less than 125 percent of the amount awarded.

(ii) For the third and fourth fiscal years of the 4-fiscal-year period, the amount of the non-Federal funds, including in-kind contributions, raised by the coalition for the applicable fiscal year is not less than 150 percent of the amount awarded.

(E) Suspension

If a grant recipient under this paragraph fails to continue to meet the criteria specified in subsection (a), the Administrator may suspend the grant, after providing written notice to the grant recipient and an opportunity to appeal.

(F) Limitation

The amount of a grant award under this paragraph may not exceed $125,000 for a fiscal year.

(4) Process for suspension

A grantee shall not be suspended or terminated under paragraph (1)(A)(ii), (2)(A)(iii), or (3)(E) unless that grantee is afforded a fair, timely, and independent appeal prior to such suspension or termination.

(c) Treatment of funds for coalitions representing certain organizations

Funds appropriated for the substance use and misuse activities of a coalition that includes a representative of the Bureau of Indian Affairs, the Indian Health Service, or a tribal government agency with expertise in the field of substance use and misuse may be counted as non-Federal funds raised by the coalition for purposes of this section.

(d) Priority in awarding grants

In awarding grants under subsection (b)(1)(A)(i), priority shall be given to a coalition serving economically disadvantaged areas.

(Pub. L. 100–690, title I, §1032, as added Pub. L. 105–20, §2(a)(2), June 27, 1997, 111 Stat. 227; amended Pub. L. 107–82, §1(d), (g), (h), Dec. 14, 2001, 115 Stat. 818, 819; Pub. L. 109–469, title VIII, §§802(a), 803, 804, Dec. 29, 2006, 120 Stat. 3535; Pub. L. 115–271, title VIII, §8203(a)(3)(A), (b)(4), formerly §8203(a)(4)(A), (b)(4), Oct. 24, 2018, 132 Stat. 4111, renumbered Pub. L. 116–74, §2(c)(1)(A)(i)(IV), Nov. 27, 2019, 133 Stat. 1157; Pub. L. 116–74, §2(c)(1)(A)(i)(V), (ii)(II), (iii), (3), Nov. 27, 2019, 133 Stat. 1157, 1158.)

Editorial Notes

Amendments

2019—Pub. L. 116–74, §2(c)(1)(A)(ii)(II), made technical amendment to directory language of Pub. L. 115–271, §8203(b)(4). See 2018 Amendment notes below.

Pub. L. 116–74, §2(c)(1)(A)(i)(V), made technical amendment to directory language of Pub. L. 115–271, §8203(a)(3)(A). See 2018 Amendment note below.

Subsec. (b)(1)(A)(iii). Pub. L. 116–74, §2(c)(1)(A)(ii)(II), (III), (3), amended directory language of Pub. L. 115–271, §8203(b)(4)(B). See 2018 Amendment note below.

Subsec. (b)(3)(D). Pub. L. 116–74, §2(c)(1)(A)(ii)(II), (III), (iii), amended directory language of Pub. L. 115–271, §8203(b)(4)(B). See 2018 Amendment note below.

2018—Pub. L. 115–271, §8203(b)(4)(A), as amended by Pub. L. 116–74, §2(c)(1)(A)(ii)(II), substituted "substance use and misuse" for "substance abuse" wherever appearing.

Pub. L. 115–271, §8203(a)(3)(A), formerly §8203(a)(4)(A), as renumbered and amended by Pub. L. 116–74, §2(c)(1)(A)(i)(IV), (V), amended directory language of Pub. L. 109–469, §§802(a), 803, 804. See 2006 Amendment notes below.

Subsec. (b)(1)(A)(iii). Pub. L. 115–271, §8203(b)(4)(B), which originally directed striking cl. (iii) and inserting a new cl. (iii), was subsequently amended by Pub. L. 116–74, §2(c)(1)(A)(ii)(II), (III), so that it no longer amended cl. (iii) but amended subsec. (b)(3)(D) instead. In addition, Pub. L. 116–74, §2(c)(3), restored the prior cl. (iii) as if the amendment made by Pub. L. 115–271, §8203(b)(4), had never been enacted. See subsec. (b)(3)(D) Amendment note below.

Subsec. (b)(3)(D). Pub. L. 115–271, §8203(b)(4)(B), as amended by Pub. L. 116–74, §2(c)(1)(A)(ii)(II), (III), (iii), amended subpar. (D) generally. Prior to amendment, text read as follows: "Subject to subparagraph (F), the Administrator may award a renewal grant to a grant recipient under this paragraph for each of the fiscal years of the 4-fiscal-year period following the fiscal year for which the initial additional grant under subparagraph (A) is awarded in an amount not to exceed amounts as follows:

"(i) For the first and second fiscal years of that 4-fiscal-year period, the amount equal to 80 percent of the non-Federal funds, including in-kind contributions, raised by the coalition for the applicable fiscal year.

"(ii) For the third and fourth fiscal years of that 4-fiscal-year period, the amount equal to 67 percent of the non-Federal funds, including in-kind contributions, raised by the coalition for the applicable fiscal year."

2006—Subsec. (a)(7). Pub. L. 109–469, §804, as amended by Pub. L. 115–271, §8203(a)(3)(A), added par. (7).

Subsec. (b)(1)(A)(iv), (2)(C)(i), (3)(F). Pub. L. 109–469, §803, as amended by Pub. L. 115–271, §8203(a)(3)(A), substituted "$125,000" for "$100,000".

Subsec. (b)(4). Pub. L. 109–469, §802(a), as amended by Pub. L. 115–271, §8203(a)(3)(A), added par. (4).

2001—Subsec. (b)(3). Pub. L. 107–82, §1(d), added par. (3).

Subsec. (c). Pub. L. 107–82, §1(g), added subsec. (c).

Subsec. (d). Pub. L. 107–82, §1(h), added subsec. (d).

Statutory Notes and Related Subsidiaries

Effective Date of 2019 Amendment

Amendment by Pub. L. 116–74 effective as if included in the enactment of subtitle K of title VIII of Pub. L. 115–271, see section 2(c)(2) of Pub. L. 116–74, set out as a note under section 1522 of this title.

Effective Date of 2018 Amendment

Amendment by section 8203(a)(3)(A) of Pub. L. 115–271 effective as if enacted as part of Pub. L. 109–469, see section 8203(a)(3)(B) of Pub. L. 115–271, set out as a note under section 1524 of this title.

Waiver of Federal Fund Limitation for the Drug-Free Communities Support Program

Pub. L. 117–103, div. P, title I, §161, Mar. 15, 2022, 136 Stat. 801, provided that:

"(a) In General.—Subject to subsection (b), if the Administrator of the Drug-Free Communities Support Program determines that, as a result of the public health emergency declared pursuant to section 319 of the Public Health Service Act (42 U.S.C. 247d) with respect to COVID–19, an eligible coalition is unable to raise the amount of non-Federal funds, including in-kind contributions, agreed to be raised by the coalition for fiscal year 2020, 2021, or 2022 under an agreement entered into with the Administrator pursuant to paragraph (1)(A) or (3) of section 1032(b) of the Anti-Drug Abuse Act of 1988 (21 U.S.C. 1532(b)), the Administrator may, notwithstanding such paragraphs, provide to the eligible coalition the grant or renewal grant, as applicable, for that fiscal year only in an amount—

"(1) with respect to an initial grant or renewal grant described under paragraph (1)(A) or (3)(A) of such section, that exceeds the amount of non-Federal funds raised by the eligible coalition, including in-kind contributions, for that fiscal year;

"(2) with respect to a renewal grant described under paragraph (3)(D)(i) of such section, that exceeds 125 percent of the amount of non-Federal funds raised by the eligible coalition, including in-kind contributions, for that fiscal year; and

"(3) with respect to a renewal grant described under paragraph (3)(D)(ii) of such section, that exceeds 150 percent of the amount of non-Federal funds raised by the eligible coalition, including in-kind contributions, for that fiscal year.

"(b) Limitation.—The Administrator may not provide a grant or renewal grant to an eligible coalition in an amount exceeding the amount of funds initially agreed to be provided by the Administrator under the applicable agreement."

Report to Congress

Pub. L. 109–469, title VIII, §802(b), Dec. 29, 2006, 120 Stat. 3535, as amended by Pub. L. 115–271, title VIII, §8203(a)(3)(A), formerly §8203(a)(4)(A), Oct. 24, 2018, 132 Stat. 4111, as renumbered by Pub. L. 116–74, §2(c)(1)(A)(i)(IV), Nov. 27, 2019, 133 Stat. 1157; Pub. L. 116–74, §2(c)(1)(A)(i)(V), Nov. 27, 2019, 133 Stat. 1157, provided that: "Not later than 60 days after the date of enactment of this Act [Dec. 29, 2006], the Director of the Office of National Drug Control Policy shall submit to Congress a report detailing the appeals process required by section 1032(b)(4) of the Anti-Drug Abuse Act of 1988 [21 U.S.C. 1532(b)(4)], as added by subsection (a)."

1 So in original. Probably should be "subparagraph (F),".

2 So in original. Probably should be "this paragraph".
21 U.S.C. § 2353 (2024) — Title 21: FOOD AND DRUGS / Chapter 28A: FENTANYL ERADICATION AND NARCOTICS DETERRENCE OFF FENTANYL / Subchapter I: SANCTIONS IN RESPONSE TO NATIONAL EMERGENCY RELATING TO FENTANYL TRAFFICKING / Section 2353: Imposition of sanctions with respect to fentanyl trafficking by transnational criminal organizations
Imposition of sanctions with respect to fentanyl trafficking by transnational criminal organizations
Status: in_force

(a) In general

The President shall impose the sanctions described in subsection (b) with respect to any foreign person the President determines—

(1) is knowingly involved in the significant trafficking of fentanyl, fentanyl precursors, or other related opioids, including such trafficking by a transnational criminal organization; or

(2) otherwise is knowingly involved in significant activities of a transnational criminal organization relating to the trafficking of fentanyl, fentanyl precursors, or other related opioids.

(b) Sanctions described

The President, pursuant to the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.), may block and prohibit all transactions in property and interests in property of a foreign person described in subsection (a) if such property and interests in property are in the United States, come within the United States, or are or come within the possession or control of a United States person.

(c) Report required

Not later than 180 days after April 24, 2024, and annually thereafter, the President shall submit to the appropriate congressional committees a report on actions taken by the executive branch with respect to the foreign persons identified under subsection (a).

(Pub. L. 118–50, div. E, title I, §3103, Apr. 24, 2024, 138 Stat. 936.)

Editorial Notes

References in Text

The International Emergency Economic Powers Act, referred to in subsec. (b), is title II of Pub. L. 95–223, Dec. 28, 1977, 91 Stat. 1626, which is classified generally to chapter 35 (§1701 et seq.) of Title 50, War and National Defense. For complete classification of this Act to the Code, see Short Title note set out under section 1701 of Title 50 and Tables.
21 U.S.C. § 1902 (2024) — Title 21: FOOD AND DRUGS / Chapter 24: INTERNATIONAL NARCOTICS TRAFFICKING / Section 1902: Purpose
Purpose
Status: in_force

The purpose of this chapter is to provide authority for the identification of, and application of sanctions on a worldwide basis to, significant foreign narcotics traffickers, their organizations, and the foreign persons who provide support to those significant foreign narcotics traffickers and their organizations, whose activities threaten the national security, foreign policy, and economy of the United States.

(Pub. L. 106–120, title VIII, §803, Dec. 3, 1999, 113 Stat. 1626.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this title", meaning title VIII of Pub. L. 106–120, Dec. 3, 1999, 113 Stat. 1626, which is classified generally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1901 of this title and Tables.
21 U.S.C. § 2223 (2024) — Title 21: FOOD AND DRUGS / Chapter 27: FOOD SAFETY MODERNIZATION / Subchapter II: IMPROVING CAPACITY TO DETECT AND RESPOND TO FOOD SAFETY PROBLEMS / Section 2223: Enhancing tracking and tracing of food and recordkeeping
Enhancing tracking and tracing of food and recordkeeping
Status: in_force

(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 conduct 1 or more pilot projects under paragraph (1) in coordination with the processed food sector and 1 or more such pilot projects in coordination with processors or distributors of fruits and vegetables that are raw agricultural commodities. The Secretary shall ensure that the pilot projects under paragraph (1) reflect the diversity of the food supply and include at least 3 different types of foods that have been the subject of significant outbreaks during the 5-year period preceding January 4, 2011, and are selected in order to—

(A) develop and demonstrate methods for rapid and effective tracking and tracing of foods in a manner that is practicable for facilities of varying sizes, including small businesses;

(B) develop and demonstrate appropriate technologies, including technologies existing on January 4, 2011, that enhance the tracking and tracing of food; and

(C) inform the promulgation of regulations under subsection (d).

(3) Report

Not later than 18 months after January 4, 2011, the Secretary shall report to Congress on the findings of the pilot projects under this subsection together with recommendations for improving the tracking and tracing of food.

(b) Additional data gathering

(1) In general

The Secretary, in coordination with the Secretary of Agriculture and multiple representatives of State departments of health and agriculture, shall assess—

(A) the costs and benefits associated with the adoption and use of several product tracing technologies, including technologies used in the pilot projects under subsection (a);

(B) the feasibility of such technologies for different sectors of the food industry, including small businesses; and

(C) whether such technologies are compatible with the requirements of this subsection.

(2) Requirements

To the extent practicable, in carrying out paragraph (1), the Secretary shall—

(A) evaluate domestic and international product tracing practices in commercial use;

(B) consider international efforts, including an assessment of whether product tracing requirements developed under this section are compatible with global tracing systems, as appropriate; and

(C) consult with a diverse and broad range of experts and stakeholders, including representatives of the food industry, agricultural producers, and nongovernmental organizations that represent the interests of consumers.

(c) Product tracing system

The Secretary, in consultation with the Secretary of Agriculture, shall, as appropriate, establish within the Food and Drug Administration a product tracing system to receive information that improves the capacity of the Secretary to effectively and rapidly track and trace food that is in the United States or offered for import into the United States. Prior to the establishment of such product tracing system, the Secretary shall examine the results of applicable pilot projects and shall ensure that the activities of such system are adequately supported by the results of such pilot projects.

(d) Additional recordkeeping requirements for high risk foods

(1) In general

In order to rapidly and effectively identify recipients of a 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, not later than 2 years after January 4, 2011, the Secretary shall publish a notice of proposed rulemaking to establish recordkeeping requirements, in addition to the requirements under section 350c of this title and subpart J of part 1 of title 21, Code of Federal Regulations (or any successor regulations), for facilities that manufacture, process, pack, or hold foods that the Secretary designates under paragraph (2) as high-risk foods. The Secretary shall set an appropriate effective date of such additional requirements for foods designated as high risk that takes into account the length of time necessary to comply with such requirements. Such requirements shall—

(A) relate only to information that is reasonably available and appropriate;

(B) be science-based;

(C) not prescribe specific technologies for the maintenance of records;

(D) ensure that the public health benefits of imposing additional recordkeeping requirements outweigh the cost of compliance with such requirements;

(E) be scale-appropriate and practicable for facilities of varying sizes and capabilities with respect to costs and recordkeeping burdens, and not require the creation and maintenance of duplicate records where the information is contained in other company records kept in the normal course of business;

(F) minimize the number of different recordkeeping requirements for facilities that handle more than 1 type of food;

(G) to the extent practicable, not require a facility to change business systems to comply with such requirements;

(H) allow any person subject to this subsection to maintain records required under this subsection at a central or reasonably accessible location provided that such records can be made available to the Secretary not later than 24 hours after the Secretary requests such records; and 1

(I) include a process by which the Secretary may issue a waiver of the requirements under this subsection if the Secretary determines that such requirements would result in an economic hardship for an individual facility or a type of facility;

(J) be commensurate with the known safety risks of the designated food;

(K) take into account international trade obligations;

(L) not require—

(i) a full pedigree, or a record of the complete previous distribution history of the food from the point of origin of such food;

(ii) records of recipients of a food beyond the immediate subsequent recipient of such food; or

(iii) product tracking to the case level by persons subject to such requirements; and

(M) include a process by which the Secretary may remove a high-risk food designation developed under paragraph (2) for a food or type of food.

