Voglio sapere a riguardo di…

Federal Register / Vol. 86, No. 193 / Friday, October 8, 2021 / Rules and Regulations links exposure to lead from lead acetate to a change in steady-state blood levels. See Submission, page 50.
Response to Objection 16 Combes argument in Objection 16 is essentially the same as its argument in Objection 15. We reiterate that our determination is based on whether the currently available scientific evidence shows that there is a reasonable certainty of no harm from the use of lead acetatecontaining hair dye.
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 17. Combe objects to FDAs conclusions about the effect of lead acetate on blood lead levels. See Submission, page 51. Combe argues that the amount of lead that lead acetate contributes to daily intake e.g., 0.3 mg is less than 1 percent of the amount contributed daily by food, and thus the effect on steady-state blood lead levels would be expected to be extremely smallon the order of 0.01 mg or less.
See Submission, page 52.
Response to Objection 17 We reiterate that, in lead acetate-containing hair dyes, up to 6,000 ppm mg/kg lead acetate calculated as lead is intentionally added as an ingredient to achieve a coloring effect; as such, the lead acetate must meet the safety standard of a reasonable certainty of no harm. There is no lead-containing compound approved for use as a food additive or color additive in food. Thus, dietary exposure to lead results from lead that is present as an impurity in raw materials that manufacturers are unable to avoid through good manufacturing practices.
The objection failed to provide new data that changes our conclusion that the scientific evidence does not support any level of lead intake that is safe.
Therefore, the information discussed in this objection is insufficient to justify a hearing 12.24b3, and we are denying the request for a hearing on this objection.
F. Category F: Permitted Lead Acetate Levels
jspears on DSK121TN23PROD with RULES1

Combes numbered objection in Category F is as follows:
Objection 19. Combe objects to FDAs failure to consider reducing the permitted lead acetate level under 21 CFR 73.2396 from 0.6 percent to 0.153 percent. Combe states, Since 1998, Combes lead acetate hair dyes have contained only 0.153 percent lead, approximately a quarter of the permitted 0.6
percent under 21 CFR Section 73.2396.
Submission, page 56. Combe asserts that the
VerDate Sep<11>2014

16:15 Oct 07, 2021

Jkt 256001

Agency refused to account for this fact in its Final Rule. Ibid.

Response to Objection 19 We addressed this consideration in the final rule in our response to Combes comment see 83 FR 54665 at 54672.
Combe states that it reformulated its lead acetate-containing products in 1998. See Submission Appendix A, page 1. Reformulating the hair dye product by reducing the lead content from 0.6
percent to 0.153 percent may reduce the exposure, but it does not establish a safe level of exposure to lead from lead acetate when used as a color additive in hair dye. We reiterate that we are not aware of data demonstrating that any level of lead is safe. We note also JECFAs concluding statement that it was not possible to establish a new PTWI for lead that would be considered health protective.
Moreover, a color additive regulation is not manufacturer or sponsor-specific and, as such, any manufacturer can use a listed color additive within the limitations of the regulation. Therefore, it is appropriate for FDA to conduct its evaluation associated with the repeal of 73.2396 based on the maximum permitted use level of 0.6 percent 6,000
ppm; mg/kg of lead acetate calculated as lead in hair dyes.
Combe has not provided data that demonstrates with reasonable certainty that no harm would result from the use of 6,000 ppm mg/kg lead acetate calculated as lead as a color additive in cosmetics for coloring hair on the scalp. 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.
V. Summary and Conclusions Section 721 of the FD&C Act requires that a color additive be shown to be safe prior to marketing. Under 70.3i, a color additive is safe if there is convincing evidence that establishes with reasonable certainty that no harm will result from the intended use of the color additive. When new scientific evidence comes to light that calls into question the safety of an approved color additive, we will evaluate the new evidence and determine if the color additive continues to be safe under the condition of use.
In our October 31, 2018, final rule, we stated that, following a full evaluation of the data submitted in support of CAP
7C0309 and other pertinent data and information, we concluded that the data currently available no longer demonstrate that there is a reasonable certainty of no harm from the use of
PO 00000

Frm 00011

Fmt 4700

Sfmt 4700

56193

lead acetate as a color additive in hair dyes authorized under 73.2396. This conclusion was based on the recognition of the current consensus that there is no safe exposure level for lead; our reevaluation of the 1980 skin absorption Moore study that may have resulted in an underestimation of exposure to lead from its use in hair dye; and the fact that blood lead levels in the United States have dropped significantly since 1980, so we no longer could conclude that exposure to lead from lead acetatecontaining hair dyes has no discernible effect on the steady-state blood lead level. Therefore, we issued a final rule repealing 73.2396.
Our responsibility in listing a color additive for safe use in a regulated product is to evaluate the currently available scientific data and other pertinent information to determine with reasonable certainty that the color additive is not harmful under the intended conditions of use. Considering all the scientific information currently available, we have not changed our conclusion that the current data no longer support the safe use of lead acetate as a color additive in cosmetics intended to color hair on the scalp.
The burden is on the objector to provide pertinent evidence that calls into question our conclusion. Despite all its objections, Combe has not provided any new scientific data or information that establish with reasonable certainty that there is a level of lead exposure that could be considered safe and health protective. Combe has also not provided any new data demonstrating that no harm would result from the use of up to 6,000 ppm of lead acetate calculated as lead as a color additive intentionally added to cosmetics for coloring hair on the scalp.
Therefore, we have determined that the objections do not raise any genuine and substantial issue of fact that can be resolved by an evidentiary hearing 12.24b. Accordingly, we are denying the requests for a hearing.
Furthermore, after evaluating the objections, we have concluded that the objections do not provide any basis for us to reconsider our decision to issue the final rule amending 73.2396 to no longer authorize the use of lead acetate as a color additive in cosmetics intended for coloring hair on the scalp.
Under sections 701e2 and 721d of the FD&C Act, the filing of objections operates to stay the effectiveness of our repeal of 73.2396 until we take final action on the objections. Section 701e3 of the FD&C Act further stipulates that, as soon as practicable, the Secretary shall, by order, act upon such objections and make such order
E:FRFM08OCR1.SGM

08OCR1