“This draft guidance provides importers with recommendations to assist them in preventing or detecting potential problems at critical points along the product’s life cycle,” said Jeffrey Shuren, M.D., J.D., associate commissioner for policy and planning at the FDA.
Recommendations are designed to anticipate potential sources of product hazards and offer preventive controls firms can implement to mitigate such hazards and help ensure imported products are safe and are compliant with U.S. requirements.
These draft Good Importer Practices are organized under four guiding principles:
1. Establishing a product safety management program.
2. Knowing the product and applicable U.S. requirements.
3. Verifying product and company compliance with U.S. requirements throughout the supply chain and product life cycle.
4. Taking corrective and preventive action when the imported product is not in compliance with U.S. requirements.
The draft guidance recommends that importers consider instituting practices to identify and minimize risks associated with imported products. The draft guidance also recommends that, in general, importers should know the producer of the foreign products they purchase and any other manufacturers with which they do business, such as consolidators, trading companies, and distributors; understand the products that they import and the vulnerabilities associated with these products; understand the hazards that may arise during the product life cycle, including all stages of production; and ensure proper control and monitoring of these hazards.
The agencies are issuing this draft guidance to implement recommendations outlined in the “Action Plan for Import Safety: A Roadmap for Continual Improvement,” issued by the Interagency Working Group on Import Safety, and to help foster a consistent approach by federal agencies and importers in ensuring the safety of products brought into the United States.
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