Benzidine-Based Chemical Substances; Di-n-pentyl Phthalate (DnPP); and Alkanes, C12-13, Chloro; Significant New Use Rule, 77891-77911 [2014-29887]

Download as PDF Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations 77891 As used in this exclusion, ‘‘anti-personnel landmine’’ means any mine placed under, on, or near the ground or other surface area, or delivered by artillery, rocket, mortar, or similar means or dropped from an aircraft and which is designed to be detonated or exploded by the presence, proximity, or contact of a person; any device or material which is designed, constructed, or adapted to kill or injure and which functions unexpectedly when a person disturbs or approaches an apparently harmless object or performs an apparently safe act; any manually-emplaced munition or device designed to kill, injure, or damage and which is actuated by remote control or automatically after a lapse of time. Note 16: The radar systems described are controlled in USML Category XI(a)(3)(i) through (v). As used in this entry, the term ‘‘systems’’ includes equipment, devices, software, assemblies, modules, components, practices, processes, methods, approaches, schema, frameworks, and models. Note 17: This exclusion does not apply to the export of defense articles previously notified to Congress pursuant to § 123.15 or § 124.11 of this subchapter. For use of the Australian and UK exemptions for congressional notification, see § 126.16(o) and § 126.17(o). Rose E. Gottemoeller, Under Secretary, Arms Control and International Security, Department of State. [FR Doc. 2014–30232 Filed 12–24–14; 8:45 am] BILLING CODE 4710–25–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 9 and 721 [EPA–HQ–OPPT–2010–0573; FRL–9915–60] RIN 2070–AJ73 Benzidine-Based Chemical Substances; Di-n-pentyl Phthalate (DnPP); and Alkanes, C12-13, Chloro; Significant New Use Rule Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: Under the Toxic Substances Control Act (TSCA), EPA is promulgating a significant new use rule (SNUR) to add nine benzidine-based chemical substances to the existing SNUR on benzidine-based chemical substances. With respect to both the newly-added benzidine-based chemical substances and the previously-listed benzidine-based chemical substances, this rule makes inapplicable the exemption relating to persons that import or process substances as part of an article. EPA is also promulgating a SNUR for di-n-pentyl phthalate (DnPP) and a SNUR for alkanes, C12-13, chloro. These actions require persons who intend to manufacture (defined by statute to include import) or process these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing such manufacture or processing. The required notifications will provide EPA with the opportunity to evaluate activities associated with a significant new use and, if necessary based on the information available at that time, an opportunity to protect against potential unreasonable risks, if any, from that activity before it occurs. EPA is also making a technical amendment to the codified list of control numbers for approved information collection mstockstill on DSK4VPTVN1PROD with RULES SUMMARY: VerDate Sep<11>2014 18:49 Dec 24, 2014 Jkt 235001 activities so that it includes the control number assigned by the Office of Management and Budget (OMB) to the information collection activities contained in this rule. DATES: This final rule is effective February 27, 2015. ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPPT–2010–0573, is available at https://www.regulations.gov or at the Office of Pollution Prevention and Toxics Docket (OPPT Docket), EPA Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OPPT Docket is (202) 566–0280. Please review the visitor instructions and additional information about the docket available at https:// www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: For technical information contact: Sara Kemme, National Program Chemicals Division (7404T), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: (202) 566–0511; email address: kemme.sara@epa.gov. For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554– 1404; email address: TSCA-Hotline@ epa.gov. SUPPLEMENTARY INFORMATION: I. Executive Summary A. Does this action apply to me? These three different SNURs may apply to different entities. 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. 1. Benzidine-based chemical substances. You may be potentially affected by this action if you manufacture (defined by statute to PO 00000 Frm 00059 Fmt 4700 Sfmt 4700 include import), or process, including as part of an article, any of the benzidinebased chemical substances listed in Tables 1 and 2 of the regulatory text in this document. Potentially affected entities may include, but are not limited to: • Manufacturers or processors of one or more of the subject chemical substances. • Entities which plan to use the listed chemical substances in conjunction with apparel and other finished products made from fabrics, leather, and similar materials. • Entities which plan to use the listed chemical substances in conjunction with paper and allied products. • Manufacturers or processors of the subject chemical substances in printing inks. These entities may include those described by the NAICS codes 325— chemical manufacturing, 31—textile manufacturers, 316—leather and allied products manufacturers, 322—paper manufacturers, 4243 apparel, piece goods, and notions wholesalers, or 443—clothing and accessories stores. 2. DnPP. You may be potentially affected by this action if you manufacture (defined by statute to include import), or process DnPP. Potentially affected entities may include, but are not limited to: Chemical industry—plastic material and resins (NAICS code 325211). 3. Alkanes, C12-13, chloro (CAS No. 71011–12–6). You may be potentially affected by this action if you manufacture or process the following short-chained chlorinated paraffin (SCCP): Alkanes, C12-13, chloro (CAS No. 71011–12–6). Potentially affected entities may include, but are not limited to: Manufacturers of SCCPs (NAICS codes 325 and 325998), chemical manufacturing; including miscellaneous chemical product and preparation manufacturing; and processors of SCCPs (NAICS codes 324 and 324191), petroleum lubricating oil and grease manufacturing. This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Persons who import any chemical substance governed by a final SNUR are subject to the TSCA section 13 (15 U.S.C. 2612) import E:\FR\FM\29DER1.SGM 29DER1 77892 Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations certification requirements and the corresponding regulations at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. Those persons must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA, including any SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of a proposed or final SNUR are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see 40 CFR 721.20) and must comply with the export notification requirements in 40 CFR part 707, subpart D. 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 for SNUR-related obligations and with respect to benzidine-based chemical substances, the applicability provisions in Unit V. 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. 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 significant new use notice (SNUN) to EPA at least 90 days before they manufacture or process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)). As described in Unit V., the general SNUR provisions are found at 40 CFR part 721, subpart A. C. What action is the agency taking? In a Federal Register proposed rule published on March 28, 2012 (77 FR 18752) (FRL–8865–2), EPA proposed three chemical specific SNURs being addressed in this final rule (Ref. 1). EPA’s response to public comments received on the proposed rule appears in Unit X. Please consult the March 28, 2012 Federal Register proposed rule (Ref. 1) for further background information for this final rule. These final SNURs will require persons to notify EPA at least 90 days before commencing the manufacture (including import) or processing of: • The nine benzidine-based chemical substances identified in Table A of Unit II., which are being added to 40 CFR 721.1660 with a designation of any use as a significant new use; • DnPP with a designation of any use other than as a chemical standard for analytical experiments as a significant new use; and • Alkanes, C12–13, chloro (CAS No. 71011–12–6) with a designation of any use as a significant new use. In addition, this final rule amends the SNUR at 40 CFR 721.1660 to make inapplicable the exemption at 40 CFR 721.45(f) for persons that import or process benzidine-based chemical substances as part of an article. For the benzidine-based chemical substances, the elimination of the article exemption at 40 CFR 721.45(f) will require persons to notify EPA at least 90 days before commencing processing or importing as part of an article any of the newly-added benzidine-based chemical substances, as well as those already covered (61 FR 52287, October 7, 1996 (FRL–5396–6), codified at 40 CFR 721.1660) (Ref. 2). D. Why is the agency taking this action? These SNURs are necessary to ensure that EPA receives timely advance notice of any future manufacturing and processing of these chemical substances for new uses that may produce changes in human and environmental exposures. The rationale and objectives for this SNUR are explained in Unit III. E. What are the estimated incremental impacts of this action? EPA has evaluated the potential costs of establishing SNUR reporting requirements for potential manufacturers and processors of the chemical substances included in this final rule. This analysis, which is available in the docket, is discussed in Unit IX., and is briefly summarized here. In the event that a SNUN is submitted, costs are estimated to be less than $8,700 per SNUN submission for large business submitters and $6,300 for small business submitters. These estimates include the cost to prepare and submit the SNUN and the payment of a user fee. In addition, for persons exporting a substance that is the subject of a SNUR, a one-time notice must be provided for the first export or intended export to a particular country, which is estimated to cost less than $100 on average per notification. The rule may also affect firms that import or process articles that may contain benzidinebased chemicals, because, while not required by the SNUR, these parties may take additional steps to determine whether benzidine-based chemicals are part of the articles that they are considering to import or process. Since EPA is unable to predict whether anyone might engage in future activities that would require reporting, potential total costs were not estimated. II. Overview of the Chemical Substances Subject to This Rule The SNURs in this final rule involve certain benzidine-based chemical substances in the existing SNUR at 40 CFR 721.1660 (Ref. 1), the nine benzidine-based chemical substances listed in Table A of this unit, DnPP (CAS No. 131–18–0), and alkanes, C1213, chloro (CAS No. 71011–12–6). TABLE A—NEWLY ADDED BENZIDINE-BASED CHEMICAL SUBSTANCES C.I. name C.I. No. Chemical name 117–33–9 ........................ Not available .................. Not available .................. 65150–87–0 .................... mstockstill on DSK4VPTVN1PROD with RULES CAS or accession No. Not available .................. Not available .................. 68214–82–4 .................... Direct Navy BH .............. Not available .................. 72379–45–4 .................... Not available .................. Not available .................. 1,3-Naphthalenedisulfonic acid, 7-hydroxy-8-[2-[4’-[2-(4hydroxyphenyl)diazenyl][1,1’- biphenyl]-4-yl]diazenyl]-. 1,3,6-Naphthalenetrisulfonic acid, 8-hydroxy-7-[2-[4’-[2-(2-hydroxy-1-naphthalenyl)diazenyl][1,1’-biphenyl]-4-yl]diazenyl]-, lithium salt (1:3). 2,7-Naphthalenedisulfonic acid, 5-amino-3-[2-[4’-[2-(7-amino-1hydroxy-3-sulfo-2naphthalenyl)diazenyl][1,1’-biphenyl]-4yl]diazenyl]-4-hydroxy-, sodium salt (1:2). 2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-3-[2-[4’-[2[2-hydroxy-4-[(2- methylphenyl)amino] phenyl]diazenyl][1,1’biphenyl]-4-yl]diazenyl]-6-(2- phenyldiazenyl)-. VerDate Sep<11>2014 18:05 Dec 24, 2014 Jkt 235001 PO 00000 Frm 00060 Fmt 4700 Sfmt 4700 E:\FR\FM\29DER1.SGM 29DER1 Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations 77893 TABLE A—NEWLY ADDED BENZIDINE-BASED CHEMICAL SUBSTANCES—Continued CAS or accession No. C.I. name C.I. No. Chemical name Accession No. 21808 ..... CAS No. CBI (NA) CBI ................................. CBI ................................. Accession No. 24921 ..... CAS No. CBI (NA) CBI ................................. CBI ................................. Accession No. 26256 ..... CAS No. CBI (NA) CBI ................................. CBI ................................. Accession No. 26267 ..... CAS No. CBI (NA) CBI ................................. CBI ................................. Accession No. 26701 ..... CAS No. CBI (NA) CBI ................................. CBI ................................. 2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy [[[(substituted phenylamino)] substituted phenylazo] diphenyl]azo-, phenylazo-, disodium salt. (generic name). 4-(Substituted naphthalenyl)azo diphenylyl azo-substituted carbopolycycle azo benzenesulfonic acid, sodium salt. (generic name). 4-(Substituted phenyl)azo biphenylyl azo-substituted carbopolycycloazo benzenesulfonic acid, sodium salt. (generic name) 4-(Substituted phenyl)azo biphenylyl azo-substituted carbopolycycle azo benzenesulfonic acid, sodium salt. (generic name). Phenylazoaminohydroxynaphthalenylazobiphenylazo substituted benzene sodium sulfonate. (generic name). CAS = Chemical Abstracts Services. CBI = Confidential Business Information. CBI (NA) = Confidential Business Information (Not Available). C.I. = Chemical Index. III. Rationale and Objectives mstockstill on DSK4VPTVN1PROD with RULES A. Rationale Consistent with EPA’s past practice for issuing SNURs under TSCA section 5(a)(2), EPA’s decision to issue a SNUR for a particular chemical use need not be based on an extensive evaluation of the hazard, exposure, or potential risk associated with that use. Rather, the Agency’s action is based on EPA’s determination that if the use begins or resumes, it may present a risk that EPA should evaluate under TSCA before the manufacturing or processing for that use begins. Since the new use does not currently exist, deferring a detailed consideration of potential risks or hazards related to that use is an effective use of resources. If a person decides to begin manufacturing or processing the chemical for the use, the notice to EPA allows EPA to evaluate the use according to the specific parameters and circumstances surrounding that intended use. 1. Benzidine-based chemical substances. As described in the proposal (Ref. 1), EPA is concerned about potential carcinogenic effects on workers and consumers from the manufacture, processing, or use of these substances. Consumers exposed via dermal exposure to consumer products containing the benzidine-based chemical substances are a particular concern because enzymes present in the human body and in bacteria on the skin aid in the reduction of these chemical substances to the benzidine unit, an established human carcinogen (Ref. 3). The main consumer products that could result in dermal exposure if containing these chemical substances include textiles and leather products because they are in prolonged contact with human skin. VerDate Sep<11>2014 18:05 Dec 24, 2014 Jkt 235001 During the review of information on benzidine-based chemical substances, EPA determined that the newly identified chemical substances that are being added to 40 CFR 721.1660 by this final rule present the same concerns (Ref. 4) as those of the benzidine-based chemical substances already listed in the rule ((Ref. 2)), codified at 40 CFR 721.1660). EPA does not believe there is any current use of these nine benzidinebased chemical substances within or outside the United States. This conclusion is based on a review of EPA’s own Inventory Update Reporting (IUR) data, and more recent Chemical Data Reporting (CDR) data as well as other sources including the Colour Index International, published by the Society of Dyers and Colourists and American Association of Textile Chemists and Colorists; IHS Chemical Economics Handbook, Dyes; and ICIS Directory of World Chemical Producers. In addition, as discussed earlier, although some of the benzidine-based chemical substances subject to the 1996 SNUR may be manufactured or processed outside the United States, an analysis of the benzidine-based chemical substances market (Ref. 4) revealed no information indicating import of articles containing benzidinebased chemical substances for nonexcluded purposes. Although it appears there is no ongoing domestic manufacture of the nine newly added benzidine-based chemical substances, or import for a non-excluded use of articles containing any benzidine-based chemical substances, the manufacture (including import) or processing of the nine newly added benzidine-based chemical substances and the import or processing of articles containing any benzidinebased chemical substances may begin at any time, without prior notice to EPA. PO 00000 Frm 00061 Fmt 4700 Sfmt 4700 Thus, EPA is concerned that commencement of the manufacture (including import) or processing for any new uses, including resumption of past uses, of benzidine-based chemical substances could significantly increase the magnitude and duration of exposure to humans over that which would otherwise exist currently. EPA is concerned that such an increase should not occur without an opportunity for the Agency to evaluate activities associated with a significant new use and an opportunity to protect against potential unreasonable risks, if any, from exposure to the chemical substance. Accordingly, EPA is finalizing a SNUR for the nine benzidine-based chemical substances by adding them to those currently listed at 40 CFR 721.1660, and making inapplicable the article exemption at 40 CFR 721.45(f) for those chemical substances newly added in this rulemaking as well as for those already listed at 40 CFR 721.1660. This final rule will require persons who intend to manufacture (including import) or process any of the benzidinebased chemical substances for a nonexcluded use, including importing or processing any listed benzidine-based chemical substance for a non-excluded use as part of an article, to submit a SNUN. 2. DnPP. As described in the proposal (Ref. 1), EPA has concerns regarding potential adverse human health and environmental effects that may be caused by DnPP. EPA has direct information from animal studies that DnPP specifically can elicit developmental/reproductive effects that are relevant to human health and also indicate potential effects in wildlife. EPA also is concerned that due to its general structure and categorization as a phthalate that DnPP may elicit adverse environmental effects similar to those E:\FR\FM\29DER1.SGM 29DER1 mstockstill on DSK4VPTVN1PROD with RULES 77894 Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations described for other phthalates. EPA is concerned that any manufacturing (including import) or processing of DnPP, beyond that for its limited ongoing use as a chemical standard for laboratory use, could significantly increase the magnitude and duration of exposure to humans over that which would otherwise exist currently. EPA is concerned that such an increase should not occur without an opportunity to evaluate activities associated with a significant new use and an opportunity to protect against potential unreasonable risks, if any, from exposure to the chemical substance. Accordingly, EPA is finalizing a SNUR for DnPP that would designate, as a significant new use, any use of the chemical substance other than use as a chemical standard for analytical experiments. A person who intends to manufacture or process DnPP for use other than use as a chemical standard for analytical experiments would be required to submit a SNUN. 3. Alkanes, C12-13, chloro (CAS No. 71011–12–6). As described in the proposal (Ref. 1), EPA has a primary concern regarding adverse environmental effects that may be caused by alkanes, C12-13, chloro (CAS No. 71011–12–6), one type of SCCP. For example, alkanes, C12-13, chloro, have been shown to be highly toxic to aquatic invertebrates following acute and chronic exposures and to fish following chronic exposures. EPA also has concerns about the persistence and bioaccumulation potential of SCCPs, including alkanes, C12-13, chloro, since these substances have been measured in a variety of biota (i.e., freshwater aquatic species, marine mammals, and avian and terrestrial wildlife) and have also been measured in human breast milk from Canada and the United Kingdom. The mechanisms or pathways by which SCCPs, including alkanes, C12-13, chloro (CAS No. 71011–12–6), move into and through the environment and humans are not fully understood, but are likely to include releases from manufacturing of the chemicals, manufacturing of products like plastics or textiles, aging and wear of products like sofas and electronics, and releases at the end of product life (e.g., disposal, recycling). EPA believes that all manufacture and processing into the United States of alkanes, C12-13, chloro (CAS No. 71011–12–6) has ceased. Given that EPA has no evidence to suggest that there is any manufacture or processing of this chemical substance in the United States, and taking into consideration the negative commercial and regulatory environment associated with this VerDate Sep<11>2014 18:05 Dec 24, 2014 Jkt 235001 chemical internationally (including the European Union (EU) and Canadian ban on marketing) and use of the alkanes, C12-13, chloro (CAS No. 71011–12–6) domestically, EPA does not expect to find such activity. However, EPA is concerned that commencement of the manufacture or processing for any new uses, including resumption of past uses, could significantly increase the magnitude and duration of exposure to humans over that which would otherwise exist. EPA is concerned that such an increase should not occur without an opportunity to evaluate activities associated with a significant new use and an opportunity to protect against potential unreasonable risks, if any, from exposure to the chemical substance. Accordingly, EPA is finalizing a SNUR for alkanes, C12-13, chloro (CAS No. 71011–12–6) that designates as a significant new use any use of the chemical substance. This SNUR requires a person who intends to manufacture or process alkanes, C12-13, chloro (CAS No. 71011–12–6) for any use to submit a SNUN. B. Objectives Based on the considerations described in the proposal (Ref. 1) and in the response to public comments, EPA expects to achieve the following objectives with regard to the significant new uses that are designated in this final rule: 1. EPA will receive notice of any person’s intent to manufacture or process the specified chemicals for the described significant new uses before that activity begins; 2. EPA will have an opportunity to review and evaluate data submitted in the SNUN before the notice submitter begins manufacturing or processing of the specified chemicals for the described significant new use; 3. EPA will be able to regulate prospective uses of the specified chemicals before the described significant new uses occur, provided that regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6 or 7; and 4. EPA would receive a notice alerting the Agency to a reversal of an industry trend toward deselecting for a chemical. IV. 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 PO 00000 Frm 00062 Fmt 4700 Sfmt 4700 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 authorizes EPA to consider any other relevant factors. To determine what constitutes a significant new use of the benzidinebased chemical substances, DnPP, and alkanes, C12-13, chloro (CAS No. 71011–12–6) subject to this rule, EPA considered relevant information about the toxicity of these substances, likely human exposures and environmental releases associated with possible uses, and the four factors listed in section 5(a)(2) of TSCA. EPA has determined that the manufacture or processing, of any of the benzidine-based chemical substances subject to the 1996 SNUR or being newly added to 40 CFR 721.1660 by this final rule, except for ongoing uses specified in 40 CFR 721.1660(a)(2)(i) of the regulatory text in this document, is a significant new use. EPA has also determined that the manufacture or processing of DnPP for any use other than use as a chemical standard for analytical experiments is a significant new use, and the manufacture or processing of alkanes, C12-13, chloro (CAS No. 71011–12–6) for any use is a significant new use. V. Applicability of the General Provisions General provisions for SNURs appear under 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 final rule. Provisions relating to user fees appear at 40 CFR part 700. According to 40 CFR 721.1(c), persons subject to SNURs must comply with the same notice requirements and EPA regulatory procedures as submitters of Premanufacture Notices (PMNs) under TSCA section 5(a)(1)(A). In particular, these requirements include the information submissions 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 E:\FR\FM\29DER1.SGM 29DER1 Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES on 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. However, 40 CFR 721.45(f) (which generally exempts persons importing or processing a substance as part of an article) will not apply to the benzidinebased chemical substances listed at 40 CFR 721.1660 and those added by this final rule. Therefore, a person who imports or processes as part of an article a benzidine-based chemical substance that is covered by this rule would not be exempt from submitting a SNUN. Persons who export or 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, subpart D. Persons who import a chemical substance identified in a final SNUR are subject to the TSCA section 13 import certification requirements, codified at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. Those persons must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA, including any SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. VI. Applicability of the Final Rule to Uses Occurring Before the Effective Date of the Final Rule As discussed in the Federal Register of April 24, 1990 (55 FR 17376) (FRL– 3658–5) (Ref. 5), EPA has decided that the intent of section 5(a)(1)(B) of TSCA is best served by designating a use as a significant new use as of the date of publication of the proposed rule rather than as of the effective date of the final rule. If uses begun after publication of the proposed rule 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 proposed significant new use before the rule became final, and then argue that the use was ongoing as of the effective date of the final rule. Thus, persons who begin the commercial manufacture or processing of a covered substance as a significant new use have to cease any such activity as of the effective date of the rule if and when finalized. 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. If a person were to meet the conditions of advance compliance under 40 CFR VerDate Sep<11>2014 18:05 Dec 24, 2014 Jkt 235001 721.45(h), that person would be considered to have met the requirements of the final SNUR for those activities. VII. Test Data and Other Information EPA recognizes that TSCA section 5 does not require developing any particular test data before submission of a SNUN. There are two exceptions: 1. Development of test data is required where the chemical substance subject to the SNUR is also subject to a test rule under TSCA section 4 (see TSCA section 5(b)(1)) and 2. Development of test data may be necessary where the chemical substance has been listed under TSCA section 5(b)(4) (see TSCA section 5(b)(2)). In the absence of a section 4 test rule or a section 5(b)(4) listing covering the chemical substance, 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 (15 U.S.C. 2604(d); 40 CFR 721.25, and 40 CFR 720.50). However, as a general matter, EPA recommends that SNUN submitters include data that would permit a reasoned evaluation of risks posed by the chemical substance during its manufacture, import, processing, use, distribution in commerce, or disposal. EPA encourages persons to consult with the Agency before submitting a SNUN. As part of this optional pre-notice consultation, EPA would discuss specific data it believes may be useful in evaluating a significant new use. SNUNs submitted for significant new uses without any test data may increase the likelihood that EPA would take action under TSCA section 5(e) to prohibit or limit activities associated with this chemical. SNUN submitters should be aware that EPA will be better able to evaluate SNUNs that provide detailed information on: • Human exposure and environmental releases that may result from the significant new uses of the chemical substance. • Potential benefits of the chemical substance. • Information on risks posed by the chemical substances compared to risks posed by potential substitutes. VIII. SNUN Submissions According to 40 CFR 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 40 CFR 720.50. SNUNs must be on EPA Form No. 7710–25, generated using e- PO 00000 Frm 00063 Fmt 4700 Sfmt 4700 77895 PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 721.25 and 720.40. E–PMN software is available electronically at https:// www.epa.gov/opptintr/newchems. IX. Economic Analysis A. SNUNs EPA has evaluated the potential costs of establishing SNUR reporting requirements for potential manufacturers and processors of these chemicals and for articles containing any of the benzidine-based chemical substances included in the 1996 SNUR and those newly added by this final rule when imported or processed as part of an article. These economic analyses, which are briefly summarized here, are available in the docket for this rule. EPA added additional information to the economic analysis for the benzidinebased chemical substances in response to public comments. The costs of submission of a SNUN would be incurred when a company decides to pursue a significant new use of one of these chemicals. In the event that a SNUN is submitted, costs are estimated at approximately $8,600 per SNUN submission, and include the cost for preparing and submitting the SNUN, recordkeeping, and the payment of a user fee. Businesses that submit a SNUN are either subject to a $2,500 user fee required by 40 CFR 700.45(b)(2)(iii), or, if they are a small business with annual sales of less than $40 million when combined with those of the parent company (if any), a reduced user fee of $100 (40 CFR 700.45(b)(1)). In its evaluation of this final rule, EPA also considered the potential costs a company might incur by avoiding or delaying the significant new use in the future, but these costs have not been quantified. B. Export Notification EPA regulations under TSCA section 12(b) (15 U.S.C. 2611(b)) at 40 CFR part 707, subpart D require that, for chemicals subject to a proposed or final SNUR, a company notify EPA of the first export or intended export to a particular country of an affected chemical substance. EPA estimated that the onetime cost of preparing and submitting an export notification to be $84. The total costs of export notification would vary per chemical, depending on the number of required notifications (i.e., number of countries to which the chemical is exported). E:\FR\FM\29DER1.SGM 29DER1 mstockstill on DSK4VPTVN1PROD with RULES 77896 Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations C. Import or Processing Benzidine-Based Chemical Substances as Part of an Article In the case of the benzidine-based chemical substances, this rule makes inapplicable the exemption relating to persons that import or process substances as part of an article. In the proposed rule EPA preliminarily determined, based on the Agency’s market research, that there was no ongoing manufacturing (including import) or processing of these chemical substances for significant new uses as part of articles or otherwise. For the nine newly-added benzidine-based chemical substances, EPA found no evidence of manufacture either domestically or abroad, and thus also no evidence of importation or processing of these chemical substances as part of articles (Ref. 1). For the majority of the 24 previously listed benzidine-based chemical substances, EPA found no evidence of manufacture, either domestically or abroad. While EPA found that some of the previously listed benzidine-based chemical substances were being manufactured domestically for discrete uses that are not subject to this SNUR, EPA found no evidence that these chemical substances were being imported or processed as part of articles (Ref. 1). EPA received no public comments indicating otherwise. Based on the global trend away from using these chemical substances, the fact that they are regulated in numerous jurisdictions, and the absence of public comments indicating their ongoing use for significant new uses, EPA is finalizing its determination that these benzidine-based chemical substances are not being manufactured (including import) or processed for a significant new use as part of articles or otherwise. However, the rule may affect firms that plan to import or process types of articles that benzidine-based chemicals are potentially a part of. Some firms have an understanding of the contents of the articles they import or process. However, EPA acknowledges that importers and processors of articles may have varying levels of knowledge about the chemical content of the articles that they import or process. These parties may need to become familiar with the requirements of the rule. And, while not required by the SNUR, these parties may take additional steps to determine whether benzidine-based chemicals are part of the articles that they are considering to import or process. This determination may involve activities such as gathering information from suppliers along the supply chain, and/ or testing samples of the article itself. VerDate Sep<11>2014 18:05 Dec 24, 2014 Jkt 235001 Costs vary across the activities chosen and the extent of familiarity a firm has regarding the articles it imports or processes. Cost ranges are presented in the ‘‘Economic Analysis of the Final Significant New Use Rule for Nine Benzidine Based Chemical Substances’’ (Ref. 4). Given existing regulatory limitations on certain benzidine-based substances both internationally and within the U.S., industry-wide processes, resources that support companies in understanding and managing their supply chains, and evidence showing minimal worldwide availability of the dyes regulated under the SNUR, EPA believes that article importers that choose to investigate their products would incur costs at the lower end of the ranges presented in the Economic Analysis as a result of this rule. For those companies choosing to undertake actions to assess the composition of the articles they import or process, EPA expects that in all likelihood, these importers and processors would take actions that are commensurate with the company’s perceived likelihood that a chemical substance might be a part of an article they intend to import into the United States and the resources it has available. X. Response to Public Comment The Agency reviewed and considered all comments received related to the proposed rule. Copies of all non-CBI comments are available in the docket for this action. A discussion of the major comments germane to the rulemaking and the Agency’s responses follow A. Legal Authority To Make Inapplicable the Exemption for Persons Who Import or Process Chemical Substances as Part of Articles One commenter suggests that if chemical substances are not exempted from the SNUR at the point they are incorporated into articles, then EPA should consider whether it is inappropriately regulating ‘‘articles under the chemical management authorities of TSCA,’’ (emphasis original) inconsistent with Congressional intent in enacting TSCA. The commenter argues further that the regulation of articles is not the primary purpose of TSCA and that such regulation should be addressed by other agencies operating under other statutes such as the Occupational Safety and Health Act of 1970 and the Consumer Product Safety Act of 1972. Another comment raises similar issues. EPA responded that the SNUR for benzidine-based chemical substances does not regulate articles per se, but rather persons who manufacture or PO 00000 Frm 00064 Fmt 4700 Sfmt 4700 process these chemical substances, including when the chemical substances are present as part of articles. TSCA clearly contemplates such regulation, as certain articles are expressly removed from TSCA jurisdiction at TSCA section 3(2). Indeed, EPA has a long history of regulating chemical substances as part of articles under TSCA. For polychlorinated biphenyls (the only chemical substance specifically addressed in TSCA as it was originally enacted), section 6(e) of TSCA provides authority for EPA to promulgate rules related to polychlorinated biphenyls in articles, such as electrical transformers. Other examples include the regulation of asbestos (40 CFR 763.160) and regulation of manufacturers of consumer products intended for use by children who also manufacture (including import) lead (40 CFR 716.21(a)(8)). TSCA section 5 provides EPA with authority to regulate chemical substances, including chemical substances that are part of articles.1 Under this section, EPA has previously regulated persons that import or process chemical substances as part of articles, including articles containing erionite fiber (40 CFR 721.2800) and mercury (40 CFR 721.10068). This is in keeping with the statutory language authorizing the Administrator to designate a ‘‘use of a chemical substance as a significant new use’’ and to require SNUN submissions from persons that intend to manufacture or process a chemical for a designated significant new use. The commenter is incorrect in suggesting that regulation to address chemical substances in articles is beyond the originally intended functions of TSCA. When TSCA was being drafted, legislators characterized it as ‘‘a mechanism to protect against dangerous chemical materials contained in consumer and industrial products’’; by way of example, the drafters cited ‘‘the presence of mercury in such consumer products as paint, home thermometers, sponges, and a variety of other products.’’ S. Rep. No. 94–698, 94th Cong., 2d Sess., 5–6 (1976). Furthermore, this application of the regulations (to persons who manufacture or process the chemical substance as part of articles) is consistent with legislators’ observation, in drafting this section, that: 1 It should be noted that there is no general SNUN exemption for uses of a chemical substances involving articles and EPA routinely defines significant new uses to include use in articles. The exemption at 40 CFR 721.45(f) relates to a different question: whether the SNUR applies to persons who process or import a chemical substance by processing or importing the substance as part of an article. E:\FR\FM\29DER1.SGM 29DER1 Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES [T]he most desirable time to determine the health and environmental effects of a substance, and to take action to protect against any potential adverse effects, occurs before commercial production begins. Not only is human and environmental harm avoided or alleviated, but the cost of any regulatory action in terms of loss of jobs and capital investment is minimized. H.R. Rep. 94–1679, 94th Cong., 2d Sess., 65 (1976). When a chemical substance is domestically produced, the substance generally exists in non-article form at the earliest point of commercial production in the United States. When a chemical substance is imported, however, it may in many instances already be part of an article, even at the earliest point that it enters U.S. commerce. By this action, EPA makes importers of specific chemical substances subject to the same SNUN requirements as domestic manufacturers of the same substance, irrespective of whether such import is as part of an article. This action is consistent with the plain text of TSCA 5(a)(1)(B) (generally, ‘‘no person may . . . manufacture or process’’ for a significant new use without proper notice) and with one of the intended goals of TSCA: to hold importers to ‘‘the same responsibilities and obligations as domestic manufacturers,’’ H.R. Rep. No. 94–1341, 94th Cong. 2d. Sess., 12–13 (1976). This action is also consistent with EPA’s identified concerns regarding benzidine-based chemical substances when they are present as part of an article (See Ref. 1, pg. 18756). Moreover, when originally promulgating the presumptive SNUN submission exemption for persons who import or process chemical substances as part of articles (40 CFR 721.45(f)), EPA did so based on a belief that people and the environment would generally not be exposed to chemical substances in articles. To address those cases where the assumption may not be valid, EPA specifically noted that, ‘‘EPA may decide to eliminate one or all of these . . . exemptions [including the exemption for importers and processors of chemicals as part of articles] if EPA decides that review under a SNUR is warranted for specific substances . . . in articles.’’ (Ref. 6). Thus, while EPA clearly has statutory authority to subject importers and processors of chemical substances in articles to SNUN requirements, they are presumptively excluded by rule at 40 CFR 721.45(f), based on an assumption that people and the environment will generally not be exposed to substances in articles. (Ref. 6). To the extent that potential exposure to a chemical substance as part of an VerDate Sep<11>2014 18:05 Dec 24, 2014 Jkt 235001 article contributes to the EPA’s determination pursuant to the factors in section 5(a)(2) of TSCA that the new use is significant (i.e., EPA has reason to anticipate that use as part of an article would raise important questions, related to potential exposure, that EPA should have an opportunity to review before such use could resume or occur), it is appropriate to make the exemption inapplicable. EPA notes that one of the commenters appears to have conflated the Federal Register notice establishing the article importers’ and article processors’ exemption from PMN requirements (Ref. 7), discussing 40 CFR 720.22(b)) with another Federal Register notice establishing the comparable exemptions from SNUR requirements (Ref. 6), discussing 40 CFR 721.45(f)). While EPA recognizes that parts 720 and 721 deal with many similar issues, they are also distinct from each other in important respects. It is significant that in the 1984 action, whereby EPA established the article importers’ and article processors’ exemption for SNURs, it did not simply mirror the 1983 rationale for the comparable exemption from PMN obligations. For PMNs, EPA noted the difficulties associated with determining the identity and Inventory status of each chemical substance in imported articles (e.g., automobiles) (Ref. 7). But for SNURs, EPA placed special emphasis on its assumption that import of the substance as part of an article would not affect human or environmental exposure to the substance, while taking particular care to reserve ongoing discretion to revise its assumption as warranted in the case of specific substances. EPA had reason to differentiate between the two rationales. SNURs are for specified chemical substances for which EPA has identified exposure-based concerns for the defined significant new use (per the TSCA section 5(a)(2) factors). By contrast, PMNs are required for all new chemicals (i.e., those not on the TSCA inventory), not a specified set of chemicals. Finally, there is no basis for the commenter’s suggestion that EPA should decline to review significant new uses, in deference to the Occupational Safety and Health Administration (OSHA) or the Consumer Product Safety Commission (CPSC), simply because a significant new use notice would be submitted by a person who imports or processes the chemical substance as part of an article. Neither the Occupational Safety and Health Act of 1970 nor the Consumer Product Safety Act of 1972 contains a comparable mechanism to ensure PO 00000 Frm 00065 Fmt 4700 Sfmt 4700 77897 advance notice and opportunity to review significant new uses of chemical substances, as part of articles or otherwise. B. Development of a Separate Policy Framework for Making Inapplicable the Exemption for Persons Who Import or Process Chemical Substances as Part of Articles 1. Comment. Some commenters suggest that before finalizing a rulemaking to make the ‘‘articles exemption’’ inapplicable to the benzidine-based chemical substances, the EPA should complete a separate public comment process to develop a general ‘‘policy framework for the issuance of article SNURs.’’ Commenters suggest that this policy framework should include science based criteria, feasibility criteria, costs, and other factors. One comment suggests that, in formulating the ‘‘policy framework’’ or criteria for making the exemption for importers and processors of chemical substances as part of articles inapplicable, EPA should address the following questions: • Can the risk posed by the chemical of concern be addressed through the standard regulation? • Why is the standard approach for SNURs that exempts articles not sufficient? • What conditions make direct regulation of articles necessary? • What gaps in health and environmental protection are likely to occur if a SNUR only regulates chemicals and mixtures? Response. The comments conflate two separate issues: The determination of a significant new use under TSCA section 5(a)(2), and the decision to make the regulatory exemption at 40 CFR 721.45(f) inapplicable. (40 CFR 721.45(f) provides that persons who import or process a chemical substance as part of an article are not subject to the notification requirements at 40 CFR 721.25; this exemption is referred to as the ‘‘articles exemption’’ by some commenters). EPA first makes a determination on whether a use of a chemical substance is a significant new use considering the factors listed in TSCA section 5(a)(2). Once that determination is made, EPA separately determines whether it would be appropriate to revoke the regulatory exemption at 40 CFR 721.45(f) for persons who import or process a chemical substance as part of an article. EPA notes that there may be a variety of cases in which it may be appropriate for EPA to include persons who import or process the chemical substance as E:\FR\FM\29DER1.SGM 29DER1 mstockstill on DSK4VPTVN1PROD with RULES 77898 Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations part of an article among the persons subject to SNUN submission obligations. Knowledge regarding chemical exposures from articles has evolved since the Agency established the exemption at 40 CFR 721.45(f) in 1984, and there has been a steady increase in international trade of chemicals in articles. Accumulated data illustrate that SNURs (and section 5(e) consent orders) that include the exemption for persons who import or process a chemical substance as part of an article are sometimes insufficient to appropriately flag significant new exposures from downstream uses. For example, there have been instances in which a section 5(e) consent order for a new chemical substance was issued, prohibiting the release of the chemical substance to water, and yet the chemical substance at issue was later found in the environment and biota. The presence of the chemical substance in the environment and in biota then appears to be associated with the use of the substance in articles (Ref. 8). There are also documented exposures (and resulting toxicity) of children to lead and cadmium and their compounds from a variety of articles, such as toys (Ref. 9), and exposures to other heavy metals from articles, as measured in indoor air and house dust samples, which are direct routes of exposure accounting for children’s levels and toxicity (Ref. 10). Other welldocumented examples are the presence of brominated flame retardants (e.g., polybrominated diphenyl ethers and brominated phthalates and benzoates) in samplings of articles, indoor air, people, and house dust. The low exchange rate of indoor air and house dust to sources outside the home support the flame retardant release from articles postulate. Likewise, other semi-sealed environments, such as automobiles, have demonstrated migration of flame retardants from treated articles to interior surfaces and indoor air, as no other source was possible. In addition, high flame retardant levels have been observed in biota raised in proximity to articles and living near article recyling sites. Further, observed flame retardant levels in biota and in the environment at locations remote from manufacturing sites suggest transport of these nonvolatile chemical substances on associated particulate matter from distributed treated articles, which strongly suggest release from articles as one potential source (Ref. 11–15). The information discussed in this unit—the well-documented exposures (and resulting toxicity) of children to lead, cadmium, and other metals from a VerDate Sep<11>2014 18:05 Dec 24, 2014 Jkt 235001 variety of articles; the data on other chemicals used in articles; and the presence in the environment and biota of certain brominated flame retardants (e.g., polybrominated diphenyl ethers and brominated phthalates and benzoates)—all illustrate that there can be exposure to the chemicals associated with their presence in articles (Refs. 9– 15). The scope of the suggested criteria (which the commenters suggest EPA should now develop to govern its exercise of its authority to make the exemption at 40 CFR 721.45(f) inapplicable) is incommensurate with the level of analysis supporting the original development of the exemption. EPA notes that TSCA section 5(a)(1) establishes a general prohibition on manufacturing or processing a chemical substance for a significant new use without prior notice to EPA. 40 CFR 721.45(f) establishes an exemption from this prohibition, but it is based on a fairly minimal rationale: ‘‘EPA believes people and the environment will generally not be exposed to substances in articles.’’ (Ref. 6). EPA counterbalanced its reliance on this generalized assumption (about all chemicals that exist as part of articles) with a broad reservation of case-by-case discretion to make the exemption inapplicable as ‘‘warranted for specific substances.’’ (Ref. 6). EPA does not think that development of a ‘‘policy framework’’ is necessary before reaching the conclusion, with respect to benzidine-based chemical substances, that persons who import or process these substances as part of articles should be subject to the notification provisions of 40 CFR 721.25. Dermal exposure can occur from the leaching of the benzidine-based chemical substances by sweat in contact with the dyed textiles (Ref. 1)). In addition, data indicate that exposure to other chemicals in materials such as textiles and foam can result from the dust that is generated from abrasion and/or degradation of the materials (Ref. 16). EPA notes that the commenter did not offer data to undercut the conclusion that such exposure can occur. Because of this information, and other information described in Unit III.E. of the (Ref. 1), EPA does not assume that new types or forms of exposure associated with new use of benzidine-based chemical substances would be insignificant merely because the chemical substance is imported or processed as part of an article. Thus, EPA does not believe the default assumption used to support 40 CFR 721.45(f) (that people and the environment will generally not be PO 00000 Frm 00066 Fmt 4700 Sfmt 4700 exposed to substances in articles) holds with respect to benzidine-based chemical substances. 2. Comment. Comments also suggest that EPA analyze the ‘‘variety of products’’ that could be construed as articles, the ‘‘practical questions that will arise’’ if the import and processing of such products were not exempt from SNURs, and the ‘‘unique channels of trade,’’ through which different varieties of products move. Commenters encouraged EPA to develop and articulate publicly a policy framework, considering the following factors on an article-specific basis, before proceeding to revoke the article exemption with respect to a particular chemical substance: • Whether there is, or will be, direct exposure to the chemical substance in the article during the course of the article’s use. • Whether there is, or will be, a release of the regulated substance, or a metabolite or breakdown product from the substance, during subsequent processing, distribution, use or disposal of the article. • Whether there is, or will be, a link between import or export of an article and cross-border exposure to the U.S. population. Response. Given the variety of substances and uses addressed under SNUR regulations, EPA believes it is more efficient to address article-specific issues as they actually arise within each regulatory action than to develop, as suggested by the commenter, an anticipatory ‘‘policy framework’’ document. The importers and processors of chemical substances present in articles are generally in the best position to know which chemical substances are used in which types of articles. When EPA identifies a particular chemical substance in a SNUR, such stakeholders have an opportunity to identify, in their public comments, any article-specific issues that concern them. Furthermore, these issues are likely to be more accurately identified and more appropriately addressed in connection with the development of a SNUR for particular chemical substances than they would be if they were reviewed generically. In this case, commenters did not raise any issues specific to certain articles. C. A Compelling Basis Standard for Making Inapplicable the Exemption for Persons Who Import or Process Chemical Substances as Part of Articles 1. Comment. Some commenters made the point that revocation of the exemption at 40 CFR 721.45(f) should E:\FR\FM\29DER1.SGM 29DER1 mstockstill on DSK4VPTVN1PROD with RULES Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations not be a presumed component of all SNURs. This was part of a broader comment that EPA should not make this exemption inapplicable unless there was a ‘‘compelling basis’’ to do so. One commenter was concerned that if EPA proceeds on a case-by-case basis, following reasoning that ‘‘could be applied to many chemicals,’’ then elimination of the exemption would come to be a ‘‘kind of ‘default’ step’’ in future SNURs. One commenter also argues that, where the SNUN submission requirement is to apply to importers and processors of substances as part of articles, the TSCA section 5(a)(2) criteria require EPA to undertake a compelling analysis of how the use and distribution of the ‘‘specific articles or article categories,’’ would ‘‘contribute to potential exposures of concern.’’ Response. As an initial matter, the comments conflate two separate issues: The determination of a significant new use under TSCA section 5(a)(2), and the decision to make the regulatory exemption at 40 CFR 721.45(f) inapplicable. The TSCA section 5(a)(2) factors do not impose a ‘‘compelling analysis’’ requirement on the elimination of the 40 CFR 721.45(f) exemption because (among other reasons) these two actions concern two discrete issues. The section 5(a)(2) factors speak to the significant new use itself. 40 CFR 721.45(f) speaks to who is required to notify EPA of the significant new use. In this case, EPA identified its reasons, under the TSCA section 5(a)(2) factor analysis, to anticipate that the new use would pose important new questions related to the substances’ potential to threaten health or the environment (Ref. 1, pg. 18756), and that EPA should have an opportunity to consider those questions before such use could occur. (In essence, a SNUR puts a particular set of uses on the same footing as a new chemical, which is subject to automatic review under TSCA section 5(a)(1) unless EPA specifically excludes it from such review.) EPA also identified a basis, specific to benzidinebased chemical substances, to question the assumption that people and the environment will generally not be exposed to the chemical substances in articles. Therefore, EPA is also making inapplicable the exemption at 40 CFR 721.45(f) for persons who import or process a chemical substance as part of an article. No commenter provided data or other information to undercut the factual basis for either decision. Neither TSCA nor the implementing regulations for SNURs establish a separate ‘‘compelling basis’’ standard, either with respect to the determination VerDate Sep<11>2014 18:05 Dec 24, 2014 Jkt 235001 of a significant new use or with respect to the decision to make the exemption at 40 CFR 721.45(f) inapplicable. Nor have commenters identified a persuasive basis for EPA to adopt such a standard under either scenario. EPA’s specific action with respect to benzidine-based chemical substances is not, as commenters suggest, tantamount to the presumptive revocation of the SNUN submission exemption for importers and processors of chemical substances as part of articles in all future instances. EPA has not proposed to globally modify or eliminate the SNUR exemption for persons who import or process chemical substances as part of articles. EPA need not presently address the merits of an action it is not presently taking, and did not previously propose to take. TSCA sections 5(a)(2)(B) and (C) require EPA to consider the extent to which a new use ‘‘changes the type or form of exposure’’ or ‘‘increases the magnitude and duration of exposure’’ before making a determination that a particular use is a ‘‘significant new use.’’ EPA disagrees that it must therefore, as one commenter suggests, conduct a multiplicity of separate significant new use analyses whenever the use under consideration involves an article (i.e., one for each specific article or article category, comparing the relative significance of each particular article or article category). In particular, the commenter’s interpretation of TSCA section 5(a)(2) misconstrues the baseline against which the ‘‘newness’’ and the ‘‘significance’’ of a significant new use are evaluated. As EPA has long maintained, the single analytical baseline is the set of uses that were ongoing ‘‘as of the date of publication’’ of the SNUR proposal. (See e.g., Ref. 1). Furthermore, the particular analytical standards the commenter suggests are not commensurate with the establishment of a one-time notice requirement intended to give EPA an opportunity to later evaluate the need for testing or other regulatory action under TSCA. Requiring upfront answers to the very questions EPA would evaluate after receiving a significant new use notice, as a pre-condition of requiring the notices, would undermine the statutory authorization to issue SNURs in the first place. EPA’s decision to propose a SNUR for a particular chemical use and to make the exemption at 40 CFR 721.45(f) inapplicable to that SNUR need not be based on an extensive evaluation of the hazard, exposure, or potential risk associated with that use. Rather, the Agency is acting because it has reason to anticipate that such use would raise PO 00000 Frm 00067 Fmt 4700 Sfmt 4700 77899 important new questions related to the substance’s potential to threaten health or the environment, and that EPA should have an opportunity to consider those questions before such use could occur. Since the use designated as a significant new use does not currently exist, deferring a detailed consideration of potential risks or hazards related to that use is an effective use of resources. If a person decides to begin manufacturing or processing the chemical for the significant new use, in articles or otherwise, the notice to EPA allows EPA to evaluate the use according to the specific parameters and circumstances surrounding that intended use. Even if it were appropriate to construe the decision to make the 40 CFR 721.45(f) exemption inapplicable as a subcomponent of the significant new use determination under section 5(a)(2) (rather than as a subsequent determination), EPA adequately considered the section 5(a)(2) factors. The first factor is the ‘‘projected volume of manufacturing and processing of a chemical substance’’ (TSCA section 5(a)(2)(A)). EPA projects that these substances will not be manufactured or processed at any volume for the new uses in question and notes that for the newly proposed nine benzidine-based chemical substances, data reported to EPA for the 2012, 2006, 2002, and 1998 reporting cycles, as required by the TSCA IUR rule, indicate no evidence of manufacture (including import) (Refs. 1 and 17). Any increase in the projected volume of manufacturing (including import) or processing of these substances, beyond the very limited uses currently ongoing, would reflect a significant departure from prior trends. Given that these chemical substances are anticipated to metabolize to the parent benzidine molecule, which is a known human carcinogen, EPA anticipates that information presented in the SNUN on the quantities manufactured (including imported) and processed of benzidine based chemical substances would be important to EPA’s overall evaluation of whether the new use may present an unreasonable risk to human health or the environment. The necessary increase in volume of this substance from any new use weighs in favor of determining that the new use is a significant new use. The second factor is ‘‘the extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance’’ (TSCA section 5(a)(2)(B)). For the newly added benzidine-based chemical substances, a general market review on E:\FR\FM\29DER1.SGM 29DER1 mstockstill on DSK4VPTVN1PROD with RULES 77900 Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations these chemical substances indicates no current manufacture within or outside the United States. Although some of the chemical substances subject to the 1996 SNUR may still have certain limited ongoing uses (e.g., as a test reagent, lab standard, or microscopy stain), such uses are expected to be confined to limited laboratory or technical applications that are not expected to represent an appreciable amount of overall exposure. Furthermore, EPA did not find evidence of actual ongoing importation or domestic production for these uses. No comments provided evidence of ongoing manufacture (including import) or processing of these chemical substances as part of articles or otherwise. Thus, EPA believes that there is no, or almost no, current exposure to these chemical substances in the United States. Should a significant new use be planned, EPA anticipates that the new use would raise important new questions such as the following: • To what extent would the use be expected to involve dermal contact with the substance? • Would the substance be used in a setting where oral exposure is likely (e.g., would young children be able to mouth the article)? • How would potential occupational exposures and releases to the environment over the substance’s lifecycle be expected to be managed? Given that these chemical substances are anticipated to metabolize to the parent benzidine molecule, which is a known human carcinogen, EPA anticipates that the answers to such questions would be important to EPA’s evaluation of whether the new use may present an unreasonable risk to human health or the environment. The potential for a new use to change the type or form of exposure weighs in favor of determining that the new use is a significant new use. The third factor is ‘‘the extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance’’ (TSCA section 5(a)(2)(C)). Should one of the designated significant new uses be planned, EPA anticipates that the planned new use would raise important new questions relating to the concentration in which the substance would be used, the potential for repeated exposure, and the potential for continuous exposure. Given these chemical substances are anticipated to metabolize to the parent benzidine molecule, which is a known human carcinogen, EPA anticipates that the answers to these questions would be important to EPA’s overall evaluation of VerDate Sep<11>2014 18:05 Dec 24, 2014 Jkt 235001 whether the new use may present an unreasonable risk to human health or the environment. EPA also notes that dermal exposure can occur from the leaching of the chemical substances by sweat in contact with the dyed textiles (Ref. 1). Because of this information, and the information described in Unit III.E. of the proposal (Ref. 1), EPA does not assume that new types or forms of exposure associated with new use of these substances would be insignificant merely because they relate to new use in an article or because the pertinent manufacturing or processing of the substance occurred as part of an article. The potential for activities related to a new use to increase the magnitude and duration of exposure weighs in favor of determining that any non-ongoing use is a significant new use. The fourth factor is ‘‘the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance’’ (TSCA section 5(a)(2)(D)). EPA anticipates that any new use, beyond the very limited uses currently ongoing, would raise important new questions such as the following: • To what extent can the anticipated manufacturing, processing, distribution in commerce, and disposal of the chemical substance be expected to result in worker exposure, user exposure, or release of the chemical substance to the environment? • What potential controls are available to limit such releases? Given these chemical substances are anticipated to metabolize to the parent benzidine molecule, which is a known human carcinogen, EPA anticipates that the answers to these questions would be important to EPA’s overall evaluation of whether the new use ‘‘may present an unreasonable risk to human health or the environment.’’ The potential for manufacturing, processing, distribution in commerce or disposal of these benzidine-based chemical substances to change the overall exposure picture weighs in favor of determining that consumer textile use is a significant new use. After considering each of the four TSCA 5(a)(2) factors, EPA has concluded that the factors taken together weigh in favor of determining that manufacture or processing of these benzidine-based chemical substances for any non-ongoing use would be a significant new use such that the Agency should have an opportunity to analyze the new use before such use (and potential exposures) occurs. This determination would still hold even if one were to consider the 40 CFR PO 00000 Frm 00068 Fmt 4700 Sfmt 4700 721.45(f) exemption as a subcomponent of the significant new use determination under section 5(a)(2). D. Narrowing the Scope of SNURs Where the Exemption for Importers and Processors of Chemical Substances as Part of Articles Is Made Inapplicable Some comments suggest that significant new uses should not be ‘‘open-ended’’ but instead must be targeted to specific articles, particularly in cases where the exemption at 40 CFR 721.45(f) is made inapplicable. The concern expressed is that if the SNUN applies to ‘‘any use of a substance, then regulated parties and the EPA would be obligated to proceed through the SNUR process for an article that would have little relevance to the perceived hazard that drove the original SNUR.’’ The commenter further writes that ‘‘openended article SNUR’s can trigger reviews for articles that may have no relationship to the hazard or exposure concerns that motivated EPA’s decision to initiate the rule.’’ EPA’s concern with these benzidinebased dyes is not limited to certain exposure pathways to specific articles. EPA’s concern is specific to the benzidine-based dyes and thus to the range of exposures that could occur for these chemical substances. The preamble of the proposed rule notes multiple potential routes and sources of exposure including inhalation, skin absorption via dyed textiles, and ingestion. (Ref. 1). Furthermore, SNURs need not be narrowly focused on the mitigation of currently foreseeable exposure scenarios—it is proper that they will also ensure EPA has timely notice of future (and currently unforeseeable) exposure scenarios. An additional requirement to make targeted predictions of the particular uses that ‘‘may be proposed in the future’’ would undermine this intended function of the SNUR. More generally, an exhaustive list of all applications that could possibly fall within the ambit of a significant new use definition is not a prerequisite for issuing a SNUR. Since the significant new use does not currently exist, deferring a detailed consideration of potential risks related to the importation or processing of these chemical substances (including as part of articles) is an effective use of resources. If a person decides to begin importing or processing the chemical, as part of an article or otherwise, the notice to EPA allows EPA to evaluate the significant new use according to the specific parameters and circumstances surrounding that intended use. E:\FR\FM\29DER1.SGM 29DER1 mstockstill on DSK4VPTVN1PROD with RULES Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations E. EPA Should Have a Reasonable Basis To Conclude That Identified Articles Would Be Distributed in the United States One comment states that ‘‘EPA presents an exposure-based rationale for why certain articles could be a concern, but indicates that there is no current expectation that these chemical substances will be used in such articles.’’ The commenter believes that before issuing an article SNUR, EPA should have a reasonable basis to conclude that identified articles of concern would be distributed in the United States. The commenter contends that EPA should identify an article containing such a chemical that is currently in global commerce and explain why it is likely to be distributed in the United States. The commenter believes that it might also be possible to identify an article at the research and development stage that is likely to proceed to commercial development. Without such findings, however, the commenter is concerned that EPA would be issuing an article SNUR for a situation that presents no current or likely future threats to health or the environment, and thus that the rule would be a waste of public resources. Another comment raises similar issues, arguing that EPA should provide even more specific information on how the significant new uses contribute to risk. Alternatively, the first commenter suggests that EPA include a specific provision suspending enforcement of the SNUR until a determination is made that there is a reasonable basis to believe that an article containing the specific chemical had been, or would be, distributed in the United States. EPA disagrees with the suggestion to limit the application of SNUN submission requirements for importers and processors of the chemical substances as part of articles to situations where importation or processing as part of an article is known to be imminent. SNURs address situations in which EPA is concerned about the potential for use to commence without prior opportunity for review and risk management action where appropriate. For purposes of SNURs, EPA cannot be expected to predict specific situations where new uses may be imminent, or how those specific uses may contribute to risk, before designating significant new uses. The purpose of a SNUR is to obtain such information so that EPA can evaluate risks associated with, and take risk management action where appropriate regarding, any notified activities. These rules serve the important function of VerDate Sep<11>2014 18:05 Dec 24, 2014 Jkt 235001 alerting EPA when a significant new use is intended. Without them, EPA would have no expectation of timely identification of new uses of these chemicals. Notice relating to the import or processing of articles is particularly important in this case, as the proposal specifically identified a concern related to the potential for dermal exposure via dyed articles (i.e., from the leaching of the benzidine-based chemical substances by sweat in contact dyed articles, such as textiles). (Ref. 1). It would not be an efficient use of government resources for EPA to continually monitor global commerce to try to predict which chemicals are about to be imported as part of articles (but have not yet been imported) into the United States. Persons who wish to manufacture (including import) or process these chemical substances for a significant new use, as part of an article or otherwise, are in a better position than EPA to evaluate when they are about to initiate a particular significant new use. Given that SNURs cannot be issued for ongoing uses, the commenter’s suggestion (that EPA must itself make an upfront demonstration that a particular new use is about to begin, to secure the opportunity to be notified of when significant new uses involving importation or processing of chemical substances as part of articles are about to begin) is impracticable. It would likely result in a scenario in which an otherwise significant new use would be allowed to commence prior to the issuance of a SNUR proposal, thereby placing that use outside of EPA’s SNUR authority. Furthermore, EPA has already considered and rejected (in 2006, following public comment on a 2004 proposal) the position that it must defer revocation of the 40 CFR 721.45(f) exemption for a SNUR until it appears likely ‘‘that these chemical substances will be imported as part of articles.’’(Ref. 18). EPA concluded in 2006, after a re-evaluation of the issue prompted by public comments, that ‘‘if the subject substances when imported as a part of articles are not subject to the SNUR, EPA could miss the opportunity to obtain notifications that would provide information of potential regulatory and assessment value.’’ (Ref. 19)(ultimately declining to make the exemption inapplicable, based on a separate concern that the use with respect to articles appeared to be already ongoing). Finally, for essentially the same reasons as set forth in this unit, EPA believes it would be inappropriate to follow one commenter’s alternative suggestion: To promulgate a SNUR PO 00000 Frm 00069 Fmt 4700 Sfmt 4700 77901 without the exemption for importers and processors of chemical substances as part of articles, while somehow ‘‘suspending enforcement’’ until the precise moment that manufacture or processing for a significant new use as part of an article is about to begin, but has not yet begun. In sum, EPA believes commenter’s suggestions would turn the regulatory process on its head. EPA would likely need to already have a SNUR in place in order to obtain the kind of timely information about significant new use that the commenter asserts should be prerequisite to issuing the SNUR in the first place. F. Intended Coverage of the BenzidineBased Chemical Substances SNUR 1. Comment. One commenter writes that ‘‘A proposed rule offering a clear explanation of what uses EPA intends to cover, including an explanation of the alternatives if certain situations are unclear, will greatly increase the chances that useful information about business practices and common terms of art in an industry will be identified.’’ EPA should define the scope of the uses to be regulated as clearly and precisely as possible. The commenter also contended that soliciting public comment on the appropriate scope of new uses to be regulated, for a specific chemical substance, constitutes ‘‘an abdication of the role that EPA should be undertaking.’’ The commenter suggests that before soliciting public comments, EPA should have first pursued an informal coordination with downstream industries and (as necessary) an exercise of its ‘‘ample authority under TSCA, either through regulatory action under section 8 or order authority under section 11(c).’’ Finally, the commenter suggests that to the extent the proposed significant new uses admit ambiguity or potential need for adjustment in response to public comment, that is evidence that EPA ‘‘should have learned more about the uses’’ before issuing the proposal and is improperly seeking ‘‘to shift the responsibility to stakeholders.’’ Response. The description of the scope of the significant new uses in the benzidine-based chemical substances proposed SNUR and the Agency’s basis for the proposal were explicit. The SNUR proposal fairly apprised stakeholders as to the chemical at issue and the particular concerns driving the proposed action. It further indicated that based on information available to EPA, the significant new uses identified are not currently on-going. Stakeholders had an opportunity to oppose any of these preliminary findings by supplying E:\FR\FM\29DER1.SGM 29DER1 mstockstill on DSK4VPTVN1PROD with RULES 77902 Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations countervailing information thorough the rulemaking process itself. Grafting additional pre-proposal steps onto the SNUR rulemaking process would be unnecessarily time-consuming and an unsound use of agency resources. The timelier, less resource-intensive, and more transparent process is for interested stakeholders, through the public comment process itself, to simply provide any pertinent countervailing information they wish to add to the initial collection of information EPA presented in the proposal. As noted earlier, TSCA section 5(a)(2) does not compel nor contemplate an article by article analysis to identify every conceivable significant new use of a chemical substance. EPA evaluates whether a new use is ‘‘significant’’ consistent with the evidence of Congressional intent underlying the enactment of TSCA. See H.R. Rep. No. 94–1341 at 24 (1976) (‘‘[B]ecause of the nature of a substance, it is possible that any new use of it will be significant. Thus, a potentially dangerous substance which is manufactured for a particular use may, if manufactured for a different use present additional health or environmental problems and consequently there should be notice of the intent to manufacture it for such different use.’’ H.R. Rep. No 94–1679 at 66 (1976) (‘‘[T]he conferees intend that any potential threats to health or the environment from the manufacture, processing, distribution in commerce, or disposal of a substance associated with a new use be considered by the Administrator when determining the significance of a new use.’’) Finally, a broad construction of the significant new use is particularly appropriate where (as in the case of benzidine-based dyes) any increase in the projected volume of manufacturing (including import) or processing of these substances, beyond the very limited uses currently ongoing, would reflect a significant departure from prior trends. 2. Comment. ‘‘It does not make sense to issue article SNUR’s [sic] for full size machines or structures. An article SNUR should focus on the specific components of more complex machines or structures that involve the chemical of concern.’’ Response. The commenter neither explains what the commenter means by ‘‘full size,’’ nor offers any specific evidence to support their general view that new uses of chemical substances in ‘‘full size machines or structures,’’ are any less likely to be significant than new uses of chemical substances in ‘‘specific components.’’ Nor does the commenter indicate why persons who import or process chemical substances VerDate Sep<11>2014 18:05 Dec 24, 2014 Jkt 235001 as part of articles would be more likely to be importing or processing the chemical substances for use in ‘‘full size’’ articles. Attempting to define and distinguish between ‘‘full size’’ article uses and other uses, and correlating such distinctions to whether persons are importing or processing these chemical substances as part of articles, would delay the rulemaking and increase its complexity, in a manner that does not seem warranted on the basis of the limited information supplied in the comment. 3. Comment. ‘‘Chemicals used in articles may sometimes be incorporated into ’internal’ mechanisms of the article that are unlikely to come into contact with people or be released into the environment during normal use of the article.’’ Response. The commenter does not explain why the basis for a SNUR should be limited to those exposures that occur concurrent with the article fulfilling its intended function, when TSCA section 5(a)(2)(D) contemplates that EPA will consider the value of ensuring it has a future opportunity to review the whole life-cycle impact (e.g., ‘‘manufacturing, processing, distribution in commerce, and disposal’’) of a significant new use of a chemical substance. The exposure to the chemical substance, including when it is in an article, may be larger during disposal or recycling than during the ‘‘normal use’’ of the chemical. Further, chemical substances that are ‘internal’ to an article may still result in exposure if the chemical substance has certain physical- chemical properties (e.g., a relatively volatile chemical used as a plasticizer in interior automobile parts) or due to abrasion of the article (e.g., a dye incorporated into furniture covering.) Nor does the commenter indicate why persons who import or process chemical substances as part of articles would be more likely than any other manufacturers or processors to be manufacturing or processing for use in the internal mechanisms of articles. Attempting to define and meaningfully distinguish between ‘‘internal’’ article uses and other uses, and correlating such distinctions to whether manufacturing or processing of the substance occurs as part of an article, would delay the rulemaking and increase its complexity, in a manner that does not seem warranted on the basis of the limited information supplied in the comment. 4. Comment. ‘‘EPA should clarify whether the SNUR applies to articles containing the chemical of concern in a solid, liquid, particle or gaseous form.’’ PO 00000 Frm 00070 Fmt 4700 Sfmt 4700 Response. This SNUR applies to the chemical substances regardless of form. To the extent the commenter seeks to continue some aspect of the exemption at 40 CFR 721.45(f), depending on the form of the chemical substance in the article that is being imported or processed, the commenter has not offered any specific support for that proposition, either generally or in any particular case. In the SNUR at issue, EPA does not believe it is prudent to limit the application of the rule based on the form (solid, liquid, or gaseous) of the chemical substances at issue. Chemicals that may have been used in one form during the manufacture of the article may be released from the article in a different physical form. Also, fluids and particles are not covered under the applicable definition of article at 40 CFR 704.3. EPA received no comments suggesting that use of these chemicals in one form or another may not be significant based on the TSCA section 5(a)(2) factors. Moreover, information relevant to a specific form of a chemical substance can be submitted in a SNUN and may be considered by EPA in review of that SNUN in determining whether follow-up action is warranted, and may support EPA’s amendment of the SNUR to limit its scope. 5. Comment. ‘‘[A] chemical may be present at a very low concentration that is unlikely to be associated with a risk warranting EPA risk management action. . . . EPA should consider whether it can establish a de minimus exclusion [from the SNUR].’’ Response. EPA notes that the SNUR already contains a general exemption for unintentionally present impurities at 40 CFR 721.45(d). To the extent chemical substances are intentionally added to articles at very low concentrations, the question of whether the substance warrants risk management action is one that EPA can address upon receipt of the SNUN, not an analytical prerequisite to deciding whether it should receive the SNUN in the first place. G. Screening for Benzidine-Based Chemical Substances Some commenters faulted the proposal for not identifying precise screening operations to be taken in response to the SNUR, and for not conducting additional analyses of the cost and feasibility of such screening operations. One commenter suggests, in particular, that an article importer should be deemed in compliance with the SNUR if the chemical is present below an established de minimis level (based on mass or concentration), or if it simply does not know the article’s E:\FR\FM\29DER1.SGM 29DER1 Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES content after conducting a reasonable inquiry for such information. With respect to processors, given the requirements of 40 CFR 721.5(a)(2), a processor of the chemical substance should have received notification that the chemical substance is the subject of a SNUR. A processor is not required to submit a SNUN for its unknowing processing of a chemical substance subject to a SNUR if (upon obtaining knowledge) the processor can document that when the past processing occurred, the processor neither knew the chemical identity of the substance it was processing nor knew that substance was subject to a SNUR. See 40 CFR 721.5(c). EPA would generally expect that processors would only fail to be aware of the presence of a chemical subject to a SNUR if the manufacturer (including importer) or upstream processor of the chemical substances failed to meet their obligations under 40 CFR 721.5(a)(2). With respect to importers, EPA disagrees that it would be appropriate or necessary for the SNUR itself to define screening procedures to be employed for compliance purposes. The Agency did not propose to require a particular screening procedure and, for the following reasons, it does not agree that particular screening procedures should be specified and incorporated into the final rule. First, EPA believes that adding these sort of screening-effort exemptions, specifically for importers of chemical substances as part of articles, would be especially difficult to reconcile with the general statutory prohibition (under TSCA section 5(a)(1)) on manufacturing or processing a chemical substance for a significant new use without prior notice to EPA. The issue under the statute is whether or not an importer actually imports a substance. This is a separate question from the importers’ level of knowledge or level of effort to obtain knowledge respecting the content of the imports.2 With respect to SNURs, EPA notes that its direct rulemaking authority is to identify significant new uses under section 5(a)(2). The Agency has been appropriately cautious in exercising its implicit rulemaking authority to limit the applicability of section 5(a)(1). EPA recognizes that it did previously exercise such implicit rulemaking authority when establishing 40 CFR 721.45(f). However, as noted in 2 The limiting clause in the definition of ‘‘principal importer’’ at 40 CFR 721.3—‘‘knowing that a chemical substance will be imported’’—is a limit based on the person’s knowledge that he or she is engaged in an import transaction, not a limit based on the person’s knowledge of a particular chemical’s identity and regulatory status. (48 FR 21727, May 13, 1983) (FRL 2998–5). VerDate Sep<11>2014 18:05 Dec 24, 2014 Jkt 235001 this unit, the exemption at 40 CFR 721.45(f) was established along with a broad reservation of authority to withdraw the exemption where, as here, it is inaccurate to assume that there would not be exposure to the substance simply because it is present as part of an article. And a screening-effort exemption is especially difficult to reconcile with the statute in the case of importers. With importers, unlike with processors, there are no upstream entities with a duty under TSCA to notify importers of the presence of a chemical substance subject to a SNUR. Second, establishing a safe-harbor for importers based on lack of knowledge would create incentives for foreign suppliers to deliberately withhold information from importers. This could greatly reduce the efficacy of this SNUR. Currently, when an importer wishes to import a substance it knows would be subject to notification requirements, but for which the chemical identity is claimed as CBI by a foreign manufacturer, EPA’s longstanding practice when reviewing PMNs and SNUNs is to accept the relevant information on chemical identity directly from the foreign manufacturer. See, (Ref. 7)(‘‘[t]he principal importer need not know the specific chemical identity of the imported substance’’ and ‘‘may have its foreign manufacturer or supplier, or some other person, report the chemical identity to EPA.’’) Offering an outright regulatory exemption to an importer simply because it is ignorant of the existence of a SNUR-regulated substance in the imported article (after conducting a prescribed inquiry) would allow foreign suppliers to short-circuit this process simply by refusing to divulge to the importer whether the import contains a chemical substance subject to SNUR. Third, to the extent the chemical substance subject to the SNUR is only ‘‘unintentionally present’’ at the point of foreign manufacture, it is already exempt from reporting by the importer as an imported impurity. See 40 CFR 721.3 (chapeau), 40 CFR 720.3(m), and 40 CFR 721.45(d). Thus, importers are not required to submit a SNUN for a substance based simply on that substance’s presence as an impurity (i.e., a chemical substances unintentionally present with another chemical substance). Fourth, whether and how it may appropriate for importers to screen for benzidine-based chemical substances will depend on many factors, including their current state of knowledge about the articles that they import and the potential risk of unknowingly importing articles that contain these chemical PO 00000 Frm 00071 Fmt 4700 Sfmt 4700 77903 substances. The relevant factors are largely impossible for EPA to establish at this time, given that there is currently no on-going import of these substances for the designated significant new uses. Finally, EPA did conduct additional analysis of potential screening burden to explore commenters’ concerns. As described in Unit X.H., EPA acknowledges the costs of the various activities that certain entities may choose to undertake, in response to this rule, to ensure that the chemicals they import or process as part of articles do not trigger SNUN submission requirements (Ref. 20). Based on EPA’s economic analysis and the responses to the proposed rule, EPA does not believe that these costs will be significant for any individual entity. H. Costs Associated With Making the Exemption for Persons That Import or Process Chemical Substances as Part of Articles Inapplicable Some comments note that the economic analysis, which focuses on the cost of filing a SNUN, does not include any analysis of the costs that might be associated with screening articles to determine whether these SNURs would apply. One comment also notes that ‘‘the preambles to the proposed rules do not discuss what, if any obligations companies have to screen articles for the chemicals included in the SNUR’s.’’ With respect to processors: existing SNUR regulations already provide that the unknowing processing of a chemical substance does not itself trigger SNUN requirements if the processor can (upon obtaining knowledge) document that when the past processing occurred, the processor neither knew the chemical identity of the substance it was processing nor knew that substance was subject to a SNUR. See 40 CFR 721.5(c). With respect to importers: Based on an assessment of current market activity in the economic analysis, EPA believes that the chemicals subject to the final SNUR are not currently being imported into the United States for the identified significant new uses in articles. EPA received no public comments on the proposed SNUR that indicate that importation of these benzidine-based chemical substances for the finalized significant new uses, in articles or otherwise, is ongoing. However, because this SNUR makes inapplicable the exemption for persons that import or process chemical substances as part of articles, companies may take actions to ensure that they do not import any articles containing the subject chemical substances after promulgation of this rule, by such means they deem E:\FR\FM\29DER1.SGM 29DER1 77904 Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations appropriate. This is not necessarily a new consideration for importers given that importers of mixtures have needed to be aware of chemical substances subject to a SNUR that may be a component of imported mixtures. Whether and how companies respond will depend on many factors, including their current state of knowledge about articles that they import and their own assessments of the potential risk of unknowingly importing articles that contain these chemicals. As noted in this unit, EPA did conduct additional analysis of burdens that may be associated with activities entities may undertake to ensure the chemicals they import or process as part of articles do not trigger SNUN submission requirements (Ref. 20). In any event, EPA did not propose to mandate any particular level of screening of imported or processed articles. The preamble to the proposed SNUR did not discuss the precise steps that an importer or processor must take in this regard because there is no precise level of screening by which the manufacturer or processor could be separately liable under the rule (if not performed) or by which a manufacturer or processor could obtain ‘‘safe harbor’’ from what would otherwise be a violation of the rule. While EPA might potentially take screening practices into consideration when evaluating a particular instance in which the SNUR was nevertheless violated, that would be as a matter of enforcement policy, not as a provision of the rule itself. EPA has included estimates for some activities that importers may undertake (e.g., supplier inquiries) in order to evaluate the likelihood of chemicals being imported as part of articles. These costs will vary for individual companies and their experience with suppliers. Awareness of article components and constituents is becoming more commonplace as companies frequently operate on a global scale and are subject to numerous regulatory requirements around the world that affect product stewardship responsibilities. Existing requirements that may compel a company to investigate an article’s components include the Consumer Product Safety Act, California’s Proposition 65, and the EU’s regulation on Registration, Evaluation, Authorization and Restriction of Chemical (REACH), which requires customer notification about the presence of certain chemical in articles that a company distributes. U.S. importing companies may already be familiar with the process of determining whether the articles they import contain restricted chemical substances, if they are subject to the requirements cited above or various U.S. regulations, such as the Product Safety Improvement Act (CPSIA) of 2008, Washington’s Children’s Safe Product Act, and Maine’s Act to Protect Children’s Health and the Environment from Toxic Chemicals in Toys and Children’s Products (Ref. 20). Given the existing regulatory limitations on certain chemicals both internationally and within the United States, regulated industries have begun to develop industry-wide processes and other resources to obtain information on chemical substances in articles. Policies and procedures could include supplier agreements, such as Hewlett Packard’s requirement that suppliers meet their General Specifications for the Environment (GSE) (Ref. 21) and Walmart’s requirement that suppliers participate in International Compliance Information Exchange (iCiX) to manage and share compliance information throughout the supply chain (Ref. 22). More extensive policies and procedures could even include product testing. Companies may choose to use existing procedures or develop new ones that could range from document review, to supplier agreements, to product testing. Additional analysis conducted by EPA on activities that companies may choose to undertake to ensure that the chemicals they import or process as part of articles do not trigger requirements of the SNUR shows a wide range of potential activities and associated costs. The conduct of these activities and associated costs are at the discretion of the company. Table B of this unit shows EPA’s estimated range of costs associated with some of these potential activities for importers of articles. TABLE B—RANGE OF COSTS ASSOCIATED WITH AN IMPORTER’S IDENTIFICATION OF CHEMICALS SUBJECT TO SNURS IN ARTICLES Activity Cost US ($) Notes Per Rule Costs 1. Rule familiarization .......... 