Reinstatement of Color Additive Listing for Lead Acetate, 12081-12083 [2019-06238]

Download as PDF Federal Register / Vol. 84, No. 62 / Monday, April 1, 2019 / Rules and Regulations substituted compliance framework helps reduce duplicative and overlapping regulatory requirements where effective comparable regulation exists, facilitates the ability of U.S. market participants to compete in foreign jurisdictions, and is consistent with the principle of international comity. The CFTC’s cross-border margin rule establishes an outcomes-based approach that considers a number of factors and does not require strict conformity with the CFTC Margin Rules. As I have said before, a comparability determination should not be based solely on the home country’s written laws and regulations, but also consider the country’s broader system of regulation, including oversight and enforcement. In addition, the nature of the other country’s relevant markets may be taken into account. Finally, in considering these issues, the Commission should keep in mind the principle of comity: the reciprocal recognition of the legislative, executive, and judicial acts of another jurisdiction.4 Given all of these factors, the analysis for each determination often is unique and can change over time as circumstances change. The Amended Japan Determination finds comparability regarding the scope of entities subject to the margin requirements and the treatment of margining for inter-affiliate transactions. The Commission’s original determination for Japan’s margin rules, issued on September 15, 2016, did not find comparability in these areas. Subsequently, it appeared that the absence of a finding of comparability regarding the scope of entities and inter-affiliate swaps issues was causing some confusion in applying the original determination. The CFTC staff therefore further reviewed applicable Japanese laws and regulations and engaged heavily with the Japan Financial Services Agency (‘‘JFSA’’) to develop a more complete understanding of how the JFSA regulates and supervises margining for the scope of entities that enter into swaps and inter-affiliate swap transactions. The in-depth analysis outlined in today’s Amended Japan Determination reflects a more holistic understanding by the Commission of the JFSA’s approach to managing the risks of swap trading for the scope of relevant entities and inter-affiliate swaps. The analysis also notes the potential for risks from these swap activities returning to the United States is expected to be significantly mitigated. For example, although the JFSA does not require variation margin for the same scope of entities covered by the CFTC Margin Rules, the JFSA indicated that the entities excluded tend to be smaller and have less regular involvement in the swap markets, thereby presenting less risk to the financial system. Furthermore, as noted in the determination, if a Japanese entity that would otherwise be subject to the CFTC Margin Rules, but for substituted compliance, enters into swaps with any U.S. entity covered by the CFTC Margin Rules, then both entities are required to exchange margin per our rules. 4 See Restatement (Third) of The Foreign Relations Law in the United States, section 101 (1987) (Am. Law Inst. 2019); https:// www.law.cornell.edu/wex/comity. VerDate Sep<11>2014 15:56 Mar 29, 2019 Jkt 247001 This requirement limits the possibility of unmargined risk coming to the U.S. Similarly, for inter-affiliate swap treatment, a more complete understanding of the JFSA’s approach to requiring Japanese affiliates to hold more capital when margin is not exchanged with other affiliates, among other things, helps offset exposures not covered when margin is not collected. As with other jurisdictions where the legal and regulatory structure does not mirror our own, and the substituted compliance determinations are based on the overall outcome of the regulatory system, subsequent monitoring may be appropriate to confirm that our initial understanding of the regulatory structure and the expected outcomes is accurate. Accordingly, I encourage the CFTC staff to periodically assess the implementation of this determination to confirm our expectations are accurate. I thank the CFTC staff for their thorough work on this determination and appreciate their responsiveness to our comments and suggestions. I would also like to thank my fellow Commissioners for their collaboration in helping us reach this positive outcome. [FR Doc. 2019–06152 Filed 3–29–19; 8:45 am] BILLING CODE 6351–01–P 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. 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 SUMMARY: PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 12081 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 § 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, § 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 § 73.2396 to the CFR. Thus, we are issuing this final rule to reinstate § 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 E:\FR\FM\01APR1.SGM 01APR1 12082 Federal Register / Vol. 84, No. 62 / Monday, April 1, 2019 / Rules and Regulations 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 (§ 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 § 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 VerDate Sep<11>2014 15:56 Mar 29, 2019 Jkt 247001 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 PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 of Food and Drugs, 21 CFR part 73 is amended as follows: PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION 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. 