[Federal Register Volume 70, Number 39 (Tuesday, March 1, 2005)]
[Proposed Rules]
[Pages 9902-9909]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-3911]



[[Page 9902]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[OPPT-2004-0111; FRL-7692-8]
RIN 2070-AJ12


2-ethoxyethanol, 2-ethoxyethanol acetate, 2-methoxyethanol, and 
2-methoxyethanol acetate; 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) which would 
require persons to notify EPA at least 90 days before commencing the 
manufacture, import, or processing of 2-ethoxyethanol (CAS No. 110-80-
5) (2-EE), 2-ethoxyethanol acetate (CAS No. 111-15-9) (2-EEA), 2-
methoxyethanol (CAS No. 109-86-4) (2-ME), or 2-methoxyethanol acetate 
(CAS No. 110-49-6) (2-MEA) for domestic use in a consumer product or 
the manufacture or import of 2-MEA at levels greater than 10,000 pounds 
per year. EPA believes that this action is necessary because these 
chemicals may be hazardous to human health and their use in a consumer 
product may result in human exposure. The required notice would provide 
EPA with the opportunity to evaluate intended new uses and associated 
activities, and if necessary, prohibit or limit those uses and 
activities before they occur.

DATES: Comments, identified by docket identification (ID) number OPPT-
2004-0111, must be received on or before May 2, 2005.

ADDRESSES: Submit your comments, identified by docket ID number OPPT-
2004-0111, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov/. 
Follow the on-line instructions for submitting comments.
     Agency Website: http://www.epa.gov/edocket/. EDOCKET, 
EPA's electronic public docket and comment system, is EPA's preferred 
method for receiving comments. Follow the on-line instructions for 
submitting comments.
     E-mail: [email protected].
     Mail: Document Control Office (DCO) (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, EPA East 
Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. 
Attention: Docket ID number OPPT-2004-0111. 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 Docket's normal hours of operation, and 
special arrangements should be made for deliveries of boxed 
information.
    Instructions: Direct your comments to docket ID number OPPT-2004-
0111. EPA's policy is that all comments received will be included in 
the public docket without change and may be made available on-line at 
http://www.epa.gov/edocket/, 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 EDOCKET, 
regulations.gov, or e-mail. The EPA EDOCKET and the regulations.gov 
websites are ``anonymous access'' systems, 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 EDOCKET or regulations.gov, your e-mail address 
will be automatically captured and included as part of the comment that 
is placed in the public 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. For additional information about EPA's public 
docket, visit EDOCKET on-line or see the Federal Register of May 31, 
2002 (67 FR 38102) (FRL-7181-7).
    Docket: All documents in the docket are listed in the EDOCKET index 
at http://www.epa.gov/edocket/. Although listed in the index, some 
information is not publicly available, i.e., CBI or other information 
whose disclosure is restricted by statute. Certain other material, such 
as copyrighted material, is not placed on the Internet and will be 
publicly available only in hard copy form. Publicly available docket 
materials are available either electronically in EDOCKET or in hard 
copy at the OPPT Docket, EPA Docket Center, EPA West, Rm. B102, 1301 
Constitution Ave., NW., Washington, DC. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The EPA Docket Center Reading Room telephone number is (202) 
566-1744, and the telephone number for the OPPT Docket, which is 
located in the EPA Docket Center, is (202) 566-0280.

FOR FURTHER INFORMATION CONTACT: For general information contact: Colby 
Lintner, Regulatory Coordinator, Environmental Assistance Division 
(7408M), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: [email protected].
    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: [email protected].

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 2-EE (CAS No. 110-80-5), 2-EEA (CAS No. 111-15-9), 
2-ME (CAS No. 109-86-4), or 2-MEA (CAS No. 110-49-6) for use in 
consumer products or manufacture or import 2-MEA (CAS No. 110-49-6) at 
levels greater than 10,000 pounds per year.
    Persons who intend to 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 to the regulations codified at 19 CFR 
12.118 through 12.127 and 127.28. Those persons must certify that they 
are in compliance with the SNUR requirements (see TSCA section 13 (15 
U.S.C. 2612) and 19 CFR 12.118 through 12.127 and 127.28). 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 March 31, 2005 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

[[Page 9903]]

export notification requirements in 40 CFR part 707, subpart D. 
Potentially affected entities may include, but are not limited to:
     Manufacturers (defined by statute to include importers) 
and processors of 2-EE, 2-EEA, 2-ME, and 2-MEA (NAICS 325 and 324110), 
e.g., chemical manufacturing and petroleum refineries.
    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 North American Industrial Classification System (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 for 
SNUR-related obligations. If you have any questions regarding the 
applicability of this action to a particular entity, consult the 
technical person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to using EDOCKET (http://www.epa.gov/edocket), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 721 
is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

C. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
EDOCKET, 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 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 rulemaking 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 Action is the Agency Taking?