(2) Designation of high-risk foods

(A) In general

Not later than 1 year after January 4, 2011, and thereafter as the Secretary determines necessary, the Secretary shall designate high-risk foods for which the additional recordkeeping requirements described in paragraph (1) are appropriate and necessary to protect the public health. Each such designation shall be based on—

(i) the known safety risks of a particular food, including the history and severity of foodborne illness outbreaks attributed to such food, taking into consideration foodborne illness data collected by the Centers for Disease Control and Prevention;

(ii) the likelihood that a particular food has a high potential risk for microbiological or chemical contamination or would support the growth of pathogenic microorganisms due to the nature of the food or the processes used to produce such food;

(iii) the point in the manufacturing process of the food where contamination is most likely to occur;

(iv) the likelihood of contamination and steps taken during the manufacturing process to reduce the possibility of contamination;

(v) the likelihood that consuming a particular food will result in a foodborne illness due to contamination of the food; and

(vi) the likely or known severity, including health and economic impacts, of a foodborne illness attributed to a particular food.

(B) List of high-risk foods

At the time the Secretary promulgates the final rules under paragraph (1), the Secretary shall publish the list of the foods designated under subparagraph (A) as high-risk foods on the Internet website of the Food and Drug Administration. The Secretary may update the list to designate new high-risk foods and to remove foods that are no longer deemed to be high-risk foods, provided that each such update to the list is consistent with the requirements of this subsection and notice of such update is published in the Federal Register.

(3) Protection of sensitive information

In promulgating regulations under this subsection, the Secretary shall take appropriate measures to ensure that there are effective procedures to prevent the unauthorized disclosure of any trade secret or confidential information that is obtained by the Secretary pursuant to this section, including periodic risk assessment and planning to prevent unauthorized release and controls to—

(A) prevent unauthorized reproduction of trade secret or confidential information;

(B) prevent unauthorized access to trade secret or confidential information; and

(C) maintain records with respect to access by any person to trade secret or confidential information maintained by the agency.

(4) Public input

During the comment period in 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 different regions an opportunity to comment.

(5) Retention of records

Except as otherwise provided in this subsection, the Secretary may require that a facility retain records under this subsection for not more than 2 years, taking into consideration the risk of spoilage, loss of value, or loss of palatability of the applicable food when determining the appropriate timeframes.

(6) Limitations

(A) Farm to school programs

In establishing requirements under this subsection, the Secretary shall, in consultation with the Secretary of Agriculture, consider the impact of requirements on farm to school or farm to institution programs of the Department of Agriculture and other farm to school and farm to institution programs outside such agency, and shall modify the requirements under this subsection, as appropriate, with respect to such programs so that the requirements do not place undue burdens on farm to school or farm to institution programs.

(B) Identity-preserved labels with respect to farm sales of food that is produced and packaged on a farm

The requirements under this subsection shall not apply to a food that is produced and packaged on a farm if—

(i) the packaging of the food maintains the integrity of the product and prevents subsequent contamination or alteration of the product; and

(ii) the labeling of the food includes the name, complete address (street address, town, State, country, and zip or other postal code), and business phone number of the farm, unless the Secretary waives the requirement to include a business phone number of the farm, as appropriate, in order to accommodate a religious belief of the individual in charge of such farm.

(C) Fishing vessels

The requirements under this subsection with respect to a food that is produced through the use of a fishing vessel (as defined in section 1802(18) of title 16) shall be limited to the requirements under subparagraph (F) until such time as the food is sold by the owner, operator, or agent in charge of such fishing vessel.

(D) Commingled raw agricultural commodities

(i) Limitation on extent of tracing

Recordkeeping requirements under this subsection with regard to any commingled raw agricultural commodity shall be limited to the requirements under subparagraph (F).

(ii) Definitions

For the purposes of this subparagraph—

(I) the term "commingled raw agricultural commodity" means any commodity that is combined or mixed after harvesting, but before processing;

(II) the term "commingled raw agricultural commodity" shall not include types of fruits and vegetables that are raw agricultural commodities for which the Secretary has determined that standards promulgated under section 350h of this title (as added by section 105) 2 would minimize the risk of serious adverse health consequences or death; and

(III) the term "processing" means operations that alter the general state of the commodity, such as canning, cooking, freezing, dehydration, milling, grinding, pasteurization, or homogenization.

(E) Exemption of other foods

The Secretary may, by notice in the Federal Register, modify the requirements under this subsection with respect to, or exempt a food or a type of facility from, the requirements of this subsection (other than the requirements under subparagraph (F), if applicable) if the Secretary determines that product tracing requirements for such food (such as bulk or commingled ingredients that are intended to be processed to destroy pathogens) or type of facility is not necessary to protect the public health.

(F) Recordkeeping regarding previous sources and subsequent recipients

In the case of a person or food to which a limitation or exemption under subparagraph (C), (D), or (E) applies, if such person, or a person who manufactures, processes, packs, or holds such food, is required to register with the Secretary under section 350d of this title with respect to the manufacturing, processing, packing, or holding of the applicable food, the Secretary shall require such person to maintain records that identify the immediate previous source of such food and the immediate subsequent recipient of such food.

(G) Grocery stores

With respect to a sale of a food described in subparagraph (H) to a grocery store, the Secretary shall not require such grocery store to maintain records under this subsection other than records documenting the farm that was the source of such food. The Secretary shall not require that such records be kept for more than 180 days.

(H) Farm sales to consumers

The Secretary shall not require a farm to maintain any distribution records under this subsection with respect to a sale of a food described in subparagraph (I) (including a sale of a food that is produced and packaged on such farm), if such sale is made by the farm directly to a consumer.

(I) Sale of a food

A sale of a food described in this subparagraph is a sale of a food in which—

(i) the food is produced on a farm; and

(ii) the sale is made by the owner, operator, or agent in charge of such farm directly to a consumer or grocery store.

(7) No impact on non-high-risk foods

The recordkeeping requirements established under paragraph (1) shall have no effect on foods that are not designated by the Secretary under paragraph (2) as high-risk foods. Foods described in the preceding sentence shall be subject solely to the recordkeeping requirements under section 350c of this title and subpart J of part 1 of title 21, Code of Federal Regulations (or any successor regulations).

(e) Evaluation and recommendations

(1) Report

Not later than 1 year after the effective date of the final rule promulgated under subsection (d)(1), the Comptroller General of the United States shall submit to Congress a report, taking into consideration the costs of compliance and other regulatory burdens on small businesses and Federal, State, and local food safety practices and requirements, that evaluates the public health benefits and risks, if any, of limiting—

(A) the product tracing requirements under subsection (d) to foods identified under paragraph (2) of such subsection, including whether such requirements provide adequate assurance of traceability in the event of intentional adulteration, including by acts of terrorism; and

(B) the participation of restaurants in the recordkeeping requirements.

(2) Determination and recommendations

In conducting the evaluation and report under paragraph (1), if the Comptroller General of the United States determines that the limitations described in such paragraph do not adequately protect the public health, the Comptroller General shall submit to Congress recommendations, if appropriate, regarding recordkeeping requirements for restaurants and additional foods, in order to protect the public health.

(f) Farms

(1) Request for information

Notwithstanding subsection (d), during an active investigation of a foodborne illness outbreak, or if the Secretary determines it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak, the Secretary, in consultation and coordination with State and local agencies responsible for food safety, as appropriate, may request that the owner, operator, or agent of a farm identify potential immediate recipients, other than consumers, of an article of the food that is the subject of such investigation if the Secretary reasonably believes such article of food—

(A) is adulterated under section 342 of this title;

(B) presents a threat of serious adverse health consequences or death to humans or animals; and

(C) was adulterated as described in subparagraph (A) on a particular farm (as defined in section 1.227 of chapter 3 21, Code of Federal Regulations (or any successor regulation)).

(2) Manner of request

In making a request under paragraph (1), the Secretary, in consultation and coordination with State and local agencies responsible for food safety, as appropriate, shall issue a written notice to the owner, operator, or agent of the farm to which the article of food has been traced. The individual providing such notice shall present to such owner, operator, or agent appropriate credentials and shall deliver such notice at reasonable times and within reasonable limits and in a reasonable manner.

(3) Delivery of information requested

The owner, operator, or agent of a farm shall deliver the information requested under paragraph (1) in a prompt and reasonable manner. Such information may consist of records kept in the normal course of business, and may be in electronic or non-electronic format.

(4) Limitation

A request made under paragraph (1) shall not include a request for information relating to the finances, pricing of commodities produced, personnel, research, sales (other than information relating to shipping), or other disclosures that may reveal trade secrets or confidential information from the farm to which the article of food has been traced, other than information necessary to identify potential immediate recipients of such food. Section 331(j) of this title and the Freedom of Information Act [5 U.S.C. 552] shall apply with respect to any confidential commercial information that is disclosed to the Food and Drug Administration in the course of responding to a request under paragraph (1).

(5) Records

Except with respect to identifying potential immediate recipients in response to a request under this subsection, nothing in this subsection shall require the establishment or maintenance by farms of new records.

(g) No Limitation on commingling of food

Nothing in this section shall be construed to authorize the Secretary to impose any limitation on the commingling of food.

(h) Small entity compliance guide

Not later than 180 days after promulgation of a final rule under subsection (d), the Secretary shall issue a small entity compliance guide setting forth in plain language the requirements of the regulations under such subsection in order to assist small entities, including farms and small businesses, in complying with the recordkeeping requirements under such subsection.

(i) Flexibility for small businesses

Notwithstanding any other provision of law, the regulations promulgated under subsection (d) shall apply—

(1) to small businesses (as defined by the Secretary in section 350g of this title, not later than 90 days after January 4, 2011) beginning on the date that is 1 year after the effective date of the final regulations promulgated under subsection (d); and

(2) to very small businesses (as defined by the Secretary in section 350g of this title, not later than 90 days after January 4, 2011) beginning on the date that is 2 years after the effective date of the final regulations promulgated under subsection (d).

(Pub. L. 111–353, title II, §204, Jan. 4, 2011, 124 Stat. 3930.)

Editorial Notes

References in Text

Section 105, referred to in subsec. (d)(6)(D)(ii)(II), means section 105 of Pub. L. 111–353.

Section 350g of this title, referred to in subsec. (i), was in the original "section 103", meaning section 103 of Pub. L. 111–353, which enacted section 350g of this title, amended section 331 of this title, and enacted provisions set out as notes under sections 342, 350d, and 350g of this title, and was translated as section 350g of this title to reflect the probable intent of Congress because section 350g(n) of this title directs the Secretary of Health and Human Services to define "small business" and "very small business".

Codification

Section is comprised of section 204 of Pub. L. 111–353. Subsec. (j) of section 204 of Pub. L. 111–353 amended sections 331 and 381 of this title.

1 So in original. The word "and" probably should not appear.

2 See References in Text note below.

3 So in original. Probably should be "title".
21 U.S.C. § 360g (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 360g: Judicial review
Judicial review
Status: in_force

(a) Petition; record

Not later than thirty days after—

(1) the promulgation of a regulation under section 360c of this title classifying a device in class I, an administrative order changing the classification of a device to class I, or an order under subsection (f)(2) of such section reclassifying a device or denying a petition for reclassification of a device,

(2) the promulgation of a regulation under section 360d of this title establishing, amending, or revoking a performance standard for a device,

(3) the issuance of an order under section 360d(b)(2) or 360e(b)(2)(B) of this title denying a request for reclassification of a device,

(4) the promulgation of a regulation under paragraph (3) of section 360e(b) of this title requiring a device to have an approval of a premarket application, a regulation under paragraph (4) of that section amending or revoking a regulation under paragraph (3), or an order pursuant to section 360e(g)(1) or 360e(g)(2)(C) of this title,

(5) the promulgation of a regulation under section 360f of this title (other than a proposed regulation made effective under subsection (b) of such section upon the regulation's publication) making a device a banned device,

(6) the issuance of an order under section 360j(f)(2) of this title,

(7) an order under section 360j(g)(4) of this title disapproving an application for an exemption of a device for investigational use or an order under section 360j(g)(5) of this title withdrawing such an exemption for a device,

(8) an order pursuant to section 360c(i) of this title, or

(9) a regulation under section 360e(i)(2) or 360j(l)(5)(B) of this title,

any person adversely affected by such regulation or order may file a petition with the United States Court of Appeals for the District of Columbia or for the circuit wherein such person resides or has his principal place of business for judicial review of such regulation or order. A copy of the petition shall be transmitted by the clerk of the court to the Secretary or other officer designated by him for that purpose. The Secretary shall file in the court the record of the proceedings on which the Secretary based his regulation or order as provided in section 2112 of title 28. For purposes of this section, the term "record" means all notices and other matter published in the Federal Register with respect to the regulation or order reviewed, all information submitted to the Secretary with respect to such regulation or order, proceedings of any panel or advisory committee with respect to such regulation or order, any hearing held with respect to such regulation or order, and any other information identified by the Secretary, in the administrative proceeding held with respect to such regulation or order, as being relevant to such regulation or order.

(b) Additional data, views, and arguments

If the petitioner applies to the court for leave to adduce additional data, views, or arguments respecting the regulation or order being reviewed and shows to the satisfaction of the court that such additional data, views, or arguments are material and that there were reasonable grounds for the petitioner's failure to adduce such data, views, or arguments in the proceedings before the Secretary, the court may order the Secretary to provide additional opportunity for the oral presentation of data, views, or arguments and for written submissions. The Secretary may modify his findings, or make new findings by reason of the additional data, views, or arguments so taken and shall file with the court such modified or new findings, and his recommendation, if any, for the modification or setting aside of the regulation or order being reviewed, with the return of such additional data, views, or arguments.

(c) Standard for review

Upon the filing of the petition under subsection (a) of this section for judicial review of a regulation or order, the court shall have jurisdiction to review the regulation or order in accordance with chapter 7 of title 5 and to grant appropriate relief, including interim relief, as provided in such chapter. A regulation described in paragraph (2) or (5) of subsection (a) and an order issued after the review provided by section 360e(g) of this title shall not be affirmed if it is found to be unsupported by substantial evidence on the record taken as a whole.

(d) Finality of judgments

The judgment of the court affirming or setting aside, in whole or in part, any regulation or order shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification, as provided in section 1254 of title 28.

(e) Remedies

The remedies provided for in this section shall be in addition to and not in lieu of any other remedies provided by law.

(f) Statement of reasons

To facilitate judicial review under this section or under any other provision of law of a regulation or order issued under section 360c, 360d, 360e, 360f, 360h, 360i, 360j, or 360k of this title each such regulation or order shall contain a statement of the reasons for its issuance and the basis, in the record of the proceedings held in connection with its issuance, for its issuance.

(June 25, 1938, ch. 675, §517, as added Pub. L. 94–295, §2, May 28, 1976, 90 Stat. 560; amended Pub. L. 101–629, §13, Nov. 28, 1990, 104 Stat. 4524; Pub. L. 102–300, §6(f), June 16, 1992, 106 Stat. 240; Pub. L. 105–115, title II, §216(a)(2), Nov. 21, 1997, 111 Stat. 2349; Pub. L. 112–144, title VI, §608(a)(2)(C), July 9, 2012, 126 Stat. 1056.)

Editorial Notes

Amendments

2012—Subsec. (a)(1). Pub. L. 112–144 substituted ", an administrative order changing the classification of a device to class I," for "or changing the classification of a device to class I".

1997—Subsec. (a)(8). Pub. L. 105–115, §216(a)(2)(A), inserted "or" at end.

Subsec. (a)(9). Pub. L. 105–115, §216(a)(2)(B), substituted comma for ", or" at end.

Subsec. (a)(10). Pub. L. 105–115, §216(a)(2)(C), struck out par. (10) which read as follows: "an order under section 360j(h)(4)(B) of this title,".

1992—Subsec. (a)(10). Pub. L. 102–300 substituted "360j(h)(4)(B)" for "360j(c)(4)(B)".

1990—Subsec. (a)(8) to (10). Pub. L. 101–629 added pars. (8) to (10).

