[Federal Register Volume 77, Number 100 (Wednesday, May 23, 2012)]
[Notices]
[Pages 30856-30869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-12493]
[[Page 30855]]
Vol. 77
Wednesday,
No. 100
May 23, 2012
Part V
Environmental Protection Agency
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Sixty-Ninth Report of the TSCA Interagency Testing Committee to the
Administrator of the Environmental Protection Agency; Receipt of Report
and Request for Comments; Notice
Federal Register / Vol. 77, No. 100 / Wednesday, May 23, 2012 /
Notices
[[Page 30856]]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2011-1020; FRL-9346-3]
Sixty-Ninth Report of the TSCA Interagency Testing Committee to
the Administrator of the Environmental Protection Agency; Receipt of
Report and Request for Comments
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The Toxic Substances Control Act (TSCA) Interagency Testing
Committee (ITC) transmitted its 69th Report to the EPA Administrator on
April 5, 2012. In the 69th ITC Report, which is included with this
notice, the ITC is adding a category of cadmium compounds including any
chemical that contains cadmium as part of that chemical's structure, 6
non-phthalate plasticizers, 25 phosphate ester flame retardants, 2
other flame retardants, 9 chemicals to which children living near
hazardous waste sites may be exposed, and a category of 69
diisocyanates and related compounds (including 14 Action Plan chemicals
and 55 related compounds) to the TSCA Priority Testing List. In
addition, the ITC is removing 103 cadmium compounds and 14 High
Production Volume (HPV) Challenge Program orphan chemicals from the
Priority Testing List during this reporting period (June to November
2011). The ITC is adding the category of cadmium compounds and removing
103 cadmium compounds to provide a more comprehensive approach to
assessing cadmium compounds' safety.
DATES: Comments must be received on or before June 22, 2012.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2011-1020, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave. NW., Washington, DC.
Attention: Docket ID Number EPA-HQ-OPPT-2011-1020. The DCO is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the DCO is (202) 564-8930. Such deliveries are
only accepted during the DCO's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2011-1020. EPA's policy is that all comments received will be included
in the docket without change and may be made available online at http://www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through regulations.gov or email. The
regulations.gov Web site is an ``anonymous access'' system, which means
EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through regulations.gov, your email
address will be automatically captured and included as part of the
comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at http://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave. NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number of the EPA/DC Public Reading Room
is (202) 566-1744, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.
FOR FURTHER INFORMATION CONTACT: For technical information contact: Dr.
John D. Walker, Interagency Testing Committee (7401M), Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-7527; fax number: (202) 564-7528; email address:
[email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
This notice is directed to the public in general. It may, however,
be of particular interest to you if you manufacture (defined by statute
to include import) and/or process TSCA-covered chemicals and you may be
identified by the North American Industrial Classification System
(NAICS) codes 325 and 32411. Because this notice is directed to the
general public and other entities may also be interested, the Agency
has not attempted to describe all the specific entities that may be
interested in this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
[[Page 30857]]
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. Background
The Toxic Substances Control Act (TSCA) (15 U.S.C. 2601 et seq.)
authorizes the EPA Administrator to promulgate regulations under TSCA
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 EPA Administrator for priority testing
consideration. Section 4(e) of TSCA directs the ITC to revise the TSCA
section 4(e) Priority Testing List at least every 6 months.
You may access additional information about the ITC at http://www.epa.gov/opptintr/itc.
A. The 69th ITC Report
The ITC is adding a category of cadmium compounds including any
chemical that contains cadmium as part of that chemical's structure, 6
non-phthalate plasticizers, 25 phosphate ester flame retardants, 2
other flame retardants, 9 chemicals to which children living near
hazardous waste sites may be exposed, and a category of 69
diisocyanates and related compounds (including 14 Action Plan chemicals
and 55 related compounds) to the TSCA section 4(e) Priority Testing
List. In addition, the ITC is removing 103 cadmium compounds and 14 HPV
Challenge Program orphan chemicals from the Priority Testing List
during this reporting period (June to November 2011). The ITC is adding
the category of cadmium compounds and removing 103 cadmium compounds to
provide a more comprehensive approach to assessing cadmium compounds'
safety.
B. Status of the Priority Testing List
The Priority Testing List includes 2 alkylphenols, 16 chemicals
with insufficient dermal absorption rate data, and 164 HPV Challenge
Program orphan chemicals, a category of cadmium compounds including any
chemical that contains cadmium as part of that chemical's structure, 6
non-phthalate plasticizers, 25 phosphate ester flame retardants, 2
other flame retardants, 9 chemicals to which children living near
hazardous waste sites may be exposed, and a category of 69
diisocyanates and related compounds (including 14 Action Plan chemicals
and 55 related compounds).
List of Subjects
Environmental protection, Chemicals, Hazardous substances.
Dated: May 15, 2012.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.
Sixty-Ninth Report of the TSCA Interagency Testing Committee to the
Administrator of the Environmental Protection Agency
Table of Contents
Summary
I. Background
II. TSCA Section 8 Reporting
A. TSCA Section 8 Reporting Rules
B. ITC's Use of TSCA Section 8 and Other Information
C. New Request To Add Chemicals to the TSCA Section 8(d) HaSDR
Rule
III. ITC's Activities During This Reporting Period (June to November
2011)
IV. Revisions to the TSCA Section 4(e) Priority Testing List
A. Chemicals Added to the Priority Testing List
1. Cadmium Compounds
2. Non-Phthalate Plasticizers, Phosphate Ester Flame Retardants,
and Other Flame Retardants
3. Chemicals to which children living near hazardous waste sites
may be exposed
4. Diisocyanates and Related Compounds
B. Chemicals Removed From the Priority Testing List
1. Cadmium Compounds
2. HPV Challenge Program Orphan Chemicals
V. References
VI. The TSCA Interagency Testing Committee
Summary
The ITC is adding a category of cadmium compounds including any
chemical that contains cadmium as part of that chemical's structure, 6
non-phthalate plasticizers, 25 phosphate ester flame retardants, 2
other flame retardants, 9 chemicals to which children living near
hazardous waste sites may be exposed, and a category of 69
diisocyanates and related compounds (including 14 Action Plan chemicals
and 55 related compounds) to the Toxic Substances Control Act (TSCA)
section 4(e) Priority Testing List. In addition, the ITC is also
removing 103 cadmium compounds and 14 High Production Volume (HPV)
Challenge Program orphan chemicals from the Priority Testing List
during this reporting period (June to November 2011). The ITC is adding
the category of cadmium compounds and removing 103 cadmium compounds to
provide a more comprehensive approach to assessing cadmium compounds'
safety.
The TSCA section 4(e) Priority Testing List is Table 1 of this
unit.
Table 1--TSCA Section 4(e) Priority Testing List
[November 2011]
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ITC Report Date Chemical name/group Action
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31............... January 1993....................... 2 Chemicals with Designated.
insufficient dermal
absorption rate data,
methyl cyclo hexane
and cyclo pentane.
32............... May 1993........................... 10 Chemicals with Designated.
insufficient dermal
absorption rate data.
35............... November 1994...................... 4 Chemicals with Designated.
insufficient dermal
absorption rate data,
cyclopentadiene,
formamide, 1,2,3-
trichloropropane and m-
nitrotoluene.
37............... November 1995...................... Branched 4-nonylphenol Recommended.
(mixed isomers).
[[Page 30858]]
41............... November 1997...................... Phenol, 4-(1,1,3,3- Recommended.
tetramethylbutyl)-.
55............... December 2004...................... 161 High Production Recommended.
Volume (HPV) Challenge
Program orphan
chemicals.
56............... August 2005........................ 3 HPV Challenge Program Recommended.
orphan chemicals.
68............... May 2011........................... Cadmium................ Recommended.
69............... November 2011...................... Cadmium compounds...... Recommended.
69............... November 2011...................... 6 Non-phthalate Recommended.
plasticizers.
69............... November 2011...................... 25 Phosphate ester Recommended.
flame retardants.
69............... November 2011...................... 2 Other flame Recommended.
retardants.
69............... November 2011...................... 9 Chemicals to which Recommended.
children living near
hazardous waste sites
may be exposed.
69............... November 2011...................... 69 Diisocyanates and Recommended.
related compounds.
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I. Background
The ITC was established by TSCA section 4(e) ``to make
recommendations to the Administrator respecting the chemical substances
and mixtures to which the Administrator should give priority
consideration for the promulgation of rules for testing under section
4(a). * * * At least every six months * * *, the Committee shall make
such revisions to the Priority Testing List as it determines to be
necessary and transmit them to the Administrator together with the
Committee's reasons for the revisions'' (Public Law 94-469, 90 Stat.
2003 et seq., 15 U.S.C. 2601 et seq.). ITC reports are available from
regulations.gov (http://www.regulations.gov) after publication in the
Federal Register. The ITC produces its revisions to the Priority
Testing List with administrative and technical support from the ITC
staff, ITC members, and their U.S. Government organizations, and
contract support provided by the Environmental Protection Agency (EPA).
ITC members and staff are listed at the end of this report.
II. TSCA Section 8 Reporting
A. TSCA Section 8 Reporting Rules
Following receipt of the ITC's report (and the revised Priority
Testing List) by the EPA Administrator, EPA's Office of Pollution
Prevention and Toxics (OPPT) may add the chemicals from the revised
Priority Testing List to the TSCA section 8(a) Preliminary Assessment
Information Reporting (PAIR) rule (40 CFR part 712) and/or the TSCA
section 8(d) Health and Safety Data Reporting (HaSDR) rule (40 CFR part
716). The PAIR rule requires manufacturers (including importers) of
chemicals added to the Priority Testing List to submit to EPA certain
production and exposure information (http://www.epa.gov/oppt/chemtest/pubs/pairform.pdf). As provided for in the PAIR rule, whenever EPA
announces the receipt of an ITC report, EPA amends, unless otherwise
instructed by the ITC, the PAIR rule by adding the recommended (or
designated) chemicals that have been added to the Priority Testing List
by the ITC.
The HaSDR rule requires certain past, current, and proposed
manufacturers, importers, and (if specified by EPA) processors of
listed chemicals to submit to EPA copies and lists of unpublished
health and safety studies on the listed chemicals that they
manufacture, import, or (if specified by EPA) process. As provided for
in the HaSDR rule, whenever EPA announces the receipt of an ITC report,
EPA amends, unless otherwise instructed by the ITC, the HaSDR rule by
adding the recommended (or designated) chemicals that have been added
to the Priority Testing List by the ITC.
B. ITC's Use of TSCA Section 8 and Other Information
The ITC's use of TSCA section 8 and other information is described
in the 52nd ITC Report (Ref. 1).
C. New Request To Add Chemicals to the TSCA Section 8(d) HaSDR Rule
The ITC is requesting that EPA add a category of cadmium compounds
including any chemical that contains cadmium as part of that chemical's
structure, 6 non-phthalate plasticizers, 25 phosphate ester flame
retardants, 2 other flame retardants, 9 chemicals to which children
living near hazardous waste sites may be exposed, and a category of 69
diisocyanates and related compounds to the TSCA section 8(d) HaSDR
rule. The category of cadmium compounds, 6 non-phthalate plasticizers,
25 phosphate ester flame retardants, 2 other flame retardants, 9
chemicals to which children living near hazardous waste sites may be
exposed, and a category of 69 diisocyanates and related compounds are
discussed in section IV of this report.
