*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 1 of 60 Rin2070-AJ73_EO12866_3-Chemical-SNUR-N PRM_FRdocument_Markup_2012-03-02.docx As revised to address comments received during the review under EO 12866.
BILLING CODE 6560-50-P ENVIRONMENTAL PRO TECTION AGENCY 40 CFR Part 721 [ EPA-HQ-OPPT-2010-0573; FRL- 8865
- 2 XXXX-X] RIN 2070

– AJ36 -AJ73 Benzidine-Based Chemical Substances; Di- n -pentyl phthalate (Dn PP); and Alkanes, C 12-

13 , Chloro; Proposed Significant New Use Rules AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. SUMMARY: Under section 5(a)(2) of the Toxic Substances Control Act (TSCA), EPA is proposing: to add nine benzidine-based chemical substances to the Significant New Use Rule (SNUR) at § 721.1660 on benzidine-based chemical substances; a SNUR for
Di- n -pentyl phthalate (DnPP) (1,2-Benzenedi carboxylic acid, 1,2-dipentyl ester) (CAS No. 131-18-0); and a SNUR for Alkanes, C 12-13 , chloro (CAS No. 71011-12-6). If finalized this rule would re quire persons who intend to manufacture, import, or process these chemical substances for an activity that is designated as a si gnificant new use to notify EPA at least 90 days before commen cing that activity. In the case of the benzidine-based chemical substances, EPA is also proposing to make inapplicable the exemption at § 721.45(f) relating to persons that import or process subs tances as part of an article. If finalized this would requir e persons who intend to import or process all listed benzidine-based chemical substances , i.e., the newly proposed nine benzidine-*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 2 of 60 based chemical substances as well as the currently listed benzidine-based chemical substances, as part of an ar ticle to notify EPA at least 90 days before commencing that activity. The required notifica tion would provide EPA with the opportunity to evaluate activities associated with a significant ne w use and an opportunity to protect against potential unreasonable risks, if any, from exposure to the chemical substance. DATES: Comments must be re ceived on or before [ insert date [90] days after date of publication in the Federal Register]. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2010-0573 by one of the following methods:

• Federal eRulemaking Portal : http://www.regulations.gov . Follow the on-line instructions for submitting comments.

• Mail : Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protect ion Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

• Hand Delivery : OPPT Document Control Office (DCO), EPA East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC. Attention: Docket ID number EPA-HQ-OPPT-2010-0573. The DCO is open fro m 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The tele phone number for the DCO is (202) 564-8930. Such deliveries are only accepted during the DCO’s normal hours of operation, and special arrangements should be made for deliveries of boxed information.

• Instructions : Direct your comments to docket ID number EPA-HQ-OPPT2010-0573. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at http://www.regulations.gov ,*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 3 of 60 including any personal information provide d, unless the comment includes information claimed to be Confidential Business Info rmation (CBI) or other information whose disclosure is restricted by st atute. Do not submit informati on that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The regulations.gov website is an “anonymous access” system, which means EP A will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. El ectronic files should a void the use of special characters, any form of encryption, and be free of any defects or viruses.

• Docket : All documents in the docket are liste d in the docket index available at http://www.regulations.gov . Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is re stricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket mate rials are available electronically at http://www.regulations.gov , or, if only available in hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 4 of 60 legal holidays. The telephone number of the EPA/DC Public Reading Room is (202) 566- 1744, and the telephone number for the OPPT Do cket is (202) 566-0280. Docket visitors are required to show photographi c identification, pass through a metal detector, and sign the EPA visitor log. All vis itor bags are processed through an X-ray machine and subject to search. Visitors will be provided an EPA/DC badge that mu st be visible at all times in the building and return ed upon departure. FOR FURTHER INFORMATION CONTACT: For technical information contact: Sara Kemme, National Program Chemicals Division (7404T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW ., Washington, DC 20460-0001; telephone number: (202) 566-0511 e-mail address: sara.kemme@epa.gov

. For general information contact : The TSCAHotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554–1404; e-mail address: TSCAHotline@epa.gov

. SUPPLEMENTARY INFORMATION: I. General Information
A. Does this Action Apply to Me? These three different SNURs may apply to different entities.
1. Benzidine-based chemical substances. You may be potentially affected by this action if you manufacture, import or process, in cluding as part of an article, any of the benzidine-based chemical substances listed in Ta bles 1 and 2 of the regu latory text in this document. Potentially affected entities may include, but are not limited to:

• Manufacturers, importers, or processors of one or more of the subject chemical substances.*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 5 of 60 • Entities which plan to use the listed ch emical substances in conjunction with apparel and other finished products made from fabrics, leather, and similar materials.

• Entities which plan to use the listed ch emical substances in conjunction with paper and allied products.

• Manufacturers, importers, or processors of the subject chemical substances in printing inks. These entities may include those desc ribed by the North Am erican Industrial Classification System (NAICS) codes 325- chemical manufact uring, 313- textile manufacturers, 316 – leat her and allied products ma nufacturers, 322- paper manufacturers, 4243- apparel, piece goods, and no tions wholesalers, or 443- clothing and accessories stores.
2. DnPP. For DnPP, you may be potentially affect ed by this action if you manufacture (defined by statute to include import), or pro cess DnPP. Potentially affected entities may include, but are not limited to: ch emical industry – plastic mate rial & resins (NAICS code 325211).
3. Alkanes, C 12-13 , chloro (CAS No. 71011-12-6). You may be potentially affected by this action if you manufacture, process, or impor t the following short-chained chlorinated paraffin (SCCP): alkanes, C 12-13 , chloro (CAS No. 71011-12-6). Potentially affected entities may include, but are not limited to: Ma nufacturers (defined by statute to include importers) of SCCPs (NAICS codes 325 and 325998), e.g., chemical manufacturing; including miscellaneous chemical product and preparation manufacturing; and processors of SCCPs (NAICS codes 324 and 324191), e.g., petroleum lubricating oil and grease*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 6 of 60 manufacturing. This listing is not intended to be exha ustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. Th e NAICS codes have been provided to assist you and others in determining whether this ac tion might apply to ce rtain entities. To determine whether you or your business may be affected by this action, you should carefully examine the appli cability provisions in § 721.5 fo r SNUR-related obligations and with respect to benzidine-based chemical substances, the applic ability provisions in Unit II.C. If you have any questions regardi ng the applicability of this action to a particular entity, consul t the technical person listed under FOR FURTHER
INFORMATION CONTACT. This action may also affect certai n entities through pre-existing import certification and export notification rules unde r TSCA. Persons who import any chemical substance governed by a final SNUR are subj ect to the TSCA section 13 (15 U.S.C. 2612) import 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 CF R part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this proposed rule on or after [ insert date 30 days after the date of publication in the Federal Register] are subject to the export notifica tion provisions of TSCA section 12( b) (15 U.S.C. 2611(b)), (see § 721.20), and must comply with the export not ification requirements in 40 CFR part 707,*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 7 of 60 subpart D.
B. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI . Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the pa rt or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is clai med as CBI. In addition to one complete version of the comment that includes inform ation claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments . When submitting comments, remember to: i. Identify the document by docket ID nu mber and other identifying information (subject heading, Federal Regist er date and page number). ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (C FR) part or section number. iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes. iv. Describe any assumptions and provid e any technical information and/or data that you used. v. If you estimate potential costs or bu rdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 8 of 60 vi. Provide specific examples to illustra te your concerns and suggest alternatives. vii. Explain your views as clearly as possible, avoidi ng the use of profanity or personal threats. viii. Make sure to submit your comments by the comment period deadline identified. II. Background
A. What Action is the Agency Taking? EPA is proposing to add nine chemical s ubstances (see Table 1 in Unit III.A.) to the existing SNUR for certain benzidine-ba sed chemical substances at § 721.1660. That regulation includes as significan t new uses “any use other than 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 anal ytical standard; and also for Colour Index (C.I.) Direct Red 28 (Congo Red, CAS No. 573-58-0) as an indicator dye.” § 721.1660(a)(2). For the nine newly-proposed benzidine-based chemical substances, EPA is proposing to designate any use as a significant new use. EPA requests comment on whether there are any o ngoing uses of these chemicals. EPA is also proposing to amend the SNUR at § 721.1660 to make inapplicable the exemption at § 721.45(f) for persons that import or process benz idine-based chemical substances as part of an article. Additionally, EPA is proposing a SNUR for DnPP that would designate, as a significant new use, any use of the substance other than as a chemical standard for laboratory use. EPA is also proposing a SNUR for alkanes, C 12-13 , chloro (CAS No. 71011-12-6)*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 9 of 60 that would designate any use of the substan ce as a significant new use. Because any use of alkanes, C 12-13 , chloro (CAS No. 71011-12-6) w ould be a new use, § 721.5(a)(2) would be inapplicable to alkanes, C 12-13 , chloro (CAS No. 71011-12-6). This provision addresses manufacturers, importers, and pro cessors who are also distributors of a chemical substance subject to a SNUR. In cer tain cases, it requires these distributors to alert their customers that the SNUR exists . This requirement serves an important communication function when certain uses of a chemical, but not others, trigger Significant New Use Notice (S NUN) requirements. Where there are no ongoing, existing uses of a chemical substance and EPA determines by rule that all future uses trigger SNUNs requirement (as with alkanes, C 12-13 , chloro (CAS No. 71011-12-6), EPA believes these alerts are not only unn ecessary, but unlikely to ever occur. These proposed SNURs would require pe rsons that manufactur e, process, or import any of the chemicals for a significant ne w use, consistent with the requirements at 40 CFR part 721.25, to notify EPA at least 90 days before commencing such manufacture, process, or import of the chemi cal substance for a significant new use. For the benzidine-based chemical substances, the proposed elimination of the article exemption at § 721.45(f) would also require persons to notify EPA at least 90 days before commencing processing or importing as part of an article any of the currentlylisted or newly-proposed benzidine-based chemical substances. The objectives and rationale for this proposed SNUR are explained in Unit VI.
B. What is the Agency's Author ity 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 "si gnificant new use." EPA must make this*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 10 of 60 determination by rule after c onsidering all releva nt factors, includi ng those listed in TSCA section 5(a)(2). Th ese factors include: • The projected volume of manufact uring and processing of a chemical substance. • The extent to which a use changes th e type or form of exposure of human beings or the environment to a chemical substance. • The extent to which a use increases th e magnitude and duration of exposure of human beings or the environment to a chemical substance. • The reasonably anticipated manner a nd methods of manufacturing, processing, distribution in commerce, and dispos al of a chemical substance. Once EPA determines that a use of a chem ical 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 manu facture, import, or process the chemical substance for that use (15 U.S.C. 2604(a)(1 )(B)). The general SNUR provisions are found at 40 CFR part 721, subpart A.
C. Applicability of General Provisions General provisions for SNURs appear under 40 CFR part 721, subpart A. These provisions describe persons subject to the ru le, 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 appe ar at 40 CFR part 700. According to § 721.1(c), persons subject to SNURs must comp ly with the same notice requirements and EPA regulatory procedures as submitters of Premanufacture Notices (PMNs) under*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 11 of 60 TSCA section 5(a)(1)(A). In particular, th ese 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 regulat ions at 40 CFR part 720. Once EPA receives a Significant New Use Notice ( SNUN ) , , EPA may take regulatory action under TSCA sec tion 5(e), 5(f), 6 or 7 to co ntrol the activities on which it has received the SNUN. If EPA does not take action, EPA is re quired under TSCA section 5(g) to explain in the Federal Register its reas ons for not taking action. However, § 721.45(f) (which generally exempts persons importing or processing a substance as part of an arti cle) would not apply to benzid ine-based chemical substances listed at 40 CFR 721.1660 and those added by this proposed rule. Therefore, a person who imports or processes as part of an arti cle a benzidine-based chemical substance that is covered by this proposed rule would not be exempt from submitting a SNUN. With respect to articles, it is st ill relevant to the rulemaking whether a use was ongoing or not at time of proposal. It is not EPA’s inte nt to subject ongoing uses of any chemical substances to the requirements of a SNUR. Thus, to the extent that additional ongoing uses of benzidine-based chemical substan ces are found in the course of rulemaking (whether or not they involve importing or processing as part of articles), EPA would exclude those uses from the final SNUR. Persons who export or intend to export a chemical substa nce identified in a proposed or final SNUR are s ubject to the export notificati on 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 cert ification requirements, codified at 19 CFR*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 12 of 60 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. III. Overview of Benzidine-Based Chemical Substances
A. What Additional Benzidine-Based Chemical Substances are Subject to this Proposed
SNUR? This proposed rule would add nine benzidine-based chemical substances to the list of twenty four chemical substances currently regul ated under § 721.1660. The nine benzidine-based chemical substances covered by this proposed SNUR are listed in Table 1. The chemicals listed in Table 1 are identi fied by Chemical Abstract Service Registry Numbers (CAS number) or if the chemical ’s CAS number is claimed confidential business information (CBI), the chemical is identified by an EPA Accession Number, along with its corresponding generic name . The accession numbers are EPA assigned numbers used to identify chemicals in place of confidential CAS numb ers. Table 1 also indicates the availability of th e Colour Index (C.I.) name and C.I. number, which is either not available or CBI for some of the chemi cals subject to this ru le. Persons who are interested in determining the precise identi ty of the chemical designated by a certain accession number and a generic name should submit a bonafide request to EPA that complies with the information requi rements stipulated in § 721.11(b). Table 1—Benzidine-Based Chemical Substances

