Inspections

For animal and human health protection, the Animal Feed Program (AFP) conducts inspections at feed manufacturing, warehousing, transport, sales, distribution and animal production facilities to assure compliance with state and federal feed safety and labeling regulations.

AFP conducts various types of compliance inspections including:

1. Current Good Manufacturing Practices For Animal Food
2. Hazard Analysis and risk-based Preventive Controls 
3. Current Good Manufacturing Practices for Medicated Feeds
4. Veterinary Feed Directives
5. Bovine Spongiform Encephalopathy (BSE)

WSDA staff also provides technical assistance and educational information to industry, groups and individuals.

Current Good Manufacturing Practices rules apply to firms that are required to register as a food facility with some exceptions 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; and
4. Creates the foundation for preventive controls (PC) (PC inspections will begin in 2019).

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.

For more information contact Animal Feed Program Manager, Ashlee-Rose Ferguson at (360) 902-1905 or email at aferguson@agr.wa.gov.

Image ©2019 IIT IFSH. Original image located on page 5-5 of the FSPCA Preventive Controls for Animal Food Participant Manual v1.1 (English)

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 reasonable foreseeable hazards that they may encounter in their operations. During a HA, there are a few things to remember:

1. The HA must be written, regardless of outcome;
2. The type of hazard (biological, chemical (including radiological), or physical);
3. Whether the Hazard occurs naturally, or could be unintentionally or intentionally introduced;
4. An evaluation of the probability and severity of each hazard and environmental pathogens; and
5. Consider the effect of following: formulation; condition, function and design of facility and equipment; raw materials and other ingredients; transportation practices; manufacturing/processing procedures; packaging and labeling activities; storage and distribution; intended or reasonably foreseeable use; sanitation, including employee hygiene; and any other relevant factor such as temporal (for example weather-related) or nature of some hazards (like natural toxins).

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.

For more information contact Animal Feed Program Manager, Ashlee-Rose Ferguson at (360) 902-1905 or email at aferguson@agr.wa.gov.

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. With PC, there are a few things to remember:

1. PCs must be written;
2. The PC rule includes: Process PC, Sanitation PC, Other PC or Supply-chain Control;
3. Every facility that produces animal food with a hazard requireming PC must have a recall plan
4. PCs have to be validate to ensure they are adequate and effective
5. PCs have varying management components such as monitoring; corrective action and corrections; and verification; and
6. The Food Safety Plan that contains all written requirements, monitoring records, etc. should be a living document. The Food Safety Plan must be reanalyzed at certain time frames or due to certain circumstances; and;
7. 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.

Access the regulation can be found here, specifically subpart C and E with applicable requirements in subpart F.

The 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.

For more information contact Animal Feed Program Manager, Ashlee-Rose Ferguson at (360) 902-1905 or email at aferguson@agr.wa.gov.

Qualified facilities are exempt from hazard analysis and preventive controls requirements within 21 CFR 507. However, in order to be considered a Qualified Facility the following has to be met:

1. Meet the definition of Qualified Facility as defined in 21 CFR 507.3 (most fall into the Very Small Business category);
2. Submit the following two attestations on the same form (FDA Form 3942b [1.12 MB]):
   • The firm meets the financial requirements to be a qualified facility; and
   • Either that:
     • The firm has identified potential hazards, are implementing preventive controls to address the hazard, and are monitoring the control (that you are identifying, preventing, and monitoring hazards); or
     • The firm is in compliance with State laws and rules (license, product registration, inspection reports, or other evidence of oversight).
3. Forms can be submitted electronically via http://www.FDA.gov/FURLS or mail in your form to FDA; and
4. Qualified Facility Attestations must be resubmitted every two years.

Qualified facilities are still required to comply with current good manufacturing practices.

If a firm does not submit attestations, then they are not exempt and therefore must comply with hazard analysis and preventive control requirements.

For various reasons such as an outbreak linked to a firm, FDA can withdraw a qualified facility exemption (21 CFR 507 subpart D).

Access the regulation can be found here, specifically 21 CFR 507.7 for qualified facility requirements.

This FDA Guidance for Industry can help with determining qualified facility status. Instructions for how to file qualified facility attestations can be found here.

For more information contact Animal Feed Program Manager, Ashlee-Rose Ferguson at (360) 902-1905 or email at aferguson@agr.wa.gov.

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; and
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.

For more information contact Animal Feed Program Manager, Ashlee-Rose Ferguson at (360) 902-1905 or email at aferguson@agr.wa.gov.

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.

The rules regarding VFDs were recently updated effective January 1, 2017. Make sure you are up-to-date on the new rules!

Useful Links:

• 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

For more information contact Animal Feed Program Manager, Ashlee-Rose Ferguson at (360) 902-1905 or email at aferguson@agr.wa.gov

Bovine Spongiform Encephalopathy (BSE) is one variety of a group of diseases known as Transmissible Spongiform Encephalopathies (TSEs). TSEs cause microscopic holes in the brain, giving it a sponge-like appearance under a microscope. TSEs are always fatal and affect both humans and animals.

BSE is the type of TSE that occurs in cattle. 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 as long as 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.

For more information contact Animal Feed Program Manager, Ashlee-Rose Ferguson at (360) 902-1905 or email at aferguson@agr.wa.gov.