Along with federal regulations, New York State has laws and rules and regulations regarding the manufacture and distribution of commercial feed. Article 8 of the Agriculture and Markets Law pertains to the sale and distribution of animal food in New York State.
For animal and human health protection, the Division of Food Safety and Inspection Animal Food Inspection Program (AFIP) will conduct inspections at feed manufacturing, warehousing, transport, distribution, and rendering/disposal facilities to assure compliance with state and federal feed safety and labeling regulations. Initial inspections will be an opportunity to educate while we regulate, where industry and regulators will learn each other’s role in animal food safety.
AFIP will conduct various types of compliance inspections including:
1. Current Good Manufacturing Practices for Animal Food (CGMP’s)
2. Hazard Analysis and risk-based Preventive Controls (HARPC)
3. Current Good Manufacturing Practices for Medicated Feeds
4. Veterinary Feed Directives (VFD)
5. Bovine Spongiform Encephalopathy (BSE)
Current Good Manufacturing Practices
Current Good Manufacturing Practices rules apply to firms that are required (with some exceptions) to register as a food facility and set forth the baseline standards for safe animal food which includes:
1. Sufficient management oversight and ensuring employees are properly trained and conform to safe practices.
2. The plants, grounds, and equipment are constructed, maintained, and used properly to prevent animal food adulteration.
3. Certain labeling requirements for holding and distribution of animal food.
4. Creates the foundation for preventive controls (PC) when applicable.
Access the regulation can be found here, specifically subpart B with applicable requirements in subparts A and F.
The FDA Guidance Document #235 details information to help firms comply with the CGMP requirements. These regulations apply to all types of facilities and equipment used in the production of animal food
Hazard Analysis (HA) requirements apply to firms that are required to register as a food facility with exceptions such as Qualified Facilities. An HA is conducted so a firm can identify and evaluate known or reasonably foreseeable hazards that they may encounter in their operations.
Access the regulation here, specifically 21 CFR 507.33 for HA requirements.
The DRAFT FDA Guidance Document #245 details information to help firms comply with the HA requirements. These regulations apply to all types of facilities in the production of animal food.
Preventive Control (PC) requirements apply to firms that are required to register as a food facility with exceptions such as Qualified Facilities. PCs are implemented to significantly minimize or prevent a hazard.
Access the regulation can be found here, specifically subpart C and E with applicable requirements in subpart F.
FDA Guidance Document #245 details information to help firms comply with the PC requirements. These regulations apply to all types of facilities used in the production of animal food.
Additional Supply-chain applied controls requirements are outlines in 21 CFR 507 subpart E. The DRAFT FDA Guidance #246 details information to help firms comply with subpart E.
Current Good Manufacturing Practices for Medicated Feed
Good Manufacturing Practices rules set forth the criteria for determining whether facilities that manufacture medicated feed:
1. Use and maintain equipment that is capable of mixing animal drugs into feed at the potency level approved by FDA.
2. Clean and maintain equipment and plant premises so that drugs are not carried over into non-medicated feeds.
3. Maintain production records and use lot numbers so that medicated feeds can be recalled if there is a problem.
The FDA Guidance Document #72 details the inspection criteria. These regulations apply to all types of facilities and equipment used in the production of medicated feeds. They also govern those instances in which failure to adhere to the regulations causes non-medicated feeds that are manufactured, processed, packed or held in the same facility to become adulterated.
Veterinary Feed Directive Inspection
A Veterinary Feed Directive (VFD) is a written (non-verbal) statement issued by a licensed veterinarian that authorizes the use of a VFD drug or combination of a VFD drug.
A VFD drug is a drug intended for use in or on animal feed that is limited to use under professional supervision of a licensed Veterinarian.
Anyone intending to manufacture or distribute feeds containing VFD drugs must notify The Center for Veterinary Medicine (CVM) prior to beginning distribution.
• FDA - General Veterinary Feed Directive Information
• FDA Guidance Document #120 - Veterinary Feed Directive Regulation Questions and Answers
• Veterinary Feed Direction for Veterinarians Video
• Veterinary Feed Directive for Feed Distributors Video
• Veterinary Feed Directive for Animal Producers Video
• List of Drugs Approved For and Transitioning to VFD Status
• CPG 615.115 Extralabel Use of Medicated Feeds for Minor Species
• VFD Distributor Notification Listing by States
Bovine Spongiform Encephalopathy Inspections
The purpose of a BSE inspection is to ensure mammalian proteins are not being fed to ruminant animals (cattle, sheep, goats, deer and elk) to prevent the spread of Bovine Spongiform Encephalopathy, also known as Mad Cow Disease.
Scientists believe cattle are infected when they eat feed that contains remnants of infected animals. Read All About BSE (Mad Cow Disease).
The most common human TSE is Creutzfeldt-Jakob Disease (CJD). Scientists believe a new variant form of CJD is caused by consuming the brain and spinal cord of animals infected with BSE.
In general BSE rules (21 CFR 589.2000-2001) require:
1. All feeds containing prohibited material (prohibited mammalian protein) must be prominently labeled with the BSE Cautionary Statement "Do Not Feed To Cattle Or Other Ruminants". Pet food products and feed for non-ruminant laboratory animals often contain prohibited material but are exempt from this label requirement if they are intended for retail sale. However, if they are sold or are intended for sale as distressed or salvage items, then the BSE Cautionary Statement is required.
2. Whenever prohibited material is handled by equipment that also handles ruminant feed, cleanout procedures that have been tested and found to be effective must be written down and followed. Each cleanout must be recorded, and these records must be kept for one year.
3. Ruminant feeders are responsible for making sure that ruminants under their care do not have access to non-ruminant feeds, such as pet food, hog feed, poultry feed, fish feed, and horse feed that may legally contain prohibited materials.
4. The rules also create a class of material called cattle material prohibited in animal feed. This material cannot be used in feed for any animal, but may be burned for energy production, used as fertilizer, or disposed of by other methods.
For details of these rules please go to FDA's BSE Home Page.
To better gauge the inventory in New York State, we would appreciate if in-state animal food manufacturers can take a moment to complete a brief survey. This information will not be used to determine who is subject to a particular type of inspection. What regulations a business may be subject to will be determined through in-person visit.
Find more information on the 2011 Food Safety and Modernization Act (FSMA) here.
Contact the Animal Food Inspection Team
Phone: (518) 547-3622 or (518) 457-5457
Email: [email protected]