[Federal Register Volume 61, Number 148 (Wednesday, July 31, 1996)]
[Rules and Regulations]
[Pages 39891-39894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-19452]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 372
[OPPTS-400095A; FRL-5389-6]
Di-(2-ethylhexyl) Adipate; Toxic Chemical Release Reporting;
Community Right-to-Know
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: EPA is deleting di-(2-ethylhexyl) adipate (DEHA) (CAS No. 103-
23-1), also known as bis(2-ethylhexyl) adipate, from the list of
chemicals subject to reporting requirements under section 313 of the
Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA) and
section 6607 of the Pollution Prevention Act of 1990 (PPA).
Specifically, EPA is deleting DEHA because the Agency has concluded
that DEHA meets the deletion criteria of EPCRA section 313(d)(3). By
promulgating this rule, EPA is relieving facilities of their obligation
to report releases of and other waste management information on DEHA
that occurred during the 1995 reporting year, and for activities in the
future.
[[Page 39892]]
EFFECTIVE DATE: This rule is effective July 31, 1996.
FOR FURTHER INFORMATION CONTACT: Daniel R. Bushman, Acting Petitions
Coordinator, 202-260-3882, e-mail: [email protected], for
specific information on this final rule, or for more information on
EPCRA section 313, 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: 1-800-535-0202, in
Virginia and Alaska: 703-412-9877, or Toll free TDD: 1-800-553-7672.
SUPPLEMENTARY INFORMATION:
I. Introduction
A. Affected Entities
Entities potentially affected by this action are those which
manufacture, process, or otherwise use di-(2-ethylhexyl) adipate (DEHA)
and which are subject to the reporting requirements of section 313 of
the Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA),
42 U.S.C. 11023 and section 6607 of the Pollution Prevention Act of
1990 (PPA), 42 U.S.C. 13106. Some of the affected categories and
entities include:
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Examples of affected
Category entities
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Industry Facilities that compound,
shape, or manufacture
plastic and rubber
products. Metal working
industries including
foundries, automotive
plants, coating and
engraving shops, and metal
products companies. Firms
that formulate or produce
adhesives and sealants;
lubricants for jet engines;
pharmaceuticals, perfumes,
and cosmetics; and other
organic chemicals.
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Federal Government Federal Agencies that
manufacture, process, or
otherwise use DEHA.
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This table is not meant to be exhaustive, but rather provides a
guide for readers regarding entities likely to be affected by this
action. This table lists the types of entities that EPA is now aware
could potentially be affected by this action. Other types of entities
not listed in the table could also be affected. To determine whether
your facility is affected by this action, you should carefully examine
the applicability criteria in part 372 subpart B of Title 40 of the
Code of Federal Regulations.
B. Statutory Authority
This action is taken under sections 313(d) and (e)(1) of EPCRA.
EPCRA is also referred to as Title III of the Superfund Amendments and
Reauthorization Act (SARA) of 1986 (Pub. L. 9909-499).
C. Background
Section 313 of EPCRA requires certain facilities manufacturing,
processing, or otherwise using listed toxic chemicals to report their
environmental releases of such chemicals annually. Beginning with the
1991 reporting year, such facilities must also report pollution
prevention and recycling data for such chemicals, pursuant to section
6607 of PPA. Section 313 of EPCRA established an initial list of toxic
chemicals that was comprised of more than 300 chemicals and 20 chemical
categories. DEHA was included in the initial list of chemicals and
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)(1), any person may petition EPA to add
chemicals to or delete chemicals from the original statutory list.
Pursuant to EPCRA section 313(e)(1), EPA must respond to petitions
within 180 days either by initiating a rulemaking or by publishing an
explanation of why the petition has been denied.
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 issued a statement of policy and guidance
regarding the recommended content of petitions to delete individual
members of the section 313 metal compounds category. EPA has published
a statement clarifying its interpretation of the section 313(d)(2) and
(3) criteria for adding and deleting chemicals from the section 313
toxic chemical list (59 FR 61439, November 30, 1994) (FRL-4922-2).
II. Description of Petition and Proposed Action
On January 18, 1995, EPA received a petition from the Chemical
Manufacturers Association (CMA) to exclude DEHA from the EPCRA section
313 list of toxic chemicals. Specifically, the petition requests that
DEHA be deleted from the list of reportable chemicals and not be
subject to the annual reporting requirements under EPCRA section 313
and section 6607 of PPA. The petitioner contends that DEHA should be
deleted from the EPCRA section 313 list because it does not meet any of
the EPCRA section 313(d)(2) criteria.
Following a review of the petition, EPA granted the petition and
issued a proposed rule in the Federal Register of August 1, 1995 (60 FR
39132) (FRL-4958-8), proposing to delete DEHA from the list of toxic
chemicals subject to the reporting requirements under EPCRA section
313. EPA's proposal was based on its preliminary conclusion that DEHA
meets the EPCRA section 313(d)(3) criteria for deletion from the list.
