[Federal Register Volume 69, Number 228 (Monday, November 29, 2004)]
[Rules and Regulations]
[Pages 69320-69325]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-26071]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[OAR-2003-0188; FRL-7841-8]
RIN 2060-AL87


List of Hazardous Air Pollutants, Petition Process, Lesser 
Quantity Designations, Source Category List; Petition To Delist of 
Ethylene Glycol Monobutyl Ether

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The EPA is amending the list of hazardous air pollutants (HAP) 
contained in section 112(b)(1) of the Clean Air Act (CAA) by removing 
the compound ethylene glycol monobutyl ether (EGBE) (2-Butoxyethanol) 
(Chemical Abstract Service (CAS) No. 111-76-2) from the group of glycol 
ethers. This action is being taken in response to a petition to delete 
EGBE from the HAP list submitted by the Ethylene Glycol Ethers Panel of 
the American Chemistry Council (ACC) (formerly the Chemical 
Manufacturers Association) on behalf of EGBE producers and consumers. 
Petitions to delete a substance from the HAP list are permitted under 
section 112(b)(3) of the CAA.
    Based on the available information concerning the potential hazards 
of and projected exposures to EGBE, EPA has made a determination 
pursuant to CAA section 112(b)(3)(C) that there are ``adequate data on 
the health and environmental effects [of EGBE] to determine that 
emissions, ambient concentrations, bioaccumulation, or deposition of 
the substance may not reasonably be anticipated to cause adverse 
effects to human health or adverse environmental effects.''

DATES: Effective November 29, 2004.

ADDRESSES: The EPA has established a docket for this action under 
Docket ID No. OAR-2003-0188 and A-99-24. 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 EPA Docket Center (Air Docket), EPA/
DC, EPA West, Room B-102, 1301 Constitution Avenue, NW, Washington, DC 
10460. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., 
Monday through Friday, excluding legal holidays. The telephone number 
for the Public Reading Room is (202) 566-1744, and the telephone number 
for the Air Docket is (202) 566-1742.

FOR FURTHER INFORMATION CONTACT: Ms. Kelly Rimer, Office of Air Quality 
Planning and Standards, Emission Standards Division, C404-01, U. S. 
EPA, Research Triangle Park, NC 27711; telephone number: (919) 541-
2962; fax number: 919-541-0840; e-mail address: <a href="/cdn-cgi/l/email-protection#e092898d8592ce8b858c8c99a0859081ce878f96"><span class="__cf_email__" data-cfemail="7002191d15025e1b151c1c09301500115e171f06">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: Regulated Entities. Entities potentially 
affected by this action are those industrial facilities that 
manufacture or use EGBE. The final rule amends the list of HAP 
contained in section 112(b)(1) of the CAA by removing the compound 
EGBE. The decision to issue a final rule to delist EGBE removes EGBE 
from regulatory consideration under section 112(d) of the CAA.
    Judicial Review. Under section 307(b)(1) of the CAA, judicial 
review is available only by filing a petition for review in the U.S. 
Court of Appeals for the District of Columbia Circuit by 60 days from 
publication in the Federal Register. Under section 307(d)(7)(B) of the 
CAA, only an objection to a rule or procedure raised with reasonable 
specificity during the period for public comment can be raised during 
judicial review. Moreover, under section 307(b)(2) of the CAA, the 
requirements established by the final rule may not be challenged 
separately in any civil or criminal proceeding brought to enforce these 
requirements.
    Outline. The information presented in this preamble is organized as 
follows:

I. Introduction
    A. The Delisting Process
    B. The Present Petition and Rulemaking
II. Peer Review of New Data on EGBE Metabolite, Butoxyacetaldehyde
III. Public Comments on Proposed Rule to Delist EGBE
IV. Final Rule
    A. Rationale for Action
    B. Effective Date
V. References
VI. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Analysis
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With 
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children from 
Environmental Health & Safety Risks
    H. Executive Order 13211: Actions that Significantly Affect 
Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act
    J. Congressional Review Act