CAS number C.I. name C.I. number Chemical name 117-33-9 Not available Not available 1,3- Naphthalenedisulfonic acid, 7-hydroxy8-[2-[4'-[2-(4-hydroxyp henyl)diazenyl][1,1'- biphenyl]-4-yl]diazenyl]-*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 13 of 60

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)- Accession No. 26267 CAS No. CBI (NA) CBI CBI 4-(Substituted phenyl)azo biphenylyl azo - substituted carbopolycycle azo benzenesulfonic acid, sodium salt. (Generic Name) Accession No. 24921 CAS No. CBI (NA) CBI CBI 4-(Substituted napht halenyl )azo diphenylyl azo-substituted carbopolycycle azo benzenesulfonic acid, sodium salt. (Generic Name) Accession No. 26256 CAS No. CBI (NA) CBI CBI 4-(Substituted phenyl)azo biphenylyl azosubstituted carbopolycycloazo benzenesulfonic acid, sodium salt. (Generic Name) Accession No. 21808 CAS No. CBI (NA) CBI CBI 2,7-Naphthalenedisu lfonic acid, 4-amino-5- hydroxy [[[(substituted phenylamino] substituted phenylazo] diphenyl]azo-, phenylazo-, disodium salt. ( Generic Name) Accession No. 26701 CAS No. CBI (NA) CBI CBI Phenylazoami nohydroxynaphthalenylazobip henylazo substituted benzene sodium sulfonate. (Generic Name)

B. What Action has the Agency Previously Taken on Other Benzidine-Based Chemical Substances? In 1996, EPA promulgated a TSCA section 5(a)(2) SNUR for the benzidine-based chemical substances listed at § 721. 1660 (61 FR 52287, October 7, 1996). That rule considered any use of the chemical substa nces except those listed in § 721.1660(a)(2) as a significant new use that requires a SNUN to be submitted to the Agency prior to*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 14 of 60 manufacture, import, or processing of the lis ted chemical substances. Because they were identified as ongoing, the SNUR excluded as si gnificant new uses the following uses: As a reagent to test for hydrogen peroxide in m ilk; a reagent to test for hydrogen sulfate, hydrogen cyanide, and nicotine; a stain in mi croscopy; as a reagen t for detecting blood; and as an analytical standa rd. In addition, for Color I ndex (C.I.) Direct Red 28 (Congo Red) (CAS No. 573-58-0), use as an indicator dy e was excluded as a significant new use. The SNUR did not require a SNUN to be s ubmitted by persons that import or process a listed substance as pa rt of an article.
C. What is the Production Volume of Newl y-Proposed and Currently-Listed Chemical Substances? For the newly proposed nine benzidine- based chemical substances, data reported to EPA for the 2006, 2002 and 1998 reporting cycles, as required by the TSCA Inventory Update Reporting (IUR) rule, i ndicate no evidence of production (including import). The IUR regulation requires manufact urers and importers of certai n chemical substances to report site and manufacturing informati on for chemicals manufactured (including imported) in amounts of 25,000 pounds or greater at a single s ite (prior to 2006, reporting was for 10,000 pounds at a site). A general market review on these chemical subs tances indicates no current manufacture (Ref. 2) within or outside the United States. In addition, four of these benzidine- based chemicals were included in EPA’s Benzidine-based Dyes Action Plan. The addi tional five chemicals were found in the confidential TSCA inventory. Designed as a part of a comprehensive approach to enhancing EPA’s Chemical Management Program, Action Plans summarize hazard,*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 15 of 60 exposure, and use information; outline the pot ential risks that each chemical may pose; and identify the specific steps the Agency is considering to addre ss those concerns (Ref. 1). EPA received no public comments ( EPA

- HQ

- OPPT

- 2010

- 0570 at http://www.regulations.gov ) on this Actio n Plan that would provide any indication of ongoing manufacturing, importing, or processing of any of the nine benzidine

- based chemical substances that are proposed for addition to the existing SNUR at § 721.1660.
F inally , a general market review on these chemical substances indicates no current manufacture (Ref. 2) within or outside the United States. For the benzidine-based chemical substa nces currently listed at § 721.1660, data reported to EPA for the 2006, 2002 and 1998 repor ting cycles, as required by the TSCA IUR rule, indicate no evidence of domestic production (including import) at IUR reportable levels. Further, EPA’s genera l market review on the currently listed benzidine-based chemical substances suggest s that the majority of these chemical substances are not currently being manufactur ed domestically or abroad (Ref. 2). Although some of these substances appear to be manufactured for allowable uses within the United States at a level below current IU R reporting thresholds, and some substances appear to be manufactured outside the Un ited States generally and may therefore potentially be imported as part of an articl e, EPA does not have information to suggest that the substances are being imported, for use as part of articles. In fact, the market review did not find evidence of any import of articles containing benzidine-based chemical substances. As stated in Unit VIII, EPA welc omes comments on any aspect of this proposed SNUR. The Agen cy specifically invites comments on whether there is*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 16 of 60 ongoing manufacture, import, or processing of these benzidine-based chemical substances, including in ar ticles, other than as ex cepted at § 721.1660(a)(2).
D. What are the Uses of These Benz idine-Based Chemical Substances? Historically, the benzidine-based chem ical substances cu rrently-listed at § 721.1660 were used as reagents, bi ological stains in laboratori es, and in food industries. Note that TSCA section 3(2)(B)(vi) exclude s foods, food additives, drugs, cosmetics or devices (as defined in the Federal Food, Dr ug, and Cosmetic Act) from the statutory definition of a “chemical substance” when su ch substances are manufactured, processed, or distributed in commerce for use as a f ood, food additive, drug, cosmetic, or device. Additionally, these previously li sted bezidine-based substances are believed to have been historically used as dyes in the textile industry. The nine newly-proposed benzidine-based chemical substances are believed to have been used in the past in the production of textiles, pa ints, printing inks paper, and pharmaceuticals. However, based on market information and the fact that the 2006 IUR had no production reports for the any of the benzidine-based chemical substances, if these chemical substances are used at all, they are likely used in sm all volumes, making it difficult to access current production and use information.
E. What are the Potential Health Effects of These Chemicals? The 1980 EPA Preliminary Risk Assessment on derivatives of benzidine established that the primary hazard concer n was for the carcinogenic effects to humans from exposure to specific metabolites of th e chemical substances (Ref. 3). There is potential for benzidine-based chemical substa nces to metabolize to the parent benzidine molecule, which is a known carcinogen (Refs. 4, 5, and 6). This metabolism occurs in*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 17 of 60 humans by an enzyme-mediated reaction. Thes e enzymes are found in the liver, in gut bacteria, and in skin bacteria. The result of this enzymatically-aided reduction is the release of the carcinogenic aromatic amine fr om the chemical substance. Studies have demonstrated that the reduction of benzidine- based chemical substances occurs in the human body as well as on the skin (Ref. 7). Th erefore, the primary human health concern for consumers is exposure to the benzidin e-based chemical substances through oral, dermal, or inhalation routes. Evidence from anim al studies suggests that there is early life susceptibility to benzidine carcinogenesis (R ef. 8). Cancer potency for benzidine was substantially increased when the dose was given in early life as compared to adults (Ref. 8). For additional information see Benzidine-Based Chemical Substances; Significant New Uses of Certain Chemical Substances; Final Rule (61 FR 52287, October 7, 1996).
F. What are the Potential R outes and Sources of Exposures to These Chemicals? There are benzidine related exposure concer ns as a result of the use of benzidine and benzidine-based chemical substances . In 1996, EPA identified inhalation, skin absorption, and ingestion as possible routes of exposure in a variety of settings where benzidine-based chemical substances are e ither manufactured orused (61 FR 52287, October 7, 1996). Although EPA estimated that the highest exposure would be to workers who were involved in dye manufacturing, EPA de termined that it was necessary to apply the SNUR to any use of the listed benzid ine-based chemical substances, with the exception of the limited uses mentioned in Un it II.A. EPA listed all the benzidine-based chemical substances that it was able to iden tify on the TSCA Inventor y at that time. Since then, EPA has identified the nine additional be nzidine-based chemical substances listed as part of Table 1 and has similar concer ns about potential consumer and worker*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 18 of 60 exposure to these substances. Dermal exposure can occur from the leaching of the chemical substances by sweat in contact with the dyed textile s (Ref. 7). Dermal exposure is also a concern since many of these chemical substances can be directly absorbed by the skin to some extent. It is well established that the enzymatically-aided dye reduction to the ca rcinogenic benzidine unit occurs internally in the liver and the gut (Refs. 9 and 10). Studies have shown that some human skin bacteria possess azo-reducta ses, the enzymes necessary to break down the benzidine-based chemical substances to release the carcinogenic amines, which can be more readily absorbed (Ref. 11). Consistent with the information on de rmal absorption that EPA reviewed in developing its recent Benzid ine-based Chemical Substa nces Action Plan (EPA-HQOPPT-2010-0570 at www.regulations.gov ), EPA identified the following main routes of consumer exposure to benzidine-based chemical substances that are of concern: (1) Dermal absorption, the primary route from w earing dyed clothing or footwear; (2) oral ingestion, an additional route for babies and young children who suck on clothing, blankets, and other non-food products which mi ght contain any of the benzidine-base chemical substances; (3) inhalation exposure, a more prevalent route in occupational settings; however, it can also occur from the use of dyed i nks during "air brushing" or from off-gassing from the dyed carpets to indo or air; and (4) contac t with the benzidinebased chemical substances entering the envi ronment, through the whole life cycle of benzidine-based chemical substanc es in textiles (Ref. 12). IV. Overview of DnPP
A. What Chemical is Incl uded in the Proposed SNUR?*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 19 of 60 This proposed SNUR would apply to DnPP (1,2-Benzenedicarboxylic acid, 1,2- dipentyl ester), CAS No. 131-18-0, an ort ho-phthalate (or phth alate ester).
B. What is the Production Volume of DnPP? No IUR production volume data were reported for DnPP during the 2006, 2002, 1998, and 1994 reporting cycles (Ref. 13). The last reporting of DnPP production to the IUR occurred in 1990 and corresponds to th e lowest reportable production volume range (10,000 to 500,000 pounds) (Ref. 13). DnPP was included in EPA’s Phthalates Action Plan

