[Federal Register Volume 84, Number 62 (Monday, April 1, 2019)]
[Rules and Regulations]
[Pages 12081-12083]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06238]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2017-C-1951]


Reinstatement of Color Additive Listing for Lead Acetate

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is reinstating 
the provision removed by our October 2018 final rule to amend the color 
additive regulations to no longer provide for the use of lead acetate 
in cosmetics intended for coloring hair on the scalp. This action does 
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. We are reinstating this provision only because 
it was removed from the Code of Federal Regulations before we had the 
opportunity to take final action on the objections we received to the 
October 2018 final rule. This provision is being reinstated pending 
final FDA action on objections to the final rule.

DATES: Effective April 1, 2019.

FOR FURTHER INFORMATION CONTACT: Molly A. Harry, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740-3835, 240-402-1075.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 31, 2018 (83 FR 54665), FDA 
issued a final rule repealing the color additive regulation at Sec.  
73.2396 (21 Code of Federal Regulations (CFR) 73.2396) to no longer 
provide for the use of lead acetate in cosmetics intended for coloring 
hair on the scalp because new data available since lead acetate was 
permanently listed demonstrate that there is no longer a reasonable 
certainty of no harm 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 the effective date of the final rule would be on December 
3, 2018, except as to any provisions that may be stayed by the proper 
filing of objections (83 FR 54665 at 54673). We received objections and 
a request for a hearing on the objections from a manufacturer of hair 
dyes containing lead acetate. Under sections 701(e)(2) and 721(d) of 
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 
371(e)(2) and 379e(d)), the filing of the objections operates to stay 
the effective date of the final rule until FDA takes final action on 
the objections. For access to the docket to read the objections 
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.
    Our October 2018 final rule provided an effective date of December 
3, 2018, and, on that date, Sec.  73.2396 was removed from the CFR. 
However, under the FD&C Act, the filing of the objections operates to 
stay the effectiveness of our revocation until we take final action on 
the objections. To implement a stay of effectiveness as required by 
sections 701(e)(2) and 721(d) of the FD&C Act, we need to restore Sec.  
73.2396 to the CFR. Thus, we are issuing this final rule to reinstate 
Sec.  73.2396 so that we may follow the appropriate process to address 
the objections that were filed. That provision will remain in place 
pending final FDA action on the objections to the October 2018 final 
rule. This action does not reflect any change in our determination that 
new data demonstrate that there is no longer a

[[Page 12082]]

reasonable certainty of no harm from the use of this color additive.
    FDA finds good cause for issuing this final rule without notice and 
comment under the Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)) 
and FDA regulations (Sec.  10.40(e)(1) (21 CFR 10.40(e)(1))). Notice 
and comment are unnecessary because this final rule is to correct the 
removal of a CFR provision where FDA's October 2018 final rule removing 
this provision was stayed under the FD&C Act pending final FDA action 
on objections to that rule. Therefore, we have determined that notice 
and comment is unnecessary. In addition, we find good cause for this 
final rule to become effective on the date of publication under 5 
U.S.C. 553(d)(3) and Sec.  10.40(c)(4)(ii).

II. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(i) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

III. Paperwork Reduction Act of 1995

    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

IV. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, Executive Order 13771, the 
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded 
Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 
13563 direct us to assess all costs and benefits of available 
regulatory alternatives and, when regulation is necessary, to select 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). Executive Order 13771 
requires that the costs associated with significant new regulations 
``shall, to the extent permitted by law, be offset by the elimination 
of existing costs associated with at least two prior regulations.'' We 
believe that this final rule is not a significant regulatory action as 
defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant economic impact 
of a rule on small entities. Because the final rule does not impose 
compliance costs on small entities, we certify that the final rule will 
not have a significant economic impact on a substantial number of small 
entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before issuing ``any rule that includes 
any Federal mandate that may result in the expenditure by State, local, 
and tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any one 
year.'' The current threshold after adjustment for inflation is $154 
million, using the most current (2018) Implicit Price Deflator for the 
Gross Domestic Product. This final rule would not result in an 
expenditure in any year that meets or exceeds this amount.

V. Federalism

    We have analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. We have determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, we have concluded that the 
rule does not contain policies that have federalism implications as 
defined in the Executive Order and, consequently, a federalism summary 
impact statement is not required.

VI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set 
forth in Executive Order 13175. We have determined that the rule does 
not contain policies that have substantial direct effects on one or 
more Indian Tribes, on the relationship between the Federal Government 
and Indian Tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian Tribes. Accordingly, we 
conclude that the rule does not contain policies that have tribal 
implications as defined in the Executive Order and, consequently, a 
tribal summary impact statement is not required.

List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
73 is amended as follows:

PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

0
1. The authority citation for part 73 continues to read as follows:

    Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 
361, 362, 371, 379e.


0
2. Add Sec.  73.2396 to subpart C to read as follows:


Sec.  73.2396  Lead acetate.

    (a) Identity. The color additive lead acetate is the trihydrate of 
lead (2+) salt of acetic acid. The color additive has the chemical 
formula Pb(OOCCH3)2[middot]3H2O.
    (b) Specifications. Lead acetate shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such impurities may be avoided by good manufacturing 
practice:
    (1) Water-insoluble matter, not more than 0.02 percent.
    (2) pH (30 percent solution weight to volume at 25 [deg]C), not 
less than 4.7 and not more than 5.8.
    (3) Arsenic (as As), not more than 3 parts per million.
    (4) Lead acetate, not less than 99 percent.
    (5) Mercury (as Hg), not more than 1 part per million.
    (c) Uses and restrictions. The color additive lead acetate may be 
safely used in cosmetics intended for coloring hair on the scalp only, 
subject to the following restrictions:
    (1) The amount of the lead acetate in the cosmetic shall be such 
that the lead content, calculated as Pb, shall not be in excess of 0.6 
percent (weight to volume).
    (2) The cosmetic is not to be used for coloring mustaches, 
eyelashes, eyebrows, or hair on parts of the body other than the scalp.
    (d) Labeling requirements. (1) The label of the color additive lead 
acetate shall conform to the requirements of Sec.  70.25 of this 
chapter, and bear the following statement or equivalent:
    Wash thoroughly if the product comes into contact with the skin.
    (2) The label of the cosmetic containing the color additive lead 
acetate, in addition to other information required by the Federal Food, 
Drug, and Cosmetic Act, shall bear the following cautionary statement, 
conspicuously displayed thereon:

[[Page 12083]]



------------------------------------------------------------------------
 
-------------------------------------------------------------------------
 CAUTION: Contains lead acetate. For external use only. Keep this
 product out of children's reach. Do not use on cut or abraded scalp. If
 skin irritation develops, discontinue use. Do not use to color
 mustaches, eyelashes, eyebrows, or hair on parts of the body other than
 the scalp. Do not get in eyes. Follow instructions carefully and wash
 hands thoroughly after each use.
------------------------------------------------------------------------

    (e) Exemption for certification. Certification of this color 
additive for the prescribed use is not necessary for the protection of 
the public health and therefore batches thereof are exempt from the 
certification requirements of section 721(c) of the Federal Food, Drug, 
and Cosmetic Act.

    Dated: March 27, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06238 Filed 3-29-19; 8:45 am]
 BILLING CODE 4164-01-P