[Federal Register Volume 70, Number 228 (Tuesday, November 29, 2005)]
[Rules and Regulations]
[Pages 71401-71406]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-23421]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[OPPT-2004-0111; FRL-7740-7]
RIN 2070-AJ12


2-ethoxyethanol, 2-ethoxyethanol acetate, 2-methoxyethanol, and 
2-methoxyethanol acetate; Significant New Use Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY:  EPA is issuing a significant new use rule (SNUR) under 
section 5(a)(2) of the Toxic Substances Control Act (TSCA) which 
requires 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. This action finalizes the SNUR proposed in the Federal 
Register of March 1, 2005 (70 FR 9902) (FRL-7692-8). EPA believes 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 will 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: This final rule is effective on December 29, 2005.

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number OPPT-2004-0111. 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, will not be 
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, Room 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

[[Page 71402]]

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: <a href="/cdn-cgi/l/email-protection#36626575771b7e59425a5f58537653465718515940"><span class="__cf_email__" data-cfemail="99cdcadad8b4d1f6edf5f0f7fcd9fce9f8b7fef6ef">[email protected]</span></a>.
    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: <a href="/cdn-cgi/l/email-protection#7e1c0c1b1b1a1211081b501f13073e1b0e1f50191108"><span class="__cf_email__" data-cfemail="92f0e0f7f7f6fefde4f7bcf3ffebd2f7e2f3bcf5fde4">[email protected]</span></a>.

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. The EPA policy in support 
of import certification appears at 40 CFR part 707, subpart B. In 
addition, any persons who export or intend to export a chemical 
substance that is the subject of this rule are subject to the export 
notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see 
40 CFR 721.20), and must comply with the export notification 
requirements in 40 CFR part 707, subpart D. Potentially affected 
entities may include, but are not limited to:
    <bullet> 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/.

II. Background

A. What Action Is the Agency Taking?

    EPA is designating 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 rule 
requires 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 activity.

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. Applicability of General 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 are 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 12.118 
through 12.127 and 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 and Response to Comments

A. Final Rule

    In the Federal Register of March 1, 2005 (70 FR 9902), EPA proposed 
a SNUR for 2-ethoxyethanol, 2-ethoxyethanol acetate, 2-methoxyethanol, 
or 2-methoxyethanol acetate where the significant new uses were for 
domestic use in a consumer product or the manufacture or import of 2-
methoxyethanol at levels greater than

[[Page 71403]]

10,000 pounds per year. The Agency reviewed and considered the six 
comments received by the end of the comment period (May 2, 2005) for 
the March 1, 2005 proposed rule. A discussion of the comments and the 
Agency's response follow in Unit III.B. None of the comments received 
identified any ongoing uses of these four chemicals in domestic 
consumer products nor any production of 2-methoxyethanol acetate. In 
addition, no new data were submitted or identified that would change 
EPA's findings regarding the SNUR for these four chemicals. Therefore, 
EPA is issuing the SNUR as proposed. This final rule requires persons 
to notify EPA at least 90 days before commencing 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), or 2-MEA (CAS No. 110-49-6) for 
domestic use in a consumer product or the manufacture or import of 2-
MEA at levels greater than 10,000 pounds per year. A complete copy of 
all comments received is available in the public docket for this 
action.

B. Response to Comments

    EPA received six comments, two from an individual and one each from 
the American Chemistry Council (ACC), on behalf of the Ethylene and 
Propylene Glycol Ethers Panel; the Lyondell Chemical Company 
(Lyondell); the National Paint and Coatings Association (NPCA); and The 
Dow Chemical Company (Dow). The one individual submitted two separate 
sets of comments. The first set was a general statement that the author 
did not think any new uses should be allowed or that the product should 
be for sale or use in the United States. The second set of comments 
pointed out the several statements in the SNUR that led the author to 
be concerned that these chemicals are sold or used at all. Neither set 
of comments recommended any specific changes to the SNUR.
    Comment: ACC and Lyondell expressed support for the SNUR. Both also 
requested that the Agency clarify whether or not products containing 1% 
or less of the substances listed in the rule are subject to the TSCA 
section 12(b) export notification requirements of 40 CFR part 707, 
subpart D. The NPCA pointed out that solvent substitutes may still 
contain trace amounts of the four chemicals listed in the SNUR which 
would trigger TSCA section 12(b) requirements. They also referred to 
EPA amending the final TSCA section 6 rulemaking for 40 CFR 749.68 
(hexavalent chromium-based water treatment chemicals in cooling 
systems) to exclude those hexavalent chromium compounds that could not 
be used in the prohibited application from section 12(b) export 
notification requirements (59 FR 42769, August 19, 1994).
    EPA response: If an exporter is aware of the presence of a chemical 
subject to this SNUR, at any level in the products to be exported, then 
pursuant to TSCA section 12(b), the exporter must notify EPA of the 
export regardless of whether the substance is being exported for the 
use regulated by the SNUR. See Chemical Imports and Exports; 
Notification of Export, final rule (45 FR 82844, at 82845; December 16, 
1980). Thirty days after publication in the Federal Register of a 
proposed SNUR, the export or intended export of a chemical subject to a 
SNUR requires export notification under TSCA section 12(b), regardless 
of the amount of the substance in a product, or its use or intended 
use. In the August 1994 hexavalent chromium rule-related action noted 
by NPCA, EPA amended 40 CFR 749.68 to clarify that only hexavalent 
chromium chemicals that can be used for water treatment were the 
subjects of the underlying TSCA section 6 regulation, not other 
hexavalent chromium chemicals. That amendment had the parallel effect 
of limiting the scope of TSCA section 12(b) export notifications that 
were required for those hexavalent chromium chemicals that could be 
used to treat water.
    Comment: ACC and Lyondell also noted that two of the SNUR 
references referred generally to glycol ethers and that all glycol 
ethers were not subject to the SNUR.
    EPA response: EPA agrees and notes that the SNUR refers only to the 
chemicals by their names, not the general term glycol ethers.
    Comment: The Dow Chemical Company requested the Agency clarify that 
the proposed rule does not apply when the subject substances appear as 
impurities in consumer products consisting primarily of other chemical 
substances. NPCA stated that EPA should limit the scope of the 
recordkeeping and reporting requirements to exempt products with only 
trace or de minimus amounts of these chemicals.
    EPA response: EPA does not intend for the SNUR reporting and 
recordkeeping requirements to apply to persons that manufacture, 
import, or process the subject substances only as an impurity.

