2010-15334. Significant New Use Rules on 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 17 chemical substances which were the subject of premanufacture notices (PMNs). Two of these chemical substances are subject to TSCA section 5(e) consent orders issued by EPA. This action requires persons who intend to manufacture, import, or process any of these 17 chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.

DATES:

This rule is effective on August 23, 2010. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on July 8, 2010.

Written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs must be received on or before July 26, 2010 (see Unit VI. of the SUPPLEMENTARY INFORMATION).

For additional information on related reporting requirement dates, see Units I.A., VI., and VII. of the SUPPLEMENTARY INFORMATION.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2008-0920, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.
• Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
• Hand Delivery: OPPT Document Control Office (DCO), EPA East, Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID Number EPA-HQ-OPPT-2008-0920. 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 [phone]. Such deliveries are only accepted during the DCO's normal hours of operation, and special arrangements should be made for deliveries of boxed information.

Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-2008-0920. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

Docket: All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available electronically at http://www.regulations.gov, or, if only available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number of the EPA/DC Public Reading Room is [phone], and the telephone number for the OPPT Docket is [phone]. Docket visitors are required to show photographic identification, pass through a metal detector, and sign the EPA visitor log. All visitor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that must be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT:

For technical information contact: Tracey Klosterman, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; e-mail address: [e-mail].

For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: [phone]; e-mail address: [e-mail].

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:

• Manufacturers, importers, or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries.

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in § 721.5. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under FOR FURTHER INFORMATION CONTACT.

This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28 (the corresponding EPA policy appears at 40 CFR part 707, subpart B). Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to these SNURs must certify their compliance with the SNUR requirements. In addition, any persons who export or intend to export a chemical substance that is the subject of this rule on or after July 26, 2010 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see § 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

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

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When submitting comments, remember to:

i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).

ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

iv. Describe any assumptions and provide any technical information and/or data that you used.

v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

vi. Provide specific examples to illustrate your concerns and suggest alternatives.

vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

viii. Make sure to submit your comments by the comment period deadline identified.

II. Background

A. What Action is the Agency Taking?

EPA is promulgating these SNURs using direct final procedures. These SNURs will require persons to notify EPA at least 90 days before commencing the manufacture, import, or processing of a chemical substance for any activity designated by these SNURs as a significant new use. Receipt of such notices allows EPA to assess risks that may be presented by the intended uses and, if appropriate, to regulate the proposed use before it occurs. Additional rationale and background to these rules 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 SNURs and on the basis for significant new use designations, including provisions for developing test data.

B. What is the Agency's Authority for Taking this Action?

Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including those listed in TSCA section 5(a)(2) (see Unit III.). 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 significant new use notice (SNUN) 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 § 721.5.

C. Applicability of General Provisions

General provisions for SNURs appear in 40 CFR part 721, subpart A. 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 rule. Provisions relating to user fees appear at 40 CFR part 700. According to § 721.1(c), persons subject to these SNURs 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 SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the activities for which it has received the SNUN. 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.

Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements codified at 19 CFR 12.118 through 12.127, and 19 CFR 127.28 (the corresponding EPA policy appears at 40 CFR part 707, subpart B). Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemical substances subject to a final SNUR must certify their compliance with the SNUR requirements. In addition, any persons who export or intend to export a chemical substance identified in a final SNUR are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611 (b)) (see § 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

III. Significant New Use Determination

Section 5(a)(2) of TSCA states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:

• The projected volume of manufacturing and processing of a chemical substance.
• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.
• The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.
• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorized EPA to consider any other relevant factors.

To determine what would constitute a significant new use for the 17 chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, likely human exposures and environmental releases associated with possible uses, and the four bulleted TSCA section 5(a)(2) factors listed in this unit.

IV. Substances Subject to this Rule

EPA is establishing significant new use and recordkeeping requirements for 17 chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance:

• 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 TSCA section 5(e) consent order or, for non-section 5(e) SNURs, the basis for the SNUR (i.e., SNURs without TSCA section 5(e) consent orders).
• Toxicity concerns.
• Tests recommended by EPA to provide sufficient information to evaluate the chemical substance (see Unit VIII. for more information).
• CFR citation assigned in the regulatory text section of this rule.

The regulatory text section of this rule specifies the activities designated as significant new uses. Certain new uses, including production volume limits (i.e., limits on manufacture and importation volume) and other uses designated in this rule, may be claimed as CBI. Unit IX. discusses a procedure companies may use to ascertain whether a proposed use constitutes a significant new use.

This rule includes 2 PMN substances that are subject to “risk-based” consent orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA determined that activities associated with the PMN substances may present unreasonable risk to human health or the environment. Those consent orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The so-called “5(e) SNURs” on these PMN substances are promulgated pursuant to § 721.160, and are based on and consistent with the provisions in the underlying consent orders. The 5(e) SNURs designate as a “significant new use” the absence of the protective measures required in the corresponding consent orders.

