[Federal Register Volume 79, Number 241 (Tuesday, December 16, 2014)]
[Rules and Regulations]
[Pages 74639-74647]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-29429]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2009-0767; FRL-9915-61]
RIN 2070-AJ52


Ethylene Glycol Ethers; Significant New Use Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: Under the Toxic Substances Control Act (TSCA), EPA is 
promulgating a significant new use rule (SNUR) for seven ethylene 
glycol ethers (also known as glymes). This rule will require persons 
who intend to manufacture (including import) or process any of the 
seven ethylene glycol ethers for an activity that is designated as a 
significant new use by this rule to notify EPA at least 90 days before 
commencing such manufacture or processing. The required notifications 
would provide EPA with the opportunity to evaluate the intended use 
and, if necessary based on the information available at that time, an 
opportunity to protect against potential unreasonable risks, if any, 
from that activity before it occurs. EPA is also making a technical 
amendment to the codified list of control numbers for approved 
information collection activities so that it includes the control 
number assigned by the Office of Management and Budget (OMB) to the 
information collection activities contained in this rule.

DATES: This final rule is effective February 17, 2015.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPPT-2009-0767, is available at 
http://www.regulations.gov or at the Office of Pollution Prevention and 
Toxics Docket (OPPT Docket), EPA 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. Please review the visitor 
instructions and additional information about the docket available at 
http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Kirsten Hesla, Chemical Control Division (7405M), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
202-564-2984; email address: <a href="/cdn-cgi/l/email-protection#0c64697f606d2267657e7f7869624c697c6d226b637a"><span class="__cf_email__" data-cfemail="5d35382e313c7336342f2e2938331d382d3c733a322b">[email protected]</span></a>.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: <a href="/cdn-cgi/l/email-protection#abfff8e8ea86e3c4dfc7c2c5ceebcedbca85ccc4dd"><span class="__cf_email__" data-cfemail="dd898e9e9cf095b2a9b1b4b3b89db8adbcf3bab2ab">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture 
(including import) or process any of the chemical substances covered by 
this final rule. The North American Industrial Classification System 
(NAICS) codes identified are not intended to be exhaustive, but rather 
provides a guide to help readers determine whether this document

[[Page 74640]]

applies to them. Potentially affected entities may include:
    <bullet> Manufacturers of one or more of subject chemical 
substances (NAICS codes 325 and 324110); e.g., chemical manufacturing 
and petroleum refineries;
    <bullet> All other basic organic chemical manufacturing (NAICS code 
325199)
    <bullet> Paint and coating manufacturing (NAICS code 325510);
    <bullet> Adhesive manufacturing (NAICS code 325520);
    <bullet> Printing ink manufacturing (NAICS code 325910); and
    <bullet> Motor vehicle brake system manufacturing (NAICS code 
336340).
    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Persons 
who import any chemical substance are subject to the TSCA section 13 
(15 U.S.C. 2612) import certification requirements and the 
corresponding regulations at 19 CFR 12.118 through 12.127; see also 19 
CFR 127.28. Those persons must certify that the shipment of the 
chemical substance complies with all applicable rules and orders under 
TSCA, including any SNUR requirements. The EPA policy in support of 
import certification appears at 40 CFR part 707, subpart B. In 
addition, any persons who export or intend to export a chemical 
substance that is the subject of this rule are subject to the export 
notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), (see 
40 CFR 721.20), and must comply with the export notification 
requirements in 40 CFR part 707, subpart D.
    To determine whether you or your business may be affected by this 
action, you should carefully examine the applicability provisions in 40 
CFR 721.5 and 40 CFR 721.10299. If you have any questions regarding the 
applicability of this action to a particular entity, consult the 
technical person listed under FOR FURTHER INFORMATION CONTACT.

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

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine that a use of a chemical substance is a ``significant new 
use.'' EPA must make this determination by rule after considering all 
relevant factors, including those listed in TSCA section 5(a)(2). Once 
EPA determines that a use of a chemical substance is a significant new 
use, TSCA section 5(a)(1)(B) requires persons to submit a significant 
new use notice (SNUN) to EPA at least 90 days before they manufacture 
or process the chemical substance for that use (15 U.S.C. 
2604(a)(1)(B)). As described in Unit V., the general SNUR provisions 
are found at 40 CFR part 721, subpart A.

C. What action is the Agency taking?

    In the Federal Register of July 12, 2011 (76 FR 40850) (FRL-8877-
8), EPA proposed a SNUR for 14 ethylene glycol ethers (Ref. 1). EPA's 
response to public comments received on the proposed rule appears in 
Unit X. Please consult the July 12, 2011 Federal Register document for 
further background information for this final rule.
    This final SNUR applies to seven of the 14 ethylene glycol ethers 
identified in the proposed rule. EPA is not finalizing the SNUR for the 
other seven ethylene glycol ethers proposed because the Agency believes 
that these chemicals are not sufficiently similar to the seven 
chemicals subject to this SNUR and therefore do not raise the same 
concern for potential exposure to these chemicals. (See Unit X.A. for 
more information.) This final SNUR will require persons to notify EPA 
at least 90 days before commencing the manufacture (including import) 
or processing of:
    <bullet> Monoethylene glycol dimethyl ether (monoglyme, CASRN 110-
71-4) for any use in a consumer product;
    <bullet> Diethylene glycol dimethyl ether (diglyme, CASRN 111-96-6) 
for any use in a consumer product;
    <bullet> Ethylene glycol diethyl ether (ethylglyme, CASRN 629-14-1) 
for any use in a consumer product;
    <bullet> Diethylene glycol diethyl ether (ethyldiglyme, CASRN 112-
36-7) for any use in a consumer product, except as a component of inks, 
coatings and adhesives, and as a component of paint/graffiti removers;
    <bullet> Triethylene glycol dimethyl ether (triglyme, CASRN 112-49-
2) for any use in a consumer product, except as a solvent in consumer 
adhesives, in brake fluid, as a component of consumer paint/graffiti 
removers, and in consumer paints;
    <bullet> Diethylene glycol dibutyl ether (butyldiglyme, CASRN 112-
73-2) for any use in a consumer product, except as a component of inks, 
coatings and adhesives, and as a component in soldering compounds; or
    <bullet> Triethylene glycol dibutyl ether (butyltriglyme, CASRN 
63512-36-7) for any use.