Statutory Notes and Related Subsidiaries

Effective Date of 1997 Amendment

Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.
21 U.S.C. § 364g (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VI: COSMETICS / Section 364g: Mandatory recall authority
Mandatory recall authority
Status: in_force

(a) In general

If the Secretary determines that there is a reasonable probability that a cosmetic is adulterated under section 361 of this title or misbranded under section 362 of this title and the use of or exposure to such cosmetic will cause serious adverse health consequences or death, the Secretary shall provide the responsible person with an opportunity to voluntarily cease distribution and recall such article. If the responsible person refuses to or does not voluntarily cease distribution or recall such cosmetic within the time and manner prescribed by the Secretary (if so prescribed), the Secretary may, by order, require, as the Secretary determines necessary, such person to immediately cease distribution of such article.

(b) Hearing

The Secretary shall provide the responsible person who is subject to an order under subsection (a) with an opportunity for an informal hearing, to be held not later than 10 days after the date of issuance of the order, on whether adequate evidence exists to justify the order.

(c) Order resolution

After an order is issued according to the process under subsections (a) and (b), the Secretary shall, except as provided in subsection (d)—

(1) vacate the order, if the Secretary determines that inadequate grounds exist to support the actions required by the order;

(2) continue the order ceasing distribution of the cosmetic until a date specified in such order; or

(3) amend the order to require a recall of the cosmetic, including any requirements to notify appropriate persons, a timetable for the recall to occur, and a schedule for updates to be provided to the Secretary regarding such recall.

(d) Action following order

Any person who is subject to an order pursuant to paragraph (2) or (3) of subsection (c) shall immediately cease distribution of or recall, as applicable, the cosmetic and provide notification as required by such order.

(e) Notice to persons affected

If the Secretary determines necessary, the Secretary may require the person subject to an order pursuant to subsection (a) or an amended order pursuant to paragraph (2) or (3) of subsection (c) to provide either a notice of a recall order for, or an order to cease distribution of, such cosmetic, as applicable, under this section to appropriate persons, including persons who manufacture, distribute, import, or offer for sale such product that is the subject of an order and to the public.

(f) Public notification

In conducting a recall under this section, the Secretary shall—

(1) ensure that a press release is published regarding the recall, and that alerts and public notices are issued, as appropriate, in order to provide notification—

(A) of the recall to consumers and retailers to whom such cosmetic was, or may have been, distributed; and

(B) that includes, at a minimum—

(i) the name of the cosmetic subject to the recall;

(ii) a description of the risk associated with such article; and

(iii) to the extent practicable, information for consumers about similar cosmetics that are not affected by the recall; and

(2) ensure publication, as appropriate, on the website of the Food and Drug Administration of an image of the cosmetic that is the subject of the press release described in paragraph (1), if available.

(g) No delegation

The authority conferred by this section to order a recall or vacate a recall order shall not be delegated to any officer or employee other than the Commissioner.

(h) Effect

Nothing in this section shall affect the authority of the Secretary to request or participate in a voluntary recall, or to issue an order to cease distribution or to recall under any other provision of this subchapter.

(June 25, 1938, ch. 675, §611, as added Pub. L. 117–328, div. FF, title III, §3502, Dec. 29, 2022, 136 Stat. 5855.)

Statutory Notes and Related Subsidiaries

Construction; Confidentiality

Nothing in section 3502 of Pub. L. 117–328, which enacted this section, to be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a note under section 364 of this title.
21 U.S.C. § 372 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VII: GENERAL AUTHORITY / Section 372: Examinations and investigations
Examinations and investigations
Status: in_force

(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.

(B) A memorandum of understanding under subparagraph (A) between the Secretary and another Federal department or agency is effective only in the case of examinations or inspections at facilities or other locations that are jointly regulated by the Secretary and such department or agency.

(C) For any fiscal year in which the Secretary and the head of another Federal department or agency carries out one or more examinations or inspections under a memorandum of understanding under subparagraph (A), the Secretary and the head of such department or agency shall with respect to their respective departments or agencies submit to the committees of jurisdiction (authorizing and appropriating) in the House of Representatives and the Senate a report that provides, for such year—

(i) the number of officers or employees that carried out one or more programs, projects, or activities under such memorandum;

(ii) the number of additional articles that were inspected or examined as a result of such memorandum; and

(iii) the number of additional examinations or investigations that were carried out pursuant to such memorandum.

(3) In the case of food packed in the Commonwealth of Puerto Rico or a Territory the Secretary shall attempt to make inspection of such food at the first point of entry within the United States when, in his opinion and with due regard to the enforcement of all the provisions of this chapter, the facilities at his disposal will permit of such inspection.

(4) For the purposes of this subsection, the term "United States" means the States and the District of Columbia.

(b) Availability to owner of part of analysis samples

Where a sample of a food, drug, or cosmetic is collected for analysis under this chapter the Secretary shall, upon request, provide a part of such official sample for examination or analysis by any person named on the label of the article, or the owner thereof, or his attorney or agent; except that the Secretary is authorized, by regulations, to make such reasonable exceptions from, and impose such reasonable terms and conditions relating to, the operation of this subsection as he finds necessary for the proper administration of the provisions of this chapter.

(c) Records of other departments and agencies

For purposes of enforcement of this chapter, records of any department or independent establishment in the executive branch of the Government shall be open to inspection by any official of the Department duly authorized by the Secretary to make such inspection.

(d) Information on patents for drugs

The Secretary is authorized and directed, upon request from the Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office, to furnish full and complete information with respect to such questions relating to drugs as the Director may submit concerning any patent application. The Secretary is further authorized, upon receipt of any such request, to conduct or cause to be conducted, such research as may be required.

(e) Powers of enforcement personnel

Any officer or employee of the Department designated by the Secretary to conduct examinations, investigations, or inspections under this chapter relating to counterfeit drugs may, when so authorized by the Secretary—

(1) carry firearms;

(2) execute and serve search warrants and arrest warrants;

(3) execute seizure by process issued pursuant to libel under section 334 of this title;

(4) make arrests without warrant for offenses under this chapter with respect to such drugs if the offense is committed in his presence or, in the case of a felony, if he has probable cause to believe that the person so arrested has committed, or is committing, such offense; and

(5) make, prior to the institution of libel proceedings under section 334(a)(2) of this title, seizures of drugs or containers or of equipment, punches, dies, plates, stones, labeling, or other things, if they are, or he has reasonable grounds to believe that they are, subject to seizure and condemnation under such section 334(a)(2). In the event of seizure pursuant to this paragraph (5), libel proceedings under section 334(a)(2) of this title shall be instituted promptly and the property seized be placed under the jurisdiction of the court.

(June 25, 1938, ch. 675, §702, 52 Stat. 1056; Pub. L. 87–781, title III, §§307(b), 308, Oct. 10, 1962, 76 Stat. 796; Pub. L. 89–74, §8(a), July 15, 1965, 79 Stat. 234; Pub. L. 91–513, title II, §701(f), Oct. 27, 1970, 84 Stat. 1282; Pub. L. 102–300, §6(b)(2), June 16, 1992, 106 Stat. 240; Pub. L. 103–80, §3(dd)(2), Aug. 13, 1993, 107 Stat. 779; Pub. L. 106–113, div. B, §1000(a)(9) [title IV, §4732(b)(12)], Nov. 29, 1999, 113 Stat. 1536, 1501A–584; Pub. L. 107–188, title III, §314, June 12, 2002, 116 Stat. 674; Pub. L. 111–31, div. A, title I, §103(g), June 22, 2009, 123 Stat. 1837.)

Editorial Notes

Amendments

2009—Subsec. (a)(1). Pub. L. 111–31 designated existing provisions as subpar. (A) and added subpar. (B).

2002—Subsec. (a). Pub. L. 107–188 inserted "(1)" before "The Secretary is authorized to conduct", added par. (2), inserted "(3)" before "In the case of food packed", and substituted "(4) For the purposes of this subsection," for "For the purposes of this subsection".

1999—Subsec. (d). Pub. L. 106–113, in first sentence, substituted "Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office" for "Commissioner of Patents" and "Director" for "Commissioner".

1993—Subsec. (c). Pub. L. 103–80 struck out "of Agriculture" after "Department".

1992—Subsec. (c). Pub. L. 102–300, which directed the amendment of subsec. (c) by striking out "of Health, Education, and Welfare", could not be executed because such words did not appear in the original statutory text. See 1993 Amendment note above and Transfer of Functions note below.

1970—Subsec. (e). Pub. L. 91–513 struck out reference to depressant or stimulant drugs.

1965—Subsec. (e). Pub. L. 89–74 added subsec. (e).

1962—Subsec. (a). Pub. L. 87–781, §307(b), inserted "the Commonwealth of Puerto Rico or" before "a Territory the Secretary".

Subsec. (d). Pub. L. 87–781, §308, added subsec. (d).

Statutory Notes and Related Subsidiaries

Effective Date of 1999 Amendment

Amendment by Pub. L. 106–113 effective 4 months after Nov. 29, 1999, see section 1000(a)(9) [title IV, §4731] of Pub. L. 106–113, set out as a note under section 1 of Title 35, Patents.

Effective Date of 1970 Amendment

Amendment by Pub. L. 91–513 effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as an Effective Date note under section 801 of this title.

Effective Date of 1965 Amendment

Amendment by Pub. L. 89–74 effective July 15, 1965, see section 11 of Pub. L. 89–74, set out as a note under section 321 of this title.

Savings Provision

Amendment by Pub. L. 91–513 not to affect or abate any prosecutions for any violation of law or any civil seizures or forfeitures and injunctive proceedings commenced prior to the effective date of such amendment, and all administrative proceedings pending before the Bureau of Narcotics and Dangerous Drugs [now Drug Enforcement Administration] on Oct. 27, 1970, to be continued and brought to final determination in accord with laws and regulations in effect prior to Oct. 27, 1970, see section 702 of Pub. L. 91–513, set out as a note under section 321 of this title.

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see note set out under section 321 of this title.
21 U.S.C. § 153 (2024) — Title 21: FOOD AND DRUGS / Chapter 5: VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS PRODUCTS / Section 153: Inspection of imports; denial of entry and destruction
Inspection of imports; denial of entry and destruction
Status: in_force

The Secretary of Agriculture is authorized to cause the Bureau of Animal Industry to examine and inspect all viruses, serums, toxins, and analogous products, for use in the treatment of domestic animals, which are being imported or offered for importation into the United States, to determine whether such viruses, serums, toxins, and analogous products are worthless, contaminated, dangerous, or harmful, and if it shall appear that any such virus, serum, toxin, or analogous product, for use in the treatment of domestic animals, is worthless, contaminated, dangerous, or harmful, the same shall be denied entry and shall be destroyed or returned at the expense of the owner or importer.

(Mar. 4, 1913, ch. 145, §1 (part), 37 Stat. 832.)

Editorial Notes

Codification

See note set out under section 151 of this title.

Statutory Notes and Related Subsidiaries

Transfer of Functions

For transfer of functions of the Secretary of Agriculture relating to agricultural import and entry inspection activities under this chapter to the Secretary of Homeland Security, and for treatment of related references, see sections 231, 551(d), 552(d), and 557 of Title 6, Domestic Security, and the Department of Homeland Security Reorganization Plan of November 25, 2002, as modified, set out as a note under section 542 of Title 6.
21 U.S.C. § 350h (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IV: FOOD / Section 350h: Standards for produce safety
Standards for produce safety
Status: in_force

(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 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 different regions an opportunity to comment.

(3) Content

The proposed rulemaking under paragraph (1) shall—

(A) provide sufficient flexibility to be applicable to various types of entities engaged in the production and harvesting of fruits and vegetables that are raw agricultural commodities, including small businesses and entities that sell directly to consumers, and be appropriate to the scale and diversity of the production and harvesting of such commodities;

(B) include, with respect to growing, harvesting, sorting, packing, and storage operations, science-based minimum standards related to soil amendments, hygiene, packaging, temperature controls, animals in the growing area, and water;

(C) consider hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced, including by acts of terrorism;

(D) take into consideration, consistent with ensuring enforceable public health protection, conservation and environmental practice standards and policies established by Federal natural resource conservation, wildlife conservation, and environmental agencies;

(E) in the case of production that is certified organic, not include any requirements that conflict with or duplicate the requirements of the national organic program established under the Organic Foods Production Act of 1990, while providing the same level of public health protection as the requirements under guidance documents, including guidance documents regarding action levels, and regulations under the FDA Food Safety Modernization Act; and

(F) define, for purposes of this section, the terms "small business" and "very small business".

(4) Prioritization

The Secretary shall prioritize the implementation of the regulations under this section for specific fruits and vegetables that are raw agricultural commodities based on known risks which may include a history and severity of foodborne illness outbreaks.

(b) Final regulation

(1) In general

Not later than 1 year after the close of the comment period for the proposed rulemaking under subsection (a), the Secretary shall adopt a final regulation to provide for minimum science-based standards for those types of fruits and vegetables, including specific mixes or categories of fruits or vegetables, that are raw agricultural commodities, based on known safety risks, which may include a history of foodborne illness outbreaks.

(2) Final regulation

The final regulation shall—

(A) provide for coordination of education and enforcement activities by State and local officials, as designated by the Governors of the respective States or the appropriate elected State official as recognized by State statute; and

(B) include a description of the variance process under subsection (c) and the types of permissible variances the Secretary may grant.

(3) Flexibility for small businesses

Notwithstanding paragraph (1)—

(A) the regulations promulgated under this section shall apply to a small business (as defined in the regulation promulgated under subsection (a)(1)) after the date that is 1 year after the effective date of the final regulation under paragraph (1); and

(B) the regulations promulgated under this section shall apply to a very small business (as defined in the regulation promulgated under subsection (a)(1)) after the date that is 2 years after the effective date of the final regulation under paragraph (1).

(c) Criteria

(1) In general

The regulations adopted under subsection (b) shall—

(A) set forth those procedures, processes, and practices that the Secretary determines to minimize the risk of serious adverse health consequences or death, including procedures, processes, and practices that the Secretary determines to be reasonably necessary to prevent the introduction of known or reasonably foreseeable biological, chemical, and physical hazards, including hazards that occur naturally, may be unintentionally introduced, or may be intentionally introduced, including by acts of terrorism, into fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities and to provide reasonable assurances that the produce is not adulterated under section 342 of this title;

(B) provide sufficient flexibility to be practicable for all sizes and types of businesses, including small businesses such as a small food processing facility co-located on a farm;

(C) comply with chapter 35 of title 44 (commonly known as the "Paperwork Reduction Act"), with special attention to minimizing the burden (as defined in section 3502(2) of such title) on the business, and collection of information (as defined in section 3502(3) of such title), associated with such regulations;

(D) acknowledge differences in risk and minimize, as appropriate, the number of separate standards that apply to separate foods; and

(E) not require a business to hire a consultant or other third party to identify, implement, certify, compliance 1 with these procedures, processes, and practices, except in the case of negotiated enforcement resolutions that may require such a consultant or third party; and

(F) permit States and foreign countries from which food is imported into the United States to request from the Secretary variances from the requirements of the regulations, subject to paragraph (2), where the State or foreign country determines that the variance is necessary in light of local growing conditions and that the procedures, processes, and practices to be followed under the variance are reasonably likely to ensure that the produce is not adulterated under section 342 of this title and to provide the same level of public health protection as the requirements of the regulations adopted under subsection (b).

(2) Variances

(A) Requests for variances

A State or foreign country from which food is imported into the United States may in writing request a variance from the Secretary. Such request shall describe the variance requested and present information demonstrating that the variance does not increase the likelihood that the food for which the variance is requested will be adulterated under section 342 of this title, and that the variance provides the same level of public health protection as the requirements of the regulations adopted under subsection (b). The Secretary shall review such requests in a reasonable timeframe.

(B) Approval of variances

The Secretary may approve a variance in whole or in part, as appropriate, and may specify the scope of applicability of a variance to other similarly situated persons.

(C) Denial of variances

The Secretary may deny a variance request if the Secretary determines that such variance is not reasonably likely to ensure that the food is not adulterated under section 342 of this title and is not reasonably likely to provide the same level of public health protection as the requirements of the regulation adopted under subsection (b). The Secretary shall notify the person requesting such variance of the reasons for the denial.

(D) Modification or revocation of a variance

The Secretary, after notice and an opportunity for a hearing, may modify or revoke a variance if the Secretary determines that such variance is not reasonably likely to ensure that the food is not adulterated under section 342 of this title and is not reasonably likely to provide the same level of public health protection as the requirements of the regulations adopted under subsection (b).