I. Introduction

A. The Delisting Process

    Section 112 of the CAA contains a mandate for EPA to evaluate and 
control emissions of HAP. Section 112(b)(1) includes an initial list of 
HAPs that are composed of specific chemical compounds and compound 
classes to be used by EPA to identify source categories for which EPA 
will subsequently promulgate emissions standards.
    Section 112(b)(2) of the CAA requires EPA to make periodic 
revisions to the initial list of HAPs set forth in section 112(b)(1) 
and outlines criteria to be applied in deciding whether to add or 
delete particular substances. Section 112(b)(2) identifies pollutants 
that should be listed as: `` * * * pollutants which present, or may 
present, through inhalation or other routes of exposure, a threat of 
adverse human health effects (including, but not limited to, substances 
which are known to be, or may reasonably be anticipated to be 
carcinogenic, mutagenic, teratogenic, neurotoxic, which cause 
reproductive dysfunction, or which are acutely or chronically toxic) or 
adverse environmental effects whether through ambient concentrations, 
bioaccumulation, deposition, or otherwise. * * * ''
    To assist EPA in making judgements about whether a pollutant causes 
an adverse environmental effect, section 112(a)(7) defines an ``adverse 
environmental effect'' as: ``* * * any significant and widespread 
adverse effect, which may reasonably be anticipated, to wildlife, 
aquatic life, or other natural resources, including adverse impacts on 
populations of endangered or threatened species or significant 
degradation of environmental quality over broad areas.''
    Section 112(b)(3) establishes general requirements for petitioning 
EPA to modify the HAP list by adding or deleting a substance. Although 
the Administrator may add or delete a substance on his or her own 
initiative, the burden is on a petitioner to include sufficient 
information to support the

[[Page 69321]]

requested addition or deletion under the substantive criteria set forth 
in CAA section 112(b)(3)(B) and (C). The Administrator must either 
grant or deny a petition within 18 months of receipt of a complete 
petition. If the Administrator decides to grant a petition, the Agency 
publishes a written explanation of the Administrator's decision, along 
with a proposed rule to add or delete the substance. If the 
Administrator decides to deny the petition, the Agency publishes a 
written explanation of the basis for denial. A decision to deny a 
petition is final Agency action subject to review in the D.C. Circuit 
Court of Appeals under CAA section 307(b).
    To promulgate a final rule deleting a substance from the HAP list, 
CAA section 112(b)(3)(C) provides that the Administrator must determine 
that there are: '' * * * adequate data on the health and environmental 
effects of the substance to determine that emissions, ambient 
concentrations, bioaccumulation, or deposition of the substance may not 
reasonably be anticipated to cause any adverse effects to the human 
health or adverse environmental effects.''
    The EPA will grant a petition to delete a substance and publish a 
proposed rule to delete that substance, if it makes an initial 
determination that these criteria have been met. After affording an 
opportunity for comment and for a hearing, EPA will make a final 
determination whether the criteria have been met.
    The EPA does not interpret CAA section 112(b)(3)(C) to require 
absolute certainty that a pollutant will not cause adverse effects on 
human health or the environment before it may be deleted from the list. 
The use of the terms ``adequate'' and ``reasonably'' indicate that the 
Agency must weigh the potential uncertainties and their likely 
significance. Uncertainties concerning the risk of adverse health or 
environmental effects may be mitigated if EPA can determine that 
projected exposures are sufficiently low to provide reasonable 
assurance that such adverse effects will not occur. Similarly, 
uncertainties concerning the magnitude of projected exposure may be 
mitigated if EPA can determine that the levels which might cause 
adverse health or environmental effects are sufficiently high to 
provide reasonable assurance that exposures will not reach harmful 
levels. However, the burden remains on a petitioner to resolve any 
critical uncertainties associated with missing information. The EPA 
will not grant a petition to delete a substance if there are major 
uncertainties which need to be addressed before EPA would have 
sufficient information to make the requisite determination.