2. Identify the type of imported articles that potentially contain the restricted substances. 3. Identify all suppliers involved. 6. Recordkeeping ................. $55 ..................................... $130 to $1,550 ................... Cost typically already included in SNUR Economic Analyses. Actual costs may vary based on number of articles imported and the complexity of the article itself (number of components). $950 ................................... Actual costs may vary depending on the number of articles imported, number of suppliers, and frequency of supplier changes. Cost typically already included in SNUR Economic Analyses. $10 ..................................... Article-Related Costs $5 to $515 per article reviewed. $0 if no data collected 5. Chemical testing .............. mstockstill on DSK4VPTVN1PROD with RULES 4. Collect data from suppliers. $130 per article tested. $0 if no testing. Should processors of articles need to demonstrate compliance with a SNUR, VerDate Sep<11>2014 18:05 Dec 24, 2014 Jkt 235001 Actual costs only apply to those companies that choose to collect data from suppliers. They will vary depending on the specific data collection method chosen. Total costs depend on considerations including the number of articles imported, number of suppliers, and frequency of supplier changes. Actual costs only apply to those companies that choose to collect data from suppliers. Total costs per company will depend on considerations including the number of articles tested, which may be affected by the number of suppliers and risk associated with each, and frequency of supplier changes. it is expected that they could use the shipping or labeling documents PO 00000 Frm 00072 Fmt 4700 Sfmt 4700 received with the article in the ordinary course of business. As these documents E:\FR\FM\29DER1.SGM 29DER1 mstockstill on DSK4VPTVN1PROD with RULES Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations would be received and stored anyway, as per standard business practices, the elimination of the exemption in the SNUR for persons that import or process chemical substances as part of articles would be unlikely to lead such persons to incur significant additional costs. To the extent that processors choose to undertake more steps to identify regulated chemicals as part of articles, the costs of these activities would be similar to those in Table B of this unit for importers of similar size, supply chain complexity, and level of compliance with other chemical regulations. There are a number of regulations, including California’s Proposition 65 and the EU’s REACH that currently restrict or otherwise affect the use of certain benzidine-based substances, particularly in their use as dyes in textiles and leather. California’s Proposition 65 Chemical List includes benzidine-based dyes as a potential carcinogen and requires that firms provide a clear and reasonable warning before knowingly and intentionally exposing anyone to a listed chemical. This warning may include the labeling of consumer products (Refs. 23–24). The EU has banned, in textile and leather articles which may come into direct and prolonged contact with humans, the use of azo dyes which can break down to release any of 22 listed carcinogenic aromatic amines (including benzidine and its congeners) in amounts above 30 ppm (Ref. 25). The European Commission’s Directorate General for Health and Consumers maintains the RAPEX database that member countries can use to report dangerous products and the measures they have taken to prevent or restrict those products. Despite the EU ban, small numbers of products containing such azo dyes have recently been listed on RAPEX. The products are typically voluntarily withdrawn from the market and/or destroyed by the importer or have been placed under an order by the authorities to cease sales (Refs. 26, 27). Therefore, azo dyes in imported articles still remain a potential issue in the EU. Other countries have also banned the manufacture and use of the azo dyes in textiles. Currently the manufacture of azo dyes is banned in South Korea and Japan (Ref. 27). Use of these chemicals is banned by Egypt, India, China, South Korea, Taiwan and Vietnam (Ref. 28), and Indonesia has banned the use of the dyes in children’s and baby’s clothing (Ref. 29). In 2012, the Japanese textiles and leather industry announced voluntary restrictions of the chemicals (Refs. 29, 30). Canada has also expressed concern about the potential release of VerDate Sep<11>2014 18:05 Dec 24, 2014 Jkt 235001 benzidine or its congeners from azo dyes and is evaluating potential approaches for addressing azo dyes (Ref. 30). Organizations, such as the American Apparel & Footwear Association (AAFA), have developed a comprehensive Restricted Substances List (RSL) as a reference for companies and have developed a toolkit to help apparel and footwear companies to better manage chemicals throughout the supply chain. Given the current level of international and domestic regulation and attention to benzidine-related chemicals, EPA believes that importers and processors of articles may already have undertaken a number of activities to manage chemicals within their supply chains and generally to deselect for these chemicals. Therefore, EPA expects that companies that could potentially commence importing or processing benzidine-based chemicals as part of articles may already have some knowledge of the chemicals within their supply chain and would undertake few of the activities listed in Table B and would fall toward the lower end of the cost range for any activities undertaken. More detailed information is included in EPA’s economic analysis. EPA does not believe that the subject chemicals are entering the United States in imported articles for the significant new uses defined by the final regulation. However, companies may screen or initiate other activities to determine if articles they import in the future contain chemicals included in this SNUR. EPA notes that no commenters provided data that could be used to estimate what, if any, costs might be associated with continued assurance that imported articles are free from the chemical substances subject to this SNUR. The number of companies that may take such actions is not known, nor is the level of action that may be taken by a particular company. Based on EPA’s economic analysis and the responses to the proposed rule, EPA does not believe that these costs will be significant for any individual entity. I. Import and Export Regulations for Chemical Substances as Part of Articles One comment noted that EPA is not proposing to change the way in which TSCA’s export and import rules (pursuant to TSCA sections 12(b) and 13, respectively) apply to articles containing these chemical substances. The comment indicates that (under the status quo of the import rules) the U.S. Customs and Border Protection (CBP) will not be screening articles for the chemical substances in the proposed SNURs. PO 00000 Frm 00073 Fmt 4700 Sfmt 4700 77905 EPA agrees that the TSCA import rules are important TSCA compliance mechanisms and that 19 CFR 12.119 allows EPA to establish section 13 import certification requirements for chemicals in articles. However, declining to subject importers to one notice requirement (section 13 import certification) does not render another notice requirement (section 5 SNUN submission) unenforceable. In this case, EPA did not propose to require section 13 import certification or section 12 export notification for the subject chemical substances when part of articles. This is consistent with EPA’s past practice of making the exemption at 40 CFR 721.45(f) inapplicable without also requiring import certification or export notification for these chemical substances as part of articles (40 CFR 721.2800; 40 CFR 721.10068). However, the Agency continues to study this issue and has not ruled out a later proposal to require import certification and/or export notification for these chemical substances as part of articles. With or without an import certification requirement, it is the importer that is ‘‘responsible for insuring that chemical importation complies with TSCA just as domestic manufacturers are responsible for insuring that chemical manufacture compliance with TSCA.’’ 40 CFR 707.20(b)(1). J. Distinguishing Between Chemicals in Non-Article Form and Other Products One comment contends that the rule, as proposed, ‘‘would not allow [EPA] to distinguish between a chemical being brought into the United States in its raw form and a chemical being brought in on a shift as a dye or finish.’’ The comment goes on to state that treating them the same way is unrealistic and scientifically unsound. EPA disagrees with the comment and notes that it was not proposing to eliminate all distinctions, in all regulatory provisions under TSCA, between import of a chemical substance in non-article form, and import of a chemical substance as part of an article. The rule simply removes one particular distinction between persons who import or process a chemical substance in nonarticle form and persons who import or process a chemical substance as part of an article. Thus, while the raw chemical manufacturer and the article importer may both be required to submit a SNUN, EPA would be able distinguish between the two scenarios, as appropriate, in its review of the SNUN. The SNUN review process will allow case-by-case analysis of each circumstance. E:\FR\FM\29DER1.SGM 29DER1 77906 Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES With respect to the commenter’s comparison of the volume at which these chemical substances are currently manufactured in non-article form and the volume at which these chemical substances are currently manufactured in article form (i.e., via import of a chemical substance as part of an article), EPA’s conclusion, with respect to the significant new uses, is that the two volumes are currently the same. This is because EPA has concluded that there is no current manufacture of these chemical substances for the significant new uses, either through domestic manufacture of the substances in nonarticle form, or through import of articles containing the substances. Thus, both production volumes are currently zero. K. Provisions for Processors In a comment submitted after the closing of the public comment period, one commenter questions the utility of a provision for processors at 40 CFR 721.5(c), as applied to notice requirements under this rule. The commenter states that 40 CFR 721.5(c) would not protect companies unless they could document lack of knowledge that a SNUR applies. The commenter believes that this requirement is therefore impossible to meet, explaining that it is impossible to document what one does not know. EPA will respond to this comment, although it was submitted after the closing of the public comment period for this action, because it relates closely to the timely submitted comments. EPA disagrees that applying 40 CFR 721.5(c) is impossible or impracticable. The provisions at 40 CFR 721.5(c) provide that the unknowing processing of a chemical substance does not itself trigger SNUN submission requirements, subject to meeting certain documentation requirements. Upon obtaining knowledge that it previously engaged in activities covered by the SNUR, a processor can at that time assemble evidence relating to the period when the past processing occurred. Specifically, this would be evidence bearing on whether the processor previously knew the chemical identity of the substance it was processing or previously knew that that substance was subject to a SNUR. Evidence to establish a prior lack of knowledge could include items such as a purchase order and, where applicable, a material safety data sheet (MSDS) that indicates neither the relevant chemical identity nor the presence of a chemical subject to a SNUR. Another type of evidence would be the affidavit of a person in a position of appropriate authority swearing to the VerDate Sep<11>2014 18:05 Dec 24, 2014 Jkt 235001 prior lack of knowledge. EPA would generally consider the wording on a purchase order and, where applicable, an MSDS, along with an affidavit as described above, in determining whether there is sufficiently clear documentation for purposes of 40 CFR 721.5(c). However, if there was also contrary documentary evidence, indicative of the prior possession of knowledge (e.g., receipt of a notice given to the processor pursuant to 40 CFR 721.5(a)(1)(i)) then the overall documentary evidence would not allow the processor to take advantage of the provisions of 40 CFR 721.5(c). L. Potential Ongoing Use of DnPP One commenter identified a potential ongoing use of DnPP in grease in automotive switches. The commenter requested that EPA exclude the identified use from the SNUR. After investigation, EPA has determined that there is no ongoing use of DnPP in grease in automotive switches. The commenter states that ‘‘[b]ased on current use information . . . [the commenter] believes that DnPP is being used in grease in some automotive switches.’’ The proposal stated that EPA ‘‘welcome[d] specific information that documents [ongoing] use.’’ Yet the commenter does not provide any current use information to substantiate this belief. When raising a potential ongoing use, it is generally preferable to include information substantiating that use, especially where the entity raising that use is not an actual manufacturer (including importer) or processor of that chemical substance for that use and thus would not be anticipated to have direct knowledge of that use. In order to determine whether there is an ongoing use of DnPP in grease in automotive switches, EPA performed targeted searches of sources including IHS Chemical Economics Handbook, MSDS search tools such as Seton’s MSDS Hazard Communication Library and patent searches and was unable to substantiate this use as an ongoing use of DnPP. EPA reviewed several grease MSDS, and no grease MSDS listed any phthalate in its composition. EPA’s DfE alternatives analysis also has not identified use in grease in automotive switches as an ongoing use of DnPP. EPA also conducted patent searches for grease in automotive switches, and dampening greases in general. A patent search found mentions of the term phthalates with electronic components, but not DnPP specifically for automotive switches. However, one patent gave a very broad alkyl range that release of phthalates C4 and C8 were observed PO 00000 Frm 00074 Fmt 4700 Sfmt 4700 during the vacuum burn pretreatment of electronic components [disc drives]. This process is routine treatment to remove volatiles from electronic components, including electronic switches (Vacuum baking process USP 6,051,169 and Electric switches USP 3,694,601). EPA does not believe the existence of this information is indicative of current use of DnPP in grease in automotive switches because, patents do not necessarily indicate current use. As noted in the proposed rule (Ref. 1), no IUR production volume data were reported for DnPP during the 2006, 2002, 1998 and 1994 reporting cycles. In addition, no production volume data were reported for the 2012 CDR (Ref. 17) Accordingly, EPA is declining to exclude use ‘‘in grease in automotive switches’’ from the significant new uses of DnPP. M. Reliance on Inventory Update Rule (IUR) Data in Assessing Ongoing Use of DnPP One commenter suggests that EPA relied solely on the IUR data for determining ongoing uses of DnPP, and that such reliance may be misleading or incomplete. The commenter notes that ongoing uses below the IUR reporting threshold of 10,000 lbs would not be reported to EPA through the IUR process. EPA uses IUR data to identify ongoing uses of chemical substances. However, this is not the sole source of information relied upon to support the SNUR. EPA first identified a SNUR as a regulatory alternative for DnPP in the Phthalates Action Plan because EPA found that the most recent IUR data contained no reports of DnPP being produced in or imported into the United States. In proposing the SNUR, EPA prepared the ‘‘Economic Analysis of the Proposed Significant New Use Rule for Di-npentyl Phthalate (DnPP)’’ (Ref. 31) and conducted internet queries in order to ascertain whether there were any ongoing uses of DnPP at levels below the IUR reporting threshold. During the course of this research EPA identified several companies which either use or sell DnPP as a chemical standard for use in phthalates testing. Accordingly, the significant new uses of DnPP does not include use of DnPP as a chemical standard for analytical experiments as a significant new use. N. Design for the Environment (DfE) Assessment for Phthalates One commenter noted that EPA has undertaken a DfE project focused on phthalates, including but not limited to, DnPP. The commenter believes that the E:\FR\FM\29DER1.SGM 29DER1 Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES DfE phthalates alternative assessment will provide valuable information about potential alternatives to industries using phthalates. The commenter recommends that EPA refrain from further action on any phthalate until the DfE project is finalized. EPA disagrees that finalization of the DnPP SNUR should be delayed until the DfE project is complete. (To the extent the comment is discussing the timing of other potential EPA actions to address phthalates, it is outside the scope of this proposal.) The comment states that the final DfE report would identify alternatives, their viability as substitutes, and EPA’s comparative hazard information. EPA disagrees that this report is likely to provide information relevant to this SNUR. When defining the ‘‘significant new use,’’ EPA is limited to uses of the chemical substance that are not ongoing. The DfE report is not expected to identify alternatives for chemical substances that are generally no longer in use. It is already clear that there are many alternatives to DnPP use, because there are almost no ongoing uses of DnPP. Furthermore, the DfE report is not expected to suggest DnPP itself as an alternative to another phthalate because of its toxicity relative to other phthalates. Even if the DfE report were to identify a significant new use of DnPP as an alternative to some other chemical substance, then EPA would have the opportunity to consider that information at such time as it received the significant new use notice for DnPP. EPA notes that it is a regular practice to finalize SNURs for chemical substances that have not undergone a DfE assessment. Given that the DfE report is unlikely to provide additional information relevant to EPA’s significant new use determination for DnPP, that newly available information respecting any particular use of DnPP could be included in the significant new use notice itself, and that further delay would increase regulatory uncertainty, EPA disagrees that it would be appropriate to delay issuance of the SNUR on DnPP pending the release of the DfE report. XI. References The following is a listing of the documents that are specifically referenced in this action. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the technical VerDate Sep<11>2014 18:05 Dec 24, 2014 Jkt 235001 person listed under FOR FURTHER INFORMATION CONTACT. 1. U.S. EPA. Proposed Rule; Benzidine-Based Chemical Substances; Di-n-pentyl phthalate (DnPP); and Alkanes, C12–13, Chloro; Significant New Use Rules. 77 FR 18752, March 28, 2012 (FRL–8865–2). 2. U.S. EPA. Benzidine-Based Chemical Substances; Significant New Uses of Certain Chemical Substances, 61 FR 52287, October 7, 1996 (FRL–5396–6). 3. U.S. EPA, 2010. U.S. Environmental Protection Agency. Chemical Substances Derived from Benzidine and Its Congeners, https://www.epa.gov/oppt/ existingchemicals/pubs/actionplans/ DCB%20Action%20Plan_ 06232010.noheader.pdf (Accessed January 24, 2011). 4. U.S. EPA. Economics and Policy Branch, USEPA/OCSPP/Economics, Exposure, and Technology Division. ‘‘Economic Analysis to Support the Final SNUR for Benzidine and Benzidine-based Chemical substances.’’ 5. U.S. EPA. Significant New Uses of Certain Chemical Substances, 55 FR 17376, April 24, 1990 (FRL–3658–5). 6. U.S. EPA. Significant New Uses of Chemical Substances; Certain Chemicals. 49 FR 35014, September 5, 1984 (FRL– 2541–8). 7. U.S. EPA. Premanufacture Notification; Premanufacture Notice Requirements and Review Procedures. 48 FR 21722, May 13, 1983 (FRL 2998–5). 8. Testimony of James J. Jones, Acting Assistant Administrator Office of Chemical Safety and Pollution Prevention, U.S. Environmental Protection Agency before the Committee on Environment and Public Works and the Subcommittee on Superfund, Toxic and Environmental Health United States Senate, July 24, 2012, available at https:// www.epa.gov/ocir/hearings/pdf/2012_ jjones_testimony1.pdf. 9. CPSC, 2011. Staff Briefing Package. Petition HP 10–2. Requesting Restriction of Cadmium in Toy Jewelry (Consumer Product Safety Commission (February 9, 2011). Staff Report, Cadmium in Children’s Metal Jewelry. Toxicity Review of Cadmium. TAB B pp19–39 https://www.cpsc.gov/PageFiles/96192/ cadmiumtoy.pdf (October 14, 2010). 10. Danish Environmental Protection Agency, Survey of Chemical Substances in Consumer Products Survey No. 25 2003, Mapping the Liberation of Organic Tin Compounds in Mattress Pads, To Mattresses, and Baby/Junior Duvets. 11. Stapleton, et al., 2008, Alternate and New Brominated Flame Retardants Detected in U.S. House Dust, Environ. Sci. Technol. 12. CPSC Staff Preliminary Risk Assessment of Flame Retardant [FR] Chemicals in Upholstered Furniture Foam, December 21, 2006. 13. Muller, et al., 2011, Car Indoor Air Pollution—Analysis of Potential Sources, Journal of Occupations Medicine and Toxicology 2011, 6:33. 14. Wu, et al., 2009, Residues of Polybrominated Diphenyl Ethers in PO 00000 Frm 00075 Fmt 4700 Sfmt 4700 77907 Frogs (Rana limnocharis) from a Contaminated Site, South China: Tissue Distribution, Biomagnification, and Maternal Transfer, Environ. Sci. Technol. 2009, 42: 5212–5217. 15. Gaylor, et al. 2012, House Crickets Can Accumulate Polybrominated Diphenyl Ethers (PBDEs) Directly from Polyurethane Foam Common in Consumer Products, Chemosphere, 2012, 86: 500–505. 16. Covaci, et al. 2006, Hexabromocyclododecanes (HBCDs) in the Environment and Humans: A Review. Environ. Sci. Technol. 2006, 40: 3679–3688. 17. U.S. EPA, Chemical Data Access Tool (CDAT), https://java.epa.gov/oppt_ chemical_search/. 18. U.S. EPA, Certain Polybrominated Diphenylethers; Proposed Significant New Use Rule. 69 FR 70409, December 6, 2004 (FRL 7633–1). 19. U.S. EPA, Certain Polybrominated Diphenylethers; Significant New Use Rule.71 FR 34018, June 13, 2006 (FRL 7743–2). 20. U.S. EPA, Understanding the Costs Associated with Eliminating Exemptions for Articles in SNURs, May 1, 2013. 21. Hewlett-Packard Development Company, LP. (2010). ‘‘International Material Data System.’’ Retrieved from https:// www.mdsystem.com/. 22. Wal-Mart. (2012). Become a Supplier: Requirements. Retrieved from https:// www.walmartstores.com/Suppliers/ 248.aspx. 23. CAEPA, 2013a. State of California Environmental Protection Agency. Chemicals Known to the State to Cause Cancer or Reproductive Toxicity. Office of Environmental Health Hazard Assessment, 04 February 2013. https:// oehha.ca.gov/prop65/prop65_list/files/ P65list020813.pdf. 24. CAEPA, 2013b. State of California Environmental Protection Agency. Proposition 65 in Plain Language! Febuary 2013. https://oehha.ca.gov/ prop65/background/p65plain.html. 25. European Commission. 2009. Commission Regulation EC No. 552/2009 Commission Regulation (EC) No 552/ 2009 of 22 June 2009 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on REACH as regards Annex XVII. 26. European Commission. 2010. RAPEX— Latest Notifications. Directorate General for Health and Consumers. https:// ec.europa.eu/consumers/dynex/rapex/ rapex_achives_en.cfm. 27. IARC, 2012. International Agency for the Research on Cancer. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans—Benzidine.Volume 100F: 53–63. 28. Textination, 2012. Textination ‘‘Textile and Apparel Weekly June, 8 2012’’. https://textination.de/en/tiw/2012/ TIW08062012.pdf. 29. Intertek, 2013. Intertek, ‘‘Requirements of Azo dyes and Formaldehyde content in fabric for babies and children clothing in Indonesia’’ Jan 4, 2013. E:\FR\FM\29DER1.SGM 29DER1 77908 Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations 30. HKTDC, 2012. HKTDC Research ‘‘Japan Industry Stipulates Voluntary AZO Dyes Standard for Textile and Leather Products’’ May 22, 2012. 31. Environment Canada. 2009. Strategic options for the management of toxic substances benzidine and 3,3dichlorobenzidine. Available at: https:// www.ec.gc.ca/toxics/docs/sor/bdine/EN/ sum.cfm (Accessed 10 September, 2009). 32. U.S. EPA. Economics and Policy Branch, USEPA/OCSPP/Economics, Exposure, and Technology Division. ‘‘Economic Analysis of the Final Significant New Use Rule for Di-n-pentyl phthalate (DnPP).’’ 33. U.S. EPA. Economics and Policy Branch, USEPA/OCSPP/Economics, Exposure, and Technology Division. ‘‘Economic Analysis of the Final Significant New Use Rule for Alkanes, C12-13, chloro (CAS RN: 71011–12–6).’’ 34. U.S. EPA. Modification of Significant New Use Rules for Certain Substances, 62 FR 42690, August 8, 1997 (FRL–5735– 4). XII. Statutory and Executive Order Reviews mstockstill on DSK4VPTVN1PROD with RULES A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review This final rule has been designated by OMB as a ‘‘significant regulatory action’’ under section 3(f) of Executive Order 12866 (58 FR 51735, October 4, 1993). Accordingly, EPA submitted this action to OMB for review under Executive Order 12866 and 13563 (76 FR 3821, January 21, 2011), and any changes made in response to OMB recommendations are documented in the docket. B. Paperwork Reduction Act (PRA) This action does not impose any new information collection burden under the PRA, 44 U.S.C. 3501 et seq. Burden is defined in 5 CFR 1320.3(b). The information collection activities associated with existing chemical SNURs are already approved by OMB under OMB control number 2070–0038 (EPA ICR No. 1188); and the information collection activities associated with export notifications are already approved by OMB under OMB control number 2070–0030 (EPA ICR No. 0795). If an entity were to submit a SNUN to the agency, the annual burden is estimated to be less than 100 hours per response, and the estimated burden for an export notifications is less than 1.5 hours per notification. In both cases, burden is estimated to be reduced for submitters who have already registered to use the electronic submission system. Additional burden, estimated to be less than 10 hours, could be incurred where additional record keeping requirements VerDate Sep<11>2014 18:05 Dec 24, 2014 Jkt 235001 are specified under 40 CFR 721.125(a), (b), and (c). 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 this SNUR. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of the PRA and OMB’s implementing regulations at 5 CFR part 1320. Since the existing OMB approval was previously subject to public notice and comment before OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend the table 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. C. Regulatory Flexibility Act (RFA) Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., I hereby certify that promulgation of this SNUR will not have a significant economic impact on a substantial number of small entities. The rationale supporting this conclusion is as follows. EPA generally finds that proposed and final SNURs are not expected to have a significant economic impact on a substantial number of small entities (See, e.g., Ref. 34). Since these SNURs will require a person who intends to engage in such activity in the future to first notify EPA by submitting a SNUN, no economic impact will occur unless someone files a SNUN to pursue a significant new use in the future or forgoes profits by avoiding or delaying the significant new use. Although some small entities may decide to engage in such activities in the future, EPA cannot presently determine how many, if any, there may be. However, EPA’s experience to date is that, in response to the promulgation of SNURs covering over 1,000 chemical substances, the Agency receives only a handful of notices per year. During the six year period from 2005–2011, only three submitters self-identified as small in their SNUN submission (Refs. 5, 32, 33). EPA believes the cost of submitting a SNUN is relatively small compared to PO 00000 Frm 00076 Fmt 4700 Sfmt 4700 the cost of developing and marketing a chemical new to a firm and that the requirement to submit a SNUN generally does not have a significant economic impact. A SNUR applies to any person (including small or large entities) who intends to engage in any activity described in the rule as a ‘‘significant new use.’’ In the proposed SNUR EPA preliminarily determined, based in part, on the Agency’s market research, that these chemical substances are not being manufactured (including imported) or processed for a significant new use. In the case of the benzidine-based dyes, this preliminary determination also included importation and processing of these chemical substances as part of articles (Ref. 1). EPA received no public comment indicating any ongoing importation of the benzidine-based chemical substances as part of articles or otherwise. Therefore, EPA is finalizing its determination that these uses, including the importation and processing of benzidine-based dyes as part of articles, are new and not ongoing. Thus no small entities presently engage in a significant new use. Therefore, EPA believes that the potential economic impact of complying with this SNUR is not expected to be significant or adversely impact a substantial number of small entities. D. Unfunded Mandates Reform Act (UMRA) 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 reason to believe that any State, local, or Tribal government would be impacted by this rulemaking. As such, EPA has determined that this regulatory action would not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of sections 202, 203, 204, or 205 of UMRA, 2 U.S.C. 1531–1538. E. Executive Order 13132: Federalism This action does 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 (64 FR 43255, August 10, 1999). E:\FR\FM\29DER1.SGM 29DER1 77909 Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments This action does not have Tribal implications because it will not have any effect (i.e., there will be no increase or decrease in authority or jurisdiction) on Tribal governments, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. Thus, Executive Order 13175 (65 FR 67249, November 9, 2000), does not apply to this action. G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because this action is not intended to address environmental health or safety risks for children. H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use This action is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not expected to affect energy supply, distribution, or use. I. National Technology Transfer and Advancement Act (NTTAA) Since this action does not involve any technical standards, section 12(d) of NTTAA, 15 U.S.C. 272 note, does not apply to this action. J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898 (59 FR 7629, February 16, 1994), because EPA has determined that this action will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations. This action does not affect the level of protection provided to human health or the environment. K. Congressional Review Act (CRA) Pursuant to the CRA, 5 U.S.C. 801 et seq., 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 action is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). 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. In § 9.1, add 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 List of Subjects 40 CFR Part 9 Environmental protection, Reporting and recordkeeping requirements. * * * 721.10226 ......................... 721.10227 ......................... * 40 CFR Part 721 Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements. * Dated: December 16, 2014. Wendy C. Hamnett, Director, Office of Pollution Prevention and Toxics. * 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, * * * 2070–0038 2070–0038 * * ■ Therefore, 40 CFR chapter I is amended as follows: * * * * 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. Revise § 721.1660 to read as follows: ■ § 721.1660 Benzidine-based chemical substances. (a) Chemical substances and significant new uses subject to reporting. (1) The benzidine-based chemical substances listed in Table 1 and Table 2 of this section are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. TABLE 1—BENZIDINE-BASED CHEMICAL SUBSTANCES C.I. name C.I. No. Chemical name 117–33–9 ..................... Not available .............. Not available .............. 65150–87–0 ................. Not available .............. Not available .............. 68214–82–4 ................. mstockstill on DSK4VPTVN1PROD with RULES CAS or accession No. Direct Navy BH .......... 22590 ......................... 72379–45–4 ................. Not available .............. Not available .............. Accession No. 21808 .. CAS No. CBI (NA) CBI ............................. CBI ............................. 1,3-Naphthalenedisulfonic acid, 7-hydroxy-8-[2-[4’-[2-(4hydroxyphenyl)diazenyl][1,1’-biphenyl]-4-yl]diazenyl]1,3,6-Naphthalenetrisulfonic acid, 8-hydroxy-7-[2-[4’-[2-(2-hydroxy-1naphthalenyl)diazenyl][1,1’- biphenyl]-4-yl]diazenyl]-, lithium salt (1:3) 2,7-Naphthalenedisulfonic acid, 5-amino-3-[2-[4’-[2-(7-amino-1-hydroxy-3-sulfo-2naphthalenyl)diazenyl][1,1’-biphenyl]-4yl]diazenyl]-4-hydroxy-, sodium salt (1:2) 2,7-Naphthalenedisulfonic acid, 4-amino-5hydroxy-3-[2-[4’-[2-[2-hydroxy-4-[(2methylphenyl)amino]phenyl]diazenyl][1,1’- biphenyl]-4-yl]diazenyl]6-(2-phenyldiazenyl)2,7-Naphthalenedisulfonic acid, 4-amino-5hydroxy [[[(substituted phenylamino)] substituted phenylazo] diphenyl]azo-, phenylazo-, disodium salt. (generic name) VerDate Sep<11>2014 18:05 Dec 24, 2014 Jkt 235001 PO 00000 Frm 00077 Fmt 4700 Sfmt 4700 E:\FR\FM\29DER1.SGM 29DER1 77910 Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations TABLE 1—BENZIDINE-BASED CHEMICAL SUBSTANCES—Continued CAS or accession No. C.I. name C.I. No. Chemical name Accession No. 24921 .. CAS No. CBI ............................. CBI ............................. Accession No. 26256 .. CAS No. CBI (NA) CBI ............................. CBI ............................. Accession No. 26267 .. CAS No. CBI (NA) CBI ............................. CBI ............................. Accession No. 26701 .. CAS No. CBI (NA) CBI ............................. CBI ............................. 4-(Substituted naphthalenyl )azo diphenylyl azo-substituted carbopolycycle azo benzenesulfonic acid, sodium salt. (generic name) 4-(Substituted phenyl)azo biphenylyl azosubstituted carbopolycycloazo benzenesulfonic acid, sodium salt. (generic name) 4-(Substituted phenyl)azo biphenylyl azo substituted carbopolycycle azo benzenesulfonic acid, sodium salt. (generic name) Phenylazoaminohydroxynaphthalenylazobiphenylazo substituted benzene sodium sulfonate. (generic name). TABLE 2—BENZIDINE-BASED CHEMICAL SUBSTANCES C.I. name C.I. No. Chemical name 92–87–5 .................. 531–85–1 ................ 573–58–0 ................ Benzidine .............. Benzidine · 2HCl ... C.I. Direct Red 28 Not available ......... Not available ......... 22120 .................... 1937–37–7 .............. C.I. Direct Black 38 30235 .................... 2302–97–8 .............. C.I. Direct Red 44 22500 .................... 2429–73–4 .............. C.I. Direct Blue 2 .. 22590 .................... 2429–79–0 .............. C.I. Direct Orange 8. C.I. Direct Brown 31. 22130 .................... 2429–81–4 .............. 2429–82–5 .............. C.I. Direct Brown 2 22311 .................... 2429–83–6 .............. Direct Black 4 ....... 30245 .................... 2429–84–7 .............. C.I. Direct Red 1 ... 22310 .................... 2586–58–5 .............. C.I. Direct Brown 1:2. 30110 .................... 2602–46–2 .............. C.I. Direct Blue 6 .. 22610 .................... 2893–80–3 .............. C.I. Direct Brown 6 30140 .................... 3530–19–6 .............. C.I. Direct Red 37 22240 .................... 3567–65–5 .............. C.I. Acid Red 85 ... 22245 .................... 3626–28–6 .............. C.I. Direct Green 1 30280 .................... 3811–71–0 .............. C.I. Direct Brown 1 30045 .................... 4335–09–5 .............. C.I. Direct Green 6 30295 .................... 6358–80–1 .............. C.I. Acid Black 94 30336 .................... 6360–29–8 .............. mstockstill on DSK4VPTVN1PROD with RULES CAS No. C.I. Direct Brown 27. C.I. Direct Brown 154. C.I. Direct Brown 74. 31725 .................... C.I. Direct Brown 95. 30145 .................... [1,1′-Biphenyl]-4,4′-diamine. [1,1′-Biphenyl]-4,4′-diamine, dihydrochloride. 1- Naphthalenesulfonic acid, 3,3′-[[1,1′-biphenyl]-4,4′-diylbis(azo)]bis[4-amino-, disodium salt. 2,7-Naphthalenedisulfonic acid, 4-amino-3-[[4′-[(2,4-diaminophenyl) azo][1,1′biphenyl]-4- yl]azo]-5-hydroxy-6-(phenylazo)-, disodium salt. 1-Naphthalenesulfonic acid, 8,8′-[[1,1′-biphenyl]-4,4′-diylbis(azo)]bis[7-hydroxy-, disodium salt. 2,7-Naphthalenedisulfonic acid, 5-amino-3-[[4′-[(7-amino-1-hydroxy-3-sulfo-2naphthalenyl)azo][1,1′-biphenyl]-4-yl]azo]-4-hydroxy-, trisodium salt. Benzoic acid, 5-[[4′-[(1-amino-4-sulfo-2-naphthalenyl) azo][1,1′-biphenyl]-4yl]azo]-2- hydroxy-, disodium salt. Benzoic acid, 5-[[4′-[[2,6-diamino-3-[[8-hydroxy-3,6-disulfo-7-[(4-sulfo-1naphthalenyl)azo]-2- naphthalenyl]azo]-5-methylphenyl]azo][1,1′- biphenyl]4-yl]azo]-2-hydroxy-, tetrasodium salt. Benzoic acid, 5-[[4′-[(7-amino-1-hydroxy-3-sulfo-2-naphthalenyl) azo][1,1′biphenyl]-4-yl]azo]-2-hydroxy-, disodium salt. 2,7-Naphthalenedisulfonic acid, 4-amino-3-[[4′-[(2,4-diamino-5methylphenyl)azo][1,1′-biphenyl]-4-yl]azo] -5-hydroxy-6-(phenylazo)-, disodium salt. Benzoic acid, 5-[[4′-[(2-amino-8-hydroxy-6-sulfo-1-naphthalenyl)azo][1,1′biphenyl]-4-yl]azo]-2-hydroxy-, disodium salt. Benzoic acid, 5-[[4′-[[2,6-diamino-3-methyl-5-[(4sulfophenyl)azo]phenyl]azo][1,1′-biphenyl]-4- yl]azo]-2-hydroxy-, disodium salt. 2,7-Naphthalenedisulfonic acid, 3,3′-[[1,1′-biphenyl]-4,4′-diylbis(azo)]bis[5amino-4-hydroxy-, tetrasodium salt. Benzoic acid, 5-[[4′-[[2,4-dihydroxy-3-[(4-sulfophenyl) azo]phenyl]azo][1,1′biphenyl]-4- yl]azo]-2-hydroxy-, disodium salt. 1,3-Naphthalenedisulfonic acid, 8-[[4′-[(4-ethoxyphenyl)azo][1,1′-biphenyl]-4yl]azo]-7-hydroxy-, disodium salt 1,3-Naphthalenedisulfonic acid, 7-hydroxy-8-[[4′-[[4-[[(4methylphenyl)sulfonyl]oxy]phenyl]azo][1,1′-biphenyl]-4-yl]azo]-, disodium salt. 2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-3-[[4′-[(4hydroxyphenyl)azo][1,1′- biphenyl]-4- yl]azo]-6-(phenylazo)-, disodium salt. Benzoic acid, 5-[[4′-[[2,4-diamino-5-[(4-sulfophenyl) azo]phenyl]azo][1,1′ biphenyl]-4- yl]azo]-2-hydroxy-, disodium salt. 2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-6-[[4′-[(4hydroxyphenyl)azo][1,1′-biphenyl]-4- yl]azo]-3-[(4-nitrophenyl)azo]-, disodium salt. 2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-3-[[4′-[[4-hydroxy-2-[(2methylphenyl)amino]phenyl]azo] [1,1′- biphenyl]-4-yl]azo]-6-[(4-sulfophenyl) azo]-, trisodium salt. Benzoic acid, 5-[[4′-[[4-[(4-amino-7-sulfo-1-naphthalenyl)azo]-6-sulfo-1naphthalenyl]azo][1,1′-biphenyl]-4-yl] azo]-2- hydroxy-, trisodium salt. Benzoic acid, 5-[[4′-[[2,6-diamino-3-methyl-5-[(4-sulfophenyl)azo]phenyl] azo][1,1′-biphenyl]-4-yl]azo]-2- hydroxy-3-methyl-, disodium salt. Benzoic acid, 3,3′-[(3,7-disulfo-1,5-naphthalenediyl)bis [azo(6-hydroxy-3,1phenylene)azo[6(or7)-sulfo-4,1-naphthalenediyl]azo[1,1′-biphenyl]-4,4′diylazo]]bis[6-hydroxy-, hexasodium salt. Cuprate(2-), [5-[[4′-[[2,6-dihydroxy-3-[(2-hydroxy-5-sulfophenyl)azo]phenyl] azo][1,1′- biphenyl]-4-yl]azo]-2-hydroxybenzoato(4-)]-, disodium salt. 6360–54–9 .............. 8014–91–3 .............. 16071–86–6 ............ VerDate Sep<11>2014 18:05 Dec 24, 2014 Jkt 235001 35660 .................... 30120 .................... 36300 .................... PO 00000 Frm 00078 Fmt 4700 Sfmt 4700 E:\FR\FM\29DER1.SGM 29DER1 Federal Register / Vol. 79, No. 248 / Monday, December 29, 2014 / Rules and Regulations (2) The significant new uses are: (i) For each of the chemical substances listed in Table 2 of this section, any use other than use as a reagent to test for hydrogen peroxide in milk; a reagent to test for hydrogen sulfate, hydrogen cyanide, and nicotine; a stain in microscopy; a reagent for detecting blood; an analytical standard; and, additionally for Colour Index (C.I.) Direct Red 28 (Congo Red) (CAS No. 573–58–0), an indicator dye. (ii) For the chemical substances listed in Table 1 of this section: Any use. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Revocation of certain notification exemptions. The provisions of § 721.45(f) do not apply to this section. A person who imports or processes a chemical substance identified in paragraph (a)(1) of this section as part of an article for a significant new use described in paragraph (a)(2) of this section is not exempt from submitting a significant new use notice. (2) [Reserved] ■ 5. Add § 721.10226 to subpart E to read as follows: § 721.10226 Di-n-pentyl phthalate (DnPP). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as di-n-pentyl phthalate (DnPP) (1,2benzenedicarboxylic acid, 1,2-dipentyl ester) (CAS No. 131–18–0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new use is: Any use other than use as a chemical standard for analytical experiments. (b) [Reserved] ■ 6. Add § 721.10227 to subpart E to read as follows: mstockstill on DSK4VPTVN1PROD with RULES § 721.10227 Alkanes, C12-13, chloro (CAS No. 71011–12–6). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as alkanes, C12-13, chloro (CAS No. 71011– 12–6) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. (2) The significant new use is: Any use. (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). (1) Persons who must report. Section 721.5 applies to this section except for § 721.5(a)(2). A person who intends to manufacture for commercial purposes a VerDate Sep<11>2014 21:03 Dec 24, 2014 Jkt 235001 substance identified in paragraph (a)(1) of this section and intends to distribute the substance in commerce must submit a significant new use notice. (2) [Reserved] [FR Doc. 2014–29887 Filed 12–24–14; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA–R03–OAR–2014–0409; FRL–9920–68– Region–3] Approval and Promulgation of Air Quality Implementation Plan; Pennsylvania; Determination of Attainment for the 2008 Lead National Ambient Air Quality Standard for the Lyons Nonattainment Area Environmental Protection Agency. ACTION: Final rule. AGENCY: The Environmental Protection Agency (EPA) is taking final action to determine that the Lyons, Pennsylvania nonattainment area (hereafter referred to as the ‘‘Lyons Area’’ or ‘‘Area’’) has attained the 2008 lead (Pb) national ambient air quality standard (NAAQS). On March 31, 2014, the Commonwealth of Pennsylvania, through the Pennsylvania Department of Environmental Protection, submitted a request to EPA to make a determination that the Lyons Area has attained the 2008 Pb NAAQS. This determination of attainment is based upon certified, quality-assured, and quality-controlled ambient air monitoring data from 2011– 2013 which shows that the Area has monitored attainment for the 2008 Pb NAAQS. Additionally, as a result of this determination, EPA is taking final action to suspend the requirements for the Area to submit an attainment demonstration, together with reasonably available control measures (RACM), a reasonable further progress (RFP) plan, and contingency measures for failure to meet RFP or attainment deadlines for so long as the Area continues to attain the 2008 Pb NAAQS. This determination does not constitute a redesignation to attainment. The Lyons Area will remain designated nonattainment for the 2008 Pb NAAQS until such time as EPA determines that the Lyons Area meets the Clean Air Act (CAA) requirements for redesignation to attainment, including an approved maintenance plan. These actions are being taken under the Clean Air Act (CAA). DATES: This final rule is effective on January 28, 2015. SUMMARY: PO 00000 Frm 00079 Fmt 4700 Sfmt 4700 77911 EPA has established a docket for this action under Docket ID Number EPA–R03–OAR–2014–0409. All documents in the docket are listed in the www.regulations.gov. Although listed in the electronic docket, some information is not publicly available, i.e., confidential business information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through www.regulations.gov or in hard copy for public inspection during normal business hours at the Air Protection Division, U.S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. FOR FURTHER INFORMATION CONTACT: Ellen Schmitt, (215) 814–5787, or by email at schmitt.ellen@epa.gov. SUPPLEMENTARY INFORMATION: ADDRESSES: I. Background On August 7, 2014 (79 FR 46211), EPA published a notice of proposed rulemaking (NPR) for the Commonwealth of Pennsylvania. In the August 7, 2014 NPR, EPA proposed to make a clean data determination, finding that the Lyons Area has attained the 2008 Pb NAAQS, based on certified, quality-assured, and quality-controlled ambient air monitoring data from 2011– 2013. The Lyons Area is located in Berks County, Pennsylvania and bounded by Kutztown Borough, Lyons Borough, Maxatawny Township, and Richmond Township. See 40 CFR 81.339. II. Summary of Rulemaking Action EPA is taking final action to determine that the Lyons Area has attaining data for the 2008 Pb NAAQS. This determination of attainment is based upon certified, quality-assured, and quality-controlled air monitoring data that shows the Area has monitored attainment of the 2008 Pb NAAQS based on 2011–2013 data. Other specific requirements of the determination of attainment and the rationale for EPA’s action are explained in the NPR published on August 7, 2014 (79 FR 46211) as well as in the Technical Support Document (TSD) that accompanied the NPR, and will not be restated here. The TSD is available in the docket for this rulemaking action at www.regulations.gov. III. Effect of This Action This final action suspends the requirements for the Lyons Area to E:\FR\FM\29DER1.SGM 29DER1

