15061 Federal Register / Vol. 68, No. 60 / Friday, March 28, 2003 / Rules and Regulations interested in commenting must do so at this time.

IV. Statutory and Executive Order Reviews A. General Requirements Under Executive Order 12866 ( 58 FR 51735, October 4, 1993), this action is not a `` significant regulatory action'' and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, `` Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use'' ( 66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act ( 5 U. S. C. 601 et seq.). Because this rule approves pre existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 ( Pub. L. 104   4). This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 ( 65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the 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 ( 64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 `` Protection of Children from Environmental Health Risks and Safety Risks'' ( 62 FR 19885, April 23, 1997), because it is not economically significant. In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards ( VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( 15 U. S. C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 ( 44 U. S. C. 3501 et seq.).

B. Submission to Congress and the Comptroller General The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This rule is not a `` major rule'' as defined by 5 U. S. C. 804( 2).

C. Petitions for Judicial Review Under section 307( b)( 1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by May 27, 2003. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action approving Philadelphia County's Air Management Regulation XIII may not be challenged later in proceedings to enforce its requirements. ( See section 307( b)( 2).)

List of Subjects in 40 CFR Part 52 Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.

Dated: March 20, 2003. Donald S. Welsh, Regional Administrator, Region III.

 40 CFR part 52 is amended as follows:

PART 52   [ AMENDED]

 1. The authority citation for part 52 continues to read as follows:

Authority: 42 U. S. C. 7401 et seq.

Subpart NN   Pennsylvania  2. Section 52.2020 is amended by adding paragraph ( c)( 203) to read as follows

§ 52.2020 Identification of plan.

* * * * * ( c) * * * ( 203) Revisions to Philadelphia Air Management Regulation XIII   ` ` Pertaining to the Construction, Modification, Reactivation, and Operation of Sources'' submitted on May 13, 1999 by the Pennsylvania Department of Environmental Protection on behalf of Philadelphia County Air Management Services: ( i) Incorporation by reference. ( A) Letter of May 13, 1999 from the Pennsylvania Department of Environmental Protection on behalf of Philadelphia County Air Management Services transmitting Regulation XIII governing the construction of new and modified sources and operation of existing sources of air pollution in the County. ( B) Philadelphia Air Management Regulation XIII   ` ` Pertaining to the Construction, Modification, Reactivation, and Operation of Sources'', except as it pertains to the new source review permit program and the title V operating permit program, effective October 30, 1995. ( ii) Additional Material.   Remainder of the State submittal pertaining to the revisions listed in paragraph ( c)( 203)( i) of this section.

[ FR Doc. 03   7510 Filed 3   27   03; 8: 45 am]

BILLING CODE 6560   50   P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 721 [ OPPT   2002   0060; FRL   6758   7]

RIN 2070   AB27 Significant New Uses of Certain Chemical Substances AGENCY: Environmental Protection Agency ( EPA).

VerDate Jan< 31> 2003 15: 12 Mar 27, 2003 Jkt 200001 PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 28MRR1. SGM 28MRR1 OPPT 2002 0060 0001 RECEIVED OPPT NCIC 2003 MAR28 7: 16AM 15062 Federal Register / Vol. 68, No. 60 / Friday, March 28, 2003 / Rules and Regulations ACTION: Direct final rule.

SUMMARY: EPA is promulgating significant new use rules ( SNURs) under section 5( a)( 2) of the Toxic Substances Control Act ( TSCA) for 62 chemical substances which were the subject of premanufacture notices ( PMNs) and subject to TSCA section 5( e) consent orders issued by EPA. Today's action requires persons who intend to manufacture, import, or process these substances for a significant new use to notify EPA at least 90 days before commencing the manufacturing or processing of the substance for a use designated by this rule as a significant new use. The required notice will provide EPA with the opportunity to evaluate the intended use, and if necessary, to prohibit or limit that activity before it occurs to prevent any unreasonable risk of injury to human health or the environment. EPA is promulgating this SNUR using direct final procedures. DATES: The effective date of this rule is May 27, 2003 without further notice, unless EPA receives adverse comment or notice of intent to submit adverse comment before April 28, 2003. This rule shall be promulgated for purposes of judicial review at 1 p. m. ( e. s. t.) on April 11, 2003. If EPA receives adverse comment or notice before April 28, 2003 that someone wishes to submit adverse or critical comments on EPA's action in establishing a SNUR for one or more of the chemical substances subject to this rule, EPA will withdraw the SNUR before the effective date for the substance for which the comment or notice of intent to comment is received and will issue a proposed SNUR providing a 30 day period for public comment.

ADDRESSES: Comments or notice of intent to submit adverse or critical comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: For general information contact: Barbara Cunningham, Acting Director, Environmental Assistance Division ( 7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 202) 554   1404; e mail address: TSCA Hotline@ epa. gov. For technical information contact: James Alwood, 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   8974; e mail address: alwood. jim@ 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 substances contained in this rule. Potentially affected entities may include, but are not limited to:   Chemical manufacturers ( NAICS 325), e. g., Manufacturers, importers, processors, and users of chemicals.   Petroleum and coal product industries ( NAICS 324), e. g., Manufacturers, importers, processors, and users of chemicals. 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 title 40 of the Code of Federal Regulations ( CFR) at 40 CFR 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.

B. How Can I Get Copies of This Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPPT   2002   0060 . The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the EPA Docket Center, Rm. B102 Reading Room, EPA West, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The EPA Docket Center Reading Room telephone number is ( 202) 566   1744 and the telephone number for the OPPT Docket, which is located in EPA Docket Center, is ( 202) 566   0280. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. The OPPTS harmonized test guidelines referenced in this document are available at http:// www. epa. gov/ opptsfrs/ home/ guidelin. htm. A frequently updated electronic version of 40 CFR part 721 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 40cfr 721_ 00. html, a beta site currently under development. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper,

VerDate Jan< 31> 2003 15: 12 Mar 27, 2003 Jkt 200001 PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 28MRR1. SGM 28MRR1 15063 Federal Register / Vol. 68, No. 60 / Friday, March 28, 2003 / Rules and Regulations will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

C. How and To Whom Do I Submit Comments? You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked `` late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I. D. Do not use EPA Dockets or e mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. 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. i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http:// www. epa. gov/ edocket, and follow the online instructions for submitting comments. Once in the system, select `` search,'' and then key in docket ID number OPPT   2002   0060. The system is an `` anonymous access'' system, which means EPA will not know your identity, e mail address, or other contact information unless you provide it in the body of your comment. ii. E mail. Comments may be sent by e mail to oppt. ncic@ epa. gov, Attention: Docket ID Number OPPT   2002   0060. In contrast to EPA's electronic public docket, EPA's e mail system is not an `` anonymous access'' system. If you send an e mail comment directly to the docket without going through EPA's electronic public docket, EPA's e mail system automatically captures your email address. E mail addresses that are automatically captured by EPA's e mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I. C. 2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Document Control Office ( 7407M), Office of Pollution Prevention and Toxics ( OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. 3. By hand delivery or courier. Deliver your comments to: OPPT Document Control Office ( DCO) in EPA East Building Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number OPPT   2002   0060. 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.

D. How Should I Submit CBI To the Agency? Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI on disk or CD ROM, 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 CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any 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 and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

We invite you to provide your views on the various options we propose, new approaches we haven't considered, the potential impacts of the various options ( including possible unintended consequences), and any data or information that you would like the Agency to consider during the development of the final action. You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the rule. 7. Make sure to submit your comments by the deadline in this document. 8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

VerDate Jan< 31> 2003 15: 12 Mar 27, 2003 Jkt 200001 PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 28MRR1. SGM 28MRR1 15064 Federal Register / Vol. 68, No. 60 / Friday, March 28, 2003 / Rules and Regulations II. Background A. What Action is the Agency Taking? This SNUR will require persons to notify EPA at least 90 days before commencing manufacturing, importing, or processing a substance for any activity designated by this SNUR as a significant new use. The supporting rationale and background to this rule are more fully set out in the preamble to EPA's first direct final SNUR published in the Federal Register of April 24, 1990 ( 55 FR 17376). Consult that preamble for further information on the objectives, rationale, and procedures for the rules and on the basis for significant new use designations including provisions for developing test data.

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 those listed in section 5( a)( 2) of TSCA. 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 721.5.

