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CommodityParts per

million

Expiration/revocation

date

Potato .............. 0.25 12/31/14.

Rhubarb .......... 10 None.

Sweet potato,roots.

10 None.

Tomato ............ 5 None.

(b) Section 18 emergency exemptions.[Reserved]

(c) Tolerances with regionalregistrations. [Reserved]

(d) Indirect or inadvertent residues.[Reserved]

3. Revise 180.276 to read as follows:

180.276 Formetanate hydrochloride;tolerances for residues.

(a) General. Tolerances areestablished for residues of theinsecticide formetanate hydrochloride,

including its metabolites anddegradates, in or on the commodities inthe table in this paragraph. Compliancewith the tolerance levels specified inthis paragraph is to be determined bymeasuring only formetanatehydrochloride, N,N-dimethyl-N-[3-[[(methylamino)carbonyl]oxy]phenyl]methanimidamide hydrochloride, in oron the commodity.

CommodityParts per

million

Expiration/revocation

date

Apple ............... 0.50 12/31/13.

Apple, wetpomace.

1.5 12/31/13.

Grapefruit ........ 1.5 None.

Lemon ............. 0.60 None.

Lime ................ 0.03 None.

Nectarine ......... 0.40 None.

Orange ............ 1.5 None.

Peach .............. 0.40 12/31/13.

Pear ................ 0.50 12/31/13.

Tangelo ........... 0.03 None.

Tangerine ........ 0.03 None.

(b) Section 18 emergency exemptions.[Reserved]

(c) Tolerances with regionalregistrations. [Reserved]

(d) Indirect or inadvertent residues.[Reserved]

[FR Doc. 20127445 Filed 32712; 8:45 am]

BILLING CODE 656050P

ENVIRONMENTAL PROTECTIONAGENCY

40 CFR Part 721

[EPAHQOPPT20100573; FRL88652]

RIN 2070AJ73

Benzidine-Based Chemical

Substances; Di-n-pentyl phthalate(DnPP); and Alkanes, C1213, Chloro;Proposed Significant New Use Rules

AGENCY: Environmental ProtectionAgency (EPA).ACTION: Proposed rule.

SUMMARY: Under the Toxic SubstancesControl Act (TSCA), EPA is proposing:To add nine benzidine-based chemicalsubstances to the Significant New UseRule (SNUR) on benzidine-basedchemical substances; a SNUR for di-n-pentyl phthalate (DnPP) (1,2-

benzenedicarboxylic acid, 1,2-dipentyl

ester) (CAS No. 131180); and a SNURfor alkanes, C1213, chloro (CAS No.71011126). In the case of the

benzidine-based chemical substances,EPA is also proposing to makeinapplicable the exemption relating topersons that import or processsubstances as part of an article. Iffinalized, this rule would requirepersons who intend to manufacture,import, or process these chemicalsubstances for an activity that isdesignated as a significant new use tonotify EPA at least 90 days beforecommencing that activity. The requirednotification would provide EPA withthe opportunity to evaluate activitiesassociated with a significant new useand an opportunity to protect againstpotential unreasonable risks, if any,from exposure to the chemicalsubstance.

DATES: Comments must be received onor before June 26, 2012.ADDRESSES: Submit your comments,identified by docket identification (ID)number EPAHQOPPT20100573, byone 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 Preventionand Toxics (OPPT), EnvironmentalProtection Agency, 1200 PennsylvaniaAve. NW., Washington, DC 204600001.

Hand Delivery:OPPT DocumentControl Office (DCO), EPA East Bldg.,Rm. 6428, 1201 Constitution Ave. NW.,Washington, DC. Attention: Docket IDnumber EPAHQOPPT20100573.The DCO is open from 8 a.m. to 4 p.m.,Monday through Friday, excluding legalholidays. The telephone number for the

DCO is (202) 5648930. Such deliveriesare only accepted during the DCOsnormal hours of operation, and specialarrangements should be made fordeliveries of boxed information.

Instructions:Direct your commentsto docket ID number EPAHQOPPT20100573. EPAs policy is that allcomments received will be included in

the docket without change and may bemade available on-line at http://www.regulations.gov,including anypersonal information provided, unlessthe comment includes informationclaimed to be Confidential BusinessInformation (CBI) or other informationwhose disclosure is restricted by statute.Do not submit information that youconsider to be CBI or otherwiseprotected through regulations.gov oremail. The regulations.gov Web site isan anonymous access system, whichmeans EPA will not know your identityor contact information unless you

provide it in the body of your comment.If you send an email comment directlyto EPA without going throughregulations.gov, your email address will

be automatically captured and includedas part of the comment that is placed inthe docket and made available on theInternet. If you submit an electroniccomment, EPA recommends that youinclude your name and other contactinformation in the body of yourcomment and with any disk or CDROMyou submit. If EPA cannot read yourcomment due to technical difficultiesand cannot contact you for clarification,EPA may not be able to consider your

comment. Electronic files should avoidthe use of special characters, any formof encryption, and be free of any defectsor viruses.

Docket:All documents in the docketare listed in the docket index availableat http://www.regulations.gov.Althoughlisted in the index, some information isnot publicly available, e.g., CBI or otherinformation whose disclosure isrestricted by statute. Certain othermaterial, such as copyrighted material,will be publicly available only in hardcopy. Publicly available docketmaterials are available electronically at

http://www.regulations.gov,or, if onlyavailable in hard copy, at the OPPTDocket. The OPPT Docket is located inthe EPA Docket Center (EPA/DC) at Rm.3334, EPA West Bldg., 1301Constitution Ave. NW., Washington,DC. The EPA/DC Public Reading Roomhours of operation are 8:30 a.m. to 4:30p.m., Monday through Friday, excludinglegal holidays. The telephone number ofthe EPA/DC Public Reading Room is(202) 5661744, and the telephonenumber for the OPPT Docket is (202)5660280. Docket visitors are required

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to show photographic identification,pass through a metal detector, and signthe EPA visitor log. All visitor bags areprocessed through an X-ray machineand subject to search. Visitors will beprovided an EPA/DC badge that must bevisible at all times in the building andreturned upon departure.FOR FURTHER INFORMATION CONTACT: For

technical information contact:SaraKemme, National Program ChemicalsDivision (7404T), EnvironmentalProtection Agency, 1200 PennsylvaniaAve. NW., Washington, DC 204600001;telephone number: (202) 5660511;email address: [email protected].

For general information contact:TheTSCA Hotline, ABVIGoodwill, 422South Clinton Ave., Rochester, NY14620; telephone number: (202) 5541404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General InformationA. Does this action apply to me?

These three different SNURs mayapply to different entities.

1. Benzidine-based chemicalsubstances. You may be potentiallyaffected by this action if youmanufacture, import, or process,including as part of an article, any of the

benzidine-based chemical substanceslisted in Tables 1. and 2. of theregulatory text in this document.Potentially affected entities mayinclude, but are not limited to:

Manufacturers, importers, or

processors of one or more of the subjectchemical substances.

Entities which plan to use the listedchemical substances in conjunctionwith apparel and other finishedproducts made from fabrics, leather, andsimilar materials.

Entities which plan to use the listedchemical substances in conjunctionwith paper and allied products.

Manufacturers, importers, orprocessors of the subject chemicalsubstances in printing inks.