    EPA is proposing to designate the manufacture, import, or 
processing of 2-EE (CAS No. 110-80-5), 2-EEA (CAS No. 111-15-9), 2-ME 
(CAS No. 109-86-4), and 2-MEA (CAS No. 110-49-6) for domestic use in 
consumer products as a significant new use, as well as the manufacture 
or import of 2-MEA (CAS No. 110-49-6) at levels greater than 10,000 
pounds per year. ``Consumer product'' is defined at 40 CFR 721.3 as ``a 
chemical substance that is directly, or as part of a mixture, sold or 
made available to consumers for their use in or around a permanent or 
temporary household or residence, in or around a school, or in 
recreation.'' This proposed rule would require persons intending to 
manufacture or import 2-MEA at levels greater than 10,000 pounds per 
year as well as those intending to manufacture, import, or process 2-
EE, 2-EEA, 2-ME, or 2-MEA for domestic use in a consumer product to 
submit a Significant New Use Notice (SNUN) to EPA at least 90 days 
before such manufacture, import, or processing.

B. What is the Agency's Authority for Taking this Action?

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine that a use of a chemical substance is a ``significant new 
use.'' EPA must make this determination by rule after considering all 
relevant factors, including those listed in TSCA section 5(a)(2). Once 
EPA determines that a use of a chemical substance is a significant new 
use, and promulgates a SNUR, section 5(a)(1)(B) of TSCA requires 
persons to submit a SNUN to EPA at least 90 days before commencement of 
manufacture, import, or processing of the chemical substance for that 
use.

C. What is the Applicability of the General Regulatory Provisions?

    General regulatory provisions for SNURs appear under subpart A of 
40 CFR part 721. These provisions describe persons subject to the rule, 
recordkeeping requirements, and exemptions to reporting requirements. 
Provisions relating to user fees appear at 40 CFR part 700. Persons 
subject to the rule, when finalized, would be required to comply with 
the same notice requirements and EPA regulatory procedures as 
submitters of premanufacture notices (PMNs) under section 5(a)(1)(A) of 
TSCA. In particular, these requirements include the information 
submission requirements of TSCA section 5(b) and 5(d)(1), the 
exemptions authorized by TSCA section 5(h)(1), (2), (3), and (5), and 
the regulations at 40 CFR part 720. Receipt of a SNUN by EPA may 
trigger regulatory action under TSCA sections 5(e), 5(f), 6, or 7, if 
appropriate, 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 intend to export a 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 intend to import a chemical 
substance identified in a final SNUR are subject to the TSCA section 13 
import certification requirements, which are codified at 19 CFR 
sections 12.118 through 12.127 and section 127.28. Such persons must 
certify that they are in compliance with TSCA requirements. The EPA 
policy relating to import certification appears at 40 CFR part 707, 
subpart B.

III. Summary of this Proposed Rule

A. Why is EPA Taking this Action?

    1. Background. On January 24, 1984, EPA published an Advance Notice 
of Proposed Rulemaking (ANPRM) (49 FR 2921) which stated that EPA 
determined, based on animal studies, that adverse reproductive and 
developmental effects are associated with the subject glycol ethers, 
i.e., 2-EE,

[[Page 9904]]

