Document ID: FDA-2021-N-0352-0001
Agency: fda
Document Type: Notice
Title: Intent To Prepare an Environmental Impact Statement for Certain Sunscreen Drug Products for Over-the-Counter Use
Posted Date: 2021-05-13T04:00Z

[Federal Register Volume 86, Number 91 (Thursday, May 13, 2021)]
[Notices]
[Pages 26224-26225]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-10091]

[[Page 26224]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0352]

Intent To Prepare an Environmental Impact Statement for Certain 
Sunscreen Drug Products for Over-the-Counter Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of intent.

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SUMMARY: Under the National Environmental Policy Act of 1969 (NEPA), as 
implemented by the Council on Environmental Quality (CEQ) regulations, 
the Food and Drug Administration (FDA or Agency) announces its intent 
to prepare an environmental impact statement (EIS) to evaluate the 
potential environmental effects of revised conditions for marketing 
certain sunscreen products for over-the-counter (OTC) use without prior 
approval of a new drug application (NDA). By this notice, FDA is 
announcing the beginning of the scoping process to solicit public 
comments and identify issues to be analyzed in this EIS.

DATES: This notice initiates the public scoping process that will close 
on June 14, 2021. FDA will consider comments in response to this notice 
to determine the need for any public scoping meetings prior to the 
preparation of a draft EIS. In order to be considered during the 
preparation of the draft EIS, all comments must be received prior to 
the close of the public scoping period. FDA anticipates that if any 
public scoping meetings are necessary, due to the impact of this COVID-
19 pandemic, such meetings will be held virtually via a live webcast. 
See FDA's website for periodic updates, available at https://www.fda.gov/drugs/guidance-compliance-regulatory-information and search 
for Environmental Impact Statement. FDA will provide additional 
opportunities for public participation upon publication of the draft 
EIS.

ADDRESSES: You may submit comments, identified by the above docket 
number by any of the following methods:

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 comments, 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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2021-N-0352 for ``Intent to Prepare an Environmental Impact 
Statement for Certain Sunscreen Drug Products for Over-The-Counter 
Use.'' Received comments will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
https://www.regulations.gov or at the Dockets Management Staff between 
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments 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.'' The Agency will 
review this copy, including the claimed confidential information, in 
its 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 Dockets Management Staff. 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.govinfo.gov/content/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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Trang Q. Tran, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 4139, Silver Spring, MD 20993; 240-402-
7945.

SUPPLEMENTARY INFORMATION: Sunscreens are topically applied OTC drug 
products indicated to help prevent sunburn and/or to decrease the risk 
of skin cancer and early skin aging caused by the sun. FDA regulates 
sunscreen products to ensure they meet safety and effectiveness 
standards.\1\ Under the Coronavirus Aid, Relief, and Economic Security 
(CARES) Act, signed into law on March 27, 2020, FDA is required to 
issue a proposed order addressing sunscreens by September 27, 2021. 
While the CARES Act does not establish a deadline for the final 
sunscreen order, it specifies that this order may not go into effect 
earlier than 1 year after its issuance. FDA expects that the final 
sunscreen order will establish revised conditions for marketing a 
sunscreen product without the prior approval of an NDA, and that among 
the conditions addressed will be the permissibility of including 
certain active ingredients in sunscreen products marketed without an 
NDA.
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    \1\ Learn more about the history of FDA's regulation of 
sunscreen products at https://www.fda.gov/drugs/status-otc-rulemakings/rulemaking-history-otc-sunscreen-drug-products.
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    Before engaging in a major Federal action, NEPA requires Federal 
agencies to consider the potential environmental

