FSMA: Legal ramifications of cGMPs are important to pet food safety
Scott Haskell explains how FSMA has helped the animal food industry decrease product health issues and reduce the need for product recalls. What are the potential hazards within your processing program?
Scott Haskell teaches the online course “Animal Health, World Trade, and Food Safety” each fall semester, and "The Law of the Preventive Controls for Human Food Rule" each spring semester.
Understanding the processing requirements of animal feed is a crucial legal component to food safety. Importantly, for the very first time the safety of pet food is regulated by the FDA (U.S. Food and Drug Administration). Prior to the Food Safety Modernization Act (FSMA), oversight concerning pet food was very limited. FSMA currently is providing the FDA with new and necessarily expanded powers of regulation and guidance to the pet food industry. Within the FDA the Center for Veterinary Medicine (CVM) does an excellent job ensuring that feed ingredients and additives utilized in pet food have a proper function, are safe, and are correctly labeled. FSMA requires that cGMPs (current Good Manufacturing Practices) are followed by industry. The FDA enforces these FSMA requirements to ensure compliance. Additionally, the Association of American Feed Control Officials (AAFCO) has also developed pet food GMPs in conjunction with the FDA. What about these cGMPs and their effects on marketable animal food products? How important are they?
The FDA through FSMA has established necessary ‘baseline’ pet food industry standards through the utilization of cGMPs. It should be noted that the FDA considers these cGMPs as the minimum standards of assurance. These cGMPs help regulate most pet food facility processing, manufacturing, packing, transporting and holding components of the final pet food product. cGMPs are important in ensuring that animal feed products meet and/or exceed the quality, food safety, production transparency and the necessary legal requirements to market this food. Examples of cGMPs for pet food include production methodology, processing and holding facilities, processing equipment, and pet food producing controls. The FDA defines the minimum food processing and sanitation requirements for producing safe pet food. The "c" or “C” in cGMP implies "current." The implication is that industry members must use up-to-date technologies or state of the art developments in food safety and monitoring, allowing product FSMA compliance which are adequate by today's standards. The implied requirement is that modern quality systems and risk management practices will meet or exceed these minimum FDA standards now and in the future.
Baseline food safety standards are met through the use of risk-based preventive controls for food for animals authorized by FSMA (78 FR 64736). “Domestic and foreign processing/manufacturing facilities that are required to register as food facilities under the Federal Food, Drug and Cosmetic Act (the FD&C Act) because they manufacture, process, pack, or hold animal food for consumption in the U.S. must comply with the current good manufacturing practice (CGMP) requirements for animal food established in the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals final rule published on September 17, 2015 (80 FR 56170)” (the Final Rule).
The FDA ensures that the cGMPs in 21 CFR part 507, subpart B provide the baseline safety and sanitation standards (and some related requirements are codified in 21 CFR part 507 (subparts A and F). The FDA definitions of pet food processing, manufacturing, foodstuff packing, and product holding are legally important to recognize and review (see Definitions for terms used in the CGMPs (21 CFR 507.3) https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=507.3
The facilities identification requirements found in 21 CFR part 507, subpart C relate to the evaluation of animal food hazards and they define measures necessary to control “hazards requiring preventive controls”. (FDA: Current Good Manufacturing Practice Requirements for Food for Animals https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-preventive-controls-animal-food).
Industry flexibility is the key to the success of cGMPs and subsequently pet food safety. This flexibility allows individual manufacturers to determine necessary implementation practices of their defined production practices. Sound scientific evaluation must be utilized by producers/manufacturers and their processing methodology must be appraised; testing procedures must be monitored and improved when necessary. The importance of this FDA requirement is that it will allow the development of consistent new innovative technologies in industry production practices. This substantial forethought of FSMA allows continuous future industry improvement, with persistently higher quality standards through monitoring and evaluation. A pet food manufacturing facility is required to follow discrete steps when conducting their hazard analysis process. “Requirement for a hazard analysis. (1) You must conduct a hazard analysis to identify and evaluate, based on experience, illness data, scientific reports, and other information, known or reasonably foreseeable for each type of food manufactured, processed, packed, or held at your facility to determine whether there are any hazards requiring a preventive control.” (21CFR117.130)https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=117.130)
Are there potential hazards which would require a preventive control within your processing program? Are there known or reasonably foreseeable hazards present? According to the FDA, “As part of its evaluation of known or reasonably foreseeable hazards, a facility must consider any relevant factors, such as the effect of manufacturing/processing procedures, on the safety of the finished animal food for the intended animal (21 CFR 507.33(d)). A facility’s use of prerequisite programs, such as cGMPs, could be a relevant factor. A facility may determine that properly implementing a prerequisite program, such as specific cGMPs, will decrease the probability that a known or reasonably foreseeable hazard will occur in the absence of a preventive control or decrease the severity of the illness or injury if the hazard were to occur.” (https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-preventive-controls-animal-food).
