Tris carbamoyl triazine; Proposed Modification of Significant New Uses, 46678-46683 [2011-19412]
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46678
Federal Register / Vol. 76, No. 149 / Wednesday, August 3, 2011 / Proposed Rules
Send submissions to:
CC:PA:LPD:PR (REG–120391–10), room
5205, Internal Revenue Service, P.O.
Box 7604, Ben Franklin Station,
Washington, DC 20044. Submissions
may be hand-delivered to:
CC:PA:LPD:PR (REG–120391–10),
Courier’s Desk, Internal Revenue
Service, 1111 Constitution Avenue,
NW., Washington, DC 20224.
Alternatively, taxpayers may submit
comments electronically via the Federal
eRulemaking Portal at https://
www.regulations.gov (IRS REG–120391–
10).
FOR FURTHER INFORMATION CONTACT:
Concerning the regulations, Karen Levin
at 202–622–6080; concerning
submissions of comments, Treena
Garrett at 202–622–7180 (not toll-free
numbers).
ADDRESSES:
SUPPLEMENTARY INFORMATION:
Background and Explanation of
Provisions
The temporary regulations published
elsewhere in this issue of the Federal
Register amend § 54.9815–2713T of the
Miscellaneous Excise Tax Regulations.
The proposed and temporary
regulations are being published as part
of a joint rulemaking with the
Department of Labor and the
Department of Health and Human
Services (the joint rulemaking). The text
of those temporary regulations also
serves as the text of these proposed
regulations. The preamble to the
temporary regulations explains the
temporary regulations and these
proposed regulations.
emcdonald on DSK2BSOYB1PROD with PROPOSALS
Special Analyses
It has been determined that this notice
of proposed rulemaking is not a
significant regulatory action as defined
in Executive Order 12866. Therefore, a
regulatory assessment is not required. It
has also been determined that section
553(b) of the Administrative Procedure
Act (5 U.S.C. chapter 5) does not apply
to these regulations, and because the
regulation does not impose a collection
of information requirement on small
entities, the Regulatory Flexibility Act
(5 U.S.C. chapter 6) does not apply.
Pursuant to section 7805(f) of the
Internal Revenue Code, this regulation
has been submitted to the Chief Counsel
for Advocacy of the Small Business
Administration for comment on its
impact on small business.
Comments and Requests for a Public
Hearing
Before these proposed regulations are
adopted as final regulations,
consideration will be given to any
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written comments (a signed original and
eight (8) copies) or electronic comments
that are submitted timely to the IRS.
Comments are specifically requested on
the clarity of the proposed regulations
and how they may be made easier to
understand. All comments will be
available for public inspection and
copying. A public hearing may be
scheduled if requested in writing by a
person that timely submits written
comments. If a public hearing is
scheduled, notice of the date, time, and
place for the hearing will be published
in the Federal Register.
Drafting Information
The principal author of these
proposed regulations is Karen Levin,
Office of the Division Counsel/Associate
Chief Counsel (Tax Exempt and
Government Entities), IRS. The
proposed regulations, as well as the
temporary regulations, have been
developed in coordination with
personnel from the U.S. Department of
Labor and the U.S. Department of
Health and Human Services.
List of Subjects in 26 CFR Part 54
Excise taxes, Health care, Health
insurance, Pensions, Reporting and
recordkeeping requirements.
Proposed Amendments to the
Regulations
Accordingly, 26 CFR part 54, as
proposed to be amended on July 19,
2010, at 75 FR 41787. is further
proposed to be amended as follows:
PART 54—PENSION EXCISE TAXES
Paragraph 1. The authority citation
for part 54 continues to read in part as
follows:
Authority: 26 U.S.C. 7805 * * *
Par. 2. Section 54.9815–2713, as
proposed to be added at 75 FR 41788,
July 19, 2010, is amended by revising
paragraph (a)(1)(iv) to read as follows:
§ 54.9815–2713 Coverage of preventive
health services.
(a) * * *
(1) * * *
(iv) [The text of proposed § 54.9815–
2713(a)(1)(iv) is the same as the text of
§ 54.9815–2713T(a)(1)(iv) published
elsewhere in this issue of the Federal
Register].
*
*
*
*
*
Steven T. Miller,
Deputy Commissioner for Services and
Enforcement.
[FR Doc. 2011–19685 Filed 8–1–11; 8:45 am]
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 721
[EPA–HQ–OPPT–2011–0108; FRL–8878–3]
RIN 2070–AB27
Tris carbamoyl triazine; Proposed
Modification of Significant New Uses
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
Under section 5(a)(2) of the
Toxic Substances Control Act (TSCA),
EPA is proposing to amend the
significant new use rule (SNUR) for the
chemical substance identified
generically as tris carbamoyl triazine,
which was the subject to
premanufacture notice (PMN) P–95–
1098. This action would amend the
SNUR to allow certain uses without
requiring a significant new use notice
(SNUN), and would extend SNUN
requirements to certain additional uses.
EPA is proposing this amendment based
on review of new toxicity test data.
DATES: Comments must be received on
or before September 2, 2011.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2011–0108, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Document Control Office
(7407M), Office of Pollution Prevention
and Toxics (OPPT), Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001.
• Hand Delivery: OPPT Document
Control Office (DCO), EPA East Bldg.,
Rm. 6428, 1201 Constitution Ave., NW.,
Washington, DC. Attention: Docket ID
Number EPA–HQ–OPPT–2011–0108.
The DCO is open from 8 a.m. to 4 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
DCO is (202) 564–8930. Such deliveries
are only accepted during the DCO’s
normal hours of operation, and special
arrangements should be made for
deliveries of boxed information.
Instructions: Direct your comments to
docket ID number EPA–HQ–OPPT–
2011–0108. EPA’s policy is that all
comments received will be included in
the docket without change and may be
made available on-line at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
SUMMARY:
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whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through regulations.gov or email. The regulations.gov Web site is an
‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an 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 docket and made available
on the Internet. If you submit an
electronic comment, EPA recommends
that you include your name and other
contact information in the body of your
comment and with any disk or CD–ROM
you submit. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
EPA may not be able to consider your
comment. Electronic files should avoid
the use of special characters, any form
of encryption, and be free of any defects
or viruses.