III. ITC's Activities During This Reporting Period (June to November
2011)
During this reporting period, the ITC discussed the need to expand
the definition of the cadmium compounds beyond the 103 cadmium
compounds recommended in the 68th ITC Report (Ref. 2). As a result the
ITC is recommending a category of cadmium compounds including any
chemical that contains cadmium as part of that chemical's structure and
removing the 103 cadmium compounds from the Priority Testing List. The
ITC is adding the category of cadmium compounds and removing 103
cadmium compounds to provide a more comprehensive approach to assessing
cadmium compounds' safety.
In addition, the ITC discussed the use of TSCA section 8(d) to
obtain biomonitoring data. As a result of these discussions, the ITC is
adding 6 non-phthalate plasticizers, 25 phosphate ester flame
retardants, 2 other flame retardants, and 9 chemicals to which children
living near hazardous waste sites may be exposed to the Priority
Testing List and asking EPA to add these chemicals to the TSCA section
8(d) HaSDR rule to obtain biomonitoring data. The ITC also discussed
adding a category of 69 diisocyanates and related compounds to the
Priority Testing List and to the TSCA section 8(d) HaSDR rule to
facilitate EPA's ability to obtain existing studies. Finally, the ITC
discussed EPA's Notice of Proposed Rulemaking (NPRM) for HPV Challenge
Program chemicals (Ref. 3). As a result of these discussions the ITC is
removing 14 HPV Challenge Program orphan chemicals from the Priority
Testing List.
IV. Revisions to the TSCA Section 4(e) Priority Testing List
A. Chemicals Added to the Priority Testing List
1. Cadmium compounds--i. Recommendation. The EPA and the
[[Page 30859]]
Consumer Product Safety Commission (CPSC) request that the ITC add the
category cadmium compounds to the Priority Testing List to obtain
health and safety studies on cadmium compounds that are present in any
consumer product. The cadmium compounds category includes any chemical
that contains cadmium as part of that chemical's structure.
ii. Rationale for recommendation. The EPA and the CPSC are
concerned with the content of cadmium and cadmium compounds in certain
children's toys, jewelry, and other consumer products due to known
toxicity and health concerns from exposure to cadmium and cadmium
compounds. The EPA has expanded the cadmium compounds category to
include any chemical that contains cadmium as part of that chemical's
structure to capture information on more than the 103 cadmium compounds
listed in the 68th ITC Report (Ref. 2). Cadmium remains on the Priority
Testing List as recommended in the 68th ITC Report.
iii. Supporting information. The supporting information for cadmium
and cadmium compounds is described in the 68th ITC Report. However, the
supporting information for this report is for cadmium and cadmium
compounds, not cadmium or cadmium compounds.
iv. Information needs. EPA and CPSC need health and safety studies
for assessing the extent and degree of exposure and potential hazard
associated with cadmium and cadmium compounds including:
Epidemiological or clinical studies; occupational exposure, health
effects, and ecological effects studies; and environmental fate studies
(including relevant physical chemical properties).
For example, EPA and CPSC need studies about the total amount of
cadmium and cadmium compounds contained in a product, the solubility,
and bioavailability of cadmium and cadmium compounds (including
accessibility of cadmium and cadmium compounds to children and studies
of the age and foreseeable behavior of children exposed to a product
for children and/or children's toys), the foreseeable duration and
route of potential cadmium and cadmium compounds exposure through
contact with products, and studies on the marketing, patterns of use,
and lifecycle of cadmium-containing products.
2. Non-phthalate plasticizers, phosphate ester flame retardants,
and other flame retardants--i. Recommendation. The CPSC requests that
the ITC add 6 non-phthalate plasticizers, 25 phosphate ester flame
retardants, and 2 other flame retardants to the Priority Testing List
to obtain biomonitoring studies on the identity and quantity of urinary
metabolites. This recommendation is coordinated with the Agency for
Toxic Substances and Disease Registry (ATSDR) and the National
Institute of Environmental Health Sciences (NIEHS).
ii. Rationale for recommendation. The CPSC is requesting that 6
non-phthalate plasticizers be added to the Priority Testing List
because they need biomonitoring data on urinary metabolites. Phthalate
plasticizers are being replaced with non-phthalate plasticizers, such
as acetyl tri-n-butyl citrate (Chemical Abstract Service Registry
Number (CAS No.) 77-90-7); di(2-ethylhexyl) adipate (CAS No. 103-23-1);
di(2-ethylhexyl) terephthalate (CAS No. 6422-86-2); 2,2,4-trimethyl-
1,3-pentanediol diisobutyrate (CAS No. 6846-50-0); 1,2-
cyclohexanedicarboxylic acid, 1,2-diisononyl ester (CAS No. 16612-78-
8); and 1,2-cyclohexanedicarboxylic acid, 1,2-dinonyl ester, branched
and linear ester (CAS No. 474919-59-0) (Table 2 of this unit). The 6
non-phthalate plasticizers identified in Table 2 of this unit are known
to be used in children's products, including teething rings and soft
plastic toys and have the potential to migrate from these products into
human saliva.
In addition, the CPSC is requesting that 25 phosphate ester flame
retardants and 2 other flame retardants be added to the Priority
Testing List because they need biomonitoring data on urinary
metabolites. The flame retardants identified in Tables 3A, 3B, and 4 of
this unit are known to be used in upholstered furniture, automobile
upholstery, and children's products such as car seats, play pens, and
toys. These flame retardants are substitutes for pentabromodiphenyl
ether, which was withdrawn from the market due to environmental and
health concerns.
iii. Supporting information--a. Non-phthalate plasticizers. The
non-phthalate plasticizer, di(2-ethylhexyl) adipate (CAS No. 103-23-1)
was added to the Priority Testing List in the 28th ITC Report (Ref. 4).
Di(2-ethylhexyl) adipate was recommended for chemical fate, ecological
effects, and health effects testing because of extensive human and
environmental exposures. Di(2-ethylhexyl) adipate was removed from the
Priority Testing List in the 32nd ITC Report because manufacturers
committed to develop dossiers and necessary test data under the
Screening Information Data Set (SIDS) program of the Organization for
Economic Cooperation and Development (OECD) (Ref. 5). Di(2-ethylhexyl)
terephthalate (CAS No. 6422-86-2) was added to the Priority Testing
List in the 11th ITC Report as bis(2-ethylhexyl) terephthalate (Ref.
6). Di(2-ethylhexyl) terephthalate was recommended for chemical fate,
ecological effects, and health effects testing because of extensive
human and environmental exposures. Di(2-ethylhexyl) terephthalate was
removed from the Priority Testing List in the 13th ITC Report (Ref. 7).
Di(2-ethylhexyl) terephthalate was removed because EPA developed a
Negotiated Testing Agreement with the chemical's manufacturers to
conduct the testing (Ref. 8). 2,2,4-Trimethyl-1,3-pentanediol
diisobutyrate (CAS No. 6846-50-0) has been reviewed by OECD and a SIDS
dossier has been developed (http://www.inchem.org/documents/sids/sids/6846500.pdf). 1,2-Cyclohexanedicarboxylic acid, 1,2-diisononyl ester
(CAS No. 166412-78-8) is a plasticizer for ``PVC and other polar
polymers and can be used in applications that are particularly
sensitive from a toxicological point of view'' (http://www2.basf.us/plasticizers/pdfs/Hex_DINCH_e_08_04.pdf). 1,2-
Cyclohexanedicarboxylic acid, 1,2-dinonyl ester, branched and linear
(CAS No. 474919-59-0) is a plasticizer that is ``recommended for
medical products, toys and food packaging applications.'' Dreyfus and
Babich have demonstrated that all six of these non-phthalate
plasticizers migrate into simulated saliva (Ref. 9).
b. Phosphate ester flame retardants. Tributyl phosphate (CAS No.
126-73-8) was recommended with intent to designate in the 18th ITC
Report (Ref. 10). Tributyl phosphate was recommended for chemical fate,
ecological effects, and health effects testing because of extensive
human and environmental exposures. Tributyl phosphate was also added to
the May 19, 1986 PAIR and HaSDR rules (Ref. 11). After reviewing
extensive voluntary data submissions from manufacturers and reports
submitted in response to the May 19, 1986 PAIR and HaSDR rules, the ITC
designated tributyl phosphate for chemical fate, ecological effects,
and health effects testing in the 19th ITC Report (Ref. 12). Tributyl
phosphate was removed from the Priority Testing List in the 22nd ITC
Report (Ref. 13). Tributyl phosphate was removed from the Priority
Testing List because EPA proposed the testing designated by the ITC in
a NPRM that was published on November 12, 1987 (Ref. 14). EPA required
the testing designated by the ITC in a final rule published on August
14, 1989 (Ref. 15).
Tributyl phosphate (CAS No. 126-73-8), triisobutyl phosphate (CAS
No. 126-
[[Page 30860]]
71-6) and tri(2-butoxyethyl) phosphate (CAS No. 78-51-3) were
recommended for chemical fate testing and added to the Priority Testing
List in the 26th ITC Report (Ref. 16). Tributyl phosphate was also
recommended for ecological effects testing (plant toxicity testing) in
the 26th ITC Report. Tributyl phosphate, triisobutyl phosphate, and
tri(2-butoxyethyl) phosphate were added to the September 28, 1990 PAIR
and HaSDR rules (Ref. 17). After reviewing reports and studies
submitted in response to the September 28, 1990 PAIR and HaSDR rules,
tributyl phosphate, triisobutyl phosphate and tri(2-butoxyethyl)
phosphate were removed from the Priority Testing List in the 33rd ITC
Report (Ref. 18). Tributyl phosphate was removed from the Priority
Testing List because testing was being conducted in response to the
August 14, 1989 final rule. Triisobutyl phosphate was removed from the
Priority Testing List because it was not known to be domestically
produced or imported in substantial quantities. Tri (2-butoxyethyl)
phosphate was removed from the Priority Testing List because it was not
a high priority for testing at that time.
Triphenyl phosphate (CAS No. 115-86-6) was added to the Priority
Testing List in the 2nd ITC Report as one of the chemicals in the aryl
phosphates category (Ref. 19). The testing recommendations for the aryl
phosphates category included carcinogenicity, mutagenicity,
teratogenicity, other chronic effects, environmental effects, and
epidemiology. Triphenyl phosphate was added to the June 22, 1982 PAIR
rule (Ref. 20) and the September 2, 1982 HaSDR rule (Ref. 21).
Triphenyl phosphate was removed from the Priority Testing List in the
14th ITC Report (Ref. 22). Triphenyl phosphate was removed from the
Priority Testing List because the aryl phosphates category was included
in a December 29, 1983 Advanced Notice of Proposed Rulemaking (ANPRM)
(Ref. 23). Triphenyl phosphate was also included in a January 17, 1992
NPRM (Ref. 24).
Tris(2-chloroethyl) phosphate (CAS No. 115-96-8) was added to the
Priority Testing List in the 23rd ITC Report (Ref. 25). Tris(2-
chloroethyl) phosphate was recommended for chemical fate and ecological
effects testing. Tris(2-chloroethyl) phosphate was added to the
November 16, 1988 PAIR and HaSDR rules (Ref. 26). After reviewing
reports and studies submitted in response to the November 16, 1988 PAIR
and HaSDR rules, tris(2-chloroethyl) phosphate was removed from the
Priority Testing List in the 36th ITC Report (Ref. 27). Tris(2-
chloroethyl) phosphate was removed from the Priority Testing List
because the data or structure activity relationships considered by the
ITC did not indicate a need for further testing at that time.