Where EPA determined that the PMN substance may present an unreasonable risk of injury to human health via inhalation exposure, the underlying TSCA section 5(e) consent order usually requires, among other things, that potentially exposed employees wear specified respirators unless actual measurements of the workplace air show that air-borne concentrations of the PMN substance are below a New Chemical Exposure Limit (NCEL) that is established by EPA to provide adequate protection to human health. In addition to the actual NCEL concentration, the comprehensive NCELs provisions in TSCA section 5(e) consent orders, which are modeled after Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs) provisions, include requirements addressing performance criteria for sampling and analytical methods, periodic monitoring, respiratory protection, and recordkeeping. However, no comparable NCEL provisions currently exist in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases, the individual SNURs in 40 CFR part 721, subpart E, will state that persons subject to the SNUR who wish to pursue NCELs as an alternative to the § 721.63 respirator requirements may request to do so under § 721.30. EPA expects that persons whose § 721.30 requests to use the NCELs approach for SNURs are approved by EPA will be required to comply with NCELs provisions that are comparable to those contained in the corresponding TSCA section 5(e) consent order for the same chemical substance.

This rule also includes SNURs on 15 PMN substances that are not subject to consent orders under TSCA section 5(e). In these cases, for a variety of reasons, EPA did not find that the use scenario described in the PMN triggered the determinations set forth under TSCA section 5(e). However, EPA does believe that certain changes from the use scenario described in the PMN could result in increased exposures, thereby constituting a “significant new use.” These so-called “non-5(e) SNURs” are promulgated pursuant to § 721.170. EPA has determined that every activity designated as a “significant new use” in all non-5(e) SNURs issued under § 721.170 satisfies the two requirements stipulated in § 721.170(c)(2), i.e., these significant new use activities, “(i) are different from those described in the premanufacture notice for the substance, including any amendments, deletions, and additions of activities to the premanufacture notice, and (ii) may be accompanied by changes in exposure or release levels that are significant in relation to the health or environmental concerns identified” for the PMN substance.

PMN Number P-02-996

Chemical name: Aliphatic triamine (generic).

CAS number: Not available.

Basis for action: The PMN states that the chemical substance will be used as a monomer for polymers with amide or imide links; a crosslinker for epoxy type coatings, adhesives and sealants; a crosslinker for epoxy type composites; a monomer for urea and urethane urea polymers used in coatings; a chemical intermediate for functional chemicals: amides, imides; a chemical intermediate for functional chemicals: isocyanates, salts; and a chemical intermediate for functional chemicals: cyclic amines, etc. Based on test data on the PMN substance and analogous substances, EPA identified concerns for corrosion of the skin, eyes, mucous membranes and lungs; respiratory tract irritation; immunotoxicity; developmental toxicity; and reproductive toxicity from exposure to the PMN substance. In addition, based on test data on the PMN substance, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 48 parts per billion (ppb) of the PMN substance in surface waters. For the use described in the PMN, worker inhalation and dermal exposures are not expected and releases to water are not expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance involving an application method which generates a vapor, mist, or aerosol may cause serious health effects and any use of the substance resulting in release to surface waters may cause significant adverse environmental effects. Based on this information, the PMN substance meets the concern criteria at § 721.170 (b)(3)(i), (b)(3)(ii), and (b)(4)(i).

Recommended testing: EPA has determined that the results of the following testing would help characterize the human health and environmental effects of the PMN substance: Either a 90-day inhalation toxicity test (OCSPP Harmonized Test Guideline 870.3465) in rodents, modified for a 28-day exposure, or a repeated dose inhalation toxicity study (Organization for Co-Operation and Development (OECD) 412 test guideline); a prenatal developmental toxicity study (OCSPP Harmonized Test Guideline 870.3700) via the oral route; a reproduction and fertility study (OCSPP Harmonized Test Guideline 870.3800) via the oral route; an immunotoxicity test (OCSPP Harmonized Test Guideline 870.7800) via the oral route; a fish chronic toxicity test (OCSPP Harmonized Test Guideline 850.1400); and a daphnid chronic toxicity test (OCSPP Harmonized Test Guideline 850.1300). All recommended tests should be performed on the PMN substance neutralized with HCl to a pH of 7.0. Further, a certificate of analysis should be included for the test substance.

CFR citation: 40 CFR 721.10184.

PMN Number P-03-106

Chemical name: 1,2-Propanediol, 3-(diethylamino)-, polymers with 5-isocyanato-1- (isocyanatomethyl)-1,3,3-trimethylcyclohexane, propylene glycol and reduced Me esters of reduced polymd. oxidized tetrafluoroethylene, 2-ethyl-1-hexanol-blocked, acetates (salts).

CAS number: 328389-90-8.

Basis for action: The PMN states that the generic (non-confidential) use of the substance will be as a surface treatment agent. Based on test data on analogous substances, EPA believes this substance could cause lung toxicity to workers if inhaled, via irritation to mucous membranes and cationic binding with membranes. For the use described in the PMN, significant worker dermal or inhalation exposure is not expected. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that use of the substance involving an application method which generates a vapor, mist, or aerosol 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 the results of a 90-day inhalation toxicity study (OCSPP Harmonized Test Guideline 870.3465) would help characterize the human health effects of the PMN substance.

CFR citation: 40 CFR 721.10185.

PMN Number P-04-132

Chemical name: Ethylhexyl oxetane (generic).

CAS number: Not available.

Effective date of TSCA section 5(e) consent order: March 7, 2007.

Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as an additive for industrial applications. The order was issued under sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) of TSCA based on findings that this substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the consent order requires use of dermal personal protective equipment, including gloves demonstrated by testing to be impervious (Polyvinyl Alcohol gloves with a thickness of no less than 31.3 mils or Silvershield/4H sleeves with a thickness of no less than 2.7 mils have been shown to satisfy this requirement for up to 8 hours), requires the establishment of a hazard communication program, and limits uses to those listed in the consent order. The SNUR designates as a “significant new use” the absence of these protective measures.

