[Federal Register Volume 61, Number 147 (Tuesday, July 30, 1996)]
[Notices]
[Pages 39832-39838]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-19333]
[[Page 39831]]
_______________________________________________________________________
Part X
Environmental Protection Agency
_______________________________________________________________________
Thirty-Eighth Report of the TSCA Interagency Testing Committee to the
Administrator Receipt of Report, Request for Comments, Solicitation of
Use and Exposure Data
Federal Register / Vol. 61, No. 147 / Tuesday, July 30, 1996 /
Notices
[[Page 39832]]
ENVIRONMENTAL PROTECTION AGENCY
[OPPTS-41045; FRL-5379-2]
Thirty-Eighth Report of the TSCA Interagency Testing Committee to
the Administrator Receipt of Report, Request for Comments, Solicitation
of Use and Exposure Data
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The TSCA Interagency Testing Committee (ITC), established
under section 4(e) of the Toxic Substances Control Act (TSCA),
transmitted its Thirty-Eighth Report to the Administrator of the EPA on
May 31, 1996. In its Thirty-Eighth Report, which is included with this
notice, the ITC revises the Priority Testing List by adding a group of
18 nonylphenol ethoxylates to the List for consideration by the EPA
Administrator for promulgation of test rules under section 4(a) of the
Act. The ITC also removes two previously recommended High Production
Volume Chemicals (HPVC), two previously designated Oxygenated Fuel
Additives and previously recommended white phosphorus. The ITC's
reasons for removing these chemicals from the List are described in the
Thirty-Eighth Report. There are no designated or recommended with
intent-to-designate chemicals or chemical groups in the Thirty-Eighth
Report. EPA invites interested persons to submit written comments on
the Report.
DATES: Written comments on the Thirty-Eighth ITC Report should be
submitted by August 29, 1996.
ADDRESSES: Comments on the Thirty-Eighth Report should be submitted to
both the ITC and the TSCA Public Docket. Send one copy of written
submissions to: John D. Walker, ITC Executive Director, U.S. EPA
(7401), 401 M St., SW., Washington, DC 20460. Send six copies of
written submissions to: TSCA Public Docket Office (7407), Office of
Pollution Prevention and Toxics, Environmental Protection Agency, Rm.
B-607 NEM, 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 5.1 file format or ASCII file format.
All comments and data in electronic form must be identified by the
docket number OPPTS-41045. No ``Confidential Business Information''
(CBI) should be submitted through e-mail. Electronic comments on the
Thirty-Eighth Report may be filed online at many Federal Depository
Libraries. Additional information on electronic submissions can be
found in Unit III of this document.
The public record supporting this action, including comments, is
available for public inspection in Rm. B-607 NEM at the address noted
above from 12:00 noon to 4 p.m., Monday through Friday, except legal
holidays.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director,
Environmental Assistance Division (7408), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 401 M Street,
SW., Rm. ET-543B,Washington, DC 20460, (202) 554-1404, TDD (202) 554-
0551, e-mail: TSCA-H[email protected].
SUPPLEMENTARY INFORMATION: EPA has received the TSCA Interagency
Testing Committee's Thirty-Eighth Report to the Administrator.
I. Background
TSCA (Pub. L. 94-469, 90 Stat. 2003 et seq; 15 U.S.C. 260l et seq.)
authorizes the Administrator of the EPA to promulgate regulations under
section 4(a) requiring testing of chemicals and chemical groups in
order to develop data relevant to determining the risks that such
chemicals and chemical groups may present to health or the environment.
Section 4(e) of TSCA established the Interagency Testing Committee
(ITC) to recommend chemicals and chemical groups to the Administrator
of the EPA for priority testing consideration. Section 4(e) directs the
ITC to revise the TSCA section 4(e) Priority Testing List at least
every 6 months. The most recent revisions to this List are included in
the ITC's Thirty-Eighth Report. The Report was received by the
Administrator on May 31, 1996, and is included in this Notice. The
Report recommends a group of 18 nonylphenol ethoxylates to the list and
removes white phosphorus, 2 High Production Volume Chemicals (HPVC) and
2 Oxygenated Fuel Additives from the list.
II. Status of List
The current TSCA section 4(e) Priority Testing List contains 2
chemicals and 10 chemical groups; of these 2 chemicals and 3 chemical
groups were designated for testing.
A notice will be published at a later date in the Federal Register
adding certain of the substances recommended in the ITC's Thirty-Eighth
Report to the TSCA section 8(d) Health and Safety Data Reporting Rule
(40 CFR part 716), which requires the reporting of unpublished health
and safety studies on the listed chemicals. That notice will also add
certain of the chemicals to the TSCA section 8(a) Preliminary
Assessment Information Rule (40 CFR part 712). The section 8(a) rule
requires the reporting of production volume, use, exposure, and release
information on the listed chemicals.
