
[Federal Register Volume 77, Number 26 (Wednesday, February 8, 2012)]
[Rules and Regulations]
[Pages 6476-6479]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-2909]



[[Page 6476]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2011-0108; FRL-9330-6]
RIN 2070-AB27


Modification of Significant New Uses of Tris Carbamoyl Triazine

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is finalizing an amendment to the significant new use rule 
(SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) 
for the chemical substance identified generically as tris carbamoyl 
triazine, which was the subject to premanufacture notice (PMN) P-95-
1098. This action requires persons who intend to manufacture, import, 
or process the chemical substance for a use that is designated as a 
significant new use by this final rule to notify EPA at least 90 days 
before commencing that activity. EPA believes that this action is 
necessary because new uses of the chemical substance may be hazardous 
to human health. The required notification would provide EPA with the 
opportunity to evaluate the intended use and, if necessary, to prohibit 
or limit that activity before it occurs.

DATES: This final rule is effective March 9, 2012.

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPPT-2011-0108. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket 
Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave. 
NW., Washington, DC. The EPA/DC Public Reading Room hours of operation 
are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number of the EPA/DC Public Reading Room is 
(202) 566-1744, and the telephone number for the OPPT Docket is (202) 
566-0280. Docket visitors are required to show photographic 
identification, pass through a metal detector, and sign the EPA visitor 
log. All visitor bags are processed through an X-ray machine and 
subject to search. Visitors will be provided an EPA/DC badge that must 
be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
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; email 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; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. 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 manufacturing 
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 
and 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 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 the 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.

II. Background

A. What action is the agency taking?

    EPA is finalizing an amendment to the SNUR for the chemical 
substance identified generically as tris carbamoyl triazine (PMN P-95-
1098) codified at 40 CFR 721.9719. This final action requires persons 
who intend to manufacture, import, or process the chemical substance 
for an activity that is designated as a significant new use by this 
final rule to notify EPA at least 90 days before commencing that 
activity.
    This rule was proposed in the Federal Register issue of August 3, 
2011 (76 FR 46678) (FRL-8878-3). EPA received no public comments in 
response to the proposal. Therefore, the Agency is issuing a final 
SNUR, as proposed that:
    1. Identifies those forms of the PMN substance that are exempt from 
the provisions of the SNUR. These exemptions apply to quantities of the 
PMN substance after it has been completely reacted (cured).
    2. Adds protection in the workplace requirements under Sec.  721.63 
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 under Sec.  721.72 
to add the human health hazard and exposures and remove the 
environmental hazards and exposures.
    4. Removes all release to water requirements under Sec.  721.90.
    5. Revises the recordkeeping requirements under Sec.  721.125 to 
reflect the modified significant new uses.

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,

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including the four bulleted TSCA section 5(a)(2) factors, listed in 
Unit IV. of this document. 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. Persons who must report are described in Sec.  
721.5.

III. Rationale for the 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 the proposed rule to amend this 
SNUR, included in the Federal Register issue of August 3, 2011 (76 FR 
46678) 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 was 
negotiated with the PMN submitter. The SNUR provisions for this 
chemical substance were consistent with the provisions of the original 
TSCA section 5(e) consent order. The 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 PMN P-95-1098 (see Unit II. of the 
proposed rule) and consideration of the factors included in TSCA 
section 5(a)(2) (see Unit IV. of this document), EPA determined that 
the chemical substance may pose an unreasonable risk to human health, 
but also that the finding that certain activities involving the 
substance may present an unreasonable risk to the environment was no 
longer supported. Consequently, EPA is finalizing this modification to 
the SNUR at Sec.  721.9719 according to procedures in Sec.  721.160 and 
Sec.  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.

IV. 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 of 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.

V. Applicability of Rule to Uses Occurring Before Effective Date of the 
Final Rule

    As discussed in the Federal Register issue of April 24, 1990 (55 FR 
17376), EPA has decided that the intent of TSCA section 5(a)(1)(B) is 
best served by designating a use as a significant new use as of the 
date of publication of the proposed SNUR rather than as of the 
effective date of the final 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 proposed significant new use before the rule 
became effective, and then argue that the use was ongoing as of the 
effective date of the final rule.
    Any persons who began commercial manufacture, import, or processing 
activities with the chemical substance identified generically as tris 
carbamoyl triazine (PMN P-95-1098), for any of the significant new uses 
designated in the proposed SNUR modification after the date of 
publication of the proposed SNUR, must stop that activity before the 
effective date of this final rule. Persons who ceased those activities 
will have to meet all SNUR notice requirements and wait until the end 
of the notice review period, including all extensions, before engaging 
in any activities designated as significant new uses.
    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.  [emsp14]721.45(h), the person would 
be considered to have met the requirements of this 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.
    The recommended testing specified in Unit II.A. of the proposed 
rule 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 substances.
     Potential benefits of the chemical substances.
     Information on risks posed by the chemical substances 
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

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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 http://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 
substance 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 action modifies 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 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 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 modified SNUR will 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 FY 2006, six in FY 2007, eight in FY 
2008, and seven in FY 2009. 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, EPA believes that the potential economic 
impacts of complying with this modified SNUR is not expected to be 
significant or adversely impact a substantial number of small entities. 
In a SNUR that published in the Federal Register issue 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 reasons to believe that any 
State, local, or Tribal government will be impacted by this final rule. 
As such, EPA has determined that this final rule 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 Unfunded Mandates Reform Act of 1995 
(UMRA) (Pub. L. 104-4).

E. Executive Order 13132

    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

    This final rule does not have Tribal implications because it is not 
expected to have substantial direct effects on Indian Tribes. This 
final rule does not significantly nor 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 9, 2000), do not apply 
to this final 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 action 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.

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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).

X. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and 
the Comptroller General of the United States. EPA will submit a report 
containing this 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 rule in the Federal Register. 
This 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: February 1, 2012.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.

    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. Amend Sec.  721.9719 as follows:
0
a. Revise paragraphs (a)(1), (a)(2)(i), and (a)(2)(ii).
0
b. Remove paragraph (a)(2)(iii).
0
c. Revise paragraph (b)(1).
0
d. Remove paragraph (b)(3).
    The revisions read as follows:


Sec.  721.9719  Tris carbamoyl triazine (generic).

    (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)(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 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. 2012-2909 Filed 2-7-12; 8:45 am]
BILLING CODE 6560-50-P


