[Federal Register Volume 59, Number 127 (Tuesday, July 5, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-16173]
[[Page Unknown]]
[Federal Register: July 5, 1994]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 372
[OPPTS-400073B; FRL-4864-8]
Glycol Ethers Category; Toxic Chemical Release Reporting;
Community Right-to-Know
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is redefining the glycol ethers category list of toxic
chemicals subject to reporting under section 313 of the Emergency
Planning and Community Right-to-Know Act of 1986 (EPCRA). EPA is
changing the present definition of the glycol ethers category to
exclude the high molecular weight glycol ethers that do not, in EPA's
judgement, meet the criteria set out in EPCRA section 313(d). This
redefinition of the glycol ethers category, which is based on EPA's
review of available human health data on short-chain length glycol
ethers, eliminates the EPCRA section 313 reporting requirements for
those glycol ethers known as surfactant glycol ethers.
EFFECTIVE DATE: This rule is effective June 28, 1994.
FOR FURTHER INFORMATION CONTACT: Maria J. Doa, Petitions Coordinator,
202-260-9592, for specific information regarding this final rule. For
further information on EPCRA section 313, contact the Emergency
Planning and Community Right-to-Know Information Hotline, Environmental
Protection Agency, Mail Stop 5101, 401 M St., SW., Washington, DC
20460, Toll free: 800-535-0202, Toll free TDD: 800-553-7672.
SUPPLEMENTARY INFORMATION:
I. Introduction
A. Statutory Authority
This action is issued under section 313(d) of the Emergency
Planning and Community Right-to-Know Act of 1986 (42 U.S.C. 11023,
``EPCRA''). EPCRA is also referred to as Title III of the Superfund
Amendments and Reauthorization Act (SARA) of 1986.
B. Background
Section 313 of EPCRA requires certain facilities manufacturing,
processing, or otherwise using toxic chemicals to report their
environmental releases of such chemicals annually. Beginning with the
1991 reporting year, such facilities also must report pollution
prevention and recycling data for such chemicals, pursuant to section
6607 of the Pollution Prevention Act (42 U.S.C. 13106). Section 313
established an initial list of toxic chemicals that was comprised of
more than 300 chemicals and 20 chemical categories. Section 313(d)
authorizes EPA to add chemicals to or delete chemicals from the list,
and sets forth criteria for these actions. Under section 313(e), any
person may petition EPA to add chemicals to or delete chemicals from
the list. EPA has added to and deleted chemicals from the original
statutory list.
EPA issued a statement of petition policy and guidance in the
Federal Register of February 4, 1987 (52 FR 3479), to provide guidance
regarding the recommended content and format for petitions. On May 23,
1991 (56 FR 23703), EPA published guidance regarding the recommended
content of petitions to delete individual members of the section 313
metal compound categories.
II. Effective Date
This action becomes effective immediately. Thus, the last year in
which facilities had to report releases of high molecular weight glycol
ethers now excluded from the list was 1993, covering releases that
occurred in 1992. The effect of this category redefinition is that,
since the high molecular weight glycol ethers being excluded from the
category will not be on the section 313 list when facilities report in
1994 for releases that occurred in 1993, these reports and all
subsequent reports need not include release data for these glycol
ethers. Facilities will therefore not have to collect release
information for any releases of the excluded glycol ethers that
occurred during the 1993 reporting year or for any releases that occur
in the future.
Section 313(d)(4) provides that ``[a]ny revision [to the section
313 list] made on or after January 1 and before December 1 of any
calendar year shall take effect beginning with the next calendar year.
Any revision made on or after December 1 and before January 1 shall
take effect beginning with the calendar year following the next
calendar year.'' The Agency interprets this delayed effective date
provision to apply only to actions that add chemicals to the section
313 list. For deletions, the Agency may, in its discretion, make such
actions immediately effective. An immediate effective date is
authorized, in these circumstances, under 5 U.S.C. section 553(d)(1)
since a deletion from the section 313 list relieves a regulatory
restriction.
