82 FR 16321 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 63 (April 4, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 63 (April 4, 2017)
| Page Range | 16321-16322 | |
| FR Document | 2017-06581 |
[Federal Register Volume 82, Number 63 (Tuesday, April 4, 2017)] [Proposed Rules] [Pages 16321-16322] From the Federal Register Online [www.thefederalregister.org] [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.thefederalregister.org/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
![Federal Register / Vol. 82, No. 63 / Tuesday, April 4, 2017 / Proposed Rules 16321
1003, is acting in compliance with § 1002.13 DEPARTMENT OF HEALTH AND • Federal eRulemaking Portal:
concerning the collection of an applicant’s HUMAN SERVICES https://www.regulations.gov. Follow the
ethnicity, race, and sex information. See also instructions for submitting comments.
comment 5(a)(2)–2.8. Application-by- Food and Drug Administration Comments submitted electronically,
application basis. For applications subject to including attachments, to https://
§ 1002.13(a)(1), a creditor may choose on an 21 CFR Part 73 www.regulations.gov will be posted to
application-by-application basis whether to the docket unchanged. Because your
collect aggregate information pursuant to [Docket No. FDA–2017–C–1951] comment will be made public, you are
§ 1002.13(a)(1)(i)(A) or disaggregated solely responsible for ensuring that your
information pursuant to § 1002.13(a)(1)(i)(B) Environmental Defense Fund,
comment does not include any
about the ethnicity and race of the applicant. Earthjustice, Environmental Working
confidential information that you or a
13(b) Obtaining of information. 1. Forms Group, Center for Environmental
third party may not wish to be posted,
for collecting data. A creditor may collect the Health, Healthy Homes Collaborative,
such as medical information, your or
information specified in § 1002.13(a) either Health Justice Project of Loyola
anyone else’s Social Security number, or
on an application form or on a separate form University Chicago School of Law,
confidential business information, such
referring to the application. Appendix B to Breast Cancer Fund, Improving Kids’
as a manufacturing process. Please note
this part provides for two alternative data Environment, Consumers Union,
that if you include your name, contact
collection model forms for use in complying Natural Resources Defense Council,
information, or other information that
with the requirements of § 1002.13(a)(1)(i) Consumer Federation of America,
identifies you in the body of your
and (ii) to collect information concerning an Learning Disabilities Association, comment, that information will be
applicant’s ethnicity, race, and sex. When a Maricel Maffini, and Howard Mielke; posted on https://www.regulations.gov.
creditor collects ethnicity and race Filing of Color Additive Petition • If you want to submit a comment
information pursuant to § 1002.13(a)(1)(i)(A), with confidential information that you
AGENCY: Food and Drug Administration,
the applicant must be offered the option to do not wish to be made available to the
HHS.
select more than one racial designation. public, submit the comment as a
When a creditor collects ethnicity and race ACTION: Notice of petition.
written/paper submission and in the
information pursuant to § 1002.13(a)(1)(i)(B), manner detailed (see ‘‘Written/Paper
SUMMARY: The Food and Drug
the applicant must be offered the option to Submissions’’ and ‘‘Instructions’’).
select more than one ethnicity designation
Administration (FDA or we) is
and more than one racial designation.
announcing that we have filed a Written/Paper Submissions
petition, submitted by the
* * * * * Environmental Defense Fund, Submit written/paper submissions as
13(c) Disclosure to applicants. 1. Earthjustice, Environmental Working follows:
Procedures for providing disclosures. The • Mail/Hand delivery/Courier (for
Group, Center for Environmental
disclosure to an applicant regarding the written/paper submissions): Division of
Health, Healthy Homes Collaborative,
monitoring information may be provided in Dockets Management (HFA–305), Food
Health Justice Project of Loyola
writing. Appendix B provides data collection and Drug Administration, 5630 Fishers
University Chicago School of Law,
model forms for use in complying with Lane, Rm. 1061, Rockville, MD 20852.
Breast Cancer Fund, Improving Kids’ • For written/paper comments
§ 1002.13 and that comply with § 1002.13(c).