D. Why is the Agency taking this action?

    This SNUR is necessary to ensure that EPA receives timely advance 
notice of any future manufacturing and processing of these ethylene 
glycol ethers for new uses that may produce changes in human and 
environmental exposures. The rationale and objectives for this SNUR are 
explained in Unit III.

E. What are the estimated incremental impacts of this action?

    EPA has evaluated the potential costs of establishing SNUR 
reporting requirements for potential manufacturers and processors of 
the chemical substances included in this final rule. This analysis, 
which is available in the docket, is discussed in Unit IX., and is 
briefly summarized here.
    In the event that a SNUN is submitted, costs are estimated to be 
less than $8,700 per SNUN submission for large business submitters and 
$6,300 for small business submitters. These estimates include the cost 
to prepare and submit the SNUN and the payment of a user fee. In 
addition, for persons exporting a substance that is the subject of a 
SNUR, a one-time notice must be provided for the first export or 
intended export to a particular country, which is estimated to cost 
less than $100 on average per notification. Since EPA is unable to 
predict whether anyone might engage in future activities that would 
require reporting, potential total costs were not estimated.

II. Overview of the Chemical Substances Subject to This Rule

    The ethylene glycol ethers and the significant new use for each 
chemical substance subject to this SNUR are identified in Table 1 of 
this unit.

                                 Table 1--Chemicals With Significant New Use(s)
----------------------------------------------------------------------------------------------------------------
                                                                       Chemical
                                                                      Abstracts
                                           Chemical Abstracts (CA)     Service
             Chemical name                       index name            Registry     Significant new use(s) \1\
                                                                         No.
                                                                       (CASRN)
----------------------------------------------------------------------------------------------------------------
Monoethylene glycol dimethyl ether or    Ethane, 1,2,-dimethoxy-...     110-71-4  Any use in a consumer product.
 monoglyme.

[[Page 74641]]

 
Diethylene glycol dimethyl ether or      Ethane, 1,1'-oxybis[2-         111-96-6  Any use in a consumer product.
 diglyme.                                 methoxy-
Diethylene glycol diethyl ether or       Ethane, 1,1'-oxybis[2-         112-36-7  Any use in a consumer product
 ethyldiglyme.                            ethoxy-.                                 except as a component of
                                                                                   inks, coatings and adhesives,
                                                                                   and as a component of paint/
                                                                                   graffiti removers.
Triethylene glycol dimethyl ether or     2,5,8,11-Tetraoxadodecane.     112-49-2  Any use in a consumer product,
 triglyme.                                                                         except as a solvent in
                                                                                   consumer adhesives, in brake
                                                                                   fluid, as a component of
                                                                                   consumer paint/graffiti
                                                                                   removers, and in consumer
                                                                                   paints.
Diethylene glycol dibutyl ether or       Butane, 1,1'-[oxybis(2,1-      112-73-2  Any use in a consumer product
 butyldiglyme.                            ethane diyloxy)]bis-.                    except as a solvent in
                                                                                   consumer inks, coatings and
                                                                                   adhesives, and as a component
                                                                                   in soldering compounds.
Ethylene glycol diethyl ether or         Ethane, 1,2-diethoxy......     629-14-1  Any use in a consumer product.
 ethylglyme.
Triethylene glycol dibutyl ether or      5,8,11,14-                   63512-36-7  Any use.
 butyltriglyme.                           Tetraoxaoctadecane.
----------------------------------------------------------------------------------------------------------------
\1\ In defining the significant new use for each chemical, the exceptions listed in this table reflect the
  identified ongoing uses, where they exist, that are excluded from the definition of significant new use.

    EPA notes that the seven chemical substances that are the subjects 
of this SNUR are not the only ethylene glycol ethers that are of 
concern based on toxicity. EPA has described the ethylene glycol ethers 
category more broadly under the TSCA New Chemicals Program and under 
Emergency Planning and Community Right-To-Know Act (EPCRA) section 313. 
(See the TSCA New Chemicals Program Chemical Categories document (Ref. 
2) and the EPCRA section 313 List of Toxic Chemicals ``Certain Glycol 
Ethers'' category at 40 CFR 372.65(c) (Ref. 3). Both categories are 
based on a consideration of structural similarity and hazard.) These 
categories are broader than the category that is subject to this SNUR. 
For this rulemaking, EPA considered past and current patterns of use as 
one factor in determining which ethylene glycol ethers would be 
included within the scope of this SNUR. EPA believes that the seven 
ethylene glycol ethers that are the subjects of this SNUR have and/or 
had similar use patterns and can be anticipated to have at least some 
similar new uses. Thus, given the potential for similar uses and the 
potential impact that these will have on type, duration, and magnitude 
of exposure, EPA believes it is appropriate to focus on these seven 
ethylene glycol ethers.

