Glymes; Proposed Significant New Use Rule, 40850-40860 [2011-17084]
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We will publish an appropriate
amendment to 39 CFR part 111 to reflect
these changes if our proposal is
adopted.
Stanley F. Mires,
Chief Counsel, Legislative.
[FR Doc. 2011–17386 Filed 7–11–11; 8:45 am]
BILLING CODE 7710–12–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 721
[EPA–HQ–OPPT–2009–0767; FRL–8877–8]
RIN 2070–AJ52
Glymes; Proposed Significant New Use
Rule
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
EPA is proposing a significant
new use rule (SNUR) under section
5(a)(2) of the Toxic Substances Control
Act (TSCA) for the 14 glymes identified
in this proposed rule. This action would
require persons who intend to
manufacture, import, or process these
chemical substances for an activity that
is designated as a significant new use by
this proposed rule to notify EPA at least
90 days before commencing that
activity. The required notification
would provide EPA with the
opportunity to evaluate the intended
use and, if necessary, to prohibit or limit
that activity before it occurs.
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SUMMARY:
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Comments must be received on
or before September 12, 2011.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2009–0767, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Document Control Office
(7407M), Office of Pollution Prevention
and Toxics (OPPT), Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001.
• Hand Delivery: OPPT Document
Control Office (DCO), EPA East Bldg.,
Rm. 6428, 1201 Constitution Ave., NW.,
Washington, DC. Attention: Docket ID
Number EPA–HQ–OPPT–2009–0767.
The DCO is open from 8 a.m. to 4 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
DCO is (202) 564–8930. Such deliveries
are only accepted during the DCO’s
normal hours of operation, and special
arrangements should be made for
deliveries of boxed information.
Instructions: Direct your comments to
docket ID number EPA–HQ–OPPT–
2009–0767. EPA’s policy is that all
comments received will be included in
the docket without change and may be
made available on-line at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through regulations.gov or
e-mail. The regulations.gov Web site is
an ‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an e-mail comment directly
to EPA without going through
regulations.gov, your e-mail address
will be automatically captured and
included as part of the comment that is
placed in the docket and made available
on the Internet. If you submit an
electronic comment, EPA recommends
that you include your name and other
contact information in the body of your
comment and with any disk or CD–ROM
you submit. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
EPA may not be able to consider your
comment. Electronic files should avoid
the use of special characters, any form
of encryption, and be free of any defects
or viruses.
Docket: All documents in the docket
are listed in the docket index available
DATES:
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at https://www.regulations.gov. Although
listed in the index, some information is
not publicly available, e.g., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
will be publicly available only in hard
copy. Publicly available docket
materials are available electronically at
https://www.regulations.gov, or, if only
available in hard copy, at the OPPT
Docket. The OPPT Docket is located in
the EPA Docket Center (EPA/DC) at
Rm. 3334, EPA West Bldg., 1301
Constitution Ave., NW., Washington,
DC. The EPA/DC Public Reading Room
hours of operation are 8:30 a.m. to
4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone
number of the EPA/DC Public Reading
Room is (202) 566–1744, and the
telephone number for the OPPT Docket
is (202) 566–0280. Docket visitors are
required to show photographic
identification, pass through a metal
detector, and sign the EPA visitor log.
All visitor bags are processed through
an X-ray machine and subject to search.
Visitors will be provided an EPA/DC
badge that must be visible at all times
in the building and returned upon
departure.
For
technical information contact: Amy
Breedlove, Chemical Control Division
(7405M), Office of Pollution Prevention
and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001; telephone
number: 202–564–9823; e-mail address:
breedlove.amy@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; e-mail address: TSCA–
Hotline@epa.gov.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you manufacture, import,
or process the chemicals listed in Unit
III.A. Potentially affected entities may
include, but are not limited to:
• Manufacturers, importers, or
processors of one or more of subject
chemical substances (North American
Industrial Classification System
(NAICS) codes 325 and 324110), e.g.,
chemical manufacturing and petroleum
refineries;
• All other basic organic chemical
manufacturing (NAICS 325199);
• Printing ink manufacturing (NAICS
325910);
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• Paint and Coating Manufacturing
(NAICS 325510);
• Adhesive Manufacturing (NAICS
325520);
• Primary Battery Manufacturing
(NAICS 335912); and
• Motor Vehicle Brake System
Manufacturing (NAICS 336340).
This listing is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
affected by this action. Other types of
entities not listed in this unit could also
be affected. The NAICS codes have been
provided to assist you and others in
determining whether this action might
apply to certain entities. 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. 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.
This action may also affect certain
entities through pre-existing import
certification and export notification
rules under TSCA. Persons who import
any chemical substance governed by a
final SNUR 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 proposed rule
on or after August 11, 2011 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.
B. What should I consider as I prepare
my comments for EPA?
1. Submitting CBI. Do not submit
confidential business information (CBI)
to EPA through regulations.gov or
e-mail. Clearly mark the part or all of
the information that you claim to be
CBI. For CBI information in a disk or
CD–ROM that you mail to EPA, mark
the outside of the disk or CD–ROM as
CBI and then identify electronically
within the disk or CD–ROM the specific
information that is claimed as CBI. In
addition to one complete version of the
comment that includes information
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claimed as CBI, a redacted copy of the
comment that does not contain the
information claimed as CBI must be
submitted for inclusion in the public
docket. Information so marked will not
be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments.
When submitting comments, remember
to:
i. Identify the document by docket ID
number and other identifying
information (subject heading, Federal
Register date and page number).
ii. Follow directions. The Agency may
ask you to respond to specific questions
or organize comments by referencing a
Code of Federal Regulations (CFR) part
or section number.
iii. Explain why you agree or disagree;
suggest alternatives and substitute
language for your requested changes.
iv. Describe any assumptions and
provide any technical information and/
or data that you used.
v. If you estimate potential costs or
burdens, explain how you arrived at
your estimate in sufficient detail to
allow for it to be reproduced.
vi. Provide specific examples to
illustrate your concerns and suggest
alternatives.
vii. Explain your views as clearly as
possible, avoiding the use of profanity
or personal
threats.
viii. Make sure to submit your
comments by the comment period
deadline identified.
II. Background
A. 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.’’ Since on-going
uses are by definition, not new, they are
identified and excluded from the SNUR.
EPA must make the determination of a
‘‘significant new use’’ by rule after
considering all relevant factors,
including those listed in TSCA section
5(a)(2). The relevant factors to be
considered are:
• The projected volume of
manufacturing and processing of a
chemical substance.
• The extent to which a use changes
the type or form of exposure of human
beings or the environment to a chemical
substance.
• The extent to which a use increases
the magnitude and duration of exposure
of human beings or the environment to
a chemical substance.
• The reasonably anticipated manner
and methods of manufacturing,
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processing, distribution in commerce,
and disposal of a chemical substance.
• In addition to the factors
enumerated in TSCA section 5(a)(2), the
statute authorizes EPA to consider any
other relevant factors.
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, import, or
process the chemical substance for that
use (15 U.S.C. 2604(a)(1)(B)). As
described in Unit VII., the general SNUR
provisions are found at 40 CFR Part 721,
Subpart A.
Section 26(c) of TSCA (15 U.S.C.
2625(c)) authorizes EPA to take action
under other sections of TSCA with
respect to categories of chemical
substances.
B. Why is the agency taking this action?
EPA has concerns about the 14 glymes
listed in this SNUR, all of which have
similar chemical structures. EPA is
concerned about the reproductive and/
or developmental toxicity of
monoglyme, diglyme, and ethylglyme
and believes that individuals could
suffer adverse effects from their use. In
addition, EPA has concerns about the
remaining 11 glymes due to the lack of
available use, exposure, and toxicity
information. Currently, exposure to
monoglyme in lithium batteries is very
limited since the batteries are sealed.
The amount of exposure to diglyme in
printing inks is less certain, but any
additional use would increase the
existing exposure to the chemical.
Ethylglyme currently has no consumer
uses but has been found in water
sources, its production level appears to
be increasing, and given its toxicity,
EPA would be concerned if this
chemical substance became prevalent in
consumer products. EPA further
believes that the use of any of these
chemical substances in consumer
products, beyond the limited, on-going
current uses, could significantly
increase the magnitude and duration of
exposure to humans and the
environment over that which would
otherwise exist and that such increase
should not occur without opportunity
for EPA review. Finally, for
pentaethylene glycol dibutyl ether and
butyltriglyme, which presently show no
reported production to the IUR or any
ongoing uses, EPA believes that any use
of these chemical substances could be a
significant increase in the magnitude
and duration of exposure to humans and
the environment over that which
currently exist.
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On March 18, 2008, EPA published
risk based prioritization related
documents on monoglyme and diglyme
(Refs. 1, 2, 3, and 4), which indicated
that it appeared these two chemical
substances are used in consumer
products and also indicated EPA’s
concerns about the potential health
effects of these two chemical
substances. Studies on monoglyme and
diglyme indicate adverse health effects
concerning reproductive and
developmental toxicity, as well as on
blood and blood-forming organs.
Studies on ethylglyme show
developmental toxicity as well as
potential for gene mutation. Several
manufacturers initially responded that,
with the exception of monoglyme use in
sealed lithium batteries, there are no
consumer uses. Follow up contact with
manufacturers revealed some additional
potential consumer uses and raised
questions about some of the other uses.
For monoglyme, diglyme, and
ethylglyme, as well as the remaining 11
chemicals, the level of toxicity is
uncertain and/or the type and extent of
the use of the chemical substance is
unclear. EPA is proposing to issue this
SNUR to require notification prior to
any new manufacturing, importing, or
processing of these chemicals for
consumer uses (with specified
exceptions), or in some cases all uses.
EPA intends to continue to monitor
production, use and other relevant
information on the subject substances
and, where appropriate, initiate further
action.
EPA previously published a SNUR on
November 29, 2005, (70 FR 71401),
(FRL–7740–7), on a major metabolite of
monoglyme, 2-methoxyethanol (2-ME),
CASRN 109–86–4, requiring notice to
the Agency before 2-ME is used in a
consumer product (40 CFR 721.10001)
(Ref. 5).
III. Significant New Use Determination
A. What chemicals are included in this
SNUR?
The proposed category of glymes to be
regulated by this SNUR consists of the
14 chemical substances shown in Table
1 and Table 2. Specifically, the
designated significant new use for the
glymes chemicals in Table 1 of this unit
would be ‘‘use in a consumer product,’’
with the exception of the ongoing uses
which are the excluded uses listed
under ‘‘Proposed Excluded Consumer
Uses,’’ and where the designated
significant new use for the chemicals in
Table 2 would be ‘‘any use.’’ ‘‘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.’’
While hazard data are only currently
available for 3 of the 14 chemical
substances in this category (see Unit
IV.D.), EPA is proposing to designate
significant new uses for all 14 chemical
substances listed in Tables 1 and 2 on
the basis of the available information.
Consistent with its authority under
TSCA section 26(c), EPA is proposing to
make all 14 chemical substances subject
to the significant new use rule based on
similarities in the molecular structures,
physical and chemical properties, uses,
and potential uses of the chemical
substances in the category. EPA
acknowledges that there are differences
in the ongoing uses of the 14 chemical
substances, and has accounted for those
differences by varying the proposed
significant new use designations for the
chemical substances, as shown in
Tables 1 and 2. Nonetheless, EPA
believes that the chemicals are
sufficiently similar such that it is
appropriate, for purposes of this SNUR,
to act on them together. EPA solicits
public comment on the scope of the
chemical substances to be subject to this
SNUR. Specifically, whether any of the
chemical substances included in the
category are sufficiently dissimilar from
the rest that they should be removed
from the category, or whether any
additional chemical substances are
sufficiently similar that they should be
added to the category.
TABLE 1—CHEMICALS WITH USE IN A CONSUMER PRODUCT AS THE PROPOSED SIGNIFICANT NEW USE AND PROPOSED
EXCLUDED CONSUMER USES
Chemical Abstract
Service
(CAS) Registry No.
(CASRN)
Chemical abstract index name
Common name
Proposed excluded consumer uses
110–71–4 ................
Ethane, 1,2-dimethoxy- ........................
111–96–6 ................
Ethane, 1,1′-oxybis[2-methoxy- ............
In electrolyte solutions for sealed lithium batteries.