Tris(1,3-dichloro-2-propyl) phosphate (CAS No. 13674-87-8), tris(2-
chloro-1-propyl) phosphate (CAS No. 6145-73-9), and tris(1-chloro-2-
propyl)phosphate (CAS No. 13674-84-5) were added to the Priority
Testing List in the 23rd ITC Report (Ref. 25). The 3 phosphate ester
flame retardants were recommended for chemical fate, ecological
effects, and health effects testing because of extensive human and
environmental exposures. The three phosphate ester flame retardants
were included in the November 16, 1988 PAIR and HaSDR rules (Ref. 26).
Several chemical fate, ecological effects and health effects studies
were submitted to EPA under the HaSDR rule. The sunset date for
submitting studies under the HaSDR rule was December 16, 1998. The
three phosphate ester flame retardants were removed from the Priority
Testing List in the 36th ITC Report because the data or structure
activity relationships considered by the ITC did not indicate a need to
designate the chemicals for further testing at that time (Ref. 27).
Tris(1,3-dichloro-2-propyl) phosphate has been identified as a probable
human carcinogen, and tris(chloropropyl) phosphate (mixture of
isomers), see Table 3B, an analog to tris(1,3-dichloro-2-propyl)
phosphate, is being tested by the National Toxicology Program (NTP).
The phosphate ester flame retardant bis(2-chloropropyl) (l-chloro-2-
isopropyl) phosphate (CAS No. 76649-15-5) was added to the Priority
Testing List in the 30th ITC Report (Ref. 28). Bis(2-chloropropyl) (l-
chloro-2-isopropyl) phosphate is a component of tris(chloropropyl)
phosphate (mixture of isomers). Bis(2-chloropropyl) (l-chloro-2-
isopropyl) phosphate was recommended for chemical fate, ecological
effects and health effects testing because of potential human and
environmental exposures and included in the May 14, 1993 PAIR and HaSDR
rules (Ref. 29). A few studies were submitted to EPA under the HaSDR
rule. Bis(2-chloropropyl) (l-chloro-2-isopropyl) phosphate was removed
from the Priority Testing List in the 36th ITC Report because the data
or structure activity relationships considered by the ITC did not
indicate a need to designate the chemical for further testing at that
time (Ref. 27).
c. Other flame retardants. The Brominated Phthalates Panel of the
American Chemistry Council submitted its test plan for bis(2-ethyl-1-
hexyl) tetrabromophthalate (CAS No. 26040-51-7]) to the EPA's HPV
Challenge Program on July 23, 2004 (http://www.epa.gov/hpv/pubs/summaries/phthacid/c15484.pdf). Partially as a result of this
submission, there are numerous data available for bis(2-ethyl-1-hexyl)
tetrabromophthalate (http://iaspub.epa.gov/oppthpv/quicksearch.display?pChem=102247). Toxicological data on 2-ethylhexyl-
2,3,4,5-tetrabromobenzoate (CAS No.183658-27-7) could not be located by
California's Office of Health Hazard Assessment (http://oehha.ca.gov/multimedia/biomon/pdf/120408flamedoc.pdf). Bis(2-ethly-1-hexyl)
tetrabromophthalate and 2-ethylhexyl-2,3,4,5-tetrabromobenzoate are
components of Firemaster[supreg]550, a flame-retardant substitute for
pentabromodiphenyl ether.
iv. Information needs. The CPSC needs biomonitoring data on the
identity and quantity of urinary metabolites for the 6 non-phthalate
plasticizers, 25 phosphate ester flame retardants and 2 other flame
retardants listed in Tables 2, 3A, 3B, and 4 of this unit.
Specifically, CPSC is seeking information that would help to estimate
human exposure to these compounds. First, CPSC needs studies on the
metabolism of these compounds in animals or humans, including the
identification of metabolites present in human urine, blood or other
fluids. For the citrates and phosphates, urinary metabolites may
include diesters; for adipate the metabolites may include the
monoester. Second, CPSC needs studies that measure the amount of
metabolite present in human urine or other media. Third, CPSC needs
quantitative studies of metabolism in animals or humans that would
allow one to estimate total exposure from metabolite levels.
Table 2--Non-Phthalate Plasticizers Being Added to the Priority Testing
List
------------------------------------------------------------------------
CAS No. Plasticizer
------------------------------------------------------------------------
77-90-7................................ 1,2,3-Propanetricarboxylic
acid, 2-(acetyloxy)-, tributyl
ester; Acetyl tri-n-butyl
citrate.
[[Page 30861]]
103-23-1............................... Hexanedioic acid, 1,6-bis(2-
ethylhexyl) ester; Di(2-
ethylhexyl) adipate.
6422-86-2.............................. 1,4-Benzenedicarboxylic acid,
1,4-bis(2-ethylhexyl) ester;
Di(2-ethylhexyl)
terephthalate.
6846-50-0.............................. Propanoic acid, 2-methyl-, 1,1'-
[2,2-dimethyl-1-(1-
methylethyl)-1,3- propanediyl]
ester; 2,2,4-Trimethyl-1,3-
pentanediol diisobutyrate.
166412-78-8............................ 1,2-Cyclohexanedicarboxylic
acid, 1,2-diisononyl ester.
474919-59-0............................ 1,2-Cyclohexanedicarboxylic
acid, 1,2-dinonyl ester,
branched and linear.
------------------------------------------------------------------------
Table 3A--Phosphate Ester Flame Retardants Being Added to the Priority
Testing List
------------------------------------------------------------------------
CAS No. Flame retardant
------------------------------------------------------------------------
78-40-0................................ Phosphoric acid, triethyl
ester; Triethyl phosphate.
78-51-3................................ Ethanol, (2-butoxy-), 1,1',1''-
phosphate; Tri(2-butoxyethyl)
phosphate.
115-86-6............................... Phosphoric acid, triphenyl
ester; Triphenyl phosphate.
115-96-8............................... Ethanol, 2-chloro-, phosphate
(3:1); Tris-(2-chloroethyl)
phosphate.
126-71-6............................... Phosphoric acid, tris(2-
methylpropyl) ester;
Triisobutyl phosphate.
126-73-8............................... Phosphoric acid tributyl ester;
Tributyl phosphate.
1241-94-7.............................. Phosphoric acid, 2-ethylhexyl
diphenyl ester; 2-Ethylhexyl
diphenyl phosphate.
1330-78-5.............................. Phosphoric acid,
tris(methylphenyl) ester;
Tricresyl phosphate, mixed
isomers.
5945-33-5.............................. Phosphoric acid, P,P'-[(1-
methylethylidene)di-4, 1-
phenylene] P,P,P 'P '-
tetraphenyl ester; Tetraphenyl
Bisphenol A diphosphate.
6145-73-9.............................. 1-Propanol, 2-chloro-, 1,1',1''-
phosphate; Tris(2-chloro-1-
propyl)phosphate.
13674-84-5............................. 2-Propanol, 1-chloro-, 2,2'2''-
phosphate; Tris(1-chloro-2-
propyl) phosphate.
13674-87-8............................. 2-Propanol, 1,3-dichloro-,
phosphate (3:1); Tris(1,3-
dichloro-2-propyl) phosphate.
25155-23-1............................. Phenol, dimethyl-, 1,1',1``-
phosphate; Trixylyl phosphate.
26444-49-5............................. Phosphoric acid, methylphenyl
diphenyl ester; Cresyl
diphenyl phosphate.
29761-21-5............................. Phosphoric acid, isodecyl
diphenyl ester; Isodecyl
diphenyl phosphate.
38051-10-4............................. Phosphoric acid, P,P'-[2,2-
bis(chloromethyl)-1,3-
propanediyl] P,P,P 'P '-
tetrakis(2-chloroethyl) ester;
2,2-Bis(chloromethyl)-1,3-
propanediyl tetrakis(2-
chloroethyl) phosphate.
56803-37-3............................. Phosphoric acid, (1,1-
dimethylethyl)phenyl diphenyl
ester; tert-Butylphenyl
diphenyl phosphate.
65652-41-7............................. Phosphoric acid, bis[(1,1-
dimethylethyl)phenyl] phenyl
ester; Bis (tert-butylphenyl)
phenyl phosphate.
68937-41-7............................. Phenol, isopropylated,
phosphate (3:1); Isopropylated
triphenyl phosphate.
68937-40-6............................. Phenol, isobutylenated,
phosphate (3:1); Isobutylated
phenol phosphate.
76025-08-6............................. Phosphoric acid, bis(2-chloro-1-
methylethyl) 2-chloropropyl
ester; Bis(1-chloro-2-
isopropyl) (2-chloropropyl)
phosphate.
76649-15-5............................. Phosphoric acid, 2-chloro-1-
methylethyl bis(2-
chloropropyl) ester; Bis(2-
chloropropyl) (l-chloro-2-
isopropyl) phosphate.
181028-79-5............................ Phosphoric trichloride,
reaction products with
bisphenol A and phenol;
Bisphenol A diphosphate.
220352-35-2............................ Phenol, tert-Bu derivs.,
phosphates (3:1); Butylated
triphenyl phosphate.
------------------------------------------------------------------------
Table 3B--The Phosphate Ester Flame Retardant, Tris(chloropropyl)
Phosphate (Mixture of Isomers), Being Added to the Priority Testing List
------------------------------------------------------------------------
Tris(Chloropropyl) phosphate
CAS No. isomers
------------------------------------------------------------------------
6145-73-9.............................. 1-Propanol, 2-chloro-, 1,1',1''-
phosphate.
13674-84-5............................. 2-Propanol, 1-chloro-, 2,2',2''-
phosphate.
76025-08-6............................. Phosphoric acid, bis(2-chloro-1-
methylethyl) 2-chloropropyl
ester.
76649-15-5............................. Phosphoric acid, 2-chloro-1-
methylethyl bis(2-
chloropropyl) ester.
------------------------------------------------------------------------
Table 4--Other Flame Retardants Being Added to the Priority Testing List
------------------------------------------------------------------------
CAS No. Flame retardant
------------------------------------------------------------------------
26040-51-7............................. 1,2-Benzenedicarboxylic acid,
3,4,5,6-tetrabromo-, 1,2-bis(2-
ethylhexyl) ester; Bis(2-ethly-
1-hexyl) tetrabromophthalate.
183658-27-7............................ Benzoic acid, 2,3,4,5-
tetrabromo-, 2-ethylhexyl
ester; 2-Ethylhexyl-2,3,4,5-
tetrabromobenzoate.
------------------------------------------------------------------------
[[Page 30862]]
3. Chemicals to which children living near hazardous waste sites
may be exposed--i. Recommendation. ATSDR requests that the ITC add nine
chemicals to which children living near hazardous waste sites may be
exposed to the Priority Testing List to obtain biomonitoring studies on
these chemicals.
ii. Rationale for recommendation. ATSDR is requesting nine
chemicals to which children living near hazardous waste sites may be
exposed be added to the Priority Testing List because children
constitute a particularly vulnerable population of individuals, who,
based upon their increased time outdoors and playtime behaviors, have a
potentially higher than normal exposure to these chemicals around
hazardous waste sites. For the chemicals in Table 5 of this unit, there
is insufficient information available concerning both background levels
and possible elevated exposure levels for children.
iii. Supporting information. ATSDR works closely with the Center
for Disease Control and Prevention's National Center for Environmental
Health (NCEH), (http://www.cdc.gov/nceh), in their biomonitoring
program known as the National Report on Human Exposure to Environmental
Chemicals (NHANES), (http://www.cdc.gov/nchs/nhanes.htm/). At least
three of the chemicals in Table 5 of this unit have been included in
past NHANES: 1,1-dichloroethane (CAS No. 75-34-3); 1,1,2,2-
tetrachloroethane (CAS No. 79-34-5); and 1,2-dichloroethane (CAS No.
