[Federal Register Volume 63, Number 68 (Thursday, April 9, 1998)]
[Notices]
[Pages 17658-17665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-9396]
[[Page 17657]]
_______________________________________________________________________
Part V
Environmental Protection Agency
_______________________________________________________________________
Forty-First Report of the TSCA Interagency Testing Committee; Notice
Federal Register / Vol. 63, No. 68 / Thursday, April 9, 1998 /
Notices
[[Page 17658]]
ENVIRONMENTAL PROTECTION AGENCY
[OPPTS-41049; FRL-5773-5]
Forty-First Report of the TSCA Interagency Testing Committee to
the Administrator; Receipt of Report and Request for Comments
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 Forty-First Report to the Administrator of the EPA on
November 28, 1997. In the Forty-First Report, which is included with
this notice, the ITC revised the TSCA section 4(e) Priority Testing
List by recommending 29 alkylphenol ethoxylates, alkylphenols, and
polyalkylphenols and removing 6 alkylphenols, 10 diaryl ethers, and 3
siloxanes.
There are no designated or recommended with intent-to-designate
chemicals or chemical groups in the Forty-First Report. EPA invites
interested persons to submit written comments on the Report.
DATES: Written comments must be received on or before May 11, 1998.
ADDRESSES: Each comment must bear the docket control number OPPTS-
41048. All comments should be sent in triplicate to: OPPT Document
Control Officer (7407), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 401 M St., SW., Rm. G-099, East Tower,
Washington, DC 20460.
Comments and data may also be submitted electronically to: oppt.
[email protected]. Follow the instructions under Unit IV of this
notice. No Confidential Business Information (CBI) should be submitted
through e-mail.
All comments which contain information claimed as CBI must be
clearly marked as such. Three sanitized copies of any comments
containing information claimed as CBI must also be submitted and will
be placed in the public record for this notice. Persons submitting
information on any portion of which they believe is entitled to
treatment as CBI by EPA must assert a business confidentiality claim in
accordance with 40 CFR 2.203(b) for each such portion. This claim must
be made at the time that the information is submitted to EPA. If a
submitter does not assert a confidentiality claim at the time of
submission, EPA will consider this as a waiver of any confidentiality
claim and the information may be made available to the public by EPA
without further notice to the submitter.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director,
Environmental Assistance Division (7408), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460, telephone: (202) 554-1404, TDD: (202) 554-0551,
e-mail: TSCA-H[email protected].
SUPPLEMENTARY INFORMATION: EPA has received the TSCA Interagency
Testing Committee's Forty-First 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 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.
II. The ITC Forty-First Report
The most recent revisions to the Priority Testing List are included
in the ITC's Forty-First Report. The Report was received by the EPA
Administrator on November 28, 1997, and is included in this notice.
Twenty-nine alkylphenol ethoxylates, alkylphenols, and polyalkylphenols
are being recommended because:
1. TSCA production and importation volumes are reported in the
multimillion pound range.
2. Releases to the environment can occur from wastewater treatment
and agricultural uses.
3. Alkylphenol ethoxylates can degrade to alkylphenols, which can
persist in the environment and be highly toxic to aquatic organisms.
4. Exposure to alkylphenols and alkylphenol ethoxylates may affect
endocrine and other important human and animal system functions.
Alkylphenol ethoxylates, alkylphenols, and polyalkylphenols are being
recommended to determine if there are unpublished studies that contain
data to meet the needs of the U.S. Government organizations represented
on the ITC and to complete the list of alkylphenols and alkylphenol
ethoxylates that were recommended in the ITC's 37th Report (61 FR 4188,
February 2, 1996)(FRL-4991-6), and 39th Report (62 FR 8578, February
25, 1997)(FRL-5580-9).
III. Status of the Priority Testing List
The current TSCA section 4(e) Priority Testing List contains 11
chemical groups; of these, 4 chemical groups were designated for
testing.
IV. Public Record and Electronic Submissions
The official record for this notice, as well as the public version,
has been established for this notice under docket control number OPPTS-
41048 (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 CBI, is available for inspection from 12 noon to
4 p.m., Monday through Friday, excluding legal holidays. The official
record is located in the TSCA Nonconfidential Information Center, Rm.
NE-B607, 401 M St., SW., Washington, DC.
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. Comments and data
will also be accepted on disks in WordPerfect 5.1/6.1 or ASCII file
format. All comments and data in electronic form must be identified by
the docket control number OPPTS-41048. Electronic comments on this
notice may be filed online at many Federal Depository Libraries.
List of Subjects
Environmental protection, Chemicals, Hazardous substances.
Authority: 15 U.S.C. 2603.
Dated: April 1, 1998.