As a solvent in printing inks for consumer products.
112–36–7 ................
Ethane, 1,1′-oxybis[2-ethoxy- ...............
112–49–2 ................
2,5,8,11-Tetraoxadodecane .................
Monoglyme or Monoethylene glycol dimethyl ether.
Diglyme or Diethylene glycol dimethyl
ether.
Ethyldiglyme or Diethylene glycol
diethyl ether.
Triglyme or Triethylene glycol dimethyl
ether.
—As a solvent in consumer adhesives.
—As a component of consumer brake
fluids.
—As a component of consumer paint/
graffiti removers.
—in consumer paints.
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112–73–2 ................
112–98–1 ................
143–24–8 ................
Butane,
1,1′-[oxybis(2,1ethanediyloxy)]bis-.
5,8,11,14,17-Pentaoxaheneicosane .....
2,5,8,11,14-Pentaoxapentadecane ......
Butyldiglyme or Diethylene glycol
dibutyl ether.
Tetraethylene glycol dibutyl ether.
Tetraglyme or Tetraethylene glycol dimethyl ether.
—As an HFC/CFC lubricant.
—As a solubilizing agent for consumer
printing inks.
—As a coalescing agent in consumer
paints.
629–14–1 ................
Ethane, 1,2-diethoxy- ...........................
4353–28–0 ..............
23601–39–0 ............
3,6,9,12,15-Pentaoxaheptadecane ......
3,6,9,12,15,18-Hexaoxaeicosane .........
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Ethylglyme or Ethylene glycol diethyl
ether.
Tetraethylene glycol diethyl ether.
Pentaethylene glycol diethyl ether.
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40853
TABLE 1—CHEMICALS WITH USE IN A CONSUMER PRODUCT AS THE PROPOSED SIGNIFICANT NEW USE AND PROPOSED
EXCLUDED CONSUMER USES—Continued
Chemical Abstract
Service
(CAS) Registry No.
(CASRN)
24991–55–7 ............
31885–97–9 ............
Chemical abstract index name
Common name
Proposed excluded consumer uses
Poly(oxy-1,2-ethanediyl), .alpha.-methyl-.omega.-methoxy-.
Poly(oxy-1,2-ethanediyl), .alpha.-butyl.omega.-butoxy-.
Polyglyme or Polyethylene glycol dimethyl ether.
Polyethylene glycol dibutyl ether.
Use in consumer paint strippers.
TABLE 2—CHEMICALS WITH ‘‘ANY USE’’ AS THE PROPOSED SIGNIFICANT NEW USE
Chemical abstract index name
51105–00–1 .........................
63512–36–7 .........................
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Chemical Abstract Service
(CAS) Registry No.
(CASRN)
5,8,11,14,17,20-Hexaoxatetracosane .............................
5,8,11,14-Tetraoxaoctadecane .......................................
B. What relevant factors were
considered for this SNUR?
To develop its preliminary
determination of what would constitute
a significant new use of the glymes
listed in Table 1 and Table 2, EPA
considered relevant information about
the toxicity of these substances, likely
human exposures and environmental
releases associated with possible uses,
and the four factors listed in section
5(a)(2) of TSCA and Unit II.A. of this
proposed SNUR.
The latest information available to
EPA, which is summarized in Unit IV.
of this SNUR, indicates that based on
historical production levels of five of
these chemicals, any production or
commencement of Inventory Update
Reporting (IUR) reporting would be
considered a significant change. For the
two chemicals which currently do not
appear to be in production or use,
commencement of production for any
use could result in a significant increase
in the type and form of exposure to both
humans and the environment. For the
seven chemicals which currently do not
have ongoing consumer uses, any
commencement of use in a consumer
product would change the type of
exposure to humans from indirect to
direct exposure and the form of
exposure from primarily inhalation to
both inhalation and skin exposure.
EPA believes that any shift from a
status of no uses in a consumer product
to any use in a consumer product would
increase the magnitude and duration of
exposure to consumers than would
otherwise exist since use of a consumer
product could result in more frequent,
direct, and longer exposures than the
infrequent or indirect exposures that
currently exist. Additional workers are
also likely to be exposed, as is the
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Common name
Pentaethylene glycol dibutyl ether.
Butyltriglyme or Triethylene glycol dibutyl ether.
surrounding environment at
manufacturing or processing sites, due
to possible increases in releases which
could contribute additional glymes into
the environment. Finally, EPA believes
that any changes in the reasonably
anticipated manner and methods of
manufacturing, processing, distribution
in commerce, or disposal of these
glymes could contribute to the type,
form, magnitude and duration of
exposure to humans and the
environment.
Based on these relevant factors, EPA
has preliminarily determined that the
manufacture, import, or processing of
ethyldiglyme, butyldiglyme,
tetraethylene glycol dibutyl ether,
ethylglyme, tetraethylene glycol diethyl
ether, pentaethylene glycol diethyl
ether, and polyethylene glycol dibutyl
ether for any use in a consumer product
is a significant new use. EPA has also
primarily determined that the
manufacture, import, or processing of
monoglyme, diglyme, triglyme,
tetraglyme, polyglyme for any use in a
consumer product, other than for the
ongoing uses listed in Table 1, is a
significant new use. In addition, EPA
has primarily determined that the
manufacture, import, or processing of
pentaethylene glycol dibutyl ether and
butyltriglyme for any use is a significant
new use.
C. What are EPA objectives for this
SNUR?
EPA wants to achieve the following
objectives with regard to the significant
new use(s) that are designated in this
proposed rule:
1. EPA would receive notice of any
person’s intent to manufacture, import,
or process the glymes listed in Table 1
and Table 2 for the described significant
new uses before that activity begins.
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2. EPA would have an opportunity to
review and evaluate data submitted in a
SNUN before the notice submitter
begins manufacturing, importing or
processing of the glymes listed in Table
1 and Table 2 for the described
significant new uses.
3. EPA would be able to regulate
prospective uses of the glymes listed in
Table 1 and Table 2 before the described
significant new uses of the chemical
substance occur, provided that
regulation is warranted pursuant to
TSCA sections 5(e), 5(f), 6 or 7.
IV. Summary of Relevant Available
Information on the Glymes
A. What are the ongoing uses of these
chemicals?
1. Known Ongoing Uses of Glymes. To
identify the ongoing consumer uses of
these glymes, as well as potential
industrial uses, EPA used information
submitted under the 2006 IUR rule,
contacted manufacturers, searched
business periodicals, and searched other
available sources. Monoglyme is used in
consumer products in electrolyte
solutions for sealed lithium batteries.
Industrial uses include printed circuit
board manufacturing; in reactions with
strong bases; in mixtures where solvent
separation and recovery is necessary; as
an inert special solvent; and as a solvent
in pharmaceutical production (Ref. 6,
p. 9).
Diglyme is used as a solvent in
printing inks for consumer products and
industrially as a solvent in a variety of
processes (Ref. 6, p. 10).
Triglyme is used in consumer
products in consumer brake fluids, as a
solvent in consumer adhesives, as a
component of consumer paint and
graffiti removers and in consumer
paints. Industrial uses include
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generation of chemicals, use as a
reaction solvent, and use as a binding
agent in porcelain powders (Ref. 6,
p. 11).
Tetraglyme is used in consumer
products as a solubilizing agent for
consumer printing inks, as a coalescing
agent in consumer paints, and as an
HFC/CFC lubricant which may be used
in consumer air conditioners. Industrial
uses include use as a solubilizing agent
in textiles and plastics, as a dye fixation
additive for cotton textiles, as a
fungicide process solvent, and as a gas
scrubbing agent (Ref. 6, p. 12).
Polyglyme is used in consumer paint
strippers. Industrial uses include use as
special, high boiling solvents for
chemical reactions, use as a solubilizing
agent for plastic, textile, and paper
processes, and use as a gas scrubbing
agent (Ref. 6, p. 13).
Ethyldiglyme, butyldiglyme,
tetraethylene glycol dibutyl ether,
ethylglyme, tetraethylene glycol diethyl
ether, pentaethylene glycol diethyl
ether, and polyethylene glycol dibutyl
ether, have no known uses in consumer
products. Industrial uses of these
glymes can include use: as a highboiling solvent for nitrocellulose, resins,
and lacquers; as a solubilizer in organic
synthesis; as a solvent in the production
of plastic resins and compounds, rubber
chemicals; as a solvent for conductive
printing ink; in the production of
printed circuit etchants; in the
preparation of and reaction with
Grignard reagents; in metal extractions;
as a solvent in pharmaceutical
syntheses; in the production of coatings;
and as a gas scrubbing liquid (Ref. 6, pp.
14–19).
The chemicals listed in Table 2,
pentaethylene glycol dibutyl ether and
butyltriglyme, have no known uses (Ref.
6, p. 19).
2. Potential for Other Ongoing Uses of
Glymes. In order to ascertain if there are
any ongoing uses of these glymes, EPA
used information submitted under the
IUR rule, contacted manufacturers,
searched business periodicals, and
searched other available sources. In
some instances, EPA could confirm the
existence of an ongoing use in a
consumer product from the information
reviewed. In other instances, the results
of EPA’s search were unclear, and EPA
could not confirm whether certain
reported consumer product uses were
actual ongoing uses.
Therefore, EPA is requesting public
comment on whether any of the
additional unconfirmed uses listed in
this unit are actual, ongoing uses in a
consumer product, and whether there
are any other ongoing uses in a
consumer product of the chemicals
listed in Table 1. For pentaethylene
glycol dibutyl ether and butyltriglyme,
EPA is requesting public comment on
whether there are any ongoing uses at
all (consumer or industrial). EPA does
not anticipate that it will add additional
exclusions to the final rule, beyond
those listed in Table 1, except where
public comment adequately
substantiates the existence of a claimed
additional ongoing use.
TABLE 3—REPORTED CONSUMER USES OF GLYMES THAT ARE UNCONFIRMED
Common name
Additional unconfirmed reports of use
(In addition to any confirmed ongoing consumer uses listed in table 1)
Monoglyme ......................................
Treat aluminum surfaces to ensure surfaces are less reactive, inner and outer layer etching of printed circuit board manufacturing.
Component in automotive care products, a component of brake fluid, a component in paints and coatings,
and a component in adhesives and sealants.
Component in paint and paint varnishes, use in coatings manufacturing, use in adhesives manufacturing,
and as a solvent in printing.
None in consumer products.
None in consumer products.
Use as an ingredient in consumer brake fluid.
Use in fabrics, textiles and apparel.
Use as a solvent in consumer paint production, use as an adhesive solvent, use as a polycarbonate swelling agent, use in consumer polishes and related products.
Use as an ingredient in consumer brake fluid.
Use as an ingredient in consumer brake fluid, use in the soldering of electronic circuit boards.
Use in adhesive removers, use in fragrance production, use in anti-fog compounds, use in brake fluid, use
in automotive care products, and use in paper products.
Use in the production of gel laundry detergents.
None.
None.
Diglyme ...........................................
Ethyldiglyme ....................................
Triglyme ..........................................
Butyldiglyme ....................................
Tetraethylene glycol dibutyl ether ...
Tetraglyme ......................................
Ethylglyme .......................................
Tetraethylene glycol diethyl ether ...
Pentaethylene glycol diethyl ether ..
Polyglyme ........................................
Polyethylene glycol dibutyl ether ....
Pentaethylene glycol dibutyl ether ..
Butyltriglyme ....................................
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B. What are the estimated production
levels of these chemicals?
The 2006 IUR regulation required
manufacturers and importers of certain
chemical substances included on the
TSCA Chemical Substance Inventory to
report site and manufacturing
information for chemicals manufactured
(including imported) in amounts of
25,000 pounds or greater at a single site.
For monoglyme and diglyme, EPA
expects that current production levels
will continue. For triglyme and
ethylglyme, predicting future
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production is infeasible, although
ethylglyme production appears to be
increasing. For ethyldiglyme,
butyldiglyme, and tetraglyme, EPA
expects that production will remain at
the previous levels. Production of
pentaethylene glycol diethyl ether
appears to be steadily increasing. For
polyglyme, EPA expects that production
will continue to decrease and/or remain
the same. For tetraethylene glycol
dibutyl ether, tetraethylene glycol
diethyl ether, polyethylene glycol
dibutyl ether, pentaethylene glycol
dibutyl ether, and butyltriglyme, EPA
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expects that production of these
chemical substances, if any, will remain
below reporting levels. Previous IUR
reporting rules required that chemicals
produced at amounts of 10,000 pounds
or greater be reported. Table 3
summarizes 2006 and prior year IUR
data for the 14 glymes. The projected
trends are based on the IUR data from
1986–2006. The projections may not be
precise since the IUR data does not
reflect 100% of chemicals and their
production and requirements for
reporting have varied over time.