III. Rationale and Objectives for This Final Rule

A. Rationale

    EPA is concerned about the potential of the seven ethylene glycol 
ethers that are the subjects of this SNUR to cause reproductive and/or 
developmental toxicity, genotoxicity and toxicity to blood and blood 
forming organs and believes that individuals could suffer adverse 
effects from their use (Refs. 1-4). This concern is based on a 
combination of data and structure-activity relationships. While a 
specific hazard evaluation is not required by TSCA section 5(a)(2), EPA 
considered hazard in designating this category of ethylene glycol 
ethers. In deciding to focus on these chemical substances, EPA 
considered use patterns as well as toxicity data and structure-activity 
relationships. EPA considered these factors in conjunction with the 
statutory factors provided in section 5(a)(2). In designating the 
significant new uses for these chemical substances, EPA will have the 
opportunity to evaluate and control, where appropriate, activities 
associated with those uses, if such manufacturing or processing for the 
significant new uses were to start or resume. The required notification 
provided by a SNUN will provide EPA with the opportunity to evaluate 
activities associated with a significant new use and an opportunity to 
protect against unreasonable risks, if any, which may occur from 
exposure to these chemical substances.
    Consistent with EPA's past practice for issuing SNURs under TSCA 
section 5(a)(2), EPA's decision to issue a SNUR for a particular 
chemical use need not be based on an extensive evaluation of the 
hazard, exposure, or potential risk associated with that use. Rather, 
the Agency's action is based on EPA's determination that if the use 
begins or resumes, it may present a risk that EPA should evaluate under 
TSCA before the manufacturing or processing for that use begins. Since 
the new use does not currently exist, deferring a detailed 
consideration of potential risks or hazards related to that use is an 
effective use of resources. If a person decides to begin manufacturing 
or processing the chemical for the use, the notice allows EPA to 
evaluate the use according to the specific parameters and circumstances 
surrounding that intended use.

B. Objectives

    Based on the considerations in Unit III.A., EPA will achieve the 
following objectives with regard to the significant new uses that are 
designated in this rule:
    1. EPA will receive notice of any person's intent to manufacture or 
process any of the chemical substances listed in Table 1 of Unit II. 
for the described significant new use before that activity begins.
    2. EPA will have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing or 
processing the chemical substances listed in Table 1 of Unit II. for 
the described significant new use.
    3. EPA will be able to regulate the prospective manufacture or 
processing of the chemical substances before the described significant 
new use of the chemical substance listed in Table 1 of Unit II. occurs, 
provided that regulation is warranted pursuant to TSCA sections 5(e), 
5(f), 6 or 7.

IV. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use 
of a chemical substance is a significant new

[[Page 74642]]

use must be made after consideration of all relevant factors including:
    <bullet> The projected volume of manufacturing and processing of a 
chemical substance.
    <bullet> The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.
    <bullet> The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
    <bullet> The reasonably anticipated manner and methods of 
manufacturing, processing, distribution in commerce, and disposal of a 
chemical substance.
    In addition to these factors enumerated in TSCA section 5(a)(2), 
the statute authorizes EPA to consider any other relevant factors.
    To determine what would constitute a significant new use of the 
chemical substances subject to this rule, as discussed herein, EPA 
considered relevant information about the potential toxicity of these 
substances, the range of uses for these chemicals and the four factors 
listed in section 5(a)(2) of TSCA.
    EPA believes that potential new consumer uses could change the type 
and form of exposure and/or the magnitude and duration of exposure to 
humans and the environment relative to what currently exists. Use in 
consumer products could result in different types of exposure, e.g., 
inhalation exposure through spray applications, dermal exposure if the 
consumer product is meant to be hand-applied to an object, than 
currently exist. Use in different consumer products can also change the 
duration of exposure, which will depend upon the type of consumer 
product in which the chemical substance is used. Also, new uses of any 
of these chemical substances would likely result in an increase of the 
magnitude of exposure relative to current exposures given that these 
uses would be in addition to ongoing uses. Consumers use a variety of 
products; thus, their potential exposures to a chemical substance in 
multiple consumer products would likely be additive.
    New uses in consumer products would also result in differences in 
the processing of the chemical substances that are the subject of this 
SNUR because these chemical substances may be mixed with other 
chemicals and may be made part of consumer products with different 
properties, e.g., different viscosities from existing consumer 
products. Based on these considerations of the statutory factors, EPA 
has determined that the uses identified in Table 1 of Unit II. are 
significant new uses. In addition, because there are no ongoing uses of 
triethylene glycol dibutyl ether, any new use would result in a change 
in the volume of manufacturing and processing of this chemical 
substance, as well as the type, form, magnitude and duration of 
exposure, and the manner and methods of manufacturing, processing, 
distribution in commerce, and disposal of this chemical substance.

V. Applicability of General Provisions

    General provisions for SNURs appear under 40 CFR part 721, subpart 
A. These provisions describe persons subject to the rule, recordkeeping 
requirements, exemptions to reporting requirements, and applicability 
of the rule to uses occurring before the effective date of the final 
rule.
    Provisions relating to user fees appear at 40 CFR part 700. 
According to 40 CFR 721.1(c), persons subject to SNURs must comply with 
the same notice requirements and EPA regulatory procedures as 
submitters of Premanufacture Notices (PMNs) under TSCA section 
5(a)(1)(A). In particular, these requirements include the information 
submissions requirements of TSCA section 5(b) and 5(d)(1), the 
exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and 
(h)(5), and the regulations at 40 CFR part 720. Once EPA receives a 
SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6 
or 7 to control the activities on which it has received the SNUN. If 
EPA does not take action, EPA is required under TSCA section 5(g) to 
explain in the Federal Register its reasons for not taking action.
    Persons who export or intend to export a chemical substance(s) 
identified in a proposed or final SNUR are subject to the export 
notification provisions of TSCA section 12(b). The regulations that 
interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D. 
Persons who import a chemical substance are subject to the TSCA section 
13 import certification requirements, codified at 19 CFR 12.118 through 
12.127; see also 19 CFR 127.28. Such persons must certify that the 
shipment of the chemical substance complies with all applicable rules 
and orders under TSCA, including any SNUR requirements. The EPA policy 
in support of import certification appears at 40 CFR part 707, subpart 
B.