2-EEA, 2-ME, and 2-MEA, at concentrations to which humans may be 
exposed. (Ref. 1). EPA was considering the regulatory options available 
under TSCA section 6 to control any unreasonable risks from these 
chemicals. It solicited comments on the appropriateness of imposing a 
partial or total ban on these chemicals. EPA had also consulted with 
the Occupational Safety and Health Administration (OSHA) and the 
Consumer Product Safety Commission (CPSC) on possible actions under 
their legal authorities. Later, in October 1984, the Agency concluded 
that these chemicals may pose a significant hazard to humans (Ref. 2). 
However, by 1986, EPA's investigation of risks to consumers had led the 
Agency to conclude that the current information would not support an 
unreasonable risk finding for consumer use. This conclusion was based 
on the fact that because of wholesale switching to substitute solvents, 
EPA had not been able to identify manufacturers who were currently 
using these glycol ethers in their consumer products. EPA stated that 
it would continue to consult with the CPSC pursuant to section 9(d) of 
TSCA to resolve outstanding issues, particularly to clarify whether 
these glycol ethers were being used in consumer products (Ref. 3). 
Additionally, EPA stated it was satisfied that any risks from the 
substitutes were less than those presented by 2-EE, 2-EEA, 2-ME, or 2-
MEA, and that use of substitutes would reduce overall risks to humans 
(Ref. 4).
    On May 20, 1986 (51 FR 18488), EPA issued a report to OSHA, under 
section 9(a) of TSCA, stating that EPA had a reasonable basis to 
conclude that the risk of injury to worker health from exposure to 2-
EE, 2-EEA, 2-ME, and 2-MEA during their manufacturing, processing, and 
use is unreasonable and that this risk may be prevented or reduced 
sufficiently by OSHA regulatory action (Ref. 3).
    2. Initial regulatory response by OSHA. OSHA published its response 
on December 11, 1986 (51 FR 44699), stating that it had preliminarily 
concluded that occupational exposures to 2-EE, 2-EEA, 2-ME, and 2-MEA 
at the current OSHA permissible exposure limits (PELs) may present 
significant risks to the health of workers (Ref. 5). On April 2, 1987 
(52 FR 10586), OSHA published an ANPRM under section 6(b) of the 
Occupational Safety and Health Act of 1970 (29 U.S.C. 654), announcing 
its intention to proceed to rulemaking to reduce occupational exposure 
to 2-EE, 2-EEA, 2-ME, and 2-MEA (Ref. 6). On March 23, 1993 (58 FR 
15526), OSHA published a proposed rule that would reduce the chemicals' 
PELs and provide other protective measures for the approximately 46,000 
workers exposed to the substances (Ref. 7). After publishing the 1993 
proposal, OSHA held informal public hearings on the proposal, and the 
record closed in March 1994 (Ref. 8).
    3. EPA regulatory activities in the 1990's. In the period 
immediately after OSHA published its proposed rule, EPA, on July 27, 
1993 (58 FR 40262) (Ref. 9), promulgated a TSCA section 4 test rule to 
require neurotoxicity testing of 2-EE (among other chemical 
substances). The required testing was based on suggestive evidence of 
neurotoxicity involving the alteration of motor performance and 
avoidance conditioning in the offspring of rats exposed to 100 and 200 
parts per million (ppm) (Refs. 10 and 11), as well as substantial 
occupational and consumer exposure, and substantial environmental 
release (Ref. 12). After publication of that rule, however, the 
producers of 2-EE told EPA that there were no consumer uses of 2-EE 
(Ref. 13). Given this information, and because OSHA was continuing to 
work toward revising the PELs for glycol ethers, EPA believed that 
exposure to 2-EE was not substantial and revoked the TSCA section 4 
testing requirements for 2-EE in a settlement agreement with producers 
in 1994 (Ref. 13). The settlement agreement required that the Chemical 
Manufacturers Association (now the American Chemistry Council (ACC)) 
and the manufacturers and processors of these chemicals perform certain 
neurotoxicity and pharmacokinetics testing on 7 of the 10 chemicals 
subject to the final neurotoxicity test rule (Ref. 14). This revocation 
was also reflected in the January 23, 1995 Federal Register (60 FR 
4514) (FRL-4924-7) (Ref. 15). At the time that EPA was considering 
revoking the testing requirements in the section 4 rule, the Agency 
also believed it would be prudent to provide some mechanism to monitor 
the possible re-emergence of the consumer use of 2-EE. Therefore, in 
the same notice in which it proposed to revoke the testing requirements 
of 2-EE (59 FR 33187, June 27, 1994) (Ref. 14), EPA announced its 
intention to propose and promulgate a SNUR. The parties to the 
settlement agreement supported such a SNUR (Ref. 13).
    4. Final OSHA regulatory actions. OSHA reopened the record on 
August 8, 2002 seeking comment on how the substances were being used in 
the workplace, including their level of production, and the industries 
and processes in which they were used (Ref. 16). Based on the 
information submitted during this comment period, OSHA determined that 
a major decline in the production of the substances was apparent and 
that their use in several key industry sectors has been eliminated or 
is in the process of being phased out. Additionally, OSHA determined 
that where these substances were still being manufactured, their 
production was virtually limited to ``closed systems'' and average 
exposures already were at or below the proposed PEL (Ref. 8). OSHA 
concluded that the proposed rule was no longer necessary and withdrew 
its proposed Glycol Ethers rule on December 31, 2003 (Ref. 8).

B. What are the Uses and Production Levels of these Chemicals?

    The chemical substances 2-EE, 2-EEA, 2-ME, and 2-MEA, are 
considered members of a broad class of chemicals known as ethylene 
glycol ethers. As with other glycol ethers, 2-EE, 2-EEA, 2-ME, and 2-
MEA are colorless, flammable liquids which are compatible with a broad 
range of resins and can be mixed with both organic solvents and water. 
They have relatively low vapor pressures, high boiling points, low 
evaporation rates and high flash points. Due to these physical 
characteristics, 2-EE, 2-EEA, 2-ME, and 2-MEA are potentially useful in 
a wide variety of applications, particularly as solvents (Ref. 7). They 
have been used in many industrial and consumer products, but concerns 
for their health effects have caused these uses to be severely 
curtailed in recent years.
    U.S. production of 2-EE peaked at 200.7 million pounds in 1980 and 
had decreased to 118 million pounds by 1999. U.S. consumption of 2-EE 
(including consumption to manufacture 2-EEA) was 175 million pounds in 
1980, and down to 53 million pounds in 1999, of which, 52 of the 53 
million pounds was used to manufacture 2-EEA. U.S. consumption of 2-EE 
for uses other than acetate production was less than 1 million pounds. 
Production and/or imports of 2-EE were below 100 million pounds based 
on data collected for the 2002 TSCA section 8(a) Inventory Update Rule 
(IUR) (see 40 CFR part 710) (Ref. 17).
    U.S. production of 2-EEA dropped from 136.7 million pounds in 1984 
to 72 million pounds in 1999. In 1999, all but one million of those 
pounds were exported. Data collected for the 2002 IUR show production 
and/or import levels of less than 100 million pounds (Ref. 17).

