Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices 1495 

In addition to publishing the full text 

of this document in the Federal 

Register, the Commission provides all 

interested persons an opportunity to 

view and/or print the contents of this 

document via the internet through the 

Commission’s Home Page (http://

ferc.gov) using the ‘‘eLibrary’’ link. 

Enter the docket number excluding the 

last three digits in the docket number 

field to access the document. At this 

time, the Commission has suspended 

access to the Commission’s Public 

Reference Room, due to the 

proclamation declaring a National 

Emergency concerning the Novel 

Coronavirus Disease (COVID–19), issued 

by the President on March 13, 2020. For 

assistance, contact the Federal Energy 

Regulatory Commission at 

FERCOnlineSupport@ferc.gov or call 

toll-free, (886) 208–3676 or TYY, (202) 

502–8659. 

Dated: January 4, 2021. 

Nathaniel J. Davis, Sr., 

Deputy Secretary. 

[FR Doc. 2021–00128 Filed 1–7–21; 8:45 am] 

BILLING CODE 6717–01–P 

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: selbymohamadu.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. 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 


tkelley on DSKBCP9HB2PROD with NOTICES
1496 Federal Register / Vol. 86, No. 5 / Friday, January 8, 2021 / Notices 

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-managingchemicals-under-tsca/risk-evaluationsexisting-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-managingchemicals-under-tsca/risk-evaluation14-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 


tkelley on DSKBCP9HB2PROD with NOTICES