[Federal Register: September 19, 2007 (Volume 72, Number 181)]
[Rules and Regulations]
[Page 53470-53487]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19se07-17]
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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: http://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 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 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 http://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
http://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 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 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 SNURs as a direct final rule, as described in
40 CFR 721.160(c)(3) and 721.170(d)(4). In accordance with 40 CFR
721.160(c)(3)(ii) and 721.170(d)(4)(i), this rule will be effective
November 19, 2007, unless EPA receives a written notice by October 19,
2007 of adverse or critical comments, or notice of intent to submit
adverse or critical comments, on EPA's action. If EPA receives such a
notice, EPA will publish a document to withdraw the direct final SNUR
for the specific chemical substance to which the adverse or critical
comments apply. EPA will then propose a SNUR for the specific chemical
substance providing a 30-day comment period.
This action establishes SNURs for a number of chemical substances.
Any person who submits adverse or critical comments or notice of intent
to submit adverse or critical comments, must identify the chemical
substance and the new use to which it applies. EPA will not withdraw a
SNUR for a chemical substance not identified in a notice.
[[Page 53479]]
VI. Test Data and Other Information
EPA recognizes that TSCA section 5 does not require developing any
particular test data before submission of a SNUN. Persons are required
only to submit test data in their possession or control and to describe
any other data known to or reasonably ascertainable by them. However,
upon review of PMNs and SNUNs, the Agency has the authority to require
appropriate testing. In cases where EPA issued a TSCA section 5(e)
consent order that requires or recommends certain testing, Unit III.
lists those tests. Unit III. also lists recommended testing for the
chemical substances that would be covered by the non-5(e) SNURs.
Descriptions of tests are provided for informational purposes. EPA
strongly encourages persons, before performing any testing, to consult
with the Agency pertaining to protocol selection. Many test guidelines
are now available on the Internet at http://www.epa.gov/opptsfrs/home/guidelin/htm.
OECD test guidelines are available from the OECD Bookshop
(http://www.oecdbookshop.org) or Source OECD (http://www
.sourceoecd.org).
In the TSCA section 5(e) consent order for the chemical notified
under P-04-909, EPA has established a production volume limit which
cannot be exceeded unless the PMN submitter first submits the results
of toxicity tests that would permit a reasoned evaluation of the
potential risks posed by this chemical substance. Under recent consent
orders, the PMN submitter is required to submit the results of the
required studies at least 14 weeks (earlier consent orders required
submissions at least 12 weeks) before reaching the specified production
limit. The tests specified in the TSCA section 5(e) consent order are
included in Unit III. The SNUR contains the same production volume
limit as the consent order. Exceeding this production limit is defined
as a significant new use. Persons who intend to exceed the production
limit must notify the Agency by submitting a SNUN at least 90 days in
advance.
The recommended tests may not be the only means of addressing the
potential risks of the chemical substances regulated under this rule.
However, SNUNs submitted for significant new uses without any test data
may increase the likelihood that EPA will take action under TSCA
section 5(e), particularly if satisfactory test results have not been
obtained from a prior submitter. EPA recommends that potential SNUN
submitters contact EPA early enough so that they will be able to
conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
1. Human exposure and environmental release that may result from
the significant new use of the chemical substances.
2. Potential benefits of the chemical substances.
3. Information on risks posed by the chemical substances compared
to risks posed by potential substitutes.
VII. Procedural Determinations
EPA is establishing through this rule certain significant new uses
which have been claimed as CBI subject to Agency confidentiality
regulations at 40 CFR part 2. EPA is required to keep this information
confidential to protect the CBI of the original PMN submitter. EPA
promulgated a procedure to deal with the situation where a specific
significant new use is CBI. This procedure appears in 40 CFR
721.1725(b)(1) and is similar to that in Sec. 721.11 for situations
where the chemical identity of the chemical substance subject to a SNUR
is CBI. This procedure is cross-referenced in each of these SNURs that
include specific significant new uses that are CBI.
