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21 U.S.C. § 350c — Maintenance and inspection of records
Federal law — U.S. Code and appendices · legal_authorities
**(a) Records inspection**
(1) **Adulterated food** — If the Secretary has a reasonable belief that an article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports such article shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such person, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to such article, and to any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, that are needed to assist the Secretary in determining whether the food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals.
(2) **Use of or exposure to food of concern** — If the Secretary believes that there is a reasonable probability that the use of or exposure to an article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals, each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports such article shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such pe
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Stable record: federal_law:legal_authorities:record_usc_8c5cac122fcd0cc8f300cd93
Source file: Laws/federal/codes/united-states-code/title-21/section-350c-maintenance-and-inspection-of-records--944edb00ee.md
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Source location: Title 21, Chapter 9, § 350c; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(a) Records inspection**
(1) **Adulterated food** — If the Secretary has a reasonable belief that an article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports such article shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such person, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to such article, and to any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, that are needed to assist the Secretary in determining whether the food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals.
(2) **Use of or exposure to food of concern** — If the Secretary believes that there is a reasonable probability that the use of or exposure to an article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals, each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports such article shall, at the request of an officer or employee duly designated by the Secretary, permit such officer or employee, upon presentation of appropriate credentials and a written notice to such person, at reasonable times and within reasonable limits and in a reasonable manner, to have access to and copy all records relating to such article and to any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, that are needed to assist the Secretary in determining whether there is a reasonable probability that the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals.
(3) **Application** — The requirement under paragraphs (1) and (2) applies to all records relating to the manufacture, processing, packing, distribution, receipt, holding, or importation of such article maintained by or on behalf of such person in any format (including paper and electronic formats) and at any location.
**(b) Regulations concerning recordkeeping** The Secretary, in consultation and coordination, as appropriate, with other Federal departments and agencies with responsibilities for regulating food safety, may by regulation establish requirements regarding the establishment and maintenance, for not longer than two years, of records by persons (excluding farms and restaurants) who manufacture, process, pack, transport, distribute, receive, hold, or import food, which records are needed by the Secretary for inspection to allow the Secretary to identify the immediate previous sources and the immediate subsequent recipients of food, including its packaging, in order to address credible threats of serious adverse health consequences or death to humans or animals. The Secretary shall take into account the size of a business in promulgating regulations under this section.
**(c) Protection of sensitive information** The Secretary shall take appropriate measures to ensure that there are in effect effective procedures to prevent the unauthorized disclosure of any trade secret or confidential information that is obtained by the Secretary pursuant to this section.
**(d) Limitations** This section shall not be construed—
(1) to limit the authority of the Secretary to inspect records or to require establishment and maintenance of records under any other provision of this chapter;
(2) to authorize the Secretary to impose any requirements with respect to a food to the extent that it is within the exclusive jurisdiction of the Secretary of Agriculture pursuant to the Federal Meat Inspection Act ([21 U.S.C. 601](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section601&num=0&edition=prelim) et seq.), the Poultry Products Inspection Act ([21 U.S.C. 451](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section451&num=0&edition=prelim) et seq.), or the Egg Products Inspection Act ([21 U.S.C. 1031](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section1031&num=0&edition=prelim) et seq.);
(3) to have any legal effect on [section 552 of title 5](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section552&num=0&edition=prelim) or [section 1905 of title 18](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title18-section1905&num=0&edition=prelim); or
(4) to extend to recipes for food, financial data, pricing data, personnel data, research data, or sales data (other than shipment data regarding sales).
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Federal law — U.S. Code and appendices · legal_authorities
Whoever, being an officer or employee of the United States or of any department or agency thereof, any person acting on behalf of the Federal Housing Finance Agency, or agent of the Department of Justice as defined in the Antitrust Civil Process Act ([15 U.S.C. 1311–131](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1311–131&num=0&edition=prelim)4), or being an employee of a private sector organization who is or was assigned to an agency under chapter 37 of title 5, publishes, divulges, discloses, or makes known in any manner or to any extent not authorized by law any information coming to him in the course of his employment or official duties or by reason of any examination or investigation made by, or return, report or record made to or filed with, such department or agency or officer or employee thereof, which information concerns or relates to the trade secrets, processes, operations, style of work, or apparatus, or to the identity, confidential statistical data, amount or source of any income, profits, losses, or expenditures of any person, firm, partnership, corporation, or association; or permits any income return or copy thereof or any book containing any abstract or particulars thereof to be seen or examined by any person except as provided by law; shall be fined under this title, or imprisoned not more than one year, or both; and shall be removed from office or employment.