Charles M. Auer,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
Administrator, U.S. Environmental Protection Agency
Summary
This is the 41st Report of the TSCA Interagency Testing Committee
(ITC) to the Administrator of the U.S. Environmental Protection Agency
(EPA). In this Report, the ITC is revising its TSCA section 4(e)
Priority Testing List by recommending 29 alkylphenols,
[[Page 17659]]
alkylphenol ethoxylates, and polyalkylphenols and removing 6
alkylphenols, 3 siloxanes, and 10 diaryl ethers. The revised TSCA
section 4(e) Priority Testing List follows as Table 1.
Table 1.--The TSCA Section 4(e) Priority Testing List (November 1997)\1\
----------------------------------------------------------------------------------------------------------------
Report Date Chemical/Group Action
----------------------------------------------------------------------------------------------------------------
26................................... May 1990............... 8 Isocyanates.......... Recommended with intent-
to-designate
27................................... November 1990.......... 62 Aldehydes........... Recommended with intent-
to-designate
28................................... May 1991............... Chemicals with low Designated
confidence Reference
Dose (RfD).
Acetone
Thiophenol
30................................... May 1992............... 5 Siloxanes............ Recommended
31................................... January 1993........... 24 Chemicals with Designated
insufficient dermal
absorption rate data.
32................................... May 1993............... 32 Chemicals with Designated
insufficient dermal
absorption rate data.
35................................... November 1994.......... 24 Chemicals with Designated
insufficient dermal
absorption rate data.
36................................... May 1995............... 9 High Production Recommended
Volume Chemicals
(HPVCs).
37................................... November 1995.......... 22 Alkylphenols and Recommended
alkylphenol
ethoxylates.
39................................... November 1996.......... 23 Nonylphenol Recommended
ethoxylates\2\.
41................................... November 1997.......... 29 Alkylphenols, Recommended
alkylphenol
ethoxylates, and
polyalkyphenols\2\.
----------------------------------------------------------------------------------------------------------------
\1\The list of discrete chemicals currently on the Priority Testing List is available from the Executive
Director of the ITC.
\2\Data requested under the ITC's Voluntary Information Submissions Policy described in this Report.
I. Background
The TSCA 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 six months..., the Committee shall make such revisions in the
Priority Testing 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.). The ITC recommends chemical substances for information
reporting, screening, and testing to meet the data needs of its member
U.S. Government organizations. Since its creation in 1976, the ITC has
submitted 40 semi-annual (May and November) Reports to the EPA
Administrator transmitting the Priority Testing List and its revisions.
ITC Reports are published in the Federal Register; they are available
from http://www.epa.gov/fedrgstr or the ITC. The ITC meets monthly and
produces its revisions of the Priority Testing 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.
II. TSCA Section 8 Reporting
A. TSCA Section 8 Rules
Following receipt of the ITC's Report and addition of chemicals to
the Priority Testing List, the EPA's Office of Pollution Prevention and
Toxics (OPPT) promulgates TSCA section 8(a) Preliminary Assessment
Information Reporting (PAIR) and TSCA section 8(d) Health and Safety
Data (HaSD) rules for new chemicals added to the Priority Testing List.
These rules require producers and importers of chemicals recommended by
the ITC to submit production and exposure reports under TSCA section
8(a) and producers, importers, and processors of chemicals recommended
by the ITC to submit unpublished health and safety studies under TSCA
section 8(d). These TSCA section 8(a) reports and section 8(d) studies
must be submitted to EPA within 60 days of the rules' effective date.
TSCA section 8(a) reports and 8(d) submissions are indexed in databases
maintained by the ITC and the EPA, respectively.
B. ITC's Use of TSCA Section 8 Data
To determine if revisions to the Priority Testing List are
necessary, 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 4(a) and 4(d) studies, TSCA section 8(c) submissions, TSCA
section 8(e) ``substantial risk'' notices, ``For Your Information''
(FYI) submissions to EPA, unpublished data submitted to U.S. Government
organizations represented on the ITC, and published papers). Revisions
can include changing recommendations to designations, modifying
recommendations, or removing chemicals from the Priority Testing List.
C. Policy Promoting More Efficient Use of TSCA Section 8 Resources
In its 40th Report (62 FR 30580, June 4, 1997)(FRL-5718-3), the ITC
proposed a policy promoting more efficient use of TSCA section 8(d)
resources. The ITC received comments on its policy from the Chemical
Manufacturers Association (CMA) (Ref. 2, Russell, 1997). In response to
these comments, the ITC has revised the policy, now referred to as the
ITC's Voluntary Information Submissions Policy (VISP).
Under the VISP, the ITC will now:
1. Request specific information necessary to meet information needs
of U.S. Government organizations represented on the ITC (e.g., specific
health and ecological effects data, use information, etc.).
2. List studies that the ITC is not requesting (e.g., studies on
waste streams).
3. Provide an opportunity for producers, importers, processors, and
users of chemicals recommended by the ITC or a consortium representing
those producers, importers, processors, and users to notify the ITC
Executive Director in writing (by e-mail or letter) that studies will
be provided voluntarily to the ITC as ITC FYI submissions. This
[[Page 17660]]
notification must be received within 30 days of the date the ITC Report
is published in the Federal Register.