Toxicity concern: Based on test data on the PMN substance, EPA identified concerns for liver toxicity, thyroid toxicity, and systemic toxicity. Further, based on test data on the PMN substance, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 20 ppb of the PMN substance in surface waters.

Recommended testing: EPA has determined that the following tests would help characterize the human health and environmental effects of the PMN substance: A 90-day oral toxicity test (OCSPP Harmonized Test Guideline 870.3100) in rodents; a fish early-life stage toxicity test (OCSPP Harmonized Test Guideline 850.1400) with rainbow trout; and a daphnid chronic toxicity test (OCSPP Harmonized Test Guideline 850.1300). The order does not require submission of the aforementioned information at any specified time or production volume. However, the order's restrictions on manufacturing, import, processing, distribution in commerce, use and disposal of the PMN substance will remain in effect until the order is modified or revoked by EPA based on submission of that or other relevant information.

CFR citation: 40 CFR 721.10186.

PMN Number P-05-186

Chemical names: (Chemical A) 4-Morpholinepropanamine, N-(1,3-dimethylbutylidene)-; (Chemical B) Fatty acids, tall-oil, reaction products with 4-methyl-2-pentanone and aliphatic polyamine (generic); (Chemical C) Fatty acids, tall-oil, reaction products with (butoxymethyl) oxirane formaldehyde-phenol polymer glycidyl ether, morpholinepropanamine, propylene glycol diamine and aliphatic polyamine, N-(1,3 -dimethylbutylidene) derivs (generic); and (Chemical D) Formaldehyde, polymer with aliphatic diamine and phenol, reaction products with 4-methyl-2-pentanone (generic).

CAS numbers: (Chemical A) 1003863-30-6; (Chemical B) not available; (Chemical C) not available; and (Chemical D) not available.

Basis for action: The PMN states that the substances will be used as curing agents for epoxy coating systems. Based on test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 10 ppb of the PMN in surface waters. For the uses described in the PMN, releases of the substances are not expected to result in surface waters concentrations that exceed 10 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that any use of the substances resulting in surface water concentrations exceeding 10 ppb may cause significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of the following tests would help characterize the environmental effects of the PMN substances: A fish acute toxicity test, freshwater and marine (OCSPP Harmonized Test Guideline 850.1075) using the static method with 24-hour renewal intervals; a fish acute toxicity test mitigated by humic acid (OCSPP Harmonized Test Guideline 850.1085) using the static method with 24-hour renewal intervals; an aquatic invertebrate acute toxicity test, freshwater daphnids (OCSPP Harmonized Test Guideline 850.1010) using the static method with 24-hour renewal intervals; and an algal toxicity test, tiers I and II (OCSPP Harmonized Test Guideline 850.5400) using the static method. For all fish and daphnid testing, the dilution water must have a water hardness of less than 180 mg/L calcium carbonate and a total organic carbon (TOC) level of less than 2.0 mg/L. Further, the stock solution should be adjusted to a pH of 7 at study initiation prior to the introduction of test organisms. Study reports must include chemical names, CAS numbers, and composition of the test substance.

CFR citations: 40 CFR 721.10187 (P-05-186, Chemical A); 40 CFR 721.10188 (P-05-186, Chemical B); 40 CFR 721.10189 (P-05-186, Chemical C); and 40 CFR 721.10190 (P-05-186, Chemical D).

PMN Numbers P-06-262, P-06-263, and P-06-264

Chemical names: (P-06-262) Amides, coco, N-[3-(dibutylamino)propyl]; (P-06-263, Chemical A) Amides, coco, N-[3-(dibutylamino)propyl], acrylates; (P-06-263, Chemical B) 1-Butanaminium, N-(3-aminopropyl)-N-butyl-N-(2-carboxyethyl)-, N-coco acyl derivs., inner salts; and (P-06-264) Dialkylcocoamidoalkylpropionate (generic).

CAS numbers: (P-06-262) 851544-20-2; (P-06-263, Chemical A) 851545-09-0; (P-06-263, Chemical B) 851545-17-0; and (P-06-264) not available.

Basis for action: The consolidated PMN states that the substances will be used as intermediates for hydrate inhibitors for oil and gas wells, production pipelines and flowlines (P-06-262); and hydrate inhibitors for oil and gas wells, production pipelines and flowlines (P-06-263 and P-06-264). Based on test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 20 ppb of the PMN substances in surface waters. For the uses described in the PMNs, these substances will not be released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that any use of the substances resulting in release to surface waters may cause significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of the following tests would help characterize the environmental effects of the PMN substance: A fish acute toxicity test, freshwater and marine (OCSPP Harmonized Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OCSPP Harmonized Test Guideline 850.1010); an algal toxicity test, tiers I and II (OCSPP Harmonized Test Guideline 850.5400); a ready biodegradability test (OCSPP Harmonized Test Guideline 835.3110); and an activated sludge sorption isotherm (OCSPP Harmonized Test Guideline 835.1110) would help characterize the environmental effects of the PMN substances. Testing should be performed on P-06-264. Further, a certificate of analysis should be included for the test substances.

CFR citations: 40 CFR 721.10191 (P-06-262); 40 CFR 721.10192 (P-06-263, Chemical A); 40 CFR 721.10193 (P-06-263, Chemical B); and 40 CFR 721.10194 (P-06-264).