B. The Present Petition and Rulemaking

    On August 29, 1997, the ACC's Glycol Ethers Panel submitted a 
petition to delete EGBE (CAS No. 111-76-2) from the HAP list in CAA 
section 112(b)(1), 42 U.S.C. 7412(b)(1). Following the receipt of the 
petition, we conducted a preliminary evaluation to determine whether 
the petition was complete according to Agency criteria. To be deemed 
complete, a petition must consider all available health and 
environmental effects data. A petition must also provide comprehensive 
emissions data, including peak and annual average emissions for each 
source or for a representative selection of sources, and must estimate 
the resulting exposures of people living in the vicinity of the 
sources.
    In addition, a petition must address the environmental impacts 
associated with emissions to the ambient air and impacts associated 
with the subsequent cross-media transport of those emissions. After 
receiving additional submittals through December 21, 1998, we 
determined the petition to delete EGBE to be complete. We published a 
notice of receipt of a complete petition in the Federal Register on 
August 3, 1999 and requested information to assist us in technically 
reviewing the petition.
    We received eight submissions in response to our request for 
comment and information which would aid our technical review of the 
petition. The comments made general statements encouraging EPA to 
delist EGBE. None of the comments included technical information.
    On November 4, 2003, based on a comprehensive review of the data 
provided in the petition and otherwise provided to EPA, the Agency made 
an initial determination that the statutory criteria for deletion of 
EGBE from the HAP list had been met. The EPA, therefore, granted the 
petition by the ACC's Glycol Ethers Panel and issued a proposed rule to 
delist EGBE (68 FR 65648, November 21, 2003).
    The EPA received a total of 18 comments on the November 21, 2003 
proposed rule. While three of the commenters opposed deleting EGBE from 
the HAP list, they provided no substantive arguments to support this 
position. There was no request for a public hearing.
    The EPA's decision to remove EGBE from the list of HAP is based on 
the results of a risk assessment demonstrating that emissions of EGBE 
may not reasonably be anticipated to result in adverse human health or 
environmental effects. In addition to the risk assessment, we have 
considered public comments, as well as other information related to 
EGBE in making this decision, namely the transformation of EGBE into 
other HAP as it decomposes in the ambient air. We conclude that ambient 
concentrations of the transformed HAP are very small, and that they 
decompose rapidly. Therefore, we do not anticipate that EGBE 
transformation will be significant enough to have an adverse impact on 
human health.
    We also considered the fact that EGBE is reported to the Toxics 
Release Inventory (TRI) as part of the group of glycol ethers. The 2000 
TRI shows the air emissions of the class of chemicals ``Certain Glycol 
Ethers'' to be ranked number 12 by volume. Under the final rule, it 
will no longer be regulated as a HAP, but it will continue to be 
reported in the TRI, as part of the group ``Certain Glycol Ethers'' and 
regulated under EPA's criteria pollutant (ozone) program.
    The EPA has made a final determination, after careful consideration 
of the petition and after completing additional analyses, that there 
are adequate data on the health and environmental effects of EGBE to 
determine that emissions, ambient concentrations, bioaccumulation, or 
deposition of EGBE may not reasonably be anticipated to cause any 
adverse effects to the human health or adverse environmental effects.

II. Peer Review of New Data on EGBE Metabolite, Butoxyacetaldehyde

    In the preamble to the proposed rule, we stated that the Agency 
believes EGBE is not genotoxic and that two distinctly different 
nonlinear modes of action are principally responsible for the increased 
forestomach and liver tumors reported by NTP (2000a). These modes of 
action are discussed in detail in the Interim Final position paper, 
``An Evaluation of the Human Carcinogenic Potential of Ethylene Glycol 
Butyl Ether,'' available from the Docket for the final rule. We also 
stated that there are reports of weak positive effects by EGBE at high 
concentrations in some in vitro assays which may indicate the potential 
for genotoxicity by butoxyacetaldehyde (BAL), an EGBE metabolite known 
to cause clastogenic changes at high in vitro concentrations (see the 
section on ``Other Possible Modes of Action for Forestomach Tumor 
Development in Female Mice'' in the Agency's position paper). However, 
available evidence from a published EGBE physiologically based 
pharmacokinetic model that had

