70155 Federal Register / Vol. 68, No. 242 / Wednesday, December 17, 2003 / Rules and Regulations Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $ 100,000,000 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

Civil Justice Reform This rule meets applicable standards in sections 3( a) and 3( b)( 2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

Protection of Children We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

Indian Tribal Governments This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does 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.

Energy Effects We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a `` significant energy action'' under that order because it is not a `` significant regulatory action'' under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211. Environment We have analyzed this rule under Commandant Instruction M16475. lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 ( NEPA) ( 42 U. S. C. 4321   4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2. B. 2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2   1, paragraph ( 34)( g), of the Instruction, from further environmental documentation because we are establishing a security zone. A final `` Environmental Analysis Check List'' and a final `` Categorical Exclusion Determination'' are available in the docket where located under ADDRESSES.

List of Subjects in 33 CFR Part 165 Harbors, Marine safety, Navigation ( water), Reporting and recordkeeping requirements, Security measures, Waterways. For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

PART 165   REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS  1. The authority citation for part 165 continues to read as follows:

Authority: 33 U. S. C. 1226, 1231; 46 U. S. C. Chapter 701; 50 U. S. C. 191, 195; 33 CFR 1.05   1( g), 6.04   1, 6.04   6, and 160.5; Pub. L. 107   295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1.

 2. Add § 165. T11   097 to read as follows:

§ 165. T11   097 Security Zone; Navigable Waters of the United States Surrounding Military Ocean Terminal Concord ( MOTCO), Concord, California. ( a) Location. The security zone, which will be marked by lighted buoys, will encompass the navigable waters, extending from the surface to the sea floor, surrounding the Military Ocean Terminal Concord, Concord, California, within a line connecting the following coordinates: latitude 38 ° 03  07  N and longitude 122 ° 03  00  W; thence to latitude 38 ° 03  15  N and longitude 122 ° 03  04  W; thence to latitude 38 ° 03  30  N and longitude 122 ° 02  35  W; thence to latitude 38 ° 03  50  N and longitude 122 ° 01  15  W; thence to latitude 38 ° 03  41  N and longitude 122 ° 00  03  W; thence to latitude 38 ° 03  18  N and longitude 121 ° 59  31  W, and along the shoreline back to the beginning point. ( b) Regulations. ( 1) In accordance with the general regulations in § 165.33 of this part, entering, transiting through or anchoring in this zone is prohibited unless authorized by the Coast Guard Captain of the Port, San Francisco Bay, or his designated representative. ( 2) Persons desiring to transit the area of the security zone may contact the Patrol Commander on scene on VHF   FM channel 13 or 16 or the Captain of the Port at telephone number 415   399   3547 to seek permission to transit the area. If permission is granted, all persons and vessels must comply with the instructions of the Captain of the Port or his or her designated representative. ( c) Authority. In addition to 33 U. S. C. 1231 and 50 U. S. C. 191, the authority for this section includes 33 U. S. C. 1226. ( d) Enforcement. The U. S. Coast Guard may be assisted in the patrol and enforcement of the security zone by local law enforcement and the MOTCO police as necessary. ( e) Effective period. This section becomes effective at 7 a. m. p. s. t. on December 8, 2003, and terminates at 11: 59 p. m. p. s. t. on December 19, 2003.

Dated: December 3, 2003. Gerald M. Swanson, Captain, U. S. Coast Guard, Captain of the Port, San Francisco Bay, California. [ FR Doc. 03   31098 Filed 12   16   03; 8: 45 am]

BILLING CODE 4910   15   P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 721 [ OPPT   2002   0078; FRL   7307   3]

RIN 2070   AB27 Significant New Uses of Certain Chemical Substances AGENCY: Environmental Protection Agency ( EPA). 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 65 chemical substances which were the subject of premanufacture notices ( PMNs) and subject to TSCA section 5( e) consent orders issued by EPA. This action requires persons who intend to manufacture, import, or process these chemical substances for a significant new use to notify EPA at least 90 days before commencing the manufacturing or processing of the chemical substance for a use designated by this rule as a significant new use. The required notification will provide EPA with the opportunity to evaluate the intended VerDate jul< 14> 2003 15: 37 Dec 16, 2003 Jkt 203001 PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 17DER1. SGM 17DER1 70156 Federal Register / Vol. 68, No. 242 / Wednesday, December 17, 2003 / Rules and Regulations 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. DATES: The effective date of this rule is February 17, 2004, without further notice, unless EPA receives adverse or critical comments, or notice of intent to submit adverse or critical comments before January 16, 2004. This rule shall be promulgated for purposes of judicial review at 1 p. m. ( e. s. t.) on December 31, 2003. If EPA receives adverse or critical comments or notice of intent to submit adverse or critical comments before January 16, 2004, 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 chemical substance for which the adverse or critical comment or notice of intent to submit adverse or critical comment is received and will issue a proposed SNUR providing a 30 day period for public comment. ADDRESSES: Adverse or critical 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, 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: TSCAHotline 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 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   0078. 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/ 40cfr721_ 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, 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 VerDate jul< 14> 2003 15: 37 Dec 16, 2003 Jkt 203001 PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 17DER1. SGM 17DER1 70157 Federal Register / Vol. 68, No. 242 / Wednesday, December 17, 2003 / Rules and Regulations 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   20027   0078. 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   0078. 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 Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number OPPT   2002   0078. 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 in this document, 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.

II. Background A. What Action is the Agency Taking? EPA is promulgating this SNUR using direct final procedures. This SNUR will require persons to notify EPA at least 90 days before commencing manufacturing, importing, or processing a chemical 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.

