I

WednesdayJuly 12, 1989

Part !11

EnvironmentalProtection Agency40 CFR Part 763

Asbestos: Manufacture, Importation,Processing, and Distribution inCommerce Prohibition% Final Rule

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29460 Federal Register / Vol. 54, No. 132 / Wednesday, July 12, 1969 I RuIes and Regulations

ENVIRONMENTAL PROTECTIONAGENCY

40 CFR F%@763

[OPTS-62036G FRL-3476-2]

Asbestow Manufacture, Importation,Processing, and Distribution inCommerce Prohibitions

AGENCWEnvironmental ProtectionAgency.

ACTIOPCFinal rule.

SUMMARY EPA is issuing this fired ruleunder section 6 of the Toxic SubstancesControl Act (TSCA) to prohibit, atstaged intervals, the future manufacture,importation, processing. and distributionin commerce of asbestos in almost allproducts, as identified in the rule. EPA isissuing this rule to reduce theunreasonable risks presented to !?umanhealth by exposure to asbestos duringactivities involving [hew products. Therule requires that asbestos-containingproducts that are subject to the bans belabeled to promote compliance with andenforcement of the r~k.-’hehe ruleprovides that exemptions from the ru!e’sbans on manufacture, importation,processing, and distribution incommerce may be granted by EPA invery limited circumstances.

DATES In accordance with 40 ~~fl 23.5,this rule shall be promulgated forpurposes of judicial review at 1 p.m.eastern time on July 26, 1989. Theeffective date of th]s rule is August 25,1989, except for the informationcollection requirements of 40 CFR763.173, 763.178, and 763.179. Theseinformation collection requirementshave not been approved by the Oifice ofManagement and Budget [O,MB) and arenot effective until OMB has approvedthem. EPA will issue a notice in thefuture establishing an effective date forthe information collection requirements.

FOR FURTHER INFORMATIONCO$4TACCMichael M. Stahl, Director, TSCAAssistance Office [TS+99), Office ofToxic Substances, EnvironmentalProtection, Agency, Rm. Ef@M, 401 MStreet SW., Washington, DC 20460,Telephone: (202-554-1404), TDf): (202-554-0551).

SUPPLEMENTARYINFORMATION ‘lhepreamble accompanying this fins } rule isdivided into the following Lfnits:

I. Authority11.TSCA Actions to D~tEI!L Provisions of tk Ru:e

A. General ProvisionsB. Manufacture, Impor!.ikm a]]d

Processing I?ansC. Bans on Distribution in (hnmel wD. Labeling

E. Exemption Application ProceduresF. Military ExemptionsG. Recor&eepin~

IV. Summary of Analysis Supporting thisFinal Rule

V. Regulatory AssessmentA. Health Effects and Magnitude of

Exposure to AsbestosB. Environment?} EffectsC. Asbestos SubstitutesD. Economic Effects of the RuleE. Other Options ConsideredF. Summary of Individool Product

CategoriesVI. Other EPA StatutesVII. Analysis under Section 9(a) of TSCA

A. other Authorities Affecting AsbestosB. EPA’s Deterrnirration Under Section 9(a)

of TSCAVHL Enforcement[X. ConfidentialityX. Rukrnaking RecordXI. ReferencesXII. Regulatory Assessment Requirements

A. Executive Order 12’291B. Regulatory Flexibility ActC. Paperwork Reduction Act

This rule prohibits the manufacture,import, processing, and distribution incommerce of certain asbestos-containing products. The rule alsoreq~ires that asbestos-containingproducts that are subject to this ru~e belabeled to facilitate compliance withand enforcement of the rule.

Public reporting burden for thiscollection of information is estimated toaverage less than z hours annually perfirm over the 3-year period reviewed forthe analysis of regulatory burderx Thisburden estimate includes the time forreviewing instructions, searchingexktin~ data sources, gathering andmaintaining the data needed, andcompIetiRg and reviewing the collectionof information. This estimate of annualburden is a relatively low figure becauseof the small number of firms affected bythe regulatory actions taken during theperiod reviewed for the anaiysis ofregulatory burden. Send commentsre~ar.ling this burden estimate or anyotfmr aspect of this collection ofinformation, including s~tg~estions forreducing this burden, to Chief.Information Branch, PM-223. u.S.Environmental Protection Agency, 401 MStreet SW., Washington. IX 204fKk andto the Office of Information andRegulatory AfFairs, Office ofManagement and Budget, Washington.DC 20503, Attention: Desk Officer forEPA.

I. Authority

‘&c!ion 6(a] of TSCA authorizes I?l]Ato impose certain regulatoryrequirements on activities involving achemical substance or ,mixture if EPAfinds that there is a reasonable basis toconc!l~tfe that ttm mi]nufacture,

processing, distribution in commerce,use, or disposal of the chemicalsubstance, or any combination of suchactivities, presents or will present anunreasomible risk of injury to humanhealth or the environment. Section6(a)(1) authorizes EPA to prohibit orlimit the manufacture, processing, ordistribution in commerce of substancesor mixtures if EPA finds that theseactivities pose an unreasonable risk.Section 6[a)[2) authorizes EPA toprohibit or iimit such activities for aparticular use of such substances ormixtures. Section 6(a)(3) authorizes EPAto require labels for such substances ormixtures. Sections 6 and 8(a) authorizeEPA LOrequire the maintenance ofrecords related to enforcement of EPAactions under section 6. These sectionsof TSCA provide EPA the authority toissue this rule.

IL TSCA Actions to Date

EPA issued an Advance Notice ofProposed Ku!emaking in the FederalRegkter of October 17,1979 (44 FR50061 ), announcing its intent to explorethe use of section 6 of T’SCA to reducethe risk to human health posed byexposuw to asbestos. EPA then issued areporling rub? under section 8(a) ofTSCA in the Federal Register of July 30,1S82 (47 FR 33207, 40 CFR 763.60), tocolkt information on industrial andcommercial uses of asbestos.Information collected under that rule, aswe!l as analyses developed by EPA andother organizations, were evalusted andused to strpport a proposed rule,published in the Federal Register ofJanuary 23,1986 (51 FR 3738).

In the proposed rule EPA found thatexpos:ire to asbestos poses anunreasonable risk to human health anddiscussed wguiatory options forprohibiting or restricting the mining andimpi~rttition uf bulk asbestos and themanufa~toring, importation, andproce?sins of asbestos-sontainicgproducts as means of reducing the risLThe iollowing options were discuss::d inthe Pmpos,xf ruie:

I. Two options involving bans of someproducts soon af[er promulgation of tlmfinaI ruie and a phase out of others over10 years by means of a permit systemfor asbestos use.

Z. A %;t.age ban, with the first ban, onasbestos construction products andcIotfring, [o begin soon afterpromuiga!ion of the final rule and the~~coficl ba~., ~n fricti or. products, tobegin iu 5 ~~i]~s, ad ~f’!~i promulgationof tile final rule, the collection ofadditional data on otiicr products.

3. A 3-s!tige ban on all asbes!osproducts to begin soon after the

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promulgation of the finol rule, :ind syears and 10 years after p~XULl@li(;:I,

Requiring labeling of usk+ii wcc;niaining prodl.lets was ;!IS{;cfis{;?fsse (i.EPA received over 200 commer !s inreqx~:lse to the prcposed ru!c

Priclr to issuing Itrc prop.~sal. J?I’4recmced and gwnte:: t\;LLT.SCA srw!ioc21 petitions (15 U.SC. 2,620]. llnrimsection 21 of TSCA, a person maypetition EPA to irrit~ate a procecrtinx forthe issuance of a rule under varioussections of TSCA. One petitionreqaested the prol~ibit ion n! the futureuse of asbestos in asbestc,s-cement pipe;this petition was granted in [he FederalRegister of October 18,1979 (44 FR60155). The other petition requested theprohibition of the future use of asbestosin motor vehicle brakes: this petitionwas granted in the Federal Register ofDecember 18,1984 (49 J% 49311). Ingranting these petitions, EPA statedthat it would, as part of the rulemakirrgproceeding and the final rule, considerincluding prohibitions of the future useof asbestos in asbestos-cement pipe andin motor vehicle brakes. Both uses areprohibited by this final rule.

Pursuant to section 6(c)(2) of TSCA,EPA also provided interested partiesopportunities to participate in alegislative hearing on the proposed rrdein July 1966, and in extensive cross-examination of EPA personnel andcontractors on factual issues relating tothe rale in October 1986.

Since the end of cross-examination inOctober 1986, EPA has updated the datacollections and regulatory analyses usedto support the findings on which thisrule is based. EPA believes thatadequate data and analyses existed inthe rulemaking record for the proposalto support the options discussed therein.The data collections and analyses wereupdated due to the passage of time sincethe publication of the proposal and inresponse to specific public commentsthat the data base supporting theproposed rule, gathered largely in IWZ,was outdated.

EPA has gathered updak;d rkiiarelating to: (I) Asbestos consumption.(2) manufacturing, import, andprocessing volumes of asLestos-containing products, (3] trends in theckwelopment of non-asbestossubstitutes, (4) costs of capita]conversion to the production of noJ:-asbestos products, (5) production,processing, use, end disposal p~a(:tiuf:sfor asbestos-containing products, and (o)occupational and no~~-occ~:p;iti~l~~;ilreleiise and exposure frwn) themanufacture. processing, inst::lt:itit; n,use, repair, removal. and dispos;i! [of

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as wstos-contmnmg proc]ucts. “I’$,iw!data win-e ckrived km, am{,ng t)ther

sources, the 1987 EPA :’ishcstosExposure st?r~rey, the 1987 WA ASIX, SI(OS$,.f:j~~et surtey, and 1987 Occupationtili !ealtfr and Safety Administration(OSJIA] compliance dtit~. EPA }]tIs ii!snmodified ttrd update(l its Asiws!os~,, ,. .!, i . .

..IiGLolJ ~LJSthf:,ti~;l (,~~?~~.!v’f].i !i,;{\:[!i+;efits Model, and ~sbestos exp[,sure

\ ,~node .s m Icb. were used to eva, [,c, (.‘ “t ~I}!*;rmsts and benefits of various regulatoryoptions. Additionally, EPA has furt!~ercdits ~n:ilvsis of the availability and

possit,l~ hazards posed by asbestossubstitutes.

These updated deta tiild allslys::swere reflected in docrrrnents relet{sed forpublic comment in notices published inthe Federal Register of April 1, i9ti8 (WR 10546], and May 4, 1988 [53 FR15857). EPA received over 40 publicccmments in response to these notices.In addition, EPA allowed further crrrss-examinetion of EPA personnel andcontractors on factual issues related tothe updated analytical data base inSeptember 1988. The materials releasedfor public comment contain thetechnical basis for the actions taken inthis final rule. EPA afforded theopportunity for public comment on theupdated documents and for furthercross-examination as an exercise of itsdiscretion and as a means of ensuringthat any remaining disputed issues ofmaterial fact in the updated data andanalyses could be identified andresolved before promulgation of thisfinal rule. EPA has reviewed thecomments received and the testimonyelicited and has updated the recordaccordingly.

Pursuant to its procedural rules at 40CFR 750.4(b), EPA also announced tointerested parties in the Federal Registerof September 16, 1988 [53 FR 36227), theopportunity to provide EPA with replycomments relating to the rulemakingproceeding. EPA received replycomments from three commenters.

The record which serves as the basisfor the rictions taken in this rule consistsof over 45,000 pages of analyses,comments, testimony, correspondence,and other materials. The record for thisrule also incorporates by reference theextensive record developed by 0S} 1A inits rulemaking to lower its permissil]leExpclsu:e Level (PEL) for asbestos,puhlistmd in the Federal Register of] tii~(!20, 1986 [51 FR 22612). EPA has fuliyconsidered these materials indeveloping this final rule. In addition. allsignificiint testimony or publiccornnwnts made on tk,e proposed ruie, incoo.junc! ion with the legislative hearing,criws-examination hearing. or replycomments. or in resporrse to themateriak ~rmrmnced in the Apr; l and~l%iyI !)88 Federal Register rroticos, citcfl

almve. were ctmsidered in thed(~ve!i]pnl,~nt C)f the find rule. EPA’s;(+sK:(;tlses to all significant commrmtsi.]e f~u~id either in this preamble or in a$Pp::rzte Respwv.r to Co,mmentst]!)cl~~lrllt that is ~vai].~[l]e in th~ Pu!)licilo{.;.r.t {F.cf 4{!).

Easeti on tiic nomemus dettiiled:initl} ses performed b,y EPA in supportof this rule 3ncf after carefulc{msidcratic,n of the extensive publicrwmments received, EPA has conc]rrriedtlut the conlinuwi rmmmercialmtmufacture, import. processing, anddis!rvbution in commerce of the productsidcnt~fied in this rule poses anunr~:usonable risk of injury to humarih<-alt}l undt;r section 6 of TSCA.

IIL Prot’isiorrs of the Rule

;1. G:ncruI &rJuisioiks

Consistent with an option describedin the proposal, this rule imposes a 3-stage ban on the manufacture,importation, processing, and distributionin commerce of various asbestos-containing products. The rule alsocontains a requirement that productssubiect to a manufacture, importation,and processing ban, but not yet subjectto a ban on distribution in commerce, belabeled in the manner described at$763.171. In addition, the rule includesprocedures for requesting an exemptionfrom the rule’s provisions,

The effective dates of the variousbans are as follows (with exceptions asnoted in Unit IILB of this preamble forsome asbestos friction products):

Manufacture, Import, and ProcessingBan:

Stage l—August 27,1990Stage 2—August 25,1993Stage 3—August 26,1996

Distribution in Commerce Ban:Stage l—August 25,1992Stage 2—J4ugust 25, 1994Stage 3-August 25, 1997

L? Afonlfocture, If,iporfrrtion, an[iProct?ssing Ems

As of the dates indicated below, themanufacture, importation, andprocessing of all asbestos-containingp:{ducts within the categories listed

flo.il!ii tense as follows or eac h stage:Si(!gt. 1: Manufacture. importation,

timi prm;essing of the following productsrnusi cei;sc by August 27, IWW

Fklwin: Feltfllmfin~ }:eii!yp(l!i:(? V$’r<ipAs!wskw/Cwnent [A/C) Flat %eetA; C Corrugated Sfwetk’ji7.~\/i\S116’St[)S F[C()~ Tilt!

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29462 Federal Register I Vol. 54, No. 132 I Wednesday, July K?, 1989 I Rides and Regulations—

Stage 2: Manufacture, imports tion,and processing of the following productsmust cease by August 25, 1993:

Beater-Add Gaskets (except specialtyindustrial gaskets)

Sheet Gaskets [except specialtyindustrial gaskets)

Clutch FacingsAutomatic Transmission ComponentsCommercial and Industrial Friction

ProductsDrum Brake Linings [Original Equipment

Market [OEM)] 1Disc Brake Pads for Light- and Medium-

weight Vehicles (M-V) (OEM) 1State 3: Manufacture, importation, and

processing of the following productsmust cease by August 26, 1996:

A/C PipeCommercial PaperCorrugated PaperRoll boardMillboardA/C ShingleSpecialty PaperRoof CoatingsNon-Roof CoatingsBrake BlocksDrum Brake Linings [Aftermarket (AM)]Disc Brake Pads, LMV (AM)Disc Brake Pads, HV (AM)

In addition, any new asbestos-containing products for whichcommercial manufacture, importation,or processing is initiated after theeffective date of this rule will be bamedas of the effective date of Stage 1, unlessEPA approves the use or productpursuant to an exemption application. Inother words, if a person devises a newapplication for asbestos that is notcovered by the product categoriesdefined in this rule, and the personwishes to commence commercialmanufacture, importation, andprocessing of the product after August25, 1989, manufacture, importation, andprocessing of the product must cease byAugust 27, 1990, and distribution incommerce of the product must cease byAugust 25,1992, These bans onmanufacture, importation, processing,and distribution in commerce may beavoided only if a person applies to EPAfor an exemption from the bans and theapplication is granted.

i These bans affect products ussd as originalequipment in vehmtes introduced in the N)94 modelyear. For example, if new model year producte areintroduced annuall:~ by a producer in October,asbestos brake prncfuc!smay be used in vnhic!esmade by that prod~cw before :he in!rnd~c:!m 01model year 1994 vehicles in October 199.J,but notthereafter. !n addition, pruducts manufactured,imported, or marketed for use as aftermarketreplacement par:s for brake systems designei to usenon-asbestosbrake pads and drums me bannedfrom manufacture, importation, and pr0cc33hg as ofAugust 25, 1993,

Pursuant to section 12(a)(2), EP.i findsthat the manufacture or processing forexport of the asbestos-containingproducts that are subject to this rule willpresent an unreasonable risk of injury tohuman health. Therefore, themanufacture and processing of theasbestos-containing products for exportis not exempted from this rule undersection 12(a)(l), and is subject to thisrule’s bans on manufacture, processing,and distribution in commerce bans.Much of the life cycle and a significantportion of risk posed by export productsoccurs in the United States. The mostsignificant source of exposure that couldbe quantified by EPA for this rule isprimary and secondary manufacturing.During primary manufacture asbestosfibers are introduced into the productionprocess. During secondary manufacture,an asbestos fiber-containing componentis used. EPA has concluded that theseactivities cause significant occupationaland non-occupational exposures toworkers and their families, populationssurrounding plant sites, and the generalpopulation. In light of the high individualrisk caused by exposure to asbestos,EPA has concluded that exposures dueto manufacturing or processing of theseasbestos-containing products for exportpose an unreasonable risk of injury tohuman health in the United States.

EPA has not found that asbestos-containing products imported into theUnited States for the sole purpose ofshipment to another country pose anunreasonable risk. Therefore, suchactivities are not subiect to this rule’sbans. However, for the reasonsdescribed above, imported products thatare repackaged or otherwise processedin the United States before shipment toanother country are subject to the rule’sbans.

The proposal would have exemptedthe import of small quantities ofotherwise banned asbestos-containingproducts for personal use from the rule’sbans. EPA received comments indicatingthat many new automobiles areimported by individuals. However, EPAis uncertain about the extent of any riskreduction that would be achieved by aban on these activities. Therefore, thefinal role’s ban on importation excludesthe act of bringing small quantities ofarticles into the United States fornormal personal or business activities(not including distribution of asbestos-containing products in commerce]ir!vol”vipg (he use of a banned pmdocteither alone or as a component or part ofa larger object. Similarly, the definitionof import excludes activities such as themovement of automobiles withasbestos-containing products as iute:ralparts of the auto, back and forth across

the United States border during thenormal course of personal or businessactivities. The final rule bans the importof products that are purchased orotherwise acquired outside of the UnitedS!ates for the sole purpose ofresa!e.

For example, after the effecti”{e dateof the ban on OEM brake pads, a 19% orlater model year automobile containingbanned asbestos-containing par!scannot be purchased in Canada manother country and be transported by aperson to the United States for resale.However, the rule does not ban theimport by a person of such a vehicle forpersonal use in the United States. Forpurposes of enforcing this provision,EPA will consider a vehicle to beimported for personal use if the personimporting the vehicle imports no morethan one vehicle containing bannedproducts every 5 years. If a personimports a vehicle more frequently. EPAwill presume that the activity is subjectto the rule’s bans. Other activities thatare excluded from the definition ofimport include driving across the U.S.border in a 1994 or later model yearautomobile containing banned productsduring the course of transactingbusiness or for recreational purposes. orpurchasing a used (i.e., pre-19M modelyear) vehicle containing asbestos brakesin another country and transporting itinto the United States.

C. Bmrs on Distribution in Commerce

Available evidence shows that t!!erelease of asbestos fibers occurs notonly in the manufacture and processingof asbestos products, but also in theiruse and maintenance. EPA proposed toban activities involving asbestosproducts because of this life cycle risk.The proposed ban also implicitly wouIdhave prohibited the eventualdistribution of these products incommerce because persons wouki no!be permitted to manufacture, import, orprocess asbestos products.

Consistent wiih the intent of theproposal, this final rule explicitlyprohibits the distribution in commerce ofasbestos products within the specifiedtimeframe after rmmufacture,importation, and processing bans for theproducts become effective. The timeperiods for distribution in commercewere established to afford affectedparties sufficient time to sell existings!ocks and therefore limit the likelyeconomic impact of lhe bau. This wasdone after bakmcing the likely riskspresented by continded use of asbestosproducts with the economic impact of onoutright ban on this ac!ivity.

AS stated above, this rule bans thed]skributi,jn in com,merce of as!>estos

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products after manufacture, importation.and processing bans for the productshtxome effective. The ban ondistribution in commerce for productssubject to the Stage 1 manufacture,irnpcrtation, and processing ban willbecome effective on Augast 25, 1!392. ForSl~ge 2 products, the ban on distributionin comnierce will become effective onAugust 25, i994. For Stage 3 products,the ban on distribution in commerce willbecome effective on August 25, 1997.

Remaining “stock-on-hand” of anaffected product must be disposed ofwithin 6 months of the effective date ofthe ban on distribution in commeme.Remaining stocks include all units of theprcrdur;t in the possession or contr~l ofthe person subject to the distribution incommerce ban. Disposal must be bymeans that are in compliance withapplicable local, State, and Federalrestrictions.

The ru!e”s distribution in commerceban does not cover all actions takenwith respect to asbestos-containingproducts. For purposes of the rufe, theterm “distribution in commerce” doesnot cover end use activities, forex~mple, sale, resale, holding, ordelivery, with respect to asbestosproducts by persons who use theproduct after it is manufactured,imported, or processed. For example, theterm “distribution in commerce” doesnot include the resale of homes or motorvehicles that contain asbestos-containing parts or products or theinstallation of asbestos-containing brakepads in a person’s automobile after thedistribution in commerce of such brakepads is banned. (However, it is aviolation of this rule for a person toengage in selling brake pads to anyone.)This provision also does not cover thedisposal of asbestos-containingproducts.

EPA recognizes that some asbestos-containing products whicff are exc!udedfrom the ban may be very similar inform to asbestos-containing productsthat are banned. For example, this rule’sbans do not cover the manufacture,importation, processing, and distributionin commerce of high-grade electricalpaper, a product which may be similarin some cases to mii]board or otherasbestos paper products. Persons mighttry to manufacture or distribute theexcluded products for uses that arcbanned. Such activities would violatethis rule’s bans because this conversionof use will be interpreted by EPA to beprocessing or distribution in commerceof the banned products. ‘he definitionsof processing and distribution incommerce are broad and will beinterpreted by EPA to cover activities

which involve the conversion ofexcluded asbestos-containing produc{sin this manner.

D. Labeling

Products that are subject to 8 m,rrcntor f’dture ban on manufaciu;ing,processing, import, or distribution incommerce must be labeled as follows:

Notice-This product contains ASBESTOS.The U.S. Environmental protection Agencyhas bamed the distribution in U.S. commerceof this product under section 6 of the ToxicSubstances Control Act (15 U.S.C. XI05) as of(inse,rt the effective date of ban ondistribution in commerce]. Distribution of thisproduct in commerce after this date andintentionally removing or tampering with thislabel am violationsof Fedeml law.

The purpose of this labeling requirementis to facilitate efforts by manufacturers,importers, processors, and distributorsto comply with this rule’s bans andEPAs efforts to enforce the rule.