[[Page 69322]]

been modified to include kinetics for the metabolism of the BAL 
intermediate (Corley, 2003) suggested that the concentrations of BAL 
metabolite predicted to occur in vivo would be much lower than the 
concentrations used in the in vitro assays. Based on this, it appears 
that genotoxicity is not a factor in tumor development in female mice. 
This increases our confidence that a nonlinear mechanism is involved in 
tumor formation (versus a linear mechanism which would be suggested if 
genotoxicity was involved). As we discussed in the preamble to the 
proposed rule, additional research (e.g., verification of these PBPK 
modeling results and further genotoxicity research using more 
appropriate assays and currently accepted test protocols) would be 
beneficial to provide a more definitive determination regarding the 
role of BAL in the formation of forestomach tumors in female mice.
    Since the publication of the proposed rule, additional research has 
been completed and submitted to EPA. Subsequently, we commissioned a 
peer review panel to evaluate the new data submitted and EPA's 
conclusions of the proposed ruling and interim final position paper in 
light of the recent research and literature that has been submitted to 
the Agency in response to the Agency's proposed EGBE ruling. The peer 
review was conducted on May 19, 2004 by an external review panel of 
seven experts. A report on the results of this peer review is included 
in the docket for the final rule. In summary, the peer review panel was 
unanimous in agreeing that there is enough information to support an 
informed decision concerning the significance of BAL genotoxicity to 
the formation of EGBE induced liver and forestomach tumors. The 
available information support a nonlinear mode of action, not a linear 
mode of action (e.g., genotoxicity) for the male mouse liver tumors and 
female mouse forestomach tumors observed following EGBE exposure. That 
is, the reviewers concluded that genotoxicity is not important in the 
development of these tumors.
    The panel also concluded that it is reasonable to expect that a 
lack of hemolytic effects in humans would preclude the formation of 
liver tumors in humans and that a lack of hyperplastic effects in the 
region of the gastroesophogeal junction in humans would preclude the 
formation of gastrointestinal tumors in humans. That is, the data 
support the finding that we would not expect to find these tumors in 
humans following environmental exposures. The RfC and RfD values for 
EGBE have been set at levels that prevent both the precursor events 
that would lead to tumors and other noncancer effects, and the Agency 
has determined that exposures to EGBE are at levels well below the RfC 
and RfD. We can therefore conclude with confidence that emissions, 
ambient concentrations, bioaccumulation, or deposition of EGBE may not 
reasonably be anticipated to cause any adverse effects to the human 
health.

III. Public Comments on Proposed Rule To Delist EGBE

    Of the 18 written comments we received pertaining to the proposed 
delisting of EGBE, 15 were supportive of the decision to delist and 3 
opposed the decision to delist.
    The EPA has considered carefully all the comments both supporting 
and opposing the proposed delisting. A summary of the comments and EPA 
responses to them has been included in the docket for this proceeding. 
We received substantive comments with regard to the BAL issue, which we 
discussed in detail above. We received no substantive negative 
comments. Two of the comments in support of the delisting also asked 
specific policy questions. We respond to those questions below.
    Comment: One commenter asked if the rule also applies to diethylene 
glycol monobutyl ether (DEGBE). The commenter expressed support for 
delisting both chemicals in the rule.
    Response: The final rule applies only to EGBE, one of the compounds 
included in the group of glycol ethers listed in the section 112(b)(1) 
HAP list. The petition requested that one single compound, EGBE, be 
delisted; it did not request EPA to consider removing any other 
compounds in the group of glycol ethers. Therefore this action pertains 
only to EGBE.
    Comment: One commenter urged EPA to address the ``Once In, Always 
In'' policy in the final rulemaking for facilities that will no longer 
be major sources for MACT standards once EGBE is delisted. This 
commenter requested that the ``Once In, Always In'' policy not apply to 
delistings in general, since a facility that was only over the major 
source threshold due to emissions of a subsequently delisted HAP may 
never have been a ``major source'' from a health perspective, and 
therefore never really ``in''. The commenter argued that the purpose of 
the policy that sources not be allowed to backslide from MACT 
standards, is not applicable to delistings because in such cases the 
health and environmental protection of a standard is not undermined 
since the delisted chemical has been determined not to be a health and 
environmental threat.
    Response: This action addresses a request to remove a specific 
pollutant from the HAP list. Any questions about the ``Once In Always 
In Policy'' are beyond the scope of today's action. The EPA will 
address the ``Once In Always In Policy'' in the future.