A manufacturer or importer may request EPA to determine whether a
proposed use would be a significant new use under this rule. Under the
procedure in Sec. 721.1725(b)(1), a manufacturer or importer must show
that it has a bona fide intent to manufacture or import the chemical
substance and must identify the specific use for which it intends to
manufacture or import the chemical substance. If EPA concludes that the
person has shown a bona fide intent to manufacture or import the
chemical substance, EPA will tell the person whether the use identified
in the bona fide submission would be a significant new use under the
rule. Since most of the chemical identities of the chemical substances
subject to these SNURs are also CBI, manufacturers and processors can
combine the bona fide submission under the procedure in Sec.
721.1725(b)(1) with that under Sec. 721.11 into a single step.
If a manufacturer or importer is told that the production volume
identified in the bona fide submission would not be a significant new
use, i.e., it is below the level that would be a significant new use,
that person can manufacture or import the chemical substance as long as
the aggregate amount does not exceed that identified in the bona fide
submission to EPA. If the person later intends to exceed that volume, a
new bona fide submission would be necessary to determine whether that
higher volume would be a significant new use. EPA is considering
whether to adopt a special procedure for use when CBI production volume
is designated as a significant new use. Under such a procedure, a
person showing a bona fide intent to manufacture or import the chemical
substance, under the procedure described in Sec. 721.11, would
automatically be informed of the production volume that would be a
significant new use. Thus, the person would not have to make multiple
bona fide submissions to EPA for the same chemical substance to remain
in compliance with the SNUR, as could be the case under the procedures
in Sec. 721.1725(b)(1).
VIII. Applicability of Rule to Uses Occurring Before Effective Date of
the Final Rule
To establish a significant ``new'' use, EPA must determine that the
use is not ongoing. The chemical substances subject to this rule have
recently undergone premanufacture review. A TSCA section 5(e) consent
order has been issued for one chemical substance and the notice
submitter is prohibited by the TSCA section 5(e) consent order from
undertaking activities which EPA is designating as significant new
uses. In cases where EPA has not received a notice of commencement
(NOC) and the chemical substance has not been added to the TSCA
Inventory, no other person may commence such activities without first
submitting a PMN. For chemical substances for which an NOC has not been
submitted at this time, EPA has concluded that the uses are not
ongoing. However, EPA recognizes in cases when chemical substances
identified in this SNUR are added to the TSCA Inventory prior to the
effective date of the rule, the chemical substances may be
manufactured, imported, or processed by other persons for a significant
new use as defined in this rule before the effective date of the rule.
However, 26 of the 38 chemical substances contained in this rule have
CBI chemical identities, and since EPA has received a limited number of
post-PMN bona fide submissions (per 40 CFR 720.25 and 721.11), the
Agency believes that it is highly unlikely that any of the significant
new uses described in the following regulatory text are ongoing. EPA
solicits comments on whether any of the uses described as significant
new uses are ongoing.
As discussed in the Federal Register of April 24, 1990 (55 FR
17376), EPA has decided that the intent of section 5(a)(1)(B) of TSCA
is best served by designating a use as a significant new
[[Page 53480]]
use as of the date of publication of this direct final rule rather than
as of the effective date of the rule. If uses begun after publication
were considered ongoing rather than new, it would be difficult for EPA
to establish SNUR notice requirements because a person could defeat the
SNUR by initiating the significant new use before the rule became
final, and then argue that the use was ongoing as of the effective date
of the final rule. Thus, persons who begin commercial manufacture,
import, or processing of the chemical substances regulated through this
SNUR will have to cease any such activity before the effective date of
this rule. To resume their activities, these persons would have to
comply with all applicable SNUR notice requirements and wait until the
notice review period, including all extensions, expires.