PMN Numbers P-06-265, P-06-266, and P-06-267

Chemical names: (P-06-265) Dialkylcornoilamidoalkylamine (generic); (P-06-266, Chemical A) Dialkylcornoilamidoacrylate (generic); (P-06-266, Chemical B) Dialkycornoilamidoalkylbetaine (generic); and (P-06-267) Dialkylcornoilamidopropionate (generic).

CAS numbers: (P-06-265) Not available; (P-06-266, Chemical A) not available; (P-06-266, Chemical B) not available; and (P-06-267) not available.

Basis for action: The consolidated PMN states that the substances will be used as intermediates for hydrate inhibitors for oil and gas wells, production pipelines and flowlines (P-06-265); and hydrate inhibitors for oil and gas wells, production pipelines and flowlines (P-06-266 and P-06-267). Based on test data on analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 20 ppb of the PMN substances in surface waters. For the uses described in the PMNs, these substances will not be released to surface waters. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substances may present an unreasonable risk. EPA has determined, however, that any use of the substances resulting in release to surface waters may cause significant adverse environmental effects. Based on this information, the PMN substances meet the concern criteria at § 721.170(b)(4)(ii).

Recommended testing: EPA has determined that the results of the following tests would help characterize the environmental effects of the PMN substance: A fish acute toxicity test, freshwater and marine (OCSPP Harmonized Test Guideline 850.1075); an aquatic invertebrate acute toxicity test, freshwater daphnids (OCSPP Harmonized Test Guideline 850.1010); an algal toxicity test, tiers I and II (OCSPP Harmonized Test Guideline 850.5400); a ready biodegradability test (OCSPP Harmonized Test Guideline 835.3110); and an activated sludge sorption isotherm (OCSPP Harmonized Test Guideline 835.1110) would help characterize the environmental effects of the PMN substances. Testing should be performed on P-06-267. Further, a certificate of analysis should be included for the test substances.

CFR citations: 40 CFR 721.10195 (P-06-265); 40 CFR 721.10196 (P-06-266, Chemical A); 40 CFR 721.10197 (P-06-266, Chemical B); and 40 CFR 721.10198 (P-06-267).

PMN Number P-06-702

Chemical name: Substituted aliphatic amine (generic).

CAS number: Not available.

Effective date of TSCA section 5(e) consent order: May 26, 2009.

Basis for TSCA section 5(e) consent order: The PMN states that the generic (non-confidential) use of the substance will be as a polymer curative. The order was issued under sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) of TSCA based on findings that this substance may present an unreasonable risk of injury to the environment and human health. To protect against these risks, the consent order requires use of dermal personal protective equipment, including gloves demonstrated by testing to be impervious (Ansell NEOX style 9-912 gloves have been shown to satisfy this requirement for up to 110 minutes), use of respiratory personal protective equipment, including a National Institute of Occupational Safety and Health (NIOSH)-approved respiratory protection with an APF of at least 50 or compliance with a New Chemical Exposure Limit (NCEL) of 0.14 mg/m³ as an 8-hour time-weighted average, establishment of a hazard communication program, and restricts releases to water. The SNUR designates as a “significant new use” the absence of these protective measures.

Toxicity concern: Based on test data on analogous substances, EPA identified concerns for chronic liver toxicity, acute oral toxicity and corrosion to membranes, dermal toxicity, inhalation toxicity, dermal and eye irritation to workers exposed to the PMN substance. EPA set the NCEL at 0.14 mg/m³ as an 8-hour time-weighted average. In addition, based on test data on the PMN substance, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb of the PMN substance in surface waters.

Recommended testing: EPA has determined that the results of the following tests would help characterize the health and environmental effects of the PMN substance: A primary skin irritation test (OECD 404 test guideline); a primary eye irritation test (OECD 405 test guideline); a 28-day repeated dose (OECD 407 test guideline) gavage in rats, a fish early life stage toxicity test (OCSPP Harmonized Test Guideline 850.1400); and a daphnid chronic toxicity test (OCSPP Harmonized Test Guideline 850.1300). The PMN submitter has agreed not to exceed the production volume limit without performing the primary skin irritation test (OECD 404 test guideline); primary eye irritation test (OECD 405 test guideline); and 28-day repeated dose test (OECD 407 test guideline) gavage in rats. The order does not require submission of the fish early life-stage toxicity test and the daphnid chronic toxicity test at any specified time or production volume. However, the order's restrictions on manufacturing, import, processing, distribution in commerce, use and disposal of the PMN substance will remain in effect until the order is modified or revoked by EPA based on submission of that or other relevant information.

CFR citation: 40 CFR 721.10199.

PMN Number P-09-75

Chemical name: Benzenacetonitrile, cyclohexylidene-alkyl substituted (generic).

CAS number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as a component of odorant compositions for highly-dispersive applications. Based on test data on the PMN substance, EPA predicts chronic toxicity to aquatic organisms at concentrations that exceed 123 ppb of the PMN substance in surface waters. For the processing and use scenario and production volume in the amended PMN, releases of the substance are not expected to result in surface water concentrations that exceed 123 ppb. Therefore, EPA has not determined that the proposed manufacturing, processing, or use of the substance may present an unreasonable risk. EPA has determined, however, that any use of the substance resulting in surface water concentrations that exceed 123 ppb, or exceedance of the annual maximum manufacturing and importation limit of 10,000 kg, 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 following tests would help characterize the environmental effects of the PMN substance: A fish early life stage toxicity test (OCSPP Harmonized Test Guideline 850.1400) and a field testing for aquatic organisms test (OCSPP Harmonized Test Guideline 850.1950). The fish early-life stage test should be performed using the flow-through method with measured concentrations. Further, a certificate of analysis should be provided for the test substance. EPA recommends conducting the early life stage fish test first, as the results of this test may affect the choice of species for subsequent field testing.

