[Federal Register Volume 65, Number 149 (Wednesday, August 2, 2000)]
[Rules and Regulations]
[Pages 47342-47348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-19375]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 63 and 302
[FRL-6843-3]
RIN 2060-AI08
Redefinition of the Glycol Ethers Category Under Section
112(b)(1) of the Clean Air Act and Section 101 of the Comprehensive
Environmental Response, Compensation, and Liability Act
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rules.
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SUMMARY: This action deletes each individual compound in a group called
the surfactant alcohol ethoxylates and their derivatives (SAED) from
the glycol ethers category in the list of hazardous air pollutants
(HAP) established by section 112(b)(1) of the Clean Air Act (CAA).
Under section 112(b)(3)(D) of the CAA, EPA may delete specific
substances from certain listed categories, including glycol ethers. To
implement this action, EPA is revising the definition of glycol ethers
to exclude the deleted compounds. This action is also making conforming
changes with respect to designation of hazardous substances under the
Comprehensive Environmental Response, Compensation, and Liability Act
(CERCLA). These final rules are being issued by EPA in response to an
analysis of potential exposure and hazards of SAED that was prepared by
the Soap and Detergent Association (SDA) and submitted to EPA. Based on
this information, EPA has made a final determination that there are
adequate data on the health and environmental effects of these
substances to determine that emissions, ambient concentrations,
bioaccumulation, or deposition of these substances may not reasonably
be anticipated to cause adverse human health or environmental effects.
EFFECTIVE DATE: August 2, 2000.
ADDRESSES: The docket is available for public inspection and copying
between 8 a.m. and 5:30 p.m., Monday through Friday, at EPA's Air and
Radiation Docket and Information Docket, Room
[[Page 47343]]
M1500, U.S. Environmental Protection Agency, 401 M Street, SW,
Washington, DC 20460.
FOR FURTHER INFORMATION CONTACT: For information concerning this final
rule, contact Dr. Roy L. Smith, Risk and Exposure Assessment Group,
Office of Air Quality Planning and Standards, U.S. EPA, Research
Triangle Park, North Carolina 27711, telephone number (919) 541-5362,
facsimile number (919) 541-0840, electronic mail address
[email protected].
SUPPLEMENTARY INFORMATION:
Docket
Docket number A-98-39 contains the supporting information for this
promulgated rule, including SDA's report on SAED and EPA's analysis of
that report. The docket also includes public comments on the proposed
rule for this action, published on January 12, 1999 (64 FR 1780). The
docket is an organized and complete file of all the information
considered by the EPA in the development of this rulemaking. The docket
is a dynamic file because material is added throughout the rulemaking
process. The docketing system is intended to allow members of the
public and industries involved to readily identify and locate documents
so that they can effectively participate in the rulemaking process.
Along with the proposed and promulgated standards and their preambles,
the contents of the docket will serve as the record in the case of
judicial review. (See section 307(d)(7)(A) of the CAA.) An index for
each docket, as well as individual items contained within the dockets,
may be obtained by calling (202) 260-7548 or (202) 260-7549.
Alternatively, docket indexes are available by facsimile, as described
on the Office of Air and Radiation, Docket and Information Center
Website at http://www.epa.gov/oar/docket. A reasonable fee may be
charged for copying docket materials.
Worldwide Web (WWW)
In addition to being available in the docket, an electronic copy of
this final rule will be available on the WWW through the Technology
Transfer Network (TTN). Following signature, a copy of the rule will be
posted on the TTN's policy and guidance page for newly proposed or
promulgated rules http://www.epa.gov/ttn/oarpg. The TTN provides
information and technology exchange in various areas of air pollution
control. If more information regarding the TTN is needed, call the TTN
HELP line at (919) 541-5384.
Effective Dates
These rules will take effect on August 2, 2000. Although section
553(d) of the Administrative Procedure 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 these rules.
First, the rule deleting specified substances from the glycol ethers
category in the CAA section 112(b)(1) HAP list 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
recognizes an exemption or relieves a restriction,'' and both rules
incorporated herein fit that criterion.