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TABLE 4—PRODUCTION REPORTING AMOUNTS TO IUR 1986–2006 (REF. 6)
2006 IUR reporting
Monoglyme .........................................................................
>1 million (M)–<10M lbs .....................
Diglyme ..............................................................................
Ethyldiglyme .......................................................................
Triglyme ..............................................................................
Butyldiglyme .......................................................................
Tetraethylene glycol dibutyl ether ......................................
Tetraglyme .........................................................................
Ethylglyme ..........................................................................
Tetraethylene glycol diethyl ether ......................................
Pentaethylene glycol diethyl ether .....................................
>1M–<10M lbs ....................................
>10K–<500K lbs .................................
No report .............................................
>10K–<500K lbs .................................
No report .............................................
>10K–<500K lbs .................................
>10K–<500K lbs .................................
No report .............................................
>1M–<10M lbs ....................................
Polyglyme ...........................................................................
10–500K ..............................................
Polyethylene glycol dibutyl ether .......................................
Pentaethylene glycol dibutyl ether .....................................
Butyltriglyme .......................................................................
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Common name
No report .............................................
No report .............................................
No report .............................................
C. What are the potential routes and
sources of exposure for these chemicals?
The following are summaries of the
potential routes and sources of exposure
for these chemicals considering ongoing
current uses. More detailed information
can be found in the Exposure
Characterization documents for
monoglyme and diglyme (Refs. 1, 2) and
in the description of ethylglyme in the
Hazardous Substances Data Bank (Ref.
7).
1. Potential exposures to the
environment, consumers, and general
population. The exposures described in
this unit reflect the actual and/or
potential indirect exposures to the
environment, consumers, and the
general population resulting from
ongoing industrial and commercial uses
of these glymes. Consumer uses,
however, also potentially allow for the
direct exposure to skin from product
handling and more immediate
inhalation exposures resulting from
proximity to the product. However,
little to no data is available for those
types of use scenarios.
Monoglyme, diglyme, ethyldiglyme,
triglyme, butyldiglyme, and ethylglyme
are included in the category of
chemicals reported as ‘‘certain glycol
ethers’’ under the ID number N230 in
the Toxics Release Inventory (TRI) (Ref.
8). The total release reported to the TRI
in 2007 from all reporting sites was
18,476,420 pounds. This total includes
air releases of 16,416,033 pounds from
on-site fugitive and point sources, in
addition to on-site water releases of
87,035 pounds. Most of the remaining
volume of release was deep-well
injected, sent to land treatment,
transferred for energy recovery or
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transferred to a Publicly Owned
Treatment Works (POTW). Release
information about the individual glymes
within the larger glycol ether category is
not known (Ref. 9). Manufacturers,
importers, or processors are required to
report releases of chemicals on the TRI
when total manufacturing, imports or
processing by a facility equals 25,000
pounds/year for the chemicals
combined.
Ethylglyme was found in the US EPA
Office of Water Storage and Retrieval
(STORET) database indicating potential
environmental exposure since this
chemical substance was found in
ground water and/or surface water (Ref.
9).
Monitoring data indicate that the
general population may be exposed to
diglyme and ethyldiglyme via
inhalation of vehicle exhaust and
ingestion of contaminated drinking
water (Refs. 10 and 11). Diglyme was
listed as a contaminant found in
drinking water (Ref. 10).
Diglyme has been detected in diluted
vehicle exhaust from a light-duty truck
using different fuel types (Ref. 10).
Industrial manufacture and
processing may result in the release of
glymes to the environment through
various waste streams (Ref. 10).
Diglyme, ethyldiglyme, and ethylglyme
have been found at measurable
concentrations in industrial wastewater
treatment systems (Refs. 10, 11, and 7).
Wastewater treatment systems discharge
to either surface waters or publicly
owned treatment works. Either of these
two discharge options could result in
exposures for the general population
and the environment to these chemicals.
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Prior IUR reporting
1986: >10 thousand (K)–<500K lbs.
1990–2002: >1M–<10M lbs. each year.
1986–2002: >1M–<10M lbs. each year.
1986–2002: >10K–<500K lbs. each year.
1994–2002: >10K–<500K lbs. each year.
1990–2002: >10K–<500K lbs. each year.
No reports 1986–2002.
1986–2002: >10K–<500K lbs. each year.
1986–2002: No reports.
No reports 1986–2002.
1986 & 1990: >10K–<500K lbs. each year.
1994: No report.
1998: >500K–<1M lbs.
2002: >1M–<10M lbs.
1986: >1M–<10M lbs.
1994: No report.
1998, 2002: >10K–<500K lbs. each year.
No reports 1986–2002.
No reports 1986–2002.
No reports 1986–2002.
Ethyldiglyme has been qualitatively
detected in drinking water from
Cincinnati, OH; in ground water from
the Hipps Road Landfill in Jacksonville,
FL; in trench leachates from Maxey
Flats, KY and West Valley, NY low-level
radioactive waste disposal sites and in
advanced waste treatment water from
Lake Tahoe, CA, Pomona, CA, and Blue
Plains, Washington, DC (Ref. 11).
Ethylglyme has been detected in
western Cleveland, OH wastewater
influents at 140 μg/L and it was
identified in Chicago Central water
works water (treated and untreated) at
2 μg/L (Ref. 7).
Monitoring data for ethylglyme
indicates that the general population
may be exposed to the chemical
substance through releases from
manufacturing facilities. The general
population can then be exposed via
inhalation of ambient air, ingestion of
drinking water, and dermal contact with
these substances and other products
containing these chemicals. Evidence of
releases from industrial manufacturing
and processing is demonstrated by
concentrations of 400 milligrams per
liter (mg/L) of diglyme which have been
found in activated sludge from the
waste treatment facility of the industry
producing the chemical substance
(Ref. 7).
For the remaining chemicals in Table
1 or Table 2, little or no release
information was found.
EPA’s Source Ranking Databank (Ref.
12) shows metal polish and polishing
cloths and papers as containing
ethylglyme. Most of the entries in this
databank for consumer products are
from the late 1990s and therefore may
not still be current. If ethylglyme is still
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found in these products, however, there
is potential that consumers and children
might be exposed to this chemical
substance from these consumer
products. Furthermore, production of
ethylglyme appears to be increasing.
Based on IUR data and
communications with manufacturers,
EPA believes that monoglyme is used as
a component of lithium batteries and
diglyme is used in printing inks, both of
which are consumer applications of
monoglyme. It is believed that disposal
of the lithium batteries containing
monoglyme and paper with printing
inks containing diglyme could present
the potential for release of these
chemicals to environmental media and
subsequent exposure to humans and
ecological receptors.
2. Potential occupational exposure.
Occupational exposure to these
chemicals may occur through inhalation
and dermal contact at workplaces where
the chemicals are produced or used.
Monoglyme, diglyme, ethylglyme,
ethyldiglyme, triglyme, and
tetraethylene glycol diethyl ether all
have vapor pressures high enough to
potentially result in significant
exposures to workers if they are near the
chemical substance (Refs. 1, 2, 9, and
13). Based on IUR data, ethyldiglyme,
butyldiglyme, tetraglyme, pentaethylene
glycol diethyl ether, and polyglyme are
manufactured in liquid forms, and
worker exposures through dermal
contact are possible (Ref. 13).
These chemicals do not have
Occupational Safety and Health
Administration (OSHA) Permissible
Exposure Limits (PELs) (Refs. 1, 2, and
9). Ferro Corporation, in their
publications, recommended a Threshold
Limit Value (TLV) for glycol ethers of 5
parts per million (ppm) (Time Weighted
Average (TWA)) with a Short Term
Exposure Limit (STEL) of 25 ppm. The
15-minute STEL should not be achieved
more than 4 times in 8 hours. For
women of child-bearing potential, Ferro
recommended a TLV of 1 ppm with a
STEL of 5 ppm (Ref. 14).
Based on the 2006 IUR reports, the
maximum total number of potentially
exposed industrial workers to
monoglyme and ethylglyme during
manufacturing and industrial processing
and use is less than 100 each, and the
maximum total number of workers
likely to be exposed to diglyme was
between 100 and 999 workers. There
may, however, be additional potentially
exposed industrial workers who are not
included in these estimates since not all
production volume may have been
accounted for in the IUR (production
below 25,000 pounds at a site does not
have to be reported to the IUR), and
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commercial workers may be exposed as
well (Refs. 1, 2, and 15).
D. What are the potential health effects
of these chemicals?
The following are summaries of the
potential health effects of these
chemicals considering ongoing current
uses. More detailed information can be
found in the Hazard Characterization
documents for monoglyme and diglyme
(Refs. 3, 4) and in the description of
ethylglyme in the Hazardous Substances
Data Bank (Ref. 7).
Toxicology studies in laboratory
animals have shown that exposure to
monoglyme results in hemolytic effects
(destruction of red blood cells), and
developmental and reproductive
toxicity. The acute toxicity of
monoglyme is low via oral, dermal and
inhalation routes of exposure.
Monoglyme’s chronic adverse health
effects generally fall into the moderate
to high hazard range based on the
classification ranges used in the
Globally Harmonized System for
Classification and Labeling of Chemicals
(GHS). The potential toxicity from
repeated exposure to monoglyme was
assessed using a major metabolite, 2methoxyethanol (CASRN 109–86–4).
Oral 90-day studies of 2methoxyethanol in rats and mice
showed testicular degeneration and
adverse effects on the process of blood
cell formation. The lowest observed
adverse effect level (LOAEL) in rats was
70 milligrams/kilograms (mg/kg)-day;
the LOAEL in mice was 300 mg/kg-day.
An oral prenatal developmental toxicity
study of monoglyme in rats showed fetal
mortality at doses as low as 60 mg/kgday, and edema at doses as low as 30
mg/kg-day. An oral prenatal
developmental toxicity study of
monoglyme in mice showed reduced
fetal body weight and increased skeletal
defects at 250 mg/kg-day. Available data
also suggest that monoglyme has the
potential to be genotoxic (Ref. 3).
Toxicology studies in laboratory
animals have shown that exposure to
diglyme results in hemolytic effects
(destruction of red blood cells), and
developmental and reproductive
toxicity. The acute toxicity of diglyme to
rats via the oral and inhalation routes of
exposure is low. The chronic adverse
health effects of diglyme generally fall
into the moderate to high hazard range
based on the classification ranges used
in the GHS. The toxicity profile
following repeated exposures to diglyme
is similar to the profile for monoglyme.
Rats showed testicular degeneration and
hemolytic effects following inhalation
exposure to diglyme for two weeks at
concentrations as low as 0.6 mg/L-day;
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a NOAEL was not established. An
inhalation dominant-lethal study in rats
showed a reduced pregnancy rate at 5.5
mg/L-day (5.5 ppm in air). An oral
prenatal developmental toxicity study
in mice showed effects on fetal growth
and viability, and an increase in
malformations at 125 mg/kg-day; the
NOAEL was 62.5 mg/kg-day. In vitro
gene mutation and in vivo chromosomal
aberration tests were negative (Ref. 4).
Toxicology studies in laboratory
animals have shown that exposure to
ethylglyme results in developmental
toxicity. The acute toxicity of
ethylglyme is low in rats. Oral prenatal
developmental toxicity studies of
ethylglyme in mice and rabbits showed
a significant decrease in fetal body
weight and viability, and a significant
increase in malformations; the NOAEL
for developmental toxicity was 50 mg/
kg-day in mice and 25 mg/kg-day in
rabbits (Ref. 7), both falling into the high
chronic hazard range based on the GHS.
Based on a review of the literature,
there is insufficient information
available to arrive at any health effects
related conclusions for the remaining
chemicals in Table 1 or Table 2.