[[Page 9905]]

    U.S. production of 2-ME, which peaked at 97.3 million pounds in 
1980, was down to 55 million pounds by 1999 (at which time most 2-ME 
produced was exported). U.S. consumption, still 50 to 53 million pounds 
in the early 1990's, had declined to approximately 3 million pounds in 
1999. 2002 IUR data show that production and/or import was less than 50 
million pounds (Ref. 17).
    U.S. production of 2-MEA in 1991 was estimated to be 0.5 million 
pounds. There were no reports of 2-MEA production or import under the 
IUR in 1994, 1998, and 2002 (Ref. 17). Therefore, EPA is proposing that 
persons intending to manufacture or import 2-MEA at levels greater than 
10,000 pounds per year as well as persons intending to manufacture, 
import, or process 2-EE, 2-EEA, 2-ME, or 2-MEA for domestic use in a 
consumer product to submit a SNUN to EPA at least 90 days before such 
manufacture, import, or processing.
    Production of the E-series glycol ethers, i.e., ethanol based 
glycol ethers and their acetates, had been declining or has ceased and 
EPA believes there is no ongoing use of these chemicals in consumer 
products in the U.S. In response to a proposed TSCA section 4 test 
rule, manufacturers of 2-EE told EPA that there was no consumer use of 
2-EE (Ref. 13). In 2004, a representative for the Ethylene Glycol 
Ethers Panel of the ACC confirmed that concerns over the toxicity of E-
series glycol ethers has subsequently resulted in the elimination of E-
series glycol ethers from all consumer products in the 1980's and the 
development of alternatives to 2-ME, 2-EE, and 2-EEA (Ref. 18).

C. What are the Potential Routes of Exposure?

    Despite the diminished potential for human exposure due to the 
decline in production and use in industrial products and the 
termination of the chemicals' use in consumer products as discussed in 
Unit III.B., EPA believes there may still be some potential for human 
exposure to 2-EE, 2-EEA, 2-ME, and 2-MEA. Their physical 
characteristics discussed in Unit III.B. make them useful in a variety 
of applications, particularly as solvents. ``A major route of exposure 
is the skin. The ubiquity of solvents and the casual approach [of 
consumers] to their use almost assure skin contact with liquid 
solvents.'' (Ref. 19). Also, as members of the ethylene series (``E-
series'' used in Unit III.B.) of glycol ethers, 2-EE, 2-EEA, 2-ME, and 
2-MEA are well absorbed from the skin. They are so readily absorbed 
through the skin that the dermal to oral 50% lethal dose 
(LD50) ratio is approximately one (Ref 19).
    Although 2-EE, 2-EEA, 2-ME, and 2-MEA are not highly volatile, high 
vapor concentrations can be generated under the conditions of solvent 
use. When glycol ether vapors enter the lungs they can readily diffuse 
across respiratory membranes and enter the bloodstream (Ref. 19).

D. What are the Potential Sources of Exposure?

    EPA believes that 2-EE, 2-ME, 2-MEA, and 2-EEA are currently used 
only in industrial products. EPA also believes that the documented 
decline in production volumes of 2-EE, 2-EEA, 2-ME, and 2-MEA discussed 
in Unit III.B. has probably already reduced the potential for 
occupational exposure. OSHA reported in late 2003 that production, use, 
and exposure to these glycol ethers has ceased or is virtually limited 
to closed system production where there is little opportunity for 
worker exposure. Exposure levels in those operations already are at or 
below the proposed PELs. In addition, use of these glycol ethers has 
largely been replaced by less-toxic substitutes, such as E-series butyl 
glycol ethers, other ethylene glycol ethers, propylene glycol ethers, 
and other types of solvents (Ref. 8). A decline in environmental 
release of 2-EE is reflected in Toxics Release Inventory (TRI) data 
from the years 1987 through 1996 which indicates a steady decline from 
2,770,113 pounds in 1987 to 192,468 pounds in 1996 (Ref. 20) to 103,513 
pounds in 2001 (Ref. 17).
    EPA has found evidence which suggests that 2-EE, as well as 2-ME, 
2-MEA, and 2-EEA, are not currently used in consumer products (Ref. 
17), and the manufacturers of 2-EE which were parties to the 1994 
settlement agreement told EPA that, to the best of their knowledge, 
there were, at that time, no consumer uses of 2-EE (Refs. 9 and 13).
    The ACC also reported in 2001, citing the SRI Chemical Economics 
Handbook as its source, that the remaining domestic consumption of 2-EE 
is in non-consumer solvents for paints, coatings, and other industrial 
uses; the only remaining domestic use of 2-EEA is in machinery and 
equipment paints and coatings; and the only remaining use of 2-ME, 
other than as a chemical intermediate, is as a jet fuel deicer. No 
information on current uses of 2-MEA was identified (Ref. 17).