(d) Enforcement

The Secretary may coordinate with the Secretary of Agriculture and, as appropriate, shall contract and coordinate with the agency or department designated by the Governor of each State to perform activities to ensure compliance with this section.

(e) Guidance

(1) In general

Not later than 1 year after January 4, 2011, the Secretary shall publish, after consultation with the Secretary of Agriculture, representatives of State departments of agriculture, farmer representatives, and various types of entities engaged in the production and harvesting or importing of fruits and vegetables that are raw agricultural commodities, including small businesses, updated good agricultural practices and guidance for the safe production and harvesting of specific types of fresh produce under this section.

(2) Public meetings

The Secretary shall conduct not fewer than 3 public meetings in diverse geographical areas of the United States as part of an effort to conduct education and outreach regarding the guidance described in paragraph (1) for persons in different regions who are involved in the production and harvesting of fruits and vegetables that are raw agricultural commodities, including persons that sell directly to consumers and farmer representatives, and for importers of fruits and vegetables that are raw agricultural commodities.

(3) Paperwork reduction

The Secretary shall ensure that any updated guidance under this section will—

(A) provide sufficient flexibility to be practicable for all sizes and types of facilities, including small businesses such as a small food processing facility co-located on a farm; and

(B) acknowledge differences in risk and minimize, as appropriate, the number of separate standards that apply to separate foods.

(f) Exemption for direct farm marketing

(1) In general

A farm shall be exempt from the requirements under this section in a calendar year if—

(A) during the previous 3-year period, the average annual monetary value of the food sold by such farm directly to qualified end-users during such period exceeded the average annual monetary value of the food sold by such farm to all other buyers during such period; and

(B) the average annual monetary value of all food sold during such period was less than $500,000, adjusted for inflation.

(2) Notification to consumers

(A) In general

A farm that is exempt from the requirements under this section shall—

(i) with respect to a food for which a food packaging label is required by the Secretary under any other provision of this chapter, include prominently and conspicuously on such label the name and business address of the farm where the produce was grown; or

(ii) with respect to a food for which a food packaging label is not required by the Secretary under any other provision of this chapter, prominently and conspicuously display, at the point of purchase, the name and business address of the farm where the produce was grown, on a label, poster, sign, placard, or documents delivered contemporaneously with the food in the normal course of business, or, in the case of Internet sales, in an electronic notice.

(B) No additional label

Subparagraph (A) does not provide authority to the Secretary to require a label that is in addition to any label required under any other provision of this chapter.

(3) Withdrawal; rule of construction

(A) In general

In the event of an active investigation of a foodborne illness outbreak that is directly linked to a farm subject to an exemption under this subsection, or if the Secretary determines that it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with a farm that are material to the safety of the food produced or harvested at such farm, the Secretary may withdraw the exemption provided to such farm under this subsection.

(B) Rule of construction

Nothing in this subsection shall be construed to expand or limit the inspection authority of the Secretary.

(4) Definitions

(A) Qualified end-user

In this subsection, the term "qualified end-user", with respect to a food means—

(i) the consumer of the food; or

(ii) a restaurant or retail food establishment (as those terms are defined by the Secretary for purposes of section 350d of this title) that is located—

(I) in the same State as the farm that produced the food; or

(II) not more than 275 miles from such farm.

(B) Consumer

For purposes of subparagraph (A), the term "consumer" does not include a business.

(5) No preemption

Nothing in this subsection preempts State, local, county, or other non-Federal law regarding the safe production, harvesting, holding, transportation, and sale of fresh fruits and vegetables. Compliance with this subsection shall not relieve any person from liability at common law or under State statutory law.

(6) Limitation of effect

Nothing in this subsection shall prevent the Secretary from exercising any authority granted in the other sections of this chapter.

(g) Clarification

This section shall not apply to produce that is produced by an individual for personal consumption.

(h) Exception for activities of facilities subject to section 350g of this title

This section shall not apply to activities of a facility that are subject to section 350g of this title.

(June 25, 1938, ch. 675, §419, as added Pub. L. 111–353, title I, §105(a), Jan. 4, 2011, 124 Stat. 3899.)

Editorial Notes

References in Text

The Organic Foods Production Act of 1990, referred to in subsec. (a)(1)(A), (3)(E), is title XXI of Pub. L. 101–624, Nov. 28, 1990, 104 Stat. 3935, which is classified generally to chapter 94 (§6501 et seq.) of Title 7, Agriculture. For complete classification of this Act to the Code, see Short Title note set out under section 6501 of Title 7 and Tables.

The FDA Food Safety Modernization Act, referred to in subsec. (a)(3)(E), is Pub. L. 111–353, Jan. 4, 2011, 124 Stat. 3885, which enacted chapter 27 (§2201 et seq.) 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 enacted provisions set out as notes under sections 331, 334, 342, 350b, 350d, 350e, 350g to 350j, 350l, and 381 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 2201 of this title and Tables.

Statutory Notes and Related Subsidiaries

Construction

Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.

Scientific and Economic Analysis of the FDA Food Safety Modernization Act

Pub. L. 113–79, title XII, §12311(a), Feb. 7, 2014, 128 Stat. 992, provided that: "When publishing a final rule with respect to 'Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption' published by the Department of Health and Human Services on January 16, 2013 (78 Fed. Reg. 3504), the Secretary of Health and Human Services (referred to in this section as the 'Secretary') shall ensure that the final rule (referred to in this section as the 'final rule') includes the following information:

"(1) An analysis of the scientific information used to promulgate the final rule, taking into consideration any information about farming and ranching operations of a variety of sizes, with regional differences, and that have a diversity of production practices and methods.

"(2) An analysis of the economic impact of the final rule.

"(3) A plan to systematically—

"(A) evaluate the impact of the final rule on farming and ranching operations; and

"(B) develop an ongoing process to evaluate and respond to business concerns."

Small Entity Compliance Policy Guide

Pub. L. 111–353, title I, §105(b), Jan. 4, 2011, 124 Stat. 3904, provided that: "Not later than 180 days after the issuance of regulations under section 419 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350h] (as added by subsection (a)), the Secretary of Health and Human Services shall issue a small entity compliance policy guide setting forth in plain language the requirements of such section 419 and to assist small entities in complying with standards for safe production and harvesting and other activities required under such section."

No Effect on HACCP Authorities

Pub. L. 111–353, title I, §105(d), Jan. 4, 2011, 124 Stat. 3905, provided that: "Nothing in the amendments made by this section [enacting this section and amending section 331 of this title] limits the authority of the Secretary [of Health and Human Services] under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public Health Service Act (42 U.S.C. 201 et seq.) to revise, issue, or enforce product and category-specific regulations, such as the Seafood Hazard Analysis Critical Controls Points Program, the Juice Hazard Analysis Critical Control [Points] Program, and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards."

1 So in original. Probably should be "or certify compliance".
21 U.S.C. § 351 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 351: Adulterated drugs and devices
Adulterated drugs and devices
Status: in_force

A drug or device shall be deemed to be adulterated—

(a) Poisonous, insanitary, etc., ingredients; adequate controls in manufacture

(1) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or (2)(A) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or (B) if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess; or (C) if it is a compounded positron emission tomography drug and the methods used in, or the facilities and controls used for, its compounding, processing, packing, or holding do not conform to or are not operated or administered in conformity with the positron emission tomography compounding standards and the official monographs of the United States Pharmacopoeia to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, that it purports or is represented to possess; or (3) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (4) if (A) it bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of section 379e(a) of this title, or (B) it is a color additive the intended use of which in or on drugs or devices is for purposes of coloring only and is unsafe within the meaning of section 379e(a) of this title; or (5) if it is a new animal drug which is unsafe within the meaning of section 360b of this title; or (6) if it is an animal feed bearing or containing a new animal drug, and such animal feed is unsafe within the meaning of section 360b of this title.

(b) Strength, quality, or purity differing from official compendium

If it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium. Such determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in such compendium, except that whenever tests or methods of assay have not been prescribed in such compendium, or such tests or methods of assay as are prescribed are, in the judgment of the Secretary, insufficient for the making of such determination, the Secretary shall bring such fact to the attention of the appropriate body charged with the revision of such compendium, and if such body fails within a reasonable time to prescribe tests or methods of assay which, in the judgment of the Secretary, are sufficient for purposes of this paragraph, then the Secretary shall promulgate regulations prescribing appropriate tests or methods of assay in accordance with which such determination as to strength, quality, or purity shall be made. No drug defined in an official compendium shall be deemed to be adulterated under this paragraph because it differs from the standard of strength, quality, or purity therefor set forth in such compendium, if its difference in strength, quality, or purity from such standard is plainly stated on its label. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homoeopathic Pharmacopoeia of the United States it shall be subject to the requirements of the United States Pharmacopoeia unless it is labeled and offered for sale as a homoeopathic drug, in which case it shall be subject to the provisions of the Homoeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia.

(c) Misrepresentation of strength, etc., where drug is unrecognized in compendium

If it is not subject to the provisions of paragraph (b) of this section and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.

(d) Mixture with or substitution of another substance

If it is a drug and any substance has been (1) mixed or packed therewith so as to reduce its quality or strength or (2) substituted wholly or in part therefor.

(e) Devices not in conformity with performance standards

(1) If it is, or purports to be or is represented as, a device which is subject to a performance standard established under section 360d of this title unless such device is in all respects in conformity with such standard.

(2) If it is declared to be, purports to be, or is represented as, a device that is in conformity with any standard recognized under section 360d(c) of this title unless such device is in all respects in conformity with such standard.

(f) Certain class III devices

(1) If it is a class III device—

(A)(i) which is required by an order issued under subsection (b) of section 360e of this title to have an approval under such section of an application for premarket approval and which is not exempt from section 360e of this title under section 360j(g) of this title, and

(ii)(I) for which an application for premarket approval or a notice of completion of a product development protocol was not filed with the Secretary within the ninety-day period beginning on the date of the issuance of such order, or

(II) for which such an application was filed and approval of the application has been denied, suspended, or withdrawn, or such a notice was filed and has been declared not completed or the approval of the device under the protocol has been withdrawn;

(B)(i) which was classified under section 360c(f) of this title into class III, which under section 360e(a) of this title is required to have in effect an approved application for premarket approval, and which is not exempt from section 360e of this title under section 360j(g) of this title, and

(ii) which has an application which has been suspended or is otherwise not in effect; or

(C) which was classified under section 360j(l) of this title into class III, which under such section is required to have in effect an approved application under section 360e of this title, and which has an application which has been suspended or is otherwise not in effect.

(2)(A) In the case of a device classified under section 360c(f) of this title into class III and intended solely for investigational use, paragraph 1 (1)(B) shall not apply with respect to such device during the period ending on the ninetieth day after the date of the promulgation of the regulations prescribing the procedures and conditions required by section 360j(g)(2) of this title.

(B) In the case of a device subject to an order issued under subsection (b) of section 360e of this title, paragraph 1 (1) shall not apply with respect to such device during the period ending—

(i) on the last day of the thirtieth calendar month beginning after the month in which the classification of the device in class III became effective under section 360c of this title, or

(ii) on the ninetieth day after the date of the issuance of such order,

whichever occurs later.

(3) In the case of a device with respect to which a regulation was promulgated under section 360e(b) of this title prior to July 9, 2012, a reference in this subsection to an order issued under section 360e(b) of this title shall be deemed to include such regulation.

(g) Banned devices

If it is a banned device.

(h) Manufacture, packing, storage, or installation of device not in conformity with applicable requirements or conditions

If it is a device and the methods used in, or the facilities or controls used for, its manufacture, packing, storage, or installation are not in conformity with applicable requirements under section 360j(f)(1) of this title or an applicable condition prescribed by an order under section 360j(f)(2) of this title.

(i) Failure to comply with requirements under which device was exempted for investigational use

If it is a device for which an exemption has been granted under section 360j(g) of this title for investigational use and the person who was granted such exemption or any investigator who uses such device under such exemption fails to comply with a requirement prescribed by or under such section.

(j) Delayed, denied, or limited inspection; refusal to permit entry or inspection

If it is a drug or device and it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.

For purposes of paragraph (a)(2)(B), the term "current good manufacturing practice" includes the implementation of oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug products.

(June 25, 1938, ch. 675, §501, 52 Stat. 1049; Pub. L. 86–618, title I, §102(b)(1), July 12, 1960, 74 Stat. 398; Pub. L. 87–781, title I, §101, Oct. 10, 1962, 76 Stat. 780; Pub. L. 90–399, §101(a), July 13, 1968, 82 Stat. 343; Pub. L. 94–295, §§3(d), 9(b)(1), May 28, 1976, 90 Stat. 576, 583; Pub. L. 101–629, §9(b), Nov. 28, 1990, 104 Stat. 4521; Pub. L. 102–571, title I, §107(8), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 105–115, title I, §121(b)(1), title II, §204(c), Nov. 21, 1997, 111 Stat. 2320, 2336; Pub. L. 112–144, title VI, §608(b)(2), title VII, §§707(a), 711, July 9, 2012, 126 Stat. 1058, 1068, 1071; Pub. L. 115–52, title VII, §702(c), Aug. 18, 2017, 131 Stat. 1056.)

Editorial Notes

Amendments

2017—Par. (j). Pub. L. 115–52 inserted "or device" after "drug".

2012—Pub. L. 112–144, §711, inserted concluding provisions.

Par. (f)(1)(A)(i). Pub. L. 112–144, §608(b)(2)(A)(i), substituted "an order issued" for "a regulation promulgated".

Par. (f)(1)(A)(ii)(I). Pub. L. 112–144, §608(b)(2)(A)(ii), substituted "issuance of such order" for "promulgation of such regulation".

Par. (f)(2)(B). Pub. L. 112–144, §608(b)(2)(B), substituted "an order issued" for "a regulation promulgated" in introductory provisions and "issuance of such order" for "promulgation of such regulation" in subcl. (ii).

Par. (f)(3). Pub. L. 112–144, §608(b)(2)(C), added subpar. (3).

Par. (j). Pub. L. 112–144, §707(a), added par. (j).

1997—Par. (a)(2)(C). Pub. L. 105–115, §121(b)(1), inserted "; or (C) if it is a compounded positron emission tomography drug and the methods used in, or the facilities and controls used for, its compounding, processing, packing, or holding do not conform to or are not operated or administered in conformity with the positron emission tomography compounding standards and the official monographs of the United States Pharmacopoeia to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, that it purports or is represented to possess;" before "or (3)".

Par. (e). Pub. L. 105–115, §204(c), designated existing provisions as subpar. (1) and added subpar. (2).

1992—Par. (a)(4). Pub. L. 102–571 substituted "379e(a)" for "376(a)" in cls. (A) and (B).

1990—Par. (f)(1). Pub. L. 101–629, §9(b), which directed the amendment of subpars. (A) to (C) of par. (f), was executed by making the amendments in cls. (A) to (C) of subpar. (1) of par. (f) as follows to reflect the probable intent of Congress: in cl. (A)(ii)(II), substituted ", suspended, or withdrawn" for "or withdrawn"; in cl. (B)(ii), substituted "which has an application which has been suspended or is otherwise not in effect" for "which does not have such an application in effect"; and in cl. (C), substituted "which has an application which has been suspended or is otherwise not in effect" for "which does not have such an application in effect".

1976—Par. (a). Pub. L. 94–295, §9(b)(1), substituted "(3) if its" for "(3) if it is a drug and its" in cl. (3), substituted "(4) if (A) it bears or contains" for "(4) if (A) it is a drug which bears or contains" in cl. (4)(A), and substituted "drugs or devices" for "drugs" in cl. (4)(B).

Pars. (e) to (i). Pub. L. 94–295, §3(d), added pars. (e) to (i).

1968—Par. (a). Pub. L. 90–399 added cls. (5) and (6).

1962—Par. (a). Pub. L. 87–781 designated existing provisions of cl. (2) as (A) and added (B).

1960—Par. (a). Pub. L. 86–618 substituted provisions in cl. (4) relating to unsafe color additives for provisions which related to a coal-tar color other than one from a batch that has been certified in accordance with regulations as provided by section 354 of this title.

