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, 16321-16322 [2017-06581]

Download as PDF Federal Register / Vol. 82, No. 63 / Tuesday, April 4, 2017 / Proposed Rules 1003, is acting in compliance with § 1002.13 concerning the collection of an applicant’s ethnicity, race, and sex information. See also comment 5(a)(2)–2.8. Application-byapplication basis. For applications subject to § 1002.13(a)(1), a creditor may choose on an application-by-application basis whether to collect aggregate information pursuant to § 1002.13(a)(1)(i)(A) or disaggregated information pursuant to § 1002.13(a)(1)(i)(B) about the ethnicity and race of the applicant. 13(b) Obtaining of information. 1. Forms for collecting data. A creditor may collect the information specified in § 1002.13(a) either on an application form or on a separate form referring to the application. Appendix B to this part provides for two alternative data collection model forms for use in complying with the requirements of § 1002.13(a)(1)(i) and (ii) to collect information concerning an applicant’s ethnicity, race, and sex. When a creditor collects ethnicity and race information pursuant to § 1002.13(a)(1)(i)(A), the applicant must be offered the option to select more than one racial designation. When a creditor collects ethnicity and race information pursuant to § 1002.13(a)(1)(i)(B), the applicant must be offered the option to select more than one ethnicity designation and more than one racial designation. * * * * * 13(c) Disclosure to applicants. 1. Procedures for providing disclosures. The disclosure to an applicant regarding the monitoring information may be provided in writing. Appendix B provides data collection model forms for use in complying with § 1002.13 and that comply with § 1002.13(c). A creditor may devise its own disclosure so long as it is substantially similar. The creditor need not orally request the monitoring information if it is requested in writing. * * * * * Dated: March 24, 2017. Richard Cordray, Director, Bureau of Consumer Financial Protection. [FR Doc. 2017–06195 Filed 4–3–17; 8:45 am] nlaroche on DSK30NT082PROD with PROPOSALS BILLING CODE 4810–AM–P 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. 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: SUMMARY: Electronic Submissions Submit electronic comments in the following way: VerDate Sep<11>2014 15:42 Apr 03, 2017 Jkt 241001 PO 00000 Frm 00015 Fmt 4702 Sfmt 4702 16321 • 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. E:\FR\FM\04APP1.SGM 04APP1 16322 Federal Register / Vol. 82, No. 63 / Tuesday, April 4, 2017 / Proposed Rules • 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/201523389.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: nlaroche on DSK30NT082PROD with PROPOSALS 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, VerDate Sep<11>2014 15:42 Apr 03, 2017 Jkt 241001 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 § 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 § 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 § 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 § 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 § 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 PO 00000 Frm 00016 Fmt 4702 Sfmt 4702 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 § 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 DEPARTMENT OF STATE 22 CFR Part 96 [Public Notice: 9940] RIN 1400–AD91 Intercountry Adoptions Department of State. Proposed rule; notice of withdrawal. AGENCY: ACTION: The Department of State (Department) published a notice of proposed rulemaking (NPRM) on September 8, 2016, proposing to amend its regulations implementing the 1993 Hague Convention on Protection of Children and Co-operation in Respect of Intercountry Adoption and the Intercountry Adoption Act of 2000. 81 FR 62322. The Department hereby withdraws that action. The comments provided in response to the NPRM will be considered in drafting a new rule, which is expected to be published later this year. DATES: September 8, 2016. FOR FURTHER INFORMATION CONTACT: Trish Maskew, (202) 485–6024. SUMMARY: Theodore ‘‘Ted’’ R. Coley Acting Deputy Assistant Secretary, Overseas Citizen Services, Bureau of Consular Affairs, U.S. Department of State. [FR Doc. 2017–06558 Filed 4–3–17; 8:45 am] BILLING CODE P E:\FR\FM\04APP1.SGM 04APP1

Agencies

[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.

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

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
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