. , which was issued on December 30, 2009 (Ref. 14a). As stated in Unit III.C., the chemical action plans were designed as a part of a comprehensive approach to enhancing EPA’s Chemical Management Program. These action plans su mmarize available hazard, exposure, and use information; outline the potential risks that each chemical may present; and identify the specific steps the Agency is c onsidering to address those concerns. EPA received no public comments submitted Please note that in response to the publ ic docket a request for this correction of the information provided in the 2009 Phthalate Action Plan (EPA

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- 0342 at http://www.regulations.gov ) that would provide any indication of ongoing manufacturing, importing or processing of DnPP that was filed under the Agency's Information Quality Guidelines by the American Chemistry Council, EPA issued a revised Phthalate Action Plan on [insert date] (Ref. 1 4 ). However, subsequent internet 14b). Copies of the request for correctio n and EPA’s response to it are available at www.epa.gov/quality/informati onguidelines/iqg-list.html.
Internetqueries performed by EPA identified seve ral companies that either use or sell DnPP as a chemical standard for laboratory use. As a result, EPA is proposing a SNUR*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 20 of 60 for DnPP, excluding use of the substance as a chemical standard for laboratory use.
C. What are the Uses of DnPP? DnPP belongs to a broad category of chemicals commonly referred to as phthalates. Although a number of phthalates are in common use, EPA believes the individual phthalate DnPP is not in general use in the United States, and only has a limited application as a chemical standard for laboratory use. As a chemical category, the major use of phthalates is as plasticizers (Ref s. 15-23) especially in polyvinyl chloride (PVC) products, where they are added to impart flexibility and other desirable properties. Phthalate-containing PVC products include a variety of industrial and commercial products, as well as specialized medical and de ntal applications. The particular phthalate or combination of phthalates used in a specific product’s formulation depends on the properties the phthalates impart , as well as their cost.
D. What are the Potential Health and Environmental Effects of DnPP?
1. Human health effects. Exposures of some phthalates in animal studies resulted in phthalate syndrome effects, which consist of changes in the feta l development of the reproductive system (Refs. 15-22 and 24-35). Th e phthalates that are the most potent at causing phthalate syndrome effects are generall y those with linear ester side chains having 4-6 carbons (Ref. 24). DnPP has a lin ear carbon chain length of 5 carbons. Of the phthalates studied, DnPP is the most potent in producing testicular toxicity in pubertal animals (Ref. 24). Developmental oral exposures in rats to DnPP showed increased resorptions, increased fetal mortality, and decreased fetal testicular testosterone production (Refs. 36 and 37); and reduced anogenital distance in male rat offspring (Ref. 38). Effects noted in*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 21 of 60 adult mice exposed to DnPP include decrease d body weight; increa sed liver weights; decreased kidney weights; decreases in the we ights of the epididymis, cauda epididymis, testes, and seminal vesicles; complete abse nce of detectable sperm; shorter average estrous cycle length in females; and decrea sed fertility (Refs. 39 and 40). Gross and microscopic evidence of degenerative change s have been observed in the testes and epididymis (including testicular atrophy, inters titial cell hyperplasia, degeneration of the seminiferous tubules, and accumulation of flui d and degenerated cells in the epididymis) of rodents (Refs. 39 and 40). There are no s ubchronic or chronic animal studies of DnPP exposure through any exposure route. There are no known human studies of e xposure to DnPP. However, due to the data discussed in this section , the data presente d and discussed in Phthalates and Cumulative Risk Assessment The Task Ahead, Committee on the Health Risks of Phthalates, National Resear ch Council (2008) (Ref. 24) and DnPP’s general structure and categorization as a phthalate, EPA is concerned notes that the human health effects of DnPP exposure may be similar to that observed for some other phthalates. Several human studies have reported associations of expos ure of some other phthalates with adverse reproductive outcomes and developmental effects similar to those in the rat, although no causal link has been establis hed (Refs. 24 and 41-50). The reproductive developmental effects of some phthalates observed in hum ans include shortened anogenital distance observed in newborn boys, shortened pregnanc y, lower sex and thyroid hormones, and reduced sperm quality in adults; however, some studies failed to show these effects (Ref. 42). Since the pathway for sexual differentiati on in the fetus is highly conserved in all mammals, the reproductive and developmental effects observed in the rat studies are*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 22 of 60 potentially relevant to humans. Studies in animals evaluating the cumulativ e effects of combinations of phthalates on testosterone fetal mortality, and male a nd female reproductive development later in life have demonstrated all mixtures were cumulative for all endpoints (Refs. 36-37 and 51-55). The reproductive effects of DnPP obser ved in animal studies, the reproductive effects of other phthalates observed in humans, and the data on the cumulative effects of mixtures of phthalates, support EPA’s c oncern for potential human health hazards following exposure to DnPP.
2. Environmental effects. EPA does not know of any studies of the environmental effects of DnPP. Due to the gene ral structure of DnPP, its behavior in an aquatic environment similar to the close analog m ono 2-ethylhexyl phth alate, its log K ow, and water solubility measurements, and its categorization as a phthalate, EPA is concerned that the environmental effects of DnPP may be similar to those of other phthalates studied. Other phthalate s studied have been shown to have biological effects in all studied animal groups and have been obser ved at environmentally relevant exposures in the nanogram/liter to microgram/liter range. The combination of the inherent toxicity, variable solubility, log of the octanol-water coeffici ent values, and bioconcentration factor (BCF) values among the studied phthalates elicit both ac ute and chronic toxicity to aquatic and terrestrial wildlife by targeting thyroid function, liver function, reproduction, and other physiological mechanisms (Refs. 31-35, 56 and 57).
E. What are the Potential Routes and Sources of Exposure to DnPP?
1. Human exposure. Data from the National Health and Nutrition Examination Survey (NHANES) indicates widespread expos ure of the general population to various*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 23 of 60 phthalates (Ref. 58). Phthalates are used in a wide array of plastic products and may be released into the environment during use and disposal of these products (Ref. 58). Biomonitoring data from amniotic fluid and urine have demonstrated that humans are exposed to various phthalates in utero , as infants, during puberty, and in adult life; and that people are exposed to several phthalate s at once. The urinary metabolites of DnPP were not specifically included in the 4 th National Report on Human Exposure to Environmental Chemicals (2010), so EPA cannot draw conclusions as to the current exposure of the general population in the United States to DnPP. 2. Environmental exposure. Due to phthalates pervasive use and release, as well as their propensity for global transport, various phthalates may be found in most environmental media, including ambient air, surface water, soil, a nd sediment (Refs. 25- 32 and 34-35). Fish and other aquatic organi sms, as well as terrestrial animals have evidenced exposure to a common phthalate: di-(2-ethylhexyl) phthala te (DEHP) (Refs. 34 and 57). EPA does not have available data on environmental exposures to DnPP. V. Overview of Alkanes, C 12-13 , Chloro (CAS No. 71011-12-6)
A. What Chemical is Included in the Proposed SNUR? This proposed SNUR would cover alkanes, C 12-13 , chloro (CAS No. 71011-12-6), one type of short-chain chlorinated pa raffin (SCCP). This consists of C 12 and C 13 alkanes with varying degrees of chlorination.
B. What is the Production Volume of Alkanes, C 12-13 , chloro (CAS No. 71011-12-6)? No production volumes for alkanes, C 12-13 chloro (CAS No. 71011-12-6) were reported to the IUR during the 2006, 2002, 1998 and 1994 reporting cycles, and EPA found no additional evidence of any importati on or manufacturing of the chemical.*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 24 of 60 Alkanes, C 12-13 , chloro (CAS No. 71011-12-6) was included in EPA’s ShortChain Chlorinated Paraffins (SCCPs) and Othe r Chlorinated Paraffins Action Plan (Ref. 59). As stated in Unit III.C., the chemical action plans were designed as a part of a comprehensive approach to enhancing EPA’ s Chemical Management Program. These action plans summarize available hazard, exposure, and use information; outline the potential risks that each chemical may present; an d identify the specific steps the Agency is considering to a ddress those concerns. EPA received no public comments sub mitted to the public docket for this Action Plan ( EPA

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- 0334 at http://www.regulations.gov ) that would provide any indication of ongoing manufacturing, importing or processing of Alkanes, C 12