V. Alternatives Considered for This
SNUR
Before proposing this SNUR, EPA
considered promulgating a TSCA
section 8(a) reporting rule for these
glymes. Under a TSCA section 8(a) rule,
EPA could, among other things,
generally require persons to report
information to the Agency when they
intend to manufacture, import, or
process a listed chemical substance for
a specific use or any use. However, for
these glymes, the use of TSCA section
8(a) rather than SNUR authority would
have several limitations. First, if EPA
was to require reporting under TSCA
section 8(a) instead of TSCA section
5(a), EPA would not have the
opportunity to review human and
environmental hazards and exposures
associated with the proposed significant
new use and, if necessary, take
immediate follow-up regulatory action
under TSCA sections 5(e) or 5(f) to
prohibit or limit the activity before it
begins. In addition, EPA may not
receive important information from
small businesses, because such firms
generally are exempt from TSCA section
8(a) reporting requirements. In view of
the level of health and environmental
concerns about monoglyme, diglyme,
and ethylglyme if used for the proposed
significant new use, and the lack of
information to be able to judge exposure
for the remaining glymes, EPA believes
that a TSCA section 8(a) rule for this
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substance would not meet EPA’s
regulatory objectives.
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VI. Applicability of 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 begin commercial
manufacture, import, or processing of
the chemical substance(s) that would be
regulated through this proposed rule, if
finalized, would have to cease any such
activity before the effective date of the
rule if and when finalized. To resume
their activities, these persons would
have to comply with all applicable
SNUR notice requirements and wait
until the notice review period,
including all extensions, expires. EPA
has 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 section 721.45(h),
that person would be considered to have
met the requirements of the final SNUR
for those activities.
VII. 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
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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 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
identified in a final SNUR 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.
VIII. Test Data and Other Information
EPA recognizes that TSCA section 5
does not require developing any
particular test data before submission of
a SNUN. There are two exceptions: i.
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 ii. 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 include data that would
permit a reasoned evaluation of risks
posed by the chemical substance during
its manufacture, 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.
SNUN submitters should be aware
that EPA will be better able to evaluate
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SNUNs that provide detailed
information on:
1. Human exposure and
environmental releases that may result
from the significant new uses of the
chemical substances.
2. Potential benefits of the chemical
substances.
3. Information on risks posed by the
chemical substances compared to risks
posed by potential substitutes.
IX. SNUN Submissions
EPA recommends that submitters
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
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 to EPA, on EPA Form
No. 7710–25 in accordance with the
procedures set forth in 40 CFR 721.25
and 720.40.
Readers are reminded that EPA
published a final rule at 75 FR 773 on
January 6, 2010, (FRL–8794–5) that
established standards and requirements
for the use of the electronic-PMN
(e-PMN) software and EPA’s Central
Data Exchange (CDX) to electronically
submit these notices. The Agency is
introducing electronic reporting via
CDX using the e-PMN in three phases
over a two-year period. The effective
date of the rule was April 6, 2010.
During the first year following the
effective date of the final rule,
submissions will be permitted via CDX,
optical disc, or paper. After April 6,
2011, paper submissions will no longer
be accepted. After April 6, 2012, all
submissions will be required to be
submitted electronically via CDX.
Regardless of the delivery method, after
April 6, 2010, EPA requires that all
submissions be generated using the new
e-PMN software. For additional
information and instructions go to:
https://www.epa.gov/opptintr/
newchems//epmn/epmn-index.htm.
Until April 6, 2012, SNUNs may still be
mailed to the Environmental Protection
Agency, OPPT Document Control Office
(7407M), 1200 Pennsylvania Avenue,
NW., Washington, DC 20460–0001.
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X. Economic Analysis
A. SNUNs
EPA has evaluated the potential costs
of establishing SNUR reporting
requirements for potential
manufacturers, importers, and
processors of the chemical substances
included in this proposed rule. While
most businesses are subject to a
$2,500 user fee required by 40 CFR
700.45(b)(2)(iii), small businesses with
annual sales of less than $40 million
when combined with those of the parent
company (if any) are subject to 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 proposed SNUR. Furthermore,
EPA believes that the expense of
submitting a notice (approximately
$6,000 plus the user fee) is unlikely to
discourage innovations of high potential
value. EPA’s complete economic
analysis is available in the public docket
for this proposed rule (Ref. 16).
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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
TSCA section 5. For persons exporting
a substance the subject of a SNUR, a
one-time notice must be provided for
the first export or intended export to a
particular country. EPA estimates the
one-time cost to be approximately $937
per exporter including mailing costs.
The total costs of export notification
will vary by chemical, depending on the
number of required notifications (i.e.,
the number of countries to which the
chemical substance is exported).
Because EPA is unable to make an
estimate of the likely number of export
notifications for the chemicals covered
in this proposed SNUR, a total export
notification cost is not available.
XI. Request for Public Comment
EPA welcomes comment on all
aspects of this proposed rule. In
addition, EPA is particularly interested
in receiving stakeholder input on a
number of issues that were identified for
public comment earlier in this proposed
rule. Please provide comments on the
following issues:
1. Scope of the chemical substances to
be subject to this SNUR. While hazard
data are only currently available for 3 of
the 14 chemical substances in the
glymes chemical category identified in
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this proposed rule (see Unit IV.D.), EPA
is proposing to designate significant
new uses for all 14 chemical substances
listed in Tables 1 and 2 in Unit III.A. on
the basis of the available information.
As discussed in Unit III.A. of this
document, EPA believes that the
chemicals are sufficiently similar such
that it is appropriate, for purposes of
this SNUR and consistent with TSCA
section 26(c), to act on them together.
However, EPA would be interested in
hearing whether any of the chemical
substances included in the category are
sufficiently dissimilar from the rest such
that they should be removed from the
category, or whether any additional
chemical substances are sufficiently
similar such that they should be added
to the category.
2. Ongoing uses. EPA solicits
comment on whether any of the
additional unconfirmed uses listed in
this proposed rule are actual ongoing
uses in a consumer product, and
whether there are any other ongoing
uses in a consumer product of the
chemicals listed in Table 1 in Unit III.A.
For pentaethylene glycol dibutyl ether
and butyltriglyme, EPA is soliciting
comment on whether there are any
ongoing uses at all (consumer or
industrial). In providing comments on
ongoing uses, it would be most helpful
if you provide sufficient information for
EPA to adequately substantiate the
existence of a claimed additional
ongoing use.
XII. References
The following is a list of the
documents that are specifically
referenced in this proposed rule and
placed in the public docket that was
established under Docket ID No. EPA–
HQ–OPPT–2009–0767. The docket
includes information considered by EPA
in developing this proposed rule. In
addition, interested parties should
consult documents that are referenced
in the documents that EPA has placed
in the public docket, regardless of
whether these referenced documents are
physically located in the public docket.
1. US EPA. Screening-Level Exposure
Characterization of High Production
Volume Chemicals: 1,2Dimethoxyethane
(CAS No. 110–71–4), [9th CI Name:
Ethane, 1,2-dimethoxy-]. March 2008,
page 21. https://www.epa.gov/chemrtk/
hpvis/rbp/Monoglyme.110714.Web.
SupportDocs.31408.pdf.
2. US EPA. Screening-Level Exposure
Characterization of High Production
Volume Chemicals: Diglyme
(CAS No. 111–96–6), [9th CI Name:
Bis(2-methoxyethyl) Ether]. March 2008,
page 16. https://www.epa.gov/chemrtk/
PO 00000
Frm 00020
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hpvis/rbp/Diglyme.111966.Web.Support
Docs.031808.pdf.
3. US EPA. Screening-Level Hazard
Characterization of High Production
Volume Chemicals: 1,2Dimethoxyethane (CAS No. 110–71–4),
[9th CI Name: Ethane, 1,2-dimethoxy-].
February 2008, page 6. https://
www.epa.gov/chemrtk/hpvis/rbp/
Monoglyme.110714.Web.Support
Docs.31408.pdf.
4. US EPA. Screening-Level Hazard
Characterization of High Production
Volume Chemicals: Diglyme (CAS No.
111–96–6), [9th CI Name: Bis(2methoxyethyl) Ether]. February 2008,
page 6. https://www.epa.gov/chemrtk/
hpvis/rbp/Diglyme.111966.Web.Support
Docs.031808.pdf
5. US EPA. ‘‘2-ethoxyethanol, 2ethoxyethanol acetate, 2methoxyethanol, and 2-methoxyethanol
acetate; Significant New Use Rule.’’ 70
FR 71401. November 29, 2005.
6. Wilson, Kimberly; Tome, Alice; and
Narayan, Tulika, Abt Associates, Inc.
‘‘Memorandum to EPA, Nishkam
Agarwal, ‘Actual and Potential Uses of
Fourteen Selected Glymes.’ ’’ September
9, 2009.
7. Hazardous Substances Data Bank (HSDB).
Entry for Ethylene glycol diethyl ether,
CASRN 629–14–1. Accessed on October
30, 2009. https://toxnet.nlm.nih.gov.
8. US EPA. TRI Web site. https://
www.epa.gov/ttn/atw/glycol2000.pdf.
9. US EPA. Exposure Characterization for
Ethylglyme. November 6, 2009.
10. Hazardous Substances Data Bank (HSDB).
Hazardous Substances Data Bank. Entry
for diglyme. Accessed October 30, 2009.
https://toxnet.nlm.nih.gov.
11. Hazardous Substances Data Bank (HSDB).
Entry for CASRN 112–36–7. Accessed on
October 28, 2009. https://
toxnet.nlm.nih.gov.
12. The Source Ranking Database is an EPA
database that performs a systematic
screening-level review of over 12,000
potential indoor pollution sources to
identify high-priority product and
material categories for further evaluation.
It can also identify the products that
have contained a specific chemical. May
1997. https://www.epa.gov/oppt/
exposure/pubs/srd_apdx.pdf.
13. US EPA. Physical-Chemical Properties
and Fate Characterization: Glycol Ethers.
Washington, DC: U.S. EPA/OPPT/EETD/
EAB. August 2009.
14. Ferro Corporation. 1,2-Dimethoxyethane
US EPA HPV Challenge Program
Submission. December 2001, pages 7–8
of 93.
15. US EPA. IUR database search results for
number of workers exposed to
ethylglyme, https://cfpub.epa.gov/
iursearch/
2006_iur_natlcheminfo.cfm?id=3975.
Accessed on October 21, 2009.
16. US EPA. Economic Analysis of the
Proposed Significant New Use Rule for
14 Glymes. Washington, DC: U.S. EPA/
OPPT/EETD/EPAB. January 12, 2010.
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Federal Register / Vol. 76, No. 133 / Tuesday, July 12, 2011 / Proposed Rules
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 the
Unfunded Mandates Reform Act of 1995
(UMRA), 2 U.S.C. 1531–1538.
B. Paperwork Reduction Act
According to the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., 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. The information collection
requirements related to this action have
already been approved by OMB
pursuant to the PRA under OMB control
number 2070–0038 (EPA ICR No. 1188).
This action does not impose any burden
requiring additional OMB approval. If
an entity were to submit a SNUN to the
Agency, the annual burden is estimated
to average 110 hours per response. This
burden estimate includes the time
needed to review instructions, search
existing data sources, gather and
maintain the data needed, and
complete, review, and submit the
required SNUN. Send any comments
about the accuracy of the burden
estimate, and any suggested methods for
minimizing respondent burden,
including through the use of automated
collection techniques, to the Director,
Collection Strategies Division, Office of
Environmental Information (2822T),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001. Please remember to
include the OMB control number in any
correspondence, but do not submit any
completed forms to this address.
significant adverse economic impact on
a substantial number of small entities.
Under RFA, small entities include small
businesses, small organizations, and
small governmental jurisdictions. For
purposes of assessing the impacts of this
proposed rule on small entities, small
entity is defined in accordance with
RFA section 601 as:
1. A small business as defined by the
Small Business Administration’s (SBA)
regulations at 13 CFR 121.201.
2. A small governmental jurisdiction
that is a government of a city, county,
town, school district or special district
with a population of less than 50,000.
3. A small organization that is any
not-for-profit enterprise which is
independently owned and operated and
is not dominant in its field.
