Significant New Use Rules on Certain Chemical Substances, 53470-53487 [E7-18502]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 72, Number 181 (Wednesday, September 19, 2007)]
[Rules and Regulations]
[Pages 53470-53487]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-18502]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2006-0898; FRL-8135-8]
RIN 2070-AB27


Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is promulgating significant new use rules (SNURs) under 
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 38 
chemical substances which were the subject of premanufacture notices 
(PMNs). One of these chemical substances is also subject to a TSCA 
section 5(e) consent order issued by EPA. This action requires persons 
who intend to manufacture, import, or process any of these 38 chemical 
substances for an activity that is designated as a significant new use 
by this rule to notify EPA at least 90 days before commencing that 
activity. The required notification will provide EPA with the 
opportunity to evaluate the intended use and, if necessary, to prohibit 
or limit that activity before it occurs.

DATES: The effective date of this rule is November 19, 2007 without 
further notice, unless EPA receives adverse or critical comments, or 
notice of intent to submit adverse or critical comments before October 
19, 2007. This rule shall be promulgated for purposes of judicial 
review at 1 p.m. (e.s.t.) on October 3, 2007.
    If EPA receives adverse or critical comments, or notice of intent 
to submit adverse or critical comments, on one or more of these SNURs 
before October 19, 2007 EPA will withdraw the relevant sections of this 
direct final rule before its effective date. EPA will then issue a 
proposed SNUR for the chemical substance(s) on which adverse or 
critical comments were received, providing a 30-day period for public 
comment.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPPT-2006-0898, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the on-line 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, Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: 
Docket ID number EPA-HQ-OPPT-2006-0898. 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-
2006-0898. EPA's policy is that all comments received will be included 
in the public docket without change and may be made available on-line 
at https://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 e-
mail. The regulations.gov website 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 e-
mail comment directly to EPA without going through regulations.gov, 
your e-mail address will be automatically captured and included as part 
of the comment that is placed in the public 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. For additional 
information about EPA's public docket, visit the EPA Docket Center 
homepage at https://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the docket index 
available in regulations.gov. To access the electronic docket, go to 
https://www.regulations.gov, select ``Advanced Search,'' then ``Docket 
Search.'' Insert the docket ID number where indicated and select the 
``Submit'' button. Follow the instructions on the regulations.gov web 
site to view the docket index or access available documents. 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 https://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 Federal 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 general information contact: Colby 
Lintner, Regulatory Coordinator, Environmental Assistance Division 
(7408M), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: TSCA-
Hotline@epa.gov.
    For technical information contact: Karen Chu, Chemical Control 
Division (7405M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (202) 564-8773; e-mail 
address: chu.karen@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you manufacture, 
import, process, or use the chemical substances contained in this rule. 
Potentially affected entities may include, but are not limited to:
     Manufacturers, importers, or processors of one or more 
subject chemical substances (NAICS codes 325 and 324110), e.g., 
Chemical manufacturing and petroleum refineries.

[[Page 53471]]

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in 40 CFR 721.5. 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.
    This action may also affect certain entities through pre-existing 
import certification and export notification rules under TSCA. Persons 
who import any chemical substance governed by a final SNUR are subject 
to the TSCA section 13 (15 U.S.C. 2612) import certification 
requirements and the corresponding regulations at 19 CFR 12.118 through 
12.127 and 19 CFR 127.28. Those persons must certify that the shipment 
of the chemical substance complies with all applicable rules and orders 
under TSCA, including any SNUR requirements. The EPA policy in support 
of import certification appears at 40 CFR part 707, subpart B. In 
addition, any persons who export or intend to export a chemical 
substance that is the subject of this rule on or after October 19, 2007 
are subject to the export notification provisions of TSCA section 12(b) 
(15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the 
export notification requirements in 40 CFR part 707, subpart D.

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 e-mail. 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.
    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

A. What Action is the Agency Taking?

    EPA is promulgating these SNURs using direct final procedures. 
These SNURs will require persons to notify EPA at least 90 days before 
commencing the manufacture, import, or processing of a chemical 
substance for any activity designated by these SNURs as a significant 
new use. Additional rationale and background to this rule are more 
fully set out in the preamble to EPA's first direct final SNUR 
published in the Federal Register of April 24, 1990 (55 FR 17376). 
Consult that preamble for further information on the objectives, 
rationale, and procedures for SNURs and on the basis for significant 
new use designations, including provisions for developing test data.

B. What is the Agency's Authority for Taking this Action?

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to 
determine that a use of a chemical substance is a ``significant new 
use.'' EPA must make this determination by rule after considering all 
relevant factors, including those listed in TSCA section 5(a)(2). Once 
EPA determines that a use of a chemical substance is a significant new 
use, TSCA section 5(a)(1)(B) requires persons to submit a significant 
new use notice (SNUN) to EPA at least 90 days before they manufacture, 
import, or process the chemical substance for that use. The mechanism 
for reporting under this requirement is established under 40 CFR 721.5.

C. Applicability of General Provisions

    General provisions for SNURs appear under 40 CFR part 721, subpart 
A. These provisions describe persons subject to the rule, recordkeeping 
requirements, exemptions to reporting requirements, and applicability 
of the rule to uses occurring before the effective date of the final 
rule. Provisions relating to user fees appear at 40 CFR part 700. 
According to 40 CFR 721.1(c), persons subject to these SNURs must 
comply with the same notice requirements and EPA regulatory procedures 
as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, 
these requirements include the information submission requirements of 
TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA 
section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 
CFR part 720. Once EPA receives a SNUN, EPA may take regulatory action 
under TSCA section 5(e), 5(f), 6, or 7 to control the activities on 
which it has received the SNUN. If EPA does not take action, EPA is 
required under TSCA section 5(g) to explain in the Federal Register its 
reasons for not taking action.
    Persons who export or intend to export a chemical substance 
identified in a proposed or final SNUR are subject to the export 
notification provisions of TSCA section 12(b). The regulations that 
interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D. 
Persons who import a chemical substance identified in a final SNUR are 
subject to the TSCA section 13 import certification requirements, 
codified at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Such 
persons must certify that the shipment of the chemical substance 
complies with all applicable rules and orders under TSCA, including any 
SNUR requirements. The EPA policy in support of the import 
certification appears at 40 CFR part 707, subpart B.