Environment, Consumers Union, submitted to the Division of Dockets
A creditor may devise its own disclosure so
Natural Resources Defense Council, Management, FDA will post your
long as it is substantially similar. The
Consumer Federation of America, comment, as well as any attachments,
creditor need not orally request the
Learning Disabilities Association, except for information submitted,
monitoring information if it is requested in
Maricel Maffini, and Howard Mielke, marked and identified, as confidential,
writing.
proposing that FDA repeal the color if submitted as detailed in
* * * * * additive regulation providing for the use ‘‘Instructions.’’
Dated: March 24, 2017. of lead acetate in cosmetics intended for Instructions: All submissions received
Richard Cordray, coloring hair on the scalp. must include the Docket No. FDA–
Director, Bureau of Consumer Financial DATES: The color additive petition was 2017–C–1951 for ‘‘Environmental
Protection. filed on February 24, 2017. Submit Defense Fund, Earthjustice,
[FR Doc. 2017–06195 Filed 4–3–17; 8:45 am] either electronic or written comments Environmental Working Group, Center
by June 5, 2017. Late, untimely filed for Environmental Health, Healthy
BILLING CODE 4810–AM–P
comments will not be considered. Homes Collaborative, Health Justice
Electronic comments must be submitted Project of Loyola University Chicago
on or before June 5, 2017. The https:// School of Law, Breast Cancer Fund,
www.regulations.gov electronic filing Improving Kids’ Environment,
system will accept comments until Consumers Union, Natural Resources
midnight Eastern Time at the end of Defense Council, Consumer Federation
June 5, 2017. Comments received by of America, Learning Disabilities
mail/hand delivery/courier (for written/ Association, Maricel Maffini, and
paper submissions) will be considered Howard Mielke; Filing of Color Additive
timely if they are postmarked or the Petition.’’ Received comments, those
nlaroche on DSK30NT082PROD with PROPOSALS
delivery service acceptance receipt is on filed in a timely manner (see DATES),
or before that date. will be placed in the docket and, except
ADDRESSES: You may submit comments for those submitted as ‘‘Confidential
as follows: Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Electronic Submissions Division of Dockets Management
Submit electronic comments in the between 9 a.m. and 4 p.m., Monday
following way: through Friday.
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![16322 Federal Register / Vol. 82, No. 63 / Tuesday, April 4, 2017 / Proposed Rules
• Confidential Submissions—To Improving Kids’ Environment, 1506.6(b)), we are placing the
submit a comment with confidential Consumers Union, Natural Resources environmental document submitted
information that you do not wish to be Defense Council, Consumer Federation with the subject petition on public
made publicly available, submit your of America, Learning Disabilities display at the Division of Dockets
comment only as a written/paper Association, Maricel Maffini, and Management (see ADDRESSES) so that
submission. You should submit two Howard Mielke, c/o Thomas Neltner, interested persons may review the
copies total. One copy will include the 1875 Connecticut Ave. NW., Suite 600, document. If we determine that the
information you claim to be confidential Washington, DC 20009. The petition petitioners’ claim of categorical
with a heading or cover note that states proposes that we repeal the color exclusion is warranted and that neither
‘‘THIS DOCUMENT CONTAINS additive regulation for lead acetate in an environmental assessment nor
CONFIDENTIAL INFORMATION.’’ We § 73.2396 (21 CFR 73.2396), which environmental impact statement is
will review this copy, including the permits the use of lead acetate in required, we will announce our
claimed confidential information, in our cosmetics intended for coloring hair on determination in the Federal Register if
consideration of comments. The second the scalp only, subject to certain this petition results in the repeal of
copy, which will have the claimed restrictions. § 73.2396. If we determine that the
confidential information redacted/ II. Repeal of § 73.2396 claim of categorical exclusion is not
blacked out, will be available for public warranted, we will place the
viewing and posted on https:// In accordance with the procedure in environmental assessment on public
www.regulations.gov. Submit both section 721(d) of the FD&C Act for display at the Division of Dockets
copies to the Division of Dockets issuance, amendment, or repeal of Management and provide notice in the
Management. If you do not wish your regulations, the petition asks us to Federal Register announcing its
name and contact information to be repeal § 73.2396 to no longer provide for availability for review and comment.
made publicly available, you can the use of lead acetate in cosmetics
intended for coloring hair on the scalp. Dated: March 29, 2017.
provide this information on the cover Dennis M. Keefe,
sheet and not in the body of your Specifically, the petitioners contend
that new data, available since we issued Director, Office of Food Additive Safety,
comments and you must identify this Center for Food Safety and Applied Nutrition.