Labels must be applied bymanufacturers, importers, andprocessors to specified productsproduced after the dates listed below,and to all stock-on-hand of theseproducts in their possession or controlat that time. The effective dates of thelabeling requirement are as follows:

+Products banned in Stage 1............... Aug. 27, 1990Products banned in Stage 2, plus Aug 25, 1992

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All othor products banned m Stage Aug 25, 1995

Therefore, a manufacturer, importer, orprocessor of a product banned in Stage 2must label all stock-on-hand of theproduct as of August 25,1992, as well asany further stock of that productmanufacturer., imported, or processedafter that da!e. Products must be labeledat the times indicated to ensure that asubstantial portion of the stock in thechain of distribution after the effectivedate of the manufacture, importation, orprocessing bans are labeled to facilitateenforcement and compliance efforts.Asbestos-containing brake pads, drumbrake linings, and brake blocks must belabeled earlier than other productsbecause of the relatively long potentialshelf life of brake products and tofacilitate compliance with the two-partban of asbestos friction products.

For purposes of this labelingrcquircrnent, “stock-on-hand” means allunits of the product in the possession orcontrol of the manufacturer, importer, orprocessor. This includes products storedby a septir:]te commercial entity, hut

still within the direction or control of themanufacturer, importer, or processor.

Manufacturers, importers, andprocessors must insert in the label theyaPPIY to their products the effecti}~e dateof !})i. ban on distribution in ccmmwcefor that product. Labels must bedisplayed prominently on productpackaging, as described below. Labelsmust be either printed on productpackaging or in the form of either asticker or tag made of plastic, paper,metal, or ano!her durable material and

securely adhered or attached to productpackaglrsg. Labels must be securelyattached so that they cannot be removedwi tholit being defaced or destroyed.They must be written in English in blockletters and numerals. Text in otherlanguages is permitted in addition to theEngIish language text. The color of thetext must contract with the backgroundof the label. Labels must be applied in avisible location on the exterior of theimmediate packaging in which a productis distributed in commerce. However, ifthe product packaging has no visiblesurfaces larger than 5 square inches, theperson subject to the labelingrequirement must either securely attacha tag containing the required language tothe product packaging or must !abel thenext outer container in which thesmaller wrapped products are packedfor storage, transport, or distribution.Labels must be applied directly ontoproducts which are stored, shipped, ordistributed in commerce withoutpackaging or wrapping. However, if aproduct is otherwise properly labeledand is removed from the properlyhsbeled packaging only when distributedto the end user, the product does notneed to also be labeled directly.

Compliance with the labelingrequirements of this rule does not fulfilllabeling requirements established underthe Federal Hazardous Substa~ces Act(FIE!.A, 15 U.S.C. 1261).

E. Exemption Application Procedures

EPA believes that exemptions fromthe rule’s bans on future manufacture,importation, processing, and distributionin commerce will fall into two differentcategories, those involving existingasbestos-containing products or existinguses of asbestos in products and thoseinvolving new uses of asbestos inproducts or new asbestos products. Thisrule provides two approaches toobtaining an exemption from these bans.

EPA !las already determined thatactivities involving most asbestos-rxmtaining products presentunreasonable risks of injury to humanhealth. Therefore, procedures in the finalrule for e~~aluating exemption

29464 Federal Register / Vol. 54, No. 132 / Wednesdav, ]UIV 12, 19W / Ru!os and Regnltrtions

applications involving manufacture,importation, processing, smcf distributionin commerce of asbestos-containingproducts in categories identified in thisrule or uses of asbestos in theseproclucts place the burden upon theapplicant to show that he or she hasmade demonstrable good faith efforts todevelop substitutes for its product andthat granting the exemption will notresult in an unreasonable risk of injuryto human health.

EPA is uncertain about the facts andcircumstances that will attend anypotential exemption involving newasbestos-containing products or newuses of asbestos. In view of thisuncertainty about these products oruses, EPA believes that it is appropriateto employ a different process forreviewing exemptions for new asbestosproducts or uses. Thus, requests forexemption for new products or uses willbe treated as a petition to amend thisrule pursuant to section 21 of TSCA,Such petitions should comply with theprocedures of section 21 and contain, ata minimum, the type of information setforth in this final rule for exemptionapplications.

The remainder of this Unit discussesgeneral exemption procedures forapplications involving productsidentified in the rule. Exemptions formiiitary uses are discussed in Unit 111.Fof this preamble.

1. Information requirements. Thisprovision allows that EPA will exemptprodlicts from the rule’s bans if anapplicant can show that the activitydescribed in the application will notresult in an unreasonable risk of injuryto hrirnan health and that the applicantbas made demonstrable good faithefforts !0 develop substitutes that do notpose an unreasonable risk, EPA willb[ilance the various informationreceived in an exemption application indetermining whether the applicant hasmet the criteria for granting anexemption. Applicants for exemptionsmi!st submit to EPA data or discussionsaddressing each of the followi:lg issuesregarding their product:

a. Data demonstr:iting the exposurelevel over the life cycle of the productthat is the subject of the application.

b. Data concerning:i. The extent to which non-asbestos

substitutes for the product that is thesubject of the application fallsignificant>, short in performance undernecessary product s!ardards orrequirements, including laws 01oidinail(;es Illi311da[iiLgproduct Silf(!tystandards.

ii. The costs of non-asbestossubstitutes relative to the costs of theasbestos-containing prod!uct and, in the

case in which the uroduct is acomponent of ano~her product, the effecton the cost of the end use product ofusing the substitute component.

iii. The extent to which the proditct oruse serves a high-valued use.

c. Evidence of demonstrable goodfaith attempts by the appiicant todevelop and use a non-asbestossubstance or product which may besubstituted for the asbestos-containingproduct or the asbestos in the product oruse that is the subject of the application.

d. An explanation of why thecontinueil manufacture, importation,processing, distribution in commerce,and use, as applicable, of the productwill not present an unreasonable risk ofinjury to human health.

Exemption applications which do notcontain these items of information andthe other information required under$ 763.173(d) will be corrsideredincomplete and will be returned to t};eapplicant without further action by EPA.Exemption applications that arereturned as incomplete can beresubmitted wi!h the additional requiredinformation. The resubmittedapplication will carry ihe resubmi[ttild~te as the date of receipt.

2. Procedures for subnzit[;:~ge.vempiion applications. Exemptionapplications ,cannot be submitted forproducts subject to the foilowiag bansbefore the dates indicated, as follows:

Manufacture, Importation, andProcessing

Stage l—August 25,1989Stage 2—February 26, 1992Stage 3-February 27, 1995

L?istrihtion in CommerceStage I—February 26, 1990Slage 2—February 26,1993Stage 3—Fcbrumy 26, 1993

EPA believes that, because of the rapiddevelopment of’ asbestos substitutes,decisions on exemption applicationsmade before these dates would bepremature, However, EPA will consider,if appropriate, arguments made for anexemption from a ban on d!stribt.ltion incommerce for a product at the t~lne andapplicant submits an application for anexemption from a manufacture,importation, or processing ban.

Exemption applications must beaddressed to: TSCA DocumentProcessing Center (TS-79O), Office ofToxic Substances, U.S. EnvironmentalProtection Agency, 401 M Street SIV.,Washington. DC 20460, ATTN: AsbmtosExemption.

3. r7~.,i IeL ,’L;V Gild u’ec:isi<,n. \,~,’L”S

review periods for exemptionapplications for existing prodocts willvary, depending on the timeliness oft!leir submission and the adeqilacy of

the data that is submitted. If a comp!utuexemption application is submittedmore than 1 year before the effectivedate of the applicable ban (or 9 monthsbefurc the effective ctate of the b;~n inthe case of Stage 1 manufacture,importi+tion, and processing bans]. W<lwill conlpiete its review of theapplication and issue its decision priorto the effective date of the ban. If EP.4fails to meet this deadline, the app!iczntv!ill be granted an automatic e~kmsicnof up to I year, or untii EPA decideswhether to approve the application,tfuring which the applicant can continuethe activity ~hat is the suhjuct of theapplication. EPA will render its decisionduring the extension period.

For example, if a ban becomese[fective on September 1, 1994, anexem.ptifrn application for a productsubject to that ban camot be subi,:i~:ed10 EPA before March 1, 1393. To eilsurea decision by EPA on an applicationbefore the ban’s effcc!ive date, theapplicant must submit the application toEPA before September 1,1993.

If an exemption application issubmitted less than 1 year befwe t~teeffective date of t!re applicable ban ora ftcr the ban, EPA will issue a decisionris soon as is feasible. The submitter ofthis “late” application must cease thebanned activity as of the effective dilteof the ban unless EPA grants theexcrnpiicm.

For example, if a manufacture orimportation ban becomes effective onSept(+mber I, lgwI, and an appk:ltio]l

for a product subject to the ban isrerxivecl by EPA on April 1, 1934. W:!wili render its decision on theapplic(i! ion as soon as is fea~;iLk. 11ET<%fitls noI re~:dcred a decision gi~~’~~g !,?exemption by September 1, IflGt, Lhe8;:p!i::a I[t must tense manufacture orimportation of the product.

If EPA denies an exemptionapplication before the effective da:,? of aban, the applicant must cwise theactivity as of the effective date of thebiln, or witbin 30 days after receiFt ofthe denial if it is issued less than 30

,.d<lys before tne ef)ccii’~e date of ;heban. If a denial is rendered during anextension period, the applicant mustcease the banned activity within 30 daysafter the issuance of the denial.

For example, if the effective date of ahan is November 1, 19s4, and EP:Ircndms a denial cn June 1, 1294, theactivity rrust cease by N-cwcmi:er I,l:@4. if the effective Chile of the bs:: isJI.dy I, 1994, and EPA renders z+deniaion June 15, 1994, the activity must ceaseby July 1.5, IWM. Further, if an extensionperiod runs until December I, 1994, and

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EPA issues a denial on June 1, IW4, theactivity must cease by July I, 1994.

The time frames discussed in thepreceding paragraphs for EPA’s reviewof exemption applications do not applyto applications pertaining to n?i+ uses ofasbestos. Applications for new u>es wi!lbe subject to the deadlines for EPAreview and decision specified in section21 of TSCA.

Upon receipt of a complete exemptionapplication, EPA will issue a notice inthe Federal Register announcing receiptof the application and invitingcomments. EPA will consider anycomments received in determiningwhether to grant or deny theapplication. EPA may request furtherinformation from the applicant to assistin determining whether the exemption.,aPphcation meets the rule’s criteria.

When denying an application, EPAwill send the applicant a copy of thedenial via registered mail. This writtendenial is a final Agency action forpwposes of judicial review.

If EPA proposes to grant anapplication EPA will issue a notice inthe Federal Register requestingcomments on its proposal or thesubmission of supplementaryinformation. EPA will consider anycomments received when preparing itsfinal decision. A final grant of anexemption application will be issued byFederal Register notice and, likewise, isa final Agency decision for purposes ofjudicial review. The notice will state thelength of the exemption period grantedby EPA. In addition, if an application isapproved, EPA may notify the applicantthat the labeling requirements (Jf$763.171 have been stayed until a laterdate indicated by EPA or otherwisemodified in the exemption applicationapproval.

Exemption renewal applicationscannot be submitted earlier than 15months before the end of the exemptionperiod, unless so allowed in the noticegranting the original exemption. Noticesreceived between 15 months and 1 yearbefore the end of the exemption periodwill be granted or denied before the endof the exemption period. Renewalapplications received thereafter will begranted or denied by EPA as soon as isfeasible. The activity that is the subjectof the renewal application may notcontinue beyond the original exemptionperiod unless EPA grants the renewal.

4. Factcrs considered in evoiuatingexemption cp.alicstions. EIIA hasconcluded that the future manuf:]ctv~re.importation, processing, and distribl~tioniil com.mercc of most asbestos-containing products results in i-munreasonable risk of injury to humanl~eaith. The rule seeks the elimination of

these risks by banning the future use ofasbestos in many products in U.S.commerce. Therefore, exemptions willbe granted by EPA only in thoseinstances where a clear showing isma~le by an applicant that the activityacsa ibed in the exempticn applicationmeeis the criteria set out in thispreamble and ru!e. The criteria requirethe applicant to demonstrate that theactivity described in the application willnot result in an unreasonable risk ofinjury to human health and that theapplicant has made demonstrable goodfaith efforts to develop substitutes thatdo not pose an unreasonable risk. EPAbelieves that these criteria areconsistent with the findings in this rule,yet provide applicants an opportunity todemonstrate that they are entitled to anexemption in certain non-routinecircumstances.

EPA’s evaluation of exemptionapplications will involve a balancing ofa number of factors which go intodetermining whether the exemptioncriteria have been met. These factorsinclude the availability of suitablesubstitutes and the feasibility ofsubstituting for asbestos in the product,asbestos exposure risks posed by thecontinued use of the asbestos product,whether the asbestos use is a high-valued use, and the efforts of theapplicant to develop substitutes. EPAwill grant an exemption only aftercarefully balancing all the factorspresented in an application. Theparagraphs that follow provideguidelines which EPA will follow inapplying the above-stated exemptioncriteria in making decisions onexemption applications.

Generally, EPA does not intend togrant exemptions to applicants who aremerely seeking to avoid their share ofthe costs imposed by the actions takenin this rule. Also, EPA does not intend togrant exemptions that would indefinitelyextend the use of asbestos in products.

F@A has concluded that exposure toasbestos during the life cycles of theproducts that are subject to this ruleposes an unreasonable risk of injury tohuman health. Therefore, EPA does notintend to grant exemption applicationstiiat are based solely on the rationalethat relatively low levels of exposureexist. b~rause exposure levels may be(j!ll~ one of’ several factors balanced ind~::e[;li:lic,q whether the use described inan exemption application would pose anunreasonable risk. EPA has also foundtli{it suit~!)le non-asbestos substitutesexist for most uses of asbestos.‘1’ilewf~,:e. if a non-asbestos substitutec:<ists for a product and is in use by oneor more of the producers in the marketfor the prodi,ct, EPA does not intend to

grant an exemption to one producerbased on the cost or difficulty ofmodifying its production process or ofsetting up a supply system for obtainingthe substitute. EPA has, in establishingthe effective datm for the bans. affordedsufficient time to allow producers anddistributors to develop and implementtransition plans. Therefore, EPA doesnot intend to grant an exemptionbecause an applicant has ye( topurchase the necessary equipment, toset up systems of supply for substitutes,or to make other transition plans.

Also, EPA does not intend to grant orrenew an exemption if the applicant hasfailed to make a tangible, documentedeffort to identify, develop, and usesuitable non-asbestos substitutes for theproduct which is the subject of theexemption application.

In addition, EPA does not intend togrant an exemption merely becauseusing a substitute is somewhat morecostly in the production of a productthan using asbestos. However, EPA maygrant an exemption for an existingasbestos product if, in addition to otherfactors, a non-asbestos substitute for theproduct has not been developed oradapted, despite the best efforts of therequestor, or if available substitutes areunreasonably expensive to purchasers.

K Military Exemptions

EPA and the Department of Defensewill develop a Memorandum ofUnderstanding establishing mechanismsfor dealing with asbestos-containingproducts used for military purposes.Along with the criteria for consideration

‘of general exemptions described in thepreceding Unit, consideration will begiven to the military nature of such usesand the mission of the Department ofDefense. EPA and the Department ofDefense will jointly develop proceduresfor exemptions from this ru!e forasbestos-containing products used formilitary purposes.

G. Recordkeeping

To ensure compliance with this rule,and to assist enforcement efforts, EPA isrequiring under the authority of sections6 and 8 of TSCA that all manufacturers,importers, and processors of certainasbestos-containing products keeprecords. Section 8[a) provides broadauthority for EPA to requiremanufacturers, importers, andprocessors to keep records. Section tl[a]exempts small businesses from reportingin certain cases. However, EPA mayrequire manufacturers, importers, andprocessors of a substance subject to arule under section 6 of TSCA tomaintain records. Since asbestos is

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i?ire, !dy su’bject to rules under section 6and is also subject to this one, the smallbusiness snemption of section 8(s)wo:lld not apply. EP.\ believes thatthese recorrtkecping requirementsrepresent very little burden and amneccssar~, for the enforcement of thisrule. “

EPA also has authority under section6 to require recordkeeping and reportingrelated to the other regulatoryrequirements imposed by EPA undersection 6. In this case, section 6 prov,desthe authority to applv the recordkeepingrequirements to distributors of asbestos-containing products who are not alsomanufacturers, importers, or processorsof these products subject to section 8(a).EPA has used this section 6recordkeeping and reporting authoritypreviously in its polychlorinatedbiphenyl and asbestos rulespromulgated under TSCA section 6 in 40CFR Parts 761 and 763.

1. Inventory. As of the effective dateof a ban on manufacture, importation, orprocessing, all manufacturers, importers,and processors of products subject tothe ban must take an inventory of theirstock-on-hand of the banned products.This inventory must consist of a count ofthe number of product units in stock, interms of the unit measure or form inwhich the product is used or sold, andthe location of current stock. “Stock-on-harrd” covers all stock owned orcontrolled by the manufacturer,importer, or processor. This includesstock in a storage location owned by thep~rson, as well as stock in storagelocations owned by others if the stockremains within the direction or controlof the person. Results of this inventorymust be retained by tffe manufacturer,importer, or processor for 3 years afterthe effective date of the ban. Thepurpose of this inventory is to serve as abaseline for EPA’s enforcement of therule’s bans on manufacture, importation,processing, and distribution incwnmerce. Inventory results will becompared by EPA inspectors with thebusiness records maintained under$ 7&~.178[b](l) to determine compliancewith this rule.

2. Records. Manufacturers, importer%and processors must maintain a copy ofail labels used in compliance with~ 763.171 for 3 years after the effectivedate of the ban on distribution incommerce to which the label applies.For example, if the label is required for aproduct banned from distribution incommerce as of October I, 19w?, therecords regarding the label must bemaintained until October 1, 1995.

Manufacturers, importers, processors,and those persons subject to bans ond~stributiw-i in commerce must maintain

normal business and sales recor[!srecording the dates and quantitiespurchased of all products subject tobins. These records must he main~tiirimlfor transactions from the effective d~teof the manufacture, importation. orprocessing ban for a product until theeffective d~te of the ban on distributionin commerce for the product. Theserecords must be maintained for 3 yetirsafter the effective date of the ban 011distribution in commerce for a product.

For example, if a manufacturerproduces an asbestos-containingproduct that is subject to a manufactureban that takes effect on September 1,1993, the manufacturer must by thatdate, make an inventory of the stock-on-hand of the banned product as of thatdate. A record of the inventory must bemaintained until September 1, 1996. Themanufacturer must also keep records ofall sales or transfers of the productbetween September 1,1993, and theeffective date of the ban on distributionin commerce (for purposes Gf thisexample, September 1, 1994). Theserecords must be maintained by themanufacturer until at least September L1997.

IV. Summary of Analysis SupportingThis Final Rule

EPAs basis for this rule, as describedin the proposal, remains largelyunchanged. EPA’s unreasonable riskfindings under section 6 of TSCA arebased on extensive data gathering,modeling, analysis, and reti.ew of publiccomments. EPA’s findings aresummarized briefly in this preamble.This preamble also addresses significantpublic comments raised during thecourse of this rulemaking. EPA hasaddressed other comments in a septirateResponse to Comnwnts document,which is incorporated by reference inthis preamble and is included in thepublic docket. The following documentsare also contained in the pubtic docketfind serve as the primary, atthough notexclusive, basis for the actions taken inthis rule.

1. Regulatory Impact .4noIysis, EPA,Y988. This document analyzes the costsand benefits of various options forregulating the risks of exposure toasbestos, and includes an analysis ofavailable substitutes for asbestos-containing products, a regulatoryflexibility analysis, and materials on themodels and computational prccedums~~cd, ~Gm.~y results, ilca!tb effects And

studies, costs of converting capitalequipment from asbes!os-usingprocesses, the producer surplus lossdetermination, economic impacts Ciiitii

~nd analyses, and sensitivity analyses.

Z. Three dccuments evaluating themagnitude of potential routes of humanexposure to asbestos: (a) AsbeskxExposure Assessment, EPA, 1988. Thisdocument analyzes the occupationalexposure to asbestos and asbestosreleases from manufacturing plants andcommercial operations in the U.S.

(b) Asbestos Moc!eling Study, EPA.1988. This document analyzes theambient exposure Ieve!s resulting fromthe release of asbestos to theatmosphere from industrial andcomrnerical sources.

(c) Non-occupational AsbestosExposure Report, EPA, 1988. Thisdocument analyzes the level ofconsumer and ambient exposures toasbestos.

3. Three reports evaluating theextensive data base on human healthhazards posed by asbestos: (a) AirborneAsbestos Health Assessment Update,EPA, 1986. This document was preparedby EPA’s Office of Research andDevelopment and was reviewed,critiqued, and updated in response topeer review comments from theEnvironmental Health Committee of theEPA Science Advisory Board (SAB]. TheSAB advises the EPA Administrator onscientific matters.

(b] Report to the US. ConsumerProduct Safety Commission by theChronic IIazard Advisory Panel onAsbestos, CPSC, 1983. This documentwas written by a panel of sevenscientists selected by CPSC from a listof nominees by the National Academyof Sciences after a nationwidesolicitation.

(c] Asbestiform Fibers: Non-occupational ~Iea]th Risks, NationalAcademy of Sciences, Committee onNon-occupational Health Risks ofAsbestiform Fibers, 1984. This documentwas written by an expert panel of 13members

4. Ifealth Iitizard Assessment of No:,-Asbestos Fibers, EPA, 1988. Thisdocument evaluated the potentialh;izard posed by major rion-asbestosfiber substitutes for asbestos. Thisdocument was based in part on RecentEpidcmiological Investigations onPopulations Exposed to Selected IVon-Asbestos Fibers, EPA, 1988.

Other materials used in thedevelopment of this rule are cited in thett:xt of this preamble and listed in UnitXJ of this preamble.

V. Regulatory .bsmsmeut

Section 6 of TSCA authorizes EPA topromulgate a rule prohibiting or limitingthe amount of a chemical substance thatmay be manufactured, processed, ordistributed in commerce in the U.S. if

Federal Register / Vol. w No. 132 / Wednesday, July 12, 1969 / Rules and Regulations 29467.

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EPA finds that there is a reasonablebasis to conclude that the manufacturer,processing, distribution in commerce,use, or d~sposal of the chemical~~j?)stance, or any combination of theseHclivities, presen!s or wi!] present anu~:wsonai)le risk cf injury io bun:-]nheaith or the enuironinent.

Section 6[c)(1) of TSCA requires EPAto consider the following factors whendetermining whether a chemicaIsubstance presents an unreasonriblerisk

1. The effects of such substance onhuman health and the magnitude of theexposure of human beings to suchsubstance.

2. The effects of such substance on theefiviromnent and the magnitxde of theexposure of the environment to suchsdmtance or mixture.

3. The benefits of such substance forvarious uses and the availability ofsubstitutes for such uses.

4. The reasonably ascertainableecononric consequences of the rule, afterconsideration of the effect on thenational economy, small businesses,technological innovation, theerwiromnent. and public health.