Reasonably foreseeable hazards are an important legal component that must be considered when developing cGMPs. Forethought is implied by FSMA with this requirement. FSMA covered facilities must develop and implement a food safety system which includes an analysis of production hazards and the utilization of risk-based preventive controls (if necessary). In order to be in compliance with FDA regulations, pet food manufacturers (both domestic and global facilities) must document and maintain records – with the cGMP, FSMA requires that each pet food facility must determine hazards requiring control. Records are an important component to compliance as well. Examples of hazard recognition requiring control include sanitation standards, physical plant facilities, training of staff and personnel, equipment and manufacturing utensils, key plumbing and water quality/supply issues, pest control, systems analysis, operational procedural analysis, record keeping, the final product distribution plan and storage of product or materials. The company must determine which of these potential components might contain hazards and/or hazardous measures requiring control and monitoring.
Hazard analysis and subsequent identification is an important first step in this process. Hazard identification must determine any known or “reasonably foreseeable” natural or introduced biological, chemical, and/or physical hazards. “The hazard analysis must be written regardless of its outcome. Hazard identification. The hazard identification must consider: (1) Known or reasonably foreseeable hazards that include: (i) Biological hazards, including microbiological hazards such as parasites, environmental pathogens, and other pathogens; (ii) Chemical hazards, including radiological hazards, substances such as pesticide and drug residues, natural toxins, decomposition, unapproved food or color additives, and food allergens; and (iii) Physical hazards (such as stones, glass, and metal fragments).” (21CFR117.130)
Should the facilities hazard analysis study disclose issues which require a preventive control, then there must be an implementable written preventive control plan developed for those hazards. FSMA requires that the development of written preventive controls must be implemented in a ‘timely manner’ but they do not specify specific legally defined time limitations. Hazards requiring preventive control will help ensure that the food is not adulterated and is safe for pet consumption. Both process control and sanitation control evaluation are also important for the facilities to remain in FSMA compliance. The development, oversight and management of preventive controls is key to producer success. Facilities must ensure the effectiveness of their control policies by continued monitoring and evaluation. This assurance process must include monitoring, proposed correction of issues, corrective actions, evaluating the animal food product, verification, and record keeping. Verification is an important step as it allows the facilities to determine if their corrective controls are effective. All of these steps must be documented and recorded. Once a hazard has been determined, FSMA requires that a preventive control must have a recall plan in place. Additionally, some pet food facilities will also be required to provide supply-chain programs which will resolve any known or “reasonably foreseeable” natural or introduced biological, chemical, and/or physical hazards or issues found in the processing/manufacturing, transportation or storage of raw materials/ingredients through a supply chain.
For the FDA to include cGMPs within their food safety guidelines was in fact a stroke of genius. This requirement allows pet food safety to be developed and monitored throughout the production process. FSMA has helped the animal food industry decrease product health issues and reduce the need for product recalls. As such, FSMA has been a worthwhile development and is definitely worth continued industry support and compliance.
FDA: #235 Current Good Manufacturing Practice Requirements for Food for Animals Guidance for Industry https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-preventive-controls-animal-food
Summary: FSMA Final Rulemaking for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (Final Rule) https://www.fda.gov/about-fda/economic-impact-analyses-fda-regulations/summary-fsma-final-rulemaking-current-good-manufacturing-practice-hazard-analysis-and-risk-based
AFFACO: Ingredient Standards https://talkspetfood.aafco.org/ingredientstandards
FSMA Final Rule for Preventive Controls for Animal Food https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-preventive-controls-animal-food#:~:text=This%20rule%20requires%20animal%20food,minimize%20or%20prevent%20those%20hazards.
Draft Guidance for Industry #239 entitled "Human Food By-Products for Use as Animal Food" https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM49 9201.pdf
CFR - Code of Federal Regulations Title 21