Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products

DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Part 730</CFR> <DEPDOC>[Docket No. FDA-2023-N-4225]</DEPDOC> <RIN>RIN 0910-AI82</RIN> <SUBJECT>Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, Department of Health and Human Services (HHS). <HD SOURCE="HED">ACTION:</HD> Proposed rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA, the Agency, or we) is proposing to require testing of talc-containing cosmetic products using standardized testing methods for detecting and identifying asbestos that may be present as a contaminant in talc. We are also proposing corresponding adulteration provisions. Asbestos is a potential contaminant in talc, which is used in certain cosmetic products, and is a known human carcinogen. This proposed rule, if finalized, will help protect users of talc-containing cosmetic products from harmful exposure to asbestos given the potential for contamination of these products. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> Either electronic or written comments on the proposed rule must be submitted by March 27, 2025. Submit written comments (including recommendations) on information collection issues under the Paperwork Reduction Act of 1995 by January 27, 2025. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The <E T="03">https://www.regulations.gov</E> electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of March 27, 2025. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. <HD SOURCE="HD2">Electronic Submissions</HD> Submit electronic comments in the following way: • <E T="03">Federal eRulemaking Portal:</E> <E T="03">https://www.regulations.gov</E> . Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to <E T="03">https://www.regulations.gov</E> will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on <E T="03">https://www.regulations.gov.</E> • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). <HD SOURCE="HD2">Written/Paper Submissions</HD> Submit written/paper submissions as follows: • <E T="03">Mail/Hand Delivery/Courier (for written/paper submissions):</E> Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” <E T="03">Instructions:</E> All submissions received must include the Docket No. FDA-2023-N-4225 for “Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products.” Received comments, those filed in a timely manner (see <E T="02">ADDRESSES</E> ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at <E T="03">https://www.regulations.gov</E> or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on <E T="03">https://www.regulations.gov</E> . Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: <E T="03">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.</E> <E T="03">Docket:</E> For access to the docket to read background documents, the plain language summary of the proposed rule of not more than 100 words as required by the “Providing Accountability Through Transparency Act,” or the electronic and written/paper 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 document, 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. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (PRA) to the Office of Management and Budget (OMB) at <E T="03">https://www.reginfo.gov/public/do/PRAMain.</E> Find this particular information collection by selecting “Currently Under Review—Open for Public Comments” or by using the search function. The title of this proposed collection is “Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products.” <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> <E T="03">With regard to the proposed rule:</E> Jennifer Ross, Office of the Chief Scientist, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-0002, 301-796-4880 (this is not a toll-free number), <E T="03">QuestionsAboutMoCRA@fda.hhs.gov.</E> <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 Proposed Rule</FP> <FP SOURCE="FP1-2">B. Summary of the Major Provisions of the Proposed Rule</FP> <FP SOURCE="FP1-2">C. Legal Authority</FP> <FP SOURCE="FP1-2">D. Costs and Benefits</FP> <FP SOURCE="FP-2">II. Table of Abbreviations/Commonly Used Acronyms in This Document</FP> <FP SOURCE="FP-2">III. Background</FP> <FP SOURCE="FP1-2">A. Introduction</FP> <FP SOURCE="FP1-2">B. Need for the Regulation</FP> <FP SOURCE="FP1-2">C. History of the Rulemaking</FP> <FP SOURCE="FP1-2">D. Incorporation by Reference</FP> <FP SOURCE="FP-2">IV. Legal Authority</FP> <FP SOURCE="FP-2">V. Description of the Proposed Rule</FP> <FP SOURCE="FP1-2">A. Who is subject to this section? (Proposed § 730.3(a))</FP> <FP SOURCE="FP1-2">B. What definitions apply to this section? (Proposed § 730.3(b))</FP> <FP SOURCE="FP1-2">C. What test methods must you use? (Proposed § 730.3(c))</FP> <FP SOURCE="FP1-2">D. How does one determine if a sample has tested positive for asbestos? (Proposed § 730.3(d))</FP> <FP SOURCE="FP1-2">E. Is there an alternative to performing finished product testing for detecting and identifying asbestos in a talc-containing cosmetic product? (Proposed § 730.3(e))</FP> <FP SOURCE="FP1-2">F. How frequently must tests be performed? (Proposed § 730.3(f))</FP> <FP SOURCE="FP1-2">G. Proposed Records/Record Retention Requirements (Proposed § 730.3(g))</FP> <FP SOURCE="FP1-2">H. Proposed Enforcement Provisions (Proposed § 730.3 (h), (i), and (j))</FP> <FP SOURCE="FP-2">VI. Proposed Effective Date</FP> <FP SOURCE="FP-2">VII. Preliminary Economic Analysis of Impacts</FP> <FP SOURCE="FP-2">VIII. Analysis of Environmental Impact</FP> <FP SOURCE="FP-2">IX. Paperwork Reduction Act of 1995</FP> <FP SOURCE="FP-2">X. Federalism</FP> <FP SOURCE="FP-2">XI. Consultation and Coordination With Indian Tribal Governments</FP> <FP SOURCE="FP-2">XII. References</FP> </EXTRACT> <HD SOURCE="HD1">I. Executive Summary</HD> <HD SOURCE="HD2">A. Purpose of the Proposed Rule</HD> We are issuing this proposed rule pursuant to the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which requires the promulgation of proposed and final regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products. This proposed rule, if finalized, will help protect users of talc-containing cosmetic products from harmful exposure to asbestos given the potential for asbestos contamination of these products. <HD SOURCE="HD2">B. Summary of the Major Provisions of the Proposed Rule</HD> T ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 105k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━