III. Substances Subject to this Rule

    EPA is establishing significant new use and recordkeeping 
requirements for 38 chemical substances under 40 CFR part 721, subpart 
E. In this unit, EPA provides the following information for each 
chemical substance:
     PMN number.
     Chemical name (generic name if the specific name is 
claimed as CBI).
     CAS number (if assigned for non-confidential chemical 
identities).

[[Page 53472]]

     Basis for the section 5(e) consent order, or, for non-5(e) 
SNURs, the basis for the SNUR.
     Toxicity concerns.
     Tests recommended by EPA to provide sufficient information 
to evaluate the chemical substance (see Unit VI. for more information).
     CFR citation assigned in the regulatory text section of 
this rule.
    The specific activities designated as significant new uses are 
listed in the regulatory text section of 40 CFR part 721, subpart E. 
Certain new uses, including production limits and other uses designated 
in the rule are claimed as CBI. The procedure for obtaining 
confidential information is set out in Unit VII.
    This rule includes a SNUR on one PMN substance that is subject to a 
``risk-based'' consent order under TSCA section 5(e)(1)(A)(ii)(I) 
wherein EPA determined that activities associated with the PMN 
substance may present unreasonable risk to health or the environment. 
The consent order requires protective measures to limit exposures or 
otherwise mitigate the potential unreasonable risk. The so-called 
``5(e) SNUR'' on this substance is promulgated pursuant to 40 CFR 
721.160, and is based on and consistent with the provisions in the 
underlying consent order. The SNUR designates as a ``significant new 
use'' the absence of the protective measures required in the consent 
order.
    This rule also includes SNURs on 37 PMN substances that are not 
subject to consent orders under TSCA section 5(e). In these cases, EPA 
did not find that the use scenario described in the PMN triggered the 
determinations set forth under section 5(e) of TSCA. EPA, however, does 
believe that certain changes from the use scenario described in the PMN 
could result in increased exposures, thereby constituting a 
``significant new use.'' These so-called ``non-5(e) SNURs'' are 
promulgated pursuant to 40 CFR 721.170. EPA has determined that every 
activity designated as a ``significant new use'' in all the non-5(e) 
SNURs issued under 40 CFR 721.170 satisfies the two requirements 
stipulated in Sec.  721.170(c)(2), i.e., these significant new use 
activities, ``(i) are different from those described in the 
premanufacture notice for the substance, including any amendments, 
deletions, and additions of activities to the premanufacture notice, 
and (ii) may be accompanied by changes in exposure or release levels 
that are significant in relation to the health or environmental 
concerns identified'' for the PMN substance.
PMN Numbers P-01-759 and P-05-555
Chemical name: Dodecandioic acid, 1, 12-dihydrazide.
CAS number: 4080-98-2.
Basis for action: The PMNs state that the generic (non-confidential) 
uses of the substance will be as a raw material for coating and 
sealants and as a curing agent. Based on molecular structure and test 
data on analogous substances, EPA has identified health concerns for 
carcinogenicity, developmental toxicity, and irritation to mucous 
membranes. Also, based on test data on the PMN substance, EPA has 
identified concerns for dermal sensitization. As described in the PMNs 
and accompanying Material Safety Data Sheets, workers will be warned 
that the substance may cause dermal sensitization and will wear gloves 
and National Institute for Occupational Safety and Health (NIOSH) 
approved respirators with an assigned protection factor (APF) of 50 or 
greater. Based on adequate personal protective equipment and hazard 
communication, significant worker exposure is unlikely. Further, 
consumer use is not expected. Therefore, EPA has not determined that 
the proposed manufacturing, processing, or use of the substance may 
present an unreasonable risk. EPA has determined, however, that use of 
the substance without workers wearing gloves and a respirator, and 
without an appropriate hazard communication program, may cause serious 
human health effects. Respirators must provide a NIOSH APF of at least 
50. The following NIOSH-approved respirators meet the minimum 
requirement for Sec.  721.63(a)(4): Air-purifying, tight-fitting full-
face respirator equipped with N100 (if oil aerosols absent), R100, or 
P100 filters; powered air-purifying respirator equipped with a tight-
fitting full facepiece and High Efficiency Particulate Air (HEPA) 
filters; supplied air respirator operated in pressure demand or 
continuous flow mode and equipped with a tight-fitting full facepiece. 
Because the substance is a dermal sensitizer and irritates mucous 
membranes, half-face respirators do not provide adequate protection. 
Based on this information, the PMN substance meets the concern criteria 
at Sec.  721.170 (b)(1)(i)(C) and (b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-day 
oral toxicity test in rats (OPPTS 870.3100 test guideline) and a 
mammalian erythrocyte micronucleus test (OPPTS 870.5395 test guideline) 
would help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10057.
PMN Numbers P-03-546, P-03-550, and P-03-551
Chemical names: (P-03-546) Reaction product of alkylphenol, aromatic 
cyclicamine, alkyl diglycidyl dibenzene, and formaldehyde (generic); 
(P-03-550) Reaction product of alkylphenyl glycidyl ether, 
polyalkylenepolyamine, and alkyl diglycidyl dibenzene (generic); and 
(P-03-551) Reaction product of alkylphenyl glycidyl ether, 
polyalkylenepolyamine, alkyl diglycidyl dibenzene, and 
polyalkylcyclicdiamine (generic).
CAS numbers: Not available.
Basis for action: The PMNs state that the substances will be used as 
epoxy curing agents. Based on test data on structurally analogous 
polycationic polymers, EPA is concerned that toxicity to aquatic 
organisms may occur at concentrations at or above 20 parts per billion 
(ppb) of the PMN substances in surface waters. As described in the 
PMNs, the substances are not released to surface waters. Therefore, EPA 
has not determined that the proposed manufacturing, processing, or use 
of the substances may present an unreasonable risk. EPA has determined, 
however, that uses of the substances resulting in release to surface 
waters may cause significant adverse environmental effects. Based on 
this information, the PMN substances meet the concern criteria at Sec.  
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of the 
following tests would help characterize the environmental effects of 
the PMN substances: A fish acute toxicity test, freshwater and marine 
(OPPTS 850.1075 test guideline (public draft)); a fish acute toxicity 
test mitigated by humic acid (OPPTS 850.1085 test guideline (public 
draft)); an aquatic invertebrate acute toxicity test, freshwater 
daphnids (OPPTS 850.1010 test guideline (public draft)); and an algal 
toxicity test, tiers I and II (OPPTS 850.5400 test guideline (public 
draft)).
CFR citations: 40 CFR 721.10058 (P-03-546); 40 CFR 721.10059 (P-03-
550); and 40 CFR 721.10060 (P-03-551).
PMN Number P-04-341
Chemical name: Pentane, 1,1,1,2,2,3,4,5,5,5-decafluoro-3-methoxy-4-
(trifluoromethyl)-.
CAS number: 132182-92-4.
Basis for action: The PMN states that the substance will be used as a 
solvent coating and heat transfer fluid. EPA has identified health and 
environmental concerns because the substance is potentially a 
persistent, bio-accumulative, and toxic (PBT) chemical, consistent with 
the New Chemical Program's PBT Category (64 FR 60194; November 4, 
1999). EPA estimates that the PMN substance will persist in the 
environment more than six months and

