[Federal Register Volume 62, Number 156 (Wednesday, August 13, 1997)] [Proposed Rules] [Pages 43297-43301] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-21412] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 721 [OPPTS-50627; FRL-5720-2] RIN 2070-AB27 Significant New Uses of Certain Chemical Substances AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: EPA is proposing significant new use rules (SNURs) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for four chemical substances which are the subject of premanufacture notices (PMNs) P-95-1584, P-96-1674/1675, and P-97-267. This proposal would require certain persons who intend to manufacture, import, or process these substances for a significant new use to notify EPA at least 90 days before commencing any manufacturing, importing, or processing activities for a use designated by this SNUR as a significant new use. The required notice would provide EPA with the opportunity to evaluate the intended use, and if necessary, to prohibit or limit that activity before it can occur. DATES: Written comments must be received by EPA by September 12, 1997. ADDRESSES: Each comment must bear the docket control number OPPTS-50627 and the name(s) of the chemical substance(s) subject to the comment. All comments should be sent in triplicate to: OPPT Document Control Officer (7407), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 401 M Street, SW., Room G-099, East Tower, Washington, DC 20460. Comments and data may also be submitted electronically by following instructions under Unit IX of this document. No confidential business information (CBI) should be submitted through e-mail. All comments which are claimed confidential must be clearly marked as such. Three additional sanitized copies of any comments containing CBI must also be submitted. Nonconfidential versions of comments on this rule will be placed in the rulemaking record and will be available for public inspection. FOR FURTHER INFORMATION CONTACT: Susan Hazen, Director, Environmental Assistance Division (7408), Office of Toxic Substances, Environmental Protection Agency, Rm. E-543B, 401 M St., SW., Washington, DC 20460, telephone: (202) 554-1404, TDD: (202) 554-0551; e-mail: TSCA- H[email protected]. SUPPLEMENTARY INFORMATION: This proposed SNUR would require persons to notify EPA at least 90 days before commencing the manufacture, import, or processing of P-95-1584, P-96-1674/1675, and P-97-267 for the significant new uses designated herein. The required notice would provide EPA with information with which to evaluate an intended use and associated activities. I. Authority 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 [[Page 43298]] ``significant new use.'' EPA must make this determination by rule after considering all relevant factors, including those listed in section 5(a)(2). Once EPA determines that a use of a chemical substance is a significant new use, section 5(a)(1)(B) of TSCA requires persons to submit a notice to EPA at least 90 days before they manufacture, import, or process the substance for that use. The mechanism for reporting under this requirement is established under 40 CFR 721.10. II. Applicability of General Provisions General provisions for SNURs appear under subpart A of 40 CFR part 721. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the final rule. Provisions relating to user fees appear at 40 CFR part 700. Persons subject to this SNUR must comply with the same notice requirements and EPA regulatory procedures as submitters of PMNs under section 5(a)(1)(A) of TSCA. In particular, these requirements include the information submission requirements of section 5(b) and 5(d)(1), the exemptions authorized by section 5 (h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUR notice, EPA may take regulatory action under section 5 (e), 5(f), 6, or 7 to control the activities on which it has received the SNUR notice. If EPA does not take action, EPA is required under section 5(g) to explain in the Federal Register its reasons for not taking action. Persons who intend to export a substance identified in a proposed or final SNUR are subject to the export notification provisions of TSCA section 12(b). The regulations that interpret section 12(b) appear at 40 CFR part 707. Persons who intend to import a chemical substance identified in a final SNUR are subject to the TSCA section 13 import certification requirements, which are codified at 19 CFR 12.118 through 12.127 and 127.28. Such persons must certify that they are in compliance with SNUR requirements. The EPA policy in support of the import certification appears at 40 CFR part 707. III. Substances Subject to This Rule EPA is proposing significant new use and recordkeeping requirements for the following chemical substances under 40 CFR part 721, subpart E. In this unit, EPA provides a brief description for each substance, including its PMN number, chemical name (generic name if the specific name is claimed as CBI), CAS number (if assigned), basis for the action taken by EPA for the substance (including the statutory citation and specific finding), toxicity concern, recommended testing, and the CFR citation assigned in the regulatory text section of this rule. The specific uses which are designated as significant new uses are cited in the regulatory text section of this document by reference to 40 CFR part 721, subpart E where the significant new uses are described in detail. Certain new uses are claimed as CBI. The procedure for obtaining confidential information is set out in Unit VI of this preamble. Data on potential exposures or releases of the substances, testing other than that specified in the section 5(e) order for the substances, or studies on analogous substances, which may demonstrate that the significant new uses being reported do not present an unreasonable risk, may be included with