Source: Supplied U.S. Code snapshot — release unconfirmed · 18 U.S.C. § 1905
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Federal law — U.S. Code and appendices · legal_authorities
**(a)** Each agency shall make available to the public information as follows:
(1) Each agency shall separately state and currently publish in the Federal Register for the guidance of the public—
(A) descriptions of its central and field organization and the established places at which, the employees (and in the case of a uniformed service, the members) from whom, and the methods whereby, the public may obtain information, make submittals or requests, or obtain decisions;
(B) statements of the general course and method by which its functions are channeled and determined, including the nature and requirements of all formal and informal procedures available;
(C) rules of procedure, descriptions of forms available or the places at which forms may be obtained, and instructions as to the scope and contents of all papers, reports, or examinations;
(D) substantive rules of general applicability adopted as authorized by law, and statements of general policy or interpretations of general applicability formulated and adopted by the agency; and
(E) each amendment, revision, or repeal of the foregoing.
Except to the extent that a person has actual and timely notice of the terms thereof, a person may not in any manner be required to resort to, or be adversely affected by, a matter required to be published in the Federal Register and not so published. For the purpose of this paragraph, matter reasonably available to the class of persons affected thereby is deemed published in the Federal Register when incorporated by reference therein with the approval of the Director of the Federal Register.
(2) Each agency, in accordance with published rules, shall make available for public inspection in an electronic format—
(A) final opinions, including concurring and dissen
Source: Supplied U.S. Code snapshot — release unconfirmed · 5 U.S.C. § 552
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Federal law — U.S. Code and appendices · legal_authorities
Poultry and poultry products are an important source of the Nation’s total supply of food. They are consumed throughout the Nation and the major portion thereof moves in interstate or foreign commerce. It is essential in the public interest that the health and welfare of consumers be protected by assuring that poultry products distributed to them are wholesome, not adulterated, and properly marked, labeled, and packaged. Unwholesome, adulterated, or misbranded poultry products impair the effective regulation of poultry products in interstate or foreign commerce, are injurious to the public welfare, destroy markets for wholesome, not adulterated, and properly labeled and packaged poultry products, and result in sundry losses to poultry producers and processors of poultry and poultry products, as well as injury to consumers. It is hereby found that all articles and poultry which are regulated under this chapter are either in interstate or foreign commerce or substantially affect such commerce, and that regulation by the Secretary of Agriculture and cooperation by the States and other jurisdictions as contemplated by this chapter are appropriate to prevent and eliminate burdens upon such commerce, to effectively regulate such commerce, and to protect the health and welfare of consumers.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 451
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Federal law — U.S. Code and appendices · legal_authorities
As used in this chapter, except as otherwise specified, the following terms shall have the meanings stated below:
**(a)** The term “Secretary” means the Secretary of Agriculture of the United States or his delegate.
**(b)** The term “firm” means any partnership, association, or other unincorporated business organization.
**(c)** The term “meat broker” means any person, firm, or corporation engaged in the business of buying or selling carcasses, parts of carcasses, meat, or meat food products of cattle, sheep, swine, goats, horses, mules, or other equines on commission, or otherwise negotiating purchases or sales of such articles other than for his own account or as an employee of another person, firm, or corporation.
**(d)** The term “renderer” means any person, firm, or corporation engaged in the business of rendering carcasses or parts or products of the carcasses, of cattle, sheep, swine, goats, horses, mules, or other equines, except rendering conducted under inspection or exemption under this subchapter.
**(e)** The term “animal food manufacturer” means any person, firm, or corporation engaged in the business of manufacturing or processing animal food derived wholly or in part from carcasses, or parts or products of the carcasses, of cattle, sheep, swine, goats, horses, mules, or other equines.