To determine whether a risk fromactivities involving asbestos-containingproducts presents an unreasonab~e risk.EPA must balance the probability thatharm wilI occur frum the activitiesagainst the effects of the proposedregulatory action on the availability tosociety of the benefits of asbestos. EPAhas considered these factors inconjunction with the extensive recordgathered in the development of this rule.EPA has concluded that the continuedmanufacture, importation, processing,and distribution in commerce of mostasbestos-containing products poses anunreasonable risk to human health. Thisconclusion is based on informationsummarized in the following paragraphsand discussed in the units that follow.

EPA has concluded that exposure toasbestos during the life cycles of manyasbestos-containing products poses anunreasonable risk of injury to humanhealth. EPA has also concluded thatsection 6 of TSCA is the ideal statutoryauthority to regulate the risks posed byasbestos exposure. This rule’s pollutionprevention actions under TSCA are boththe preferable and the least burdensomemeans of controlling the exposure risksposed throughout the life cycle ofasbestos-containing products. Findingssupporting this conclusion include thefollowing:

1. Exposure to asbestos causes manypainful. premature deaths due tornesotheliorna and lung, gastrointestinal,and other cancers. as well as asbestosisand other diseases. Risks attributable to

asbestos exposure and ;ddressed bythis rule are serious and are calculatedfor this rule using direct evidence fromnumerous humarr epidemiologicalstudies. Studies show that asbestos is ahighly po?ent carcirmgen and that severehe~!th effects occur after even sirori-term, high-kwel or longer-term, low-levelexposures to asbestos. Asbestosexposure is cm-npatible with a linear, no-threshold dose-response model for lungcancer. In addition. there is noundisputed evidence of quantitativedifferences in potency based on fibersize or type.

For the quantitati~e risk assessmentperformed as part of this rulemaking,EPA used dose-resporise constants forlung carrcer and mesotheliorna that werethe geometric means of the “bestestimates” from a number ofepidemiologica~ studies. If EPA hadinstead used an upper bound estimate,as is normally done by the scientificcommunity and in EPA regulatory riskassessment when only data from animalstudies is available to extrapolatehuman health risk. predicted lung cancerdeaths couid increase by a factor of 10and mesothe!ioma deaths could increaseby a factor of 20 (Ref. 1).

Z. People are frequently unknowinglyexposed to asbestos and are rarely in aposition to protect themselves. Asbestosis generally invisible, odorless, veryduruble, and highly aerodynamic. It cantravel long distances and exist in theenvironment for extended periods.Therefore. exposure can take place longafter the release of asbestos and at adistant location from the source ofrelease.

3. Additions to the current stock ofasbestos-containing products wouldcontribute to the environmental loadingof asbestos. This poses the potential foran increased risk to the generalpopulation of asbestos-related diseaseand an increased risk to futuregenerations because of asbestos’longevity.

4. Asbestos fibers are released to the~ir at many stages of the commercial lifeof the products that are subject to thisrule. Activities that migh lead to therelease of asbestos include mining of thesubstance, processing asbestos fibersinto products. and transport.installation, use, maintenance. repair,removal, and disposal of asbestos-containing products. EPA has found thatthe occupational and non-occupationalexposure existing over the entire lifecycles of each of the banned asbestos-containing products poses a high level ofindividual risk. EPA has determined thatthousands of persons involved in themanufacture. processing. transport,installation. use, repair, removal, and

disposal of t}w asbestos-containingproducts affected by this rule areexposed to a serious lifetime asbestosexposure risk, despite OSIIA’S relativelylow workplace PEL. In addition,according to the EPA AsbestosMccfe!ing St:lc!y. mil!ions 0: n;embers ofthe general U.S. populatitrn are exposedto elevated leueis of lifetime risk due toasbestos released throughout the lifecycle of asbestos-containing products.EPA beiie~’es that the exposurequantified for the analyses supportingthis rule represent an understatement ofactual exposure.

5. Release of asbestos fibers frommany prorlucts during life cycleactivities can be su.bstantia!. OSHAstated in setting its PEL of O.2 f/cc thatremaining exposures pose a serious riskbecause of limitations on a~ailableexposure control technologies. Evenwith OSHAS controls, thousands ofworkers involved in the manufactureand processing of asbestos-containingproducts are exposed to a lifetime riskof 1 in 1,000 of developing cancer. Manyother exposures addressed by this ruleare not affected by engineering controlsrequired by OSHA’S PEL or by othergovernment regulation. Becauseasbestrrs is a highly potent carcinogen,the uncontrolled high peak episodicexposures that are faced by largepopulations pose a significant risk.

6. Because of the life cycle or “cradle-to-grave” nature of the risk posed byasbestos, attempts by OSHA, theConsumer Product Safety Commission(CPSC], and other EPA offices toregulate the continued commercial useof asbestos still leave many personsunprotected from the hazards ofasbestos exposure. Technologicallimitations inhibit the effectiveness ofexisting or possible exposure controlactions under non-TSCA authorities.Many routes of asbestos exposure posedby the products subject to this rule areoutside the jurisdictions of regulatoryauthorities other than TSCA. EPA hasdetermined that the residual exposure toasbestos that exists despite the actionstaken under other authorities poses asericms health risk throughout the lifecycle of many asbestos-containingproducts. This residual exposure canonIy be adequately controlled by theexposure prevention actions taken int}lis rule.

7. Despite the proven risks of asbestosexposure and the current or imminentexistence of suitable substitutes formost uses of asbestos, asbestoscontinues to be used in large quantitiesin the U.S. in the manufacture orprocessing of a wide variety ofcommercial products. Total annual U.S.

29468 Federal Register / Vol. 54, No. 13z I Wednesday, ]Lsly 12, 1989 j Rules and Regulations

consumption of asbestos dropped from a1984 total of about z40,000 metric tons toless than 85,000 metric tons in 1987,according to the U.S. Department ofInterior, Bureau of Mines data. Thischange suggests that the use ofsubstitrrtes has increased markedlysince the proposal. However, the 1987consumption total indicates thatsignificant exposure due to thecornmeicial use of asbestos and theresultant risks would continue for theforeseeable future ~hsent the ~ction~

taken in this ru!e.Evidence supports the conclusion thilt

substitutes already exist or will soonexist fm- each of the products that aresubject to the rule’s bans. In schedulingproducts for the different stages of thebans, EPA has analyzed the prubablea~vailability of non-asbestos substitutes.In the rule, the various asbestosproduc&s are scheduled to be banned attimes when it is likely that srii!able non-asbestos substitutes will be avai!able.However, the rule also includes anexemption provision to account forinstances in which technology might nothave advanced sufficiently by the timeof a ban to produce substitutes forcertain specialized or limited uses ofasbestos.

8. EPA has calculated that the productbans in this rule will result in thea,;oidance of Z02 quantifiable cancercases, if benefits are not discolwrted, and148 cases, if benefits are discounted at 3percent. The figures decrease to 164cases, if benefits are not discounted, and120 cases, if benefits are disco,~nted at ~percent, if analogous exposures are notincluded in the analysis. In alllikelihood, the rule will result in theavoidance of a large number of othercdncer cases that cannot be quantified,as well as many cases of asbestos-related diseases. Estimates of benefitsresulting from the action taken in thisrule are limited to mesothelioma andlung and gastrointestinal cancer-cases-avoided, and do not include cases ofasbestosis and other diseases a~oid(:~and avuided costs from treatingasks!os diseases. lost productivity, mother factors. EPA has estimated thatthe cost of this rule, for the 13-yearperiod of the analyses performed, willbe approximately $458.89 million, orS806.51 million if a 1 percent annualdecline in the price of substitutes is notassumed. This cost will be spread overtime and a large population so that thecost to any persorl is likely co lWnegligible. In addition, the rule’sexemption provision is a qualitati~,efactor that supports the actions taken inthis rule. EPA has concluded that thequantifiable and unq{iantifiab!e benefits

of the rule’s staged-ban of the identifiedasbestos-containing products willoutweigh the resultant economicco~sequences to consumers, producers,and users of the products.

9. EPA has determined that, within thefindings required by section 6 of “l’SCA,only the staged-ban approach employedin this final rule will adequately controlthe asbestos exposure risk posed by theproduct categories affected by this rule.Other options either fail to addresssignificant portions of the life cycle riskposed by products subject to the rule orare unreasonably burdensome. EPA has,therefore, concluded that the actionstaken in this rule represent the leastburdensome means of reducing the riskposed by exposure to asbestos duringthe life cycles of the products that aresubject to the bans.

10. Based on the reasons summarizedin this preamb!e, this rule bans mostasbestos-containing products in the U.S.because they pose an unreasonable riskto human health. These banned productsaccount for approximately 94 percent ofU.S. asbestos consumption, based on1985 consumption figures. ‘l’he actionstaken will result in a substantialred!] ctioi~ in the unreasonable riskcdused by asbestos exposuxe in the U.S.

A few minor uses of asbestos andasbestos products are not included inthe ban. These uses, which account for!ess than 6 percent of U.S. asbestosconsumption based on 1985 data, do notpose an unreasonable risk, based onc)m’rent knowledge. For some productcategories, EPA was unable to find thatthe products pose an unreasonable riskbecause asbestos exposure is minimalover the product’s life cycle relative tothe exposures posed by other prodricts.In other instances EPA currently hasinsufficient information about eitherasbestos exposure attributable to theprodu(;ts or the future availability ofsuitable substitutes to make a finding ofunreasonable risk. Exposure informationwas considered insufficient in caseswhere monitoring data was largelyunavailable for most major stages of aproduct’s life cycle and too little wasknown about exposures during thesestages to estimate exposure by analogyto !hose posed by other products. Whenno information is available for a productindicating that cost-effective substitutesexist, the estimated cost of a productban is very high. In ali of these cases,the risk reduction pcteiltial that EP.4could quantitatively or qualitativelyestimate as a result of possiblerc3u]ato W actions could not be justifiedin light of the resultant costs, under thecriteria of section 6 of TSCA.

Human health effects of asbestos andEPA’s cancer risk extrapolation arediscussed in Units V.A.I and V.A.Z ofthis preamble. The extent of humanexposure to asbes!os and the resultingrisks are discussed in Unit V.A.3 of thispreamble. Asbestos substitutes arediscussed in Units V.C. and V.F. of thispreamble. EPA’s evaluation of theviability of other regulatory optionsunder TSCA is discussed in Unit V.E. ofthis preamble. EPA’s evaluation of theviability- of actions under authoritiesother than TSCA to control the riskposed by asbestos exposure is discussedin Units VI and VII of this preamble.EPA’s estimates of the costs andbenefits of this rule are discussed inUnit V. L). of this preamble. EPA’sevaluations (Jf the risks posed by thedifferent categories of asbestos-corltainii~g products are summarized inUnit V.F. of this preamble.

A. Heo!th Effects and Magnitude ofExposure To Asbestos

1. Health effects. The hluman healtheffects caused by exposure to asbestosare well-documented. This Unitreiterates the major heaith effects andthe uncertainties that exist regardingthis subject. More comprehensiveanalysis can be found in the AirborneAsbestos HeaIth Assessment Update(Ref. 1), the Report to the U.S. ConsumerProduct Safety Commission by theChronic HazardAdvisory Panel onAsbestos (Ref. 2), and AsbestiformFibers: Non-occupational Health Risks(Ref. 3]. Further responses to commentson this subject can be found in thaResponse to Comments document.

Asbestos is a chemical substance asthat term is defined in section 3(2] ofTSCA. It is well-recognized thatasbestos is a human carti.nogen and isone of the most hazardous substances towhich humans are exposed in bothoccupational and non-occ~patiortalsettings. As OSHA stated in its finalrule, pubiished in the Federal Register ofJune 20,1986 (51 FR 22612), establishinga 0.2 fibers-per-cubic-centimeter (f/cc)PEL for asbestos, “OSHA is aware of noinstance in which exposure to a toxicsubstance has more chxrrlydemonstrated detrimental health effectson humans than has asbestos exposure.”There is wide agreement that all typesof asbestos fibers are associated withpulmonary fibrosis (asbestosis), lungcancw, and rnesotlielioma.Gastrcinttistinal lancer and o:hercancers at extra thoracic sites, as well asother lung disorders and diseases, havealso been associated with asbes!osexposure, a!though the consistency andmagnitude of the excess risks of these

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diseases are not as great as for lungcfirrrxr and mesothelioma. All of thesetishestos-rek~tt?d diseases are lifc-tf-!wa:cnirrg or disabling and c:iuse~{ll~st~nti:ll pain and suffering.

The co:~clusicns w’ached by EPA:egfi[(jin:~ itle }Icalt!7 eifrwxs of aslwjtosexposure repi~oent a widely a(;ceptcdc[, nscmsiis of opinions of healthag+mcies, scientific organizations, andindependent experts. The major healtheffects of ashes!os are stlmmarizecfbelow.

a. I.urg cancer mld mt?sul.beliurnu.Lung cancer has been responsible furthe largest number of deathsattribut~ble to occupational exposure to:111of the principal commercial asbestosmineral types: chrysotile, amosite,crocirfolite, and anthophyllite. Excesslung cancers have been documentedamong workers involved in asbestosmining and milling and in themanufacturing and use of a variety ofasbestos products. Lung cancer risktsppears to increase with both the leveland duration of exposure. The latencyperiod for the disease is generally zoyears or more after exposure. Thismeans that hrng cancer usually does nutmanifest itself until zo years after thedisease-initiating exposure, Mostpersons who develop lung cancer diewithin z years of diagnosis.

While both asbestos and cigarettesmoking can separately increase risk oflung cancer, together they appear tointeract synergistically to multiply lungcancer risk in humans. Commentershave suggested that smoking should becontrolled to reduce the very high lungcancer risk due to combined asbestosexposure and smoking. However, evencomplete control of the smoking factor,if possible, would leave a substantialhealth risk since the asbestos-relatedrisk of lung cancer to nonsmokers ,and ofmesothelioma (which is apparently notaffected by smoking] would remain,

Mesothelioma is a rare cancer of thelining of the lung (pleural mesothelioma]or abdominal cavity (peritonealmesothelioma). Mesothelioma has beenassociated with occupational exposureto chrysotile, amosite, and crocidolite.Epidemio!ogical studies suggest th:itmesothelial risk rises rapidly with timefrom the onset of exposure. Risk alsoincreases with both intensity andduration of exposure. The latency periodfor the disease is generally between 25and 30 years. In almost all instances, thedisease is rapidly fatal, with sur~’ivaltimes of less than z years afterdiagnosis. There is no evidence thatcigarette smoking increases the risk ofdeveloping asbes!os-inducedmcsotlmliorna.

Most epidemiologic! studies havebeen conrfucted cn occup:itionalpopul:itions exposed to high i+~rborneconcentrations of asbestos for relaiiv{; lylong pwiocls of time. I{owever. sh(mt-term ocr. ”tip:+tic,Jiei ~~.xposl]res have L,cen.

? “ ‘[b Cfff?(;ts.s:h(.f,~,.r: ?0 c(ause s[~;lrrus , e,. .For example, one group of asbes[osfactory workers with less than 2 monthsof occupational exposure had a two foldincrease in lung cancer risk [Ref. 4].Also, many documented cases ofmesothe}ioma have been linked toextremely brief exposures to reltitivelyhigh concentrations of ashestes (Ref. I).

There is aiso di[ect e~idence ofadverse health effects from r\on-occupalional asbestos exposure.Increaseci risk of pleural a.bnormaiitiwand mesothelioma have been observedin families of asbestos workers,presumably due to the dissemination offibers in the home from contaminatedwork clothes. Mesotheliomas have alsobeen documented in populations whoseordy identified exposure was living newasbestos mines or asbestos productfactories, or shipyards with heavyasbestos use (Ref. I).

Animal studies confirm theepidemiological findings regarding thehealth effects of asbestos exposure. Allcommercial forms of asbestos have beenshown to produce lung tumors andmesothelioma in laboratory animalswith no substantial differences betweerrthe form of asbestos forms incarcinogenic potency.

b. Gastrointestinal cancer. A numberof epidemiological studies havedocumented significant increases in theincidence of gastrointestinal cancer dueto occupational exposure to asbestos.Gastrointestinal cancers consist largelyof cancers of the esophagus, stomach,colon, and rectum. However, themagnitude of gastrointestinal cancer riskis lower than that of lung cancer ormesothelioma and no dose-responsedata are available.

A number of commenters argued thatthe evidence indicating a positiveassociation between gastrointestinalcancer and asbestos exposure is weakand inconclusive. They indicated thatunidentified facts may cause the excessgastrointestinal c~ncers, Commenterssugges:(.d that many of the excess

cancers attributed io gastrointestinalsites may be due to misdiagnosis ofperiiorreal mesotheliomas. Othercommenters contended that in theabsence of any positive experimcmttilevidence, the epidemiology data alonedo not support the conclusion thatexposure to asbestos can crruse~fistruinles!inti] (;ancer.

EPA reco~nizvs that the evidencestjpportir]g an association betweengilStroiJltt+$ii f)Ml cancer and asbestosexposure is not os strong as that whichis ~jvaj]+ijl~ io support an association;,,.!:!,y:.fin aslw+tos (>x{)osuie and Il]nqcaccer ~nr! rrwscthc!iorr.ti. Howev e;.after weif&irr3 avail:+blc information,EP.q lx:lievt:s that there is evidence of astrong causal relationship betweenastlestos exposure and gastrointestinalcancer excess. This evidence includesii3e fol}cwing: (1] A statisticallysigjli[icant irxrcase in f+s,troiritestinalcancer was found in 10 of 23cpidemiolo~ica] studies. (2) A consistentrelationship exists between increasedgastiointestird cancer r~sk ar.dincre;ised lung cancer risk(approximately 10 to 30 percent of thelung cancer excess). (3) It is biologicallypl:iusible that asbestos could beassociated with these tumor sites,because it is conceivable that themajority of fibers inha!ed are clearedfrom the respiratory tract andsubsequently swallowed, allowing thefibers to enter the gastrointestinal tract(Ref. 5). Additionally fibers may beswallowed directly. (4) One studydemonstrated some evidence ofcarcinogenicity in male rats fed dietscontaining intermediate range sizechrysotile asbestos (65 percent 10microns iii length] (Ref. 6).

Further, EPA does not accept theargument that all gastrointestinalr;ancers identified in the epidemiologystudies described above are the result ofmisdiagnosis. Cancers of somegastrointestinal cancer sites (e.g.,stomach and pancreas] could be theresult of misdiagnosis of peritonealmesotheliomas. However, this does notaccount for all of the excess cancersseen at sites such as the colon orrectum. 0!3HA, in its final rule loweringthe asbestos PEL concluded that thestudies conducted to date “constitutesubstantial evidence of an associationbetween asbestos exposure and a risk ofincurring gastrointestinal cancer.” EPAagrees with this conclusion.

c. Concers rrt other sites. Increasedrisk of (;~rlcers other than mesothelioma[ind lung and gastrointestinal cancershave been observed in populationsoccupa!kmaily exposed to asbestos. Anel(;ess of la>yngetil cancer in asbestosworkers has been reported in a nirmberof studies [Ref. z). Available data,however, indicate that there may be aninteraction between smoking andasbestos exposure in the eiiolog~ oflaryn8c~l cancer. Elevated risk ofkidney cancer has also been observed intwo epictemiological studies (Refs. 7 andH]. In addition., an increased incidence of

294?0 FederaB Register / Vol. W, No. 132 / Wednesday, July 12, 1989 / Ihiks and Regulations.——. —.. -..—.-.. =—— —.— ————— .

ovarian carrcer has been found amongfemale workers in three studies (Refs. 9,10, and 11). Therefore, evidence suggestan association between asbe~tosexposure and cancers other than lungcancer, mesotheliorno, andgastrointestinal cancer. IIowever,because of study limitations,inconsistencies among studies, and thepossibility of misdiagnosis of disease,the relationship between asbestosexposure and cancer at theseextrathoracic sites is not clear. Becauseof this uncertainty, EPA &,d notcalculate the risk of cancers at othersites for purposes of the quantitativerisk assessment for this rule.

d. Asbestosis. Asbestosis is adisabling fibrotic lung disease that hasbeen associated with high levels ofoccupational exposure to asbestos.Clinical signs and symptoms associatedwith asbestosis include shortness ofbreath, pulmonary functional changes,basal rales, and small, mainly irregular,cpacities on chest radiographs.Asbestosis can both appear andprogress many years after thetermination of exposure. All types ofasbestos have been associated with thedevelopment of asbestosis.Epidemio]ogica} data indicate that theiswidence rate increases and the diseasebecomes more severe with increasingdust level and duration of exposure.l-his has also been confirmed in animalstudies via inhalation exposure. It is notclear whether an exposure thresholdexists for asbestrwis. However, there isno available evidence that disablingasbestosis is caused by non-occupational asbestos exposure mrelatively low levels of occupationalexposure. Therefore, the risk ofdisabling asbestosis from low levels ofexposure to asbestos was riot calculatedfor purposes of the quantitative riskassessment performed for this final ru!e.

e. Effect cf jiber type. A n 1ml her ofcommenters argued that chrysotile, themajor commercial form of asbestos, isRlr !ess carcinogenic than the amphibole

asbestos types (e.g., amosite ar. d~rocido~ite) and thus, cfiffertint

carcinogenic potency values forchrysotiie and amphiboles should beusfid for quantitative risk assessment.

For lung cancer, EPA finds thevvidence supporting this argument to beinconclusive and inconsistent. Some ofthe lowest unit risk factors observed forl~wrgcancer are among cmhorts mpowrlto preclor, inmr:ly chrysutil~ askstoslRefs. 12 and 12). However, some of the\hi@est unit values are also fromexposure to primarily chry”sotile (Kefs.14 and 15). This suggests that chrysotileexposures can confer on extremeiy high

risk of’lung cancer. The cause cf theobserved variability in lung carwer unitrisk for chrysotile in different studies isunkrro~vn, but some of the variabilitiescan be attributed to differences ii] thefiber characteristics associated \vithdifferent processes, uncertainties due tosma!l numbers in epidemiologicalstudies, and incorrect estimates of theexposures of earlier years (Refs. 1 and2).

For mesothelioma, EPA recognizesthat peritoneal mesotheliomas havelargely been associated with crocidoliteexposure and that there is someepidemiological evidence suggestingthat crocidolite is more potent thanchrysotile in inducing pleuralmesothelioma, However, definitiveconclusions concerning the relativepotency of various fiber types ininducing m.esothelioma cannot be madeon the basis of availableepidemiological information. This isbecause: (I) iMesotheliomas are difficultto diagnose; (z] dose-responseinformation for mesothelioma forindividual fiber types is unavailable; (3)exposure data are iilridequ~te; and (4]exposure to crocidolite fibers could behigher because they become airbornemore easily than other fiber types.Further, numerous animal studies havedemonstrated that chrysotile is at leastas potcat as amphiboles in inducingboth mescthelicma and lung cancer byinhalation, as ~~eli as by injection orimplantation

Avai!ab]e inform,atiorr indicates thatthe combined epidemiological andanimal evidence fail to establishconclusively differences inmesothelioma hazard for the varioustypes of asbestos fibers. In view of theinconsistencies end uncertaintyregarding this issue, EPA believes that itis prudent and in the pub!!s interest toconsider a!l fiber types as baringconlparable carcinoge~lic pu!en~ y in i[squantitative assessment ofmeso!he]iuma risk. EPA does recognizethat some evidence exists indicatingthat amphiboles may be more potent ininducin~ mest]~!le!ioma than chrysoiile.Howe”/er, the need for further study toresoive !his issue, and the resultingdelay in EPA’s risk assessment forasbestos, cannot be justified given tirevolu,me of data showing thecarcinogenic ~otency of cd] fiber types.Simila[ concl~lsions w(:ie reachedpre+ 0(j51~b,~ crlher ~ciectific bodlf~$ a~d

9 3, and 16].+!;t:r,;;,t;~ (h~i~. -,f. Effirt of,fjber (ii.wcnsic,n. A number

of comrmmters stated that while lungfibers (>5 microns) ale associated withbiolo~i[:al acti~(!ty, fibers less than smit;rorrs ii~ Ici:gth rr:iy be in]i~~(,{)~[s.