These entities may include thosedescribed by the North American

Industrial Classification System(NAICS) codes 325-chemicalmanufacturing, 313-textilemanufacturers, 316-leather and alliedproducts manufacturers, 322-papermanufacturers, 4243-apparel, piecegoods, and notions wholesalers, or 443-clothing and accessories stores.

2. DnPP. For DnPP, you may bepotentially affected by this action if youmanufacture (defined by statute toinclude import), or process DnPP.Potentially affected entities mayinclude, but are not limited to: Chemical

industryplastic material & resins(NAICS code 325211).

3. Alkanes, C1213, chloro (CAS No.71011126). You may be potentiallyaffected by this action if youmanufacture, import, or process thefollowing short-chained chlorinatedparaffin (SCCP): Alkanes, C1213, chloro

(CAS No. 71011126). Potentiallyaffected entities may include, but arenot limited to: Manufacturers (defined

by statute to include importers) ofSCCPs (NAICS codes 325 and 325998),e.g., chemical manufacturing; includingmiscellaneous chemical product andpreparation manufacturing; andprocessors of SCCPs (NAICS codes 324and 324191), e.g., petroleum lubricatingoil and grease manufacturing.

This listing is not intended to beexhaustive, but rather provides a guidefor readers regarding entities likely to beaffected by this action. Other types of

entities not listed in this unit could alsobe affected. The NAICS codes have beenprovided to assist you and others indetermining whether this action mightapply to certain entities. To determinewhether you or your business may beaffected by this action, you shouldcarefully examine the applicabilityprovisions in 721.5 for SNUR-relatedobligations and with respect to

benzidine-based chemical substances,the applicability provisions in Unit II.C.If you have any questions regarding theapplicability of this action to aparticular entity, consult the technical

person listed under FOR FURTHERINFORMATION CONTACT.

This action may also affect certainentities through pre-existing importcertification and export notificationrules under TSCA. Persons who importany chemical substance governed by afinal SNUR are subject to the TSCAsection 13 (15 U.S.C. 2612) importcertification requirements and thecorresponding regulations at 19 CFR12.118 through 12.127; see also 19 CFR127.28. Those persons must certify thatthe shipment of the chemical substancecomplies with all applicable rules and

orders under TSCA, including anySNUR requirements. The EPA policy insupport of import certification appearsat 40 CFR part 707, subpart B. Inaddition, any persons who export orintend to export a chemical substancethat is the subject of a proposed or finalSNUR are subject to the exportnotification provisions of TSCA section12(b) (15 U.S.C. 2611(b)) (see 721.20)and must comply with the exportnotification requirements in 40 CFR part707, subpart D.

B. What should I consider as I preparemy comments for EPA?

1. Submitting CBI. Do not submit thisinformation to EPA throughregulations.gov or email. Clearly markthe part or all of the information thatyou claim to be CBI. For CBIinformation in a disk or CDROM thatyou mail to EPA, mark the outside of thedisk or CDROM as CBI and thenidentify electronically within the disk orCDROM the specific information thatis claimed as CBI. In addition to onecomplete version of the comment thatincludes information claimed as CBI, acopy of the comment that does notcontain the information claimed as CBImust be submitted for inclusion in thepublic docket. Information so markedwill not be disclosed except inaccordance with procedures set forth in40 CFR part 2.

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

to:i. Identify the document by docket ID

number and other identifyinginformation (subject heading, FederalRegister date and page number).

ii. Follow directions. The Agency mayask you to respond to specific questionsor organize comments by referencing aCode of Federal Regulations (CFR) partor section number.

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

iv. Describe any assumptions andprovide any technical information and/

or data that you used.v. If you estimate potential costs orburdens, explain how you arrived atyour estimate in sufficient detail toallow for it to be reproduced.

vi. Provide specific examples toillustrate your concerns and suggestalternatives.

vii. Explain your views as clearly aspossible, avoiding the use of profanityor personal threats.

viii. Make sure to submit yourcomments by the comment perioddeadline identified.

II. Background

A. What action is the agency taking?EPA is proposing to add nine

chemical substances (see Table 1. inUnit III.A.) to the existing SNUR forcertain benzidine-based chemicalsubstances at 721.1660. Thatregulation includes as significant newuses any use other than as a reagent totest for hydrogen peroxide in milk; areagent to test for hydrogen sulfate,hydrogen cyanide, and nicotine; a stainin microscopy; a reagent for detecting

blood; an analytical standard; and also

mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]

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for Colour Index (C.I.) Direct Red 28(Congo Red, CAS No. 573580) as anindicator dye. 721.1660(a)(2). For thenine newly-proposed benzidine-basedchemical substances, EPA is proposingto designate any use as a significant newuse. EPA requests comment on whetherthere are any ongoing uses of thesechemicals.

EPA is also proposing to amend theSNUR at 721.1660 to makeinapplicable the exemption at 721.45(f) for persons that import orprocess benzidine-based chemicalsubstances as part of an article.

Additionally, EPA is proposing aSNUR for DnPP that would designate, asa significant new use, any use of thesubstance other than as a chemicalstandard for laboratory use.

EPA is also proposing a SNUR foralkanes, C1213, chloro (CAS No. 71011126) that would designate any use of

the substance as a significant new use.Because any use of alkanes, C1213,chloro (CAS No. 71011126) would bea new use, 721.5(a)(2) would beinapplicable to alkanes, C1213, chloro(CAS No. 71011126). This provisionaddresses manufacturers, importers, andprocessors who are also distributors ofa chemical substance subject to a SNUR.In certain cases, it requires thesedistributors to alert their customers thatthe SNUR exists. This requirementserves an important communicationfunction when certain uses of achemical, but not others, triggerSignificant New Use Notice (SNUN)requirements. Where there are noongoing, existing uses of a chemicalsubstance and EPA determines by rulethat all future uses trigger SNUNsrequirement (as with alkanes, C1213,chloro (CAS No. 71011126)), EPA

believes these alerts are not onlyunnecessary, but unlikely to ever occur.

These proposed SNURs would requirepersons that manufacture, import, orprocess any of the chemicals for asignificant new use, consistent with therequirements at 721.25, to notify EPAat least 90 days before commencing

such manufacture, process, or import ofthe chemical substance for a significantnew use. For the benzidine-basedchemical substances, the proposedelimination of the article exemption at 721.45(f) would also require persons tonotify EPA at least 90 days beforecommencing processing or importing aspart of an article any of the currently-listed or newly-proposed benzidine-

based chemical substances. Theobjectives and rationale for thisproposed SNUR are explained in UnitVI.

B. What is the agencys authority fortaking this action?

Section 5(a)(2) of TSCA (15 U.S.C.2604(a)(2)) authorizes EPA to determinethat a use of a chemical substance is asignificant new use. EPA must makethis determination by rule afterconsidering all relevant factors,including those listed in TSCA section5(a)(2). These factors include:

The projected volume ofmanufacturing and processing of achemical substance.

The extent to which a use changesthe type or form of exposure of human

beings or the environment to a chemicalsubstance.

The extent to which a use increasesthe magnitude and duration of exposureof human beings or the environment toa chemical substance.

The reasonably anticipated mannerand methods of manufacturing,processing, distribution in commerce,

and disposal of a chemical substance.Once EPA determines that a use of achemical substance is a significant newuse, TSCA section 5(a)(1)(B) requirespersons to submit a SNUN to EPA atleast 90 days before they manufacture,import, or process the chemicalsubstance for that use (15 U.S.C.2604(a)(1)(B)). The general SNURprovisions are found at 40 CFR part 721,subpart A.

