Contact Person:

Brook Duer Staff Attorney

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Email:

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Statutes and Regulations

Rules

Final Rules

FDA, Determining the Number of Employees for Purposes of the “Small Business” Definition (Current Good Manufacturing Practices and Preventive Controls Regulations for Human and Animal Food): Guidance for Industry; Availability, 84 F.R. 29,054 (Jun. 21, 2019) (to be codified at 21 C.F.R. §§ 117, 507)

FDA, Laboratory Accreditation for Analyses, 83 F.R. 46,104 (Sep. 12, 2018) (to be codified at 21 C.F.R. § 110)

FDA, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, 83 F.R. 46,104 (Sep. 12, 2018) (to be codified at 21 C.F.R. § 110)

FDA, The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules: What You Need To Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide; Availability, 83 F.R. 22,193 (May 14, 2018) (to be codified at 21 C.F.R. §§ 1, 11, 16, 106, 110, 111, 112, 114, 117, 120, 123, 129, 179, 211, 507)

FDA, Application of the Foreign Supplier Verification Program Regulation to the Importation of Live Animals: Guidance for Industry; Availability, 83 F.R. 12,483 (Mar. 22, 2018) (to be codified at 21 C.F.R. § 1)

FDA, Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs; Guidance for Industry; Availability, 83 F.R. 598 (Jan. 5, 2018) (to be codified at 21 C.F.R. §§ 1, 11, 16, 106, 110, 111, 112, 114, 117, 120, 123, 129, 179, 211, 507)

FDA, Amendments to Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications To Provide for the User Fee Program, 81 F.R. 90,186 (Dec. 14, 2016) (to be codified at 21 C.F.R. § 1)

FDA, The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules, 81 F.R. 57,784 (Aug. 24, 2016) (to be codified at 21 C.F.R. §§ 1, 11, 16, 106, 110, 111, 112, 114, 117, 120, 123, 129, 179, 211, 507)

FDA, Substances Generally Recognized as Safe, 81 F.R. 54,959 (Aug. 17, 2016) (to be codified at 21 C.F.R. §§ 170, 184, 186, 20, 25, 570)

FDA, Registration of Food Facilities: Amendments to Food Facility Registration Requirements, 81 F.R. 45,911 (Jul. 14, 2016) (to be codified at 21 C.F.R. § 1)

FDA, Mitigation Strategies to Protect Food Against Intentional Adulteration, 81 F.R. 34,165 (May 27, 2016) (to be codified at 21 C.F.R. §§ 11, 121)

OSHA, Procedures for Handling Retaliation Complaints Under Section 402 of the FDA Food Safety Modernization Act, 81 F.R. 22,530 (Apr. 18, 2016) (to be codified at 29 C.F.R. § 1987)

FDA, Sanitary Transportation of Human and Animal Food, 81 F.R. 20,091 (Apr. 6, 2016) (to be codified at 21 C.F.R. §§ 1, 11)

FDA, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption:

FDA, Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications, 80 F.R. 74,569 (Nov. 27, 2015) (to be codified at 21 C.F.R. §§ 11, 121)

FDA, Foreign Supplier Verification Programs for Importers of Food for Humans and Animals:

FDA, Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements, 79 F.R. 18799 (Apr. 4, 2014) (to be codified at 21 C.F.R. § 1)

FDA, Information Required in Prior Notice of Imported Food, 78 F.R. 32,359 (May 30, 2013) (to be codified at 21 C.F.R. § 1)

FDA, Criteria Used To Order Administrative Detention of Food for Human or Animal Consumption, 78 F.R. 7,994 (Feb. 5, 2013) (to be codified at 21 C.F.R. § 1)

Proposed Rules
(Where a final rule has not been published)

FDA, Temporary Policy Regarding Preventive Controls and Foreign Supplier Verification Programs Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency: Guidance for Industry; Availability, 85 F.R. 17,008 (Mar. 26, 2020) (to be codified at 21 C.F.R. §§ 1, 117, 507)

FDA, Requirements for Additional Traceability Records for Certain Foods; Extension of Comment Period; Reopening of the Comment Period, 85 F.R. 82,393 (Dec. 18, 2020) (to be codified at 21 C.F.R. § 1)

FDA, Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability, 84 F.R. 53,347 (Oct. 7, 2019) (to be codified at 21 C.F.R. § 117)

FDA, Label Requirement for Food That Has Been Refused Admission Into the United States, 83 F.R. 49,022 (Sep. 28, 2018) (to be codified at 21 C.F.R. § 1)

FDA, Product Jurisdiction; Correction, 83 F.R. 26,392 (Jun. 7, 2018) (to be codified at 21 C.F.R. § 3)

FDA, Foreign Supplier Verification Programs for Importers of Food for Humans and Animals; Draft Guidance for Industry; Availability, 83 F.R. 3,445 (Jan. 25, 2018) (to be codified at 21 C.F.R. § 1)

FDA, Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR Part 112 or the Preventive Controls Requirements in Part 117 or 507; Draft Guidance for Industry; Availability, 83 F.R. 3,447 (Jan. 25, 2018) (to be codified at 21 C.F.R. §§ 1, 112, 117, 507)

FDA, Application of the Foreign Supplier Verification Program Regulation to Importers of Grain Raw Agricultural Commodities: Guidance for Industry; Availability, 83 F.R. 3,443 (Jan. 25, 2018) (to be codified at 21 C.F.R. § 1)

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Compliance Dates for Subpart E; Correction, 82 F.R. 47,656 (Oct. 13, 2017) (to be codified at 21 C.F.R. § 112)

FDA, User Fee Program To Provide for Accreditation of Third-Party Auditors/Certification Bodies To Conduct Food Safety Audits and To Issue Certifications; Correction, 80 F.R. 55,802 (Sep. 17, 2015) (to be codified at 21 C.F.R. § 1)

FDA, Implementation of the Food and Drug Administration Food Safety Modernization Act Amendments to the Reportable Food Registry Provisions of the Federal Food, Drug, and Cosmetic Act, 79 F.R. 34,668 (Jun. 18, 2014) (to be codified at 21 C.F.R. § 1)