According !0 these comrnenters, shortfibers to not contribute to anysignificant risk to humans and thereforeEPA should base its cancer riskc~timates on only fibers longer than 5microns in length,

krjecticm or implantation studies inanimals indicate that longer, finer fibersof the same asbestos fiber type appearto have greater carcinogenic potentialthan shorter, thicker fibers (Refs. 1, 2,and 3). Results of several recentinhalation studies also indicate that longfibers (> 5 microns) are morecarcinogenic than short fibers [<Smicrons) (Refs. 17 snd 18). How-ever.studies performed to date have notestablished fiber dimensional thresholdsfor potency.

Although animal studies haveprovided an indication of the qualitativerelationship between fiber dimensionand carcinogenic potency, they are notused for quantifying dose-responserelationships for h~mans because EPAbelieves that extrapolation of data fromhuman exposures in the workplace tohuman exposure in non-occupationalsettings is more appropriate. EPA basedmost of its estimates of non-occupational exposure in terms of thetotal mass of asbestos re!eased to air.To estimate health ris!w from the non-occupational exposure, the massmeasurements need to be conve~ted tothe equivalent optical fiberconcentration (fibers longer than 5microns and greater than c.25 pm indiameter) that are used as dosemeasurements in workplaces for whichdose-response relationship has beendeveloped. Some data exist t}i~t relateoptical fiber counts to the total mass ofasbestos. The range of conversionfactors between optical fiber count massconcentration is large [5 to 150 pg/m3/f/ml) because these values vary withdifferent environments and samplingtecti,ques, and any average vaiuerler!~’ed frOi~l this range has a largeun.cerlainty. Despi~e the uncertainties,they me the best data available for suchassessments and therefore EPA believesthat for the purpose of extrapolating tolow mass ccmcentration from fibercount, the approximate geomet~ic mean,30 @ins/I/ml is appropriate (F.ef. 1).Additiorrally, rmcertainty may beintroduced in the assuraption made inthis :issessrnent tha! the fiber sizedistribution is the same in bothcwccpt~!~rmal and non-occup~!; onai airenvironments. ‘1’ie ass(iinp[i(lfi isconsidered prudc~t in view of the facttbiat qluaiitatively, short fibers are foundmore preciomimm!?y than long fi!mrs in}mth occi!pafional and non-occupationalsettings, ‘Ile ~arne approach has been

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Federal Register / Val. 54, No. 132 / Wednesday, ]uly 1% 1!389 J Rules and Regulations 2%27X

adopted by the hla!iorral Academy ofSciences (Ref. 3] and the Chwrric~!i+zi~~d .AJvisory i%rsel (Cl ii’@] onAS~eStOS (Ref. 2] in estimating humanheai:h risk associated wiih Iov-levelncn-9ccrrpati0J?al eiposure to asbestos.

~. P(’~(’J@’ v~~]ti(<.~.~~~~Lf?n!?~s sti~~d:h,it c-mcer risLs vary fr~m cne indcstrysegment to another and maintained thatEPA should rise different potency vaiuesfor different industries in its qoarttitativecancer risk assessment for asbesios.Mos! of the com]Jlenters singled out twosegrmmts of the aobestos industry,manufacturers of chr-ysotile frictionproducts and P./C; pr[jducts mride fwrnch:ysotile, in W!iich the lung cancerri~ks wrw cons~:ierab!y !owcr thantho.w in chrysotile textile production.

EP.A has concl~ded that the datasi:pporting this suggestion are notconvincing beczrrse of significantmethodological or statisticaluncertainties in these studies. Further,when the 95 percent confidence limitscn the potency factors for lung cancerare considered along with theuncertainties associated with estimatesof exposures, there is considerableoverlap of t!le unit risk estimates acrossindustry segments and fiber types (Ref.I). Accordingly, EPA believes that itsuse of a geometric mean unit riskderived from II studies that cover allindustrial processes (with the exceptionof mining and millirrg) and that providea dose-response relationship isreasonable. This approach recognizesthat lower cancer risks may exist insome industr~ segments because ofrrrrcertainties m the measurement ofexposure or statistical variabilities, butthe Foten,;y factor fm asbestos isconsidered to be equil:a!ent acrossindustry segments. IrJ fact, a follow-upstudy (Ref. 24) reported a lung cancerunit risk nf 0.0076 for A/C productionworkers who wc?e exposed~r?dominan!]:v to drrysoti!e, This va!ueis closer to the best estimate for thefractional increase in lung cancer, KL,for asbestos exposure, 0.010. This studyprovides further support for the use of asing!e potency fac!or for aH asbestosexposure seer.arios.

2. QLwn[iic!i,Je Risk .Is.sess:nen[. Riskassessment usLIal!y requires

L + .Ioell ,d:fferent rOute Sextrapolation I.C,I.Gof exposure, from aniru.+ls to hlumi; ns,i~~d fmrn test gl’:31Jp9to the population a[large. Despite ticcci!ainties, riskasse~smen! provid:s an esti>mate of themagnitude of r:sk fc~ making decisionsabout cent.rcl!;:lg exposure [0 ahazardous sob:; t:Inct:. }iowever, heceuschcaith risk f~om a:;be~tm exposl.];e isestimated usirr;< dkect evicfmce fronl alarge numbw of ~qiricmiologic,al studies,

the risk posed by asbestos exposure isf:ir mc>ie certain tfl:m that posmi byexposIJw to other hazardous substancesfor which on!y anima! data andjor!cwcr, 1[:ss conclusive human da!a a~eav3ilable.

fJ~t? fmm li study’ Of U.S. ii? ’irI!t:fiC~

v~~:kers a;!otv .mcdels to be dw:eioptidfOi-ti)e time and age dependence of !t:ngcancer and mesothe]iom~ risk (Ref. 4).Thil !een other epiderniological studiesdem{jns!rate a iinear dose-responserelationship bztwern cumulati~eoccupationdj asbestos exposure andlung cancer. Aithough ntuch less dataare avail tib!e rcsarding a dose-responsercititionship for mesothciiorna. existingdata sugg,.st a Iioear response with doseand Ltl~!”atioriOf exposure. TrJ O!ltaiilr!ose-resp(,nse estimates for currerltocrxpat:,2n::1 and non-occu!>ationalexposures to ~sbestos, ii is necessary !0extra j]o!ate the effects observed inoccupational scttjngs with historicallyhigh exposure to anticipated effects atlow levels of exposure. This is based ona no-thresho!li !inear extrapolation. Theassumption of no-threshold low d[~selinearity for asbestos camirrogeniciiy isreasoria’ule and well-supported becatrse(1] cumulative dose-responserelationship have been shown in severalepidemiological studies over a widerange of exposure; (z) threshold dosehas not been demonstrated; and (3) theconcept is consistent with acceptedtheories of carcinogenesis.

Both the lung cancer -andn~csoihelioma nlode]s used for this finalrule have been adopted by OSHA [Ref.16). The National Academy of Sciences[Ref. 3) also adopted a similar no-threshold model to estimate lung cancerrisk to non-occllpational populationsfrom exposure to asbestos. No-thresholdlinear models have widespread support(Refs. 2,3, 16,22, and 23]. The derivationand validation of the modeis as well asthe assumptions and uncertaintiesin~jolved in the rrmdel, are discussed indetail in Refs. I, .2, and ?1.d~,.,~,==drrrotion of exposure from onset until

10 years (mini.mLTmkitency period) Imforepresent (years].

f = intensity of exposure NJfiber equiva!enislonger than 5 microns (f/cc).

KL = dose response constant = 0.010.(Refs. I and 21)

Ekc<luse mc:j:?:!leliorna is a very rareform of canc(,l in the genewl population,an absoltrte r:sk model is used toestimate e,..ce:,s mescthelioma incidencedlJe to askws[os exposure. According tothis model, the added risk ofmesotheliom<, is preporf.ional !0 thecumulative clposure to asbestos ar:ciincreasw in proportion !.o the thudpower of time after onset of exposure.

‘f’his trmdei incorporates a delay of 10years for the rnarrifesta!~rm of disnase(i.e., a minimum latency period of 10years). Four epideminlngical s!l]diesprovided quantit~tive rla!a suitab!e forcalcu]atiorr of potrx?cy factors forv’+$otheliomd (Ki,). iiPI\ ~Ref 1}selected iifi aver+,.) valtie for Kt~ oi 1.0 x10-S as [!1s best eskaie for

%ithoagh itenvmonmentz! expcsurm. .w-as not possib{c to ~,;!mm-ri~;e di:ectiythe % percent con !iik:nce iimits on KM,amu!tip~icative facim ofs was estimatedfor the average v,]lue cf & and arnuitiplicative factor d’ zo \vas estimatedfur its appliciiticn !O :~ny unstudiedexposure circumstanw.

The absolute risk model formesuthelioma can .be expressed as:

Iw(t, d, ff=K~”f[(? -10) 3 -(!-10- ri)g] fort>lo+d

~lrl =K~”f(t-lO) SforlO+d> t >=Ofort<lO<

Lung cancer is best described by arelative risk modei. According to thismodel, excess tisk of lung cancer fromasbestos exposure is proportional to thecumulative exposure (i.e., the durationof exposure times the intensity ofexposure, in terms of fif2er-year/cc) andthe background risk in the absence ofexposure. EPA used this model and datafrom 11 studies of workers exposed toasbestos in textile production, asbestosproduct manufacturing, and insulationapplication to calculate potency factorsfor lung cancer (K., the fractionalincrease in risk per fiber-year/cc ofexposure) (Ref. I). The geometric meanvalue of KL for these studies, 0.010, wasused as the best estimate forenvironmental asbestos exposure. The95 percent confidence limits for thisvaiue are 0.0040 and 0.027(multiplicative faclor of 2.5) based on ananaIysis of variances in the 11 studiesfrom which the K,, was calculated. The95 percent confidence limits for KL thatmight be applied in any imstudiedexposure circumstances rme estimated tobe a multiplicative factor ofapproximately 10.

The relative risk model for lungcancer can be expressed as:

IL = IL[1 +- K~ f d!: m]

\tihere:

11,:= age – specific lung cancer death mtewith exposure to asbestos.

IF = age – specific Imrg cancer death ratewithout exposure to astrnstos.

: ~ time fr~m onset of E?XpOSIiTF!until present[years].

~h(.ro.,.. .

IV(t. d, ~ ‘= mesothel;oma incidence at tyears from onsr+ of ~~.pomrre,fromdw?iiml d, st conccn:ration f.

2(J47~ Federal Register / $?o1. 54, No, 13z / Wednesdzy, juiy 12, 1989 / Rules and Regulations—. ——.. .—.. — ..—..—-. .. -. ..— — —..-———~.

K“ = carcinogenic potency expressed as theirrci(!ence of mesoti,eliorna pm unit of~xp:jsrme in fiber-years ‘/cc.

i = i]~tcns;!y of exposure to fiber equivalentsI(mger than 5 microns {f/cc).

i = time [if!er exposure in years.~ .= [l~?[{tionof exposure in years. (Ref$.,1

and 21)

1:1 extrapolating rates of excessasbestos-relatwf de~ttts fromgastrointestinal cancer, EPA achrp{ed theapproach userf by OSHA [Ref. 16) jnassuming that excess gastrnirlt. ~stinalcancers wili be equal to 10 percent ofthuse for lung cancer in eiich timleperiod. However, this approach maYactually understate the rate ofg~st~ointe~tinal cancers, O$HA notedthat this approach could result in anunderestimate, and EPA’s analysisindicates that the excess gastrointestinalcancer rate could be as high as 30percent of the lung cancer rate [Ref, 1).

There are inconsistencies in findingsamong different epidemiological studieswith regard to excess mortality forcancers at sites other than the lung,mesothelial linings, and gastrointestinaltract (e.g., laryngeal, kidney, and ovarycancers). Also, there are uncertaintiesabout the development of disablingasbestosis at low exposure. Therefore,EPA has not made numerical estimatesof the risks for these asbestos-relateddiseases for purposes of this analysis.Since estimates of these diseases arenot included in the overall riskestimates, EPA believes that the totalhealth risk posed by exposure toasbestos is underestimated.

A number of commenters contendedthat it is inappropriate to adhere to alinear, no-threshold dose-responsemodel for estimating lung cancer andmesothelioma risk from asbestosexposure. They cited a m~mber ofepidemiological studies which theyststed show that there is a thresholdbelow which asbestos-related diseasedoes not occur (Refs 12,13, 25, and 26).EPA has reviewed these studies andfuund that they are al! insufficient to{ietect a threshold at iow duses (Ref. 1).

Other commenters expressed concernabout the !ow-dose iinearity assumptionijecause the shape of the dc)se-response{.~rve at extremely low doses is subjectto conjecture and that the use of nothreshold liriear model greatlyoverestimates true risk. Others believethat ashes!os is a non-geneticcarcinogen. As discussed above, EPAiias concl’udui that the lo~v-doseILne?rity Assumption is -c,lson.]}l]ebecause ciirfwt e~ icfence fur Iilmaritv ofiurcinogenic response aSSOCiilt~Ci i~ithas be5tos exposure is found in severalrpir-iemiological studies over a widet;inge of exposure. Whether the

response is linear at very low {ioses isnot known (Ref. 1). li~ the disco ssiim ofthe choice of mathem.utic~l proceriuresin ctircinogen Iisk assessment, droWhite House Office of $cimce andTechnology Policy (OSTF] sttited:“When data and information are iimit+xi,however, and when such uncertaintyexists regarding the mec}wnism ofr-aminogenic action, models orprocedures which incorporate iotk-duselinearity are preferred when com~?a[iblewith the limited information” (Ref. 27).EPA generally concurs with this positionas reflected in EPA’s Guidelines forCarcinogen Risk Assessment (5I FR33992). Thus, given the la~k of complcieunderstanding of the mec;hsnisms bywhich asbestos induces cancer, and thegoal of protecting human health, EPAbelieves that the choice of low-doselinearity is most prudent.

3. Magnitude of human exposure,Exposure to asbestos is discussed inmore detail in the Asbestos ExposureAssessment (Ref. 29), the AsbestosModeling Study (Ref. 30), and the Non-occupational Asbestos Exposure Report(Ref. 31). Further responses to commentson this subject can be found in theResponse to Comments document,

Most of the population of the UnjtedStates is exposed to some level ofairborne asbestos from asbestos-containing products. Asbestos productshave been in wide use in the U.S. fordecades. Although US. asbestosconsumption has declined in recerityears, thousands of tons of asbestos arestill used annually in the manufacture inthe U.S. of the products that are subjectto this rule (Ref. ZI). Fibers can bereleased to the air and exposure canoccur at all stages of the life cycle ofasbestos products, including mining,processing, and the transport,installation, use, repair, removal, antidisposal of asbesios-containirrgproducts.

Once releused, usbestos fi!~ers e~hiirita number of characteristics that teilri toincrease human exposure to thc:m. Th?yzire ordorless and fibers of res~ir~h!~size are largely invisible, presenii.mg rishto persons who are no! aw,ar:, fh::? tbo:;are being exposed. ‘I’hey are :iisocxtreme!y durable and possessaerodynamic properties th~t ailot~ ihemto remain suspended in the cir f(>ra ii)~:

time and to rmr.ter the air rc::diiy cftprsettling O!IL.Asbestos, there fure, cz~np~’rsi~t fur :: wry l.or~ ti!n(; In the

1 ,l<~,~?,,]c(jenulronnlent [ind tuin trave. -dis!tinces through the ;iil, ‘1’hcse f;z(;t{;:sincrease the intensity, (iurat ion, antiarea 0[ exposure an:i complicateattemp!.s to control or uPdLIcc: ekpos IIrf,.

EPA }WScluantifieri many of the lifecycie exposcres anticipated from thecontinued manufacture, irnporiution,procesq!rrg, and use of the asbes?osproducts that are subject to this ru!e.EPA estimates tir.st over 135,000 fuli-iimrequivalent {IH’E) workers are e~pr-rserfdi~ring the life cycles of these productsto IcY::Is of asbestos carrying lifetimerisks of between 7 in 10,000 ar.d 7 inI.000 [Ref. w). At least 40 .mi!licmcocsumers face a potential hazard asthey install, use, repair, ar.d dispose ofthrse proriticts [Ref. 31). In addition, thegeneral population is exposed toasbestos that is released into thewnbi~nt air during all of these activities.Both conswners iind members of thegeneral population frequently incurind[’;idual lifetime risks of 1 in 1,000,000or greater of developing cancer fromthese exposures [Ref. 31).

There are other exposures associatedwith the continued production ofasbestos products that cannot be readilyquantified, but which could pose asignificant risk to large populations. Asdiscussed in more detail below, manyreleases of asbestos from asbestosproducts take place intermittently andover long periods, making them difficultto measure. Because of the difficulty ofobtaining accurate monitoring data forthese releases, they have not beenquantified for purposes of this rule’sanalyses, but qualitative evidenceindicates that cumulatively, they areprobably significant. Similarly, becauseit is difficult to quantify the tendency ofasbestos to be resuspended in air, EPAhas not quantified in its analyses therisk posed by asbestos that is repeatedlyreentrained after settling out. However,some reentrainment certainly occurs,and asbestos may pose some threatyears after its initial release fro”masbestos products, These exposures,although unquantified, have theputential to affect large numbers ofpeople tor long periods of time. Thus, inti~iciition to the exposures quantified fortt,is rule, they are a sohrce ofc:)~sideriib!e concern.

H. (?{Cli#Gt;Oiltrl exposures, Si nceiIP;\’s ploposed rule was issued, OSliAi~:{spromi,igated new occupations]~Y.[JCISlirE? standards for asbestos,!cwering the 8-hour Time WeightedAv{;roge (TWA) PEL from 2.0 to 0,2 f/cc(C,I FR ~~~lz]. OSIiA has also set an[lxcu~sion Lirnil (iZL) of 1 f,lrx iis a h:! If-hrIuI TiAiA in a Septernbe~ I!2fitt

, (<’i F:/.;i~(, :i:iv, t.r, t [e the star.d~rdh ..

31,1f]j. ‘!”} ’f!p~+l)t{bl(? irilpSCt Of Ii?:?0.2 f/cc T;F.l.Oil ~vo:kcrs’ exposures toils!i,st[).~ :vas dificusse d in the pwpc,sa!.~~.s:o.otecftmkh in :ha{ proposal i~nd in[)S[ [,I”S l{ii?ml:k~n~. C><p,lSUf’(!Sat th[!

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Federal Register / Vol. 54, No. 132 / Wednesday, July 12, 1989 / Rules and Regulations 29473

new PEL still pose significant risks, “asdo exposure at the EL. OSHA notes thatthe new PEL and EL do not represent“safe” levels of asbestos exposure, butare the lowest levels that industry canfensibly achieve during current controltcchcr?lcgies. SPA estimates tkit underthe new PEL, approximately 135,000 FTEworkers engaged in the manufacture,processing, installation, repair, anddisposal of the products to be bannedare exposed to levels of airborneasbestos between 0.02 f/cc and 0..%f/cc(Ref. 29). Assuming that workers areexposed to these levels over a 45-yearworking lifetime, they incur individualrisks of between 7 in Iti,000 and 7 in1,000 of developing czncer (5I FR 2%44).

A number of commenters criticizedthe occupational exposure data baserxed to support the proposai as beingoutdated and incomplete. Much of thatdata came from the 1982 TSCA section8(a) reporting rule (40 CFR 7&80). Inresponse to these comments andbecause of the passage of time since theproposal, EPA has updated andexpanded its analysis of occupationalexposures, making use of availableliterature and data bases andconducting surveys of asbestos use andexposure levels. Materials used by EPAin the updated analysis include OSHAand Mine Safety and HealthAdministration (MSHA) complianceinspection reports, National Institute forOccupational Safety and Health (NIOSH]studies, academic and industry studies,and public comments. In 1986 and 1987,EPA conducted the Asbestos ExposureSurvey and gathered exposure andrelease information on the manufactureof most of the major asbestos productcategories from primary and secondarymanufacturers of asbestos products.EPA gathered data on populationsengaged in manufacturing in the 1966-87Asbestos Market Survey.

EPA was able to obtain extensiveinformation on occupational exposuresduring primary and secondarymanufacturing for many productcategories. Air monitorirrg data forprimary and secondary manufacturingwere available for many products fromthe 1986-87 EPA Exposure SuNcy,OSHA inspections, and uumeroltsstudies. EPA has estimated thatapproximately 9,300 workers in t!le LJ.S.are exposed to asbestos during theprimary and secondary manufacturingof the products that are affected by thisru!e [Ref. 29). These exposures are listedin Tab!e I of this Unii.

EEA also gathered infu~nxiticm onoccup.:tional ehposums fl om theinstal!a!ion, repair, and disposaj of mostfriction and consiruciicm prod). }cts, the

two product groups for which exposuresare likely to be highest during these lifecycle stages. For the installation andremoval of construction products(roofing felt and A/C pipe, sheet, andshingle), air monitoring data wereavailable from several s(udies.Ocovpational popu!atioris [in terms ofITES) were estimated on the basis ofcrew size, productivity, and totalmanufacture and import volumes of theproducts. Exposures associated with thereplacement and repair of frictionmaterials were estimated in a similarfashion. EPA estimates that 125,400Fl13s are exposed to asbestos during theinstallation, repair, and disposal ofasbestos fricticn and constmctionproducts. More than 125,400 workers areactually exposed to asbestos duringthese processes (OSHA es!imates that556,320 persons are exposed), but manyare exposed on a less than a full-timebasis (Ref. 29). FI’E exposures are listedin Table I of this Unit.

Very little monitoring data onoccupational exposures duringinstallation, repair, and disposal wereavailable for the other asbestosprod:.:cts th~t me subject to this ruIe,arrd EPA’s estimates therefore do notinclude exposures from the installationrepair, and disposal of these products.However, on the basis of the limiteddata that exist for these products and onthe basis of data for similar productsand processes, EPA believes thatsignificant exposures during installation,repair, and disposal of these products dotake place (Ref. 57). Therefore, EPAbelieves that its analysis underestimatesexposures associated with theseproducts. EPA conducted an anaiysis inorder to gauge the possible impact of theabsence of some occupational exposuredata on calculations of the rule’sbenefits; the wsults of this analysisappear in Table 11of this Unit and TableVIII of Unit V.D.

In general, when data relating to acertain type of exposure could not beobiained, EPA did not quantify the t typeof exposure, reflecting what EPAconsiders to be a reasonable approachto risk assessment. EPA finds theexposures quantified for this rulesuffh. ient in themselves to supportEP.4’s risk 2ssessm.ent conclusions forasbestos. However, EPA notes that if ailexposures to asbestos from the productsaffected by this rule could have beenquantified, the benefits calculated forthis rule would probably have beensignific::~i{ly greeter th:~a not[~d in Ep.4’srisk assessment, lendin;; further s~lpportto EPA’s unreasmwble ~~sk finding forasbcstas.

