[Federal Register Volume 60, Number 147 (Tuesday, August 1, 1995)]
[Proposed Rules]
[Pages 39132-39134]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-18870]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 372
[OPPTS-400095; FRL-4958-8]
Di-(2-ethylhexyl) Adipate; Toxic Chemical Release Reporting;
Community Right-to-Know
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing to grant a petition to delist di-(2-
ethylhexyl) adipate (DEHA) (Chemical Abstract Service (CAS) No. 103-23-
1), also known as bis-(2-ethylhexyl) adipate, from the 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). This action is based on EPA's preliminary
conclusion that DEHA meets the deletion criteria of EPCRA section
313(d)(3). Specifically, EPA is proposing to grant this petition
because, based on the total weight of available data, EPA believes
that: (1) DEHA cannot reasonably be anticipated to cause significant
acute adverse human health effects at concentration levels expected to
occur beyond facility site boundaries and thus does not meet the
criterion of EPCRA section 313(d)(2)(A); (2) DEHA does not meet the
criterion of EPCRA section 313(d)(2)(B) because it cannot reasonably be
anticipated to cause cancer, teratogenic effects, immunotoxicity,
neurotoxicity, gene mutations, liver, kidney, reproductive, or
developmental toxicity or other serious or irreversible chronic health
effects; and (3) DEHA does not meet the criterion of EPCRA section
313(d)(2)(C) because it cannot reasonably be anticipated to cause
significant and serious adverse effects on the environment.
DATES: Written comments on this proposed rule must be received by
October 2, 1995.
ADDRESSES: Submit written comments in triplicate and identified with
docket number ``OPPTS-400095'' to: OPPT Document Control Officer
(7407), Environmental Protection Agency, Rm. NE-G99, 401 M St., SW.,
Washington, DC 20460.
Comments and data may also be submitted electronically by sending
electronic mail (e-mail) to: [email protected]. Electronic comments
must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Comments and data will also be
accepted on disks in WordPerfect in 5.1 file format or ASCII file
format. All comments and data in electronic form must be identified by
the docket number OPPTS-400095. No CBI should be submitted through e-
mail. Electronic comments on this proposed rule may be filed online at
many Federal Depository Libraries. Additional information on electronic
submissions can be found in Unit V. of this document.
FOR FURTHER INFORMATION CONTACT: Maria J. Doa, 202-260-9592, e-mail:
[email protected], for specific information regarding this
proposed 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, in Virginia and Alaska:
703-412-9877, or Toll free TDD: 800-553-7672.
SUPPLEMENTARY INFORMATION:
I. Introduction
A. Statutory Authority
This action is taken under sections 313(d) and (e)(1) of the
Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA), 42
U.S.C. 11023. EPCRA is also referred to as Title III of the Superfund
Amendments and Reauthorization Act (SARA) of 1986 (Pub. L. 99-499).
B. 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 also must report pollution
prevention and recycling data for such chemicals, pursuant to section
6607 of the Pollution Prevention Act of 1990 (PPA), 42 U.S.C. 13106.
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
categories. Section 313(d) authorizes EPA to add or delete chemicals
from the list, and sets forth criteria for these actions. EPA has added
and deleted chemicals from the original statutory list. Under section
313(e), any person may petition EPA to add chemicals to or delete
chemicals from the list. EPA must respond to petitions within 180 days,
either by initiating a rulemaking or by publishing an explanation of
why the petition is 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 submitting petitions.
On May 23, 1991 (56 FR 23703), EPA issued guidance regarding the
recommended content of petitions to delete individual members of the
section 313 metal compound categories. EPA has also published a
statement clarifying its interpretation of the section 313(d)(2) and
(3) criteria for adding and deleting chemical substances from the
section 313 list (59 FR 61439, November 30, 1994).
II. Description of Petition and Other Applicable Regulations
On January 18, 1995, EPA received a petition from the Chemical
Manufacturers Association to exclude di-(2-ethylhexyl) adipate (DEHA)
from section 313 of EPCRA. 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 the PPA. The petitioner contends that DEHA should
be deleted from the EPCRA section 313 list because, in their opinion,
the available data show that DEHA does not meet the criteria for
inclusion on the list of EPCRA section 313 chemicals.