2. Add § 73.2396 to subpart C to read as follows: ■ § 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)2·3H2O. (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 °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 § 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: E:\FR\FM\01APR1.SGM 01APR1 Federal Register / Vol. 84, No. 62 / Monday, April 1, 2019 / Rules and Regulations 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. DEPARTMENT OF HEALTH AND HUMAN SERVICES provides only technical changes to correct inaccurate cross-references. In the Federal Register of September 24, 2013 (78 FR 58821), FDA added the definition of ‘‘Human cells, tissues, or cellular or tissue-based product (HCT/P) regulated as a device’’ at § 806.2(f). The addition of this definition caused the paragraphs following paragraph (f) in § 806.2 to be redesignated alphabetically. Although the definitions of the terms were correct in § 806.2, the paragraphs in § 806.1(b) crossreferenced three of the definitions (market withdrawal, routine servicing, and stock recovery) from § 806.2 based on the previous designations. Food and Drug Administration List of Subjects in 21 CFR Part 806 21 CFR Part 806 Imports; Medical devices; Reporting and recordkeeping requirements. [Docket No. FDA–2019–N–1345] Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 806 is amended as follows: (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 Medical Devices; Technical Amendment AGENCY: Food and Drug Administration; HHS. PART 806—MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Final rule; technical amendment. ACTION: The Food and Drug Administration (FDA or Agency) is amending the medical device reports of corrections and removals regulation to correct three inaccurate crossreferences. This action is editorial in nature and is intended to improve the accuracy of the Agency’s regulations. DATES: This rule is effective April 1, 2019. SUMMARY: Madhusoodana Nambiar, Office of the Center Director, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5518, Silver Spring, MD 20993–0002, 301–796–5837. SUPPLEMENTARY INFORMATION: FDA is amending 21 CFR 806.1 to correct three inaccurate cross-references to ensure accuracy and clarity in the Agency’s medical device regulations regarding medical device reports of corrections and removals. Publication of this document constitutes final action under the Administrative Procedure Act (5 U.S.C. 553). FDA has determined that notice and public comment are unnecessary because this amendment to the regulation is nonsubstantive and 15:56 Mar 29, 2019 Jkt 247001 Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374. 2. In § 806.1, revise paragraphs (b)(2) through (4) to read as follows: ■ § 806.1 Scope. * FOR FURTHER INFORMATION CONTACT: VerDate Sep<11>2014 1. The authority citation for part 806 continues to read as follows: ■ * * * * (b) * * * (2) Market withdrawal as defined in § 806.2(i) (3) Routine servicing as defined in § 806.2(l). (4) Stock recovery as defined in § 806.2(m). Dated: March 26, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019–06139 Filed 3–29–19; 8:45 am] BILLING CODE 4164–01–P PO 00000 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA–2011–N–0103] RIN 0910–AH98 Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to classify in vitro diagnostic devices for Bacillus species (spp.) detection into class II (special controls) and to continue to require a premarket notification (510(k)) to provide a reasonable assurance of safety and effectiveness of the device. FDA is also establishing special controls in a special controls guideline in addition to restricting use and distribution of the devices. An in vitro diagnostic device for Bacillus spp. detection is a prescription device used to detect and differentiate among Bacillus spp. and presumptively identify B. anthracis and other Bacillus spp. from cultured isolates or clinical specimens as an aid in the diagnosis of anthrax and other diseases caused by Bacillus spp. DATES: This rule is effective May 1, 2019. See further discussion in section V ‘‘Implementation Strategy’’. ADDRESSES: For access to the docket to read background documents or comments received, go to https:// www.regulations.gov and insert the docket number found in brackets in the heading of this final rule into the ‘‘Search’’ box and follow the prompts, and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Beena Puri, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4502, Silver Spring, MD 20993–0002, 301–796–6202. Beena.Puri@fda.hhs.gov. SUPPLEMENTARY INFORMATION: SUMMARY: Table of Contents I. Executive Summary Frm 00037 Fmt 4700 Sfmt 4700 E:\FR\FM\01APR1.SGM 01APR1

Agencies

[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

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.