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Federal Register / Vol. 86, No. 193 / Friday, October 8, 2021 / Rules and Regulations
jspears on DSK121TN23PROD with RULES1

public. We have completed our evaluation of the objections and conclude that a continuation of the stay is not warranted.
In the absence of any other objections and requests for a hearing, we conclude that this document constitutes final action on the objections received in response to the October 31, 2018, final rule as prescribed in section 701e2 of the FD&C Act. Therefore, under sections 701 and 721 of the FD&C Act, notice is given that the objections and the requests for a hearing filed in response to the final rule that appeared in the Federal Register of October 31, 2018, do not form a basis for further stay of the effectiveness of the final rule.
Accordingly, we are ending the stay of the final rule and we are repealing the listing for lead acetate in 73.2396 as a color additive in cosmetics intended for coloring hair on the scalp as of January 6, 2022.
In the October 31, 2018, final rule, we stated our intention to exercise enforcement discretion for a period of 12 months from the effective date of the final rule regarding marketed hair dye products that contain the color additive lead acetate to provide an opportunity for industry to deplete the current stock of hair dye products with lead acetate and reformulate products prior to enforcing the requirements of the final rule. We also stated that we had taken into consideration the fact that bismuth citrate, which is listed in 73.2110 for use in cosmetic hair dye products at a level up to 2.0 percent weight/volume, was already being used as an alternative for lead acetate in hair dye products marketed both in the United States and other countries. Therefore, our intent is to exercise enforcement discretion for a period of 12 months from the effective date of the final rule for those hair dye products containing the color additive lead acetate that comply with the requirements of 73.2396, including the specifications, uses and restrictions, and labeling requirements.
VI. References The following references marked with an asterisk are on display with the Dockets Management Staff see ADDRESSES and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https
www.regulations.gov. References without asterisks are not on public display at https www.regulations.gov because they have copyright restriction.
Some may be available at the website address, if listed. FDA has verified the website addresses, as of the date this
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document publishes in the Federal Register, but websites are subject to change over time.
1. Moore, M.R., P.A. Meredith, W.S. Watson, et al., 1980. The Percutaneous Absorption of Lead-203 in Humans from Cosmetic Preparations Containing Lead Acetate, as Assessed by Whole-Body Counting and Other Techniques. Food and Cosmetics Toxicology, 18:399405.
2. Memorandum from M.K. Wyatt, Cosmetics Division, Office of Cosmetics and Colors, CFSAN, FDA to M. Harry, Division of Petition Review, Office of Food Additive Safety, CFSAN, FDA, September 18, 2018.
3. HHS, National Toxicology Program, NTP
Monograph on Health Effects of LowLevel Lead, June 2012. https
ntp.niehs.nih.gov/ntp/ohat/lead/final/
monographhealtheffectslowlevellead_
newissn_508.pdf.
4. Evaluation of Certain Food Additives and Contaminants: Seventy-Third Report of the Joint FAO/WHO Expert Committee on Food Additives, WHO Tech Report Series No. 960, 2011. http
apps.who.int/iris/bitstream/10665/
44515/1/WHO_TRS_960_eng.pdf.
5. WHO, Fact Sheet: Lead Poisoning and Health, August 23, 2019. https
www.who.int/news-room/fact-sheets/
detail/lead-poisoning-and-health.
6. HHS, FDA, Center for Food Safety and Applied Nutrition. Lead in Cosmetic Lip Products and Externally Applied Cosmetics: Recommended Maximum Level. Draft Guidance, December 2016, available at https www.fda.gov/media/
99866/download.
7. Supporting Document for Recommended Maximum Lead Level in Cosmetic Lip Products and Externally Applied Cosmetics. December 2016, Docket No.
FDA2014D2275. http wcmsinternet.fda.gov/cosmetics/cosmeticsguidance-documents/supportingdocument-recommended-maximumlead-level-cosmetic-lip-products-andexternally-appliedVIII.
8. HHS, FDA, Center for Drug Evaluation and Research. Maximal Usage Trials for Topical Active Ingredients being Considered for Inclusion in an Over-TheCounter Monograph: Study Elements and Considerations. Draft Guidance for Industry. Clinical Pharmacology/OTC, May 2018; Final Guidance: Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-The-Counter Monograph: Study Elements and Special Considerations, May 2019. https
www.fda.gov/regulatory-information/
search-fda-guidance-documents/
maximal-usage-trials-topically-appliedactive-ingredients-being-consideredinclusion-over-counter.
9. European Commission. The SCCPS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation. 6th Revision, 2006. https
ec.europa.eu/health/ph_risk/
committees/04_sccp/docs/sccp_o_
03j.pdf.

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10. Easy Directions. Grecian Formula16
LIQUID. Grecian Formula16 CREAM.
11. Frasch, H.F., G.S. Dotson, and S.
Wilkinson. Analysis of Finite Dose Dermal Absorption Data: Implications for Dermal Exposure Assessment. Journal of Exposure Science & Environmental Epidemology, 24: 6573, 2014. https
www.ncbi.nlm.nih.gov/pmc/articles/
PMC3868874/.
12. Kissel, J.C. The Mismeasure of Dermal Absorption. Journal of Exposure Science & Environmental Epidemiology, 213: 302309, 2010. https
pubmed.ncbi.nlm.nih.gov/20424648/.
13. Van Veen, M.P. A General Model for Exposure and Uptake from Consumer Products. Risk Analysis, 16:331338, 1996.
14. Health Canada. Screening Assessment Acrylates and Methacrylates Group.
October 2018. https www.canada.ca/
en/environment-climate-change/
services/evaluating-existing-substances/
screening-assessment-acrylatesmethacrylates-group.html.
15. Fitzpatrick D., J. Corish, and B. Hayes.
Modelling Skin Permeability for Risk AssessmentThe Future.
Chemosphere, 55:13091314, 2004.
16. Korinth, G., K.H. Schaller, and H. Drexler.
Is the Permeability Coefficient Kp a Reliable Tool in 34 Percutaneous Absorption Studies? Archives of Toxicology, 79, 155159, 2005.
17. National Institute for Public Health and the Environment, Ministry of Health, Welfare and Sport. ConsExpo Web, Consumer Exposure models model documentation, 2017. https
www.rivm.nl/bibliotheek/rapporten/
2017-0197.pdf.
18. EPA. Interim Report. Dermal Exposure Assessment: Principles and Applications. Office of Health and Environmental Assessment EPA/600/8
91/011B, January 1992.
19. EPA July 2004. Risk Assessment Guidance for Superfund Volume I:
Human Health Evaluation Manual Part E, Supplemental Guidance for Dermal Risk Assessment Final. EPA/540/R/99/
005, OSWER 9285.702EP, PB99
962212.
20. Dolan, L.C., B.M. Flannery, D. HoffmanPennesi, et al. A Review of the Evidence to Support Interim Reference Level for Dietary Lead Exposure in Adults. FDA, Center for Food Safety and Applied Nutrition, Journal of the International Society of Regulatory Toxicology and Pharmacology, 111.
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21. Hostynek, J.J., R.S. Hinz, C.R. Lorence, and R.H. Guy. Human Skin Penetration by Metal Compounds. Drugs and the Pharmaceutical Sciences, 91:647668, 1998.
22. M.S. Roberts and K.A. Walters, eds.
Dermal Absorption and Toxicity Assessment, Marcel Dekker, Inc., New York.

List of Subjects in 21 CFR Part 73
Color additives, Cosmetics, Drugs, Foods, Medical devices.

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