Tris carbamoyl triazine; Proposed Modification of Significant New Uses, 46678-46683 [2011-19412]

Download as PDF 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 VerDate Mar<15>2010 16:11 Aug 02, 2011 Jkt 223001 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] BILLING CODE 4830–01–P PO 00000 Frm 00028 Fmt 4702 Sfmt 4702 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: E:\FR\FM\03AUP1.SGM 03AUP1 emcdonald on DSK2BSOYB1PROD with PROPOSALS Federal Register / Vol. 76, No. 149 / Wednesday, August 3, 2011 / Proposed Rules 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 VerDate Mar<15>2010 16:11 Aug 02, 2011 Jkt 223001 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 PO 00000 Frm 00029 Fmt 4702 Sfmt 4702 46679 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 E:\FR\FM\03AUP1.SGM 03AUP1 46680 Federal Register / Vol. 76, No. 149 / Wednesday, August 3, 2011 / Proposed Rules emcdonald on DSK2BSOYB1PROD with PROPOSALS 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 VerDate Mar<15>2010 16:11 Aug 02, 2011 Jkt 223001 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 PO 00000 Frm 00030 Fmt 4702 Sfmt 4702 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 E:\FR\FM\03AUP1.SGM 03AUP1 Federal Register / Vol. 76, No. 149 / Wednesday, August 3, 2011 / Proposed Rules 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. emcdonald on DSK2BSOYB1PROD with PROPOSALS 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 VerDate Mar<15>2010 16:11 Aug 02, 2011 Jkt 223001 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. PO 00000 Frm 00031 Fmt 4702 Sfmt 4702 46681 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 E:\FR\FM\03AUP1.SGM 03AUP1 46682 Federal Register / Vol. 76, No. 149 / Wednesday, August 3, 2011 / Proposed Rules 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 emcdonald on DSK2BSOYB1PROD with PROPOSALS 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 VerDate Mar<15>2010 16:11 Aug 02, 2011 Jkt 223001 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 PO 00000 Frm 00032 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, E:\FR\FM\03AUP1.SGM 03AUP1 Federal Register / Vol. 76, No. 149 / Wednesday, August 3, 2011 / Proposed Rules 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. VerDate Mar<15>2010 16:11 Aug 02, 2011 Jkt 223001 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 PO 00000 Frm 00033 Fmt 4702 Sfmt 9990 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 E:\FR\FM\03AUP1.SGM 03AUP1

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.

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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
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