Under the Safe Drinking Water Act, DEHA has a Maximum Contaminant
Level of 0.4 milligrams per liter (mg/L).
III. EPA's Technical Review of Di-(2-ethylhexyl) adipate
A. Chemistry
DEHA (CAS No. 103-23-1), also known as bis(2-ethylhexyl) adipate
and as dioctyl adipate, is an aliphatic ester used primarily as a
plasticizer in a variety of products such as polyvinyl chloride (PVC)
and other plastics, cellophane, rubber, and cosmetics. It is a light-
colored, oily liquid with low water solubility (0.78 milligrams/liter
(mg/L) at 22 deg.C measured in 1986). DEHA has a very high boiling
point (410 deg.C), low volatility, very low pour point, and excellent
low temperature fluidity (Ref. 1).
B. Toxicological Evaluation
Information on DEHA was reviewed for evidence indicating: (1)
Bioavailability and metabolism; (2) acute toxicity; (3) chronic
toxicity; (4) carcinogenicity; and (5) ecotoxicity.
[[Page 39133]]
1. Bioavailability and metabolism. DEHA is well absorbed from the
gastrointestinal tract of rats, mice, monkeys, and humans (Ref. 2). No
data were available concerning the possible absorption of DEHA from the
lung or through the skin.
DEHA is rapidly hydrolyzed to adipic acid and 2-ethylhexanol both
in vivo and in vitro. 2-Ethylhexanol is subsequently metabolized to
ethylhexanoic acid and other acid and hydroxy acid derivatives and
their gluconuride conjugates. Adipic acid is further oxidized to carbon
dioxide. Excretion is primarily in the urine, with smaller amounts
excreted in the expired air (carbon dioxide) and feces (Ref. 2).
2. Acute toxicity. DEHA exhibits slight acute toxicity. The oral
median Lethal Dose (LD50) value for rats is greater than 8 grams
per kilogram (g/kg), and the dermal LD50 value for rabbits is
greater than 9 g/kg (Ref. 2). There was no mortality among rats exposed
by inhalation to a saturated vapor. DEHA was not irritating to rabbit
eyes and skin, and it was not a dermal sensitizer in guinea pigs.
3. Chronic toxicity. Several chronic and subchronic feeding studies
in rats and mice show that DEHA is not highly toxic. The primary effect
in both species appears to be body weight depression. In rats, the
Lowest Observed Adverse Effect Level (LOAEL) was 1,125 milligrams per
kilogram per day (mg/kg/day) for both the 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) (Ref. 2).
The weight of the evidence from several mutagenicity assays
indicates that DEHA is probably not mutagenic (Ref. 2). Although most
mutagenicity assays on DEHA are negative, DEHA does produce chromosome
mutations in mammalian cells in culture (weakly), increase DNA
synthesis in rats in vivo, and induce dominant lethals in mice in vivo.
A positive response in the dominant lethal without collaborating
genotoxicity data in assay systems designed to assess basic
mutagenicity hazard is not an indication of potential mutagenicity
(Ref. 2).
Data on both developmental and reproductive system toxicity are
limited (Ref. 2). For developmental toxicity, a standard protocol test
is available for only one species. For reproductive toxicity, there is
a one-generation test, but not a multi-generation test. The one-
generation reproduction study on male and female rats showed a
reduction in litter size with administration of approximately 1,080 mg/
kg/day of DEHA in feed, but the reduction was small and not
statistically significant. The dominant-lethal assay discussed above
found a dose-related increase in early fetal death, but the increase
was not statistically significant and doses (0.46 to 9.2 g/kg, by
single interperitoneal injection) were high.
4. Carcinogenicity. The National Toxicology Program tested DEHA for
carcinogenicity in male and female rats and mice treated via diet (Ref.