E. What are the Health Effects of these Chemicals?

    Toxicity studies in rats, rabbits, mice, and monkeys via 
inhalation, dermal, and oral exposure, have shown clearly and 
consistently that 2-EE and 2-ME can cause adverse hematologic, 
reproductive, and developmental effects. These effects include 
decreased white and red blood cell counts, decreased hemoglobin, 
decreased fertility, decreased sperm count, decreased testes size and 
weight, increased resorptions, increased fetal malformations, and 
behavioral and neurochemical alterations in the neonate (Refs. 7 and 
2).
    Although data on workers is often compromised by confounding 
exposure to other solvents, studies of workers exposed to 2-ME and 2-EE 
have documented adverse effects on the hematologic and male 
reproductive systems. Blood effects observed among the exposed workers 
include bone marrow injury, reduced red and white blood cell counts, 
and anemia, while the major reproductive effect observed is reduced 
sperm count (Ref. 7). Thus, although the human data have their 
limitations, there is evidence of certain adverse effects in humans 
exposed to 2-EE and 2-ME and this evidence is consistent with a strong 
body of evidence of the same or similar effects in experimental 
animals.
    Animal studies with 2-EEA and 2-MEA have shown that these acetates 
induce adverse reproductive, developmental, and hematological effects 
similar to those ascribed to their parent glycol ethers, 2-EE and 2-ME. 
These studies confirm the findings of metabolic studies which indicate 
that 2-ME, 2-EE, and their acetates follow similar metabolic pathways, 
producing the same metabolites, which are the active agents most likely 
responsible for the observed effects (Ref. 7).

IV. Determining a Significant New Use

    Section 5(a)(2) of TSCA provides that EPA's determination that a 
use of a chemical substance is a significant new use must be made after 
consideration of all relevant factors including:
     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.
    EPA construes the statute to allow consideration of any other 
relevant factors, in addition to those enumerated

[[Page 9906]]

in section 5(a)(2)(A) through (D) of TSCA.
    To determine what would constitute a significant new use of 2-EE, 
2-EEA, 2-ME, and 2-MEA, EPA considered relevant information about the 
toxicity of the substances, likely exposures/releases associated with 
possible uses, and the four factors listed in section 5(a)(2) of TSCA.
    The latest information available to EPA indicates that there is no 
ongoing domestic use of 2-EE, 2-EEA, 2-ME, or 2-MEA in consumer 
products. EPA believes that the renewed use of 2-EE, 2-EEA, 2-ME, or 2-
MEA in a consumer product would increase the magnitude and duration of 
exposure. Considering the health concerns for 2-EE, 2-EEA, 2-ME, and 2-
MEA, EPA believes that individuals could suffer adverse effects from 
their use in consumer products. Thus, EPA is proposing to designate 
``domestic use in a consumer product'' as well as the manufacture or 
import of 2-MEA at levels greater than 10,000 pounds per year as a 
significant new use of 2-EE, 2-EEA, 2-ME, and 2-MEA.
    Based on these considerations, EPA is pursuing the following 
objectives with regard to the use of 2-EE, 2-EEA, 2-ME, and 2-MEA in 
consumer products:
     EPA wants to ensure that it would receive notice of any 
person's intent to manufacture or import 2-MEA at levels greater than 
10,000 pounds per year or intending to manufacture, import, or process 
2-EE, 2-EEA, 2-ME, and 2-MEA for domestic use in a consumer product 
before that activity begins.
     EPA wants to ensure that it would have the opportunity to 
review and evaluate data submitted in a SNUN before the notice 
submitter begins manufacturing, importing, or processing 2-EE, 2-EEA, 
2-ME, and 2-MEA for domestic use in a consumer product or manufacturing 
or importing 2-MEA at levels greater than 10,000 pounds per year.
     EPA wants to ensure that it would be able to regulate 
prospective manufacturers, importers, or processors of 2-EE, 2-EEA, 2-
ME, and 2-MEA before use of any of these chemicals in a consumer 
product occurs, provided that the degree of potential risk is 
sufficient to warrant such regulation.
    As noted in Unit III.B., the production of the chemicals included 
in this SNUR have declined significantly over time. EPA is not aware of 
current domestic consumer uses for the chemicals, and substitutes are 
available. The Agency will use information submitted pursuant to the 
Inventory Update Rule (40 CFR part 710) to track the production volumes 
and uses of these chemicals. If needed, EPA may pursue additional 
regulatory actions as appropriate under TSCA sections 4, 5, 6, or 8.

V. Test Data and Other Information

    EPA recognizes that section 5 of TSCA does not require the 
development of any particular test data before submission of a SNUN. 
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).
    However, SNUN submitters should be aware that EPA will be better 
able to evaluate SNUNs which provide detailed information on:
     Human exposure and environmental releases that may result 
from the significant new use of the chemical substances.
     Potential benefits of the chemical substances.
     Information on risks posed by the chemical substances 
relative to risks posed by potential substitutes.
    Submitters should consider including with a SNUN any other 
available studies on the chemical substances or studies on analogous 
substances which may demonstrate that the significant new uses being 
reported are unlikely to present an unreasonable risk.
    In view of the potential risks posed by these chemicals, EPA would 
recommend that potential SNUN submitters include data that would permit 
a reasoned evaluation of risks posed by these chemicals. EPA encourages 
persons to consult with the Agency before submitting a SNUN for these 
substances. As part of this optional pre-notice consultation, EPA would 
discuss specific data it believes are necessary to evaluate a 
significant new use. A SNUN submitted without sufficient data to 
reasonably evaluate risks posed by a significant new use of 2-EE, 2-
EEA, 2-ME, and/or 2-MEA may increase the likelihood that EPA will take 
action under TSCA section 5(e) to prohibit or limit activities 
associated with these chemicals. EPA recommends that potential SNUN 
submitters contact the Agency early enough that they will be able to 
conduct any appropriate tests.