VerDate jul< 14> 2003 15: 37 Dec 16, 2003 Jkt 203001 PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 17DER1. SGM 17DER1 70158 Federal Register / Vol. 68, No. 242 / Wednesday, December 17, 2003 / Rules and Regulations 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 TSCA section 5( a)( 2). Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5( a)( 1)( B) requires persons to submit a notice to EPA at least 90 days before they manufacture, import, or process the chemical 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 TSCA section 5( a)( 1)( A). 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 chemical 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 appear 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 chemical 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 chemical 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 chemical substance, the tests are described in this unit. As explained further in Unit VI., the SNUR for such chemical 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 chemical 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 chemical substances, testing other than that specified in the TSCA section 5( e) consent order for the chemical substances, or studies on analogous chemical 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 99   255, 99   314, 99   350/ 351/ 352/ 353, 99   534,99   848, 00   277/ 278/ 280, 00   281   285, 00   286   292, 00   502/ 503/ 504, 00   574/ 575/ 576/ 577/ 608,00   901, 00   1085, 00   1093, 01   558, 01   584, 01   629, 01   728, 01   757, 01   776, 02   16, 02   195, 02   415, 02   536, 02   609, and 02   700, which are subject to a final TSCA section 5( e) consent order. The TSCA section 5( e) consent orders for these chemical 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 chemical 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 chemical substances which are subject to a final section 5( e) consent order under TSCA. PMN Number P   97   1108 Chemical name: ( generic) Polycarboxylic acid ester. CAS number: Not available. Basis for action: The PMN substance will be used as a plasticizer. Based on structural analogy to esters, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 part per billion ( ppb) of the PMN substance in surface waters. Since VerDate jul< 14> 2003 15: 37 Dec 16, 2003 Jkt 203001 PO 00000 Frm 00038 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 17DER1. SGM 17DER1 70159 Federal Register / Vol. 68, No. 242 / Wednesday, December 17, 2003 / Rules and Regulations environmental releases are not expected as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that release of the PMN substance 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), a daphnid chronic toxicity study ( OPPTS 850.1300 test guideline), and an algal toxicity study ( OPPTS 850.5400 test guideline) would help to characterize the environmental effects of the PMN substance. A porous pot study ( OPPTS 835.3220 test guideline) would help to characterize possible environmental effects of the PMN substance as well. CFR citation: 40 CFR 721.3110. PMN Number P   98   848 Chemical name: Silicic acid ( H6SiO2O7), magnesium strontium salt( 1: 1: 2), dysprosium and europium doped. CAS number: 181828   07   9. Effective date of section 5( e) consent order: June 1, 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 the PMN substance may present an unreasonable risk to human health. Recommended testing: EPA has determined that a 90 day subchronic inhalation study ( OPPTS 870.3465 test guideline) and a 2 year bioassay ( OPPTS 870.4200) would help to characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.9511. PMN Number P   98   1033/ 1034/ 1035 Chemical name: ( generic) Halogen substituted oxetanes. CAS number: Not available. Effective date of section 5( e) consent order: April 6, 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)( II) of TSCA based on a finding that these PMN substances are expected to be produced in substantial quantities, there may be significant or substantial human exposure to the PMN substances, and the PMN substances may enter the environment in substantial quantities. Recommended testing: EPA has determined that the following studies would help to characterize the health effects of these PMN substances: A 28 day oral toxicity study in rats ( OPPTS 870.3050) that includes a neurotoxicity functional observational battery ( National Technical Information Service ( NTIS): PB 91   154617) for all test doses with the highest dose set at 1,000 milligram/ kilogram ( mg/ kg), and for the highest test dose group only, histopathologic examination to include testes/ ovaries and lungs; an in vivo mouse micronucleus assay ( intraperitoneal) ( OPPTS 870.5395); and an oral developmental toxicity study in one species ( OPPTS 870.3700). EPA has determined that a fish acute toxicity study ( OPPTS 850.1075), a daphnid acute toxicity study ( OPPTS 850.1010), and an algal acute toxicity study ( OPPTS 850.5400) would help to characterize the environmental effects of these PMN substances. The PMN submitter has agreed not to exceed the production volume limit without performing these toxicity studies using P   98   1033. CFR citation: 40 CFR 721.5546. PMN Number P   99   783 Chemical name: ( generic) Chromate( 2), [ 3 hydroxy 4[( 2 hydroxy 1 naphthenyl) azo] 7 nitro 1 substituted][ N[ 7 hydroxy 8[( 2 hydroxy 5 nitrophenyl) azo] 1 substituted], salt. CAS number: Not available. Basis for action: The PMN substance will be used for the dyeing of wool fiber. Based on structural analogy to anionic dyes, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 7 part per billion ( ppb) of the PMN substance in surface waters. Since significant environmental exposure is not expected as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that release of the PMN substance to surface waters in significant amounts from domestic manufacture 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 daphnid acute toxicity study ( OPPTS 850.1010 test guideline), and an algal toxicity study ( OPPTS 850.5400 test guideline) would help to characterize the environmental effects of the PMN substance. A stock solution should be prepared and its pH adjusted to 7.0 prior to testing. The dilution water of the daphnid acute toxicity test should have a hardness of less than 180.0 mg/ liter( L) as CaCO3 and a total organic carbon ( TOC) concentration of less than 2.0 mg TOC/ L. The green algal growth medium should also have a TOC of less than 2.0 mg TOC/ L. The daphnid test should be done with a flow through method and measured concentrations. The algal toxicity test should be done with the static method and measured concentrations. CFR citation: 40 CFR 721.5288. PMN Number P   99   817 Chemical name: ( generic) Salt of an acrylic acid   acrylamide terpolymer CAS number: Not available. Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogy to polyanionic polymers, EPA has identified concerns for lung toxicity from respiratory overload if the PMN substance is inhaled. Since significant human exposure is unlikely when the PMN substance is used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that use of the PMN substance as a solid may result in significant human exposure. Based on this information, the PMN substance meets the concern criteria at § 721.170( b)( 3)( ii). Recommended testing: EPA has determined that the 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), bronchoalveolar 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 721.9640. PMN Number P   99   897 Chemical name: ( generic) Substituted benzothiazole azo substituted benzoquinoline nickel complex. CAS number: Not available Basis for action: The PMN substance will be used as a material for optical disks. Based on analogy to nickel, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 5 ppb of the PMN substance in surface waters. Since environmental releases are not expected as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that release of the PMN substance to surface waters may cause significant adverse environmental effects. Based on this VerDate jul< 14> 2003 15: 37 Dec 16, 2003 Jkt 203001 PO 00000 Frm 00039 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 17DER1. SGM 17DER1 70160 Federal Register / Vol. 68, No. 242 / Wednesday, December 17, 2003 / Rules and Regulations 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), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline), and an algal toxicity study ( OPPTS 850.5400 test guideline) would help to characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.5340. PMN Number P   99   920 Chemical name: Poly( oxy 1,2 ethanediyl), alpha( 9Z) 9 octadecenyl . omega. hydroxy, phosphate, ammonium salt. CAS number: 58857   49   1 Basis for action: The PMN substance will be used as a dispersing agent for pigment pastes. Based on structural analogy to anionic surfactants, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 8 ppb of the PMN substance in surface waters. Since significant environmental releases are not expected as described in the PMN, EPA has not determined that the proposed processing, and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that domestic manufacture may result in release of the PMN substance to surface waters which 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), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline), and an algal toxicity study ( OPPTS 850.5400 test guideline) would help to characterize the environmental effects of the PMN substance. Tests for fish and daphnids should be done with a flow through method and measured concentrations. The algal test can be done with a static method and measured concentrations. A stock solution of PMN substance should be prepared and adjusted to pH 7 with either HCl or NaOH. CFR citation: 40 CFR 721.5293. PMN Number P   99   928 Chemical name: 2 propanol, 1,1', 1' nitrilotris, compds. with ethanol 2[ 2 ( C12   14 alkyloxy) ethoxy] derivs. hydrogen sulfates. CAS number: 222975   06   6. Basis for action: The PMN substance will be used as a surfactant in a toilet bowl cleaner. Based on structural analogy to anionic surfactants, EPA is concerned that toxicity to aquatic organisms from the PMN substance may occur at a concentration of 50 ppb in surface waters. Since significant environmental releases are not expected, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that other uses of the PMN substance could result in releases to surface waters resulting 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 a fish acute toxicity study ( OPPTS 850.1075 test guideline), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline), and an algal toxicity study ( OPPTS 850.5400 test guideline) would help to characterize the environmental effects of the PMN substance. Fish and daphnid tests should be done with a flow through method and measured concentrations. The algal test should also be done with measured concentrations of PMN substance. CFR citation: 40 CFR 721.5358. PMN Number P   99   951 and P   99   952 Chemical name: ( generic) Polyisobutene epoxide. CAS number: Not available. Basis for action: The PMN substances will be used as described in the PMNs. Based on structural analogy to epoxides, EPA is concerned that toxicity to aquatic organisms from the PMN substances may occur at a concentration as low as 10 ppb in surface waters. Since significant environmental releases are not expected as described in the PMNs, EPA has not determined that the proposed manufacturing, processing, and use of the PMN substances may present an unreasonable risk. EPA has determined, however, that other uses of the PMN substances may result in releases that 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), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline), and an algal toxicity study ( OPPTS 850.5400 test guideline) would help to characterize the environmental effects of the PMN substances. The fish and daphnid tests should be done using the flow though method and measured concentrations. The algae test should be done using the static method and measured concentrations. CFR citation: 40 CFR 721.2685. PMN Number P   99   1075 Chemical name: 2 Propenoic acid, 2 methyl, ( octahydro 4,7 methano 1H indene 5,? diyl) bis( methylene) ester. CAS number: 43048   08   4. Basis for action: The PMN substance will be used as a coating agent for resin curing. Based on analogy to methacrylates and esters, EPA is concerned that toxicity to aquatic organisms from the PMN substance may occur at a concentration as low as 5 ppb in surface waters. EPA determined that use of the PMN substance as described in the PMN did not present an unreasonable risk because the PMN substance is imported and would not be released to surface waters. EPA has determined that domestic manufacturing and other uses of the PMN substance may result in releases to surface waters which exceed the concern concentration. 