**(f)** The term “State” means any State of the United States and the Commonwealth of Puerto Rico.
**(g)** The term “Territory” means Guam, the Virgin Islands of the United States, American Samoa, and any other territory or possession of the United States, excluding the Canal Zone.
**(h)** The term “commerce” means commerce between any State, any Territory, or the District of Columbia, and any place outside thereof; or within any Territory not organized with a legisl
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 601
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Federal law — U.S. Code and appendices · legal_authorities
Eggs and egg products are an important source of the Nation’s total supply of food, and are used in food in various forms. They are consumed throughout the Nation and the major portion thereof moves in interstate or foreign commerce. It is essential, in the public interest, that the health and welfare of consumers be protected by the adoption of measures prescribed herein for assuring that eggs and egg products distributed to them and used in products consumed by them are wholesome, otherwise not adulterated, and properly labeled and packaged. Lack of effective regulation for the handling or disposition of unwholesome, otherwise adulterated, or improperly labeled or packaged egg products and certain qualities of eggs is injurious to the public welfare and destroys markets for wholesome, not adulterated, and properly labeled and packaged eggs and egg products and results in sundry losses to producers and processors, as well as injury to consumers. Unwholesome, otherwise adulterated, or improperly labeled or packaged products can be sold at lower prices and compete unfairly with the wholesome, not adulterated, and properly labeled and packaged products, to the detriment of consumers and the public generally. It is hereby found that all egg products and the qualities of eggs which are regulated under this chapter are either in interstate or foreign commerce, or substantially affect such commerce, and that regulation by the Secretary of Agriculture and the Secretary of Health and Human Services, and cooperation by the States and other jurisdictions, as contemplated by this chapter, are appropriate to prevent and eliminate burdens upon such commerce, to effectively regulate such commerce, and to protect the health and welfare of consumers.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 1031
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Federal law — U.S. Code and appendices · legal_authorities
**(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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342&num=0&edition=prelim) or misbranded under [section 343(w) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section343/w&num=0&edition=prelim).
(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
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 2223
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Voluntary procedures** If the Secretary determines, based on information gathered through the reportable food registry under [section 350f of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350f&num=0&edition=prelim) or through any other means, that there is a reasonable probability that an article of food (other than infant formula) is adulterated under [section 342 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342&num=0&edition=prelim) or misbranded under [section 343(w) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section343/w&num=0&edition=prelim) and the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals, the Secretary shall provide the responsible party (as defined in [section 350f of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350f&num=0&edition=prelim)) with an opportunity to cease distribution and recall such article.
**(b) Prehearing order to cease distribution and give notice**
(1) **In general** — If the responsible party refuses to or does not voluntarily cease distribution or recall such article within the time and in the manner prescribed by the Secretary (if so prescribed), the Secretary may, by order require, as the Secretary deems necessary, such person to—
(A) immediately cease distribution of such article; and
(B) as applicable, immediately notify all persons—
(i) manufacturing, processing, packing, transporting, distributing, receiving, holding, or importing and selling such article; and
(ii) to which such article has been distributed, transported, or sold, to immediately cease distribution of such ar
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 350l
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Right of agents to enter; scope of inspection; notice; promptness; exclusions**
(1) For purposes of enforcement of this chapter, officers or employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, are authorized (A) to enter, at reasonable times, any factory, warehouse, or establishment in which food, drugs, devices, tobacco products, or cosmetics are manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hold such food, drugs, devices, tobacco products, or cosmetics in interstate commerce; and (B) to inspect, at reasonable times and within reasonable limits and in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein. In the case of any person (excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports foods, the inspection shall extend to all records and other information described in [section 350c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350c&num=0&edition=prelim), when the standard for records inspection under paragraph (1) or (2) of [section 350c(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350c/a&num=0&edition=prelim) applies, subject to the limitations established in [section 350c(d) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350c/d&num=0&edition=prelim). In the case of a facility (as defined in [section 364 of this title](https://uscode.house.gov/vi
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 374
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Definitions** In this section:
(1) **Audit agent** — The term “audit agent” means an individual who is an employee or agent of an accredited third-party auditor and, although not individually accredited, is qualified to conduct food safety audits on behalf of an accredited third-party auditor.