[[Page 53473]]

estimates a bioaccumulation factor of greater than or equal to 1,000, 
based on test data indicating a fish bioaccumulation factor of 3.2 and 
a log Kow of 4.70. As described in the PMN, the substance is 
not released to surface water. Therefore, EPA has not determined that 
the proposed manufacturing, processing, or use of the substance may 
present an unreasonable risk. EPA has determined, however, that any 
release of the PMN substance to surface waters may cause significant 
adverse environmental effects, since the PMN substance has been 
characterized by EPA as a PBT. Based on this information, the PMN 
substance meets the concern criteria at Sec.  721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of the tiered 
testing as described in the New Chemicals Program's PBT Category would 
help characterize the PBT attributes of the substance. EPA has 
determined that the results of an algal toxicity test, tiers I and II 
(OPPTS 850.5400 test guideline (public draft)), a fish early-life stage 
toxicity test (OPPTS 850.1400 test guideline (public draft)), and a 
daphnid chronic toxicity test (OPPTS 850.1300 test guideline (public 
draft)) would further characterize the environmental effects of the PMN 
substance.
CFR citation: 40 CFR 721.10061.
PMN Number P-04-627
Chemical name: 2,5-Furandione, polymer with oxybis[propanol], benzoate.
CAS number: 103458-14-6.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a spray-applied filled backing resin. 
Based on test data on structurally similar acrylates and esters, EPA is 
concerned that toxicity to aquatic organisms may occur at 
concentrations at or above 9 ppb of the PMN substance in surface 
waters. As described in the PMN, the substance is not released to 
surface waters. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substances may present an 
unreasonable risk. EPA has determined, however, that other uses of the 
substances resulting in release to surface waters may cause significant 
adverse environmental effects. Based on this information, the PMN 
substance meets the concern criteria at Sec.  721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS 850.1075 test 
guideline (public draft)), an aquatic invertebrate acute toxicity test, 
freshwater daphnids (OPPTS 850.1010 test guideline (public draft)), and 
an algal toxicity test, tiers I and II (OPPTS 850.5400 test guideline 
(public draft)) would help characterize the environmental effects of 
the PMN substance.
CFR citation: 40 CFR 721.10062.
PMN Number P-04-792
Chemical name: Halo substituted hydroxy nitrophenyl amide (generic).
CAS number: Not available.
Basis for action: The PMN states that generic (non-confidential) use of 
the substance will be as a chemical intermediate. Based on test data on 
structurally analogous phenols, EPA is concerned that toxicity to 
aquatic organisms may occur at concentrations at or above 2 ppb of the 
PMN substance in surface waters. As described in the PMN, the substance 
is not released to surface waters. Therefore, EPA has not determined 
that the proposed manufacturing, processing, or use of the substance 
may present an unreasonable risk. EPA has determined, however, that 
other uses of the substance resulting in release to surface waters may 
cause significant adverse environmental effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of the 
following tests would help characterize the environmental effects of 
the PMN substance: An algal toxicity test, tiers I and II (OPPTS 
850.5400 test guideline (public draft)); a fish early-life stage 
toxicity test (OPPTS 850.1400 test guideline (public draft)); a daphnid 
chronic toxicity test (OPPTS 850.1300 test guideline (public draft)); 
and either a porous pot test (OPPTS 835.3220 test guideline) or an 
aerobic sewage treatment test (Organization for Economic Cooperation 
and Development (OECD) 303A test guideline). The algal toxicity study 
should be performed using the static method with measured 
concentrations and the fish and daphnid tests should be performed using 
the flow-through method with measured concentrations.
CFR citation: 40 CFR 721.10063.
PMN Number P-04-909
Chemical name: 2-Propenoic acid, 2-[2-(ethenyloxy)ethoxy]ethyl ester.
CAS number: 86273-46-3.
Effective date of section 5(e) consent order: 6-26-2006.
Basis for section 5(e) consent order: The PMN states the substance will 
be used as an ultraviolet-curable monomer for polymerization. The order 
was issued under section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA, 
based on a finding that this substance may present an unreasonable risk 
of injury to human health. To protect against this risk, the consent 
order requires use of gloves demonstrated by testing to be impervious 
(North Butyl Black gloves and T-1 Dailove Ethylene Vinylalcohol 
Copolymer Laminated Blue gloves have satisfied this requirement) and a 
hazard communication program. The SNUR designates as a `significant new 
use' the absence of these protective measures.
Toxicity concern: Based on test data on chemicals analogous to the PMN 
substance, EPA has concerns that the PMN substance may cause 
developmental toxicity, mutagenicity, reproductive toxicity, and 
oncogenicity. Also, EPA has health concerns for sensitization based on 
submitted test data on the PMN substance and via analogy to TSCA 
section 8(e) submission number 8EHQ-1092-11387, skin irritation and 
kidney toxicity concerns based on data for a bismethacrylate analog 
TSCA section 8(e) submission number 8EHQ-0695-13474, and skin cancer 
concerns (if exposed individuals are not protected from skin damage 
from the irritant properties of the chemical) based on male mouse 
chronic dermal toxicity test data for an analog, For Your Information 
(FYI) submission number FYI-0691-01262.
Recommended testing: EPA has determined that the results of a combined 
repeated dose toxicity test with reproduction/developmental screening 
(OPPTS 870.3650 test guideline) would help characterize the human 
health effects of the PMN substance. The test should be done in rats, 
through the oral route of exposure, and be modified to dose for 70 
days, an entire sperm cycle, before mating occurs. The PMN submitter 
has agreed not to exceed the production volume limit without performing 
this test.
CFR citation: 40 CFR 721.10064.
PMN Numbers P-04-961 and P-04-962
Chemical names: (P-04-961) 1-Tetradecanesulfonic acid, 
(dimethylphenyl)- and (P-04-962) 1-Hexanesulfonic acid, 
(dimethylphenyl)-.
CAS numbers: (P-04-961) 671756-61-9 and (P-04-962) 676143-36-5.
Basis for action: The PMNs state that the generic (non-confidential) 
use of the substances will be to help recover additional quantities of 
oil from subterranean reservoirs and also to impart improved properties 
to products derived from such recovered oil. Based on test data on 
chemicals with molecular structures similar to the PMN substances, EPA 
is concerned that toxicity to aquatic organisms may occur at 
concentrations at or above 20 ppb of