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), a daphnid chronic toxicity study ( OPPTS 850.1300 test guideline), and an algal toxicity study ( OPPTS 850.5400 test guideline) would help to characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.8485. PMN Number P   99   1202 Chemical name: ( generic) Sulfonyl azide intermediate. CAS number: Not available Basis for action: The PMN substance will be used as a reactive additive for polymers. Based on structural analogy to azides, 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 environmental releases are not expected as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that any release of the PMN substance 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). Also, based on submitted test data, EPA has identified concerns for blood, kidney and lung toxicity from inhalation exposure to the PMN substance. Since significant human exposure is unlikely when used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that use of the VerDate jul< 14> 2003 15: 37 Dec 16, 2003 Jkt 203001 PO 00000 Frm 00040 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 17DER1. SGM 17DER1 70161 Federal Register / Vol. 68, No. 242 / Wednesday, December 17, 2003 / Rules and Regulations PMN substance as a powder may result in significant human exposure. Based on this information, the PMN substance meets the concern criteria at § 721.170( b)( 3)( i). Recommended testing: EPA has determined that a fish chronic toxicity study ( OPPTS 850.1400 test guideline), a daphnid chronic toxicity study ( OPPTS 850.1300 test guideline), and an algal toxicity study ( OPPTS 850.5400 test guideline) would help to characterize the environmental effects of the PMN substance. The fish and daphnid tests should use a flow through method and measured concentrations. The algal toxicity test should use the static method and measured concentrations. A 90 day inhalation toxicity study ( OPPTS 870.3465 test guideline) would help to characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.983. PMN Number P   99   1288 Chemical name: ( generic) Substituted anilino halobenzamide. CAS number: Not available. Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogues for anilines and 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 environmental releases are not expected as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that domestic manufacture may result in release of the PMN substance to surface waters which 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), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline), and an algal toxicity study ( OPPTS 850.5400 test guideline) would help to characterize the environmental effects of the PMN substance. The fish and daphnid tests should be performed with a flowthrough method and measured concentrations. The algal test should be done with measured concentrations. A stock solution of the PMN substance should be prepared and its pH adjusted to pH 7 with either HCl or NaOH. CFR citation: 40 CFR 721.4096. PMN Number P   99   1295 Chemical name: ( generic) Chlorohydroxyalkyl butyl ether. CAS number: Not available Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogy to halo alcohols, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 3 ppb of the PMN substance in surface waters. Since environmental releases are not expected as the PMN substance is not released to surface waters above 3 ppb, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that other uses of the PMN substance resulting in release to surface waters 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 a fish acute toxicity study ( OPPTS 850.1075 test guideline), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline), and an algal toxicity study ( OPPTS 850.5400 test guideline) would help to characterize the environmental effects of the PMN substance. The fish and daphnid tests should be performed under flow through conditions with measured concentrations. The algal test should be performed under static conditions with measured concentrations. CFR citation: 40 CFR 721.3438. PMN Number P   99   1304 Chemical name: ( generic) Substituted benzenesulfonic acid salt. CAS number: Not available. 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 2 ppb of the PMN substance in surface waters. Since significant environmental releases are not expected, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the PMN substance may present an unreasonable risk to the environment. EPA has determined, however, that other uses of the PMN substance resulting in release to surface waters in significant amounts, may cause significant adverse environmental effects. Based on this information the PMN substance meets the concern criteria at § 721.170( b)( 4)( ii). Also, based on structural analogues, EPA has identified concerns for lung effects from inhalation exposure to the PMN substance. Since significant human exposure is unlikely for the use described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the PMN substance may present an unreasonable risk to human health. EPA has determined, however, that other uses of the PMN substance, may result in significant human exposure. Based on this information, the PMN substance meets the concern criteria at § 721.170( b)( 3)( ii). Recommended testing: EPA has determined that a fish acute toxicity study ( OPPTS 850.1075 test guideline), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline), and an algal toxicity study ( OPPTS 850.5400 test guideline) 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. A stock solution should be prepared and its pH adjusted to 7.0 with either HCl or NaOH. A 90 day inhalation toxicity study ( OPPTS 870.3465 test guideline) would help to characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.1648. PMN Number P   99   1341 Chemical name: 2 Naphthalenecarboxylic acid, 4,4' methylenebis [ 3 hydroxy, strontium salt. CAS number: 235083   90   6. Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogy to phenols, anionic surfactants, and inorganic metal salts, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 3 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 above10 ppb, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that other uses of the PMN 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); a daphnid acute toxicity study ( OPPTS 850.1010 test guideline), an algal toxicity study ( OPPTS 850.5400 test guideline) would help to characterize the environmental effects of the PMN substance. All studies should use the VerDate jul< 14> 2003 15: 37 Dec 16, 2003 Jkt 203001 PO 00000 Frm 00041 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 17DER1. SGM 17DER1 70162 Federal Register / Vol. 68, No. 242 / Wednesday, December 17, 2003 / Rules and Regulations static method and nominal concentrations. CFR citation: 40 CFR 721.5253. PMN Number P   99   1342 Chemical name: 2 Naphthalenecarboxylic acid, 4,4' methylenebis [ 3 hydroxy, zinc salt CAS number: 235083   88   2. Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogy to phenols, anionic surfactants, and inorganic metal salts, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 3 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 PMN substance may present an unreasonable risk. EPA has determined, however, that other uses of the PMN 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), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline), and an algal toxicity study ( OPPTS 850.5400 test guideline) would help to characterize the environmental effects of the PMN substance. All studies should use the static method and nominal concentrations. CFR citation: 40 CFR 721.5252. PMN Number P   00   7 Chemical name: D Glucuronic acid, polymer with 6 deoxy L mannose and D glucose, acetate, calcium magnesium potassium sodium salt. CAS number: 125005   87   0. Basis for action: The PMN substance will be used as an oilfield drilling fluid, an oilfield spacer fluid, in oilfield cementing, in cementitious packaged products, in concrete applications, and in foam applications. Based on structural analogues and submitted test data, EPA has identified concerns for lung effects from inhalation exposure to the PMN substance. Since significant inhalation exposure is unlikely when used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that use of the PMN substance other than as described in the PMN may result in significant human exposure. 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 the 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), ( 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 in the 90 day study. CFR citation: 40 CFR 721.2076. PMN Number P   00   368 Chemical name: ( generic) Benzenesulfonamide, alkylphenylsubstitutedphenyl substituted carbonyl. CAS number: Not available. Effective date of section 5( e) consent order: March 28, 2001. Basis for section 5( e) consent order: The Order was issued under section 5( e)( 1)( A)( i) and ( e)( 1)( A)( ii)( I) of TSCA based on a finding that the PMN substance may present an unreasonable risk of injury to human health and the environment. Recommended testing: EPA has determined that a subchronic inhalation toxicity study ( OPPTS 870.3465) would help to characterize the potential health effects of the PMN substance. EPA has also determined that a fish chronic toxicity study ( OPPTS 850.1400) and a daphnid chronic toxicity test ( OPPTS 850.1300) would help to characterize potential environmental effects. CFR citation: 40 CFR 721.1620. PMN Number P   00   636 Chemical name: ( generic) Alkylated nitroso phenylenediamine. CAS number: Not available. Basis for action: The PMN substance will be used as a polymerization inhibitor. Based on test data for the PMN substance and analogy to structurally similar compounds, EPA has identified human health concerns for systemic effects, reproductive effects, and cancer from dermal exposure to the PMN substance. Since significant worker exposure is unlikely when the PMN substance is used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that use of the PMN substance without dermal protection could result in worker exposures which may cause significant adverse human 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: The Agency has determined that the results of a 2 generation reproduction/ fertility effects study ( OPPTS 870.3800 test guideline) and a carcinogenicity study ( OPPTS 870.4200 test guideline) would help to characterize possible human health effects of the PMN substance. CFR citation: 40 CFR 721.5935. PMN Number P   00   838 Chemical name: ( generic) Substituted alkyl sulfonamide. CAS number: Not available. Basis for action: The PMN substance will be used for a contained use in an article. Based on structural analogy to neutral organic compounds, 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 waters above 1 ppb, EPA has not determined that the proposed processing and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that releases 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 a fish chronic toxicity study ( OPPTS 850.1400 test guideline) would help to characterize possible environmental effects of the PMN substance. This test should be conducted with flow through