C. 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 TSCA section 5( b) and 5( d)( 1), the exemptions authorized by TSCA 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 TSCA 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 TSCA 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 TSCA 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 establishing 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 for non confidential chemical identities), basis for the action taken by EPA in the TSCA section 5( e) consent order or as a non section 5( e) SNUR for the substance ( including the statutory citation and specific finding), toxicity concern, 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, including production limits and other uses designated in the rule are claimed as CBI. The procedure for obtaining confidential information is set out in Unit VII. Where the underlying TSCA section 5( e) consent order prohibits the PMN submitter from exceeding a specified production limit without performing specific tests to determine the health or environmental effects of a substance, the tests are described in this unit. As explained further in Unit VI., the SNUR for such substances contains the same production limit, and exceeding the production limit is defined as a significant new use. Persons who intend to exceed the production limit must notify the Agency by submitting a significant new use notice ( SNUN) at least 90 days in advance. In addition, this unit describes tests that are recommended by EPA to provide sufficient information to evaluate the substance, but for which no production limit has been established in the TSCA section 5( e) consent order. Descriptions of recommended tests are provided for informational purposes. Data on potential exposures or releases of the substances, testing other than that specified in the TSCA section 5( e) consent 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. EPA is not publishing SNURs for PMNs for P   99   309, P   99   492/ 493/ 494/ 495/ 496/ 497, P   99   847, P   99   1106, P   99   1166, and P   99   1389, which are subject to a final TSCA section 5( e) consent order. The TSCA section 5( e) consent orders for these substances are derived from an exposure finding based solely on substantial production volume and significant or substantial human exposure and/ or release to the environment of substantial quantities. For these cases there were limited or no toxicity data available for the PMN substances. In such cases, EPA regulates the new chemical substances under TSCA section 5( e) by requiring certain toxicity tests. For instance, chemical substances with potentially substantial releases to surface waters would be subject to toxicity testing of aquatic organisms and chemicals with potentially substantial human exposures would be subject to health effects testing for mutagenicity, acute effects, and subchronic effects. However, for these substances, the short term toxicity testing required by the TSCA section 5( e) consent order is usually completed within 1 to 2 years of notice of commencement ( NOC). EPA's experience with exposure based SNURs requiring short term testing is that the SNUR is often revoked within 1 to 2 years when the test results are received. Rather than issue and revoke SNURs in such a short span of time, EPA will defer publication of exposure based SNURs until either a NOC or data demonstrating risk are received unless the toxicity testing required is longterm EPA is issuing this explanation and notification as required in 40 CFR 721.160( a)( 2) as it has determined that SNURs are not needed at this time for these substances which are subject to a final section 5( e) consent order under TSCA. PMN Numbers P   98   0082/ 0083/ 0084 VerDate Jan< 31> 2003 15: 12 Mar 27, 2003 Jkt 200001 PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 28MRR1. SGM 28MRR1 15065 Federal Register / Vol. 68, No. 60 / Friday, March 28, 2003 / Rules and Regulations Chemical names: ( generic) ( P   98   0082 and P   98   0083) Alkoxylated alkylpolyol acrylates, adduct with alkylamine and ( generic) ( P   98   0084) Alkoxylated alkylpolyol acrylates. CAS numbers: Not available. Basis for action: The PMN substances will be used as binders for UV or electron beam curable coatings for wood, paper, and plastics. Based on structural analogy to aliphatic amines, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 part per billion ( ppb) of the PMN substances in surface waters. Since significant environmental exposure is not expected, as the substances are not released to surface waters, as described in the PMNs, EPA has not determined that the proposed manufacturing, processing, and use of the substances may present an unreasonable risk. EPA has determined, however, that other uses of the substances resulting in release to surface waters may cause significant adverse environmental effects. Based on this information the PMN substances meet the concern criteria at § 721.170( b)( 4)( ii). Recommended testing: EPA has determined that a fish acute toxicity study ( OPPTS 850.1075 test guideline ( public draft)), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline public draft)), and an algal toxicity study ( OPPTS 850.5400 test guideline ( public draft)) would help to characterize the environmental effects of the PMN substances. All tests should be conducted with the static methods and nominal concentrations. CFR citation: 40 CFR 721.465. PMN Numbers P   98   0497 and P   98   0509 Chemical name: Propanoic acid, 2 methyl, ( 1R, 2R, 4R) 1,7,7 trimethylbicyclo[ 2.2.1] hept 2 yl ester, rel. CAS number: 85586   67   0. Basis for action: The PMN substances will be used as a fragrance compound for air fresheners, soaps, shampoo, household detergents, and bleach. Toxicity data on structurally similar esters indicate that the PMN substances may cause toxicity to aquatic organisms. Based on these data, EPA is concerned that toxicity to aquatic organisms may occur at a concentration of 10 ppb of the PMN substances in surface waters. Since significant environmental exposure is not expected as the PMN substances are not released to surface waters in significant quantities, EPA has not determined that the proposed processing and use of the substances may present an unreasonable risk. EPA has determined, however, that an increase in production volume may result in releases of the PMN substances to surface waters which may cause significant adverse environmental effects. Based on this information the PMN substances meet the concern criteria at § 721.170 ( b)( 4)( ii). Recommended testing: The Agency has determined that an algal toxicity study ( OPPTS 850.5400 test guideline ( public draft)), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline ( public draft)), and a fish acute toxicity study ( OPPTS 850.1075 test guideline ( public draft)) would help to characterize possible environmental effects of the substances. The fish and daphnid tests should be conducted with flow through methods and measured concentrations. The algal test should be conducted with static methods and measured concentrations. CFR citation: 40 CFR 721.4486. PMN Number P   98   0823 Chemical name: Dodecanoic acid, 12 amino. CAS number: 693   57   2. Effective date of section 5( e) consent order: August 18, 2000. Basis for section 5( e) consent order: The order was issued under section 5( e)( 1)( A)( i) and section 5( e)( 1)( A)( ii) of TSCA based on a finding that this substance may present an unreasonable risk of injury to human health and the environment. Toxicity concern: This PMN substance will be used as a raw material for Nylon 12. EPA has identified a health concern for carcinogenicity via inhalation exposure based on analogy to 11 aminoundodecanoic acid which caused neoplastic nodules in the liver and transitional cell carcinomas in the urinary bladder of male rats. Recommended testing: EPA has determined that a carcinogenicity study ( OPPTS 870.4200 test guideline) would help to characterize the human health effects. CFR citation: 40 CFR 721.2584. PMN Number P   98   1125 Chemical name: ( generic) Fatty acid, reaction product with substituted oxirane, formaldehyde phenol polymer glycidyl ether, substituted propylamine and polythylenepolyamines. CAS number: Not available. Basis for action: The PMN substance will be used as a curing agent for epoxy coating systems. Based on structural analogy to aliphatic amines, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 10 ppb of the PMN substance in surface waters. Since significant environmental exposure is not expected as the PMN substance is not released to surface water above 10 ppb, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface waters above 10 ppb may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 4)( ii). Recommended testing: EPA has determined that a fish acute toxicity study ( OPPTS 850.1075 test guideline ( public draft)); a daphnid acute toxicity study ( OPPTS 850.1010 test guideline ( public draft)), an algal toxicity study ( OPPTS 850.5400 test guideline ( public draft)), and a fish acute toxicity mitigated by humic acid (` HA') of 10 and 20 mg HA per liter diluent would help to characterize the environmental effects of the PMN substance. All studies should use the static methods and nominal concentrations. CFR citation: 40 CFR 721.6181. PMN Number P   98   1262 Chemical name: ( generic) Reaction product of alkylene diamine, MD1, substituted carbomonocyclic amine and alkylamine. CAS number: Not available. Basis for action: The PMN substance will be used as described in the PMN. Based on test data on structurally similar neutral organic chemicals, the PMN substance may cause toxicity to aquatic organisms. Based on the data, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 ppb of the PMN substance in surface waters. Since significant environmental exposure is not expected, as the substance is not released to surface waters, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface waters may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 4)( ii). Recommended testing: EPA has determined that the results of the following testing would help characterize the environmental effects of the PMN substance: a Melting point ( OPPTS 830.7200 test guideline), a fish early life stage toxicity test ( OPPTS 850.1400 test guideline ( public draft)), and a daphnid chronic toxicity test VerDate Jan< 31> 2003 15: 12 Mar 27, 2003 Jkt 200001 PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 28MRR1. SGM 28MRR1 15066 Federal Register / Vol. 68, No. 60 / Friday, March 28, 2003 / Rules and Regulations ( OPPTS 850.1300 test guideline ( public draft)). The fish and daphnid tests should be conducted with the flowthrough methods and measured concentrations, and hardness of dilution water less than 180 mg/ L as CaC03. CFR citation: 40 CFR 721.2582. PMN Number P   99   0044 Chemical name: Formaldehyde, polymer with phenol and 1,2,3 propanetriol, methylated. CAS number: 209810   57   1. Basis for action: The PMN substance will be used as a bonding agent for mineral aggregates. Based on structural analogy to phenols, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 2 ppb of the PMN substance in surface waters. Since significant environmental exposure is not expected as the PMN substance is not released to surface water above 3 ppb, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in releases to surface water above 3 ppb may cause adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 4)( ii). Recommended testing: EPA has determined that an activated sludge sorption isotherm test ( OPPTS 835.1110 test guideline), a fish acute toxicity study ( OPPTS 850.1075 test guideline ( public draft)), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline ( public draft)), and an algal toxicity study ( OPPTS 850.5400 test guideline ( public draft)) would help characterize the environmental effects of the PMN substance. The fish and daphid tests should be performed under flow through methods and measured concentrations. The algal test should be performed under static methods and measured concentrations. CFR citation: 40 CFR 721.3807. PMN Number P   99   0510 Chemical name: ( generic) Hexamethylenediamine adduct of substituted piperidinyloxy. CAS number: Not available. Effective date of section 5( e) consent order: December 24, 1999. Basis for section 5( e) consent order: The order was issued under section 5( e)( 1)( A)( i) and section 5( e)( 1)( A)( ii)( i) of TSCA based on a finding that this substance may present an unreasonable risk of injury to human health. Toxicity concern: Based on submitted data on a 28 day subchronic study in rats, the PMN substance has been shown to cause potential liver toxicity, hemolytic effects, and immunotoxicity from inhalation exposure to the PMN substance. Recommended testing: A 90 day subchronic oral study in rats with emphasis on hematology, the immune system, and male reproductive system ( OPPTS 870.3100 test guideline) would help to characterize possible effects of the substance. The PMN submitter has agreed not to exceed the production volume limit without performing the 90 day subchronic oral study. CFR citation: 40 CFR 721.6205. PMN Number P   99   0669 Chemical name: Oxirane, methyl, polymer with oxirane, mono( 3,5,5, trimethylhexyl) ether. CAS number: 204336   40   3. Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogy to nonionic surfactants, EPA is concerned that toxicity to aquatic organisms may occur at a concentration of 600 ppb in surface waters. Since significant environmental exposure is unlikely, as the substance is not released to surface waters, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in releases to surface waters may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 4)( ii). Recommended testing: EPA has determined that a fish acute toxicity study ( OPPTS 850.1075 test guideline ( public draft)), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline ( public draft)), and an algal toxicity study ( OPPTS 850.5400 test guideline ( public draft)) would help to characterize the environmental effects of the PMN substances. The fish and daphnid tests should be conducted with the flow through methods and measured concentrations, and the algal test should be conducted with static methods and measured concentrations. CFR citation: 40 CFR 721.522. PMN Number P   99   0848 Chemical name: ( generic) Alkenyl carboxylate, metal salt. CAS number: Not available. Effective date of section 5( e) consent order: August 2, 2000. Basis for section 5( e) consent order: The order was issued under section 5( e)( 1)( A)( i) and section 5( e)( 1)( A)( ii)( I) of TSCA based on a finding that this substance is expected to enter the environment in substantial quantities and may present an unreasonable risk of injury to the environment. Toxicity concern: Based on analogy to anionic surfactants the PMN substance may be toxic to aquatic organisms at concentrations as low as 1 ppb. Recommended testing: EPA has determined that an algal toxicity study ( OPPTS 850.5400 test guideline ( public draft)), an daphnid acute toxicity study ( OPPTS 850.1010 test guideline ( public draft)), and an fish acute toxicity study ( OPPTS 850.1075 test guideline ( public draft)) would help to characterize the environmental effects of the PMN substance. The fish and daphnid tests should be conducted with flow through methods and measured concentrations and hardness of dilution water with less than 180 mg/ L as CaC03. The algal test should be conducted with static methods and measured concentrations. The PMN submitter has agreed not to exceed the production volume limit without performing these tests. CFR citation: 40 CFR 721.2093. PMN Number P   99   0873 Chemical name: ( generic) Propanetriol polyalkylenepolyolamine aryl aldimine. CAS number: Not available. Basis for action: The PMN substance will be used as a binder for industrial coating. Based on additional information and structural analogy to schiff bases and aliphatic amines, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 2 ppb of the PMN substance in surface waters. Since significant environmental exposure is not expected, as the substance is not released to surface waters, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface waters may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 4)( ii). Recommended testing: EPA has determined that an algal toxicity study ( OPPTS 850.5400 test guideline ( public draft)), a fish acute toxicity study ( OPPTS 850.1075 test guideline ( public draft)), a daphnid chronic toxicity study ( OPPTS 850.1300 test guideline ( public draft)) would help to characterize the environmental effects of the PMN substance. The fish and daphnid tests should be conducted with the flowthrough methods and measured concentrations and the algal test should be conducted with static methods and measured concentrations.

