[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

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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

[[Page 47345]]

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