EPA has promulgated provisions to allow persons to comply with this
SNUR before the effective date. If a person were to meet the conditions
of advance compliance under Sec. 721.45(h), the person would be
considered to have met the requirements of the final SNUR for those
activities.
IX. SNUN Submissions
EPA recommends that submitters consult with the Agency prior to
submitting a SNUN to discuss what data may be useful in evaluating a
significant new use. Discussions with the Agency prior to submission
can afford ample time to conduct any tests that might be helpful in
evaluating risks posed by the substance. According to 40 CFR 721.1(c),
persons submitting a SNUN must comply with the same notice requirements
and EPA regulatory procedures as persons submitting a PMN, including
submission of test data on health and environmental effects as
described in 40 CFR 720.50.
SNUNs must be mailed to the Environmental Protection Agency, OPPT
Document Control Office (7407M), 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. Information must be submitted in the form
and manner set forth in EPA Form No. 7710-25. This form is available
from the Environmental Assistance Division (7408M), 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001 (see 40 CFR 721.25 and 720.40).
Forms and information are also available electronically at http://www.epa.gov/opptintr/newchems/pubs/pmnforms.htm
.
X. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers, importers, and processors of
the chemical substances subject to this rule. EPA's complete economic
analysis is available in the public docket.
XI. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review
Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), the Office of Management and
Budget (OMB) has determined that proposed or final SNURs are not a
``significant regulatory action'' subject to review by OMB, because
they do not meet the criteria in section 3(f) of the Executive order.
B. Paperwork Reduction Act
According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., an Agency may not conduct or sponsor, and a person is not
required to respond to a collection of information that requires OMB
approval under the PRA, unless it has been approved by OMB and displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register, are listed in 40 CFR part 9, and included on the related
collection instrument or form, if applicable.
The information collection requirements related to this action have
already been approved by OMB pursuant to the PRA under OMB control
number 2070-0012 (EPA ICR No. 574). This action does not impose any
burden requiring additional OMB approval. If an entity were to submit a
SNUN to the Agency, the annual burden is estimated to average between
30 and 170 hours per response. This burden estimate includes the time
needed to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
Collection Strategies Division, Office of Environmental Information
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. Please remember to include the OMB control
number in any correspondence, but do not submit any completed forms to
this address.
C. Regulatory Flexibility Act
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation
of this SNUR will not have a significant adverse economic impact on a
substantial number of small entities. The rationale supporting this
conclusion is as follows. A SNUR applies to any person (including small
or large entities) who intends to engage in any activity described in
the rule as a ``significant new use.'' By definition of the word
``new,'' and based on all information currently available to EPA, it
appears that no small or large entities presently engage in such
activity. Since a SNUR only requires that any person who intends to
engage in such activity in the future must first notify EPA by
submitting a SNUN, no economic impact will even occur until someone
decides to engage in those activities. Although some small entities may
decide to conduct such activities in the future, EPA cannot presently
determine how many, if any, there may be. However, EPA's experience to
date is that, in response to the promulgation of over 1,000 SNURs, the
Agency receives on average only 10 notices per year. Of those SNUNs
submitted, none appear to be from small entities in response to any
SNUR. In addition, the estimated reporting cost for submission of a
SNUN (see Unit IX.), are minimal regardless of the size of the firm.
Therefore, EPA believes that the potential economic impacts of
complying with this SNUR are not expected to be significant or
adversely impact a substantial number of small entities. In a SNUR that
published on June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency
presented it's general determination that proposed and final SNURs are
not expected to have a significant economic impact on a substantial
number of small entities, which was provided to the Chief Counsel for
Advocacy of the Small Business Administration.
D. Unfunded Mandates Reform Act
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government will be impacted by this rulemaking.
As such, EPA has determined that this regulatory action does not impose
any enforceable duty, contain any unfunded mandate, or otherwise have
any affect on small governments subject to the requirements of sections
202, 203, 204, or 205 of the
[[Page 53481]]
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).