conditions and measured concentrations. CFR citation: 40 CFR 721.9572. PMN Number P   00   912 Chemical name: ( generic) Epoxy resin containing phosphorus. CAS number: Not available. Basis for action: The PMN substance will be used as described in the PMN. EPA has identified health concerns for carcinogenicity, reproductive toxicity in males, and developmental toxicity based on structural analogy to epoxides. EPA also identified health and environmental concerns because the PMN substance may be persistent, bioaccumulative, and potentially toxic based on physical/ chemical properties of the PMN substance as described in the New Chemical Program's Persistent, Bioiaccumulative, and Toxic ( PBT) Category ( 64 FR 60194, FRL 6907 7, November 4, 1999). Since significant worker and environmental exposure is VerDate jul< 14> 2003 15: 37 Dec 16, 2003 Jkt 203001 PO 00000 Frm 00042 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 17DER1. SGM 17DER1 70163 Federal Register / Vol. 68, No. 242 / Wednesday, December 17, 2003 / Rules and Regulations unlikely when used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the PMN 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 chronic effects and significant environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 ( b)( l)( i)( C), ( b)( 3)( ii), and ( b)( 4)( ii). Recommended testing: EPA has determined that the results of the tiered testing as described in the New Chemical Program's PBT Category would help to characterize the PBT properties of the PMN substance. EPA has also determined that a fish chronic toxicity study ( OPPTS 850.1400 test guideline), a daphnid chronic toxicity study ( OPPTS 850.1300 test guideline), and an algal toxicity study ( OPPTS 850.5400 test guideline) 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. In addition, a 2 year, two species oral carcinogenicity study ( OPPTS 870.4200 test guideline) and a 90 day oral subchronic in rats ( OPPTS 870.3100 test guideline), with attention to pathology of the reproductive organs, would help to characterize the health effects of the PMN substance. CFR citation: 40 CFR 721.2752. PMN Number P   00   966 Chemical name: ( generic) Haloarylalkylketoester. CAS number: Not available. Basis for action: The PMN substance will be used as an agricultural product intermediate. Toxicity data on structurally similar esters indicate that the PMN substance may cause toxicity to aquatic organisms. Based on this data, EPA expects toxicity to aquatic organisms to occur at a concentration as low as 200 ppb of the PMN substance in surface waters. Since environmental releases to surface waters are not expected to exceed 200 ppb, EPA has not determined that the proposed processing and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that if releases to surface waters were to exceed a concentration of 200 ppb, the PMN substance 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 an algal toxicity test ( OPPTS 850.5400 test guideline), an aquatic invertebrate acute toxicity test ( OPPTS 850.1010 test guideline), and a fish acute toxicity test ( OPPTS 850.1075 test guideline) would help to characterize possible environmental effects of the PMN substance. Ready biodegradation testing ( OPPTS 835.3110 test guideline) would help to characterize possible environmental effects of the PMN substance as well. The aquatic toxicity tests should be conducted with flow through conditions and measured concentrations. CFR citation: 40 CFR 721.3062. PMN Number P   00   991 Chemical name: Formaldehyde, polymer with ( chloromethyl) oxirane and phenol, reaction products with 6Hdibenz c, e][ 1,2] oxaphosphorin 6 oxide. CAS number: 300371   38   4. Basis for action: The PMN substances will be used in the manufacturing of composites. Based on structural analogy to epoxides, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 6 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 above 6 ppb, as described in the PMNs, EPA has not determined that the proposed manufacturing, processing, and use of the PMN substances may present an unreasonable risk. EPA has determined, however, that other uses of the PMN substances resulting in release to surface waters above 6 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), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline), and an algal acute toxicity study ( OPPTS 850.5400 test guideline) would help to characterize the environmental effects of the PMN substances. CFR citation: 40 CFR 721.5560 PMN Number P   00   1055 Chemical name: ( generic) Sulfonatedcopper phthalocyanine salt of a triarylmethane dye CAS number: Not available. Basis for action: The PMN substance will be used as a shading additive for ink. Based on analogy to cationic dyes, 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 waters above 1 ppb, as described in the PMN, EPA has not determined that proposed manufacturing, processing, and use of the use of the PMN substance may present an unreasonable risk. EPA has determined, however, that other uses of the PMN substance resulting in release to surface waters above 1 ppb may cause significant adverse environmental effects. Also, based on analogy to triarylmethane pigments and dyes, EPA has identified health concerns for mutagenicity and cancer effects from inhalation exposure to the PMN substance. Since significant inhalation exposure is unlikely when the PMN substance is used described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that use of the PMN substance in the form of a powder may result in significant human exposure. Based on this information, the PMN substance meets the concern criteria at § 721.170( b)( 4)( ii) and ( b)( l)( i)( C). Recommended testing: EPA has determined that a developmental toxicity study with two species ( rats and mice) by gavage ( OPPTS 870.3700 test guideline), a 2 generation reproductive and toxicity study ( OPPTS 870.3800 test guideline), an Ames assay/ salmonella study ( OPPTS 870.5100 test guideline), a micronucleus assay ( OPPTS 870.5395 test guideline), and a carcinogenicity study in rats ( OPPTS 870.4200 test guideline) would help to characterize human health effects. In addition, a fish acute toxicity study ( OPPTS 850.1075 test guideline), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline), and an algal acute toxicity study ( OPPTS 850.5400 test guideline) would help to characterize the environmental effects. CFR citation: 40 CFR 721.9674. PMN Number P   00   1205 Chemical name: ( generic) 6 Methoxy 1H benz[ de] isoquinoline 2 [ 3H] dione derivative. CAS number: Not available. Basis for action: The PMN substance will be used as an intermediate in the manufacture of aqueous dyes. Toxicity data on structurally similar chemicals indicate that the PMN substance may cause toxicity to aquatic organisms. Based on this data, EPA expects toxicity to aquatic organisms to occur at a concentration of 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 waters above 30 ppb, EPA has not determined that the VerDate jul< 14> 2003 15: 37 Dec 16, 2003 Jkt 203001 PO 00000 Frm 00043 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 17DER1. SGM 17DER1 70164 Federal Register / Vol. 68, No. 242 / Wednesday, December 17, 2003 / Rules and Regulations proposed processing and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that other uses of the PMN 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: The Agency has determined that the results of a fish acute toxicity test ( OPPTS 850.1075 test guideline) and a fish acute toxicity mitigated by humic acid ( OPPTS 850.1085 test guideline), and an activated sludge sorption/ desorption isotherm test ( OPPTS 835.1110 test guideline) would help to characterize environmental effects of the PMN substance. CFR citation: 40 CFR 721.9078. PMN Number P   00   1220 Chemical name: ( generic) Phenolbiphenyl polymer condensate. CAS number: Not available. Basis for action: The PMN substance will be used as an electric molding. 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 PMN substance is not released to surface water, EPA has not determined that the proposed manufacturing, processing, and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that any release of the PMN substance 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), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline), and an algal acute toxicity study ( OPPTS 850.5400 test guideline) would help to characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.5713. PMN Number P   01   1 Chemical name: ( generic) Chloroformate. CAS number: Not available Basis for action: The PMN substance will be used as an intermediate. Based on analogy to acid halides and neutral organic compounds, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 2 ppb of the PMN substance and 70 ppb of the PMN substance's hydrolysis product in surface waters. EPA has not determined that the proposed manufacturing, processing, and use of the PMN substance may present an unreasonable risk as the PMN substance is not released to surface waters above 2 ppb. EPA has determined, however, that other uses of the PMN substance resulting in releases to surface waters above 2 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 hydrolysis study at 25 ° C and pH 7 ( OPPTS 835.2120 test guideline), a ready biodegradability study ( OPPTS 835.3110 test guideline), a fish acute toxicity study ( OPPTS 850.1075 test guideline), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline), and an algal acute toxicity study ( OPPTS 850.5400 test guideline) would help to characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.3835. PMN Number P   01   7 Chemical name: ( generic) Ethylenediaminetetraacetic acid mixed salt. CAS number: Not available. Basis for action: The PMN substance will be used as described in the PMN. EPA has identified concerns for reproductive toxicity in males and mutagenicity based on submitted test data, and carcinogenicity based on analogy to nitrilotriacetic acid. Since significant worker exposure is unlikely when the PMN substance is used as described in the PMN, EPA has not determined that the proposed processing and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that domestic manufacture or use of the PMN 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)( i) and ( b)( l)( i)( C). Recommended testing: EPA has determined that a prenatal developmental toxicity study by the oral route in two species ( OPPTS 870.3700) and a carcinogenicity study in rats ( OPPTS 870.4200) would help to characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.2098. PMN Number P   01   9 Chemical name: ( generic) Halogenated arylsilane. CAS number: Not available. Basis for action: The PMN substance will be used as described in the PMN. EPA has identified environmental concerns because the PMN substance may be persistent, bioaccumulative, and potentially toxic based on physical/ chemical properties of the PMN substance as described in the New Chemical Program's PBT Category. Also, based on structural analogy to neutral organics, EPA expects toxicity to aquatic organisms at surface water concentrations as low as 1 ppb. 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 PMN substance may present an unreasonable risk. EPA has determined, however, that 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 Category would help to characterize the PBT properties of the PMN substance. EPA has determined that the results of a fish chronic toxicity study ( OPPTS 850.1400), a daphnid chronic toxicity study ( OPPTS 850.1300), and an algal toxicity study ( OPPTS 850.5400) 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. CFR citation: 40 CFR 721.9506. PMN Number P   01   22 Chemical name: Propanoic acid, 2( trimethoxysilyl), ethyl ester. CAS number: 137787   41   8. Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogy to alkoxysilanes, 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 above 10 ppb, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that other uses of the PMN 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).