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 activity. Since this
proposed SNUR would require a person
who intends to engage in such activity
in the future to first notify EPA by
submitting a 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 conduct 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
over 1,000 SNURs, the Agency receives
on average only 5 notices per year. Of
those SNUNs submitted, only one
appears to be from a small entity in
response to any SNUR. 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.
C. Small Entity Impacts
Pursuant to section 605(b) of the
Regulatory Flexibility Act (RFA), 5
U.S.C. 601 et seq., the Agency hereby
certifies that this action will not have a
D. Unfunded Mandates Reform Act
Based on EPA’s experience with
proposing and finalizing SNURs, State,
local, and Tribal governments have not
been impacted by these rulemakings,
I. Technical Standards
Because this action does not involve
any technical standards, section 12(d) of
the National Technology Transfer and
Advancement Act of 1995 (NTTAA) (15
XIII. Statutory and Executive Order
Reviews
A. Regulatory Planning and Review
Under Executive Order 12866,
entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993),
the Office of Management and Budget
(OMB) has designated this a ‘‘significant
regulatory action’’ under section 3(f) of
the Executive Order. Accordingly, this
action was submitted to OMB for review
under Executive Order 12866 and any
changes made in response to OMB
recommendations have been
documented in the docket for this
rulemaking as required by section
6(a)(3)(E) of the Executive Order.
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E. Federalism
This action would 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, entitled
Federalism (64 FR 43255, August 10,
1999).
F. Tribal Implications
This proposed rule would not have
Tribal implications because it is not
expected to have substantial direct
effects on Indian Tribes. This proposed
rule would not significantly or uniquely
affect the communities of Indian Tribal
governments, nor would it involve or
impose any requirements that affect
Indian Tribes. Accordingly, the
requirements of Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000), do not apply
to this proposed rule.
G. Children’s Health Protections
This action is not subject to Executive
Order 13045, entitled Protection of
Children from Environmental Health
Risks and Safety Risks (62 FR 19885,
April 23, 1997), because this is not an
economically significant regulatory
action as defined by Executive Order
12866, and this action does not address
environmental health or safety risks
disproportionately affecting children.
H. Affect on Energy Supply,
Distribution, or Use
This proposed rule is not subject to
Executive Order 13211, entitled Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001), because this action is not
expected to affect energy supply,
distribution, or use.
E:\FR\FM\12JYP1.SGM
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40860
Federal Register / Vol. 76, No. 133 / Tuesday, July 12, 2011 / Proposed Rules
U.S.C. 272 note), does not apply to this
action.
J. Environmental Justice
This action does not entail special
considerations of environmental justice
related issues as delineated by
Executive Order 12898, entitled Federal
Actions to Address Environmental
Justice in Minority Populations and
Low-Income Populations (59 FR 7629,
February 16, 1994).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
Dated: June 30, 2011.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and
Toxics.
Therefore, it is proposed that 40 CFR
chapter I be amended as follows:
PART 721—[AMENDED]
1. The authority citation for part 721
continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and
2625(c).
2. Add § 721.10229 to subpart E to
read as follows:
§ 721.10229
Glymes.
Chemical substances and significant
new uses subject to reporting. The
chemical substances identified in Table
1 are subject to reporting under this
section for the significant new uses
described in Table 1, Column 3
‘‘Significant New Use.’’
TABLE 1—CHEMICALS SUBJECT TO REPORTING AND DESIGNATED SIGNIFICANT NEW USES
CAS Registry No.
(CASRN)
CA index name
Significant new use
110–71–4 .............................
Ethane, 1,2-dimethoxy- ...................................................
111–96–6 .............................
Ethane, 1,1′-oxybis[2-methoxy- .......................................
112–36–7 .............................
112–49–2 .............................
Ethane, 1,1′-oxybis[2-ethoxy- ..........................................
2,5,8,11-Tetraoxadodecane ............................................
112–73–2 .............................
112–98–1 .............................
143–24–8 .............................
Butane, 1,1′-[oxybis(2,1-ethanediyloxy)]bis- ...................
5,8,11,14,17-Pentaoxaheneicosane ................................
2,5,8,11,14-Pentaoxapentadecane .................................
629–14–1 .............................
4353–28–0 ...........................
23601–39–0 .........................
24991–55–7 .........................
Ethane, 1,2-diethoxy- ......................................................
3,6,9,12,15-Pentaoxaheptadecane .................................
3,6,9,12,15,18-Hexaoxaeicosane ....................................
Poly(oxy-1,2-ethanediyl),
.alpha.-methyl-.omega.methoxy-.
Poly(oxy-1,2-ethanediyl), .alpha.-butyl-.omega.-butoxy5,8,11,14,17,20-Hexaoxatetracosane .............................
5,8,11,14-Tetraoxaoctadecane .......................................
Any use in a consumer product except in electrolyte solutions for sealed lithium batteries.
Any use in a consumer product except as a solvent in
printing inks for consumer products.
Any use in a consumer product.
Any use in a consumer product except:
—As a solvent in consumer adhesives.
—As a component of consumer brake fluids.
—As a component of consumer paint/graffiti removers.
—In consumer paints.
Any use in a consumer product.
Any use in a consumer product.
Any use in a consumer product except:
—As an HFC/CFC lubricant.
—As a solubilizing agent for consumer printing
inks.
—As a coalescing agent in consumer paints.
Any use in a consumer product.
Any use in a consumer product.
Any use in a consumer product.
Any use in a consumer product except in consumer
paint strippers.
Any use in a consumer product.
Any use.
Any use.
31885–97–9 .........................
51105–00–1 .........................
63512–36–7 .........................
Notice of intent; request for
scoping comments.
ACTION:
[FR Doc. 2011–17084 Filed 7–11–11; 8:45 am]
BILLING CODE 6560–50–P
Pursuant to the National
Environmental Policy Act (NEPA),
NHTSA plans to analyze the potential
environmental impacts of the agency’s
rulemaking to implement the Pedestrian
Safety Enhancement Act of 2010. The
Pedestrian Safety Enhancement Act
mandates a rulemaking to establish a
standard requiring electric and hybrid
vehicles to be equipped with a
pedestrian alert sound system that
would activate in certain vehicle
operating conditions to aid visuallyimpaired and other pedestrians in
detecting the presence, direction,
location, and operation of those
vehicles.
Under NEPA, once an agency
determines the purpose and need of the
SUMMARY:
DEPARTMENT OF TRANSPORTATION
National Highway Traffic Safety
Administration
49 CFR Part 571
jdjones on DSK8KYBLC1PROD with PROPOSALS-1
[Docket No. NHTSA–2011–0100]
Notice of Intent To Prepare an
Environmental Assessment for
Pedestrian Safety Enhancement Act of
2010 Rulemaking
National Highway Traffic
Safety Administration (NHTSA),
Department of Transportation (DOT).
AGENCY:
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proposed federal action, it engages in
scoping. This is the process by which
the scope of the issues and the
alternatives to be examined are
determined. This notice initiates the
scoping process by inviting comments
from Federal, State, and local agencies,
Indian Tribes, and the public to help
identify the environmental issues and
reasonable alternatives to be examined
under NEPA. This notice also provides
guidance for participating in the scoping
process and additional information
about the alternatives NHTSA expects to
consider in its NEPA analysis.
DATES: The scoping process will
culminate in the preparation and
issuance of an Environmental
Assessment (EA), which will be made
available for public comment. To ensure
that NHTSA has an opportunity to
consider scoping comments fully and to
E:\FR\FM\12JYP1.SGM
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Agencies
[Federal Register Volume 76, Number 133 (Tuesday, July 12, 2011)]
[Proposed Rules]
[Pages 40850-40860]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17084]
=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2009-0767; FRL-8877-8]
RIN 2070-AJ52
Glymes; Proposed Significant New Use Rule
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing a significant new use rule (SNUR) under
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the 14
glymes identified in this proposed rule. This action would require
persons who intend to manufacture, import, or process these chemical
substances for an activity that is designated as a significant new use
by this proposed rule to notify EPA at least 90 days before commencing
that activity. The required notification would provide EPA with the
opportunity to evaluate the intended use and, if necessary, to prohibit
or limit that activity before it occurs.
DATES: Comments must be received on or before September 12, 2011.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2009-0767, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC.
Attention: Docket ID Number EPA-HQ-OPPT-2009-0767. The DCO is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the DCO is (202) 564-8930. Such deliveries are
only accepted during the DCO's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2009-0767. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
https://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index
available at https://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at https://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number of the EPA/DC Public Reading Room
is (202) 566-1744, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.
FOR FURTHER INFORMATION CONTACT: For technical information contact: Amy
Breedlove, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
202-564-9823; e-mail address: breedlove.amy@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; e-mail address: TSCA-Hotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
import, or process the chemicals listed in Unit III.A. Potentially
affected entities may include, but are not limited to:
Manufacturers, importers, or processors of one or more of
subject chemical substances (North American Industrial Classification
System (NAICS) codes 325 and 324110), e.g., chemical manufacturing and
petroleum refineries;
All other basic organic chemical manufacturing (NAICS
325199);
Printing ink manufacturing (NAICS 325910);
[[Page 40851]]
Paint and Coating Manufacturing (NAICS 325510);
Adhesive Manufacturing (NAICS 325520);
Primary Battery Manufacturing (NAICS 335912); and
Motor Vehicle Brake System Manufacturing (NAICS 336340).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The NAICS codes have been provided to assist you and others
in determining whether this action might apply to certain entities. 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. 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.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Persons
who import any chemical substance governed by a final SNUR 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 proposed rule on or after August
11, 2011 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.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit confidential business information
(CBI) to EPA through regulations.gov or e-mail. Clearly mark the part
or all of the information that you claim to be CBI. For CBI information
in a disk or CD-ROM that you mail to EPA, mark the outside of the disk
or CD-ROM as CBI and then identify electronically within the disk or
CD-ROM the specific information that is claimed as CBI. In addition to
one complete version of the comment that includes information claimed
as CBI, a redacted copy of the comment that does not contain the
information claimed as CBI must be submitted for inclusion in the
public docket. Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal
threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
A. 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.'' Since on-going uses are by definition, not new, they are
identified and excluded from the SNUR. EPA must make the determination
of a ``significant new use'' by rule after considering all relevant
factors, including those listed in TSCA section 5(a)(2). The relevant
factors to be considered are:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In addition to the factors enumerated in TSCA section
5(a)(2), the statute authorizes EPA to consider any other relevant
factors.
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, import, or process the chemical substance for that use (15
U.S.C. 2604(a)(1)(B)). As described in Unit VII., the general SNUR
provisions are found at 40 CFR Part 721, Subpart A.
Section 26(c) of TSCA (15 U.S.C. 2625(c)) authorizes EPA to take
action under other sections of TSCA with respect to categories of
chemical substances.
B. Why is the agency taking this action?
EPA has concerns about the 14 glymes listed in this SNUR, all of
which have similar chemical structures. EPA is concerned about the
reproductive and/or developmental toxicity of monoglyme, diglyme, and
ethylglyme and believes that individuals could suffer adverse effects
from their use. In addition, EPA has concerns about the remaining 11
glymes due to the lack of available use, exposure, and toxicity
information. Currently, exposure to monoglyme in lithium batteries is
very limited since the batteries are sealed. The amount of exposure to
diglyme in printing inks is less certain, but any additional use would
increase the existing exposure to the chemical. Ethylglyme currently
has no consumer uses but has been found in water sources, its
production level appears to be increasing, and given its toxicity, EPA
would be concerned if this chemical substance became prevalent in
consumer products. EPA further believes that the use of any of these
chemical substances in consumer products, beyond the limited, on-going
current uses, could significantly increase the magnitude and duration
of exposure to humans and the environment over that which would
otherwise exist and that such increase should not occur without
opportunity for EPA review. Finally, for pentaethylene glycol dibutyl
ether and butyltriglyme, which presently show no reported production to
the IUR or any ongoing uses, EPA believes that any use of these
chemical substances could be a significant increase in the magnitude
and duration of exposure to humans and the environment over that which
currently exist.
[[Page 40852]]
On March 18, 2008, EPA published risk based prioritization related
documents on monoglyme and diglyme (Refs. 1, 2, 3, and 4), which
indicated that it appeared these two chemical substances are used in
consumer products and also indicated EPA's concerns about the potential
health effects of these two chemical substances. Studies on monoglyme
and diglyme indicate adverse health effects concerning reproductive and
developmental toxicity, as well as on blood and blood-forming organs.