VerDate Jan< 31> 2003 15: 12 Mar 27, 2003 Jkt 200001 PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 28MRR1. SGM 28MRR1 15067 Federal Register / Vol. 68, No. 60 / Friday, March 28, 2003 / Rules and Regulations CFR citation: 40 CFR 721.910. PMN Number P   99   0874 Chemical name: ( generic) Modified polymer of vinyl acetate and quaternary ammonium compound. CAS number: Not available. Basis for action: The PMN substance will be used as a modified polyvinyl alcohol. Based on submitted toxicity data for other high molecular weight, water swellable polymers, EPA has identified health concerns for inhalation exposure. Since significant inhalation exposure is unlikely when the substance is used as identified in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that domestic manufacture of the PMN may lead to inhalation exposure which could cause serious health effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 3)( ii). Recommended testing: EPA has determined that a 90 day inhalation toxicity study with a 60 day holding period ( OPPTS 870.3465 test guideline) would help to characterize the human health effects of the PMN substance. Attention should be given to the lungs, including histopathology of the lungs ( inflamation, epithelial hyperplasia, and fibrosis), bronchoalvelar lavage ( BAL) analysis for markers of lung injury, and lung burden analysis for clearance of the test material ( EPA   748   R   96   001). The neurotoxicity components and examination of organs other than the lungs are not required. CFR citation: 40 CFR 721.8658. PMN Number P   99   0965 Chemical name: Furan, octafluorotetrahydro. CAS number: 773   14   8. Basis for action: The PMN substance will be used as heat transfer agent. EPA believes that other uses of the PMN substance are likely and they have the potential for more widespread environmental exposure causing potential atmospheric changes. EPA is concerned that such atmospheric changes may contribute to global warming. Since significant environmental exposure is unlikely, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance may result in significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 4)( ii). Recommended testing: EPA has determined that infrared absorption, destruction of OH by radical and rate of production of HF for global warming would help to characterize the atmospheric effects of the PMN substance. CFR citation: 40 CFR 721.3818. PMN Number P   99   0990 Chemical name: Cobaltate ( 5), bis[ 4[[ 6 [( 4 amino 6 chloro 1,3,5 triazin 2 yl) amio] 1 hydroxy 3 sulfo 2 naphthalenyl] azo] 3 hydroxy 7 nitro 1 naphthalenesulfonato( 4)], pentasodium. CAS number: 91144   26   2. Basis for action: Based on structural analogues and submitted test data, EPA has identified health concerns for carcinogenicity and mutagenicity from inhalation exposure to the PMN substance. Since significant worker exposure is unlikely because inhalation exposure is not expected when the substance is used with protective equipment as identified in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that uses of the substance other than as described in the PMN may cause serious health effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 1)( i)( B) and ( b)( 1)( i)( C). Recommended testing: EPA has determined that a combined chronic toxicity/ carcinogenicity study ( OPPTS 870.4300 test guideline) would help to characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.5283. PMN Number P   99   1167 Chemical name: L aspartic acid, N, N' [( 1E)  1,2  ethenediylbis[( 3 sulfo 4, 1 phenylene) imino[ 6( phenylamino) 1,3,5 triazine 4,2  diyl]]] bis, hexasodium salt. CAS number: 205764   98   3. Basis for action: The PMN substance will be used as a fluorescent whitener for coated paper. Based on submitted test data, EPA has identified concerns for liver effects. Since significant worker exposure is unlikely because there would not be significant inhalation exposure for the use identified in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance as described in the PMN present an unreasonable risk. EPA has determined, however, that uses of the substance in a powder form or domestic manufacture may cause serious health effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 3)( i). Recommended testing: EPA has determined that a 90 day subchronic oral toxicity study in rodents ( OPPTS 870.3100 test guideline) would help to characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.4575. PMN Number P   99   1189 Chemical name: 2 propenoic acid, 2 methyl, C11 14 isoalkyl esters, C13 rich. CAS number: 85736   97   6. Basis for action: The PMN substance will be used as a monomer for casting automotive parts adhesives or as an impregnation fluid. Based on analogy to structurally similar methacrylates and esters, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 ppb of the PMN substance in surface waters. Since significant environmental exposure is not expected, as the substance is not released to surface waters above 1 ppb, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface waters above 1 ppb may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 4)( ii). Recommended testing: The Agency has determined that the results of the following testing would help to characterize possible environmental effects of the substance: A ready biodegradability test ( OPPTS 835.3110 test guideline); a fish early life stage toxicity study ( OPPTS 850.1400 test guideline ( public draft)); a mysid chronic toxicity study ( OPPTS 850.1350 test guideline ( public draft)) for 21 days, flow through methods and measured concentrations; and a saltwater algal toxicity study, tiers I and II ( OPPTS 850.5400 test guideline ( public draft)) with the static methods and measured concentrations. CFR citation: 40 CFR 721.4792. PMN Numbers P   99   1191 and P   99   1192 Chemical name: ( generic) Rare earth phosphate. CAS number: Not available. Basis for action: The PMN substances will be used as phosphors. Based on structural analogy to soluble salts and test data for inorganic phosphates, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 2 ppb of the PMN substances in surface waters. Since significant environmental exposure is not expected, as the substances are not released to VerDate Jan< 31> 2003 15: 12 Mar 27, 2003 Jkt 200001 PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 28MRR1. SGM 28MRR1 15068 Federal Register / Vol. 68, No. 60 / Friday, March 28, 2003 / Rules and Regulations surface waters above 10 ppb, as described in the PMNs, EPA has not determined that the proposed manufacturing, processing, and use of the substances may present an unreasonable risk. EPA has determined, however, that other uses of the substances resulting in release to surface waters above 10 ppb may cause significant adverse environmental effects. Based on this information the PMN substances meet the concern criteria at § 721.170( b)( 4)( ii). Recommended testing: EPA has determined that a fish acute toxicity study ( OPPTS 850.1075 test guideline ( public draft)), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline public draft)), and an algal toxicity study ( OPPTS 850.5400 test guideline ( public draft)) would help to characterize the environmental effects of the PMN substances. A flow through method with measured concentrations of the rare earth metal is recommended for the fish and daphnid study and the static method with measured concentrations for green algae. In addition, the test dilution water and/ or test medium should have a measured hardness of less than 180.0 mg/ L as CaC03 and a total organic carbon ( TOC) concentration of less than 2.0 mg TOC/ L. CFR citation: 40 CFR 721.6005. PMN Number P   99   1287 Chemical name: ( generic) Alkylaminated polyolefin. CAS number: Not available. Basis for action: The PMN substance will be used as a gasoline fuel additive. Based on structural analogy to aliphatic amines, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 40 ppb of the PMN substance in surface waters. Since significant environmental exposure is not expected, as the substance is not released to surface waters, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface waters may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 4)( ii). Recommended testing: EPA has determined that a fish acute toxicity study ( OPPTS 850.1075 test guideline ( public draft)), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline ( public draft)), and an algal toxicity study ( OPPTS 850.5400 test guideline ( public draft)) would help to characterize the environmental effects of the PMN substance. These tests should be conducted with static methods and nominal concentrations, total organic carbon TOC of dilution water < 2.0 mg TOC/ L, hardness of dilution water < 180.0 mg/ L as CaC03, and stock solution adjusted to pH 7.0 with HCl. CFR citation: 40 CFR 721.6178. PMN Number P   99   1327 Chemical name: Propane, 1,1,1,3,3 pentachloro. CAS number: 23153   23   3. Basis for action: The PMN substance will be used as an intermediate for hydrofluorocarbon production. Based on submitted test data, EPA has identified health concerns for carcinogenicity, liver and kidney toxicity. Based on submitted data on hexachloropropane, concern for immunotoxicity was identified. Also, the Agency identified concern for neurotoxicity, reproductive toxicity in males and females, and concern for irritation and lesions in nasal passages and respiratory passages based on test data on other structural analogues. Since significant worker exposure is unlikely when the substance is used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance other than as described in the PMN could result in exposures which may cause serious health effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 1)( i)( A), ( b)( 3)( i), and ( b)( 3)( ii). Recommended testing: EPA has determined that a prenatal developmental toxicity study ( OPPTS 870.3700 test guideline), carcinogenicity study ( OPPTS 870.4200 test guideline), and a reproduction fertility effects study ( OPPTS 870.3800 test guideline) by the inhalation route will help to characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.533. PMN Number P   99   1346 Chemical name: Silane, triethoxy ( 3,3,4,4,5,5,6,6,7,7,8,8,8 tridecafluorooctyl). CAS number: 51851   37   7. Basis for action: The PMN substance will be used as in anti graffiti coatings as described in the PMN. Based on structural analogy to alkoxysilanes, EPA has identified health concerns for lung toxicity. Since significant worker exposure is unlikely, when the substance is used with protective equipment as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that use of the PMN substance other than as described in the PMN could result in exposures which may cause serious health effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 3)( ii). Recommended testing: EPA has determined that a 90 day subchronic inhalation toxicity study in rats ( OPPTS 870.3465 test guideline) would help to characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.9504. PMN Number P   99   1366 Chemical name: ( generic) 4,6 Disubstituted pyrimidine. CAS number: Not available. Basis for action: The PMN substance will be used as a starting material for synthesis of a chemical intermediate. EPA has identified health concerns for neurotoxicity and immunotoxicity ( effects to the spleen) based on test data on an analogous substance, concerns for carcinogenicity and developmental toxicity based on the potential for the PMN substance to act as an arylating agent or as an antimetabolite. Since significant worker exposure is unlikely, when the substance is used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that domestic manufacture could result in exposures which may cause serious chronic and developmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 3)( ii) and ( b)( 1)( i)( C). Recommended testing: EPA has determined that a 90 day subchronic oral toxicity study in rodents ( OPPTS 870.3100 test guideline) would help to characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.8920. PMN Number P   99   1399 Chemical name: ( generic) Aromatic epoxide resin. CAS number: Not available. Basis for action: The PMN substance will be used as a thermoset resin. EPA has identified health concerns for mutagenicity, carcinogenicity, developmental toxicity, male reproductive effects, liver and kidney toxicity based on the epoxide groups. Since significant worker exposure is unlikely, when the substance is used as described in the PMN, EPA has not determined that the proposed VerDate Jan< 31> 2003 15: 12 Mar 27, 2003 Jkt 200001 PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 28MRR1. SGM 28MRR1 15069 Federal Register / Vol. 68, No. 60 / Friday, March 28, 2003 / Rules and Regulations manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that use of the PMN substance other than as described in the PMN may cause serious health effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 3)( ii). Recommended testing: EPA has determined that a 90 day subchronic oral toxicity study in rodents with attention to pathology of the reproductive organs ( OPPTS 870.3100 test guideline), a reproduction fertility effects study ( OPPTS 870.3800 test guideline), and a combined chronic toxicity/ carcinogenicity study ( OPPTS 870.4300 test guideline) would help to characterize the health effects of the substance. CFR citation: 40 CFR 721.2673. PMN Number P   00   0045 Chemical name: ( generic) Benzenediazonium, [[[[( substituted) azo] phenyl] sulfonyl] amino], coupled with aminophenol, diazotized aminobenzoic acid, diazotized ( substituted) benzenesulfonic acid and naphthalenol. CAS number: Not available. Basis for action: The PMN substance will be used as described in the PMN. Based on submitted test data, EPA has identified health concerns for methemoglobinemia. Since significant worker exposure is unlikely when used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may cause significant adverse effects. EPA has determined, however, that domestic manufacture may result in serious health effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 3)( ii). Recommended testing: EPA has determined that a 90 day subchronic oral toxicity study in rodents ( OPPTS 870.3100 test guideline) would help to characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.5286. PMN Number P   00   0067 Chemical name: ( generic) Alkyl heteropolycyclic aniline. CAS number: Not available. Basis for action: The PMN substance will be used as an industrial intermediate. Based on test data and on structural analogy to anilines, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 ppb of the PMN substance in surface waters. Since significant environmental exposure is not expected as the substance is not released to surface water above 1 ppb as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface above 1 ppb may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 4)( i) and ( b)( 4)( ii). Recommended testing: EPA has determined that a daphnid chronic toxicity test ( OPPTS 850.1300 test guideline ( public draft)), a fish early life stage toxicity test ( OPPTS 850.1400 test guideline ( public draft)) conducted with flow through methods and measured concentrations, dilution water hardness < 180.0 mg/ L as CaC03, and a Porous Pot ( OPPTS 835.3220 test guideline) would help to characterize the environmental effects. CFR citation: 40 CFR 721.4136. PMN Number P   00   0094 Chemical name: ( generic) Salt of a substituted sulfonated aryl azo compound. CAS number: Not available. Basis for action: The PMN substance will be used as a colorant for coating compositions. EPA has identified health concerns for testicular effects, blood effects, and liver toxicity based on submitted test data. Since significant worker exposure is unlikely, when the substance is used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined however, that domestic manufacture could result in exposures which may cause serious health effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 3)( i). Recommended testing: EPA has determined that a 90 day subchronic oral toxicity study in rodents ( OPPTS 870.3100 test guideline) would help to characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.9597. PMN Number P   00   0108 Chemical name: ( generic) Alkoxyaminoalkyl coumarin. CAS number: Not available. Basis for action: The PMN substance will be used as a chemical tracer. Based on structural analogy to coumarins, EPA has identified health concerns for developmental toxicity and carcinogenicity. Since significant worker exposure is unlikely when the substance is used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that domestic manufacture could result in exposures which may cause serious health effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 3)( ii) and ( b)( 1)( i)( C). Recommended testing: EPA has determined that a 90 day subchronic oral study in rodents ( OPPTS 870.3100 test guideline) and a prenatal developmental toxicity study ( OPPTS 870.3700 test guideline) would help to characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.2155. PMN Number P   00   0202 Chemical name: ( generic) Reaction product of substituted aromatic diol, formaldehyde and alkanolamine, propoxylated. CAS number: Not available. Basis for action: The PMN substance will be used as foam insulation. Based on structural analogy to aliphatic amines, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 10 ppb of the PMN substance in surface waters. Since significant environmental exposure is not expected, as the substance is not released to surface waters, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface water may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 4)( ii). Recommended testing: EPA has determined that a fish acute toxicity study ( OPPTS 850.1075 test guideline ( public draft)), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline ( public draft)), and an algal toxicity study ( OPPTS 850.5400 test guideline ( public draft)) would help to characterize the environmental effects of the PMN substance. All tests should be conducted with static methods and nominal concentrations, dilution water total organic carbon TOC < 2.0 mg TOC/ L dilution water hardness < 180.0 mg/ L as CaC03, and stock solution adjusted to pH 7.0. CFR citation: 40 CFR 721.8085. PMN Number P   00   0330 Chemical name: Oxirane, [[[( 1R, 2S, 5R) 5 methyl 2( 1 methylethyl) cyclohexyl] oxy] methyl]. CAS number: 249297   16   3.

