Document ID: EPA-HQ-OPPT-2009-0767-0001
Agency: epa
Document Type: Proposed Rule
Title: Significant New Use Rules: Glymes
Posted Date: 2011-07-12T04:00Z

[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.

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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: http://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 
http://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 http://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 http://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: http://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. http://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. http://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. http://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. http://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. http://toxnet.nlm.nih.gov.
8. US EPA. TRI Web site. http://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. http://toxnet.nlm.nih.gov.
11. Hazardous Substances Data Bank (HSDB). Entry for CASRN 112-36-7. 
Accessed on October 28, 2009. http://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. http://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, http://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.

[[Page 40859]]

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.

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.

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 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.

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, 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.

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.

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

[[Page 40860]]

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 Sec.  721.10229 to subpart E to read as follows:

Sec.  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-          Any use in a
                               dimethoxy-.           consumer product
                                                     except in
                                                     electrolyte
                                                     solutions for
                                                     sealed lithium
                                                     batteries.
111-96-6....................  Ethane, 1,1'-         Any use in a
                               oxybis[2-methoxy-.    consumer product
                                                     except as a solvent
                                                     in printing inks
                                                     for consumer
                                                     products.
112-36-7....................  Ethane, 1,1'-         Any use in a
                               oxybis[2-ethoxy-.     consumer product.
112-49-2....................  2,5,8,11-             Any use in a
                               Tetraoxadodecane.     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.
112-73-2....................  Butane, 1,1'-         Any use in a
                               [oxybis(2,1-          consumer product.
                               ethanediyloxy)]bis-.
112-98-1....................  5,8,11,14,17-         Any use in a
                               Pentaoxaheneicosane.  consumer product.
143-24-8....................  2,5,8,11,14-          Any use in a
                               Pentaoxapentadecane.  consumer product
                                                     except:
                                                       --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- Any use in a
                               .                     consumer product.
4353-28-0...................  3,6,9,12,15-          Any use in a
                               Pentaoxaheptadecane.  consumer product.
23601-39-0..................  3,6,9,12,15,18-       Any use in a
                               Hexaoxaeicosane.      consumer product.
24991-55-7..................  Poly(oxy-1,2-         Any use in a
                               ethanediyl),          consumer product
                               .alpha.-methyl-       except in consumer
                               .omega.-methoxy-.     paint strippers.
31885-97-9..................  Poly(oxy-1,2-         Any use in a
                               ethanediyl),          consumer product.
                               .alpha.-butyl-
                               .omega.-butoxy-.
51105-00-1..................  5,8,11,14,17,20-      Any use.
                               Hexaoxatetracosane.
63512-36-7..................  5,8,11,14-            Any use.
                               Tetraoxaoctadecane.
------------------------------------------------------------------------

[FR Doc. 2011-17084 Filed 7-11-11; 8:45 am]
BILLING CODE 6560-50-P