[Federal Register Volume 60, Number 171 (Tuesday, September 5, 1995)]
[Proposed Rules]
[Pages 46076-46079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-21943]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 372
[OPPTS-400096; FRL-4970-5]
Diethyl Phthalate; Toxic Chemical Release Reporting; Community
Right-to-Know
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is granting a petition by proposing to delete diethyl
phthalate (DEP) 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 proposing to delete
DEP because the Agency has preliminarily concluded that it meets the
deletion criteria of EPCRA section 313(d)(3).
DATES: Written comments on this proposed rule must be received by EPA
on or before November 6, 1995.
ADDRESSES: Written comments should be submitted in triplicate to: OPPT
Docket Clerk, TSCA Nonconfidential
[[Page 46077]]
Information Center (NCIC), (7407), Environmental Protection Agency, Rm.
NE-B607, 401 M St., SW., Washington, DC 20460. Comments should include
the docket control number for this proposal, OPPTS-400096.
Comments and data may also be submitted electronically by sending
electronic mail (e-mail) to: ncic@epamail.epa.gov. 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-400096. 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 VI. of this document.
FOR FURTHER INFORMATION CONTACT: Maria J. Doa, Petitions Coordinator,
202-260-9592, e-mail: doa.maria@epamail.epa.gov, for specific
information on this proposed 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. 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 of 1986 (SARA) (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 must also 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. 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 (November 30, 1994; 59 FR 61439).
II. Description of Petition and General Information
On February 7, 1995, the Fragrance Materials Association petitioned
the Agency to delete DEP (Chemical Abstract Service (CAS) 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.
DEP is listed on several environmental statutory lists other than
EPCRA. It is on the list of hazardous substances (40 CFR 302.4) under
section 102(a) of the Comprehensive Environmental Response,
Compensation, and Liability Act (42 U.S.C. 9601-9675) with a reportable
quantity of 1,000 pounds and is listed under section 3001 of the
Resource Conservation and Recovery Act (42 U.S.C. 6921). In addition,
DEP is a priority water pollutant under section 307(a) of the Clean
Water Act (33 U.S.C. 1317).
III. EPA's Technical Review of DEP
The technical review of the petition to delete DEP includes an
analysis of production, release, health and environmental effects, and
exposure and fate (Refs. 1, 2, 3, 4, and 5).
A. Chemistry.
DEP has low volatility (boiling point: 295 deg.C; vapor pressure:
0.00165 torr), and high water solubility (1 gram/liter (g/L)).
B. Toxicological Evaluation
1. Absorption and metabolism. There is evidence from a toxicity
study that DEP is absorbed from the gastrointestinal tract. There are
no data on lung absorption of DEP following inhalation. A dermal
absorption study using rats indicated that 50 percent of the dermal
dose was absorbed in 7 days. In vitro studies indicate that the major
metabolite of DEP is the monoester.
2. Acute toxicity. DEP has low acute toxicity. The oral median
lethal dose (LD50) in rabbits is 1 gram/kilogram (g/kg);
intraperitoneal LD50 values in rats and mice are greater than 5.6
and 2.8 g/kg, respectively.
3. Carcinogenicity. There is insufficient evidence to reasonably
anticipate that DEP would cause cancer in humans. In a National
Toxicology Program dermal bioassay, there was no evidence of
carcinogenicity in male and female rats. However, there were increased
incidences of hepatocellular adenomas (benign tumors) in male and
female mice. These findings were considered equivocal because: (1) The
incidence of hepatocellular neoplasms in control and dosed males was
within the historical range; and (2) in the females, there was no clear
dose-response relationship. In an initiation-promotion study, there was
no evidence of initiating activity of DEP in male mice.
4. Mutagenicity. The overall weight of evidence from several
mutagenicity assays indicates that DEP is not of concern for
mutagenicity. DEP did not induce gene mutations in prokaryotes or
chromosome mutations in mammalian cells in culture. The only positive
mutagenicity data are for DNA effects (sister chromatid exchanges) in
mammalian cells in culture.
5. Systemic toxicity. Based on subchronic and chronic feeding
studies in rats, DEP has low systemic toxicity. Body weight loss was
the primary effect in all available studies and it was seen only at the
highest dose, 5 percent of the diet or approximately 3,160 milligrams/
kilogram/day (mg/kg/day). The no-observed-adverse-effect-level (NOAEL)
was 750 mg/kg/day.
6. Developmental/reproductive toxicity. The available animal data
indicate that DEP does cause developmental effects, but only at high
doses (greater than 3,000 mg/kg/day). The reproductive effects seen in
[[Page 46078]]
animals, also at high doses, were not biologically significant.