CFR citation: 40 CFR 721.10200.

V. Rationale and Objectives of the Rule

A. Rationale

During review of the PMNs submitted for the chemical substances that are the subjects of these SNURs, EPA concluded that for 2 of the 17 chemical substances, regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV. 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 are consistent with the provisions of the TSCA section 5(e) consent orders. These SNURs are promulgated pursuant to § 721.160.

In the other 15 cases, where the 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 § 721.170 were met, as discussed in Unit IV.

B. Objectives

EPA is issuing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this rule:

• EPA will receive notice of any person's intent to manufacture, import, or process a listed chemical substance for the described significant new use before that activity begins.
• EPA will have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing, importing, or processing a listed chemical substance for the described significant new use.
• EPA will be able to regulate prospective manufacturers, importers, or processors of a listed chemical substance before the described significant new use of that chemical substance occurs, provided that regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6, or 7.
• EPA will ensure that all manufacturers, importers, and processors of the same chemical substance that 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. Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the Internet at http://www.epa.gov/​opptintr/​newchems/​pubs/​invntory.htm.

VI. Direct Final Procedures

EPA is issuing these SNURs as a direct final rule, as described in § 721.160(c)(3) and § 721.170(d)(4). In accordance with § 721.160(c)(3)(ii) and § 721.170(d)(4)(i)(B), the effective date of this rule is August 23, 2010 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before July 26, 2010.

If EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs before July 26, 2010, EPA will withdraw the relevant sections of this direct final rule before its effective date. EPA will then issue a proposed SNUR for the chemical substance(s) on which adverse or critical comments were received, providing a 30-day period for public comment.

This rule 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 the comment.

VII. Applicability of Rule to Uses Occurring Before Effective Date of the Rule

Significant new use designations for a chemical substance are legally established as of the date of publication of this direct final rule June 24, 2010.

To establish a significant “new” use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule have undergone premanufacture review. TSCA section 5(e) consent orders have been issued for 2 chemical substances and the PMN submitters are prohibited by the TSCA section 5(e) consent orders from undertaking activities which EPA is designating as significant new uses. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no other person may commence such activities without first submitting a PMN. For chemical substances for which an NOC has not been submitted at this time, EPA concludes that the uses are not ongoing. However, EPA recognizes that prior to the effective date of the rule, when chemical substances identified in this SNUR are added to the TSCA Inventory, other persons may engage in a significant new use as defined in this rule before the effective date of the rule. However, 12 of the 17 chemical substances contained in this rule have CBI chemical identities, and since EPA has received a limited number of post-PMN bona fide submissions (per §§ 720.25 and 721.11), the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this rule are ongoing.

As discussed in the Federal Register of April 24, 1990, EPA has decided that the intent of TSCA section 5(a)(1)(B) is best served by designating a use as a significant new use as of the date of publication of this direct final rule rather than as of the effective date of the rule. If uses begun after publication were considered ongoing rather than new, it would be difficult for EPA to establish SNUR notice requirements because a person could defeat the SNUR by initiating the significant new use before the rule became effective, and then argue that the use was ongoing before the effective date of the rule. Thus, persons who begin commercial manufacture, import, or processing of the chemical substances regulated through this SNUR will have to cease any such activity before the effective date of this rule. To resume their activities, these persons would have to comply with all applicable SNUR notice requirements and wait until the notice review period, including all extensions, expires (see Unit III.).

EPA has promulgated provisions to allow persons to comply with this SNUR before the effective date. If a person meets the conditions of advance compliance under § 721.45(h), the person is considered exempt from the requirements of the SNUR.

VIII. Test Data and Other Information

EPA recognizes that TSCA section 5 does not require developing any particular test data before submission of a SNUN, except where the chemical substance subject to the SNUR is also subject to a test rule under TSCA section 4 (see TSCA section 5(b)). Persons are required only to submit test data in their possession or control and to describe any other data known to or reasonably ascertainable by them (see § 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. In cases where EPA issued a TSCA section 5(e) consent order that requires or recommends certain testing, Unit IV. lists those tests. Unit IV. also lists recommended testing for non-5(e) SNURs. Descriptions of tests are provided for informational purposes. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. To access the Harmonized Test Guidelines referenced in this document electronically, please go to http://www.epa.gov/​ocspp and select “Test Methods and Guidelines.” The Organisation for Economic Co-operation and Development (OECD) test guidelines are available from the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org.

In the TSCA section 5(e) consent orders for several of the chemical substances regulated under this rule, EPA has established production volume limits 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 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 TSCA section 5(e) consent orders, each PMN submitter is required to submit each study at least 14 weeks (earlier TSCA section 5(e) 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 IV. The SNURs contain the same production volume limits as the TSCA section 5(e) consent orders. Exceeding these production limits is defined as a significant new use. Persons who intend to exceed the production limit must notify the Agency by submitting a SNUN at least 90 days in advance of commencement of non-exempt commercial manufacture, import, or processing.

The recommended tests may not be the only means of addressing the potential risks of the chemical substance. However, SNUN submitting for significant new use without any test data may increase the likelihood that EPA will take action under TSCA section 5(e), particularly if satisfactory test results have not been obtained from a prior PMN or SNUN submitter. EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.

SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following:

• Human exposure and environmental release that may result from the significant new use of the chemical substances.
• Potential benefits of the chemical substances.
• Information on risks posed by the chemical substances compared to risks posed by potential substitutes.

IX. Procedural Determinations

By this rule, EPA is establishing certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a final determination or other disposition of the confidentiality claim under 40 CFR part 2 procedures, EPA is required to keep this information confidential. EPA promulgated a procedure to deal with the situation where a specific significant new use is CBI. This rule cross-references § 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 SNUR that includes specific significant new uses that are CBI.

Under these procedures a manufacturer, importer, or processor may request EPA to determine whether a proposed use would be a significant new use under the rule. The manufacturer, importer, or processor must show that it has a bona fide intent to manufacture, import, or process the chemical substance and must identify the specific use for which it intends to manufacture, import, or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture, import, or process 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 subject to these SNURs are also CBI, manufacturers, importers, 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 EPA determines that the use identified in the bona fide submission would not be a significant new use, i.e., the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture, import, or process the chemical substance so long as the significant new use trigger is not met. In the case of a production volume trigger, this means that the aggregate annual production volume does not exceed that identified in the bona fide submission to EPA. Because of confidentiality concerns, EPA does not typically disclose the actual production volume that constitutes the use trigger. Thus, 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.

X. SNUN Submissions

As stated in Unit II.C., according to § 721.1(c), persons submitting a SNUN must comply with the same notice requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in § 720.50. SNUNs must be submitted to EPA, on EPA Form No. 7710-25 in accordance with the procedures set forth in §§ 721.25 and 720.40. This form is available from the Environmental Assistance Division (7408M), 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. Forms and information are also available electronically at http://www.epa.gov/​opptintr/​newchems.

XI. Economic Analysis

EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers, importers, and processors of the chemical substances subject to this rule. EPA's complete economic analysis is available in the docket.

XII. Statutory and Executive Order Reviews

A. Executive Order 12866

This rule establishes SNURs for several new chemical substances that were the subject of PMNs, or TSCA section 5(e) consent orders. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).

B. Paperwork Reduction Act

According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., an Agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under the PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable. EPA is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this rule. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB's implementing regulations at 5 CFR part 1320. This Information Collection Request (ICR) was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is “good cause” under section 553(b)(3)(B) of the Administrative Procedure Act, 5 U.S.C. 553(b)(3)(B), to amend this table without further notice and comment.

The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.

Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Collection Strategies Division, Office of Environmental Information (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.

C. Regulatory Flexibility Act

Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation of these SNURs will not have a significant adverse economic impact on a substantial number of small entities. The rationale supporting this conclusion is discussed in this unit. The requirement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the rule as a “significant new use.” Because these uses are “new,” based on all information currently available to EPA, it appears that no small or large entities presently engage in such activities. A SNUR requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN. Although some small entities may decide to pursue a significant new use in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of over 1,400 SNURs, the Agency receives on average only 5 notices per year. Of those SNUNs submitted from 2006-2008, only one appears to be from a small entity. In addition, the estimated reporting cost for submission of a SNUN (see Unit XI.) is minimal regardless of the size of the firm. Therefore, EPA believes that the potential economic impacts of complying with these SNURs are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published in the Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency presented its general determination that final SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration.

D. Unfunded Mandates Reform Act

Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this rule. As such, EPA has determined that this rule does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any affect on small governments subject to the requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

E. Executive Order 13132

This action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999).

F. Executive Order 13175

This rule does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This does not significantly or uniquely affect the communities of Indian Tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000), do not apply to this rule.

G. Executive Order 13045

This action is not subject to Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.

H. Executive Order 13211

This action is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use and because this action is not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act

In addition, since this action does not involve any technical standards, section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note), does not apply to this action.

J. Executive Order 12898

This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

XIII. Congressional Review Act

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

List of Subjects

40 CFR Part 9

Environmental protection, Reporting and recordkeeping requirements.

40 CFR Part 721

Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements.

Dated: June 17, 2010.

Wendy C. Hamnett,

Director, Office of Pollution Prevention and Toxics.

Therefore, 40 CFR parts 9 and 721 are amended as follows:

PART 9—[AMENDED]

1. The authority citation for part 9 continues to read as follows:

Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 9601-9657, 11023, 11048.

2. The table in § 9.1 is amended by adding the following sections in numerical order under the undesignated center heading “Significant New Uses of Chemical Substances” to read as follows:

§ 9.1

OMB approvals under the Paperwork Reduction Act.

* * * * *

 

40 CFR citation	OMB control No.
*    *    *      *     *
Significant New Uses of Chemical Substances
*    *    *      *     *
721.10184	2070-0012
721.10185	2070-0012
721.10186	2070-0012
721.10187	2070-0012
721.10188	2070-0012
721.10189	2070-0012
721.10190	2070-0012
721.10191	2070-0012
721.10192	2070-0012
721.10193	2070-0012
721.10194	2070-0012
721.10195	2070-0012
721.10196	2070-0012
721.10197	2070-0012
721.10198	2070-0012
721.10199	2070-0012
721.10200	2070-0012
*    *    *      *     *

* * * * *

 

PART 721—[AMENDED]

3. The authority citation for part 721 continues to read as follows:

Authority: 15 U.S.C. 2604, 2607, and 2625(c).