E. Executive Order 13132: Federalism
This action will not have a substantial direct effect on States, on
the relationship between the national government and the States, or on
the distribution of power and responsibilities among the various levels
of government, as specified in Executive Order 13132, entitled
Federalism (64 FR 43255, August 10, 1999).
F. Executive Order 13175: Consultation and Coordination with Indian
Tribal Governments
This rule does not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This does
not significantly or uniquely affect the communities of Indian Tribal
governments, nor does it involve or impose any requirements that affect
Indian Tribes. Accordingly, the requirements of Executive Order 13175,
entitled Consultation and Coordination with Indian Tribal Governments
(65 FR 67249, November 6, 2000), do not apply to this rule.
G. Executive Order 13045: Protection of Children from Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997), because this is not an economically
significant regulatory action as defined by Executive Order 12866, and
this action does not address environmental health or safety risks
disproportionately affecting children.
H. Executive Order 13211: Actions that Significantly Affect Energy
Supply, Distribution, or Use
This rule is not subject to Executive Order 13211, entitled Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001), because this action
is not expected to affect energy supply, distribution, or use.
I. National Technology Transfer Advancement Act
In addition, since this action does not involve any technical
standards, section 12(d) of the National Technology Transfer and
Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15
U.S.C. 272 note), does not apply to this action.
J. Executive Order 12898: Federal Actions to Address Environmental
Justice in Minority Populations and Low-Income Populations
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898, entitled
Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
K. Executive Order 12630: Governmental Actions and Interference with
Constitutionally Protected Property Rights (Takings)
EPA has complied with Executive Order 12630, entitled Governmental
Actions and Interference with Constitutionally Protected Property
Rights (53 FR 8859, March 15, 1988), by examining the takings
implications of this rule in accordance with the ``Attorney General's
Supplemental Guidelines for the Evaluation of Risk and Avoidance of
Unanticipated Takings'' issued under the Executive order.
L. Executive Order 12988: Civil Justice Reform
In issuing this rule, EPA has taken the necessary steps to
eliminate drafting errors and ambiguity, minimize potential litigation,
and provide a clear legal standard for affected conduct, as required by
section 3 of Executive Order 12988, entitled Civil Justice Reform (61
FR 4729, February 7, 1996).
XII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a final rule may take effect, the Agency
promulgating it must submit a final rule report to each House of the
Congress and to the Comptroller General of the United States. EPA will
submit a report containing this final rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the final rule in the Federal Register. This final rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: September 6, 2007.
Charles M. Auer,
Director, Office of Pollution Prevention and Toxics.
0
Therefore, 40 CFR part 721 is amended as follows:
PART 721--[AMENDED]
0
1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
2. By adding new Sec. 721.10057 to subpart E to read as follows:
Sec. 721.10057 Dodecanedioic acid, 1, 12-dihydrazide.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as dodecanedioic acid,
1, 12-dihydrazide (PMNs P-01-759 and P-05-555; CAS No. 4080-98-2) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(1), (a)(2)(i), (a)(3), (a)(4), (a)(5), (a)(6), (b), and (c).
Respirators must provide a National Institute for Occupational Safety
and Health (NIOSH) assigned protection factor (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.
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 0.1
percent), (f), (g)(1)(i), (g)(1)(vii), (g)(1)(ix), and (g)(2)(i).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), (d), (f), (g), and (h) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The
[[Page 53482]]
provisions of Sec. 721.185 apply to this section.
