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]
=======================================================================
-----------------------------------------------------------------------
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