VerDate jul< 14> 2003 15: 37 Dec 16, 2003 Jkt 203001 PO 00000 Frm 00044 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 17DER1. SGM 17DER1 70165 Federal Register / Vol. 68, No. 242 / Wednesday, December 17, 2003 / Rules and Regulations Recommended testing: EPA has determined that a fish acute toxicity study ( OPPTS 850.1075), a daphnid acute toxicity study ( OPPTS 850.1010), and an algal toxicity study ( OPPTS 850.5400) would help to characterize the environmental effects of the PMN substance. The fish and daphnid tests should be conducted with flow through conditions and measured concentrations. The algae test should be conducted with static conditions and measured concentrations. CFR citation: 40 CFR 721.7290. PMN Number P   01   69 Chemical name: ( generic) Substituted naphthalene hydrazide. CAS number: Not available. Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogy to phenols and hydrazines. 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 environmental releases are not expected as described in the PMN, EPA has not determined that the proposed manufacturing, processing and use of the PMN substance as described in the PMN may present an unreasonable risk. EPA has determined, however, that any release of the PMN substance 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), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline), and an algal toxicity study ( OPPTS 850.5400 test guideline) would help to characterize the environmental effects of the PMN substance. The fish and daphnid tests should be conducted with the flowthrough method and measured concentrations. The algae test should be conducted with the static method and measured concentrations. CFR citation: 40 CFR 721.4258. PMN Number P   01   71 Chemical name: Phenol, 2,2'[ 6( 2,4 dibutoxyphenyl) 1,3,5 triazine 2,4 diyl] bis[ 5 butoxy. CAS number: 208343   47   9. Basis for action: The PMN substance will be used as an ultraviolet absorber for use in photographic emulsions. 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 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 PMN substance may present an unreasonable risk. EPA has determined, however, that any release to surface waters 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 chronic toxicity study ( OPPTS 850.1400 test guideline), and a daphnid chronic toxicity study ( OPPTS 850.1300 test guideline) would help to characterize the environmental effects of the PMN substance. The fish and daphnid studies should be conducted with flow through method and measured concentrations. CFR citation: 40 CFR 721.5718. PMN Number P   01   77 Chemical name: ( generic) Disubstituted benzenedicarboxcylic acid. CAS number: Not available. Basis for action: The PMN substance will be used as described in the PMN. EPA has identified health concerns for developmental toxicity based on structural analogy to phthalate esters. Since significant worker exposure is unlikely when the PMN substance is used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that use of the PMN substance other than as an intermediate 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). Also, based on structural analogy to esters, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 12 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 PMN substance as described in the PMN may present an unreasonable risk. EPA has determined, however, that other uses of the PMN 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 Combined Repeated Dose with Reproductive/ Developmental Toxicity ( OPPTS 870.3650) or a Reproductive/ Development Toxicity Test ( OPPTS 870.3550) 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), a daphnid acute toxicity study ( OPPTS 850.1010), and an algal toxicity study ( OPPTS 850.5400) would help characterize the environmental effects of the PMN substance. The fish and daphnid tests should be conducted with the flowthrough conditions and measured concentrations. The algae test should be conducted with the static method and measured concentrations. CFR citation: 40 CFR 721.2060. PMN Number P   01   85 Chemical name: ( generic) Mono esters from 2 propenoic acid. CAS number: Not available. Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogy to 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 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 PMN substance may present an unreasonable risk. EPA has determined, however, that any 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), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline), and an algal toxicity study ( OPPTS 850.5400 test guideline) would help to characterize the environmental effects of the PMN substance. All tests should be conducted with flow through methods and measured concentrations. CFR citation: 40 CFR 721.8340. PMN Number P   01   97 Chemical name: ( generic) Polyaziridinyl ester of an aliphatic alcohol. CAS number: Not available. Basis for action: The PMN substance will be used as described in the PMN. EPA has identified health concerns for mutagenicity, carcinogenicity, male reproductive toxicity, and developmental toxicity based on structural analogy to epoxides. Since significant worker exposure is unlikely, when used as described in the PMN, EPA has not determined that the proposed manufacturing, processing,