C. Applicability of general provisions

General provisions for SNURs appearunder 40 CFR part 721, subpart A.These provisions describe persons

subject to the rule, recordkeepingrequirements, exemptions to reportingrequirements, and applicability of therule to uses occurring before theeffective date of the final rule.

Provisions relating to user fees appearat 40 CFR part 700. According to 721.1(c), persons subject to SNURsmust comply with the same noticerequirements and EPA regulatoryprocedures as submitters ofPremanufacture Notices (PMNs) underTSCA section 5(a)(1)(A). In particular,these requirements include theinformation submissions requirements

of TSCA section 5(b) and 5(d)(1), theexemptions authorized by TSCA section5(h)(1), (h)(2), (h)(3), and (h)(5), and theregulations at 40 CFR part 720. OnceEPA receives a SNUN, EPA may takeregulatory action under TSCA section5(e), 5(f), 6 or 7 to control the activitieson which it has received the SNUN. IfEPA does not take action, EPA isrequired under TSCA section 5(g) toexplain in the Federal Register itsreasons for not taking action.

However, 721.45(f) (which generallyexempts persons importing or

processing a substance as part of anarticle) would not apply to benzidine-

based chemical substances listed at 40CFR 721.1660 and those added by thisproposed rule. Therefore, a person whoimports or processes as part of an articlea benzidine-based chemical substancethat is covered by this proposed rulewould not be exempt from submitting a

SNUN. With respect to articles, it is stillrelevant to the rulemaking whether ause was ongoing or not at time ofproposal. It is not EPAs intent tosubject ongoing uses of any chemicalsubstances to the requirements of aSNUR. Thus, to the extent thatadditional ongoing uses of benzidine-

based chemical substances are found inthe course of rulemaking (whether ornot they involve importing orprocessing as part of articles), EPAwould exclude those uses from the finalSNUR.

Persons who export or intend to

export a chemical substance identifiedin a proposed or final SNUR are subjectto the export notification provisions ofTSCA section 12(b). The regulations thatinterpret TSCA section 12(b) appear at40 CFR part 707, subpart D. Personswho import a chemical substanceidentified in a final SNUR are subject tothe TSCA section 13 import certificationrequirements, codified at 19 CFR 12.118through 12.127; see also 19 CFR 127.28.Those persons must certify that theshipment of the chemical substancecomplies with all applicable rules andorders under TSCA, including anySNUR requirements. The EPA policy insupport of import certification appearsat 40 CFR part 707, subpart B.

III. Overview of Benzidine-BasedChemical Substances

A. What additional benzidine-basedchemical substances are subject to this

proposed SNUR?

This proposed rule would add ninebenzidine-based chemical substances tothe list of twenty-four chemicalsubstances currently regulated under 721.1660. The nine benzidine-basedchemical substances covered by thisproposed SNUR are listed in Table 1.The chemicals listed in Table 1 areidentified by Chemical Abstract ServiceRegistry Numbers (CAS number) or ifthe chemicals CAS number is claimedCBI, the chemical is identified by anEPA accession number, along with itscorresponding generic name. Theaccession numbers are EPA assignednumbers used to identify chemicals inplace of confidential CAS numbers.Table 1 also indicates the availability ofthe Colour Index (C.I.) name and C.I.number, which is either not available or


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CBI for some of the chemicals subject tothis proposed rule. Persons who areinterested in determining the precise

identity of the chemical designated by acertain accession number and a genericname should submit a bonafide request

to EPA that complies with theinformation requirements stipulated in 721.11(b).

TABLE 1NEWLY ADDED BENZIDINE-BASED CHEMICAL SUBSTANCES

CAS or Accession No. C.I. name C.I. No. Chemical name

117339 ............................. Not available ...................... Not available ...................... 1,3-Naphthalenedisulfonic acid, 7-hydroxy-8-[2-[4-[2-(4-hydroxyphenyl)diazenyl][1,1-biphenyl]-4-yl]diazenyl]-

65150870 ......................... 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)

68214824 ......................... 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)

72379454 ......................... Not available ...................... Not available ...................... 2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-3-[2-[4-[2-[2-hydroxy-4-[(2-methylphenyl)amino]phenyl]diazenyl][1,1-biphenyl]-4-yl]diazenyl]-6-(2-phenyldiazenyl)-

Accession No. 21808 CASNo. CBI (NA).

CBI ..................................... CBI ..................................... 2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy[[[(substituted phenylamino)] substituted phenylazo]diphenyl]azo-, phenylazo-, disodium salt. (genericname)


CBI ..................................... CBI ..................................... 4-(Substituted naphthalenyl)azo diphenylyl azo-sub-stituted carbopolycycle azo benzenesulfonic acid,sodium salt. (generic name)


CBI ..................................... CBI ..................................... 4-(Substituted phenyl)azo biphenylyl azo-substitutedcarbopolycycloazo benzenesulfonic acid, sodiumsalt. (generic name)


CBI ..................................... CBI ..................................... 4-(Substituted phenyl)azo biphenylyl azosubstitutedcarbopolycycle azo benzenesulfonic acid, sodiumsalt. (generic name)


CBI ..................................... CBI ..................................... Phenylazoaminohydroxynaphthalenylazobiphenylazosubstituted benzene sodium sulfonate. (genericname)

B. What action has the agencypreviously taken on other benzidine-based chemical substances?

In 1996, EPA promulgated a TSCAsection 5(a)(2) SNUR for the benzidine-

based chemical substances listed at 721.1660 (61 FR 52287, October 7,1996) (FRL53966). That ruleconsidered any use of the chemicalsubstances except those listed in 721.1660(a)(2) as a significant new usethat requires a SNUN to be submitted tothe Agency prior to manufacture,import, or processing of the listedchemical substances. Because they wereidentified as ongoing, the SNURexcluded as significant new uses the

following uses: As a reagent to test forhydrogen peroxide in milk; a reagent totest for hydrogen sulfate, hydrogencyanide, and nicotine; a stain inmicroscopy; as a reagent for detecting

blood; and as an analytical standard. Inaddition, for Colour Index (C.I.) DirectRed 28 (Congo Red) (CAS No. 573580), use as an indicator dye was excludedas a significant new use. The SNUR didnot require a SNUN to be submitted bypersons that import or process a listedsubstance as part of an article.

C. What is the production volume ofnewly-proposed and currently-listedchemical substances?

For the newly proposed ninebenzidine-based chemical substances,data reported to EPA for the 2006, 2002,and 1998 reporting cycles, as required

by the TSCA Inventory UpdateReporting (IUR) rule, indicate noevidence of production (includingimport). The IUR regulation requiresmanufacturers and importers of certainchemical substances to report site andmanufacturing information forchemicals manufactured (includingimported) in amounts of 25,000 poundsor greater at a single site (prior to 2006,

reporting was for 10,000 pounds at asite). A general market review on thesechemical substances indicates nocurrent manufacture (Ref. 1) within oroutside the United States.

In addition, four of these benzidine-based chemicals were included in EPAsBenzidine-based Dyes Action Plan. Theadditional five chemicals were found inthe confidential TSCA inventory.Designed as part of a comprehensiveapproach to enhancing EPAs ChemicalManagement Program, action planssummarize hazard, exposure, and use

information; outline the potential risksthat each chemical may pose; andidentify the specific steps the Agency isconsidering to address those concerns(Ref. 2).