IV. Final Rule

A. Rationale for Action

    The detailed factual rationale for supporting the Agency's initial 
determination that the criteria in Clean Air Act section 112(b)(3)(C) 
had been met is set forth in the proposed rule published in the Federal 
Register on November 21, 2003 (68 FR 65648). However, as described 
above, EPA received additional data during the public comment period 
and had those data peer reviewed. The results of the peer review 
strengthen the case for delisting. The EPA also received 18 public 
comments on the proposed rule, none of which caused EPA to revise the 
scientific basis upon which the initial determination to delist EGBE 
was predicated. The EPA hereby incorporates into its rationale for the 
final rule the substantive assessment of potential hazards, projected 
exposures, human risk, and environmental effects set forth in the 
proposed rule to delist EGBE. Based on that assessment, the Agency's 
evaluation of the comments, and additional information submitted during 
the rulemaking (as summarized above), EPA has made a determination that 
there are adequate data on the health and environmental effects of EGBE 
to determine that emissions, ambient concentrations, bioaccumulation, 
or deposition of the compound may not reasonably be anticipated to 
cause adverse human health or environmental effects.

B. Effective Date

    The final rule will be effective on November 29, 2004, the date it 
is published in the Federal Register. Although Section 553(d) of the 
Administrative Procedures Act, 5 U.S.C. 553(d), provides that 
substantive rules must be published at least 30 days prior to their 
effective date, this requirement does not apply to this action. First, 
the rule was promulgated pursuant to CAA section 307(d), and that 
provision expressly states that the provisions of section 553 do not 
apply to this action. Second, even under section 553, the requirement 
that a rule be published 30 days prior to its effective date does not 
apply to a rule, ``which grants or

[[Page 69323]]

recognizes an exemption or relieves a restriction.''

V. References

    References cited in the preamble can be viewed in the docket for 
the final rule.

VI. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), EPA 
must determine whether the regulatory action is ``significant'' and 
therefore subject to Office of Management and Budget (OMB) review and 
the requirements of the Executive Order. The Executive Order defines 
``significant regulatory action'' as one that is likely to result in a 
rule that may:
    (1) Have an annual effect on the economy of $100 million or more or 
adverse affect in a material way the economy, a sector to the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or state, local or tribal governments or communities;
    (2) Create a serious inconsistency or otherwise interfere with an 
action taken or planned by another agency;
    (3) Materially alter the budgetary impact of entitlements, grants, 
user fees, or loan programs, or the rights and obligation of recipients 
thereof; or
    (4) Raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
the Executive Order.
    Pursuant to the terms of Executive Order 12866, it has been 
determined that the final action does not constitute a ``significant 
regulatory action'' and is, therefore, not subject to OMB review.

B. Paperwork Reduction Act

    This action does not impose an information collection burden under 
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. 
The final action will remove EGBE from the CAA section 112 (b)(1) HAP 
list and, therefore, eliminate the need for information collection 
under the CAA. Burden means the total time, effort, or financial 
resources expended by persons to generate, maintain, retain, or 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; develop, acquire, 
install, and utilize technology and systems for the purposes of 
collecting, validating, and verifying information, processing and 
maintaining information, and disclosing and providing information; 
adjust the existing ways to comply with any previously applicable 
instructions and requirements; train personnel to be able to respond to 
a collection of information; search data sources; complete and review 
the collection of information; and transmit or otherwise disclose the 
information. An Agency may not conduct or sponsor, and a person is not 
required to respond to a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for EPA's 
regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