VI. Applicability of the Rule to Uses Occurring Before Effective Date 
of the Final Rule

    As discussed in the Federal Register of April 24, 1990 (55 FR 
17376), EPA has decided that the intent of section 5(a)(1)(B) of TSCA 
is best served by designating a use as a significant new use as of the 
date of publication of the proposed rule rather than as of the 
effective date of the final rule. If uses begun after publication of 
the proposed rule were considered ongoing rather than new, it would be 
difficult for EPA to establish SNUR notice requirements, because a 
person could defeat the SNUR by initiating the proposed significant new 
use before the rule became final, and then argue that the use was 
ongoing as of the effective date of the final rule. Thus, persons who 
may have begun commercial manufacture or processing of the chemical 
substance(s) subject to this rule after the proposal was published on 
July 12, 2011, must cease such activity before the effective date of 
this final rule. To resume their activities, these persons will have to 
comply with all applicable SNUR notice requirements and wait until the 
notice review period, including all extensions, expires. Uses arising 
after the publication of the proposed rule are distinguished from uses 
that exist at publication of the proposed rule. The former would be new 
uses, the latter ongoing uses. To the extent that additional ongoing 
uses were found in the course of rulemaking, EPA has excluded these 
uses from the final SNUR. EPA promulgated provisions to allow persons 
to comply with this SNUR before the effective date. If a person were to 
meet the conditions of advance compliance under 40 CFR 721.45(h), that 
person would be considered to have met the requirements of the final 
SNUR for those activities.

VII. Test Data and Other Information

    EPA recognizes that TSCA section 5 does not usually require 
developing any particular test data before submission of a SNUN. There 
are two exceptions:
    1. Development of test data is required where the chemical 
substance subject to the SNUR is also subject to a test rule under TSCA 
section 4 (see TSCA section 5(b)(1)); and
    2. Development of test data may be necessary where the chemical 
substance has been listed under TSCA section 5(b)(4) (see TSCA section 
5(b)(2)).


In the absence of a section 4 test rule or a section 5(b)(4) listing 
covering the chemical substance, persons are required only to submit 
test data in their possession or control and to describe any other data 
known to or reasonably ascertainable by them (15 U.S.C. 2604(d); 40 CFR 
721.25, and 40 CFR 720.50). However, as a general matter, EPA 
recommends that SNUN submitters

[[Page 74643]]

include data that would permit a reasoned evaluation of risks posed by 
the chemical substance during its manufacture (including import), 
processing, use, distribution in commerce, or disposal. EPA encourages 
persons to consult with the Agency before submitting a SNUN. As part of 
this optional pre-notice consultation, EPA would discuss specific data 
it believes may be useful in evaluating a significant new use. SNUNs 
submitted for significant new uses without any test data may increase 
the likelihood that EPA will take action under TSCA section 5(e) to 
prohibit or limit activities associated with this chemical substance.
    SNUN submitters should be aware that EPA will be better able to 
evaluate SNUNs that provide detailed information on:
    <bullet> Human exposure and environmental releases that may result 
from the significant new uses of the chemical substance.
    <bullet> Potential benefits of the chemical substance.
    <bullet> Information on risks posed by the chemical substances 
compared to risks posed by potential substitutes.

VIII. SNUN Submissions

    EPA recommends that entities consult with the Agency prior to 
submitting a SNUN to discuss what data may be useful in evaluating a 
significant new use. Discussions with the Agency prior to submission 
can afford ample time to conduct any tests that might be helpful in 
evaluating risks posed by the intended use of the chemical substance. 
According to 40 CFR 721.1(c), persons submitting a SNUN must comply 
with the same notice requirements and EPA regulatory procedures as 
persons submitting a PMN, including submission of test data on health 
and environmental effects as described in 40 CFR 720.50. SNUNs must be 
submitted on EPA Form No. 7710-25, generated using e-PMN software, and 
submitted to the Agency in accordance with the procedures set forth in 
40 CFR 721.25 and 40 CFR 720.40. E-PMN software is available 
electronically at http://www.epa.gov/opptintr/newchems.

IX. Economic Analysis

A. SNUNs

    EPA has evaluated the potential costs of establishing SNUR 
reporting requirements for potential manufacturers and processors of 
the chemical substance included in this rule (Ref. 5). In the event 
that a SNUN is submitted, costs are estimated at approximately $8,589 
per SNUN submission for large business submitters and $6,189 for small 
business submitters. These estimates include the cost to prepare and 
submit the SNUN, and the payment of a user fee. Businesses that submit 
a SNUN would be subject to either a $2,500 user fee required by 40 CFR 
700.45(b)(2)(iii), or, if they are a small business with annual sales 
of less than $40 million when combined with those of the parent company 
(if any), a reduced user fee of $100 (40 CFR 700.45(b)(1)). The costs 
of submission of SNUNs will not be incurred by any company unless a 
company decides to pursue a significant new use as defined in this 
SNUR. EPA's complete economic analysis is available in the public 
docket for this rule (Ref. 5).

B. Export Notification

    Under section 12(b) of TSCA and the implementing regulations at 40 
CFR part 707, subpart D, exporters must notify EPA if they export or 
intend to export a chemical substance or mixture for which, among other 
things, a rule has been proposed or promulgated under section 5. For 
persons exporting a substance that is the subject of a SNUR, a one-time 
notice must be provided for the first export or intended export to a 
particular country. The total costs of export notification will vary by 
chemical substance, depending on the number of required notifications 
(i.e., the number of countries to which the chemical substance is 
exported). EPA is unable to make any estimate of the likely number of 
export notifications for the chemical substances covered in this SNUR.

