[Federal Register Volume 86, Number 5 (Friday, January 8, 2021)]
[Notices]
[Pages 1495-1496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-00114]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2019-0238; FRL-10017-46]


1,4-Dioxane; Final Toxic Substances Control Act (TSCA) Risk 
Evaluation; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) is announcing the 
availability of the final Toxic Substances Control Act (TSCA) risk 
evaluation of 1, 4-dioxane. The purpose of conducting risk evaluations 
under TSCA 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, without consideration 
of costs or other nonrisk factors. EPA has determined that specific 
conditions of use of 1, 4-dioxane present an unreasonable risk of 
injury to health or the environment. For those conditions of use for 
which EPA has found an unreasonable risk, EPA must take regulatory 
action to address that unreasonable risk through risk management 
measures enumerated in TSCA. EPA has also determined that specific 
conditions of use do not present an unreasonable risk of injury to 
health or the environment. For those conditions of use for which EPA 
has found no unreasonable risk of injury to health or the environment, 
the Agency's determination is a final Agency action and is issued via 
order in the risk evaluation.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPPT-2019-0238, is available online 
at http://www.regulations.gov or in-person at the Office of Pollution 
Prevention and Toxics Docket (OPPT Docket), Environmental Protection 
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., 
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC. The Public Reading 
Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, 
excluding legal holidays. The telephone number for the Public Reading 
Room is (202) 566-1744, and the telephone number for the OPPT Docket is 
(202) 566-0280.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Public Reading Room are closed to visitors 
with limited exceptions. The EPA/DC staff continue 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, Office of Pollution Prevention and Toxics 
(7403M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, 
Washington, DC 20460-0001; telephone number: (202) 564-5245; email 
address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may 
be of interest to persons who are or may be interested in risk 
evaluations of chemical substances under TSCA, 15 U.S.C. 2601 et seq. 
Since other entities may also be interested in this final risk 
evaluation, the EPA has not attempted to describe all the specific 
entities that may be affected by this action.

B. What is EPA's authority for taking this action?

    TSCA section 6, 15 U.S.C. 2605, requires EPA to conduct 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 a potentially exposed or susceptible subpopulation 
identified as relevant to the risk evaluation by the Administrator, 
under the conditions of use.'' 15 U.S.C. 2605(b)(4)(A). TSCA sections 
6(b)(4)(A) through (H) enumerate the deadlines and minimum requirements 
applicable to this process, including provisions that provide 
instruction on chemical substances that must undergo evaluation, the 
minimum components of a TSCA risk evaluation, and the timelines for 
public comment and completion of the risk evaluation. TSCA also 
requires that EPA operate in a manner that is consistent with the best 
available science, make decisions based on the weight of the scientific 
evidence and consider the reasonably available information. 15 U.S.C. 
2625(h), (i), and (k). TSCA section 6(i) directs that a determination 
of ``no unreasonable risk'' shall be issued by order and considered to 
be a final Agency action, while a determination of ``unreasonable 
risk'' is not considered to be a final Agency action. 15 U.S.C. 
2605(i).
    The statute identifies the minimum components for all chemical 
substance risk evaluations. For each risk evaluation, EPA must publish 
a document that outlines the scope of the risk evaluation to be 
conducted, which includes the hazards, exposures, conditions of use, 
and the potentially exposed or susceptible subpopulations that EPA 
expects to consider. 15 U.S.C. 2605(b)(4)(D). The statute further 
provides that each risk evaluation must also: (1) Integrate and assess 
available information on hazards and exposures for the conditions of 
use of the chemical substance, including information that is relevant 
to specific risks of injury to health or the environment and 
information on relevant potentially exposed or susceptible 
subpopulations; (2) describe whether aggregate or sentinel exposures 
were considered and the basis for that consideration; (3) take into 
account, where relevant, the likely duration, intensity, frequency, and 
number of exposures under the conditions of use; and (4) describe the 
weight of the scientific evidence for the identified hazards and 
exposures. 15 U.S.C. 2605(b)(4)(F)(i) through (ii) and (iv) through 
(v). Each risk evaluation