Judicial Review
The final rule deleting specified substances from the glycol ethers
category in the CAA section 112(b)(1) HAP list is based on a
determination of nationwide scope and effect. A petition for judicial
review of this final rule may be filed solely in the United States
Court of Appeals for the District of Columbia. Any such petition for
judicial review of this rule must be filed no later than October 2,
2000, except for judicial review challenging solely the amendment to
the CERCLA regulations in 40 CFR part 302, which must be filed no later
than October 31, 2000. In any resulting action, no objection can be
made which was not raised with reasonable specificity during the period
for public comment.
Outline
The information presented in this preamble is organized as follows:
I. What is the background for this rule?
II. What was our analysis of the information SDA submitted?
III. What is the basis for our final decision to delete SAED
compounds from the glycol ethers category under the CAA?
IV. What is the basis for the revised designation of glycol ethers
as hazardous substances under CERCLA?
V. How have we involved stakeholders in this rulemaking?
VI. What are the administrative requirements for these final rules?
A. Executive Order 12866
B. Paperwork Reduction Act
C. Regulatory Flexibility Act (RFA), as amended by the Small
Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), (5
U.S.C. 601, et seq.)
D. Unfunded Mandates Reform Act
E. Executive Order 13045
F. Executive Order 13084
G. National Technology Transfer and Advancement Act
H. The Congressional Review Act
I. Executive Order 13132
I. What Is the Background for This Rule?
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
HAP that is composed of specific chemical compounds and groups of
compounds. This list is used to identify source categories for which we
will subsequently promulgate emissions standards.
Section 112(b)(2) requires EPA to conduct periodic reviews of the
initial list of HAP 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
added to the list 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, * * *.
Section 112(b)(3) establishes general requirements for petitioning
the Agency to modify the HAP list by adding or deleting a substance. In
general, the burden is on a petitioner to include sufficient
information to support the requested addition or deletion under the
substantive criteria set forth in section 112(b)(3)(B) and (C). The
Administrator must either grant or deny a petition within 18 months of
receipt. If the Administrator decides to grant a petition, we publish a
written explanation of the Administrator's decision, along with a
proposed rule to add or delete the substance. The proposed rule is open
to public comment and public hearing and any additional information
received is considered prior to issuance of a final rule. If the
Administrator decides to deny the petition, we publish a written
explanation of the basis for denial. A decision to deny a petition and/
or the issuance of a final rule granting a petition is final Agency
action subject to review in the D.C. Circuit Court of Appeals under
section 307(b).
To promulgate a final rule deleting a substance from the HAP list,
section 112(b)(3)(C) provides that the Administrator must determine
that:
* * * there is adequate data on the health and environmental
effects of the substance to
[[Page 47344]]
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.
We will grant a petition to delete a substance and publish a
proposed rule to delete that substance if we make an initial
determination that this criterion has been met. After affording an
opportunity for comment and for a hearing, we will make a final
determination whether the criterion has been met.
The Administrator may also act to add or delete a substance on her
own initiative. In this instance, we have been engaged in a substantive
dialogue with the SDA, a national trade association representing
manufacturers of cleaning products and ingredients, concerning the
toxicity of and exposure to SAED, a group of compounds that is within
the definition of the glycol ethers category as listed in section
112(b)(1). The SDA initiated this dialogue by requesting that we revise
the definition of glycol ethers to exclude SAED. We asked the SDA to
support its request by compiling information to satisfy the statutory
criteria for delisting this class of compounds under section 112(b)(3).
The SDA submitted this information in a report to us. Although SDA
elected not to formally petition us to delete SAED compounds from the
HAP list, we chose to evaluate the SDA report against the standards by
which substances may be removed from the list of HAP. We made an
initial determination that the statutory criteria for delisting SAED
were satisfied and published a notice of proposed rulemaking (64 FR
1780, January 12, 1999).
We do not interpret section 112(b)(3)(C) to require absolute
certainty that a pollutant will not cause adverse effects to human
health or the environment before it may be deleted from the list. The
use of the terms ``adequate'' and ``reasonably'' indicate that we
should weigh the potential uncertainties and their likely significance.