For the benzidine-based chemicalsubstances currently listed at 721.1660, data reported to EPA for the2006, 2002, and 1998 reporting cycles,as required by the TSCA IUR rule,indicate no evidence of domesticproduction (including import) at IURreportable levels. Further, EPAs generalmarket review on the currently listed

benzidine-based chemical substancessuggests that the majority of thesechemical substances are not currently

being manufactured domestically orabroad (Ref. 1). Although some of thesesubstances appear to be manufacturedfor allowable uses within the UnitedStates at a level below current IURreporting thresholds, and somesubstances appear to be manufacturedoutside the United States generally andmay therefore potentially be imported aspart of an article, EPA does not haveinformation to suggest that thesubstances are being imported, for useas part of articles. In fact, the marketreview did not find evidence of any


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import of articles containing benzidine-based chemical substances. As stated inUnit VIII, EPA welcomes comments onany aspect of this proposed SNUR. TheAgency specifically invites commentson whether there is ongoingmanufacture, import, or processing ofthese benzidine-based chemicalsubstances, including in articles, other

than as excepted at 721.1660(a)(2).D. What are the uses of these benzidine-based chemical substances?

Historically, the benzidine-basedchemical substances currently listed at 721.1660 were used as reagents,

biological stains in laboratories, and infood industries. Note that TSCA section3(2)(B)(vi) excludes foods, foodadditives, drugs, cosmetics or devices(as defined in the Federal Food, Drug,and Cosmetic Act) from the statutorydefinition of a chemical substancewhen such substances aremanufactured, processed, or distributedin commerce for use as a food, foodadditive, drug, cosmetic, or device.Additionally, these previously listed

bezidine-based substances are believedto have been historically used as dyes inthe textile industry.

The nine newly-proposed benzidine-based chemical substances are believedto have been used in the past in theproduction of textiles, paints, printinginks paper, and pharmaceuticals.However, based on market informationand the fact that the 2006 IUR had noproduction reports for any of the

benzidine-based chemical substances, if

these chemical substances are used atall, they are likely used in smallvolumes, making it difficult to accesscurrent production and use information.

E. What are the potential health effectsof these chemicals?

The 1980 EPA Preliminary RiskAssessment on derivatives of benzidineestablished that the primary hazardconcern was for the carcinogenic effectsto humans from exposure to specificmetabolites of the chemical substances(Ref. 3). There is potential for benzidine-

based chemical substances to

metabolize to the parent benzidinemolecule, which is a known carcinogen(Refs. 4, 5, and 6). This metabolismoccurs in humans by an enzyme-mediated reaction. These enzymes arefound in the liver, in gut bacteria, andin skin bacteria. The result of thisenzymatically-aided reduction is therelease of the carcinogenic aromaticamine from the chemical substance.Studies have demonstrated that thereduction of benzidine-based chemicalsubstances occurs in the human body aswell as on the skin (Ref. 7). Therefore,

the primary human health concern forconsumers is exposure to the benzidine-

based chemical substances through oral,dermal, or inhalation routes. Evidencefrom animal studies suggests that thereis early life susceptibility to benzidinecarcinogenesis (Ref. 8). Cancer potencyfor benzidine was substantiallyincreased when the dose was given in

early life as compared to adults (Ref. 8).For additional information seeBenzidine-Based Chemical Substances;Significant New Uses of CertainChemical Substances; Final Rule (61 FR52287, October 7, 1996).

F. What are the potential routes andsources of exposures to these chemicals?

There are benzidine related exposureconcerns as a result of the use of

benzidine and benzidine-basedchemical substances. In 1996, EPAidentified inhalation, skin absorption,and ingestion as possible routes ofexposure in a variety of settings where

benzidine-based chemical substancesare either manufactured or used (61 FR52287, October 7, 1996). Although EPAestimated that the highest exposurewould be to workers who were involvedin dye manufacturing, EPA determinedthat it was necessary to apply the SNURto any use of the listed benzidine-basedchemical substances, with the exceptionof the limited uses mentioned in UnitII.A. EPA listed all the benzidine-basedchemical substances that it was able toidentify on the TSCA Inventory at thattime. Since then, EPA has identified thenine additional benzidine-based

chemical substances listed as part ofTable 1 and has similar concerns aboutpotential consumer and workerexposure to these substances.

Dermal exposure can occur from theleaching of the chemical substances bysweat in contact with the dyed textiles(Ref. 7). Dermal exposure is also aconcern since many of these chemicalsubstances can be directly absorbed bythe skin to some extent. It is wellestablished that the enzymatically-aideddye reduction to the carcinogenic

benzidine unit occurs internally in theliver and the gut (Refs. 9 and 10).

Studies have shown that some humanskin bacteria possess azo-reductases, theenzymes necessary to break down the

benzidine-based chemical substances torelease the carcinogenic amines, whichcan be more readily absorbed (Ref. 11).

Consistent with the information ondermal absorption that EPA reviewed indeveloping its recent Benzidine-basedChemical Substances Action Plan (EPAHQOPPT20100570 at http://www.regulations.gov), EPA identifiedthe following main routes of consumerexposure to benzidine-based chemical

substances that are of concern: (1)Dermal absorption, the primary routefrom wearing dyed clothing or footwear;(2) oral ingestion, an additional route for

babies and young children who suck onclothing, blankets, and other non-foodproducts which might contain any ofthe benzidine-base chemical substances;(3) inhalation exposure, a more

prevalent route in occupational settings;however, it can also occur from the useof dyed inks during air brushing orfrom off-gassing from the dyed carpetsto indoor air; and (4) contact with the

benzidine-based chemical substancesentering the environment, through thewhole life cycle of benzidine-basedchemical substances in textiles (Ref. 12).

IV. Overview of DnPP

A. What chemical is included in theproposed SNUR?

This proposed SNUR would apply to

DnPP (1,2-Benzenedicarboxylic acid,1,2-dipentyl ester), CAS No. 131180,an ortho-phthalate (or phthalate ester).

B. What is the production volume ofDnPP?

No IUR production volume data werereported for DnPP during the 2006,2002, 1998, and 1994 reporting cycles(Ref. 13). The last reporting of DnPPproduction to the IUR occurred in 1990and corresponds to the lowestreportable production volume range(10,000 to 500,000 pounds) (Ref. 13).

DnPP was included in EPAs

Phthalates Action Plan, which wasissued on December 30, 2009 (Ref. 14a).As stated in Unit III.C., the chemicalaction plans were designed as a part ofa comprehensive approach to enhancingEPAs Chemical Management Program.These action plans summarize availablehazard, exposure, and use information;outline the potential risks that eachchemical may present; and identify thespecific steps the Agency is consideringto address those concerns. Please notethat in response to a request forcorrection of the information providedin the 2009 Phthalate Action Plan thatwas filed under the AgencysInformation Quality Guidelines by theAmerican Chemistry Council, EPAissued a revised Phthalate Action Planon March 14, 2012 (Ref. 14b). Copies ofthe request for correction and EPAsresponse to it are available at http://www.epa.gov/quality/informationguidelines/iqg-list.html.Internet queries performed by EPAidentified several companies that eitheruse or sell DnPP as a chemical standardfor laboratory use. As a result, EPA isproposing a SNUR for DnPP, excluding

http://www.regulations.gov/http://www.regulations.gov/http://www.regulations.gov/http://www.epa.gov/quality/informationguidelines/iqg-list.htmlhttp://www.epa.gov/quality/informationguidelines/iqg-list.htmlhttp://www.epa.gov/quality/informationguidelines/iqg-list.htmlhttp://www.regulations.gov/http://www.regulations.gov/http://www.epa.gov/quality/informationguidelines/iqg-list.htmlhttp://www.epa.gov/quality/informationguidelines/iqg-list.htmlhttp://www.epa.gov/quality/informationguidelines/iqg-list.html

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use of the substance as a chemicalstandard for laboratory use.

