By Stephen Sundlof, D.V.M., Ph.D., EAS Independent Advisor, Animal and Human Food Safety
The Food and Drug Administration released an amended final rule last month establishing user fees so the agency can administer the FSMA program for accreditation of third-party certification bodies to conduct food safety audits.
The fees apply to accreditation bodies seeking FDA recognition as well as to third-party certification bodies that seek direct accreditation from FDA. In addition to application fees, the agency will also seek annual user fees and renewal fees.
Third-party certification is an important component of FSMA’s preventive approach. The landmark food safety legislation gave FDA the authority to require risk-based import certification of food. And importers can use facility certifications to qualify for other programs such as the Voluntary Qualified Importer Program (VQIP), which offers expedited review of import entries of food.
In a separate December 14 notice, FDA issued a fee schedule for fiscal year 2017, effective from January 13 through September 30, 2017. The hourly fee for review work by FDA staff will be $204 excluding travel costs — or $285 per hour if travel is involved, the agency says.
The estimated application fee, including travel, for an accreditation body seeking direct accreditation from FDA in FY 2017 will be $35,100. The agency estimates it will take 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 assessment.
In its justification of the fees, the agency offered some insights into its typical costs for overseas travel. In fiscal year 2015, for example, FDA’s Office of Regulatory Affairs spent more than $2.5 million on 269 foreign inspection trips for programs related to the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine. The average cost was $9,373 per foreign inspection trip and the trips averaged 3 weeks or 120 paid hours.
Because this user fee program is just getting under way, renewals and annual fees will not be collected in 2017, but the agency has set the following estimated fees for planning purposes:
- Annual fee for a recognized accreditation body — $1,579.
- Annual fee for an accredited certification body — $1,974.
- Annual fee for a certification body directly-accredited by FDA — $20,208.
- Renewal application fee for a recognized accreditation body — $18,855.
- Renewal application fee for a certification body directly-accredited by FDA — $26,460.
FDA says there will be no exemptions or reduced fees for participation in the program by small businesses or entities or for public-sector entities. It notes that the cost to the agency for performing the application review and monitoring “will not vary greatly regardless of the entity’s size or public versus private status.”
I believe the third-party certification program provides FDA a way to extend its reach and leverage its resources to improve the safety of food imported into the United States. And although fee-based programs are unpopular among the regulated community, they do allow the agency to reliably fund programs that are scalable and sustainable.