Agencies

ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 79, Number 248 (Monday, December 29, 2014)]
[Rules and Regulations]
[Pages 77891-77911]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-29887]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[EPA-HQ-OPPT-2010-0573; FRL-9915-60]
RIN 2070-AJ73

Benzidine-Based Chemical Substances; Di-n-pentyl Phthalate
(DnPP); and Alkanes, C12-13, Chloro; Significant New Use Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: Under the Toxic Substances Control Act (TSCA), EPA is
promulgating a significant new use rule (SNUR) to add nine benzidine-
based chemical substances to the existing SNUR on benzidine-based
chemical substances. With respect to both the newly-added benzidine-
based chemical substances and the previously-listed benzidine-based
chemical substances, this rule makes inapplicable the exemption
relating to persons that import or process substances as part of an
article. EPA is also promulgating a SNUR for di-n-pentyl phthalate
(DnPP) and a SNUR for alkanes, C12-13, chloro. These actions
require persons who intend to manufacture (defined by statute to
include import) or process these chemical substances for an activity
that is designated as a significant new use to notify EPA at least 90
days before commencing such manufacture or processing. The required
notifications will provide EPA with the opportunity to evaluate
activities associated with a significant new use and, if necessary
based on the information available at that time, an opportunity to
protect against potential unreasonable risks, if any, from that
activity before it occurs. EPA is also making a technical amendment to
the codified list of control numbers for approved information
collection activities so that it includes the control number assigned
by the Office of Management and Budget (OMB) to the information
collection activities contained in this rule.

