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Federal Register / Vol. 86, No. 193 / Friday, October 8, 2021 / Rules and Regulations
justify a hearing 12.24b3.
Therefore, we are denying the request for a hearing on this objection.
E. Category E: Lead Exposure and Blood Lead Levels Combes numbered objections included in Category E are as follows:

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3. Combe objects to FDAs reliance on sources that discuss blood levels of lead and not exposure levels see, e.g., NTP
monograph.
14. Combe objects to FDAs conclusion that lower median blood levels in lead since 1990
mean that any the lead contributed by lead acetate is less safe now.
15. Combe objects to FDAs entire analysis because it is missing two critical linksFDA
never relates exposure from lead acetate to any change in blood lead levels, and thus it never relates it to any predicted harm.
16. Combe objects to FDAs whole argument as FDA never links exposure to lead from lead acetate to a change in steadystate blood lead levels.
17. Combe objects to FDAs conclusions about the effect of lead acetate on blood lead levels.

Objection 3. Combe objects to FDAs reliance on sources that discuss blood levels of lead and not exposure levels see, e.g., NTP monograph. Combe asserts that the NTP monograph does not support that lead is harmful at low levels in adults. See Submission, pages 3032. Combe argues that the NTP
showed increased risk of potential health effects heart and kidney associated with blood lead levels of 5
10 micrograms per decaliter mg/dL, while noting that the current mean blood lead level in U.S. adults is 0.92
mg/dL. See Submission, at pages 3031.
Combe asserts that there is no evidence that the use of lead acetate-containing hair dye can raise blood lead levels to >5 mg/dL. See Submission, page 31.
Response to Objection 3 With regard to the NTP monograph, the evaluation found sufficient evidence for an association of adverse effects on kidney function with blood lead levels of less than 5 mg/dL in adults Ref. 3, page 87.
A recent literature review by FDA found that the overall body of evidence . . .
suggests that some adverse effects may occur at a blood lead level of 3 mg/dL
. . . in adults Ref. 20. In addition, as discussed in our response to Objection 2, there is a lack of evidence of a safe level of exposure for lead. For example, JECFA has stated that because the dose-response analyses do not provide any indication of a threshold for the key effects of lead, the Committee concluded that it was not possible to establish a new PTWI that would be considered to be health protective Ref.
4, page 212. Furthermore, Combe fails to provide any data that shows the
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impact of the use of lead acetatecontaining hair dye on blood lead levels.
Combe has not provided scientific evidence to support its contention that the intended use of lead acetate is safe.
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 14. Combe objects to FDAs conclusion that lower median blood levels in lead since 1990 mean that any of the lead contributed by lead acetate is less safe now. Combe asserts that because blood lead levels in the U.S. population are lower now, any amount of lead contributed by lead acetate is safer now because of the overall lower levels of lead. See Submission, page 48.
Response to Objection 14 In the October 31, 2018, final rule, we concluded that any increase in exposure to lead resulting from use of lead acetate containing hair dye can no longer be considered insignificant in terms of public health 83 FR 54665 at 54671.
Given that there is no known safe exposure level for lead, we disagree that any amount of lead contributed by lead acetate-containing hair dye is safer now.
The decrease in blood lead levels since 1990 resulted from the actions taken by multiple regulatory and public health agencies to reduce lead exposure in order to minimize potential adverse effects. For example, we have taken measures to reduce exposure to lead from our-regulated products to the lowest level that is technically feasible to protect the public health. Such measures include but are not limited to prohibiting the use of tin-coated lead foil capsules for wine bottles 21 CFR
189.301 and prohibiting the use of leadsoldering in food cans 21 CFR 189.240.
The decrease in blood lead levels in the U.S. population, resulting from these measures, does not mean that the use of lead acetate in hair dye is safe.
To the contrary, as the science has evolved, more sensitive endpoints have been identified at lower blood lead levels than known in the 1970s. A
growing body of evidence indicates that adults may experience adverse health impacts from exposure to lead levels lower than those previously believed to be harmful. For example, in 2012, the NTP provided evidence of adverse effects in adult humans e.g., increased blood pressure, hypertension, decreased glomerular filtration rate at blood lead levels less than 10 mg/dL, based on epidemiological evidence Ref. 3. Also see recent literature review by FDA that
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the overall body of evidence . . .
suggests that some adverse effects may occur at a blood lead level of 3 mg/dL
. . . in adults Ref. 20. We further note that any additional lead exposure would contribute to the occurrence of the reported adverse effects of lead.
Combe has not provided data to demonstrate that the intended use of lead acetate-containing hair dyes would not elevate the lead level in blood and other tissues. 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 15. Combe objects to FDAs entire analysis because it is missing two critical linksFDA never relates exposure from lead acetate to any change in blood levels, and thus it never relates it to any predicted harm. See Submission, page 49. Combe argues that FDA, in its conclusion in the final rule that we no longer can conclude that exposure to lead from lead acetatecontaining hair dye has no discernible effect on the steady-state blood lead level, did not link exposure to lead from lead acetate to any change in steady-state blood lead levels. See Submission, page 49.
Response to Objection 15 To satisfy its burden that would justify its request for a hearing, it is the objectors responsibility to provide data and scientific information that calls into question our conclusions. It is not enough to just make an allegation; the objection needs to contain scientific information to demonstrate the safety of the color additive under the intended conditions of use. We evaluated the data and information submitted in the petition CAP 7C0309 along with comments submitted in response to the petition and other available information including published literature to arrive at our conclusion. Based on currently available data, we conclude that there is no known safe exposure level for lead.
This view is consistent with conclusions by other U.S. agencies responsible for ensuring public health e.g., CDC, EPA and international bodies e.g., JECFA.
Combe has not provided data showing that use of lead acetate-containing hair dyes would not increase the lead level in blood or in other tissues including bones. Because a hearing will not be granted on the basis of mere allegations or general descriptions of positions and contentions 12.24b2, we are denying the request for a hearing on this objection.
Objection 16. Combe objects to FDAs whole argument as FDA never
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