IV. Significant New Use Determination

    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:
    <bullet> The projected volume of manufacturing and processing of a 
chemical substance.
    <bullet> The extent to which a use changes the type or form of 
exposure of human beings or the environment to a chemical substance.
    <bullet> The extent to which a use increases the magnitude and 
duration of exposure of human beings or the environment to a chemical 
substance.
    <bullet> The reasonably anticipated manner and methods of 
manufacturing, processing, distribution in commerce, and disposal of a 
chemical substance.
    EPA construes the statute to allow consideration of any other 
relevant factors, in addition to those enumerated 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 designating ``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:
    <bullet> 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.
    <bullet> 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

[[Page 71404]]

levels greater than 10,000 pounds per year.
    <bullet> 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 as well as prospective manufacturers or imports of 2-MEA 
before manufacture or import of the substance at levels greater than 
10,000 pounds per year occurs, provided that the degree of potential 
risk is sufficient to warrant such regulation.
    As noted in Unit III.B. of the proposed SNUR (70 FR 9902, March 1, 
2005), 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:
    <bullet> Human exposure and environmental releases that may result 
from the significant new use of the chemical substances.
    <bullet> Potential benefits of the chemical substances.
    <bullet> 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. 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)).

VII. 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 proposal rather than as of the effective date of the 
final rule. If uses begun after publication of the proposed SNUR 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 effective.
    Any person who began manufacture, import, or processing of 2-EE, 2-
EEA, 2-ME, or 2-MEA for the significant new use listed in the proposed 
SNUR after the date of publication of the proposed SNUR must stop that 
activity before the effective date of this final rule. Persons who 
ceased those activities will have to meet all SNUR notice requirements 
and wait until the end of the notification review period, including all 
extensions, before engaging in any activities designated as significant 
new uses. If, however, persons who began manufacture, import, or 
processing of any of these chemical substances between the date of 
publication of the proposed SNUR and the effective date of this 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 final SNUR 
requirements for those activities.

VIII. Economic Analysis

    EPA evaluated the potential costs of establishing SNUR reporting 
requirements for potential manufacturers, importers, and processors of 
the chemical substances included in this 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). 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 rule.
    Under section 12(b) of TSCA, among other requirements, 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 TSCA 
section 5, such as this SNUR. 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

[[Page 71405]]

estimate of the likely number of export notifications for chemicals 
covered in this SNUR.

IX. 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. of the proposed SNUR (70 FR 9902, March 1, 2005), is 
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 does not have a substantial direct effect on States, on 
the relationship between the national government and the States, or on 
the distribution of power and responsibilities among the various levels 
of government, as specified in Executive Order 13132, entitled 
Federalism (64 FR 43255, August 10, 1999).

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

    This rule does not have Tribal implications because it is not 
expected to have substantial direct effects on Indian Tribes. This rule 
does not significantly or uniquely affect the communities of Indian 
Tribal governments, nor does 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 rule.

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 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.

[[Page 71406]]

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 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).

X. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the Agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and the Comptroller General of the United 
States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of the rule in the Federal Register. This rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 721

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


    Dated: November 17, 2005.
Charles M. Auer,
Director, Office of Pollution Prevention and Toxics.

0
Therefore, 40 CFR part 721 is amended as follows:

PART 721--[AMENDED]

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

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

0
2. By adding 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. 05-23421 Filed 11-28-05; 8:45 am]
BILLING CODE 6560-50-S


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