Uncertainties concerning the risk of adverse health or environmental
effects may be mitigated if we 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 exposures may be mitigated if we can determine
that the levels that might cause adverse health or environmental
effects are sufficiently high to provide reasonable assurance that
exposures will not reach harmful levels.
II. What Was Our Analysis of the Information SDA Submitted?
The SDA contended that the present definition of glycol ethers
adopted by Congress in section 112(b)(1) was incorporated verbatim from
the definition of glycol ethers utilized in section 313 of the
Emergency Planning and Community Right-to-Know Act (EPCRA), 42 U.S.C.
11023. The SDA noted that we subsequently modified the definition of
glycol ethers under EPCRA to exclude SAED compounds (59 FR 34386, July
5, 1994) and the SDA requested that we make a conforming change in the
CAA list. We responded that the substantive criteria for deleting
chemicals under EPCRA section 313(d) are materially different than the
criteria for deleting a hazardous pollutant under section 112(b)(3). It
is our view that whatever the origins of the glycol ethers definition
in section 112(b)(1), we cannot redefine the glycol ethers category to
exclude particular compounds without making a substantive determination
that such compounds meet the applicable criteria for HAP delisting.
Under section 112(b)(3)(D), we may delete specific substances included
in certain listed categories without a Chemical Abstract Service
number, including the glycol ethers category.
Although the SDA does not necessarily agree with us that deletion
of individual compounds is the only manner in which we may adopt the
requested redefinition of the glycol ethers category, the SDA agreed to
assist us in this effort by collecting information concerning SAED
compounds that would enable us to make a substantive assessment of
potential risks under section 112(b)(3). On April 25, 1997, the SDA
submitted a report entitled ``Exposure Assessment Undertaken to Support
the Evaluation of the HAP Definition of `Glycol Ethers'.''
Surfactant alcohol ethoxylates and their derivatives comprise a
group of compounds that, individually, satisfy the following
definition:
R-(OCH2CH2)n-OR'
Where:
n = 1, 2, or 3;
R = alkyl C8 or greater
R'= any group.
Rather than asking the SDA to compile an exhaustive list of each
specified SAED compound, we requested that the SDA undertake a generic
analysis of the potential toxicity of, and potential exposure to, SAED
compounds as a group. We requested that the analysis be based, to the
extent possible, on worst-case assumptions that could be deemed to be
conservative with respect to each and every individual compound in the
SAED group. Such an approach to delisting would normally be
impracticable due to the likelihood that use of such extreme
assumptions would greatly exaggerate the magnitude of potential risks.
In this instance, such an approach was considered practical only
because of assertions by the SDA that SAED compounds present both very
low potential toxicity and very limited exposure potential.
The report submitted by the SDA presented estimates of both the
potential exposure to, and potential toxicity of, SAED compounds. The
principal emissions estimate in the report was based on a hypothetical
facility either manufacturing SAED or formulating products from an SAED
precursor. The facility was assumed to use 600 million pounds per year
of SAED, the total annual domestic production of Shell Chemical
Company, the largest SAED manufacturer. The report developed
conservative emissions estimates for this facility associated with the
storage and transfer, processing, and fugitive releases of SAED
compounds.
Emissions of SAED from raw materials during storage and transfer
were estimated by assuming emissions of a volume of air, fully
saturated with SAED, equal to the total volume of 600 million pounds of
displaced SAED liquid per year. The estimated SAED concentration in
this air was based on the vapor pressure of the lowest molecular weight
compound in the SAED category, although typical SAED compounds have
greater molecular weight and substantially lower volatility.
Additional SAED emissions from manufacture of SAED compounds and
formulation of other products containing SAED were estimated by a
process factor derived from industry experience. The process factor
incorporated assumptions on the effect on emissions of higher
temperatures and air contact rates that are characteristic of SAED
processing. Potential SAED emissions during processing were estimated
to be three times greater than during storage and transfer.