VI. Recordkeeping Requirements

    In addition to the recordkeeping requirements of 40 CFR 721.40 
which require persons subject to a SNUR to retain documentation of 
information contained in a SNUN, EPA is proposing to require the 
recordkeeping requirements in 40 CFR 721.125 (a), (b), and (c) in this 
SNUR. Section 721.125(a) requires records documenting manufacture and 
importation volume and dates; Sec.  721.125(b) documents volumes 
purchased in the U.S. by processors, the names and addresses of 
suppliers, and the dates of purchase; and Sec.  721.125(c) requires 
records documenting the names and addresses (including shipment 
destination address, if different) of all persons outside the site of 
manufacture, importation, or processing to whom the manufacturer, 
importer, or processor directly sells or transfers the substance, the 
date, and the quantity of each sale or transfer. EPA is also proposing 
to require the maintenance of records documenting the compliance with 
the significant new use of domestic use in a consumer product or the 
manufacture or import of 2-MEA at levels greater than 10,000 pounds per 
year. For the significant new use of 2-MEA manufacture or import at 
levels greater than 10,000 pounds per year, records required by Sec.  
721.125(a) would be sufficient. For the significant new use of domestic 
use in a consumer product, required documentation must demonstrate 
compliance with the significant new use, i.e.,: 1) That 2-EE, 2-EEA, 2-
ME or 2-MEA were not manufactured, imported, or processed for use in a 
consumer product; and, 2) that, where no significant new use notice is 
filed, any recipients of these chemicals either (a) were notified of 
the SNUR and its provisions by the manufacturer, importer, or 
processor, (b) knew of the SNUR independently, or (c) cannot undertake 
the significant new use. See 40 CFR 720.5(a)(2). These records will 
enable EPA to determine compliance with the SNUR.

VII. SNUN Submissions

    SNUNs should be mailed to the Environmental Protection Agency, OPPT 
Document Control Office (7407M), 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001. Information must be submitted in the form 
and manner set forth in EPA Form No. 7710-25. This form is available 
from the Environmental Assistance Division (7408M), OPPT, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001 (see 40 CFR 721.25(a) and 720.40(a)(2)(i)).

VIII. Alternatives

    Before proposing this SNUR, EPA considered promulgating a TSCA 
section 8(a) reporting rule for 2-EE, 2-EEA, 2-ME, and 2-MEA. Under 
such a rule, EPA could generally require any person to report 
information to the Agency when they intend to manufacture, import, or 
process 2-EE, 2-EEA, 2-ME, or 2-MEA. However, in the case of these 
particular substances, the

[[Page 9907]]

use of TSCA section 8(a) rather than SNUR authority would have several 
drawbacks. First, EPA would not be able to 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 concerns for 2-EE, 2-EEA, 2-ME, and 2-MEA, 
EPA believes that a TSCA section 8(a) rule for these substances would 
not meet EPA's regulatory objectives.
    Currently 2-EE, 2-EEA, 2-ME, and 2-MEA are not subject to any other 
Federal regulation which would notify the Federal Government of 
activities that might result in adverse exposures associated with the 
proposed significant new uses, or provide a mechanism that could 
protect against potentially adverse exposures associated with those 
uses before they occur.

IX. 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 believes that the intent of TSCA section 5(a)(1)(B) is best 
served by designating a use as a significant new use as of the date of 
publication of the proposed SNUR rather than as of the effective date 
of the final rule. If uses begun after publication of the proposed SNUR 
were considered to be ongoing rather than new, it would be difficult 
for EPA to establish SNUR notice requirements, because any person could 
defeat the SNUR by initiating the proposed significant new use before 
the rule became final.
    Any person who, after publication of this proposed SNUR, begins to 
manufacture, import, or process 2-EE, 2-EEA, 2-ME, or 2-MEA for a 
proposed significant new use must stop such activity before the 
effective date of the final rule. Persons who cease those activities 
will have to meet all SNUR notice requirements and wait until the end 
of the notice review period, including all extensions, before engaging 
in any activities designated as significant new uses. If, however, 
persons who begin to manufacture, import, or process any of these 
chemicals between the proposal and the effective date of the final SNUR 
meet the conditions of advance compliance as codified at 40 CFR 
721.45(h), those persons would be considered to have met the 
requirements of the final SNUR for those activities.