III. Electronic and Oral Comments
The EPA invites interested persons to submit detailed comments on
the ITC's Report.
A record has been established for this notice under docket number
[OPPTS-41045] (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 contain any
information claimed as CBI, is available for inspection from 12 noon to
4 p.m., Monday through Friday, excluding legal holidays. The public
record is located in the TSCA Non-confidential Information Center, Rm.
NE-B607, 401 M St., SW., Washington, DC. 20460. Electronic comments can
be sent directly to the ITC at [email protected] and to the
EPA at: [email protected]
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of ecryption.
The official record for the Thirty-Eighth report, 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 record which will also include all comments
submitted directly in writing. The official record is the paper record
maintained at the EPA address in ``ADDRESSES'' at the beginning of this
document.
Authoriy: 15 U.S.C. 2603.
Dated: July 18, 1996.
Charles M. Auer,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
Thirty-Eighth Report of the Interagency Testing Committee to the
Administrator
Summary
This is the 38th Report of the TSCA Interagency Testing Committee
(ITC) to the Administrator of the U.S.
[[Page 39833]]
Environmental Protection Agency (EPA). In this Report, the ITC is
revising its TSCA section 4(e) Priority Testing List by recommending 18
nonylphenol ethoxylates and removing white phosphorus, 2 High
Production Volume Chemicals (diethylene glycol monoethyl ether acetate
and diethylene glycol dimethyl ether), and 2 Oxygenated Fuel Additives
(ethyl tert-butyl ether and tert-amyl methyl ether). Comments on this
Report should be submitted both to the ITC and the TSCA Public Docket.
The revised TSCA section 4(e) Priority Testing List follows as Table 1.
Table 1.--The TSCA Section4(e) Priority Testing List (May 1996)
------------------------------------------------------------------------
Report Date Chemical/Group Action
------------------------------------------------------------------------
26......... May 1990 10 Isocyanates Recommended with
intent-to-
designate
27......... November 1990 62 Aldehydes Recommended with
intent-to-
designate
28......... May 1991 Acetone Designated
28......... May 1991 Thiophenol Designated
29......... November 1991 10 Alkyl-, bromo-, Recommended
chloro-,
hydroxymethyl
diaryl ethers
30......... May 1992 13 Siloxanes Recommended
31......... January 1993 24 Chemicals with Designated
no dermal
toxicity data
32......... May 1993 32 Chemicals with Designated
insufficient
dermal absorption
data
35......... November 1994 24 Chemicals with Designated
insufficient
dermal absorption
data
36......... May 1995 10 High Production Recommended
Volume Chemicals
37......... November 1995 28 Alkylphenols Recommended
and Ethoxylates
38......... May 1996 18 Nonylphenol Recommended
Ethoxylates
------------------------------------------------------------------------
I. Background
The TSCA Interagency Testing Committee (ITC) was established by
section 4(e) of the Toxic Substances Control Act (TSCA) ``to make
recommendations to the Administrator respecting the chemical substances
and mixtures to which the Administrator should give priority
consideration for the promulgation of a rule for testing under section
4(a).... At least every 6 months..., the Committee shall make such
revisions in the List as it determines to be necessary and to transmit
them to the Administrator together with the Committee's reasons for the
revisions'' (Pub. L. 94-469, 90 Stat. 2003 et seq., 15 U.S.C. 2601 et
seq.). Since its creation in 1976, the ITC has submitted 37 semi-annual
Reports to the EPA Administrator transmitting the Priority Testing List
and its revisions. These Reports have been published in the Federal
Register and are also available from the ITC. The ITC meets monthly and
produces its revisions of the List with the help of staff and technical
contract support provided by EPA. ITC members and support personnel are
listed at the end of this Report.
Following receipt of the ITC's Report and the addition of chemicals
to the Priority Testing List, EPA's Office of Pollution Prevention and
Toxics adds new chemicals from the List to TSCA section 8(a) and 8(d)
rules that require manufacturers and importers of these chemicals to
submit TSCA section 8(a) production and exposure data and
manufacturers, importers and processors of the listed chemicals to
submit TSCA section 8(d) health and safety studies within 60 days of
the rule's effective date. The submissions are indexed and maintained
by EPA. The ITC reviews the TSCA section 8(a) and 8(d) information and
other available data on chemicals and chemical groups (e.g., TSCA
section 8(e) ``substantial risk'' studies, ``For Your Information''
(FYI) submissions to EPA, and published papers) to determine if
revisions to the List are necessary. Revisions can include changing a
general recommendation to a specific designation for testing action by
the EPA Administrator within 12 months, modifying the recommended
testing, or removing the chemical or chemical group from the List.
II. Revisions to the TSCA Section 4(e) Priority Testing List
Revisions to the TSCA section 4(e) Priority Testing List are
summarized in Table 2.