VerDate Jan< 31> 2003 15: 12 Mar 27, 2003 Jkt 200001 PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 28MRR1. SGM 28MRR1 15070 Federal Register / Vol. 68, No. 60 / Friday, March 28, 2003 / Rules and Regulations Basis for action: The PMN substance will be used as a chemical intermediate. Based on data for monoepoxides, EPA has identified health concerns for mutagenicity, carcinogenicity, male reproductive toxicity, developmental toxicity, and liver and kidney toxicity for the epoxide. Also, based on analogy to epoxides, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 30 ppb of the PMN substance in surface waters. Since significant worker and environmental exposure is unlikely when the substance is used as described in the PMN, EPA has not determined that the manufacturing, processing, and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that use of the substance other than as an intermediate could result in exposures which may cause serious health effects and significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 3)( ii), ( b)( 1)( i) ( C), and ( b)( 4)( ii). Recommended testing: EPA has determined that a 90 day subchronic oral toxicity study in rodents ( OPPTS 870.3100 test guideline), with attention to pathology of the reproductive organs, and a carcinogenicity study ( OPPTS 870.4200 test guideline) would help to characterize the health effects of the substance. In addition, the following acute aquatic toxicity tests would help to characterize the environmental effects. A fish acute toxicity study ( OPPTS 850.1075 test guideline ( public draft)), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline ( public draft)), and an algal toxicity study ( OPPTS 850.5400 test guideline ( public draft)). The fish and daphnid tests should be conducted with flow through methods and measured concentrations. The algal test should be conducted with static methods and measured concentrations. CFR citation: 40 CFR 721.5590. PMN Numbers P   00   0333 and P   00   0334 Chemical name: ( generic) Salt of an acrylate copolymer. CAS number: Not available. Basis for action: The PMN substances will be used as an additive. EPA has identified concerns for lung toxicity and lung tumors based on data on certain high molecular weight polymers. Since significant worker exposure is unlikely as inhalation exposure is not expected for the uses described in the PMNs, EPA has not determined that the proposed manufacturing, processing, and use of the substances may present an unreasonable risk. EPA has determined, however, that uses of the substances in a solid form may cause serious health effects. Based on this information the PMN substances meet the concern criteria at § 721.170( b)( 3)( ii). Recommended testing: EPA has determined that a 90 day inhalation toxicity study with a 60 day holding period ( OPPTS 870.3465 test guideline) would help characterize the human health effects of the PMN substance. Attention should be given to the lungs, including histopathology of the lungs ( inflamation, epithelial hyperplasia, and fibrosis), bronchoalvelar lavage ( BAL) analysis for markers of lung injury, and lung burden analysis for clearance of the test material ( EPA   748   R   96   001). The neurotoxicity components and examination of organs other than the lungs are not required. CFR citation: 40 CFR 721.338. PMN Number P   00   0351 Chemical name: ( generic) Aminohydroxy sulfonaphthylazo disubstituted phenyl azo benzene carboxylate salt. CAS number: Not available. Basis for action: The PMN substance will be used as described in the PMN. Based on submitted data on a 28 day study in rats with a no observed adverse effect level ( NOAEL) of 25 mg/ kg/ day, EPA has identified concerns for liver and kidney effects. Additionally, based on analogy of the azo reduction product of the PMN substance, EPA has concerns for carcinogenicity, developmental toxicity, and immunotoxicity. Since significant worker exposure is unlikely as inhalation exposure is not expected for the use described in the PMN, EPA has not determined that manufacturing, processing, and use of the substance as described in the PMN may present an unreasonable risk. EPA has determined, however, that use of the substance as a solid may cause serious health effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 3)( ii), ( b)( 3)( iii), and ( b)( 1)( i)( D). Recommended testing: EPA has determined that a prenatal developmental toxicity study by the oral route in two species ( OPPTS 870.3700 test guideline) and an Ames assay with the Prival modification and a concurrent positive control ( OPPTS 870.5100 test guideline) would help to characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.984. PMN Number P   00   0353 Chemical name: ( generic) Alkoxylated aliphatic diisocyanate allyl ether. CAS number: Not available. Basis for action: The PMN substance will be used as an additive for surface coatings and for plastics and plastic surfaces. Based on structural analogy to esters and allylic and vinyl ethers, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 9 ppb of the PMN substance in surface waters. Since significant environmental exposure is not expected, as the PMN substance is not released to surface waters, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface waters may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 4)( ii). Recommended testing: EPA has determined that a fish chronic toxicity study ( OPPTS 850.1400 test guideline ( public draft)), a daphnid chronic toxicity study ( OPPTS 850.1300 test guideline ( public draft)), and an algal toxicity study ( OPPTS 850.5400 test guideline ( public draft)) would help to characterize the environmental effects of the PMN substance. The fish and daphnid tests should be conducted with flow through methods and measured concentrations, dilution water hardness less than 180.0 mg/ L as CaC03. The algal test should be conducted with static methods and measured concentrations. CFR citation: 40 CFR 721.9952. PMN Numbers P   00   0364 and P   00   0365 Chemical name: ( generic) Copper complex of ( substituted sulfonaphthyl azo substituted phenyl) disulfonaphthyl azo, amine salt. CAS number: Not available. Basis for action: The PMN substances will be used as described in the PMNs. Based on analogy to structurally similar substances, EPA has identified concerns for mutagenicity, carcinogenicity, and developmental toxicity. Since significant worker exposure is unlikely as inhalation exposure is not expected for the uses described in the PMNs, EPA has not determined that the proposed manufacturing, processing, and use of the substances may present an unreasonable risk. EPA has determined, however, that use of the substances as a powder may cause serious health effects. Based on this information the PMN substances meet the concern criteria at § 721.170( b)( 3)( ii) and ( b)( 1)( i)( C). Recommended testing: EPA has determined that a prenatal VerDate Jan< 31> 2003 15: 12 Mar 27, 2003 Jkt 200001 PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 28MRR1. SGM 28MRR1 15071 Federal Register / Vol. 68, No. 60 / Friday, March 28, 2003 / Rules and Regulations developmental toxicity study by the oral route in two species ( OPPTS 870.3700 test guideline) would help to characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.2577. PMN Number P   00   0420 Chemical name: ( generic) Substituted phenylazophenylazo phenol. CAS number: Not available. Basis for action: The PMN substance will be used as a colorant. Based on structural analogy to phenols, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 ppb of the PMN substance in surface waters. Since significant environmental exposure is not expected, as the substance is not released to surface waters, as described in the PMN, EPA has not determined that the proposed manufacturing, processing and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface water may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 4)( ii). Recommended testing: EPA has determined that a fish acute toxicity study ( OPPTS 850.1075 test guideline ( public draft)), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline ( public draft)), and an algal toxicity study ( OPPTS 850.5400 test guideline ( public draft)) would help to characterize the environmental effects of the PMN substance. The fish and daphnid tests should be conducted with flow through methods and measured concentrations. The algal test should be conducted with static methods and measured concentrations. Dilution water hardness less than 180.0 mg/ L as CaC03. CFR citation: 40 CFR 721.843 PMN Number P   00   0469 Chemical name: Glycine, N ( carboxymethyl) N dodecyl, monosodium salt. CAS number: 141321   68   8. Basis for action: The PMN substance will be used as a surfactant. Based on structural analogy to alkyl amphoteric surfactants, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 30 ppb of the PMN substance in surface waters. Since significant environmental exposure is not expected as the PMN substance is not released to surface water above 30 ppb, as described in the PMN, EPA has not determined that the proposed manu facturing, processing, and use of the substance may present an unreasonable environmental risk. EPA has determined, however, that other uses of the substance resulting in release to surface water above 30 ppb may cause significant adverse environmental effects. Based on this infor mation the PMN substance meets the concern criteria at § 721.170( b)( 4)( ii). Recommended testing: EPA has determined that the following acute aquatic toxicity tests would help to characterize the environmental effects: a fish acute toxicity study ( OPPTS 850.1075 test guideline ( public draft)), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline ( public draft)), and an algal toxicity study ( OPPTS 850.5400 test guideline ( public draft)). The fish and daphnid tests should be conducted with flow through methods and measured concentrations. The algal test should be conducted with static methods and measured concentrations, dilution water total organic carbon TOC < 2.0 mg TOC/ L dilution water hardness < 180.0 mg/ L as CaC03, and stock solution adjusted to pH 7.0. CFR citation: 40 CFR 721.3848. PMN Number P   00   0490 Chemical name: ( generic) Substituted acrylamides and acrylic acid copolymer. CAS number: Not available. Basis for action: The PMN substance will be used as a delivery substrate. EPA has identified concerns for lung toxicity and carcinogenicity if the substance is inhaled based on data for certain high molecular weight polymers. Since significant worker exposure is unlikely as inhalation exposure to worker is not expected for the use described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substances may present an unreasonable risk. EPA has determined, however, that domestic manufacture, or processing and use of the substance in a powder form may cause serious health effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 3)( ii) and ( b( 1)( i)( C). Recommended testing: EPA has determined that a 90 day inhalation toxicity study with a 60 day holding period ( OPPTS 870.3465 test guideline) would help characterize the human health effects of the PMN substance. Attention should be given to the lungs, including histopathology of the lungs ( inflamation, epithelial hyperplasia, and fibrosis), bronchoalvelar lavage ( BAL) analysis for markers of lung injury, and lung burden analysis for clearance of the test material ( EPA   748   R   96   001). The neurotoxicity components and examination of organs other than the lungs are not required. CFR citation: 40 CFR 721.321. PMN Number P   00   0542 Chemical name: ( generic) Substituted phenols and formaldehyde polymer, alkylated. CAS number: Not available. Basis for action: The PMN substance will be used as a resin for can and tube coatings. Based on structural analogy to polyphenol reaction products, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 4 ppb of the PMN substance in surface waters. Since significant environmental exposure is unlikely, as the substance is not released to surface waters, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may prevent an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in releases to surface waters may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 4)( ii). Recommended testing: EPA has determined that a fish acute toxicity study ( OPPTS 850.1075 test guideline ( public draft)), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline ( public draft)), and an algal toxicity study ( OPPTS 850.5400 test guideline ( public draft)) would help to characterize the environmental effects of the PMN substance. The fish and daphnid tests should be conducted with flow through methods and measured concentration. The algal test should be conducted with static methods and measured concentration. Dilution water hardness < 180 mg/ L as CaC03. CFR citation: 40 CFR 721.3812. PMN Number P   00   0559 Chemical name: ( generic) Methylatedpara rosaniline salt of a trisulfonated triarylmethane dye. CAS number: Not available. Basis for action: The PMN substance will be used as a colorant for inks. EPA has identified