0
3. By adding new Sec. 721.10058 to subpart E to read as follows:
Sec. 721.10058 Reaction product of alkylphenol, aromatic cyclicamine,
alkyl diglycidyl dibenzene, and formaldehyde (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
reaction product of alkylphenol, aromatic cyclicamine, alkyl diglycidyl
dibenzene, and formaldehyde (PMN P-03-546) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
4. By adding new Sec. 721.10059 to subpart E to read as follows:
Sec. 721.10059 Reaction product of alkylphenyl glycidyl ether,
polyalkylenepolyamine, and alkyl diglycidyl dibenzene (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
reaction product of alkylphenyl glycidyl ether, polyalkylenepolyamine,
and alkyl diglycidyl dibenzene (PMN P-03-550) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
5. By adding new Sec. 721.10060 to subpart E to read as follows:
Sec. 721.10060 Reaction product of alkylphenyl glycidyl ether,
polyalkylenepolyamine, alkyl diglycidyl dibenzene, and
polyalkylcyclicdiamine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
reaction product of alkylphenyl glycidyl ether, polyalkylenepolyamine,
alkyl diglycidyl dibenzene, and polyalkylcyclicdiamine (PMN P-03-551)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
6. By adding new Sec. 721.10061 to subpart E to read as follows:
Sec. 721.10061 Pentane, 1,1,1,2,2,3,4,5,5,5-decafluoro-3-methoxy-4-
(trifluoromethyl)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as pentane,
1,1,1,2,2,3,4,5,5,5-decafluoro-3-methoxy-4-(trifluoromethyl)- (PMN P-
04-341; CAS No. 132182-92-4) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
7. By adding new Sec. 721.10062 to subpart E to read as follows:
Sec. 721.10062 2,5-Furandione, polymer with oxybis[propanol],
benzoate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2,5-furandione,
polymer with oxybis[propanol], benzoate (PMN P-04-627; CAS No. 103458-
14-6) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
8. By adding new Sec. 721.10063 to subpart E to read as follows:
Sec. 721.10063 Halo substituted hydroxy nitrophenyl amide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as halo
substituted hydroxy nitrophenyl amide (PMN P-04-792) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
9. By adding new Sec. 721.10064 to subpart E to read as follows:
[[Page 53483]]
Sec. 721.10064 2-Propenoic acid, 2-[2-(ethenyloxy)ethoxy]ethyl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propenoic acid,
2-[2-(ethenyloxy)ethoxy]ethyl ester (PMN P-04-909; CAS No. 86273-46-3)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(1), (a)(2)(i), (a)(3)(i), (b), and (c). North Butyl Black
gloves and T-1 Dailove Ethylene Vinylalcohol Copolymer Laminated Blue
gloves have been demonstrated to satisfy (a)(3)(i). Other demonstrated
impervious gloves that satisfy (a)(3)(i) are also permissible.
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (f), (g)(1)(i), (g)(1)(iv),
(g)(1)(vi), (g)(1)(ix), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(v),
and (g)(5).
(iii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(q).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), (d), (e), (f), (g), (h), and (i) are applicable
to manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
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10. By adding new Sec. 721.10065 to subpart E to read as follows:
Sec. 721.10065 1-Tetradecanesulfonic acid, (dimethylphenyl)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-
tetradecanesulfonic acid, (dimethylphenyl)- (PMN P-04-961; CAS No.
671756-61-9) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
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11. By adding new Sec. 721.10066 to subpart E to read as follows:
Sec. 721.10066 1-Hexanesulfonic acid, (dimethylphenyl)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-hexanesulfonic
acid, (dimethylphenyl)- (PMN P-04-962; CAS No. 676143-36-5) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
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12. By adding new Sec. 721.10067 to subpart E to read as follows:
Sec. 721.10067 Ether amine phosphonate salt (generic).