With respect to deletions, EPCRA provides at section 313(d)(3) that
``[a] chemical may be deleted if the Administrator determines there is
not sufficient evidence to establish any of the criteria described in
paragraph [(d)(2)(A)-(C)].'' In the proposed rule, EPA preliminarily
concluded that the available toxicological data indicates that DEHA
does not cause adverse acute human health effects at concentration
levels that are reasonably likely to exist beyond facility site
boundaries, and causes systemic, developmental, and reproductive
toxicities only at relatively high doses and thus has low chronic
toxicity. Furthermore, EPA preliminarily concluded that DEHA does not
pose a significant hazard to the environment. EPA also preliminarily
concluded that releases of DEHA will not result in exposures of
concern. Therefore, EPA preliminarily concluded that based on the total
weight of available data, DEHA cannot reasonably be anticipated to
cause a significant adverse effect on human health or the environment.
III. Final Rule and Rationale for Delisting
In response to the petition from CMA, EPA is deleting DEHA from the
list of chemicals for which reporting is required under section 313 of
EPCRA and PPA section 6607. EPA is delisting this chemical because the
Agency has determined that DEHA satisfies the delisting criteria of
EPCRA section 313(d)(3).
A. Response to Comments
EPA received three comments in response to the proposed rule. All
three of the commenters noted their support for the deletion of DEHA
from the EPCRA section 313 list. EPA agrees with the commenters that
DEHA satisfies the criterion for delisting.
[[Page 39893]]
B. Rationale for Delisting and Conclusions
EPA has concluded that the assessment set out in the proposed rule
should be affirmed. Because of questions raised recently about the
ability of DEHA to produce hormone disruption, EPA has looked at this
issue. EPA is aware of limited and preliminary in vitro data indicating
that DEHA reduced the binding of the tritiated natural estrogen,
17-estradiol, to the rainbow trout estrogen receptor (Ref. 1).
However, these results were obtained only at high concentrations and
indicated that DEHA's potential binding activity is very weak compared
to the estradiol. In addition, EPA is not aware of any data that
demonstrate that DEHA produces estrogenic effects in vivo. The in vivo
toxicity data on DEHA, discussed below, also indicate that DEHA is a
weak developmental and reproductive toxicant. However, at this time,
there is no indication that these effects are due to binding to the
estrogen receptor. Accordingly, EPA has determined that there is
insufficient evidence, at this time, to demonstrate that DEHA causes
hormone disruption. In summary, based on the total weight of available
data, EPA has concluded that DEHA cannot reasonably be anticipated to
cause a significant adverse effect on human health or the environment,
and therefore DEHA meets the delisting criterion of section 313(d)(3).
A more detailed discussion of the rationale for delisting is given in
the proposed rule (August 1, 1995, 60 FR 39134) (FRL-4958-8).
Based on current data, EPA concludes that DEHA does not meet the
toxicity criterion of EPCRA section 313(d)(2)(A) because DEHA exhibits
acute oral toxicity only at levels that greatly exceed estimated
exposures outside the facility. Specifically, DEHA cannot reasonably be
anticipated to cause ``. . . significant adverse acute human health
effects at concentration levels that are reasonably likely to exist
beyond facility site boundaries as a result of continuous, or
frequently recurring, releases.''
EPA has concluded that there is not sufficient evidence to
establish that DEHA meets the criterion of EPCRA section 313(d)(2)(B).
The lowest-observed-adverse-effect-level (LOAEL) for systemic toxicity,
in rats, is 1,125 milligrams/kilogram/day (mg/kg/day) for both chronic
and 13-week studies. In mice, the LOAELs ranged from 2,800 mg/kg/day
(chronic study) to 900 mg/kg/day (13-week study). Also, based on
limited data, the LOAEL for developmental toxicity is 1,080 mg/kg/day
and the no-observed-adverse-effect-level (NOAEL) is 170 mg/kg/day.
Based on limited data, the LOAEL and NOAEL for reproductive toxicity
are 1,080 and 170 mg/kg/day. EPA has no information indicating that
DEHA causes any other section 313(d)(2)(B) effects. EPA considers the
above doses where DEHA caused adverse effects to be relatively high and
concludes that DEHA has low chronic toxicity. Therefore, EPA conducted
an exposure assessment for chronic human exposure and found that
exposures at the estimate levels are not likely to result in adverse
health risks in humans. EPA has estimated that releases of DEHA will
not result in exposures of concern. Therefore, EPA has concluded that
DEHA does not meet the EPCRA section 313(d)(2)(B) listing criterion.
EPA has also concluded that DEHA does not meet the toxicity
criterion of EPCRA section 313(d)(2)(C) because it cannot reasonably be
anticipated to cause adverse effects on the environment of sufficient
seriousness to warrant continued reporting. EPA considers DEHA to
exhibit low toxicity to aquatic organisms. Based on structure activity
relationships (SARs), no toxic effects are anticipated for both
freshwater and saltwater species at saturation. For sediment species,
acute and chronic toxicity are expected to occur only at high
concentrations: 1,000 and 100 mg/kg (dry weight), respectively.