Table 2.--Revisions to the TSCA section 4(e) Priority Testing List
----------------------------------------------------------------------------------------------------------------
CAS No. Chemical Name Action Date
----------------------------------------------------------------------------------------------------------------
................................... Nonylphenol ethoxylates Recommended 5/96
(NPEs)
07311-27-5........................... Ethanol, 2-[2-[2-[2-(p-
nonylphenoxy)
ethoxy]ethoxy]ethoxy]-
09016-45-9........................... Nonylphenol
polyethylene glycol
ether
20636-48-0a..........................
26027-38-3a..........................
26064-02-8a..........................
27177-01-1a..........................
37205-87-1a..........................
20427-84-3........................... Ethanol, 2-[2-(p-
nonylphenoxy)ethoxy]-
26027-38-3........................... p-Nonylphenol
polyethylene glycol
ether
27986-36-3a..........................
37205-87-1a..........................
98113-10-1a..........................
26571-11-9........................... Nonylphenol
octa(oxyethylene)ethan
ol
27176-93-8........................... Nonylphenoxydiglycol
27177-05-5........................... Nonylphenol
hepta(oxyethylene)etha
nol
27177-08-8........................... Nonylphenol
nona(oxyethylene)ethan
ol
27986-36-3........................... Nonylphenoxy ethanol
37205-87-1........................... Poly(oxy-1,2-
ethanediyl),alpha-
(isononylphenyl)-omega-
hydroxy
51938-25-1........................... Poly(oxy-1,2-
ethanediyl),alpha-(2-
nonylphenyl)-omega-
hydroxy
[[Page 39834]]
65455-72-3........................... Decaethylene glycol,
isononylphenyl ether
68412-54-4........................... Nonylphenoxypolyoxyetha
nol
152143-22-1a.........................
127087-87-0.......................... Nonylphenol
polyethylene glycol
ether
NAb.................................. Nonoxynol-2
NA................................... Nonoxynol-3
NA................................... Nonoxynol-7
NA................................... alpha-(p-Nonylphenol)-
omega-
hydroxypoly(oxyethylen
e)
7723-14-0............................ White phosphorus Remove previously 5/96
designated chemical
12185-10-3a..........................
----------------------------------------------------------------------------------------------------------------
................................... High Production Volume Remove previously 5/96
Chemicals recommended chemicals
111-96-6............................. Diethylene glycol
dimethyl ether
112-15-2............................. Diethylene glycol
monoethyl ether
acetate
----------------------------------------------------------------------------------------------------------------
................................... Oxygenated Fuel Remove previously 5/96
Additives recommended chemicals
637-92-3............................. Ethyl tert-butyl ether
994-05-8............................. Tert-amyl methyl ether
----------------------------------------------------------------------------------------------------------------
a Alternate CAS number.
b Not Assigned
III. Rationale for the revisions
A. ITC's Activities During this Reporting Period
Alkylphenols and ethoxylates, isocyanates and siloxanes. During the
six months covered by this Report, the ITC evaluated several chemicals
and chemical groups and the ITC's Subcommittees met with two Chemical
Manufacturers Association (CMA) Panels and the Silicones Environmental
Health and Safety Council (SEHSC). To facilitate communication between
U.S. Government organizations needing data on alkylphenols and
ethoxylates and the manufacturers, importers, processors, users and
distributors of these chemicals, an ITC Subcommittee and the CMA's
Alkylphenols and Ethoxylates Panel established the ITC-CMA Alkylphenols
and Ethoxylates Dialog Group. To learn more about potential consumer
uses of isocyanates, the ITC's Isocyanates Subcommittee met with the
CMA's Diisocyanates Panel. To promote cogent discussions of siloxanes
health and safety data the ITC's Siloxanes Subcommittee continued to
meet with SEHSC.
Diaryl ethers. The ITC is evaluating published and unpublished data
for the diaryl ethers recommended in its 29th Report (56 FR 67424,
December 30, 1991). The ITC is interested in meeting with
manufacturers, importers, processors, and users of these chemicals to
discuss use and exposure data and to develop Structure Activity
Relationships for predicting potential degradability and safety.
B. Specific Rationales
1. Recommended chemicals-- a. Nonylphenol ethoxylates.
Recommendation. Nonylphenol ethoxylates are being added to the Priority
Testing List to obtain TSCA section 8(a) exposure information and TSCA
section 8(d) health and safety studies.
Rationale for recommendation. Nonylphenol ethoxylates are being
recommended to meet the data needs of the Department of the Interior,
the EPA, and the Food and Drug Administration. Currently, these needs
include data on chemical composition of components and impurities,
environmental fate of components and impurities and health and
ecological effects, toxicokinetics and potential endocrine-modulating
effects. The ITC will consider information discussed during meetings of
the ITC-CMA Alkylphenols and Ethoxylates Dialog Group and review
documents submitted under TSCA section 8 before determining if these
chemicals should be removed from the Priority Testing List or
designated for testing to meet U.S. Government data needs.