significant new use notification. Persons submitting a SNUN must comply with the same notice requirements and EPA regulatory procedures as submitters of PMNs, as stated in 40 CFR 721.1(c), including submission of test data on health and environmental effects as described in 40 CFR 720.50. PMN Number P-95-1584 Chemical name: Organosolv lignin. CAS number: 8068-03-9. Basis for action: The PMN substance will have the following uses: (1) As a phenolic resin substitute for wood adhesives, rubber trackifer and brake pads; (2) an additive to enhance degradability of polymer blends; and (3) as a moisture barrier for paper lamination. Based on structural activity relationships derived from test data on structurally similar phenols and aldehydes, EPA expects toxicity to aquatic organisms to occur at a concentration of 10 parts per billion (ppb) PMN substance in surface waters. Use of the PMN substance could result in releases that significantly exceeded the concern level. However if the PMN substance is manufactured, processed or used with a number average molecular weight greater than or equal to 1000 daltons (an oligomer content less than 10 percent below molecular weight 500 and less than 25 percent below molecular weight 1000), EPA does not have environmental concerns for aquatic toxicity. EPA determined that uses of the substance as described in the PMN did not present an unreasonable risk to the environment because the submitter would manufacture, process, and use the PMN substance with a number average molecular weight greater than or equal to 1000 daltons (an oligomer content less than 10 percent below molecular weight 500 and less than 25 percent below molecular weight 1000). EPA has determined that uses of the substance in any other molecular weight form may result in toxicity to the aquatic environment. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(b)(3)(iii). Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400), a daphnid acute toxicity study (40 CFR 797.1300), an algal acute toxicity study (40 CFR 797.1050), a ready biodegradability study (OPPTS 835.3110 test guideline (public draft)) and an anaerobic biodegradation study (OPPTS 835.3400 test guideline (public draft)) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.5460. PMN Numbers P-96-1674/1675 Chemical name: Alkyl amino nitriles. CAS number: Not available. Basis for action: The PMN substances will be used as intermediates. Based on submitted test data and test data for analogous substances, EPA is concerned that workers exposed via the ocular route may be at risk of death. There is also concern for acute oral and dermal toxicity. EPA determined that use of the substances as described in the PMN did not present an unreasonable risk because workers would not be subject to significant exposures. EPA has determined that use other than as an intermediate, in non-industrial uses, and use of the substances without appropriate protective equipment and adequate hazard communication may result in significant exposure to workers. Based on this information the PMN substances meet the concern critera at Sec. 721.170(b)(3)(i) and (b)(3)(ii). Recommended testing: EPA has determined that an acute dermal toxicity study in rabbits (OPPTS 870.1200 test guideline (public draft)) would help characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.555. PMN Number P-97-267 Chemical name: (generic) Substituted carbazate. CAS number: Not available. Basis for action: The PMN substance will be used in an enclosed process. Based on analogy to hydrazines there are concerns for liver toxicity, developmental toxicity, oncogenicity, and mutagenicity. Based on submitted toxicity data there are concerns for lethality via the oral, dermal, inhalation, [[Page 43299]] and eye routes and for neurotoxicity. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because workers would not be subject to significant exposures. EPA has determined that uses of the substance in a non-enclosed process, without appropriate hazard communication, and other than for the specific use designated in the PMN may result in significant exposures to workers. Based on this information the PMN substance meets the concern criteria at Sec. 721.170 (b)(1)(i)(c), (b)(3)(i), and (b)(3)(ii). Recommended testing: None. CFR citation: 40 CFR 721.2077. IV. Objectives and Rationale of the Rule During review of the PMNs submitted for the chemical substances that are subject to this SNUR, EPA determined that one or more of the criteria of concern established at 40 CFR 721.170 were met. EPA is proposing this SNUR for specific chemical substances which have undergone premanufacture review to ensure that: (1) EPA will receive notice of any company's intent to manufacture, import, or process a listed chemical substance for a significant new use before that activity begins. (2) EPA will have an opportunity to review and evaluate data submitted in a SNUR notice before the notice submitter begins manufacturing, importing, or processing a listed chemical substance for a significant new use. (3) When necessary to prevent unreasonable risks EPA will be able to regulate prospective manufacturers, importers, or processors of a listed chemical substance before a significant new use of that substance occurs. Issuance of a SNUR for a chemical substance does not signify that the substance is listed on the TSCA Inventory. Manufacturers, importers, and processors are responsible for ensuring that a new chemical substance subject to a final SNUR is listed on the TSCA Inventory. V. Test Data and Other Information EPA recognizes that section 5 of TSCA does not require developing any particular test data before submission of a SNUN. Persons are required only to submit test data in their possession or control and to describe any other data known to or reasonably ascertainable by them. Unit III of this preamble lists