Yesterday, FDA announced in the Federal Register, the Agency’s 2019 user fee rate for recognized accreditation bodies and accredited certification bodies, and the fee rate for accreditation bodies applying to be recognized in the third-party certification program.
Under the current third-party certification program, as required by the Food Safety Modernization Act (FSMA), FDA established a system to accredit third party’s to conduct food safety audits and issue food and facility certifications to eligible foreign entities. Under the program, FDA may recognize accreditation bodies that accredit certification bodies. Alternatively, FDA may also directly accredit certification bodies.
The average employee hourly rate of $235 is based on a full time equivalent average employee cost of $273,139 per year, including adjustments for inflation. The hourly rate was adjusted up to $282 to account for travel costs. Based on the forgoing the FSMA fee schedule for FY 2019 is
| Fee Category | Fee Rates for FY 2019 |
| Hourly rate without travel | $235 |
| Hourly rate if travel is required | $282 |
Based on man hours and travel required, FDA used the above rates to calculate the user fees for accreditation bodies and certification bodies in the program for FY 2019. These include:
| Fee Category | Fee Rates for FY 2019 |
| Initial Application Fee for Accreditation Body Seeking Recognition | $38,211 |
| Annual Fee for Recognized Accreditation Body | $1,775 |
| Annual Fee for Accredited Certification Body | $2,219 |
| Initial Application Fee for a Certification Body Seeking Direct Accreditation from FDA | $38,211 |
The above 2019 user fee rates are effective October 1, 2018 until September 30, 2019.
FDA also provided projections for renewal applications (even though FDA will not yet collect such fees in 2019). These include:
| Fee Category | Estimated Fee Rates for FY 2019 |
| Renewal application fee for recognized accreditation body | $21,350 |
| Renewal application fee for directly accredited certification body | $28,999 |
| Annual fee for certification body directly accredited by FDA | $21,056 |
The above fees must be paid within 30 days of FDA’s invoice date; otherwise the application will be considered incomplete and FDA will not review the application.