Docket: All documents in the docket
are listed in the docket index available
at https://www.regulations.gov. Although
listed in the index, some information is
not publicly available, e.g., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
will be publicly available only in hard
copy. Publicly available docket
materials are available electronically at
https://www.regulations.gov, or, if only
available in hard copy, at the OPPT
Docket. The OPPT Docket is located in
the EPA Docket Center (EPA/DC) at Rm.
3334, EPA West Bldg., 1301
Constitution Ave., NW., Washington,
DC. The EPA/DC Public Reading Room
hours of operation are 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding
legal holidays. The telephone number of
the EPA/DC Public Reading Room is
(202) 566–1744, and the telephone
number for the OPPT Docket is (202)
566–0280. Docket visitors are required
to show photographic identification,
pass through a metal detector, and sign
the EPA visitor log. All visitor bags are
processed through an X-ray machine
and subject to search. Visitors will be
provided an EPA/DC badge that must be
visible at all times in the building and
returned upon departure.
FOR FURTHER INFORMATION CONTACT: For
technical information contact: Tracey
Klosterman, Chemical Control Division
(7405M), Office of Pollution Prevention
and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001; telephone
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number: (202) 564–2209; e-mail
address: klosterman.tracey@epa.gov.
For general information contact: The
TSCA–Hotline, ABVI–Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; e-mail address: TSCA–
Hotline@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 substance
identified generically as tris carbamoyl
triazine (PMN P–95–1098). Potentially
affected entities may include, but are
not limited to:
• Manufacturers, importers, or
processors of the subject chemical
substance (NAICS codes 325 and
324110), e.g., chemical manufacturers
and petroleum refineries.
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
§ 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. Chemical importers
are subject to the TSCA section 13 (15
U.S.C. 2612) import certification
requirements promulgated at 19 CFR
12.118 through 12.127; see also 19 CFR
127.28. Chemical importers must certify
that the shipment of the chemical
substance complies with all applicable
rules and orders under TSCA. Importers
of chemicals subject to a final SNUR
must certify their compliance with the
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 a proposed or final
SNUR are subject to the export
notification provisions of TSCA section
12(b) (15 U.S.C. 2611(b)) (see § 721.20),
and must comply with the export
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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?
In the Federal Register of August 20,
1998 (63 FR 44562) (FRL–5788–7), EPA
published a final SNUR (codified at
§ 721.9719) for the chemical substance
identified generically as tris carbamoyl
triazine (PMN P–95–1098), in
accordance with the procedures at
§ 721.160.
EPA is proposing to amend the
requirements of the SNUR as detailed in
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this unit. The modified SNUR would
require persons who intend to
manufacture, import, or process the
chemical substance for an activity
designated as a significant new use to
notify EPA at least 90 days before
commencing that activity. The docket
established for this proposed SNUR is
available under docket ID number EPA–
HQ–OPPT–2011–0108. The docket
includes information considered by the
Agency in developing the final rule and
the modified TSCA section 5(e) consent
order negotiated with the PMN
submitter.
PMN Number P–95–1098
Chemical name: Tris carbamoyl
triazine (generic).
CAS number: Not available.
Effective date of the TSCA section 5(e)
consent order: April 25, 1997.
Effective date of the modified TSCA
section 5(e) consent order: December 1,
2010.
Federal Register publication date and
reference for the final SNUR: August 20,
1998 (63 FR 44562).
Basis for the modified TSCA section
5(e) consent order: The generic (nonconfidential) use of the PMN substance
is as a cross linking resin. The original
TSCA section 5(e) consent order was
issued under sections 5(e)(1)(A)(i),
5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II)
based on the findings that the chemical
substance may present an unreasonable
risk of injury to the environment, that it
will be produced in substantial
quantities, and there may be significant
or substantial human exposure to the
chemical substance. The original 5(e)
consent order required establishment of
a hazard communication program;
established a maximum manufacture
and importation volume limit for
submission of required human health
testing; and prohibited purposeful or
predictable releases of the PMN
substance in concentrations that exceed
40 parts per billion (ppb) in surface
waters. The proposed SNUR for this
chemical substance is based on and
consistent with the provisions of the
modified TSCA section 5(e) consent
order, discussed below. The proposed
SNUR designates as a ‘‘significant new
use’’ the absence of the protective
measures required in the corresponding
modified consent order.
Human Health Toxicity Concerns:
During the initial PMN review process,
EPA established a no-observable-effect
level (NOEL) of 15 mg/kg/day and a
lowest-observable-effect level (LOEL) of
150 mg/kg/day for systemic effects
based on the results of a 28-day
inhalation study in rats on the PMN
substance, but did not determine that
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the PMN substance may present an
unreasonable risk to human health as a
result of expected exposure. However,
the TSCA section 5(e) consent order
required the PMN submitter to complete
and submit a prenatal developmental
toxicity study at a certain production
volume limit. This is consistent with the
exposure-based finding pursuant to
section 5(e)(1)(A)(ii)(II) of TSCA. The
PMN submitter completed this study
and based on the results the Agency
established a NOEL of 30 mg/kg/day for
maternal toxicity and 1,000 mg/kg/day
for fetal toxicity. Using the results from
both this prenatal developmental study
and the earlier 28-day study, the Agency
then reevaluated the predicted
workplace exposures and determined
that there may be an unreasonable risk
of maternal and systemic toxicity
resulting from unprotected inhalation
exposure to the PMN substance.