Studies on ethylglyme show developmental toxicity as well as potential
for gene mutation. Several manufacturers initially responded that, with
the exception of monoglyme use in sealed lithium batteries, there are
no consumer uses. Follow up contact with manufacturers revealed some
additional potential consumer uses and raised questions about some of
the other uses. For monoglyme, diglyme, and ethylglyme, as well as the
remaining 11 chemicals, the level of toxicity is uncertain and/or the
type and extent of the use of the chemical substance is unclear. EPA is
proposing to issue this SNUR to require notification prior to any new
manufacturing, importing, or processing of these chemicals for consumer
uses (with specified exceptions), or in some cases all uses. EPA
intends to continue to monitor production, use and other relevant
information on the subject substances and, where appropriate, initiate
further action.
EPA previously published a SNUR on November 29, 2005, (70 FR
71401), (FRL-7740-7), on a major metabolite of monoglyme, 2-
methoxyethanol (2-ME), CASRN 109-86-4, requiring notice to the Agency
before 2-ME is used in a consumer product (40 CFR 721.10001) (Ref. 5).
III. Significant New Use Determination
A. What chemicals are included in this SNUR?
The proposed category of glymes to be regulated by this SNUR
consists of the 14 chemical substances shown in Table 1 and Table 2.
Specifically, the designated significant new use for the glymes
chemicals in Table 1 of this unit would be ``use in a consumer
product,'' with the exception of the ongoing uses which are the
excluded uses listed under ``Proposed Excluded Consumer Uses,'' and
where the designated significant new use for the chemicals in Table 2
would be ``any use.'' ``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.''
While hazard data are only currently available for 3 of the 14
chemical substances in this category (see Unit IV.D.), EPA is proposing
to designate significant new uses for all 14 chemical substances listed
in Tables 1 and 2 on the basis of the available information. Consistent
with its authority under TSCA section 26(c), EPA is proposing to make
all 14 chemical substances subject to the significant new use rule
based on similarities in the molecular structures, physical and
chemical properties, uses, and potential uses of the chemical
substances in the category. EPA acknowledges that there are differences
in the ongoing uses of the 14 chemical substances, and has accounted
for those differences by varying the proposed significant new use
designations for the chemical substances, as shown in Tables 1 and 2.
Nonetheless, EPA believes that the chemicals are sufficiently similar
such that it is appropriate, for purposes of this SNUR, to act on them
together. EPA solicits public comment on the scope of the chemical
substances to be subject to this SNUR. Specifically, whether any of the
chemical substances included in the category are sufficiently
dissimilar from the rest that they should be removed from the category,
or whether any additional chemical substances are sufficiently similar
that they should be added to the category.
Table 1--Chemicals With Use in a Consumer Product as the Proposed Significant New Use and Proposed Excluded
Consumer Uses
----------------------------------------------------------------------------------------------------------------
Chemical Abstract Service (CAS) Chemical abstract index Proposed excluded
Registry No. (CASRN) name Common name consumer uses
----------------------------------------------------------------------------------------------------------------
110-71-4......................... Ethane, 1,2-dimethoxy-... Monoglyme or In electrolyte solutions
Monoethylene glycol for sealed lithium
dimethyl ether. batteries.
111-96-6......................... Ethane, 1,1'-oxybis[2- Diglyme or Diethylene As a solvent in printing
methoxy-. glycol dimethyl ether. inks for consumer
products.
112-36-7......................... Ethane, 1,1'-oxybis[2- Ethyldiglyme or
ethoxy-. Diethylene glycol
diethyl ether.
112-49-2......................... 2,5,8,11-Tetraoxadodecane Triglyme or Triethylene --As a solvent in
glycol dimethyl ether. consumer adhesives.
--As a component of
consumer brake fluids.
--As a component of
consumer paint/graffiti
removers.
--in consumer paints.
112-73-2......................... Butane, 1,1'-[oxybis(2,1- Butyldiglyme or
ethanediyloxy)]bis-. Diethylene glycol
dibutyl ether.
112-98-1......................... 5,8,11,14,17- Tetraethylene glycol
Pentaoxaheneicosane. dibutyl ether.
143-24-8......................... 2,5,8,11,14- Tetraglyme or --As an HFC/CFC
Pentaoxapentadecane. Tetraethylene glycol lubricant.
dimethyl ether.
--As a solubilizing
agent for consumer
printing inks.
--As a coalescing agent
in consumer paints.
629-14-1......................... Ethane, 1,2-diethoxy-.... Ethylglyme or Ethylene
glycol diethyl ether.
4353-28-0........................ 3,6,9,12,15- Tetraethylene glycol
Pentaoxaheptadecane. diethyl ether.
23601-39-0....................... 3,6,9,12,15,18- Pentaethylene glycol
Hexaoxaeicosane. diethyl ether.
[[Page 40853]]
24991-55-7....................... Poly(oxy-1,2-ethanediyl), Polyglyme or Use in consumer paint
.alpha.-methyl-.omega.- Polyethylene glycol strippers.
methoxy-. dimethyl ether.
31885-97-9....................... Poly(oxy-1,2-ethanediyl), Polyethylene glycol
.alpha.-butyl-.omega.- dibutyl ether.
butoxy-.
----------------------------------------------------------------------------------------------------------------
Table 2--Chemicals With ``Any Use'' as the Proposed Significant New Use
------------------------------------------------------------------------
Chemical Abstract Service Chemical abstract
(CAS) Registry No. (CASRN) index name Common name
------------------------------------------------------------------------
51105-00-1.................. 5,8,11,14,17,20- Pentaethylene glycol
Hexaoxatetracosane. dibutyl ether.
63512-36-7.................. 5,8,11,14- Butyltriglyme or
Tetraoxaoctadecane. Triethylene glycol
dibutyl ether.
------------------------------------------------------------------------
B. What relevant factors were considered for this SNUR?
To develop its preliminary determination of what would constitute a
significant new use of the glymes listed in Table 1 and Table 2, EPA
considered relevant information about the toxicity of these substances,
likely human exposures and environmental releases associated with
possible uses, and the four factors listed in section 5(a)(2) of TSCA
and Unit II.A. of this proposed SNUR.
The latest information available to EPA, which is summarized in
Unit IV. of this SNUR, indicates that based on historical production
levels of five of these chemicals, any production or commencement of
Inventory Update Reporting (IUR) reporting would be considered a
significant change. For the two chemicals which currently do not appear
to be in production or use, commencement of production for any use
could result in a significant increase in the type and form of exposure
to both humans and the environment. For the seven chemicals which
currently do not have ongoing consumer uses, any commencement of use in
a consumer product would change the type of exposure to humans from
indirect to direct exposure and the form of exposure from primarily
inhalation to both inhalation and skin exposure.
EPA believes that any shift from a status of no uses in a consumer
product to any use in a consumer product would increase the magnitude
and duration of exposure to consumers than would otherwise exist since
use of a consumer product could result in more frequent, direct, and
longer exposures than the infrequent or indirect exposures that
currently exist. Additional workers are also likely to be exposed, as
is the surrounding environment at manufacturing or processing sites,
due to possible increases in releases which could contribute additional
glymes into the environment. Finally, EPA believes that any changes in
the reasonably anticipated manner and methods of manufacturing,
processing, distribution in commerce, or disposal of these glymes could
contribute to the type, form, magnitude and duration of exposure to
humans and the environment.
Based on these relevant factors, EPA has preliminarily determined
that the manufacture, import, or processing of ethyldiglyme,
butyldiglyme, tetraethylene glycol dibutyl ether, ethylglyme,
tetraethylene glycol diethyl ether, pentaethylene glycol diethyl ether,
and polyethylene glycol dibutyl ether for any use in a consumer product
is a significant new use. EPA has also primarily determined that the
manufacture, import, or processing of monoglyme, diglyme, triglyme,
tetraglyme, polyglyme for any use in a consumer product, other than for
the ongoing uses listed in Table 1, is a significant new use. In
addition, EPA has primarily determined that the manufacture, import, or
processing of pentaethylene glycol dibutyl ether and butyltriglyme for
any use is a significant new use.
C. What are EPA objectives for this SNUR?
EPA wants to achieve the following objectives with regard to the
significant new use(s) that are designated in this proposed rule:
1. EPA would receive notice of any person's intent to manufacture,
import, or process the glymes listed in Table 1 and Table 2 for the
described significant new uses before that activity begins.
2. EPA would have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing,
importing or processing of the glymes listed in Table 1 and Table 2 for
the described significant new uses.
3. EPA would be able to regulate prospective uses of the glymes
listed in Table 1 and Table 2 before the described significant new uses
of the chemical substance occur, provided that regulation is warranted
pursuant to TSCA sections 5(e), 5(f), 6 or 7.
IV. Summary of Relevant Available Information on the Glymes
A. What are the ongoing uses of these chemicals?
1. Known Ongoing Uses of Glymes. To identify the ongoing consumer
uses of these glymes, as well as potential industrial uses, EPA used
information submitted under the 2006 IUR rule, contacted manufacturers,
searched business periodicals, and searched other available sources.
Monoglyme is used in consumer products in electrolyte solutions for
sealed lithium batteries. Industrial uses include printed circuit board
manufacturing; in reactions with strong bases; in mixtures where
solvent separation and recovery is necessary; as an inert special
solvent; and as a solvent in pharmaceutical production (Ref. 6, p. 9).
Diglyme is used as a solvent in printing inks for consumer products
and industrially as a solvent in a variety of processes (Ref. 6, p.
10).
Triglyme is used in consumer products in consumer brake fluids, as
a solvent in consumer adhesives, as a component of consumer paint and
graffiti removers and in consumer paints. Industrial uses include
[[Page 40854]]
generation of chemicals, use as a reaction solvent, and use as a
binding agent in porcelain powders (Ref. 6, p. 11).
Tetraglyme is used in consumer products as a solubilizing agent for
consumer printing inks, as a coalescing agent in consumer paints, and
as an HFC/CFC lubricant which may be used in consumer air conditioners.
Industrial uses include use as a solubilizing agent in textiles and
plastics, as a dye fixation additive for cotton textiles, as a
fungicide process solvent, and as a gas scrubbing agent (Ref. 6, p.
12).
Polyglyme is used in consumer paint strippers. Industrial uses
include use as special, high boiling solvents for chemical reactions,
use as a solubilizing agent for plastic, textile, and paper processes,
and use as a gas scrubbing agent (Ref. 6, p. 13).
Ethyldiglyme, butyldiglyme, tetraethylene glycol dibutyl ether,
ethylglyme, tetraethylene glycol diethyl ether, pentaethylene glycol
diethyl ether, and polyethylene glycol dibutyl ether, have no known
uses in consumer products. Industrial uses of these glymes can include
use: as a high-boiling solvent for nitrocellulose, resins, and
lacquers; as a solubilizer in organic synthesis; as a solvent in the
production of plastic resins and compounds, rubber chemicals; as a
solvent for conductive printing ink; in the production of printed
circuit etchants; in the preparation of and reaction with Grignard
reagents; in metal extractions; as a solvent in pharmaceutical
syntheses; in the production of coatings; and as a gas scrubbing liquid
(Ref. 6, pp. 14-19).
The chemicals listed in Table 2, pentaethylene glycol dibutyl ether
and butyltriglyme, have no known uses (Ref. 6, p. 19).
2. Potential for Other Ongoing Uses of Glymes. In order to
ascertain if there are any ongoing uses of these glymes, EPA used
information submitted under the IUR rule, contacted manufacturers,
searched business periodicals, and searched other available sources. In
some instances, EPA could confirm the existence of an ongoing use in a
consumer product from the information reviewed. In other instances, the
results of EPA's search were unclear, and EPA could not confirm whether
certain reported consumer product uses were actual ongoing uses.
Therefore, EPA is requesting public comment on whether any of the
additional unconfirmed uses listed in this unit are actual, ongoing
uses in a consumer product, and whether there are any other ongoing
uses in a consumer product of the chemicals listed in Table 1. For
pentaethylene glycol dibutyl ether and butyltriglyme, EPA is requesting
public comment on whether there are any ongoing uses at all (consumer
or industrial). EPA does not anticipate that it will add additional
exclusions to the final rule, beyond those listed in Table 1, except
where public comment adequately substantiates the existence of a
claimed additional ongoing use.