VerDate jul< 14> 2003 15: 37 Dec 16, 2003 Jkt 203001 PO 00000 Frm 00045 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 17DER1. SGM 17DER1 70166 Federal Register / Vol. 68, No. 242 / Wednesday, December 17, 2003 / Rules and Regulations and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that use of the PMN substance other than as described in the PMN may result in serious health effects. Based on this information, the PMN substance meets the concern criteria at § 721.170( b)( 3)( ii) and ( b)( l)( i)( C). Recommended testing: EPA has determined that a 90 day oral subchronic toxicity study in rats ( OPPTS 870.3100 test guideline), with attention to pathology of the reproductive organs, and a carcinogenicity study in rats ( OPPTS 870.4200 test guideline) would help to characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.7250. PMN Number P   01   144 Chemical name: Propanamide, N( 2 hydroxyethyl) 3 methoxy. CAS number: 35544   45   7. Basis for action: The PMN substance will be used as an organic stripper additive. EPA has identified health concerns for the solvent properties of the PMN substance. Since significant worker exposure is unlikely, when the PMN substance is used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the PMN 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 prenatal developmental toxicity study ( OPPTS 870.3700 test guideline), a 28 day oral toxicity study in rats ( OPPTS 870.3050) that includes a neurotoxicity functional observational battery ( NTIS: PB 91 154617) for all test doses with the highest test dose set at 1,000 mg/ kg, and for the highest test dose group only, histopathologic examination shall be extended to include testes/ ovaries and lungs, an acute oral toxicity ( OPPTS 870.1100 test guideline), a mammalian erythrocyte micronucleus test ( OPPTS 870.5395 test guideline), and a salmonella typhimurium reverse mutation assay ( OPPTS 870.5265 test guideline) would help to characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.8130. PMN Number P   01   149 Chemical name: Sulfuric acid, mono C9   11 alkyl esters, sodium salts. CAS number: 84501   49   5. Basis for action: The PMN substance will be used as a component in surfactant/ foaming agent for leather processing. Based on structural activity relationship analysis, EPA has identified health concerns for internal organ effects. Since significant worker exposure is unlikely, when the PMN substance is used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that an increase in production volume 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 ( OPPTS 870.3100 test guideline) would help to characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.3130. PMN Number P   01   152 Chemical name: Benzenamine, 4 methoxy 2 methyl N( 3 methylphenyl). CAS number: 93072   06   1. Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogy to neutral organic compounds, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 5 ppb of the PMN substance in surface waters. EPA also identified environmental concerns because the PMN substance may be persistent, bioaccumulative, and potentially toxic based on physical/ chemical properties of the PMN substance as described in the New Chemical Program's PBT Category. Since significant environmental exposure is not expected as the PMN substance is not released to surface water above 5 ppb, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that other uses of the PMN substance resulting in release to surface waters above 5 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 results of the tiered testing as described in the New Chemicals Program's PBT Category would help to characterize the PBT properties of the PMN substance. EPA has determined that the results of a fish acute toxicity study ( OPPTS 850.1075 test guideline), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline), and an algal toxicity study ( OPPTS 850.5400 test guideline) would help to characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.1070. PMN Number P   01   170 Chemical name: Acetic acid, [( 5 chloro 8 quinolinyl) oxy], 1 methylhexyl ester. CAS number: 99607   70   2. Basis for action: The PMN substance will be used as a seed safener. Based on test data, there is concern for liver toxicity and thyroid effects. Since significant worker exposure is unlikely, EPA has not determined that the proposed processing, and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that domestic manufacture or use without protective equipment may cause serious health effects. Based on this information, the PMN substance meets the concern criteria in § 721.170( b)( 3)( i). Recommended testing: The Agency recommends no further toxicity testing for hazard assessment of the PMN substance. However, additional information on human exposures to the PMN substance would help to characterize potential risks. CFR citation: 40 CFR 721.304. PMN Number P   01   298 Chemical name: ( generic) Substituted propane CAS number: Not available. Basis for action: The PMN substance will be used as a polymer additive. EPA has identified health concerns for mutagenicity, neurotoxicity, developmental toxicity, liver toxicity and kidney toxicity based on submitted test data. 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 PMN substance may cause significant adverse effects. EPA has determined, however, that use of the PMN substance other than as described in the PMN may result in 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 prenatal development toxicity study by the oral route in two species ( OPPTS 870.3100 test guideline) would help to characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.8140. PMN Number P   01   320 Chemical name: Propane, 1, 1,1,2,2,3,3 heptafluoro 3 methoxy. CAS number: 375   03   1. Basis for action: The PMN substance will be used as heating transfer fluid and a refrigerant. EPA has identified VerDate jul< 14> 2003 15: 37 Dec 16, 2003 Jkt 203001 PO 00000 Frm 00046 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 17DER1. SGM 17DER1 70167 Federal Register / Vol. 68, No. 242 / Wednesday, December 17, 2003 / Rules and Regulations health concerns for liver and kidney toxicity based on submitted test data and cardiac sensitization and developmental toxicity based on analog data. Since significant worker exposure is unlikely, when the PMN substance is used described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that an increase in production volume or use of the PMN substance other than as described in the PMN could result in serious health 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 90 day subchronic inhalation study in rodents ( OPPTS 870.3465 test guideline) would help to characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.8145. PMN Number P   01   397 Chemical name: ( generic) Dihydro quinacridone derivative. CAS number: Not available. Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogy to neutral organic compounds, 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 2 ppb, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that an increase in production volume or other uses of the PMN substance resulting in releases to surface waters above 2 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 chronic toxicity study ( OPPTS 850.1400 test guideline), a daphnid chronic toxicity study ( OPPTS 850.1300 test guideline), and an algal toxicity study ( OPPTS 850.5400 test guideline) would help to characterize the environmental effects of the PMN substance. The fish and daphnid tests should be conducted with flow through conditions and measured concentrations. The algae test should be conducted with static condition and nominal concentrations. CFR citation: 40 CFR 721.9079. PMN Number P   01   420 Chemical name: ( generic) Aromatic acrylate. CAS number: Not available. Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogy to acrylates, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 3 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 PMN substance may present an unreasonable risk. EPA has determined, however, that other uses of the PMN 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), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline), and an algal toxicity study ( OPPTS 850.5400 test guideline) would help to characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.330. PMN Number P   01   423 Chemical name: ( generic) Substituted benzoic acid. CAS number: Not available. Basis for action: The PMN substance will be used as a dye intermediate. EPA has identified health concerns for developmental toxicity, irritation to lung, skin, eyes, and mucous membranes, blood toxicity, male reproductive toxicity, and dermal sensitization based on analogue data. Since significant worker exposure is unlikely, when the PMN substance is used as described in the PMN, EPA has not determined that the proposed processing, and use of the PMN 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). Recommended testing: EPA has determined that a 90 day subchronic inhalation study in rodents ( OPPTS 870.3465 test guideline) would help to characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.1680. PMN Number P   01   433 Chemical name: ( generic) Halogenated alkane. CAS number: Not available. Basis for action: The PMN substance will be used as an intermediate. Based on analogy to structural analogues, EPA has concerns for carcinogenicity and cardiac sensitization. Also, based on analogy to neutral organic chemicals, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 400 ppb of the PMN substance in surface waters. Since significant worker and environmental exposure is unlikely, when the PMN 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 determined, however, that use of the PMN substance other than as an intermediate may 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) and ( b)( 4)( ii). Recommended testing: EPA has determined that a 90 day subchronic inhalation study in rodents ( OPPTS 870.3465 test guideline) and a cardiac sensitization study 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), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline), and an algal toxicity study ( OPPTS 850.5400 test guideline) would help to characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.535. PMN Number P   01   441 Chemical name: ( generic) Modified phenolic resin CAS number: Not available. Basis for action: The PMN substance will be used as described in the PMN. EPA has identified environmental concerns because the PMN substance may be persistent, bioaccumulative, and potentially toxic based on physical/ chemical properties of the PMN substance as described in the New Chemical Program's PBT Category. 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 based on structural analogy to phenols. Since 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 PMN substance may present an unreasonable risk. EPA has VerDate jul< 14> 2003 15: 37 Dec 16, 2003 Jkt 203001 PO 00000 Frm 00047 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 17DER1. SGM 17DER1 70168 Federal Register / Vol. 68, No. 242 / Wednesday, December 17, 2003 / Rules and Regulations determined, however, that other uses of the PMN 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 tiered testing as described in the New Chemical Program's PBT Category would help to characterize the PBT properties of the PMN substance. EPA has also determined that a fish acute toxicity study ( OPPTS 850.1075 test guideline), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline), and an algal toxicity study ( OPPTS 850.5400 test guideline) would help to characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.5905. PMN Number P   01   459 Chemical name: Chromate( 3), bis[ 3[[ 6 amino 1,4 dihydro 2[[[ 4[( 2 hydroxy 1 naphthalenyl) azo] phenyl] sulfonyl] amino] 4( oxo . kappa. O) 5 pyrimidinyl] azo . kappa. N1] 4( hydroxy. kappa. O) 5 nitrobenzenesulfonato( 3)], trisodium. CAS number: 178452   72   7 Basis for action: The PMN substance will be used as an acid dye for dyeing leather. Based on submitted test data, EPA has identified human health concerns for blood, liver, and spleen effects. Since significant worker exposure is unlikely, as inhalation exposure is not expected for the use described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that use of the PMN 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)( i). Recommended testing: EPA has determined that a 90 day inhalation 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 721.8940. PMN Number P   01   460 Chemical name: Chromate( 3), bis[ 3[[ 6 amino 1,4 dihydro 2[[[ 4[( 2 hydroxy 1 naphthalenyl) azo] phenyl] sulfonyl] amino] 4( oxo . kappa. O) 5 pyrimidinyl] azo . kappa. N1] 4( hydroxy. kappa. O) 5 nitrobenzenesulfonato( 3)], sodium triethanolamine salts. CAS number: 327177   98   0. Basis for action: The PMN substance will be used as an acid dye for dyeing leather. Based on submitted test data, EPA has identified human health concerns for blood, liver, and spleen effects. Since significant worker exposure is unlikely, as inhalation exposure is not expected for the use described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that use of the PMN 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)( i). Recommended testing: EPA has determined that a 90 day inhalation 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 721.8950. PMN Numbers P   00   992 and P   01   471 Chemical name: ( generic) Phosphorous modified epoxy resin. CAS number: Not available. Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogy to epoxides, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 6 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 6 ppb, as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that use of the PMN substance other than as described in the PMN could cause releases to surface waters above 6 ppb which 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), a daphnid chronic toxicity study ( OPPTS 850.1300 test guideline), and an algal toxicity study ( OPPTS 850.5400 test guideline) would help to characterize the environmental effects of the PMN substance. The fish and daphnid tests should be conducted with flow through conditions and measured concentrations. The algae test should be conducted with static conditions and nominal concentrations. CFR citation: 40 CFR 721.3135. PMN Number P   01   481 Chemical name: ( generic) Polyurethane polymer. CAS number: Not available. Basis for action: The PMN substance will be used as described in the PMN. Based on physical/ chemical properties and submitted test data, EPA has identified health concerns for inhalation exposure. Since significant inhalation exposure to workers is unlikely, when the PMN substance is used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that use of the PMN substance other than that 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). Recommended testing: The Agency is not recommending further toxicity testing to evaluate potential health effects. However, additional information on human exposures to the PMN substance would help to characterize potential health risks. CFR citation: 40 CFR 721.9959. PMN Number P   01   561 Chemical name: ( generic) Modified phenolic resin. CAS number: Not available. Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogy to polyphenols, 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 PMN substance may present an unreasonable risk. EPA has determined, however, that any 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), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline), and an algal toxicity study ( OPPTS 850.5400 test guideline) would help to characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.5908. PMN Number P   01   573 Chemical name: ( generic) Aromatic aldehyde phenolic resin CAS number: Not available. Basis for action: The PMN substance will be used as described in the PMN. Based on structural analogy to phenols, EPA is concerned that toxicity to VerDate jul< 14> 2003 15: 37 Dec 16, 2003 Jkt 203001 PO 00000 Frm 00048 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 17DER1. SGM 17DER1 70169 Federal Register / Vol. 68, No. 242 / Wednesday, December 17, 2003 / Rules and Regulations aquatic organisms may occur at a concentration of 1 ppb in surface waters. Since significant environmental exposure is unlikely, as the PMN substance is not released to surface waters, as described in the PMN, EPA has not determined that manufacturing, processing, and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that any 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), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline), and an algal toxicity study ( OPPTS 850.5400 test guideline) would help to characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.5762. PMN Number P   01   578 Chemical name: ( generic) Alkoxylated alkyl amine. CAS number: Not available. Basis for action: The PMN substance will be used as described in the PMN. Based on analogy to cationic surfactants, 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 unlikely, when the PMN substance is used as described in the PMN, EPA has not determined that the proposed manufacturing and use of the PMN 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 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), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline), and a fish acute toxicity study ( OPPTS 850.1075 test guideline) would help to characterize the environmental effects of the PMN substance. All tests should be conducted with static methods and nominal concentrations. CFR citation: 40 CFR 721.647. PMN Number P   01   646 Chemical name: 1 propanaminium, 3 amino, N, N, N trimethyl N soya acyl derivs., chloride CAS number: 391232   99   8 Basis for action: The PMN substance will be used as described in the PMN. Based on analogy to cationic surfactants, 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 unlikely, when the PMN substance is used as described in the PMN, EPA has not determined that the proposed manufacturing and use of the PMN 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 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), a daphnid acute toxicity study OPPTS 850.1010 test guideline), and a fish acute toxicity study ( OPPTS 850.1075 test guideline) would help to characterize the environmental effects of the PMN substance. All tests should be conducted with static methods and nominal concentrations. CFR citation: 40 CFR 721.7270 PMN Number P   01   716 Chemical name: ( generic) Polyurea. CAS number: Not available. Basis for action: The PMN substance will be used as described in the PMN. EPA has identified environmental concerns because the PMN substance may be persistent, bioaccumulative, and potentially toxic based on physical/ chemical properties of the PMN substance as described in the New Chemical Program's PBT category. 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 based on submitted test data. Since 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 PMN substance may present an unreasonable risk. EPA has determined, however, that other uses of the PMN 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)( i). Recommended testing: EPA has determined that the results of the tiered testing as described in the New Chemical Program's PBT Category would help to characterize the PBT properties of the PMN substance. EPA has also determined that an algal toxicity study ( OPPTS 850.5400 test guideline), a fish chronic toxicity study ( OPPTS 850.1400 test guideline), a daphnid chronic toxicity study ( OPPTS 850.1300 test guideline), a fish bioaccumulation test ( OPPTS 850.1730), and a shake flask die away test ( OPPTS 835.3170 test guideline) would help to characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.9929. PMN Number P   01   781 Chemical name: Silane, triethoxy[ 3 ( oxiranylmethoxy) propyl] CAS number: 2602   34   8. Basis for action: The PMN substance will be used as described in the PMN. EPA has identified health concerns for carcinogenicity based on analogy to epoxides. EPA has concerns also for mutagenicity, developmental toxicity, reproductive toxicity, irritation, and sensitization based on analogy to trimethoxy silane derivatives. Since significant worker exposure is unlikely, when the PMN substance is used as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the PMN 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)( 1)( i)( C) and ( b)( 3)( ii) . Also, based on structural analogy to epoxides, 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 environmental exposure is not expected as the PMN substance is not released to surface waters above 10 ppb, as described in the PMN, EPA has not determined that the proposed manufacturing, processing and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that releases 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 combined chronic toxicity/ carcinogenicity study ( OPPTS 870.4300 test guideline) and a 90 day subchronic inhalation study in rodents with attention to pathology of the reproductive organs ( OPPTS 870.3465 test guidelines) would help to characterize the health effects of the PMN substance. EPA has determined that a fish acute toxicity study ( OPPTS 850.1075 test guideline), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline), and an algal toxicity VerDate jul< 14> 2003 15: 37 Dec 16, 2003 Jkt 203001 PO 00000 Frm 00049 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 17DER1. SGM 17DER1 70170 Federal Register / Vol. 68, No. 242 / Wednesday, December 17, 2003 / Rules and Regulations study ( OPPTS 850.5400 test guideline) would help to characterize the environmental effects of the PMN substance. The fish and daphnid tests should be conducted with the flowthrough conditions and measured concentrations. The algae test should be conducted with the static method and measured concentrations. CFR citation: 40 CFR 721.9501. PMN Number P   01   833 Chemical name: ( generic) Polyethyleneamine crosslinked with substituted polyethylene glycol. CAS number: Not available. Basis for action: The PMN substance will be used as an absorbent polymer. Based on toxicity data for other high molecular weight, water swellable polymers, EPA has identified potential lung toxicity from inhalation exposure. Since significant inhalation exposure is unlikely when the PMN substance is used as identified in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that use of the PMN substance other than as described in 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), 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 721.7255. PMN Number P   02   17 Chemical name: ( generic) Phenyl azo dye. CAS number: Not available. Basis for action: The PMN substance will be used as described in the PMN. Based on the submitted 28 day study, EPA has concerns for effects to the testes. Also, based on structural analogy to the azo reduction product, EPA has concerns for developmental toxicity, hemolytic anemia, kidney toxicity, liver toxicity, spleen toxicity, and irreversible ocular phototoxicity. Since significant inhalation exposure to workers is unlikely for the use described in the PMN, EPA has not determined that manufacturing, processing, and use of the PMN substance as described in the PMN may present an unreasonable risk. EPA has determined, however, that use of the PMN 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)( i) and ( b)( 3)( ii). Recommended testing: EPA has 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 721.5917. PMN Number P   02   90 Chemical name: ( generic) Nickel, cobalt mixed metal oxide. CAS number: Not available. Basis for action: The PMN substance will be used as described in the PMN. EPA has identified health concerns for developmental toxicity, mutagenicity, carcinogenicity, cardiotoxicity, immunotoxicity, neurotoxicity, and allergenicity based on the presence of various metal oxides as well as lung effects from exposure to insoluble particles and pulmonary carcinogenicity due to the crystalline nature of the PMN material. 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 PMN substance may cause significant adverse effects. EPA has determined, however, that domestic manufacture or use of the PMN substance other than as described in the PMN 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 inhalation toxicity study in rat ( OPPTS 870.3465 test guideline) would help to characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.5315. PMN Number P   02   207 Chemical name: Piperdinium, 1,1 dimethyl, chloride. CAS number: 24307   26   4. 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 neurotoxicity and chronic toxic effects for the PMN substance. 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 PMN substance may cause significant adverse effects. EPA has determined, however, that use of the PMN substance other than as described in the PMN may result in serious health effects. Also, based on structural analogy to cationic surfactants, EPA is concerned that toxicity to aquatic organisms may occur at surface water concentrations as low as 300 ppb of the PMN substance in surface waters. Since environmental releases are not expected as described in the PMN, EPA has not determined that the proposed manufacturing, processing, and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that release of the PMN substance to surface water may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170( b)( 3)( i), and ( b)( 4)( ii). Recommended testing: EPA has determined that information on potential human and environmental exposures would help to characterize the potential health and environmental risks of the PMN substance. CFR citation: 40 CFR 721.6167. PMN Number P   02   262 Chemical name: ( generic) Substituted benzophenone. CAS number: Not available. Basis for action: The PMN substance will be used as described in the PMN. Based on analogy to benzophenones, EPA has identified health concerns for neurotoxicity and liver toxicity. Since significant worker exposure is unlikely when the PMN substance is used as described in the PMN, EPA has not determined that the proposed processing, and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that domestic manufacture of the PMN substance 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). Also, based on structural analogy to neutral organic chemicals, 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 environmental releases are not expected as described in the PMN, EPA has not determined that the proposed manufacturing, processing and use of the PMN substance may present an unreasonable risk. EPA has determined, however, that any release of the PMN substance 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 90 day oral VerDate jul< 14> 2003 15: 37 Dec 16, 2003 Jkt 203001 PO 00000 Frm 00050 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 17DER1. SGM 17DER1 70171 Federal Register / Vol. 68, No. 242 / Wednesday, December 17, 2003 / Rules and Regulations subchronic study in rats ( OPPTS 870.3465 test guideline) would help characterize the human health effects of the PMN substance. EPA has also determined that a fish acute toxicity study ( OPPTS 850.1075 test guideline), a daphnid acute toxicity study ( OPPTS 850.1010 test guideline), and an algal acute toxicity study ( OPPTS 850.5400 test guideline) would help to characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.1747.