[[Page 53474]]

the PMN substances in surface waters. As described in the consolidated 
PMNs, the substances will not be released to surface waters. Therefore, 
EPA has not determined that the proposed manufacturing, processing, or 
use of the substances may present an unreasonable risk. EPA has 
determined, however, that other uses of the substances resulting in 
release to surface waters may cause significant adverse environmental 
effects. Based on this information, the PMN substances meet the concern 
criteria at Sec.  721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of the 
following tests would help characterize the environmental effects of 
the PMN substances: A porous pot test (OPPTS 835.3220 test guideline); 
a fish acute toxicity test, freshwater and marine (OPPTS 850.1075 test 
guideline (public draft)); an aquatic invertebrate acute toxicity test 
freshwater in daphnids (OPPTS 850.1010 test guideline (public draft)); 
and an algal toxicity test, tiers I and II (OPPTS 850.5400 test 
guideline (public draft)).
CFR citations: 40 CFR 721.10065 (P-04-961) and 40 CFR 721.10066 (P-04-
962).
PMN Numbers P-05-57, P-05-58, P-05-59, P-05-60, P-05-61, P-05-62, P-05-
63, P-05-64, and P-05-65
Chemical names: (P-05-57, P-05-58, P-05-59, P-05-61, P-05-62, P-05-63, 
P-05-64, and P-05-65) Ether amine phosphonate salt (generic) and (P-05-
60) Ether amine phosphonate (generic).
CAS numbers: Not available.
Basis for action: The PMNs state that the generic (non-confidential) 
use of the substances will be as a contained use in energy production. 
Based on test data on chemicals with molecular structures similar to 
the PMN substances, EPA is concerned that toxicity to aquatic organisms 
may occur at concentrations at or above 30 ppb of the PMN substances in 
surface waters. As described in the consolidated PMNs, the substances 
will not be released to surface waters. Therefore, EPA has not 
determined that the proposed manufacturing, processing, or use of the 
substances may present an unreasonable risk. EPA has determined, 
however, that other uses of the substances resulting in release to 
surface waters may cause significant adverse environmental effects. 
Based on this information, the PMN substances meet the concern criteria 
at Sec.  721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of an algal 
toxicity test, tiers I and II (OPPTS 850.5400 test guideline (public 
draft)) on P-05-57, P-05-58, and P-05-64 and a ready biodegradation 
test (OPPTS 835.3110 test guideline) on P-05-57, P-05-59, and P-05-61 
or P-05-64 would help characterize the environmental effects of the PMN 
substances.
CFR citations: 40 CFR 721.10067 (P-05-57, P-05-58, P-05-59, P-05-61, P-
05-62, P-05-63, P-05-64, and P-05-65) and 40 CFR 721.10069 (P-05-60).
PMN Number P-05-309
Chemical name: 1,3-Butanediol, 3-methyl-.
CAS number: 2568-33-4.
Basis for action: The PMN states that the substance will be used as 
inkjet ink. Based on test data on the PMN substance and on analogous 
chemicals, the PMN substance may cause developmental toxicity, liver 
toxicity, blood/immune system effects and possibly digestive tract and 
kidney effects. As described in the PMN, the substance is imported in 
an inkjet cartridge so domestic worker exposure is not expected. 
Although there is potential for short-term, infrequent consumer dermal 
exposure, based on test data on the closest analog, the margin of 
exposure is greater than 1,000. Therefore, EPA has not determined that 
the proposed use of the substance may present an unreasonable risk. EPA 
has determined, however, that domestic manufacturing or use other than 
as described in the PMN could result in serious health effects. Based 
on this information, the PMN substance meets the concern criteria at 
Sec.  721.170 (b)(3)(i) and (b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-day 
oral toxicity test in rodents (OPPTS 870.3100 test guideline) and a 
prenatal developmental toxicity study (OPPTS 870.3700 test guideline) 
would help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10070.
PMN Number P-05-364
Chemical name: 9H-Thioxanthenium, 10-[1,1'-biphenyl]-4-yl-2-(1-
methylethyl)-9-oxo-, hexafluorophosphate (1-) (1:1).
CAS number: 591773-92-1.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a benzene-free cationic photoinitiator. 
Based on submitted test data on the PMN substance, the substance may 
cause mutagenicity, lung toxicity, thyroid toxicity, irritation to 
eyes, mucous membranes and lung, dermal sensitization, and 
developmental toxicity resulting from thyroid effects. In addition, 
based on submitted test data on the PMN substance, EPA is concerned 
that toxicity to aquatic organisms may occur at concentrations at or 
above 6 ppb of the PMN substance in surface waters. As described in the 
PMN, significant inhalation exposure is unlikely, and the substance is 
not released to water. Therefore, EPA has not determined that the 
proposed manufacturing, processing, or use of the substance may present 
an unreasonable risk. EPA has determined, however, that domestic 
manufacture or any import, processing, or use of the PMN substance in a 
solid form may cause serious health and environmental effects. Based on 
this information, the PMN substance meets the concern criteria at Sec.  
721.170 (b)(3)(i) and (b)(4)(i).
Recommended testing: EPA has determined that the results of a fish 
early-life stage toxicity test (OPPTS 850.1400 test guideline (public 
draft)), a daphnid chronic toxicity test (OPPTS 850.1300 test guideline 
(public draft)), and a 90-day oral toxicity test in rodents (OPPTS 
870.3100 test guideline) would help characterize the environmental and 
human health effects of the PMN substance. The fish and daphnid tests 
should be performed using the flow-through method with measured 
concentrations.
CFR citation: 40 CFR 721.10071.
PMN Number P-05-380
Chemical name: Benzene, 1,1'-methylenebis[4-isocyanato-, polymer with 
benzenedicarboxylic acid, butyl dialkyl ester, poly[oxy(methyl-1,2-
ethanediyl)], .alpha.-hydro-.omega.-hydroxy-, oxirane, alkyl-, polymer 
with oxirane, ether with propanepolyol and Sartomer's HLBH P-3000 and 
Lexorez 1180 (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a 
roofing adhesive for bonding roof membranes. Based on test data on 
analogous substances, the PMN substance may cause lung toxicity. As 
described in the PMN, significant worker inhalation exposure is 
unlikely. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk. EPA has determined, however, that use of the 
substance involving an application method that generates a vapor, mist, 
or aerosol may cause serious health effects. Based on this information, 
the PMN substance meets the concern criteria at Sec.  
721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-day 
inhalation toxicity test in rats (OPPTS 870.3465 test guideline) would 
help characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10072.
PMN Number P-05-536
Chemical name: Modified alkyl acrylamide (generic).