107-06-2). In the NHANES 2003-2004 subsample: 1,1-dichloroethane (CAS
No.75-34-3); 1,1,2,2-tetrachloroethane (CAS No. 79-34-3); and 1,2-
dichloroethane (CAS No. 107-06-2) were detectable in less than a few
percent of the participants. In a non-representative sample of adults
in NHANES III (1988-1994), blood levels were also non-detectable or
detected in <10% of samples. ATSDR needs to know if children living
near hazardous waste sites have elevated blood levels of the chemicals
in Table 5 of this unit.
1,1-Dichloroethane was added to the Priority Testing List in the
32nd ITC Report because it was recommended for dermal absorption rate
testing (Ref. 5). 1,1-Dichloroethane was also added to the Priority
Testing List in the 55th ITC Report because it was a HPV chemical that
was not sponsored for testing (Ref. 30). 1,1-Dichloroethane was removed
from the Priority Testing List in the 56th ITC Report because it was no
longer a HPV chemical (Ref. 31). 1,1-Dichloroethane's toxicity includes
effects on the heart, such as irregular heartbeats, which prompted
discontinuing its use as a surgical anesthetic. It is also known to
cause kidney disease after long-term high exposure and has delayed
growth in offspring of experimental animals exposed to high
concentrations during pregnancy.
1,1,2,2-Tetrachloroethane has been observed to cause liver damage
in experimental animals exposed to lower doses for long periods.
Benzidine (CAS No. 92-87-5), determined by the Department of Health
and Human Services (HHS), World Health Organization (WHO) and EPA to be
a carcinogen, can increase the risk of urinary bladder cancer in long
term occupational exposures.
1,2-Dibromomethane (CAS No. 106-93-4) has been found to cause
reproductive effects in some male workers including sperm damage.
Experimental animal studies found birth defects in the young of animals
exposed while in utero.
Acrolein (CAS No. 107-02-8) was added to the Priority Testing List
in the 27th ITC Report as 1 of 89 aldehydes (Ref. 32). Acrolein was
recommended for ecological effects testing because there were
insufficient data to reasonably determine or predict the ecological
effects of aldehydes that were submitted to the EPA as new chemicals.
Acrolein was removed from the Priority Testing List in the 45th ITC
Report (Ref. 33). Acrolein was removed because it was added to the OECD
HPV Chemical Program (http://webnet.oecd.org/Hpv/UI/SIDS_Details.aspx?id=6E4A94A8-0068-4088-8CF7-C193F61012D0). Acrolein is a
component of tobacco smoke and animal studies have found that inhaling
it causes irritation to the nasal cavity and damage to the lining of
lungs. Oral exposure through drinking water can cause stomach
irritations, ulcers, and bleeding.
1,2-Dichloroethane (a.k.a. ethylene dichloride) was added to the
Priority Testing List in the 35th ITC Report because it was recommended
for dermal absorption rate testing (Ref. 34). 1,2-Dichloroethane was
removed from the Priority Testing List in the 45th ITC Report (Ref.
33). 1,2-Dichloroethane was removed from the Priority Testing List
because EPA published a June 9, 1999 NPRM for dermal absorption rate
testing (Ref. 35). 1,2-Dichloroethane has been found to cause nervous
system disorders, liver, and kidney disease and lung effects in humans
ingesting or inhaling large amounts. It has also been found to cause
kidney disease in experimental animals that ingested low doses.
Phenol (CAS No. 108-95-2) was added to the Priority Testing List in
the 27th ITC Report because of its very high production volume,
potential for release, and presence in commercial and consumer products
(Ref. 32). Phenol was removed from the Priority Testing List because
EPA proposed the testing designated by the ITC in a test rule that was
published on November 22, 1993 (Ref. 36). Phenol, which is used as an
antiseptic at low doses, can cause lung irritation, headaches and
burnings eyes if inhaled at high doses. Repeated exposures can induce
muscle tremors and loss of coordination, and high exposures in air for
several weeks can cause paralysis, severe injury to the heart, liver,
kidneys, and lungs.
Cresols (CAS No. 1319-77-3) were added to the Priority Testing List
in the 1st ITC Report because their wide use as industrial solvents
caused concerns for substantial occupational exposures (Ref. 37).
Cresols were removed from the Priority Testing List in the 13th ITC
Report (Ref. 7). Cresols were removed from the Priority Testing List
because EPA proposed the testing designated by the ITC in a test rule
that was published on July 11, 1983 (Ref. 38). Cresols were again added
to the Priority Testing List in the 61st ITC Report to obtain dermal
sensitization data (Ref. 39). Cresols were removed from the Priority
Testing List in the 62nd ITC Report because the Cresols Panel of the
American Chemistry Council submitted studies that met the ITC's data
needs (Ref. 40). Cresols at high levels for even short exposures can
cause irritation of the eyes, nose, and throat. Skin contact with high
levels can burn the skin and can damage the kidneys, liver, blood,
lungs, and brain. Experimental animal studies found lesions in the nose
and thyroid gland via food exposure.
Exposure to large amounts of aluminum (CAS No. 7429-90-5) dust can
cause lung problems and decreased performance in some tests that
measure functions of the nervous system. Also, some people with kidney
disease can store a lot of aluminum in their bodies and sometimes
develop bone or brain diseases which may be caused by the excess
aluminum.
iv. Information needs. For the chemicals listed in Table 5 of this
unit, ATSDR needs blood levels in children not living near hazardous
waste sites and in children living near hazardous waste sites. ATSDR
needs these data to determine if the children living near hazardous
waste sites have elevated levels of these chemicals and may be more
susceptible to their toxic effects.
[[Page 30863]]
Table 5--Chemicals to Which Children Living Near Hazardous Waste Sites May Be Exposed
----------------------------------------------------------------------------------------------------------------
CAS No. Chemical
----------------------------------------------------------------------------------------------------------------
75-34-3.......................... Ethane, 1,1-dichloro-; 1,1-Dichloroethane.
79-34-5.......................... Ethane, 1,1,2,2-tetrachloro-; 1,1,2,2-Tetrachloroethane.
92-87-5.......................... [1,1'-Biphenyl]-4,4'diamine; Benzidine.
106-93-4......................... Ethane, 1,2-dibromo-; 1,2-Dibromoethane.
107-02-8......................... 2-Propenal; Acrolein.
107-06-2......................... Ethane, 1,2-dichloro-; 1,2-Dichloroethane.
108-95-2......................... Phenol.
1319-77-3........................ Phenol, methyl-; Cresol.
7429-90-5........................ Aluminum.
----------------------------------------------------------------------------------------------------------------
4. Diisocyanates and related compounds--i. Recommendation. The EPA
requests that the ITC add the category of 69 diisocyanates and related
compounds to the Priority Testing List to obtain use, fate, and
exposure studies on uncured (unreacted) diisocyanates and their related
compounds that are used in the manufacture of, and present in,
products.
ii. Rationale for recommendation. EPA is concerned about
diisocyanates and related compounds in the manufacture and use of
products that may result in exposures to consumers, children, and the
general population. Diisocyanates are well known dermal and inhalation
sensitizers in the workplace and have been documented to cause asthma,
lung damage, and in severe cases, fatal reactions. EPA is especially
concerned about the potential health effects that may result from
exposures to the consumer or self-employed worker while using products
containing uncured diisocyanates (e.g., spray applied foam insulation
(rigid foam), sealants, adhesives, paints, floor finishes, and
coatings) and incidental exposures to the children and the general
population while such products are used in or around buildings
including homes or schools (for example on floors and athletic tracks)
before the product has fully reacted and cured.
In April 2011, EPA published Action Plans for toluene diisocyanate
(TDI) and 5 related compounds (http://www.epa.gov/oppt/existingchemicals/pubs/actionplans/tdi.pdf) and methylene diphenyl
diisocyanate (MDI) and 7 related compounds (http://www.epa.gov/oppt/existingchemicals/pubs/actionplans/mdi.pdf). These Action Plans outline
EPA's screening-level review of available hazard and exposure
information on uncured (unreacted) MDI, TDI, and 12 additional related
compounds. However, after further review, EPA recognizes that aspects
of an exposure scenario to consumers are generally applicable to many
diisocyanate compounds. Therefore, in addition to the 14 diisocyanates
and related compounds listed in the Action Plans, EPA identified 29
aromatic and 26 aliphatic diisocyanate compounds, such as hexamethylene
diisocyanate (HDI). These 29 aromatic and 26 aliphatic diisocyanate
compounds are used in sealants, coatings, spray foams, elastomers or
adhesives and may be substituted in such products for the 14
diisocyanates and related compounds listed in the Action Plans. The ITC
is adding the 14 diisocyanates and related compounds listed in the
Action Plans and the 29 aromatic and 26 aliphatic diisocyanate
compounds to the Priority Testing List to provide a more comprehensive
approach to assessing hazard and exposure information for diisocyanates
and related compounds. The 14 diisocyanates and related compounds
listed in the Action Plans and the 29 aromatic and 26 aliphatic
diisocyanate compounds are identified in Table 6 of this unit.
ITC is recommending that the 69 diisocyanates and related compounds
be added to the TSCA section 8(d) HaSDR rule to facilitate EPA's
ability to obtain existing studies. Studies obtained on these chemicals
may provide updated information from prior requests and assist EPA in
taking appropriate action(s) to protect consumers, commercial workers,
and other affected citizens from exposure to uncured diisocyanate-
containing products during their use. In addition, any updated
information may assist EPA in taking appropriate action(s) to protect
bystanders and building occupants, including children from inadvertent
exposure to diisocyanates and related compounds that might be released
during and after application of diisocyanate-containing products.
The ITC recommended priority consideration of isocyanates as part
of the 26th ITC Report (Ref. 16). EPA subsequently issued a TSCA
section 8(d) HaSDR rule for these chemicals on September 28, 1990 (Ref.
17). Given the time elapsed since that reporting rule was issued, the
changes in the industry, and the increased use of diisocyanate-
containing products, EPA believes issuing another rule that would
require reporting of unpublished health and safety studies that were
not previously submitted is appropriate.
iii. Supporting information--a. Health. Most of the data on human
health hazards resulting from diisocyanate exposures are based on
occupational populations. These data indicate that exposure to
diisocyanates can cause contact dermatitis, skin and respiratory tract
irritation, immune sensitization, and asthma (Ref. 41). It is well
documented that isocyanate exposure is an attributable cause of work-
related asthma, and prevalence in the exposed workforce is estimated at
1-20% (Refs. 42 and 43).
Occupational skin exposures in workers exposed to MDI are of
concern because isocyanate sensitization and/or asthma has occurred in
cases where the potential for skin exposure is substantial, but
measured airborne MDI monomer levels are below occupational exposure
levels (OELs) or below the limits of detection with the methods used,
or where similar MDI levels would be expected but MDI air monitoring
data are not available (Refs. 44-48).