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 5 of the 65 chemical 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 chemical 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 chemical substances listed in this document are consistent with the provisions of the TSCA section 5( e) consent orders. In the other 60 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 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 chemical 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 chemical 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 February 17, 2004, unless EPA receives a written notice by January 16, 2004, of adverse or critical comments, or notice of intent to submit 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 chemical substance to which the adverse or critical comments apply. EPA will then propose a SNUR for the specific chemical substance providing a 30 day comment period. This action establishes SNURs for a number of chemical substances. Any person who submits adverse or critical comments or notice of intent to submit adverse or critical comments, must identify the chemical substance and the new use to which it applies. EPA will not withdraw a SNUR for a chemical substance not identified in a notice.

VI. Test Data and Other Information EPA recognizes that TSCA section 5 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 chemical 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 chemical 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 chemical 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 chemical 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 chemical substances. 3. Information on risks posed by the chemical 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 chemical 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 in § 721.1725( b)( 1), a manufacturer or importer must show that it has a bona fide intent to manufacture or import the chemical substance and must identify the specific use for which it intends to manufacture or import the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture or import the chemical 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 chemical substances VerDate jul< 14> 2003 15: 37 Dec 16, 2003 Jkt 203001 PO 00000 Frm 00051 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 17DER1. SGM 17DER1 70172 Federal Register / Vol. 68, No. 242 / Wednesday, December 17, 2003 / Rules and Regulations 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 chemical 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 chemical 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 chemical substance to remain in compliance with the SNUR, as could be the case under the procedures in § 721.1725( b)( 1).