(2) **Accreditation body** — The term “accreditation body” means an authority that performs accreditation of third-party auditors.
(3) **Third-party auditor** — The term “third-party auditor” means a foreign government, agency of a foreign government, foreign cooperative, or any other third party, as the Secretary determines appropriate in accordance with the model standards described in subsection (b)(2), that is eligible to be considered for accreditation to conduct food safety audits to certify that eligible entities meet the applicable requirements of this section. A third-party auditor may be a single individual. A third-party auditor may employ or use audit agents to help conduct consultative and regulatory audits.
(4) **Accredited third-party auditor** — The term “accredited third-party auditor” means a third-party auditor accredited by an accreditation body to conduct audits of eligible entities to certify that such eligible entities meet the applicable requirements of this section. An accredited third-party auditor may be an individual who conducts food safety audits to certify that eligible entities meet the applicable requirements of this section.
(5) **Consultative audit** — The term “consultative audit” means an audit of an eligible entity—
(A) to determine whether such entity is in compliance with the provisions of this chapter and with applicable industry standards and practices; and
(B) the results of which are for internal purposes only.
(6) **El
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 384d
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Federal law — U.S. Code and appendices · legal_authorities
Page 911
TITLE 21—FOOD AND DRUGS
§ 1031
CHAPTER 14—ALCOHOL AND DRUG ABUSE
EDUCATIONAL PROGRAMS AND ACTIVITIES
§§ 1001 to 1007. Repealed. Pub. L. 97–35, title V,
§ 587(a)(3), Aug. 13, 1981, 95 Stat. 480
Section 1001, Pub. L. 91–527, § 2, Dec. 3, 1970, 84 Stat.
1385; Pub. L. 93–422, § 2(b), Sept. 21, 1974, 88 Stat. 1154;
Pub. L. 95–336, § 2, Aug. 4, 1978, 92 Stat. 451, set forth
Congressional declaration of purpose for Alcohol and
Drug Abuse Education Act.
Section 1002, Pub. L. 91–527, § 3, Dec. 3, 1970, 84 Stat.
1386; Pub. L. 93–422, § 2(c), Sept. 21, 1974, 88 Stat. 1155;
Pub. L. 95–336, §§ 3, 4, Aug. 4, 1978, 92 Stat. 451, 452; S.
Res. 30, Mar. 7, 1979; Pub. L. 96–88, title III, § 301(a)(1),
(2)(Q), (b)(1), title V, § 507, Oct. 17, 1979, 93 Stat. 677, 678,
692, set forth grant and contract authority, etc., for
projects and programs.
Section 1003, Pub. L. 91–527, § 4, Dec. 3, 1970, 84 Stat.
1387; Pub. L. 93–422, § 2(d), Sept. 21, 1974, 88 Stat. 1157;
Pub. L. 96–88, title III, § 301(a)(1), title V, § 507, Oct. 17,
1979, 93 Stat. 677, 692, related to recordkeeping require-
ments, and access to and inspection of records.
Section 1004, Pub. L. 91–527, § 5, Dec. 3, 1970, 84 Stat.
1388; Pub. L. 93–422, § 2(e), Sept. 21, 1974, 88 Stat. 1157;
Pub. L. 96–88, title V, § 508(i), Oct. 17, 1979, 93 Stat. 693,
related to technical assistance to local agencies, etc.
Section 1005, Pub. L. 91–527, § 6, Dec. 3, 1970, 84 Stat.
1388, related to nature of payments.
Section 1006, Pub. L. 91–527, § 7, Dec. 3, 1970, 84 Stat.
1388, related to utilization of services and facilities of
Federal agencies and public and private agencies and
institutions.
Section 1007, Pub. L. 91–527, § 8, Dec. 3, 1970, 84 Stat.
1388; Pub. L. 93–422, § 2(f), Sept. 21, 1974, 88 Stat. 1157;
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 1031
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