Statutory Notes and Related Subsidiaries

Effective and Termination Dates of 1997 Amendment

Pub. L. 105–115, title I, §121(b)(2), Nov. 21, 1997, 111 Stat. 2320, provided that: "Section 501(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(C)) shall not apply 4 years after the date of enactment of this Act [Nov. 21, 1997] or 2 years after the date on which the Secretary of Health and Human Services establishes the requirements described in subsection (c)(1)(B) [section 121(c)(1)(B) of Pub. L. 105–115, set out as a note under section 355 of this title], whichever is later."

Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

Effective Date of 1968 Amendment

Amendment by Pub. L. 90–399 effective on first day of thirteenth calendar month after July 13, 1968, see section 108(a) of Pub. L. 90–399, set out as an Effective Date and Transitional Provisions note under section 360b of this title.

Effective Date of 1962 Amendment; Exceptions

Amendment by Pub. L. 87–781 effective on first day of seventh calendar month following October 1962, see section 107 of Pub. L. 87–781, set out as a note under section 321 of this title.

Effective Date of 1960 Amendment

Amendment by Pub. L. 86–618 effective July 12, 1960, subject to the provisions of section 203 of Pub. L. 86–618, see section 202 of Pub. L. 86–618, set out as a note under section 379e of this title.

Effective Date; Postponement

Par. (a)(4) effective Jan. 1, 1940, see act June 23, 1939, ch. 242, 53 Stat. 853, set out as an Effective Date; Postponement in Certain Cases note under section 301 of this title.

Approval by Regulation Prior to July 9, 2012

Pub. L. 112–144, title VI, §608(b)(3), July 9, 2012, 126 Stat. 1059, provided that: "The amendments made by this subsection [amending this section and section 360e of this title] shall have no effect on a regulation that was promulgated prior to the date of enactment of this Act [July 9, 2012] requiring that a device have an approval under section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e) of an application for premarket approval."

Guidance

Pub. L. 112–144, title VII, §707(b), July 9, 2012, 126 Stat. 1068, provided that: "Not later than 1 year after the date of enactment of this section [July 9, 2012], the Secretary of Health and Human Services shall issue guidance that defines the circumstances that would constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection, for purposes of section 501(j) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 351(j)] (as added by subsection (a))."

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.

1 So in original. Probably should be "subparagraph".
21 U.S.C. § 350k (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IV: FOOD / Section 350k: Laboratory accreditation for analyses of foods
Laboratory accreditation for analyses of foods
Status: in_force

(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 1 (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 Secretary of Homeland Security, may determine the time, manner, and form in which the registry established under paragraph (1)(B) is made publicly available.

(5) Foreign laboratories

Accreditation bodies recognized by the Secretary under paragraph (1) may accredit laboratories that operate outside the United States, so long as such laboratories meet the accreditation standards applicable to domestic laboratories accredited under this section.

(6) Model laboratory standards

The Secretary shall develop model standards that a laboratory shall meet to be accredited by a recognized accreditation body for a specified sampling or analytical testing methodology and included in the registry provided for under paragraph (1). In developing the model standards, the Secretary shall consult existing standards for guidance. The model standards shall include—

(A) methods to ensure that—

(i) appropriate sampling, analytical procedures (including rapid analytical procedures), and commercially available techniques are followed and reports of analyses are certified as true and accurate;

(ii) internal quality systems are established and maintained;

(iii) procedures exist to evaluate and respond promptly to complaints regarding analyses and other activities for which the laboratory is accredited; and

(iv) individuals who conduct the sampling and analyses are qualified by training and experience to do so; and

(B) any other criteria determined appropriate by the Secretary.

(7) Review of recognition

To ensure compliance with the requirements of this section, the Secretary—

(A) shall periodically, and in no case less than once every 5 years, reevaluate accreditation bodies recognized under paragraph (1) and may accompany auditors from an accreditation body to assess whether the accreditation body meets the criteria for recognition; and

(B) shall promptly revoke the recognition of any accreditation body found not to be in compliance with the requirements of this section, specifying, as appropriate, any terms and conditions necessary for laboratories accredited by such body to continue to perform testing as described in this section.

(b) Testing procedures

(1) In general

Not later than 30 months after January 4, 2011, food testing shall be conducted by Federal laboratories or non-Federal laboratories that have been accredited for the appropriate sampling or analytical testing methodology or methodologies by a recognized accreditation body on the registry established by the Secretary under subsection (a)(1)(B) whenever such testing is conducted—

(A) by or on behalf of an owner or consignee—

(i) in response to a specific testing requirement under this chapter or implementing regulations, when applied to address an identified or suspected food safety problem; and

(ii) as required by the Secretary, as the Secretary deems appropriate, to address an identified or suspected food safety problem; or

(B) on behalf of an owner or consignee—

(i) in support of admission of an article of food under section 381(a) of this title; and

(ii) under an Import Alert that requires successful consecutive tests.

(2) Results of testing

The results of any such testing shall be sent directly to the Food and Drug Administration, except the Secretary may by regulation exempt test results from such submission requirement if the Secretary determines that such results do not contribute to the protection of public health. Test results required to be submitted may be submitted to the Food and Drug Administration through electronic means.

(3) Exception

The Secretary may waive requirements under this subsection if—

(A) a new methodology or methodologies have been developed and validated but a laboratory has not yet been accredited to perform such methodology or methodologies; and

(B) the use of such methodology or methodologies are necessary to prevent, control, or mitigate a food emergency or foodborne illness outbreak.

(c) Review by Secretary

If food sampling and testing performed by a laboratory run and operated by a State or locality that is accredited by a recognized accreditation body on the registry established by the Secretary under subsection (a) result in a State recalling a food, the Secretary shall review the sampling and testing results for the purpose of determining the need for a national recall or other compliance and enforcement activities.

(d) No limit on Secretarial authority

Nothing in this section shall be construed to limit the ability of the Secretary to review and act upon information from food testing, including determining the sufficiency of such information and testing.

(June 25, 1938, ch. 675, §422, as added Pub. L. 111–353, title II, §202(a), Jan. 4, 2011, 124 Stat. 3926.)

Statutory Notes and Related Subsidiaries

Construction

Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.

1 So in original. Probably should be "subsection".
21 U.S.C. § 372a (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VII: GENERAL AUTHORITY / Section 372a: Transferred
Transferred
Status: transferred

Editorial Notes

Codification

Section, act June 25, 1938, ch. 675, §702A, formerly June 30, 1906, ch. 3915, §10A, as added June 22, 1934, ch. 712, 48 Stat. 1204, and amended, which related to examination of sea food, was renumbered section 706 of act June 25, 1938, by Pub. L. 102–571, title I, §106(3), Oct. 29, 1992, 106 Stat. 4498, and transferred to section 376 of this title.
21 U.S.C. § 1042 (2024) — Title 21: FOOD AND DRUGS / Chapter 15: EGG PRODUCTS INSPECTION / Section 1042: Reporting of violation to United States attorney for institution of criminal proceedings; procedure; presentation of views
Reporting of violation to United States attorney for institution of criminal proceedings; procedure; presentation of views
Status: in_force

Before any violation of this chapter is reported by the Secretary of Agriculture or Secretary of Health and Human Services to any United States attorney for institution of a criminal proceeding, the person against whom such proceeding is contemplated shall be given reasonable notice of the alleged violation and opportunity to present his views orally or in writing with regard to such contemplated proceeding. Nothing in this chapter shall be construed as requiring the Secretary of Agriculture or Secretary of Health and Human Services to report for criminal prosecution violations of this chapter whenever he believes that the public interest will be adequately served and compliance with this chapter obtained by a suitable written notice of warning or an action to assess civil penalties.

(Pub. L. 91–597, §13, Dec. 29, 1970, 84 Stat. 1628; Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 102–237, title X, §1012(e), Dec. 13, 1991, 105 Stat. 1900.)

Editorial Notes

References in Text

This chapter, referred to in text, was in the original "this Act", meaning Pub. L. 91–597, Dec. 29, 1970, 84 Stat. 1620, which is classified principally to this chapter. For complete classification of this Act to the Code, see Short Title note set out under section 1031 of this title and Tables.

Amendments

1991—Pub. L. 102–237 inserted "or an action to assess civil penalties" before period at end.

Statutory Notes and Related Subsidiaries

Change of Name

"Secretary of Health and Human Services" substituted in text for "Secretary of Health, Education, and Welfare" pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education.

Effective Date of 1991 Amendment

Amendment by Pub. L. 102–237 effective 12 months after promulgation of final implementing regulations, see section 1012(h) of Pub. L. 102–237, set out as a note under section 1034 of this title.

Effective Date

For effective date of this section, see section 29 of Pub. L. 91–597, set out as a note under section 1031 of this title.
21 U.S.C. § 863 (2024) — Title 21: FOOD AND DRUGS / Chapter 13: DRUG ABUSE PREVENTION AND CONTROL / Subchapter I: CONTROL AND ENFORCEMENT / Section 863: Drug paraphernalia
Drug paraphernalia
Status: in_force

(a) In general

It is unlawful for any person—

(1) to sell or offer for sale drug paraphernalia;

(2) to use the mails or any other facility of interstate commerce to transport drug paraphernalia; or

(3) to import or export drug paraphernalia.

(b) Penalties

Anyone convicted of an offense under subsection (a) of this section shall be imprisoned for not more than three years and fined under title 18.

(c) Seizure and forfeiture

Any drug paraphernalia involved in any violation of subsection (a) of this section shall be subject to seizure and forfeiture upon the conviction of a person for such violation. Any such paraphernalia shall be delivered to the Administrator of General Services, General Services Administration, who may order such paraphernalia destroyed or may authorize its use for law enforcement or educational purposes by Federal, State, or local authorities.

(d) "Drug paraphernalia" defined

The term "drug paraphernalia" means any equipment, product, or material of any kind which is primarily intended or designed for use in manufacturing, compounding, converting, concealing, producing, processing, preparing, injecting, ingesting, inhaling, or otherwise introducing into the human body a controlled substance, possession of which is unlawful under this subchapter. It includes items primarily intended or designed for use in ingesting, inhaling, or otherwise introducing marijuana,1 cocaine, hashish, hashish oil, PCP, methamphetamine, or amphetamines into the human body, such as—

(1) metal, wooden, acrylic, glass, stone, plastic, or ceramic pipes with or without screens, permanent screens, hashish heads, or punctured metal bowls;

(2) water pipes;

(3) carburetion tubes and devices;

(4) smoking and carburetion masks;

(5) roach clips: meaning objects used to hold burning material, such as a marihuana cigarette, that has become too small or too short to be held in the hand;

(6) miniature spoons with level capacities of one-tenth cubic centimeter or less;

(7) chamber pipes;

(8) carburetor pipes;

(9) electric pipes;

(10) air-driven pipes;

(11) chillums;

(12) bongs;

(13) ice pipes or chillers;

(14) wired cigarette papers; or

(15) cocaine freebase kits.

(e) Matters considered in determination of what constitutes drug paraphernalia

In determining whether an item constitutes drug paraphernalia, in addition to all other logically relevant factors, the following may be considered:

(1) instructions, oral or written, provided with the item concerning its use;

(2) descriptive materials accompanying the item which explain or depict its use;

(3) national and local advertising concerning its use;

(4) the manner in which the item is displayed for sale;

(5) whether the owner, or anyone in control of the item, is a legitimate supplier of like or related items to the community, such as a licensed distributor or dealer of tobacco products;

(6) direct or circumstantial evidence of the ratio of sales of the item(s) to the total sales of the business enterprise;

(7) the existence and scope of legitimate uses of the item in the community; and

(8) expert testimony concerning its use.

(f) Exemptions

This section shall not apply to—

(1) any person authorized by local, State, or Federal law to manufacture, possess, or distribute such items; or

(2) any item that, in the normal lawful course of business, is imported, exported, transported, or sold through the mail or by any other means, and traditionally intended for use with tobacco products, including any pipe, paper, or accessory.

(Pub. L. 91–513, title II, §422, as added and amended Pub. L. 101–647, title XXIV, §2401(a)–(c), Nov. 29, 1990, 104 Stat. 4858, 4859; Pub. L. 106–310, div. B, title XXXVI, §3614, Oct. 17, 2000, 114 Stat. 1230.)

Editorial Notes

Codification

The text of section 857(b) to (f) of this title, which was transferred to subsecs. (b) to (f) of this section by Pub. L. 101–647, §2401(b), was based on Pub. L. 99–570, title I, §1822(b)–(f), Oct. 27, 1986, 100 Stat. 3207–51; Pub. L. 100–690, title VI, §6485, Nov. 18, 1988, 102 Stat. 4384.

Amendments

2000—Subsec. (d). Pub. L. 106–310 inserted "methamphetamine," after "PCP," in introductory provisions.

1990—Subsec. (b). Pub. L. 101–647, §2401(c)(1), substituted "fined under title 18" for "fined not more than $100,000".

Pub. L. 101–647, §2401(b), redesignated subsec. (b) of section 857 of this title as subsec. (b) of this section. See Codification note above.

Subsecs. (c) to (e). Pub. L. 101–647, §2401(b), redesignated subsecs. (c) to (e) of section 857 of this title as subsecs. (c) to (e) of this section. See Codification note above.

Subsec. (f). Pub. L. 101–647, §2401(c)(2), made technical amendment to reference to "This section" to correct reference to corresponding provision of original act.

Pub. L. 101–647, §2401(b), redesignated subsec. (f) of section 857 of this title as subsec. (f) of this section. See Codification note above.

1 So in original. Probably should be "marihuana,".
21 U.S.C. § 387u (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter IX: TOBACCO PRODUCTS / Section 387u: Studies of progress and effectiveness
Studies of progress and effectiveness
Status: in_force

(a) FDA report

Not later than 3 years after June 22, 2009, and not less than every 2 years thereafter, the Secretary of Health and Human Services shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report concerning—

(1) the progress of the Food and Drug Administration in implementing this division, including major accomplishments, objective measurements of progress, and the identification of any areas that have not been fully implemented;

(2) impediments identified by the Food and Drug Administration to progress in implementing this division and to meeting statutory timeframes;

(3) data on the number of new product applications received under section 387j of this title and modified risk product applications received under section 387k of this title, and the number of applications acted on under each category; and

(4) data on the number of full time equivalents engaged in implementing this division.

(b) GAO report

Not later than 5 years after June 22, 2009, the Comptroller General of the United States shall conduct a study of, and submit to the Committees described in subsection (a) a report concerning—

(1) the adequacy of the authority and resources provided to the Secretary of Health and Human Services for this division to carry out its goals and purposes; and

(2) any recommendations for strengthening that authority to more effectively protect the public health with respect to the manufacture, marketing, and distribution of tobacco products.

(c) Public availability

The Secretary of Health and Human Services and the Comptroller General of the United States, respectively, shall make the reports required under subsection 1 (a) and (b) available to the public, including by posting such reports on the respective Internet websites of the Food and Drug Administration and the Government Accountability Office.

(Pub. L. 111–31, div. A, title I, §106, June 22, 2009, 123 Stat. 1841.)

Editorial Notes

References in Text

This division, referred to in subsecs. (a)(1), (2), (4) and (b)(1), is div. A of Pub. L. 111–31, June 22, 2009, 123 Stat. 1776, known as Family Smoking Prevention and Tobacco Control Act. For complete classification of division A to the Code, see Short Title of 2009 Amendment note set out under section 301 of this title and Tables.

Codification

Section was enacted as part of the Family Smoking Prevention and Tobacco Control Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Statutory Notes and Related Subsidiaries

Modification of Deadlines for Secretarial Action

With respect to any time periods specified in div. A of Pub. L. 111–31 that begin on June 22, 2009, within which the Secretary of Health and Human Services is required to carry out and complete specified activities, with certain limitations, the calculation of such time periods shall commence on the first day of the first fiscal quarter following the initial 2 consecutive fiscal quarters of fiscal year 2010 for which the Secretary has collected fees under section 387s of this title, and the Secretary may extend or reduce the duration of one or more such time periods, except that no such period shall be extended for more than 90 days, see section 6 of Pub. L. 111–31, set out as a note under section 387 of this title.