DATES: This final rule is effective February 27, 2015.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPPT-2010-0573, is available at
https://www.regulations.gov or at the Office of Pollution Prevention and
Toxics Docket (OPPT Docket), EPA Docket Center (EPA/DC), EPA West
Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPPT
Docket is (202) 566-0280. Please review the visitor instructions and
additional information about the docket available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
For technical information contact: Sara Kemme, National Program
Chemicals Division (7404T), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; telephone number: (202) 566-0511; email
address: kemme.sara@epa.gov.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

These three different SNURs may apply to different entities. 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.
1. Benzidine-based chemical substances. You may be potentially
affected by this action if you manufacture (defined by statute to
include import), or process, including as part of an article, any of
the benzidine-based chemical substances listed in Tables 1 and 2 of the
regulatory text in this document. Potentially affected entities may
include, but are not limited to:
Manufacturers or processors of one or more of the subject
chemical substances.
Entities which plan to use the listed chemical substances
in conjunction with apparel and other finished products made from
fabrics, leather, and similar materials.
Entities which plan to use the listed chemical substances
in conjunction with paper and allied products.
Manufacturers or processors of the subject chemical
substances in printing inks. These entities may include those described
by the NAICS codes 325--chemical manufacturing, 31--textile
manufacturers, 316--leather and allied products manufacturers, 322--
paper manufacturers, 4243 apparel, piece goods, and notions
wholesalers, or 443--clothing and accessories stores.
2. DnPP. You may be potentially affected by this action if you
manufacture (defined by statute to include import), or process DnPP.
Potentially affected entities may include, but are not limited to:
Chemical industry--plastic material and resins (NAICS code 325211).
3. Alkanes, C12-13, chloro (CAS No. 71011-12-6). You may be
potentially affected by this action if you manufacture or process the
following short-chained chlorinated paraffin (SCCP): Alkanes,
C12-13, chloro (CAS No. 71011-12-6). Potentially affected
entities may include, but are not limited to: Manufacturers of SCCPs
(NAICS codes 325 and 325998), chemical manufacturing; including
miscellaneous chemical product and preparation manufacturing; and
processors of SCCPs (NAICS codes 324 and 324191), petroleum lubricating
oil and grease manufacturing.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Persons
who import any chemical substance governed by a final SNUR are subject
to the TSCA section 13 (15 U.S.C. 2612) import

[[Page 77892]]

certification requirements and the corresponding regulations at 19 CFR
12.118 through 12.127; see also 19 CFR 127.28. Those persons must
certify that the shipment of the chemical substance complies with all
applicable rules and orders under TSCA, including any SNUR
requirements. The EPA policy in support of import certification appears
at 40 CFR part 707, subpart B. In addition, any persons who export or
intend to export a chemical substance that is the subject of a proposed
or final SNUR are subject to the export notification provisions of TSCA
section 12(b) (15 U.S.C. 2611(b)) (see 40 CFR 721.20) and must comply
with the export notification requirements in 40 CFR part 707, subpart
D.
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 for SNUR-related obligations and with respect to benzidine-
based chemical substances, the applicability provisions in Unit V. 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. 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 significant
new use notice (SNUN) to EPA at least 90 days before they manufacture
or process the chemical substance for that use (15 U.S.C.
2604(a)(1)(B)). As described in Unit V., the general SNUR provisions
are found at 40 CFR part 721, subpart A.

C. What action is the agency taking?

In a Federal Register proposed rule published on March 28, 2012 (77
FR 18752) (FRL-8865-2), EPA proposed three chemical specific SNURs
being addressed in this final rule (Ref. 1). EPA's response to public
comments received on the proposed rule appears in Unit X. Please
consult the March 28, 2012 Federal Register proposed rule (Ref. 1) for
further background information for this final rule.
These final SNURs will require persons to notify EPA at least 90
days before commencing the manufacture (including import) or processing
of:
The nine benzidine-based chemical substances identified in
Table A of Unit II., which are being added to 40 CFR 721.1660 with a
designation of any use as a significant new use;
DnPP with a designation of any use other than as a
chemical standard for analytical experiments as a significant new use;
and
Alkanes, C12-13, chloro (CAS No. 71011-12-6) with a
designation of any use as a significant new use.
In addition, this final rule amends the SNUR at 40 CFR 721.1660 to
make inapplicable the exemption at 40 CFR 721.45(f) for persons that
import or process benzidine-based chemical substances as part of an
article. For the benzidine-based chemical substances, the elimination
of the article exemption at 40 CFR 721.45(f) will require persons to
notify EPA at least 90 days before commencing processing or importing
as part of an article any of the newly-added benzidine-based chemical
substances, as well as those already covered (61 FR 52287, October 7,
1996 (FRL-5396-6), codified at 40 CFR 721.1660) (Ref. 2).

D. Why is the agency taking this action?

These SNURs are necessary to ensure that EPA receives timely
advance notice of any future manufacturing and processing of these
chemical substances for new uses that may produce changes in human and
environmental exposures. The rationale and objectives for this SNUR are
explained in Unit III.

E. What are the estimated incremental impacts of this action?

EPA has evaluated the potential costs of establishing SNUR
reporting requirements for potential manufacturers and processors of
the chemical substances included in this final rule. This analysis,
which is available in the docket, is discussed in Unit IX., and is
briefly summarized here. In the event that a SNUN is submitted, costs
are estimated to be less than $8,700 per SNUN submission for large
business submitters and $6,300 for small business submitters. These
estimates include the cost to prepare and submit the SNUN and the
payment of a user fee. In addition, for persons exporting a substance
that is the subject of a SNUR, a one-time notice must be provided for
the first export or intended export to a particular country, which is
estimated to cost less than $100 on average per notification. The rule
may also affect firms that import or process articles that may contain
benzidine-based chemicals, because, while not required by the SNUR,
these parties may take additional steps to determine whether benzidine-
based chemicals are part of the articles that they are considering to
import or process. Since EPA is unable to predict whether anyone might
engage in future activities that would require reporting, potential
total costs were not estimated.

II. Overview of the Chemical Substances Subject to This Rule

The SNURs in this final rule involve certain benzidine-based
chemical substances in the existing SNUR at 40 CFR 721.1660 (Ref. 1),
the nine benzidine-based chemical substances listed in Table A of this
unit, DnPP (CAS No. 131-18-0), and alkanes, C12-13, chloro (CAS No.
71011-12-6).

Table A--Newly Added Benzidine-Based Chemical Substances
----------------------------------------------------------------------------------------------------------------
CAS or accession No. C.I. name C.I. No. Chemical name
----------------------------------------------------------------------------------------------------------------
117-33-9........................... Not available......... Not available......... 1,3-Naphthalenedisulfonic
acid, 7-hydroxy-8-[2-[4'-
[2-(4-
hydroxyphenyl)diazenyl][1,
1'- biphenyl]-4-
yl]diazenyl]-.
65150-87-0......................... Not available......... Not available......... 1,3,6-
Naphthalenetrisulfonic
acid, 8-hydroxy-7-[2-[4'-
[2-(2-hydroxy-1-
naphthalenyl)diazenyl][1,1
'-biphenyl]-4-yl]diazenyl]-
, lithium salt (1:3).
68214-82-4......................... Direct Navy BH........ Not available......... 2,7-Naphthalenedisulfonic
acid, 5-amino-3-[2-[4'-[2-
(7-amino-1-hydroxy-3-sulfo-
2-
naphthalenyl)diazenyl][1,1
'-biphenyl]-4-
yl]diazenyl]-4-hydroxy-,
sodium salt (1:2).
72379-45-4......................... Not available......... Not available......... 2,7-Naphthalenedisulfonic
acid, 4-amino-5-hydroxy-3-
[2-[4'-[2-[2-hydroxy-4-[(2-
methylphenyl)amino]
phenyl]diazenyl][1,1'-
biphenyl]-4-yl]diazenyl]-6-
(2- phenyldiazenyl)-.

[[Page 77893]]

Accession No. 21808................ CBI................... CBI................... 2,7-Naphthalenedisulfonic
CAS No. CBI (NA)................... acid, 4-amino-5-hydroxy
[[[(substituted
phenylamino)] substituted
phenylazo] diphenyl]azo-,
phenylazo-, disodium salt.
(generic name).
Accession No. 24921................ CBI................... CBI................... 4-(Substituted
CAS No. CBI (NA)................... naphthalenyl)azo
diphenylyl
azo-substituted
carbopolycycle azo
benzenesulfonic acid,
sodium salt. (generic
name).
Accession No. 26256................ CBI................... CBI................... 4-(Substituted phenyl)azo
CAS No. CBI (NA)................... biphenylyl azo-substituted
carbopolycycloazo
benzenesulfonic acid,
sodium salt. (generic
name)
Accession No. 26267................ CBI................... CBI................... 4-(Substituted phenyl)azo
CAS No. CBI (NA)................... biphenylyl azo-substituted
carbopolycycle azo
benzenesulfonic acid,
sodium salt. (generic
name).
Accession No. 26701................ CBI................... CBI................... Phenylazoaminohydroxynaphth
CAS No. CBI (NA)................... alenylazobiphenylazo
substituted benzene sodium
sulfonate. (generic name).
----------------------------------------------------------------------------------------------------------------
CAS = Chemical Abstracts Services. CBI = Confidential Business Information. CBI (NA) = Confidential Business
Information (Not Available). C.I. = Chemical Index.

III. Rationale and Objectives

A. Rationale

Consistent with EPA's past practice for issuing SNURs under TSCA
section 5(a)(2), EPA's decision to issue a SNUR for a particular
chemical use need not be based on an extensive evaluation of the
hazard, exposure, or potential risk associated with that use. Rather,
the Agency's action is based on EPA's determination that if the use
begins or resumes, it may present a risk that EPA should evaluate under
TSCA before the manufacturing or processing for that use begins. Since
the new use does not currently exist, deferring a detailed
consideration of potential risks or hazards related to that use is an
effective use of resources. If a person decides to begin manufacturing
or processing the chemical for the use, the notice to EPA allows EPA to
evaluate the use according to the specific parameters and circumstances
surrounding that intended use.
1. Benzidine-based chemical substances. As described in the
proposal (Ref. 1), EPA is concerned about potential carcinogenic
effects on workers and consumers from the manufacture, processing, or
use of these substances. Consumers exposed via dermal exposure to
consumer products containing the benzidine-based chemical substances
are a particular concern because enzymes present in the human body and
in bacteria on the skin aid in the reduction of these chemical
substances to the benzidine unit, an established human carcinogen (Ref.
3). The main consumer products that could result in dermal exposure if
containing these chemical substances include textiles and leather
products because they are in prolonged contact with human skin.
During the review of information on benzidine-based chemical
substances, EPA determined that the newly identified chemical
substances that are being added to 40 CFR 721.1660 by this final rule
present the same concerns (Ref. 4) as those of the benzidine-based
chemical substances already listed in the rule ((Ref. 2)), codified at
40 CFR 721.1660). EPA does not believe there is any current use of
these nine benzidine-based chemical substances within or outside the
United States. This conclusion is based on a review of EPA's own
Inventory Update Reporting (IUR) data, and more recent Chemical Data
Reporting (CDR) data as well as other sources including the Colour
Index International, published by the Society of Dyers and Colourists
and American Association of Textile Chemists and Colorists; IHS
Chemical Economics Handbook, Dyes; and ICIS Directory of World Chemical
Producers.
In addition, as discussed earlier, although some of the benzidine-
based chemical substances subject to the 1996 SNUR may be manufactured
or processed outside the United States, an analysis of the benzidine-
based chemical substances market (Ref. 4) revealed no information
indicating import of articles containing benzidine-based chemical
substances for non-excluded purposes.
Although it appears there is no ongoing domestic manufacture of the
nine newly added benzidine-based chemical substances, or import for a
non-excluded use of articles containing any benzidine-based chemical
substances, the manufacture (including import) or processing of the
nine newly added benzidine-based chemical substances and the import or
processing of articles containing any benzidine-based chemical
substances may begin at any time, without prior notice to EPA. Thus,
EPA is concerned that commencement of the manufacture (including
import) or processing for any new uses, including resumption of past
uses, of benzidine-based chemical substances could significantly
increase the magnitude and duration of exposure to humans over that
which would otherwise exist currently. EPA is concerned that such an
increase should not occur without an opportunity for the Agency to
evaluate activities associated with a significant new use and an
opportunity to protect against potential unreasonable risks, if any,
from exposure to the chemical substance.
Accordingly, EPA is finalizing a SNUR for the nine benzidine-based
chemical substances by adding them to those currently listed at 40 CFR
721.1660, and making inapplicable the article exemption at 40 CFR
721.45(f) for those chemical substances newly added in this rulemaking
as well as for those already listed at 40 CFR 721.1660. This final rule
will require persons who intend to manufacture (including import) or
process any of the benzidine-based chemical substances for a non-
excluded use, including importing or processing any listed benzidine-
based chemical substance for a non-excluded use as part of an article,
to submit a SNUN.
2. DnPP. As described in the proposal (Ref. 1), EPA has concerns
regarding potential adverse human health and environmental effects that
may be caused by DnPP. EPA has direct information from animal studies
that DnPP specifically can elicit developmental/reproductive effects
that are relevant to human health and also indicate potential effects
in wildlife. EPA also is concerned that due to its general structure
and categorization as a phthalate that DnPP may elicit adverse
environmental effects similar to those

[[Page 77894]]

described for other phthalates. EPA is concerned that any manufacturing
(including import) or processing of DnPP, beyond that for its limited
ongoing use as a chemical standard for laboratory use, could
significantly increase the magnitude and duration of exposure to humans
over that which would otherwise exist currently. EPA is concerned that
such an increase should not occur without an opportunity to evaluate
activities associated with a significant new use and an opportunity to
protect against potential unreasonable risks, if any, from exposure to
the chemical substance. Accordingly, EPA is finalizing a SNUR for DnPP
that would designate, as a significant new use, any use of the chemical
substance other than use as a chemical standard for analytical
experiments. A person who intends to manufacture or process DnPP for
use other than use as a chemical standard for analytical experiments
would be required to submit a SNUN.
3. Alkanes, C12-13, chloro (CAS No. 71011-12-6). As described in
the proposal (Ref. 1), EPA has a primary concern regarding adverse
environmental effects that may be caused by alkanes, C12-13, chloro
(CAS No. 71011-12-6), one type of SCCP. For example, alkanes, C12-13,
chloro, have been shown to be highly toxic to aquatic invertebrates
following acute and chronic exposures and to fish following chronic
exposures. EPA also has concerns about the persistence and
bioaccumulation potential of SCCPs, including alkanes, C12-13, chloro,
since these substances have been measured in a variety of biota (i.e.,
freshwater aquatic species, marine mammals, and avian and terrestrial
wildlife) and have also been measured in human breast milk from Canada
and the United Kingdom. The mechanisms or pathways by which SCCPs,
including alkanes, C12-13, chloro (CAS No. 71011-12-6), move into and
through the environment and humans are not fully understood, but are
likely to include releases from manufacturing of the chemicals,
manufacturing of products like plastics or textiles, aging and wear of
products like sofas and electronics, and releases at the end of product
life (e.g., disposal, recycling).
EPA believes that all manufacture and processing into the United
States of alkanes, C12-13, chloro (CAS No. 71011-12-6) has ceased.
Given that EPA has no evidence to suggest that there is any manufacture
or processing of this chemical substance in the United States, and
taking into consideration the negative commercial and regulatory
environment associated with this chemical internationally (including
the European Union (EU) and Canadian ban on marketing) and use of the
alkanes, C12-13, chloro (CAS No. 71011-12-6) domestically, EPA does not
expect to find such activity. However, EPA is concerned that
commencement of the manufacture or processing for any new uses,
including resumption of past uses, could significantly increase the
magnitude and duration of exposure to humans over that which would
otherwise exist. EPA is concerned that such an increase should not
occur without an opportunity to evaluate activities associated with a
significant new use and an opportunity to protect against potential
unreasonable risks, if any, from exposure to the chemical substance.
Accordingly, EPA is finalizing a SNUR for alkanes, C12-13, chloro (CAS
No. 71011-12-6) that designates as a significant new use any use of the
chemical substance. This SNUR requires a person who intends to
manufacture or process alkanes, C12-13, chloro (CAS No. 71011-12-6) for
any use to submit a SNUN.

B. Objectives

Based on the considerations described in the proposal (Ref. 1) and
in the response to public comments, EPA expects to achieve the
following objectives with regard to the significant new uses that are
designated in this final rule:
1. EPA will receive notice of any person's intent to manufacture or
process the specified chemicals for the described significant new uses
before that activity begins;
2. EPA will have an opportunity to review and evaluate data
submitted in the SNUN before the notice submitter begins manufacturing
or processing of the specified chemicals for the described significant
new use;
3. EPA will be able to regulate prospective uses of the specified
chemicals before the described significant new uses occur, provided
that regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6 or
7; and
4. EPA would receive a notice alerting the Agency to a reversal of
an industry trend toward deselecting for a chemical.

IV. 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 authorizes EPA to consider any other relevant factors.
To determine what constitutes a significant new use of the
benzidine-based chemical substances, DnPP, and alkanes, C12-13, chloro
(CAS No. 71011-12-6) subject to this rule, EPA considered relevant
information about the toxicity of these substances, likely human
exposures and environmental releases associated with possible uses, and
the four factors listed in section 5(a)(2) of TSCA. EPA has determined
that the manufacture or processing, of any of the benzidine-based
chemical substances subject to the 1996 SNUR or being newly added to 40
CFR 721.1660 by this final rule, except for ongoing uses specified in
40 CFR 721.1660(a)(2)(i) of the regulatory text in this document, is a
significant new use. EPA has also determined that the manufacture or
processing of DnPP for any use other than use as a chemical standard
for analytical experiments is a significant new use, and the
manufacture or processing of alkanes, C12-13, chloro (CAS No. 71011-12-
6) for any use is a significant new use.

V. Applicability of the General Provisions

General provisions for SNURs appear under 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 final
rule.
Provisions relating to user fees appear at 40 CFR part 700.
According to 40 CFR 721.1(c), persons subject to SNURs must comply with
the same notice requirements and EPA regulatory procedures as
submitters of Premanufacture Notices (PMNs) under TSCA section
5(a)(1)(A). In particular, these requirements include the information
submissions 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

[[Page 77895]]

on 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.
However, 40 CFR 721.45(f) (which generally exempts persons
importing or processing a substance as part of an article) will not
apply to the benzidine-based chemical substances listed at 40 CFR
721.1660 and those added by this final rule. Therefore, a person who
imports or processes as part of an article a benzidine-based chemical
substance that is covered by this rule would not be exempt from
submitting a SNUN.
Persons who export or 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, subpart D.
Persons who import a chemical substance identified in a final SNUR are
subject to the TSCA section 13 import certification requirements,
codified at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. Those
persons must certify that the shipment of the chemical substance
complies with all applicable rules and orders under TSCA, including any
SNUR requirements. The EPA policy in support of import certification
appears at 40 CFR part 707, subpart B.

VI. Applicability of the Final Rule to Uses Occurring Before the
Effective Date of the Final Rule

As discussed in the Federal Register of April 24, 1990 (55 FR
17376) (FRL-3658-5) (Ref. 5), EPA has decided that the intent of
section 5(a)(1)(B) of TSCA is best served by designating a use as a
significant new use as of the date of publication of the proposed rule
rather than as of the effective date of the final rule. If uses begun
after publication of the proposed rule 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
proposed significant new use before the rule became final, and then
argue that the use was ongoing as of the effective date of the final
rule. Thus, persons who begin the commercial manufacture or processing
of a covered substance as a significant new use have to cease any such
activity as of the effective date of the rule if and when finalized. 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. If a person were to meet the
conditions of advance compliance under 40 CFR 721.45(h), that person
would be considered to have met the requirements of the final SNUR for
those activities.

VII. Test Data and Other Information

EPA recognizes that TSCA section 5 does not require developing any
particular test data before submission of a SNUN. There are two
exceptions:
1. Development of test data is required where the chemical
substance subject to the SNUR is also subject to a test rule under TSCA
section 4 (see TSCA section 5(b)(1)) and
2. Development of test data may be necessary where the chemical
substance has been listed under TSCA section 5(b)(4) (see TSCA section
5(b)(2)).
In the absence of a section 4 test rule or a section 5(b)(4)
listing covering the chemical substance, 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 (15 U.S.C.
2604(d); 40 CFR 721.25, and 40 CFR 720.50). However, as a general
matter, EPA recommends that SNUN submitters include data that would
permit a reasoned evaluation of risks posed by the chemical substance
during its manufacture, import, processing, use, distribution in
commerce, or disposal. EPA encourages persons to consult with the
Agency before submitting a SNUN. As part of this optional pre-notice
consultation, EPA would discuss specific data it believes may be useful
in evaluating a significant new use. SNUNs submitted for significant
new uses without any test data may increase the likelihood that EPA
would take action under TSCA section 5(e) to prohibit or limit
activities associated with this chemical. SNUN submitters should be
aware that EPA will be better able to evaluate SNUNs that provide
detailed information on:
Human exposure and environmental releases that may result
from the significant new uses of the chemical substance.
Potential benefits of the chemical substance.
Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.

VIII. SNUN Submissions

According to 40 CFR 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 40 CFR 720.50. SNUNs must be
on EPA Form No. 7710-25, generated using e-PMN software, and submitted
to the Agency in accordance with the procedures set forth in 40 CFR
721.25 and 720.40. E-PMN software is available electronically at https://www.epa.gov/opptintr/newchems.

IX. Economic Analysis

A. SNUNs

EPA has evaluated the potential costs of establishing SNUR
reporting requirements for potential manufacturers and processors of
these chemicals and for articles containing any of the benzidine-based
chemical substances included in the 1996 SNUR and those newly added by
this final rule when imported or processed as part of an article. These
economic analyses, which are briefly summarized here, are available in
the docket for this rule. EPA added additional information to the
economic analysis for the benzidine-based chemical substances in
response to public comments.
The costs of submission of a SNUN would be incurred when a company
decides to pursue a significant new use of one of these chemicals. In
the event that a SNUN is submitted, costs are estimated at
approximately $8,600 per SNUN submission, and include the cost for
preparing and submitting the SNUN, recordkeeping, and the payment of a
user fee. Businesses that submit a SNUN are either subject to a $2,500
user fee required by 40 CFR 700.45(b)(2)(iii), or, if they are a small
business with annual sales of less than $40 million when combined with
those of the parent company (if any), a reduced user fee of $100 (40
CFR 700.45(b)(1)). In its evaluation of this final rule, EPA also
considered the potential costs a company might incur by avoiding or
delaying the significant new use in the future, but these costs have
not been quantified.

B. Export Notification

EPA regulations under TSCA section 12(b) (15 U.S.C. 2611(b)) at 40
CFR part 707, subpart D require that, for chemicals subject to a
proposed or final SNUR, a company notify EPA of the first export or
intended export to a particular country of an affected chemical
substance. EPA estimated that the one-time cost of preparing and
submitting an export notification to be $84. The total costs of export
notification would vary per chemical, depending on the number of
required notifications (i.e., number of countries to which the chemical
is exported).

[[Page 77896]]

C. Import or Processing Benzidine-Based Chemical Substances as Part of
an Article

In the case of the benzidine-based chemical substances, this rule
makes inapplicable the exemption relating to persons that import or
process substances as part of an article. In the proposed rule EPA
preliminarily determined, based on the Agency's market research, that
there was no ongoing manufacturing (including import) or processing of
these chemical substances for significant new uses as part of articles
or otherwise. For the nine newly-added benzidine-based chemical
substances, EPA found no evidence of manufacture either domestically or
abroad, and thus also no evidence of importation or processing of these
chemical substances as part of articles (Ref. 1). For the majority of
the 24 previously listed benzidine-based chemical substances, EPA found
no evidence of manufacture, either domestically or abroad. While EPA
found that some of the previously listed benzidine-based chemical
substances were being manufactured domestically for discrete uses that
are not subject to this SNUR, EPA found no evidence that these chemical
substances were being imported or processed as part of articles (Ref.
1). EPA received no public comments indicating otherwise. Based on the
global trend away from using these chemical substances, the fact that
they are regulated in numerous jurisdictions, and the absence of public
comments indicating their ongoing use for significant new uses, EPA is
finalizing its determination that these benzidine-based chemical
substances are not being manufactured (including import) or processed
for a significant new use as part of articles or otherwise.
However, the rule may affect firms that plan to import or process
types of articles that benzidine-based chemicals are potentially a part
of. Some firms have an understanding of the contents of the articles
they import or process. However, EPA acknowledges that importers and
processors of articles may have varying levels of knowledge about the
chemical content of the articles that they import or process. These
parties may need to become familiar with the requirements of the rule.
And, while not required by the SNUR, these parties may take additional
steps to determine whether benzidine-based chemicals are part of the
articles that they are considering to import or process. This
determination may involve activities such as gathering information from
suppliers along the supply chain, and/or testing samples of the article
itself. Costs vary across the activities chosen and the extent of
familiarity a firm has regarding the articles it imports or processes.
Cost ranges are presented in the ``Economic Analysis of the Final
Significant New Use Rule for Nine Benzidine Based Chemical Substances''
(Ref. 4). Given existing regulatory limitations on certain benzidine-
based substances both internationally and within the U.S., industry-
wide processes, resources that support companies in understanding and
managing their supply chains, and evidence showing minimal worldwide
availability of the dyes regulated under the SNUR, EPA believes that
article importers that choose to investigate their products would incur
costs at the lower end of the ranges presented in the Economic Analysis
as a result of this rule. For those companies choosing to undertake
actions to assess the composition of the articles they import or
process, EPA expects that in all likelihood, these importers and
processors would take actions that are commensurate with the company's
perceived likelihood that a chemical substance might be a part of an
article they intend to import into the United States and the resources
it has available.