health concerns for carcinogenicity and developmental toxicity based on analogy to gentian violet. Since significant worker exposure is unlikely when the substance is used as described in the PMN, EPA has not determined that the proposed processing and use of the substance may present a unreasonable risk. EPA has determined however, that domestic manufacturing could result in exposures which may cause serious health effects. Also, based on analogy to cationic dyes. EPA is also concerned that toxicity to aquatic organisms may occur at a concentration as low as 2 ppb of the VerDate Jan< 31> 2003 15: 12 Mar 27, 2003 Jkt 200001 PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 28MRR1. SGM 28MRR1 15072 Federal Register / Vol. 68, No. 60 / Friday, March 28, 2003 / Rules and Regulations PMN substance in surface waters. Since significant environmental exposure is not expected as the PMN substance is not released to surface water above 2 ppb, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable environmental risk. EPA has determined, however, that other uses of the substance resulting in release to surface water above 2 ppb may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170 ( b)( 1)( i)( C), ( b)( 3)( ii), and ( b)( 4)( ii). Recommended testing: EPA has determined that the following acute aquatic toxicity tests would help to characterize the environmental effects: a fish acute toxicity study ( OPPTS 850.1075 test guideline ( public draft)), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline ( public draft)), and an algal toxicity study ( OPPTS 850.5400 test guideline ( public draft)). The fish and daphnid tests should be conducted with flow through methods and measured concentrations, dilution water total organic carbon TOC < 2.0 mg TOC/ L. The algal test should be conducted with static methods and measured concentration. Dilution water hardness < 180.0 mg/ L as CaC03. EPA has also determined that a prenatal developmental toxicity study by the oral route in two species ( OPPTS 870.3700 test guideline) would help to characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.9520. PMN Number P   00   0618 Chemical name: ( generic) Substituted hydroxyalkane acetate. CAS number: Not available. Basis for action: The PMN substance will be used as described in the PMN. EPA has concerns for liver toxicity, kidney toxicity, and developmental toxicity based on a 28 day subchronic inhalation study in rats and a developmental toxicity study in rats for an analog of the PMN material; EPA identified concerns for neurotoxicity and carcinogenicity based on analog data. Since significant worker exposure is unlikely as inhalation exposure is not expected for the use described in the PMN, EPA has not determined that manufacturing, processing, and use of the substance as described in the PMN may present an unreasonable risk. EPA has determined, however, that use of the substance other than as described in the PMN may cause serious health effects. Based on this information the PMN substance meets the concern criteria at § 721.170 ( b)( 3)( i), ( b)( 3)( ii), and ( b)( 1)( i)( C). Recommended testing: EPA has determined that a prenatal developmental toxicity study by the oral route in two species ( OPPTS 870.3700 test guideline) and a 90 day inhalation toxicity study with a 60 day holding period ( OPPTS 870.3465 test guideline) would help to characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.532. PMN Number P   00   0626 Chemical name: ( generic) Acrylate of polymer based on isophorone diisocyanate. CAS number: Not available. Basis for action: The PMN substance will be used as an additive for inks and coatings. Based on structural analogy to acrylates, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 ppb of the PMN substance in surface waters. Since significant environmental exposure is not expected as the PMN substance is not released to surface water above 3 ppb, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable environmental risk. EPA has determined, however, that other uses of the substance resulting in release to surface water above 3 ppb may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 4)( ii). Recommended testing: EPA has determined that the following acute aquatic toxicity tests would help to characterize the environmental effects: a fish acute toxicity study ( OPPTS 850.1075 test guideline ( public draft)), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline ( public draft)), and an algal toxicity study ( OPPTS 850.5400 test guideline ( public draft)). The fish and daphnid tests should be conducted with flow through methods and measured concentrations The algal test should be conducted with static methods and measured concentrations. Dilution water hardness < 180.0 mg/ L as CaC03. CFR citation: 40 CFR 721.463. PMN Number P   00   0637 Chemical name: Methylium, triphenyl, tetrakis( pentafluorophenyl) borate ( l). CAS number: 136040   19   2. Basis for action: The use of the substance is as described in the PMN. Based on structural analogy to organoborates, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 ppb of the PMN substance in surface waters. Since significant environmental exposure is not expected, as the substance is not released to surface waters, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface waters may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 4)( ii). Recommended testing: EPA has determined that a fish acute toxicity study ( OPPTS 850.1075 test guideline ( public draft)), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline ( public draft)), and an algal toxicity study ( OPPTS 850.5400 test guideline ( public draft)) would help to characterize the environmental effects of the PMN substance. The fish and daphnid tests should be conducted with flow through methods and measured concentrations. The algal test should be conducted with static methods and measured concentrations. Dilution water hardness less than 180.0 mg/ L as CaC03. CFR citation: 40 CFR 721.5454. PMN Number P   00   0638 Chemical name: ( generic) Alkali metal salt of halogenated organoborate. CAS number: Not available. Basis for action: The use of the substance is as described in the PMN. Based on structural analogy to organoborates, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 3 ppb of the PMN substances in surface waters. Since significant environmental exposure is not expected, as the substance is not released to surface waters, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface waters may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 4)( ii). Recommended testing: EPA has determined that a fish acute toxicity study ( OPPTS 850.1075 test guideline ( public draft)), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline ( public draft)), and an algal toxicity study ( OPPTS 850.5400 test guideline ( public draft)) would help to characterize the environmental effects of the PMN substance. The fish and VerDate Jan< 31> 2003 15: 12 Mar 27, 2003 Jkt 200001 PO 00000 Frm 00028 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 28MRR1. SGM 28MRR1 15073 Federal Register / Vol. 68, No. 60 / Friday, March 28, 2003 / Rules and Regulations daphnid tests should be conducted with flow through methods and measured concentrations. The algal test should be conducted with static methods and measured concentrations. Dilution water hardness less than 180.0 mg/ L as CaC03. CFR citation: 40 CFR 721.5452. PMN Number P   00   0691 Chemical name: Amides, from ammonium hydroxide  maleic anhydride polymer and hydrogenated tallow alkyl amines, sodium salts, compds. with ethanolamine. CAS number: 208408   03   1. Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogy to anionic surfactants. EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 80 ppb of the PMN substance in surface waters. Since significant environmental exposure is not expected as the PMN substance is not released to surface water above 80 ppb, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, other uses of the substance resulting in release to surface waters above 80 ppb may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 4)( ii). Recommended testing: EPA has determined that the following acute aquatic toxicity tests would help to characterize the environmental effects: a fish acute toxicity study ( OPPTS 850.1075 test guideline ( public draft)), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline ( public draft)), and an algal toxicity study ( OPPTS 850.5400 test guideline ( public draft)). The fish and daphnid tests should be conducted with flow through methods and measured concentrations. The algal test should be conducted with static methods and measured concentrations. Dilution water hardness < 180.0 mg/ L as CaC03. CFR citation: 40 CFR 721.6183. PMN Number P   00   0698 Chemical name: ( generic) Lithium salt of a sulfophenyl azo phenyl azo disulfostilbene. CAS number: Not available. Basis for action: The PMN substance will be used as described in the PMN. Based on analogy to structurally similar substance, EPA has identified concerns for liver toxicity, developmental toxicity, neurotoxicity, and blood toxicity for the aromatic amine azo reduction product. Since significant worker exposure is unlikely as inhalation exposure is not expected for the uses described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance as a solid may cause serious health effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 3)( iii). Recommended testing: EPA has determined that a prenatal developmental toxicity study by the oral route in two species ( OPPTS 870.3700 test guideline) and a 90 day subchronic oral toxicity study in rodents ( OPPTS 870.3100 test guideline) would help to characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.9538. PMN Number P   00   0738 Chemical name: Formaldehyde, reaction products with 1,3 benzenedimethanamine and bisphenol A. CAS number: 259871   68   6. Basis for action: The PMN substance will be used as coatings for railcars and marine vessels. Based on structural analogy to phenols and aliphatic amines, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 20 ppb of the PMN substance in surface waters. Since significant environmental exposure is not expected as the PMN substance is not released to surface waters, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in releases to surface waters may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 4)( ii). Recommended testing: EPA has determined that a fish acute toxicity study ( OPPTS 850.1075 test guideline ( public draft)), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline ( public draft)), and an algal toxicity study ( OPPTS 850.5400 test guideline ( public draft)) would help to characterize the environmental effects of the PMN substance. These tests should be conducted with the static methods and nominal concentrations, dilution water total organic carbon TOC < 2.0 mg TOC/ L dilution water hardness < 180.0 mg/ L as CaC03, and stock solution adjusted to pH 7.0. EPA has also determined that an activated sludge isotherm test ( OPPTS 835.1110 test guideline) would help to characterize the environmental fate of the PMN substance. CFR citation: 40 CFR 721.3805. PMN Number P   00   0789 Chemical name: 1,4 Benzedicarboxylic acid, dimethyl ester, polymer with 1,4  butanediol, cyclized. CAS number: 263244   54   8. Basis for action: The PMN substance will be used as a curable thermoplastic resin. EPA has identified health and environmental concerns because the substance is potentially a persistent, bioaccumulative, and toxic ( PBT) chemical, EPA estimates that the PMN substance will persist in the environment more than two months and estimates a bioaccumulation factor of greater than or equal to 1,000. Also based on structural analogy to esters, EPA expects toxicity to aquatic organisms at surface water concentrations as low as 9 ppb. Since significant environmental exposure is not expected as the substance is not released to surface waters, described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface water may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 4)( ii). Recommended testing: EPA has determined that the results of the tiered testing as described in the New Chemicals Program's PBT Policy Statement ( 63 FR 60194; November 4, 1999) ( FRL   6097   7) would help to characterized the properties of the substance. EPA has also determined that the following aquatic toxicity tests: a fish chronic toxicity study ( OPPTS 850.1400 test guideline ( public draft)), a daphnid chronic toxicity study ( OPPTS 850.1300 test guideline ( public draft)), and an algal toxicity study ( OPPTS 850.5400 test guideline ( public draft)) would help to characterize the environmental effects of the PMN substance. The fish and daphnid tests should be conducted with flow through methods and measured concentrations. The algal test should be conducted with static methods and measured concentrations. Dilution water hardness < 180.0 mg/ L as CaC03. CFR citation: 40 CFR 721.990. PMN Number P   00   0803 Chemical name: ( generic) 2,7 Naphthalenedisulfonic acid, 5[[ 4 chloro 6[ substituted] amino] 1,3,5