1 So in original. Probably should be plural.
21 U.S.C. § 360m (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter V: DRUGS AND DEVICES / Section 360m: Accredited persons
Accredited persons
Status: in_force

(a) In general

(1) Review and classification of devices

Not later than 1 year after November 21, 1997, the Secretary shall, subject to paragraph (3), accredit persons for the purpose of reviewing reports submitted under section 360(k) of this title and making recommendations to the Secretary regarding the initial classification of devices under section 360c(f)(1) of this title.

(2) Requirements regarding review

(A) In general

In making a recommendation to the Secretary under paragraph (1), an accredited person shall notify the Secretary in writing of the reasons for the recommendation.

(B) Time period for review

Not later than 30 days after the date on which the Secretary is notified under subparagraph (A) by an accredited person with respect to a recommendation of an initial classification of a device, the Secretary shall make a determination with respect to the initial classification.

(C) Special rule

The Secretary may change the initial classification under section 360c(f)(1) of this title that is recommended under paragraph (1) by an accredited person, and in such case shall provide to such person, and the person who submitted the report under section 360(k) of this title for the device, a statement explaining in detail the reasons for the change.

(3) Certain devices

(A) In general

An accredited person may not be used to perform a review of—

(i) a class III device;

(ii) a device classified under section 360c(f)(2) of this title or designated under section 360e–3(d) 1 of this title;

(iii) a device that is intended to be permanently implantable, life sustaining, or life supporting, unless otherwise determined by the Secretary in accordance with subparagraph (B)(i)(II) and listed as eligible for review under subparagraph (B)(iii); or

(iv) a device that is of a type, or subset of a type, listed as not eligible for review under subparagraph (B)(iii).

(B) Designation for review

The Secretary shall—

(i) issue draft guidance on the factors the Secretary will use in determining whether a class I or class II device type, or subset of such device types, is eligible for review by an accredited person, including—

(I) the risk of the device type, or subset of such device type; and

(II) whether the device type, or subset of such device type, is permanently implantable, life sustaining, or life supporting, and whether there is a detailed public health justification for permitting the review by an accredited person of such device type or subset;

(ii) not later than 24 months after the date on which the Secretary issues such draft guidance, finalize such guidance; and

(iii) beginning on the date such guidance is finalized, designate and post on the internet website of the Food and Drug Administration, an updated list of class I and class II device types, or subsets of such device types, and the Secretary's determination with respect to whether each such device type, or subset of a device type, is eligible or not eligible for review by an accredited person under this section based on the factors described in clause (i).

(C) Interim rule

Until the date on which the updated list is designated and posted in accordance with subparagraph (B)(iii), the list in effect on August 18, 2017, shall be in effect.

(b) Accreditation

(1) Programs

The Secretary shall provide for such accreditation through programs administered by the Food and Drug Administration, other government agencies, or by other qualified nongovernment organizations.

(2) Accreditation

(A) In general

Not later than 180 days after November 21, 1997, the Secretary shall establish and publish in the Federal Register criteria to accredit or deny accreditation to persons who request to perform the duties specified in subsection (a). The Secretary shall respond to a request for accreditation within 60 days of the receipt of the request. The accreditation of such person shall specify the particular activities under subsection (a) for which such person is accredited.

(B) Withdrawal of accreditation

The Secretary may suspend or withdraw accreditation of any person accredited under this paragraph, after providing notice and an opportunity for an informal hearing, when such person is substantially not in compliance with the requirements of this section or poses a threat to public health or fails to act in a manner that is consistent with the purposes of this section.

(C) Performance auditing

To ensure that persons accredited under this section will continue to meet the standards of accreditation, the Secretary shall—

(i) make onsite visits on a periodic basis to each accredited person to audit the performance of such person; and

(ii) take such additional measures as the Secretary determines to be appropriate.

(D) Periodic reaccreditation

(i) Period

Subject to suspension or withdrawal under subparagraph (B), any accreditation under this section shall be valid for a period of 3 years after its issuance.

(ii) Response to reaccreditation request

Upon the submission of a request by an accredited person for reaccreditation under this section, the Secretary shall approve or deny such request not later than 60 days after receipt of the request.

(iii) Criteria

Not later than 120 days after July 9, 2012, the Secretary shall establish and publish in the Federal Register criteria to reaccredit or deny reaccreditation to persons under this section. The reaccreditation of persons under this section shall specify the particular activities under subsection (a), and the devices, for which such persons are reaccredited.

(3) Qualifications

An accredited person shall, at a minimum, meet the following requirements:

(A) Such person may not be an employee of the Federal Government.

(B) Such person shall be an independent organization which is not owned or controlled by a manufacturer, supplier, or vendor of devices and which has no organizational, material, or financial affiliation with such a manufacturer, supplier, or vendor.

(C) Such person shall be a legally constituted entity permitted to conduct the activities for which it seeks accreditation.

(D) Such person shall not engage in the design, manufacture, promotion, or sale of devices.

(E) The operations of such person shall be in accordance with generally accepted professional and ethical business practices.

(F) Such person shall agree, at a minimum, to include in its request for accreditation a commitment to, at the time of accreditation, and at any time it is performing any review pursuant to this section—

(i) certify that reported information accurately reflects data reviewed;

(ii) limit work to that for which competence and capacity are available;

(iii) treat information received, records, reports, and recommendations as proprietary information;

(iv) promptly respond and attempt to resolve complaints regarding its activities for which it is accredited; and

(v) protect against the use, in carrying out subsection (a) with respect to a device, of any officer or employee of the person who has a financial conflict of interest regarding the device, and annually make available to the public disclosures of the extent to which the person, and the officers and employees of the person, have maintained compliance with requirements under this clause relating to financial conflicts of interest.

(4) Selection of accredited persons

The Secretary shall provide each person who chooses to use an accredited person to receive a section 360(k) of this title report a panel of at least two or more accredited persons from which the regulated person may select one for a specific regulatory function.

(5) Compensation of accredited persons

Compensation for an accredited person shall be determined by agreement between the accredited person and the person who engages the services of the accredited person, and shall be paid by the person who engages such services.

(c) Duration

The authority provided by this section terminates on October 1, 2027.

(June 25, 1938, ch. 675, §523, as added Pub. L. 105–115, title II, §210(a), Nov. 21, 1997, 111 Stat. 2342; amended Pub. L. 107–250, title II, §202, Oct. 26, 2002, 116 Stat. 1609; Pub. L. 110–85, title II, §221, Sept. 27, 2007, 121 Stat. 852; Pub. L. 111–31, div. A, title I, §103(f), June 22, 2009, 123 Stat. 1837; Pub. L. 112–144, title VI, §611, July 9, 2012, 126 Stat. 1059; Pub. L. 114–255, div. A, title III, §3102(4), Dec. 13, 2016, 130 Stat. 1156; Pub. L. 115–52, title II, §206, Aug. 18, 2017, 131 Stat. 1018; Pub. L. 117–180, div. F, title II, §2006, Sept. 30, 2022, 136 Stat. 2154; Pub. L. 117–229, div. C, title III, §309, Dec. 16, 2022, 136 Stat. 2312; Pub. L. 117–328, div. FF, title III, §3109, Dec. 29, 2022, 136 Stat. 5808.)

Editorial Notes

References in Text

Section 360e–3 of this title, referred to in subsec. (a)(3)(A)(ii), was in the original a reference to section 515C of act June 25, 1938, which was renumbered section 515B by Pub. L. 115–52, title IX, §901(f)(2), Aug. 18, 2017, 131 Stat. 1077.

Amendments

2022—Subsec. (c). Pub. L. 117–328 substituted "on October 1, 2027" for "December 24, 2022".

Pub. L. 117–229 substituted "December 24, 2022" for "December 17, 2022".

Pub. L. 117–180 substituted "December 17" for "October 1".

2017—Subsec. (a)(3)(A)(ii) to (iv). Pub. L. 115–52, §206(1)(A), added cls. (ii) to (iv) and struck out former cls. (ii) and (iii) which read as follows:

"(ii) a class II device which is intended to be permanently implantable or life sustaining or life supporting; or

"(iii) a class II device which requires clinical data in the report submitted under section 360(k) of this title for the device, except that the number of class II devices to which the Secretary applies this clause for a year, less the number of such reports to which clauses (i) and (ii) apply, may not exceed 6 percent of the number that is equal to the total number of reports submitted to the Secretary under such section for such year less the number of such reports to which such clauses apply for such year."

Subsec. (a)(3)(B). Pub. L. 115–52, §206(1)(B), added subpar. (B) and struck out former subpar. (B). Prior to amendment, text read as follows: "In determining for a year the ratio described in subparagraph (A)(iii), the Secretary shall not include in the numerator class III devices that the Secretary reclassified into class II, and the Secretary shall include in the denominator class II devices for which reports under section 360(k) of this title were not required to be submitted by reason of the operation of section 360(m) of this title."

Subsec. (a)(3)(C). Pub. L. 115–52, §206(1)(C), added subpar. (C).

Subsec. (b)(2)(D), (E). Pub. L. 115–52, §206(2)(A), redesignated subpar. (E) as (D) and struck out former subpar. (D). Prior to amendment, text of subpar. (D) read as follows: "The Secretary shall include in the annual report required under section 393(g) of this title the names of all accredited persons and the particular activities under subsection (a) for which each such person is accredited and the name of each accredited person whose accreditation has been withdrawn during the year."

Subsec. (b)(3)(E). Pub. L. 115–52, §206(2)(B)(iii), added subpar. (E). Former subpar. (E) redesignated (F).

Subsec. (b)(3)(F). Pub. L. 115–52, §206(2)(B)(i), (ii), redesignated subpar. (E) as (F) and substituted "Such person shall agree, at a minimum, to include in its request for accreditation a commitment to, at the time of accreditation, and at any time it is performing any review pursuant to this section" for "The operations of such person shall be in accordance with generally accepted professional and ethical business practices and shall agree in writing that as a minimum it will" in introductory provisions.

Subsec. (c). Pub. L. 115–52, §206(3), substituted "2022' for "2017".

2016—Subsec. (d). Pub. L. 114–255 struck out subsec. (d) which related to report to Congress.

2012—Subsec. (b)(2)(E). Pub. L. 112–144, §611(a), added subpar. (E).

Subsec. (c). Pub. L. 112–144, §611(b), substituted "October 1, 2017" for "October 1, 2012".

2009—Subsec. (b)(2)(D). Pub. L. 111–31 made technical amendment to reference in original act which appears in text as reference to section 393(g) of this title.

2007—Subsec. (c). Pub. L. 110–85 substituted "2012" for "2007".

2002—Subsec. (c). Pub. L. 107–250, §202(1), substituted "The authority provided by this section terminates October 1, 2007." for "The authority provided by this section terminates—

"(1) 5 years after the date on which the Secretary notifies Congress that at least 2 persons accredited under subsection (b) of this section are available to review at least 60 percent of the submissions under section 360(k) of this title, or

"(2) 4 years after the date on which the Secretary notifies Congress that the Secretary has made a determination described in paragraph (2)(B) of subsection (a) of this section for at least 35 percent of the devices that are subject to review under paragraph (1) of such subsection,

whichever occurs first."

Subsec. (d). Pub. L. 107–250, §202(2), added subsec. (d).

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under subpart 3 of part C of subchapter VII of this chapter to be assessed for all submissions listed in section 379j(a)(2)(A) of this title received on or after Oct. 1, 2022, see section 2008 of Pub. L. 117–180, set out as a note under section 360d of this title.

Effective Date of 2017 Amendment

Amendment by Pub. L. 115–52 effective Oct. 1, 2017, with fees under subpart 3 of part C of subchapter VII of this chapter to be assessed for all submissions listed in section 379j(a)(2)(A) of this title received on or after Oct. 1, 2017, see section 209 of Pub. L. 115–52, set out as a note under section 379i of this title.

Effective Date

Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

Reports on Program of Accreditation

Pub. L. 105–115, title II, §210(d), Nov. 21, 1997, 111 Stat. 2345, provided that:

"(1) Comptroller general.—

"(A) Implementation of program.—Not later than 5 years after the date of the enactment of this Act [Nov. 21, 1997], the Comptroller General of the United States shall submit to the Committee on Commerce [now Committee on Energy and Commerce] of the House of Representatives and the Committee on Labor and Human Resources [now Committee on Health, Education, Labor, and Pensions] of the Senate a report describing the extent to which the program of accreditation required by the amendment made by subsection (a) [enacting this section] has been implemented.

"(B) Evaluation of program.—Not later than 6 months prior to the date on which, pursuant to subsection (c) of section 523 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360m(c)] (as added by subsection (a)), the authority provided under subsection (a) of such section will terminate, the Comptroller General shall submit to the Committee on Commerce [now Committee on Energy and Commerce] of the House of Representatives and the Committee on Labor and Human Resources [now Committee on Health, Education, Labor, and Pensions] of the Senate a report describing the use of accredited persons under such section 523, including an evaluation of the extent to which such use assisted the Secretary in carrying out the duties of the Secretary under such Act [21 U.S.C. 301 et seq.] with respect to devices, and the extent to which such use promoted actions which are contrary to the purposes of such Act.

"(2) Inclusion of certain devices within program.—Not later than 3 years after the date of the enactment of this Act [Nov. 21, 1997], the Secretary of Health and Human Services shall submit to the Committee on Commerce of the House of Representatives and the Committee on Labor and Human Resources [now Committee on Health, Education, Labor, and Pensions] of the Senate a report providing a determination by the Secretary of whether, in the program of accreditation established pursuant to the amendment made by subsection (a), the limitation established in clause (iii) of section 523(a)(3)(A) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360m(a)(3)(A)] (relating to class II devices for which clinical data are required in reports under section 510(k) [21 U.S.C. 360(k)]) should be removed."

1 See References in Text note below.
21 U.S.C. § 607 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter I: INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING / Section 607: Labeling, marking, and container requirements
Labeling, marking, and container requirements
Status: in_force

(a) Labeling receptacles or coverings of meat or meat food products inspected and passed; supervision by inspectors

When any meat or meat food product prepared for commerce which has been inspected as hereinbefore provided and marked "Inspected and passed" shall be placed or packed in any can, pot, tin, canvas, or other receptacle or covering in any establishment where inspection under the provisions of this chapter is maintained, the person, firm, or corporation preparing said product shall cause a label to be attached to said can, pot, tin, canvas, or other receptacle or covering, under the supervision of an inspector, which label shall state that the contents thereof have been "inspected and passed" under the provisions of this chapter; and no inspection and examination of meat or meat food products deposited or inclosed in cans, tins, pots, canvas, or other receptacle or covering in any establishment where inspection under the provisions of this chapter is maintained shall be deemed to be complete until such meat or meat food products have been sealed or inclosed in said can, tin, pot, canvas, or other receptacle or covering under the supervision of an inspector.

(b) Information on articles or containers; legible form

All carcasses, parts of carcasses, meat and meat food products inspected at any establishment under the authority of this subchapter and found to be not adulterated, shall at the time they leave the establishment bear, in distinctly legible form, directly thereon or on their containers, as the Secretary may require, the information required under paragraph (n) of section 601 of this title.

(c) Labeling: type styles and sizes; definitions and standards of identity or composition; standards of fill of container; consistency of Federal and Federal-State standards

The Secretary, whenever he determines such action is necessary for the protection of the public, may prescribe: (1) the styles and sizes of type to be used with respect to material required to be incorporated in labeling to avoid false or misleading labeling in marketing and labeling any articles or animals subject to this subchapter or subchapter II of this chapter; (2) definitions and standards of identity or composition for articles subject to this subchapter and standards of fill of container for such articles not inconsistent with any such standards established under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.], and there shall be consultation between the Secretary and the Secretary of Health and Human Services prior to the issuance of such standards under either Act relating to articles subject to this chapter to avoid inconsistency in such standards and possible impairment of the coordinated effective administration of these Acts. There shall also be consultation between the Secretary and an appropriate advisory committee provided for in section 661 of this title, prior to the issuance of such standards under this chapter, to avoid, insofar as feasible, inconsistency between Federal and State standards.

(d) Sales under false or misleading name, other marking or labeling or in containers of misleading form or size; trade names, and other marking, labeling, and containers approved by Secretary

No article subject to this subchapter shall be sold or offered for sale by any person, firm, or corporation, in commerce, under any name or other marking or labeling which is false or misleading, or in any container of a misleading form or size, but established trade names and other marking and labeling and containers which are not false or misleading and which are approved by the Secretary are permitted.