Nonylphenol ethoxylates are also being recommended to supplement
the list of alkylphenols and ethoxylates that was recommended in the
37th Report (61 FR 4188, February 2, 1996)(FRL-4991-6). The rationale
described in the 37th Report for alkylphenols and ethoxylates also
applies to the nonylphenol ethoxylates listed in Table 2.
Supporting information--Nonylphenol ethoxylates. The Substructure-
based Computerized Chemical Selection Expert System (SuCCSES) is used
to identify chemicals with shared substructures and associated health
or ecological effects and similar TSCA production or importation
volumes (Ref. 16). SuCCSES was used to identify the alkylphenols and
ethoxylates that were added to the Priority Testing List in the 37th
Report.
After the 37th Report was transmitted to the EPA Administrator, the
ITC-CMA Alkylphenols and Ethoxylates Dialog Group developed a strategy
to identify important nonylphenol ethoxylates. First, a nonylphenol
ethoxylate substructure from SuCCSES and a nonylphenol ethoxylate name
fragment was used to search the original TSCA Inventory. Second, the
nonylphenol ethoxylates identified by this search were compared to
those listed in the Code of Federal Regulations title 21, parts 174-186
(indirect food additives), the Cosmetic Toiletries and Fragrances
Association Dictionary, the U.S. Pharmacopoeia/National Formulary and
the Food Chemical News Guide. Third, the nonylphenol ethoxylates
identified by this comparison were screened against nonylphenol
ethoxylates in the OPD Chemical Buyers Directory, McHutcheon's
Functional Materials and Chemcyclopedia '96. This strategy produced a
list of 18 nonylphenol ethoxylates (Table 2). For these 18 nonylphenol
ethoxylates there were several Chemical Abstract Service (CAS) numbers
including alternate CAS
[[Page 39835]]
numbers, and several chemical names including many synonyms (Table 3).
Table 3.-- Chemical Names, Synonyms and Ethoxylate Units (EO) for
Nonylphenol Ethoxylates Added to the Revised TSCA Section 4(e) Priority
Testing List
------------------------------------------------------------------------
Average
Chemical Names Synonyms Number of
EO Units
------------------------------------------------------------------------
Ethanol,2-[2-[2-[2-(p- Nonoxynol-4 4
nonylphenoxy)
ethoxy]ethoxy]ethoxy]-.
Nonylphenol polyethylene glycol Ethoxylated nonylphenol > 1
ether.
............................... Nonylphenol polyglycol > 1
ether
............................... Nonylphenol polyethylene > 1
oxide
............................... Nonylphenoxypoly(oxyethy > 1
lene)ethanol
............................... Poly(oxy-1,2- > 1
ethanediyl), alpha-
(nonylphenyl)-omega-
hydroxy
............................... Poly(oxyethylene) mono > 1
(nonylphenol) ether
............................... Nonoxynol-5 > 5
............................... Nonoxynol-6 > 6
Ethanol, 2-[2-(p- 1.5
nonylphenoxy)ethoxy]-.
p-Nonylphenol polyethylene glycol Glycols, polyethylene, > 1
ether. mono(p-nonylphenyl)
ether
............................... Alpha-(p-nonylphenyl)- > 1
omega-
hydroxypoly(oxyethylene
)
............................... Nonoxynol-1 > 1.5
Nonylphenol Nonoxynol-9 9
octa(oxyethylene)ethanol.
Nonylphenoxydiglycol............. Ethanol, 2-[2- 2
(nonylphenoxy)ethoxy-
Nonylphenol Nonylphenol 8
hepta(oxyethylene)ethanol. octaethoxylate
............................... Nonylphenol octaglycol 8
ether
............................... Nonoxynol-8 8
Nonylphenol Nonylphenol decaethylene 10
nona(oxyethylene)ethanol. glycol ether
Nonylphenoxyethanol.............. Nonylphenoxyglycol 1-1.5
............................... Ethanol, 2- 1-1.5
(nonylphenoxy)-
Poly(oxy-1,2-ethanediyl), alpha- > 1
(isononylphenyl)-omega-hydroxy.
Poly(oxy-1,2-ethanediyl), alpha- >1
(2-nonylphenyl)-omega-hydroxy.
Decaethylene glycol, 10
isononylphenyl ether.
Nonylphenoxypolyoxyethanol....... Poly(oxy-1,2- > 1
ethanediyl), alpha-
(nonylphenyl) omega-
hydroxy - branched
Nonylphenol polyethylene glycol Poly(oxy-1,2- > 1
ether. ethanediyl), alpha (4-
nonylphenyl)-omega-
hydroxy - branched
Nonoxynol-2...................... 2
Nonoxynol-3...................... 3
Nonoxynol-7...................... 7
alpha-(p-Nonylphenol)-omega- 1 to 100
hydroxypoly(oxyethylene).