Supernumerary ribs were noted in the offspring of rats fed DEP in
the diet at 5 percent concentration (about 3,210 mg/kg/day). The NOAEL
for developmental toxicity was 2.5 percent of the diet (about 1,910 mg/
kg/day), and the NOAEL for maternal toxicity was about 0.25 percent of
the diet (about 200 mg/kg/day). In another study, supernumerary ribs
and other skeletal abnormalities were noted in rats administered 568,
1,136, and 1,793 mg/kg of DEP intraperitoneally on gestation days 5,
10, and 15. This study is limited, however, because the animals were
not dosed throughout gestation.
In a reproduction study in mice, dietary administration of DEP at
2.5 percent of the diet (approximately 3,750 mg/kg/day) produced
decreases in sperm concentration and body weight, and increases in
prostate weight in the F1 generation. There was no biologically
significant impairment of fertility or development after fertilization.
Therefore, the highest dose tested, 2.5 percent of the diet, was
considered as the NOAEL for reproductive effects.
7. Neurotoxicity. There are no data to support a concern for
neurotoxicity.
8. Environmental effects. DEP does not pose a significant
environmental hazard. It exhibits low toxicity to aquatic organisms and
it is not likely to bioconcentrate. The fish 96-hr median lethal
concentration (LC50) values range from 12 to 110 milligrams/liter
(mg/l). Daphnid 48-hr LC50 values range from 50 to 90 mg/l, and
algae 96-hr median effective concentration (EC50) values range
from 30 to 86 mg/l. The bioconcentration factor (BCF) in fish is 117,
which indicates low bioconcentration potential. In the environment, DEP
will undergo hydrolysis to the monoester, which is less toxic than DEP
to aquatic organisms.
C. Production, Use and Release
DEP is produced by refluxing one equivalent of phthalic anhydride
with a greater than two-fold excess of ethanol in the presence of one
percent of concentrated sulfuric acid. The U. S. production volume in
1989 was 11 million kilograms (24.2 million pounds) with an estimated
annual import volume of 100,000 kilograms (220,000 pounds). The primary
use of DEP (90 percent consumption) is as a plasticizer for cellulose-
based products used in making recording tapes, photographic films, food
wrap, and molded and extruded plastic articles. It is also used as a
carrier or fixative in cosmetics in concentrations ranging from 0.1
percent to 50 percent. In addition, DEP is also used in solvents,
varnishes, dyes, coating agents for foodstuffs, and insect repellents.
The Toxic Release Inventory (TRI) data indicate that during 1993 a
total of 159,386 pounds of DEP were released to the environment. Of
that total, 93,471 pounds were released to air, 260 pounds were
released to water, and 505 pounds were released to land. In addition, a
total of 851,894 pounds of DEP were transferred to various off-site
locations. Of that total, 302,115 pounds were transferred to public
owned treatment works (POTWs) prior to being discharged to surface
waters.
D. Exposure and Fate Analysis
The two principal and relevant fate processes for DEP in the
environment are reaction with photochemically-generated hydroxyl
radicals in the atmosphere and aerobic biodegradation in soil and
water. A half-life of 22.2 hours at 25 deg.C was estimated from
reaction of DEP vapor with photochemically-generated hydroxyl radicals.
When DEP is aerobically biodegraded in a semicontinuous activated
sludge system (SCAS), greater than 95 percent was degraded in 24 hours.
In a screening test, a half-life of 2.2 days was measured when DEP is
incubated with a mixed microbial population. Removal of DEP by
anaerobic biodegradation, oxidation, chemical hydrolysis, and direct
photolysis, as well as, from volatilization and bioaccumulation in
aquatic organisms should not be significant.
Because DEP has low chronic mammalian toxicity, the Agency
conducted an exposure assessment for chronic human exposure. Nationwide
releases to air and surface water retrieved from the TRI data base were
modeled using TRIAIR and TRIWATER models.
Based on 1992 TRI data, the highest estimated DEP air concentration
to which people are expected to be exposed is 3.5 micrograms/cubic
meter (ug/m3); about 129 people live in the area in which this
concentration is expected to occur. The Lifetime Average Daily
Potential Dose (LADDpot) calculated based on the estimated
atmospheric concentrations is 0.001 mg/kg/day. Based on 1992 data, the
highest estimated DEP acute concentration at five drinking water
utility intakes under low flow conditions is about 2 parts per billion
(ppb); this results in a LADDpot of about 4.5-6.5 x 10-5 mg/
kg/day; about 40,160 people are potentially exposed at this level. The
highest estimated DEP chronic concentration at five drinking water
utility intakes under medium flow conditions is about 0.3 ppb; this
results in a LADDpot of about 1 x 10-5 mg/kg/day; about
40,160 people are potentially exposed at this level.
