Document ID: EPA-HQ-OPPT-2019-0238-0066
Agency: epa
Document Type: Notice
Title: 1,4-Dioxane; Supplemental Analysis to the Draft Toxic Substances Control Act (TSCA) Risk Evaluation; Notice of Availability and Public Comment
Posted Date: 2020-11-20T05:00Z

[Federal Register Volume 85, Number 225 (Friday, November 20, 2020)]
[Notices]
[Pages 74341-74342]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25618]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2019-0238; FRL-10016-77]

1,4-Dioxane; Supplemental Analysis to the Draft Toxic Substances 
Control Act (TSCA) Risk Evaluation; Notice of Availability and Public 
Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing the 
availability of and soliciting public comment on a supplemental 
analysis to the draft risk evaluation of 1,4-dioxane under the Toxic 
Substances Control Act (TSCA). EPA conducts risk evaluations to 
determine whether a chemical substance presents an unreasonable risk of 
injury to health or the environment without consideration of costs or 
other nonrisk factors, including an unreasonable risk to potentially 
exposed or susceptible subpopulations, under the conditions of use. 
This supplemental analysis has been developed in response to public and 
peer review comments on the draft risk evaluation, and includes 
additional conditions of use for 1,4-dioxane as a by-product in 
consumer products, as well as an analysis of recreational activities in 
ambient/surface water as an exposure pathway under all conditions of 
use included in the draft risk evaluation and this supplemental 
analysis. EPA is announcing the opening of a docket for a 20-day 
comment period to allow the public to review the supplemental analysis 
to the draft risk evaluation.

DATES: Comments must be received on or before December 10, 2020.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2019-0238, on the Federal eRulemaking Portal at 
http://www.regulations.gov. Follow the online instructions for 
submitting comments. Do not submit electronically any information you 
consider to be Confidential Business Information (CBI) or other 
information whose disclosure is restricted by statute. To make special 
arrangements for hand delivery or delivery of boxed information, please 
follow the instructions at http://www.epa.gov/dockets/contacts.html.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Yvette Selby-Mohamadu, Existing 
Chemicals Risk Assessment Division, Office of Pollution Prevention and 
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, 
Washington, DC 20460-0001; telephone number: (202) 564-5245; email 
address: selby-mohamadu.yvette@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. What action is EPA taking?

    Public and peer review comment on the 1,4-dioxane draft risk 
evaluation suggested that the Agency had omitted both conditions of use 
associated with 1,4-dioxane as a by-product in consumer products and 
potential exposure from the ambient surface water pathway. EPA has 
provided a supplemental analysis to the draft risk evaluation to 
include these two additions and seeks public comment. Therefore, EPA is 
providing public notice and an opportunity to comment on this 
supplemental draft risk evaluation prior to publishing a final risk 
evaluation.

B. Does this action apply to me?

    This action is directed to the public in general. This action may, 
however, be of interest to those involved in the manufacture, 
processing, distribution, use, disposal, and/or the assessment of risks 
involving chemical substances and mixtures. You may be potentially 
affected by this action if you manufacture (defined under TSCA to 
include import), process, distribute in commerce, use or dispose 1,4-
dioxane. Since other entities may also be interested, the Agency has 
not attempted to describe all the specific entities and corresponding 
NAICS codes for entities that may be interested in or affected by this 
action.

C. What is the Agency's authority for taking this action?

    TSCA section 6(b) requires that EPA conduct risk evaluations on 
existing chemical substances and identifies the minimum components EPA 
must include in all chemical substance risk evaluations. 15 U.S.C. 
2605(b). The risk evaluation must not consider costs or other nonrisk 
factors. 15 U.S.C. 2605(b)(4)(F)(iii). TSCA section 6(b)(4)(H) requires 
EPA to provide public notice and an opportunity for comment on a draft 
risk evaluation prior to publishing a final risk evaluation. The 
specific risk evaluation process is set out in 40 CFR part 702 and 
summarized on EPA's website at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluations-existing-chemicals-under-tsca.