(e) Use withholding directive respecting false or misleading marking, labeling, or container; modification of false or misleading matter; hearing; withholding use pending proceedings; finality of Secretary's action; judicial review; application of section 194 of title 7

If the Secretary has reason to believe that any marking or labeling or the size or form of any container in use or proposed for use with respect to any article subject to this subchapter is false or misleading in any particular, he may direct that such use be withheld unless the marking, labeling, or container is modified in such manner as he may prescribe so that it will not be false or misleading. If the person, firm, or corporation using or proposing to use the marking, labeling or container does not accept the determination of the Secretary, such person, firm, or corporation may request a hearing, but the use of the marking, labeling, or container shall, if the Secretary so directs, be withheld pending hearing and final determination by the Secretary. Any such determination by the Secretary shall be conclusive unless, within thirty days after receipt of notice of such final determination, the person, firm, or corporation adversely affected thereby appeals to the United States court of appeals for the circuit in which such person, firm, or corporation has its principal place of business or to the United States Court of Appeals for the District of Columbia Circuit. The provisions of section 194 of title 7 shall be applicable to appeals taken under this section.

(f) Lamb and mutton

The Secretary, consistent with United States international obligations, shall establish standards for the labeling of sheep carcasses, parts of sheep carcasses, sheepmeat, and sheepmeat food products.

(Mar. 4, 1907, ch. 2907, title I, §7, formerly 5th par., 34 Stat. 1262; renumbered §7 and amended Pub. L. 90–201, §§1, 3(a), 6, Dec. 15, 1967, 81 Stat. 584, 588; Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 104–127, title II, §279, Apr. 4, 1996, 110 Stat. 979.)

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (c)(2), 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.

Either Act and these Acts, referred to in subsec. (c)(2), mean the Federal Meat Inspection Act and the Federal Food, Drug, and Cosmetic Act. The Federal Meat Inspection Act is titles I to V of act Mar. 4, 1907, ch. 2907, as added Pub. L. 90–201, Dec. 15, 1967, 81 Stat. 584, and Pub. L. 110–246, title XI, §11015(a), June 18, 2008, 122 Stat. 2124, which are classified generally to subchapters I to IV–A (§601 et seq.) of this chapter. For complete classification of this Act to the Code, see Short Title note under section 601 of this title and Tables.

Codification

Section was formerly classified to section 75 of this title.

Amendments

1996—Subsec. (f). Pub. L. 104–127 added subsec. (f).

1967—Subsec. (a). Pub. L. 90–201, §§3(a), 6(a), (b), struck out "interstate or foreign" before "commerce" and provisions prohibiting sales of meat or meat food products in interstate or foreign commerce under any false or deceptive names and permitting trade names or names which are usual to such products and are not false and deceptive and are approved by the Secretary of Agriculture, now incorporated in subsec. (d), and designated remaining provisions as subsecs. (a), respectively.

Subsecs. (b) to (e). Pub. L. 90–201, §6(c), added subsecs. (b) to (e).

Statutory Notes and Related Subsidiaries

Change of Name

"Secretary of Health and Human Services" substituted for "Secretary of Health, Education, and Welfare" in subsec. (c)(2) pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education.

Effective Date of 1967 Amendment

Amendment by Pub. L. 90–201 effective Dec. 15, 1967, except that with respect to equines (other than horses) and their carcasses and parts thereof, meat, and meat food products thereof, amendment effective upon expiration of sixty days after Dec. 15, 1967, see section 20(b) of Pub. L. 90–201, set out as an Effective Date note under section 601 of this title.
21 U.S.C. § 371 (2024) — Title 21: FOOD AND DRUGS / Chapter 9: FEDERAL FOOD, DRUG, AND COSMETIC ACT / Subchapter VII: GENERAL AUTHORITY / Section 371: Regulations and hearings
Regulations and hearings
Status: in_force

(a) Authority to promulgate regulations

The authority to promulgate regulations for the efficient enforcement of this chapter, except as otherwise provided in this section, is vested in the Secretary.

(b) Regulations for imports and exports

The Secretary of the Treasury and the Secretary of Health and Human Services shall jointly prescribe regulations for the efficient enforcement of the provisions of section 381 of this title, except as otherwise provided therein. Such regulations shall be promulgated in such manner and take effect at such time, after due notice, as the Secretary of Health and Human Services shall determine.

(c) Conduct of hearings

Hearings authorized or required by this chapter shall be conducted by the Secretary or such officer or employee as he may designate for the purpose.

(d) Effectiveness of definitions and standards of identity

The definitions and standards of identity promulgated in accordance with the provisions of this chapter shall be effective for the purposes of the enforcement of this chapter, notwithstanding such definitions and standards as may be contained in other laws of the United States and regulations promulgated thereunder.

(e) Procedure for establishment

(1) Any action for the issuance, amendment, or repeal of any regulation under section 343(j), 344(a), 346, 351(b), or 352(d) or (h) of this title, and any action for the amendment or repeal of any definition and standard of identity under section 341 of this title for any dairy product (including products regulated under parts 131, 133 and 135 of title 21, Code of Federal Regulations) shall be begun by a proposal made (A) by the Secretary on his own initiative, or (B) by petition of any interested person, showing reasonable grounds therefor, filed with the Secretary. The Secretary shall publish such proposal and shall afford all interested persons an opportunity to present their views thereon, orally or in writing. As soon as practicable thereafter, the Secretary shall by order act upon such proposal and shall make such order public. Except as provided in paragraph (2), the order shall become effective at such time as may be specified therein, but not prior to the day following the last day on which objections may be filed under such paragraph.

(2) On or before the thirtieth day after the date on which an order entered under paragraph (1) is made public, any person who will be adversely affected by such order if placed in effect may file objections thereto with the Secretary, specifying with particularity the provisions of the order deemed objectionable, stating the grounds therefor, and requesting a public hearing upon such objections. Until final action upon such objections is taken by the Secretary under paragraph (3), the filing of such objections shall operate to stay the effectiveness of those provisions of the order to which the objections are made. As soon as practicable after the time for filing objections has expired the Secretary shall publish a notice in the Federal Register specifying those parts of the order which have been stayed by the filing of objections and, if no objections have been filed, stating that fact.

(3) As soon as practicable after such request for a public hearing, the Secretary, after due notice, shall hold such a public hearing for the purpose of receiving evidence relevant and material to the issues raised by such objections. At the hearing, any interested person may be heard in person or by representative. As soon as practicable after completion of the hearing, the Secretary shall by order act upon such objections and make such order public. Such order shall be based only on substantial evidence of record at such hearing and shall set forth, as part of the order, detailed findings of fact on which the order is based. The Secretary shall specify in the order the date on which it shall take effect, except that it shall not be made to take effect prior to the ninetieth day after its publication unless the Secretary finds that emergency conditions exist necessitating an earlier effective date, in which event the Secretary shall specify in the order his findings as to such conditions.

(f) Review of order

(1) In a case of actual controversy as to the validity of any order under subsection (e), any person who will be adversely affected by such order if placed in effect may at any time prior to the ninetieth day after such order is issued file a petition with the United States court of appeals for the circuit wherein such person resides or has his principal place of business, for a judicial review of such order. A copy of the petition shall be forthwith transmitted by the clerk of the court to the Secretary or other officer designated by him for that purpose. The Secretary thereupon shall file in the court the record of the proceedings on which the Secretary based his order, as provided in section 2112 of title 28.

(2) If the petitioner applies to the court for leave to adduce additional evidence, and shows to the satisfaction of the court that such additional evidence is material and that there were reasonable grounds for the failure to adduce such evidence in the proceeding before the Secretary, the court may order such additional evidence (and evidence in rebuttal thereof) to be taken before the Secretary, and to be adduced upon the hearing, in such manner and upon such terms and conditions as to the court may seem proper. The Secretary may modify his findings as to the facts, or make new findings, by reason of the additional evidence so taken, and he shall file such modified or new findings, and his recommendation, if any, for the modification or setting aside of his original order, with the return of such additional evidence.

(3) Upon the filing of the petition referred to in paragraph (1) of this subsection, the court shall have jurisdiction to affirm the order, or to set it aside in whole or in part, temporarily or permanently. If the order of the Secretary refuses to issue, amend, or repeal a regulation and such order is not in accordance with law the court shall by its judgment order the Secretary to take action, with respect to such regulation, in accordance with law. The findings of the Secretary as to the facts, if supported by substantial evidence, shall be conclusive.

(4) The judgment of the court affirming or setting aside, in whole or in part, any such order of the Secretary shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as provided in section 1254 of title 28.

(5) Any action instituted under this subsection shall survive notwithstanding any change in the person occupying the office of Secretary or any vacancy in such office.

(6) The remedies provided for in this subsection shall be in addition to and not in substitution for any other remedies provided by law.

(g) Copies of records of hearings

A certified copy of the transcript of the record and proceedings under subsection (e) shall be furnished by the Secretary to any interested party at his request, and payment of the costs thereof, and shall be admissible in any criminal, libel for condemnation, exclusion of imports, or other proceeding arising under or in respect to this chapter, irrespective of whether proceedings with respect to the order have previously been instituted or become final under subsection (f).

(h) Guidance documents

(1)(A) The Secretary shall develop guidance documents with public participation and ensure that information identifying the existence of such documents and the documents themselves are made available to the public both in written form and, as feasible, through electronic means. Such documents shall not create or confer any rights for or on any person, although they present the views of the Secretary on matters under the jurisdiction of the Food and Drug Administration.

(B) Although guidance documents shall not be binding on the Secretary, the Secretary shall ensure that employees of the Food and Drug Administration do not deviate from such guidances without appropriate justification and supervisory concurrence. The Secretary shall provide training to employees in how to develop and use guidance documents and shall monitor the development and issuance of such documents.

(C)(i) For guidance documents that set forth initial interpretations of a statute or regulation, changes in interpretation or policy that are of more than a minor nature, complex scientific issues, or highly controversial issues, the Secretary shall ensure public participation prior to implementation of guidance documents, unless the Secretary determines that such prior public participation is not feasible or appropriate. In such cases, the Secretary shall provide for public comment upon implementation and take such comment into account.

(ii) With respect to devices, if a notice to industry guidance letter, a notice to industry advisory letter, or any similar notice sets forth initial interpretations of a regulation or policy or sets forth changes in interpretation or policy, such notice shall be treated as a guidance document for purposes of this subparagraph.

(D) For guidance documents that set forth existing practices or minor changes in policy, the Secretary shall provide for public comment upon implementation.

(2) In developing guidance documents, the Secretary shall ensure uniform nomenclature for such documents and uniform internal procedures for approval of such documents. The Secretary shall ensure that guidance documents and revisions of such documents are properly dated and indicate the nonbinding nature of the documents. The Secretary shall periodically review all guidance documents and, where appropriate, revise such documents.

(3) The Secretary, acting through the Commissioner, shall maintain electronically and update and publish periodically in the Federal Register a list of guidance documents. All such documents shall be made available to the public.

(4) The Secretary shall ensure that an effective appeals mechanism is in place to address complaints that the Food and Drug Administration is not developing and using guidance documents in accordance with this subsection.

(5) Not later than July 1, 2000, the Secretary after evaluating the effectiveness of the Good Guidance Practices document, published in the Federal Register at 62 Fed. Reg. 8961, shall promulgate a regulation consistent with this subsection specifying the policies and procedures of the Food and Drug Administration for the development, issuance, and use of guidance documents.

(June 25, 1938, ch. 675, §701, 52 Stat. 1055; June 25, 1948, ch. 646, §32, 62 Stat. 991; Apr. 15, 1954, ch. 143, §2, 68 Stat. 55; Aug. 1, 1956, ch. 861, §2, 70 Stat. 919; Pub. L. 85–791, §21, Aug. 28, 1958, 72 Stat. 948; Pub. L. 86–618, title I, §103(a)(4), July 12, 1960, 74 Stat. 398; Pub. L. 101–535, §8, Nov. 8, 1990, 104 Stat. 2365; Pub. L. 102–300, §6(b)(1), June 16, 1992, 106 Stat. 240; Pub. L. 103–80, §§3(y), (dd)(1), 4(c), Aug. 13, 1993, 107 Stat. 778, 779; Pub. L. 103–396, §3(b), Oct. 22, 1994, 108 Stat. 4155; Pub. L. 105–115, title IV, §405, Nov. 21, 1997, 111 Stat. 2368; Pub. L. 112–144, title VI, §619, July 9, 2012, 126 Stat. 1063.)

Editorial Notes

Amendments

2012—Subsec. (h)(1)(C). Pub. L. 112–144 designated existing provisions as cl. (i) and added cl. (ii).

1997—Subsec. (h). Pub. L. 105–115 added subsec. (h).

1994—Subsec. (e)(1). Pub. L. 103–396 which directed the amendment of par. (1) by striking out "or maple syrup (regulated under section 168.140 of title 21, Code of Federal Regulations).", was executed by striking out "or maple sirup (regulated under section 168.140 of title 21, Code of Federal Regulations)" before "shall be begun by a proposal", to reflect the probable intent of Congress.

1993—Subsec. (b). Pub. L. 103–80, §3(dd)(1), substituted "Health and Human Services" for "Agriculture" in two places.

Subsec. (e)(1). Pub. L. 103–80, §4(c), made technical correction to directory language of Pub. L. 101–535, §8. See 1990 Amendment note below.

Pub. L. 103–80, §3(y)(1), struck out period after second reference to "Regulations)".

Subsec. (f)(4). Pub. L. 103–80, §3(y)(2), substituted reference to section 1254 of title 28 for "sections 239 and 240 of the Judicial Code, as amended".

1992—Subsec. (b). Pub. L. 102–300, which directed the substitution of "Health and Human Services" for "Health, Education, and Welfare", could not be executed because such words did not appear in the original statutory text. See 1993 Amendment note above and Transfer of Functions note below.

1990—Subsec. (e)(1). Pub. L. 101–535, §8, as amended by Pub. L. 103–80, §4(c), substituted "Any action for the issuance, amendment, or repeal of any regulation under section 343(j), 344(a), 346, 351(b), or 352(d) or (h) of this title, and any action for the amendment or repeal of any definition and standard of identity under section 341 of this title for any dairy product (including products regulated under parts 131, 133 and 135 of title 21, Code of Federal Regulations) or maple sirup (regulated under section 168.140 of title 21, Code of Federal Regulations)" for "Any action for the issuance, amendment, or repeal of any regulation under section 341, 343(j), 344(a), 346, 351(b), or 352(d) or (h) of this title".

1960—Subsec. (e). Pub. L. 86–618 substituted "section 341, 343(j), 344(a), 346, 351(b), or 352(d) or (h), of this title" for "section 341, 343(j), 344(a), 346(a) or (b), 351(b), 352(d) or (h), 354 or 364 of this title".

1958—Subsec. (f)(1). Pub. L. 85–791, §21(a), substituted provisions requiring transmission of a copy of the petition by clerk to Secretary, and filing of the record by Secretary, for provisions which permitted service of summons and petition any place in United States and required Secretary to certify and file transcript of the proceedings and record upon service.

Subsec. (f)(3). Pub. L. 85–791, §21(b), inserted "Upon the filing of the petition referred to in paragraph (1) of this subsection".

1956—Subsec. (e). Act Aug. 1, 1956, simplified procedures governing prescribing of regulations under certain provisions of this chapter.

1954—Subsec. (e). Act Apr. 15, 1954, struck out reference to section 341 of this title, before "343(j)", such section 341 now containing its own provisions with respect to hearings regarding the establishment of food standards.

Statutory Notes and Related Subsidiaries

Change of Name

Circuit Court of Appeals of the United States changed to United States court of appeals by act June 25, 1948, eff. Sept. 1, 1948.

Effective Date of 1997 Amendment

Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

Effective Date of 1960 Amendment

Amendment by Pub. L. 86–618 effective July 12, 1960, subject to the provisions of section 203 of Pub. L. 86–618, see section 202 of Pub. L. 86–618, set out as a note under section 379e of this title.

Construction of Amendments by Pub. L. 101–535

Amendments by Pub. L. 101–535 not to be construed to alter the authority of the Secretary of Health and Human Services and the Secretary of Agriculture under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), see section 9 of Pub. L. 101–535, set out as a note under section 343 of this title.