(a) Chemical substances and significant new uses subject to
reporting. (1) The chemical substances identified generically as ether
amine phosphonate salt (PMNs 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) are subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
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13. By adding new Sec. 721.10069 to subpart E to read as follows:
Sec. 721.10069 Ether amine phosphonate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as ether
amine phosphonate (PMN P-05-60) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
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14. By adding new Sec. 721.10070 to subpart E to read as follows:
Sec. 721.10070 1,3-Butanediol, 3-methyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,3-butanediol, 3-
methyl- (PMN P-05-309; CAS No. 2568-33-4) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (f) and (j)(use as inkjet ink).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
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15. By adding new Sec. 721.10071 to subpart E to read as follows:
[[Page 53484]]
Sec. 721.10071 9H-Thioxanthenium, 10-[1,1'-biphenyl]-4-yl-2-(1-
methylethyl)-9-oxo-, hexafluorophosphate (1-) (1:1).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 9H-thioxanthenium,
10-[1,1'-biphenyl]-4-yl-2-(1-methylethyl)-9-oxo-, hexafluorophosphate
(1-) (1:1) (PMN P-05-364; CAS No. 591773-92-1) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (f), (v)(2), (w)(2), and (x)(2).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
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16. By adding new Sec. 721.10072 to subpart E to read as follows:
Sec. 721.10072 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).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
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 (PMN P-05-380) is subject to reporting under this section
for the significant new uses described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(y)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
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17. By adding new Sec. 721.10073 to subpart E to read as follows:
Sec. 721.10073 Modified alkyl acrylamide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
modified alkyl acrylamide (PMN P-05-536) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
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18. By adding new Sec. 721.10074 to subpart E to read as follows:
Sec. 721.10074 Acetic acid, 2-chloro-, 1-(3,3-
dimethylcyclohexyl)ethyl ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as acetic acid, 2-
chloro-, 1-(3,3-dimethylcyclohexyl)ethyl ester (PMN P-05-568; CAS No.
477218-59-0) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(h).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
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19. By adding new Sec. 721.10075 to subpart E to read as follows:
Sec. 721.10075 Carbon black, 4-[[2-(Sulfooxy) ethyl]substituted]
phenyl- modified, sodium salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as carbon
black, 4-[[2-(Sulfooxy) ethyl]substituted] phenyl-modified, sodium
salts (PMN P-05-722) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(1), (a)(2)(i), (a)(3), (b) (concentration set at 1 percent),
and (c).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (j), (v)(1), (w)(1), and (x)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), (d), (e) and (i) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
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20. By adding new Sec. 721.10076 to subpart E to read as follows:
Sec. 721.10076 Substituted benzenediamine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted benzenediamine (PMN P-05-792) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=2).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to
[[Page 53485]]
manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
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21. By adding new Sec. 721.10077 to subpart E to read as follows:
Sec. 721.10077 3H-1,2,4-Triazol-3-one, 1,2-dihydro-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 3H-1,2,4-triazol-3-
one, 1,2-dihydro- (PMNs P-06-1 and P-06-166; CAS No. 930-33-6) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(4), (a)(5), (a)(6), (b), and (c). Respirators must provide a
National Institute for Occupational Safety and Health (NIOSH) assigned
protection factor of at least 10. The following NIOSH-approved
respirators with an assigned protection factor (APF) of 10-25 meet the
minimum requirements for Sec. 721.63(a)(4): Air-purifying, tight-
fitting respirator equipped with N100 (if aerosols absent), R100, or
P100 filters (either half- or full-face); powered air-purifying
respirator equipped with a loose-fitting hood or helmet and High
Efficiency Particulate Air (HEPA) filters; powered air-purifying
respirator equipped with a tight-fitting facepiece (either half- or
full-face) and HEPA filters; and supplied-air respirator operated in
pressure demand or continuous flow mode and equipped with a hood or
helmet or tight-fitting facepiece (either half- or full-face).
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (g)(1)(ix), (g)(2)(iv), (g)(3)(ii), and (g)(4)(iii).