[[Page 53475]]

CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a chemical intermediate. Based on 
analogy to acrylamide, the PMN substance may cause neurotoxicity, 
mutagenicity, carcinogenicity, reproductive toxicity, developmental 
toxicity, and immunotoxicity. As described in the PMN, worker dermal 
exposure is not expected and inhalation exposure is expected to be 
negligible. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the PMN substance may present an 
unreasonable risk. EPA has determined, however, that use of the PMN 
substance other than as described in the PMN may cause serious health 
effects. Based on this information, the PMN substance meets the concern 
criteria at Sec.  721.170 (b)(1)(i)(C) and (b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-day 
oral toxicity test with neuropathology in rodents (OPPTS 870.3100 test 
guideline) would help characterize the human health effects of the PMN 
substance.
CFR citation: 40 CFR 721.10073.
PMN Number P-05-568
Chemical name: Acetic acid, 2-chloro-, 1-(3,3-dimethylcyclohexyl)ethyl 
ester.
CAS number: 477218-59-0.
Basis for action: The PMN states that the substance will be used as an 
isolated intermediate. Based on test data on analogous esters, the PMN 
substance may cause toxicity to aquatic organisms at concentrations at 
or above 6 ppb of the PMN substance in surface waters. As described in 
the PMN, the substance is not released in significant amounts to 
surface waters. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk. EPA has determined, however, that use of the PMN 
substance other than as a site-limited intermediate may cause 
significant adverse environmental effects. Based on this information, 
the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS 850.1075 test 
guideline (public draft)), an aquatic invertebrate acute toxicity test, 
freshwater daphnids (OPPTS 850.1010 test guideline (public draft)), and 
an algal toxicity test, tiers I and II (OPPTS 850.5400 test guideline 
(public draft)) would help characterize the environmental effects of 
the PMN substance.
CFR citation: 40 CFR 721.10074.
PMN Number P-05-722
Chemical name: Carbon black, 4-[[2-(Sulfooxy)ethyl] substituted] 
phenyl-modified, sodium salts (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of this substance will be as a step 1 black pigment intermediate. 
Based on test data on analogous respirable, poorly soluble, 
particulates, the PMN substance may cause lung effects. Based on its 
physical properties, dermal exposure to the PMN substance may cause 
systemic effects. As described in the PMN, dermal and inhalation 
exposure are not expected. Therefore, EPA has not determined that the 
proposed manufacturing, processing, or use of the substance may present 
an unreasonable risk. EPA has determined, however, that use of the 
substance other than as described in the PMN, or any manufacturing, 
processing, or use of the substance as a powder may cause serious 
health effects. Based on this information, the PMN substance meets the 
concern criteria at Sec.  721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-day 
inhalation toxicity test (OPPTS 870.3465 test guideline) would help 
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10075.
PMN Number P-05-792
Chemical name: Substituted benzenediamine (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a chemical intermediate that will be 
destroyed during use. Based on test data on analogous chemicals, EPA is 
concerned that toxicity to aquatic organisms may occur at 
concentrations above 2 ppb of the PMN substance in surface waters. As 
described in the PMN, releases of the PMN substance are not expected to 
result in surface water concentrations above 2 ppb. Therefore, EPA has 
not determined that the proposed manufacturing, processing, or use of 
the substance may present an unreasonable risk. EPA has determined, 
however, that other uses of the substance resulting in surface water 
concentrations above 2 ppb may cause significant adverse environmental 
effects. Based on this information, the PMN substance meets the concern 
criteria at Sec.  721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of the 
following tests would help characterize the environmental effects of 
the PMN substance: A ready biodegradability test (OPPTS 835.3110 test 
guideline); a fish acute toxicity test, freshwater and marine (OPPTS 
850.1075 test guideline (public draft)); an aquatic invertebrate acute 
toxicity test, freshwater daphnids (OPPTS 850.1010 test guideline 
(public draft)); and an algal toxicity test, tiers I and II (OPPTS 
850.5400 test guideline (public draft)).
CFR citation: 40 CFR 721.10076.
PMN Numbers P-06-1 and P-06-166
Chemical name: 3H-1,2,4-Triazol-3-one, 1,2-dihydro-.
CAS number: 930-33-6.
Basis for action: The PMNs state that the substance will be used as a 
chemical intermediate. Based on test data on 1,2,4-Triazole, EPA has 
concern for developmental toxicity. Also, based on test data on 
structural analogues, EPA is concerned that toxicity to aquatic 
organisms may occur at concentrations at or above 20 ppb of the PMN 
substance in surface waters. As described in the PMNs, the substance 
will not be released to surface water and worker exposure will be 
minimal due to adequate personal protective equipment. Therefore, EPA 
has not determined that the proposed manufacturing, processing, or use 
of the substance may present an unreasonable risk. EPA has determined, 
however, that use of the substance resulting in release to surface 
waters or use of the substance without appropriate hazard communication 
and worker respiratory protection may cause significant adverse 
environmental and human health effects. Based on this information, the 
PMN substance meets the concern criteria at Sec.  721.170 (b)(3)(ii) 
and(b)(4)(ii).
Recommended testing: EPA has determined that the results of the 
following tests would help characterize the environmental and health 
effects of the PMN substance: A ready biodegradability test using any 
of the six methods (OPPTS 835.3110 test guideline); a porous pot test 
(OPPTS 835.3220 test guideline); a fish acute toxicity test, freshwater 
and marine (OPPTS 850.1075 test guideline (public draft)); an aquatic 
invertebrate acute toxicity test, freshwater daphnids (OPPTS 850.1010 
test guideline (public draft)); an algal toxicity test, tiers I and II 
(OPPTS 850.5400 test guideline (public draft)); and a prenatal 
developmental toxicity study (OPPTS 870.3700 test guideline). The 
porous pot test is suggested only if the substance does not pass the 
ready biodegradation test.
CFR citation: 40 CFR 721.10077.
PMN Number P-06-4
Chemical name: Butanamide, 2-[(2-methoxy-4-nitrophenyl)azo]-N-(2-