recommended tests (if any) that would address the potential risks of the substances. The recommended studies may not be the only means of addressing the potential risks of the substance. However, SNUNs submitted for significant new uses without any test data may increase the likelihood that EPA will take action under section 5(e), particularly if satisfactory test results have not been obtained from a prior submitter. EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests. SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on: (1) Human exposure and environmental release that may result from the significant new use of the chemical substances. (2) Potential benefits of the substances. (3) Information on risks posed by the substances compared to risks posed by potential substitutes. VI. Procedural Determinations EPA is establishing through this rule some significant new uses which have been claimed as CBI. EPA is required to keep this information confidential to protect the CBI of the original PMN submitter. EPA promulgated a procedure to deal with the situation where a specific significant new use is CBI. This procedure appears in 40 CFR 721.1725(b)(1) and is similar to that in Sec. 721.11 for situations where the chemical identity of the substance subject to a SNUR is CBI. This procedure is cross-referenced in each of these SNURs. A manufacturer or importer may request EPA to determine whether a proposed use would be a significant new use under this rule. Under the procedure incorporated from Sec. 721.1725(b)(1), a manufacturer or importer must show that it has a bona fide intent to manufacture or import the substance and must identify the specific use for which it intends to manufacture or import the substance. If EPA concludes that the person has shown a bona fide intent to manufacture or import the substance, EPA will tell the person whether the use identified in the bona fide submission would be a significant new use under the rule. Since most of the chemical identities of the substances subject to these SNURs are also CBI, manufacturers and processors can combine the bona fide submission under the procedure in Sec. 721.1725(b)(1) with that under Sec. 721.11 into a single step. VII. Applicability of Rule to Uses Occurring Before Effective Date of the Final Rule To establish a significant ``new'' use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule have recently undergone premanufacture review. In cases where EPA has not received a notice of commencement (NOC) and the substance has not been added to the Inventory, no other person may commence such activities without first submitting a PMN. For substances for which an NOC has not been submitted at this time, EPA has concluded that the uses are not ongoing. However, EPA recognizes in cases when chemical substances identified in this SNUR are added to the Inventory prior to the effective date of the rule, the substances may be manufactured, imported, or processed by other persons for a significant new use as defined in this rule before the effective date of the rule. However, all four of the substances contained in this rule have CBI chemical identities, and since EPA has received a limited number of post-PMN bona fide submissions, the Agency believes that it is highly unlikely that any of the significant new uses described in the following regulatory text 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) is best served by designating a use as a significant new use as of the date of proposal rather than as of the effective date of the rule. Thus, persons who begin commercial manufacture, import, or processing of the substances regulated through this SNUR will have to cease any such activity before the effective date of this rule. To resume their activities, these persons would have to comply with all applicable SNUR notice requirements and wait until the notice review period, including all extensions, expires. EPA has promulgated provisions to allow persons to comply with this SNUR before the effective date. If a person were to meet the conditions of advance compliance under Sec. 721.45(h), the person would be considered to have met the requirements of the final SNUR for those activities. If persons who begin commercial manufacture, import, or processing of the substance between publication and the effective date of the SNUR do not meet the conditions of advance compliance, they must cease that activity before the effective date of the rule. To resume their activities, these persons would have to comply with all applicable SNUR notice [[Page 43300]] requirements and wait until the notice review period, including all extensions, expires. VIII. Economic Analysis EPA has evaluated the potential costs of establishing significant new use notice requirements for potential manufacturers, importers, and processors of the chemical substance subject to this proposed rule. EPA's complete economic analysis is available in the public record for this proposed rule (OPPTS-50627). IX. Rulemaking Record The official record for this rulemaking, as well as the public version, has been established for this rulemaking under docket number OPPTS-50627 (including comments and data submitted electronically as described below). A public version of this record, including printed, paper versions of electronic comments, which does not include any information claimed as CBI, is available for inspection from 12 noon to 4 p.m., Monday through Friday, excluding legal holidays. The official rulemaking record is located in the TSCA Nonconfidential Information Center, Rm. NE-B607, 401 M St., SW., Washington, DC. Electronic comments can be sent directly to EPA at: [email protected] Electronic comments must be submitted as an ASCII file avoiding the use of special characters and any form of encryption. Comments and data will also be accepted on disks in WordPerfect 