information as ‘‘confidential.’’ Any § 73.2396 in 1980 (45 FR 72112, October
information marked as ‘‘confidential’’ 31, 1980), demonstrate that lead acetate: [FR Doc. 2017–06581 Filed 4–3–17; 8:45 am]
will not be disclosed except in (1) Is readily absorbed through human BILLING CODE 4164–01–P
skin; (2) once absorbed, is transported to
accordance with 21 CFR 10.20 and other
various organs, including the brain, and
applicable disclosure law. For more
into extracellular fluid compartments; DEPARTMENT OF STATE
information about FDA’s posting of
(3) has been designated as ‘‘reasonably
comments to public dockets, see 80 FR
anticipated to be a human carcinogen’’ 22 CFR Part 96
56469, September 18, 2015, or access
based on evidence of carcinogenicity in
the information at: https://www.gpo.gov/ [Public Notice: 9940]
experimental animals; (4) has other
fdsys/pkg/FR-2015-09-18/pdf/2015-
adverse health effects including RIN 1400–AD91
23389.pdf.
neurotoxicity; and (5) there is no safe
Docket: For access to the docket to
level of exposure to lead. The Intercountry Adoptions
read background documents or the
petitioners cite, as evidence,
electronic and written/paper comments AGENCY: Department of State.
conclusions by the National Toxicology
received, go to https://
Program, the Centers for Disease Control ACTION:Proposed rule; notice of
www.regulations.gov and insert the and Prevention, the Environmental withdrawal.
docket number, found in brackets in the Protection Agency, and decisions
heading of this document, into the related to lead and lead compounds by SUMMARY: The Department of State
‘‘Search’’ box and follow the prompts other national regulatory agencies, (Department) published a notice of
and/or go to the Division of Dockets including Health Canada. The proposed rulemaking (NPRM) on
Management, 5630 Fishers Lane, Rm. petitioners claim that there is no longer September 8, 2016, proposing to amend
1061, Rockville, MD 20852. a reasonable certainty of no harm from its regulations implementing the 1993
FOR FURTHER INFORMATION CONTACT: the use of lead acetate for coloring hair Hague Convention on Protection of
Molly A. Harry, Center for Food Safety on the scalp. Children and Co-operation in Respect of
and Applied Nutrition, Food and Drug We invite comments and additional Intercountry Adoption and the
Administration, 5001 Campus Dr., scientific data and other information Intercountry Adoption Act of 2000. 81
College Park, MD 20740, 240–402–1075. related to the issues raised by this FR 62322. The Department hereby
SUPPLEMENTARY INFORMATION: petition. If we determine that the withdraws that action. The comments
available data justify repealing § 73.2396 provided in response to the NPRM will
I. Background be considered in drafting a new rule,
to no longer provide for the use of lead
Under section 721(d)(1) of the Federal acetate, we will publish our decision in which is expected to be published later
Food, Drug, and Cosmetic Act (the the Federal Register in accordance with this year.
FD&C Act) (21 U.S.C. 379e(d)(1)), we are 21 CFR 71.20. DATES: September 8, 2016.
giving notice that we have filed a color We also are reviewing the potential FOR FURTHER INFORMATION CONTACT:
nlaroche on DSK30NT082PROD with PROPOSALS
additive petition (CAP 7C0309), environmental impact of the petitioners’ Trish Maskew, (202) 485–6024.
submitted by the Environmental requested action. The petitioners claim
Defense Fund, Earthjustice, a categorical exclusion from preparing Theodore ‘‘Ted’’ R. Coley
Environmental Working Group, Center an environmental assessment or Acting Deputy Assistant Secretary, Overseas
for Environmental Health, Healthy environmental impact statement under Citizen Services, Bureau of Consular Affairs,
Homes Collaborative, Health Justice 21 CFR 23.32(m). In accordance with U.S. Department of State.
Project of Loyola University Chicago regulations issued under the National [FR Doc. 2017–06558 Filed 4–3–17; 8:45 am]
School of Law, Breast Cancer Fund, Environmental Policy Act (40 CFR BILLING CODE P
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Document Created: 2017-04-03 23:53:47
Document Modified: 2017-04-03 23:53:47
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Notice of petition. | |
| 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. | |
| 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. | |
| FR Citation | 82 FR 16321 |
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