VerDate Jan< 31> 2003 15: 12 Mar 27, 2003 Jkt 200001 PO 00000 Frm 00029 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 28MRR1. SGM 28MRR1 15074 Federal Register / Vol. 68, No. 60 / Friday, March 28, 2003 / Rules and Regulations triazin 2 yl] amino] 4 hydroxy 3[( 1 sulfo 2 naphthalenyl) azo], trisodium salt. CAS number: Not available. Basis for action: The PMN substance will be used as a textile dye. EPA has identified health concerns for mutagenicity and developmental toxicity based on one of the substituents on an azo reduction product. Since significant worker exposure is unlikely when the substance is used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that domestic manufacture could result in exposures which may cause serious health effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 3)( iii). Recommended testing: EPA has determined that a prenatal developmental toxicity study by the oral route in rats ( OPPTS 870.3700 test guideline) would help to characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.5262. PMN Number P   00   0806 Chemical name: 1,3,6 Naphthalenetrisulfonic acid, 7[[ 2 [( aminocarbonyl) amino] 4[[ 4[[ 2[ 2 ( ethenylsulfonyl) ethoxy] ethyl] amino] 6 fluoro 1,3,5 triazin 2 yl] amino] phenyl] azo], trisodium salt. CAS number: 106359   91   5. Basis for action: The PMN substance will be used as a textile dye. Based on submitted test data, EPA has identified health concerns for mutagenicity, dermal sensitization and possible irreversible cornea staining; developmental toxicity and carcinogenicity based on one of the substituents on an azo reduction product. Since significant worker exposure is unlikely when the substance is used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that domestic manufacture could result in exposures which may cause serious health effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 3)( i), ( b)( l)( i)( D), and ( b)( 3)( iii). Recommended testing: EPA has determined that a prenatal developmental toxicity study by the oral route in rats ( OPPTS 870.3700 test guideline) would help to characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.5260. PMN Number P   00   0816 Chemical name: ( generic) Alkyl dialkylamino phenylsulfonyl alkenoate. CAS number: Not available. Basis for action: The PMN substance will be used as described in the PMN. Based on test data for structurally similar compounds, EPA has identified health concerns for kidney and liver toxicity. Since significant worker exposure is unlikely when the substance is used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that domestic manufacture could result in exposures which may cause serious health effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 3)( i). Also, based on structural analogy to aliphatic amines, acrylates, and allylic and vinyl sulfones, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 ppb of the PMN substance in surface waters. Since significant environmental exposure is not expected as the substance is not released to surface waters, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface waters may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 4)( ii). Recommended testing: EPA has determined that a 90 day subchronic oral study in rats ( OPPTS 870.3100) would help characterize the human health effects of the PMN substance. Also the following aquatic toxicity test would help characterize the environmental effects of the PMN substance: a fish acute toxicity study ( OPPTS 850.1075 test guideline ( public draft)), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline ( public draft)), and an algal toxicity study ( OPPTS 850.5400 test guideline ( public draft)). The fish and daphnid tests should be conducted with flow through methods and measured concentrations. The algal test should be conducted with static methods and measured concentrations, dilution water total organic carbon TOC < 2.0 mg TOC/ L dilution water hardness < 180.0 mg/ L as CaC03. CFR citation: 40 CFR 721.648. PMN Number P   00   0827 Chemical name: 1 propanol, 3 propoxy . CAS number: 4161   22   2. Basis for action: The PMN substance will be used as described in the PMN. EPA has identified health concerns for liver toxicity based on submitted test data and neurotoxicity based on the solvent properties of the substance. Since significant worker exposure is unlikely, when the substance is used with protective equipment as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance other than as described in the PMN including handling the material without the use of impervious gloves could result in exposures which may cause serious health effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 3)( i) and ( b)( 3)( ii). Recommended testing: EPA has determined that a 90 day subchronic oral study ( OPPTS 870.3100 test guideline), and a prenatal developmental toxicity study ( OPPTS 870.3700 test guideline) would help to characterize the health effects of the substance. CFR citation: 40 CFR 721.525. PMN Number P   00   0922 Chemical name: Borate( 1), tris( acetato . kappa. O) hydro, sodium, ( T 4). CAS number: 56553   60   7. Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogy to other boron compounds, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 300 ppb of the PMN substance in surface waters. Since significant environmental exposure is not expected as the PMN substance is not released to surface water above 300 ppb, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface water above 300 ppb may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170 ( b)( 4)( ii). Recommended testing: EPA has determined that a fish acute toxicity study ( OPPTS 850.1075 test guideline ( public draft)), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline ( public draft)), and an algal toxicity study ( OPPTS 850.5400 test guideline ( public draft)) would help to VerDate Jan< 31> 2003 15: 12 Mar 27, 2003 Jkt 200001 PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 28MRR1. SGM 28MRR1 15075 Federal Register / Vol. 68, No. 60 / Friday, March 28, 2003 / Rules and Regulations characterize the environmental effects of the PMN substance. The fish and daphnid tests should be conducted with flow through methods and measured concentrations. The algal test should be conducted with static methods and measured concentrations. Dilution water hardness less than 180.0 mg/ L as CaC03. CFR citation: 40 CFR 721.1880. PMN Number P   00   0993 Chemical name: ( generic) Substituted 6,6'( 1 methylethylidene) bis[ 3,4 dihydro 3 phenyl 1,3 benzoxazine]. CAS number: Not available. Basis for action: The PMN substance will be used as resin for structural composites and electronic laminates. EPA has identified health and environmental concerns because the substance is potentially a PBT chemical. Since significant environmental exposure is not expected, as the substance is not released to surface waters, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in releases to surface waters may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 4)( ii). Recommended testing: EPA has determined that the results of the tiered testing as described in the New Chemicals Program's PBT Category ( 63 FR 60194; November 4, 1999) would help to characterized the properties of the substance. EPA has also determined that the results of the following aquatic toxicity tests: a fish chronic toxicity study ( OPPTS 850.1400 test guideline ( public draft)), a daphnid chronic toxicity study ( OPPTS 850.1300 test guideline ( public draft)), and an algal toxicity study ( OPPTS 850.5400 test guideline ( public draft)), would help to characterize the environmental effects of the PMN substance. The fish and daphnid tests should be conducted with flow through methods and measured concentrations, dilution water hardness < 180.0 mg/ L as CaC03. The algal test should be conducted with static methods and measured concentrations. CFR citation: 40 CFR 721.1767 PMN Number P   00   1086 Chemical name: ( generic) Silyl amine, potassium salt. CAS number: Not available. Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogy to aliphatic amines, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 10 ppb of the PMN substance in surface waters. Since significant environmental exposure is not expected as the PMN substance is not released to surface waters as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface waters may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170 ( b)( 4)( ii). Recommended testing: EPA has determined that a fish acute toxicity study ( OPPTS 850.1075 test guideline ( public draft)), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline ( public draft)), and an algal toxicity study ( OPPTS 850.5400 test guideline ( public draft)) would help to characterize the environmental effects of the PMN substance. The fish and daphnid tests should be conducted with flow through methods and measured concentrations. The algal test should be conducted with static methods and measured concentrations, dilution water total organic carbon TOC < 2.0 mg TOC/ L dilution water hardness < 180.0 mg/ L as CaC03. CFR citation: 40 CFR 721.638. PMN Number P   00   1087 Chemical name: ( generic) Di alkyl borane. CAS number: Not available. Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogy to organoborane compounds, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 200 ppb of the PMN substance in surface waters. Since significant environmental exposure is not expected as the PMN substance is not released to surface water above 200 ppb, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface waters above 200 ppb may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 4)( ii). Recommended testing: EPA has determined that a fish acute toxicity study ( OPPTS 850.1075 test guideline ( public draft)), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline ( public draft)), and an algal toxicity study ( OPPTS 850.5400 test guideline ( public draft)) would help to characterize the environmental effects of the PMN substance. The fish and daphnid tests should be conducted with flow through methods and measured concentration. The algal test should be conducted with static methods and measured concentration. Dilution water hardness < 180 mg/ L as CaC03. CFR citation: 40 CFR 721.1852. PMN Number P   00   1089 Chemical name: ( generic) Alkali metal alkyl borohydride. CAS number: Not available. Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogy to organoborane compounds, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 300 ppb of the PMN substance in surface waters. Since significant environmental exposure is not expected, as the substance is not released to surface waters as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that other uses of the substance resulting in release to surface waters may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 4)( ii). Recommended testing: EPA has determined that a fish acute toxicity study ( OPPTS 850.1075 test guideline ( public draft)), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline ( public draft)), and an algal toxicity study ( OPPTS 850.5400 test guideline ( public draft)) would help to characterize the environmental effects of the PMN substance. The fish and daphnid tests should be conducted with flow through methods and measured concentration. The algal test should be conducted with static methods and measured concentration. Dilution water hardness < 180 mg/ L as CaC03. CFR citation: 40 CFR 721.1878. PMN Number P   00   1132 Chemical name: ( generic) Siloxanes and silicones, aminoalkyl, fluorooctyl, hydroxy terminated salt. CAS number: Not available. Basis for action: The PMN substance will be used in anti graffiti systems as described in the PMN. Based on structural analogy to perfluoro alkyl polycationic polymers, EPA has identified health concerns for lung toxicity from inhalation exposure. Since VerDate Jan< 31> 2003 15: 12 Mar 27, 2003 Jkt 200001 PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 28MRR1. SGM 28MRR1 15076 Federal Register / Vol. 68, No. 60 / Friday, March 28, 2003 / Rules and Regulations significant worker exposure is unlikely when used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may cause significant adverse effects. EPA has determined, however, that use of the PMN substance other than as described in the PMN could result in exposures which may cause serious health effects. In addition, EPA has identified health concerns for potential incineration products for the PMN substance based on analogy to perfluorinated octane sulfonate ( PFOS) and perfluorinated octanoic acid ( PFOA). These incineration products are PBT. Based on this information, the PMN substance meets the concern criteria at § 721.170( b)( 3)( ii). Recommended testing: EPA has determined that a 90 day inhalation toxicity study in rats with a 60 day holding period ( OPPTS 870.3465 test guideline) would help characterize the human health effects of the PMN substance. Special attention should be given to histopathology ( inflammation and cell proliferation) of the lung tissues and to various parameters of the bronchoalveolar lavage fluid ( BALF), e. g., marker enzyme activities, total protein content, total cell count, cell differential, and cell viability. It is not necessary to look at internal organs. The Agency has also determined that the following tests would help characterize fate and ecotoxicity of the PMN substance: A Decomposition Kinetics by Thermogravimeter ( ASTM E1641), a Compositional Analysis by Thermogravimeter ( ASTM E1131), and a Laboratory `` Burn'' test  protocol to be agreed upon by EPA and the Company. The purpose of this test is to determine the disposition of the material and to identify degradates, especially the presence of components that can lead to the formation of perfluofo alkyl carboxylic acid after burning or incineration. CFR citation: 40 CFR 721.9502. PMN Number P   00   1195 Chemical name: Xanthylium, 9( 2 ( ethoxycarbonyl) phenyl) 3,6 bis( ethylamino) 2,7 dimethyl, ethyl sulfate. CAS number: 26694   69   9. Basis for action: The PMN substance will be used as a dye for complex basic dye pigment manufacture. Based on submitted test data for an analog, EPA has identified health concerns for toxic effects to the liver and heart. Since significant worker exposure is unlikely when used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance may present an unreasonable risk. EPA has determined, however, that domestic manufacture or use of the PMN substance other than as an intermediate could result in serious health effects. Also, based on structural analogy to cationic dyes, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 2 ppb of the PMN substance in surface waters. Since significant environmental exposure is not expected when the PMN substance is used as described in the PMN, EPA has not determined that the proposed use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance other than as described in the PMN may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 3)( ii) and ( b)( 4)( ii). Recommended testing: EPA has determined that an acute oral toxicity study ( 40 CFR part 799.9110( d)( 1)( i)( A)), a Salmonella typhimurium reverse mutation assay ( OPPTS 870.5100 test guideline), a 28 day oral toxicity study Organization for Economic Cooperation and Development ( OECD) guideline no. 407 or OPPTS 870.3050 test guideline), and an in vivo mammalian cytogenetics test by the intraperitoneal ( i. p.) route: micronucleus assay ( OPPTS 870.5395 test guideline) would help to characterize the human health effects of the PMN substance. EPA has also determined that a fish acute toxicity study ( OPPTS 850.1075 test guideline ( public draft)), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline ( public draft)), and an algal acute toxicity study ( OPPTS 850.5400 test guideline ( public draft)) would help to characterize the environmental effects of the PMN substance. The fish and daphnid tests should be conducted with flow through methods and measured concentration. The algal test should be conducted with static methods and measured concentration. Dilution water hardness < 180 mg/ L as CaC03. CFR citation: 40 CFR 721.2465. PMN Number P   01   0432 Chemical name: ( generic) Bis heterocyclic phenylene derivative. CAS number: Not available. Basis for action: The PMN substance will be used as a reactive modifier for polymeric substances. EPA has identified health concerns for neurotoxicity, developmental toxicity, mutagenicity, carcinogenicity, lung and liver toxicity, and sensitization based on test data. Since significant worker exposure is unlikely because there would not be significant inhalation exposure for the use identified in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the substance as described in the PMN present an unreasonable risk. EPA has determined, however, that an increase in production volume over that described in the PMN could result in significant exposure to human health. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 3)( ii) and ( b)( 1)( i)( A). Recommended testing: EPA has determined that a mouse micronucleus test by the i. p. route ( OPPTS 870.5395 test guideline) and a 28 day oral toxicity in rats OECD guideline number 407 or ( OPPTS 870.3050) with a Functional Observational Battery ( FOB) would help to characterize the health effects of the substance. If the above tests indicate a health concern, then the following tests may be necessary to qualify the potential health effects: a 90 day subchronic oral study in rats ( OPPT 870.3100 test guideline), a prenatal development toxicity study by oral route in two species ( OPPTS 870.3700 test guideline), a reproduction and fertility effects ( OPPTS 870.3800 test guideline), and a carcinogenicity study ( OPPTS 870.4200 test guideline). CFR citation: 40 CFR 721.5925.