C. What are the uses of DnPP?

DnPP belongs to a broad category ofchemicals commonly referred to asphthalates. Although a number ofphthalates are in common use, EPA

believes the individual phthalate DnPP

is not in general use in the UnitedStates, and only has a limitedapplication as a chemical standard forlaboratory use. As a chemical category,the major use of phthalates is asplasticizers (Refs. 1523) especially inpolyvinyl chloride (PVC) products,where they are added to impartflexibility and other desirableproperties. Phthalate-containing PVCproducts include a variety of industrialand commercial products, as well asspecialized medical and dentalapplications. The particular phthalate orcombination of phthalates used in aspecific products formulation dependson the properties the phthalates impart,as well as their cost.

D. What are the potential health andenvironmental effects of DnPP?

1. Human health effects. Exposures ofsome phthalates in animal studiesresulted in phthalate syndrome effects,which consist of changes in the fetaldevelopment of the reproductive system(Refs. 1522 and 2435). The phthalatesthat are the most potent at causingphthalate syndrome effects are generallythose with linear ester side chainshaving 46 carbons (Ref. 24). DnPP has

a linear carbon chain length of 5carbons. Of the phthalates studied,DnPP is the most potent in producingtesticular toxicity in pubertal animals(Ref. 24).

Developmental oral exposures in ratsto DnPP showed increased resorptions,increased fetal mortality, and decreasedfetal testicular testosterone production(Refs. 36 and 37); and reducedanogenital distance in male rat offspring(Ref. 38). Effects noted in adult miceexposed to DnPP include decreased

body weight; increased liver weights;decreased kidney weights; decreases in

the weights of the epididymis, caudaepididymis, testes, and seminal vesicles;complete absence of detectable sperm;shorter average estrous cycle length infemales; and decreased fertility (Refs. 39and 40). Gross and microscopicevidence of degenerative changes have

been observed in the testes andepididymis (including testicularatrophy, interstitial cell hyperplasia,degeneration of the seminiferoustubules, and accumulation of fluid anddegenerated cells in the epididymis) ofrodents (Refs. 39 and 40). There are no

subchronic or chronic animal studies ofDnPP exposure through any exposureroute.

There are no known human studies ofexposure to DnPP. However, due to thedata discussed in this section, the datapresented and discussed in Phthalatesand Cumulative Risk Assessment: TheTasks Ahead, Committee on the Health

Risks of Phthalates, National ResearchCouncil (2008) (Ref. 24) and DnPPsgeneral structure and categorization as aphthalate, EPA notes that the humanhealth effects of DnPP exposure may besimilar to that observed for some otherphthalates. Several human studies havereported associations of exposure ofsome other phthalates with adversereproductive outcomes anddevelopmental effects similar to those inthe rat, although no causal link has beenestablished (Refs. 24 and 4150). Thereproductive developmental effects ofsome phthalates observed in humans

include shortened anogenital distanceobserved in newborn boys, shortenedpregnancy, lower sex and thyroidhormones, and reduced sperm quality inadults; however, some studies failed toshow these effects (Ref. 42). Since thepathway for sexual differentiation in thefetus is highly conserved in allmammals, the reproductive anddevelopmental effects observed in therat studies are potentially relevant tohumans.

Studies in animals evaluating thecumulative effects of combinations ofphthalates on testosterone fetalmortality, and male and female

reproductive development later in lifehave demonstrated all mixtures werecumulative for all endpoints (Refs. 3637 and 5155). The reproductive effectsof DnPP observed in animal studies, thereproductive effects of other phthalatesobserved in humans, and the data on thecumulative effects of mixtures ofphthalates, support EPAs concern forpotential human health hazardsfollowing exposure to DnPP.

2. Environmental effects. EPA doesnot know of any studies of theenvironmental effects of DnPP. Due tothe general structure of DnPP, its

behavior in an aquatic environmentsimilar to the close analog mono 2-ethylhexyl phthalate, its log Kow, andwater solubility measurements, and itscategorization as a phthalate, EPA isconcerned that the environmentaleffects of DnPP may be similar to thoseof other phthalates studied. Otherphthalates studied have been shown tohave biological effects in all studiedanimal groups and have been observedat environmentally relevant exposuresin the nanogram/liter to microgram/literrange. The combination of the inherent

toxicity, variable solubility, log of theoctanol-water coefficient values, and

bioconcentration factor (BCF) valuesamong the studied phthalates elicit bothacute and chronic toxicity to aquaticand terrestrial wildlife by targetingthyroid function, liver function,reproduction, and other physiologicalmechanisms (Refs. 3135, 56 and 57).

E. What are the potential routes andsources of exposure to DnPP?

1. Human exposure. Data from theNational Health and NutritionExamination Survey (NHANES)indicates widespread exposure of thegeneral population to various phthalates(Ref. 58). Phthalates are used in a widearray of plastic products and may bereleased into the environment duringuse and disposal of these products (Ref.58). Biomonitoring data from amnioticfluid and urine have demonstrated thathumans are exposed to various

phthalates in utero, as infants, duringpuberty, and in adult life; and thatpeople are exposed to several phthalatesat once. The urinary metabolites ofDnPP were not specifically included inthe 4th National Report on HumanExposure to Environmental Chemicals(2010), so EPA cannot draw conclusionsas to the current exposure of the generalpopulation in the United States toDnPP.

2. Environmental exposure. Due tophthalates pervasive use and release, aswell as their propensity for globaltransport, various phthalates may befound in most environmental media,including ambient air, surface water,soil, and sediment (Refs. 2532 and 3435). Fish and other aquatic organisms,as well as terrestrial animals haveevidenced exposure to a commonphthalate: di-(2-ethylhexyl) phthalate(DEHP) (Refs. 34 and 57). EPA does nothave available data on environmentalexposures to DnPP.

V. Overview of Alkanes, C1213, Chloro(CAS No. 71011126)

A. What chemical is included in theproposed SNUR?

This proposed SNUR would coveralkanes, C1213, chloro (CAS No. 71011126), one type of short-chainchlorinated paraffin (SCCP). Thisconsists of C12 and C13 alkanes withvarying degrees of chlorination.

B. What is the production volume ofalkanes, C1213, chloro (CAS No. 71011126)?

No production volumes for alkanes,C1213 chloro (CAS No. 71011126)were reported to the IUR during the2006, 2002, 1998, and 1994 reporting


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cycles, and EPA found no additionalevidence of any importation ormanufacturing of the chemical.

Alkanes, C1213, chloro (CAS No.71011126) was included in EPAsShort-Chain Chlorinated Paraffins(SCCPs) and Other Chlorinated ParaffinsAction Plan (Ref. 59). As stated in UnitIII.C., the chemical action plans were

designed as a part of a comprehensiveapproach to enhancing EPAs ChemicalManagement Program. These actionplans summarize available hazard,exposure, and use information; outlinethe potential risks that each chemicalmay present; and identify the specificsteps the Agency is considering toaddress those concerns.

