The Food Safety Modernization Act requires the Food and Drug Administration to establish an accreditation program to strengthen foreign food safety audits. The agency issued a proposed rule for an accreditation program on July 29, 2013. In a related July 24, 2015 notice, the agency released a proposed rule that would introduce user fees to pay for the new program.
FDA anticipates issuing a final accreditation rule in October 2015 and it is inviting public comment by October 7, 2015 on the proposed user fees. The agency lists four main groups for the purposes of the “reimbursement” charges:
- Accreditation bodies submitting applications or renewal applications for recognition in the third-party accreditation program;
- Recognized accreditation bodies participating in the third-party accreditation program subject to FDA monitoring activities;
- Certification bodies submitting applications or renewal applications for direct accreditation; and
- Accredited certification bodies (whether accredited by recognized accreditation bodies or by FDA through direct accreditation) participating in the third-party accreditation program subject to FDA monitoring activities.
Under the agency’s July 24 proposal, accreditation bodies and certification bodies would be subject to application fees for the estimated average cost of the work FDA performs in reviewing and evaluating applications. Alternatively, the agency could charge an hourly rate or could use a combination of those two methods.
FDA estimates that it would take, on average, 60 person-hours to review an accreditation body’s application, 48 person-hours for an onsite performance evaluation of the applicant and 45 person-hours to prepare a written report documenting the onsite audit.
To provide a sense of the proposed fees — which the agency expects to finalize in the fall – it proposes $202 as the base unit fee in determining the hourly fee rate, prior to including domestic or foreign travel costs. With an estimated hourly travel cost of $103, the total fee would be $305 per paid hour for each direct hour of work requiring foreign inspection travel and most applications are likely to involve foreign travel. The agency proposes to set lower hourly rates for domestic travel.
The agency is also considering whether it should establish a flat fee or an hourly rate and is inviting comments on which approach is likely to work best in terms of encouraging high-quality applications.
If it bills using the actual number of hours worked, applications that are faster to review – because they are better-prepared, for example — could result in lower fees, while applications that are slower to review — because they are less organized or require more back-and-forth with the applicant — could result in higher fees, the agency notes.
Similarly, applicants that facilitate the onsite audit process and have higher quality operations would likely have shorter onsite audits than other applicants.
The agency is also considering whether it should have hourly fees for the onsite audit while maintaining a flat fee for other activities, such as the paper application review. This hybrid approach may be most consistent with how accreditation bodies currently charge certification bodies and could “provide a balance of predictability and incentives,” the agency suggests.
Along with the Foreign Supplier Verification Program, the recognition of third parties by FDA to perform audits and inspections is central to FSMA’s goal of achieving parity between domestic and imported food safety programs. By charging user fees, FDA is less reliant on Congressional appropriations, and in the process new jobs will be created in the private sector with the ultimate result of improved food safety. Sounds like a win-win-win to me!