C. Regulatory Flexibility Act (RFA)

    The RFA generally requires an agency to prepare a regulatory 
flexibility analysis of any rule subject to notice and comment 
rulemaking requirements under the Administrative Procedure Act or any 
other statute unless the agency certifies that the rule will not have a 
significant economic impact on a substantial number of small entities. 
Small entities include small business, small organizations, and small 
governmental jurisdictions. For the purposes of assessing the impacts 
of today's final rule on small entities, small entity is defined as: 
(1) A small business that meets the definitions for small business 
based on the Small Business Association (SBA) size standards which, for 
this final action, can include manufacturing (NAICS 3999-03) and air 
transportation (NAICS 4522-98 and 4512-98) operations that employ less 
1,000 people and engineering services (NAICS 8711-98) operations that 
earn less than $20 million annually; (2) a small governmental 
jurisdiction that is a government of a city, county, town, school 
district or special district with a population of less than 50,000; and 
(3) a small organization that is any not-for-profit enterprise which is 
independently owned and operated and is not dominant in its field.
    After considering the economic impact of today's final rule on 
small entities, I certify that this final action will not have a 
significant economic impact on a substantial number of small entities. 
In determining whether a rule has significant economic impact on a 
substantial number of small entities, the impact of concern is any 
significant adverse economic impact on small entities, since the 
primary purpose of the regulatory flexibility analysis is to identify 
and address regulatory alternatives ``which minimize any significant 
economic impact of the final rule on small entities.'' (5 U.S.C. 603 
and 604). Thus, an agency may certify that a rule will not have a 
significant economic impact on a substantial number of small entities 
if the rule relieves regulatory burden, or otherwise has a positive 
economic effect on all of the small entities subject to the rule. The 
final rule will eliminate the burden of additional controls necessary 
to reduce EGBE emissions and the associated operating, monitoring and 
reporting requirements. We have, therefore, concluded that today's 
final rule will relieve regulatory burden for all small entities. We 
continue to be interested in the potential impacts of the final rule on 
small entities and welcome comments on issues related to such impacts.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public 
Law 1044, establishes requirements for Federal agencies to assess the 
effects of their regulatory actions on State, local, and tribal 
governments and the private sector. Under section 202 of the UMRA, EPA 
generally must prepare a written statement, including a cost-benefit 
analysis, for final and final rules with ``Federal mandates'' that may 
result in expenditures to State, local, and tribal governments, in the 
aggregate, or to the private sector, of $100 million or more in any 1 
year. Before promulgating an EPA rule for which a written statement is 
needed, section 205 of the UMRA generally requires EPA to identify and 
consider a reasonable number of regulatory alternatives and adopt the 
least costly, most cost-effective or least burdensome alternative that 
achieves the objectives of the rule. The provisions of section 205 do 
not apply when they are inconsistent with applicable law. Moreover, 
section 205 allows EPA to adopt an alternative other than the least 
costly, most cost-effective or least burdensome alternative if the 
Administrator publishes with the final rule an explanation why that 
alternative was not adopted. Before EPA establishes any regulatory 
requirements that may significantly or uniquely affect small 
governments, including tribal governments, it must have developed under 
section 203 of the UMRA a small government agency plan. The plan must 
provide for notifying potentially affected small governments, enabling 
officials of affected small governments to have meaningful and timely 
input in the development of EPA regulatory proposals with significant 
Federal intergovernmental mandates, and informing, educating, and 
advising small governments on compliance with the regulatory 
requirements.
    Today's final rule contains no Federal mandates for State, local, 
or tribal

[[Page 69324]]

governments or the private sector. The final rule imposes no 
enforceable duty on any State, local or tribal governments or the 
private sector. The EPA has determined that the final rule does not 
contain a Federal mandate that may result in expenditures of $100 
million or more for State, local, and tribal governments, in the 
aggregate, or the private sector in any 1 year. Because the final rule 
removes a compound previously labeled in the CAA as a HAP, it actually 
reduces the burden established under the CAA. Thus, today's final rule 
is not subject to the requirements of sections 202 and 205 of the UMRA.

E. Executive Order 13132, Federalism

    Executive Order 13132 (64 FR 43255, August 10, 1999) requires to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the 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.''
    Under Executive Order 13132, EPA may not issue a regulation that 
has federalism implications, that imposes substantial direct compliance 
costs, and that is not required by statute, unless the Federal 
government provides the funds necessary to pay the direct compliance 
costs incurred by State and local governments, or EPA consults with 
State and local officials early in the process of developing the final 
regulation. The EPA also may not issue a regulation that has federalism 
implications and that preempts State law unless the Agency consults 
with State and local officials early in the process of developing the 
final regulation.
    Today's final rule removes the substance EGBE from the list of HAP 
contained under section 112(b)(1) of the CAA. It does not impose any 
additional requirements on the States and does not affect the balance 
of power between the States and the Federal government. Thus, the 
requirements of section 6 of the Executive Order do not apply to the 
final rule.

F. Executive Order 13175, Consultation and Coordination With Indian 
Tribal Governments

    Executive Order 13175, entitled ``Consultation and Coordination 
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000), 
requires EPA to develop an accountable process to ensure ``meaningful 
and timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' The final rule does not have 
tribal implications, as specified in Executive Order 13175. The final 
rule will eliminate control requirements for EGBE and, therefore, 
reduces control costs and reporting requirements for any tribal entity 
operating a EGBE source subject to control under the CAA. Thus, 
Executive Order 13175 does not apply to the final rule.

