[Federal Register: November 29, 2005 (Volume 70, Number 228)]
[Rules and Regulations]
[Page 71401-71406]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29no05-6]
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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:
TSCA-Hotline@epa.gov.
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.
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:
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:
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 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:
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
[[Page 71404]]
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 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:
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. 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.
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Therefore, 40 CFR part 721 is amended as follows:
PART 721--[AMENDED]
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1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
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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