Ecotoxicity Concerns: In addition, to
address Agency environmental
concerns, the PMN submitter completed
a fish early-life stage toxicity test and a
daphnid chronic toxicity test on the
PMN substance. During the initial
review of the PMN, EPA’s preliminary
Ecological Structural Activity
Relationship (EcoSAR) analysis of test
data on structurally analogous
substances resulted in a predicted
toxicity to aquatic organisms at
concentrations that exceed the
concentration of concern (COC) of 40
ppb of the PMN substance in surface
waters. Based on the results of the
submitted fish and daphnid tests, fish
were identified as the most sensitive
species and a revised COC for aquatic
toxicity of 66 ppb was established.
Based on the revised COC, EPA then
performed environmental modeling
assessments for the PMN releases to
surface waters and determined that the
new COC would not be exceeded under
expected conditions of manufacture,
import, processing, distribution in
commerce, use or disposal of the PMN
substance.
The Agency concluded, after
examining this new information and
reexamining the test data and other
information supporting its findings
under section 5(e)(1)(A)(ii)(I) of TSCA in
the original TSCA section 5(e) consent
order, that the finding that certain
activities involving the substance may
present an unreasonable risk of injury to
the environment is no longer supported.
The Agency also concluded that certain
additional activities involving the
substance may present an unreasonable
risk of injury to human health, pursuant
to 5(e)(1)(A)(ii)(I). To conform with
these findings and to protect against the
remaining potential risks, the Agency
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has modified the TSCA section 5(e)
consent order (‘‘modified order’’); these
modifications became effective on
December 1, 2010. The modified TSCA
section 5(e) consent order:
1. Identifies those forms of the PMN
substance that are exempt from the
provisions of the consent order. These
exemptions apply to quantities of the
PMN substance after it has been
completely reacted (cured).
2. Adds protection in the workplace
requirements for respiratory protection
and alternative New Chemical Exposure
Limit (NCEL) exposure monitoring to
address the newly-identified potential
risks from inhalation exposure in the
workplace.
3. Revises the hazard communication
requirements to add the human health
hazard and exposures and remove the
environmental hazards and exposures.
4. Removes all release to water
requirements.
5. Revises the recordkeeping
requirements to reflect the
aforementioned modified consent order
requirements.
The proposed rule would conform to
the scope of the significant new uses in
the SNUR to mirror the modified
consent order.
Recommended testing: EPA has
determined that the results of the 90-day
inhalation toxicity test in rats (OPPTS
Test Guideline 870.3465) would help
further characterize the human health
effects of the PMN substance. The
modified TSCA section 5(e) consent
order does not require submission of the
aforementioned information at any
specified time or production volume.
However, the order’s restrictions on
manufacturing, import, processing,
distribution in commerce, use and
disposal of the PMN substance will
remain in effect until the order is
modified or revoked by EPA based on
submission of that or other relevant
information.
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 the TSCA section 5(a)(2)
factors, listed in Unit III. of this
document. Once EPA determines that a
use of a chemical substance is a
significant new use, TSCA section
5(a)(1)(B) and 40 CFR part 721 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
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use. Persons who must report are
described in § 721.5.
EPA may respond to SNUNs by,
among other things, issuing or
modifying a TSCA section 5(e) consent
order and/or amending the SNUR
promulgated under TSCA section
5(a)(2). Amendment of the SNUR will
often be necessary to allow persons
other than the SNUN submitter to
engage in the newly authorized use(s),
because even after a person submits a
SNUN and the review period expires,
other persons still must submit a SNUN
before manufacturing on processing for
the significant new use. Procedures and
criteria for modifying or revoking SNUR
requirements appear at § 721.185.
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III. Significant New Use Determination
Section 5(a)(2) of TSCA states that
EPA’s determination that a use of a
chemical substance is a significant new
use must be made after consideration of
all relevant factors, including:
• The projected volume of
manufacturing and processing of a
chemical substance.
• The extent to which a use changes
the type or form of exposure to human
beings or the environment to a chemical
substance.
• The extent to which a use increases
the magnitude and duration of exposure
of human beings or the environment to
a chemical substance.
• The reasonably anticipated manner
and methods of manufacturing,
processing, distribution in commerce,
and disposal of a chemical substance.
In addition to these factors
enumerated in TSCA section 5(a)(2), the
statute authorizes EPA to consider any
other relevant factors.
To determine what would constitute a
significant new use for the chemical
substance identified generically as Tris
carbamoyl triazine (PMN P–95–1098),
EPA considered relevant information
about the toxicity of the chemical
substance, likely human exposures and
environmental releases associated with
possible uses, taking into consideration
the four bulleted TSCA section 5(a)(2)
factors listed in this unit.
IV. Rationale for the Proposed Rule
During review of PMN P–95–1098, the
chemical substance identified
generically as tris carbamoyl triazine,
EPA concluded that regulation was
warranted under TSCA section 5(e),
pending the development of information
sufficient to make reasoned evaluations
of the health or environmental effects of
this chemical substance. The basis for
such findings is outlined in Unit II. of
this notice and in the Federal Register
document of August 20, 1998 (63 FR
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44562) (FRL–5788–7). Based on these
findings, a TSCA section 5(e) consent
order requiring the use of appropriate
exposure controls were negotiated with
the PMN submitter. The SNUR
provisions for this chemical substance
are consistent with the provisions of the
original TSCA section 5(e) consent
order. This SNUR was promulgated
pursuant to § 721.160.
After the review of test data submitted
pursuant to the TSCA section 5(e)
consent order for P–95–1098 (see Unit
II.) and consideration of the factors
included in TSCA section 5(a)(2) (see
Unit III.), EPA determined that the
chemical substance may pose an
unreasonable risk to human health, but
no longer may present an unreasonable
risk to the environment. Consequently,
EPA is proposing this modification to
the SNUR at § 721.9719 according to
procedures in §§ 721.160 and 721.185 so
that SNUR provisions for this chemical
substance remain consistent with the
provisions of the TSCA section 5(e)
consent order, as modified.
