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Explore This IssueFebruary/March 2014
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The release of the proposed rule on the Preventive Controls on Animal Food late last year gives us the complete picture of FDA’s approach on the “big 5” proposed rules. While few if any new or groundbreaking requirements were included beyond what we have seen so far, it’s important to view this proposed rule in terms of how far many in the industry will need to go to achieve compliance.
This proposed rule applies to animal facilities required to register with FDA under section 415 of the FD&C Act, unless subject to an exemption. This would include anyone involved in manufacturing, processing, packing, and holding of finished products that are intended to be fed to animals, including livestock, pets, and other captive animals; and ingredients that may be used in animal foods. Industry sectors, such as renderers and grain and oilseed processors, have long been considered animal food manufacturers and would now be subject to the proposed rule. Newer industry sectors, such as biofuels manufacturing, or other entities that may not have been thought of as animal food manufacturers in the past, such as mineral refining and manufacturing, would be subject to the proposed rule.
This rule applies to domestic and imported animal food in interstate commerce, including pet food, animal feed, and raw materials and ingredients to be sold in the U.S. The rule does not apply to farms that manufacture food for their own animals or fruits and vegetables, or other food facilities not required to register under section 415 of the FD&C Act.
Modified Hazard Analysis and Critical Control Points (HACCP) Preventive Controls requirements apply to:
- A facility with animal food sales averaging less than $500,000 per year during last three years and sales to qualified end users exceeding sales to others.
- Very small businesses (pending FDA definition;
- Facilities, such as warehouses, that only store packaged animal foods not exposed to the environment; and
- Packaged animal food for which temperature control is required for safety.
Exempt from these requirements are:
- Animal foods subject to the low-acid canned food regulation;
- Activities within the definition of “farm,” including farm activities that are covered by produce safety rule;
- Certain low-risk manufacturing/processing activities, packing or holding activities that are conducted by small or very small businesses on farms for specific animal foods. Examples including conveying/weighing/sorting/culling/grading grain, oilseed, grain and oilseed by-products, and forage;
- Facilities such as grain elevators and warehouses storing only raw agricultural commodities (other than fruits and vegetables covered under produce safety rule) intended for further distribution or processing provided they are solely engaged in such storage;
- Facilities such as warehouses that only store packaged animal foods that are not exposed to the environment; and
- Packaged animal food for which refrigeration is not required for safety.
A nutritional requirement is included in the hazard analysis based on data derived from the risk assessment, stating in part: The Hazard Identification section of the RA (Risk Assessment) identified nutrient imbalances, too much or too little of essential nutrients, called subpotent and superpotent ratios of nutrients, as hazardous to animals. Proper nutrient balance is particularly important for animal food because often one animal food type is the sole source of an animal’s diet. Nutrient imbalance is therefore hazardous in a finished feed.
Good Manufacturing Practices
The proposed rule establishes a specific set of current Good Manufacturing Practices (cGMPs) for the animal food industry very similar to those involved in human food production. For the first time, the basic prerequisite programs for personnel and facilities that have been required elsewhere for years must be put in place by those covered by the proposed rule. The cGMP requirements cover:
- Personnel practices such as following good hygiene and protecting food against contamination from personal effects;
- The plant and grounds including proper cleaning, maintenance, and elimination of pests;
- Sanitary operations such as maintaining clean and sanitary conditions of food contact surfaces, proper use and storage of toxic cleaning compounds, and exclusion of pests;
- Sanitary facilities and controls such as the plant’s water supply, plumbing, and toilet and handwashing facilities;
- Equipment and utensils including the cleaning and maintenance of such items and protecting animal food from contamination;
- Processes and controls including following adequate sanitation principles, proper labeling of ingredients and finished animal food, ensuring the safety of raw materials, and prevention of contamination of animal food during processing; and
- Warehousing and distribution to protect animal food against contamination and deterioration.
The preventive control provisions intended to implement section 103 of the FDA Food Safety Modernization Act for animal food are also similar to those published for human food and produce safety. Along with language used in the cGMPs, they mirror terminology and definitions previously set forth by FDA to form the foundation. These preventive controls would include requirements to:
- Maintain a written food safety plan,
- Perform a written hazard analysis with preventive controls,
- Monitor procedures,
- Verify procedures were effective,
- Develop corrective actions, and
- Maintain records.
The proposed rule also establishes the baseline qualification requirements for a “qualified individual” (QI).
A QI must prepare or oversee the preparation of the food safety plan, validation of preventive controls, review records for implementation and effectiveness of preventive controls and the appropriateness of corrective actions, and perform the reanalysis of a food safety plan.
Considering it is likely FDA’s intent to be consistent across all three proposed preventive controls rules, then the QI requirements described in more detail in the human food rule apply here also. In that rule, it states the QI qualifications may be met by more than one individual on the HACCP or food safety team comprised of plant personnel or an outside consultant meeting the requirements.
Most stakeholders agree the animal feed/pet food sector has significant ground to cover to achieve compliance with the two major provisions of the rule and the need for technical support could be substantial. The QI could play a significant role to provide support as they mobilize resources to meet these requirements. However, as it currently stands, it appears it will operate under a model including an initial training and exam with a onetime certificate issued to the attendee. While that system has worked well in the past, many believe there’s an opportunity to improve the QI training program and increase its value by operating it similar to an ISO 17024 Personnel Certification Program, which includes continuing education requirements, publicly available registry of credentialed personnel, and renewal frequency that ensures continued competency.
FDA views a supplier approval program as an appropriate verification activity, even though it doesn’t specifically require one at this time. Much of the raw materials used in animal food are derived from the human food sector via product that doesn’t meet specifications for attributes such as color or shape, and concerns have been raised over the impact of a supplier approval program on this practice.
The rule would take effect 60 days after the final rule is published in the Federal Register, with tiered compliance dates for small and very small businesses.
However, industry experts are supporting a submitted proposal to allow additional compliance time. Under this plan, GMPs and preventive controls would be in place within two years for large firms, three years for small businesses, and four years for very small businesses.
The animal food industry is facing tremendous challenges ahead, they must implement cGMP’s and preventive controls, currently in the same timeframe and at a time when demand for competent technical support is high across all industry sectors. While some have already implemented programs and procedures that address these requirements, many have not or have not covered everything so the news of possible extended compliance is surely welcome indeed.
Wester is president of PA Wester Consulting. Reach her at firstname.lastname@example.org.