[[Page 1496]]

must not consider costs or other nonrisk factors. 15 U.S.C. 
2605(b)(4)(F)(iii).
    The statute requires that the risk evaluation process be completed 
within a specified timeframe and provide an opportunity for public 
comment on a draft risk evaluation prior to publishing a final risk 
evaluation. 15 U.S.C. 2605(b)(4).
    Subsection 5.4.1 of the final risk evaluation for 1, 4-dioxane 
constitutes the order required under TSCA section 6(i)(1), and the ``no 
unreasonable risk'' determinations in that subsection are considered to 
be a final Agency action effective on the date of issuance of the 
order. In conducting risk evaluations, ``EPA will determine whether the 
chemical substance presents an unreasonable risk of injury to health or 
the environment under each condition of use within the scope of the 
risk evaluation . . . .'' 40 CFR 702.47. Under EPA's implementing 
regulations, ``[a] determination by EPA that the chemical substance, 
under one or more of the conditions of use within the scope of the risk 
evaluation, does not present an unreasonable risk of injury to health 
or the environment will be issued by order and considered to be a final 
Agency action, effective on the date of issuance of the order.'' 40 CFR 
702.49(d). For purposes of TSCA section 19(a)(1)(A), the date of 
issuance of the TSCA section 6(i)(1) order for 1, 4-dioxane shall be at 
1:00 p.m. Eastern time (standard or daylight, as appropriate) on the 
date that is two weeks after the date when this notice is published in 
the Federal Register, which is in accordance with 40 CFR 23.5.

C. What action is EPA taking?

    EPA is announcing the availability of the risk evaluation of the 
chemical substance identified in Unit II. In this risk evaluation, EPA 
has made unreasonable risk determinations on some of the conditions of 
use within the scope of the risk evaluation for this chemical. For 
those conditions of use for which EPA has found an unreasonable risk of 
injury to health or the environment, EPA must initiate regulatory 
action to address those risks through risk management measures 
enumerated in 15 U.S.C. 2605(a).
    EPA also is announcing the availability of the information required 
to be provided publicly with each risk evaluation, which is available 
online at http://www.regulations.gov in the dockets identified. 40 CFR 
702.51. Specifically, EPA has provided:
     The scope document and problem formulation (in Docket ID 
No. EPA-HQ-OPPT-2016-0723);
     Draft risk evaluation, supplemental analysis to the draft 
risk evaluation, and final risk evaluation (in Docket ID No. EPA-HQ-
OPPT-2019-0238);
     All notices, determinations, findings, consent agreements, 
and orders (in Docket ID No. EPA-HQ-OPPT-2019-0238);
     Any information required to be provided to the Agency 
under 15 U.S.C. 2603 (in Docket ID No. EPA-HQ-OPPT-2016-0723 and Docket 
ID No. EPA-HQ-OPPT-2019-0238);
     A nontechnical summary of the risk evaluation (in Docket 
ID No. EPA-HQ-OPPT-2019-0238);
     A list of the studies, with the results of the studies, 
considered in carrying out each risk evaluation (Risk Evaluation for 1, 
4-dioxane) in Docket ID No. EPA-HQ-OPPT-2019-0238);
     The final peer review report, including the response to 
peer review and public comments received during peer review (in Docket 
ID No. EPA-HQ-OPPT-2019-0238); and
     Response to public comments received on the draft scope, 
the draft risk evaluation and the supplemental analysis to the draft 
risk evaluation (in Docket ID No. EPA-HQ-OPPT-2019-0238).

II. TSCA Risk Evaluation

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 review 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 is being followed for the first ten chemical substances 
undergoing risk evaluation to the maximum extent practicable.
    Prior to the publication of this final risk evaluation, a draft 
risk evaluation was subject to peer review and public comment and a 
supplemental analysis to the draft risk evaluation was subject to 
public comment. EPA reviewed the report from the peer review committee 
and public comments and has amended the risk evaluation in response to 
these comments as appropriate. The public comments, peer review report, 
and EPA's response to comments is in Docket ID No. EPA-HQ-OPPT-2019-
0238. 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 ID No. EPA-HQ-OPPT-2016-0723. Additionally, information about 
the scope, problem formulation, and draft risk evaluation phases of the 
TSCA risk evaluation for this chemical is available at EPA's website 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.

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

Andrew Wheeler,
Administrator.
[FR Doc. 2021-00114 Filed 1-7-21; 8:45 am]
BILLING CODE 6560-50-P