The Agency believes that the purpose behind the section 313(d)(4)
effective date provision is to allow facilities adequate planning time
to incorporate newly added chemicals to their Toxic Release Inventory
(TRI) release data collection processes. A facility would not need
additional planning time to not report releases of a given chemical.
Thus, a reasonable construction of section 313(d)(4), given the overall
purpose and structure of EPCRA -- to provide the public with
information about chemicals which meet the criteria for inclusion on
the section 313 list -- is to apply the delayed effective date
requirement only to additions to the list. Where the Agency has
determined, as it has with the excluded glycol ethers, that a chemical
does not satisfy the criteria of section 313(d)(2)(A)-(C), no purpose
is served by requiring facilities to collect release data or file
release reports for that chemical, or, therefore, by leaving that
chemical on the section 313 list for any additional period of time.
Nothing in the legislative history suggests that section 313(d)(4) was
intended to apply to deletions as well as additions; indeed, such a
construction would be incongruous, since deleted chemicals, by
definition, do not satisfy the criteria for being on the section 313
list and their deletion from that list should not be delayed in the
absence of any compelling reason to the contrary. This construction of
section 313(d)(4) is also consistent with previous rules deleting
chemicals from the section 313 list. Indeed, the Agency has not given
any of its rules deleting chemicals from the section 313 list the
delayed effective dates specified in section 313(d)(4).
EPA has not deleted all glycol ethers from reporting requirements
under EPCRA section 313. Reporting will still be required for those
glycol ethers which meet the revised definition.
III. Description of the EPCRA Section 313 Glycol Ethers Category
In the Federal Register of July 6, 1993 (58 FR 36180), EPA issued a
proposed rule to redefine the glycol ethers category on the EPCRA
section 313 list of toxic chemicals. EPA has evaluated the current
scope of the section 313 glycol ethers category and believes that it is
overly broad. The existing category includes substances that
traditionally have not been considered glycol ethers. Also, it is
apparent that this category contains members that do not meet the EPCRA
section 313(d)(2) criteria for listing. EPA has reviewed the current
glycol ethers category and is redefining it to exclude the surfactant
glycol ethers. Surfactant glycol ethers are those glycol ethers with
pendant alkyl groups which typically consist of eight or more carbon
atoms (i.e., high molecular weight glycol ethers). However, EPA does
not believe that the category can be more narrowly defined at this
time.
EPA's revised glycol ethers category for which section 313
reporting is required, consists of those glycol ethers which meet the
following definition:
Certain Glycol Ethers:
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.
IV. Rationale for Redefinition
EPA's concerns for the included chemicals is based on a review of
available human health data on short-chain length glycol ethers.
Specifically, EPA believes that these chemicals meet the criterion of
EPCRA section 313(d)(2)(B) because the individual members of this
category can be reasonably anticipated to cause one or more of the
following effects: Kidney toxicity, liver toxicity, adverse blood
effects, adverse central nervous system effects, reproductive effects,
and developmental effects. EPA believes that the category can be
redefined to exclude those glycol ethers known as surfactant glycol
ethers because these high molecular weight glycol ethers do not meet
the listing criteria in section 313(d)(2)(A) or (B). None of the
chemicals in the current glycol ethers category meet the toxicity
criterion of section 313(d)(2)(C) based on their ecotoxicity. EPA's
rationale for this redefinition is detailed in the proposed rule and is
based on the Agency's review of various relevant materials.
V. Response to Comments
EPA received 11 comments on the proposed rule, all in support of
the proposed redefinition of the glycol ethers category. However,
several of the commenters expressed the opinion that the proposed rule
does not narrow the definition sufficiently, and that EPA should
consider a further narrowing of the definition in the future. As
discussed below, EPA does not believe that it currently has sufficient
data to further narrow the category definition.
Two commenters, the Chemical Manufacturers Association (CMA),
Propylene Glycol Ethers Panel, and CMA Ethylene Glycol Ethers Panel,
stated that the name of the category should be changed to ``certain
glycol ethers'' to more accurately characterize the chemicals that are
within the category. EPA has incorporated this comment, since this
category does not consist of all chemicals that contain the glycol
ether functionality.