X. Response to Public Comment

The Agency reviewed and considered all comments received related to
the proposed rule. Copies of all non-CBI comments are available in the
docket for this action. A discussion of the major comments germane to
the rulemaking and the Agency's responses follow

A. Legal Authority To Make Inapplicable the Exemption for Persons Who
Import or Process Chemical Substances as Part of Articles

One commenter suggests that if chemical substances are not exempted
from the SNUR at the point they are incorporated into articles, then
EPA should consider whether it is inappropriately regulating ``articles
under the chemical management authorities of TSCA,'' (emphasis
original) inconsistent with Congressional intent in enacting TSCA. The
commenter argues further that the regulation of articles is not the
primary purpose of TSCA and that such regulation should be addressed by
other agencies operating under other statutes such as the Occupational
Safety and Health Act of 1970 and the Consumer Product Safety Act of
1972. Another comment raises similar issues.
EPA responded that the SNUR for benzidine-based chemical substances
does not regulate articles per se, but rather persons who manufacture
or process these chemical substances, including when the chemical
substances are present as part of articles. TSCA clearly contemplates
such regulation, as certain articles are expressly removed from TSCA
jurisdiction at TSCA section 3(2). Indeed, EPA has a long history of
regulating chemical substances as part of articles under TSCA. For
polychlorinated biphenyls (the only chemical substance specifically
addressed in TSCA as it was originally enacted), section 6(e) of TSCA
provides authority for EPA to promulgate rules related to
polychlorinated biphenyls in articles, such as electrical transformers.
Other examples include the regulation of asbestos (40 CFR 763.160) and
regulation of manufacturers of consumer products intended for use by
children who also manufacture (including import) lead (40 CFR
716.21(a)(8)).
TSCA section 5 provides EPA with authority to regulate chemical
substances, including chemical substances that are part of articles.\1\
Under this section, EPA has previously regulated persons that import or
process chemical substances as part of articles, including articles
containing erionite fiber (40 CFR 721.2800) and mercury (40 CFR
721.10068). This is in keeping with the statutory language authorizing
the Administrator to designate a ``use of a chemical substance as a
significant new use'' and to require SNUN submissions from persons that
intend to manufacture or process a chemical for a designated
significant new use. The commenter is incorrect in suggesting that
regulation to address chemical substances in articles is beyond the
originally intended functions of TSCA. When TSCA was being drafted,
legislators characterized it as ``a mechanism to protect against
dangerous chemical materials contained in consumer and industrial
products''; by way of example, the drafters cited ``the presence of
mercury in such consumer products as paint, home thermometers, sponges,
and a variety of other products.'' S. Rep. No. 94-698, 94th Cong., 2d
Sess., 5-6 (1976).
---------------------------------------------------------------------------

\1\ It should be noted that there is no general SNUN exemption
for uses of a chemical substances involving articles and EPA
routinely defines significant new uses to include use in articles.
The exemption at 40 CFR 721.45(f) relates to a different question:
whether the SNUR applies to persons who process or import a chemical
substance by processing or importing the substance as part of an
article.
---------------------------------------------------------------------------

Furthermore, this application of the regulations (to persons who
manufacture or process the chemical substance as part of articles) is
consistent with legislators' observation, in drafting this section,
that:

[[Page 77897]]

[T]he most desirable time to determine the health and
environmental effects of a substance, and to take action to protect
against any potential adverse effects, occurs before commercial
production begins. Not only is human and environmental harm avoided
or alleviated, but the cost of any regulatory action in terms of
loss of jobs and capital investment is minimized.

H.R. Rep. 94-1679, 94th Cong., 2d Sess., 65 (1976).

When a chemical substance is domestically produced, the substance
generally exists in non-article form at the earliest point of
commercial production in the United States. When a chemical substance
is imported, however, it may in many instances already be part of an
article, even at the earliest point that it enters U.S. commerce. By
this action, EPA makes importers of specific chemical substances
subject to the same SNUN requirements as domestic manufacturers of the
same substance, irrespective of whether such import is as part of an
article. This action is consistent with the plain text of TSCA
5(a)(1)(B) (generally, ``no person may . . . manufacture or process''
for a significant new use without proper notice) and with one of the
intended goals of TSCA: to hold importers to ``the same
responsibilities and obligations as domestic manufacturers,'' H.R. Rep.
No. 94-1341, 94th Cong. 2d. Sess., 12-13 (1976). This action is also
consistent with EPA's identified concerns regarding benzidine-based
chemical substances when they are present as part of an article (See
Ref. 1, pg. 18756).
Moreover, when originally promulgating the presumptive SNUN
submission exemption for persons who import or process chemical
substances as part of articles (40 CFR 721.45(f)), EPA did so based on
a belief that people and the environment would generally not be exposed
to chemical substances in articles. To address those cases where the
assumption may not be valid, EPA specifically noted that, ``EPA may
decide to eliminate one or all of these . . . exemptions [including the
exemption for importers and processors of chemicals as part of
articles] if EPA decides that review under a SNUR is warranted for
specific substances . . . in articles.'' (Ref. 6). Thus, while EPA
clearly has statutory authority to subject importers and processors of
chemical substances in articles to SNUN requirements, they are
presumptively excluded by rule at 40 CFR 721.45(f), based on an
assumption that people and the environment will generally not be
exposed to substances in articles. (Ref. 6). To the extent that
potential exposure to a chemical substance as part of an article
contributes to the EPA's determination pursuant to the factors in
section 5(a)(2) of TSCA that the new use is significant (i.e., EPA has
reason to anticipate that use as part of an article would raise
important questions, related to potential exposure, that EPA should
have an opportunity to review before such use could resume or occur),
it is appropriate to make the exemption inapplicable.
EPA notes that one of the commenters appears to have conflated the
Federal Register notice establishing the article importers' and article
processors' exemption from PMN requirements (Ref. 7), discussing 40 CFR
720.22(b)) with another Federal Register notice establishing the
comparable exemptions from SNUR requirements (Ref. 6), discussing 40
CFR 721.45(f)). While EPA recognizes that parts 720 and 721 deal with
many similar issues, they are also distinct from each other in
important respects. It is significant that in the 1984 action, whereby
EPA established the article importers' and article processors'
exemption for SNURs, it did not simply mirror the 1983 rationale for
the comparable exemption from PMN obligations. For PMNs, EPA noted the
difficulties associated with determining the identity and Inventory
status of each chemical substance in imported articles (e.g.,
automobiles) (Ref. 7). But for SNURs, EPA placed special emphasis on
its assumption that import of the substance as part of an article would
not affect human or environmental exposure to the substance, while
taking particular care to reserve ongoing discretion to revise its
assumption as warranted in the case of specific substances. EPA had
reason to differentiate between the two rationales. SNURs are for
specified chemical substances for which EPA has identified exposure-
based concerns for the defined significant new use (per the TSCA
section 5(a)(2) factors). By contrast, PMNs are required for all new
chemicals (i.e., those not on the TSCA inventory), not a specified set
of chemicals.
Finally, there is no basis for the commenter's suggestion that EPA
should decline to review significant new uses, in deference to the
Occupational Safety and Health Administration (OSHA) or the Consumer
Product Safety Commission (CPSC), simply because a significant new use
notice would be submitted by a person who imports or processes the
chemical substance as part of an article. Neither the Occupational
Safety and Health Act of 1970 nor the Consumer Product Safety Act of
1972 contains a comparable mechanism to ensure advance notice and
opportunity to review significant new uses of chemical substances, as
part of articles or otherwise.

B. Development of a Separate Policy Framework for Making Inapplicable
the Exemption for Persons Who Import or Process Chemical Substances as
Part of Articles

1. Comment. Some commenters suggest that before finalizing a
rulemaking to make the ``articles exemption'' inapplicable to the
benzidine-based chemical substances, the EPA should complete a separate
public comment process to develop a general ``policy framework for the
issuance of article SNURs.'' Commenters suggest that this policy
framework should include science based criteria, feasibility criteria,
costs, and other factors.
One comment suggests that, in formulating the ``policy framework''
or criteria for making the exemption for importers and processors of
chemical substances as part of articles inapplicable, EPA should
address the following questions:
Can the risk posed by the chemical of concern be addressed
through the standard regulation?
Why is the standard approach for SNURs that exempts
articles not sufficient?
What conditions make direct regulation of articles
necessary?
What gaps in health and environmental protection are
likely to occur if a SNUR only regulates chemicals and mixtures?
Response. The comments conflate two separate issues: The
determination of a significant new use under TSCA section 5(a)(2), and
the decision to make the regulatory exemption at 40 CFR 721.45(f)
inapplicable. (40 CFR 721.45(f) provides that persons who import or
process a chemical substance as part of an article are not subject to
the notification requirements at 40 CFR 721.25; this exemption is
referred to as the ``articles exemption'' by some commenters). EPA
first makes a determination on whether a use of a chemical substance is
a significant new use considering the factors listed in TSCA section
5(a)(2). Once that determination is made, EPA separately determines
whether it would be appropriate to revoke the regulatory exemption at
40 CFR 721.45(f) for persons who import or process a chemical substance
as part of an article.
EPA notes that there may be a variety of cases in which it may be
appropriate for EPA to include persons who import or process the
chemical substance as

[[Page 77898]]

part of an article among the persons subject to SNUN submission
obligations. Knowledge regarding chemical exposures from articles has
evolved since the Agency established the exemption at 40 CFR 721.45(f)
in 1984, and there has been a steady increase in international trade of
chemicals in articles. Accumulated data illustrate that SNURs (and
section 5(e) consent orders) that include the exemption for persons who
import or process a chemical substance as part of an article are
sometimes insufficient to appropriately flag significant new exposures
from downstream uses. For example, there have been instances in which a
section 5(e) consent order for a new chemical substance was issued,
prohibiting the release of the chemical substance to water, and yet the
chemical substance at issue was later found in the environment and
biota. The presence of the chemical substance in the environment and in
biota then appears to be associated with the use of the substance in
articles (Ref. 8). There are also documented exposures (and resulting
toxicity) of children to lead and cadmium and their compounds from a
variety of articles, such as toys (Ref. 9), and exposures to other
heavy metals from articles, as measured in indoor air and house dust
samples, which are direct routes of exposure accounting for children's
levels and toxicity (Ref. 10). Other well-documented examples are the
presence of brominated flame retardants (e.g., polybrominated diphenyl
ethers and brominated phthalates and benzoates) in samplings of
articles, indoor air, people, and house dust. The low exchange rate of
indoor air and house dust to sources outside the home support the flame
retardant release from articles postulate. Likewise, other semi-sealed
environments, such as automobiles, have demonstrated migration of flame
retardants from treated articles to interior surfaces and indoor air,
as no other source was possible. In addition, high flame retardant
levels have been observed in biota raised in proximity to articles and
living near article recyling sites. Further, observed flame retardant
levels in biota and in the environment at locations remote from
manufacturing sites suggest transport of these non-volatile chemical
substances on associated particulate matter from distributed treated
articles, which strongly suggest release from articles as one potential
source (Ref. 11-15).
The information discussed in this unit--the well-documented
exposures (and resulting toxicity) of children to lead, cadmium, and
other metals from a variety of articles; the data on other chemicals
used in articles; and the presence in the environment and biota of
certain brominated flame retardants (e.g., polybrominated diphenyl
ethers and brominated phthalates and benzoates)--all illustrate that
there can be exposure to the chemicals associated with their presence
in articles (Refs. 9-15).
The scope of the suggested criteria (which the commenters suggest
EPA should now develop to govern its exercise of its authority to make
the exemption at 40 CFR 721.45(f) inapplicable) is incommensurate with
the level of analysis supporting the original development of the
exemption. EPA notes that TSCA section 5(a)(1) establishes a general
prohibition on manufacturing or processing a chemical substance for a
significant new use without prior notice to EPA. 40 CFR 721.45(f)
establishes an exemption from this prohibition, but it is based on a
fairly minimal rationale: ``EPA believes people and the environment
will generally not be exposed to substances in articles.'' (Ref. 6).
EPA counterbalanced its reliance on this generalized assumption (about
all chemicals that exist as part of articles) with a broad reservation
of case-by-case discretion to make the exemption inapplicable as
``warranted for specific substances.'' (Ref. 6).
EPA does not think that development of a ``policy framework'' is
necessary before reaching the conclusion, with respect to benzidine-
based chemical substances, that persons who import or process these
substances as part of articles should be subject to the notification
provisions of 40 CFR 721.25. Dermal exposure can occur from the
leaching of the benzidine-based chemical substances by sweat in contact
with the dyed textiles (Ref. 1)). In addition, data indicate that
exposure to other chemicals in materials such as textiles and foam can
result from the dust that is generated from abrasion and/or degradation
of the materials (Ref. 16). EPA notes that the commenter did not offer
data to undercut the conclusion that such exposure can occur. Because
of this information, and other information described in Unit III.E. of
the (Ref. 1), EPA does not assume that new types or forms of exposure
associated with new use of benzidine-based chemical substances would be
insignificant merely because the chemical substance is imported or
processed as part of an article. Thus, EPA does not believe the default
assumption used to support 40 CFR 721.45(f) (that people and the
environment will generally not be exposed to substances in articles)
holds with respect to benzidine-based chemical substances.
2. Comment. Comments also suggest that EPA analyze the ``variety of
products'' that could be construed as articles, the ``practical
questions that will arise'' if the import and processing of such
products were not exempt from SNURs, and the ``unique channels of
trade,'' through which different varieties of products move. Commenters
encouraged EPA to develop and articulate publicly a policy framework,
considering the following factors on an article-specific basis, before
proceeding to revoke the article exemption with respect to a particular
chemical substance:
Whether there is, or will be, direct exposure to the
chemical substance in the article during the course of the article's
use.
Whether there is, or will be, a release of the regulated
substance, or a metabolite or breakdown product from the substance,
during subsequent processing, distribution, use or disposal of the
article.
Whether there is, or will be, a link between import or
export of an article and cross-border exposure to the U.S. population.
Response. Given the variety of substances and uses addressed under
SNUR regulations, EPA believes it is more efficient to address article-
specific issues as they actually arise within each regulatory action
than to develop, as suggested by the commenter, an anticipatory
``policy framework'' document.
The importers and processors of chemical substances present in
articles are generally in the best position to know which chemical
substances are used in which types of articles. When EPA identifies a
particular chemical substance in a SNUR, such stakeholders have an
opportunity to identify, in their public comments, any article-specific
issues that concern them. Furthermore, these issues are likely to be
more accurately identified and more appropriately addressed in
connection with the development of a SNUR for particular chemical
substances than they would be if they were reviewed generically. In
this case, commenters did not raise any issues specific to certain
articles.

C. A Compelling Basis Standard for Making Inapplicable the Exemption
for Persons Who Import or Process Chemical Substances as Part of
Articles

1. Comment. Some commenters made the point that revocation of the
exemption at 40 CFR 721.45(f) should

[[Page 77899]]

not be a presumed component of all SNURs. This was part of a broader
comment that EPA should not make this exemption inapplicable unless
there was a ``compelling basis'' to do so. One commenter was concerned
that if EPA proceeds on a case-by-case basis, following reasoning that
``could be applied to many chemicals,'' then elimination of the
exemption would come to be a ``kind of `default' step'' in future
SNURs. One commenter also argues that, where the SNUN submission
requirement is to apply to importers and processors of substances as
part of articles, the TSCA section 5(a)(2) criteria require EPA to
undertake a compelling analysis of how the use and distribution of the
``specific articles or article categories,'' would ``contribute to
potential exposures of concern.''
Response. As an initial matter, the comments conflate two separate
issues: The determination of a significant new use under TSCA section
5(a)(2), and the decision to make the regulatory exemption at 40 CFR
721.45(f) inapplicable. The TSCA section 5(a)(2) factors do not impose
a ``compelling analysis'' requirement on the elimination of the 40 CFR
721.45(f) exemption because (among other reasons) these two actions
concern two discrete issues. The section 5(a)(2) factors speak to the
significant new use itself. 40 CFR 721.45(f) speaks to who is required
to notify EPA of the significant new use.
In this case, EPA identified its reasons, under the TSCA section
5(a)(2) factor analysis, to anticipate that the new use would pose
important new questions related to the substances' potential to
threaten health or the environment (Ref. 1, pg. 18756), and that EPA
should have an opportunity to consider those questions before such use
could occur. (In essence, a SNUR puts a particular set of uses on the
same footing as a new chemical, which is subject to automatic review
under TSCA section 5(a)(1) unless EPA specifically excludes it from
such review.) EPA also identified a basis, specific to benzidine-based
chemical substances, to question the assumption that people and the
environment will generally not be exposed to the chemical substances in
articles. Therefore, EPA is also making inapplicable the exemption at
40 CFR 721.45(f) for persons who import or process a chemical substance
as part of an article. No commenter provided data or other information
to undercut the factual basis for either decision.
Neither TSCA nor the implementing regulations for SNURs establish a
separate ``compelling basis'' standard, either with respect to the
determination of a significant new use or with respect to the decision
to make the exemption at 40 CFR 721.45(f) inapplicable. Nor have
commenters identified a persuasive basis for EPA to adopt such a
standard under either scenario.
EPA's specific action with respect to benzidine-based chemical
substances is not, as commenters suggest, tantamount to the presumptive
revocation of the SNUN submission exemption for importers and
processors of chemical substances as part of articles in all future
instances. EPA has not proposed to globally modify or eliminate the
SNUR exemption for persons who import or process chemical substances as
part of articles. EPA need not presently address the merits of an
action it is not presently taking, and did not previously propose to
take.
TSCA sections 5(a)(2)(B) and (C) require EPA to consider the extent
to which a new use ``changes the type or form of exposure'' or
``increases the magnitude and duration of exposure'' before making a
determination that a particular use is a ``significant new use.'' EPA
disagrees that it must therefore, as one commenter suggests, conduct a
multiplicity of separate significant new use analyses whenever the use
under consideration involves an article (i.e., one for each specific
article or article category, comparing the relative significance of
each particular article or article category). In particular, the
commenter's interpretation of TSCA section 5(a)(2) misconstrues the
baseline against which the ``newness'' and the ``significance'' of a
significant new use are evaluated. As EPA has long maintained, the
single analytical baseline is the set of uses that were ongoing ``as of
the date of publication'' of the SNUR proposal. (See e.g., Ref. 1).
Furthermore, the particular analytical standards the commenter
suggests are not commensurate with the establishment of a one-time
notice requirement intended to give EPA an opportunity to later
evaluate the need for testing or other regulatory action under TSCA.
Requiring upfront answers to the very questions EPA would evaluate
after receiving a significant new use notice, as a pre-condition of
requiring the notices, would undermine the statutory authorization to
issue SNURs in the first place. EPA's decision to propose a SNUR for a
particular chemical use and to make the exemption at 40 CFR 721.45(f)
inapplicable to that SNUR need not be based on an extensive evaluation
of the hazard, exposure, or potential risk associated with that use.
Rather, the Agency is acting because it has reason to anticipate that
such use would raise important new questions related to the substance's
potential to threaten health or the environment, and that EPA should
have an opportunity to consider those questions before such use could
occur. Since the use designated as a significant new use does not
currently exist, deferring a detailed consideration of potential risks
or hazards related to that use is an effective use of resources. If a
person decides to begin manufacturing or processing the chemical for
the significant new use, in articles or otherwise, the notice to EPA
allows EPA to evaluate the use according to the specific parameters and
circumstances surrounding that intended use.
Even if it were appropriate to construe the decision to make the 40
CFR 721.45(f) exemption inapplicable as a subcomponent of the
significant new use determination under section 5(a)(2) (rather than as
a subsequent determination), EPA adequately considered the section
5(a)(2) factors.
The first factor is the ``projected volume of manufacturing and
processing of a chemical substance'' (TSCA section 5(a)(2)(A)). EPA
projects that these substances will not be manufactured or processed at
any volume for the new uses in question and notes that for the newly
proposed nine benzidine-based chemical substances, data reported to EPA
for the 2012, 2006, 2002, and 1998 reporting cycles, as required by the
TSCA IUR rule, indicate no evidence of manufacture (including import)
(Refs. 1 and 17). Any increase in the projected volume of manufacturing
(including import) or processing of these substances, beyond the very
limited uses currently ongoing, would reflect a significant departure
from prior trends. Given that these chemical substances are anticipated
to metabolize to the parent benzidine molecule, which is a known human
carcinogen, EPA anticipates that information presented in the SNUN on
the quantities manufactured (including imported) and processed of
benzidine based chemical substances would be important to EPA's overall
evaluation of whether the new use may present an unreasonable risk to
human health or the environment. The necessary increase in volume of
this substance from any new use weighs in favor of determining that the
new use is a significant new use.
The second factor is ``the extent to which a use changes the type
or form of exposure of human beings or the environment to a chemical
substance'' (TSCA section 5(a)(2)(B)). For the newly added benzidine-
based chemical substances, a general market review on

[[Page 77900]]

these chemical substances indicates no current manufacture within or
outside the United States. Although some of the chemical substances
subject to the 1996 SNUR may still have certain limited ongoing uses
(e.g., as a test reagent, lab standard, or microscopy stain), such uses
are expected to be confined to limited laboratory or technical
applications that are not expected to represent an appreciable amount
of overall exposure. Furthermore, EPA did not find evidence of actual
ongoing importation or domestic production for these uses. No comments
provided evidence of ongoing manufacture (including import) or
processing of these chemical substances as part of articles or
otherwise. Thus, EPA believes that there is no, or almost no, current
exposure to these chemical substances in the United States.
Should a significant new use be planned, EPA anticipates that the
new use would raise important new questions such as the following:
To what extent would the use be expected to involve dermal
contact with the substance?
Would the substance be used in a setting where oral
exposure is likely (e.g., would young children be able to mouth the
article)?
How would potential occupational exposures and releases to
the environment over the substance's lifecycle be expected to be
managed?
Given that these chemical substances are anticipated to metabolize
to the parent benzidine molecule, which is a known human carcinogen,
EPA anticipates that the answers to such questions would be important
to EPA's evaluation of whether the new use may present an unreasonable
risk to human health or the environment. The potential for a new use to
change the type or form of exposure weighs in favor of determining that
the new use is a significant new use.
The third factor is ``the extent to which a use increases the
magnitude and duration of exposure of human beings or the environment
to a chemical substance'' (TSCA section 5(a)(2)(C)). Should one of the
designated significant new uses be planned, EPA anticipates that the
planned new use would raise important new questions relating to the
concentration in which the substance would be used, the potential for
repeated exposure, and the potential for continuous exposure. Given
these chemical substances are anticipated to metabolize to the parent
benzidine molecule, which is a known human carcinogen, EPA anticipates
that the answers to these questions would be important to EPA's overall
evaluation of whether the new use may present an unreasonable risk to
human health or the environment. EPA also notes that dermal exposure
can occur from the leaching of the chemical substances by sweat in
contact with the dyed textiles (Ref. 1). Because of this information,
and the information described in Unit III.E. of the proposal (Ref. 1),
EPA does not assume that new types or forms of exposure associated with
new use of these substances would be insignificant merely because they
relate to new use in an article or because the pertinent manufacturing
or processing of the substance occurred as part of an article. The
potential for activities related to a new use to increase the magnitude
and duration of exposure weighs in favor of determining that any non-
ongoing use is a significant new use.
The fourth factor is ``the reasonably anticipated manner and
methods of manufacturing, processing, distribution in commerce, and
disposal of a chemical substance'' (TSCA section 5(a)(2)(D)). EPA
anticipates that any new use, beyond the very limited uses currently
ongoing, would raise important new questions such as the following:
To what extent can the anticipated manufacturing,
processing, distribution in commerce, and disposal of the chemical
substance be expected to result in worker exposure, user exposure, or
release of the chemical substance to the environment?
What potential controls are available to limit such
releases?
Given these chemical substances are anticipated to metabolize to
the parent benzidine molecule, which is a known human carcinogen, EPA
anticipates that the answers to these questions would be important to
EPA's overall evaluation of whether the new use ``may present an
unreasonable risk to human health or the environment.'' The potential
for manufacturing, processing, distribution in commerce or disposal of
these benzidine-based chemical substances to change the overall
exposure picture weighs in favor of determining that consumer textile
use is a significant new use.
After considering each of the four TSCA 5(a)(2) factors, EPA has
concluded that the factors taken together weigh in favor of determining
that manufacture or processing of these benzidine-based chemical
substances for any non-ongoing use would be a significant new use such
that the Agency should have an opportunity to analyze the new use
before such use (and potential exposures) occurs. This determination
would still hold even if one were to consider the 40 CFR 721.45(f)
exemption as a subcomponent of the significant new use determination
under section 5(a)(2).

D. Narrowing the Scope of SNURs Where the Exemption for Importers and
Processors of Chemical Substances as Part of Articles Is Made
Inapplicable

Some comments suggest that significant new uses should not be
``open-ended'' but instead must be targeted to specific articles,
particularly in cases where the exemption at 40 CFR 721.45(f) is made
inapplicable. The concern expressed is that if the SNUN applies to
``any use of a substance, then regulated parties and the EPA would be
obligated to proceed through the SNUR process for an article that would
have little relevance to the perceived hazard that drove the original
SNUR.'' The commenter further writes that ``open-ended article SNUR's
can trigger reviews for articles that may have no relationship to the
hazard or exposure concerns that motivated EPA's decision to initiate
the rule.''
EPA's concern with these benzidine-based dyes is not limited to
certain exposure pathways to specific articles. EPA's concern is
specific to the benzidine-based dyes and thus to the range of exposures
that could occur for these chemical substances. The preamble of the
proposed rule notes multiple potential routes and sources of exposure
including inhalation, skin absorption via dyed textiles, and ingestion.
(Ref. 1). Furthermore, SNURs need not be narrowly focused on the
mitigation of currently foreseeable exposure scenarios--it is proper
that they will also ensure EPA has timely notice of future (and
currently unforeseeable) exposure scenarios. An additional requirement
to make targeted predictions of the particular uses that ``may be
proposed in the future'' would undermine this intended function of the
SNUR.
More generally, an exhaustive list of all applications that could
possibly fall within the ambit of a significant new use definition is
not a prerequisite for issuing a SNUR. Since the significant new use
does not currently exist, deferring a detailed consideration of
potential risks related to the importation or processing of these
chemical substances (including as part of articles) is an effective use
of resources. If a person decides to begin importing or processing the
chemical, as part of an article or otherwise, the notice to EPA allows
EPA to evaluate the significant new use according to the specific
parameters and circumstances surrounding that intended use.

[[Page 77901]]

E. EPA Should Have a Reasonable Basis To Conclude That Identified
Articles Would Be Distributed in the United States

One comment states that ``EPA presents an exposure-based rationale
for why certain articles could be a concern, but indicates that there
is no current expectation that these chemical substances will be used
in such articles.'' The commenter believes that before issuing an
article SNUR, EPA should have a reasonable basis to conclude that
identified articles of concern would be distributed in the United
States. The commenter contends that EPA should identify an article
containing such a chemical that is currently in global commerce and
explain why it is likely to be distributed in the United States. The
commenter believes that it might also be possible to identify an
article at the research and development stage that is likely to proceed
to commercial development. Without such findings, however, the
commenter is concerned that EPA would be issuing an article SNUR for a
situation that presents no current or likely future threats to health
or the environment, and thus that the rule would be a waste of public
resources. Another comment raises similar issues, arguing that EPA
should provide even more specific information on how the significant
new uses contribute to risk.
Alternatively, the first commenter suggests that EPA include a
specific provision suspending enforcement of the SNUR until a
determination is made that there is a reasonable basis to believe that
an article containing the specific chemical had been, or would be,
distributed in the United States.
EPA disagrees with the suggestion to limit the application of SNUN
submission requirements for importers and processors of the chemical
substances as part of articles to situations where importation or
processing as part of an article is known to be imminent. SNURs address
situations in which EPA is concerned about the potential for use to
commence without prior opportunity for review and risk management
action where appropriate. For purposes of SNURs, EPA cannot be expected
to predict specific situations where new uses may be imminent, or how
those specific uses may contribute to risk, before designating
significant new uses. The purpose of a SNUR is to obtain such
information so that EPA can evaluate risks associated with, and take
risk management action where appropriate regarding, any notified
activities. These rules serve the important function of alerting EPA
when a significant new use is intended. Without them, EPA would have no
expectation of timely identification of new uses of these chemicals.
Notice relating to the import or processing of articles is particularly
important in this case, as the proposal specifically identified a
concern related to the potential for dermal exposure via dyed articles
(i.e., from the leaching of the benzidine-based chemical substances by
sweat in contact dyed articles, such as textiles). (Ref. 1).
It would not be an efficient use of government resources for EPA to
continually monitor global commerce to try to predict which chemicals
are about to be imported as part of articles (but have not yet been
imported) into the United States. Persons who wish to manufacture
(including import) or process these chemical substances for a
significant new use, as part of an article or otherwise, are in a
better position than EPA to evaluate when they are about to initiate a
particular significant new use.
Given that SNURs cannot be issued for ongoing uses, the commenter's
suggestion (that EPA must itself make an upfront demonstration that a
particular new use is about to begin, to secure the opportunity to be
notified of when significant new uses involving importation or
processing of chemical substances as part of articles are about to
begin) is impracticable. It would likely result in a scenario in which
an otherwise significant new use would be allowed to commence prior to
the issuance of a SNUR proposal, thereby placing that use outside of
EPA's SNUR authority. Furthermore, EPA has already considered and
rejected (in 2006, following public comment on a 2004 proposal) the
position that it must defer revocation of the 40 CFR 721.45(f)
exemption for a SNUR until it appears likely ``that these chemical
substances will be imported as part of articles.''(Ref. 18). EPA
concluded in 2006, after a re-evaluation of the issue prompted by
public comments, that ``if the subject substances when imported as a
part of articles are not subject to the SNUR, EPA could miss the
opportunity to obtain notifications that would provide information of
potential regulatory and assessment value.'' (Ref. 19)(ultimately
declining to make the exemption inapplicable, based on a separate
concern that the use with respect to articles appeared to be already
ongoing).
Finally, for essentially the same reasons as set forth in this
unit, EPA believes it would be inappropriate to follow one commenter's
alternative suggestion: To promulgate a SNUR without the exemption for
importers and processors of chemical substances as part of articles,
while somehow ``suspending enforcement'' until the precise moment that
manufacture or processing for a significant new use as part of an
article is about to begin, but has not yet begun.
In sum, EPA believes commenter's suggestions would turn the
regulatory process on its head. EPA would likely need to already have a
SNUR in place in order to obtain the kind of timely information about
significant new use that the commenter asserts should be prerequisite
to issuing the SNUR in the first place.