[[Page 53476]]

methoxyphenyl)-3-oxo-, 4-[(17-substituted-3,6,9,12,15-pentaazaheptadec-
1-yl)substituted]phenyl derivs., hydrochlorides (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a step 2 yellow pigment intermediate. 
Based on test data on other aliphatic polyamines and cationic dyes, EPA 
is concerned that toxicity to aquatic organisms may occur at 
concentrations above 10 ppb of this substance in surface waters. As 
described in the PMN, releases of the PMN substance are not expected to 
result in surface water concentrations above 10 ppb. Therefore, EPA has 
not determined that the proposed manufacturing, processing, or use of 
the substance may present an unreasonable risk. EPA has determined, 
however, that uses of the substance resulting in surface water 
concentrations above 10 ppb may cause significant adverse environmental 
effects. Based on this information, the PMN substance meets the concern 
criteria at Sec.  721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of the 
following tests would help characterize the environmental effects of 
the PMN substance: A Zahn-Wellens/EMPA test (OPPTS 835.3200 test 
guideline); a fish acute toxicity test, freshwater and marine (OPPTS 
850.1075 test guideline (public draft)); an aquatic invertebrate acute 
toxicity test, freshwater daphnids (OPPTS 850.1010 test guideline 
(public draft)); and an algal toxicity test, tiers I and II (OPPTS 
850.5400 test guideline (public draft)).
CFR citation: 40 CFR 721.10078.
PMN Number P-06-7
Chemical name: Quino[2,3-b]acridine-7, 14-dione, 5,12-dihydro-2,9-
dimethyl-, 4-[(17-substituted-3,6,9,12,15-pentaazaheptadec-1-
yl)substituted]phenyl derivs., hydrochlorides (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a step 2 magenta pigment intermediate. 
Based on test data on analogous respirable, poorly soluble, 
particulates, the PMN substance may cause lung toxicity. Based on its 
physical properties, EPA has concerns for dermal exposure to the PMN 
substance. Based on test data on analogous aliphatic polyamines and 
cationic dyes, EPA is concerned that toxicity to aquatic organisms may 
occur at concentrations above 10 ppb of the PMN substance in surface 
waters. As described in the PMN, dermal and inhalation exposures to the 
PMN substance are not expected and environmental releases of the 
substance are not expected to result in surface water concentrations 
above 10 ppb. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk. EPA has determined, however, that use of the 
substance without appropriate worker protection, use other than as 
described in the PMN, and manufacturing, processing, or use as a solid 
may cause serious health effects. Additionally, use of the substance 
resulting in surface water concentrations above 10 ppb may cause 
significant adverse environmental effects. Based on this information, 
the PMN substance meets the concern criteria at Sec.  721.170 
(b)(3)(ii) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of the 
following tests would help characterize the environmental and health 
effects of the PMN substance: A Zahn-Wellens/EMPA test (OPPTS 835.3200 
test guideline); a fish acute toxicity test, freshwater and marine 
(OPPTS 850.1075 test guideline (public draft)); an aquatic invertebrate 
acute toxicity test, freshwater daphnids (OPPTS 850.1010 test guideline 
(public draft)); an algal toxicity test, tiers I and II (OPPTS 850.5400 
test guideline (public draft)); and a 90-day inhalation toxicity test 
(OPPTS 870.3465 test guideline).
CFR citation: 40 CFR 721.10079.
PMN Number P-06-8
Chemical name: Carbon black, 4-[(17-substituted-3,6,9,12,15-
pentaazaheptadec-1-yl) substituted] phenyl-modified, hydrochlorides 
(generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a step 2 black pigment intermediate. 
Based on test data on analogous respirable, poorly soluble, 
particulates, the PMN substance may cause lung toxicity. Based on its 
physical properties, EPA has concerns for dermal exposure to the PMN 
substance. Based on test data on analogous aliphatic polyamines and 
cationic dyes, EPA is concerned that toxicity to aquatic organisms may 
occur at concentrations above 10 ppb of the PMN substance in surface 
waters. As described in the PMN, dermal and inhalation exposures to the 
PMN substance are not expected and environmental releases of the 
substance are not expected to result in surface water concentrations 
above 10 ppb. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk. EPA has determined, however, that use of the 
substance without appropriate worker protection, use other than as 
described in the PMN, and manufacturing, processing, or use as a solid 
may cause serious health effects. Additionally, use of the substance 
resulting in surface water concentrations above 10 ppb may cause 
significant adverse environmental effects. Based on this information, 
the PMN substance meets the concern criteria at Sec.  721.170 
(b)(3)(ii) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of the 
following tests would help characterize the environmental and health 
effects of the PMN substance: A Zahn-Wellens/EMPA test (OPPTS 835.3200 
test guideline); a fish acute toxicity test, freshwater and marine 
(OPPTS 850.1075 test guideline (public draft)); an aquatic invertebrate 
acute toxicity test, freshwater daphnids (OPPTS 850.1010 test guideline 
(public draft)); an algal toxicity test, tiers I and II (OPPTS 850.5400 
test guideline (public draft)); and a 90-day inhalation toxicity test 
(OPPTS 870.3465 test guideline).
CFR citation: 40 CFR 721.10080.
PMN Number P-06-26
Chemical name: Aromatic urethane acrylate oligomer (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as an 
aromatic urethane acrylate oligomer in ultraviolet-curable inks and 
coatings. Based on test data on structurally analogous polyanionic 
polymers and monomers, EPA is concerned that toxicity to aquatic 
organisms may occur at concentrations at or above 90 ppb of the PMN 
substance in surface waters. As described in the PMN, the substance 
will not be released to surface waters. Therefore, EPA has not 
determined that the proposed manufacturing, processing, or use of the 
substance may present an unreasonable risk. EPA has determined, 
however, that other uses of the substance resulting in release to 
surface waters may cause significant adverse environmental effects. 
Based on this information, the PMN substance meets the concern criteria 
at Sec.  721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish 
acute toxicity test, freshwater and marine (OPPTS 850.1075 test 
guideline (public draft)), an aquatic invertebrate acute toxicity test, 
freshwater daphnids (OPPTS 850.1010 test guideline (public draft)), and 
an algal toxicity test, tiers I and II (OPPTS 850.5400 test guideline 
(public draft)) would help characterize

