Description
On April 25, 2008, FDA published a final rule in the Federal Register, entitled “Substances Prohibited from Use in Animal Food or Feed” (73 FR 22719). See also 74 FR 18626; April 24, 2009, which confirmed the effective date and established a compliance date of October 26, 2009. This final rule established a new regulation at 21 CFR 589.2001 entitled, “Cattle materials prohibited in animal food or feed to prevent the transmission of bovine spongiform encephalopathy” and, amended the previously existing ruminant feed regulation at 21 CFR 589.2000 entitled, “Animal proteins prohibited in animal feed.” FDA has prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121). This document is intended to provide guidance on the requirements of Title 21, Code of Federal Regulations, new Section 589.2001, and amended Section 589.2000.
Scope & Applicability
Product Classes
4Cattle Materials Prohibited from Animal Feed.; Cattle Materials Prohibited from Animal Feed, including brain and spinal cord from cattle 30 months or older.
Food intended for animal consumption subject to Part 507; Food for animal consumption manufactured, processed, packed, or held; Subject of the preventive controls regulation; Product manufactured by contract feed mills
Feed intended for animals other than ruminants where certain cattle parts may be used if processed correctly.
Rendered fat of cattle subject to insoluble impurity standards.
Stakeholders
2Any firm or individual that processes slaughter byproducts or animals unfit for human consumption.; Entity responsible for processing cattle materials and maintaining records.; Entity responsible for processing cattle material and ensuring compliance.
different supplier or contract manufacturer
Regulatory Context
Attributes
2Age threshold for determining prohibited cattle materials.; Age threshold for determining if cattle material is prohibited.; Regulatory threshold for substances prohibited from use in animal food
Age threshold for cattle determining if certain tissues are CMPAF.
Related CFR Sections (3)
- 21CFR589.2001§ 589.2001 Cattle materials prohibited in animal food or feed to prevent the transmission of bovine spongiform encephalopathy.
(a) Purpose. The purpose of this section is to prohibit the use of certain cattle origin materials in the food or feed of all animals to further reduce the risk of the spread of bovine spongiform encephalopathy (BSE) within the United States.Read full regulation →
- 21CFR589.2000§ 589.2000 Animal proteins prohibited in ruminant feed.
(a) Definitions —Read full regulation →
- 21CFR189.5§ 189.5 Prohibited cattle materials.
(a) Definitions. The definitions and interpretations of terms contained in section 201 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) apply to such terms when used in this part. The following definitions also apply:Read full regulation →
Related Warning Letters (2)
- 2022-06-28
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Fagron Group B.V.
- 2020-05-05
CGMP/Dietary Supplement/Adulterated/Misbranded
Hawaii Pharm LLC
See Also (8)
- CVM GFI #70 Small Entities Compliance Guide for Feeders of Ruminant Animals Without On-Farm Feed Mixing Operations (Status: Final)
- CVM GFI #203 Ensuring Safety of Animal Feed Maintained and Fed On-Farm (Status: Final)
- Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans: Guidance for Industry (Status: Final)
- CVM GFI #245 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (Status: Final)
- Guidance for Industry: Sanitary Transportation of Food (Status: Final)
- CVM GFI #68 Small Entities Compliance Guide for Protein Blenders, Feed Manufacturers, and Distributors (Status: Final)
- CVM GFI #76 Questions and Answers BSE Feed Regulations (Status: Final)
- Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs): Guidance for FDA Reviewers and Sponsors (Status: Final)