Finally, fugitive emissions were estimated by applying a
proportionality factor of 41 percent to the sum of raw material and
process emissions. This factor was derived from reported emissions for
all glycol ethers in the EPA Toxics Release Inventory database,
although it is likely that the proportion of total emissions
attributable to fugitive releases would be much less for SAED
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compounds than for the lower molecular weight glycol ethers.
This analysis estimated a total emissions rate for the hypothetical
facility of 105 pounds of SAED per year from raw materials storage and
transfer, manufacturing processes, and fugitive emissions combined.
Exposures at the fence line for the hypothetical facility were then
estimated using the SCREEN3 dispersion model, the calculated total
emissions rate, and a variety of assumptions concerning terrain, stack
height and configuration, and distance to the fence line. The predicted
annual average SAED concentration associated with an emissions rate of
105 pounds per year was 0.03 micrograms of SAED per cubic meter of air
for a ``representative'' facility and 97.3 micrograms per cubic meter
for a ``hypothetical worst-case'' facility.
The SDA submission also summarized the available toxicity data on
SAED compounds. There have been few acute and no subchronic or chronic
inhalation studies utilizing SAED compounds. Available animal study
data do not indicate any adverse effects at air concentrations up to
those produced by full saturation with SAED vapors. Acute toxicity has
been demonstrated only when animals inhaled undiluted SAED in the form
of a respirable aerosol. In one 10-day repeated inhalation study, test
animals exhibited local respiratory irritation. Long-term animal
studies of SAED administered by the oral or dermal routes have not
reported any significant effects such as skin sensitization,
reproductive or developmental toxicity, genetic mutations, or cancer.
Evidence on the toxic potential of glycol ethers as a group strongly
suggests that toxic potency decreases as molecular weight increases.
Therefore, SAED (which have high molecular weights) are likely to be
substantially less toxic than lighter glycol ether compounds for which
more complete toxicity data are available.
There is no verified or proposed reference concentration (RfC) for
any SAED compound. The SDA developed a proposed ``key exposure index''
for chronic exposure to SAED compounds based on the subchronic RfC for
2-methoxy-1-propanol (MP), a structurally similar compound which also
has no demonstrated systemic toxicity by inhalation. 2-Methoxy-1-
propanol has a lower molecular weight (90 grams per mole) than the
lightest SAED compound (ethylene glycol octyl ether, 174 grams per
mole). Therefore, MP is expected to be more toxic than any SAED
compound, and its use as a surrogate should be conservative.
The SDA's analysis began with the subchronic RfC for MP, then
reduced it by a factor of 10 to account for the differences between
subchronic effects and chronic effects, and by an additional factor of
between 1 and 10 to account for the use of data for a structurally
related compound. This resulted in a proposed concentration range of
0.2 to 2.0 milligrams per cubic meter (mg/m \3\) at which no adverse
effects would be expected in human populations, including sensitive
individuals. The SDA's proposed concentration range is approximately
1,000 to 10,000 times lower than the acutely toxic level for inhalation
in rats. It is also approximately 1,000 to 10,000 times greater than
the exposure estimated by the SDA for a ``representative'' facility and
2 to 20 times greater than the estimated exposure for a ``hypothetical
worst-case'' facility.
The proposed chronic no-effect concentration range for SAED of 0.2
to 2.0 mg/m \3\ is also consistent with chronic RfCs available from
EPA's Integrated Risk Information System (IRIS) for lower-molecular
weight, non-SAED glycol ethers (i.e., 0.02 mg/m \3\ for 2-
methoxyethanol, 0.2 mg/m \3\ for 2-ethoxyethanol, and 13 mg/m \3\ for
ethylene glycol monobutyl ether). The SDA's analysis has, therefore,
treated SAED as if they were as toxic as much lighter glycol ether
compounds, which EPA considers to be unlikely and conservative.