One commenter, General Electric, suggested that the definition
should not identify reportable glycol ethers by molecular structure.
Instead, the commenter recommended listing the glycol ethers of concern
individually, and identifying those which must be reported on an
individual basis. All remaining glycol ethers would then be reported in
an aggregate form. EPA believes this approach to defining the category
is inappropriate and unnecessary. EPA has identified by molecular
formula a specific group of glycol ethers having a common structure
that pose similar hazards. EPA currently believes that the most
appropriate way to report on this group of glycol ethers is in
aggregate by category. A listing of glycol ethers as proposed by the
commenter may exclude from reporting certain glycol ethers within the
scope of the definition in this rulemaking that meet the section
313(d)(2) criterion. Therefore, EPA is adopting the redefinition of the
glycol ethers category based on a molecular structure formula. A
reporting facility must make aggregate reporting threshold and
estimated release determinations for all glycol ethers in the category.
The Soap and Detergent Association proposed that the revised
definition exclude sulfonate in the category of OR' because ``carbon
sulfur bonds are not easily broken and, therefore, sulfonates are not
readily hydrolyzable from surfactants.'' EPA proposed the inclusion of
sulfonate not because of the possible reaction at the carbon sulfur
bond in the sulfonate, e.g., desulfonation of aromatic sulfonates, but
rather because the sulfonate ion is a reactive leaving group and thus
can reasonably be anticipated to be hydrolyzed to yield a glycol ether
of concern. Specifically hydrolysis of R-
(OCH2CH2)nOSO2R'' (where R'' is any organic
substituent) yields R-(OCH2CH2)nOH and R''SO2OH.
Therefore, EPA reaffirms its inclusion of sulfonate as an appropriate
member in the category of OR'.
The Chemical Manufacturers Association stated that the category
should be limited to four specific ethylene glycol ether solvents: 2-
Methoxyethanol, 2-ethoxyethanol, and their acetates. As stated in the
proposed rule, with respect to the glycol ethers and developmental
effects, there is evidence that the toxicity is reduced going from the
methyl to the butyl ether. However, data for other toxic effects on
glycol ethers with pendant alkyl groups of one to seven carbons or a
phenyl group do not indicate a trend towards increased toxicity based
on chain length for other toxic effects. Low molecular weight ethylene
glycol ethers disturb the hemopoiesis and the blood picture at low
doses. Hemolysis has been reported in varying degrees for ethylene
glycol ethers of one to five carbons in the alkyl chain. The optimum
alkyl chain length for hemolysis is four carbons. 2-Phenoxyethanol has
also been found to cause intravascular hemolysis. Therefore, the
concerns for ethylene glycol ethers are not limited to the four
specific compounds mentioned by the commenter.
In the proposed rule, EPA requested comment on whether the
definition of R' should include only straight chained alkyl groups of
seven of fewer carbons or both straight and branched alkyl groups of
seven or fewer carbons. No comments on this issue were received.
Therefore, the definition of R' will include both straight and branched
alkyl groups of seven or fewer carbons.
Rochester Midland, Soap and Detergent Association, Henkel
Corporation, and Union Carbide Corporation asked that the definition
also exclude alkylated phenols containing seven or more carbon atoms.
As stated in the proposed rule, 2-phenoxyethanol is known to cause
hemolysis. No data have been found for alkyl substituted phenoxyethanol
derivatives. Henkel Corporation stated that ``[t]he C8, C9,
and C12 alkyl phenol ethoxylates have also been used for many
years as surfactants. There is no evidence that they present adverse
human effects such as those which caused the listing of the glycol
ether category or would otherwise meet the section 313 criteria.''
However, this commenter did not supply data to substantiate this
assertion. The Soap and Detergent Corporation provided two studies to
support its position (Smyth and Calandra, 1969; Dudek and Ribelin,
1988). Neither of these studies specifies the composition of the test
material by number of ethylene oxide units. The commenter did provide
the typical weight percent of the test substances as sold in commerce.
