[Federal Register Volume 62, Number 105 (Monday, June 2, 1997)] [Proposed Rules] [Pages 29684-29688] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-14297] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 721 [OPPTS-50626, etc.; FRL-5597-1] Proposed Modification of Significant New Use Rules For Certain Substances AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: EPA is proposing to modify significant new use rules (SNURs) for six substances promulgated under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for certain chemical substances based on new data. Based on the data the Agency determined that the SNURs should be modified. DATES: Written comments must be received by July 2, 1997. ADDRESSES: Each comment must bear the appropriate docket control number OPPTS-50626, etc. 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 the instructions under Unit III of this preamble. 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 [[Page 29685]] 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. Unit IV of this preamble contains additional information on submitting comments containing CBI. FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director, Environmental Assistance Division (7408), Office of Pollution Prevention and Toxics, Environmental Protection Agency, Rm. E-543A, 401 M St., SW., Washington, DC 20460; telephone: (202) 554-1404; TDD: (202) 554-0551; e-mail: TSCA-H[email protected]. SUPPLEMENTARY INFORMATION: In the Federal Register referenced for each substance, OPPTS-50577, June 26, 1990 (55 FR 26110); OPPTS-50588, November 6, 1990 (55 FR 46774); OPPTS-50592, August 13, 1991 (56 FR 40212); OPPTS-50601, September 23, 1992 (57 FR 44070); and OPPTS-50622, March 1, 1995 (60 FR 11042) (FRL-4868-4); EPA issued a SNUR establishing significant new uses for the substances listed in Unit I of this preamble. Because of additional data EPA has received for these substances, EPA is proposing to modify the SNURs. I. Proposed Modifications EPA is proposing to modify the 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 the substances, including its premanufacture notice (PMN) number, chemical name (generic name if the specific name is claimed as CBI), CAS number (if assigned), the proposed modification and basis, Federal Register reference, docket number, and the CFR citation in the regulatory text section of this proposed rule. Further background information for the substances is contained in the rulemaking record referenced in Unit III of this preamble. PMN Number P-89-31 Chemical name: 2-propenoic acid, 7-oxabicyclo[4.1.0]hept-3-ylmethyl ester. CAS number: Not available. Federal Register publication date and reference: November 6, 1990 (55 FR 46774). Docket number: OPPTS-50588. Basis for modification of SNUR: EPA received a second PMN for this substance. Based on analogy to acrylates and epoxides, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 80 parts per billion (ppb) of the PMN substance in surface waters. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because the substance would not be released to surface waters in significant quantities. Based on the information in the PMN, EPA has determined that other uses of the substance may result in releases to surface waters which exceed the concern concentration. Therefore, EPA has decided that a modification to the SNUR, requiring notification if the substance is released to water was necessary to prevent significant changes in environmental exposure. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii). CFR number: 40 CFR 721.8350. PMN Number P-91-43 Chemical name: (generic) Fluorene substituted aromatic amine. CAS number: Not available. Federal Register publication date and reference: September 23, 1992 (57 FR 44065). Amended on June 6, 1994 (59 FR 29204). Docket number: Docket Number: OPPTS-50601. Basis for modification of SNUR: The original PMN submitter submitted a 90-day subchronic study on the PMN substance according to the terms of the section 5(e) consent order for the substance between EPA and the PMN submitter. The test results demonstrated liver effects at 50 and 500 mg/kg/day dose levels and blood effects at the 500 mg/kg/day dose level. No adverse effects were seen at the lowest dose level of 5 mg/ kg/day. Based on the test results, EPA set a No Observed Adverse Effect Level (NOAEL) at 5/mg/kg/day. The PMN submitter requested that EPA revoke the consent order for the substance based on the 90-day study and mutagencity data it had developed and submitted for a similar substance, P-88-998. The mutagencity test results were negative in the Ames assay, negative in a mitotic recombination assay (S. Cerevisiae), weakly mutagenic in a mouse lymphoma assay, negative in a mouse micronucleus assay (intraperitoneal route), and was not a chromosome mutagen in human peripheral blood lymphocyte cells in culture during a human lymphocyte study. EPA chose to modify the order based on continued concerns for environmental effects from potential water releases and liver effects to unprotected workers. The modification eliminates hazard communication requirements for cancer and reproductive toxicity, requires less stringent respiratory protection, and eliminates triggered toxicity testing. The proposed modification of this SNUR is consistent with the modification to the consent order. CFR number: 40 CFR 721.3764. PMN Number P-85-1331 Chemical name: Naphthalene, 1,2,3,4-tetrahydro(1-phenylethyl). CAS number: Not available. Federal Register publication date and reference: June 26, 1990 (55 FR 26110). Docket number: OPPTS-50577. Basis for modification of SNUR: A significant new use notice (SNUN) was submitted for this substance describing limited but measurable releases to water of the substance. After review of the SNUN, EPA determined