- 13 , chloro (CAS No. 71011

- 12

- 6) (Ref. 59 ).
C. What Were the Uses of this SCCP? Alkanes, C 12-13 , chloro (CAS No. 71011-12-6) is an individual chemical substance that belongs to a category of chemicals refe rred to as short-chain chlorinated paraffins (SCCPs). There are many different chemical substances that are members of the SCCP category. Generally these SCCPs have betw een 10 and 13 carbon atoms and contain 40 – 70 percent chlorine by weight. Of the di fferent SCCPs that are listed on the TSCA Inventory, EPA believes the SCCP named “Alkanes, C 12-13 , chloro (CAS No. 71011-12- 6)” is not in use in the Un ited States and EPA has found no information that indicates it has ever been used. All of the data discusse d in this section associated with the SCCPs general category would pertain to any indivi dual member of that category, including alkanes, C 12-13 , chloro (CAS No. 71011-12-6).
D. What are the Potential Envir onmental Effects of Alkanes, C 12-13 , chloro (CAS No. 71011-12-6)?*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 25 of 60 The primary concern for SCCPs is ecotoxicity. There are internationally accepted data specifically on the ecotoxicity of alkanes, C 12-13 , chloro (CAS No. 71011-12-6 ) (Ref.
60 ). Alkanes, C 12-13 , chloro (CAS No. 71011-12-6) ar e highly toxic to aquatic invertebrates following acute and chronic e xposures. In fish, this high toxicity is associated with chronic exposures, but not fo r acute exposures. For aquatic plants, there is high toxicity associated with both acute and chronic e xposures to SCCPs in general (Ref. 6 0 59-61 ). Both Health Canada and Environment Ca nada have characteri zed all chlorinated paraffins (short chain chlorinated paraffins, medium chain chlorinated paraffins, and long chain chlorinated paraffins), which include the chemical substance covered by this proposed rule, as “toxic” under the Canadian Environmental Protection Act (CEPA) (Ref. 61). Their assessment found that these SCCPs have or may have an immediate or long term harmful effect on the environment or its biological diversity; and that they are persistent, bioaccumulative, inherently toxic and present in the environment primarily as a result of human activity (Ref. 61).
E. What are the Potential Routes and Sources of Exposure to Alkanes, C 12-13 , Chloro (CAS No. 71011-12-6)? The mechanisms or pathways by whic h the SCCPs, including alkanes, C 12-13 , chloro (CAS No. 71011-12-6), move into a nd through the environment and humans are not fully understood, but are likely to incl ude releases from manufacturing of the chemicals, manufacturing of products like plasti cs or textiles, aging and wear of products like sofas and electronics, and releases at the end of product life (e.g., disposal, recycling).*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 26 of 60 EPA has concerns regarding the envir onmental fate and the exposure pathways that lead to any SCCP presence, including C12 and C13 SCCPs (for example, Alkanes,
C 12-13 , Chloro (CAS No. 71011-12-6)), in a variet y of biota, including freshwater aquatic species, marine mammals, and avian and te rrestrial wildlife (R ef. 60). In addition, SCCPs, including C12 and C13 SCCPs, have be en detected in samples of human breast milk from Canada and the United Kingdom, as well as in a variety of food items from Japan and various regions of Europe (Ref. 6 0 62-63 ). SCCPs are routinely found in soil and sediment samples. EPA also has concer ns about the persistence, bioaccumulation, and toxicity (PBT) of SCCPs (Ref. 60). VI. Rationale and Objectives
A. Rationale Consistent with EPA’s past practice for issuing SNURs under TSCA Section 5(a)(2), EPA’s decision to propose a SNUR for a particular chemical use need not be based on an extensive evaluation of the hazard, e xposure, or potential ri sk associated with that use. Rather, the Agency’s action is ba sed on EPA’s determination that if the use begins or resumes, it may present a risk th at EPA should evaluate under TSCA before the manufacturing or processing for that use be gins. Since the new use does not currently exist, deferring a detailed consideration of potenti al risks or hazards related to that use is an effective use of resources. If a person decides to begin manufact uring or processing the chemical for the use, the notice to EPA allows EPA to evaluate the use according to the specific parameters and circumst ances surrounding that intended use.
1. Benzidine-based Chemical Substances. As summarized in Unit III, EPA is concerned about potential ca rcinogenic effects on workers and consumers from the*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 27 of 60 manufacture, processing, importing, or use of these substances. Consumers exposed via dermal exposure to consumer products c ontaining 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. 8) . The main consumer products that could result in dermal exposure if containing thes e chemical substances include textiles and leather products because they are in prolonged contact wi th human skin. During the review of information on be nzidine-based chemical substances, EPA determined that the newly identified chemi cal substances covered by this proposed rule present the same concerns (Ref. 1) as those of the benzidine-based chemical substances currently listed under § 721.1660. However, based on a review of IUR data and a separate market review, EPA does not believ e there is any current manufacture of these nine benzidine-based chemical substances within or outside the United States. In addition, as discussed ear lier, although some of the currently liste d benzidinebased chemical substances may be manufactur ed or processed outsi de the United States, EPA does not have specific information that su ggests they are entering into the United States in imported articles (Ref. 4). In fact , an analysis of the benzidine-based chemical substances market (Ref. 2) revealed no information indicating import of articles containing benzidine-based chemical substa nces for non-excluded purposes. Supporting a conclusion that there is no import of textile articles containing benzidine-based chemical substances, the American Apparel and Footwear Association, the national trade association representing appare l, footwear, and other sewn products companies and their suppliers, which compete in the global ma rket, includes benzidine on its Restricted*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 28 of 60 Substances List (RSL) (Ref. 6 2 64 ). The RSL is a compilation of chemicals, regulated or banned, that are used by appare l and footwear industries. Although it appears there is no ongoing manuf acture of the nine newly proposed benzidine-based chemical substances, or import for a non-excluded use of articles containing any benzidine-base d chemical substances, the manufacture (including import) or processing of the nine newly proposed benzidine-based chemical substances and the import or processing of articles containing a ny benzidine-based chemical substances may begin at any time, without prior notice to EPA. Thus, EPA is concerned that commencement of the manufacture, import or processing for any new uses, including resumption of past uses, of benzidine-base d chemical substances could significantly increase the magnitude and duration of e xposure to humans over that which would otherwise exist curren tly. EPA is concerned that such an increase should not occur without an opportunity to eval uate activities associated with a significant new use and an opportunity to protect against potential unreasonable risks, if any, from exposure to the chemical substance. Therefore, EPA is proposing a SNUR for the nine benzidine-based chemical substances by adding them to those currently listed at 40 CFR § 721.1660, and to make inapplicable the article exemption at 40 CF R § 721.45(f) for those chemical substances newly proposed in this rulemaking as well as for those already listed at 40 CFR § 721.1660. If finalized, a person who intends to manufacture (inc luding import) or process any of the benzidine-based chemical substances for a non-excluded use, or to import or process any listed benzidine-based chemical substance for a non-excluded use, would be required to submit a SNUN.*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 29 of 60 2. DnPP. As summarized in Unit IV., EPA has concerns regarding potential adverse human health and environmental effects that may be caused by DnPP. EPA has direct information from animal studi es that DnPP specifically can elicit developmental/reproductive effects that are re levant to human health and also indicate potential effects in wildlife. EPA also is c oncerned that due to its general structure and categorization as a phthalate that DnPP may e licit adverse environmental effects similar to those 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, coul d significantly increase the magnitude and duration of exposure to humans over that wh ich would otherwise exist currently. EPA is concerned that such an increase should not occur without an oppor tunity to evaluate activities associated with a significant ne w use and an opportunity to protect against potential unreasonable risks, if any, from expos ure to the chemical substance. Therefore, EPA is proposing a SNUR for DnPP that would designate, as a signifi cant new use, any use of the chemical substance other than as a chemical standard for laboratory use. If finalized, a person who intends to manufactur e, import or process DnPP for use other than as a chemical standard for laboratory use would be required to submit a SNUN.
3. Alkanes, C 12-13 , chloro (CAS No. 71011-12-6). The mechanisms or pathways by which the SCCPs, including alkanes, C 12-13 , chloro (CAS No. 71011-12-6), move into and through the environment and humans ar e not fully understood, but are likely to include releases from manufacturing of th e chemicals, manufacturing of products like plastics or textiles, aging and wear of produc ts like sofas and electr onics, and releases at the end of product life (e.g., disposal, recycling).*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 30 of 60 EPA believes that all manufacture, pro cessing, and import into the United States of alkanes, C 12-13 , chloro (CAS No. 71011-12-6) has ceas ed. Given EPA has no evidence to suggest that there is any manufacture, pr ocessing, or importation of this chemical substance in the United States, and taking in to consideration the negative commercial and regulatory environment associated with this chemical internationally (including the EU and Canadian ban on marketing) and use of the alkanes, C 12-13 , chloro (CAS No. 71011- 12-6) domestically, EPA does not expect to find such activity. However, EPA is concerned that commencement of the manufacture, import or processing for any new uses, including resumption of past uses, coul d significantly increase the magnitude and duration of exposure to humans over that whic h would otherwise exist. EPA is concerned that such an increase should not occur w ithout an opportunity to evaluate activities associated with a significant new use and an opportunity to prot ect against potential unreasonable risks, if any, from exposure to the chemical substance. Therefore, EPA is proposing a SNUR for alkanes, C 12-13 , chloro (CAS No. 71011-12-6) that would designate as a significant new use any use of the chemical substance. If finalized, a person who intends to manufacture, import or process alkanes, C 12-13 , chloro (CAS No. 71011-12-6) for any use would be required to subm it a SNUN. EPA is requesting comment on whether any of the significant new uses identified are currently ongoing. However, if EPA determines, based on comments on this proposed rule or on other information the Agen cy identifies, that a ny proposed significant new use of any of the chemical substances has been ongoing (including, in the case of benzidine-based chemical substances, that an article containing benz idine-based chemical substances was being imported or processed) prior to date of publication of the final rule,*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 31 of 60 EPA would exclude such ongoing uses from th e final SNUR and consider pursuing other regulatory action, as appropriate.
B. Objectives Based on the considerations in Un it VI.A.1-3, EPA wants to achieve the following objectives with regard to the signifi cant new use(s) that are designated in this proposed rule: 1. EPA would receive notice of any person’ s intent to manufacture or process the specified chemicals for the described significan t new uses before that activity begins; 2. EPA would have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing of the specified chemicals for the describe d significant new use; and 3. EPA would be able to regulate prosp ective uses of the specified chemicals before the described significant new uses o ccur, provided that regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6 or 7. VII. 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 us e must be made after consider ation of all relevant factors including: • The projected volume of manufact uring and processing of a chemical substance. • The extent to which a use changes th e type or form of exposure of human beings or the environment to a chemical substance. • The extent to which a use increases th e magnitude and duration of exposure of*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 32 of 60 human beings or the environment to a chemical substance. • The reasonably anticipated manner a nd methods of manufacturing, processing, distribution in commerce, and dispos al of a chemical substance. In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorizes EPA to consider a ny other relevant factors. To determine what would constitute a si gnificant new use of the benzidine-based chemical substances subject to this proposed rule, DnPP and the alkanes, C 12-13 , chloro (CAS No. 71011-12-6), as discus sed herein, EPA considered relevant information about the toxicity of these substances, likely hum an exposures and environmental releases associated with possible uses, and the four f actors listed in section 5(a)(2) of TSCA. EPA has preliminarily determined that the ma nufacture, import, processing, or import or processing as part of an article of any of th e benzidine-based chemical substances subject to this proposed rule, except ongoing uses specified in § 721.1660( a)(2)(i) of the regulatory text in this docu ment, is a significant new use. EPA has also preliminarily determined that the manufacture, import, or processing of DnPP for any use other than as a chemical standard for laboratory use is a significant new use, and the manufacture, processing, or import of alkanes, C 12-13 , chloro (CAS No. 71011-12-6) for any use is a significant new use. VIII. Request for Public Comment EPA welcomes comments on any aspect of this proposed SNUR. Information available about environmental effects, health effects, and exposure would be beneficial. EPA is also requesting public comment on wh ether there are any ongoing uses of any of these chemicals for the pr oposed significant new uses , (including processing or import of*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 33 of 60 benzidine-based chemical substances in articles), and would welcome specific information that documents such uses. IX. Alternatives Before proposing these SNURs, EPA considered the following alternative regulatory actions:
A. Promulgate a TSCA Section 8(a) Reporting Rule Under a TSCA section 8(a) rule, EP A could, among other things, generally require persons to report information to th e Agency when they intend to manufacture, import, or process a listed chemical for a specific use or any use. However, for the chemical substances subject to this proposed rule, the use of TSCA section 8(a) rather than SNUR authority would have several lim itations. First, if EPA were to require reporting under TSCA section 8(a) instead of TSCA section 5(a), EPA would not have the opportunity to review human and envir onmental hazards and exposures associated with the proposed significant new use a nd, if necessary, take immediate follow-up regulatory action under TSCA secti ons 5(e) or 5(f) to prohib it or limit the activity before it begins. In addition, EPA may not receive im portant information from small businesses, because such firms generally are exempt from TSCA section 8(a) reporting requirements. In view of the level of hea lth and environmental concerns about the chemicals subject to this proposed rule if used for the proposed significant new uses, EPA believes that a TSCA section 8(a) rule for this substance would not meet EPA's regulatory objectives.
B. Regulate Under TSCA Section 6 EPA may regulate under TSCA section 6 if "the Administrator fi nds that there is a reasonable basis to conclude th at the manufacture, processi ng, distribution in commerce,*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 34 of 60 use or disposal of a chemical substance or mixture presents or will present an unreasonable risk of injury to health or the environment. " (TSCA section 6(a)). Given that the benzidine-based chemical substances subject to this proposed rule are no longer being used except as provided in the regulator y text of this document, DnPP is no longer being used except as a chemical standard for laboratory use, and alkanes, C 12-13 , chloro (CAS No. 71011-12-6) is no longe r used in the United States , EPA concluded that risk management action under TSCA section 6 is not necessary at this time. This proposed SNUR would allow the Agency to address the potential risks a ssociated with the proposed significant new uses. If EPA learns that these chemicals are in use, EPA may reconsider this decision and pursue additional regulatory action as appropriate. X. Applicability of Proposed Rule to Uses O ccurring Before Effective Date of the Final Rule As discussed in the Federal Register of April 24, 1990 (55 FR 17376), EPA has decided that the intent of s ection 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 pr oposed rule rather than as of the effective date of the final rule. If us es 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, import, or processi ng of a covered substa nce 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, thes e persons would have to comply with all*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 35 of 60 applicable SNUR notice requirements and wa it until the notice review period, including all extensions, expires. Uses arising after the publica tion of the proposed rule are distinguished from uses that exist at publication of the propos ed rule. The former would be new uses, the latter ongoing uses. To the extent that additional ongoing uses are found in the course of rulemaking, EPA would ex clude those uses from the final SNUR. EPA has promulgated provisions to allow persons to comply with this SNUR before the effective date. If a person were to meet the conditions of advance compliance under 40 CFR § 721.45(h), that person woul d be considered to have met the requirements of the final SNUR for those activities. XI. Test Data and Other Information EPA recognizes that TSCA section 5 doe s not require developing any particular test data before submission of a SNUN. Ther e are two exceptions: 1) Development of test data is required where the chemical substan ce subject to the SNUR is also subject to a test rule under TSCA section 4 (see TSCA s ection 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 ab sence of a section 4 te st 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 desc ribe any other data know n to or reasonably ascertainable by them (15 U.S.C. 2604(d) ; § 721.25, and §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, distri bution in commerce, or dispos al. EPA encourages persons to consult with the Agency before submitting a SNUN. As part of this optional pre-notice*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 36 of 60 consultation, EPA would discuss specific data it believes may be useful in evaluating a significant new use. SNUNs submitted for signifi cant new uses without any test data may increase the likelihood that EP A 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 deta iled information on: 1. Human exposure and environmental releases that may result from the significant new uses of the chemical substance. 2. Potential benefits of the chemical substance. 3. Information on risks posed by the ch emical substances compared to risks posed by potential substitutes. XII. SNUN Submissions According to 40 CFR § 721.1(c), persons submitting a SNUN must comply with the same notice requirements and EPA regul atory procedures as persons submitting a PMN, including submission of test data on he alth and environmental effects as described in § 720.50. SNUNs must be on EPA Form No. 7710–25, generated using e-PMN software, and submitted to the Agency in accord ance with the procedures set forth in §§ 721.25 and 720.40. E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems. XIII. Economic Analysis
A. SNUNs EPA has evaluated the potential co sts of establishing SNUR reporting requirements for potential manufacturers and processors of these chemicals and for*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 37 of 60 articles containing any of the benzidine-base d chemical substances included in this proposed rule. These economic analyses, which are briefly summarized here, are available in the docket for this proposed rule. The costs of submission of a SNUN w ould be incurred when a company decides to pursue a significant new use of one of thes e chemicals. In the event that a SNUN is submitted, costs are estimated at approximately $8,112 per SNUN submission, and include the cost for preparing and submitti ng the SNUN, recordkeep ing, and the payment of a user fee. Businesses that submit a SNUN are either subject to a $2,500 user fee required by § 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 (§ 700.45(b)(1)). In its evaluation of this proposed rule, EPA also considered the potential costs a compa ny might incur by avoiding or delaying the significant new use in the future, but th ese costs have not been quantified.
B. Export Notification EPA regulations under TSCA section 12( b) (15 U.S.C. 2611(b)) at § 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 $78.54. The to tal costs of export notificatio n would vary per chemical, depending on the number of required notificatio ns (i.e., number of countries to which the chemical is exported). XIV. References As indicated under ADDRESSES, a docket ha s been established for this proposed*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 38 of 60 rule under docket ID number EPA–HQ–OPPT –2010-0573. The following is a listing of the documents that have been placed in the docket for this proposed rule. The docket includes information considered by EPA in de veloping this proposed rule, including the documents listed in this unit, which are physi cally located in the docket. In addition, interested parties should cons ult documents that are referenced in the documents that EPA has placed in the docket, regardless of whether these referenced documents are physically located in the docket. For assistan ce in locating documents that are referenced in documents that EPA has placed in the docke t, but that are not phys ically located in the docket, please consult either tec hnical person listed under FOR FURTHER INFORMATION CONTACT. The docket is av ailable for review as specified under
ADDRESSES. 1. U.S. EPA, 2010. U.S. Environmental Pr otection Agency. Chemical Substances Derived from Benzidine and Its Congeners, http://www.epa.gov/oppt/existingchemical s/pubs/actionplans/D CB%20Action%20Plan_0 6232010.noheader.pdf (Accessed January 24, 2011). 2. U.S. EPA. Economics and Policy Branch, USEPA/OCSPP/ Economics, Exposure, and Technology Division. “Economic Analysis to Support the Proposed SNUR for Benzidine and Benzidine-based Chemical substances,'' (May 24, 2011). 3. EPA. 1980. Preliminary Risk Assessment: Phase I. Benzidine, its congeners, and their derivative dyes and pigments. EPA-560/11-80-019, June 1980. 4. IARC (1982). Some industrial chemi cals and dyestuffs. IARC monographs on the evaluation of carcinogenic risk of ch emicals to humans, Suppl.7, International Agency for Research on Cancer, Lyon, France.*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 39 of 60 5. IARC (1987). Overall evaluation of carcinogenicity. IARC monographs on the evaluation of carcinogenic risk of chemicals to humans, vol.29, International Agency for Research on Cancer