X. Economic Analysis

    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 there is no precise way to calculate the total annual cost of 
compliance with the final rule, given the uncertainties related to 
predicting the number of SNUN's that would be submitted as a result of 
this SNUR, EPA estimates that the cost for preparing and submitting a 
SNUN is $7,174, including a $2,500 user fee required by 40 CFR part 
700.45(b)(2)(iii) (Ref. 18). 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 part 
700.45(b)(1)). Based on past experience with SNURs and the low number 
of SNUNs which are submitted on an annual basis, EPA believes that 
there will be few, if any, SNUNs submitted as a result of this SNUR. 
The costs of submission of SNUNs will not be incurred by any company 
unless a company decides to pursue a significant new use as defined in 
this SNUR. Furthermore, while the expense of a notice and the 
uncertainty of possible EPA regulation may discourage certain 
innovations, that impact would be limited because such factors are 
unlikely to discourage an innovation that has high potential value. 
EPA's complete economic analysis is available in the public docket for 
this proposed rule (Ref. 18).
    Under section 12(b) of TSCA, exporters must notify EPA if they 
export or intend to export a chemical substance or mixture for which a 
rule has been proposed or promulgated under section 5 or 6. Notice must 
be provided for the first export or intended export to a particular 
country in a calendar year. In an economic analysis of an amendment to 
the rules implementing TSCA section 12(b), EPA estimated that the one-
time cost of preparing and submitting an export notification was $62.60 
in 1992, or $93.02 when inflated to 2003 dollars by a factor of 
approximately 1.5, from the Employment Cost Index for White Collar 
Occupations. The total costs of export notification will vary per 
chemical, depending on the number of required notifications (i.e., 
number of countries to which the chemical is exported). EPA is unable 
to make any estimate of the likely number of export notifications for 
chemicals covered in this SNUR (Ref. 17).

XI. References

    The public docket for this action, OPPT-2004-0111, currently 
includes the following documents:
    1. USEPA. ``2-Methoxyethanol and 2-Ethoxyethanol and their 
Acetates; Initiation of Regulatory Investigation, Advance Notice of 
Proposed Rulemaking.'' 49 FR 2921. (January 24, 1984).
    2. USEPA. ``Glycol Ethers Health Effects Assessment.'' Intra-agency 
memorandum from M.S. Ottley to Harry Teitelbaum, Existing Chemicals 
Assessment Division. (October 31, 1984).
    3. U.S. Environmental Protection Agency (USEPA). ``Toxic and 
Hazardous Substances Control; 2-Methoxyethanol, 2-Ethoxyethanol and 
their Acetates; Referral For Additional Action.'' TSCA section 9 
referral to OSHA. 51 FR 18488. (May 20, 1986).
    4. USEPA. ``Substitutes for 2-Ethoxyethanol (2-EE), 2-
Methoxyethanol (2-ME) and their Acetates.'' Intra-agency memorandum 
from Harry Teitelbaum, Risk Management Branch to Joseph Merenda, 
Existing Chemicals Assessment Division. (March 15, 1984).
    5. OSHA. ``Occupational Exposure to 2-Methoxyethanol, 2-
Ethoxyethanol and Their Acetates; Response to the Environmental 
Protection Agency under section 9(a) of the Toxic Substances Control 
Act.'' 51 FR 44699. (December 11, 1986).
    6. OSHA. ``Occupational Exposure to 2-Methoxyethanol, 2-
Ethoxyethanol and Their Acetates; Advance Notice of Proposed 
Rulemaking.'' 52 FR 10586. (April 2, 1987).
    7. Occupational Health and Safety Administration (OSHA). 
``Occupational Exposure to 2-Methoxyethanol, 2-Ethoxyethanol and their 
Acetates (Glycol Ethers); Proposed Rule.'' 58 FR 15526 (March 23, 
1993).
    8. OSHA. ``Occupational Exposure to 2-Methoxyethanol, 2-
Ethoxyethanol and Their Acetates (Glycol Ethers); Withdrawal of 
Proposed Rule.'' 68:75475-75476. (December 31, 2003).
    9. USEPA. ``Multi-substance Rule for the Testing of Neurotoxicity; 
Final Rule.'' 58 FR 40262. (July 27, 1993).
    10. Nelson, B.K., Brightwell, W.S., Setzer, J.V., Taylor, B.J., 
Hornung, R.W. and O'Donohue, T.L. ``Ethoxyethanol Behavioral Teratology 
in Rats.'' Neurotoxicology. 2:231-249. (1981).
    11. Nelson, B.K., Brightwell, W.S. and Setzer, J.V. ``Prenatal 
Interaction Between Ethanol and the Industrial Solvent 2-Ethoxyethanol 
in Rats; Maternal and Behavioral Teratogenic Effects.'' Neurobehavioral 
Toxicology and Teratology. 4:387-394. (1982).