X. Response to Comments

    The Agency reviewed and considered all comments received related to 
the proposed rule. Copies of all non-CBI comments are available in the 
docket for this action (EPA-HQ-OPPT-2009-0767). A discussion of the 
major comments germane to the rulemaking and the Agency's responses 
follow. Responses to all germane comments received are in the document 
titled: ``Response to Comments on the Proposed Ethylene Glycol Ethers 
(Glymes) Significant New Use Rule (SNUR)'' (Ref. 6), which is also 
available in the docket.

A. Scope of Ethylene Glycol Ethers Category

    1. Comment. One commenter contends that the term glymes, while 
technically correct, is a less well-known term for these ethylene 
glycol ethers. The commenter asserts it may not have been clear to many 
what chemicals are subject to this rulemaking.
    Response. EPA disagrees that it was unclear what chemical 
substances were the subjects of the proposed SNUR. Even if an 
individual manufacturer or processor were unfamiliar with the term EPA 
used to designate the category (``glymes''), all of the chemical 
substances proposed to be included in the SNUR were also individually 
identified by their CASRN, CA Index Name, and ethylene glycol ether 
common name. Notice of the proposal was adequate; there were several 
ways in which stakeholders could have determined which chemical 
substances were the subjects of the proposal. However, to increase 
clarity, EPA will list the ``ethylene glycol ether'' name instead of 
the name ``glymes'' to characterize the chemicals subject to this SNUR.
    2. Comment. One commenter contends that while the ethylene glycol 
ethers are structurally similar, they vary in molecular weight, in the 
number of ethylene glycol groups, and in the length of the terminal 
alkyl groups. The commenter asserts that the presence of 
characteristics, such as longer terminal alkyl groups and more ethylene 
glycol groups act to reduce the developmental and reproductive toxicity 
of the higher molecular weight ethylene glycol ethers, as compared to 
the lower molecular weight ethylene glycol ethers. The commenter states 
that there is a decrease in ethylene glycol ether toxicity with 
increasing terminal alkyl length and/or increasing ethylene glycol 
groups, and that the category should be limited to monoglyme, diglyme 
and ethylglyme. Another commenter contends that the category should be 
limited based on a consideration of metabolism. The commenter contends 
that the category should be limited to monoglyme, diglyme, ethyl 
diglyme and triglyme because only these will be metabolized in the body 
to chemical substances that have toxicity characteristics of ethylene 
glycol monomethyl ether and ethylene glycol monoethyl ether. The 
commenter contends that none of the other ethylene glycol ethers 
exhibit developmental or reproductive toxicity similar to that of these 
four chemical substances.
    Response. A specific evaluation of hazard is not required by TSCA 
section 5(a)(2) to issue a SNUR. Nonetheless, EPA has based this SNUR 
in part on considerations of toxicity, so toxicity considerations are 
relevant in this instance.
    EPA believes that based on both toxicity data and structure-
activity relationships (Refs. 1-4) ethylene glycol ethers that consist 
of 1, 2 or 3 glycol ether groups and terminal alkyl groups

[[Page 74644]]