that releases to water of less than 1 part per billion (ppb) would result in no significant environmental exposures. The Agency has determined, therefore, that modifying the SNUR by allowing releases to water of less than 1 ppb will not result in significant changes in environmental exposure. CFR number: 40 CFR 721.5225. PMN Number P-91-598 Chemical name: (generic) Epoxidized copolymer of phenol and substituted phenol. CAS number: Not available. Federal Register publication date and reference: September 23, 1992 (57 FR 44071). Docket number: OPPTS-50601. Basis for modification of SNUR: A SNUN was submitted for this substance detailing its use as a densified tablet formulation of an epoxy molding compound. After review of the SNUN, EPA determined that use of the substance as a densified tablet formulation of an epoxy molding compound would result in no significant dermal or inhalation exposures. The Agency has determined, therefore, that modifying the SNUR by allowing use as a densified tablet formulation of an epoxy molding compound will not result in significant changes in human exposure. CFR number: 40 CFR 721.7210. PMN Number P-93-955 Chemical name: (generic) Formaldehyde, polymer with substituted phenols, glycidyl ether. CAS number: Not available. Federal Register publication date and reference: August 30, 1995 (60 FR 45084). Docket number: OPPTS-50622. Basis for modification of SNUR: A SNUN was submitted for a similar substance (40 CFR 721.7210) detailing its use as a densified tablet formulation of an epoxy molding compound. The [[Page 29686]] SNUN submitter petitioned the Agency to modify the SNUR for this substance based on the data in that SNUN. After review of the SNUN and the SNUR for this substance, EPA determined that use of the substance as a densified tablet formulation of an epoxy molding compound would result in no significant dermal or inhalation exposures. The Agency has determined, therefore, that modifying the SNUR allowing use as a densified tablet formulation of an epoxy molding compound will not result in significant changes in human exposure. CFR number: 40 CFR 721.7046. PMN Number P-90-226 Chemical name: (generic) Titanate [Ti6013 (2-)] dipotassium. CAS number: Not available. Federal Register publication date and reference: August 13, 1991 (56 FR 40215). Docket number: OPPTS-50592. Basis for modification of SNUR: A SNUN was submitted for the substance detailing an additional manufacturing process. In addition a 90-day subchronic inhalation study was submitted by the PMN submitter under the terms of the section 5(e) consent order. The study demonstrated no evidence of fibrosis to test animals. After review of the SNUN, EPA determined that the substance produced by that manufacturing process contained some fibers that are indicated in the development of fibrosis, but concluded that such levels would be unlikely to result in significant inhalation risk from exposure. After review of the test data, EPA determined that use of the substance without requiring hazard communication or a production volume trigger as described in the consent order and SNUR would result in no significant inhalation exposures. The Agency has determined, therefore, that modifying the SNUR allowing the manufacturing process described in the SNUN and removing the hazard communication and production volume limit requirements will not result in significant changes in human exposure. CFR number: 40 CFR 721.9675. II. Rationale for Modification of the Rules During review of the PMNs submitted for the chemical substances that are the subject of these modifications, EPA concluded that regulation was warranted based on the fact that activities not described in the section 5(e) consent order or the PMN may result in significant changes in human or environmental exposure. The basis for such findings is in the rulemaking records referenced in Unit III of this preamble. Based on these findings, a section 5(e) consent order was negotiated with the PMN submitter and/or a SNUR was promulgated. In light of the modification to a consent order, the data submitted in a PMN, or the data submitted in a SNUN, the Agency has determined that modifying these SNURs would not result in significant changes in human or environmental exposure. The modification of SNUR provisions for these substances designated herein is consistent with the provisions of the section 5(e) order or data submitted in the PMN/SNUN. III. Rulemaking Record The official record for this rulemaking, as well as the public version, has been established for this rulemaking under docket number OPPTS-50626, etc. (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 confidential business information (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-50626, etc. Electronic comments on this proposed rule may be filed online at many Federal Depository Libraries. IV. Comments Containing Confidential Business Information Any person who submits comments claimed as CBI must mark the comments as ``confidential,'' ``trade secret,'' or other appropriate designation. Comments not claimed as confidential at the time of submission will be placed in the public file. Any comments marked as confidential must prepare and submit a public version of the comments that EPA can place in the public file. V. Regulatory Assessment 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). Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby certifies that any promulgation of a SNUR, including this rule, will not have a significant adverse economic impact on a substantial number of small entities. Because this certification is applicable to all SNURs, it will also serve as the generic certification for the promulgation of any SNUR and EPA will incorporate it by reference in future individual SNUR actions. In addition, this certification and rationale presented below will be provided to the Chief Counsel for Advocacy of the Small Business Administration. The certification presented above is based on the following rationale. A SNUR 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.'' By definition of the word ``new,'' and based on all information currently available to EPA, it appears that no small or large entities presently engage in such activity. Since a SNUR only requires that any person who intends to engage in such activity in the future must first notify EPA (by submitting a Significant New Use Notice (SNUN)), no economic impact will even occur until someone decides to engage in those activities. Although some small entities may decide to conduct such activities 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 over 530 SNURs, the Agency has received fewer than 15 SNUNs. Of those SNUNs submitted, none appear to be from small entities. In fact, EPA expects to receive few, if any, SNUNs from either large or small entities in response to any SNUR. Therefore, EPA believes that, the economic impact of complying with a SNUR is not expected to be [[Page 29687]] significant or adversely impact a substantial number of small entities. 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. VI. 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 rule and other required information to the U.S. Senate, the U.S. House ofRepresentatives, and the Comptroller General of the General Accounting Office prior to publication of this 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: May 20, 1997. William H. Sanders, III Director, 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 revising Sec. 721.3764 to read as follows: Sec. 721.3764 Fluorene substituted aromatic amine. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as a fluorene substituted aromatic amine (PMN P-91-43) 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) Protection in the workplace. Requirements as specified in Sec. 721.63 (a)(1), (a)(2)(iii), (a)(3), (a)(4), (a)(5)(iii), (a)(5)(iv), (a)(5)(v), (a)(5)(vi), (a)(6)(i), (b) (concentration set at 1.0 percent) and (c). However, these requirements do not apply after the PMN substance is adhered onto film or incorporated into prepreg form (resin impregnated substrate). (ii) Hazard communication program. Requirements as specified in Sec. 721.72 during manufacture (a), (b), (c), (d), (e) (concentration set at 1.0 percent), (f), (g)(1)(iv), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(iii) and (g)(5). (iii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80(l). (iv) Release to water. Requirements as specified in Sec. 721.90 (a)(1), (b)(1), and (c)(1). (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) through (i) and (k) 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. In Sec. 721.5225 by revising paragraph (a)(2)(v) to read as follows: Sec. 721.5225 Naphthalene, 1,2,3,4-tetrahydro(1-phenylethyl) (specific name). (a) Chemical substance and significant new uses subject to reporting. * * * (2) * * * (v) Release to water. Requirements as specified in Sec. 721.90 (a)(4), (b)(4), and (c)(4) (where n = 1). * * * * * 4. In Sec. 721.7046 by revising paragraph (a)(1) to read as follows: Sec. 721.7046 Formaldehyde, polymer with substituted phenols, glycidyl ether. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as formaldehyde, polymer with substituted phenols, glycidyl ether (PMN P-93-955) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply once the substance is a component of a highly densified tablet formulation of an epoxy molding compound. * * * * * 5. In Sec. 721.7210 by revising paragraph (a)(1) to read as follows: Sec. 721.7210 Epoxidized copolymer of phenol and substituted phenol. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as epoxidized copolymer of phenol and substituted phenol (PMN P-91-598) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply once the substance is a component of a highly densified tablet formulation of an epoxy molding compound. * * * * * 6. In Sec. 721.8350 by adding paragraph (a)(2)(iv) to read as follows: Sec. 721.8350 2-Propenoic acid, 7-oxabicyclo[4.1.0]hept-3-ylmethyl ester . (a) Chemical substance and significant new uses subject to reporting. * * * (2) * * * (iv) Release to water. Requirements as specified in Sec. 721.90 (a)(1), (b)(1), and (c)(1). * * * * * 7. In Sec. 721.9675 by removing and reserving paragraph (a)(2)(i) and revising paragraphs (a)(2)(ii) introductory text, (a)(2)(ii)(A), and (b)(1) to read as follows: Sec. 721.9675 Titanate [Ti6013 (2-)] dipotassium. (a) Chemical substance and significant new uses subject to reporting. * * * (2) * * * (i) [Reserved] (ii) Industrial, commercial, and consumer activities. Requirements as specified in Sec. 721.80 (f) and (l). In addition, a significant new use of the substance is importation of the PMN substance if: (A) Manufactured by other than the method described in premanufacture notice P-90-226 or significant new use notice P-96-1408. If manufactured by the method described in significant new use notice P-96-1408 then notification requirements for the bulk density measurements in paragraph (a)(2)(i)(B) of this section do not apply. * * * * * (b) Specific requirements. * * * (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 721.125 (a), (b), (c), and (i) are applicable to [[Page 29688]] manufacturers, importers, and processors of this substance. In addition, records shall be kept identifying the foreign supplier and documenting, by lot, for each shipment, the method of manufacture and bulk density measurements. Records of bulk density measurements are required only when notification requirements are applicable. * * * * * [FR Doc. 97-14297 Filed 5-30-97; 8:45 am] BILLING CODE 6560-50-F