(iii) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), (d), (f), (g), (h), and (k) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
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22. By adding new Sec. 721.10078 to subpart E to read as follows:
Sec. 721.10078 Butanamide, 2-[(2-methoxy-4-nitrophenyl)azo]-N-(2-
methoxyphenyl)-3-oxo-, 4-[(17-substituted-3,6,9,12,15-pentaazaheptadec-
1-yl)substituted]phenyl derivs., hydrochlorides (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
butanamide, 2-[(2-methoxy-4-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxo-
, 4-[(17-substituted-3,6,9,12,15-pentaazaheptadec-1-
yl)substituted]phenyl derivs., hydrochlorides (PMN P-06-4) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=10).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
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23. By adding new Sec. 721.10079 to subpart E to read as follows:
Sec. 721.10079 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).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
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 (PMN P-06-7) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(1), (a)(2)(i), (a)(3), (b) (concentration set at 1 percent),
and (c).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (j), (v)(1), (w)(1), and (x)(1).
(iii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=10).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), (d), (e), (i), and (k) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
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24. By adding new Sec. 721.10080 to subpart E to read as follows:
Sec. 721.10080 Carbon black, 4-[(17-substituted-3,6,9,12,15-
pentaazaheptadec-1-yl) substituted] phenyl-modified, hydrochlorides
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as carbon
black, 4-[(17-substituted-3,6,9,12,15-pentaazaheptadec-1-yl)
substituted] phenyl-modified, hydrochlorides (PMN P-06-8) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(1), (a)(2)(i), (a)(3), (b) (concentration set at 1 percent),
and (c).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (j), (v)(1), (w)(1), and (x)(1).
(iii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=10).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), (d), (e), (i), and (k) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
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25. By adding new Sec. 721.10081 to subpart E to read as follows:
Sec. 721.10081 Aromatic urethane acrylate oligomer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aromatic urethane
[[Page 53486]]
acrylate oligomer (PMN P-06-26) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
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26. By adding new Sec. 721.10082 to subpart E to read as follows:
Sec. 721.10082 Amine modified monomer acrylate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as amine
modified monomer acrylate (PMN P-06-29) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
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27. By adding new Sec. 721.10083 to subpart E to read as follows:
Sec. 721.10083 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).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 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 (PMN
P-06-70) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(1), (a)(2)(i), (a)(3), (b) (concentration set at 1 percent),
and (c).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (j), (v)(1), (w)(1), and (x)(1).
(iii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=10).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), (d), (e), (i), and (k) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
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28. By adding new Sec. 721.10084 to subpart E to read as follows:
Sec. 721.10084 Modified thionocarbamate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
modified thionocarbamate (PMN P-06-124 is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
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29. By adding new Sec. 721.10085 to subpart E to read as follows:
Sec. 721.10085 Substituted polyaryl sulfonium polyhalide phosphate
salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted polyaryl sulfonium polyhalide phosphate salt (PMN P-06-232)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (f) and (j) (photo initiator used in
photo-curable compositions).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
30. By adding new Sec. 721.10086 to subpart E to read as follows:
Sec. 721.10086 Ethane, 2-(difluoromethoxy)-1,1,1-trifluoro-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as ethane, 2-
(difluoromethoxy)-1,1,1-trifluoro- (PMN P-06-295; CAS No. 1885-48-9) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(1), (a)(2)(i), (a)(3), (b), and (c).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(g).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), (d), (e) and (i) are applicable to
manufacturers, importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
31. By adding new Sec. 721.10087 to subpart E to read as follows:
[[Page 53487]]
Sec. 721.10087 Substituted alkyl phosphine oxide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted alkyl phosphine oxide (PMN P-06-332) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(s) (100,000 kilograms/year).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
0
32. By adding new Sec. 721.10088 to subpart E to read as follows:
Sec. 721.10088 Thiophene, 2,5-dibromo-3-hexyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as thiophene, 2,5-
dibromo-3-hexyl- (PMN P-07-283; CAS No. 116971-11-0) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(s) (500 kilograms).
(ii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (N=1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), (i), and (k) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[FR Doc. E7-18502 Filed 9-18-07; 8:45 am]
BILLING CODE 6560-50-S