4. Ask those producers, importers, processors, and users of
chemicals who notify the ITC (see Unit II.C.3. of this Report) to
provide the EPA with an electronic list (table) of studies within 60
days of the date the ITC Report is published in the Federal Register
and ITC FYI submissions within 90 days of the date the ITC Report is
published in the Federal Register. The electronic table should contain
columns for the Chemical Abstracts Service (CAS) Registry number,
chemical name, study date, study title, Document Control Number (DCN),
and a column indicating whether the study will be submitted on disk as
a WordPerfect 6.1 file or as a hard copy. The EPA will add DCNs to the
table and send it back to the submitter and to the ITC Executive
Director. In addition, the EPA will send to each submitter of the
electronic table, adhesive labels containing DCNs. These labels should
be affixed to the first page of each ITC FYI study submitted as a hard
copy, not a document containing multiple studies, or the first page of
an ITC FYI study printed from an electronic copy (only a hard copy of
the first page of each electronic study should be submitted).
5. Encourage producers, importers, processors, and users who submit
an electronic table of studies to submit the TSCA electronic cover
sheet (including an abstract) for each study to the EPA within 90 days
of the date the ITC Report is published in the Federal Register. The
TSCA electronic cover sheet is available from http://www.epa.gov/
opptintr/itc. The DCN should be recorded on each TSCA electronic cover
sheet. CBI must not be recorded on the TSCA electronic cover sheet and
must not be sent by e-mail. Individual TSCA electronic cover sheets
must be sent by e-mail to [email protected]. The EPA will send
each final TSCA electronic cover sheet to the ITC Executive Director.
Multiple TSCA electronic cover sheets (one for each study) can be sent
on 3 \1/2\ disks or a CD ROM; the disks or CD ROM should be mailed to
the Document Processing Center (7407), ET-G-099, Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. For those producers, importers, processors, and
users who submit a TSCA electronic cover sheet for each study, the ITC
will extend the deadline for providing ITC FYI submissions to 120 days
from the date the ITC Report is published in the Federal Register.
6. Request that two hard copies of each ITC FYI study (or
preferably one disk or CD ROM containing each study as a WordPerfect
6.1 file) should be mailed to the Document Processing Center (7407),
ET-G-099, Attn: FYI Coordinator, Office of Pollution Prevention and
Toxics, Environmental Protection Agency, 401 M St., SW., Washington, DC
20460. It is not necessary to submit cover letters for each ITC FYI
study because:
a. A TSCA electronic cover sheet bearing a DCN would have been
submitted for each ITC FYI study.
b. The first page of the ITC FYI study would bear the adhesive
label containing the pre-assigned DCN. EPA will provide the ITC
Executive Director with an electronic (preferable) or hard copy of each
ITC FYI study.
III. ITC's Dialogue Group Activities During This Reporting Period
(May 1997 to November 1997)
A. Alkylphenols and Alkylphenol Ethoxylates
The ITC-CMA Alkylphenols and Ethoxylates Dialogue Group was formed
by the ITC's Alkylphenols and Ethoxylates Subcommittee and the CMA's
Alkylphenols and Ethoxylates Panel. The Dialogue Group was established
in March 1996 to facilitate the ITC's retrieval of information on uses,
exposures, and health and ecological effects of alkylphenols and
alkylphenol ethoxylates and the CMA's understanding of data needed by
the U.S. Government organizations represented on the ITC. Since the
establishment of this Dialogue Group, numerous activities have occurred
(see the ITC's 38th Report (61 FR 39832, July 30, 1996)(FRL-5379-2),
39th Report (62 FR 8578, February 25, 1997)(FRL-5580-9), and 40th
Report. During this reporting period, the Dialogue Group met to
discuss:
1. Results of a qualitative survey of Panel member companies
regarding production or importation of alkylphenols, alkylphenol
ethoxylates, and polyalkylphenols.
2. TSCA section 8(d) studies submitted for alkyphenols and
alkyphenol ethoxylates recommended in the 37th Report (FRL-4991-6) (61
FR 4188, February 2, 1996).
3. Data needs of U.S. Government organizations represented on the
ITC.
4. Ongoing and planned studies sponsored by the Panel.
5. Development of Structure Activity Relationships (SARs).
6. Voluntary testing processes that might be used to provide needed
data.
In its survey of member companies, the Panel identified 29
alkylphenols, alkylphenol ethoxylates, and polyalkylphenols out of 74
remaining on the Priority Testing List that were produced, imported, or
used in 1995, but recommended that the results of this informal survey
should not be viewed as representative of the entire industry. The
Dialogue Group acknowledged that about 500 TSCA section 8(d) studies
were submitted in equal numbers by Panel member companies and non-Panel
member companies for the alkylphenols and alkylphenol ethoxylates
recommended in the 37th Report. Most of those studies provided data on
acute toxicity, dermal irritation, or eye irritation of mixtures
containing alkylphenols and alkylphenol ethoxylates.