[[Page 74342]]

D. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit CBI information to EPA through 
regulations.gov or email. If your comments contain any information that 
you consider to be CBI or otherwise protected, please contact the Peer 
Review Leader listed under FOR FURTHER INFORMATION CONTACT to obtain 
special instructions before submitting your comments.
    2. Tips for preparing your comments. When preparing and submitting 
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Background

A. What is EPA's risk evaluation process for existing chemicals under 
TSCA?

    The risk evaluation process is the second step in EPA's existing 
chemical process under TSCA, following prioritization and before risk 
management. As this chemical is one of the first ten chemical 
substances undergoing risk evaluation, the chemical substance was not 
required to go through prioritization (81 FR 91927, December 19, 2016) 
(FRL-9956-47). The purpose of conducting risk evaluations is to 
determine whether a chemical substance presents an unreasonable risk of 
injury to health or the environment under the conditions of use, 
including an unreasonable risk to a relevant potentially exposed or 
susceptible subpopulation. As part of this process, EPA must evaluate 
both hazard and exposure, not consider costs or other nonrisk factors, 
use reasonably available information and approaches in a manner that is 
consistent with the requirements in TSCA for the use of the best 
available science, and ensure decisions are based on the weight of the 
scientific evidence.
    The specific risk evaluation process that EPA has established by 
rule to implement the statutory process is set out in 40 CFR part 702 
and summarized on EPA's website at http://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluations-existing-chemicals-under-tsca. As explained in the preamble to EPA's final rule on 
procedures for risk evaluation (82 FR 33726, July 20, 2017) (FRL-9964-
38), the specific regulatory process set out in 40 CFR part 702, 
subpart B will be followed for the first ten chemical substances 
undergoing risk evaluation to the maximum extent practicable.
    In September 2019, EPA published a draft risk evaluation that was 
subject to peer review and public comment. EPA reviewed the peer review 
report from the Science Advisory Committee on Chemicals (SACC) and 
public comments and has supplemented the risk evaluation in response to 
these comments as appropriate. The public comments and peer review 
report are in Docket EPA-HQ-OPPT-2019-0238 at www.regulations.gov. 
Prior to the publication of the draft risk evaluation, EPA made 
available the scope and problem formulation, and solicited public input 
on uses and exposure. EPA's documents and the public comments are in 
Docket EPA-HQ-OPPT-2019-0238. Additionally, information about the 
scope, problem formulation, and draft risk evaluation phases of the 
TSCA risk evaluation for this chemical is available at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluation-14-dioxane.

B. What is 1,4-dioxane?

    1,4-dioxane is used primarily as a solvent in a variety of 
commercial and industrial applications like in the manufacture of other 
chemicals, as a processing aid, a laboratory chemical, and in adhesives 
and sealants. 2016 CDR data shows that there were two manufacturers 
producing or importing 1,059,980 pounds of 1,4-dioxane in the U.S. in 
2015.

C. What input came from the public comment and peer review?

    In response to the publication of the draft risk evaluation for 
1,4-dioxane, published in September 2019, members of the SACC, as well 
as public commenters, highlighted potential omissions in the draft 
evaluation, specifically concerning 1,4-dioxane exposures when present 
as a by-product in consumer products and potential general population 
exposure from the ambient surface water pathway. In response, those 
conditions of use from the presence of 1,4-dioxane as a byproduct in 
consumer use and products are included in the scope of this 
supplemental analysis to the draft risk evaluation. Because the 
analytical approaches to assessing the unreasonable risk associated 
with these conditions of use mirror those used for the conditions of 
use evaluated in the September 2019 draft risk evaluation and there is 
not new or novel scientific information to consider, the Agency 
determined that additional peer review is not warranted. It is, 
however, appropriate to seek public comment for the supplemental 
analysis to the 1,4-dioxane draft risk evaluation that was not part of 
the original draft risk evaluation.
    Additionally, in the September 2019 draft risk evaluation, an 
ambient water exposure pathway to general population exposure was 
excluded from the draft risk evaluation mistakenly on the premise that 
it was addressed by other EPA-administered authorities. In response to 
comments, EPA did evaluate hazards and exposures to the general 
population from ambient surface water for all the conditions of use in 
this supplemental analysis and the draft risk evaluation, and the 
unreasonable risk determinations for relevant conditions of use account 
for exposures to the general population via surface water. The 
exposures to general population via drinking water, ambient air and 
sediment pathways fall under the jurisdiction of other environmental 
statutes administered by EPA, i.e., the Clean Air Act, 42 U.S.C. 7401 
et seq.; the Safe Drinking Water Act, 42 U.S.C. 300f et seq.; the 
Comprehensive Environmental Response, Compensation, and Liability Act, 
42 U.S.C. 9601 et seq.; and the Resource Conservation and Recovery Act, 
42 U.S.C. 6901 et seq.

III. Request for Comment

    The docket associated with this request contains the Supplemental 
Analysis to the Draft Risk Evaluation, the SACC Peer Review Report, and 
Supplemental Files to support the Revised Draft Risk Evaluation.
    EPA is seeking public comment on, and information relevant to, the 
Supplemental Analysis to the Draft Risk Evaluation.

    Authority: 15 U.S.C. 2601 et seq.

Andrew Wheeler,
Administrator.
[FR Doc. 2020-25618 Filed 11-19-20; 8:45 am]
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