------------------------------------------------------------------------
During development of the strategy by the ITC-CMA Alkylphenols and
Ethoxylates Dialog Group, issues related to the complex nomenclature
and chemical composition of nonylphenol ethoxylates were discussed.
During these discussions, it was recognized that for some nonylphenol
ethoxylates it is possible to quantify the average number of ethoxylate
(EO) units, while for others that are complex mixtures or polymers, it
is only possible to state that the average number of EO units is > 1
(Table 3). Obtaining recent production and importation volumes for
nonylphenol ethoxylates that are complex mixtures or polymers was a
concern for the Dialog Group because these chemicals were exempt from
reporting requirements of the EPA's 1986, 1990 and 1994 TSCA section
8(a) Inventory Update Rules (51 FR 21438, June 12, 1986; 55 FR 39586,
September 27, 1990; 59 FR 30652, June 14, 1994). However, the Dialog
Group recognized that the TSCA section 8(a) Preliminary Assessment
Information Rule (PAIR) that EPA automatically promulgates for any
chemicals that the ITC adds to the Priority Testing List requires the
submission of recent production and importation volume data for all
chemicals on the List, including complex mixtures or polymers. The ITC
will review the PAIR data for all alkylphenols and ethoxylates that are
on the List and use these data as well as use and exposure data and
other information provided to the ITC-CMA Alkylphenols and Ethoxylates
Dialog Group to determine which alkylphenols and ethoxylates should be
removed from the List and which should be considered for designation.
Existing U.S. Government data needs. The ITC identified the same
data needs for nonylphenol ethoxylates that were identified for
alkylphenols and alkylphenol ethoxylates in its 37th Report. These data
needs are summarized above in the rationale for recommendation.
Completed activities of the ITC-CMA Alkylphenols and Ethoxylates
Dialog Group. The Dialog Group discussed the history of the ITC's
recommendation, nomenclature issues, chemical composition data, uses of
alkylphenols and ethoxylates, ongoing testing and (as discussed above)
strategies for identifying nonylphenol ethoxylates. The Dialog Group
discussed the TSCA Test Submissions (TSCATS) compatible database that
the SEHSC-ITC-EPA workgroup developed for silicone chemicals. The
Dialog Group committed to develop a database for alkylphenols and
ethoxylates that would include elements that were compatible with
TSCATS, the Confidential Business Information Tracking System (CBITS)
and the TSCA submissions electronic cover sheet and abstract form.
2. Removal of Chemicals from the Priority Testing List-- a. White
Phosphorus. Based on concerns of the Department of Interior (DOI),
white phosphorus was recommended for chemical fate and ecological
effects testing in the ITC's 29th Report (56 FR 67424, December 30,
1991). These concerns included the paucity of data on the persistence
of white phosphorus in wetland sediments, the adverse
[[Page 39836]]
effects of white phosphorus to birds and wildlife that feed on
sediments contaminated with white phosphorus, and the potential for
food chain effects including possible elimination of endangered species
that may feed on carcasses of birds and wildlife that die from white
phosphorus poisoning. In response to the ITC's recommendations, the EPA
added white phosphorus (CAS number 7723-14-0) to TSCA section 8(a) and
8(d) rules (58 FR 13556, March 12, 1993). This CAS number also applies
to yellow, red and black phosphorus. After these rules were published,
the ITC asked EPA to add a second, less commonly used CAS number
(12185-10-3) for white phosphorus to TSCA section 8 rules to assure
retrieval of unpublished TSCA section 8 data that were indexed on that
CAS number. The EPA added this CAS number to TSCA section 8 rules that
were published on December 27, 1993 (58 FR 68311). The ITC reviewed
published data and data submitted in response to these rules. These
data demonstrated the persistence of white phosphorus in sediments, but
did not provide any new information to alleviate the DOI's concerns for
the ecological effects of white phosphorus. As a result, the ITC
designated white phosphorus for ecological effects testing in its 34th
Report (59 FR 35720, July 13, 1994).
The ITC did not receive any comments on the EPA's Toxic Release
Inventory (TRI) data for white phosphorus that were referenced in its
29th Report. In this Report, the ITC referenced the 1988 and 1989 TRI
which reported that over 3,000,000 pounds of white phosphorus were
released to the environment. Prior to publishing its 34th Report, the
ITC considered whether data from the 1991 and 1992 TRI (which reported
that about 300,000 pounds of white phosphorus were released to the
environment) would be sufficient environmental release to justify a
designation under TSCA section 4(e)(1)(A)(ii). Under this section of
TSCA, the ITC must consider ``the quantities in which the substance or
mixture enters or will enter the environment'' before designating any
chemical to the EPA Administrator for priority testing consideration.