4. Add § 721.10184 to subpart E to read as follows:

§ 721.10184

Aliphatic triamine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aliphatic triamine (PMN P-02-996) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(y)(1).

(ii) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and (c)(1).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (i), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

5. Add § 721.10185 to subpart E to read as follows:

§ 721.10185

1,2-Propanediol, 3-(diethylamino)-, polymers with 5-isocyanato-1- (isocyanatomethyl)-1,3,3-trimethylcyclohexane, propylene glycol and reduced Me esters of reduced polymd. oxidized tetrafluoroethylene, 2-ethyl-1-hexanol-blocked, acetates (salts).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,2-propanediol, 3-(diethylamino)-, polymers with 5-isocyanato-1- (isocyanatomethyl)-1,3,3-trimethylcyclohexane, propylene glycol and reduced Me esters of reduced polymd. oxidized tetrafluoroethylene, 2-ethyl-1-hexanol-blocked, acetates (salts) (PMN P-03-106; CAS No. 328389-90-8) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(y)(l).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (i) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

6. Add § 721.10186 to subpart E to read as follows:

§ 721.10186

Ethylhexyl oxetane (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as ethylhexyl oxetane (PMN P-04-132) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this rule do not apply to quantities of the PMN substance after it has been completely reacted (cured).

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(1), (a)(2)(i), (a)(2)(iii), (a)(3)(i), (b) (concentration set at 1.0 percent), and (c). Polyvinyl Alcohol gloves with a thickness of no less than 31.3 mils or Silvershield/4H sleeves with a thickness of no less than 2.7 mils have been shown to satisfy the requirements of § 721.63(a)(3)(i) for up to 8 hours.

(ii) Hazard communication program. Requirements as specified in § 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), (f), (g)(1)(iii), (g)(1)(iv), (g)(2)(i), (g)(2)(v), (g)(3)(ii), and (g)(5).

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (d), (e), (f), (g), (h), and (i) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to this section.

7. Add § 721.10187 to subpart E to read as follows:

§ 721.10187

4-Morpholinepropanamine, N-(1,3-dimethylbutylidene)-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 4-morpholinepropanamine, N-(1,3-dimethylbutylidene)- (PMN P-05-186, Chemical A; CAS No. 1003863-30-6) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=10). However, when this chemical substance is released in combination with any of the substances in § 721.10188, § 721.10189, or § 721.10190, then the value of N shall instead be adjusted according to the following formula:

[(N1 x Release1) + (N2 x Release2) + (N3 x Release3) + (N4 x Release4)] / (Release1 + Release2 + Release3 + Release4) = Adjusted N

Where the “N” variables are the N values for each of the four substances as specified in this section and § 721.10188, § 721.10189, § 721.10190 and the “Release” variables are the number of kilograms released of the respective four substances (in units of kg/site/day) per § 721.91(a).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

8. Add § 721.10188 to subpart E to read as follows:

§ 721.10188

Fatty acids, tall-oil, reaction products with 4-methyl-2-pentanone and aliphatic polyamine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as fatty acids, tall-oil, reaction products with 4-methyl-2-pentanone and aliphatic polyamine (PMN P-05-186, Chemical B) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=10). However, when this chemical substance is released in combination with any of the substances in § 721.10187, § 721.10189, or § 721.10190, then the value of N shall instead be adjusted according to the following formula:

[(N1 x Release1) + (N2 x Release2) + (N3 x Release3) + (N4 x Release4)] / (Release1 + Release2 + Release3 + Release4) = Adjusted N

Where the “N” variables are the N values for each of the four substances as specified in this section and § 721.10187, § 721.10189, § 721.10190 and the “Release” variables are the number of kilograms released of the respective four substances (in units of kg/site/day) per § 721.91(a).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

9. Add § 721.10189 to subpart E to read as follows:

§ 721.10189

Fatty acids, tall-oil, reaction products with (butoxymethyl) oxirane formaldehyde-phenol polymer glycidyl ether, morpholinepropanamine, propylene glycol diamine and aliphatic polyamine, N-(1,3 -dimethylbutylidene) derivs (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as fatty acids, tall-oil, reaction products with (butoxymethyl) oxirane formaldehyde-phenol polymer glycidyl ether, morpholinepropanamine, propylene glycol diamine and aliphatic polyamine, N-(1,3 -dimethylbutylidene) derivs (PMN P-05-186, Chemical C) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=10). However, when this chemical substance is released in combination with any of the substances in § 721.10187, § 721.10188, or § 721.10190, then the value of N shall instead be adjusted according to the following formula:

[(N1 x Release1) + (N2 x Release2) + (N3 x Release3) + (N4 x Release4)] / (Release1 + Release2 + Release3 + Release4) = Adjusted N

Where the “N” variables are the N values for each of the four substances as specified in this section and § 721.10187, § 721.10188, § 721.10190 and the “Release” variables are the number of kilograms released of the respective four substances (in units of kg/site/day) per § 721.91(a).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

10. Add § 721.10190 to subpart E to read as follows:

§ 721.10190

Formaldehyde, polymer with aliphatic diamine and phenol, reaction products with 4-methyl-2-pentanone (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as formaldehyde, polymer with aliphatic diamine and phenol, reaction products with 4-methyl-2-pentanone (PMN P-05-186; Chemical D) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=10). However, when this chemical substance is released in combination with any of the substances in § 721.10187, § 721.10188, or § 721.10189, then the value of N shall instead be adjusted according to the following formula:

[(N1 x Release1) + (N2 x Release2) + (N3 x Release3) + (N4 x Release4)] / (Release1 + Release2 + Release3 + Release4) = Adjusted N

Where the “N” variables are the N values for each of the four substances as specified in this section and § 721.10187, § 721.10188, § 721.10189 and the “Release” variables are the number of kilograms released of the respective four substances (in units of kg/site/day) per § 721.91(a).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

11. Add § 721.10191 to subpart E to read as follows:

§ 721.10191

Amides, coco, N-[3-(dibutylamino)propyl].