Although the SDA document does not include a discussion of levels
of SAED that would be protective of non-human species, the toxicity
data used to support the health impact assessment were obtained from
animal studies. The derivation of human no-effect levels from these
animal data, appropriately adjusted for uncertainty, should be
protective of non-human animal species as well. Overall, there is no
evidence to suggest that any species or any ecosystem would be harmed
by any exposure below the SAED no-effect level proposed for humans.
III. What Is the Basis for Our Final Decision To Delete SAED
Compounds From the Glycol Ethers Category Under the CAA?
Based on the SDA submission as a whole, we believe that the
available data on potential exposure to, and toxicity of, SAED
compounds are considerably more limited than would normally be
necessary to support the findings required by section 112(b)(3) before
we may delete a substance from the HAP list. However, there is a
sufficiently large discrepancy between the maximum predicted exposure
level for these compounds based on plausible worst-case assumptions and
the lowest concentration likely to present any potential risk of
adverse effects to compensate for the paucity of the data. The
conservative techniques used by the SDA in its submission, which tend
to overestimate both exposure to and toxicity of SAED, are appropriate
in the context of the limited data that are available on SAED
compounds.
We cannot construe the process by which Congress adopted the
current definition of glycol ethers in section 112(b)(1) as relieving
us of the obligation to apply the statutory criteria before deleting
any substance included in the present definition. Nevertheless, it is
important to observe that there is no evidence suggesting that the
current broader definition of glycol ethers was adopted because of any
actual concerns regarding the potential hazards of SAED compounds. We
believe that the absence of any discernable affirmative rationale for
the initial inclusion of SAED compounds in the statutory HAP list,
while not dispositive in itself, lends additional support to our
conclusion that the available evidence supports deletion of these
compounds.
Based on the available information, we have made a final
determination, with respect to each and every individual substance that
satisfies the definition of SAED compounds set forth above, that there
are adequate data on the health and environmental effects of those
substances to determine that emissions, ambient concentrations,
bioaccumulation or deposition of the substances may not reasonably be
anticipated to cause adverse human health or environmental effects.
Based on that determination, we have decided to delete from the glycol
ethers category in the HAP list established by CAA section 112(b)(1)
each and every SAED compound. The EPA will implement this action to
delete all SAED compounds by adopting a revised definition of the
entire glycol ethers category that excludes each of the deleted
substances.
IV. What Is the Basis for the Revised Designation of Glycol Ethers
as Hazardous Substances Under CERCLA?
When a HAP is listed under section 112 of the CAA, it is also
defined as a hazardous substance under section 101(14) of CERCLA, 42
U.S.C. 9601(14). In an April 4, 1985 final rule, under our authority in
section 102(a) of CERCLA, we designated and listed, in the table at 40
CFR 302.4, all the elements and compounds and hazardous wastes
incorporated as hazardous substances
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by reference to other environmental statutes under section 101(14)(50
FR 13456). In a June 12, 1995 final rule, we revised Table 302.4 to
add, among other HAP newly listed by the 1990 CAA Amendments, the broad
generic category of glycol ethers (60 FR 30926). We designated the
broad generic category of glycol ethers as hazardous under CERCLA based
solely on its inclusion in the CAA HAP list. We have no independent
basis upon which to retain the current definition of the glycol ethers
category in order to include the SAED compounds as CERCLA hazardous
substances. Therefore, in addition to revising the definition of glycol
ethers in the HAP list in the CAA, we are also making a corresponding
change to the list of CERCLA hazardous substances at 40 CFR part 302,
Table 302.4.
V. How Have We Involved Stakeholders in This Rulemaking?
The SDA has worked with us for several years to compile evidence
supporting this action. This evidence, submitted in April 1997 as a
technical report, is summarized above and can be obtained in complete
form from the docket. The proposed rules were signed on December 30,
1998 and published in the Federal Register on January 12, 1999 (64 FR
1780). We solicited public comments on the proposal for a 2-month
period ending on March 15, 1999, and received letters conveying
comments from the Chemical Manufacturers Association, the Chemical
Specialties Manufacturers Association, the Illinois Environmental
Protection Agency, and the SDA.
All commenters expressed full approval of the proposed action, its
likely effects, and the rationale on which it is based. We received no
negative comments.