The ITC determined that these releases were sufficient and referenced
the 1991 and 1992 TRI in its 34th Report when it designated white
phosphorus. After the 34th Report was published, the EPA received a
letter from the CMA which identified serious errors in white phosphorus
environmental release data reported by industry under the requirements
of the TRI (Ref. 5). According to the CMA, the 1993 TRI releases of
white phosphorus should have been about 27,000 pounds, not 318,000
pounds (Ref. 5). According to the 1994 TRI (which includes releases
from Federal facilities) about 50,000 pounds of white phosphorus were
released to the environment (Ref. 15).
After reviewing the 1995 CMA letter and the 1994 TRI data, EPA
requested that the ITC withdraw its designation of white phosphorus
because ``errors made by industry in TRI reporting have resulted in a
serious misconception about the actual environmental releases of white
phosphorus and 1994 TRI data indicate that environmental releases of
white phosphorus are almost an order of magnitude less than that upon
which the ITC based it decision to designate this chemical for testing
under section 4 of TSCA'' (Ref. 8). In this request EPA also committed
``to explore alternative ways to have the needed testing conducted''
(Ref. 8).
After reviewing the 1994 TRI data, letters from the CMA and the
EPA, and considering EPA's commitment to explore alternative testing
mechanisms, the ITC is withdrawing its designation and removing white
phosphorus from the Priority Testing List.
b. Oxygenated Fuel Additives. The ITC designated the oxygenated
fuel additive, methyl tert-butyl ether (MTBE) (CAS number 1634-04-4)
for health effects testing in its 20th Report because of concerns for
widespread human exposure to low level fugitive emissions of MTBE at
gasoline pumps and the need for chronic health effects data (52 FR
19020; May 20, 1987). In response to the ITC's designation, the EPA and
MTBE manufacturers negotiated a TSCA section 4 Enforceable Consent
Agreement (ECA) to develop pharmacokinetics, genotoxicity, subchronic
toxicity, reproductive effects, developmental toxicity, neurotoxicity,
and oncogenicity data (53 FR 10391, March 31, 1988). The ITC removed
MTBE from the Priority Testing List in its 22nd Report (53 FR 18196,
May 20, 1988). EPA and other Federal Agencies continue to assess the
risks of human exposure to MTBE.
Subsequent to this designation, the ITC recommended ethyl tert-
butyl ether (ETBE) (CAS number 637-92-3) and tert-amyl methyl ether
(TAME) (CAS number 994-05-8) for health effects testing to meet the
data needs of the U.S. EPA (59 FR 35720, July 13, 1994). Subsequently,
EPA promulgated TSCA section 8(a) and 8(d) rules for ETBE and TAME (59
FR 60716, November 28,1994) and met with ETBE and TAME manufacturers to
discuss testing to meet these data needs.
On September 21, 1994, and March 23, 1995, the EPA received letters
from the ARCO Chemical Company announcing their intention to
voluntarily conduct health effects tests for ETBE (Refs. 1 and 2).
These letters indicate that pharmacokinetics, genotoxicity, subchronic
toxicity, and neurotoxicity testing will be conducted first, followed
by developmental toxicity and reproductive effects testing. EPA's
Office of Pollution Prevention and Toxics (OPPT) added ETBE to its
Master Testing List (MTL) as a member of the category of ``Oxygenated
Fuel Additives'' to obtain test data to support ongoing activities in
EPA's Office of Air and Radiation (OAR).
On March 21, 1995, OPPT published a TSCA section 4 ECA for TAME (60
FR 14910)(FRL-4935-4). The ECA requires pharmacokinetics, genotoxicity,
subchronic toxicity, developmental toxicity, and reproductive toxicity
testing. Testing will be conducted by the TAME Producers Group which is
comprised of the following companies: Amerada Hess Corporation, Chevron
U.S.A. Products Company, Citgo Petroleum, Exxon Company U.S.A., and
Texaco Refining and Marketing. In addition, TAME is being considered
for inclusion in the Screening Information Data Set (SIDS) program, a
voluntary international testing program operated under the auspices of
the Organization for Economic Cooperation and Development (OECD). OPPT
also added TAME to its MTL as a member of the ``Oxygenated Fuel
Additives'' category to obtain test data to support ongoing OAR
activities.
The ITC is removing ETBE and TAME from the Priority Testing List at
this time because testing programs for both chemicals are likely to
meet EPA's data needs. If further testing of ETBE or TAME is needed,
the EPA may request that the ITC designate the chemicals for testing.
In the future, the EPA may nominate other oxygenated fuel additives to
the ITC.
c. High Production Volume Chemicals (HPVCs)/Glycol Ethers.