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as amides, coco, N-[3-(dibutylamino)propyl] (PMN P-06-262; CAS No. 851544-20-2) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

12. Add § 721.10192 to subpart E to read as follows[U1]:

§ 721.10192

Amides, coco, N-[3-(dibutylamino)propyl], acrylates.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as amides, coco, N-[3-(dibutylamino)propyl], acrylates (PMN P-06-263, Chemical A; CAS No. 851545-09-0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

13. Add § 721.10193 to subpart E to read as follows:

§ 721.10193

1-Butanaminium, N-(3-aminopropyl)-N-butyl-N-(2-carboxyethyl)-, N-coco acyl derivs., inner salts.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1-butanaminium, N-(3-aminopropyl)-N-butyl-N-(2-carboxyethyl)-, N-coco acyl derivs., inner salts (PMN P-06-263, Chemical B; CAS No. 851545-17-0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

14. Add § 721.10194 to subpart E to read as follows:

§ 721.10194

Dialkylcocoamidoalkylpropionate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as dialkylcocoamidoalkylpropionate (PMN P-06-264) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

15. Add § 721.10195 to subpart E to read as follows:

§ 721.10195

Dialkylcornoilamidoalkylamine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as dialkylcornoilamidoalkylamine (PMN P-06-265) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

16. Add § 721.10196 to subpart E to read as follows:

§ 721.10196

Dialkylcornoilamidoacrylate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as dialkylcornoilamidoacrylate (PMN P-06-266, Chemical A) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

17. Add § 721.10197 to subpart E to read as follows:

§ 721.10197

Dialkycornoilamidoalkylbetaine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as dialkycornoilamidoalkylbetaine (PMN P-06-266, Chemical B) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

18. Add § 721.10198 to subpart E to read as follows:

§ 721.10198

Dialkylcornoilamidopropionate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as dialkylcornoilamidopropionate (PMN P-06-267) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and (c)(1).

(ii) [Reserved]

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

19. Add § 721.10199 to subpart E to read as follows:

§ 721.10199

Substituted aliphatic amine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted aliphatic amine (PMN P-06-702) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this rule do not apply to quantities of the PMN substance after it has been completely reacted (cured).

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63 (a)(1), (a)(2), (a)(3)(i), (a)(4), (a)(5), (a)(6), (b) (concentration set at 1.0 percent), and (c). Ansell NEOX style 9-912 gloves have been shown to satisfy the requirements of § 721.63(a)(3)(i) for up to 110 minutes. Respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 50. The following NIOSH-approved respirators meet the requirements for § 721.63(a)(4): Air purifying, tight-fitting full-face respirator equipped with the appropriate combination cartridges, cartridges should be tested and approved for the gas/vapor substance (i.e., organic vapor, acid gas, or substance-specific cartridge) and should include a particulate filter (N100 if oil aerosols are absent, R100, or P100); powered air-purifying respirator equipped with a tight-fitting facepiece (full-face) and the appropriate combination cartridges, cartridges should be tested and approved for the gas/vapor substance (i.e., organic vapor, acid gas, or substance-specific cartridges) and should include High Efficiency Particulate Air (HEPA) filters; supplied-air respirator operated in pressure demand or continuous flow mode and equipped with a tight-fitting face piece (full-face). As an alternative to the respiratory requirements listed here, a manufacturer, importer, or processor may choose to follow the new chemical exposure limit (NCEL) provisions listed in the Toxic Substances Control Act (TSCA) section 5(e) consent order for this substance. The NCEL is 0.14 mg/m³ as an 8-hour time-weighted average. Persons who wish to pursue NCELs as an alternative to the § 721.63 respirator requirements may request to do so under § 721.30. Persons whose § 721.30 requests to use the NCELs approach are approved by EPA will receive NCELs provisions comparable to those contained in the corresponding section 5(e) consent order.

(ii) Hazard communication program. Requirements as specified in § 721.72 (a), (b), (c), (d), (e) (concentration set at 1.0 percent), (f), (g)(1)(i), (g)(1)(ii), (g)(1)(iv), (g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(iv), (g)(2)(v), (g)(3)(i), (g)(3)(ii), (g)(4)(iii), and (g)(5).

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(r).

(iv) Release to water. Requirements as specified in § 721.90 (a)(1), (b)(1), and (c)(1).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (d), (e), (f), (g), (h), (i), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of § 721.1725(b)(1) apply to this section.

20. Add § 721.10200 to subpart E to read as follows:

§ 721.10200

Benzenacetonitrile, cyclohexylidene-alkyl substituted (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as benzenacetonitrile, cyclohexylidene-alkyl substituted (PMN P-09-75) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(s) (10,000 kg).

(ii) Release to water. Requirements as specified in § 721.90 (a)(4), (b)(4), and (c)(4) (N=123).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph.

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125 (a), (b), (c), (i), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitations or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.