Food Additives: Food Contact Substance Notification That Is No Longer Effective

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Part 170</CFR> <DEPDOC>[Docket No. FDA-2021-N-0403]</DEPDOC> <RIN>RIN 0910-AI01</RIN> <SUBJECT>Food Additives: Food Contact Substance Notification That Is No Longer Effective</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, Department of Health and Human Services (HHS). <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA or we) is amending its regulations relating to the procedures for determining that a premarket notification for a food contact substance (FCN) is no longer effective. The final rule provides additional reasons that could form the basis for FDA to determine that an FCN is no longer effective. The final rule also ensures that manufacturers or suppliers have the opportunity to provide input before we determine that an FCN is no longer effective. We are making these changes to allow FDA to respond better to new information on the safety and use of food contact substances (FCSs), as well as manufacturers' business decisions, and also improve the efficiency of the premarket notification program. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This rule is effective May 21, 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> Sharon Koh-Fallet, Center for Food Safety and Applied Nutrition (HFS-275), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 301-796-7732; or Carrol Bascus, Center for Food Safety and Applied Nutrition (HFS-024), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378. <E T="03">With regard to the information collection:</E> Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733; <E T="03">PRAStaff@fda.hhs.gov.</E> </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 This 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 General Comments</FP> <FP SOURCE="FP1-2">C. Comments on a Change to the Process for Obtaining Data or Other Information To Demonstrate the Intended Use of a Food Contact Substance Is No Longer Safe</FP> <FP SOURCE="FP1-2">D. Comments on Determining a Premarket Notification for a Food Contact Substance Is No Longer Effective Due to Abandonment</FP> <FP SOURCE="FP1-2">E. Comments on Determining a Premarket Notification for a Food Contact Substance Is No Longer Effective Because It Is Authorized by a Food Additive Regulation or Is the Subject of an Issued Threshold of Regulation Exemption</FP> <FP SOURCE="FP1-2">F. Comments on Confidentiality of Information Related to Premarket Notification for a Food Contact Substance</FP> <FP SOURCE="FP1-2">G. Miscellaneous Comments</FP> <FP SOURCE="FP1-2">H. Nonsubstantive Changes</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. Summary of Cost and Benefits</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. Reference</FP> </EXTRACT> <HD SOURCE="HD1">I. Executive Summary</HD> <HD SOURCE="HD2">A. Purpose of the Final Rule</HD> We are amending our regulations to provide additional reasons that may be the basis for FDA to determine that an FCN is no longer effective and to provide the manufacturer or supplier of the substance an opportunity to provide input before we make such a determination. These changes will create administrative mechanisms to improve the efficiency of the premarket notification program for food contact substances (FCSs). We are also amending related confidentiality of information regulations. <HD SOURCE="HD2">B. Summary of the Major Provisions of the Final Rule</HD> The final rule provides reasons other than safety as the basis on which we may determine that an FCN is no longer effective. These reasons include instances where the production, supply, or use of the FCS for its intended use by the manufacturer or supplier has ceased or will cease (referred to in this rule as “abandonment”), or where the use of an FCS identified in an FCN is either authorized by a food additive regulation or is the subject of an issued Threshold of Regulation (TOR) exemption. The final rule also provides the manufacturer or supplier, who submitted an FCN, the opportunity to address our safety concerns or to otherwise show why an FCN should continue to be effective before we could determine that an FCN is no longer effective, resulting in the use no longer being authorized. Additionally, the final rule amends the confidentiality of information provisions to provide for the disclosure of certain information relating to our determination that an FCN is no longer effective. <HD SOURCE="HD2">C. Legal Authority</HD> We are issuing the final rule consistent with our authority in sections 201, 409, and 701(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321, 348, and 371(a)). <HD SOURCE="HD2">D. Costs and Benefits</HD> The final rule amends the food additive regulations relating to premarket notifications for FCSs also known as Food Contact Notifications (FCNs) and the procedures by which we determine that an FCN is no longer effective. The final rule will allow manufacturers or suppliers of FCSs to request that FDA determine that an FCN is longer effective for reasons other than safety. We expect that cost savings of the final rule take the form of a reduced time burden to FCS manufacturers and suppliers responding to FDA's safety concerns with information that they no longer produce, use, or supply the FCS for the intended use. The final rule will also reduce the time burden to FDA for the review of such information. We estimate that cost savings of the final rule to manufacturers and suppliers and FDA range from zero to $0.4 million, with a central estimate of $0.1 million, annualized over 10 years at a 2 percent discount rate. We estimate that there will be little to no costs associated with the final rule. <HD SOURCE="HD1">II. Background</HD> <HD SOURCE="HD2">A. Need for the Regulation/History of This Rulemaking</HD> Our regulations at § 170.105 set forth the process by which FDA may determine that an FCN is no longer effective. This determination currently only applies when data or other information demonstrating the intended use of an FCS is no longer safe. Presently, our regulations do not provide reasons other than safety as the basis for FDA to determine that an FCN is no longer effective. Also, our regulations do not provide manufacturers or suppliers the opportunity to show why an FCN should continue to be effective prior to FDA making a determination that the FCN is no longer effective. Rather, manufacturers and suppliers must respond to FDA after we provide notice of our determination that the FCN is no longer effective. In the <E T="04">Federal Register</E> of January 26, 2022 (87 FR 3949), we published a proposed rule that would amend § 170.105 to address these issues and better enable FDA to respond to new information on the safety and use of FCSs. We proposed additional reasons to permit us to make a determination that an FCN is no longer effective for reasons other than safety. We proposed that a manufacturer or supplier could request that we determine an FCN to no longer be effective because it has ceased (or intends to cease) producing, supplying, or using an FCS for the intended use. To reduce confusion created by duplicative authorizations, we proposed to remove effective FCNs for intended uses already authorized by food additive regulations or the subject of an issued TOR exemption. We proposed to provide the manufacturer or supplier of an FCS an opportunity to provide information before FDA makes a determination that an FCN is no longer effective. Additionally, we explained that the proposed changes to § 170.105 would create administrative efficiencies in the FCN program. We also proposed to amend the confidentiality of information provisions in § 170.102 to address the disclosure of certain information related to FDA's determination that an FCN is no longer effective. <HD SOURCE="HD2">B. Summary of Comments to the Proposed Rule</HD> The proposed rule provided a 60-day comment period. We received fewer than 20 comments on the proposed rule. The comments were from individuals, a consumer advocacy group, a law firm, and an indust ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 76k characters. 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