Modifications of Significant New Uses:
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
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: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
Hand Delivery: OPPT Document Control Office (DCO), EPA
East 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 http://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 http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available electronically at http://www.regulations.gov, or, if only available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566-1744, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
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:
-
General Information
-
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.
-
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.
-
-
Background
-
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.
-
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.
-
-
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.
-
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.
-
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.
-
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 http://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.
-
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 http://www.epa.gov/opptintr/newchems.
-
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.
-
Statutory and Executive Order Reviews
-
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).
-
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.
-
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.
-
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).
-
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).
-
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.
-
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.
-
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.
-
-
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.
-
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
-