The ITC members proposed studies to address the data needs for
alkylphenols and alkylphenol ethoxylates (see Unit IV.A.1.d. of this
Report). The Panel described planned studies that may meet some of the
data needs listed in Unit IV.A.1.d. of this Report. Development of
SARs, voluntary testing and uses of alkylphenols and alkylphenol
ethoxylates will be discussed in more detail in future Dialogue Group
meetings. The Dialogue Group acknowledged that during the past 10
years, the Panel has sponsored many studies to evaluate the safety of
alkylphenols and alkylphenol ethoxylates.
B. Isocyanates
The ITC-CMA Isocyanates Dialogue Group was formed by the ITC's
Isocyanates Subcommittee and CMA's Diisocyanates Panel. The Dialogue
Group was established in November 1996 to facilitate the ITC's
retrieval of information on uses, exposures, and health effects of
isocyanates and the CMA's understanding of data needed by the U.S.
Government organizations represented on the ITC. Since the
establishment of this Dialogue Group, numerous activities have occurred
(see the ITC's 38th, 39th, and 40th Reports). This Dialogue Group
continues to discuss production, commercial uses, and health and safety
data for 8 of 43 isocyanates that were recommended in the ITC's 26th
Report (55 FR 23050, June 5, 1990).
C. Siloxanes
The ITC-Silicones Environmental Health and Safety Council (SEHSC)
Dialogue Group was formed by the ITC's Siloxanes Subcommittee and
SEHSC. This Dialogue Group was established in March 1993 to facilitate
the ITC's retrieval of information on uses, exposures, and health
effects of siloxanes and the SEHSC's
[[Page 17661]]
understanding of data needed by the U.S. Government organizations
represented on the ITC. Since the establishment of this Dialogue Group,
numerous activities have occurred (see the ITC's 37th, 38th, 39th, and
40th Reports). During this reporting period, the Dialogue Group met to
discuss ongoing reproductive effects, biochemical toxicology,
pharmacokinetic, metabolism, and immunology studies of siloxanes
sponsored by SEHSC member companies. The studies sponsored by these
companies are being conducted on 5 of 56 siloxanes that were
recommended in the ITC's 30th Report (57 FR 30608, July 9, 1992).
IV. 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
----------------------------------------------------------------------------------------------------------------
Alkylphenols and Recommended November 1997
Alkylphenol Ethoxylates
C5 Alkylphenols do do
136-81-2............................ Phenol, 2-pentyl-....... do do
3279-27-4........................... Phenol, 2-(1,1- do do
dimethylpropyl)-.
25735-67-5.......................... Phenol, 4-sec-pentyl-... do do
26401-74-1.......................... Phenol, 2-sec-pentyl-... do do
C6 Alkylphenols do do
2446-69-7........................... Phenol, 4-hexyl-........ do do
C7 Alkylphenols do do
1987-50-4........................... Phenol, 4-heptyl-....... do do
72624-02-3.......................... Phenol, heptyl derivs... do do
84605-25-4.......................... Phenol, 1-methylhexyl do do
derivs..
C8 Alkylphenols do do
140-66-9............................ Phenol, 4-(1,1,3,3- do do
tetramethylbutyl)-.
71902-25-5.......................... Phenol, octenylated..... do do
C9 Alkylphenols do do
68081-86-7.......................... Phenol, nonyl derivs.... do do
91672-41-2.......................... Phenol, 2-nonyl-, do do
branched.
C10 Alkylphenols do do
27157-66-0.......................... Phenol, decyl-.......... do do
C12 Alkylphenols do do
74499-35-7.......................... Phenol, (tetrapropenyl) do do
derivs..
C14 Alkylphenols do do
70682-80-3.......................... Phenol, tetradecyl-..... do do
C16 Alkylphenols do do
2589-78-8........................... Phenol, 4-hexadecyl-.... do do
25401-86-9.......................... Phenol, 2-hexadecyl-.... do do
C18-C30 Alkylphenols do do
68784-24-7.......................... Phenol, C18-C30-alkyl do do
derivs..
Monosubstituted do do
Polyalkylphenols
68954-70-1.......................... Phenol, polyethylene do do
derivs..
68891-67-8.......................... Phenol, polypropene do do
derivs..
68908-55-4.......................... Phenol, polybutene do do
derivs..
112375-88-9......................... Phenol, polyisobutylene do do
derivs..
112375-89-0......................... Phenol, poly(2,4,4- do do
trimethylpentene)
derivs..
C8 Alkylphenol do do
Ethoxylates
9004-87-9........................... Poly(oxy-1,2- do do
ethanediyl), -
(isooctylphenyl)--hydroxy-.
9063-89-2........................... Poly(oxy-1,2- do do
ethanediyl), -
(octylphenyl)--hydroxy-.