. 6. Report on Carcinogens, 11 th ed. (2008). http://ntp.niehs.nih.gov /?objectid=035E5806-F735-FE81-FF769DFE5509AF0A

. 7. Golka, K., Kopps, S., Myslak, Z.W. 2004. Carcinogencitiy of azo colorants: influence of solubility and bioavailability. Tox Lett 151:203-210.
8. E PA. Vesselinovitch, SD; Rao, KV; Mihail ovich, N. Transplacental and lactational carcinogenesis by safrole. Cancer Res 39(11):4378

− 4380 (as cited in EPA. 2005. Supplemental Guidance for Assessing Susc eptibility from Early Life Exposure to Carcinogens. EPA 630/R-03/003F, March 2005

. .). 9. Levine, W.G. (1991). Metabolism of azo dyes: implication for detoxification and activation. Drug Metab. Rev. 23(3&4):253-309. 10. Platzek, T., Lang, C.; Grohmann, G., Giu, -S.; Baltes, W. (1999). Formation of a carcinogenic aromatic amine from an azo dye by human skin bacteria in vitro

. Human & Experimental Toxicology , 18: 552-559. 11. Stingley, R., Zou, W., Heinze, T., Chen, H. and Cerniglia, C. 2009. Metabolism of azo dyes by human skin microbiota. J Med Microbiol (2009), DOI: 10.1099/jmm.0.012617-0

. 12. NIOSH, Special Occupational Hazard Review for Benzidine-Based Dyes (1980). 13. U.S. EPA, 2009. U.S. Environmental Pr otection Agency. Inventory Update Reporting IUR: Non Confidential IUR Produc tion Volume Data 1986-2002. Available at:*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 40 of 60 http://www.epa.gov/oppt/iur/tools/data/2002-vol.html (Updated October 26, 2009).
1 4 14a . U.S. EPA, 2010 2009 . U.S. Environmental Protection Agency. Phthalates Action Plan. 14 b. U.S. EPA, 2012. U.S. Environmental Protection Agency. Phthalates Action Plan (Revised). http://www.epa.gov/oppt/existingchemica ls/pubs/actionplans /phthalates.html (Accessed January 2 4, 2011).