V. Applicability of Proposed 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. EPA solicits comments on
whether any of the uses proposed 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
use as of the date of publication of the
proposed rule, rather than as of the
effective date of the final rule. If uses
begun after publication of the proposed
rule 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, any persons who begin
commercial manufacture, import, or
processing activities with the chemical
substances that are not currently a
significant new use under the current
rule but which would be regulated as a
‘‘significant new use’’ if this proposed
rule if this rule is finalized, must cease
any such activity as of the effective date
of the rule if and when finalized. 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.
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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 § 721.45(h),
the person would be considered to have
met the requirements of the final SNUR
for those activities.
VI. Test Data and Other Information
EPA recognizes that TSCA section 5
does not require the development of any
particular test data before submission of
a SNUN. There are two exceptions:
1. Development of test data is
required where the chemical substance
subject to the SNUR is also subject to a
test rule under TSCA section 4 (see
TSCA section 5(b)(1)).
2. Development of test data may be
necessary where the chemical substance
has been listed under TSCA section
5(b)(4) (see TSCA section 5(b)(2)).
In the absence of a TSCA section 4
test rule or a TSCA section 5(b)(4)
listing covering the chemical substance,
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 (see
§ 720.50). However, upon review of
PMNs and SNUNs, the Agency has the
authority to require appropriate testing.
In this case, EPA recommends persons,
before performing any testing, to consult
with the Agency pertaining to protocol
selection. To access the Harmonized
Test Guidelines referenced in this
document electronically, please go to
https://www.epa.gov/ocspp and select
‘‘Test Methods and Guidelines.’’
The modified TSCA section 5(e)
consent order for the chemical
substance that would be regulated under
this proposed rule does not require
submission of the test at any specified
time or volume. However, the
restrictions on manufacture, import,
processing, distribution in commerce,
use and disposal of the PMN substance
would remain in effect until the consent
order is modified or revoked by EPA
based on submission of that or other
relevant information. These restricted
activities cannot be commenced 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. The test specified in the
modified TSCA section 5(e) consent
order is included in Unit II. The
proposed SNUR would contain the same
restrictions as the modified TSCA
section 5(e) consent order. Persons who
intend to commence non-exempt
commercial manufacture, import, or
processing for those activities proposed
as significant new uses would be
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required to notify the Agency by
submitting a SNUN at least 90 days in
advance of commencement of those
activities.
The recommended testing specified in
Unit II. of this document may not be the
only means of addressing the potential
risks of the chemical substance.
However, SNUNs submitted 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 PMN or SNUN
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:
• Human exposure and
environmental release that may result
from the significant new use of the
chemical substance.
• Potential benefits of the chemical
substance.
• Information on risks posed by the
chemical substance compared to risks
posed by potential substitutes.
VII. SNUN Submissions
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
§ 720.50. SNUNs must be on EPA Form
No. 7710–25, generated using e-PMN
software, and submitted to the Agency
in accordance with the procedures set
forth in §§ 721.25 and 720.40. E–PMN
software is available electronically at
https://www.epa.gov/opptintr/newchems.
VIII. Economic Analysis
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EPA evaluated the potential costs of
establishing SNUN requirements for
potential manufacturers, importers, and
processors of the chemical substances
during the development of the direct
final rule. The Agency’s complete
Economic Analysis is available in the
docket under docket ID number EPA–
HQ–OPPT–2011–0108.
IX. Statutory and Executive Order
Reviews
A. Executive Order 12866
This proposed rule would modify a
SNUR for a chemical substance that is
the subject of a PMN and TSCA section
5(e) consent order. The Office of
Management and Budget (OMB) has
exempted these types of actions from
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review under Executive Order 12866,
entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993).
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. EPA is amending the table in
40 CFR part 9 to list the OMB approval
number for the information collection
requirements contained in this proposed
rule. This listing of the OMB control
numbers and their subsequent
codification in the CFR satisfies the
display requirements of PRA and OMB’s
implementing regulations at 5 CFR part
1320. This Information Collection
Request (ICR) was previously subject to
public notice and comment prior to
OMB approval, and given the technical
nature of the table, EPA finds that
further notice and comment to amend it
is unnecessary. As a result, EPA finds
that there is ‘‘good cause’’ under section
553(b)(3)(B) of the Administrative
Procedure Act, 5 U.S.C. 553(b)(3)(B), to
amend this table without further notice
and comment.
The information collection
requirements related to this action have
already been approved by OMB
pursuant to PRA under OMB control
number 2070–0012 (EPA ICR No. 574).
This action would 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
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Fmt 4702
Sfmt 4702
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
would not have a significant adverse
economic impact on a substantial
number of small entities. The rationale
supporting this conclusion is discussed
in this unit. The requirement to submit
a SNUN 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.’’ Because these uses are
‘‘new,’’ based on all information
currently available to EPA, it appears
that no small or large entities presently
engage in such activities. A SNUR
requires that any person who intends to
engage in such activity in the future
must first notify EPA by submitting a
SNUN. Although some small entities
may decide to pursue a significant new
use 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 SNURs covering over 1,000
chemicals, the Agency receives only a
handful of notices per year. For
example, the number of SNUNs was
four in Federal fiscal year 2005, eight in
FY2006, six in FY2007, eight in FY2008,
and seven in FY2009. During this fiveyear period, three small entities
submitted a SNUN. In addition, the
estimated reporting cost for submission
of a SNUN (see Unit VIII.) is minimal
regardless of the size of the firm.
Therefore, the potential economic
impacts of complying with this SNUR
would not be expected to be significant
or adversely impact a substantial
number of small entities. In a SNUR that
published in the Federal Register of
June 2, 1997 (62 FR 29684) (FRL–5597–
1), the Agency presented its general
determination that 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 reason to
believe that any State, local, or Tribal
government would be impacted by this
proposed rule. As such, EPA has
determined that this proposed rule
would not impose any enforceable duty,
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contain any unfunded mandate, or
otherwise have any effect on small
governments subject to the requirements
of sections 202, 203, 204, or 205 of the
Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104–4).
E. Executive Order 13132
This action would 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
This proposed rule would not have
Tribal implications because it is not
expected to have substantial direct
effects on Indian Tribes. This proposed
rule would not significantly nor
uniquely affect the communities of
Indian Tribal governments, nor would 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 9, 2000), do not apply
to this proposed rule.