Much of EPA’s occupationalexposure data base for this rulerepresents exposure that took placebefore OSHA’S lowered PEL of 0.2 f/ccbecame effective in 1986. To estimateexposures taking place after thelowering o: the PEL, EPA first loweredto 0.2 f/cc all data points which reper!edexposures above 0.2 f/cc. EPA thenaveraged these points with those pointsthat were reported as lower than 0.2 f/ccfor each job category in each productcategory. For purposes of this analysis,EP.4 considered it appropriate toassume that previously high exposureswill probably not be loweredsignificantly beIow the PEL. OSHAdetermined that (?.2 f/c~ which is I()times lower than the previous PEL, wasthe lowest PEL that most of the asbestosindustry could feasibly achieve usingwork practices and engineering controls.The asbestos industry challengedOSHAS standards, arguing that a PEL of0.5 f/cc was the lowest feasiblestandard, and OSHA acknowledged thatscme industry sectors might not be ableto control exposures to 0.2 f/cc withoutthe use of respirators. Thus, while EPAbelieves that it is possible that somecompanies are below the 0.2 f/cc PEL bysome margin, it is probable that othersare not and that some of these actuallyexceed the PEL. EPA believes thatadjusting previously high exposurepoints to 0.2 f/cc is a reasonable meansof adjusting for facilities that may beabove the PEL.

In estimating the benefits of its 0.2 f/cc PEL OSHA used somewhat differentassumptions than EPA has in this rule toestimate the impact of the PEL onworkplace exposure levels. OSHA’Sanalysis adjusted all exposures in i!sdata base that were at or above 0.2 f/ccto 0.15 f/cc in cases where OSHAassumed that engineering controls wereused. In cases where OSHA assumedthat respirators were used, OSHAreduced the exposures by a factor equalto the effective protection factor of therespirator. OSHA assumed thatexposures below 0.2 f/cc would bereduced by 20 percent due toengineering controls. OSHA’S approachassumes not ordy general compliancewith iis fiber level standards, but alsothat, on average, those subject to thePEL will reduce their workplaceexposures significantly below thestandards to ensure compliance. OSl 1Adid not factor non-compliance into itsaha!ysis of the costs and benefits of thePEL because both costs and benefitsdcc!ine in proportion to any non-compliance, lsaving cost-benefit ratiosfor the OSH.A rule unchanged.

29474 Federal Register / Vol. 54, No. 132 / Wednesday, ]u1y 12, 1989 \ Rules and Regulations—

On the other hand, EPA’s assessmentcf the costs and benefits of this rule isaffected by non-compliance with theOSHA PEL. llPAs approach assumesgeneral compliance with the PEL, butalso accommodates the possibility thatsome levei of non-compliance with thestandard exists. As is discussed furtherbelow, OSHA issued many citations forviolations of the asbestos standards inthe first year after they went into effect.Using OSHA’S fiber level adjustmentassumptions in place of EPAs toestimate the effects of this rule results inan approximately 20 percent lowerestimate of cancer-cases-avoided foroccupational settings. However, if anon-compliance rate of 2 percent (arelatively low rate based on non-compliance rates in other Federal healthand environmental regulatory settings]is assumed in conjunction with theOSHA fiber level adjustments, theresulting estimated benefits are virtuallyihe same as those estimated using EPA’sassumption about fiber level averageexposure (Ref. 21). Therefore, EPAbelieves that its assumptions areappropriate for purposes of calculatingthe benefits of this rule. In practice,given some level of non-compliance withOSHA’S asbestos regulations, actualcancer cases that would have occurredas a result of that non-compliance willnow be prevented by this rule’s productbans.

One commenter maintained that EPAshould base its analyses solely on thedata collected before OSfiApromulgated its asbestos standard andshould not adjust the data to ref!cctcompliance with the standard. However,EPA considers it reasonable to assumethat previously high exposure levelshave been reduced to some lower levelas a result of OSHA’S action, and asdiscussed above, EPA has selected thePEL as a logical approximation of thislevel. Other commenters contended thatEPA’s approximation of occupationalexposures taking place after theiowering of the PEL was too high,arguing that because exposure levelsvary considerably from day to day,industry keeps average exposuressignificantly below the PEL to guarmteeconstant compliance. These cornmentersmade similar arguments during OSIHA’Srulemaking setting the new PEL.However, in that instance, thecornmenters used the variabilityargument to support a claim that the PM.was iufeasi!de hecau~e averageexyostires could not he kzpt IOW enoughto guarantee constant compliance.OSHA refuted this argument. noting thatday-to-day variability can be reducedby employers and that while exposures

mjght be above the PEL some of thetime, a finding of technologicalfeasibility does not require thatemployers be able to comply with astandard constantly (51 FR 22653).

Moreover, data from recent OSHAinspections do not support the assertionthat current exposures are significantlybelow the PEL. OSHA cited employersfor nearly 1,000 violations of its asbestosstandards in the first year after thestandards went into effect, and theviolation most frequently cited was thefailure of employers to instituteengineering controls to maintainemployee exposure at or below the PEL(Ref. 32). Personal monitoring data fromrecent inspections showed that 91 out of655 establishments inspected hadconcentrations of airborne asbestosabove the PEI+ and the averageconcentration level for allestablishments inspected was 0,29 f/cc,45 percent higher than the PEL (Ref, 33).While respirators were in use in many of!he establishments with airconcentrations higher than the PEL, 20percent of these establishments werecited for violations of respiratoryprotection provisions or for violations ofthe PEL (Ref. 49).

On a related issue, some commentersstated that EPA had ignored the effect ofusing best availabie control technology(BACT) to reduce exposures, arguingthat industry-wide exposure values are“not relevant to determination of theconsequences of an effective PEL andconsistent use of good work practice.”As is discussed more fully in Unit V.E.and in the Response to Commentsdocument, EPA has analyzed the likelyeffectiveness of mandating the use ofEIACT and has concluded that thisregulatory option would not sufficientlyreduce exposures to asbestos from theproducts affected by this rule. Forcalculating the cancer-cases-avoidedthrough regulation, EPA considersexisting rather than besi-case exposuresto be the appropriate baseline. Theevidence discussed in the precedingparagraphs indicates that manyworkplaces do not utilize BA(H andthat the arl]ustments EPA has made toits exposure data account for the impactof the 0.2 f/cc PEL. Where BACT isutilized. EP.4’s analysis has taken it intoaccount. For instance, in its analysis ofexposures during brake repair, EPAestimsted that 9.6 percent of brakerepair shops used BAC~, and EPAcakxdated an avera:e of industry-wide:xpos,mcs includi:g i~e relati.:el} lowexposures from this group.

On September 14,1988 (53 FR 3W31O),0S11A amended its Asbestos Standards[o incorporate an El.. \\hich limits

ailowable short-term exposures to 1 f/ccover a half-hour period. OSHA took thisaction after noting that controllingepisodic expos~mes to asbestos wouldlower the significant risk posed byasbestos in the workplace. However,while the Ef, will probably reduceworkplace exposures, EPA does notbelieve that this reduction will be verygreat. EPA bases its judgment on anumber of observations regarding thenature of and circumstancessurroundi~~ episodic exposures.

First, many exposures that areepisodic are also unpredictable, defyingattempts to control them. In industrialsettings, episodic exposures are likely tobe associated with unexpected eventssuch as equipment breakdown (53 FR35620). In the maintenance and repairsector of the construction industry,episodic exposures take place whenindividuals who only occasionally comeinto contact with asbestos materials andwho may not recognize such materialsdisturb them accidentally or unwittinglyin the course of their work (53 FR 35624].OSHA directs employers to conductinitial monitoring of employees’exposures where they “may reasonablybe expected’” to exceed the excursionlimit. However, if peak exposurescannot reasonably be expected, they areunlikely to be either monitored for orprotected against.

Second, the initial monitoring requiredto measure short-term, peak exposureswhere they are expected to occur issubject to error. To obtain accurateestimates of short-term exposures,monitoring must be conducted using thestrictest sampling strategies andanalytical techniques. If the properprotocol is not observed precisely,violations of the EL can go undetected[53 FF. 35618 and 35619).

Third, where violations of the EL aredetected and control measures areimplemented. these control measureswill freqoendy be ineffective. OSHAexpects that for many of the employeesexposed to predictable bursts ofairborne asbestos, including workers inindustry and in baiitling maintenanceand repair, respirator use wiIi prove theonly feasible means of controllingexposure (53 FR 35616 and 35624).L’nfortunately, respiratory protectionhas not been found to be very reliable.OSHA ranked respirator use last in itsrecommended hierarchy of controls ini !S IW6 revisioin to the asbestosstandc]rciq, o!xwving.

Respin+tors a;e wpob!e of provi{iingadequate protection on!y if they are properlyselected for the concentrations of airborneccmtamina nts present, properly fitted to theemployee. properiy and conscientiously worn

i

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Federal Register / Vol. 54, No. 132 I Wednesday, July 12, 1989 I Rules and Regulations 29475

by the employee, carefully maintained. aridreplaced when they have ceased to provideadequate protection. While theoretimi!y it ispowibie for 811of these conditions to be met,it is more often the case that they are not (s]FR 2289?].

T!re drawb:icks ci~ed ahovc :,xaggravated if ihose ~sing the respiratorsare noi accustomed to working withthem or with asbestos. OS1-!A states inits amendment establishing the EL thatit “is concerned about relying onrespirator use to meet the EL in themaintenance and repair sector of theconstruction industry,” where coniactwith asbestos is often cnly occasional(53 FR 35824]. Fina!ly, even if all theconditions mentioned above are met,respirator wili do nothing to reduce thequantity of asbestos released into theimmediate environ~.e~t of respiratorwearers. Thus, during the activity thatgenerates the airborne asbestos, personsnear the respirator wearer can beexposed to levels that are quite higheven if they do not violate the EL; andafter the activity, all persons in the area,including those who have removed theirrespirators, can be exposed to dust thatremains airborne or that is reentrainedafter settling out.

Like respirators, other controlmeasures may reduce some short-termexposures without having much impacton long-term exposures. Some con!rolmeasures replace one opportunity forexposure with another. For instance. toreduce short-term exposures duringbrake repair, OSHA recommends thatmechanics utilize either a solvent sprayor a vacuum enclosure equipped with aHigh Efficiency Particulate and Aerwsol(HEPA) filter. While both of thesecontrols can be effective in reducingshort-term exposures during the brakejob, exposures can be high later if theasbestos-contaminated solvent isallowed to remain in the area toevaporate, or if care is not taken duringthe removal of the HEPA filter from thevacuum device (Ref. 29). Becausewtablishments using HEPA vacournenclosures are exempt from monitoringunder the OSHA standard, highexposures during filter removal may notbe detected. Again, as is the case forrespirators, the effectiveness of thebrake repair control measures inreducing overall exposures dependsheavily on the knowledge and

conscientiousness of th”e user. This isalso true for shrouded tools, the controlmeasure recommended by 0Si3A forreducing short-term exposures duringthe cutting of A/C pipe (53 FR 35622).

Fourth, the implementation ofadditional contwl rncasures wi!l bedifficult, expensive, and time-consumingfor much of the reguiated community,discouraging compliance with the EL.For instance, although some brakerepair establishments servicing largegovernment fleets utilize HEPA vacuumenclosures, smaller establishmentsrepairing brakes less frequently are lesslikely to invest in these relativelyexpensive devices. Moreover, whiIeemployees in government brake repairshops are usually paid by the hour.employees in private establishments areeften paid by the job, which discourag~sthe use of time-consuming workpra(;tices and engineering controls (Ref.50). A similar situation exists in themaintenance and repuir sector of theconstruction industry where, as notedearlier, many smaller building firms mayfind it difficult to institute adequaterespirator programs. In these industrysectors and others, limitations onresources and time may discourage thediligent use of control measures that isrequired to achieve substantialreductions in occupational exposures toasbestos. The record of compliance withOSHAS 0.2 f/cc PEL supports thisprojection. The provisions mostfrequently violated in the year afterOSHAS 1988 PEL went into effectincluded the requirements to conductini!ial and daily monitoring, to instituteengineering controls, and to institute arespirator program, all .of which are asimportant to achieving the EL as thePEL. In fact, achievement of the ELrequires siricter application of theserequirements than does achievement ofthe PEL, making uniform compliancemore difficult. Moreover, the structure ofthe brake repair and buildingmaintenance and repair industries, inwhich numerous, small businesses arethe norm, will also make enforr,ernent ofthe EL difficult.

in summary, attempts to reduce short-term exposures are likely to have only alimited effect in eliminating theexposure risks posed by asbestos. Peakexposures are both unpredictiible anddiffi~ult ?0 detect. Efforts to co]ltrol them

mist rely largely on respirators andwork practice controls, control measoreswhose effectiveness is uneven,depending upon the conscientiousnessof the user. Implementation of thesecontrol measures also requires resourcesthat ornployers am.f ewployees nmy havedifficulty investing, and ihe record t ,fcompliance with the 0.2 f/cc PELindicates that in many cases, theinvestment will not be made. For thesereasons, occupational exposures willprobably not be greatly lowered as aresult of the EL. Although the estimatesgiven below may slightly overestimateoccupation! exposures in those caseswhere the impact of the EL is greatest,EPA believes that any overes[irna te islikely to be minor overa!l.

The following table summarizes EPA’sestimates of occupational exposures toasbestos by product category andprocess. This table and the other tablesin this Unit present exposure levels interms of millions of fibers breathed peryear (l& f/yr), an index of exposure thataccounts for varying breathing rates, airconcentration levels, and frequenciesand durations of exposure amongworkers, consumers, and the genera!population. Assuming an 8-hourworkday, a 250-day work year (bOthconditions do not always hold in theinrfustries below), and a breathing rateof 1.3 rn3/hr, 100 XII18 fibers/year =0.038 f/cc. Assuming a 45-year workinglifetime exposure, exposure to 100X106fibers/year carries a risk of 1.29 x10-3(1.29 in 1,000) of developing cancer (51FR 35610). In many cases, blank spacesin the table signify that information wasnot a..railable, not that no exposuretakes place. The high fiber levels andrelatively low populations’ given for therepair and disposal of A/C shingle, A/Csheet, and roofing felt are a result of theFTE approach to the calculation ofbenefits (cancer-cases-avoided). Inreality, per person fiber levels are lowerand populations are higher. Except asnoted, all exposure informationpresented in this Unit of the preambledates from IW15, the most recent year forwhich a complete set of data wasavailable in the Market and ExposureSurveys. In calculating the cancer-cases-avoided through the rule, however. EPAhas assumed that expcsed populationswould decline at the same rate asproduction volumes.

TABLE l—OCCUPATIONAL EXPOSURES

ProductI Pfimsfy manufact. ] Saconda~ fnanohct.

-__..___- .....__...-p?fEzICzs2YfEp5.’s’

‘a’:o’f’r “:’IZ’XCommercial paper ‘ ..... . .. . ..... ....... . .....................................................Rol!board ' ............................................................................................

2%76 Federal Register / Vol. 54, No. 132 / ;%’ednesday, July 12, 1909 / Rules and Regulations—— ._ —. —..——

TABLE LOCCUPA rIONAL ExPosuREs-Continued

—— ———-.

I Pnnwy rnzvwf.ct. / Sewmdar ]anufact.

10 ‘f/yr

Install..-—Pop 1081/yr

———.

439

23672372313rl

Pop.

263

i5i9

22586,398

32,666117

3,93573

43

145 449134110 1,296

1235

235

57

57

57

125146

127166

195

276

3%

9s349

7323

——

296

2,0802,080

244376386390382!125

120

II

2

28653

717,565

9i615

263239

11191

1675s2553

111 I 1A9

270 )478

4733tJ53903653774043li3398

2,719300

194t3

28

~No U.S. manufecfure or import~&&wsuraa Iiared kw)ude a relabvefy small numbar of sxposuree posarf durrng the production of spmalty industrial gaskets, which are not banned by this rule‘ Repair and dtsposal fgures include rebuilding only.

EPA was not able to quantify all the accidental disturbance of asbestos FIRS) were estimated on the basis ofoccupational exposures to asbestos. As material by a maintenance worker. production volumes and the person-noted earlier, there are few data on As a means of representing part of hours typically required for the activityexposures during the installation, use, this recognized but unmeasured of concern. These estimates arerepair, removal, and disposal of a exposure, EPA estimated occupational rrresented in the table below, and are Inumtrer of products, although exposure exposures associated with theis believed to take place during these

~sed as indicated in this preamble toinstallation, repair, and disposal of

processes for many of these products. certain products on the basis of theassess the possible impact of the

Moreover, existing exposure data do not limited data that exist for these productsabsence of some occupational exposure

reflect the elevated levels of airbornedata on calculations of the rule’s

and processes and on the basis ofasbestos that can result from

benefits.exposure data for similar products and

I

unpredictable episodic events, such as processes. Populations (in terms of

TABLE II—ANALOGOUS EXPOSURE ESTIMATES

I-t=-.

installationProduct

Population———— —

Fiepeirtl——. —

Population

Sposaf

10Sfly

57235757

296395276

Io’ffyr

I

57525757(9

275390

xl

2,72553,417

3501,459

4?55.741

I

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Federal Register / Vol. 54, No. 132 / Wednesday, July 12, 1989 / Rules and Regulations 29477

manufacture, installation, use, repair,and disposal of asbestos products. Risksfrom non-occupational exposure are notonly incurred by very large populationsbut occasionally can be quite high. EPAestimates that approximately 40 millionconstnners and 19 million of thosee~p~s~d tO arnbierit asbestos incur risksof 1 in 1,000,000 or more of developingcancer from their exposure.Approximately 223,000 of those exposedto ambient asbestos incur lifetime risksof 1 in 10,000 or greater of developingcancer (Ref. 30).

Historically, consumer exposures toasbestos have not received as muchattention as occupational exposures toasbestos, but they arc a source ofsig~ificant cmcern. While consumerexposures are not likely to be asfrequent for individual consumers asoccupational exposures are for workers,they are likely to be more intense thanoccupational exposures becauseconsumers generally lack the exposure-reducing equipment and expertiseevailable to protect workers. Forinstance, consumers replacing theirbrakes are not likely to use eithersolvent spray or a HEPA enclosure, thetwo pieces of equipment recommendedby OSliA for use in reducing exposuresto asbestos during brake repair.Consumers may in fact employ a shop orhousehold vacuum cleaner to removeasbestos dust from brake assemblies, atechnique that can lead to very highexposures because most vacuumcleaners fail to capture asbestos dustand simply force it back out into the air(Ref. 59).

Consumer exposures are alsoexperienced by a much largerpopulation than occupational exposures.According to two recent, independentconsumer surveys, approximately 40million coltsumers repair their ownbrakes oilce every 3 years, and otherconsumer surveys indicate that at least840,000 consumers repair their own roofsevery 4 years (Ref. 31). These figures dorrot include consumer populationsexposed to asbestos from theinstallation, repair, and removal cfgaskets, A/C sheet, and A/C shingle,o[her processing during which consumerexposures are likely, but not qnarrtified.Populations annually qxposed toasbestos during brake and roof repairan? presented a!ong with equi~>alerrfinformation for exp~sures to ambientasbestos in Ti)ble IV of this Unit. Airconccntra!iol] ILwcls kvcrc estima[cdf!-om o(.~lipr!t:o~:jl ,!,I.I. This :niy resulti:, [L~,j~r:2sti!ll<jt(;S l; C(;<ill S~, i!S noted=;Iov:.:, cons!jnlcrs art: unlfht?ly to h:)t~enccew to [}?(?!?X~J(i Silrt. -r(?l!ll(; i~lg w{~rk

prnctices and engineering controls usedby workers.

The ability of asbestos to persist andto spread in the environment makes it ahazard to millions of people who maynot have any direct occupation! orconsumer contact with asbestosprotiuds, Several ions of asbestos arereleased k the ambient air duringmining and milling, during themanufacture of asbestos products,during brake use and repair, and duringconstruction and demolition (Ref. 29].Additional asbestos is released fromasbestos products during other parts oftheir life cycles. Once released, thisasbestos accumulates and spredds in theenvironment. Air monitoring studieshave demonst~ated that nrhan areas,with their high concentrations of motorvehicles, construction, and demolition,generally have levels of airborneasbestos one or two orders of magnitudehigher than rural areas. While ruralbackground levels range between 0.01and 0.1 #g/m3, readings in large citiesrange from I pg/n13 upward [Ref. 3).Thus, asbestos released during the Iifccycle of asbestos prducts is capable ofelevating ambient levels of asbestos toseveral times the background le’.rel.

The release estimates andatmospheric modeling that EPA used toestimate ambient exposures capture atleast part of the contribution ofasbestos-containing products producedand used in the future to ambjent levels.For this rulemaking, EPA crilcula!edambient exposures attributable toreleases from mining and milling, themailufacture of asbestos products, brakeuse and repair, and construction withasbestos products. Since the proposal,these calculations have been expandedand refined to include ambientexposures from brake repair,construction, and demolition.

To estimate ambient exposm-csattributable to milling and productmanufacturing, EPA first estimated ~iremissions per facility in milling and ineach product category, using productionvolumes and the efficiency of pollutioncontrol equipment for eech jJrodoctcategory. EPA then used atmosphericdispersion modeling based on site-specific meteorological data to estim;iteambienl concentrations and exposedpO~::l:i!ii>rlS. Bemuse the numb,?r ofpldiifS in<olved in !!Ie manufacture ofi]~b~stos products is qoiie large,lilOlli[O1’i17gair concen(ra!ions art}undeach plan! is impractical. Theatn)c~;rll(?ric modeling used in EPA’Sa.sbt:stcs exposure iiil:il~s~s hi]s beentv. s!cd on other pollutants and hiis imenf:Int! ~cnerally to predict their

concentrations within a factor of two(Ref. 47).

As explained in the AsbestosExposure Assessment (Ref. 29], EPA’smethodology to estimate asbestos airreleases from manufacturing andprocessing plants is presented in tile~!alch 5,1907 draft EPA repor! E?ntit!cfiNational Emission Standards forAsbestos-Background Information f,jrProposed Standards (Ref. 46). Thisdocument presents emission scenariosbased on the only published study onthe efficiency of baghouses in theasbestos industry. For each industry,three emissions scenarios werepresented for baghouses operating innormal, non-failure mode: minimum.maximum, and “best estimate’”emissions. These scenarios were basedupon three different assumptionsregarding the sensitivity of thegravimetric analytical method used inthe study. For all three scenarios, TWAefficiencies were also calculated takinginto account occasional baghousefailures. Time-weigh!ed efficiencies furvarious asbestos product categoriesrange from between 99.965 and 99.65gpercent under the maximum emissionscenario with occasional baghcusefailure assumed to 99.99 percent for a!lproducts under the minimum emissionscenario with no baghouse failureassumed. Under the “best estimate”emission scenario with occasioni]lbagbouse failure assumed, efficienciesrange between 99.968 and 99.988.

