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The Food and Drug Administration released two key FSMA-mandated regulations last month — a final rule on current good manufacturing practices (CGMPs) and risk-based preventive controls for food for humans and a related final rule on food for animals. The rules were released on September 10 and formally published September 17 in the Federal Register.

FDA now plans to release numerous guidance documents to help covered companies comply with the new requirements. For human foods, the agency is preparing guidance on hazard analysis and preventive controls, environmental monitoring, allergen controls, validation of process controls, and a compliance guide for small and very small businesses. For the animal food rule, it is developing guidance on CGMPs, hazard analysis and preventive controls, human food by-products for use as animal food, and on compliance for small or very small businesses.

The new preventive controls regulations apply equally to domestic U.S. operations and to international exporters of food to the U.S. market. With this in mind, the agency has translated its fact sheets on the two preventive controls rules into 12 major languages — including Arabic, traditional and simple Chinese, Spanish, French, Italian, Japanese, Korean, Portuguese, Russian, Thai and Hindi. Given the increasing importance of imported food in the U.S. market. Effective outreach to the international community will be a key component of a successful implementation of FSMA’s preventive control principles and I believe it is one of the biggest challenges facing the agency.

For the most part, the final rules reflect the proposed and supplemental rules, but they include some revisions made in response to comments from stakeholders. In a notable revision relating to auditing of facilities covered by the new rules, FDA revised the definition of a “qualified auditor.” The final rules use the term “qualified individual” rather than “preventive controls qualified individual.”

In response to a question about the qualifications needed for a preventive controls qualified auditor, the agency said a qualified auditor might get the necessary auditing expertise in part through education, as well as through training and experience, and it revised the definition of qualified auditor. But it concluded that a person must have some actual experience in auditing to meet the definition of a qualified auditor and that the technical expertise cannot be obtained solely through education and/or training.

Further clarification of the qualifications needed by auditors will be included in a separate Proposed Rule on Accreditation of Third-Party Auditors which has yet to be finalized.

Because the new provision refers to provisions in a future third-party certification rule, FDA plans to publish a document in the Federal Register announcing the effective date of the provision once the third-party certification rule is finalized.

EAS has a network of auditors with both the training and experience needed to conduct audits to assess compliance with the risk-based preventive controls rules. They are also available to conduct a gap-analysis for facilities wishing to ensure that they will be in compliance with the new CGMP and risk-based preventives controls requirements by the appropriate deadline.

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