. 15. Australian Government, 2008a. Existing Chemical Hazard Assessment Report for Butylbenzyl Phthalate . Department of Health a nd Ageing, National Industrial Chemicals Notification and Assessment Scheme (NICNAS): Sydney, Australia. Available at: http://www.nicnas.gov.au/Publicat ions/CAR/Other/Phthalates.asp (accessed Aug 13, 2009). 16. Australian Government, 2008b. Existing Chemical Hazard Assessment Report for Dibutyl Phthalate . Department of Health and Ag eing, National Industrial Chemicals Notification and Assessment Scheme (NIC NAS): Sydney, Australia. Available at: http://www.nicnas.gov.au/Publica tions/CAR/Other/Phthalates.asp (accessed Aug 13, 2009). 17. Australian Government, 2008c. Existing Chemical Hazard Assessment Report for Diethylhexyl Phthalate . Department of Health a nd Ageing, National Industrial Chemicals Notification and Assessment Scheme (NICNAS): Sydney, Australia. Available at: http://www.nicnas.gov.au/Publicat ions/CAR/Other/Phthalates.asp (accessed Aug 13, 2009). 18. Australian Government, 2008d. Existing Chemical Hazard Assessment*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 41 of 60 Report for Diisobutyl Phthalate . Department of Health and Ageing, National Industrial Chemicals Notification and Assessment Scheme (NICNAS): Sydney, Australia. Available at: http://www.nicnas.gov.au/Publicat ions/CAR/Other/Phthalates.asp (accessed Aug 13, 2009). 19. Australian Government, 2008e. Existing Chemical Hazard Assessment Report for Diisodecyl Phthalate . Department of Health a nd Ageing, National Industrial Chemicals Notification and Assessment Scheme (NICNAS): Sydney, Australia. Available at: http://www.nicnas.gov.au/Publica tions/CAR/Other/Phthalates.asp (accessed Aug 13, 2009). 20. Australian Government, 2008f. Existing Chemical Hazard Assessment Report for Diisonoyl Phthalate . Department of Health an d Ageing, National Industrial Chemicals Notification and Assessment Scheme (NICNAS): Sydney, Australia. Available at: http://www.nicnas.gov.au/Publicat ions/CAR/Other/Phthalates.asp (accessed Aug 13, 2009). 21. Australian Government, 2008g. Existing Chemical Hazard Assessment Report for Di-n-octyl Phthalate . Department of Health a nd Ageing, National Industrial Chemicals Notification and Assessment Scheme (NICNAS): Sydney, Australia. Available at: http://www.nicnas.gov.au/Publicat ions/CAR/Other/Phthalates.asp (accessed Aug 13, 2009). 22. Australian Government, 2008h. Phthalates Hazard Co mpendium. A Summary of Physicochemical and Human Health Haza rd Data for 24 Ortho-Phthalate Chemicals

. Department of Health and Ageing, Nationa l Industrial Chemicals Notification and Assessment Scheme (NICNAS): Sydney, Australia. Available at:*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 42 of 60 www.nicnas.gov.au/Publications/CAR/Other/Phthalates.asp (accessed Aug 13, 2009). 23. HSDB, 2009. Hazardous Substance Data Bank. U.S. National Library of Medicine TOXNET System. http://toxnet.nlm.nih.gov/cgi -bin/sis/htmlgen?HSDB (accessed Aug 13, 2009). 24. NAS, 2008. National Academy of Sciences . Phthalates and Cumulative Risk Assessment: The Tasks Ahead. 25. NTP-CERHR, 2003a. Monograph on the Potential Human Reproductive and Developmental Effects of Di- n -Butyl Phthalate (DBP). U.S. Department of Health and Human Services. Available at: http://cerhr.niehs.nih.gov /evals/phthalates/dbp/dbp.html

. 26. NTP-CERHR, 2003b. National Toxico logy Program - Center for the Evaluation of Risks to Human Reproduc tion. Monograph on the Potential Human Reproductive and Developmental Effects of Butyl Benzyl Phthalate (BBP); NIH Pub. No. 03-4487; U.S. Department of Hea lth and Human Services. Available

at: http://cerhr.niehs .nih.gov/evals/phthalates/bb- phthalate/bb-phthalate.html

. 27. NTP-CERHR, 2003c. National Toxicology Program - Center for the Evaluation of Risks to Human Reproduc tion. Monograph on the Potential Human Reproductive and Developmental Effects of Di -n-Octyl Phthalate (DnOP); NIH Pub. No. 03-4488; U.S. Department of Health and Human Services. Available at: http://cerhr.niehs.nih.gov/evals/phthalates/dnop/dnop.html

. 28. NTP-CERHR, 2003d. National Toxico logy Program - Center for the Evaluation of Risks to Human Reproduc tion. Monograph on the Potential Human Reproductive and Developmental Effects of Diisononyl Phthalate (DINP); U.S. Department of Health and Human Services. Available at:*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 43 of 60 http://cerhr.niehs.nih.gov/eva ls/phthalates/dinp/dinp.html

. 29. NTP-CERHR, 2003e. National Toxicology Program - Center for the Evaluation of Risks to Human Reproduc tion. Monograph on the Potential Human Reproductive and Developmental Effects of Di -Isodecyl Phthalate (DIDP); NIH Pub. No. 03-4485; U.S. Department of Health and Human Services. Available at: http://cerhr.niehs.nih.gov/eva ls/phthalates/didp/didp.html

. 30. NTP-CERHR, 2006. National Toxico logy Program - Center for the Evaluation of Risks to Human Reproduc tion. Monograph on the Potential Human Reproductive and Developmental Effects of Di-(2-ethylhexyl) Ph thalate (DEHP); NIH Pub. No. 06-4476; U.S. Department of Hea lth and Human Services. Available at: http://cerhr.niehs.nih.gov/evals/phthalates/dehp/dehp.html

. 31. EC, 2003a. European Commission. Eur opean Union Risk Assessment Report: 1,2-Benzenedicarboxylic Acid, Di-C8-10-Bran ched Alkyl Esters, C9-Rich And Di- “Isononyl” Phthalate [DINP] , CAS-Nos. 68515-48-0, 28553-12-0. Vol. 35; EUR 20784EN; Office for Official Publications of the European Communities: Luxembourg. Available at: http://ecb.jrc.ec.europa .eu/DOCUMENTS/ExistingChemicals/RISK_ASSESSMENT/REPORT/dinpreport046.pdf

. 32. EC, 2003b. European Commission. Europe an Union Risk Assessment Report: 1,2-Benzenedicarboxylic Acid, Di-C9-11-Bran ched Alkyl Esters, C10-Rich And Di- “Isodecyl” Phthalate [DIDP], CAS-No s 68515-49-1 and 26761-40-0. Vol. 36; EUR 20785EN; Office for Official Publications of the European Communities: Luxembourg. Available at: http://ecb.jrc.ec.europa .eu/DOCUMENTS/ExistingChemicals/RISK_ASSESSMENT/REPORT/didpreport041.pdf

.*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 44 of 60 33. EC, 2004. European Commission. Eur opean Union Risk Assessment Report: Dibutyl Phthalate [DBP], CA S-No. 84-74-2. Vol. 29; EUR 19840EN; Office for Official Publications of the European Comm unities: Luxembourg. Available at:http://ecb.jrc.ec.europa.eu/DOCUMENTS/ExistingChemicals/RISK_ASSESSMENT/REPORT /dibutylphthalatereport003.pdf

. 34. EC, 2008a. European Commission. Eur opean Union Risk Assessment Report Bis(2-Ethylhexyl) Phthalate (DEHP), CAS-No. 117-81-7. Vol. 80; EUR 23384EN; Office for Official Publications of the Eu ropean Communities: Luxembourg. Available

at: http://ecb.jrc.ec.europ a.eu/DOCUMENTS/ExistingChemicals/RISK_ASSESSMENT/REPORT/dehpreport042.pdf

. 35. EC, 2008b EC. 2008b. Eu ropean Commission. European Union Risk Assessment Report Benzyl Bu tyl Phthalate (BBP), CASNo. 85-68-7. Vol. 76; EUR 22773EN; Luxembourg: Office for Official Publ ications of the European Communities, 36. Howdeshell, K.L.; Rider, C.V.; Wilson, V.S.; Gray, L.E. Jr. 2008a. Mechanisms of action of phthalate esters, individually and in combination, to induce abnormal reproductive development in male laboratory rats. Environ Res . 108(2):168-76. 37. Howdeshell K.L., Wilson V.S., Furr J., Lambright C.R., Rider C.V., Blystone C.R., Hotchkiss A.K., Gray L.E. Jr. 2008b. A mi xture of five phthala te esters inhibits fetal testicular testosterone production in the sprague-dawley rat in a cumulative, doseadditive manner. Toxicol Sci. 105(1):153-65. 38. Liu et al., 2005. Liu, K; Lehmann, KP; Sar, M; et al. (2005) Gene expression profiling following in utero exposure to phthala te esters reveals new gene targets in the etiology of testicular dysgenesis . Biol Reprod 73(1):180–192.*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 45 of 60 39. Heindel et al., 1989. Heindel, JJ; Gulati, DK; Mounce, RC; et al. (1989) Reproductive toxicity of three phthalic acid esters in a c ontinuous breeding protocol. Fundam Appl Toxicol 12(3):508–518. 40. NTP, 1985. NTP (National T oxicology Program). (1985) Di-npentylphthalate: reproduction a nd fertility assessment in CD-1 mice when administered in feed. Research Triangle Park, NC: National Toxicology Program. PB86-118999. 41. Swan et al, 2005. an, S. H.; Main, K. M.; Stewart, S. L.; Kruse, R. L.; Calafat, A. M.; Mao, C. S.; Redmon, J. B.; Ternand, C. L.;Sullivan, S.; Teague. J. L. 2005. Study for Future Families Research Team. Decreas e in Anogenital Distance among male Infants with Prenatal Phthalate Exposure. Environ. Health Perspect . Aug 2005, 113(8) , 1056–61. 42. Huang, P.C.; Kuo, P.L.; Chou, Y.Y.; Lin, S.J.; Lee, C.C. 2009. Association between prenatal exposure to phthalates and the health outcome of newborns. Environ.
Int. 35(1):14–20. 43. Meeker, J.D.; Calafat, A.M.; Hauser , R. 2007. Di(2-ethylhexyl) phthalate metabolites may alter thyroid hormone levels in men. Environ Health Perspect

. 115(7):1029-34. 44. Qiao, L.; Zheng, L.; Cai, D. 2007. St udy on the di-n-butyl phthalate and di-2- ethylhexyl phthalate level of girl serum re lated with precocious puberty in Shanghai. Wei Sheng Yan Jiu . 36(1): 93-5

