In a significant milestone in the Food and Drug Administration’s implementation of FSMA, the agency is expected to issue a final rule next month on preventive controls for human and animal foods.
FDA released a series of videos on FSMA implementation last month featuring comments and insights from stakeholders and agency officials. Many of those speakers expressed the view – and I agree with them – that outreach and education by the agency will be the key to the successful implementation of the new requirements.
Also last month, FDA released draft guidance on the Voluntary Qualified Importer Program (VQIP) for importers of human or animal food, for companies that might become participants in the user-fee-funded program. The agency estimates that the annual fee would be approximately $16,400 for participation in the voluntary program.
The program would allow for expedited importation of food from importers who volunteer to participate. The draft guidance describes the eligibility criteria and also reviews what might cause VQIP eligibility to be revoked, as well as criteria for reinstatement. And it describes how the agency plans to set user fees to fund the voluntary program.
FDA says the program will incentivize companies to adopt robust supplier verification programs and will allow the agency to focus its resources on food shipments that pose a higher risk to public health.
The agency estimates it will take an applicant 80 person-hours to compile all the information and complete the application for the VQIP program. FDA expects that it will receive 200 notices of intent to participate in the first year. It also expects to be able to review 200 applications in the first year, depending on the available resources. It anticipates that the program will cost $3.4 million in FY 2018, including the costs of the application review process for 200 applications, the costs of conducting inspections of importers (both foreign and domestic) accepted into the program, the costs of the final determination of eligibility into the program, and annual information technology maintenance costs.
FDA is inviting comments on the draft guidance by August 19, 2015.