The minimum exposure to isocyanates that can elicit sensitization
responses or asthma is not known. In addition, immune response and
subsequent disease in humans can be quite variable (Ref. 49).
Fatalities linked to occupational diisocyanate exposures in sensitized
persons have been reported (Refs. 50 and 51).
Cross-sensitization has been observed between MDI, TDI, HDI, and
dicyclohexylmethane diisocyanate (HMDI) in mice, and between MDI, TDI,
and HDI in humans (Ref. 52).
Animal data indicate that MDI may be carcinogenic; however, a
consistent association has not been reported in epidemiologic studies
(Refs. 53 and 54). Animal data indicate that TDI may be carcinogenic
(Ref. 55). HDI was negative
[[Page 30864]]
for carcinogenicity in a 2-year bioassay in rats (Ref. 56).
b. Exposure. In contrast to the large amount of exposure data
available for professional workers who work with diisocyanates, EPA is
hoping to obtain additional exposure data characterizing the use and
exposure scenarios of consumer and commercial products containing
uncured diisocyanates. In addition, comparing concentrations to which
the consumer and general population is or can be exposed with existing
workplace exposure limits to determine overexposure is not appropriate
because the OSHA permissible exposure limits (PELs) are not intended to
protect consumers and the general population (Ref. 49).
Until polyurethane products fully cure, there may be the potential
for inhalation and dermal exposure. These exposures may result from
direct use of products or from bystander exposure. The use of spray
polyurethane foam insulation (rigid foam) products has resulted in
personal and area air samples of MDI above the OSHA PEL (Refs. 57-60).
Potential bystander exposures to TDI products have been found in the
literature, including emissions of TDI from concrete patio sealants
(Refs. 61 and 62). Levels of moisture curing polyurethanes, including
TDI were found in air hallway samples of an apartment building when the
moisture curing polyurethanes were being used (Ref. 63). There were
emissions during emergency response of an overturned truck carrying TDI
(Ref. 64), and para-occupational exposure for secretaries and janitors
who worked in the vicinity of but not directly with TDI (Ref. 65).
Unbound aliphatic isocyanates used in coatings may remain on the
surface of curing coating products, like paint, for up to several weeks
(Ref. 47). In addition, there is potential for significant exposures to
aliphatic isocyanates for direct users and bystanders in the auto
refinishing and auto repair industry (Ref. 66).
Children exposed to the same airborne concentrations of MDI as
adults may receive a larger dose because children take more breaths per
minute and have a higher relative tidal volume. An accidental acute
exposure of children to high levels of MDI in a polyurethane sealant
used on a school athletic track was associated with asthma-like
symptoms, including among children with no prior history of respiratory
dysfunction (Ref. 67). Children with asthma are an especially
vulnerable population for exposure; they are more susceptible to
inflammatory narrowing of the airways, which results in a
proportionally greater obstruction of their smaller respiratory system
(Refs. 68 and 69).
Additional data characterizing the concentration of diisocyanates
and related compounds in the air during and after use of products that
may result in dermal, eye, or inhalation exposures to uncured
diisocyanates will be helpful to the Agency. It would be helpful to
receive additional information on the extent factors such as
application techniques, product composition, ambient conditions, and
method of measurement that influence the availability of uncured
diisocyanates. EPA is also aware that there is uncertainty about the
curing time of various products under different situations and that
additional data could help address certain concerns, such as re-entry
time, which are important for improving communication to prevent
exposure.
c. Ecotoxicity. Although there is a moderate acute ecotoxicity
profile for MDI and TDI, the hazards associated with exposures to these
chemicals have centered on human health effects not ecological effects.
Experimental ecotoxicological data for MDI and TDI and their
degradation products indicate moderate to low toxicity to aquatic
organisms (Refs. 57 and 70-73). Other toxicity data suggest low
likelihood of effects to terrestrial biota such as plants and
earthworms (Refs. 74 and 75).
iv. Information needs. Information is needed on diisocyanates and
related compounds used to formulate a broad class of polyurethane
products (e.g., sealants, adhesives, etc.) that are intended to further
react upon end-use. Information is also needed on the percent of
diisocyanates remaining, if any, in the final products, and/or studies
that assess exposure to uncured (unreacted) diisocyanates. Studies are
needed that provide information on the inhalation, dermal, and eye
exposure potential and/or exposure levels for various populations;
e.g., workers, consumers, bystanders, and building occupants, including
children (through characterizing concentrations of diisocyanates in
indoor air, outdoor air, blood, or urine) during and after use of
products containing uncured diisocyanates. Studies are also needed on
induction of sensitization, asthma development, other lung or health
effects (irritation to the mucous membranes of the eyes and
gastrointestinal and respiratory tracts, chest tightness, cough, nasal
congestion, death), biomarkers of recent and long-term exposure to
diisocyanates, and the contributory nature of skin exposure to the
development of diisocyanate asthma.
Also needed are dermal exposure assessments in terms of dermal
exposure potential and extent of exposure to diisocyanates during
diisocyanate-containing product use in occupational as well as non-
occupational (e.g., consumer use) settings. Although some techniques
and methods have been developed to measure human skin exposure to
diisocyanates, these techniques and methods have several limitations.
Consequently studies that provide improved qualitative and quantitative
methods for detecting and quantifying skin exposures to diisocyanates
and any associated data on measured exposures are required. Studies
investigating associations between dermal exposure to diisocyanates and
individual differences in metabolism with biomarkers of exposure would
also provide useful information for exposure assessment. Additionally,
studies are needed that characterize uncured diisocyanate levels within
products over time. Background conditions and information on frequency
and duration (use patterns) to diisocyanates are also needed.
EPA is also interested in obtaining studies that contain
information on sampling and analytical methods under development for
dermal exposures; methods for assessing exposure to total reactive
diisocyanates; methods and techniques to determine potential dermal
exposure and uptake of diisocyanates through the skin; biological
monitoring methods for estimating exposure to diisocyanates through all
routes of exposure; and efficacy of currently used personal protective
equipment in protecting workers and other populations during product
use.
Specifically, EPA is interested in health and safety studies
evaluating professional-, commercial-, and consumer-use products
containing uncured diisocyanates with special emphasis on the following
types of studies:
a. Inhalation monitoring studies characterizing potential worker
and consumer exposures including associated airborne levels of total
reactive diisocyanates and other chemicals.
b. Inhalation monitoring studies characterizing incidental
exposures of bystanders and building occupants including associated
airborne levels of total reactive diisocyanates and other chemicals.
c. Industrial hygiene or epidemiological assessments of dermal
[[Page 30865]]
exposure to uncured diisocyanate-containing products in occupational
settings as well as for consumers, including impact of curing time on
such exposures.
d. Studies focusing on the contributory nature of skin exposure to
the development of diisocyanate asthma in workers, consumers, and the
general population, including modification of skin uptake of
polyisocyanates by co-exposure to solvents and other agents or by skin
cuts/abrasions.
e. Epidemiological studies that address induction of sensitization
and asthma development and other observed health effects in exposed
populations including exposure-response relationships. Also of interest
is a discussion of factors that impact these processes, physiological
or otherwise.
f. Studies on advances in biomonitoring for sensitive biological
markers of recent and long-term exposure to diisocyanates including
studies that associate dermal exposure and individual differences in
metabolism with biomarkers.
g. Studies on recent developments and refinements in specific
qualitative and quantitative techniques and methods for dermal exposure
assessment including and beyond those currently available (e.g., pads,
wipes, and tape stripping methods).
h. Studies that have used emission testing protocols (environmental
chambers) for sample testing that provide levels of uncured
diisocyanates over time and associated curing rates in accordance with
specific humidity and temperature levels and ventilation rates and/or
building re-occupancy guidance after installation or use of products.
i. Studies that provide information on new or under development
sampling and analytical methods for total reactive diisocyanates in
diverse media (vapor, aerosol, dust, hard surfaces) including studies
that provide details of industry methods.
j. Studies with information on testing protocols currently in use
or in development for air monitoring, products testing, biomonitoring,
or dermal exposure.
k. Field studies that report on ventilation rates in existing and
new buildings and their relationship to detected airborne levels of
chemicals.
l. Efficacy assessments of engineering control strategies such as
dilution ventilation, local exhaust ventilation, and containment in
reducing worker exposure as well as bystander/occupant exposure.
m. Efficacy assessments of personal protective equipment (PPE) used
for exposure reduction, e.g., respirators, chemical protective suits,
gloves, aprons, overalls used by workers, and for specific types of PPE
that could be used by consumers or bystanders.
EPA needs the information described in Unit IV.A.4. iv.a. through
m. on the diisocyanates and related compounds, which are listed in
Table 6 of this unit.
Table 6--Diisocyanates and Related Compounds
------------------------------------------------------------------------
CAS No. Chemical name Action
------------------------------------------------------------------------
91-08-7.................... Benzene, 1,3- A, B
diisocyanato-2-
methyl-.
91-97-4.................... 1,1'-Biphenyl, 4,4'- A, C
diisocyanato-3,3'-
dimethyl-.
101-68-8................... Benzene, 1,1'- A, D
methylenebis[4-
isocyanato-.
104-49-4................... Benzene, 1,4- A, C
diisocyanato-.
123-61-5................... Benzene, 1,3- A, C
diisocyanato-.
139-25-3................... Benzene, 1,1'- C
methylenebis[4-
isocyanato-3-methyl-.
584-84-9................... Benzene, 2,4- A, B
diisocyanato-1-
methyl-.
822-06-0................... Hexane, 1,6- A, E
diisocyanato-.
2422-91-5.................. Benzene, 1,1',1''- A, C
methylidynetris[4-
isocyanato-.
2536-05-2.................. Benzene, 1,1'- D
methylenebis[2-
isocyanato-.
2778-42-9.................. Benzene, 1,3-bis(1- C
isocyanato-1-
methylethyl)-.
3173-72-6.................. Naphthalene, 1,5- C
diisocyanato-.
3634-83-1.................. Benzene, 1,3- C
bis(isocyanatomethyl
)-.
3779-63-3.................. 1,3,5-Triazine- E
2,4,6(1H,3H,5H)-
trione, 1,3,5-tris(6-
isocyanatohexyl)-.
4035-89-6.................. Imidodicarbonic A, E
diamide, N,N',2-
tris(6-
isocyanatohexyl)-.
4098-71-9.................. Cyclohexane, 5- A, E
isocyanato-1-
(isocyanatomethyl)-
1,3,3-trimethyl-.
4128-73-8.................. Benzene, 1,1'- C
oxybis[4-isocyanato-.
5124-30-1.................. Cyclohexane, 1,1'- A, E
methylenebis[4-
isocyanato-.
5873-54-1.................. Benzene, 1-isocyanato- A, D
2-[(4-
isocyanatophenyl)met
hyl]-.
7517-76-2.................. Cyclohexane, 1,4- E
diisocyanato-, trans-
.
9016-87-9.................. Isocyanic acid, D
polymethylenepolyphe
nylene ester.
9017-01-0.................. Benzene, 1,3- B
diisocyanatomethyl-,
homopolymer; TDI
homopolymer.
9019-85-6.................. Benzene, 1,3- C
diisocyanatomethyl-,
trimer.
10347-54-3................. Cyclohexane, 1,4- E
bis(isocyanatomethyl
)-.
13622-90-7................. Cyclohexane, 1,1'- E
methylenebis[4-
isocyanato-,
(trans,trans)-.