IV. Objectives and Rationale of the Rule During review of the PMNs submitted for the chemical substances that are subject to this SNUR, EPA concluded that for 3 of the 62 substances, regulation was warranted under section 5( e) of TSCA, pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the substances. The basis for such findings is outlined in Unit III. Based on these findings, TSCA section 5( e) consent orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters; the SNUR provisions for these substances designated herein are consistent with the provisions of the TSCA section 5( e) consent orders. In the other 59 cases for which the proposed uses are not regulated under a TSCA section 5( e) consent order, EPA determined that one or more of the criteria of concern established at 40 CFR 721.170 were met. EPA is issuing 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 VerDate Jan< 31> 2003 15: 12 Mar 27, 2003 Jkt 200001 PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 28MRR1. SGM 28MRR1 15077 Federal Register / Vol. 68, No. 60 / Friday, March 28, 2003 / Rules and Regulations 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. 4. All manufacturers, importers, and processors of the same chemical substance which is subject to a TSCA section 5( e) consent order are subject to similar requirements. 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. Direct Final Procedures EPA is issuing these SNURs as a direct final rule, as described in 40 CFR 721.160( c)( 3) and 721.170( d)( 4). In accordance with 40 CFR 721.160( c)( 3)( ii), this rule will be effective May 27, 2003, unless EPA receives a written notice by April 28, 2003 that someone wishes to make adverse or critical comments on EPA's action. If EPA receives such a notice, EPA will publish a document to withdraw the direct final SNUR for the specific substance to which the adverse or critical comments apply. EPA will then propose a SNUR for the specific substance providing a 30 day comment period. This action establishes SNURs for a number of chemical substances. Any person who submits a notice of intent to submit adverse or critical comments must identify the substance and the new use to which it applies. EPA will not withdraw a SNUR for a substance not identified in a notice.