G. Executive Order 13045
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
emcdonald on DSK2BSOYB1PROD with PROPOSALS
This proposed 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 and because this
action is not a significant regulatory
action under Executive Order 12866.
I. National Technology Transfer and
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.
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J. Executive Order 12898
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).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
Dated: July 22, 2011.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and
Toxics.
Therefore, 40 CFR part 721 is
proposed to be amended as follows:
PART 721—[AMENDED]
1. The authority citation for part 721
continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and
2625(c).
2. Amend § 721.9719 as follows:
a. Revise the section heading.
b. Revise paragraphs (a)(1), (a)(2)(i),
and (a)(2)(ii).
c. Remove paragraph (a)(2)(iii).
d. Revise paragraph (b)(1).
e. Remove paragraph (b)(3).
The revisions and addition read as
follows:
§ 721.9719
Tris carbamoyl triazine.
(a) * * *
(1) The chemical substance identified
generically as tris carbamoyl triazine
(PMN P–95–1098) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section. The requirements of this
rule do not apply to quantities of the
chemical substance after it has been
completely reacted (cured).
(2) * * *
(i) Protection in the workplace.
Requirements as specified in § 721.63
(a)(4), (a)(5), (a)(6)(v), (b) (concentration
set at 1.0 percent), and (c). Respirators
must provide a National Institute for
Occupational Safety and Health
(NIOSH) assigned protection factor
(APF) of at least 5. As an alternative to
the respiratory requirements listed, a
manufacturer, importer, or processor
may choose to follow the new chemical
exposure limit (NCEL) provisions listed
in the Toxic Substances Control Act
(TSCA) section 5(e) consent order for
this substance. The NCEL is 1.0 mg/m3
as an 8-hour time weighted average.
Persons who wish to pursue NCELs as
an alternative to the § 721.63 respirator
requirements may request to do so
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46683
under § 721.30. Persons whose § 721.30
requests to use the NCELs approach are
approved by EPA will receive NCELs
provisions comparable to those
contained in the corresponding section
5(e) consent order. The following
NIOSH-certified respirators meet the
requirements for § 721.63(a)(4):
(A) Air purifying, tight-fitting halfface respirator equipped with the
appropriate combination cartridges;
cartridges should be tested and
approved for the gas/vapor substance
(i.e., organic vapor, acid gas, or
substance-specific cartridge) and should
include a particulate filter (N100 if oil
aerosols are absent, R100, or P100);
(B) Air purifying, tight-fitting full-face
respirator equipped with the
appropriate combination cartridges,
cartridges should be tested and
approved for the gas/vapor substance
(i.e., organic vapor, acid gas, or
substance-specific cartridge) and should
include a particulate filter (N100 if oil
aerosols are absent, R100, or P100);
(C) Powered air-purifying respirator
equipped with loose-fitting hood or
helmet equipped with a High Efficiency
Particulate Air (HEPA) filter; powered
air-purifying respirator equipped with
tight-fitting facepiece (either half-face or
full-face) equipped with a High
Efficiency Particulate Air (HEPA) filter;
(D) Supplied-air respirator operated in
pressure demand or continuous flow
mode and equipped with a hood or
helmet, or tight-fitting face piece (either
half-face or full-face).
(ii) Hazard communication program.
Requirements as specified in § 721.72
(a), (b), (c), (d), (e) (concentration set at
1.0 percent), (f), (g)(1)(ii), (g)(1)(iv),
(g)(1)(ix), (g)(2)(ii), (g)(2)(iv), and (g)(5).
(b) * * *
(1) Recordkeeping. Recordkeeping
requirements as specified in § 721.125
(a), (b), (c), (d), (f), (g), and (h) are
applicable to manufacturers, importers,
and processors of this substance.
*
*
*
*
*
[FR Doc. 2011–19412 Filed 8–2–11; 8:45 am]
BILLING CODE 6560–50–P
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Agencies
[Federal Register Volume 76, Number 149 (Wednesday, August 3, 2011)]
[Proposed Rules]
[Pages 46678-46683]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19412]
=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2011-0108; FRL-8878-3]
RIN 2070-AB27
Tris carbamoyl triazine; Proposed Modification of Significant New
Uses
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: Under section 5(a)(2) of the Toxic Substances Control Act
(TSCA), EPA is proposing to amend the significant new use rule (SNUR)
for the chemical substance identified generically as tris carbamoyl
triazine, which was the subject to premanufacture notice (PMN) P-95-
1098. This action would amend the SNUR to allow certain uses without
requiring a significant new use notice (SNUN), and would extend SNUN
requirements to certain additional uses. EPA is proposing this
amendment based on review of new toxicity test data.
DATES: Comments must be received on or before September 2, 2011.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2011-0108, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC.
Attention: Docket ID Number EPA-HQ-OPPT-2011-0108. The DCO is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the DCO is (202) 564-8930. Such deliveries are
only accepted during the DCO's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2011-0108. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
https://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information
[[Page 46679]]
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 Web site is an
``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an 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 docket and made available on the Internet. If you submit
an electronic comment, EPA recommends that you include your name and
other contact information in the body of your comment and with any disk
or CD-ROM you submit. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.
Docket: All documents in the docket are listed in the docket index
available at https://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at https://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number of the EPA/DC Public Reading Room
is (202) 566-1744, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Tracey Klosterman, Chemical Control Division (7405M), Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202) 564-2209; e-mail address: klosterman.tracey@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; e-mail address: TSCA-Hotline@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 substance identified generically
as tris carbamoyl triazine (PMN P-95-1098). Potentially affected
entities may include, but are not limited to:
Manufacturers, importers, or processors of the subject
chemical substance (NAICS codes 325 and 324110), e.g., chemical
manufacturers and petroleum refineries.
