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Federal Register / Vol. 86, No. 193 / Friday, October 8, 2021 / Rules and Regulations
Final rule; response to objections and denial of public hearing requests; removal of administrative stay.

ACTION:

The Food and Drug Administration FDA or we is responding to objections and a public hearing request that we received from Combe Inc., on the final rule entitled Termination of Listing of Color Additives Exempt From Certification;
Lead Acetate, which published on October 31, 2018. The final rule amended the color additive regulations to no longer provide for the safe use of lead acetate in cosmetics intended for coloring hair on the scalp. After reviewing the objections, we have concluded that the objections do not raise issues of material fact that justify a hearing. Therefore, the stay of the effectiveness for the repeal and delisting of the color additive regulation is now lifted, and we are amending the color additive regulations to no longer provide for the safe use of lead acetate in cosmetics intended for coloring hair on the scalp.
DATES: This rule is effective January 6, 2022.
ADDRESSES: For access to the docket to read background documents or comments received, go to https
www.regulations.gov 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, 2404027500.
FOR FURTHER INFORMATION CONTACT:
Shayla West-Barnette, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 207403835, 240
4021262.
SUPPLEMENTARY INFORMATION:
SUMMARY:

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I. Background In the Federal Register of October 31, 2018 83 FR 54665, we issued a final rule repealing the color additive regulation in 73.2396 21 CFR 73.2396
to no longer provide for the safe use of lead acetate in cosmetics intended for coloring hair on the scalp because new data available since lead acetate was permanently listed have demonstrated that there is no longer a reasonable certainty that no harm will result from the use of this color additive. We gave interested persons until November 30, 2018, to file objections and requests for a hearing on the final rule. The preamble to the final rule stated that the effective date of the final rule would be on December 3, 2018, except as to any provisions that may be stayed by the
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filing of proper objections 83 FR 54665
at 54673. On December 3, 2018, 73.2396 was removed from the CFR.
However, we had received objections and requests for a hearing on the objections from Combe Inc. Combe, a manufacturer of hair dyes containing lead acetate. Under sections 701e2
and 721d of the FD&C Act 21 U.S.C.
371e2 and 379ed, the filing of objections operates to stay the effectiveness of our repeal until we take final action on the objections.
To implement a stay of effectiveness as required by sections 701e2 and 721d of the FD&C Act, we published a final rule in the Federal Register of April 1, 2019 84 FR 12081, reinstating 73.2396 pending final FDA action on the objections to the October 31, 2018, final rule. We also stated that this action did not reflect any change in our determination that new data demonstrate that there is no longer a reasonable certainty of no harm from the use of this color additive.
FDA listed lead acetate in 73.2396 in 1980 as a color additive for safe use in cosmetics intended for coloring hair on the scalp, subject to certain restrictions and labeling requirements, at levels up to 0.6 percent weight to volume;
equivalent to 6,000 parts per million ppm lead in the cosmetic product 45
FR 72112. Lead acetate is used in progressive hair dyes that, when applied to gray hair, gradually change the color with repeated applications.1
II. Objections and Requests for a Hearing Sections 701e2 and 721d of the Federal Food, Drug, and Cosmetic Act FD&C Act collectively provide that, within 30 days after publication of an order relating to a color additive regulation, any person adversely affected by such an order may file objections, specifying with particularity the provisions of the order deemed objectionable, stating the grounds therefor, and requesting a public hearing upon such objections. We may deny a hearing request if the objections to the regulation do not raise genuine and substantial issues of fact that can be resolved at a hearing 12.24b1 21
CFR 12.24b1. See also Community Nutrition Institute v. Young, 773 F.2d 1356, 1364 D.C. Cir. 1985.
Objections and requests for a hearing are governed by 21 CFR part 12 of our 1 For example, as indicated in a lead acetatecontaining progressive hair dye product manufacturers use direction Ref. 10, after the initial application, users might apply the progressive hair dye daily until the desired color shade is achieved, and once or twice per week to maintain the hair color thereafter.

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regulations. Under 21 CFR 12.22a, each objection must meet the following conditions: 1 Must be submitted on or before the 30th day after the date of publication of the final rule; 2 must be separately numbered; 3 must specify with particularity the provision of the regulation or proposed order objected to; 4 must specifically state the provision of the regulation or proposed order on which a hearing is requested failure to request a hearing on an objection constitutes a waiver of the right to a hearing on that objection; and 5 must include a detailed description and analysis of the factual information to be presented in support of the objection if a hearing is requested failure to include a description and analysis for an objection constitutes a waiver of the right to a hearing on that objection.
Following publication of the final rule repealing the regulation in 73.2396 to no longer provide for the safe use of lead acetate in cosmetics intended for coloring hair on the scalp, we received a submission from Combe, a manufacturer of hair dyes containing lead acetate, providing 19 objections and requesting a hearing on each of the objections. Combe provided the following numbered objections:
Objection 1: Combe objects to FDAs finding that there is no safe level of exposure for lead.
Objection 2: Combe objects to FDAs reliance on information about lead exposure in children e.g., recommendations from the Centers for Disease Control and Prevention CDC.
Objection 3: Combe objects to FDAs reliance on sources that discuss blood level of lead, not exposure levels see, e.g., National Toxicology Program NTP
monograph.
Objection 4: Combe objects to the conclusions FDA draws from the Joint Food and Agriculture Organization/World Health Organization FAO/WHO Expert Committee on Food Additives JECFA 2011.
Objection 5: Combe objects to FDAs reliance on the Environmental Protection Agencys EPAs goals for lead in drinking water.
Objection 6: Combe objects to FDAs conclusion that the 1980 Moore et al. study Ref. 1, the Moore study underestimated the exposure of lead.
Objection 7: Combe objects to FDAs criticisms of Moore.
Objection 8: Combe objects to FDAs finding that the lead in the Moore study could have been absorbed by other parts of the body than the blood.
Objection 9: Combe objects to FDAs reliance on a novel and unvalidated computer model.
Objection 10: Combe objects to FDAs treating an unvalidated computer model as more reliable than robust human data.

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