Description
Chronic Wasting Disease (CWD) is a neurological (brain) disease of farmed and wild deer and elk that belong in the animal family cervidae (cervids). Only deer and elk are known to be susceptible to CWD by natural transmission. The disease has been found in farmed and wild mule deer, white-tailed deer, North American elk, and in farmed black-tailed deer. CWD belongs to a family of animal and human diseases called transmissible spongiform encephalopathies (TSEs). These include bovine spongiform encephalopathy (BSE or “mad cow” disease) in cattle; scrapie in sheep and goats; and classical and variant Creutzfeldt-Jakob diseases (CJD and vCJD) in humans. There is no known treatment for these diseases, and there is no vaccine to prevent them. In addition, although validated postmortem diagnostic tests are available, there are no validated diagnostic tests for CWD that can be used to test for the disease in live animals.
Scope & Applicability
Product Classes
2Components used in animal feed that may contain CWD material.
The primary product category regulated by this guidance.
Stakeholders
1Authorities who declare areas endemic for CWD.
Regulatory Context
Attributes
1Classification for animals from endemic areas or exposed captive herds.
Identified Hazards
Hazards
1Animals confirmed to have Chronic Wasting Disease.
Related CFR Sections (1)
See Also (8)
- 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)
- CVM GFI #195 Small Entities Compliance Guide For Renderers—Substances Prohibited From Use In Animal Food Or Feed (Status: Final)
- 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)