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.
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Explore This IssueFebruary/March 2014
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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.