Even if EPA assumed these typical compositions represent the test
materials of these two studies, the dose levels presented in the
studies would not be considered adequate to establish the lack of
toxicity associated with ethylene glycol ethers with alkyl groups
consisting of seven or greater carbon atoms.
Because only phenoxyethanol has been tested for systemic toxicity,
change in the glycol ethers category definition which would exclude
alkylphenol ethoxylates is not supportable, based on the available
data. To evaluate the alkylphenol ethoxylates subcategory of the
ethylene glycol ether category, EPA would require subchronic toxicity
data for one or more specific members of the category (e.g., 2-
nonylphenoxyethanol). In the absence of these data, the Agency believes
that the glycol ethers category should continue to include these
substances.
General Electric contended that individual glycol ethers should be
listed in lieu of a category because EPCRA section 313 ``clearly states
that additions to the EPCRA section 313 list must be done on a
chemical-by-chemical basis. Each statutory provision that deals with
revising the section 313 list speaks only in terms of a chemical-by-
chemical basis, and EPCRA is silent on the issue of regulating by
chemical categories.'' The Agency believes that the statutory authority
to add ``a chemical'' to the list may be reasonably interpreted to
include the authority to add groups or categories of chemicals to the
list, particularly in light of the fact that the original list adopted
by Congress in section 313(c) of EPCRA included 20 chemical categories.
These consist mostly of metal compounds categories, but also include
categories of organic chemicals, such as glycol ethers (as noted in the
proposed rule, Congress listed this category without a delimiting
definition).
General Electric further contended that Congress listed ``glycol
ethers'' in addition to the two individually listed glycol ethers, ``2-
methoxyethanol'' and ``2-ethoxyethanol,'' to allow facilities the
option of aggregating the releases of the two individually listed
glycol ether chemicals and filing one TRI Form R report for ``glycol
ether'' rather than two separate Form R reports. EPA does not accept
this interpretation of Congress' intent in listing 20 chemical
categories on the original EPCRA section 313(c) list of chemicals
subject to TRI reporting. There is no clear statement of Congressional
intent to adopt the type of ``optional'' reporting scheme advocated by
General Electric. Indeed, the legislative history cited by General
Electric supports EPA's current interpretation and implementation of
EPCRA's reporting structure, i.e., persons manufacturing, processing,
or otherwise using more than one member of a chemical category above
the applicable reporting threshold may report the releases of all such
chemicals, in the aggregate, on a single Form R report, rather than
listing data separately for each chemical in the group.
Furthermore, contrary to General Electric's contention, several of
the original chemical categories did not have corresponding
``individual'' chemicals listed on the original (CAS number specific)
section 313(c) list. In their comments, General Electric acknowledged
this to be the case only with regard to the polybrominated biphenyls
(PBBs) category. However, there was no individual listing for any
barium compounds, cadmium compounds, chromium compounds, or several
other metal compounds in the original list transmitted to EPA by
Congress. See 53 FR 4500; February 16, 1988. Taken to its logical
conclusion, General Electric's interpretation would result in no
reporting of any members of the PBBs category unless and until EPA
listed individual members of that category. EPA does not believe that
this would be consistent with Congress' intent in listing this category
on the initial section 313(c) list. If Congress had intended to include
category listings as an optional method of reporting individually
listed chemicals, it could have clearly stated so in the statute. At a
minimum, some members of all the listed chemical categories would have
been included in the CAS number specific list. In sum, EPA believes
that its interpretation of the category reporting structure is a
reasonable reading of EPCRA.
General Electric objected to the continued listing of a glycol
ethers category because categories are difficult for EPA to administer
and/or for the public and industry to understand. In addition, the
commenter contended that industry compliance with reporting and
supplier notification requirements is more difficult for categories,
such as glycol ethers, because facilities are not provided with
discrete chemical names and Chemical Abstract Service (CAS) registry
numbers. The commenter contended that these problems are magnified in
the case of the glycol ethers category because the category is defined
by molecular structure formula.