of 1 to 4 carbons can be anticipated to cause developmental and 
reproductive toxicity and/or hemolytic toxicity. Based on these same 
data and structure-activity relationships, EPA agrees with commenters 
that chemical substances with more than 3 repeating glycol ether units 
should not be included in the category because the toxicity of such 
substances is dissimilar from the remaining members of the category. 
Therefore, EPA removed seven of the proposed category members from the 
final rule.
    While there is evidence that the toxicity is reduced going from 
methyl to butyl ether and with increasing number of ethylene glycol 
groups, toxicity is still observed (Refs. 3, 4). Indeed, data provided 
by one commenter demonstrate the developmental toxicity of six of the 
seven ethylene glycol ethers (Ref. 7). Among the seven substances 
listed in Table 1 of Unit II., EPA disagrees that the relevant evidence 
establishes sufficient variation in degree of toxicity to cull any 
further substances from the group. Differing doses at which toxicity 
occurs does not equate with lack of toxicity. Thus, EPA disagrees with 
the commenter that the category should be further limited to only those 
chemicals which induce toxicity at the lowest doses. Inclusion in the 
category is appropriately predicated on similarity of toxicity. (EPA 
notes also that the commenters' individual lists are not in agreement 
with respect to ethylene glycol ethers that they consider to be the 
most developmentally toxic, and that there is only partial overlap 
between these two lists.)
    Further, ethylene glycol ethers cause adverse effects in addition 
to reproductive and developmental toxicity. Data for other toxic 
effects of ethylene glycol ethers with terminal alkyl groups of one to 
four carbons do not indicate a trend toward decreasing toxicity with 
increasing alkyl chain length (Ref. 4). Hemolysis has been reported in 
varying degrees for ethylene glycol ethers of one to five carbons in 
the alkyl chains (Ref. 4). Hemolysis is associated with chain length, 
and a chain length of four carbons causes this type of toxicity at the 
lowest dose (Ref. 4).
    One commenter contends that ``the lower glymes that are generally 
considered to be toxic following repeated exposure are: Monoglyme, 
diglyme and ethylglyme. The higher glymes that are less toxic following 
repeated exposure are triglyme, tetraglyme, polyglyme, ethyldiglyme and 
butyldiglyme'' (Ref. 7). EPA disagrees that molecular weight can be 
appropriately applied, by itself, to establish which substances are 
sufficiently similar to be included in the SNUR. EPA notes that some 
level of variation within chemical categories is inevitable when 
placing similar chemicals into groups, and therefore, variation is 
expected. The similarity in the toxicity of the chemical substances 
that are the subject of this SNUR is not primarily based on molecular 
weight but as discussed above is based on both toxicity data and 
structure-activity relationships (Refs 1-4). Ethylene glycol ethers 
that consist of 1, 2 or 3 glycol ether groups and terminal alkyl groups 
of 1 to 4 carbons can be anticipated to cause developmental and 
reproductive toxicity and/or hemolytic toxicity. Based on these 
toxicity considerations, EPA notes that it did, in fact remove some of 
the higher molecular weight ethylene glycol ethers from the final rule. 
But EPA disagrees that varying molecular weight, in itself, should be a 
deciding factor in eliminating a chemical substance from a category of 
similar chemical substances. While the commenter provides limited data 
on developmental and reproductive toxicity, they provide no data with 
respect to other toxicity endpoints of concern (including toxicity to 
blood and blood forming organs, and potential for gene mutation) and 
the commenter does not speculate on possible similarities or 
differences among the chemical substances with respect to these 
endpoints (Ref. 7).
    3. Comment. Several commenters contend that the ethylene glycol 
ether category is too broad. While the chemical substances in the 
category are similar because they have one or more repeating glycol 
ether groups and terminal alkyl chains, structural similarity is not 
sufficient to predict toxicity. One commenter further states that 
structural similarities alone should not be the basis for toxicity 
determinations, risk assessment and subsequent regulation.
    Response. EPA acknowledges the commenters' assertions that the 
category of ethylene glycol ethers in the proposed SNUR was too broad, 
and is finalizing this SNUR for only seven of the original 14 
chemicals.
    The commenters' remaining arguments (about the relevance of 
structural similarities to risk assessment, and subsequent regulation) 
are premature. This SNUR is not based on a risk assessment, and it does 
not establish that subsequent regulation of the ethylene glycol ethers 
would be necessary in the event EPA receives a significant new use 
notice after promulgating this rule.
    While EPA did consider toxicity in deciding to focus on these 
chemical substances, under TSCA section 5(a)(2), EPA is neither 
required to determine that a particular new use of any chemical 
substance presents, nor even that it may present, an unreasonable risk 
to human health or the environment. Rather, EPA issues a SNUR for a 
particular new use of a substance if it has reason to anticipate that 
the use would raise significant questions related to potential 
exposure, so that it should have an opportunity to review the use 
before such use could occur. EPA bases this judgment on a consideration 
of all relevant factors, including the specific factors identified at 
section 5(a)(2). EPA considered similarities in toxicity and potential 
toxicity among these chemical substances, similarities in uses and 
considered the extent to which the significant new uses that are the 
subject of this SNUR could result in changes to the processing of these 
chemical substances and the type, duration and magnitude of exposures 
to these chemicals.

B. Use

    4. Comment. Two commenters request clarification on whether 
automobiles are considered consumer products. These commenters point to 
the definition of consumer product at section 3(a)(5) of the Consumer 
Product Safety Act (CPSA), which excludes motor vehicles. These 
commenters contend that the EPA definition at 40 CFR 721.3 should be 
clarified to be consistent with CPSA and exclude motor vehicles.
    Response. CPSA is a different statute from TSCA. For purposes of 
significant new use rules issued pursuant to TSCA, consumer product is 
defined at 40 CFR 721.3 as ``. . . a chemical substance that is 
directly, or as part of a mixture, sold or made available to consumers 
for their use in or around a permanent or temporary household or 
residence, in or around a school, or in recreation.'' This is the 
pertinent regulatory text and it contains no exclusion for automobiles.
    However, EPA would not consider ethylene glycol ethers to have been 
``sold or made available to consumers for their use'' merely because 
they have been sold or made available to automobile manufacturers or 
commercial auto service establishments (for their use in manufacturing 
or maintaining customers' motor vehicles). By contrast, ethylene glycol 
ethers that are sold or made available to a consumer, for the 
consumer's own use in maintaining his or her own motor vehicle (e.g., 
as part of an aftermarket brake fluid) would fall within the definition 
of ``consumer product.''

[[Page 74645]]

    5. Comment. One commenter asks that EPA clarify the status of brake 
fluid contained in a new or used motor vehicle at point of sale.
    Response. EPA would not consider an ethylene glycol ether to have 
been ``sold or made available to consumers for their use,'' merely 
because it has been made available to motor vehicle manufacturers (as 
part of a brake fluid mixture for their use in manufacturing customers' 
motor vehicles) or used car dealers. By contrast, ethylene glycol 
ethers that are sold or made available to a consumer, for the 
consumer's own use in maintaining his or her own motor vehicle (e.g., 
as part of an aftermarket brake fluid) would fall within the definition 
of ``consumer product.''
    6. Comment. One commenter requested that EPA clarify how 
aftermarket components are addressed in this rulemaking.
    Response. An aftermarket component is any product offered for sale 
or installation in or on a motor vehicle after such vehicle has left 
the manufacturer's production line. Use in an aftermarket component 
would qualify as use in a consumer product if the chemical substances 
in an aftermarket component are ``sold or made available to consumers 
for their use in or around a permanent or temporary household or 
residence, in or around a school, or in recreation.'' 40 CFR 721.3.
    7. Comment. Two commenters request that EPA modify the listed 
ongoing use for monoethylene glycol dimethyl ether (monoglyme) listed 
in the proposed rule--``any use in a consumer product except in 
electrolyte solution in sealed lithium batteries'' to ``any use in a 
consumer product except in electrolyte solutions for primary and 
secondary sealed lithium batteries''--because this would clarify that 
the ongoing use of monoglyme is in all primary and secondary batteries.
    Response. For purposes of defining the scope of the significant new 
use, EPA has determined that the use of ethylene glycol ethers in 
sealed lithium batteries (whether primary or secondary) is not use in a 
consumer product. An ethylene glycol ether is not being ``sold or made 
available to consumers for their use,'' 40 CFR 721.3, merely because it 
is contained in the electrolyte of sealed lithium batteries, which are 
themselves used by consumers. With this clarification, EPA is 
finalizing the significant new use for monoethylene glycol dimethyl 
ether as ``any use in a consumer product.''