15646-96-5................. Hexane, 1,6- A, E
diisocyanato-2,4,4-
trimethyl-.
16325-38-5................. Benzene, 1,2,4,5- C
tetrachloro-3,6-
bis(isocyanatomethyl
)-.
16938-22-0................. Hexane, 1,6- A, E
diisocyanato-2,2,4-
trimethyl-.
17589-24-1................. 1,3-Diazetidine-2,4- D
dione, 1,3-bis[4-[(4-
isocyanatophenyl)met
hyl]phenyl]-.
23370-68-5................. 1,3-Diazetidine-2,4- E
dione, 1,3-bis[(5-
isocyanato-1,3,3-
trimethylcyclohexyl)
methyl]-.
25686-28-6................. Benzene, 1,1'- D
methylenebis[4-
isocyanato-,
homopolymer; MDI
homopolymer.
25854-16-4................. Benzene, A, C
bis(isocyanatomethyl
)-.
26447-40-5................. Benzene, 1,1'- A, D
methylenebis[isocyan
ato-.
26471-62-5................. Benzene, 1,3- A, B
diisocyanatomethyl-.
26603-40-7................. 1,3,5-Triazine- A, B
2,4,6(1H,3H,5H)-
trione, 1,3,5-tris(3-
isocyanatomethylphen
yl)-.
26747-90-0................. 1,3-Diazetidine-2,4- A, B
dione, 1,3-bis(3-
isocyanatomethylphen
yl)-.
28182-81-2................. Hexane, 1,6- E
diisocyanato-,
homopolymer;
hexamethylene
diisocyanate (HDI)
homopolymer.
31107-36-5................. 1,3-Diazetidin-2-one, D
1,3-bis[4-[(4-
isocyanatophenyl)met
hyl]phenyl]-4-[[4-
[(4-
isocyanatophenyl)
methyl]phenyl]imino]-
.
38661-72-2................. Cyclohexane, 1,3- E
bis(isocyanatomethyl
)-.
42170-25-2................. Cyclohexane, E
bis(isocyanatomethyl
)-.
50639-37-7................. 2H-1,3,5-Oxadiazine- E
2,4,6(3H,5H)-trione,
3,5-bis(6-
isocyanatohexyl)-.
[[Page 30866]]
50830-59-6................. 1,3,4-Thiadiazole, 2- C
isocyanato-5-
(trifluoromethyl)-,
dimer.
51508-06-6................. 1,3,4-Thiadiazole, 2- C
(1,1-dimethylethyl)-
5-isocyanato-, dimer.
53880-05-0................. Cyclohexane, 5- E
isocyanato-1-
(isocyanatomethyl)-
1,3,3-trimethyl-,
homopolymer;
Isophorone
diisocyanate
homopolymer.
55525-54-7................. Urea, N,N'-bis[(5- E
isocyanato-1,3,3-
trimethylcyclohexyl)
methyl]-.
60732-52-7................. Carbamic acid, N,N '- C
(3-
isocyanatomethylphen
yl)-, C,C'-(oxydi-
2,1-ethanediyl)
ester.
65087-21-0................. Carbamic acid, N-[4- E
[(4-
isocyanatocyclohexyl
)methyl]cyclohexyl]-
, C,C'-(oxydi-2,1-
ethanediyl) ester.
65104-99-6................. Imidodicarbonic C
diamide, 2,2'-
[methylenebis(2-
chloro-4,1-
phenylene)]bis[N,N '-
bis(3-isocyanato-
methylphenyl)-.
65105-00-2................. Carbamic acid, N-(3- C
isocyanatomethylphen
yl)-, C,C'-(1-methyl-
1,3-propanediyl)
ester.
65105-02-4................. Carbamic acid, N-(3- C
isocyanatomethylphen
yl)-, C,C'-(1,4-
butanediyl) ester.
67873-91-0................. 1,3,5-Triazine- E
2,4,6(1H,3H,5H)-
trione, 1,3,5-
tris[(5-isocyanato-
1,3,3-
trimethylcyclohexyl)
methyl]-.
68083-39-6................. Benzenamine, N,N'- C
methanetetraylbis[3-
isocyanato-2,4,6-
tris(1-methylethyl)-.
68092-73-9................. Carbamic acid, N-(3- C
isocyanatomethylphen
yl)-, C,C'-(1,2-
ethanediyl) ester.
68092-74-0................. Carbamic acid, N-(3- C
isocyanatomethylphen
yl)-, C,C'-[oxybis(1-
methyl-2,1-
ethanediyl)] ester.
68133-14-2................. Carbamic acid, N-(3- C
isocyanatomethylphen
yl)-, C,C'-
[[[(diethoxyphosphin
yl) methyl]imino]di-
2,1-ethanediyl]
ester.
68239-06-5................. Cyclohexane, 2-heptyl- A, E
3,4-bis(9-
isocyanatononyl)-1-
pentyl-.
68310-46-3................. Hexanoic acid, [[2- E
ethyl-2-[[[[[5-
isocyanato-1(or 5)-
(methoxycarbonyl)pen
tyl]
amino]carbonyl]oxy]
methyl]-1,3-
propanediyl]bis(oxyc
arbonylimino)]bis[is
ocyanato-, 1,1'-
dimethyl ester.
68366-14-3................. Carbamic acid, N-[5- C
isocyanato-2(or 4)-
methylphenyl]-, C,C'-
(1-methyl-1,3-
propanediyl) ester.
68555-56-6................. 1,3-Diazetidine-2,4- C
dione, 1,3-bis(4-
isocyanato-3-
methylphenyl)-.
68975-84-8................. Carbamic acid, N-[(5- E
isocyanato-1,3,3-
trimethylcyclohexyl)
methyl]-, C,C'-
(oxydi-2,1-
ethanediyl) ester.
69878-18-8................. Hexanoic acid, 2,6- E
diisocyanato-, 2-
isocyanatoethyl
ester.
70024-76-9................. Hexatriacontane, E
diisocyanato-,
branched.
70198-24-2................. Undecane, 1,6,11- E
triisocyanato-.
71130-76-2................. Urea, N-(3- C
isocyanatomethylphen
yl)-N'-[[[4-[[[(3-
isocyanatomethylphen
yl)
amino]carbonyl]amino
]
phenyl]methyl]phenyl
]-.
71832-70-7................. Carbamic acid, N-[4- C
[(4-
isocyanatophenyl)met
hyl]phenyl]-, C,C'-
(oxydi-2,1-
ethanediyl) ester.
75790-84-0................. Benzene, 2-isocyanato- C
4-[(4-
isocyanatophenyl)met
hyl]-1-methyl-.
75790-87-3................. Benzene, 1-isocyanato- C
2-[(4-
isocyanatophenyl)thi
o]-.
85702-90-5................. 2,9,11,13- E
Tetraazanonadecaneth
ioic acid, 19-
isocyanato-11-(6-
isocyanatohexyl)-
10,12-dioxo-, S-[3-
(trimethoxysilyl)pro
pyl] ester.
106790-31-2................ Benzenamine, 4- C
isocyanato-N,N-bis(4-
isocyanatophenyl)-
2,5-dimethoxy-.
------------------------------------------------------------------------
Notes: A--Previously added to the ITC's Priority Testing List in the
26th ITC Report (Ref. 16).
B--In the Toluene Diisocyanate (TDI) Action Plan (http://www.epa.gov/oppt/existingchemicals/pubs/actionplans/tdi.pdf).
C--One of the 29 aromatic diisocyanate compounds.
D--In the Methylene Diphenyl Diisocyanate (MDI) Action Plan (http://www.epa.gov/oppt/existingchemicals/pubs/actionplans/mdi.pdf).
E--One of the 26 aliphatic diisocyanate compounds.
B. Chemicals Removed From the Priority Testing List
1. Cadmium compounds. As a result of EPA's expanding the cadmium
compounds category to include any chemical that contains cadmium as
part of that chemical's structure, the ITC is removing 103 cadmium
compounds, but not cadmium from the Priority Testing List. The 103
cadmium compounds were listed in the 68th ITC Report (Ref. 2).
2. HPV Challenge Program orphan chemicals. Two hundred seventy HPV
Challenge Program orphan chemicals were added to the Priority Testing
List in the 55th ITC Report (Ref. 30) and 5 were added to the Priority
Testing List in the 56th ITC Report (Ref. 31).
Thirty HPV Challenge Program orphan chemicals were removed from the
Priority Testing List in the 56th ITC Report (Ref. 31). Eight HPV
Challenge Program orphan chemicals were removed from the Priority
Testing List in the 58th ITC Report (Ref. 76). Thirty-five HPV
Challenge Program orphan chemicals were removed from the Priority
Testing List in the 61st ITC Report (Ref. 39). One HPV Challenge
Program orphan chemical was removed from the Priority Testing List in
the 63rd ITC Report (Ref. 77). Twenty-nine HPV Challenge Program orphan
chemicals were removed from the Priority Testing List in the 68th ITC
Report (Ref. 2).
Fourteen HPV Challenge Program orphan chemicals are being removed
from the Priority Testing List because they were included in the EPA's
October 21, 2011 TSCA section 4 proposed test rule (Ref. 3). These 14
HPV Challenge Program orphan chemicals are listed in Table 7 of this
unit.
Table 7--Fourteen HPV Challenge Program Orphan Chemicals Being Removed From the Priority Testing List
--------------------------------------------------------------------------------------------------------------------------------------------------------
CAS No. Chemical name
--------------------------------------------------------------------------------------------------------------------------------------------------------
98-16-8...................... Benzenamine, 3-(trifluoromethyl)-.
124-63-0..................... Methanesulfonyl chloride.
460-00-4..................... Benzene, 1-bromo-4-fluoro-.
542-92-7..................... 1,3-Cyclopentadiene.
928-72-3..................... Glycine, N-(carboxymethyl)-, disodium salt.
28106-30-1................... Benzene, ethenylethyl-.
35203-06-6................... Benzenamine, 2-ethyl-6-methyl-N-methylene-.
[[Page 30867]]
35203-08-8................... Benzenamine, 2,6-diethyl-N-methylene-.
37734-45-5................... Carbonochloridothioic acid, S-(phenylmethyl) ester.
37764-25-3................... Acetamide, 2,2-dichloro-N,N-di-2-propenyl-.
65996-91-0................... Distillates (coal tar), upper.
68153-60-6................... Fatty acids, tall-oil, reaction products with diethylenetriamine, acetates.
68442-77-3................... 2-Butenediamide, (2E)-, N1,N4-bis[2-(4,5-dihydro-2-nortall-oil alkyl-1H-imidazol-1-yl)ethyl] derivs.
68909-77-3................... Ethanol, 2,2'-oxybis-, reaction products with ammonia, morpholine derivs. Residues.
--------------------------------------------------------------------------------------------------------------------------------------------------------
V. References
1. ITC. Fifty-Second Report of the ITC; Notice. Federal Register (68
FR 43608, July 23, 2003) (FRL-7314-4). Available online at: http://www.regulations.gov. Docket ID number: EPA-HQ-OPPT-2011-1020.
2. ITC. Sixty-Eighth Report of the ITC; Notice. Federal Register (76
FR 46174, August 1, 2011) (FRL-8879-3). Available online at: http://www.regulations.gov. Docket ID number: EPA-HQ-OPPT-2011-1020.
3. EPA. Certain High Production Volume Chemicals; Test Rule and
Significant New Use Rule; Fourth Group of Chemicals; Proposed rule.