Diethylene glycol monoethyl ether acetate (DGEEA) (CAS number 112-15-2)
and diethylene glycol dimethyl ether (DGDME) (CAS number 111-96-6) were
members of a group of 35 HPVCs that were recommended for 90-day
subchronic toxicity testing in the ITC's 27th Report (56 FR 99534,
March 6, 1991). SuCCSES was used to select these HPVCs during the ITC's
sixth scoring exercise. These HPVCs had annual production volumes
exceeding 1 million pounds, but no 90-day subchronic toxicity data to
identify
[[Page 39837]]
potential health effects concerns. In its 36th Report (60 FR 42982,
August 17, 1995)(FRL-4965-6), the ITC solicited specific use and
exposure information on DGEEA, DGDME, and ten other HPVCs to facilitate
its ability to decide whether these chemicals should be removed from
the Priority Testing List or designated for testing.
As noted in the 37th Report (61 FR 4188, February 2, 1996), Eastman
Chemical Company and Ferro Corporation responded to that solicitation
for DGEEA and DGDME, respectively (Refs. 7 and 9). Both DGEEA and DGDME
are used as solvents in various applications. Ferro reported that DGDME
is also used in reaction medium for the synthesis of certain chemicals
and that the use of DGDME as a solvent in semiconductor cleaning
operations has decreased. In their letters, both manufacturers stated
that exposures to DGEEA and DGDME are low.
Although 90-day subchronic toxicity studies are not available for
DGEEA or DGDME, existing toxicity data on these and related glycol
ethers and acetates indicate that such studies are not necessary to
further identify potential health effects concerns.
DGEEA is expected to be metabolized to diethylene glycol monoethyl
ether (DGEE) (CAS number 111-90-0), based on the metabolism of other
glycol ether acetates (Ref. 13). Subchronic toxicity studies in which
rats, mice and pigs were fed DGEE for 90 days have been conducted (Ref.
10). There was reduced growth in rats and mice at the highest dose
levels (5.0% and 5.4%, respectively). Hemoglobin was reduced and
relative kidney weights increased in all 3 species at the highest dose
levels. In pigs (the most sensitive species in this study), three
deaths due to uremia were recorded within the first 3 weeks of exposure
at the highest dose level of 1,500 mg/kg after which the dose was
reduced to 1,000 mg/kg. The no-observed effect levels established from
these studies were 250 mg/kg/day for rats, 850 to 1,000 mg/kg/day for
mice and 167 mg/kg/day for pigs. These DGEE data satisfy the need for
subchronic toxicity testing of DGEEA.
DGDME caused dose-dependent testicular toxicity in male rats
following short-term (10 to 20 days) exposure by inhalation (Ref. 12)
and oral administration (Ref. 4). DGDME also caused developmental
toxicity when administered to rabbits (Ref. 14) and pregnant CD-1 mice
(Ref. 11). Following administration of doses of DGDME, to the male rat
(Ref. 3) and the pregnant CD-1 mouse (Ref. 6) some of the DGDME was
metabolized to the well-studied reproductive toxicant, ethylene glycol
monomethyl ether (EGME) (CAS number 109-86-4), and its toxic
metabolite, methoxyacetic acid. Since 10- to 20-day repeated dose
studies with DGDME have identified potential toxicities of concern, 90-
day subchronic toxicity testing for the purposes of general toxicity
screening is not warranted.
The ITC is removing DGEEA and DGDME from the Priority Testing List
because sufficient screening data exist to identify potential
subchronic toxicities of concern and no additional U.S. Government data
needs were identified at this time.
References
1. ARCO. Letter from Dr. Larry S. Andrews, Manager, Toxicology
Regulatory Compliance, ARCO Chemical Company to Mr. Charles M. Auer,
Director, Chemical Control Division, OPPT/EPA, Washington, DC
(1994).
2. ARCO. Letter from Dr. Larry S. Andrews, Manager, Toxicology
Regulatory Compliance, ARCO Chemical Company to Mr. Charles M. Auer,
Director, Chemical Control Division, OPPT/EPA, Washington, DC
(1995).
3. Cheever, K.L., Richards, D.E., Weigal, W.W., Lal, J.B.
Dinsmore, A.M. and Daniel, F.B. Metabolism of Bis (2-methoxyethyl)
Ether in the Adult Male Rat: Evaluation of the Principal Metabolite
as a Testicular Toxicant. Toxicology and Applied Pharmacology.
94:150-159 (1988).
4. Cheever, K.L., Weigal, W.W., Richards, D.E., Lal, J.B., and
Plotnick, H.B. Testicular Effects of Bis (2-methoxyethyl) Ether in
the Adult Male Rat. Toxicology and Industrial Health. 5:1099-1110
(1989).
5. CMA. Letter from Ms. Cecilia W. Spearing, Manager, Chemical
Manufacturers Association's Phosphorus Panel to Mr. Charles M. Auer,
Director, Chemical Control Division, OPPT/EPA, Washington, DC
(1995).