Table 3--Reported Consumer Uses of Glymes That Are Unconfirmed
------------------------------------------------------------------------
Additional unconfirmed reports of
use (In addition to any confirmed
Common name ongoing consumer uses listed in
table 1)
------------------------------------------------------------------------
Monoglyme......................... Treat aluminum surfaces to ensure
surfaces are less reactive, inner
and outer layer etching of printed
circuit board manufacturing.
Diglyme........................... Component in automotive care
products, a component of brake
fluid, a component in paints and
coatings, and a component in
adhesives and sealants.
Ethyldiglyme...................... Component in paint and paint
varnishes, use in coatings
manufacturing, use in adhesives
manufacturing, and as a solvent in
printing.
Triglyme.......................... None in consumer products.
Butyldiglyme...................... None in consumer products.
Tetraethylene glycol dibutyl ether Use as an ingredient in consumer
brake fluid.
Tetraglyme........................ Use in fabrics, textiles and
apparel.
Ethylglyme........................ Use as a solvent in consumer paint
production, use as an adhesive
solvent, use as a polycarbonate
swelling agent, use in consumer
polishes and related products.
Tetraethylene glycol diethyl ether Use as an ingredient in consumer
brake fluid.
Pentaethylene glycol diethyl ether Use as an ingredient in consumer
brake fluid, use in the soldering
of electronic circuit boards.
Polyglyme......................... Use in adhesive removers, use in
fragrance production, use in anti-
fog compounds, use in brake fluid,
use in automotive care products,
and use in paper products.
Polyethylene glycol dibutyl ether. Use in the production of gel laundry
detergents.
Pentaethylene glycol dibutyl ether None.
Butyltriglyme..................... None.
------------------------------------------------------------------------
B. What are the estimated production levels of these chemicals?
The 2006 IUR regulation required manufacturers and importers of
certain chemical substances included on the TSCA Chemical Substance
Inventory to report site and manufacturing information for chemicals
manufactured (including imported) in amounts of 25,000 pounds or
greater at a single site. For monoglyme and diglyme, EPA expects that
current production levels will continue. For triglyme and ethylglyme,
predicting future production is infeasible, although ethylglyme
production appears to be increasing. For ethyldiglyme, butyldiglyme,
and tetraglyme, EPA expects that production will remain at the previous
levels. Production of pentaethylene glycol diethyl ether appears to be
steadily increasing. For polyglyme, EPA expects that production will
continue to decrease and/or remain the same. For tetraethylene glycol
dibutyl ether, tetraethylene glycol diethyl ether, polyethylene glycol
dibutyl ether, pentaethylene glycol dibutyl ether, and butyltriglyme,
EPA expects that production of these chemical substances, if any, will
remain below reporting levels. Previous IUR reporting rules required
that chemicals produced at amounts of 10,000 pounds or greater be
reported. Table 3 summarizes 2006 and prior year IUR data for the 14
glymes. The projected trends are based on the IUR data from 1986-2006.
The projections may not be precise since the IUR data does not reflect
100% of chemicals and their production and requirements for reporting
have varied over time.
[[Page 40855]]
Table 4--Production Reporting Amounts to IUR 1986-2006 (Ref. 6)
----------------------------------------------------------------------------------------------------------------
Common name 2006 IUR reporting Prior IUR reporting
----------------------------------------------------------------------------------------------------------------
Monoglyme....................... >1 million (M)-<10M 1986: >10 thousand (K)-<500K lbs.
lbs. 1990-2002: >1M-<10M lbs. each year.
Diglyme......................... >1M-<10M lbs....... 1986-2002: >1M-<10M lbs. each year.
Ethyldiglyme.................... >10K-<500K lbs..... 1986-2002: >10K-<500K lbs. each year.
Triglyme........................ No report.......... 1994-2002: >10K-<500K lbs. each year.
Butyldiglyme.................... >10K-<500K lbs..... 1990-2002: >10K-<500K lbs. each year.
Tetraethylene glycol dibutyl No report.......... No reports 1986-2002.
ether.
Tetraglyme...................... >10K-<500K lbs..... 1986-2002: >10K-<500K lbs. each year.
Ethylglyme...................... >10K-<500K lbs..... 1986-2002: No reports.
Tetraethylene glycol diethyl No report.......... No reports 1986-2002.
ether.
Pentaethylene glycol diethyl >1M-<10M lbs....... 1986 & 1990: >10K-<500K lbs. each year.
ether. 1994: No report.
1998: >500K-<1M lbs.
2002: >1M-<10M lbs.
Polyglyme....................... 10-500K............ 1986: >1M-<10M lbs.
1994: No report.
1998, 2002: >10K-<500K lbs. each year.
Polyethylene glycol dibutyl No report.......... No reports 1986-2002.
ether.
Pentaethylene glycol dibutyl No report.......... No reports 1986-2002.
ether.
Butyltriglyme................... No report.......... No reports 1986-2002.
----------------------------------------------------------------------------------------------------------------
C. What are the potential routes and sources of exposure for these
chemicals?
The following are summaries of the potential routes and sources of
exposure for these chemicals considering ongoing current uses. More
detailed information can be found in the Exposure Characterization
documents for monoglyme and diglyme (Refs. 1, 2) and in the description
of ethylglyme in the Hazardous Substances Data Bank (Ref. 7).
1. Potential exposures to the environment, consumers, and general
population. The exposures described in this unit reflect the actual
and/or potential indirect exposures to the environment, consumers, and
the general population resulting from ongoing industrial and commercial
uses of these glymes. Consumer uses, however, also potentially allow
for the direct exposure to skin from product handling and more
immediate inhalation exposures resulting from proximity to the product.
However, little to no data is available for those types of use
scenarios.
Monoglyme, diglyme, ethyldiglyme, triglyme, butyldiglyme, and
ethylglyme are included in the category of chemicals reported as
``certain glycol ethers'' under the ID number N230 in the Toxics
Release Inventory (TRI) (Ref. 8). The total release reported to the TRI
in 2007 from all reporting sites was 18,476,420 pounds. This total
includes air releases of 16,416,033 pounds from on-site fugitive and
point sources, in addition to on-site water releases of 87,035 pounds.
Most of the remaining volume of release was deep-well injected, sent to
land treatment, transferred for energy recovery or transferred to a
Publicly Owned Treatment Works (POTW). Release information about the
individual glymes within the larger glycol ether category is not known
(Ref. 9). Manufacturers, importers, or processors are required to
report releases of chemicals on the TRI when total manufacturing,
imports or processing by a facility equals 25,000 pounds/year for the
chemicals combined.
Ethylglyme was found in the US EPA Office of Water Storage and
Retrieval (STORET) database indicating potential environmental exposure
since this chemical substance was found in ground water and/or surface
water (Ref. 9).
Monitoring data indicate that the general population may be exposed
to diglyme and ethyldiglyme via inhalation of vehicle exhaust and
ingestion of contaminated drinking water (Refs. 10 and 11). Diglyme was
listed as a contaminant found in drinking water (Ref. 10).
Diglyme has been detected in diluted vehicle exhaust from a light-
duty truck using different fuel types (Ref. 10).
Industrial manufacture and processing may result in the release of
glymes to the environment through various waste streams (Ref. 10).
Diglyme, ethyldiglyme, and ethylglyme have been found at measurable
concentrations in industrial wastewater treatment systems (Refs. 10,
11, and 7). Wastewater treatment systems discharge to either surface
waters or publicly owned treatment works. Either of these two discharge
options could result in exposures for the general population and the
environment to these chemicals.
Ethyldiglyme has been qualitatively detected in drinking water from
Cincinnati, OH; in ground water from the Hipps Road Landfill in
Jacksonville, FL; in trench leachates from Maxey Flats, KY and West
Valley, NY low-level radioactive waste disposal sites and in advanced
waste treatment water from Lake Tahoe, CA, Pomona, CA, and Blue Plains,
Washington, DC (Ref. 11).
Ethylglyme has been detected in western Cleveland, OH wastewater
influents at 140 [mu]g/L and it was identified in Chicago Central water
works water (treated and untreated) at 2 [mu]g/L (Ref. 7).
Monitoring data for ethylglyme indicates that the general
population may be exposed to the chemical substance through releases
from manufacturing facilities. The general population can then be
exposed via inhalation of ambient air, ingestion of drinking water, and
dermal contact with these substances and other products containing
these chemicals. Evidence of releases from industrial manufacturing and
processing is demonstrated by concentrations of 400 milligrams per
liter (mg/L) of diglyme which have been found in activated sludge from
the waste treatment facility of the industry producing the chemical
substance (Ref. 7).
For the remaining chemicals in Table 1 or Table 2, little or no
release information was found.
EPA's Source Ranking Databank (Ref. 12) shows metal polish and
polishing cloths and papers as containing ethylglyme. Most of the
entries in this databank for consumer products are from the late 1990s
and therefore may not still be current. If ethylglyme is still
[[Page 40856]]
found in these products, however, there is potential that consumers and
children might be exposed to this chemical substance from these
consumer products. Furthermore, production of ethylglyme appears to be
increasing.
Based on IUR data and communications with manufacturers, EPA
believes that monoglyme is used as a component of lithium batteries and
diglyme is used in printing inks, both of which are consumer
applications of monoglyme. It is believed that disposal of the lithium
batteries containing monoglyme and paper with printing inks containing
diglyme could present the potential for release of these chemicals to
environmental media and subsequent exposure to humans and ecological
receptors.
2. Potential occupational exposure. Occupational exposure to these
chemicals may occur through inhalation and dermal contact at workplaces
where the chemicals are produced or used. Monoglyme, diglyme,
ethylglyme, ethyldiglyme, triglyme, and tetraethylene glycol diethyl
ether all have vapor pressures high enough to potentially result in
significant exposures to workers if they are near the chemical
substance (Refs. 1, 2, 9, and 13). Based on IUR data, ethyldiglyme,
butyldiglyme, tetraglyme, pentaethylene glycol diethyl ether, and
polyglyme are manufactured in liquid forms, and worker exposures
through dermal contact are possible (Ref. 13).
These chemicals do not have Occupational Safety and Health
Administration (OSHA) Permissible Exposure Limits (PELs) (Refs. 1, 2,
and 9). Ferro Corporation, in their publications, recommended a
Threshold Limit Value (TLV) for glycol ethers of 5 parts per million
(ppm) (Time Weighted Average (TWA)) with a Short Term Exposure Limit
(STEL) of 25 ppm. The 15-minute STEL should not be achieved more than 4
times in 8 hours. For women of child-bearing potential, Ferro
recommended a TLV of 1 ppm with a STEL of 5 ppm (Ref. 14).
Based on the 2006 IUR reports, the maximum total number of
potentially exposed industrial workers to monoglyme and ethylglyme
during manufacturing and industrial processing and use is less than 100
each, and the maximum total number of workers likely to be exposed to
diglyme was between 100 and 999 workers. There may, however, be
additional potentially exposed industrial workers who are not included
in these estimates since not all production volume may have been
accounted for in the IUR (production below 25,000 pounds at a site does
not have to be reported to the IUR), and commercial workers may be
exposed as well (Refs. 1, 2, and 15).
D. What are the potential health effects of these chemicals?
The following are summaries of the potential health effects of
these chemicals considering ongoing current uses. More detailed
information can be found in the Hazard Characterization documents for
monoglyme and diglyme (Refs. 3, 4) and in the description of ethylglyme
in the Hazardous Substances Data Bank (Ref. 7).
Toxicology studies in laboratory animals have shown that exposure
to monoglyme results in hemolytic effects (destruction of red blood
cells), and developmental and reproductive toxicity. The acute toxicity
of monoglyme is low via oral, dermal and inhalation routes of exposure.
