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Federal Register / Vol. 86, No. 193 / Friday, October 8, 2021 / Rules and Regulations resulting from lead exposure are the reason why there is a government-wide effort to limit lead exposure to the public. Our decision to repeal the regulation was based on the recognition that there is no scientific data demonstrating a safe level of exposure to lead and that the data currently available no longer demonstrate that there is reasonable certainty of no harm from the use of lead acetate as a color additive in hair dyes authorized under 73.2396. Combe fails to show that there is a genuine and substantial issue of fact for resolution at a hearing. A
hearing will not be granted on the basis of mere allegations or general descriptions of positions and contentions 12.24b2. Therefore, we are denying the request for a hearing on this objection.
Objection 18. Combe objects to FDA
taking a zero-tolerance approach to lead. Combe argues that FDA appears to draw a legal distinction between lead that is intentionally added and lead that is present as impurities. Although such a distinction can be legally drawn for food, FDA cannot do this for cosmetics. See Submission, page 54.
Combe claims that the safety standard for cosmetics is the same, whether the lead is intentionally added or present as an impurity. Combe asserts that under section 406 of the FD&C Act 21 U.S.C.
346, FDA can only set tolerances for poisonous and deleterious substances for food, and not cosmetics. Combe further asserts that FDA is acting arbitrarily and capriciously by banning lead acetate in hair dyes, but not banning it in lipstick. See Submission, pages 5556.
Response to Objection 18 We disagree that the presence of lead as an impurity in some cosmetic products means that FDA must find that there is a reasonable certainty of no harm from the use of lead acetate in hair dyes at levels up to 6,000 ppm mg/kg. The intended use of lead acetate is as a color additive and as such we are acting under sections 721d and 601e 21
U.S.C. 361e of the FD&C Act. See 28
FR 13374 December 10, 1963
providing FDAs interpretation of sections 601a and e of the FD&C Act.
We have concluded that intended use of lead acetate does not meet the safety standard of reasonable certainty of no harm set forth at 70.3i for color additives. Combe has not demonstrated that the intended use of lead acetate meets this safety standard. Therefore, we are repealing the listing of lead acetate under section 721d of the FD&C Act, and its use adulterates a cosmetic under section 601e of the FD&C Act.

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Our repeal of the listing of lead acetate as a color additive in hair dye and our recommendation to limit lead as an unavoidable impurity in lipstick and other cosmetics are not arbitrary and capricious actions, as Combe asserts. In our Draft Guidance for Industry: Lead in Cosmetic Lip Products and Externally Applied Cosmetics:
Recommended Maximum Level 2016, we recommend lead not be present as an impurity not an intentionally added ingredient in cosmetics at levels exceeding 10 ppm 10 mg/kg Ref. 6.2
Lead as an impurity may occur in any cosmetics due to its background presence in the environment. Lead as an impurity cannot be completely avoided, although we have concluded that limiting trace amounts of lead to less than 10 ppm 10 mg/kg can be achieved through reasonable and practical approaches to control raw materials and through other good manufacturing practices Ref. 7. The draft guidance does not apply to hair dyes that contain lead acetate as an ingredient Ref. 6 at page 3.
By contrast, lead acetate as a color additive is an intentionally added ingredient in hair dye and must meet the safety standard for color additives.
We believe that the available data demonstrate that exposure to lead acetate from the intended use may cause adverse effects Refs. 3 and 4.
Therefore, the use of lead acetate in hair dye products that would result in lead levels up to 6,000 ppm 6,000 mg/kg in the final products does not meet the safety standard for color additives.
Because there is no factual issue Combe identifies in this objection that can be resolved by available and specifically identified reliable evidence, we are denying the request for a hearing on this objection 12.24b1.
B. Category B: The Moore Study Combes numbered objections included in Category B are as follows:
6. Combe objects to FDAs conclusions that the Moore study underestimated the exposure to lead.
7. Combe objects to FDAs criticisms of Moore.
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.
11. Combe objects to FDAs argument that the absorption percentage from the Moore 2 The draft guidance, only when finalized, will represent the current thinking of the FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

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study is invalid because it tested only a small patch of skin.

Objection 6. Combe objects to FDAs conclusions that the Moore study underestimated the exposure of lead.
Combe asserts that the Moore study remains the best evidence of the absorption of lead from lead acetate, that the Moore study protocol was developed with guidance from FDA, and that FDA acknowledged as much because it used some of the figures derived from the Moore study in its own modeling. See Submission, pages 3334.
Response to Objection 6 FDA
acknowledges that the Moore study has some scientific merit. As discussed in our responses to Objections 9, 12, and 13, the fractional absorption the percentage of the total amount of lead applied that is absorbed through the skin from this study was used to calculate EPAs permeability coefficient Kp value the rate at which a chemical penetrates the skin, which we used in our assessment.3 Additionally, the results generated by Moore et al. would be reliable for a situation where the experimental conditions reflected the intended use conditions. However as explained below, the intended conditions of use of the lead acetatecontaining progressive hair dyes are different from the experimental conditions in the Moore study.
New scientific information and computational tools have become available since the Moore study protocol was developed in the 1970s to 1980. We considered newer scientific information, including peer-reviewed publications describing nonclinical and clinical studies that demonstrate that dermally applied lead acetate and other lead compounds penetrate human and animal skin Ref. 2. Additionally, newer computational tools have shown that the surface area of the application site is an important factor for estimating dermal absorption of lead and other compounds. This includes the in silico i.e., via computer simulation, as opposed to in vitro or in vivo experimental studies ConsExpo dermal absorption model that we used to predict the percentage of dermal lead absorption. Using a surface area that is representative of the actual application area is also consistent with our recent guidance for industry,4 which provides recommendations for conducting in vivo absorption trials for topically applied active ingredients Ref. 8. The 3 Objection 12 provides an additional explanation of fractional absorption and Kp.
4 The Wyatt Memorandum Ref. 2 refers to the draft guidance Ref. 6, which has since been finalized.

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