For [he maximum emission scenariowith no baghouse failure assurncd, anormal operating mode consisting of Iwoefficiencies, 99.95 percent for asbestosproduct categories with high inletconcentrations (greater than 0.1 grain/cuft) and 99.67 percent for productcategories with low in!et concentratioils(less than 0.1 grain/cu ft) was used. Th?asbestos product categories with highinlet concentrations, for which anefficiency of99.95 percent was used, areasbestos-cement sheet and pipe, frictionmaterials, and reinforced plastics. Thoswith low inlet concentrations, Cw whic!~an efficiency of 99.67 percent was use{].are paper, coatings rind sealants,gaske!s, and textiles. For purposes otcomparison, EPA presm:ts some rcsalisin this preami)le using both themaximum emissions scenario ~vith nobagfrouse failure assumed and the “1,.,:’estimate” emissions scenario withoc[;as[onal baghouse failure assumc:i.kiowcvcr, in many cases, EP;\ presentsr~”~ul{s in this prean; b)e using only !!!(’maximam emissions scenario ~f~fh 11,~baghoum? f’dilure assumed.

EPA estimates that 12? mil!ion pl’op]t’arc exposed to arnbieni as~cstos

I

2$?’178 Rxierai Register / VrJ1. 54, No. 132 / ‘W:ednesclay, July 12, 3%39 \ Ru]es and Regulations———- —

AFiY ~ANUFXWFf HiG

,I

TABLE 111—EXPOSUnES TO AM13\HJT As-5.ESTOS FROM PRIMARY AND SECc,m-

AFiY tvtANUFACTURING-&h7tinUed

—.————..._. -r______

—.— ——-—––~— ----

Drl.m brake Iiomgs(L}.!V) ......................... .[ 3A,542 ,107

Disc brake paos(Lh4V)................ 24,065,022

CISCbrake pads (HV) .... 1,704,883Brake blocks 9,785,424CMl:cnf6cings 8,761,571Autcxnatm

;rar~-sm&cmcomp~nen!s, ............... o

Fnctlon materials ......... 12,922,247A9bs9tos clothing 0Sheet gasuets r ............. 43,612,019Roof coatings .....[...........[ S4,570 ,429Ncm-reef coatings ..........1 70,389,388

AveI .7qeE!qxmxe(to” !yr)

0.0575

ow’f40.0000008.270 00srja00027

00.0023400.005610.002330.0000394

1 Exposures hsted include a rdafiwely smallnumbw GI exposures posed during the pmducbon ofspecla!ty ?ndustnalgaskets, wh!cn am not banned byWIISrule,

To calculate exposures to asbestosreleased into the ambient air frommining and construction sites and frombrake repair facilities. EPA estimatedemissions on the basis of its inkn-mtitionon occupational exposures duringmining, cons’mction, mrd brake repair.Then EPA used atmospheric [dispersionmodelling to calculate concentrationlevels and exposed populations.

The following Table IV lists theexposures and populations associatedwi [h releases from construction andbrake repair. The populations exposedare ~FProximatei Y equal tO the urbanp~puiation of the LJ.S. “r!lere are twoexce~t ions: (I) brtikes for tight- aGdmedium., weight vtihicks, fur whichAT::}I:]l corisurner exposures are addedin, anti (z) roof coatings, for whichann[lal cuusumer exposures alone areCour; ted.

L.>:o :?OW’ ,GEPAII?— --- ————. —.—__ —— ...

I Pm

product, —- --- -—..—_________ ._I Irlwi!!:itlrm

lC $ fl’yr———

0 WOO180.00002640.000002380.CWOCW30.000!)052

).1{.,4

;s

Repair and dlsDosat————. ~.——.

Prrpulaaon I 10@f/yr

17f 136 J73~-—

—.——

,7;,136;73 / 0.000006~

. . . 0.0000173171,136,373 0.000G025171,136,373 0.0000067I a3.793,774 0.0123J79,442,3~4 000624170,071,494 I o owXrrr587170,771 .$9.’ 0.000017 i

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“[’OGllClll~t(? e.\p{)’SL!rCS!0 LiLb&StOS briikt~ USC, EI>A first calcultir~d the total in ea[;h of 24 A.mericrin cities, using

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Federal Register / Vol. 54, No. 132 / Wednesday, ~uly 12, 19119 I Rules and FteguIations 2947S—.

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w[ima[e$ ofm:les traveled by vehicletype [bf?ci:usf! f?!I:issicns vary by vcfticle

.,type) in C227 city. Sceond, EPA~prf:x-rm~’d ;>~~ospheric dispersion

m,wfel{ng :’f t~i?~e emi:; sions to cstiin J!P?cancer]tr%ti~}~~s in each city. Third, EP,\p,-wuwd !h$?r!it:es 10:W!:Z by~{]~(]?;lfi,.-:l,ot, izin. ing Z!”Jf21~clsfir .c~lp,cCF,fI’iT’~(ll).Sfor each group. rOes.’imat~ :;;~ .Fopu~atiG!ls expused toe~:cfi of these average concentrationsnationwide. EPA added up thepopulations living in the U.S. citiessimilar in size to the cities of each groltp.Ilecause Rone of the original 24 citieshad fewer then 25,000 inhabitants andbecause vchitxhr traffic is lessconcentrated ir. rural areas than incities, popu!atioli~ living in areas with

fewer tfwn 25.000 inhabitants wereassumed to have no expomre toasbestos releaseij during brake use.Finaily, EPA averaged the estimatedconcentra tiorks over all populationflro~]ps from areas with tnore tharr 25.000

iri!abitants, weig!:ting e~chcmncentretkm bj~ the population.exposed to it. Using this technique, EPAestimates that 100 c~il!iwr people (the1930 U.S. population living in areas ofmore than 2s,(Y12people) are exposed to8.7 x N’c pgjm$ of asbestos resultingfrom the use of cshestos brakes (Ref.31). The individual risk of developingcancer from a Iifetiine of exposure tothis cortcer, !ration of asbestos isestimated at approximately I in amillion, a !e.vei wltit!l is Sigilificant giventhe very large population exposed.Because populations living in areas withfewer than z5,000 pecple (55.5 percent ofthe U.S. popu!:i!icm) probably areexpcwd to St letist some asbes!os frombrake use, this estimate should beconsidered a lower bound.

In add]tion to the expcwuresquafliifisd ,,bo~-e, EPA believes thatother s;gr~~l]:ant amllient exposuresoccur thsi cannu; be easily quailtified,tine type of unqu~ntified exposureresults from releasm of asbestos thata;e difficult to measure, SUCk as i~e

gradual weat!ler@, and disintegration cfconstruction products used outdoors. Anumber of stadies iildicate that thesercl~ases ax probably sigriificant.Indirect e~iidence of weathering comesfrom severs! studies Of corrosion in A/Cpipe; soft, ricid water has been found todissolve A/C pipe in some imswnces(Ref. 84). Beczuse rain water is likely tobe botfr soft and acid, it is !ikely to beI,ery corrosive to A/C materials.

Direct evidence of weatheringsupports this i>relectiwt. A study oferosion in A/C shingle found visibicdifferences in wear between areas ofshingle that were exposed to the

eIemen:s a~!ii areas that i.vere protei;ted,and in.spertl:m uf tke worn awls Wiifl asca:zning lcctnm nl[croscope revca!ed anetwork of asfie!;tos fibers on theshingle sl.mfqce. ;n add]tirrn,Cmcclitratio?s of aslws~cs as !rip,h as54? mil!i.~!l .F!:Ors p~r !i:f. r (n)fi,) ivf~rrf{]ullii in r ~:l,:ff ~:n!~~~tcd fre.~ rOof~r;cvc,-cd in .4 ~C sin~!e. Ten mff, is[:n~qj(--<.~p} ::;:~:~;>,~{,!!lY i@: iR~~f.5?)..k?lOitJC? StL?,:~ dc{ecisd aSkJ,?S!W3

rc!e4sr?s frf.~mconstruction materiaisaf!er a shirr~le storm; several airszrnrJ!cs :n! iJ.I after a hr~avy rein a! :isch:~c! Ivitb A,/C w~!k.ways. and roofp<,rt?!s ZEw+ed significantly elevatedasbestos concentrations [Ref. I). Thus,in arc;ls wfrwe there is widespwad useor A/Z sheet afid A/C shi~lq!o,weall]erixlg is prob8!Jly a!l !n~portantsource of arntr~cnt asbestos.

Anodier iype of unqwrrtifiedexposme results fro~. the ie~:dencies cfasbestm !:2 pmsist in the wrvironm. erttand to reer-,!er the air after settling out.Both !he riwfibility and aerodynamicproperties cf asbestos are welldocumented. The extraordinary abilityof asbestos to survi~e for long periodsunder :1v~r!et ‘ ri different conditions is}foften cited as an importani re~son for itsmcoiporaticn into a number of products,incladirig paper products used asinsulation, frwtion meterials, asbestoscement products, packings, and gaskets.Reentrainrneni is supported by studiesfinding hig]i :ii~bome asbestosconcentr:llions not rmly near waste pilesbut upwind as well as downwind ofpoint w;[lrces (R:: f. 48), a finding mostlikely to result from the resuspension ofasbestos rfcposited earlier “bywindsblowing in i!re opprwite direction. Thisevidenc;e indicates thai over time,asbestos buiids up to some degree insurface wa!crs and soils and that someof this build-tip is contiiluous]yreentrairmd in the air. Tk, is process ofbuild-up an;i reen!rainment is referredta as environmenta~ loading. f3ecausethe likeiihm,ci ~f reantrainment in theenvironment depen{:s upon a v~~mber offa(;tors that are difficult to measure,il>ciudi~fg the frar. timr of ast)est(js that iswashed ,JwLiy by rainf.; !i or buriedunde~ ],::c} ~oi} dep{)s~{s, reen:rsillmen[has nut bc~:u included in EPA’satmospl:c?ic modeiirrg. Thus, EPA hasnot qu~]ri+~]~cuiexposures attributable topnviror,.~!erlttii loir,lin~, Nonetheless,EPA is t vrj’ c.or:cerned shout thepossifile impact of tl;;s process onex.l~osu; ~s to .m,lbient asbestos. Civsmits cfur:+hIii:::, asbestos may persist inthe en} mc:lment for a cfeca~ie m mrjrrafter its o[:~inal rel:~ase, andtmvironnlcntai ioading is likely to bemost set’r:e i:; urban areas, where large

populations both crea!e ond come iiltocontact with 3sbcs Los rwleases. In fact,the ~~ev:J~ed ~oncel~tratiflIiS Of ‘d~b~sIOSfound Ijy numerous s!udies in urban

] ‘. Tm.areas pro bol) !-v rwu t .l! ,L<lSt in ~p:lrt

from en. imi}mfintal loadii~i~. The1 lI; :j,. itv of !5c risk o~~scd bV,P(!!LJ7)*!L.

. ...1. .,: .-cclvlron,me].i=,t ICJ<j...Ing Wau &mf.){~rfac!o: in FP:”i’s !,cisic:l to r’J~min3tethat risk at ii:; s~ljrce 1;> bari:]in~ MOS!asbzstos pl”o(fucts.

S(:me cornn~enters argued !hatexposures to asbestos re!cased into theam~>ien? aiI !l~ t}le martufactlme,in>portatic!i, p?{]c.,ssins, and US(: O!

asbestos-c oJl$:3i:;ing pr9ducts =Peinsignificant because the risksassociated with such cxprxru:es are verys~r-rail.However, individual risks fromasbes!os in the ambieni a~r t;an be quitehigh frw persons living n.mr asbestcsproduct plants, construction sites, orother sources of reioase. As notedear!ier, under the maximum emissionscenario with no baghmrse faiiureassumed, a number of people wouldii~cur risks of ai least I in 1,000 ofdeveloping cancer by living m suchareas. Under the “best estima!e”emissions scenario, many thousands ofpersons wouid stili incur a risk of atleast 1 in 10.OO9 from ambient exposureto asbestos from plant emissions.Moreover, whiie most people exposed toambient asbestos from asb/stos-containing products incur individualrisks smaller than 1 in 1.000, the numberof people exposed is exu-emely large,making the Iotal risk a concern.

c. Exposti,Fe from imported crndexported asbestos products. EPA hasdctet-rnmed that sigiiificaitt exposure islikely from imported asbestos products.Although some exposure to U.S.populations is avoided when asbestosproducts are ma fiufacturcd abroad andimported rather than manufactured inthe U.S. (for~iga exposures and resuilingcancer cases are not included in theesthmates for t!lis rule), significantexposures still occur af!er import of theproducts intu t}.is coontry. 11.S.exposures occur during transport,ins!a!!;3?]on, use. niainten;ince, removal,and d~sposai oi ~he produ~i. As nottidabw:e, large numbers of people areexmrscd to Jsbcstc;s during thesea(; tivities and the level of f;xposure ~soften quite high.

Significant exposures ;1s0 occtirduring the U.S. porii,on cf the life cycleof asbestos-containing prodwstsmanufa::tured in this count~y for expo; t.These exposures occur during ~hemining azld mil!ing of asbes;cs fiber andthe processin~ of fiber into producis.Famiiirs of workers and populationsliving near mining and manufacturing

2@Mfl Fedwd Register / VO!. 54, No. 132 / %Vpdnesday, ju!y 12, 1939 / Rules and Regulations-e .= --—.— .. . ..-—____________ .. . . . . . ..._ ._ —w-— .— . . . . .. . . ___ .———... —--- ~.—— .—— —— _..

sif:s are also exposed to asbw!os as G

restdt of these activities. ‘I%wefow, ris isdiscussed in (Jrrit HLff of this prenmbie,EPA finds under section 72(a) {2) ofTSCA that the m~~ofacture orprocessing for export of asbe\t~w-containing prociucts that fire su}~j<~cttothe rrr!e wii! present air ur,rpssoQal,leri~li of irtjur~ to hljii];irt ttLL:l!h,‘Uhere:ore, the rn;lnufac?ure andprocessing of esl?es!os-c[;rtt!,il~ingproducts for expert is not exemptedfrom this rule unrf:r section 12(i+][l ]. nndis subjtxt to the rule’s fmris.

d. Exposllre cOrr[;!li.SiO:lS. h

corrc!usim, EPA finds the intensl!y,scope, and potential Iongeviiy of humanexposure to asbestos released during thelife cycles of the products subject to thisrule cause for serious concern. In spiteof efforts to control exposure, asbestosis released and inhaled at all stages ofthe life cycles of asbestos products;extensive exposures have beenquantified for workers, consumers, andthe general population. EPA estimatesthat thousands of asbestos workers andmembers of the general population incurindividual risks near 1 in 1,000 fromexposure to asbestos released from theproducts subject to this rule and thatmillions of people incur risks near I in1,000,000 from such exposure. Theserisks are very large. Moreover, evidenceindicates that significant exposures takepIace that cannot be quantified. EPA isespecially concerned about exposuresfrom environmental loading, which mnyoccur long after the initial release ofasbestos from a product,

B. Environmental Effects

‘f’he unreasonable risk finding for thisru!e is based on the risks to humanhealth posed by exposure to asbestos.These risks are the most readilyquantifiable ccmsequerice~ of thecommercial use 0! asbestos and i{i O

sufficient to support the actions tafw:~ inthis rule. However, EPA is cuncwnrcf~bout the potential (:nvironiner{tuleffects of ambient loading due t:jcontinued mfinlifdcture, impr; rtif kio(~,processing, and use of rx)mmev;iaI

‘Las wsios prwlacts. Exposo~e to ,:.r ~hg~t(]f<fillers has beprr clearly shmvc in bothhuman and animal studies to causesevere health effects. Effects (In ~~iidi!fehave not been quantified for purposes orthis rule. Iiowevw, l]ecause AS!YQ! .5fibers are extremeiy fiu:abie :J\],i

!P:mnsport~l’r~ie, r,P,A bp!it, ,.,f,s ?}l.!m~rrtiin{lec asbestos usf; wi]] I,f:i,& ~. ;1

k?gacy of serious hci~lth :Indenvironmental effects due k; uil!l:~t{lral!yhigh concentrations of :.sb(:stos in !i]::drnhient dir.

(;. ,~.q[jf.s~o~s(,~$~ifu~~

‘This Unit ciiscusses the reiat ive. .>.va~labd(ty of substitutes f(w asbestos in~j5~1astos-cont[iin ing products and the

potential health hazards posed ~,y such~ci[)3~~tiifp~.~pfs has found (h:it Sui!aiJie

~ffbs!itutes currently exisi for r7wst uses

of tisbestos. EPA believes tbrtt thebenefits to society of asbt.su~s -containing products are rel~!ive!y sm;i(l

because of the current availti5i Ll:y ofmany s~ib~titutes and the e-=:pectedde~:elcpnwni of others afterpw.nllilgation of this final rule,

1. Availability o,fsubstitotcs. Thissut;ject is described in more detai~ inVoiume 111,Appendix F of theRr@atory Impact Analysis (RIA).Further responses to comments on thesesubjects can be found in the Response toComments document. The availability ofsubstitutes for the various productgroupings subject to this rule arediscussed in Unit V.F. of this preamble.

The following Table V lists currently-available major substitutes for asbestos-containhg products that are banned bythis rule and the market shares for eachproduct category projected for thesubstitutes in the absence of asbestos,This breakdown does not take intoaccount the development of newsubstitutes or new applications offixisting substitutes since thepreparation of the RfA. It also does notoccount for the likely development ofnew substitutes before the effective dateof this rule’s bans. EPA is aware that itmay not have identified all substitutesfor asbestos-containing products andthat the costs of the ruie may beoverstated as a result.

TABLE v. —PROJECTED MARKET SHARES

OF CURRENT SUBSTITUTES. ..— ————

I Apofo,imale

%odu:l and substltctiteI M%.W%3

_—— ._ !__ (P~cent)..— .——

4832

20

25302010105

405010

TAEfLE v. –-PFKMCTED MARKET %AFWS

OF @RRfNT SUf3STlTUTES-COntinued.—. - ..—-. —..——. -

----lzm.wm

—.

...-. -..— .—.—..—— —— ..—pe~~n:~_WC pipe.

Ppiywnylch!onde (PVC) .. . ..... .. . .

ilb:!l!e iron. .... . . .... ... .. ........,~ f~ ~1~~~h~~

Cai;vim skate.. ..................... . ...!km-calciurn swca$c .... ... . . .. .. jLa!wa!cuyst,aet . ..... ...1

AK corfdgaterl sheet~b~rglass ~~nforced plastic .......

Alummirm.... ....... ... . ............ ... ... .Sleel ...... .............................................Poiyviv~lchh>dde . .. .... ... ..........

AIC a3mgiesWood. ...... ...................................vinyl....................... .................... .......Asphatt...............................................Aluminum...........................................Tile .. ........ ............... ............ ...........

Drum brake liningsNon-asbestos organics ...................~%l-metaillc .....................................

Disc brake pads (LMV and HMV):Semi-metrillic ....................................

Brake b!ocksNon-asbestos orgarrics....................Serni.mf3t9111c.....................................

clutch facingsEuroperin woven ...............................U.S. woven ........................................MoMed aramid ..................................Molded fiberglass ............... .............

Automatic transmission compe-nrmtsCellulose ............................................

Other friction materialsFiberglass & pera-aramid .......... .....

M}!lboerd:Standard board .................................Premium board .................................

Specialty paperEarth and cellulose ..........................Loosa cellulose .................................

Roof ceafingsCellulow ............................................Polyethylene . . . .

:rL-

othEx ........ ..........................................

S@)ehc I)bers...,.. ... .... ... .. ....... .Clay and mineral.........................

937

764

20

4832tl9

322720192

39i

100

991

50301010

100

100

8020

5050

8765

7030

.—

Suhstit~i!es for asbestos pr~ducts mesteadily being developed and acceptedin t!~e marketplace. R should be notedth~t a riiii]:ber of products that arest!i)je{; t iO this rule’s bans are no longermunufitcturecf or imported in the U.S. In~bt,se ~:ises, ~ia~ie substitutes have

ZIPP~+rt:f~t~Y-fOr~ed asbestos-containingproducts from the U.S. market. Anincreasing rate of availability andacceptance 0! substitutes us evickmcwiby a inure rapiff decrease in asbestosusc in ii~os? prodluct categories than wasDrfdiclc{i in ihe Ml for iii: i;ro~omi.i~it:’i{: {ij?jTiCi-iiS E ,Jve i~er?:lfe:i ne,.

i ‘-dicated that s\l!jstiluteSill lSltii12,S iln{ 11:

prices have derxeo~ed substantiallybeyond the estimates generated in theWA for this fins! r~le. [n riddition, EPAh~li(:~r~.s !ii;it ljli S r(;le %Vili further splir

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Federal Register / Vol. 54, No. 132 / Wednesday, July 12, 1989 / Rules and Regulations 29481

the development of substitutes, therebyincreasing availability and decreasingcosts.

Z. ifealfh risk review of fibrousasbestos substitutes. This Unitaddresses the potenhal health riskscatJsed by exposure to various fiberspmjecter! to replace asbestos inproducts banned by this rule. Thissubject is discussed in more detail in (I)“Review of Recent Epidemiologic]Investigations on Populations Exposedto Selected Non-asbestos Fibers” (Ref.35): (2) “Ilurablc Fiber ExposureAssessment” (Ref. 36); (3) “DurableFiber Industry Pmiile and NfarketOutlook” (Ref. 37]; and [4] “I{ealthHazard Assessment of Non-asbestosFibers” [Ref. 38). Further responses tocommen!s on this subject can be foundin the Response to Comments document

Based on available information and apubIic health policy regarding asbestos,EPA has more concerts about thecontinued use arrd exposure to asbestosthan it has for the future ?ep!accment ofasbestcs in the products subject !O thisrule with other fi!~rol~s substances.Available information about the fibroussubstitutes under review for thisrulemaking supports t!le conclusion thatthe fibrous substitutes appear to pose alower human health hazard thanasbestos (Ref. 38), However, due toIi-mited data, EFA cannot quantify therisk that may be posed by fibrousasbestos substitutes. EPi\ believes it isprudent puMic health policy to regulateasbestos rather than !O delay regulationuntil all risks of substitute products aredefinitively determined. This conclusionis based on a consideration of (I]Available data on the health hazardsand exposures posed by asbestos andits substitutes; [2) the factors thatenhance or mitigate fiber pathogenicity;(3) an understanding of the deficienciesof the data available on health hazardsand exposures of substitutes; and (4)EPA’s public hea!th policy of reducingknowm, serious hea!lh risks.

a. Background EPA, for the propusedrule, performed a review of the availablehazard and exposure information oneight fibrous substances that couldsubstitute for asbestos in “AsbestosSubstitutes and Relaid klateri:~!s” (Ref.39). !n respor.se !0 public comments

received on !!]e proposal, EPAconductd an extensive rm,iew ofavailable infomuitinn and (}~di~+(+diishazard and exposure asswsment offibrous asbestos substi!u!cs (see Re.is.35, 36, 37, and 38].