C12 Alkylphenol do do
Ethoxylates
9014-92-0........................... Poly(oxy-1,2- do do
ethanediyl), -
(dodecylphenyl)--hydroxy-.
26401-47-8.......................... Poly(oxy-1,2- do do
ethanediyl), -
(4-dodecylphenyl)-
-hydroxy-.
C13 Alkylphenol do do
Ethoxylates
61723-87-3.......................... Poly(oxy-1,2- do do
ethanediyl), -
(tridecylphenyl)--hydroxy-.
C16 Alkylphenol do do
Ethoxylates
59911-95-4.......................... Poly(oxy-1,2- do do
ethanediyl), -
(4-hexadecylphenyl)-
-hydroxy-.
Alkylphenols Removed do
1322-69-6........................... (1,1,3,3- do do
Tetramethylbutyl)phenol
(mixed isomers).
29932-96-5.......................... (1,1,3,3- do do
Tetramethylbutyl)phenol
(mixed isomers).
[[Page 17662]]
30105-54-5.......................... (1,1,3,3- do do
Tetramethylbutyl)phenol
(mixed isomers).
62744-41-6.......................... (1,1,3,3- do do
Tetramethylbutyl)phenol
(mixed isomers).
1300-16-9........................... Nonylphenol (mixed do do
isomers).
1331-57-3........................... Dodecylphenol (mixed do do
isomers).
Diaryl Ethers do do
101-84-8............................ 1,1'-Oxybisbenzene...... do do
3586-14-9........................... 1-Methyl-3- do do
phenoxybenzene.
13826-35-2.......................... 3- do do
Phenoxybenzenemethanol.
28299-41-4.......................... 1,1'- do do
Oxybis[methylbenzene].
28984-89-6.......................... Phenoxy-1,1'-biphenyl... do do
42874-96-4.......................... 2-Chloro-1-(3- do do
methylphenoxy)-4-
(trifluoromethyl)benzen
e.
50594-77-9.......................... 3-[2-Chloro-4- do do
(trifluoromethyl)phenox
y] phenol, acetate.
51632-16-7.......................... 1-(Bromomethyl)-3- do do
phenoxybenzene.
63734-62-3.......................... 3-[2-Chloro-4- do do
(trifluoromethyl)phenox
y]benzoic acid.
72252-48-3.......................... 3-[2-Chloro-4- do do
(trifluoromethyl)phenox
y] benzoic acid,
potassium salt.
Siloxanes do do
107-51-7............................ Octamethyltrisiloxane do do
(L3).
141-62-8............................ Decamethyltetrasiloxane do do
(L4).
141-63-9............................ Dodecamethylpentasiloxan do do
e (L5)
----------------------------------------------------------------------------------------------------------------
A. Chemicals Added to the Priority Testing List
1. Alkylphenols, alkylphenol ethoxylates, and polyalkylphenols--a.
Recommendation. Add 29 alkylphenols, alkylphenol ethoxylates, and
polyalkylphenols to the Priority Testing List to obtain information to
meet U.S. Government data needs.
b. Rationale for recommendation. Twenty-nine alkylphenols,
alkylphenol ethoxylates, and polyalkylphenols are being recommended
because:
i. TSCA production and importation volumes are reported in the
multi-million pound range.
ii. Releases to the environment can occur from wastewater treatment
and agricultural uses.
iii. Alkylphenol ethoxylates can degrade to alkylphenols, which can
persist in the environment and be highly toxic to aquatic organisms.
iv. Exposure to alkylphenols and alkylphenol ethoxylates may affect
endocrine and other important human and animal system functions.
Alkylphenols, alkylphenol ethoxylates, and polyalkylphenols are being
recommended to determine if there are unpublished studies that contain
data to meet the needs of the U.S. Government organizations represented
on the ITC and to complete the list of alkylphenols and alkylphenol
ethoxylates that were recommended in the ITC's 37th and 39th Reports.
c. Supporting information. As noted in the 37th, 38th, and 39th
Reports, ITC used its Substructure-based Computerized Chemical
Selection Expert System (SuCCSES) to identify the alkylphenols and
alkylphenol ethoxylates that were added to the Priority Testing List.
Following the SAR rationale for adding alkylphenols and alkylphenol
ethoxylates to the Priority Testing List that was described in the 37th
Report, only 29 alkylphenols, alkylphenol ethoxylates, and
polyalkylphenols with a single-alkyl chain in either the para or ortho
position are being added to the Priority Testing List in this Report.
One of the alkylphenols being added to the Priority Testing List (4-
(1,1,3,3-tetramethylbutyl)phenol, CAS No. 140-66-9) was added to the
Priority Testing List in the ITC's 11th Report (47 FR 54626, December
3, 1982) and removed from the Priority Testing List in the 13th Report
(48 FR 55674, December 14, 1983) because the producers conducted
chemical fate and aquatic toxicity testing. It is being added to the
Priority Testing List at this time to obtain information to meet other
U.S. Government data needs.
d. Implementation of ITC's VISP promoting more efficient use of
TSCA section 8(d) resources. The ITC is implementing its VISP (to
promote more efficient use of TSCA section 8(d) resources) for 23
nonylphenol ethoxylates recommended in its 39th Report and the 29
alkylphenols, alkylphenol ethoxylates, and polyalkylphenols added to
the Priority Testing List in this Report.