5.1 file format or ASCII file format. All comments and data in electronic form must be identified by the docket number OPPTS-50627. Electronic comments on this proposed rule may be filed online at many Federal Depository Libraries. The OPPTS harmonized test guidelines referenced in this document are available on EPA's World Wide Web site under ``Researchers and Scientists,'' ``Environmental Test Methods & Guidelines'' (http:// www.epa.gov/epahome/research.htm). X. Regulatory Assessment Requirements Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a ``significant regulatory action'' subject to review by the Office of Management and Budget (OMB). In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), or require prior consultation with State officials as specified by Executive Order 12875 (58 FR 58093, October 28, 1993), or involve special considerations of environmental justice related issues as required by Executive Order 12898 (59 FR 7629, February 16, 1994). An agency may not conduct or sponsor, and a person is not required to respond to, an information collection request unless it displays a currently valid OMB control number. The information collection requirements related to this action have already been approved by OMB pursuant to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burdens requiring additional OMB approval. The public reporting burden for this collection of information is estimated to average 100 hours per response. The burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete and review the collection of information. In addition, pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency has determined that the promulgation of a SNUR does not have a significant adverse economic impact on a substantial number of small entities. The Agency's generic certification for promulgation of new SNURs appears on June 2, 1997 (62 FR 29684) (FRL-5597-1), and was provided to the Chief Counsel for Advocacy of the Small Business Administration. XI. Submission to Congress and the General Accounting Office Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business Regulatory Enforcement Fairness Act of 1996, the Agency has submitted a report containing this proposed rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the General Accounting Office prior to publication of this proposed rule in today's Federal Register. This is not a major rule as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 721 Environmental protection, Chemicals, Hazardous materials, Recordkeeping and reporting requirements. Dated: August 4, 1997. Ward Penberthy, Acting Director, Chemical Control Division, Office of Pollution Prevention and Toxics. Therefore, it is proposed that 40 CFR part 721 be amended as follows: PART 721--[AMENDED] 1. The authority citation for part 721 would continue to read as follows: Authority: 15 U.S.C. 2604, 2607, and 2625(c). 2. By adding new Sec. 721.555 to subpart E to read as follows: Sec. 721.555 Alkyl amino nitriles. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substances identified as alkyl amino nitriles (PMNs P-96-1674 and P-96-1675) are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in Sec. 721.63 (a)(2)(iii), (a)(4), (a)(5)(i), (a)(6)(ii),(a)(6)(v), and (c). A full face shield is required if splashing or spraying occurs. (ii) Hazard communication program. Requirements as specified in Sec. 721.72 (c)(1) and (c)(2)(iv). The MSDS required by this paragraph shall include the following statement: Ocular exposure may cause death. (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80 (g) and (l). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125 (a), (b), (c), (d), (h), and (i) are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. 3. By adding new Sec. 721.2077 to subpart E to read as follows: Sec. 721.2077 Substituted carbazate. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a substituted carbazate (PMN P-97-267) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new uses are: (i) Hazard communication program. Requirements as specified in Sec. 721.72 [[Page 43301]] (c)(1) and (c)(2)(iv). The MSDS required by this paragraph shall include the following statements: Overexposure to this material may cause severe acute toxicity including death. This concern is particularly true with respect to direct contact to the eyes. Exposure to the eyes may cause severe acute toxicity including death. (ii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80 (a), (b), (c), and (j). (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125 (a), (b), (c), (h), and (i) are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. (3) Determining whether a specific use is subject to this section. The provisions of Sec. 721.1725(b)(1) apply to this section. 4. By adding new Sec. 721.5460 to subpart E to read as follows: Sec. 721.5460 Organosolv lignin. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as an organosolv lignin (PMN P-95-1584; CAS No. 8068-03-9) is subject to reporting under this section for the significant new use described in paragraph (a)(2) of this section. (2) The significant new use is any manufacture, processing or use of the substance with a number average molecular weight less than 1000 daltons or greater than or equal to 1000 daltons with an oligomer content greater than 10 percent below molecular weight 500 and greater than 25 percent below molecular weight 1000. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph. (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125 (a), (b), (c), and records documenting compliance with the designated molecular weight requirements are applicable to manufacturers, importers, and processors of this substance. (2) Limitations or revocation of certain notification requirements. The provisions of Sec. 721.185 apply to this section. [FR Doc. 97-21412 Filed 8-12-97; 8:45 am] BILLING CODE 6560-50-F