Therefore, DEHA is not expected to pose a significant hazard to the
environment.
Thus, in accordance with EPCRA section 313(d)(3), EPA is deleting
DEHA from the section 313 list of toxic chemicals. Today's action is
not intended, and should not be inferred, to affect the status of DEHA
under any other statute or program other than the reporting
requirements under EPCRA section 313 and PPA section 6607.
IV. Effective Date
This action becomes effective July 31, 1996. Thus, the last year in
which facilities had to file a Toxics Release Inventory (TRI) report
for DEHA was 1995, covering releases and other activities that occurred
in 1994.
EPCRA section 313(d)(4) provides that ``[a]ny revision'' to the
section 313 list of toxic chemicals shall take effect on a delayed
basis. EPA interprets this delayed effective date provision to apply
only to actions that add chemicals to the section 313 list. For
deletions, EPA 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) because a deletion from
the section 313 list relieves a regulatory restriction.
EPA believes that where the Agency had determined, as it has with
this chemical, that a chemical does not satisfy any of the criteria of
section 313(d)(2)(A)-(C), no purpose is served by requiring facilities
to collect data or file TRI reports for that chemical, or, therefore,
by leaving that chemical on the section 313 list for any additional
period of time. This construction of section 313(d)(4) is consistent
with previous rules deleting chemicals from the section 313 list. For
further discussion of the rationale for immediate effective dates for
EPCRA section 313 delistings, see 59 FR 33205 (June 28, 1994).
V. Rulemaking Record
The record supporting this final rule is contained in docket
control number OPPTS-400095A. All documents, including an index of the
docket and the reference listed in Unit VI. of this preamble, are
available in the TSCA Nonconfidential Information Center (NCIC), also
known as, TSCA Public Docket Office, from 12 noon to 4 p.m., Monday
through Friday, excluding legal holidays. TSCA NCIC is located at EPA
Headquarters, Rm. NE-B607, 401 M St., SW., Washington, DC 20460.
VI. References
1. Jobling, S., Reynolds, T., White, R., Parker, M. G., Sumpter, J.
P., ``A Variety of Environmentally Persistent Chemicals, Including Some
Phthalate Plasticizers Are Weakly Estrogenic,'' Environmental Health
Perspectives, 103, (1995), pp. 582-587.
VII. Regulatory Assessment Requirements
It has been determined that this action is not a ``significant
regulatory action'' within the meaning of Executive Order 12866 (58 FR
51735, October 4, 1993), because this action eliminates an existing
regulatory requirement. The Agency estimates the total cost savings to
industry from this action to be approximately $322,620 and the savings
to EPA would be approximately $8,664.
This action does not impose any Federal mandate on State, local or
tribal governments or the private sector within the meaning of the
Unfunded Mandates Reform Act of 1995 (Pub. L. 1041). Also, given its
deregulatory nature, I hereby certify pursuant to the Regulatory
Flexibility Act (5 U.S.C. 605(b)), that this action does not have a
significant economic impact on a substantial number of small entities.
As required, information to this effect has been
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forwarded to the Small Business Administration.
This action does not have any information collection requirements
subject to the provisions of the Paperwork Reduction Act of 1980, 44
U.S.C. 3501 et seq. The elimination of the information collection
components for this action is expected to result in the elimination of
6,383 paperwork reduction hours.
In addition, pursuant to Executive Order 12898 (59 FR 7629,
February 16, 1994), entitled ``Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations,'' the
Agency has determined that there are no environmental justice-related
issues with regard to this action since this final rule simply
eliminates reporting requirements for a chemical that, under the
criteria of EPCRA section 313, does not pose a concern for human health
or the environment.
Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act
(APA) as amended by the Small Business Regulatory Enforcement Fairness
Act of 1996 (Title II of Pub. L. 104-121, 110 Stat. 847), EPA submitted
a report containing this rule and other required information to the
U.S. Senate, the U.S. House of Representatives and the Comptroller
General of the General Accounting Office prior to publication of the
rule in today's Federal Register. This rule is not a ``major rule'' as
defined by 5 U.S.C. 804(2) of the APA as amended.
List of Subjects in 40 CFR Part 372
Environmental protection, Community right-to-know, Reporting and
recordkeeping requirements, and Toxic chemicals.
Dated: July 25, 1996.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
Therefore, 40 CFR part 372 is amended as follows:
1. The authority citation for part 372 continues to read as
follows:
Authority: 42 U.S.C. 11023 and 11048.
Sec. 372.65 [Amended]
2. Sections 372.65(a) and (b) are amended by removing the entry for
bis(2-ethylhexyl) adipate under paragraph (a) and the entire CAS number
entry for 103-23-1 under paragraph (b).
[FR Doc. 96-19452 Filed 7-31-96; 8:45 am]
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