. 45. Hauser, R.; Williams, P.; Altshul, L.; Calafat, A.M. 2005. Evidence of interaction between polychlorinated biphenyls and phthalates in rela tion to human sperm motility. Environ Health Perspect . 113(4):425-30. 46. Hauser, R.; Meeker, J.D.; Duty, S,; Silv a, M.J.; Calafat, A.M. 2006. Altered*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 46 of 60 semen quality in relation to ur inary concentrations of phtha late monoester and oxidative metabolites. Epidemiology . 17(6):682-91. 47. Hauser, R.; Meeker, J.D.; Singh, N.P.; Silv a, M.J.; Ryan, L.; Duty, S.; Calafat, A.M. 2007. DNA damage in human sperm is related to urinary levels of phthalate monoester and oxidati ve metabolites. Hum Reprod. 22(3):688-95. 48. Duty, S.M.; Calafat, A.M.; Silva, M.J. ; Ryan, L.; Hauser, R. 2005. Phthalate exposure and reproductive hormones in adult men. Hum Reprod . 20(3):604-10. 49. Colón, I.; Caro, D,; Bourdony, C.J.; Rosario, O. 2000. Identification of phthalate esters in the se rum of young Puerto Rican gi rls with premature breast development. Environ Health Perspect . 108(9):895-900. 50. Latini, G.; De Felice, C.; Presta, G.; Del Vecchio, A.; Paris, I.; Ruggieri, F.; Mazzeo, P. 2003. Exposure to Di(2-ethylhexy l)phthalate in humans during pregnancy. A preliminary report. Biol Neonate . 83(1):22-4. 51. Rider, C.V.; Furr, J.; Wilson, V.S.; Gr ay, L.E. Jr. 2008. A mixture of seven antiandrogens induces reproducti ve malformations in rats. Int J Androl . 31(2):249-62. 52. Rider, C.V.; Wilson, V.S.; Howdeshell, K.L.; Hotchkiss, A.K.; Furr, J.R.; Lambright, C.R.; Gray, LE Jr. 2009. Cumulativ e effects of in utero administration of mixtures of "antiandrogens" on ma le rat reproductive development. Toxicol Pathol

. 37(1):100-13. 53. Howdeshell, K.L.; Furr, J.; Lambright, C.R.; Rider, C.V.; Wilson, V.S.; Gray, L.E. Jr. 2007. Cumulative effects of dibutyl phthalate and diethylhe xyl phthalate on male rat reproductive tract devel opment: altered fetal steroid hormones and genes. Toxicol Sci

. 99(1):190-202.*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 47 of 60 54. Gray, L.E. Jr; Wilson, V.S.; Stoker, T.; Lambright, C.; Furr, J.; Noriega, N.; Howdeshell, K.; Ankley, G.T.; Guillette, L. 2006. Adverse effects of environmental antiandrogens and androgens on repr oductive development in mammals. Int J Androl

. 29(1): 96-108. 55. Hotchkiss, A.K.; Parks-Saldutti. L.G. ; Ostby, J.S.; Lambright, C.; Furr, J.; Vandenbergh, J.G.; Gray, L.E. Jr. 2004. A mi xture of the "antiandrogens" linuron and butyl benzyl phthalate alters sexual differentia tion of the male rat in a cumulative fashion. Biol Reprod . 71(6):1852-61. 56. Oehlmann et al., 2008. Oehlmann, J.; Schulte-Oehlmann, U.; Werner, K.; Jagnytsch, O.; Lutz, I.; Kresten, K.; Wollenberger , L.; Santos, E. .; Paull, G. C.; Van Look, K. J. W.; Tyler, C. R. 2008. A Critical Analysis of the Bi ological Impacts of lasticizers on Wildlife. Philos. Trans. R. Soc ., B: Biol. Sci. 2008, 364(1526) , 2047–2062. 57. Staples et al., 1997. Staple s, C. A.; Adams, W. J.; Parkerton, T. F.; Gorsuch, J. W.; Biggingers, G. R.; Reiner, K. H. 1997. Aquatic Toxicity of Eighteen Phthalate
Esters. Environ. Toxicol. Chem . 1997, 16 (5) , 875–891. 58. CDC, 2009. Centers for Dis ease Control and Prevention. Fourth National Report on Human Exposure to Environmental Ch emicals. National Health and Nutrition Examination Survey (NHANES), Centers for Disease Control and Prevention, Atlanta (GA). Available at: http://www.cdc.gov/exposurereport/faq.html

. 59. U.S. EPA, 2010. U.S. Environmenta l Protection Agency. Short-Chain Chlorinated Paraffins (SCCPs) and Other Ch lorinated Paraffins Action Plan. Available

at: http://www.epa.gov/oppt/existingchemi cals/pubs/actionplans/sccps.html (Accessed March 7, 2011).*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 48 of 60 60. UNEP. 2009. United Nations Environment Programme. S tockholm Convention on UNEP. 2011. United Nations En vironment Programme. Stockholm Convention on Persistent Organic Pollutant s (POPs). Persistent Organic Pollutants Review Committee. Report of the Persistent Organic Pollutants Review Committee on the Work of its Seventh Meeting. 17 October 2011. UNEP/PO PS/POPRC.7/19. Available

at: http://chm.pops.int/Convention/POPsRevi ewCommittee/POPRCMeetings/POPRC7/POP RC7ReportandDecisions/t abid/2472/Default.aspx. Accessed January 20, 2010. As noted in this document "Consensus has been reached on the data considered.[in UNEP. 2009. United Nations Environment Programme. St ockholm Convention on Persistent Organic Pollutants (POPs). Persistent Organic Pollutants Review Committee. Revised Draft Risk Profile: Short-Chained Chlorinated Paraffins . 9 July 2009. UNEP/POPS/POPRC.5/2.]” The document cited is available at: http://chm.pops.int/Convention/POPsRevi ewCommittee/hrPOPRCMeetings/POPRC5/PO PR%205Documents/tabid/592/langu age/en-US/Default.aspx. Accessed December 11, 2009].
61. Government of Canada. 2008. Order Adding Toxic Substances to Schedule 1 to the Canadian Environm ental Protection Act, 1999 . Canada Gazette. September 20, 2008, 142 (38).
62. Iino F., T. Takasuga, K. Senthilkumar, N. Nakamura and J. Nakanish. 2005. Risk assessment of short-chain chlorinated paraffins in Japan based on the first market basket study and species sensitivity distributions. E nviron. Sci. Technol. 39:859-866 (as cited in UNEP. 2009. United Nations Environmen t Programme. Stockholm Convention on*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 49 of 60 Persistent Organic Pollutants (POPs). Pers istent Organic Pollutants Review Committee. Revised Draft Risk Profile: Short-Chained Chlorinated Paraffins . 9 July 2009. UNEP/POPS/POPRC.5/2. Available at: http://chm.pops.int/Convention/POPsRevi ewCommittee/hrPOPRCMeetings/POPRC5/PO
PR 5Documen ts/tabid/592/language/en-US/Default.aspx . Accessed December 11, 2009

. .)
6 1

. 63. Lahaniatis, M.R., Coelhan, M ., H. Parlar. 2000. Clean-up and quantification of short and medium chain polychlorinated n- alkanes in fish, fish oil, and fish feed. Organohalogen Compounds. 47: 276-279(as cited in UNEP. 2009. United Nations Environment Programme. Stockhol m Convention on Persistent Organic Pollutants (POPs). Persistent Organic Pollutants Review Committee. Revised Draft Risk Profile: Short-Chained Chlorinated Paraffins . 9 July 2009. UNEP/POPS/POPRC.5/2. Available at: http://chm.pops.int/Convention/POPsRevi ewCommittee/hrPOPRCMeetings/POPRC5/PO PR 5Documents/tabid/592 /language/en-US/Default.aspx . Accessed December 11, 2009.)
64. Government of Canada. 2008. Order Adding Toxic Substances to Schedule 1 to the Canadian Environmental Protection Act, 1999 . Canada Gazette. September 20, 2008, 142 (38).
62. American Apparel and Footwear Associ ation (AAFA) Restricted Substance List (RSL), September, 2010. XV. Statutory and Executive Order Reviews
A. Regulatory Planning and Review Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), the Office of Management and Budget (OMB) has determined*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 50 of 60 that this proposed SNUR this action is a “significant regulator y action” under section 3(f) of the Executive Order. Accordingly, EPA submitted this action to OMB for review under Executive Order 12866 and 13563, entitled Improving Regulation and Regulatory
Review (76 FR 3821, January 21, 2011). EPA prepared an analysis of the potential costs and benefits associated with this action, which is summarized in Unit XIII. Changes made in response to OMB recommendations have been documented in the docket for this rulemaking as required by section 6(a)(3)(E) of the Executive Order.
B. Paperwork Activities According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq ., an Agency may not conduct or sponsor, and a pe rson is not required to respond to a collection of information that requires OM B approval under the PRA, unless it has been approved by OMB and displays a curren tly valid OMB control number. The OMB control numbers for EPA's regulations in Titl e 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR, pa rt 9, and included on the related collection instrument, or form, if applicable. The information collection requirements re lated to this action have already been approved by OMB pursuant to the PRA under OMB control number 2070-0038 (EPA ICR No. 1188). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average 97 hours per respons e. This burden estimate includes the time needed to review instructions , search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN. Send any comments about the accuracy of the burden estimate, and any suggested*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 51 of 60 methods for minimizing respondent burden, including through the use of automated collection techniques, to th e Director, Collection Strate gies Division, Office of Environmental Information (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, D.C. 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.
C. Small Entity Impacts Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA ) ( ), 5 U.S.C.
601 et seq