2). Doses were approximately 700 or 1,500 mg/kg/day in the rat and
2,800 or 7,000 mg/kg/day in the mouse. The chemical was carcinogenic
for female mice, inducing a significantly increased incidence of
hepatocellular carcinomas. A marginally significant increase in
hepatocellular carcinomas and adenomas combined was reported for male
mice as compared with that of the concurrent controls. DEHA was not
carcinogenic for the rats of either sex.
5. Ecotoxicity. DEHA is not expected to pose a significant hazard
to the environment. Based on structure activity relationships (SARs),
no toxic effects are anticipated for both freshwater and saltwater
species at saturation (Ref. 2). For sediment species, acute and chronic
toxicity are expected to occur only at high concentrations: 1,000 and
100 mg/kg (dry weight), respectively.
C. Environmental Fate
DEHA released to air has an estimated half-life for hydroxy radical
oxidation of 5.2 hours. No information was found on photolysis of DEHA
in air.
DEHA released to water is expected to undergo biodegradation in the
water column with a half-life on the order of days to weeks. It will
also partition readily to sediment based on its estimated soil organic
carbon partition coefficient of 15,500. Once bound to sediments, DEHA
will probably continue to biodegrade, but possibly at a significantly
slower rate (halflife on the order of months). Hydrolysis is not
expected to be a significant removal process below pH 9 (estimated
half-life = 3.2 years at pH 7).
DEHA released to soil is expected to adsorb strongly based on its
estimated soil organic carbon partition coefficient (15,500).
Biodegradation is possible, and could further mitigate migration
through soil. Biodegradation half-life in soils is estimated on the
order of weeks.
DEHA is expected to be removed from wastewater in biological
wastewater treatment systems by adsorption and biodegradation. Based on
available biodegradation data and physical chemistry properties, 90
percent removal in Publicly Owned Treatment Works was estimated.
D. Exposure and Releases
Reported releases of DEHA were retrieved from the Toxic Release
Inventory System (TRIS) and used to estimate air and water
concentrations using TRIAIR and TRIWATER modeling techniques. The
estimated maximum Lifetime Average Daily Potential Dose via inhalation
(0.00178 mg/kg/day) is over 300-fold less than the Reference Dose (RfD)
(0.6 mg/kg/day). The difference for oral exposure is much greater for
water (Ref. 3). Based on this information, releases of DEHA are not
expected to result in exposures of concern for human health or the
environment.
The Agency believes that exposure considerations are appropriate in
making determinations: (1) Under section 313(d)(2)(A); (2) under
section 313(d)(2)(B) for chemicals that exhibit low to moderately low
toxicity based on a hazard assessment; and (3) under section
313(d)(2)(C) for chemicals that are low or moderately ecotoxic but do
not induce well-documented serious adverse effects. The Agency believes
that exposure considerations are not appropriate in making
determinations: (1) Under section 313(d)(2)(B) for chemicals that
exhibit moderately high to high human toxicity based on a hazard
assessment; and (2) under section 313(d)(2)(C) for chemicals that are
highly ecotoxic or induce well-established adverse environmental
effects. Given DEHA's low chronic toxicity and low ecotoxicity,
exposure considerations are appropriate for detrminations under
sections 313(d)(2)(B) and (C) as part of this proposed rule to delist.
A more detailed discussion of EPA's listing determination guidelines is
provided in the Federal Register of November 30, 1994 (59 FR 61442).
E. Technical Summary
Based on the total weight of available toxicity data, EPA believes
that DEHA cannot reasonably be anticipated to cause significant adverse
effects on human health or the environment. DEHA exhibits slight acute
toxicity and causes adverse chronic effects only at high doses.
Furthermore, DEHA is not expected to pose a significant hazard to the
environment. In addition, based on EPA's exposure assessment, releases
of DEHA are not expected to result in exposures of concern.
IV. Rationale for Proposal to Grant
EPA is granting the petition by proposing to delete DEHA from the
EPCRA section 313 list of toxic chemicals. This decision is based on
the
[[Page 39134]]
Agency's preliminary determination that DEHA does not meet the toxicity
criterion of EPCRA section 313(d)(2)(A) because it 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 preliminarily concluded that DEHA does not meet the
criterion of EPCRA section 313(d)(2)(B) because it cannot reasonably be
anticipated to cause teratogenic effects, immunotoxicity,
neurotoxicity, or liver, kidney, reproductive, or developmental
toxicity or other serious or irreversible chronic health effects.