Monoglyme's chronic adverse health effects generally fall into the
moderate to high hazard range based on the classification ranges used
in the Globally Harmonized System for Classification and Labeling of
Chemicals (GHS). The potential toxicity from repeated exposure to
monoglyme was assessed using a major metabolite, 2-methoxyethanol
(CASRN 109-86-4). Oral 90-day studies of 2-methoxyethanol in rats and
mice showed testicular degeneration and adverse effects on the process
of blood cell formation. The lowest observed adverse effect level
(LOAEL) in rats was 70 milligrams/kilograms (mg/kg)-day; the LOAEL in
mice was 300 mg/kg-day. An oral prenatal developmental toxicity study
of monoglyme in rats showed fetal mortality at doses as low as 60 mg/
kg-day, and edema at doses as low as 30 mg/kg-day. An oral prenatal
developmental toxicity study of monoglyme in mice showed reduced fetal
body weight and increased skeletal defects at 250 mg/kg-day. Available
data also suggest that monoglyme has the potential to be genotoxic
(Ref. 3).
Toxicology studies in laboratory animals have shown that exposure
to diglyme results in hemolytic effects (destruction of red blood
cells), and developmental and reproductive toxicity. The acute toxicity
of diglyme to rats via the oral and inhalation routes of exposure is
low. The chronic adverse health effects of diglyme generally fall into
the moderate to high hazard range based on the classification ranges
used in the GHS. The toxicity profile following repeated exposures to
diglyme is similar to the profile for monoglyme. Rats showed testicular
degeneration and hemolytic effects following inhalation exposure to
diglyme for two weeks at concentrations as low as 0.6 mg/L-day; a NOAEL
was not established. An inhalation dominant-lethal study in rats showed
a reduced pregnancy rate at 5.5 mg/L-day (5.5 ppm in air). An oral
prenatal developmental toxicity study in mice showed effects on fetal
growth and viability, and an increase in malformations at 125 mg/kg-
day; the NOAEL was 62.5 mg/kg-day. In vitro gene mutation and in vivo
chromosomal aberration tests were negative (Ref. 4).
Toxicology studies in laboratory animals have shown that exposure
to ethylglyme results in developmental toxicity. The acute toxicity of
ethylglyme is low in rats. Oral prenatal developmental toxicity studies
of ethylglyme in mice and rabbits showed a significant decrease in
fetal body weight and viability, and a significant increase in
malformations; the NOAEL for developmental toxicity was 50 mg/kg-day in
mice and 25 mg/kg-day in rabbits (Ref. 7), both falling into the high
chronic hazard range based on the GHS.
Based on a review of the literature, there is insufficient
information available to arrive at any health effects related
conclusions for the remaining chemicals in Table 1 or Table 2.
V. Alternatives Considered for This SNUR
Before proposing this SNUR, EPA considered promulgating a TSCA
section 8(a) reporting rule for these glymes. Under a TSCA section 8(a)
rule, EPA could, among other things, generally require persons to
report information to the Agency when they intend to manufacture,
import, or process a listed chemical substance for a specific use or
any use. However, for these glymes, the use of TSCA section 8(a) rather
than SNUR authority would have several limitations. First, if EPA was
to require reporting under TSCA section 8(a) instead of TSCA section
5(a), EPA would not have the opportunity to review human and
environmental hazards and exposures associated with the proposed
significant new use and, if necessary, take immediate follow-up
regulatory action under TSCA sections 5(e) or 5(f) to prohibit or limit
the activity before it begins. In addition, EPA may not receive
important information from small businesses, because such firms
generally are exempt from TSCA section 8(a) reporting requirements. In
view of the level of health and environmental concerns about monoglyme,
diglyme, and ethylglyme if used for the proposed significant new use,
and the lack of information to be able to judge exposure for the
remaining glymes, EPA believes that a TSCA section 8(a) rule for this
[[Page 40857]]
substance would not meet EPA's regulatory objectives.
VI. Applicability of 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
begin commercial manufacture, import, or processing of the chemical
substance(s) that would be regulated through this proposed rule, if
finalized, would have to cease any such activity before the effective
date of the rule if and when finalized. To resume their activities,
these persons would have to comply with all applicable SNUR notice
requirements and wait until the notice review period, including all
extensions, expires. EPA has 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 section 721.45(h), that
person would be considered to have met the requirements of the final
SNUR for those activities.
VII. 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
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 identified in a final SNUR 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.
VIII. Test Data and Other Information
EPA recognizes that TSCA section 5 does not require developing any
particular test data before submission of a SNUN. There are two
exceptions: i. 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 ii. 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 include data that would permit a reasoned evaluation of
risks posed by the chemical substance during its manufacture, 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.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs that provide detailed information on:
1. Human exposure and environmental releases that may result from
the significant new uses of the chemical substances.
2. Potential benefits of the chemical substances.
3. Information on risks posed by the chemical substances compared
to risks posed by potential substitutes.
IX. SNUN Submissions
EPA recommends that submitters 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 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 to EPA, on EPA Form
No. 7710-25 in accordance with the procedures set forth in 40 CFR
721.25 and 720.40.
Readers are reminded that EPA published a final rule at 75 FR 773
on January 6, 2010, (FRL-8794-5) that established standards and
requirements for the use of the electronic-PMN (e-PMN) software and
EPA's Central Data Exchange (CDX) to electronically submit these
notices. The Agency is introducing electronic reporting via CDX using
the e-PMN in three phases over a two-year period. The effective date of
the rule was April 6, 2010. During the first year following the
effective date of the final rule, submissions will be permitted via
CDX, optical disc, or paper. After April 6, 2011, paper submissions
will no longer be accepted. After April 6, 2012, all submissions will
be required to be submitted electronically via CDX. Regardless of the
delivery method, after April 6, 2010, EPA requires that all submissions
be generated using the new e-PMN software. For additional information
and instructions go to: https://www.epa.gov/opptintr/newchems//epmn/epmn-index.htm. Until April 6, 2012, SNUNs may still be mailed to the
Environmental Protection Agency, OPPT Document Control Office (7407M),
1200 Pennsylvania Avenue, NW., Washington, DC 20460-0001.
[[Page 40858]]
X. Economic Analysis
A. SNUNs
EPA has evaluated the potential costs of establishing SNUR
reporting requirements for potential manufacturers, importers, and
processors of the chemical substances included in this proposed rule.
While most businesses are subject to a $2,500 user fee required by 40
CFR 700.45(b)(2)(iii), small businesses with annual sales of less than
$40 million when combined with those of the parent company (if any) are
subject to 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
proposed SNUR. Furthermore, EPA believes that the expense of submitting
a notice (approximately $6,000 plus the user fee) is unlikely to
discourage innovations of high potential value. EPA's complete economic
analysis is available in the public docket for this proposed rule (Ref.
16).
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 TSCA section 5.
For persons exporting a substance the subject of a SNUR, a one-time
notice must be provided for the first export or intended export to a
particular country. EPA estimates the one-time cost to be approximately
$937 per exporter including mailing costs. The total costs of export
notification will vary by chemical, depending on the number of required
notifications (i.e., the number of countries to which the chemical
substance is exported). Because EPA is unable to make an estimate of
the likely number of export notifications for the chemicals covered in
this proposed SNUR, a total export notification cost is not available.
XI. Request for Public Comment
EPA welcomes comment on all aspects of this proposed rule. In
addition, EPA is particularly interested in receiving stakeholder input
on a number of issues that were identified for public comment earlier
in this proposed rule. Please provide comments on the following issues:
1. Scope of the chemical substances to be subject to this SNUR.
While hazard data are only currently available for 3 of the 14 chemical
substances in the glymes chemical category identified in this proposed
rule (see Unit IV.D.), EPA is proposing to designate significant new
uses for all 14 chemical substances listed in Tables 1 and 2 in Unit
III.A. on the basis of the available information. As discussed in Unit
III.A. of this document, EPA believes that the chemicals are
sufficiently similar such that it is appropriate, for purposes of this
SNUR and consistent with TSCA section 26(c), to act on them together.
However, EPA would be interested in hearing whether any of the chemical
substances included in the category are sufficiently dissimilar from
the rest such that they should be removed from the category, or whether
any additional chemical substances are sufficiently similar such that
they should be added to the category.
2. Ongoing uses. EPA solicits comment on whether any of the
additional unconfirmed uses listed in this proposed rule are actual
ongoing uses in a consumer product, and whether there are any other
ongoing uses in a consumer product of the chemicals listed in Table 1
in Unit III.A. For pentaethylene glycol dibutyl ether and
butyltriglyme, EPA is soliciting comment on whether there are any
ongoing uses at all (consumer or industrial). In providing comments on
ongoing uses, it would be most helpful if you provide sufficient
information for EPA to adequately substantiate the existence of a
claimed additional ongoing use.
XII. References
The following is a list of the documents that are specifically
referenced in this proposed rule and placed in the public docket that
was established under Docket ID No. EPA-HQ-OPPT-2009-0767. The docket
includes information considered by EPA in developing this proposed
rule. In addition, interested parties should consult documents that are
referenced in the documents that EPA has placed in the public docket,
regardless of whether these referenced documents are physically located
in the public docket.
1. US EPA. Screening-Level Exposure Characterization of High
Production Volume Chemicals: 1,2-Dimethoxyethane (CAS No. 110-71-4),
[9th CI Name: Ethane, 1,2-dimethoxy-]. March 2008, page 21. https://www.epa.gov/chemrtk/hpvis/rbp/Monoglyme.110714.Web.SupportDocs.31408.pdf.
2. US EPA. Screening-Level Exposure Characterization of High
Production Volume Chemicals: Diglyme (CAS No. 111-96-6), [9th CI
Name: Bis(2-methoxyethyl) Ether]. March 2008, page 16. https://www.epa.gov/chemrtk/hpvis/rbp/Diglyme.111966.Web.SupportDocs.031808.pdf.
3. US EPA. Screening-Level Hazard Characterization of High
Production Volume Chemicals: 1,2-Dimethoxyethane (CAS No. 110-71-4),
[9th CI Name: Ethane, 1,2-dimethoxy-]. February 2008, page 6. https://www.epa.gov/chemrtk/hpvis/rbp/Monoglyme.110714.Web.SupportDocs.31408.pdf.
4. US EPA. Screening-Level Hazard Characterization of High
Production Volume Chemicals: Diglyme (CAS No. 111-96-6), [9th CI
Name: Bis(2-methoxyethyl) Ether]. February 2008, page 6. https://www.epa.gov/chemrtk/hpvis/rbp/Diglyme.111966.Web.SupportDocs.031808.pdf
5. US EPA. ``2-ethoxyethanol, 2-ethoxyethanol acetate, 2-
methoxyethanol, and 2-methoxyethanol acetate; Significant New Use
Rule.'' 70 FR 71401. November 29, 2005.
6. Wilson, Kimberly; Tome, Alice; and Narayan, Tulika, Abt
Associates, Inc. ``Memorandum to EPA, Nishkam Agarwal, `Actual and
Potential Uses of Fourteen Selected Glymes.' '' September 9, 2009.
7. Hazardous Substances Data Bank (HSDB). Entry for Ethylene glycol
diethyl ether, CASRN 629-14-1. Accessed on October 30, 2009. https://toxnet.nlm.nih.gov.
8. US EPA. TRI Web site. https://www.epa.gov/ttn/atw/glycol2000.pdf.
9. US EPA. Exposure Characterization for Ethylglyme. November 6,
2009.
10. Hazardous Substances Data Bank (HSDB). Hazardous Substances Data
Bank. Entry for diglyme. Accessed October 30, 2009. https://toxnet.nlm.nih.gov.
11. Hazardous Substances Data Bank (HSDB). Entry for CASRN 112-36-7.
Accessed on October 28, 2009. https://toxnet.nlm.nih.gov.
12. The Source Ranking Database is an EPA database that performs a
systematic screening-level review of over 12,000 potential indoor
pollution sources to identify high-priority product and material
categories for further evaluation. It can also identify the products
that have contained a specific chemical. May 1997. https://www.epa.gov/oppt/exposure/pubs/srd_apdx.pdf.
13. US EPA. Physical-Chemical Properties and Fate Characterization:
Glycol Ethers. Washington, DC: U.S. EPA/OPPT/EETD/EAB. August 2009.
14. Ferro Corporation. 1,2-Dimethoxyethane US EPA HPV Challenge
Program Submission. December 2001, pages 7-8 of 93.
15. US EPA. IUR database search results for number of workers
exposed to ethylglyme, https://cfpub.epa.gov/iursearch/2006_iur_natlcheminfo.cfm?id=3975. Accessed on October 21, 2009.
16. US EPA. Economic Analysis of the Proposed Significant New Use
Rule for 14 Glyme