VI. What Are the Administrative Requirements for These Final Rules?
A. Executive Order 12866
Under Executive Order 12866 (58 FR 51735, October 4, 1993), EPA
must determine whether a regulatory action is ``significant'' and
therefore subject to Office of Management and Budget (OMB) review and
the requirements of the Executive Order 12866. 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
adversely affect in a material way the economy, a sector of 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 obligations 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.
Although EPA is not aware of any effects associated with the
present inclusion of SAED compounds on the CAA HAP and the CERCLA
hazardous substance lists, the effect of the final rules will be to
reduce potential regulatory obligations. Neither of the final rules
included in this action appear to meet any of the criteria enumerated
above, and EPA, therefore, has determined that neither of these actions
constitute a ``significant regulatory action'' under the terms of
Executive Order 12866.
B. Paperwork Reduction Act
As required by the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., OMB must clear any reporting and recordkeeping requirements that
qualify as an ``information collection request'' under the PRA. Neither
of the final rules in this notice contain any new information
collection requirements.
C. Regulatory Flexibility Act (RFA), as Amended by the Small Business
Regulatory Enforcement Fairness Act of 1996 (SBREFA), (5 U.S.C. 601, et
seq.)
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 proposed 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 proposed action, can include manufacturing (SIC 20 and SIC 30) and
air transportation (SIC 45) operations that employ less 1,000 people
and engineering services (SIC 87) 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 proposed rule on
small entities, I certify that this 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 proposed rule on small entities.'' (5 U.S.C.
sections 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 rules will eliminate the burden of additional controls
necessary to reduce SAED emissions and the associated operating,
monitoring and reporting requirements. We have therefore concluded that
today's final rules will relieve regulatory burden for all small
entities.
D. Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, 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 proposed 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
[[Page 47347]]
Administrator publishes with the final rule an explanation why that
alternative was not adopted. Before EPA establishes any regulatory
requirement 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.
The EPA has determined that today's action does not include a
Federal mandate that may result in estimated costs of $100 million or
more to either State, local, or tribal governments in the aggregate, or
to the private sector, in any 1 year. Therefore, the requirements of
sections 202 and 205 of the UMRA do not apply to this action. The EPA
has likewise determined that today's action does not include regulatory
requirements that would significantly or uniquely affect small
governments. Thus, today's action is not subject to the requirements of
section 203 of the UMRA.
E. Executive Order 13045
The Executive Order 13045, entitled ``Protection of Children from
Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23,
1997), applies to any rule that EPA determines (1) is economically
significant as defined under Executive Order 12866, and (2) for which
the environmental health or safety risk addressed by the rule may have
a disproportionate effect on children. If the regulatory action meets
both criteria, EPA 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 EPA.
Today's action is not subject to Executive Order 13045 because it
is not an economically significant regulatory action as defined by
Executive Order 12866, and it does not address an environmental health
or safety risk that would have a disproportionate effect on children.
Nevertheless, the estimated human no-effect levels on which this action
is based were derived in a manner designed to protect children and
other sensitive members of human populations. The EPA, therefore,
anticipates that the action will impose no disproportionate risks upon
children.
F. Executive Order 13084
Under Executive Order 13084, EPA may not issue a regulation that is
not required by statute, that significantly or uniquely affects the
communities of Indian tribal governments, and that imposes substantial
direct compliance costs on those communities, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by the tribal governments, or EPA consults with those
governments. If EPA complies by consulting, Executive Order 13084
requires EPA to provide to OMB, in a separately identified section of
the preamble to the rule, a description of the extent of EPA's prior
consultation with representatives of affected tribal governments, a
summary of the nature of their concerns, and a statement supporting the
need to issue the regulation. In addition, Executive Order 13084
requires EPA to develop an effective process permitting elected
officials and other representatives of Indian tribal governments ``to
provide meaningful and timely input in the development of regulatory
policies on matters that significantly or uniquely affect their
communities.'' Today's rules do not significantly or uniquely affect
the communities of Indian tribal governments because they will result
in no increase either in air pollution or reporting requirements.