Since the glycol ethers category consists of chemicals that are
similar chemically and in potential effect, EPA believes that this
category will not be difficult for the public or industry to understand
or for the Agency to administer. The Agency will work with the public
and the regulated community to develop, as appropriate, any
interpretations and guidance the Agency determines are necessary to
facilitate accurate reporting for the ``certain glycol ethers''
category. The Agency does not believe that the glycol ethers category
is unique in that it is defined by molecular structure formula. All of
the metal compound categories are defined based on molecular structure
formula, i.e., to be considered a member of a metal compound category,
the compound must consist of the parent metal and at least one
substituent group. Both the chlorophenols and cyanide compound
categories are defined by molecular structure formulas on the EPCRA
section 313 list. EPA believes that defining the category by molecular
structure formula ensures that all members of the category that meet
the EPCRA section 313(d)(2) criteria are included and thus reportable.
Three commenters, the Soap and Detergent Association, Proctor and
Gamble Co., and Union Carbide contended that EPA should be consistent
between EPCRA and TSCA on its treatment of identical materials. Union
Carbide cited the TSCA section 8(b) Inventory provisions. EPA believes
that the differing treatment of glycol ether species with a low degree
of ethoxylation under EPCRA and TSCA is appropriate given the differing
purposes and standards of TSCA section 8(b) and EPCRA section 313. TSCA
is concerned with the regulation of unreasonable risks to human health
and the environment posed by chemical substances and mixtures in
commerce; the section 8(b) Inventory, with few exceptions, provides a
list of those chemical substances and mixtures. For purposes of
developing an inventory of chemical substances in commerce, it is less
important to specify whether those substances consist of a discrete
species, e.g., chloroform, or a species with a range of molecular
weights. EPCRA's goal is to provide the general public with a broad
range of information on releases of certain chemicals.
Under TSCA, for example, glycol ether surfactant ``mixtures'' are
considered as a single entity for purposes of entry on the Inventory;
however, for purposes of reviewing the potential health or
environmental unreasonable risks posed by activities involving such
chemical substances, the impacts of their various components would be
considered. Because the intent of EPCRA section 313 is community right-
to-know, EPA wants to ensure that the public has access to information
on each listed toxic chemical or chemical category to which the public
could be exposed, regardless of whether it is in a mixture. Therefore,
where a surfactant contains species with a low degree of ethoxylation
that fit the glycol ether category definition, EPA requires that those
chemicals be reported.
Union Carbide also contended that ``[a]s a legal matter, the
current and proposed definitions exclude polymers from the category of
glycol ethers. Since polymers potentially include their low molecular
weight species (n = 1, 2, 3), the exemption for polymers precludes the
need to report low molecular weight species under [s]ection 313.''
EPA disagrees with Union Carbide's conclusion regarding species
with low degrees of ethoxylation. The proposed definition being
finalized today continues to exclude polymer molecules (i.e., those
molecules which include at least four covalently linked subunits at
least two of which are internal subunits), and to include low molecular
weight glycol ethers with a low degree of ethoxylation. The change in
regulatory text deleting the phrase ``polymers are excluded from this
category,'' does not change EPA's position regarding the scope of the
glycol ethers category.
One commenter, the Cosmetic, Toiletry, and Fragrance Association,
stated support for the proposal to change the definition of glycol
ethers on other EPA lists. Today's action is not intended, and should
not be inferred to affect the definition or regulatory requirements for
glycol ethers under any statute or EPA program other than the Toxic
Release Inventory reporting requirements under EPCRA section 313 and
the Pollution Prevention Act section 6607. Specifically, the
redefinition of glycol ethers on the EPCRA section 313 list does not in
any way alter their definition under section 112(b) of the Clean Air
Act (CAA), 42 U.S.C. section 7412(b) as amended, or, by virtue of their
status as ``hazardous air pollutants'' (HAP) under the CAA, as
``hazardous substances'' under section 101(14) of the Comprehensive
Environmental Response, Compensation and Liability Act (CERCLA), 42
U.S.C section 9601(14).