XI. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket includes these documents and 
other information considered by EPA in developing this rule, including 
the documents referenced within the documents that are in the docket, 
even if the referenced document is not physically located in the 
docket. For assistance in locating these other documents, please 
consult the technical person listed under FOR FURTHER INFORMATION 
CONTACT.

    1. US EPA. Glymes; Proposed Significant New Use Rule. 76 FR 
40850, July 12, 2011.
    2. US EPA. TSCA New Chemicals Program (NCP) Chemical Categories. 
Last revised August 2010, pages 68-69. http://www.epa.gov/oppt/newchems/pubs/npcchemicalcategories.pdf.
    3. US EPA. Glycol Ethers Category; Toxic Chemical Release 
Reporting; Community Right-To-Know. 58 FR 36180, July 6, 1993.
    4. US EPA. Glycol Ethers Category; Toxic Chemical Release 
Reporting; Community Right-To-Know. 59 FR 34386, July 5, 1994.
    5. US EPA. Economic Analysis of the Significant New Use Rule for 
Seven Ethylene Glycol Ethers. Prepared by Nishkam Agarwal and Abt 
Associates Inc. September 30, 2013.
    6. US EPA. Response to Comments on the Proposed Ethylene Glycol 
Ethers (Glymes) Significant New Use Rule (SNUR). October 30, 2013.
    7. Novolyte Technologies. Attachment 1: Categorization of Glymes 
Based on Toxicology and Structural Characteristics. October 12, 
2011, pages 1-21.

XII. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulation and Regulatory Review

    This final rule has been designated by OMB as a ``significant 
regulatory action'' under section 3(f) of Executive Order 12866 (58 FR 
51735, October 4, 1993). Accordingly, EPA submitted this action to OMB 
for review under Executive Orders 12866 and 13563 (76 FR 3821, January 
21, 2011) and any changes made in response to OMB recommendations have 
been documented in the docket for this action.

B. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden 
under the PRA, 44 U.S.C. 3501 et seq. Burden is defined in 5 CFR 
1320.3(b). The information collection activities associated with 
existing chemical SNURs are already approved by OMB under OMB control 
number 2070-0038 (EPA ICR No. 1188); and the information collection 
activities associated with export notifications are already approved by 
OMB under OMB control number 2070-0030 (EPA ICR No. 0795). If an entity 
were to submit a SNUN to the Agency, the annual burden is estimated to 
be less than 100 hours per response, and the estimated burden for an 
export notifications is less than 1.5 hours per notification. In both 
cases, burden is estimated to be reduced for submitters who have 
already registered to use the electronic submission system. Additional 
burden, estimated to be less than 10 hours, could be incurred where 
additional record keeping requirements are specified under 40 CFR 
721.125(a), (b), and (c).
    An agency may not conduct or sponsor, and a person is not required 
to respond to a collection of information that requires OMB approval 
under the PRA, unless it has been approved by OMB and displays a 
currently valid OMB control number. The OMB control numbers for EPA's 
regulations in Title 40 of the CFR, after appearing in the Federal 
Register, are listed in 40 CFR, part 9, and included on the related 
collection instrument, or form, if applicable. EPA is amending the 
table in 40 CFR part 9 to list this SNUR. This listing of the OMB 
control numbers and their subsequent codification in the CFR satisfies 
the display requirements of the PRA and OMB's implementing regulations 
at 5 CFR part 1320. Since the existing OMB approval was previously 
subject to public notice and comment before OMB approval, and given the 
technical nature of the table, EPA finds that further notice and 
comment to amend the table is unnecessary. As a result, EPA finds that 
there is ``good cause'' under section 553(b)(3)(B) of the 
Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this 
table without further notice and comment.

C. Regulatory Flexibility Act (RFA)

    Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., I 
hereby certify that promulgation of this SNUR will not have a 
significant economic impact on a substantial number of small entities. 
The rationale supporting this conclusion is as follows.
    A SNUR applies to any person (including small or large entities) 
who intends to engage in any activity described in the rule as a 
``significant new use.'' By definition of the word ``new'' and based on 
all information currently available to EPA, it appears that no small or 
large entities presently engage in such activities. Since this SNUR 
will require a person who intends to engage in such activity in the 
future to first notify EPA by submitting a

[[Page 74646]]

SNUN, no economic impact will occur unless someone files a SNUN to 
pursue a significant new use in the future or forgoes profits by 
avoiding or delaying the significant new use. Although some small 
entities may decide to engage in such activities in the future, EPA 
cannot presently determine how many, if any, there may be. However, 
EPA's experience to date is that, in response to the promulgation of 
SNURs covering over 1,000 chemical substances, the Agency receives only 
a handful of notices per year. During the six year period from 2005-
2011, only three submitters self-identified as small in their SNUN 
submission (Ref. 5). EPA believes the cost of submitting a SNUN is 
relatively small compared to the cost of developing and marketing a 
chemical new to a firm and that the requirement to submit a SNUN 
generally does not have a significant economic impact.
    Therefore, EPA believes that the potential economic impact of 
complying with this SNUR is not expected to be significant or adversely 
impact a substantial number of small entities. In a SNUR that published 
as a final rule on August 8, 1997 (62 FR 42690) (FRL-5735-4), the 
Agency presented its general determination that proposed and final 
SNURs are not expected to have a significant economic impact on a 
substantial number of small entities, which was provided to the Chief 
Counsel for Advocacy of the Small Business Administration.