C. What were the uses of this SCCP?

Alkanes, C1213, chloro (CAS No.71011126) is an individual chemicalsubstance that belongs to a category ofchemicals referred to as SCCPs. Thereare many different chemical substancesthat are members of the SCCP category.Generally these SCCPs have between 10and 13 carbon atoms and contain 4070 percent chlorine by weight. Of thedifferent SCCPs that are listed on theTSCA Inventory, EPA believes the SCCPnamed Alkanes, C1213, chloro (CASNo. 71011126) is not in use in theUnited States and EPA has found noinformation that indicates it has ever

been used. All of the data discussed inthis section associated with the SCCPsgeneral category would pertain to anyindividual member of that category,including alkanes, C1213, chloro (CAS

No. 71011126).D. What are the potential environmentaleffects of alkanes, C1213, chloro (CASNo. 71011126)?

The primary concern for SCCPs isecotoxicity. There are internationallyaccepted data specifically on theecotoxicity of alkanes, C1213, chloro(CAS No. 71011126) (Ref. 60).Alkanes, C1213, chloro (CAS No. 71011126) are highly toxic to aquaticinvertebrates following acute andchronic exposures. In fish, this hightoxicity is associated with chronic

exposures, but not for acute exposures.For aquatic plants, there is high toxicityassociated with both acute and chronicexposures to SCCPs in general (Ref. 5961).

Both Health Canada and EnvironmentCanada have characterized allchlorinated paraffins (short chainchlorinated paraffins, medium chainchlorinated paraffins, and long chainchlorinated paraffins), which includethe chemical substance covered by thisproposed rule, as toxic under theCanadian Environmental Protection Act

(CEPA) (Ref. 61). Their assessmentfound that these SCCPs have or mayhave an immediate or long term harmfuleffect on the environment or its

biological diversity; and that they arepersistent, bioaccumulative, inherentlytoxic and present in the environmentprimarily as a result of human activity(Ref. 61).

E. What are the potential routes andsources of exposure to alkanes, C1213,chloro (CAS No. 71011126)?

The mechanisms or pathways bywhich the SCCPs, including alkanes,C1213, chloro (CAS No. 71011126),move into and through the environmentand humans are not fully understood,

but are likely to include releases frommanufacturing of the chemicals,manufacturing of products like plasticsor textiles, aging and wear of productslike sofas and electronics, and releasesat the end of product life (e.g., disposal,

recycling).EPA has concerns regarding theenvironmental fate and the exposurepathways that lead to any SCCPpresence, including C12 and C13 SCCPs(for example, Alkanes, C1213, Chloro(CAS No. 71011126)), in a variety of

biota, including freshwater aquaticspecies, marine mammals, and avianand terrestrial wildlife (Ref. 60). Inaddition, SCCPs, including C12 and C13SCCPs, have been detected in samplesof human breast milk from Canada andthe United Kingdom, as well as in avariety of food items from Japan andvarious regions of Europe (Ref. 6263).SCCPs are routinely found in soil andsediment samples. EPA also hasconcerns about the persistence,

bioaccumulation, and toxicity (PBT) ofSCCPs (Ref. 60).

VI. Rationale and Objectives

A. Rationale

Consistent with EPAs past practicefor issuing SNURs under TSCA section5(a)(2), EPAs decision to propose aSNUR for a particular chemical useneed not be based on an extensiveevaluation of the hazard, exposure, or

potential risk associated with that use.Rather, the Agencys action is based onEPAs determination that if the use

begins or resumes, it may present a riskthat EPA should evaluate under TSCA

before the manufacturing or processingfor that use begins. Since the new usedoes not currently exist, deferring adetailed consideration of potential risksor hazards related to that use is aneffective use of resources. If a persondecides to begin manufacturing orprocessing the chemical for the use, thenotice to EPA allows EPA to evaluate

the use according to the specificparameters and circumstancessurrounding that intended use.

1. Benzidine-based chemicalsubstances. As summarized in Unit III.,EPA is concerned about potentialcarcinogenic effects on workers andconsumers from the manufacture,processing, importing, or use of these

substances. Consumers exposed viadermal exposure to consumer productscontaining the benzidine-basedchemical substances are a particularconcern because enzymes present in thehuman body and in bacteria on the skinaid in the reduction of these chemicalsubstances to the benzidine unit, anestablished human carcinogen (Ref. 8).The main consumer products that couldresult in dermal exposure if containingthese chemical substances includetextiles and leather products becausethey are in prolonged contact withhuman skin.

During the review of information onbenzidine-based chemical substances,EPA determined that the newlyidentified chemical substances covered

by this proposed rule present the sameconcerns (Ref. 2) as those of the

benzidine-based chemical substancescurrently listed under 721.1660.However, based on a review of IUR dataand a separate market review, EPA doesnot believe there is any currentmanufacture of these nine benzidine-

based chemical substances within oroutside the United States.

In addition, as discussed earlier,although some of the currently listed

benzidine-based chemical substancesmay be manufactured or processedoutside the United States, EPA does nothave specific information that suggeststhey are entering into the United Statesin imported articles (Ref. 4). In fact, ananalysis of the benzidine-basedchemical substances market (Ref. 1)revealed no information indicatingimport of articles containing benzidine-

based chemical substances for non-excluded purposes. Supporting aconclusion that there is no import oftextile articles containing benzidine-

based chemical substances, the

American Apparel and FootwearAssociation, the national tradeassociation representing apparel,footwear, and other sewn productscompanies and their suppliers, whichcompete in the global market, includes

benzidine on its Restricted SubstancesList (RSL) (Ref. 64). The RSL is acompilation of chemicals, regulated or

banned, that are used by apparel andfootwear industries.

Although it appears there is noongoing manufacture of the nine newlyproposed benzidine-based chemical


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substances, or import for a non-excluded use of articles containing any

benzidine-based chemical substances,the manufacture (including import) orprocessing of the nine newly proposed

benzidine-based chemical substancesand the import or processing of articlescontaining any benzidine-basedchemical substances may begin at any

time, without prior notice to EPA. Thus,EPA is concerned that commencementof the manufacture, import, orprocessing for any new uses, includingresumption of past uses, of benzidine-

based chemical substances couldsignificantly increase the magnitude andduration of exposure to humans overthat which would otherwise existcurrently. EPA is concerned that suchan increase should not occur without anopportunity to evaluate activitiesassociated with a significant new useand an opportunity to protect againstpotential unreasonable risks, if any,

from exposure to the chemicalsubstance.Therefore, EPA is proposing a SNUR

for the nine benzidine-based chemicalsubstances by adding them to thosecurrently listed at 721.1660, and tomake inapplicable the article exemptionat 721.45(f) for those chemicalsubstances newly proposed in thisrulemaking as well as for those alreadylisted at 721.1660. If finalized, aperson who intends to manufacture(including import) or process any of the

benzidine-based chemical substancesfor a non-excluded use, or to import orprocess any listed benzidine-based

chemical substance for a non-excludeduse as part of an article, would berequired to submit a SNUN.