6. Daniel, F.B., Cheever, K.L. Bagley, K.B., Richards, D.E.,
Weigal, W.W., and Eisenmann, C.J. Bis (2-methoxyethyl) Ether:
Metabolism and Embryonic Disposition of a Developmental Toxicant in
the Pregnant CD-1 Mouse. Fundamental and Applied Toxicology. 16:567-
575 (1991).
7. Eastman. Letter from Dr. Roderick D. Gerwe, Senior Technical
Associate, Eastman Chemical Company, Kingsport, Tennessee to Dr.
John D. Walker, Executive Director, ITC, OPPT/EPA, Washington, DC
(1995).
8. EPA. March 5, 1996 Letter from Mr. Charles M. Auer, Director,
Chemical Control Division, OPPT/EPA, Washington, DC to Dr. Victor
Fung, Chairperson, ITC, National Cancer Institute, Bethesda, MD
(1996).
9. Ferro. Letter from Mr. Edward J. Ballow, Product Manager,
Ferro Corporation, Zachary, Louisiana to Dr. John D. Walker,
Executive Director, ITC, OPPT/EPA, Washington, DC (1995).
10. Gaunt, I.F., Colley, J., Grasso, P., Landsdown, A.B.G., and
Gangolli, S.D. Short-term Toxicity of Diethylene Glycol Monoethyl
Ether in the Rat, Mouse, and Pig. Food and Cosmetics Toxicology.
6:689-705 (1968).
11. Hardin, B.D. and Eisenmann, C.J. Relative Potency of Four
Ethylene Glycol Ethers for Induction of Paw Malformations in the CD-
1 Mouse. Teratology. 35:321-328 (1987).
12. Lee, K.P., Kinney, L.A., and Valentine, R. Comparative
Testicular Toxicity of Bis (2-methoxyethyl) ether and 2-
methoxyethanol in rats. Toxicology. 59:239-258 (1989).
13. NTP. Project Report No. 11 ``The In Vitro Hydrolysis of 2-
Methoxyethyl Acetate, 2-Ethoxyethyl Acetate and 2-Butoxyethyl
Acetate by Rat Blood.'' Study report submitted to the National
Toxicology Program (NTP) by Research Triangle Institute under
Contract No. N01-ES-1- 5007 (1986).
14. Schwetz, B.A., Price, C.J., George, J.D., Kimmel, C.A.,
Morrissey, R.E., and Marr, M.C. The Developmental Toxicity of
Diethylene and Triethylene Glycol Dimethyl Ethers in Rabbits.
Fundamental and Applied Toxicology. 19:238-245 (1992).
15. TRI (Toxic Release Inventory). Database retrieval 3/1/96.
U.S. Environmental Protection Agency (1996).
16. Walker, J.D. Estimation Methods Used by the TSCA Interagency
Testing Committee to Prioritize Chemicals for Testing: Exposure and
Biological Effects Scoring and Structure Activity Relationships.
Toxicology Modeling. 1:123-141 (1995).
TSCA Interagency Testing Committee
Statutory Organizations and Their Representatives
Council on Environmental Quality
Brad Campbell, Member
Ann Holbrow, Alternate
Department of Commerce
Edward White, Member
Environmental Protection Agency
David R. Williams, Member
Lois Dicker, Alternate
National Cancer Institute
Victor Fung, Member
Harry Seifried, Alternate
National Institute of Environmental Health Sciences
William Eastin, Member
H.B. Matthews, Alternate
National Institute for Occupational Safety and Health
Henryka Nagy, Member
David A. Dankovic, Alternate
National Science Foundation
Linda Duguay, Member
Occupational Safety and Health Administration
Lyn Penniman, Member
Christine Whittaker, Alternate
Liaison Organizations and Their Representatives
Agency for Toxic Substances and Disease Registry
William Cibulas, Member
Consumer Product Safety Commission
Val Schaeffer, Member
Lakshmi C. Mishra, Alternate
[[Page 39838]]
Department of Agriculture
Clifford Rice, Member
Department of Defense
David A. Macys, Member
Department of the Interior
Barnett A. Rattner, Member
Food and Drug Administration
Edwin J. Matthews, Member
Raju Kammula, Alternate
National Library of Medicine
Vera Hudson, Member
National Toxicology Program
NIEHS, FDA and NIOSH Members
Counsel
Mary Ellen Levine, Office of General Counsel, EPA
Technical Support Contractor
Syracuse Research Corporation
ITC Staff
John D. Walker, Executive Director
Norma S.L. Williams, Executive Assistant, TSCA Interagency
Testing Committee, U.S. EPA/OPPT (MC/7401) 401 M St., SW.,
Washington, DC 20460, (202) 260-1825, Fax (202) 260-7895; Internet:
[email protected].
[FR Doc. 96-19333 Filed 7-29-96; 8:45 am]
BILLING CODE 6560-50-F