Under its VISP, the ITC requests:
1. Specific information to meet data needs of U.S. Government
organizations represented on the ITC:
a. Fish and amphibian multigeneration reproductive effects data.
b. Avian acute toxicity data (oral feeding and egg exposure
studies).
c. Avain reproductive effects data.
d. Fish and wildlife field data.
e. Bioaccumulation or bioavailability data.
f. Health effects data, including absorption, toxicokinetics,
systemic toxicity, endocrine disruption, reproductive effects, and
carcinogenicity data.
g. SARs to estimate effects or degradation.
Data needs 1a-1e and 1g are also applicable to the alkylphenols and
alkylphenol ethoxylates recommended in the 37th Report for which the
ITC has reviewed unpublished studies submitted under TSCA section 8(d)
and determined that they do not meet U.S. Government data needs listed
in Unit IV.A.1.d.1.a.-g. of this Report.
2. No submissions on the following:
a. Any data on non-isomeric mixtures containing <90% of the
recommended alkylphenols, alkylphenol ethoxylates, or polyalkylphenols,
Exception: Absorption data.
b. Dermal irritation data.
c. Eye irritation data.
d. Corrosivity data.
e. Data on waste streams.
3. The EPA to revoke the TSCA section 8(a) PAIR and TSCA section
8(d) HaSD rules for the ITC's 38th Report for which EPA published a
stay on December 11, 1996 (61 FR 65186)( FRL-5577-6) (Ref. 1, Fung,
1997). In its 39th Report, the ITC eliminated the use of alternate CAS
numbers for nonylphenol ethoxylates recommended in the 38th Report.
4. The EPA not to promulgate TSCA section 8(d) HaSD rules for the
[[Page 17663]]
nonylphenol ethoxylates recommended in the ITC's 39th Report and the
alkylphenols, alkylphenol ethoxylates, and polyalkylphenols added to
the Priority Testing List in this 41st Report (Ref. 1, Fung, 1997).
5. Producers, importers, processors, and users of alkylphenols,
alkylphenol ethoxylates, and polyalkylphenols recommended by the ITC in
its 37th, 39th, and 41st Reports or a consortium representing those
producers, importers, processors, and users to follow the generic
procedures listed in Unit II.C.3-6 of this Report.
6. The EPA to promulgate (upon receipt of a letter from the ITC
Chair) a TSCA section 8(d) HaSD rule for the alkylphenols and
alkylphenol ethoxylates recommended in the 39th and 41st Reports. The
ITC will submit this letter if there is no notification of intent to
submit studies or if studies voluntarily submitted are insufficient to
satisfy data needs.
As noted in Unit III.A. of this Report, the ITC has reviewed
reports and studies submitted in response to the PAIR and HaSD rules
promulgated for alkylphenols and alkylphenol ethoxylates recommended in
the 37th Report. Based on its review, the ITC recognizes that there are
many non-CMA Panel member companies that produce, import, process, or
use alkylphenols and alkylphenol ethoxylates. The ITC encourages all
companies to submit studies following the procedures described in the
VISP.
B. Chemicals Removed From the Priority Testing List
1. Alkylphenols and Alkylphenol Ethoxylates. The ITC is removing
six alkylphenols from the Priority Testing List that were recommended
in the 37th Report. The rationales for these removals are listed in
Table 3.
Table 3.-- Alkylphenols Being Removed From the Priority Testing List
------------------------------------------------------------------------
CAS No. Chemical name Rationale
------------------------------------------------------------------------
1322-69-6 (1,1,3,3- Already
Tetramethylbutyl)p represented by
henol(mixed (1,1,3,3-
isomers) tetramethylbutyl)
phenol (mixed
isomers) (CAS No.
27193-28-8) and
no data submitted
in response to
TSCA section 8(a)
PAIR rule (61 FR
7421, February
28, 1996)(FRL-
4996-9) .
29932-96-5 (1,1,3,3- do
Tetramethylbutyl)p
henol (mixed
isomers)
30105-54-5 (1,1,3,3- do
Tetramethylbutyl)p
henol (mixed
isomers)
62744-41-6 (1,1,3,3- do
Tetramethylbutyl)p
henol (mixed
isomers)
1300-16-9 Nonylphenol (mixed Already
isomers) represented by
nonylphenol
(mixed isomers)
(CAS No. 25154-52-
3) and no data
submitted in
response to TSCA
section 8(a) PAIR
rule (61 FR 7421,
February 28,
1996).