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 Sec. 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. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements promulgated at 19 CFR 12.118 through 12.127;
see also 19 CFR 127.28. Chemical importers must certify that the
shipment of the chemical substance complies with all applicable rules
and orders under TSCA. Importers of chemicals subject to a final SNUR
must certify their compliance with the 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 a proposed or final SNUR are
subject to the export notification provisions of TSCA section 12(b) (15
U.S.C. 2611(b)) (see Sec. 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?
In the Federal Register of August 20, 1998 (63 FR 44562) (FRL-5788-
7), EPA published a final SNUR (codified at Sec. 721.9719) for the
chemical substance identified generically as tris carbamoyl triazine
(PMN P-95-1098), in accordance with the procedures at Sec. 721.160.
EPA is proposing to amend the requirements of the SNUR as detailed
in
[[Page 46680]]
this unit. The modified SNUR would require persons who intend to
manufacture, import, or process the chemical substance for an activity
designated as a significant new use to notify EPA at least 90 days
before commencing that activity. The docket established for this
proposed SNUR is available under docket ID number EPA-HQ-OPPT-2011-
0108. The docket includes information considered by the Agency in
developing the final rule and the modified TSCA section 5(e) consent
order negotiated with the PMN submitter.
PMN Number P-95-1098
Chemical name: Tris carbamoyl triazine (generic).
CAS number: Not available.
Effective date of the TSCA section 5(e) consent order: April 25,
1997.
Effective date of the modified TSCA section 5(e) consent order:
December 1, 2010.
Federal Register publication date and reference for the final SNUR:
August 20, 1998 (63 FR 44562).
Basis for the modified TSCA section 5(e) consent order: The generic
(non-confidential) use of the PMN substance is as a cross linking
resin. The original TSCA section 5(e) consent order was issued under
sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II) based
on the findings that the chemical substance may present an unreasonable
risk of injury to the environment, that it will be produced in
substantial quantities, and there may be significant or substantial
human exposure to the chemical substance. The original 5(e) consent
order required establishment of a hazard communication program;
established a maximum manufacture and importation volume limit for
submission of required human health testing; and prohibited purposeful
or predictable releases of the PMN substance in concentrations that
exceed 40 parts per billion (ppb) in surface waters. The proposed SNUR
for this chemical substance is based on and consistent with the
provisions of the modified TSCA section 5(e) consent order, discussed
below. The proposed SNUR designates as a ``significant new use'' the
absence of the protective measures required in the corresponding
modified consent order.
Human Health Toxicity Concerns: During the initial PMN review
process, EPA established a no-observable-effect level (NOEL) of 15 mg/
kg/day and a lowest-observable-effect level (LOEL) of 150 mg/kg/day for
systemic effects based on the results of a 28-day inhalation study in
rats on the PMN substance, but did not determine that the PMN substance
may present an unreasonable risk to human health as a result of
expected exposure. However, the TSCA section 5(e) consent order
required the PMN submitter to complete and submit a prenatal
developmental toxicity study at a certain production volume limit. This
is consistent with the exposure-based finding pursuant to section
5(e)(1)(A)(ii)(II) of TSCA. The PMN submitter completed this study and
based on the results the Agency established a NOEL of 30 mg/kg/day for
maternal toxicity and 1,000 mg/kg/day for fetal toxicity. Using the
results from both this prenatal developmental study and the earlier 28-
day study, the Agency then reevaluated the predicted workplace
exposures and determined that there may be an unreasonable risk of
maternal and systemic toxicity resulting from unprotected inhalation
exposure to the PMN substance.
Ecotoxicity Concerns: In addition, to address Agency environmental
concerns, the PMN submitter completed a fish early-life stage toxicity
test and a daphnid chronic toxicity test on the PMN substance. During
the initial review of the PMN, EPA's preliminary Ecological Structural
Activity Relationship (EcoSAR) analysis of test data on structurally
analogous substances resulted in a predicted toxicity to aquatic
organisms at concentrations that exceed the concentration of concern
(COC) of 40 ppb of the PMN substance in surface waters. Based on the
results of the submitted fish and daphnid tests, fish were identified
as the most sensitive species and a revised COC for aquatic toxicity of
66 ppb was established. Based on the revised COC, EPA then performed
environmental modeling assessments for the PMN releases to surface
waters and determined that the new COC would not be exceeded under
expected conditions of manufacture, import, processing, distribution in
commerce, use or disposal of the PMN substance.
The Agency concluded, after examining this new information and
reexamining the test data and other information supporting its findings
under section 5(e)(1)(A)(ii)(I) of TSCA in the original TSCA section
5(e) consent order, that the finding that certain activities involving
the substance may present an unreasonable risk of injury to the
environment is no longer supported. The Agency also concluded that
certain additional activities involving the substance may present an
unreasonable risk of injury to human health, pursuant to
5(e)(1)(A)(ii)(I). To conform with these findings and to protect
against the remaining potential risks, the Agency has modified the TSCA
section 5(e) consent order (``modified order''); these modifications
became effective on December 1, 2010. The modified TSCA section 5(e)
consent order:
1. Identifies those forms of the PMN substance that are exempt from
the provisions of the consent order. These exemptions apply to
quantities of the PMN substance after it has been completely reacted
(cured).
2. Adds protection in the workplace requirements for respiratory
protection and alternative New Chemical Exposure Limit (NCEL) exposure
monitoring to address the newly-identified potential risks from
inhalation exposure in the workplace.
3. Revises the hazard communication requirements to add the human
health hazard and exposures and remove the environmental hazards and
exposures.
4. Removes all release to water requirements.
5. Revises the recordkeeping requirements to reflect the
aforementioned modified consent order requirements.
The proposed rule would conform to the scope of the significant new
uses in the SNUR to mirror the modified consent order.
Recommended testing: EPA has determined that the results of the 90-
day inhalation toxicity test in rats (OPPTS Test Guideline 870.3465)
would help further characterize the human health effects of the PMN
substance. The modified TSCA section 5(e) consent order does not
require submission of the aforementioned information at any specified
time or production volume. However, the order's restrictions on
manufacturing, import, processing, distribution in commerce, use and
disposal of the PMN substance will remain in effect until the order is
modified or revoked by EPA based on submission of that or other
relevant information.