D. Unfunded Mandates Reform Act (UMRA)

    Based on EPA's experience with proposing and finalizing SNURs, 
State, local, and Tribal governments have not been impacted by these 
rulemakings, and EPA does not have any reason to believe that any 
State, local, or Tribal government would be impacted by this 
rulemaking. As such, EPA has determined that this regulatory action 
would not impose any enforceable duty, contain any unfunded mandate, or 
otherwise have any effect on small governments subject to the 
requirements of sections 202, 203, 204, or 205 of UMRA, 2 U.S.C. 1531-
1538.

E. Executive Order 13132: Federalism

    This action does not have a substantial direct effect on States, on 
the relationship between the national government and the States, or on 
the distribution of power and responsibilities among the various levels 
of government, as specified in Executive Order 13132 (64 FR 43255, 
August 10, 1999).

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This rule does not have Tribal implications because it will not 
have any effect (i.e., there will be no increase or decrease in 
authority or jurisdiction) on Tribal governments, on the relationship 
between the Federal government and the Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
government and Indian tribes. Thus, Executive Order 13175 (65 FR 67249, 
November 9, 2000) does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    This action is not subject to Executive Order 13045 (62 FR 19885, 
April 23, 1997), because this action is not intended to address 
environmental health or safety risks for children.

H. Executive Order 13211: Actions That Significantly Affect Energy 
Supply, Distribution, or Use

    This rule is not subject to Executive Order 13211 (66 FR 28355, May 
22, 2001), because this action is not expected to affect energy supply, 
distribution, or use.

I. National Technology Transfer Advancement Act (NTTAA)

    Since this action does not involve any technical standards, NTTAA 
section 12(d), 15 U.S.C. 272 note, does not apply to this action.

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    This action does not entail special considerations of environmental 
justice related issues as delineated by Executive Order 12898 (59 FR 
7629, February 16, 1994), because EPA has determined that this action 
will not have disproportionately high and adverse human health or 
environmental effects on minority or low-income populations. This 
action does not affect the level of protection provided to human health 
or the environment.

XIII. Congressional Review Act (CRA)

    Pursuant to the CRA, 5 U.S.C. 801 et seq., EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of the rule in the Federal Register. 
This action is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 9

    Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.

    Dated: December 10, 2014.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.

    Therefore, 40 CFR chapter I is amended as follows:

PART 9--[AMENDED]

0
1. The authority citation for part 9 continues to read as follows:

    Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 
9601-9657, 11023, 11048.


0
2. In Sec.  [emsp14]9.1, add the following section in numerical order 
under the undesignated center heading ``Significant New Uses of 
Chemical Substances'' to read as follows:


Sec.  [emsp14]9.1  OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
                                                            OMB control
                     40 CFR citation                            No.
------------------------------------------------------------------------
 
                                * * * * *
------------------------------------------------------------------------
               Significant New Uses of Chemical Substances
------------------------------------------------------------------------
 
                                * * * * *
721.10229...............................................       2070-0038
 
                                * * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

0
3. The authority citation for part 721 continues to read as follows:

    Authority: 15 U.S.C. 2604, 2607, and 2625(c).


0
4. Add Sec.  721.10229 to subpart E to read as follows:

[[Page 74647]]

Sec.  721.10229  Ethylene glycol ethers.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified in Table 1 of this 
paragraph are subject to reporting under this section for the 
significant new uses described in Table 1 of this paragraph.

                  Table 1--Ethylene Glycol Ethers and Significant New Uses Subject to Reporting
----------------------------------------------------------------------------------------------------------------
                                                                       Chemical
                                                                      Abstracts
             Chemical name               Chemical  Abstracts  index    Service        Significant new use(s)
                                                    name               Registry
                                                                     No. (CASRN)
----------------------------------------------------------------------------------------------------------------
Monoethylene glycol dimethyl ether or    Ethane, 1,2,-dimethoxy-...     110-71-4  Any use in a consumer product.
 monoglyme.
Diethylene glycol dimethyl ether or      Ethane, 1,1'-oxybis[2-         111-96-6  Any use in a consumer product.
 diglyme.                                 methoxy-.
Diethylene glycol diethyl ether or       Ethane, 1,1'-oxybis[2-         112-36-7  Any use in a consumer product
 ethyldiglyme.                            ethoxy-.                                 except as a component of
                                                                                   inks, coatings and adhesives,
                                                                                   and as a component of paint/
                                                                                   graffiti removers.
Triethylene glycol dimethyl ether or     2,5,8,11-Tetraoxadodecane.     112-49-2  Any use in a consumer product,
 triglyme.                                                                         except as a solvent in
                                                                                   consumer adhesives, in brake
                                                                                   fluid, as a component of
                                                                                   consumer paint/graffiti
                                                                                   removers, and in consumer
                                                                                   paints.
Diethylene glycol dibutyl ether or       Butane, 1,1'-[oxybis(2,1-      112-73-2  Any use in a consumer product
 butyldiglyme.                            ethanediyloxy)]bis-.                     except as a solvent in
                                                                                   consumer inks, coatings and
                                                                                   adhesives, and as a component
                                                                                   in soldering compounds.
Ethylene glycol diethyl ether or         Ethane, 1,2-diethoxy......     629-14-1  Any use in a consumer product.
 ethylglyme.
Triethylene glycol dibutyl ether or      5,8,11,14-                   63512-36-7  Any use.
 butyltriglyme.                           Tetraoxaoctadecane.
----------------------------------------------------------------------------------------------------------------

    (2) [Reserved]
    (b) [Reserved]


[FR Doc. 2014-29429 Filed 12-15-14; 8:45 am]
BILLING CODE 6560-50-P


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