1331-57-3 Dodecylphenol Already
(mixed isomers) represented by
dodecylphenol
(mixed isomers)
(CAS No. 27193-86-
8) and no data
submitted in
response to TSCA
section 8(a) PAIR
rule (61 FR 7421,
February 28,
1996).
------------------------------------------------------------------------
2. Diaryl ethers--a. Rationale for removal. The ITC is removing 10
diaryl ethers from the Priority Testing List (Table 2) because:
i. There are no current U.S. Government data needs.
ii. Routine uses are not likely to result in environmental releases
or exposures to workers, consumers, or the general population.
iii. There is information to predict water solubilities, vapor
pressures, atmospheric, and aquatic half lives, rodent acute
toxicities, irritancy potential, aquatic toxicity, and binding to
estrogen receptor(s).
b. Supporting information. In its 29th Report (56 FR 67424,
December 30, 1991), the ITC recommended a group of 14 alkyl, bromo,
chloro, and hydroxy-methyl diaryl ethers for physical chemical
properties, biodegradation rate, health effects, and ecological effects
screening tests. The 14 diaryl ethers were selected from 261 aryl
ethers (55 diaryl ethers) by using SuCCSES. The 14 were selected
because of their potential to intercalate with DNA (56 FR 67424,
December 30, 1991). SuCCSES is used by the ITC to identify chemicals
with shared substructures and associated health or ecological effects
(Ref. 4, Walker, 1991; Ref. 5, Walker, 1995). The ITC removed 4 of the
previously recommended diaryl ethers from the Priority Testing List in
its 35th Report (59 FR 67596, December 29, 1994).
The ITC reviewed all the PAIR reports and all the TSCA section 8(d)
studies and concluded that the 10 remaining diaryl ethers were likely
to be used as intermediates or starting materials, but not as end
products. The ITC estimated that these diaryl ethers should:
1. Be metabolized through ortho or para hydroxylation.
2. Have water solubilities 20 milligram/liter (mg)/(L).
3. Have vapor pressures 2 x 10-2 millimeter
Mercury (mm)(Hg) @ 25 deg.C.
4. Have atmospheric-half lives <1 day.
5. Have aquatic-half lives <1 week.
6. Have low-binding affinity for estrogen receptor(s).
To analyze existing data, the ITC organized the 10 remaining diaryl
ethers into 2 SuCCSES categories:
1. Non-fluoromethyl diaryl ethers.
2. Trifluoromethyl diaryl ethers.
Based on available data, the ITC estimated that non-fluoromethyl
diaryl ethers (alkyl, aryl, bromo, diaryl ether, and hydroxymethyl
diaryl ethers) would have rodent oral LD50 values >2 gram/
kilogram (g)/(kg) and that most would be mild irritants, be negative in
an Ames assay, have low-oncogenicity potential, and have
LC50 values <1 mg/L for aquatic organisms. The ITC
recognized that 1-methyl-3-phenoxybenzene could have marginal
oncogenicity potential based on a positive Ames assay and that 1-
(bromomethyl)-3-phenoxybenzene could have moderate oncogenicity
potential based on its structural relationship to benzyl chloride, a
known alkylating agent.
During its review of data for these chemicals, the ITC used SuCCSES
to identify three additional non-fluoromethyl alkyl diaryl ethers:
[[Page 17664]]
1. Phenoxytetrapropylene benzene (mixture of isomers) (CAS No.
68938-96-5).
2. Decylphenoxybenzene (mixture of isomers) (CAS No. 69834-17-9).
3. 1,1'-Oxybis-benzene, tetrapropylene derivatives (mixture of
isomers) (CAS No. 119345-02-7). At the present time, ITC is deferring
these chemicals based on the data reviewed for other diaryl alkyl
ethers.
Based on available data, the ITC estimated that trifluoromethyl
diaryl ethers would have rodent oral LD50 values >1 g/kg and
that most would be mild irritants, be negative in an Ames assay, have
low-moderate oncogenicity potential and have LC50 values >1
mg/L for aquatic organisms. The ITC recognized that the trifluoromethyl
diaryl ethers are structurally similar to diaryl ether herbicides
except they lack a nitro group (Acifluorfen,
Fomesafen, Lactofen, and
Oxyfluorfen) or a branched carboxylic acid group
(Verdict). The ITC is aware of the possibility that the
trifluoromethyl diaryl ether moiety may play a possible receptor-
mediated role in oncogenicity.