F. Intended Coverage of the Benzidine-Based Chemical Substances SNUR

1. Comment. One commenter writes that ``A proposed rule offering a
clear explanation of what uses EPA intends to cover, including an
explanation of the alternatives if certain situations are unclear, will
greatly increase the chances that useful information about business
practices and common terms of art in an industry will be identified.''
EPA should define the scope of the uses to be regulated as clearly and
precisely as possible.
The commenter also contended that soliciting public comment on the
appropriate scope of new uses to be regulated, for a specific chemical
substance, constitutes ``an abdication of the role that EPA should be
undertaking.'' The commenter suggests that before soliciting public
comments, EPA should have first pursued an informal coordination with
downstream industries and (as necessary) an exercise of its ``ample
authority under TSCA, either through regulatory action under section 8
or order authority under section 11(c).'' Finally, the commenter
suggests that to the extent the proposed significant new uses admit
ambiguity or potential need for adjustment in response to public
comment, that is evidence that EPA ``should have learned more about the
uses'' before issuing the proposal and is improperly seeking ``to shift
the responsibility to stakeholders.''
Response. The description of the scope of the significant new uses
in the benzidine-based chemical substances proposed SNUR and the
Agency's basis for the proposal were explicit. The SNUR proposal fairly
apprised stakeholders as to the chemical at issue and the particular
concerns driving the proposed action. It further indicated that based
on information available to EPA, the significant new uses identified
are not currently on-going. Stakeholders had an opportunity to oppose
any of these preliminary findings by supplying

[[Page 77902]]

countervailing information thorough the rulemaking process itself.
Grafting additional pre-proposal steps onto the SNUR rulemaking process
would be unnecessarily time-consuming and an unsound use of agency
resources. The timelier, less resource-intensive, and more transparent
process is for interested stakeholders, through the public comment
process itself, to simply provide any pertinent countervailing
information they wish to add to the initial collection of information
EPA presented in the proposal.
As noted earlier, TSCA section 5(a)(2) does not compel nor
contemplate an article by article analysis to identify every
conceivable significant new use of a chemical substance. EPA evaluates
whether a new use is ``significant'' consistent with the evidence of
Congressional intent underlying the enactment of TSCA. See H.R. Rep.
No. 94-1341 at 24 (1976) (``[B]ecause of the nature of a substance, it
is possible that any new use of it will be significant. Thus, a
potentially dangerous substance which is manufactured for a particular
use may, if manufactured for a different use present additional health
or environmental problems and consequently there should be notice of
the intent to manufacture it for such different use.'' H.R. Rep. No 94-
1679 at 66 (1976) (``[T]he conferees intend that any potential threats
to health or the environment from the manufacture, processing,
distribution in commerce, or disposal of a substance associated with a
new use be considered by the Administrator when determining the
significance of a new use.'') Finally, a broad construction of the
significant new use is particularly appropriate where (as in the case
of benzidine-based dyes) any increase in the projected volume of
manufacturing (including import) or processing of these substances,
beyond the very limited uses currently ongoing, would reflect a
significant departure from prior trends.
2. Comment. ``It does not make sense to issue article SNUR's [sic]
for full size machines or structures. An article SNUR should focus on
the specific components of more complex machines or structures that
involve the chemical of concern.''
Response. The commenter neither explains what the commenter means
by ``full size,'' nor offers any specific evidence to support their
general view that new uses of chemical substances in ``full size
machines or structures,'' are any less likely to be significant than
new uses of chemical substances in ``specific components.'' Nor does
the commenter indicate why persons who import or process chemical
substances as part of articles would be more likely to be importing or
processing the chemical substances for use in ``full size'' articles.
Attempting to define and distinguish between ``full size'' article uses
and other uses, and correlating such distinctions to whether persons
are importing or processing these chemical substances as part of
articles, would delay the rulemaking and increase its complexity, in a
manner that does not seem warranted on the basis of the limited
information supplied in the comment.
3. Comment. ``Chemicals used in articles may sometimes be
incorporated into 'internal' mechanisms of the article that are
unlikely to come into contact with people or be released into the
environment during normal use of the article.''
Response. The commenter does not explain why the basis for a SNUR
should be limited to those exposures that occur concurrent with the
article fulfilling its intended function, when TSCA section 5(a)(2)(D)
contemplates that EPA will consider the value of ensuring it has a
future opportunity to review the whole life-cycle impact (e.g.,
``manufacturing, processing, distribution in commerce, and disposal'')
of a significant new use of a chemical substance. The exposure to the
chemical substance, including when it is in an article, may be larger
during disposal or recycling than during the ``normal use'' of the
chemical. Further, chemical substances that are `internal' to an
article may still result in exposure if the chemical substance has
certain physical- chemical properties (e.g., a relatively volatile
chemical used as a plasticizer in interior automobile parts) or due to
abrasion of the article (e.g., a dye incorporated into furniture
covering.)
Nor does the commenter indicate why persons who import or process
chemical substances as part of articles would be more likely than any
other manufacturers or processors to be manufacturing or processing for
use in the internal mechanisms of articles. Attempting to define and
meaningfully distinguish between ``internal'' article uses and other
uses, and correlating such distinctions to whether manufacturing or
processing of the substance occurs as part of an article, would delay
the rulemaking and increase its complexity, in a manner that does not
seem warranted on the basis of the limited information supplied in the
comment.
4. Comment. ``EPA should clarify whether the SNUR applies to
articles containing the chemical of concern in a solid, liquid,
particle or gaseous form.''
Response. This SNUR applies to the chemical substances regardless
of form. To the extent the commenter seeks to continue some aspect of
the exemption at 40 CFR 721.45(f), depending on the form of the
chemical substance in the article that is being imported or processed,
the commenter has not offered any specific support for that
proposition, either generally or in any particular case. In the SNUR at
issue, EPA does not believe it is prudent to limit the application of
the rule based on the form (solid, liquid, or gaseous) of the chemical
substances at issue. Chemicals that may have been used in one form
during the manufacture of the article may be released from the article
in a different physical form. Also, fluids and particles are not
covered under the applicable definition of article at 40 CFR 704.3. EPA
received no comments suggesting that use of these chemicals in one form
or another may not be significant based on the TSCA section 5(a)(2)
factors. Moreover, information relevant to a specific form of a
chemical substance can be submitted in a SNUN and may be considered by
EPA in review of that SNUN in determining whether follow-up action is
warranted, and may support EPA's amendment of the SNUR to limit its
scope.
5. Comment. ``[A] chemical may be present at a very low
concentration that is unlikely to be associated with a risk warranting
EPA risk management action. . . . EPA should consider whether it can
establish a de minimus exclusion [from the SNUR].''
Response. EPA notes that the SNUR already contains a general
exemption for unintentionally present impurities at 40 CFR 721.45(d).
To the extent chemical substances are intentionally added to articles
at very low concentrations, the question of whether the substance
warrants risk management action is one that EPA can address upon
receipt of the SNUN, not an analytical prerequisite to deciding whether
it should receive the SNUN in the first place.

G. Screening for Benzidine-Based Chemical Substances

Some commenters faulted the proposal for not identifying precise
screening operations to be taken in response to the SNUR, and for not
conducting additional analyses of the cost and feasibility of such
screening operations. One commenter suggests, in particular, that an
article importer should be deemed in compliance with the SNUR if the
chemical is present below an established de minimis level (based on
mass or concentration), or if it simply does not know the article's

[[Page 77903]]

content after conducting a reasonable inquiry for such information.
With respect to processors, given the requirements of 40 CFR
721.5(a)(2), a processor of the chemical substance should have received
notification that the chemical substance is the subject of a SNUR. A
processor is not required to submit a SNUN for its unknowing processing
of a chemical substance subject to a SNUR if (upon obtaining knowledge)
the processor can document that when the past processing occurred, the
processor neither knew the chemical identity of the substance it was
processing nor knew that substance was subject to a SNUR. See 40 CFR
721.5(c). EPA would generally expect that processors would only fail to
be aware of the presence of a chemical subject to a SNUR if the
manufacturer (including importer) or upstream processor of the chemical
substances failed to meet their obligations under 40 CFR 721.5(a)(2).
With respect to importers, EPA disagrees that it would be
appropriate or necessary for the SNUR itself to define screening
procedures to be employed for compliance purposes. The Agency did not
propose to require a particular screening procedure and, for the
following reasons, it does not agree that particular screening
procedures should be specified and incorporated into the final rule.
First, EPA believes that adding these sort of screening-effort
exemptions, specifically for importers of chemical substances as part
of articles, would be especially difficult to reconcile with the
general statutory prohibition (under TSCA section 5(a)(1)) on
manufacturing or processing a chemical substance for a significant new
use without prior notice to EPA. The issue under the statute is whether
or not an importer actually imports a substance. This is a separate
question from the importers' level of knowledge or level of effort to
obtain knowledge respecting the content of the imports.\2\ With respect
to SNURs, EPA notes that its direct rulemaking authority is to identify
significant new uses under section 5(a)(2). The Agency has been
appropriately cautious in exercising its implicit rulemaking authority
to limit the applicability of section 5(a)(1). EPA recognizes that it
did previously exercise such implicit rulemaking authority when
establishing 40 CFR 721.45(f). However, as noted in this unit, the
exemption at 40 CFR 721.45(f) was established along with a broad
reservation of authority to withdraw the exemption where, as here, it
is inaccurate to assume that there would not be exposure to the
substance simply because it is present as part of an article. And a
screening-effort exemption is especially difficult to reconcile with
the statute in the case of importers. With importers, unlike with
processors, there are no upstream entities with a duty under TSCA to
notify importers of the presence of a chemical substance subject to a
SNUR.
---------------------------------------------------------------------------

\2\ The limiting clause in the definition of ``principal
importer'' at 40 CFR 721.3--``knowing that a chemical substance will
be imported''--is a limit based on the person's knowledge that he or
she is engaged in an import transaction, not a limit based on the
person's knowledge of a particular chemical's identity and
regulatory status. (48 FR 21727, May 13, 1983) (FRL 2998-5).
---------------------------------------------------------------------------

Second, establishing a safe-harbor for importers based on lack of
knowledge would create incentives for foreign suppliers to deliberately
withhold information from importers. This could greatly reduce the
efficacy of this SNUR. Currently, when an importer wishes to import a
substance it knows would be subject to notification requirements, but
for which the chemical identity is claimed as CBI by a foreign
manufacturer, EPA's longstanding practice when reviewing PMNs and SNUNs
is to accept the relevant information on chemical identity directly
from the foreign manufacturer. See, (Ref. 7)(``[t]he principal importer
need not know the specific chemical identity of the imported
substance'' and ``may have its foreign manufacturer or supplier, or
some other person, report the chemical identity to EPA.'') Offering an
outright regulatory exemption to an importer simply because it is
ignorant of the existence of a SNUR-regulated substance in the imported
article (after conducting a prescribed inquiry) would allow foreign
suppliers to short-circuit this process simply by refusing to divulge
to the importer whether the import contains a chemical substance
subject to SNUR.
Third, to the extent the chemical substance subject to the SNUR is
only ``unintentionally present'' at the point of foreign manufacture,
it is already exempt from reporting by the importer as an imported
impurity. See 40 CFR 721.3 (chapeau), 40 CFR 720.3(m), and 40 CFR
721.45(d). Thus, importers are not required to submit a SNUN for a
substance based simply on that substance's presence as an impurity
(i.e., a chemical substances unintentionally present with another
chemical substance).
Fourth, whether and how it may appropriate for importers to screen
for benzidine-based chemical substances will depend on many factors,
including their current state of knowledge about the articles that they
import and the potential risk of unknowingly importing articles that
contain these chemical substances. The relevant factors are largely
impossible for EPA to establish at this time, given that there is
currently no on-going import of these substances for the designated
significant new uses.
Finally, EPA did conduct additional analysis of potential screening
burden to explore commenters' concerns. As described in Unit X.H., EPA
acknowledges the costs of the various activities that certain entities
may choose to undertake, in response to this rule, to ensure that the
chemicals they import or process as part of articles do not trigger
SNUN submission requirements (Ref. 20). Based on EPA's economic
analysis and the responses to the proposed rule, EPA does not believe
that these costs will be significant for any individual entity.

H. Costs Associated With Making the Exemption for Persons That Import
or Process Chemical Substances as Part of Articles Inapplicable

Some comments note that the economic analysis, which focuses on the
cost of filing a SNUN, does not include any analysis of the costs that
might be associated with screening articles to determine whether these
SNURs would apply. One comment also notes that ``the preambles to the
proposed rules do not discuss what, if any obligations companies have
to screen articles for the chemicals included in the SNUR's.''
With respect to processors: existing SNUR regulations already
provide that the unknowing processing of a chemical substance does not
itself trigger SNUN requirements if the processor can (upon obtaining
knowledge) document that when the past processing occurred, the
processor neither knew the chemical identity of the substance it was
processing nor knew that substance was subject to a SNUR. See 40 CFR
721.5(c).
With respect to importers: Based on an assessment of current market
activity in the economic analysis, EPA believes that the chemicals
subject to the final SNUR are not currently being imported into the
United States for the identified significant new uses in articles. EPA
received no public comments on the proposed SNUR that indicate that
importation of these benzidine-based chemical substances for the
finalized significant new uses, in articles or otherwise, is ongoing.
However, because this SNUR makes inapplicable the exemption for persons
that import or process chemical substances as part of articles,
companies may take actions to ensure that they do not import any
articles containing the subject chemical substances after promulgation
of this rule, by such means they deem

[[Page 77904]]

appropriate. This is not necessarily a new consideration for importers
given that importers of mixtures have needed to be aware of chemical
substances subject to a SNUR that may be a component of imported
mixtures. Whether and how companies respond will depend on many
factors, including their current state of knowledge about articles that
they import and their own assessments of the potential risk of
unknowingly importing articles that contain these chemicals. As noted
in this unit, EPA did conduct additional analysis of burdens that may
be associated with activities entities may undertake to ensure the
chemicals they import or process as part of articles do not trigger
SNUN submission requirements (Ref. 20).
In any event, EPA did not propose to mandate any particular level
of screening of imported or processed articles. The preamble to the
proposed SNUR did not discuss the precise steps that an importer or
processor must take in this regard because there is no precise level of
screening by which the manufacturer or processor could be separately
liable under the rule (if not performed) or by which a manufacturer or
processor could obtain ``safe harbor'' from what would otherwise be a
violation of the rule. While EPA might potentially take screening
practices into consideration when evaluating a particular instance in
which the SNUR was nevertheless violated, that would be as a matter of
enforcement policy, not as a provision of the rule itself.
EPA has included estimates for some activities that importers may
undertake (e.g., supplier inquiries) in order to evaluate the
likelihood of chemicals being imported as part of articles. These costs
will vary for individual companies and their experience with suppliers.
Awareness of article components and constituents is becoming more
commonplace as companies frequently operate on a global scale and are
subject to numerous regulatory requirements around the world that
affect product stewardship responsibilities. Existing requirements that
may compel a company to investigate an article's components include the
Consumer Product Safety Act, California's Proposition 65, and the EU's
regulation on Registration, Evaluation, Authorization and Restriction
of Chemical (REACH), which requires customer notification about the
presence of certain chemical in articles that a company distributes.
U.S. importing companies may already be familiar with the process of
determining whether the articles they import contain restricted
chemical substances, if they are subject to the requirements cited
above or various U.S. regulations, such as the Product Safety
Improvement Act (CPSIA) of 2008, Washington's Children's Safe Product
Act, and Maine's Act to Protect Children's Health and the Environment
from Toxic Chemicals in Toys and Children's Products (Ref. 20).
Given the existing regulatory limitations on certain chemicals both
internationally and within the United States, regulated industries have
begun to develop industry-wide processes and other resources to obtain
information on chemical substances in articles. Policies and procedures
could include supplier agreements, such as Hewlett Packard's
requirement that suppliers meet their General Specifications for the
Environment (GSE) (Ref. 21) and Walmart's requirement that suppliers
participate in International Compliance Information Exchange (iCiX) to
manage and share compliance information throughout the supply chain
(Ref. 22). More extensive policies and procedures could even include
product testing. Companies may choose to use existing procedures or
develop new ones that could range from document review, to supplier
agreements, to product testing.
Additional analysis conducted by EPA on activities that companies
may choose to undertake to ensure that the chemicals they import or
process as part of articles do not trigger requirements of the SNUR
shows a wide range of potential activities and associated costs. The
conduct of these activities and associated costs are at the discretion
of the company. Table B of this unit shows EPA's estimated range of
costs associated with some of these potential activities for importers
of articles.

Table B--Range of Costs Associated With an Importer's Identification of Chemicals Subject to SNURs in Articles
----------------------------------------------------------------------------------------------------------------
Activity Cost US ($) Notes
----------------------------------------------------------------------------------------------------------------
Per Rule Costs
----------------------------------------------------------------------------------------------------------------
1. Rule familiarization................. $55........................ Cost typically already included in SNUR
Economic Analyses.
2. Identify the type of imported $130 to $1,550............. Actual costs may vary based on number of
articles that potentially contain the articles imported and the complexity of
restricted substances. the article itself (number of
components).
3. Identify all suppliers involved...... $950....................... Actual costs may vary depending on the
number of articles imported, number of
suppliers, and frequency of supplier
changes.
6. Recordkeeping........................ $10........................ Cost typically already included in SNUR
Economic Analyses.
----------------------------------------------------------------------------------------------------------------
Article-Related Costs
----------------------------------------------------------------------------------------------------------------
4. Collect data from suppliers.......... $5 to $515 per article Actual costs only apply to those
reviewed. $0 if no data companies that choose to collect data
collected from suppliers. They will vary depending
on the specific data collection method
chosen. Total costs depend on
considerations including the number of
articles imported, number of suppliers,
and frequency of supplier changes.
5. Chemical testing..................... $130 per article tested. $0 Actual costs only apply to those
if no testing. companies that choose to collect data
from suppliers. Total costs per company
will depend on considerations including
the number of articles tested, which may
be affected by the number of suppliers
and risk associated with each, and
frequency of supplier changes.
----------------------------------------------------------------------------------------------------------------

Should processors of articles need to demonstrate compliance with a
SNUR, it is expected that they could use the shipping or labeling
documents received with the article in the ordinary course of business.
As these documents

[[Page 77905]]

would be received and stored anyway, as per standard business
practices, the elimination of the exemption in the SNUR for persons
that import or process chemical substances as part of articles would be
unlikely to lead such persons to incur significant additional costs. To
the extent that processors choose to undertake more steps to identify
regulated chemicals as part of articles, the costs of these activities
would be similar to those in Table B of this unit for importers of
similar size, supply chain complexity, and level of compliance with
other chemical regulations.
There are a number of regulations, including California's
Proposition 65 and the EU's REACH that currently restrict or otherwise
affect the use of certain benzidine-based substances, particularly in
their use as dyes in textiles and leather. California's Proposition 65
Chemical List includes benzidine-based dyes as a potential carcinogen
and requires that firms provide a clear and reasonable warning before
knowingly and intentionally exposing anyone to a listed chemical. This
warning may include the labeling of consumer products (Refs. 23-24).
The EU has banned, in textile and leather articles which may come
into direct and prolonged contact with humans, the use of azo dyes
which can break down to release any of 22 listed carcinogenic aromatic
amines (including benzidine and its congeners) in amounts above 30 ppm
(Ref. 25). The European Commission's Directorate General for Health and
Consumers maintains the RAPEX database that member countries can use to
report dangerous products and the measures they have taken to prevent
or restrict those products. Despite the EU ban, small numbers of
products containing such azo dyes have recently been listed on RAPEX.
The products are typically voluntarily withdrawn from the market and/or
destroyed by the importer or have been placed under an order by the
authorities to cease sales (Refs. 26, 27). Therefore, azo dyes in
imported articles still remain a potential issue in the EU. Other
countries have also banned the manufacture and use of the azo dyes in
textiles. Currently the manufacture of azo dyes is banned in South
Korea and Japan (Ref. 27). Use of these chemicals is banned by Egypt,
India, China, South Korea, Taiwan and Vietnam (Ref. 28), and Indonesia
has banned the use of the dyes in children's and baby's clothing (Ref.
29). In 2012, the Japanese textiles and leather industry announced
voluntary restrictions of the chemicals (Refs. 29, 30). Canada has also
expressed concern about the potential release of benzidine or its
congeners from azo dyes and is evaluating potential approaches for
addressing azo dyes (Ref. 30). Organizations, such as the American
Apparel & Footwear Association (AAFA), have developed a comprehensive
Restricted Substances List (RSL) as a reference for companies and have
developed a toolkit to help apparel and footwear companies to better
manage chemicals throughout the supply chain. Given the current level
of international and domestic regulation and attention to benzidine-
related chemicals, EPA believes that importers and processors of
articles may already have undertaken a number of activities to manage
chemicals within their supply chains and generally to deselect for
these chemicals. Therefore, EPA expects that companies that could
potentially commence importing or processing benzidine-based chemicals
as part of articles may already have some knowledge of the chemicals
within their supply chain and would undertake few of the activities
listed in Table B and would fall toward the lower end of the cost range
for any activities undertaken. More detailed information is included in
EPA's economic analysis.
EPA does not believe that the subject chemicals are entering the
United States in imported articles for the significant new uses defined
by the final regulation. However, companies may screen or initiate
other activities to determine if articles they import in the future
contain chemicals included in this SNUR. EPA notes that no commenters
provided data that could be used to estimate what, if any, costs might
be associated with continued assurance that imported articles are free
from the chemical substances subject to this SNUR. The number of
companies that may take such actions is not known, nor is the level of
action that may be taken by a particular company. Based on EPA's
economic analysis and the responses to the proposed rule, EPA does not
believe that these costs will be significant for any individual entity.

I. Import and Export Regulations for Chemical Substances as Part of
Articles

One comment noted that EPA is not proposing to change the way in
which TSCA's export and import rules (pursuant to TSCA sections 12(b)
and 13, respectively) apply to articles containing these chemical
substances. The comment indicates that (under the status quo of the
import rules) the U.S. Customs and Border Protection (CBP) will not be
screening articles for the chemical substances in the proposed SNURs.
EPA agrees that the TSCA import rules are important TSCA compliance
mechanisms and that 19 CFR 12.119 allows EPA to establish section 13
import certification requirements for chemicals in articles. However,
declining to subject importers to one notice requirement (section 13
import certification) does not render another notice requirement
(section 5 SNUN submission) unenforceable.
In this case, EPA did not propose to require section 13 import
certification or section 12 export notification for the subject
chemical substances when part of articles. This is consistent with
EPA's past practice of making the exemption at 40 CFR 721.45(f)
inapplicable without also requiring import certification or export
notification for these chemical substances as part of articles (40 CFR
721.2800; 40 CFR 721.10068). However, the Agency continues to study
this issue and has not ruled out a later proposal to require import
certification and/or export notification for these chemical substances
as part of articles.
With or without an import certification requirement, it is the
importer that is ``responsible for insuring that chemical importation
complies with TSCA just as domestic manufacturers are responsible for
insuring that chemical manufacture compliance with TSCA.'' 40 CFR
707.20(b)(1).

J. Distinguishing Between Chemicals in Non-Article Form and Other
Products

One comment contends that the rule, as proposed, ``would not allow
[EPA] to distinguish between a chemical being brought into the United
States in its raw form and a chemical being brought in on a shift as a
dye or finish.'' The comment goes on to state that treating them the
same way is unrealistic and scientifically unsound.
EPA disagrees with the comment and notes that it was not proposing
to eliminate all distinctions, in all regulatory provisions under TSCA,
between import of a chemical substance in non-article form, and import
of a chemical substance as part of an article. The rule simply removes
one particular distinction between persons who import or process a
chemical substance in non-article form and persons who import or
process a chemical substance as part of an article. Thus, while the raw
chemical manufacturer and the article importer may both be required to
submit a SNUN, EPA would be able distinguish between the two scenarios,
as appropriate, in its review of the SNUN. The SNUN review process will
allow case-by-case analysis of each circumstance.

[[Page 77906]]

With respect to the commenter's comparison of the volume at which
these chemical substances are currently manufactured in non-article
form and the volume at which these chemical substances are currently
manufactured in article form (i.e., via import of a chemical substance
as part of an article), EPA's conclusion, with respect to the
significant new uses, is that the two volumes are currently the same.
This is because EPA has concluded that there is no current manufacture
of these chemical substances for the significant new uses, either
through domestic manufacture of the substances in non-article form, or
through import of articles containing the substances. Thus, both
production volumes are currently zero.

K. Provisions for Processors

In a comment submitted after the closing of the public comment
period, one commenter questions the utility of a provision for
processors at 40 CFR 721.5(c), as applied to notice requirements under
this rule. The commenter states that 40 CFR 721.5(c) would not protect
companies unless they could document lack of knowledge that a SNUR
applies. The commenter believes that this requirement is therefore
impossible to meet, explaining that it is impossible to document what
one does not know.
EPA will respond to this comment, although it was submitted after
the closing of the public comment period for this action, because it
relates closely to the timely submitted comments. EPA disagrees that
applying 40 CFR 721.5(c) is impossible or impracticable. The provisions
at 40 CFR 721.5(c) provide that the unknowing processing of a chemical
substance does not itself trigger SNUN submission requirements, subject
to meeting certain documentation requirements. Upon obtaining knowledge
that it previously engaged in activities covered by the SNUR, a
processor can at that time assemble evidence relating to the period
when the past processing occurred. Specifically, this would be evidence
bearing on whether the processor previously knew the chemical identity
of the substance it was processing or previously knew that that
substance was subject to a SNUR. Evidence to establish a prior lack of
knowledge could include items such as a purchase order and, where
applicable, a material safety data sheet (MSDS) that indicates neither
the relevant chemical identity nor the presence of a chemical subject
to a SNUR. Another type of evidence would be the affidavit of a person
in a position of appropriate authority swearing to the prior lack of
knowledge. EPA would generally consider the wording on a purchase order
and, where applicable, an MSDS, along with an affidavit as described
above, in determining whether there is sufficiently clear documentation
for purposes of 40 CFR 721.5(c). However, if there was also contrary
documentary evidence, indicative of the prior possession of knowledge
(e.g., receipt of a notice given to the processor pursuant to 40 CFR
721.5(a)(1)(i)) then the overall documentary evidence would not allow
the processor to take advantage of the provisions of 40 CFR 721.5(c).

L. Potential Ongoing Use of DnPP

One commenter identified a potential ongoing use of DnPP in grease
in automotive switches. The commenter requested that EPA exclude the
identified use from the SNUR.
After investigation, EPA has determined that there is no ongoing
use of DnPP in grease in automotive switches.
The commenter states that ``[b]ased on current use information . .
. [the commenter] believes that DnPP is being used in grease in some
automotive switches.'' The proposal stated that EPA ``welcome[d]
specific information that documents [ongoing] use.'' Yet the commenter
does not provide any current use information to substantiate this
belief. When raising a potential ongoing use, it is generally
preferable to include information substantiating that use, especially
where the entity raising that use is not an actual manufacturer
(including importer) or processor of that chemical substance for that
use and thus would not be anticipated to have direct knowledge of that
use.
In order to determine whether there is an ongoing use of DnPP in
grease in automotive switches, EPA performed targeted searches of
sources including IHS Chemical Economics Handbook, MSDS search tools
such as Seton's MSDS Hazard Communication Library and patent searches
and was unable to substantiate this use as an ongoing use of DnPP. EPA
reviewed several grease MSDS, and no grease MSDS listed any phthalate
in its composition. EPA's DfE alternatives analysis also has not
identified use in grease in automotive switches as an ongoing use of
DnPP.
EPA also conducted patent searches for grease in automotive
switches, and dampening greases in general. A patent search found
mentions of the term phthalates with electronic components, but not
DnPP specifically for automotive switches. However, one patent gave a
very broad alkyl range that release of phthalates C4 and C8 were
observed during the vacuum burn pretreatment of electronic components
[disc drives]. This process is routine treatment to remove volatiles
from electronic components, including electronic switches (Vacuum
baking process USP 6,051,169 and Electric switches USP 3,694,601). EPA
does not believe the existence of this information is indicative of
current use of DnPP in grease in automotive switches because, patents
do not necessarily indicate current use. As noted in the proposed rule
(Ref. 1), no IUR production volume data were reported for DnPP during
the 2006, 2002, 1998 and 1994 reporting cycles. In addition, no
production volume data were reported for the 2012 CDR (Ref. 17)
Accordingly, EPA is declining to exclude use ``in grease in
automotive switches'' from the significant new uses of DnPP.