2. DnPP. As summarized in Unit IV.,EPA has concerns regarding potentialadverse human health andenvironmental effects that may becaused by DnPP. EPA has directinformation from animal studies thatDnPP specifically can elicitdevelopmental/reproductive effects thatare relevant to human health and alsoindicate potential effects in wildlife.EPA also is concerned that due to itsgeneral structure and categorization as a

phthalate that DnPP may elicit adverseenvironmental effects similar to thosedescribed for other phthalates. EPA isconcerned that any manufacturing(including import) or processing ofDnPP, beyond that for its limitedongoing use as a chemical standard forlaboratory use, could significantlyincrease the magnitude and duration ofexposure to humans over that whichwould otherwise exist currently. EPA isconcerned that such an increase shouldnot occur without an opportunity toevaluate activities associated with a

significant new use and an opportunityto protect against potential unreasonablerisks, if any, from exposure to thechemical substance. Therefore, EPA isproposing a SNUR for DnPP that woulddesignate, as a significant new use, anyuse of the chemical substance other thanas a chemical standard for laboratoryuse. If finalized, a person who intends

to manufacture, import, or process DnPPfor use other than as a chemicalstandard for laboratory use would berequired to submit a SNUN.

3. Alkanes, C1213, chloro (CAS No.71011126). The mechanisms orpathways by which the SCCPs,including alkanes, C1213, chloro (CASNo. 71011126), move into andthrough the environment and humansare not fully understood, but are likelyto include releases from manufacturingof the chemicals, manufacturing ofproducts like plastics or textiles, agingand wear of products like sofas and

electronics, and releases at the end ofproduct life (e.g., disposal, recycling).EPA believes that all manufacture,

processing, and import into the UnitedStates of alkanes, C1213, chloro (CASNo. 71011126) has ceased. Given EPAhas no evidence to suggest that there isany manufacture, processing, orimportation of this chemical substancein the United States, and taking intoconsideration the negative commercialand regulatory environment associatedwith this chemical internationally(including the EU and Canadian ban onmarketing) and use of the alkanes,C1213, chloro (CAS No. 71011126)

domestically, EPA does not expect tofind such activity. However, EPA isconcerned that commencement of themanufacture, import or processing forany new uses, including resumption ofpast uses, could significantly increasethe magnitude and duration of exposureto humans over that which wouldotherwise exist. EPA is concerned thatsuch an increase should not occurwithout an opportunity to evaluateactivities associated with a significantnew use and an opportunity to protectagainst potential unreasonable risks, ifany, from exposure to the chemical

substance. Therefore, EPA is proposinga SNUR for alkanes, C1213, chloro (CASNo. 71011126) that would designateas a significant new use any use of thechemical substance. If finalized, aperson who intends to manufacture,import, or process alkanes, C1213,chloro (CAS No. 71011126) for anyuse would be required to submit aSNUN.

EPA is requesting comment onwhether any of the significant new usesidentified are currently ongoing.However, if EPA determines, based on

comments on this proposed rule or onother information the Agency identifies,that any proposed significant new use ofany of the chemical substances has beenongoing (including, in the case of

benzidine-based chemical substances,that an article containing benzidine-

based chemical substances was beingimported or processed) prior to date of

publication of the final rule, EPA wouldexclude such ongoing uses from thefinal SNUR and consider pursuing otherregulatory action, as appropriate.

B. Objectives

Based on the considerations in UnitVI.A.13, EPA wants to achieve thefollowing objectives with regard to thesignificant new use(s) that aredesignated in this proposed rule:

1. EPA would receive notice of anypersons intent to manufacture orprocess the specified chemicals for thedescribed significant new uses before

that activity begins;2. EPA would have an opportunity toreview and evaluate data submitted in aSNUN before the notice submitter

begins manufacturing or processing ofthe specified chemicals for thedescribed significant new use; and

3. EPA would be able to regulateprospective uses of the specifiedchemicals before the describedsignificant new uses occur, providedthat regulation is warranted pursuant toTSCA sections 5(e), 5(f), 6 or 7.

VII. Significant New Use Determination

Section 5(a)(2) of TSCA states that

EPAs determination that a use of achemical substance is a significant newuse must be made after consideration ofall relevant factors including:

The projected volume ofmanufacturing and processing of achemical substance.

The extent to which a use changesthe type or form of exposure of human

beings or the environment to a chemicalsubstance.

The extent to which a use increasesthe magnitude and duration of exposureof human beings or the environment toa chemical substance.

The reasonably anticipated mannerand methods of manufacturing,processing, distribution in commerce,and disposal of a chemical substance.

In addition to these factorsenumerated in TSCA section 5(a)(2), thestatute authorizes EPA to consider anyother relevant factors.

To determine what would constitute asignificant new use of the benzidine-

based chemical substances subject tothis proposed rule, DnPP and thealkanes, C1213, chloro (CAS No. 71011126), as discussed herein, EPA


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considered relevant information aboutthe toxicity of these substances, likelyhuman exposures and environmentalreleases associated with possible uses,and the four factors listed in section5(a)(2) of TSCA. EPA has preliminarilydetermined that the manufacture,import, processing, or import orprocessing as part of an article of any of

the benzidine-based chemicalsubstances subject to this proposed rule,except ongoing uses specified in 721.1660(a)(2)(i) of the regulatory textin this document, is a significant newuse. EPA has also preliminarilydetermined that the manufacture,import, or processing of DnPP for anyuse other than as a chemical standardfor laboratory use is a significant newuse, and the manufacture, processing, orimport of alkanes, C1213, chloro (CASNo. 71011126) for any use is asignificant new use.

VIII. Request for Public Comment

EPA welcomes comments on anyaspect of this proposed SNUR.Information available aboutenvironmental effects, health effects,and exposure would be beneficial. EPAis also requesting public comment onwhether there are any ongoing uses ofany of these chemicals for the proposedsignificant new uses (includingprocessing or import of benzidine-basedchemical substances in articles) andwould welcome specific informationthat documents such uses.

IX. Alternatives

Before proposing these SNURs, EPAconsidered the following alternativeregulatory actions:

A. Promulgate a TSCA Section 8(a)Reporting Rule

Under a TSCA section 8(a) rule, EPAcould, among other things, generallyrequire persons to report information tothe Agency when they intend tomanufacture, import, or process a listedchemical for a specific use or any use.However, for the chemical substancessubject to this proposed rule, the use ofTSCA section 8(a) rather than SNUR

authority would have severallimitations. First, if EPA were to requirereporting under TSCA section 8(a)instead of TSCA section 5(a), EPAwould not have the opportunity toreview human and environmentalhazards and exposures associated withthe proposed significant new use and, ifnecessary, take immediate follow-upregulatory action under TSCA sections5(e) or 5(f) to prohibit or limit theactivity before it begins. In addition,EPA may not receive importantinformation from small businesses,

because such firms generally are exemptfrom TSCA section 8(a) reportingrequirements. In view of the level ofhealth and environmental concernsabout the chemicals subject to thisproposed rule if used for the proposedsignificant new uses, EPA believes thata TSCA section 8(a) rule for thissubstance would not meet EPAs

regulatory objectives.B. Regulate Under TSCA Section 6

EPA may regulate under TSCAsection 6 if the Administrator findsthat there is a reasonable basis toconclude that the manufacture,processing, distribution in commerce,use or disposal of a chemical substanceor mixture presents or will present anunreasonable risk of injury to health orthe environment. (TSCA section 6(a)).Given that the benzidine-basedchemical substances subject to thisproposed rule are no longer being usedexcept as provided in the regulatory textof this document, DnPP is no longer

being used except as a chemicalstandard for laboratory use, and alkanes,C1213, chloro (CAS No. 71011126) isno longer used in the United States,EPA concluded that risk managementaction under TSCA section 6 is notnecessary at this time. This proposedSNUR would allow the Agency toaddress the potential risks associatedwith the proposed significant new uses.If EPA learns that these chemicals are inuse, EPA may reconsider this decisionand pursue additional regulatory actionas appropriate.

