[Federal Register Volume 61, Number 146 (Monday, July 29, 1996)]
[Rules and Regulations]
[Pages 39356-39359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-19075]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 372
[OPPTS-400096A; FRL-5372-6]
Diethyl Phthalate; Toxic Chemical Release Reporting; Community
Right-to-Know
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: EPA is deleting diethyl phthalate (DEP) from the list of
chemicals subject to the reporting requirements under section 313 of
the Emergency Planning and Community
[[Page 39357]]
Right-to-Know Act of 1986 (EPCRA) and section 6607 of the Pollution
Prevention Act of 1990 (PPA). Specifically, EPA is deleting DEP because
the Agency has concluded that DEP meets the deletion criterion 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 DEP that occurred during the 1995 reporting
year, and for activities in the future.
DATES: This rule is effective July 29, 1996.
FOR FURTHER INFORMATION CONTACT: Daniel R. Bushman, Acting Petitions
Coordinator, 202-260-3882, e-mail: bushman.daniel@epamail.epa.gov, for
specific information on this final rule, or for more information on
EPCRA section 313, the Emergency Planning and Community Right-to-Know
Hotline, Environmental Protection Agency, Mail Code 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 diethyl phthalate (DEP) 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 produce
soaps, detergents,
cleaners, perfumes,
cosmetics, other toilet
preparations, unsupported
film and sheet plastics,
other plastic products, and
miscellaneous industrial
organic chemicals.
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Federal Government Federal Agencies that
manufacture, process, or
otherwise use DEP.
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This table is not intended 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 of 1986 (SARA) (Pub. L. 99-9499).
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 established an initial list of toxic chemicals
that was comprised of more than 300 chemicals and 20 chemical
categories. DEP 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 list. EPA has added and
deleted 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 compound categories. 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 61432, November 30, 1994) (FRL-4922-2).
II. Description of Petition and Proposed Action
On February 7, 1995, the Fragrance Materials Association petitioned
the Agency to delete DEP (Chemical Abstract Service (CAS) Registry No.
84-66-2) from the EPCRA section 313 list of toxic chemicals. The
petitioner contends that DEP, which is mainly used as a plasticizer,
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 September 5, 1995 (60
FR 46076) (FRL-4970-5) proposing to delete DEP from the list of
chemicals subject to the reporting requirements under EPCRA section
313. EPA's proposal was based on its preliminary conclusion that DEP
meets the deletion criteria of EPCRA section 313(d)(3). 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 DEP does not cause
adverse acute human health effects at concentration levels that are
reasonably likely to exist beyond facility cite boundaries, and causes
systemic, developmental, and reproductive toxicities only at relatively
high doses and thus has low chronic toxicity. Furthermore, EPA
preliminarily concluded that DEP exhibits low toxicity to aquatic
organisms, and is not likely to bioconcentrate. EPA also preliminarily
concluded that releases of DEP will not result in exposures of concern.
Therefore, EPA preliminarily concluded that based on the total weight
of available data, DEP 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 the Fragrance Materials
Association, EPA is deleting DEP from the list of chemicals for which
reporting is required under EPCRA section 313 and PPA section 6607. EPA
is delisting this chemical because the Agency has determined that DEP
satisfies the delisting criterion of EPCRA section 313(d)(3).
[[Page 39358]]
A. Response to Comments
EPA received four comments in response to the proposed rule, all in
support of the proposed deletion. EPA agrees with the commenters that
DEP satisfies the criterion for delisting. One commenter requests that
EPA make this action effective as of the date of the proposal,
September 5, 1995, in order for the deletion to apply for the 1995
reporting year. While this action is effective as of the date of
publication of this final rule, not the date of the proposal, EPA
agrees that DEP should not be reported for the 1995 calendar year. As
discussed in Unit IV. of this preamble, reporting for DEP is not
required for the 1995 reporting year, covering activities and releases
which occurred in 1995.