[[Page 9908]]

    12. USEPA. ``Multi-substance Rule for the Testing of Neurotoxicity; 
Proposed Rule.'' 56 FR 9105. (March 4, 1991).
    13. United States Court of Appeals for the Fifth Circuit. 
Settlement Agreement between Environmental Protection Agency and 
petitioners (Chemical Manufacturers Association et al.), No. 93-5381. 
(April 28, 1994).
    14. USEPA. ``Proposed Revocation of Final Multi-substance Rule for 
the Testing of Neurotoxicity; Proposed Rule.'' 59 FR 33187 (June 27, 
1994).
    15. USEPA. ``Revocation of Final Multi-substance Rule for the 
Testing of Neurotoxicity.'' 60 FR 4514. (January 23, 1995).
    16. OSHA. ``Occupational Exposure to 2-Methoxyethanol, 2-
Ethoxyethanol and Their Acetates (Glycol Ethers).'' 67 FR 51524. 
(August 8, 2002).
    17. USEPA, 2004. ``Economic Analysis of Expedited Significant New 
Use Rules for Four Glycol Ethers.'' Washington, DC: U.S. EPA/OPPT/EETD/
EPAB, October 27, 2004.
    18. ACC, 2004. Personal Communication Between American Chemistry 
Council, Ethylene Glycol Ethers Panel representative and Jason Sacks, 
Abt Associates Inc. May 10, 2004.
    19. Casarett and Doull's Toxicology. Editors: Klaassen, C.D., 
Amdur, M.O., and Doull J. Chapter 20: Toxic Effects of Solvents and 
Vapors. Pages 636-638 and 656-658, 3rd Edition. (1986).
    20. USEPA. Toxic Release Inventory (TRI). Total annual 
environmental releases of 2-ethoxyethanol for the years 1987 through 
1996. TRI printouts. (April 26, 1994, May 6, 1994, May 19, 1998, and 
May 28, 1998).

XII. Statutory and Executive Order Reviews

A. Executive Order 12866: 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 determined that proposed or final SNURs are not a 
``significant regulatory action'' subject to review by OMB, because 
they do not meet the criteria in section 3(f) 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 would 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 105 hours 
per submission. 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. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) 
(5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation 
of this SNUR would not have a significant adverse economic impact on a 
substantial number of small entities. The rationale supporting this 
conclusion is as follows. A SNUR applies to any person (including small 
or large entities) who intends to engage in any activity described in 
the rule as a ``significant new use.'' By definition of the word 
``new,'' and based on all information currently available to EPA, it 
appears that no small or large entities presently engage in such 
activity. Since a SNUR only requires that any person who intends to 
engage in such activity in the future must first notify EPA by 
submitting a SNUN, no economic impact would even occur until someone 
decides to engage in those activities. 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 10 notices per year. Of those SNUNs 
submitted, none appear to be from small entities in response to any 
SNUR. In addition, the estimated reporting cost for submission of a 
SNUN (see Unit X.), are minimal regardless of the size of the firm. 
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 on June 
2, 1997 (62 FR 29684) (FRL-5597-1), 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 reasons 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 affect on small governments subject to the 
requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Public Law 104-4).

E. Executive Order 13132: 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. Executive Order 13175: Consultation and Coordination with Indian 
Tribal Governments

    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 6, 
2000), do not apply to this proposed rule.

[[Page 9909]]

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

    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. Executive Order 13211: Actions that Significantly Affect 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. National Technology Transfer Advancement Act

    In addition, since this action does not involve any technical 
standards, section 12(d) of the National Technology Transfer and 
Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 
U.S.C. 272 note), does not apply to this action.

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

    This action does not entail special considerations of environmental 
justice related issues as delineated by Executive Order 12898, entitled 
Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

K. Executive Order 12988: Civil Justice Reform

    In issuing this proposed rule, EPA has taken the necessary steps to 
eliminate drafting errors and ambiguity, minimize potential litigation, 
and provide a clear legal standard for affected conduct, as required by 
section 3 of Executive Order 12988, entitled Civil Justice Reform (61 
FR 4729, February 7, 1996).

List of Subjects in 40 CFR Part 721

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

    Dated: February 16, 2005.
Charles M. Auer,
Director, Office of Pollution Prevention and Toxics.
    Therefore, it is proposed that 40 CFR part 721 be amended as 
follows:

PART 721--[AMENDED]

    1. The authority citation for part 721 would continue to read as 
follows:

    Authority:  15 U.S.C. 2604, 2607, and 2625(c).
    2. Add new Sec.  721.10001 to subpart E to read as follows:


Sec.  721.10001  2-Ethoxyethanol, 2-ethoxyethanol acetate, 2-
methoxyethanol, and 2-methoxyethanol acetate.

    (a) Chemical substances and significant new uses subject to 
reporting. (1) The chemical substances identified as 2-ethoxyethanol 
(CAS No. 110-80-5), 2-ethoxyethanol acetate (CAS No. 111-15-9), 2-
methoxyethanol (CAS No. 109-86-4), and 2-methoxyethanol acetate (CAS 
No. 110-49-6) are subject to reporting under this section for the 
significant new use described in paragraph (a)(2) of this section.
    (2) The significant new use is domestic use in a consumer product 
or the manufacture or import of 2-methoxyethanol acetate at levels 
greater than 10,000 pounds per year.
    (b) Specific requirements. The provisions of subpart A of this part 
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.  
721.125 (a), (b), and (c) apply to the significant new use specified in 
Sec.  721.10001. In addition, records documenting compliance with the 
significant new use of domestic use in a consumer product or the 
manufacture or import of 2-methoxyethanol acetate at levels greater 
than 10,000 pounds per year must be maintained.
    (2) [Reserved]

[FR Doc. 05-3911 Filed 2-28-05; 8:45 am]
BILLING CODE 6560-50-S