. ),

. , the Agency hereby certifies that pr omulgation of this SNUR would not have a significant adverse ec onomic impact on a substantia l number of small entities. The rationale supporting this c onclusion is as follows. Under the RFA, small entities include small businesses, small organizations, and small governmental jurisdictions. Small entity is defined in accordance with section 601of the RFA as: A small business as defined by th e Small Business Administration’s (SBA) regulations at 13 CFR 121.201; A small government al jurisdiction that is a government of a city, county, town, school district or special district with a p opulation of less than 50,000; and A small organizati on that is any not-for-pro fit enterprise which is independently owned and operated and is not dominant in its field. For purposes of assessing the impacts of th is proposed rule on small entities, EPA has determined that this propos ed rule is not expected to impact any small not-for-profit organizations or small governmental jurisdictions. As such, the Agency estimated potential impacts on small business. A SNUR applies to any person (including small or large entities) who intends to engage in any ac tivity described in the rule as a “significant*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 52 of 60 new use.” By definition of the word “n ew” and based on all information currently available to EPA, it appears that no small or large entities presently engage in such activity. Since this action would require a person who intends to engage in such activity in the future to first notify EPA by subm itting a SNUN, no economic impact would occur unless someone files a SNUN to pursue a signif icant new use in the future or forgoes profits by avoiding or delaying the significant new use. Although some small entities may decide to conduct such activ ities in the future, EPA cannot presently determine how many, if any, there may be. EPA's experience to date is that, in response to the promulgation of over 1,000 SNURs, the Agency receives on average only 5 notices per year. Of those SNUNs submitted, only one appears to be from a small entity in response to any SNUR. 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. In a SNUR that published as a final rule on August 8, 1997 (62 FR 42690) (FRL5735-4), the Agency presented its general de termination that propos ed and final SNURs are not expected to have a si gnificant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration.
D. State, Local, and Tribal Governments In EPA’s experience with proposing a nd finalizing SNURs since 1980, no State, local, or Tribal government has initiated the manufacture of a chemical for a new use. Furthermore, EPA does not have any reason to believe that any State, local, or Tribal government would do so for the chemicals in this rulemaking. For that reason, EPA has*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 53 of 60 determined that this action does not have federalism implications as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999), or Tribal implications as specified in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000). In addition, this action does not impos e any enforceable duty or contain any unfunded mandate for State, local, or tribal governments under the prov isions of Title II of the Unfunded Mandates Reform Act (UMRA), 2 U.S.C. 1531-1538. Nor does it otherwise have any effect on small governments, or estimated impacts on the private sector that might exceed $100 million in any year. Thus, sections 202, 203, 204, or 205 of UMRA, Executive Order 13132, and Executive Order 13175 do not apply to this action.
E. Protection of Children This action is not subject to Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), because this action is not an economical ly significant regulator y action as defined by Executive Order 12866, and it is not intende d to address environmental health or safety risks for children.
F. Effect on Energy Supply, Distribution, or Use This action is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), because this action is not an ec onomically significant regulatory action as defined by Executive Order 12866, and it is no t expected to affect energy supply, distribution, or use.*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 54 of 60 G. Technical Standards Since this action does not invol ve any technical standards, section 12(d) of the National Technology Transfer and Advancement Act (NTTAA), 15 U.S.C. 272 note, does not apply to this action.
H. Environmental Justice This action does not entail sp ecial considerations of environmental justice related issues as delineated by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Po pulations and Low-Income Populations (59 FR 7629, February 16, 1994).*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 55 of 60 List of Subjects in 40 CFR Part 721 Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements. Dated: _________________

__________________________________________ Director, Office of Pollution Prevention and Toxics.*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 56 of 60 Therefore, it is proposed that 40 CFR Part 721 be amended as follows: [AMENDED] 1. The authority citation for part 72 1 continues to read as follows: Authority: 15 U.S.C. 2604, 2607, and 2625(c). 2. In § 721.1660, revise paragraph (a) and (b) 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
CAS number C.I. name C.I. number Chemical name 117-33-9 Not available Not available 1,3-Na phthalenedisulfonic 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-Naphthale nedisulfonic 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. 26267 CAS. No. CBI (NA) CBI CBI 4-(Substituted phenyl)azo biphenylyl azo - substituted carbopolycycle azo benzenesulfonic acid, sodium salt. (Generic Name)
Accession No. 24921 CAS No. CBI (NA) CBI CBI 4-(Substituted naphtha lenyl )azo diphenylyl azosubstituted carbopolycycle azo benzenesulfonic acid, sodium salt. (Generic Name) Accession No. 4-(Substituted phenyl)azo biphenylyl azo-*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 57 of 60 26256 CAS No. CBI (NA) CBI CBI substituted carbopolycycloazo benzenesulfonic acid, sodium salt. (Generic Name)
Accession No. 21808 CAS No. CBI (NA) CBI CBI 2,7-Naphthalenedisu lfonic acid, 4-amino-5- hydroxy [[[(substituted phenylamino] substituted phenylazo] diphenyl]azo-, phenylazo-, disodium salt. ( Generic Name) Accession No. 26701 CAS No. CBI (NA) CBI CBI Phenylazoaminohydrox ynaphthalenylazobiphenyla zo substituted benzene sodium sulfonate. (Generic Name)

Table 2.—Benzidine-Based Chemical Substances
CAS number C.I. name C.I. number Chemical Name 92–87–5 Benzidine Not available [1,1’-Biphenyl]-4,4’-diamine 531–85–1 Benzidine · 2HCL Not available [1,1’-Biphenyl]-4,4’-diamine, dihydrochloride
573–58–0 C.I. Direct Red 28 22120 1- Naphthalenesulfonic acid, 3,3'-[[1,1'-biphenyl]- 4,4'-diylbis(azo)]bis[4-amino-, disodium salt 1937–37–7 C.I. Direct Black 38 30235 2,7-Naphthalenedisulfonic acid, 4-amino-3-[[4’- [(2,4-diaminophenyl) azo][1,1’-biphenyl]-4- yl]azo]-5-hydroxy-6-(phe nylazo)-, disodium salt 2302–97–8 C.I. Direct Red 44 22500 1-Naphthalenesulfonic acid, 8,8’-[[1,1’-biphenyl]- 4,4’-diylbis(azo)]bis[7- hydroxy-, disodium salt 2429–73–4 C.I. Direct Blue 2 22590 2,7-Naphthalenedisulfonic acid, 5-amino-3-[[4’- [(7-amino-1-hydroxy-3-sulfo-2- naphthalenyl)azo][1,1’-b iphenyl]-4-yl]azo]-4- hydroxy-,trisodium salt 2429–79–0 C.I. Direct Orange 8 22130 Benzoic acid, 5-[[4’-[(1-amino-4-sulfo-2- naphthalenyl) azo][1,1’-b iphenyl]-4-yl]azo]-2- hydroxy-, disodium salt 2429–81–4 C.I. Direct Brown 31 35660 Benzoic acid, 5-[[4’-[[2,6-diamino-3-[[8-hydroxy3,6-disulfo-7-[(4-sulfo- 1-naphthalenyl)azo]-2- naphthalenyl]azo]-5-methylphenyl]azo][1,1’- biphenyl]-4-yl]azo]-2-hy droxy-,tetrasodium salt 2429–82–5 C.I. Direct Brown 2 22311 Benzoic acid, 5-[[4’-[(7-amino-1-hydroxy-3-sulfo2-naphthalenyl) azo][1,1’-b iphenyl]-4-yl]azo]-2- hydroxy-, disodium salt 2429–83–6 Direct Black 4 C.I. 30245 2,7-Naphthale nedisulfonic acid, 4-amino-3-[[4’- [(2,4-diamino-5-methylphe nyl)azo][1,1’-biphenyl]- 4-yl]azo] -5-hydroxy-6-( phenylazo)-,disodium salt 2429–84–7 C.I. Direct Red 1 22310 Benzoic ac id, 5-[[4’-[(2-amino-8-hydroxy-6-sulfo1-naphthalenyl)azo][1,1’-b iphenyl]-4-yl]azo]-2- hydroxy-, disodium salt*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 58 of 60 2586–58–5 C.I. Direct Brown 1:2 30110 Benzoic acid, 5-[[4’-[[2,6-diamino-3-methyl-5-[(4- sulfophenyl)azo]phenyl]azo][1,1’-biphenyl]-4- yl]azo]-2-hydroxy-, disodium salt 2602–46–2 C.I. Direct Blue 6 22610 2,7-Naphthalenedisulfonic acid, 3,3’-[[1,1’- biphenyl]-4,4’-diylbis (azo)]bis[5-amino-4- hydroxy-, tetrasodium salt 2893–80–3 C.I. Direct Brown 6 30140 Benzoic acid, 5-[[4’-[[2,4-dihydroxy-3-[(4- sulfophenyl) azo]phenyl]azo][1,1’-biphenyl]-4- yl]azo]-2-hydroxy-, disodium salt 3530–19–6 C.I. Direct Red 37 22240 1,3-Naphthalenedisulfonic acid, 8-[[4’-[(4- ethoxyphenyl) azo][1,1’-biphenyl]-4-yl] azo]-7-hydroxy-,disodium salt 3567–65–5 C.I. Acid Red 85 22245 1,3-Naphthale nedisulfonic 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 1 30280 2,7-Naphthalenedisulfonic acid, 4-amino-5- hydroxy-3-[[4’-[(4-hydroxyphenyl)azo][1,1’- biphenyl]-4- yl]azo]-6-(phe nylazo)-, disodium salt 3811–71–0 C.I. Direct Brown 1 30045 Benzoic acid, 5-[[4’-[[2,4-diamino-5-[(4- sulfophenyl) azo]phenyl]azo][1,1’-biphenyl]-4- yl]azo]-2-hydroxy-, disodium salt 4335–09–5 C.I. Direct Green 6 30295 2,7-Naphthalenedisulfonic acid, 4-amino-5- 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 94 30336 2,7-Naphthalenedisulfonic acid, 4-amino-5- 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 27 31725 Benzoic acid, 5-[[4’-[[4-[(4-amino-7-sulfo-1- naphthalenyl)azo]-6-sulfo-1- naphthalenyl]azo][1,1’-bi phenyl]-4-yl] azo]-2- hydroxy-,trisodium salt 6360–54–9 C.I. Direct Brown 154 30120 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 8014–91–3 C.I. Direct Brown 74 36300 Benzoic acid, 3,3’-[(3,7-disulfo-1,5- 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 95 30145 Cuprate(2-), [5-[[4’-[[2,6-dihydroxy-3-[(2- hydroxy-5-sulfophenyl)azo]phenyl] azo][1,1’- biphenyl]-4-yl]azo]-2- hydroxybenzoato(4-)]-*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 59 of 60 ,disodium salt
(2) The significant new uses are: (i) Any use other than use as: (A) For the chemicals listed in Tabl e 2, as reagent to test for hydrogen peroxide in milk; a reagent to test for hydrogen sulfate, hydrogen cyanid e, and nicotine; a stain in microscopy; a reagent for detecting bl ood and as an analytical standard (B) For Color Index (C.I.) Direct Red 28 (Congo Red) (CAS No. 573-58-0) listed in Table 2, as an indicator dye (ii) For the 9 chemical substances listed in Table 1: any use. (3) Revocation of article exemption. The provisions of § 721.45( f) do not apply to this section. A person who imports or proces ses the chemical substances identified in paragraph (a)(1) of this section as part of an article for the significant new use described in paragraph (a)(2) of this section mu st submit a significant new use notice. 3. By adding new § 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-penty l phthalate (DnPP) (1,2-Benzenedicarboxylic acid, 1,2-dipentyl ester) (CAS N o.131-18-0) is subject to repo rting under this section for the significant new uses described in paragraph (a) (2) of this section. (2) The significant new use is: any use othe r than as a chemical standard for laboratory

use. (b) [Reserved] 4. Add § 721.10227 to subpart E to read as follows:*** EO12866/13563 Interagency Review Draft – Do No t Cite, Quote, or Release During the Review ***

RIN 2070-AJ73 Page 60 of 60 § 721.10227 Alkanes, C 12-13 , chloro (CAS No. 71011-12-6). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified Alkanes, C 12-13 , chloro (CAS No. 71011- 12-6) is subject to reporting unde r this section for the signif icant 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. (1) Persons who must report . § 721.5 applies to th is section except for §721.5(a)(2). A person who intends to manufactur e or import for commercial purposes a substance identified in paragr aph (a)(1) of this section and intends to distribute the substance in commerce must subm it a significant new use notice. (2) [Reserved].