VI. Rulemaking Record
The record supporting this final rule is contained in the docket
number OPPTS-400073B. All documents, including an index of the docket,
are available for viewing and photocopying in the TSCA Nonconfidential
Information Center (NCIC), also known as the TSCA Public Docket Office,
from noon to 4 p.m., Monday through Friday, excluding legal holidays.
The TSCA NCIC is located at EPA Headquarters, Rm. NE-B607, 401 M St.,
SW., Washington, DC 20460.
VII. Regulatory Assessment Requirements
A. Executive Order 12866
Under Executive Order (E.O.) 12866 (58 FR 51735, October 4, 1993),
the Agency must determine whether the regulatory action is
``significant'' and therefore subject to review by the Office of
Management and Budget (OMB) and the requirements of the Executive
Order. Section 3(f) of the Order defines a ``significant regulatory
action'' as an action likely to lead to a rule (1) Having an annual
effect on the economy of $100 million or more, or adversely and
materially affecting a sector of the economy, productivity,
competition, jobs, the environment, public health or safety, or State,
local or tribal governments or communities (also referred to as
``economically significant''); (2) creating serious inconsistency or
otherwise interfering with an action taken or planned by another
agency; (3) materially altering the budgetary impacts of entitlements,
grants, user fees, or loan programs; or (4) raising novel legal or
policy issues arising out of legal mandates, the President's
priorities, or the principles set forth in this Executive Order.
Pursuant to the terms of this Executive Order, it has been
determined that this final rule is not ``significant'' and therefore
not subject to OMB review.
B. Regulatory Flexibility Act
The Regulatory Flexibility Act of 1980 requires each Federal agency
to perform a Regulatory Flexibility Analysis for all rules that are
likely to have a ``significant impact on a substantial number of small
entities.''
40 CFR part 372 exempts certain small businesses (specifically,
those facilities with fewer than 10 full-time employees) from
reporting. This exclusion exempts about one-half of all manufacturing
facilities in Standard Industrial Classification (SIC) codes 20 through
39 from section 313 reporting. Additionally, facilities which
manufacture or process less than 25,000 pounds or otherwise use less
than 10,000 pounds of these chemicals annually are not required to
report for these chemicals. Thus, many small facilities will not incur
any regulatory costs in association with this rule. Small businesses
are not expected to be adversely affected by this rule, since the rule
would increase the likelihood that they would not be required to report
glycol ether releases. Therefore, EPA certifies that this rule is not
likely to significantly impact small entities.
C. Paperwork Reduction Act
There are no unique reporting requirements associated with this
final rule because it redefines the glycol ethers category to exclude
certain high molecular weight glycol ethers from reporting under
section 313. Reporting of chemicals that are subject to section 313 has
been approved by OMB under the provisions of the Paperwork Reduction
Act, 44 U.S.C. 3501 et seq., and has been assigned the OMB control
number 2070-0093.
The public reporting burden for section 313 chemicals is estimated
to average 43 hours per response, including time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information. This rule's redefinition will reduce the
number of responses required, thus reducing overall burden.
List of Subjects in 40 CFR Part 372
Environmental protection, Community right-to-know, Reporting and
recordkeeping requirements, Toxic chemicals.
Dated: June 28, 1994.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
Therefore, 40 CFR part 372 is amended as follows:
PART 372--[AMENDED]
1. The authority citation for part 372 continues to read as
follows:
Authority: 42 U.S.C. 11023 and 11048.
2. In Sec. 372.65(c) by amending the category, glycol ethers to
read as follows:
Sec. 372.65 Chemicals and chemical categories to which the part
applies.
* * * * *
(c) * * *
------------------------------------------------------------------------
Category Name Effective Date
------------------------------------------------------------------------
*****
Certain Glycol Ethers................................ 1/1/95
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. 94-16173 Filed 6-29-94; 1:07 pm]
BILLING CODE 6560-50-F