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Federal Register / Vol. 86, No. 193 / Friday, October 8, 2021 / Rules and Regulations
lead are safe, especially for the population that uses hair dye containing lead acetateolder men with graying hair. See Submission, page 26.
Response to Objection 1 Our determination that a color additive is safe means that there is convincing evidence that establishes with reasonable certainty that no harm will result from the intended use of the color additive 70.3i. The regulation in 73.2396 permits the use of lead acetate calculated as lead at levels not to exceed 0.6 percent 6,000 parts per million ppm; milligrams/kilograms mg/kg as a color additive in cosmetics intended for coloring hair on the scalp. Combe did not provide scientific data to support its objection or to demonstrate that there is a level of exposure to lead that could be considered safe.
Following our full evaluation of data submitted in color additive petition CAP 7C0309 requesting repeal of 73.2396 and other pertinent data and information see September 18, 2018, memorandum from M.K. Wyatt to M.
Harry, the Wyatt Memorandum Ref.
2, we have determined that there is no known level of exposure to lead that does not produce adverse effects. While Combe states that . . . lead does not pose a danger to adults at low levels . . ., Combe failed to provide in this objection the specific levels at which lead does not pose a danger to adults and any corresponding scientific evidence to support this statement. See Submission, page 27.
The objection failed to include new data or information that would refute our findings about the lack of a safe level of lead exposure. The objection merely alleges that low levels of lead are safe, without providing any scientific basis. A hearing will not be granted on the basis of mere allegations or general descriptions of positions and contentions 12.24b2. The objector must, at a minimum, raise a genuine and substantial issue of fact for resolution at a hearing. Therefore, we are denying the request for a hearing on this objection.
Objection 2. Combe objects to FDAs reliance on information about lead exposure in children e.g., recommendations from the CDC. In this objection, Combe does not dispute the fact that lead exposure can harm a developing child, but states that this fact has no bearing on the use of lead acetate in a progressive hair dye for older men. See Submission, page 27.
Combe also asserts that lead poses no danger at low levels to older adults.
See Submission, page 28.

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Response to Objection 2 We acknowledge that Combes products i.e., lead acetate-containing progressive hair dyes are intended for use by adults and not by children. Our decision to repeal the regulation is based on the evidence of lead-related adverse health effects reported at low levels of lead in adults, such as adverse cardiovascular and kidney effects, cognitive dysfunction, and adverse reproductive outcomes Ref. 3, and the lack of evidence of a safe level of exposure for lead. Currently, available data and information do not support the safe use of lead acetate intentionally added to cosmetics for coloring hair on the scalp of any age group or gender. Therefore, the use of lead acetate as a color additive no longer meets the safety standard of reasonable certainty of no harm.
We also note that we did not rely on the toxicity information about lead exposure in children; rather, in the final rule, we referred to the CDC statement that there is no safe blood lead level in children to further demonstrate the risks of lead exposure and why there is a U.S.
Government-wide effort to limit lead exposure to the public. We continue to work to limit consumers exposure to lead in all FDA-regulated products, including cosmetics.
Combe failed to provide scientific data and information demonstrating that there is a safe level of lead exposure from the listed use of lead acetate as a color additive. A hearing will not be granted on the basis of mere allegations or general descriptions of positions and contentions 12.24b2. The objector must, at a minimum, raise a genuine and substantial issue of fact for resolution at a hearing. Therefore, we are denying the request for a hearing on this objection.
Objection 4. Combe objects to the conclusions FDA draws from JECFA
2011. See Submission, page 32. In this objection, Combe cites JECFAs conclusion that it could not establish a new provisional tolerable weekly intake PTWI that would be considered health protective, and that JECFA
instead established a negligible risk level for food. See Submission, at page 32. Combe alleges that FDA did not analyze the underlying scientific discussion in JECFA 2011. See Submission, page 32.
Response to Objection 4 JECFA
stated that because the dose-response analyses do not provide any indication of a threshold for the key effects of lead, the Committee therefore concluded that it was not possible to establish a new PTWI that would be considered to be health protective Ref. 4. Notably,
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JECFAs statement about negligible risk was within the context of unavoidable lead exposure as an impurity in food, instead of intentionally added, avoidable exposures to lead in a cosmetic product.
We are not aware of any statement by a competent, national regulatory authority or an international risk assessment body establishing a safe level of lead exposure that would support a determination that there is a reasonable certainty of no harm from the use of lead acetate as a color additive in hair dye. Instead, for example, the WHO
has stated that there is no level of exposure to lead that is known to be without harmful effects. Ref. 5.
Contrary to Combes assertion, JECFAs statement establishing a negligible risk level for lead as an unavoidable food impurity does not provide a safe harbor for any intentionally added lead in a cosmetic product. See Submission, page 33. Also, JECFAs negligible risk level for food does not support Combes claim that the intended use of lead acetate in hair dye meets the safety standard of reasonable certainty of no harm set forth at 70.3i 21 CFR 70.3i because as JEFCA states, currently available data do not provide any indication of a threshold for the reported adverse effects from exposure to lead Ref. 4.
The objection failed to include any new information or data that would change our findings about the lack of a safe exposure level of lead. The objection merely alleges that FDA did not analyze JECFAs conclusion and does not provide scientific information to support Combes argument. A hearing will not be granted on the basis of mere allegations or general descriptions of positions and contentions 12.24b2. The objector must, at a minimum, raise a genuine and substantial issue of fact for resolution at a hearing. Therefore, we are denying the request for a hearing on this objection.
Objection 5. Combe objects to FDAs reliance on EPAs goals for lead in drinking water. Combe states that the EPA goal in setting the maximum contaminant level for lead in drinking water at zero is based on the effect of lead in children. See Submission, page 33. Combe contends that EPAs goal for lead in drinking water in no way means, however, that lead is unsafe in a progressive hair dye for aging men with graying hair. Ibid.
Response to Objection 5 FDA did not rely on EPAs goal for lead in drinking water; we referred to it to further document the adverse effects resulting from lead exposure. Adverse effects to the public more generally
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