Color Additive Certification; Increase in Fees for Certification Services

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Part 80</CFR> <DEPDOC>[Docket No. FDA-2022-N-1635]</DEPDOC> <RIN>RIN 0910-AI69</RIN> <SUBJECT>Color Additive Certification; Increase in Fees for Certification Services</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration is amending the regulation setting fees for color additive certification services to increase these fees. This increase will allow FDA to continue to provide, maintain, and equip an adequate color additive certification program as required by the Federal Food, Drug, and Cosmetic Act (FD&C Act). </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This rule is effective December 9, 2024. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> For access to the docket to read background documents or comments received, go to <E T="03">https://www.regulations.gov</E> and insert the docket number found in brackets in the heading of this final rule into the “Search” box and follow the prompts, and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> <E T="03">With regard to the final rule:</E> Bryan Bowes, Office of the Chief Scientist, Office of Cosmetics and Colors, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1122; or Carrol Bascus, Office of Policy, Regulations and Information, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">Table of Contents</HD> <EXTRACT> <FP SOURCE="FP-2">I. Executive Summary</FP> <FP SOURCE="FP1-2">A. Purpose of the Final Rule</FP> <FP SOURCE="FP1-2">B. Summary of the Major Provisions of the Final Rule</FP> <FP SOURCE="FP1-2">C. Legal Authority</FP> <FP SOURCE="FP1-2">D. Costs and Benefits</FP> <FP SOURCE="FP-2">II. Background</FP> <FP SOURCE="FP1-2">A. Need for the Regulation/History of the Rulemaking</FP> <FP SOURCE="FP1-2">B. Summary of Comments to the Proposed Rule</FP> <FP SOURCE="FP1-2">C. General Overview of the Final Rule</FP> <FP SOURCE="FP-2">III. Legal Authority</FP> <FP SOURCE="FP-2">IV. Comments on the Proposed Rule and FDA Response</FP> <FP SOURCE="FP1-2">A. Introduction</FP> <FP SOURCE="FP1-2">B. Description of Comments and FDA Response</FP> <FP SOURCE="FP-2">V. Effective/Compliance Date(s)</FP> <FP SOURCE="FP-2">VI. Economic Analysis of Impacts</FP> <FP SOURCE="FP1-2">A. Introduction</FP> <FP SOURCE="FP1-2">B. Overview of Benefits, Costs, and Transfers</FP> <FP SOURCE="FP-2">VII. Analysis of Environmental Impact</FP> <FP SOURCE="FP-2">VIII. Paperwork Reduction Act of 1995</FP> <FP SOURCE="FP-2">IX. Federalism</FP> <FP SOURCE="FP-2">X. Consultation and Coordination With Indian Tribal Governments</FP> <FP SOURCE="FP-2">XI. References</FP> </EXTRACT> <HD SOURCE="HD1">I. Executive Summary</HD> <HD SOURCE="HD2">A. Purpose of the Final Rule</HD> The Food and Drug Administration (FDA or we) is amending the regulation setting fees for color additive certification services to increase these fees. This increase will allow FDA to continue to provide, maintain, and equip an adequate color additive certification program as required by the FD&C Act. The fees will help to recover the full costs of operating FDA's color additive certification program. <HD SOURCE="HD2">B. Summary of the Major Provisions of the Final Rule</HD> The final rule amends the color additive regulation to increase the fees for certification services. The fees for straight colors including lakes will be $0.45 per pound ($0.10 per pound increase) with a minimum fee of $288. There will be similar increases in fees for repacks of certified color additives and color additive mixtures. <HD SOURCE="HD2">C. Legal Authority</HD> We are issuing the final rule consistent with our statutory authority, under the FD&C Act, which requires fees to provide, maintain, and equip an adequate color additive certification program, as specified in our regulations. <HD SOURCE="HD2">D. Costs and Benefits</HD> The final rule amends existing color additive regulations to increase fees for certification services. The costs of the rule include the cost to read and understand the rule. As the increase in fees is not associated with any change in our certification program, no economic benefits are expected to result from the final rule. Similarly, the impact of the increase in certification fees on color additive manufacturers is considered a transfer, rather than an economic cost. Accordingly, we do not estimate economic benefits associated with this final rule, and the impact of the increase in color certification fees is estimated as an ongoing transfer from manufacturers of color additives to the Federal Government. The economic burden of the final rule accrues to color additive manufacturers. We estimate a one-time cost to read and understand the rule for all color additive manufacturers. The