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 the TSCA section 5(a)(2) factors, listed in
Unit III. of this document. Once EPA determines that a use of a
chemical substance is a significant new use, TSCA section 5(a)(1)(B)
and 40 CFR part 721 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
[[Page 46681]]
use. Persons who must report are described in Sec. 721.5.
EPA may respond to SNUNs by, among other things, issuing or
modifying a TSCA section 5(e) consent order and/or amending the SNUR
promulgated under TSCA section 5(a)(2). Amendment of the SNUR will
often be necessary to allow persons other than the SNUN submitter to
engage in the newly authorized use(s), because even after a person
submits a SNUN and the review period expires, other persons still must
submit a SNUN before manufacturing on processing for the significant
new use. Procedures and criteria for modifying or revoking SNUR
requirements appear at Sec. 721.185.
III. Significant New Use Determination
Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure to human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorizes EPA to consider any other relevant factors.
To determine what would constitute a significant new use for the
chemical substance identified generically as Tris carbamoyl triazine
(PMN P-95-1098), EPA considered relevant information about the toxicity
of the chemical substance, likely human exposures and environmental
releases associated with possible uses, taking into consideration the
four bulleted TSCA section 5(a)(2) factors listed in this unit.
IV. Rationale for the Proposed Rule
During review of PMN P-95-1098, the chemical substance identified
generically as tris carbamoyl triazine, EPA concluded that regulation
was warranted under TSCA section 5(e), pending the development of
information sufficient to make reasoned evaluations of the health or
environmental effects of this chemical substance. The basis for such
findings is outlined in Unit II. of this notice and in the Federal
Register document of August 20, 1998 (63 FR 44562) (FRL-5788-7). Based
on these findings, a TSCA section 5(e) consent order requiring the use
of appropriate exposure controls were negotiated with the PMN
submitter. The SNUR provisions for this chemical substance are
consistent with the provisions of the original TSCA section 5(e)
consent order. This SNUR was promulgated pursuant to Sec. 721.160.
After the review of test data submitted pursuant to the TSCA
section 5(e) consent order for P-95-1098 (see Unit II.) and
consideration of the factors included in TSCA section 5(a)(2) (see Unit
III.), EPA determined that the chemical substance may pose an
unreasonable risk to human health, but no longer may present an
unreasonable risk to the environment. Consequently, EPA is proposing
this modification to the SNUR at Sec. 721.9719 according to procedures
in Sec. Sec. 721.160 and 721.185 so that SNUR provisions for this
chemical substance remain consistent with the provisions of the TSCA
section 5(e) consent order, as modified.
V. Applicability of Proposed 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. EPA solicits comments on whether any of the uses
proposed 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 use as of the date of publication of the
proposed rule, rather than as of the effective date of the final rule.
If uses begun after publication of the proposed rule 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, any persons who begin commercial manufacture, import, or
processing activities with the chemical substances that are not
currently a significant new use under the current rule but which would
be regulated as a ``significant new use'' if this proposed rule if this
rule is finalized, must cease any such activity as of the effective
date of the rule if and when finalized. 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.
VI. Test Data and Other Information
EPA recognizes that TSCA section 5 does not require the development
of any particular test data before submission of a SNUN. There are two
exceptions:
1. Development of test data is required where the chemical
substance subject to the SNUR is also subject to a test rule under TSCA
section 4 (see TSCA section 5(b)(1)).
2. Development of test data may be necessary where the chemical
substance has been listed under TSCA section 5(b)(4) (see TSCA section
5(b)(2)).
In the absence of a TSCA section 4 test rule or a TSCA section
5(b)(4) listing covering the chemical substance, 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 (see Sec.
720.50). However, upon review of PMNs and SNUNs, the Agency has the
authority to require appropriate testing. In this case, EPA recommends
persons, before performing any testing, to consult with the Agency
pertaining to protocol selection. To access the Harmonized Test
Guidelines referenced in this document electronically, please go to
https://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''
The modified TSCA section 5(e) consent order for the chemical
substance that would be regulated under this proposed rule does not
require submission of the test at any specified time or volume.
However, the restrictions on manufacture, import, processing,
distribution in commerce, use and disposal of the PMN substance would
remain in effect until the consent order is modified or revoked by EPA
based on submission of that or other relevant information. These
restricted activities cannot be commenced 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. The test specified in the modified TSCA section 5(e) consent
order is included in Unit II. The proposed SNUR would contain the same
restrictions as the modified TSCA section 5(e) consent order. Persons
who intend to commence non-exempt commercial manufacture, import, or
processing for those activities proposed as significant new uses would
be
[[Page 46682]]
required to notify the Agency by submitting a SNUN at least 90 days in
advance of commencement of those activities.
The recommended testing specified in Unit II. of this document may
not be the only means of addressing the potential risks of the chemical
substance. However, SNUNs submitted 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 PMN or SNUN 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:
Human exposure and environmental release that may result
from the significant new use of the chemical substance.
Potential benefits of the chemical substance.
Information on risks posed by the chemical substance
compared to risks posed by potential substitutes.
VII. SNUN Submissions
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 Sec. 720.50. SNUNs must be
on EPA Form No. 7710-25, generated using e-PMN software, and submitted
to the Agency in accordance with the procedures set forth in Sec. Sec.
721.25 and 720.40. E-PMN software is available electronically at https://www.epa.gov/opptintr/newchems.
VIII. Economic Analysis
EPA evaluated the potential costs of establishing SNUN requirements
for potential manufacturers, importers, and processors of the chemical
substances during the development of the direct final rule. The
Agency's complete Economic Analysis is available in the docket under
docket ID number EPA-HQ-OPPT-2011-0108.