G. Executive Order 13045, Protection of Children From Environmental 
Health Risks and Safety Risks

    Executive Order 13045 (62 FR 19885, April 23, 1997) applies to any 
rule that: (1) Is determined to be ``economically significant'' as 
defined under Executive Order 12866, and (2) concerns an environmental 
health or safety risk that EPA has reason to believe may have a 
disproportionate effect on children. If the regulatory action meets 
both criteria, the Agency must evaluate the environmental health or 
safety effects of the planned rule on children, and explain why the 
planned regulation is preferable to other potentially effective and 
reasonably feasible alternatives considered by the Agency.
    The EPA interprets Executive Order 13045 as applying only to those 
regulatory actions that are based on health or safety risks, such that 
the analysis required under section 5-501 of the Executive Order has 
the potential to influence the regulation. The final rule is not 
subject to Executive Order 13045 because it is not economically 
significant as defined in Executive Order 12866, and because the Agency 
does not have reason to believe the environmental health or safety 
risks addressed by this action present a disproportionate risk to 
children. This determination is based on the fact that the RfC is 
determined to be protective of sensitive sub-populations, including 
children.

H. Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use

    Executive Order 13211, ``Actions Concerning Regulations that 
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 
28355, May 22, 2001), requires EPA to prepare and submit a Statement of 
Energy Effects to the Administrator of the Office of Information and 
Regulatory Affairs, Office of Management and Budget, for certain 
actions identified as ``significant energy actions.'' The final rule is 
not a ``significant energy action'' because it is not likely to have a 
significant adverse effect on the supply, distribution, or use of 
energy.

I. National Technology Transfer and Advancement Act

    Section 112(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law No. 104-113, section 12(d) 915 U.S.C. 
272 note), directs all Federal agencies to use voluntary consensus 
standards instead of government-unique standards in their regulatory 
activities unless to do so would be inconsistent with applicable law or 
otherwise impractical. Voluntary consensus standards are technical 
standards (e.g., material specifications, test method, sampling and 
analytical procedures, business practices, etc.) that are developed or 
adopted by one or more voluntary consensus standards bodies. Examples 
of organizations generally regarded as voluntary consensus standards 
bodies include the American society for Testing and Materials (ASTM), 
the National Fire Protection Association (NFPA), and the Society of 
Automotive Engineers (SAE). The NTTAA requires Federal agencies like 
EPA to provide Congress, through OMB, with explanations when an agency 
decides not to use available and applicable voluntary consensus 
standards. The final rule does not involve technical standards. 
Therefore, EPA is not considering the use of any voluntary consensus 
standards.

J. 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 to the Comptroller General of the 
United States. The EPA will submit a report containing the 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. A major rule cannot 
take effect until 60 days after it is published in the Federal 
Register. However, this action is not a major rule as defined by 5 
U.S.C. 804(2). The final rule will be effective November 29, 2004.

List of Subjects in 40 CFR Part 63

    Environmental protection, Air pollution control, Hazardous

[[Page 69325]]

substances, Reporting and recordkeeping requirements.

    Dated: November 18, 2004.
Michael O. Leavitt,
Administrator.


0
For the reasons set out in the preamble, part 63, title 40, chapter I 
of the Code of Federal Regulations is amended as follows:

PART 63--[AMENDED]

0
1. The authority citation for part 63 continues to read as follows:

    Authority: 42 U.S.C. 7401, et seq.

Subpart C--[AMENDED]

0
2. Subpart C is amended by adding Sec.  63.63 to read as follows:


Sec.  63.63  Deletion of ethylene glycol monobutyl ether from the list 
of hazardous air pollutants.

    The substance ethylene glycol monobutyl ether (EGBE,2-
Butoxyethanol) (CAS Number 111-76-2) is deleted from the list of 
hazardous air pollutants established by 42 U.S.C. 7412(b)(1).

[FR Doc. 04-26071 Filed 11-26-04; 8:45 am]
BILLING CODE 6560-50-P


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