Specifically, this analysis included sixman-made or syntheiic fibrous materials(aramid fibers, carbon fiber, ceramicfibers, fibrous glass, minerai wool, andpolyolefin fibers). and two naturally -

occurring fibers (attapulgite andwollastonite]. These eight fibers wereimfividualiy selected for review because(1) They al-e commercially important: (2)they are potentially the major fibroussubstitutes for asbestos: (3) theyrepresent fiber types with b;o.sdlydifferent physical and chemicaicharacteristics; and [4] hazard andexposure data are available. EPA choseto place its emphasis cm tbe review offibrous substitutes because theirmorphological similarity to asbestossuggested that they may induce ci~nax.Other non-fibrous substitutes,specifically, vvood and other celluloseproducts, cement, and bricks, appear topose little or no health hazard and. forthis reason. their potential nealth effectshave not been analyzed in detail for

?urpo~es of this rule.b. Health e,ffect.s of fibrous

substitutes. EPA conducied acomprehensive review of theexperimeiital and epidemiologicaIhazard data for the eight fibroiissubstitutes (Rcfs. 35 and 38). Avai L>bleepidemio]ogical al~d toxicological dataindicate that inhalation exposure tosome fibrous subst]lutes Imay beassociated v:ith malignant and non-rna]ignant diseases in humans.However, the evidence ofcarcinogenicity and fibrogenicity oftnese substitutes is more limited tha~ forasbestos. Based on available data, EPAhas concluded that, under similarexperimental conditions, the fibroussubstitutes are generally lessbiolc~ically active and pathogenic thanasbestos (Ref. 38). Unlike the fibroussubstitutes, asbestos is a well-recognized, potent human carcinogen.which a!so causes non-malignantpuhnonary effects. At this time, EPAcannot make a definitive assessment ofthe biological activity and pa!hogenicityof fibrous substitutes in comparisonwith asbestos because available data onthe health effects of the substitutes areincomplete. EPA has not derived rtcarcinogenic potency for any of [hefibrous asbestos substitutes suspectedto pose a carcinogenic concern, becauseeither available epidemio]ogical dataand/or animal inhalation data areinadequate to estab!ish a quaotitati~eexposure-response relationship or tumorresponse h+s only been Observed ii~

anima!s via non-physiolo~ic(]l rol!!cs ofadministration, such as inira!~eritonciilinjection [Ref. 38].

One commwi!er contended th.]t apotency val(]e could k cietermined i’orfibrous @ss and minerai wool based onepidemio~~>gical data and concluded thatthe potency may be comp,lrable to orexceed the potency established forasbestos. ISPA has conrluded that a

po~ency value cannot be derived forfibrous glass because theepiriemio]ogical evidence forczrcinogenicity of these substances isinadequate. The data cited bycommmters do not show consistentt:it:~t:tiOil of lung cancer risks in exposedworkers or provide sufficientil)fi>rmatirrn to demonstrate a dose-response relationship (Ref. 35]. Further,it is not appropriate to compute potencyvalues from the available experimentaldata because the inhalation studies inanimals did not produce tumorigenicresponses (Ref. 38). Similarly,carcinogenic potency cannot bedetermined for mineral wool becausedose-response information is notavailable from existing epiderniologica!st~dies (Ref. 35) and no tumorigenicresponses were fowid in availableinba!afiun studies (Ref. 38).

The com,meniw aIso stated that a unitcancer risk cwlld be developed for~ramid fibers using results from ananiili~] inhalation bioassay for ultrafinepara-aramid. The commenter made useof the linearized multi-stage procedureto (;}~!culate risk. [n calculating the unitcancer risk va!ue, the commenter onlyconsidered a subset of the bioassay data(Ref. 56). Consequently, EPA does notbel;eve that the analysis presented bythe commenter adequately reflects theresults of the bioassay (Ref. 56). EPA iscontinuing to gather additionali~formation to evaluate potential cancerrisk of respirable aramid fibrils.Additionally, EPA is assessing theappropriate model to use to extrapolatecancer risk for aramid fibrils.

Unprocessed commercial-grade para -mwmid, a type of aramid fiber, ismanufactured in sizes that are too ]argeto be respirable (Ref. 36). [n addition,not all types of aramid fibers areexpected to produce fibrils (e.g.,,continuous para-aramid) [Ref. 36]. Thepara-aramid used in the cited animalstudy was a highly respirable materialmade specifi(;ally for the study (Ref. 38).Although the commercial-grade of para-araroid is believed to have the potentialto generate respirable fibers as the Smi+llfibrils peel off from the norr-respirableCOI,C matrix, expoSllre data are too

Iimite(i to de!crmine if fibril formationpuses a significant concer:~ Limitedmo~ii[oj i.n~ d{ta (combined areasi; mpics and personal samples) in(iicatethat ~~j}osures to para-aramid fibriisra::+~, ~wm not detectable to a maximumof 7.5 !’/cc [Refs. 36,54. and 55].According to a comm.enter, duringmiinufacture. a maximum likely 8-hoilr‘T1’VA[)f O.I f/cc was recorded.Accord int; to the same commenter,(iuric~ ;]rwfuction and processing of

29482 Federal Register j VoL 54, No. 132 / Wednesday, July 12. 1989 / Rules and ~egu~at~ons—— —.—. —

friction materials. the maximum likely 8-hour TWA was less than 0.1 f/cc. Due tothe way that the monitoring data werepresented, it is difficult to determine ifthese data are representative ofoccupational exposure [Refs. 52 and 53).In addition to the limited monitoringdata, exposures were only monitored ata few industrial operations which aresuspected of producing respirable fibers(Ref. 52). Additionally, it is not known ifthese operations are representative ofthe industry (Ref. 53). Based onavailable information, EPA believes thatneither commercial-grade aramidproducts nor fibrils formed from suchproducts may pose major occupational,cmsumer, and ambient exposures.Generally, it appears that aramid fibrilstend to curl and clump together, thusreducing their tendency to become orremain airborne. Fibril formationappears to be a by-product of aramidmanufacture and processing. Fibriis arenot expected to become an integralcomponent of aramid products. Incontrast, asbestos becomes airborneeasily and can remain airborne for longperiods of time.

c. Respirability. A basic propertywhich allows a fiber’s potential toxicityto be expressed is its respirability, i.e.,the ability to penetrate into the lowerrespiratory tract. Respirable fibers aregeneralIy defined as fibers with actualdiameters of less than about 3.5 micronsor an aerodynamic diameter of less thanabout 10 microns. Once in the lowerrespiratory tract, other factors such asfiber length and diameter, surface, andchemical properties are thought toinfluence biological activity (Ref. 38].

According to available information, alarge percentage of the productionvolume of these fibrous substitutesconsists of non-respirable fibers (Ref.36). Because non-respirable fibers areunlikely to enter and penetrate the lung,such fibers pose minimal risk ofinhalation !oxicity. However, someportion of the production volume formany of these substitutes containsfibers of respiiable size. Such fibers areof concern to EPA. However, availableinformation indicates that fibers in therespirable size range are generallymanufactured for specialty uses, such ashigh-temperature insulation materials,filtration media, ear defenders,spacecraft, and aircraft insulation (Ref.36). Specialty uses may be of concern interms of risk tc individuals but dc nothave as great a potmtial for broad;opl:lat;on exposures.

d. Exposure of fibrous substitutes.EPA conducted an analysis of thedurable fibers industry which includedinformation about producers, uses, and

futu’re trends of the eight fi!jroussubstitutes (Ref. 37]. EPA also developedan exposure profile of durable fibers(Ref. 36). To this end, EPA conducted asearch of the literature and surveyedindustry sources. This analysis focusedprimarily on activities and applicationsmost likely to generate airborne films ofrespirable size. Exposure data forfibrous substitutes, although verylimited, were available for all fibersexcept polyolefins. Most exposure dataavailable in the literature are for fibermanufacture. Exposures during man-made and synthetic fiber production aretypically less than 1.0 f/cc becauseprocesses are highly automated and -often enclosed, meaning that operatorsare rarely in contact with the fiber [Ref.36). Many of the packaging operationsare also automated and ventilated, andthe exhaust is sent to dust collectionequipment (Ref. 36). Often the fiber sizecomposition of a sample of airbornematerial is not noted. When fiber sizedistinctions have been made, respirablefibers can constitute 50 percent or moreof airborne fibers. However, as notedabove, airborne fibers typicallymeasured less than 1.0 f/cc. Mach of theairborne occupational exposure dataavailable to EPA is outdated. Sincemany of these data were developed, theindustry has become increasinglyautomated (Ref. 36). Therefore, currentexposure levels may be lower.

Production of natural! y-occurringsubstitute fibers presents a differentexposure scenario than man-made fiberssince the former are mined and milled.Mining and milling have traditionallybeen “dusty” operations where the useof engineering controls or perscnalprotective equipment are difficult tointegrate into the routine operations ofthe industry. Mining operations arelabor intensive and exposures are like!y;however, most mining is performed inopen pits which allows for someventilation. Milling operations usemechanical grinding and screeningmachines and exposure occurs toworkers who run these machines. Bothdust and fiber concentrations have beenshown to significantly exceed OSIIA’Snuisance dust standards (Ref. 36).During wollastonite milling. a limiledstudy found fiber concentrations rangingfrom 30 to 60 fibers/cc (Ref. 36).

Whiie worker exposure to attapulgiteand w-ollastonite may be high dwringcertain mining and milling activities,zvailabie information indicates lowhaz~rd for wollastcciite or short fi!mattapu!gite (Ref. 38). Attapulgite minedin the U.S. is of the short fiber variety{Ref. 36]. The U.S. supplies over 90percent of the world-wide demzind for

attapuigite [Ref. 37). Based on EPA’sanalysis (See Unit V.C.1 of thispreambie], neither attapulgite orwolktstonite are expected to beimportant asbestos substitutes.

Some cornmenters cited exposure datafor various fibrous products andconcluded that the exposures scmetimesexceeded the asbestos PEL. Thesecommenters were concerned thatexposures may pose a significant risk. ingenerai, production and use ofrespirable-size man-made fibers andmining and milling of the naturally-occurring mineral fibers, may potentiallyresult in some exposures that exceedexposures from asbestos [Ref. 36). Whilethe data on certain fibrous substitutesindicate that occupational exposure mayrange from not detectable to levels thatexceed the asbestos PEL. levels inexcess of the asbestos PEL alone willnot lead to significant risks unless thesubstitutes present a health hazard of amagnitude approaching that of asbestos.As explained above, availableinformation on the hazards of thefibrous substitutes indicate that they areless biologically active and pathogenicthan asbestos.

Given the scarcity of exposure data,the numerous types of processes oractivities involved, and the variablecharacteristics of the mariy fibrousmaterials, EPA has concluded thatreliable projections cannot be madeabout exposures to fibrous asbestossubstitutes. This is contrasted withasbestos manufacturing, processing, anduse practices, about which much isknown aad such conclusions orreasonable projections about exposurecan be made.

e. Risk o.ffibrous substitutes. Somecommenters stated that EPA shouldperform risk analyses of the same depthfor the non-asbestos substitutes as EPAperformed for asbestos. Commentersalso stated that EPA’s substituteanalysis should considw the entire lifecycle of the substitute, including the riskassociated with non-asbestos rawmaterials, by-products, contaminants,and energy production. Additionally,so,ne ccunmenters stated that EPAshould consider other health andenvironmental effects in addition tocancer associated with the substitutes,inchwfin.g silicosis and death due totza umw

For reasons described previously,Ef]J~ bel~eves that the available data

base on the hazards and exposure toisu!]siitu!e fibe:s is n~t sufficient for E.PAto perform a quantitative risk analysis.W’bile EPA adopted a life cycleapproach to its risk analysis forasbestos, EPA did not include in that

~

II

I

I

I

1’

T

I

I

Federal Register / Vol. 54, No. 132 I Wednesday, July 12, 1989 I Rules and Regulations 29483

analysis additional risks that may resultfrom: (1) Exposure to raw rnateriais,byproducts, or contaminants associatedwith production and use of aslwstcw-ccmtaining products; (2) accidents; or [3)energy production and consilnlpt ionrtiquired to produce ashtob LJIo12r.iLfs.

EPA quantified, to the extent possible,only risks of cancer Associated withexposure to asbestos fibers. E1)Aadopted a similar life cycIe approach inits review of substitutes and onlyevaluated the potential that the fiberitself may ctiuse cancer or non-malignant Iung effects. In surnm.ary, thereview approach adopted for substitutesis comparable to the approach used forasbestos and is only limited by theavailability of data.

Some commenters stated that EPAcould not conclude, based on availabledata. that substitutes pose lower riskthan asbestos. EPA ~grees that the database is insufficient to quantify the riskof substitutes; however, in spite of thedeficiencies of the data base,information is available to indicate that:(I) Some non-fibrous asbestossubstitutes pose little or no health riskconcern; (2) the inherent biologicalactivity or pathogenicity of thesubstitute fibers appears to be less thanasbestos; (3) a large percentage of thetotaf production volume of fibroussubstitutes is non-respirabie, and thusdoes not pose a risk concern; and (4) thediameter size of man-made andsynthetic fibers may be controlled, thusenhancing efforts to reduce the presenceof contaminants or unnecessaryrespirable fibers in substitute products.

f. Policy approach to asbestos andasbestos substitutes. Regulatorydecisions about asbestos which poseswell-recognized, serious risks should notbe delayed until the risk of allreplacement materials are fullyquantified. EPA believes that this is aprudent policy since: (1) Asbestos is ahuman carcingen and poses a seriousrisk to health; (z) substitute fibersappears to pose less hazard; (3) yearsare likeiy to pass before experimentaltoxicoiugical data are available toquantify or adequately evaluate thepossible health effects of substitutes; [4)a decade or more may pass beforeepidemiological data of the quality thatexists for asbestos may be available toconfirm any hazards of substitutesidentified in experimental data; (5)evolving fiber technology and theadvances within the chemical industryare likely to create new substitutes, thusmaking it quite difficult to ever fuliyanalyze the risks of all possible majorsubstitutes; and (6) risks associated withman-made and synthetic fibers appears

easier to control than the risks resultingfrom asbestos use because fiberdiameter size can be technologieiillycontrolled.

EPA will control to evaluate hazardsand exposures posed by fibmiJsm;itericls and wi!i dctem)irleappropriate regulatory action to mifiga{eany unreasonable risks that may beidentified. EPA may consider regulationof fiber diameter and length ofsubstitute fibers if it is determined thatsuch risk reduction action is needed.EPA recommends. that, wheneverfeasible, manufacturers, processors andusers avoid the production and use ofrespirable fibers. WA also stronglyencourages manufacturers andprocessors of fibers to institute quaiitycontrol practices that minimize if noteliminate the inad~’ertcnt pr[du[; tiori ofrespirahle fibers.

D. Economic Effects of the fi:~le

EPA has prepared a Re,guiutoi-.ylrnpacl Analysis of Controls onAsbestos and Asbestos Product.< (Ref.21) which analyzes the pchmu;~leconomic impact of the rule. E1>A’sassessment of the “reasonablyascertainable economic consequences ofthe rule,” pursuant to section 6(c)(l)[D),is summarized below. Themethodologies used by EPA to estimatethe costs and benefits of this rulecomport with widely-accepted cost-bcmefit techniques. The methodologiesused znd the data on which costs andbenefit estimates are based have beenupdated to refiect public comments.Further responses to comments on thissubject can be found in the Response toComments document.

1. Estimated costs. Estimated costswere derived using the AsbestosRegulatory Cost Model [ARCM), whichis described in the RIA and whichprimarily used information collectedduring telephone surveys conducted byan EPA contractor during 1!386 and 1937.EPA also used some data obtainedunder the TSCA section 8(a) asbestosrule to estimate costs< Some infmmationwas adjusted to reflect more currentdata obtained through public commentsand from other sources. The sources ofinformation are noted in the record forthis rule,

The CUSLSrepresent the net presentvalue of costs incurred due to changes inasbestos production volume betweenthe years 1987 and ZOOO,using a socialrate of discount of 3 percent. The 13-year time period serves as a reasonableendpoint for the analysis at a point wellafter all the actions taken in the ruleha~’e become effective. The 3 pm-centrate used to discount costs (andbenefits, as discussed below) is a

reasonable rate set by consensus by,EPA economists. This figure falls withinthe range of social discount ratessuggested by the economics literature

In estimating the costs of this rule,allowance is made by the economicmode! t:> esl{mate rfe(liines in the pricesof substitutes. In practice, the cost Gf aproduct. in real terms, declines over itsproduction as experience is gained inthe manufacturing process. In addition,experience under other regulations hasshown that the number of substituteswill increase as a result of productregulation. Some of the new substituteswill be of lower cost than some of theexisting substitutes or they will notcapture market share from the existingsubstitutes. Both of these effects willlower the prices of substitutes. Neitherof these efiects can be fully quantified.!Iowever, as the cost of substitutesdecreases, the overall cost of this rulewill also decrease.

The economic model does not takeinto account the cost reduction benefitsof using substitutes which currentlyhave lower costs than the asbestos-containing products. In other words, theanalysis assumes that the price ofsubstitutes, after being adjusted forproduct life and performance, is alwaysgreater than or equal to the price of thecomparable asbestos-containingproduct. This was done to account fordifferences in the characteristics ofusbestos and non-asbestos substituteproducts that cannot be captured in costdifferences. For example, becauseasbestos-containing products have beentraditionally used in these markets. abias may exist toward the use ofasbestos products rather than similarly-priced substitutes. However, thisassumption overstates the costsimposed by the rule whenever thesubstitute actually costs less than theasbestos-containing product and there isno significant difference in productperformance characteristics.

EPA attempted to gauge the possibleeffects of expected declines in the priceof substitutes on the overall cost of therule. The analysis of costs of the actionstaken in this rule assumes that theprices of substitutes for asbestosproducts will decrease by 1 percentannually over the life of the 13-yearperiod analyzed in the ARChl. Efoweverthe ana!ysis also assumes that the costof individual substitute products willalways remain greater than or equal tothe price of the comparable asbestos-containing product, for the reasonsdescribed in the preceding paragraph.EPA believes that the assumption of alimited 1 percent decline in the price ofsubstitutes is a reasonable “best

29434 Federal Register / Vol. 54, fQo. 332 / LVednesday, July 12, 1989 / Rules and Regulations.—

estimate’+ in light of the effects of thegrowing markets for such products,increasing competition and productionknow-how in these markets, and theIike!y development of new, more cost-effective substitutes that have not beenquantified for the ARCM.

C@ts estimated in the RfA includecosts to consumers and costs toproducers. Consumer losses due to therule result from increases in costsincurred for asbestos products orsubstitutes for asbestos products or frominferior performance of substitutes, tothe extent that these latter costs couldbe quantified. It is estimated thatconsumers will incur $375.4 million inlosses as a result of the actions taken inthis rule, for the period of the analysis,spread across the retire consumerpopulation.

Producer losses due to this rule wouldaccrue when producers are forced toforego the portion of the return on theircapital stock used to produce asbestosproducts. This occurs when the capitalstock used in the production andprocessing of asbestos-containingprodacts either cannot be used orcannot be used as efficiently in theproduction of substitute products. It isestimated that the rule will result in&33.49 million in total producer costs.

The rule will also result in sometransition costs to workers who aredisplaced by product bans. These lossesare incurred in the form of lost wagesand job search costs. EPA believes thatthese transition costs will be relativelylow compared to consumer andproducer costs because of (1) Theamount of time allowed for companiesto plan before the effective dates ofmost bans and (z) the already occurringtransition to non-asbestos substitutes bymany former producers of asbestosproducts.

Ths total casts of the rule wereestimated first with costs discounted at3 percent and benefits not discounted(hereafter 3 percent/O percent) and thenwith both costs and benefits discountedat 3 percent (hereafter 3 pcrcmrt/3percent). The results of both analyseswill be cited throughout the text of thispreamble. Both analyses support theactions taken in this rule. The totalestimated cost of the rule is $4 G3,EKIulil!ion. This COS!will be sprcii~ over 13

~~’~rs and e large pOpuia!ivu. Therefore.“h!: ilrrpact on mos~ pcrsuns v. i;l t,!?r.,’giigtb!e.

Ektm~ated total costs of individualproduct bans are set for:h in thefollowing Table W:

TABLE VI—COST OF THE RULE BY PROD-

UCT CATEGORY ASSUMING A 1 PERCENT

ANNUAL DECLINE IN THE PRICE OF SUB-

STITUTES

P?o151Jct

Asbes@s/ceme@ [A/C) sheet..

A/C shingles ..... .AfC PIW . .................. ... .. .... ... .Products noi currentiy in U.S.

prod,>ctimr (ashstos protec-L!ve clothing and vinyl/asbe-stosfloor file)................................

Papar products (commercialpaper, rollboard. rndlboard,corrugated pacw, and apecial-fy paper) ......................................

Felt products (f!oonng and roo-fingfelt and ptpehne wrap)

Gaskets 1...................... .......... . ...Disc and drum brake pads for

original Gqulgment mar~e:(OEM) and brake Mxka. ..........

DISC and brake pads for aft&-market (AM) .............................

Other asbestos fnctmrr products(automatii tiarfamiss+on rxsrrponenfa, clutch facings, andcommercial and industrial fnc-tron pmducfs) ..............................

Coatings (rcof coatings and nomroof C.uatirrgs).................. ...........

1Does not include apeciaffy

TrXal cost (inS mlillon,

dtscoun@d at 3percent)

2662357

f 2803

0

373

f338207.72

12.97

1273

15.20

46.29

justrtal gaskets.

EPA also analyzed the costs of therule without the assumption about thedeclining price of substitutes that isdescribed in the preceding paragraphs.Under this scenario, the total cost of therule would rise from $458.89 million to$806.51 million. Estimated total costs ofindividual product bans under thisscenario are set forth in the followingTable VII:

TABLE VII--COST OF THE RULE BY PROD-

UCT CATEGORY WITVOUT THE ASSUMP-

TION OF A I PERCENT ANNUAL DECLINE

IN THE PRICE OF SUBSTITUTES

~

Asbestoslcemeni (A/;) sheet .. ...1AIC shlngiesA/C pipe .!Products not curremfy in U S j

produc!ton (asmestos protec- Itwe cktfw 19 aria vmyl/asbes-

?0s flow tile) . . . .

Paper .tXoduc:s (Cccmtnerc]al,paper. roilbowfj, m}l:board, Icomugated paper. and scEcIai- ~fy P.29&. . ~

F:~lt prcti~cts (W wxj ; fid rwfimj f;!!! ard mp.IIoe wa,n, .I

:;.. ,< ,’ :[fist aud drum, Drake pa,~s fcr i

Wl(!m,sl equwwn: market(~~M) ard bra~e blocks.. .,

DISC ar!d b{ahe pads 10: af!er-mark@ (PM! (

3.3534.18

2!?7.33

o

3168

2515

TABLE Vll~COST OF THE F?LLE 8Y Pi?oD-

UCT CATEGORY WITHOLIT THE ASSUMP-

TION OF A 1 .PEFWENT ANNUAL DECLINE

IN THE PRICE OF SURSTITUTES—Contin-

ued

Total cosr (M $

Prod :ct mdllon,~ dmcoun;m~t 3

—I

Otk ~sb:$t:s t~;,;i{O~p,OductsLsu:cma!tc trzrrsmwwan corn.ponents, clutch facings, andcorrmerclai and Wustnal fnc-t!un produces)...............................

Coabngs (roof coatings and non-roof coafmgs) ....

27.92

160.56

1Does no! mckrda spec!alty industrial gaskets

The costs in both of these analysesare likely overstated for a number ofreasons. The methodology used in thisanalysis for dealing with a lack ofinformation tends by design towardsoverestimating costs andunderestimating benefits. This“cautious” approach is taken to ensurethat the analysis provides a strong basisfor the regulatory decision made in thisrule.

