Document ID: FDA-2017-C-1951-0001
Agency: fda
Document Type: Proposed Rule
Title: Environmental Defense Fund, Earthjustice, Environmental Working
Group, Center for Environmental Health, Healthy Homes Collaborative,
Health Justice Project of Loyola University Chicago School of Law,
Breast Cancer Fund, Improving Kids’ Environment, Consumers Union,
Natural Resources Defense Council, Consumer Federation of America,
Learning Disabilities Association, Maricel Maffini, Howard Mielke
Posted Date: 2017-04-04T04:00Z

[Federal Register Volume 82, Number 63 (Tuesday, April 4, 2017)]
[Proposed Rules]
[Pages 16321-16322]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-06581]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

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

Environmental Defense Fund, Earthjustice, Environmental Working 
Group, Center for Environmental Health, Healthy Homes Collaborative, 
Health Justice Project of Loyola University Chicago School of Law, 
Breast Cancer Fund, Improving Kids' Environment, Consumers Union, 
Natural Resources Defense Council, Consumer Federation of America, 
Learning Disabilities Association, Maricel Maffini, and Howard Mielke; 
Filing of Color Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petition.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that we have filed a petition, submitted by the Environmental Defense 
Fund, Earthjustice, Environmental Working Group, Center for 
Environmental Health, Healthy Homes Collaborative, Health Justice 
Project of Loyola University Chicago School of Law, Breast Cancer Fund, 
Improving Kids' Environment, Consumers Union, Natural Resources Defense 
Council, Consumer Federation of America, Learning Disabilities 
Association, Maricel Maffini, and Howard Mielke, proposing that FDA 
repeal the color additive regulation providing for the use of lead 
acetate in cosmetics intended for coloring hair on the scalp.

DATES: The color additive petition was filed on February 24, 2017. 
Submit either electronic or written comments by June 5, 2017. Late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before June 5, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of June 5, 2017. Comments received by 
mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comment, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-C-1951 for ``Environmental Defense Fund, Earthjustice, 
Environmental Working Group, Center for Environmental Health, Healthy 
Homes Collaborative, Health Justice Project of Loyola University 
Chicago School of Law, Breast Cancer Fund, Improving Kids' Environment, 
Consumers Union, Natural Resources Defense Council, Consumer Federation 
of America, Learning Disabilities Association, Maricel Maffini, and 
Howard Mielke; Filing of Color Additive Petition.'' Received comments, 
those filed in a timely manner (see DATES), will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

[[Page 16322]]

     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comment only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review 
this copy, including the claimed confidential information, in our 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on https://www.regulations.gov. Submit both 
copies to the Division of Dockets Management. If you do not wish your 
name and contact information to be made publicly available, you can 
provide this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments 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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

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, 240-402-1075.

SUPPLEMENTARY INFORMATION: 

I. Background

    Under section 721(d)(1) of the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) (21 U.S.C. 379e(d)(1)), we are giving notice that we 
have filed a color additive petition (CAP 7C0309), submitted by the 
Environmental Defense Fund, Earthjustice, Environmental Working Group, 
Center for Environmental Health, Healthy Homes Collaborative, Health 
Justice Project of Loyola University Chicago School of Law, Breast 
Cancer Fund, Improving Kids' Environment, Consumers Union, Natural 
Resources Defense Council, Consumer Federation of America, Learning 
Disabilities Association, Maricel Maffini, and Howard Mielke, c/o 
Thomas Neltner, 1875 Connecticut Ave. NW., Suite 600, Washington, DC 
20009. The petition proposes that we repeal the color additive 
regulation for lead acetate in Sec.  73.2396 (21 CFR 73.2396), which 
permits the use of lead acetate in cosmetics intended for coloring hair 
on the scalp only, subject to certain restrictions.

II. Repeal of Sec.  73.2396

    In accordance with the procedure in section 721(d) of the FD&C Act 
for issuance, amendment, or repeal of regulations, the petition asks us 
to repeal Sec.  73.2396 to no longer provide for the use of lead 
acetate in cosmetics intended for coloring hair on the scalp. 
Specifically, the petitioners contend that new data, available since we 
issued Sec.  73.2396 in 1980 (45 FR 72112, October 31, 1980), 
demonstrate that lead acetate: (1) Is readily absorbed through human 
skin; (2) once absorbed, is transported to various organs, including 
the brain, and into extracellular fluid compartments; (3) has been 
designated as ``reasonably anticipated to be a human carcinogen'' based 
on evidence of carcinogenicity in experimental animals; (4) has other 
adverse health effects including neurotoxicity; and (5) there is no 
safe level of exposure to lead. The petitioners cite, as evidence, 
conclusions by the National Toxicology Program, the Centers for Disease 
Control and Prevention, the Environmental Protection Agency, and 
decisions related to lead and lead compounds by other national 
regulatory agencies, including Health Canada. The petitioners claim 
that there is no longer a reasonable certainty of no harm from the use 
of lead acetate for coloring hair on the scalp.
    We invite comments and additional scientific data and other 
information related to the issues raised by this petition. If we 
determine that the available data justify repealing Sec.  73.2396 to no 
longer provide for the use of lead acetate, we will publish our 
decision in the Federal Register in accordance with 21 CFR 71.20.
    We also are reviewing the potential environmental impact of the 
petitioners' requested action. The petitioners claim a categorical 
exclusion from preparing an environmental assessment or environmental 
impact statement under 21 CFR 23.32(m). In accordance with regulations 
issued under the National Environmental Policy Act (40 CFR 1506.6(b)), 
we are placing the environmental document submitted with the subject 
petition on public display at the Division of Dockets Management (see 
ADDRESSES) so that interested persons may review the document. If we 
determine that the petitioners' claim of categorical exclusion is 
warranted and that neither an environmental assessment nor 
environmental impact statement is required, we will announce our 
determination in the Federal Register if this petition results in the 
repeal of Sec.  73.2396. If we determine that the claim of categorical 
exclusion is not warranted, we will place the environmental assessment 
on public display at the Division of Dockets Management and provide 
notice in the Federal Register announcing its availability for review 
and comment.

    Dated: March 29, 2017.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 2017-06581 Filed 4-3-17; 8:45 am]
BILLING CODE 4164-01-P