Federal Register (76 FR 65580, October 21, 2011) (FRL-8876-6).
Available online at: http://www.regulations.gov. Docket ID number:
EPA-HQ-OPPT-2011-1020.
4. ITC. Twenty-Eighth Report of the ITC; Notice. Federal Register
(56 FR 41212, August 19, 1991) (FRL-3937-4). Available online at:
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5. ITC. Thirty-Second Report of the ITC; Notice. Federal Register
(58 FR 38490, July 16, 1993) (FRL-4630-2). (Available online at:
http://www.regulations.gov. ID number: EPA-HQ-OPPT-2011-1020.
6. ITC. Eleventh Report of the ITC; Notice. Federal Register (47 FR
54626, December 3, 1982) (FRL-2254-7). Available online at: http://www.regulations.gov. Docket ID number: EPA-HQ-OPPT-2011-1020.
7. ITC. Thirteenth Report of the ITC; Notice. Federal Register (48
FR 55674, December 14, 1983) (FRL-2484-7). Available online at:
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Testing Committee; Notice. Federal Register (48 FR 51845, November
14, 1983) (FRL-2450-3). Available online at: http://www.regulations.gov. Docket ID number: EPA-HQ-OPPT-2011-1020.
9. Dreyfus, M. A. and Babich, M. A. Plasticizer migration from toys
and child care articles. The Toxicologist, Vol. 20, abstract 1243,
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FR 18368, May 19, 1986) (FRL-3017-2). Available online at: http://www.regulations.gov. Docket ID number: EPA-HQ-OPPT-2011-1020.
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rule. Federal Register (51 FR 18323, May 19, 1986) (FRL-3017-3).
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FR 41417, November 14, 1986) (FRL-3109-7). Available online at:
http://www.regulations.gov. Docket ID number: EPA-HQ-OPPT-2011-1020.
13. ITC. Twenty-second Report of the ITC; Notice. Federal Register
(53 FR 18196, May 20, 1988) (FRL-3381-7). Available online at:
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(55 FR 23050, June 5, 1990) (FRL-3765-4). Available online at:
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(59 FR 3764, January 26, 1994) (FRL-4750-9). Available online at:
http://www.regulations.gov. Docket ID number: EPA-HQ-OPPT-2011-1020.
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FR 26992, June 22, 1982) (FRL-2039-7). Available online at: http://www.regulations.gov. Docket ID number: EPA-HQ-OPPT-2011-1020.
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(47 FR 38780, September 2, 1982) (FRL-2112-2). Available online at:
http://www.regulations.gov. Docket ID number: EPA-HQ-OPPT-2011-1020.
22. ITC. Fourteenth Report of the ITC; Notice. Federal Register (49
FR 22389, May 29, 1984) (FRL-2594-4). Available online at: http://www.regulations.gov. Docket ID number: EPA-HQ-OPPT-2011-1020.
23. EPA. Aryl Phosphates; Response to the Interagency Testing
Committee; Advanced Notice of Proposed Rulemaking. Federal Register
(48 FR 57452, December 29, 1983) (FRL-2458-1). Available online at:
http://www.regulations.gov. Docket ID number: EPA-HQ-OPPT-2011-1020.
24. EPA. Aryl Phosphate Base Stocks; Proposed Test Rule Including
Reporting and Recordkeeping Requirements. Federal Register (57 FR
2138, January 17, 1992) (FRL-3883-4). Available online at: http://www.regulations.gov. Docket ID number: EPA-HQ-OPPT-2011-1020.
25. ITC. Twenty-Third Report of the ITC; Notice. Federal Register
(53 FR 46262, November 16, 1988) (FRL-3476-6). Available online at:
http://www.regulations.gov. Docket ID number: EPA-HQ-OPPT-2011-1020.
26. EPA. Preliminary Assessment Information and Health and Safety
Data Reporting; Addition of Chemicals; Final rule. Federal Register
(53 FR 46279, November 16, 1988) (FRL-3476-3). Available online at:
http://www.regulations.gov. Docket ID number: EPA-HQ-OPPT-2011-1020.
27. ITC. Thirty-Sixth Report of the ITC; Notice. Federal Register
(60 FR 42982, August 17, 1995) (FRL-4965-6). Available online at:
http://www.regulations.gov. Docket ID number: EPA-HQ-OPPT-2011-1020.
28. ITC. Thirtieth Report of the ITC; Notice. Federal Register (57
FR 30608, July 9, 1992) (FRL-4071-4). Available online at: http://www.regulations.gov. Docket ID number: EPA-HQ-OPPT-2011-1020.
29. EPA. Preliminary Assessment Information and Health and Safety
Data Reporting; Addition of Chemicals; Final rule. Federal Register
(58 FR 28511, May
[[Page 30868]]
14, 1993) (FRL-4182-1). Available online at: http://www.regulations.gov. Docket ID number: EPA-HQ-OPPT-2011-1020.
30. ITC. Fifty-Fifth Report of the ITC; Notice. Federal Register (70
FR 7364, February 11, 2005) (FRL-7692-1). Available online at:
http://www.regulations.gov. Docket ID number: EPA-HQ-OPPT-2011-1020.
31. ITC. Fifty-Sixth Report of the ITC; Notice. Federal Register (70
FR 61520, October 24, 2005) (FRL-7739-9). Available online at:
http://www.regulations.gov. Docket ID number: EPA-HQ-OPPT-2011-1020.
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(56 FR 9534, March 6, 1991) (FRL-3845-3). Available online at:
http://www.regulations.gov. Docket ID number: EPA-HQ-OPPT-2011-1020.
33. ITC. Forty-Fifth Report of the ITC; Notice. Federal Register (65
FR 75544, December 1, 2000) (FRL-6399-5). Available online at:
http://www.regulations.gov. Docket ID number: EPA-HQ-OPPT-2011-1020.
34. ITC. Thirty-Fifth Report of the ITC; Notice. Federal Register
(59 FR 67596, December 29, 1994) (FRL-4923-2). Available online at:
http://www.regulations.gov. Docket ID number: EPA-HQ-OPPT-2011-1020.
35. EPA. Proposed Test Rule for In Vitro Dermal Absorption Rate
Testing of Certain Chemicals of Interest to Occupational Safety and
Health Administration. Federal Register (64 FR 31074, June 9, 1999)
(FRL-5760-3). Available online at: http://www.regulations.gov.
Docket ID number: EPA-HQ-OPPT-2011-1020.
36. EPA. Acetophenone, Phenol, N,N-Dimethylaniline, Ethyl Acetate
and 2,6-Dimethylphenol; Proposed Test Rule, Notice of Opportunity to
Initiate Negotiations for TSCA Section 4 Testing Consent Agreements.
Federal Register (58 FR 61654, November 22, 1993) (FRL-4010-2).
Available online at: http://www.regulations.gov. Docket ID number:
EPA-HQ-OPPT-2011-1020.
37. ITC. First Report of the ITC; Notice. Federal Register (42 FR
55026, October 12, 1977). Available online at: http://www.regulations.gov. Docket ID number: EPA-HQ-OPPT-2011-1020.
38. EPA. Cresols; Proposed Test Rule. Federal Register (48 FR 31812,
July 11, 1983) (FRL-2341-2). Available online at: http://www.regulations.gov. Docket ID number: EPA-HQ-OPPT-2011-1020.
39. ITC. Sixty-First Report of the ITC; Notice. Federal Register (73
FR 5080, January 28, 2008) (FRL-8347-1). Available online at: http://www.regulations.gov. Docket ID number: EPA-HQ-OPPT-2011-1020.
40. ITC. Sixty-Second Report of the ITC; Notice. Federal Register
(73 FR 27450, May 12, 2008) (FRL-8363-2). Available online at:
http://www.regulations.gov. Docket ID number: EPA-HQ-OPPT-2011-1020.
41. National Institute for Occupational Safety and Health (NIOSH).
Preventing Asthma and Death from MDI Exposure during Spray-on Truck
Bed Liner and Related Applications: NIOSH Alert. DHHS (NIOSH)
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http://www.cdc.gov/niosh/docs/2006-149.
42. Ott, M. G., Diller, W. F., and Jolly, A.T. 2003. Respiratory
Effects of Toluene Diisocyanate in the Workplace: A Discussion of
Exposure-Response Relationships. Critical Reviews in Toxicology. 33:
1-59. Available online at: http://www.regulations.gov. Docket ID
number: EPA-HQ-OPPT-2011-1020.
43. Bello, D., Woskie, S. R., Streicher, R. P., Liu, Y., Stowe, M.
H., Eisen, E. A., Ellenbecker, M. J., Sparer, J., Youngs, F.,
Cullen, M. R., and Redlich, C. A. 2004. Polyisocyanates in
Occupational Environments: A Critical Review of Exposure Limits and
Metrics. American Journal of Industrial Medicine. 46: 480-491.
Available online at: http://www.regulations.gov. Docket ID number:
EPA-HQ-OPPT-2011-1020.
44. Bernstein, D. I., Korbee, L., Stauder, T., Bernstein, J. A.,
Scinto, J., Herd, Z. L., and Bernstein, I. L. 1993. The low
prevalence of occupational asthma and antibody-dependent
sensitization to diphenylmethane diisocyanate in a plant engineered
for minimal exposure to diisocyanates. Journal of Allergy and
Clinical Immunology. 92: 387-396. Available on online at: http://www.regulations.gov. Docket ID number: EPA-HQ-OPPT-2011-1020.
45. Ulvestad, B., Melbostad, E., and Fuglerud, P. 1999. Asthma in
tunnel workers exposed to synthetic resins. Scandinavian Journal of
Work, Environment & Health. 25(4): 335-341. Available online at:
http:[sol][sol]www.regulations.gov. Docket ID number: EPA-HQ-OPPT-
2011-1020.
46. Petsonk, E., Wang, M., Lewis, D., Siegel, P., and Husberg, B.
2000. Asthma-Like Symptoms in Wood Product Plant Workers Exposed to
Methylene Diphenyl Diisocyante. Chest. 118: 1183-1193. Available
online at: http:[sol][sol]www.regulations.gov. Docket ID number:
EPA-HQ-OPPT-2011-1020.
47. Sommer, B. G., Sherson, D. L., Kjoller, H., Hansen, I., Clausen,
G., and Jepsen, J. R., 2000. Asthma caused by methylene-diphenyl-
diisocyanate cast in a nurse. Ugeskr Lateger 162(4): 505-506 as
cited in Bello, D., Herrick, C. A., Smith, T. J., Woskie, S. R.,
Streicher, R. P., Cullen, M.R., Liu, Y., and Redlich, C.A. 2007.
Skin Exposure to Isocyanates: Reasons for Concern. Environmental
Health Perspectives. 115: 328-335. Available on line at:
http:[sol][sol]ehp03.niehs.nih.gov/article/
fetchArticle.action?articleURI=info%3Adoi%2F10.1289%2Fehp.9557.
48. Donnelly, R., Buick, J. B., and Macmahon, J. 2003. Occupational
asthma after exposure to plaster casts containing methylene diphenyl
diisocyanate. Occupational Medicine. 53: 432-434. Available online
at: http:[sol][sol]www.regulations.gov. Docket ID number: EPA-HQ-
OPPT-2011-1020.