present value of this cost is approximately $5,384 at a 3 percent rate of discount, and $5,183 at a 7 percent rate of discount. The annualized value of these costs estimates is approximately $631 at a 3 percent discount rate and $738 at a 7 percent discount rate. <HD SOURCE="HD1">II. Background</HD> <HD SOURCE="HD2">A. Need for the Regulation/History of the Rulemaking</HD> In accordance with section 721(a)(1)(B) of the FD&C Act (21 U.S.C. 379e(a)(1)(B)), certain color additives must be certified for use by FDA in food, drugs, cosmetics, and certain medical devices. Section 721(e) of the FD&C Act provides in relevant part that the certification of color additives must only be performed upon payment of fees, to be specified by regulation, as necessary to provide, maintain, and equip an adequate service for such purpose. When certifying a color additive, FDA analyzes samples from each batch of color additive received from a manufacturer and verifies that it meets composition and purity specifications. FDA certification is necessary before color additives that are subject to certification are permitted to be used in these FDA-regulated products. Under the color additive certification fee regulation, manufacturers pay fees, based on the weight of each batch for certification. These fees support the full costs of operating FDA's color additive certification program. The current fee schedule specified in part 80 (21 CFR part 80) became effective in 2005 (and was amended in 2006 to correct a typographical error). Since 2005, the costs of the certification program have significantly increased because of the increase in general operating expenses, including the purchase and maintenance of critical equipment, rent and facility charges, and staff payroll. Therefore, in the <E T="04">Federal Register</E> of November 2, 2022 (87 FR 66116), we published a proposed rule to amend the color additive regulation to increase the fees for certification services. The change in fees will allow FDA to continue to provide, maintain, and equip an adequate color additive certification program as required by section 721(e) of the FD&C Act. We proposed to increase the fees for certifying color additives to reflect increasing operating costs for the certification program. The fee schedule for color certification, as provided for in our regulations, is designed to cover all the costs involved in certifying batches of color additives. This includes the cost of specific tests required by the regulations and the general costs associated with the certification program, such as costs of accounting, reviewing data, issuing certificates, conducting research, inspecting establishments, and purchasing and maintaining equipment. The current fee schedule is insufficient to provide, maintain, and equip an adequate color additive certification program. As fees have not kept pace with inflation, we have struggled to recover the full costs of operating FDA's color certification program, resulting in a financial shortfall for the program. Our Color Certification Fee Study (Fee Study) (Ref. 1) provides data and information about the current financial condition of the color additive certification program. As noted in our Fee Study, in recent years, successful operation of color certification activities has relied upon prior year carryover funding to address a deficit between program expenses and annual fee collections. This is not sustainable because carryover funding and annual fee collections are diminishing due to increased costs and low collections. Therefore, the fee increase will help to ensure that collected fees are sufficient to fund the full cost of our color certification activities. Consistent with section 721(e) of the FD&C Act, the fee increase in the final rule is necessary to cover rising operating costs and maintain an adequate color additive certification program. <HD SOURCE="HD2">B. Summary of Comments to the Proposed Rule</HD> The proposed rule provided a 60-day comment period. Based on a request from stakeholders, we re-opened the comment period for an additional 45 days (88 FR 4117 (January 24, 2023)). In April 2024, we reopened the comment period a second time to add the Fee Study to the docket (89 FR 32384 (April 26, 2024)). In May 2024, based on a request from stakeholders, we extended the comment period again for 30 days (89 FR 46042 (May 28, 2024)). We received fewer than 15 comments on the proposed rule. The comments were from individuals and an industry trade association. A few comments supported the rulemaking. Other comments raised questions and concerns about our rationale for the $0.10 per pound increase. The comments urged FDA ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 44k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━