3. Silicone chemicals--a. Rationale for removal. The ITC is
removing octamethyltrisiloxane (L3, CAS No. 107-51-7),
decamethyltetrasiloxane (L4, CAS No. 141-62-8), and
dodecamethylpentasiloxane (L5, CAS No. 141-63-9) from the
Priority Testing List because:
i. Annual production and importation volumes are less than 1
million pounds.
ii. Routine uses are not likely to result in substantial
environmental releases or human exposurures.
b. Supporting information. Fifty-six siloxanes were recommended for
health effects testing in the ITC's 30th Report (57 FR 30608, July 9,
1992) to meet the data needs of the U.S. Government organizations
represented on the ITC. After this recommendation, the ITC's Siloxanes
Subcommittee and the Silicones Environmental Health and Safety Council
(SEHSC) established a Dialogue Group to develop a TSCA Test Submissions
database (TSCATS)-compatible computer file of physical and chemical
properties, health effects and use data, and to develop health effects
data to meet the needs of the U.S. Government organizations represented
on the ITC. The ITC-SEHSC computer file has been used by other
organizations and serves as the prototype TSCA section 8 database for
the EPA's TSCA Electronic Commerce Workgroup. The ITC accepted a letter
of commitment (LOC) from the SEHSC to discuss ongoing and planned
siloxanes testing that is being conducted to meet the data needs
described in the ITC's 30th Report (Ref. 3, SEHSC, 1996). The testing
(on the 5 siloxanes remaining on the Priority Testing List) is being
conducted voluntarily as part of an April 9, 1996, Memorandum of
Understanding (MOU) between EPA and the Dow Corning Corporation; the
MOU describes a model Product Stewardship program. The LOC provides the
ITC and SEHSC member companies the opportunity to discuss protocols,
planned and ongoing studies, and to meet as often as necessary with Dow
Corning Corporation and the SEHSC until the testing program has been
completed.
As a result of continuing discussions, the ITC removed 43 of the
previously recommended siloxanes chemicals from the Priority Testing
List in its 37th Report and five siloxanes from the Priority Testing
List in its 39th Report. The ITC is removing three linear siloxanes
(L3, L4, and L5) from the Priority
Testing List in this Report (Table 2). L3, L4,
and L5 have annual production and import volumes less than 1
million pounds and are used primarily for industrial and/or commercial
applications such as solvent cleaning, carriers, water displacement,
and polyurethane foam blowing that are not likely to result in
substantial environmental releases or human exposures.
The five siloxanes remaining on the Priority Testing List are shown
in Table 4.
Table 4.--Siloxanes Remaining on the Priority Testing List
------------------------------------------------------------------------
CAS No. Chemical name
------------------------------------------------------------------------
Cyclic Siloxanes
556-67-2.................................. Octamethylcyclotetrasiloxane
(D4)
541-02-6.................................. Decamethylcyclopentasiloxane
(D5)
540-97-6.................................. Dodecamethylcyclohexasiloxan
e (D6)
Linear Siloxanes
107-46-0.................................. Hexamethyldisiloxane (L2)
Polymers
63148-62-9................................ Dimethyl silicones and
siloxanes
------------------------------------------------------------------------
V. References
1. Fung, V.A. September 15, 1997, letter from Dr. Victor A. Fung,
ITC Chairperson to the Honorable Carol M. Brown, Administrator, U.S.
Environmental Protection Agency, 401 M St., SW., Washington, DC.
2. Russell, S. July 7, 1997, E-mail from Steven Russell, Esq. to
Dr. John D. Walker. ``Comments of the Chemical Manufacturers
Association on the 40th Report of the TSCA Interagency Testing
Committee before the U.S. Environmental Protection Agency.''.
3. SEHSC. July 26, 1996, Letter of Commitment from Bill Smock,
Executive Director, SEHSC, 1767 Business Center Drive, Suite 302,
Reston, VA to John Walker, Executive Director, ITC, U.S. Environmental
Protection Agency (7401), 401 M St., SW., Washington, DC.
4. Walker, J.D. Chemical selection by the TSCA Interagency Testing
Committee: Use of computerized substructure searching to identify
chemical groups for health effects, chemical fate and ecological
effects testing. The Science of the Total Environment 109/110:691-700
(1991).
5. 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).
VI. TSCA Interagency Testing Committee
Statutory Organizations and Their Representatives
Council on Environmental Quality
Brad Campbell, Member
Douglas Sanders, Alternate
Department of Commerce
Edward White, Member
Environmental Protection Agency
Paul Campanella, Member
David R. Williams, Alternate
National Cancer Institute
Victor Fung, Member, Chair
Harry Seifried, Alternate
National Institute of Environmental Health Sciences
William Eastin, Member, Vice Chair
H.B. Matthews, Alternate
National Institute for Occupational Safety and Health
Albert E. Munson, Member
Christine Sofge, Alternate
National Science Foundation
Linda Duguay, Member
Occupational Safety and Health Administration
Lyn Penniman, Member
Liaison Organizations and Their Representatives
Agency for Toxic Substances and Disease Registry
William Cibulas, Member
Consumer Product Safety Commission
Val H. Schaeffer, Member
Lakshmi C. Mishra, Alternate
Department of Agriculture
[[Page 17665]]
Clifford P. Rice, Alternate
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, Phone: 202-260-1825, Fax: 202-260-7895, E-
mail: [email protected].
[FR Doc. 98-9396 Filed 4-8-98; 8:45 am]
BILLING CODE 6560-50-F