B. Rationale for Delisting and Conclusions
EPA has concluded that the assessment set out in the proposed rule
should be affirmed. Further, because of questions raised recently about
the ability of phthalates to produce hormone disruption, EPA has looked
at this issue as it relates to DEP. While EPA is aware of limited and
preliminary in vitro data indicating that some phthalates bind/activate
estrogen receptors at high concentrations, EPA has not located any such
information on DEP. Further, for those few phthalates tested in vitro,
there is no indication that any common structural feature of these
compounds is responsible for the observed activity. In addition, EPA is
not aware of any data that demonstrate that DEP produces estrogenic
effects in vivo. Accordingly, EPA has determined that there is
insufficient evidence, at this time, to demonstrate that DEP causes
hormone disruption. In summary, based on the total weight of available
data, EPA has concluded that DEP cannot reasonably be anticipated to
cause a significant adverse effect on human health or the environment,
and therefore DEP meets the delisting criterion of 313(d)(3). A more
detailed discussion of the rationale for delisting is given in the
proposed rule (60 FR 46076, September 5, 1995) (FRL-4970-5).
Based on current data, EPA concludes that DEP does not meet the
toxicity criterion of EPCRA section 313(d)(2)(A) because DEP exhibits
acute oral toxicity only at levels that greatly exceed estimated
exposures outside the facility. Specifically, DEP 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 DEP meets the criterion of EPCRA section 313(d)(2)(B).
The lowest-observed-adverse-effect-level (LOAEL) for systemic toxicity
is 3,160 milligrams/kilogram/day (mg/kg/day) and the no-observed-
adverse-effect-level (NOAEL) is 750 mg/kg/day. The LOAEL for
developmental toxicity is 3,210 mg/kg/day and the NOAEL is 1,910 mg/kg/
day. The NOAEL for reproductive toxicity is approximately 3,750 mg/kg/
day, which was the highest dose tested. EPA has no information
indicating that DEP causes any other section 313(d)(2)(B) effects. EPA
considers the above doses where DEP caused adverse effects to be
relatively high and concludes that DEP has low chronic toxicity.
Therefore, EPA conducted an exposure assessment for chronic human
exposure and found that exposure to DEP at the estimated levels is not
likely to result in adverse health risks in humans. EPA has estimated
that releases of DEP will not result in exposures of concern.
Therefore, EPA has concluded that DEP does not meet the EPCRA section
313(d)(2)(B) listing criterion.
EPA has also concluded that DEP 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. DEP exhibits low toxicity
to aquatic organisms (fish 96 hr median lethal concentration
(LC50), 12 to 100 milligrams/liter (mg/l); daphnid 48 hr
LC50, 50 to 90 mg/l; and algae 96 hr median effective
concentration (EC50), 30 to 86 mg/l, and is not likely to
bioconcentrate.
Thus, in accordance with EPCRA section 313(d)(3), EPA is deleting
DEP from the section 313 list of toxic chemicals. Today's action is not
intended, and should not be inferred, to affect the status of DEP under
any other statute or program other than the reporting requirements
under EPCRA section 313.
IV. Effective Date
This action becomes effective July 29, 1996. Thus, the last year in
which facilities had to file a Toxic Release Inventory (TRI) report for
DEP was 1995, covering releases and other activities that occurred in
1994.
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 has determined, as it has with
DEP, 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 decision is contained in docket control
number OPPTS-400096A. All documents, including an index of the docket,
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. 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 $124,000 per year. The cost savings to
EPA is estimated at $3,000 per year.
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. 104-4). And, 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 forwarded to the Small
Business Administration.
This action does not have any information collection requirements
subject to the provisions of the
[[Page 39359]]
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 2,305 paperwork burden 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, Toxic chemicals.
Dated: July 19, 1996.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
Therefore, 40 CFR part 372 is amended to read as follows:
1. The authority citation for part 372 continues to read as
follows:
Authority: 42 U.S.C. 11013 and 11028.
Sec. 372.65 [Amended]
Sections 372.65(a) and (b) are amended by removing the entire entry
for diethyl phthalate under paragraph (a) and removing the entire CAS
No. entry for 84-66-2 under paragraph (b).
[FR Doc. 96-19075 Filed 7-26-96; 8:45 am]
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