[[Page 53477]]

the environmental effects of the PMN substance. The fish and daphnid 
tests should use flow-through conditions and measured concentrations. 
The algal test should use the static method and measured 
concentrations.
CFR citation: 40 CFR 721.10081.
PMN Number P-06-29
Chemical name: Amine modified monomer acrylate (generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as an 
amine-modified monomer acrylate in ultraviolet-curable inks and 
coatings. Based on structural analogy to polyanionic polymers/monomers, 
EPA is concerned that toxicity to aquatic organisms may occur at 
concentrations at or above 10 ppb of the PMN substance in surface 
waters. As described in the PMN, the substance will not be released to 
surface waters. Therefore, EPA has not determined that the proposed 
manufacturing, processing, or use of the substance may present an 
unreasonable risk. EPA has determined, however, that other uses of the 
substance resulting in release to surface waters may cause significant 
adverse environmental effects. Based on this information, the PMN 
substance meets the concern criteria at Sec.  721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of the 
following tests would help characterize the environmental effects of 
the PMN substance: A ready biodegradability test (OPPTS 835.3110 test 
guideline); a fish acute toxicity test, freshwater and marine (OPPTS 
850.1075 test guideline (public draft)); an aquatic invertebrate acute 
toxicity test, freshwater daphnids (OPPTS 850.1010 test guideline 
(public draft)); and an algal toxicity test, tiers I and II (OPPTS 
850.5400 test guideline (public draft)). EPA recommends that the 
biodegradability testing be performed first. The fish and daphnid tests 
should use flow-through conditions and measured concentrations. The 
algal test should use the static method and measured concentrations.
CFR citation: 40 CFR 721.10082.
PMN Number P-06-70
Chemical name: Copper, [29H, 31H-phthalocyaninato (2-)-[b.kappa]N29, 
[b.kappa]N30, [b.kappa]N31, [b.kappa]N32]-, 4-[(17-substituted-
3,6,9,12,15- pentaazaheptadec-1-yl) substituted] phenyl derivs., 
hydrochlorides (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a step 2 cyan pigment intermediate. 
Based on test data on analogous respirable, poorly soluble, 
particulates, the PMN substance may cause lung toxicity. Based on its 
physical properties, EPA has concerns for dermal exposure to the PMN 
substance. Based on test data on analogous aliphatic amines, EPA is 
concerned that toxicity to aquatic organisms may occur at 
concentrations above 10 ppb of the PMN substance in surface waters. As 
described in the PMN, dermal and inhalation exposures to the PMN 
substance are not expected and environmental releases of the substance 
are not expected to result in surface water concentrations above 10 
ppb. Therefore, EPA has not determined that the proposed manufacturing, 
processing, or use of the substance may present an unreasonable risk. 
EPA has determined, however, that use of the substance without 
appropriate worker protection, use other than as described in the PMN, 
and manufacturing, processing, or use as a solid may cause serious 
health effects. Additionally, use of the substance resulting in surface 
water concentrations above 10 ppb may cause significant adverse 
environmental effects. Based on this information, the PMN substance 
meets the concern criteria at Sec.  721.170 (b)(3)(ii) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of the 
following tests would help characterize the environmental and health 
effects of the PMN substance: A Zahn-Wellens/EMPA test (OPPTS 835.3200 
test guideline); a fish acute toxicity test, freshwater and marine 
(OPPTS 850.1075 test guideline (public draft)); an aquatic invertebrate 
acute toxicity test, freshwater daphnids (OPPTS 850.1010 test guideline 
(public draft)); an algal toxicity test, tiers I and II (OPPTS 850.5400 
test guideline (public draft)); and a 90-day inhalation toxicity test 
(OPPTS 870.3465 test guideline).
CFR citation: 40 CFR 721.10083.
PMN Number P-06-124
Chemical name: Modified thionocarbamate (generic).
CAS number: Not available.
Basis for action: The PMN states that generic (non-confidential) use of 
the substance will be as a sulfide mineral processing reagent. Based on 
test data on structurally similar analogs, EPA is concerned that 
toxicity to aquatic organisms may occur at concentrations at or above 2 
ppb of the PMN substance in surface waters. As described in the PMN, 
the substance will not be released to surface waters. Therefore, EPA 
has not determined that the proposed manufacturing, processing, or use 
of the substance may present an unreasonable risk. EPA has determined, 
however, that other uses of the substance resulting in release to 
surface waters may cause significant adverse environmental effects. 
Based on this information, the PMN substance meets the concern criteria 
at Sec.  721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of an 
activated sludge sorption isotherm test (OPPTS 835.1100 test 
guideline), a fish early-life stage toxicity test (OPPTS 850.1400 test 
guideline (public draft)), and a daphnid chronic toxicity test (OPPTS 
850.1300 test guideline (public draft)) would help characterize the 
environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10084.
PMN Number P-06-232
Chemical name: Substituted polyaryl sulfonium polyhalide phosphate salt 
(generic).
CAS number: Not available.
Basis for action: The PMN states that the substance will be used as a 
photo initiator used in photo-curable compositions. Based on test data 
on the PMN substance, EPA has concerns for widespread systemic toxicity 
in most organ systems, persistent eye irritation, male reproductive 
toxicity, and developmental-neurotoxicity in off-spring (caused by 
maternal thyroid toxicity) for the PMN material. As described in the 
PMN, worker inhalation and eye exposure are not expected. Therefore, 
EPA has not determined that the proposed manufacturing, processing, or 
use of the substance may present an unreasonable risk. EPA has 
determined, however, that domestic manufacture or the use of the 
substance other than as described in the PMN may cause serious health 
effects. Based on this information, the PMN substance meets the concern 
criteria at Sec.  721.170(b)(3)(i).
Recommended testing: EPA has determined that the results of a combined 
repeated dose toxicity study with the reproduction/developmental 
screening test (OPPTS 870.3650 test guideline) would help characterize 
the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10085.
PMN Number P-06-295
Chemical name: Ethane, 2-(difluoromethoxy)-1,1,1-trifluoro-.
CAS number: 1885-48-9.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as an intermediate. Based on test data on 
structural analogues, EPA has concerns for solvent neurotoxicity, 
solvent irritation, and developmental toxicity for the PMN substance. 
As described in the PMN, only limited worker dermal and