Savings Provision

Savings clause of act Aug. 1, 1956, see note set out under section 341 of this title.

Transfer of Functions

Secretary and Department of Health, Education, and Welfare redesignated Secretary and Department of Health and Human Services by Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93 Stat. 695, which is classified to section 3508(b) of Title 20, Education.

Notification of FDA Intent To Regulate Laboratory-Developed Tests

Pub. L. 112–144, title XI, §1143, July 9, 2012, 126 Stat. 1130, provided that the Food and Drug Administration could not issue any draft or final guidance on the regulation of laboratory-developed tests under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) without, at least 60 days prior to such issuance, notifying the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate of the Administration's intent to take such action and including in such notification the anticipated details of such action, and that such provision ceased to have force or effect on the date that was 5 years after the date of enactment of Pub. L. 112–144, which was approved July 9, 2012.

Approval of Supplemental Applications for Approved Products

Pub. L. 105–115, title IV, §403, Nov. 21, 1997, 111 Stat. 2367, provided that:

"(a) Standards.—Not later than 180 days after the date of enactment of this Act [Nov. 21, 1997], the Secretary of Health and Human Services shall publish in the Federal Register standards for the prompt review of supplemental applications submitted for approved articles under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or section 351 of the Public Health Service Act (42 U.S.C. 262).

"(b) Guidance to Industry.—Not later than 180 days after the date of enactment of this Act [Nov. 21, 1997], the Secretary shall issue final guidances to clarify the requirements for, and facilitate the submission of data to support, the approval of supplemental applications for the approved articles described in subsection (a). The guidances shall—

"(1) clarify circumstances in which published matter may be the basis for approval of a supplemental application;

"(2) specify data requirements that will avoid duplication of previously submitted data by recognizing the availability of data previously submitted in support of an original application; and

"(3) define supplemental applications that are eligible for priority review.

"(c) Responsibilities of Centers.—The Secretary shall designate an individual in each center within the Food and Drug Administration (except the Center for Food Safety and Applied Nutrition) to be responsible for—

"(1) encouraging the prompt review of supplemental applications for approved articles; and

"(2) working with sponsors to facilitate the development and submission of data to support supplemental applications.

"(d) Collaboration.—The Secretary shall implement programs and policies that will foster collaboration between the Food and Drug Administration, the National Institutes of Health, professional medical and scientific societies, and other persons, to identify published and unpublished studies that may support a supplemental application, and to encourage sponsors to make supplemental applications or conduct further research in support of a supplemental application based, in whole or in part, on such studies."

Hearings Pending on April 15, 1954, With Respect to Food Standards

Provisions of this chapter in effect prior to Apr. 15, 1954, as applicable with respect to hearings begun prior to such date under subsection (e) of this section, regarding food standards, see Savings Provisions note set out under section 341 of this title.

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.
21 U.S.C. § 114 (2024) — Title 21: FOOD AND DRUGS / Chapter 4: ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS / Subchapter III: PREVENTION OF INTRODUCTION AND SPREAD OF CONTAGION / Section 114: Repealed. Pub. L. 107-171, title X, §10418(a)(8), (9), May 13, 2002, 116 Stat. 508
Repealed. Pub. L. 107-171, title X, §10418(a)(8), (9), May 13, 2002, 116 Stat. 508
Status: repealed

Section 114, act May 29, 1884, ch. 60, §3, 23 Stat. 32, related to regulations for suppression of diseases and cooperation of States and Territories.

Section 114a, act May 29, 1884, ch. 60, §11, as added Sept. 21, 1944, ch. 412, title I, §101(a), 58 Stat. 734; amended Oct. 30, 1951, ch. 637, §1, 65 Stat. 693; Aug. 8, 1953, ch. 381, 67 Stat. 493; Aug. 3, 1956, ch. 950, §2, 70 Stat. 1032; Pub. L. 87–518, §7, July 2, 1962, 76 Stat. 131; Pub. L. 101–624, title XXV, §2509(c)(2), Nov. 28, 1990, 104 Stat. 4071, related to control and eradication of diseases, cooperation of States and farmers' associations, purchase and destruction of diseased animals, and defined "State" for statutory purposes.

A prior section 11 of act May 29, 1884, required annual reports to Congress concerning the suppression of contagious diseases among domestic animals, and was classified to section 560 of former Title 5, prior to repeal by act May 29, 1928, ch. 901, §1, 45 Stat. 993.

Section 114a–1, act May 29, 1884, ch. 60, §13, as added Oct. 30, 1951, ch. 637, §2, 65 Stat. 693, related to interstate movement of domestic animals reacting to tests for brucellosis, immediate slaughter, and rules and regulations.

Section 114b, act Feb. 28, 1947, ch. 8, §1, 61 Stat. 7; Pub. L. 89–521, §1, July 27, 1966, 80 Stat. 330; Pub. L. 92–152, §1, Nov. 5, 1971, 85 Stat. 418; Pub. L. 94–231, §3, Mar. 15, 1976, 90 Stat. 216; Pub. L. 101–255, §1(1), Mar. 15, 1990, 104 Stat. 114; Pub. L. 101–624, title XXV, §2505, Nov. 28, 1990, 104 Stat. 4068, related to cooperation in animal disease control.

Section 114c, act Feb. 28, 1947, ch. 8, §2, 61 Stat. 7; Aug. 3, 1956, ch. 950, §3, 70 Stat. 1033; Pub. L. 92–152, §2, Nov. 5, 1971, 85 Stat. 419; Pub. L. 101–255, §1(2), Mar. 15, 1990, 104 Stat. 114, related to use of funds.

Section 114d, act Feb. 28, 1947, ch. 8, §3, as added Pub. L. 101–255, §1(3), Mar. 15, 1990, 104 Stat. 114, related to sale of sterile screwworms.

A prior section 114d, act Feb. 28, 1947, ch. 8, §3, 61 Stat. 8, related to reports by Secretary of Agriculture to Congress with respect to activities carried on under sections 114b and 114c of this title, prior to repeal by Pub. L. 86–533, §1(20), June 29, 1960, 74 Stat. 249.

Section 114d–1, act Feb. 28, 1947, ch. 8, §5, as added Pub. L. 89–521, §2, July 27, 1966, 80 Stat. 330; amended Pub. L. 101–255, §1(5), Mar. 15, 1990, 104 Stat. 114, related to cooperation with public and private entities.

Statutory Notes and Related Subsidiaries

Short Title

Section 6 of act Feb. 28, 1947, ch. 8, as added by Pub. L. 101–255, §1(6), Mar. 15, 1990, 104 Stat. 114, provided that the act Feb. 28, 1947, ch. 8, which enacted sections 114b to 114d–1 of this title and provisions set out as a note under former section 114b of this title, could be referred to as the "Animal Disease Control Cooperation Act of 1947".
21 U.S.C. § 661 (2024) — Title 21: FOOD AND DRUGS / Chapter 12: MEAT INSPECTION / Subchapter III: FEDERAL AND STATE COOPERATION / Section 661: Federal and State cooperation
Federal and State cooperation
Status: in_force

(a) Congressional statement of policy

It is the policy of the Congress to protect the consuming public from meat and meat food products that are adulterated or misbranded and to assist in efforts by State and other Government agencies to accomplish this objective. In furtherance of this policy—

(1) Development and administration of State meat inspection program equal to subchapter I ante and post mortem inspection, reinspection, and sanitation requirements

The Secretary is authorized, whenever he determines that it would effectuate the purposes of this chapter, to cooperate with the appropriate State agency in developing and administering a State meat inspection program in any State which has enacted a State meat inspection law that imposes mandatory ante mortem and post mortem inspection, reinspection and sanitation requirements that are at least equal to those under subchapter I of this chapter, with respect to all or certain classes of persons engaged in the State in slaughtering cattle, sheep, swine, goats, or equines, or preparing the carcasses, parts thereof, meat or meat food products, of any such animals for use as human food solely for distribution within such State.

(2) Development and administration of State program with authorities equal to subchapter II authorities; cooperation with Federal agencies

The Secretary is further authorized, whenever he determines that it would effectuate the purposes of this chapter, to cooperate with appropriate State agencies in developing and administering State programs under State laws containing authorities at least equal to those provided in subchapter II of this chapter; and to cooperate with other agencies of the United States in carrying out any provisions of this chapter.

(3) Scope of cooperation: advisory assistance, technical and laboratory assistance and training, and financial and other aid; limitation on amount; equitable allocation of Federal funds; adequacy of State program to obtain Federal cooperation and payments

Cooperation with State agencies under this section may include furnishing to the appropriate State agency (i) advisory assistance in planning and otherwise developing an adequate State program under the State law; and (ii) technical and laboratory assistance and training (including necessary curricular and instructional materials and equipment), and financial and other aid for administration of such a program. The amount to be contributed to any State by the Secretary under this section from Federal funds for any year shall not exceed 50 per centum of the estimated total cost of the cooperative program; and the Federal funds shall be allocated among the States desiring to cooperate on an equitable basis. Such cooperation and payment shall be contingent at all times upon the administration of the State program in a manner which the Secretary, in consultation with the appropriate advisory committee appointed under paragraph (4), deems adequate to effectuate the purposes of this section.

(4) Advisory committees

The Secretary may appoint advisory committees consisting of such representatives of appropriate State agencies as the Secretary and the State agencies may designate to consult with him concerning State and Federal programs with respect to meat inspection and other matters within the scope of this chapter, including evaluating State programs for purposes of this chapter and obtaining better coordination and more uniformity among the State programs and between the Federal and State programs and adequate protection of consumers.

(b) Single State agency; subordinate governmental unit as part of State agency

The appropriate State agency with which the Secretary may cooperate under this chapter shall be a single agency in the State which is primarily responsible for the coordination of the State programs having objectives similar to those under this chapter. When the State program includes performance of certain functions by a municipality or other subordinate governmental unit, such unit shall be deemed to be a part of the State agency for purposes of this section.

(c) State meat inspection requirements

(1) Notice to Governor of nondevelopment or nonenforcement; designation of State as subject to subchapters I and IV; delay and revocation of designation; publication in Federal Register; notice of production of adulterated meat or meat food products; designation of State

If the Secretary has reason to believe, by thirty days prior to the expiration of two years after December 15, 1967, that a State has failed to develop or is not enforcing, with respect to all establishments within its jurisdiction (except those that would be exempted from Federal inspection under subparagraph (2)) at which cattle, sheep, swine, goats, or equines are slaughtered, or their carcasses, or parts or products thereof, are prepared for use as human food, solely for distribution within such State, and the products of such establishments, requirements at least equal to those imposed under subchapter I and IV of this chapter, he shall promptly notify the Governor of the State of this fact. If the Secretary determines, after consultation with the Governor of the State, or representative selected by him, that such requirements have not been developed and activated, he shall promptly after the expiration of such two-year period designate such State as one in which the provisions of subchapters I and IV of this chapter shall apply to operations and transactions wholly within such State: Provided, That if the Secretary has reason to believe that the State will activate such requirements within one additional year, he may delay such designation for said period, and not designate the State, if he determines at the end of the year that the State then has such requirements in effective operation. The Secretary shall publish any such designation in the Federal Register and, upon the expiration of thirty days after such publication, the provisions of subchapters I and IV shall apply to operations and transactions and to persons, firms, and corporations engaged therein in the State to the same extent and in the same manner as if such operations and transactions were conducted in or for commerce. Thereafter, upon request of the Governor, the Secretary shall revoke such designation if the Secretary determines that such State has developed and will enforce requirements at least equal to those imposed under subchapter I and subchapter IV of this chapter: And provided further, That, notwithstanding any other provision of this section, if the Secretary determines that any establishment within a State is producing adulterated meat or meat food products for distribution within such State which would clearly endanger the public health he shall notify the Governor of the State and the appropriate Advisory Committee provided by section 661 of this title of such fact for effective action under State or local law. If the State does not take action to prevent such endangering of the public health within a reasonable time after such notice, as determined by the Secretary, in light of the risk to public health, the Secretary may forthwith designate any such establishment as subject to the provisions of subchapters I and IV of this chapter, and thereupon the establishment and operator thereof shall be subject to such provisions as though engaged in commerce until such time as the Secretary determines that such State has developed and will enforce requirements at least equal to those imposed under subchapter I and subchapter IV of this chapter.

(2) Exemptions of retail stores, restaurants, and similar retail-type establishments; operations conducted at a restaurant central kitchen facility

The provisions of this chapter requiring inspection of the slaughter of animals and the preparation of carcasses, parts thereof, meat and meat food products shall not apply to operations of types traditionally and usually conducted at retail stores and restaurants, when conducted at any retail store or restaurant or similar retail-type establishment for sale in normal retail quantities or service of such articles to consumers at such establishments if such establishments are subject to such inspection provisions only under this paragraph (c). For the purposes of this subparagraph, operations conducted at a restaurant central kitchen facility shall be considered as being conducted at a restaurant if the restaurant central kitchen prepares meat or meat food products that are ready to eat when they leave such facility and are served in meals or as entrees only to customers at restaurants owned or operated by the same person, firm, or corporation owning or operating such facility: Provided, That such facility shall be subject to the provisions of section 642 of this title: Provided further, That the facility may be subject to the inspection requirements under subchapter I of this chapter for as long as the Secretary deems necessary, if the Secretary determines that the sanitary conditions or practices of the facility or the processing procedures or methods at the facility are such that any of its meat or meat food products are rendered adulterated.

(3) Termination of designation of State upon development and enforcement of minimum requirements; redesignation; designation for nonenforcement of minimum requirements: notice and publication in Federal Register

Whenever the Secretary determines that any State designated under this paragraph (c) has developed and will enforce State meat inspection requirements at least equal to those imposed under subchapters I and IV, with respect to the operations and transactions within such State which are regulated under paragraph (1), he shall terminate the designation of such State under this paragraph (c), but this shall not preclude the subsequent redesignation of the State at any time upon thirty days notice to the Governor and publication in the Federal Register in accordance with this paragraph, and any State may be designated upon such notice and publication at any time after the period specified in this paragraph whether or not the State has theretofore been designated upon the Secretary determining that it is not effectively enforcing requirements at least equal to those imposed under subchapters I and IV.

(4) Periodic review; report to Congressional committees

The Secretary shall promptly upon December 15, 1967, and periodically thereafter, but at least annually, review the requirements, including the enforcement thereof, of the several States not designated under this paragraph (c), with respect to the slaughter, and the preparation, storage, handling and distribution of carcasses, parts thereof, meat and meat food products, of such animals, and inspection of such operations and annually report thereon to the Committee on Agriculture of the House of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate in the report required under section 691 1 of this title.

(d) "State" defined

As used in this section, the term "State" means any State (including the Commonwealth of Puerto Rico) or organized Territory.

(Mar. 4, 1907, ch. 2907, title III §301, as added Pub. L. 90–201, §15, Dec. 15, 1967, 81 Stat. 595; amended Pub. L. 98–487, §1, Oct. 17, 1984, 98 Stat. 2264; Pub. L. 103–437, §8(2), Nov. 2, 1994, 108 Stat. 4588.)

Editorial Notes

References in Text

Section 691 of this title, referred to in subsec. (c)(4), was omitted from the Code.

Codification

In subsec. (c)(1), (4), "December 15, 1967" substituted for "enactment of the Wholesome Meat Act".

Amendments

1994—Subsec. (c)(4). Pub. L. 103–437 substituted "Agriculture, Nutrition, and Forestry" for "Agriculture and Forestry".

1984—Subsec. (c)(2). Pub. L. 98–487 inserted provisions relating to operations conducted at a restaurant central kitchen facility.

Statutory Notes and Related Subsidiaries

Effective Date

Section effective Dec. 15, 1967, see section 20 of Pub. L. 90–201, set out as a note under section 601 of this title.

Termination of Advisory Committees

Advisory committees in existence on Jan. 5, 1973, to terminate not later than the expiration of the 2-year period following Jan. 5, 1973, and advisory committees established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless in the case of a committee established by the President or an officer of the Federal Government, such committee is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a committee established by Congress, its duration is otherwise provided by law. See section 1013 of Title 5, Government Organization and Employees.

1 See References in Text note below.