[[Page 26225]]

consequences of proposed actions, and any reasonable alternatives. 
Under FDA regulations, FDA will prepare an EIS when data or information 
in an environmental assessment or otherwise available to the Agency 
leads to a finding that the proposed agency action may significantly 
affect the quality of the human environment.\2\ Because of questions 
raised about the extent to which two sunscreen active ingredients 
(oxybenzone and octinoxate) may affect coral and/or coral reefs, FDA is 
initiating the public scoping process to consider any potential 
environmental impacts associated with the use of oxybenzone and 
octinoxate in sunscreens so that an EIS, if necessary, can be completed 
prior to issuance of a final sunscreen order addressing sunscreens 
containing these ingredients.
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    \2\ See 21 CFR 25.22(b); 40 CFR 1508.27.
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    We note the Agency's docket to the 2019 proposed rule ``Sunscreen 
Drug Products for Over-the-Counter Human Use'' (84 FR 6204 February 26, 
2019) received comments that raised concerns about the potential 
impacts from sunscreens containing oxybenzone or octinoxate on coral 
and/or coral reefs. FDA is also aware that the National Oceanic and 
Atmospheric Administration (NOAA) Coral Reef Conservation Program is 
currently evaluating research related to coral reef health, including 
the potential impacts of sunscreen products that include oxybenzone and 
octinoxate on coral reefs and other aquatic systems.\3\ The Agency is 
also aware that at least one state has restricted the sale of 
sunscreens that include the active ingredients oxybenzone or 
octinoxate. On July 3, 2018, the state of Hawaii signed into law S. 
2571, Act 104, prohibiting the sale, offer of sale, and distribution of 
sunscreens that contain oxybenzone and/or octinoxate, to protect 
Hawaii's marine ecosystems, including coral reefs. This law became 
effective January 1, 2021. All of these actions raise questions about 
the potential environmental impacts of sunscreens containing oxybenzone 
and/or octinoxate on coral and/or coral reefs that warrant further 
evaluations.
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    \3\ See NOAA's Coral Reef Information article ``The effects of 
ultraviolet filters and sunscreen on corals and aquatic 
ecosystems,'' available at the NOAA web page https://www.coris.noaa.gov/activities/effects-ultraviolet-filters-sunscreen-corals/welcome.html.
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    The purpose of the public scoping process is to determine relevant 
issues that will influence the scope of the environmental analysis, 
including potential alternatives and the extent to which those issues 
and impacts will be analyzed. At this initial stage of the scoping 
process, we have identified the following four alternatives: (1) FDA 
will conclude that the inclusion of oxybenzone and octinoxate in 
sunscreens marketed without an NDA is impermissible; (2) FDA will 
conclude that the inclusion of oxybenzone and octinoxate in sunscreens 
marketed without an NDA is permissible; (3) FDA will conclude that 
inclusion of oxybenzone in sunscreens marketed without an NDA is 
permissible but that the inclusion of octinoxate in sunscreens marketed 
without an NDA is impermissible; or (4) FDA will conclude that 
inclusion of octinoxate in sunscreens marketed without an NDA is 
permissible but that the inclusion of oxybenzone in sunscreens marketed 
without an NDA is impermissible.
    The EIS will be prepared in accordance with section 102(2)(C) of 
NEPA, 42 U.S.C. 4332(2)(C), FDA's NEPA implementing regulations (21 CFR 
part 25), and the CEQ regulations for implementing NEPA (40 CFR parts 
1500-1508).\4\ Federal, State, and local agencies, along with Tribes 
and other stakeholders that may be interested in or affected by the 
sunscreen proposed order are invited to participate in the scoping 
process. Some Federal agencies may request or be requested by the FDA 
to participate in the development of the environmental analysis as a 
cooperating agency. FDA encourages other stakeholders to comment on 
this scoping process, on what specific issues, alternatives, mitigation 
measures, or other information FDA should include for further analysis 
in the EIS.
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    \4\ FDA began activities relating to the environmental 
assessment of the use of oxybenzone and octinoxate in sunscreens 
marketed without an NDA before September 14, 2020. Consistent with 
40 CFR 1506.13, FDA will apply the regulations in place prior to 
implementation of the new CEQ regulations. See the Council on 
Environmental Quality's final rule, ``Update to the Regulations 
Implementing the Procedural Provisions of the National Environmental 
Policy Act'' (40 CFR 1506.13, 85 FR 43304 at 43372 (July 16, 2020)).

    Dated: May 7, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10091 Filed 5-12-21; 8:45 am]
BILLING CODE 4164-01-P