M. Reliance on Inventory Update Rule (IUR) Data in Assessing Ongoing
Use of DnPP

One commenter suggests that EPA relied solely on the IUR data for
determining ongoing uses of DnPP, and that such reliance may be
misleading or incomplete. The commenter notes that ongoing uses below
the IUR reporting threshold of 10,000 lbs would not be reported to EPA
through the IUR process.
EPA uses IUR data to identify ongoing uses of chemical substances.
However, this is not the sole source of information relied upon to
support the SNUR. EPA first identified a SNUR as a regulatory
alternative for DnPP in the Phthalates Action Plan because EPA found
that the most recent IUR data contained no reports of DnPP being
produced in or imported into the United States. In proposing the SNUR,
EPA prepared the ``Economic Analysis of the Proposed Significant New
Use Rule for Di-n-pentyl Phthalate (DnPP)'' (Ref. 31) and conducted
internet queries in order to ascertain whether there were any ongoing
uses of DnPP at levels below the IUR reporting threshold. During the
course of this research EPA identified several companies which either
use or sell DnPP as a chemical standard for use in phthalates testing.
Accordingly, the significant new uses of DnPP does not include use of
DnPP as a chemical standard for analytical experiments as a significant
new use.

N. Design for the Environment (DfE) Assessment for Phthalates

One commenter noted that EPA has undertaken a DfE project focused
on phthalates, including but not limited to, DnPP. The commenter
believes that the

[[Page 77907]]

DfE phthalates alternative assessment will provide valuable information
about potential alternatives to industries using phthalates. The
commenter recommends that EPA refrain from further action on any
phthalate until the DfE project is finalized.
EPA disagrees that finalization of the DnPP SNUR should be delayed
until the DfE project is complete. (To the extent the comment is
discussing the timing of other potential EPA actions to address
phthalates, it is outside the scope of this proposal.)
The comment states that the final DfE report would identify
alternatives, their viability as substitutes, and EPA's comparative
hazard information. EPA disagrees that this report is likely to provide
information relevant to this SNUR. When defining the ``significant new
use,'' EPA is limited to uses of the chemical substance that are not
ongoing. The DfE report is not expected to identify alternatives for
chemical substances that are generally no longer in use. It is already
clear that there are many alternatives to DnPP use, because there are
almost no ongoing uses of DnPP. Furthermore, the DfE report is not
expected to suggest DnPP itself as an alternative to another phthalate
because of its toxicity relative to other phthalates. Even if the DfE
report were to identify a significant new use of DnPP as an alternative
to some other chemical substance, then EPA would have the opportunity
to consider that information at such time as it received the
significant new use notice for DnPP.
EPA notes that it is a regular practice to finalize SNURs for
chemical substances that have not undergone a DfE assessment. Given
that the DfE report is unlikely to provide additional information
relevant to EPA's significant new use determination for DnPP, that
newly available information respecting any particular use of DnPP could
be included in the significant new use notice itself, and that further
delay would increase regulatory uncertainty, EPA disagrees that it
would be appropriate to delay issuance of the SNUR on DnPP pending the
release of the DfE report.

XI. References

The following is a listing of the documents that are specifically
referenced in this action. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are in the docket, even if the
referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.

1. U.S. EPA. Proposed Rule; Benzidine-Based Chemical Substances; Di-
n-pentyl phthalate (DnPP); and Alkanes, C12-13, Chloro; Significant
New Use Rules. 77 FR 18752, March 28, 2012 (FRL-8865-2). 2. U.S.
EPA. Benzidine-Based Chemical Substances; Significant New Uses of
Certain Chemical Substances, 61 FR 52287, October 7, 1996 (FRL-5396-
6).
3. U.S. EPA, 2010. U.S. Environmental Protection Agency. Chemical
Substances Derived from Benzidine and Its Congeners, https://www.epa.gov/oppt/existingchemicals/pubs/actionplans/DCB%20Action%20Plan_06232010.noheader.pdf (Accessed January 24,
2011).
4. U.S. EPA. Economics and Policy Branch, USEPA/OCSPP/Economics,
Exposure, and Technology Division. ``Economic Analysis to Support
the Final SNUR for Benzidine and Benzidine-based Chemical
substances.''
5. U.S. EPA. Significant New Uses of Certain Chemical Substances, 55
FR 17376, April 24, 1990 (FRL-3658-5).
6. U.S. EPA. Significant New Uses of Chemical Substances; Certain
Chemicals. 49 FR 35014, September 5, 1984 (FRL-2541-8).
7. U.S. EPA. Premanufacture Notification; Premanufacture Notice
Requirements and Review Procedures. 48 FR 21722, May 13, 1983 (FRL
2998-5).
8. Testimony of James J. Jones, Acting Assistant Administrator
Office of Chemical Safety and Pollution Prevention, U.S.
Environmental Protection Agency before the Committee on Environment
and Public Works and the Subcommittee on Superfund, Toxic and
Environmental Health United States Senate, July 24, 2012, available
at https://www.epa.gov/ocir/hearings/pdf/2012_jjones_testimony1.pdf.
9. CPSC, 2011. Staff Briefing Package. Petition HP 10-2. Requesting
Restriction of Cadmium in Toy Jewelry (Consumer Product Safety
Commission (February 9, 2011). Staff Report, Cadmium in Children's
Metal Jewelry. Toxicity Review of Cadmium. TAB B pp19-39 https://www.cpsc.gov/PageFiles/96192/cadmiumtoy.pdf (October 14, 2010).
10. Danish Environmental Protection Agency, Survey of Chemical
Substances in Consumer Products Survey No. 25 2003, Mapping the
Liberation of Organic Tin Compounds in Mattress Pads, To Mattresses,
and Baby/Junior Duvets.
11. Stapleton, et al., 2008, Alternate and New Brominated Flame
Retardants Detected in U.S. House Dust, Environ. Sci. Technol.
12. CPSC Staff Preliminary Risk Assessment of Flame Retardant [FR]
Chemicals in Upholstered Furniture Foam, December 21, 2006.
13. Muller, et al., 2011, Car Indoor Air Pollution--Analysis of
Potential Sources, Journal of Occupations Medicine and Toxicology
2011, 6:33.
14. Wu, et al., 2009, Residues of Polybrominated Diphenyl Ethers in
Frogs (Rana limnocharis) from a Contaminated Site, South China:
Tissue Distribution, Biomagnification, and Maternal Transfer,
Environ. Sci. Technol. 2009, 42: 5212-5217.
15. Gaylor, et al. 2012, House Crickets Can Accumulate
Polybrominated Diphenyl Ethers (PBDEs) Directly from Polyurethane
Foam Common in Consumer Products, Chemosphere, 2012, 86: 500-505.
16. Covaci, et al. 2006, Hexabromocyclododecanes (HBCDs) in the
Environment and Humans: A Review. Environ. Sci. Technol. 2006, 40:
3679-3688.
17. U.S. EPA, Chemical Data Access Tool (CDAT), https://java.epa.gov/oppt_chemical_search/.
18. U.S. EPA, Certain Polybrominated Diphenylethers; Proposed
Significant New Use Rule. 69 FR 70409, December 6, 2004 (FRL 7633-
1).
19. U.S. EPA, Certain Polybrominated Diphenylethers; Significant New
Use Rule.71 FR 34018, June 13, 2006 (FRL 7743-2).
20. U.S. EPA, Understanding the Costs Associated with Eliminating
Exemptions for Articles in SNURs, May 1, 2013.
21. Hewlett-Packard Development Company, LP. (2010). ``International
Material Data System.'' Retrieved from https://www.mdsystem.com/.
22. Wal-Mart. (2012). Become a Supplier: Requirements. Retrieved
from https://www.walmartstores.com/Suppliers/248.aspx.
23. CAEPA, 2013a. State of California Environmental Protection
Agency. Chemicals Known to the State to Cause Cancer or Reproductive
Toxicity. Office of Environmental Health Hazard Assessment, 04
February 2013. https://oehha.ca.gov/prop65/prop65_list/files/P65list020813.pdf.
24. CAEPA, 2013b. State of California Environmental Protection
Agency. Proposition 65 in Plain Language! Febuary 2013. https://oehha.ca.gov/prop65/background/p65plain.html.
25. European Commission. 2009. Commission Regulation EC No. 552/2009
Commission Regulation (EC) No 552/2009 of 22 June 2009 amending
Regulation (EC) No 1907/2006 of the European Parliament and of the
Council on REACH as regards Annex XVII.
26. European Commission. 2010. RAPEX--Latest Notifications.
Directorate General for Health and Consumers. https://ec.europa.eu/consumers/dynex/rapex/rapex_achives_en.cfm.
27. IARC, 2012. International Agency for the Research on Cancer.
IARC Monographs on the Evaluation of Carcinogenic Risks to Humans--
Benzidine.Volume 100F: 53-63.
28. Textination, 2012. Textination ``Textile and Apparel Weekly
June, 8 2012''. https://textination.de/en/tiw/2012/TIW08062012.pdf.
29. Intertek, 2013. Intertek, ``Requirements of Azo dyes and
Formaldehyde content in fabric for babies and children clothing in
Indonesia'' Jan 4, 2013.

[[Page 77908]]

30. HKTDC, 2012. HKTDC Research ``Japan Industry Stipulates
Voluntary AZO Dyes Standard for Textile and Leather Products'' May
22, 2012.
31. Environment Canada. 2009. Strategic options for the management
of toxic substances benzidine and 3,3-dichlorobenzidine. Available
at: https://www.ec.gc.ca/toxics/docs/sor/bdine/EN/sum.cfm (Accessed
10 September, 2009).
32. U.S. EPA. Economics and Policy Branch, USEPA/OCSPP/Economics,
Exposure, and Technology Division. ``Economic Analysis of the Final
Significant New Use Rule for Di-n-pentyl phthalate (DnPP).''
33. U.S. EPA. Economics and Policy Branch, USEPA/OCSPP/Economics,
Exposure, and Technology Division. ``Economic Analysis of the Final
Significant New Use Rule for Alkanes, C12-13, chloro (CAS
RN: 71011-12-6).''
34. U.S. EPA. Modification of Significant New Use Rules for Certain
Substances, 62 FR 42690, August 8, 1997 (FRL-5735-4).

XII. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

This final rule has been designated by OMB as a ``significant
regulatory action'' under section 3(f) of Executive Order 12866 (58 FR
51735, October 4, 1993). Accordingly, EPA submitted this action to OMB
for review under Executive Order 12866 and 13563 (76 FR 3821, January
21, 2011), and any changes made in response to OMB recommendations are
documented in the docket.

B. Paperwork Reduction Act (PRA)

This action does not impose any new information collection burden
under the PRA, 44 U.S.C. 3501 et seq. Burden is defined in 5 CFR
1320.3(b). The information collection activities associated with
existing chemical SNURs are already approved by OMB under OMB control
number 2070-0038 (EPA ICR No. 1188); and the information collection
activities associated with export notifications are already approved by
OMB under OMB control number 2070-0030 (EPA ICR No. 0795). If an entity
were to submit a SNUN to the agency, the annual burden is estimated to
be less than 100 hours per response, and the estimated burden for an
export notifications is less than 1.5 hours per notification. In both
cases, burden is estimated to be reduced for submitters who have
already registered to use the electronic submission system. Additional
burden, estimated to be less than 10 hours, could be incurred where
additional record keeping requirements are specified under 40 CFR
721.125(a), (b), and (c).
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 this SNUR. This listing of the OMB
control numbers and their subsequent codification in the CFR satisfies
the display requirements of the PRA and OMB's implementing regulations
at 5 CFR part 1320. Since the existing OMB approval was previously
subject to public notice and comment before OMB approval, and given the
technical nature of the table, EPA finds that further notice and
comment to amend the table 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.

C. Regulatory Flexibility Act (RFA)

Pursuant to section 605(b) of the RFA, 5 U.S.C. 601 et seq., I
hereby certify that promulgation of this SNUR will not have a
significant economic impact on a substantial number of small entities.
The rationale supporting this conclusion is as follows.
EPA generally finds that proposed and final SNURs are not expected
to have a significant economic impact on a substantial number of small
entities (See, e.g., Ref. 34). Since these SNURs will require a person
who intends to engage in such activity in the future to first notify
EPA by submitting a SNUN, no economic impact will occur unless someone
files a SNUN to pursue a significant new use in the future or forgoes
profits by avoiding or delaying the significant new use. Although some
small entities may decide to engage in such activities in the future,
EPA cannot presently determine how many, if any, there may be. However,
EPA's experience to date is that, in response to the promulgation of
SNURs covering over 1,000 chemical substances, the Agency receives only
a handful of notices per year. During the six year period from 2005-
2011, only three submitters self-identified as small in their SNUN
submission (Refs. 5, 32, 33). EPA believes the cost of submitting a
SNUN is relatively small compared to the cost of developing and
marketing a chemical new to a firm and that the requirement to submit a
SNUN generally does not have a significant economic impact.
A SNUR applies to any person (including small or large entities)
who intends to engage in any activity described in the rule as a
``significant new use.'' In the proposed SNUR EPA preliminarily
determined, based in part, on the Agency's market research, that these
chemical substances are not being manufactured (including imported) or
processed for a significant new use. In the case of the benzidine-based
dyes, this preliminary determination also included importation and
processing of these chemical substances as part of articles (Ref. 1).
EPA received no public comment indicating any ongoing importation of
the benzidine-based chemical substances as part of articles or
otherwise. Therefore, EPA is finalizing its determination that these
uses, including the importation and processing of benzidine-based dyes
as part of articles, are new and not ongoing. Thus no small entities
presently engage in a significant new use.
Therefore, EPA believes that the potential economic impact of
complying with this SNUR is not expected to be significant or adversely
impact a substantial number of small entities.

D. Unfunded Mandates Reform Act (UMRA)

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 reason to believe that any
State, local, or Tribal government would be impacted by this
rulemaking. As such, EPA has determined that this regulatory action
would not impose any enforceable duty, contain any unfunded mandate, or
otherwise have any effect on small governments subject to the
requirements of sections 202, 203, 204, or 205 of UMRA, 2 U.S.C. 1531-
1538.

E. Executive Order 13132: Federalism

This action does 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 (64 FR 43255,
August 10, 1999).

[[Page 77909]]

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

This action does not have Tribal implications because it will not
have any effect (i.e., there will be no increase or decrease in
authority or jurisdiction) on Tribal governments, on the relationship
between the Federal government and the Indian tribes, or on the
distribution of power and responsibilities between the Federal
government and Indian tribes. Thus, Executive Order 13175 (65 FR 67249,
November 9, 2000), does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks

This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because this action is not intended to address
environmental health or safety risks for children.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

This action is not subject to Executive Order 13211 (66 FR 28355,
May 22, 2001), because it is not expected to affect energy supply,
distribution, or use.

I. National Technology Transfer and Advancement Act (NTTAA)

Since this action does not involve any technical standards, section
12(d) of NTTAA, 15 U.S.C. 272 note, does not apply to this action.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898 (59 FR
7629, February 16, 1994), because EPA has determined that this action
will not have disproportionately high and adverse human health or
environmental effects on minority or low-income populations. This
action does not affect the level of protection provided to human health
or the environment.

K. Congressional Review Act (CRA)

Pursuant to the CRA, 5 U.S.C. 801 et seq., 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 action 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: December 16, 2014.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.

Therefore, 40 CFR chapter I is amended as follows:

PART 9--[AMENDED]

0
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.

0
2. In Sec. [emsp14]9.1, add the following sections in numerical order
under the undesignated center heading ``Significant New Uses of
Chemical Substances'' to read as follows:

Sec. [emsp14]9.1 OMB approvals under the Paperwork Reduction Act.

* * * * *

------------------------------------------------------------------------
40 CFR citation OMB Control No.
------------------------------------------------------------------------

* * * * *
------------------------------------------------------------------------
Significant New Uses of Chemical Substances
------------------------------------------------------------------------

* * * * *
721.10226............................................. 2070-0038
721.10227............................................. 2070-0038

* * * * *
------------------------------------------------------------------------

* * * * *

PART 721--[AMENDED]

0
3. The authority citation for part 721 continues to read as follows:

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

0
4. Revise Sec. 721.1660 to read as follows:

Sec. 721.1660 Benzidine-based chemical substances.

(a) Chemical substances and significant new uses subject to
reporting. (1) The benzidine-based chemical substances listed in Table
1 and Table 2 of this section are subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.

Table 1--Benzidine-Based Chemical Substances
--------------------------------------------------------------------------------------------------------------------------------------------------------
CAS or accession No. C.I. name C.I. No. Chemical name
--------------------------------------------------------------------------------------------------------------------------------------------------------
117-33-9.............................. Not available............ Not available........... 1,3-Naphthalenedisulfonic acid, 7-hydroxy-8-[2-[4'-[2-(4-
hydroxyphenyl)diazenyl][1,1'-biphenyl]-4-yl]diazenyl]-
65150-87-0............................ Not available............ Not available........... 1,3,6-Naphthalenetrisulfonic acid, 8-hydroxy-7-[2-[4'-[2-(2-
hydroxy-1-naphthalenyl)diazenyl][1,1'- biphenyl]-4-
yl]diazenyl]-, lithium salt (1:3)
68214-82-4............................ Direct Navy BH........... 22590................... 2,7-Naphthalenedisulfonic acid, 5-amino-3-[2-[4'-[2-(7-
amino-1-hydroxy-3-sulfo-2- naphthalenyl)diazenyl][1,1'-
biphenyl]-4- yl]diazenyl]-4-hydroxy-, sodium salt (1:2)
72379-45-4............................ Not available............ Not available........... 2,7-Naphthalenedisulfonic acid, 4-amino-5-
hydroxy-3-[2-[4'-[2-[2-hydroxy-4-[(2-
methylphenyl)amino]phenyl]diazenyl][1,1'- biphenyl]-4-
yl]diazenyl]-6-(2-phenyldiazenyl)-
Accession No. 21808................... CBI...................... CBI..................... 2,7-Naphthalenedisulfonic acid, 4-amino-5-
CAS No. CBI (NA)...................... hydroxy [[[(substituted phenylamino)] substituted
phenylazo] diphenyl]azo-, phenylazo-, disodium salt.
(generic name)

[[Page 77910]]

Accession No. 24921................... CBI...................... CBI..................... 4-(Substituted naphthalenyl )azo diphenylyl azo-substituted
CAS No................................ carbopolycycle azo benzenesulfonic acid, sodium salt.
(generic name)
Accession No. 26256................... CBI...................... CBI..................... 4-(Substituted phenyl)azo biphenylyl azo-
CAS No. CBI (NA)...................... substituted carbopolycycloazo benzenesulfonic acid, sodium
salt. (generic name)
Accession No. 26267................... CBI...................... CBI..................... 4-(Substituted phenyl)azo biphenylyl azo -
CAS No. CBI (NA)...................... substituted carbopolycycle azo benzenesulfonic acid, sodium
salt. (generic name)
Accession No. 26701................... CBI...................... CBI..................... Phenylazoaminohydroxynaphthalenylazobiphenylazo substituted
CAS No. CBI (NA)...................... benzene sodium sulfonate. (generic name).
--------------------------------------------------------------------------------------------------------------------------------------------------------

Table 2--Benzidine-Based Chemical Substances
----------------------------------------------------------------------------------------------------------------
CAS No. C.I. name C.I. No. Chemical name
----------------------------------------------------------------------------------------------------------------
92-87-5....................... Benzidine........ Not available.... [1,1'-Biphenyl]-4,4'-diamine.
531-85-1...................... Benzidine Not available.... [1,1'-Biphenyl]-4,4'-diamine,
[middot] 2HCl. dihydrochloride.
573-58-0...................... C.I. Direct Red 22120............ 1- Naphthalenesulfonic acid, 3,3'-[[1,1'-
28. biphenyl]-4,4'-diylbis(azo)]bis[4-amino-,
disodium salt.
1937-37-7..................... C.I. Direct Black 30235............ 2,7-Naphthalenedisulfonic acid, 4-amino-3-
38. [[4'-[(2,4-diaminophenyl) azo][1,1'-
biphenyl]-4- yl]azo]-5-hydroxy-6-
(phenylazo)-, disodium salt.
2302-97-8..................... C.I. Direct Red 22500............ 1-Naphthalenesulfonic acid, 8,8'-[[1,1'-
44. biphenyl]-4,4'-diylbis(azo)]bis[7-hydroxy-
, disodium salt.
2429-73-4..................... C.I. Direct Blue 22590............ 2,7-Naphthalenedisulfonic acid, 5-amino-3-
2. [[4'-[(7-amino-1-hydroxy-3-sulfo-2-
naphthalenyl)azo][1,1'-biphenyl]-4-
yl]azo]-4-hydroxy-, trisodium salt.
2429-79-0..................... C.I. Direct 22130............ Benzoic acid, 5-[[4'-[(1-amino-4-sulfo-2-
Orange 8. naphthalenyl) azo][1,1'-biphenyl]-4-
yl]azo]-2- hydroxy-, disodium salt.
2429-81-4..................... C.I. Direct Brown 35660............ Benzoic acid, 5-[[4'-[[2,6-diamino-3-[[8-
31. hydroxy-3,6-disulfo-7-[(4-sulfo-1-
naphthalenyl)azo]-2- naphthalenyl]azo]-5-
methylphenyl]azo][1,1'- biphenyl]-4-
yl]azo]-2-hydroxy-, tetrasodium salt.
2429-82-5..................... C.I. Direct Brown 22311............ Benzoic acid, 5-[[4'-[(7-amino-1-hydroxy-3-
2. sulfo-2-naphthalenyl) azo][1,1'-biphenyl]-
4-yl]azo]-2-hydroxy-, disodium salt.
2429-83-6..................... Direct Black 4... 30245............ 2,7-Naphthalenedisulfonic acid, 4-amino-3-
[[4'-[(2,4-diamino-5-
methylphenyl)azo][1,1'-biphenyl]-4-
yl]azo] -5-hydroxy-6-(phenylazo)-,
disodium salt.
2429-84-7..................... C.I. Direct Red 1 22310............ Benzoic acid, 5-[[4'-[(2-amino-8-hydroxy-6-
sulfo-1-naphthalenyl)azo][1,1'-biphenyl]-
4-yl]azo]-2-hydroxy-, disodium salt.
2586-58-5..................... C.I. Direct Brown 30110............ Benzoic acid, 5-[[4'-[[2,6-diamino-3-
1:2. methyl-5-[(4-
sulfophenyl)azo]phenyl]azo][1,1'-
biphenyl]-4- yl]azo]-2-hydroxy-, disodium
salt.
2602-46-2..................... C.I. Direct Blue 22610............ 2,7-Naphthalenedisulfonic acid, 3,3'-
6. [[1,1'-biphenyl]-4,4'-diylbis(azo)]bis[5-
amino-4-hydroxy-, tetrasodium salt.
2893-80-3..................... C.I. Direct Brown 30140............ Benzoic acid, 5-[[4'-[[2,4-dihydroxy-3-[(4-
6. sulfophenyl) azo]phenyl]azo][1,1'-
biphenyl]-4- yl]azo]-2-hydroxy-, disodium
salt.
3530-19-6..................... C.I. Direct Red 22240............ 1,3-Naphthalenedisulfonic acid, 8-[[4'-[(4-
37. ethoxyphenyl)azo][1,1'-biphenyl]-4-
yl]azo]-7-hydroxy-, disodium salt
3567-65-5..................... C.I. Acid Red 85. 22245............ 1,3-Naphthalenedisulfonic acid, 7-hydroxy-
8-[[4'-[[4-[[(4-
methylphenyl)sulfonyl]oxy]phenyl]azo][1,1
'-biphenyl]-4-yl]azo]-, disodium salt.
3626-28-6..................... C.I. Direct Green 30280............ 2,7-Naphthalenedisulfonic acid, 4-amino-5-
1. hydroxy-3-[[4'-[(4-
hydroxyphenyl)azo][1,1'- biphenyl]-4-
yl]azo]-6-(phenylazo)-, disodium salt.
3811-71-0..................... C.I. Direct Brown 30045............ Benzoic acid, 5-[[4'-[[2,4-diamino-5-[(4-
1. sulfophenyl) azo]phenyl]azo][1,1'
biphenyl]-4- yl]azo]-2-hydroxy-, disodium
salt.
4335-09-5..................... C.I. Direct Green 30295............ 2,7-Naphthalenedisulfonic acid, 4-amino-5-
6. hydroxy-6-[[4'-[(4-
hydroxyphenyl)azo][1,1'-biphenyl]-4-
yl]azo]-3-[(4-nitrophenyl)azo]-, disodium
salt.
6358-80-1..................... C.I. Acid Black 30336............ 2,7-Naphthalenedisulfonic acid, 4-amino-5-
94. hydroxy-3-[[4'-[[4-hydroxy-2-[(2-
methylphenyl)amino]phenyl]azo] [1,1'-
biphenyl]-4-yl]azo]-6-[(4-sulfophenyl)
azo]-, trisodium salt.
6360-29-8..................... C.I. Direct Brown 31725............ Benzoic acid, 5-[[4'-[[4-[(4-amino-7-sulfo-
27. 1-naphthalenyl)azo]-6-sulfo-1-
naphthalenyl]azo][1,1'-biphenyl]-4-yl]
azo]-2- hydroxy-, trisodium salt.
6360-54-9..................... C.I. Direct Brown 30120............ Benzoic acid, 5-[[4'-[[2,6-diamino-3-
154. methyl-5-[(4-sulfophenyl)azo]phenyl]
azo][1,1'-biphenyl]-4-yl]azo]-2- hydroxy-
3-methyl-, disodium salt.
8014-91-3..................... C.I. Direct Brown 36300............ Benzoic acid, 3,3'-[(3,7-disulfo-1,5-
74. naphthalenediyl)bis [azo(6-hydroxy-3,1-
phenylene)azo[6(or7)-sulfo-4,1-
naphthalenediyl]azo[1,1'-biphenyl]-4,4'-
diylazo]]bis[6-hydroxy-, hexasodium salt.
16071-86-6.................... C.I. Direct Brown 30145............ Cuprate(2-), [5-[[4'-[[2,6-dihydroxy-3-[(2-
95. hydroxy-5-sulfophenyl)azo]phenyl]
azo][1,1'- biphenyl]-4-yl]azo]-2-
hydroxybenzoato(4-)]-, disodium salt.
----------------------------------------------------------------------------------------------------------------

[[Page 77911]]

(2) The significant new uses are:
(i) For each of the chemical substances listed in Table 2 of this
section, any use other than use as a reagent to test for hydrogen
peroxide in milk; a reagent to test for hydrogen sulfate, hydrogen
cyanide, and nicotine; a stain in microscopy; a reagent for detecting
blood; an analytical standard; and, additionally for Colour Index
(C.I.) Direct Red 28 (Congo Red) (CAS No. 573-58-0), an indicator dye.
(ii) For the chemical substances listed in Table 1 of this section:
Any use.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Revocation of certain notification exemptions. The provisions
of Sec. 721.45(f) do not apply to this section. A person who imports
or processes a chemical substance identified in paragraph (a)(1) of
this section as part of an article for a significant new use described
in paragraph (a)(2) of this section is not exempt from submitting a
significant new use notice.
(2) [Reserved]

0
5. Add Sec. 721.10226 to subpart E to read as follows:

Sec. 721.10226 Di-n-pentyl phthalate (DnPP).

(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as di-n-pentyl
phthalate (DnPP) (1,2-benzenedicarboxylic acid, 1,2-dipentyl ester)
(CAS No. 131-18-0) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new use is: Any use other than use as a
chemical standard for analytical experiments.
(b) [Reserved]

0
6. Add Sec. 721.10227 to subpart E to read as follows:

Sec. 721.10227 Alkanes, C[bdi1][bdi2]-[bdi1][bdi3], chloro
(CAS No. 71011-12-6).

(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as alkanes,
C12-13, chloro (CAS No. 71011-12-6) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new use is: Any use.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Persons who must report. Section 721.5 applies to this section
except for Sec. 721.5(a)(2). A person who intends to manufacture for
commercial purposes a substance identified in paragraph (a)(1) of this
section and intends to distribute the substance in commerce must submit
a significant new use notice.
(2) [Reserved]

[FR Doc. 2014-29887 Filed 12-24-14; 8:45 am]
BILLING CODE 6560-50-P

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