Accordingly, the requirements of section 3(b) of Executive Order 13084
do not apply to these rules.
G. National Technology Transfer and Advancement Act
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), directs EPA to use voluntary consensus standards in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., materials specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by voluntary consensus standards bodies. The NTTAA directs EPA
to provide Congress, through OMB, explanations when the Agency decides
not to use available and applicable voluntary consensus standards.
This rulemaking does not involve technical standards. Therefore,
EPA is not considering the use of any voluntary consensus standards,
and the requirements of the NTTAA do not apply.
H. The Congressional Review Act
The Congressional Review Act, 5 U.S.C. Sec. 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
these rules 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 rules in the Federal Register. A
major rule cannot take effect until 60 days after it is published in
the Federal Register. This action is not a ``major rule'' as defined by
5 U.S.C. 804(2). These rules will be effective August 2, 2000.
I. Executive Order 13132
The Executive Order 13132, entitled ``Federalism'' (64 FR 43255,
August 10, 1999) requires EPA 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
section 6 of 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
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
regulation.
These rules do not have federalism implications. They will not 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, as
specified in
[[Page 47348]]
Executive Order 13132. Thus, the requirements of section 6 of Executive
Order 13084 do not apply to these amendments.
List of Subjects
40 CFR Part 63
Environmental protection, Administrative practice and procedure,
Air pollution control, Chemicals, Glycol ethers, Hazardous substances,
Reporting and recordkeeping requirements.
40 CFR Part 302
Air pollution control, Chemicals, Glycol ethers, Hazardous
substances, Intergovernmental relations, Reporting and recordkeeping
requirements, Superfund.
Dated: July 24, 2000.
Carol M. Browner,
Administrator.
For the reasons set out in the preamble, title 40, chapter I, parts
63 and 302 of the Code of Federal Regulations are amended as follows:
PART 63--NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS
FOR SOURCE CATEGORIES
1. The authority citation for part 63 continues to read as follows:
Authority: 42 U.S.C. 7401 et seq.
Subpart C--[Amended]
2. Subpart C is amended by adding Sec. 63.62 to read as follows:
Sec. 63.62 Redefinition of glycol ethers listed as hazardous air
pollutants.
The following definition of the glycol ethers category of hazardous
air pollutants applies instead of the definition set forth in 42 U.S.C.
7412(b)(1), footnote 2: Glycol ethers include mono- and di-ethers of
ethylene glycol, diethylene glycol, and triethylene glycol R-
(OCH2CH2)n-OR'.
Where:
n = 1, 2, or 3;
R = alkyl C7 or less; or
R = phenyl or alkyl substituted phenyl;
R'= H or alkyl C7 or less; or
OR' consisting of carboxylic acid ester, sulfate, phosphate,
nitrate, or sulfonate.
PART 302--DESIGNATION, REPORTABLE QUANTITIES, AND NOTIFICATION
1. The authority citation for part 302 continues to read as
follows:
Authority: 42 U.S.C. 9602, 9603, and 9604; 33 U.S.C. 1321 and
1361.
2. In Sec. 302.4, footnote d to Table 302.4 is revised to read as
follows:
Sec. 302.4 Designation of hazardous substances.
* * * * *
Table 302.4.--List of Hazardous Substances and Reportable Quantities
------------------------------------------------------------------------
-------------------------------------------------------------------------
* * * *
* * *
------------------------------------------------------------------------
d Includes mono- and di-ethers of ethylene glycol, diethylene glycol,
and triethylene glycol R-(OCH2CH2)n-OR'.
Where:
n = 1, 2, or 3;
R = alkyl C7 or less; or
R = phenyl or alkyl substituted phenyl;
R' = H or alkyl C7 or less; or
OR' consisting of carboxylic acid ester, sulfate, phosphate, nitrate, or
sulfonate.
* * * *
* * *
[FR Doc. 00-19375 Filed 8-1-00; 8:45 am]
BILLING CODE 6560-50-P