VI. 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. In cases where a TSCA section 5( e) consent order requires or recommends certain testing, Unit III. lists those recommended tests. However, EPA has established production limits in the TSCA section 5( e) consent orders for several of the substances regulated under this rule, in view of the lack of data on the potential health and environmental risks that may be posed by the significant new uses or increased exposure to the substances. These production limits cannot be exceeded unless the PMN submitter first submits the results of toxicity tests that would permit a reasoned evaluation of the potential risks posed by these substances. Under recent consent orders, each PMN submitter is required to submit each study at least 14 weeks ( earlier consent orders required submissions at least 12 weeks) before reaching the specified production limit. Listings of the tests specified in the TSCA section 5( e) consent orders are included in Unit III. The SNURs contain the same production volume limits as the consent orders. Exceeding these production limits is defined as a significant new use. 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 TSCA 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.

VII. Procedural Determinations EPA is establishing through this rule some significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2. 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 § 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 § 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 § 721.1725( b)( 1) with that under § 721.11 into a single step. If a manufacturer or importer is told that the production volume identified in the bona fide submission would not be a significant new use, i. e. it is below the level that would be a significant new use, that person can manufacture or import the substance as long as the aggregate amount does not exceed that identified in the bona fide submission to EPA. If the person later intends to exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use. EPA is considering whether to adopt a special procedure for use when CBI production volume is designated as a significant new use. Under such a procedure, a person showing a bona fide intent to manufacture or import the substance, under the procedure described in § 721.11, would automatically be informed of the production volume that would be a significant new use. Thus, the person would not have to make multiple bona fide submissions to EPA for the same substance to remain in compliance with the SNUR, as could be the case under the procedures in § 721.1725( b)( 1).

VIII. 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. TSCA section 5( e) consent orders have been issued for 3 substances and notice submitters are prohibited by the TSCA section 5( e) consent orders from undertaking activities which EPA is designating as significant new uses. In cases where EPA has not received an NOC and the substance has not been VerDate Jan< 31> 2003 15: 12 Mar 27, 2003 Jkt 200001 PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 28MRR1. SGM 28MRR1 15078 Federal Register / Vol. 68, No. 60 / Friday, March 28, 2003 / Rules and Regulations 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, 41 of the 62 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, 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 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 § 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 requirements and wait until the notice review period, including all extensions, expires.