IX. Statutory and Executive Order Reviews
A. Executive Order 12866
This proposed rule would modify a SNUR for a chemical substance
that is the subject of a PMN and TSCA section 5(e) consent order. The
Office of Management and Budget (OMB) has exempted these types of
actions from review under Executive Order 12866, entitled Regulatory
Planning and Review (58 FR 51735, October 4, 1993).
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. EPA is amending the table
in 40 CFR part 9 to list the OMB approval number for the information
collection requirements contained in this proposed rule. This listing
of the OMB control numbers and their subsequent codification in the CFR
satisfies the display requirements of PRA and OMB's implementing
regulations at 5 CFR part 1320. This Information Collection Request
(ICR) was previously subject to public notice and comment prior to OMB
approval, and given the technical nature of the table, EPA finds that
further notice and comment to amend it is unnecessary. As a result, EPA
finds that there is ``good cause'' under section 553(b)(3)(B) of the
Administrative Procedure Act, 5 U.S.C. 553(b)(3)(B), to amend this
table without further notice and comment.
The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0012 (EPA ICR No. 574). This action would 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 would not have a significant adverse economic impact on a
substantial number of small entities. The rationale supporting this
conclusion is discussed in this unit. The requirement to submit a SNUN
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.'' Because these uses are ``new,'' based on all information
currently available to EPA, it appears that no small or large entities
presently engage in such activities. A SNUR requires that any person
who intends to engage in such activity in the future must first notify
EPA by submitting a SNUN. Although some small entities may decide to
pursue a significant new use 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 SNURs covering over
1,000 chemicals, the Agency receives only a handful of notices per
year. For example, the number of SNUNs was four in Federal fiscal year
2005, eight in FY2006, six in FY2007, eight in FY2008, and seven in
FY2009. During this five-year period, three small entities submitted a
SNUN. In addition, the estimated reporting cost for submission of a
SNUN (see Unit VIII.) is minimal regardless of the size of the firm.
Therefore, the potential economic impacts of complying with this SNUR
would not be expected to be significant or adversely impact a
substantial number of small entities. In a SNUR that published in the
Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency
presented its general determination that 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 reason to believe that any
State, local, or Tribal government would be impacted by this proposed
rule. As such, EPA has determined that this proposed rule would not
impose any enforceable duty,
[[Page 46683]]
contain any unfunded mandate, or otherwise have any effect on small
governments subject to the requirements of sections 202, 203, 204, or
205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).
E. Executive Order 13132
This action would 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
This proposed rule would not have Tribal implications because it is
not expected to have substantial direct effects on Indian Tribes. This
proposed rule would not significantly nor uniquely affect the
communities of Indian Tribal governments, nor would 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 9,
2000), do not apply to this proposed rule.
G. Executive Order 13045
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
This proposed 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 and because this action is not a significant
regulatory action under Executive Order 12866.
I. National Technology Transfer and 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
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).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: July 22, 2011.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.
Therefore, 40 CFR part 721 is proposed to be amended as follows:
PART 721--[AMENDED]
1. The authority citation for part 721 continues to read as
follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
2. Amend Sec. [emsp14]721.9719 as follows:
a. Revise the section heading.
b. Revise paragraphs (a)(1), (a)(2)(i), and (a)(2)(ii).
c. Remove paragraph (a)(2)(iii).
d. Revise paragraph (b)(1).
e. Remove paragraph (b)(3).
The revisions and addition read as follows:
Sec. 721.9719 Tris carbamoyl triazine.
(a) * * *
(1) The chemical substance identified generically as tris carbamoyl
triazine (PMN P-95-1098) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
The requirements of this rule do not apply to quantities of the
chemical substance after it has been completely reacted (cured).
(2) * * *
(i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(4), (a)(5), (a)(6)(v), (b) (concentration set at 1.0
percent), and (c). Respirators must provide a National Institute for
Occupational Safety and Health (NIOSH) assigned protection factor (APF)
of at least 5. As an alternative to the respiratory requirements
listed, a manufacturer, importer, or processor may choose to follow the
new chemical exposure limit (NCEL) provisions listed in the Toxic
Substances Control Act (TSCA) section 5(e) consent order for this
substance. The NCEL is 1.0 mg/m\3\ as an 8-hour time weighted average.
Persons who wish to pursue NCELs as an alternative to the Sec. 721.63
respirator requirements may request to do so under Sec. 721.30.
Persons whose Sec. 721.30 requests to use the NCELs approach are
approved by EPA will receive NCELs provisions comparable to those
contained in the corresponding section 5(e) consent order. The
following NIOSH-certified respirators meet the requirements for Sec.
721.63(a)(4):
(A) Air purifying, tight-fitting half-face respirator equipped with
the appropriate combination cartridges; cartridges should be tested and
approved for the gas/vapor substance (i.e., organic vapor, acid gas, or
substance-specific cartridge) and should include a particulate filter
(N100 if oil aerosols are absent, R100, or P100);
(B) Air purifying, tight-fitting full-face respirator equipped with
the appropriate combination cartridges, cartridges should be tested and
approved for the gas/vapor substance (i.e., organic vapor, acid gas, or
substance-specific cartridge) and should include a particulate filter
(N100 if oil aerosols are absent, R100, or P100);
(C) Powered air-purifying respirator equipped with loose-fitting
hood or helmet equipped with a High Efficiency Particulate Air (HEPA)
filter; powered air-purifying respirator equipped with tight-fitting
facepiece (either half-face or full-face) equipped with a High
Efficiency Particulate Air (HEPA) filter;
(D) Supplied-air respirator operated in pressure demand or
continuous flow mode and equipped with a hood or helmet, or tight-
fitting face piece (either half-face or full-face).
(ii) Hazard communication program. Requirements as specified in
Sec. 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0
percent), (f), (g)(1)(ii), (g)(1)(iv), (g)(1)(ix), (g)(2)(ii),
(g)(2)(iv), and (g)(5).
(b) * * *
(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.
* * * * *
[FR Doc. 2011-19412 Filed 8-2-11; 8:45 am]
BILLING CODE 6560-50-P