Furthermore, while EPA has classified DEHA as a Group C, possible human
carcinogen, clear evidence of carcinogenicity was observed in only one
species-sex group (mice-female) in the animal studies. EPA believes
that there is a lack of clear evidence of possible carcinogenicity in
male mice. Therefore, EPA believes that, overall, the evidence is too
limited to establish that DEHA is likely to cause cancer. EPA believes
that DEHA has low chronic toxicity and accordingly has considered
exposure factors. As stated above, EPA has concluded that anticipated
exposure concentrations of DEHA are not expected to result in
significant adverse effects. Therefore, EPA has preliminarily concluded
that DEHA does not meet the EPCRA section 313(d)(2)(B) listing
criterion.
EPA has also preliminarily determined 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.
Thus, in accordance with EPCRA section 313(d)(3), EPA is proposing
to delete DEHA from the section 313 list of toxic chemicals.
V. Rulemaking Record
A record has been established for this proposed rule under docket
number ``OPPTS-400095'' (including comments and data submitted
electronically as described below). A public version of this record,
including printed, paper versions of electronic comments, which does
not include any information claimed as confidential business
information (CBI), is available for inspection from noon to 4 p.m.,
Monday through Friday, excluding legal holidays. The public record is
located in the TSCA Nonconfidential Information Center, Rm. NE-B607,
401 M St., SW., Washington, DC 20460.
Electronic comments can be sent directly to EPA at:
[email protected]
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer all comments received electronically into printed,
paper form as they are received and will place the paper copies in the
official rulemaking record which will also include all comments
submitted directly in writing. The official rulemaking record is the
paper record maintained at the address in ``ADDRESSES'' at the
beginning of this document.
VI. References
(1) USEPA, OPPT, EETD. Jenny Tou, ``Chemistry Report on Di(2-
ethylhexyl) Adipate,'' dated April 27, 1995.
(2) USEPA, OPPT, CSRAD. Memorandum from Lorraine Randecker to Fred
Metz, entitled ``Petition to Delist Di(2-ethylhexyl) Adipate,'' dated
May 22, 1995.
(3) USEPA, OPPT, EETD. David Lynch, ``Exposure Assessment for DEHA
in Response to Delisting Petition,'' dated March 21, 1995.
VII. Regulatory Assessment Requirements
A. Executive Order 12866
Under Executive Order 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. Pursuant to the
terms of this Executive Order, it has been determined that this
proposed rule is not ``significant'' and therefore not subject to OMB
review.
EPA estimates that the reduction in costs to industry associated
with the deletion of DEHA would be approximately $322,620. The costs
savings to EPA are estimated at $8,664, if DEHA is deleted from the
EPCRA section 313 list.
B. Regulatory Flexibility Act
Under the Regulatory Flexibility Act of 1980, the Agency must
conduct a small business analysis to determine whether a substantial
number of small entities would be significantly affected by the rule.
Because this proposed rule eliminates an existing requirement, it would
result in cost savings to facilities, including small entities.
C. Paperwork Reduction Act
This proposed rule 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.
D. Unfunded Mandates Reform Act
Pursuant to Title II of the Unfunded Mandates Reform Act of 1995,
which the President signed into law on March 22, 1995, EPA has assessed
the effects of this regulatory action on State, local or tribal
governments, and the private sector. This action does not result in the
expenditure of $100 million or more by any State, local or tribal
governments, or by anyone in the private sector. The costs associated
with this action are described in the Executive Order 12866 unit above.
List of Subjects in 40 CFR Part 372
Environmental protection, Chemicals, Community Right-to-Know,
Reporting and recordkeeping requirements, Toxic chemicals.
Dated: July 24, 1995.
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 would continue 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 deleting 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. 95-18870 Filed 7-31-95; 8:45 am]
BILLING CODE 6560-50-F