The above estimated doses are well below the Agency's reference
dose (RfD) of 0.8 mg/kg/day that is considered significantly protective
of human health. This observation further suggests that the exposure
estimates are not likely to result in adverse health risks in humans
from acute or chronic exposure to DEP from the atmosphere or from
drinking water as a result of continuous or frequently, recurring
releases from facility sites.
E. Summary of EPA's Assessment
EPA's toxicological evaluation of the current data on DEP indicates
that it exhibits acute, systemic, and developmental and reproductive
toxicities only at relatively high doses. Furthermore, DEP exhibits low
toxicity to aquatic organisms, and is not likely to bioconcentrate.
Releases of DEP will not result in exposures of concern for adverse
human health risks. 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.
F. Rationale for Granting
EPA is granting the petition by proposing to delete DEP from the
EPCRA section 313 list. Based on current data, EPA preliminarily
concludes that DEP does not meet the toxicity criteria of EPCRA section
313(d)(2)(A) because DEP exhibits acute oral toxicity only at levels
that greatly exceed estimated resultant exposures. 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 preliminarily concluded that there is not sufficient
evidence to establish that DEP meets the criterion of EPCRA section
313(d)(2)(B), because it cannot reasonably be anticipated to cause
teratogenic effects, immunotoxicity, neurotoxicity, or liver or kidney
toxicity, and it cannot be anticipated to cause reproductive or
developmental toxicity except at relatively high dose levels. EPA
believes that DEP has low chronic toxicity and accordingly has
considered exposure factors. As stated above, EPA believes that
anticipated exposure concentrations of DEP are not expected to result
in significant adverse effects. Therefore, EPA has preliminarily
[[Page 46079]]
concluded that DEP does not meet the EPCRA section 313(d)(2)(B) listing
criterion.
EPA has also preliminarily determined 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.
Thus, in accordance with EPCRA section 313(d)(3), EPA is proposing
to delete DEP from the section 313 list of toxic chemicals.
IV. Request for Public Comment
EPA requests public comment on this proposal to delete DEP from the
list of chemicals subject to EPCRA section 313. Comments should be
submitted to the address listed under the ADDRESSES unit. All comments
must be received by EPA on or before [Insert date 60 days after date of
publication in the Federal Register].
V. Rulemaking Record
A record has been established for this proposal under docket number
``OPPTS-400096'' (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 8 a.m. 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:
ncic@epamail.epa.gov
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 proposal, 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 rulmaking 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, OPPTS. 1995. Chemistry Report on Diethyl Phthalate by
Stephen C. DeVito, Industrial Chemistry Branch, Economics, Exposure,
and Technology Division. Office of Pollution Prevention and Toxics.
(May 8, 1995).
(2) USEPA, OPPTS. 1995. Economic Analysis of the Proposed Deletion
of Diethyl Phthalate from the EPCRA Section 313 List of Toxic Chemicals
by Fred Arnold, Regulatory Impacts Branch, Economics, Exposure, and
Technology Division, Office of Pollution Prevention and Toxics. (April
5, 1995).
(3) USEPA, OPPTS. 1995. Memorandum from Lorraine M. Randecker,
Hazard Integrator, Chemical Screening and Risk Assessment Division,
with attachments, re: Petition to Delist Diethyl Phthalate. (April 24,
1995).
(4) USEPA, OPPTS. 1995. Engineering Report for the Proposed
Delisting of Diethyl Phthalate from the EPCRA Section 313 List of Toxic
Chemicals by Monica Sweet, Chemical Engineering Branch, Economics,
Exposure and Technology Division, Office of Pollution Prevention and
Toxics. (April 3, 1995).
(5) USEPA, OPPTS. 1995. Memorandum from Andrew Mamantov, Exposure
Assessment Branch, Economics, Exposure and Technology Division, Office
of Pollution Prevention and Toxics, with attachments, re: Diethyl
Phthalate (DEP) Delisting Petition Fate and Exposure Assessment. (June
15, 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 estimated that the delisting of DEP from the EPCRA section 313
toxic chemical list would result in a total annual cost savings to
industry of $124,200. The cost savings to EPA are estimated at $3,000.
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
proposed 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 under 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, and Toxic chemicals.
Dated: August 27, 1995.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
Therefore, it is proposed that 40 CFR part 372 be amended to read
as follows:
1. The authority citation for part 372 would continue to read as
follows:
Authority: 42 U.S.C. 11013 and 11028.
Sec. 372.65 [Amended]
2. 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 86-66-2 under paragraph (b).
[FR Doc. 95-21943 Filed 9-1-95; 8:45 am]
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