The U.S. Food and Drug Administration (FDA) has taken two important steps to launch the Voluntary Qualified Importer Program (VQIP) under the FDA Food Safety Modernization Act (FSMA). First, FDA has started accepting applications for participation in VQIP, a voluntary, fee-based program which offers expedited review and entry of human and animal food into the United States. Second, FDA has recognized the first accreditation body under the voluntary Accredited Third-Party Certification Program created by FSMA, a step needed to implement VQIP. This post discusses both developments.
The Food and Drug Administration (FDA) recently issued Draft Guidance on its interpretation of what constitutes a refusal of inspection by a foreign food establishment or foreign government. Though the target audience is foreign food establishments and foreign governments, the Draft Guidance provides insight into FDA’s perspective on the legal obligations that apply to all food facility inspections. In particular, FDA describes refusal to permit photography during an inspection as a refusal of inspection. We provide an overview of the Draft Guidance, including the various actions FDA considers to constitute a refusal of inspection and the repercussions when foreign food establishments or foreign governments refuse inspection. FDA requests that comments on the Draft Guidance be submitted by February 26, 2018.
FDA has started conducting inspections to assess compliance with its Foreign Supplier Verification Programs (FSVP) regulation. The initial FSVP compliance date was May 30, 2017, though FSVP importers may have later compliance dates for their various suppliers that are smaller sized businesses. Inspections started earlier this summer. In this post we provide a brief overview of how these inspections are progressing based on the inspections we have learned about.
There have been several recent developments regarding implementation of the FDA Food Safety Modernization Act (FSMA) of interest to the food industry. In this post, we summarize the following topics:
- Delayed start date for inspections for compliance with the preventive controls requirements under the Preventive Controls for Animal Food (PCAF) rule and under the Foreign Supplier Verification Programs (FSVP) rule for animal food importers;
- Guidance for low-acid canned food (LACF), seafood, and juice manufacturers regarding compliance and exemptions under FSMA;
- Updated domestic and foreign reinspection fee rates for fiscal year (FY) 2018;
- Release of new Food Safety Plan Builder software to assist with development of food safety plans; and,
- Clarification regarding the definition of “retail food establishment” for purposes of the waiver from requirements under the Sanitary Transportation of Human and Animal Food rule.
Click here to read our update.
There will be significant changes at the U.S. border starting May 30, 2017, that will affect all imported FDA-regulated foods—even if they are exempt from the Foreign Supplier Verification Programs (FSVP) regulation under the FDA Food Safety Modernization Act (FSMA). All food imports will be rejected at entry unless certain new information is provided to FDA. We summarize these new data requirements below.
Earlier this month, the Food and Drug Administration (FDA) held a two-day public hearing that addressed the agency’s plans to engage in strategic partnerships to enhance the safety of imported foods. FDA used the hearing as an opportunity to ask questions of and learn from private entities and food safety authorities in other countries. The key topics discussed were the use of third-party certification bodies in regulatory decision-making, systems recognition, international capacity building, and commodity-specific exports and programs. We summarized some of the highlights from the hearing that may be of particular interest to food manufacturers and their trade associations. FDA has opened a docket for comments on the issues discussed at the hearing, which is open through May 16, 2017.
Click here to read the summary.