X. Applicability of Proposed Rule toUses Occurring Before Effective Date ofthe Final Rule

As discussed in the Federal Registerof April 24, 1990 (55 FR 17376), EPAhas decided that the intent of section5(a)(1)(B) of TSCA is best served bydesignating a use as a significant newuse as of the date of publication of theproposed rule rather than as of theeffective date of the final rule. If uses

begun after publication of the proposedrule were considered ongoing ratherthan new, it would be difficult for EPA

to establish SNUR notice requirements,because a person could defeat the SNURby initiating the proposed significantnew use before the rule became final,and then argue that the use was ongoingas of the effective date of the final rule.Thus, persons who begin thecommercial manufacture, import, orprocessing of a covered substance as asignificant new use have to cease anysuch activity as of the effective date ofthe rule if and when finalized. Toresume their activities, these personswould have to comply with all

applicable SNUR notice requirementsand wait until the notice review period,including all extensions, expires. Usesarising after the publication of theproposed rule are distinguished fromuses that exist at publication of theproposed rule. The former would benew uses, the latter ongoing uses. To theextent that additional ongoing uses are

found in the course of rulemaking, EPAwould exclude those uses from the finalSNUR. EPA has promulgated provisionsto allow persons to comply with thisSNUR before the effective date. If aperson were to meet the conditions ofadvance compliance under 721.45(h),that person would be considered to havemet the requirements of the final SNURfor those activities.

XI. Test Data and Other Information

EPA recognizes that TSCA section 5does not require developing anyparticular test data before submission of

a SNUN. There are two exceptions: (1)Development of test data is requiredwhere the chemical substance subject tothe SNUR is also subject to a test ruleunder TSCA section 4 (see TSCAsection 5(b)(1)) and (2) development oftest data may be necessary where thechemical substance has been listedunder TSCA section 5(b)(4) (see TSCAsection 5(b)(2)). In the absence of asection 4 test rule or a section 5(b)(4)listing covering the chemical substance,persons are required only to submit testdata in their possession or control andto describe any other data known to or

reasonably ascertainable by them (15U.S.C. 2604(d); 721.25, and 720.50).However, as a general matter, EPArecommends that SNUN submittersinclude data that would permit areasoned evaluation of risks posed bythe chemical substance during itsmanufacture, import, processing, use,distribution in commerce, or disposal.EPA encourages persons to consult withthe Agency before submitting a SNUN.As part of this optional pre-noticeconsultation, EPA would discussspecific data it believes may be usefulin evaluating a significant new use.SNUNs submitted for significant newuses without any test data may increasethe likelihood that EPA would takeaction under TSCA section 5(e) toprohibit or limit activities associatedwith this chemical.

SNUN submitters should be awarethat EPA will be better able to evaluateSNUNs that provide detailedinformation on:

1. Human exposure andenvironmental releases that may resultfrom the significant new uses of thechemical substance.


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2. Potential benefits of the chemicalsubstance.

3. Information on risks posed by thechemical substances compared to risksposed by potential substitutes.

XII. SNUN Submissions

According to 40 CFR 721.1(c), personssubmitting a SNUN must comply with

the same notice requirements and EPAregulatory procedures as personssubmitting a PMN, includingsubmission of test data on health andenvironmental effects as described in 720.50. SNUNs must be on EPA FormNo. 771025, generated using e-PMNsoftware, and submitted to the Agencyin accordance with the procedures setforth in 721.25 and 720.40. EPMNsoftware is available electronically athttp://www.epa.gov/opptintr/newchems.

XIII. Economic Analysis

A. SNUNs

EPA has evaluated the potential costsof establishing SNUR reportingrequirements for potentialmanufacturers and processors of thesechemicals and for articles containingany of the benzidine-based chemicalsubstances included in this proposedrule. These economic analyses, whichare briefly summarized here, areavailable in the docket for this proposedrule.

The costs of submission of a SNUNwould be incurred when a companydecides to pursue a significant new useof one of these chemicals. In the event

that a SNUN is submitted, costs areestimated at approximately $8,112 perSNUN submission, and include the costfor preparing and submitting the SNUN,recordkeeping, and the payment of auser fee. Businesses that submit a SNUNare either subject to a $2,500 user feerequired by 700.45(b)(2)(iii), or, if theyare a small business with annual salesof less than $40 million when combinedwith those of the parent company (ifany), a reduced user fee of $100( 700.45(b)(1)). In its evaluation of thisproposed rule, EPA also considered thepotential costs a company might incur

by avoiding or delaying the significantnew use in the future, but these costshave not been quantified.

B. Export Notification

EPA regulations under TSCA section12(b) (15 U.S.C. 2611(b)) at 40 CFR part707, subpart D require that, forchemicals subject to a proposed or finalSNUR, a company notify EPA of the firstexport or intended export to a particularcountry of an affected chemicalsubstance. EPA estimated that the one-time cost of preparing and submitting an

export notification to be $78.54. Thetotal costs of export notification wouldvary per chemical, depending on thenumber of required notifications (i.e.,number of countries to which thechemical is exported).

XIV. References

As indicated under ADDRESSES, a

docket has been established for thisproposed rule under docket ID numberEPAHQOPPT20100573. Thefollowing is a listing of the documentsthat have been placed in the docket forthis proposed rule. The docket includesinformation considered by EPA indeveloping this proposed rule,including the documents listed in thisunit, which are physically located in thedocket. In addition, interested partiesshould consult documents that arereferenced in the documents that EPAhas placed in the docket, regardless ofwhether these referenced documents arephysically located in the docket. Forassistance in locating documents thatare referenced in documents that EPAhas placed in the docket, but that arenot physically located in the docket,please consult the technical personlisted under FOR FURTHER INFORMATIONCONTACT. The docket is available forreview as specified under ADDRESSES.

1. U.S. EPA. Economics and Policy Branch,USEPA/OCSPP/Economics, Exposure,and Technology Division. EconomicAnalysis to Support the Proposed SNURfor Benzidine and Benzidine-basedChemical substances (May 24, 2011).

2. U.S. EPA, 2010. U.S. Environmental

Protection Agency. Chemical SubstancesDerived from Benzidine and ItsCongeners, http://www.epa.gov/oppt/existingchemicals/pubs/actionplans/DCB%20Action%20Plan_06232010.noheader.pdf(Accessed

January 24, 2011).3. EPA. 1980. Preliminary Risk Assessment:

Phase I. Benzidine, Its Congeners, andtheir derivative dyes and pigments.EPA560/1180019, June 1980.

4. IARC (1982). Some industrial chemicalsand dyestuffs. IARC monographs on theevaluation of carcinogenic risk ofchemicals to humans, Suppl. 7,International Agency for Research onCancer, Lyon, France.

5. IARC (1987). Overall evaluation ofcarcinogenicity. IARC monographs onthe evaluation of carcinogenic risk ofchemicals to humans, vol. 29,International Agency for Research onCancer.

6. Report on Carcinogens, 11th ed. (2008).National Toxicology Program,Department of Health and HumanServices.

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