49. Redlich, C. A., Bello, D., and Wisnewski, A. 2006. Isocyanate
Exposures and Health Effects. Environmental and Occupational
Medicine (W. Rom and S. Markowitz, Eds.), pp. 502-516. Lippincott
Williams & Wilkins. Philadelphia, PA. Available online at:
http:[sol][sol]www.regulations.gov. Docket ID number: EPA-HQ-OPPT-
2011-1020.
50. NIOSH. Preventing Asthma and Death from Diisocyanate Exposure:
NIOSH Alert. DHHS (NIOSH) Publication Number 96-111. 1996. Available
online at: http:[sol][sol]www.cdc.gov/niosh/docs/96-111.
51. American Chemistry Council (ACC). TSCA 8(e) Notice of
Substantial Risk 8EHQ-0905-16225 Fatalities linked to diisocyanates.
EPA. September 2005. Available online at:
http:[sol][sol]www.regulations.gov. Docket ID Number: EPA-HQ-OPPT-
2011-1020.
52. O'Brien, I. M., Harries, M. G., Burge, P. S., and Pepys, J.
1979. Toluene di-isocyanate-induced asthma I. Reactions to TDI, MDI,
HDI and histamine. Clinical & Experimental Allergy. 9: 1-6.
Available online at: http:[sol][sol]www.regulations.gov. Docket ID
number: EPA-HQ-OPPT-2011-1020.
53. International Agency for Research on Cancer (IARC). 1987. 4,4'-
Methylenediphenyl Diisocyanate and Polymeric 4,4'-Methylenediphenyl
Diisocyanate. Vol. 71, Monographs 71-47, pp. 1049-1058. Available
online at: http:[sol][sol]www.regulations.gov. Docket ID number:
EPA-HQ-OPPT-2011-1020.
54. European Chemicals Bureau (ECB). 2005. European Union Risk
Assessment Report methylenediphenyl diisocyanate (MDI). Available
online at: http:[sol][sol]www.regulations.gov. Docket ID number:
EPA-HQ-OPPT-2011-1020.
55. Collins, M. A. 2002. Toxicology of Toluene Diisocyanate. Applied
Occupational and Environmental Hygiene. 17: 846-855. Available
online at: http:[sol][sol]www.regulations.gov. Docket ID number:
EPA-HQ-OPPT-2011-1020.
56. OECD. Screening Information Data Set (SIDS) Initial Assessment
Report for 12th SIAM: Hexamethylene Diisocyanate CAS No: 822-06-0
(HDI). June 2001. pp. 1-73. United National Environment Programme
(UNEP). Paris, France. Available online at:
http:[sol][sol]www.regulations.gov. Docket ID number: EPA-HQ-OPPT-
2011-1020.
57. Bayer Material Science. 2009. FYI 1209-01618. Available online
at: http:[sol][sol]www.regulations.gov. Docket ID number: EPA-HQ-
OPPT-2011-1020.
58. Crespo, J. and Galan, J. 1999. Exposure to MDI During the
process of insulating buildings with sprayed polyurethane foam.
Annals of Occupational Hygiene. 43: 415-419. Available online at:
http:[sol][sol]www.regulations.gov. Docket ID number: EPA-HQ-OPPT-
2011-1020.
59. Occupational Health and Safety Research Institute. 2009. 4,4'-
Diphenylmethane diisocyanate (MDI) safety practices and
concentration during polyurethane foam spraying. R-629, pp. 1-66.
Available
[[Page 30869]]
online at: http:[sol][sol]www.irsst.qc.ca/files/documents/PubIRSST/
R-629.pdf.
60. Lesage, J., Stanley, J., Karoly, W. J., and Lichtenberg, F. W.
2007. Airborne Methylene Diphenyl Diisocyanate (MDI) Concentrations
Associated with the Application of Polyurethane Spray Foam in
Residential Construction. Journal of Occupational and Environmental
Hygiene. 4: 145-155. Available online at:
http:[sol][sol]www.regulations.gov. Docket ID number: EPA-HQ-OPPT-
2011-1020.
61. Kelly, T. J., Myers, J. D., and Holdren, M. W. 1999. Testing of
Household Products and Materials for Emission of Toluene
Diisocyanate. Indoor Air. 9: 117-124. Available online at: http://www.regulations.gov. Docket ID Number: EPA-HQ-OPPT-2011-1020.
62. Jarand, C. W., Akapo, S. O., Swenson, L. J., and Kelman, B. J.
2002. Diisocyanate Emission from a Paint Product: A Preliminary
Analysis. Applied Occupational and Environmental Hygiene. 17: 491-
494. Available online at: http://www.regulations.gov. Docket ID
number: EPA-HQ-OPPT-2011-1020.
63. New York City Department of Health and Mental Hygiene (NYC-
DOHMH). Environmental Investigation of Chemical Ingredients of
Moisture Cure Urethanes Used as Wood Floor Coatings. May 20, 2003.
Available online at:http://home2.nyc.gov/html/doh/downloads/pdf/epi/epi-mcu-report.pdf.
64. Luo, J., Nelsen K., and Fischbein, A. 1990. Persistent reactive
airway dysfunction syndrome after exposure to toluene diisocyanate.
British Journal of Industrial Medicine. 47: 239-241. Available
online at: http://www.regulations.gov. Docket ID number: EPA-HQ-
OPPT-2011-1020-0064.
65. Zotti, R., Muran, A., and Zambon, F., 2000. Two cases of
paraoccupational asthma due to toluene diisocyanate (TDI).
Occupational and Environmental Medicine. 57: 837-839. Available
online at: http://www.regulations.gov. Docket ID number: EPA-HQ-
OPPT-2011-1020.
66. Woskie, S., Sparer, J., Gore, R., Stowe, M., Bello, D., Liu, Y.,
Youngs, F., Redlich, C., Eisen, E., and Cullen M. 2004. Determinants
of Isocyanate Exposures in Auto Body Repair and Refinishing Shops.
Annals of Occupational Hygiene. Vol. 48, No. 5, 393-403. Available
online at: http://www.regulations.gov. Docket ID number: EPA-HQ-
OPPT-2011-1020.
67. Jan, R. L., Chen, S. H., Chang, H. Y., Yeh, H. J., Shieh, C. C.,
and Wang, J. Y. 2008. Asthma-like syndrome in school children after
accidental exposure to xylene and methylene diphenyl diisocyanate.
Journal of Microbiology, Immunology and Infection. 41: 337-341.
Available online at: http://www.regulations.gov. Docket ID number:
EPA-HQ-OPPT-2011-1020.
68. National Institutes of Health (NIH). Asthma in Children. Medline
Plus. October 13, 2011. Available online at: http://www.nlm.nih.gov/medlineplus/asthmainchildren.html.
69. Trasande, L. and Thurston, G. 2005. The role of air pollution in
asthma and other pediatric morbidities. Journal of Allergy and
Clinical Immunology. 115: 689-699. Available online at: http://www.regulations.gov. Docket ID number: EPA-HQ-OPPT-2011-1020.
70. Bayer, A.G. 1992. Determination on the ecological behavior of
Desmodur W. Unpublished Report 218 A/90 1992-05-29. As cited in SIDS
Initial Assessment Report For SIAM 20, Paris, France. April 19-22,
2005. Available online at: http://www.alipa.org/uploads/Modules/Publications/OECD_DraftSIDS_5124301.pdf.
71. Bayer, A.G. 2000b. Fish test. Unpublished Report 858 A/99 F,
2000-01-07. As cited in SIDS Initial Assessment Report For SIAM 20,
Paris, France. April 19-22, 2005. Available online at: http://www.alipa.org/uploads/Modules/Publications/OECD_DraftSIDS_5124301.pdf.
72. Bayer, A.G. 2000c. Daphnia test. Unpublished Report 858 A/99 D,
2000-01-06. As cited in SIDS Initial Assessment Report For SIAM 20,
Paris, France. April 19-22, 2005. Available online at: http://www.alipa.org/uploads/Modules/Publications/OECD_DraftSIDS_5124301.pdf.
73. Bayer, A.G. 2000d. Algal test. Unpublished Report 858 A/99 Al,
2000-01-06. As cited in SIDS Initial Assessment Report For SIAM 20,
Paris, France. April 19-22, 2005. Available online at: http://www.alipa.org/uploads/Modules/Publications/OECD_DraftSIDS_5124301.pdf.
74. Van der Hoeven, N., Roza, P., and Henzen, L. 1992a.
Determination of the effect of TDI, TDA, MDI, and MIDA on the
emergence and growth of the plant species Avena sativa and Lactuca
sativa according to OECD Guideline No. 208. TNO. 111 Report No.
11024. Available from: British Library Document Supply Centre,
Boston Spa, Wetherby, West Yorkshire. As cited in Allport, D.,
Gilbert, D., and Outterside, S. 2003. MDI and TDI: Safety, Health
and the Environment. John Wiley & Sons, Ltd. West Sussex, England,
264. Available online at: http://www.regulations.gov. Docket ID
number: EPA-HQ-OPPT-2011-1020.
75. Van der Hoeven, N., Roza, P., and Henzen, L., 1992b.
Determination of the LC50 (14 days) of TDI, TDA, MDI, and MDA to the
earthworm Eisenia fetida according to OECD guideline No. 207. TNO.
111 Report No. 11025. Available from: British Library Document
Supply Centre, Boston Spa, Wetherby, West Yorkshire. As cited in
Allport, D., Gilbert, D., and Outterside, S. 2003. MDI and TDI:
Safety, Health and the Environment. John Wiley & Sons, Ltd. West
Sussex, England, 265. Available online at: http://www.regulations.gov. Docket ID number: EPA-HQ-OPPT-2011-1020.
76. ITC. Fifty-Eighth Report of the ITC; Notice. Federal Register
(71 FR 39188, July 11, 2006) (FRL-8073-7). Available online at:
http://www.regulations.gov. Docket ID number: EPA-HQ-OPPT-2011-1020.
77. ITC. Sixty-Third Report of the ITC; Notice. Federal Register (73
FR 65486, November 3, 2008) (FRL-8387-6). Available online at:
http://www.regulations.gov. Docket ID number: EPA-HQ-OPPT-2011-1020.
VI. The TSCA Interagency Testing Committee
Statutory Organizations With Representatives
Department of Commerce, National Institute of Standards and Technology
Dianne L. Poster, Alternate.
Environmental Protection Agency
Robert W. Jones, Member.
John E. Schaeffer, Alternate.
National Institute of Environmental Health Sciences
Nigel Walker, Member.
Scott Masten, Alternate.
National Institute for Occupational Safety and Health
Gayle DeBord, Member.
Dennis W. Lynch, Alternate.
Occupational Safety and Health Administration
Thomas Nerad, Member.
Janet Carter, Alternate.
Liaison Organizations With Representatives
Agency for Toxic Substances and Disease Registry
Glenn D. Todd, Member.
Consumer Product Safety Commission
Dominique Johnson, Member.
Department of Agriculture
Clifford P. Rice, Member.
Department of Defense
Laurie E. Roszell, Member.
Department of the Interior
Barnett A. Rattner, Member.
Food and Drug Administration
Kirk Arvidson, Member.
Ronald F. Chanderbhan, Alternate.
ITC Staff
John D. Walker, Director.
Carol Savage, Administrative Assistant (NOWCC Employee).
TSCA Interagency Testing Committee (7401M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; email address:
[email protected]; url: http://www.epa.gov/opptintr/itc.
[FR Doc. 2012-12493 Filed 5-22-12; 8:45 am]
BILLING CODE 6560-50-P