[[Page 53478]]

inhalation exposures are expected. Therefore, EPA has not determined 
that the proposed manufacturing, processing, or use of the substance 
may present an unreasonable risk. EPA has determined, however, that use 
of the substance other than as an intermediate with workers wearing 
impervious gloves may cause serious human health effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-day 
inhalation toxicity study (OPPTS 870.3465 test guideline) with a 
neurotoxicity functional observational battery (National Technical 
Information Service (NTIS) PB 91-154617) and neuropathology would help 
characterize the human health effects of the PMN substance.
CFR citation: 40 CFR 721.10086.
PMN Number P-06-332
Chemical name: Substituted alkyl phosphine oxide (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-confidential) 
use of the substance will be as a bonded flame retardant. Based on test 
data on analogous alkyl and aryl phosphates, EPA believes the PMN 
substance may cause delayed neurotoxicity in humans. At the production 
volume stated in the PMN, significant human exposure is unlikely. 
Therefore, EPA has not determined that the proposed manufacturing, 
processing, or use of the substance may present an unreasonable risk. 
EPA has determined, however, that increased importation or production 
volumes may result in increased exposure to the PMN substance which may 
cause significant adverse human health effects. Based on this 
information, the PMN substance meets the concern criteria at Sec.  
721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of an acute 
and 28-day delayed neurotoxicity of organophosphorus substances study 
(OPPTS 870.6100 test guideline) would help characterize the human 
health effects of the PMN substance.
CFR citation: 40 CFR 721.10087.
PMN Number P-07-283
Chemical name: Thiophene, 2,5-dibromo-3-hexyl-.
CAS number: 116971-11-0.
Basis for action: The PMN states that the substance will be used as a 
reactive intermediate monomer for use in manufacturing a p-type organic 
semiconductor polymer. The polymer will be used in printed organic 
electronics applications. Based on structure activity relationship 
analyses for thiophenes, EPA is concerned that toxicity to aquatic 
organisms may occur at concentrations above 1 ppb of the PMN substance 
in surface waters. At the production volume stated in the PMN, releases 
of the PMN substance are not expected to result in surface water 
concentrations above 1 ppb. Therefore, EPA has not determined that the 
proposed manufacturing, processing, or use of the substance may present 
an unreasonable risk. EPA has determined, however, that increased 
production or importation volumes or other uses of the substance 
resulting in surface water concentrations above 1 ppb may cause 
significant adverse environmental effects. Based on this information, 
the PMN substance meets the concern criteria at Sec.  
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of an algal 
toxicity test, tiers I and II (OPPTS 850.5400 test guideline (public 
draft)), a fish early-life stage toxicity test (OPPTS 850.1400 test 
guideline (public draft)), and a daphnid chronic toxicity test (OPPTS 
850.1300 test guideline (public draft)) would help characterize the 
environmental effects of the PMN substance. The fish and daphnid tests 
should use flow-through conditions and measured concentrations.
CFR citation: 40 CFR 721.10088.

IV. Objectives and Rationale of the Rule

A. Rationale

    During review of the PMNs submitted for the chemical substances 
that are subject to these SNURs, EPA concluded that for one of the 38 
chemical substances, regulation was warranted under section 5(e) of 
TSCA, pending the development of information sufficient to make a 
reasoned evaluation of the health effects of the chemical substance. 
The basis for such findings is outlined in Unit III. Based on these 
findings, a TSCA section 5(e) consent order requiring the use of 
appropriate exposure controls was negotiated with the PMN submitter; 
the SNUR provisions for this chemical substance listed in this document 
are consistent with the provisions of the TSCA section 5(e) consent 
order.
    In the other 37 cases for which the proposed uses are not regulated 
under a TSCA section 5(e) consent order, EPA determined that one or 
more of the criteria of concern established at 40 CFR 721.170 were met, 
as discussed in Unit III.

B. Objectives

    EPA is issuing these SNURs for specific chemical substances which 
have undergone premanufacture review because the Agency wants to 
achieve the following objectives with regard to the significant new 
uses designated in this rule:
    1. EPA will receive notice of any person's intent to manufacture, 
import, or process a listed chemical substance for the described 
significant new use before that activity begins.
    2. EPA will have an opportunity to review and evaluate data 
submitted in a SNUN before the notice submitter begins manufacturing, 
importing, or processing a listed chemical substance for the described 
significant new use.
    3. EPA will be able to regulate prospective manufacturers, 
importers, or processors of a listed chemical substance before the 
described significant new use of that chemical substance occurs, 
provided that regulation is warranted pursuant to TSCA sections 5(e), 
5(f), 6 or 7.
    4. EPA will ensure that all manufacturers, importers, and 
processors of the same chemical substance that is subject to a TSCA 
section 5(e) consent order are subject to similar requirements.
    Issuance of a SNUR for a chemical substance does not signify that 
the chemical substance is listed on the TSCA Inventory. Manufacturers, 
importers, and processors are responsible for ensuring that a new 
chemical substance subject to a final SNUR is listed on the TSCA 
Inventory.

V. Direct Final Procedures

    EPA is issuing these S