A commenter stated that EPA, in theanalyses used to support the proposedrule, underestimated the costs ofbanning the manufacture, importation,and processing of asbestos-containingproducts. The commenter argued thatEPA overestimated the rate ofdevelopment of asbestos substitutes,underestimated future asbeatosconsumption rates, and erred in anumber of other ways, discussed inmore detail in the Response toComments document, in estimating thecosts associated with the variousoptions described in the proposed r-tile.

For the final rule, EPA has updatedthe data base used to support itsanalysis of the costs and benefits of therule and has modified its analytical

. .approdch m respolnse to comruen!s. Inaddition, the decline in the rate ofconsumption crf aabestos in the U.S. hasbeen more rapid in recent years :hanwas predicted in EPA’s mocie]s. 2 otaiannual consumption of’ as bf:slf~s Iii the11.S, dropped from a 1984 tots 1of 240,00!)rnelrlc torts to !ess than 8.5,000 metrictons in 1987. This change su~gests thatthe use of asbwics substitutes hasincreased mar-kedl:: since tbc proposedrt; le ~las published.

1:, Federal Register / Vol. 54, No. 132 / Wednesday, July 12, 1989 / Rules and Regulations 29485

been adopted for those market sectorsfor which substitution for asbestos wasrelatively uncomplicated. it alsoassumes a constant rate of asbestosconsumption unless EPA is aware ofspecific instances in which substitutionhiJs been made. In addition, the analysisassumes that tfie price o! a substitute foran asbestos product will not fall belowthe price of the asbestos product forwhich it is being substituted. Therefore,the analysis adopts a number ofassumptions that likely overestimate thecosts of the actions taken in this ruler;] ther than underestimate them.

2. Estimated benefits. The costsdescribed above will be offset to some~,xtent by a number of avoided costs.While EPA did not attempt to place av:llu~ on the 10SS of life itself, or onassociated costs such as “pain andsuffering, “ “loss due to leisure time,” orother similar factors, EPA has estimatedthat the actions taken in this rule willresult in the avoidance of at least 2(]2quantifiable cases of lung andgastrointestinal cancer andmeso{helioma when benefits are nutdiscounted and at least 148 callci;r caseswhen benefits are discounted at 3twrccnt from the time of exposure,l-hese estimates assume theoccupational exposure levels based onother analogous exposure scenariosdiscussed in Unit V.A.3 of this preamble.These estimates do not, for reasonsdiscttssecl in Unit V.A of this preamble,include the number of asbestosis casesand cases of other diseases a~oided. Inaddition, EPA did not estimate !OSSW

due to lost work days or medical carecosts. Thus the benefits of the rule (costsavoided by this rule) represent prudentesti~mates that likely understate actualbenefits. The cancer-cases-avoided byindiviiiuid product category are set forthin the following Table VIII:

TABLE VIII—CANCER-CASES-AVOIDED BY

PRODUCT CATEGORY ASSUMING ANALO-G~gS EXpOSURE FOR SELECTED PROD.

ucl CATEGORIES—— .—

T ---------

—

DISCOWNrate

ProduclI p,&mt ~ pe~ent

- -–-—---–- --—- ------ --–—- -4-- - --- .+ ---- ------

I+ch-sto:fcement (WC) ,Snot.................................... 096! 1 19

AiC Sh@2S ..................... 0..23! 0.32AIC pipe ,..1 3171 430Products nc! Curren!l? in U.S ~

producl:cn (asbesicx pro. \ I!ectr:e Cloitxng arid vinyl/ 1asbc.xos :!ocr tit?) Q

~apcr products (ccmmerclal l~”paper, rollbo?rd. m!ilhoard, Icorrugated paper, alnd spe- ~ ]oaity paper) ,. i 032 0 ;3

TABLE VIII—CANCER-CASES-AVOIDED BY

PRODUCT CATEGORY ASSUMING ANALO-

GOUS EXPOSURE FOR SELECTED PROD-

UCT CATEGORIES—COrrtinued

FwS,JC1

Felt products (flooring androofing felt and pipelmcwrap) ......................................

Gaskets 1..................................Dtsc and drum brake pads

for ofiginal equipmentmarket (OEM) and brakeblocks ..................................

Disc and brake pads for af-termarket (AM) .....................

Other asbestos friction prod-ucts (automatic tram.rots-SiOn components, cJutchfacings, and cornrrwrcfaland indusL-ial Irictlon prod-ucts).......................................

Coatings (roof coatings andnon-roof coatings)................

Dtsccunt rate

3pewent

3.533224

14.55

6s.37

1.45

2.41

0percent

4.3842.S4

19,60

122.11

1.91

3.33

i UOISS riot include specialty indusfrfal gaskets.

A.naloguus exposures could not beassumed for a num!ler of exposures.Therefore, benefits are understated tothe extent that these exposures are notincluded. For example, some exposuresresult when asbestos fibers are releasedto air due to weathering of A/C productsand other products used in exterior uses.

Also, the analysis did not quantify theincreased risk due to high conceritration,episodic exposures to asbestos for manyproducts. Further, additions to ambientloading caused by the activities affectedby this rule and the resul!ant riskreduction from this rule’s actions couldnot be adequately quantified. The effectthese factors would have on thecalculation of benefits is difficult todetermine because of technologicaldifficulties in quantifying the extent ofthese releases and the resultantexposures. However, the effect could besignificant because releases via theseroutes are frequent and, on aggregate,broad-ranging.

EPA also analyzed the benefits thataccrue due to the actions taken in thisrule if the analogous exposure analysisdescribed in Unit v.A.3 of this preambleare not assumed, In this analysis, in allins(<+u{;f~s where exposure is believed toexis!. but specific exposure data are notavailable, EPA asstimed no exposure,The figures in :he following uiuirt,therefore, undwsta!e t}iC actual numberOr citll(jt)r-c:ises-ai~}ided doe to Iliis rule

to the ext I,i7[ that i;~.’jli!a[}[C monitoringdata uscIi in t!Ie, e\pusIIre andlysis

uni~ersi(if~x actudl exposure to ii St- WS{f I~.

Iil this tinalvsis, esiiniates of cancer-r.ist?s-;II:cIi~i~,~idecrease fron; 202 cases

to 164 cases if benefits are notdiscounted and from 148 cases to IZ(Icases if benefits are discounted at 3percent. The cancer-cases-avoided byindividual product category using thisanalysis are set forth in the followingn!)k Ix:

TABLE IX—CANCER-CASES-AVOIDED BY

PRODUCT CATEGORY WITHOUT ANALO-

GOUS EXPOSURE ASSUMPTIONS—._.

Product

/lsbestos/ cement (A/C)shed ... . . . ..... ... ..........

A/C shingles .. ............. . .......A/C pips ...................................Products not currently in U.S.

production (asbestos pro-tective clotfvrrg and vinyl/asbestos floor file) ...............

Paper products (commercialpaper, rollboard, mdlboard,corrugated paper, and spe-cialty paper),, ........................

Felt products (flooring androofing feit and pipelinewrap) ......................................

Gaskets ) . . . . . .. . .. .... ......t31sc and drum brake pads

for omgirmi equipmentmarket (OEM) and brakeblocks ....................................

DISC and brake pads for af.termarket (AM) . .

Other asbestos frictton prod-ucts (automatic transmis-sion components, clutchfacings, and commercialand industrial friction prod-ucts)........................................

coatings (roof coatings andnon-roof coatings) ..,..,...........

Discount Rate

3percent

—

0.%0.232.25

0

0.43

2.626.68

14.55

88.37

1.45

1.29

0percent

1190.323.11

0

0,60

3.25861

19.6a

122.11

1.91

1.79

LDoes not include specialiy industrial gaskets.

As stated earlier, EP.4 decided for thisrrdemaking to estimate potential riskfrom plant emissions using anassumption of baghouse efficiency of9%95 percent for some productcategories and 99.67 percent for otherproduct categories [the maximumemission scenario with no baghousefailure assumed). However, EPA alsoestimated the number of cancer-cases-avoided using the assumptions of !39.968to 99.988 percent efficiency (the bestcstima!e scenario with occasionalbaghouse fai!ure assumed). Theserstima:es, assuming the occupaiiona]c~posure levels based on other\IilillO~<~lJS expos’are scenarios discussedilb OVe. arc 183 cases if benefits are notdiscounted and 134 cases if benefits arediscounted at 3 percent. The cancer-c:]scs-a~oidecf by individual productC:i!e<gorj. us!ng these estimates are sefforth in ttr(~ following Tablr? X:

I

29486 Federal Register / Vol. 54, No. 132 I Wedaesday, July 12, 1989 / Rules and Regulations

TABLE X—CANCER-CASES-,TJOIOED BY

PROOUCT CATEGORY ASSUMING ANAL-

oGous ExpOsUREs ANi3 ALTERNATIVE

EMISSIONS CONTROL RATES

Produc!

.—. —

asbestos/cemen: (A/C)sheet .............................

stwrgles. ...........................AIC pipe.......................Products not currently m

U.S. prodtictlon(asbestos protectweclot!!:ng and vinyl/asbestos floor tile) ......

Paper proddc:s(commercml paper,rollboerd, rndlboard,corrugated paper, andspeual!y paper) ...........

Felt products (flooringand roofing felt andplpelme wrap) .. .. .. ..

Gasketsl ........ .. . ........Disc and drum brake

pads for ongiralequipment market(OEM) and brakeblocks ..... ....... .. ..... ..

Disc and brake pads foraftermarket (AM)

Other asbestos fnc.ttonproducts (actpma!wtransrnksioncomponents, clutchfacings, andcommercial andindustrial frictionproducts) .. . .. .. . .

Coatings (roof coabngsand non-roofcoatings )................... .

Discount Rate

3 percent———.

0.48022210

0

0.18

22026.63

J2.72

8538

1.29

2.L)3

o percent.—

0.590.31290

0

0.2s

2.7235.41

17.27

li”?98

170

2.80

{ Does not inctude specialty industrial gaskets

The different assumptions abouttmghouse efficiency do no! have aSigilificanteffcct on the estimatesofcancer-cases-a voided. Under both thebest estimate scenario with occasionalbaghmrse failure assumed and themaximum emission scenario with nobaghouse failrire assumed, EPA believesthat the manufacture, importation,processing, and distribution incornmercecf these products presenwanunreasonable risk of injury to humanhealth.

The rule will result in a number ofother significant benefits. However,many of these benefits are either in thefuture and are relatively small in currentterms after discounting or are difficult toc~uantify. For examp!e, costs avoidedinclude the societal cost of the resourcesnecessary to treat asbestos-relatedillnessm and the productivity lost as aresult of asbestos disease th~t will beavLJ~dwi due t!] actions tsken under thisFuic. EPA h:, s out estiroate~ I\jese ,,ust:+avoided because [hey would bewla!ively small because !he types ofcancers reviewed in this analysis

generally result in death after re!atit ciyshort periods of treatment orhospitalization In addition, this tokalwould be further lowered whendiscounted due to the fact that mostasbestos-related diseases appear onlyafter a long latency period.

Continued manufacture, importtition,processing, and use of the asbestos-containing products banned by this ru!ewould result in environmental lo::ding ofasbestos. The effect of environmectailoading is discussed in more de;~il InUnit V,A.3 of this preamble. The actionstaken under this rule will reduce theincremental increase in ambientconcentrations of asbestos and thusreduce the risk of asbestos exposurefaced by the general population. EPAhas not attempted to quantify thesebenefits, due to the difficulty andprobable imprecision of such ananalysis. However, EPA believes thatthe long-!errn benefits derived from thisincremental decrease in ambientconcentrations of asbestos will result insubstantial benefits because of the largepopulations that are affected. EPA hasalso concluded that these benefits canbe attained through the source reductionactions taken in this rule, rather than byuse of other options considered.

Further, due to the rule’s bans, thesubstantial future costs associated withremoval and disposal of asbestos-containiryg products that would haveotherwise been produced and used willbe avoided. These included higherremoval, demolition, and disposal costsfor asbestos products than those fornon-asbestos products, as well as higherhealth risk expenses for asbestosproducts. Future removal, demolition,and disposal of asbestos constructionproducts will likely be higher becausespecial precautions will probably benecessary to meet OS.HA, Clean Air Act(CAA), or other requirements. Thesecosts can be substantial, but they havenot been estimated for purposes of thismiernaking !Jecause estilnates of thetiming and frequency of buildingremoval or renovation would bespeculative.

Also, the continued use of astwsloswill likely exacerbate the heavy I]lirtlenon courts and workman’s compensationboarde that have, in recent years, lweninundated with claims related to harmc~used by asbestos exposure. This rule,

by reducing the occurrence of asbestos-related diseases, will eventllally rediicetile costs related to clfrims arisi:-,g out ofil!wsse~ and deaths calwr=d h,v .]{jl)est~~C,?p(?aicr?.

Since the proposal, EPA has obse,weda rapid development of substitutes fort~sl~cst~)s~ont;iining products. F,f~A

Ivelicves th:~t this ruie v:i]i furthersiimulate technological innovation in thedevr’lopmont of substitutes for asbestosand that this strong trend toward useand acceptance of substitutes willcontinue.

Different health benefits wereestimated in support of the proposalthan those development for the fir-mlrule. The number of cancer-cases-~voicfed estimated for the proposal[approximately 1,0%3 cases :ind more,depenchrrg on the regsiatory option) ishig!)er than the esiirmte for the finalrole {202 and 148 cases if an:ilogousexposures are assumed] for a number ofreasons: [I) Several product categoriesare not included in this final ruleestimates because they are no longerniwrufactured or imported in the U.S.[e.g., vinyl-asbestos floor tile). ‘f’hischange accounts for approximately 475of the cancer-cases-avoi citid quantifiedin the proposal rule. (2) The productionand exposure data supporting therulemakirrg were updated for the finalrule. U.S. asbestos consumption hasdecreased and substitute use hadincreased since the publication of theproposed rule. ‘f%ercfore, the proposal’sestimates of carxer-cases-avoided werehigher than those for the final rulebecriuso consumption rates and resultingexposure totals were higher at the timeof the proposal. (3) Updated exposureassessments were used in the healthbenefits model. The updated data werelower for some products than those usedfor the proposal, meaning that t!leprogosal’s estimsftes of cancer-cascs-uvoiderf were higher than those for thefinal rule. (4) The time fra,me used forestimating health benefits for theproposal was IS years: for the final rule,the period k 13 years. Therefore, thefin~il rule analysis covered z fewer ye~rsof exposure, resulting in fewer estimatedhe~ilth benefits. [5] Son:e modifiwtions

d]w:ere made to the health effecis mo cused for the fin,ll rule [e.g., minormodifications, including quantificationof gastrointestinal cancer risk, and the{ise of a lower dose response constantfor rrwsothelioma (wing an avera~e ofthe dose response constants from anumber of studies, rather than theconstant from o~le large study)] thatrestiitcd in an estimate of benefits thatWaS approximately 20 percent lower forthe final rule than for the proposal.

Severul cornmrmters stated that EPAlkn{if,ri::,~inl:ttctl the benefits as‘sociatedW’ikii the prodllc! bans described in the .pr{~poswj rule. ?’hf’sc commenters::, .:;,,:t~(, t~.,: ~:.l :,~,p.Iysis of bcnc~ts

ui’.dt:rsidntrxl risks because it Jid not

take io~o sccount disesises other thanIllng and g;is!wintestinal cancer and

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rrmsotheliorna or exposures to families& asbestos workers, and failed to~lll:ln!,f~ fa[, tors like avoided ptiin and

SL3f[eri!I:; and increased workerproduci; ~ity. EPA agrees ihat [hebe::efits of the rule ziay be urrderstuted,,,, ,,. , -possl t,.,, ,. a si~-li~.~anr extent, i,n Ikie

,.\.i JSU~!)O~:iI ~ &i_:~ } S.S GLIC tfl teCh.ilC>lOg;.Xflcr Ct}.er :irlll!ation.s. Th,~:~ factors,~{l~l,e, -r, !~l.,,c beE)i~considered

qua!itative]y in EPA’s analysis.One conrrncnter a:gued that EPA

significantly overestimated the benefits{;f the rule by overstating aslJestospOieIIC~”a::d iXpOSlil’6? lCVCIS. ‘rh~ llirl~c~~ncer and mescthe!iomir potencyvalues used by TWA in its tmalysis ofbenefits are -r:dl-supporied and are

‘+h fl[K,se us~d by 0S1!,1 k~c:lsisl.efl: ...JI. . .reducing i:: PEL !L 0.2 fjcc. T}; t po!ency

N“a]U~s fOr !LIG~ ~~[l~~r H?p7WSL!71[ tkle

mean of the rcs:dts of 11 hrrmanepidemiologicai sto~ics on the effects ofasbestos exposure, The potency valuesfor n,esothslioma represent the mean ofthe results of 4 kwnan epidemiologicalstudiw on the effects cf asbestosexposure. In addition, the exposureestimates used in this analysisunderstate actual exposwe for a nu. mlwrcf re~sons., as expiained in Unit V.A.3 ofthis preamble. Tberef’ore, EPA may haveactwdly rmdersia{ed, not overstated, tfiebenefits of this u-rl~,

Some commenters argued thut EPA, inthe proposal, improperly failed todismrunt bcne~lts to be deri~ed fro, mtheruie, and in suppnrt documents for afinal rule, only discounted benefits untilt},e tic; e (:: the ,-xposure that resu!ts inthe cancer raihcr than un:i! theorxurrcnce of the r.fiscase Othercorc,menters ~r~~ed that EPA sho~ld notdiscount b~r~.efiis, stating thatrfiscountin.g the benefit of saying humtinlife is inaFprcpriate methodolilgy f~~rthis ruiernaking.

This final ru?e provides estimatedbcn~fits both with and withoutdiscount~rrg. Arguments can be madethat esti.nmting benefits w-rthoutdiscounting is preferable in cases liket}lis one where the primary benefitsJcrived is the avoidaoce of humancancer cases. I Iowever, arguments dlsncan be w-ticul:ited supporting thediscounting of benefits. EPA believesthat if benefits in ihe form of cancer-c:~ses-~~.,cided a~e to be discoiir. ted, th(,y:Jre prrperiy disc,ounte d to !?le timewherr tisk is ,educed or av,;ided. Sincethe brmefit of a regtilation to control ahazardous Sii!3St;JnCe occurs ~t the timeof the reduced exposure, EPA hasconc!uded that the appropriate periodc~’er which to di~count is until tile time[?f Cxpwuw 1’Cdii~tiO~. This apprnach. .lv:ls LIscd in t.m.s case a!lfjr extensive

review of applicable literature and anexamination of the inherent biases andfeatures of other approaches.

3. Smo!i businesses. EPA has,pursuant to section 6(c](I)(D) of TSCA,

also arwlyzed the economic impact ofthid ruie on small businesses. The ru!e1~.ili Out have a >ign;iicmt effect on

;,sm., businesses because !he~e are iewsu{h Irusine:. ws affected by the rde andincfividu~l company producer losses arenot expected to }]e substantial sincecapit~l equip,mcnt for the production ofasbestos-containing products has littlercrntiining w.f:fd li~e, is inexpensive, orCiifi gene!a!ly be cr)nvertcd at lcw costto mariufactiiie of alternative products.A snlall fraction of the manufacturers,irnpcrtem, and processors subject t(; tffisrule are small producers and srr,me could!,e ;]~ver~~:ly affected by the rule. In

tidciltion, a number of sin~llgovemmeriis may be affected by the banof some asbestos products, for example.A/C pipe. However, the economicimpzct ljf this rule is generally spreadwi(iely throughout the economy and anyconcentrated effect will not be focusedmi specific market sectors or on small1ousinesscs.

4. E.w’tiG[io:~ of the rule’s rcononticimpoct. The o~reral] costs of this rule aresignificant. I {o.wever, the overall

Lerrefiis of the rule are also significant,a!tho!lgh many of the benefits cannot beeasily quanhfied.

The anti;ysis performed to ascertainthe economic consequences of the rulelike!y overstates the costs of the actions.tiowever, tl,c analysis points ou! severalimpur(ai~t factors: (I) The societalbenefit, or “essential ity,” of asbestoshas decreased, and contirium to do so,as asbestos consumption declines andsrrtrstitutes for the mineral aredeveloped for many applications; (2)most of the cmts associated with theruie are sl~ort-t:’rrn and spread over arclati~’cly idrgc population: (3) thecontinued de,elc,pment of price- andperformance-comparable substitutes forasb~stos indic:ites that the rule will notlead to either dramatic increases inconsumer prices or decreases in theavailability of products af’fected by this~[ilr; and (~) the producer arxf consumercosts imposed by this rule are offset bythe rule’s bt,n:,fits (e.g., currr,er-cases-avoidecf, medical costs, and lostprc[!uctivity a.,oicfed), althoug!! many ofthese bt:nefits are either difficrrit toqiltintify or to express in monetaryterms.

EP.A, t!:ij rfore, fin[!s that, under t!]es!cn(iar<!s {J!wcticn 6 of TSCA, t!~ecosts of ttle rule to be reasonable in lightof tbe unretisonab!y large number of:i~!)~s!os-r[:li]t(:(~ deaths and serious

i!lllcsses {hat would OCCLlr if lhe aCtiOnSin this ru!e were not taken.

E. O:h<?r(217tio1xCCJnsidercd

Section 6 of TSCA requires EPA toselect the !cast burdensome means toredutx an unre:ison:t,:e r;:,!. ‘Ills lf~itdescribes tzr)~’se(a!uatio, of optionsthat wou!d reduce or eliminate t?~eunreasonable risk to hiJmfin ir{?a~th

posed by exposure to asbestcs. Furtherresponses to comments on this sul)jectcan be found in the Response toCommwrts document.

The options considered inc!ude theond selected for the final rule, a sta~f’~i-ban of the rnariufacturing. importation,processin~, and distribution incommerce of a nwnber of categori(’s ofasbestos products. EPA seiec!ed astrigsd-ban for tk~s final ru!e ratlmr lht:none of the other rcgtdatory optionsdiscussed in the proposal or identified incomments becarrse these other optionswould either F~il to afiequateiy reducethe unreasoriatrle risk posed b:y asbestosexposure or impose an excessiveburden. Conversely, the final rule’sstaged-ban app~oach prohibits, atdifferent !imcs, the ZIAnLl!LiC?ilre,

imputation, processing, or distributionin comrncr-ce for uses of asbestos thatpose ail rmreason:bie r{~k. Timing of

these baw is ba5ed l.Irgc!y cjn the

availability of sl:itahle tivailtiblc or

anticipated nO~-[J5kIf5tO$ subsii!utes forthe banned products. Ttrr, rcfore, thestaged-ban approsic h !akes in!o accountthe potential economi~ effects of thev:irious bans, whil F st;]] eliminating thesources of the fi(sk. Olhrr Opt;i)ns werediscussed in the proposed rule cmidcmtifled in comments. but were notse!pcted for the reasons describedbelow.

Under two proposed rule alternatives,

some product categories would betranned soon after the effech’:e date oftlie rule and the remain~ng i}rO:~uctcategories would be “phased down.”This would be accomplished byins:i{ritiq+ a permit system vilii~ h wouldcreate Iimik on the U.S. mining ofashes!tis and the irnporta!irm ofasbestos and asbestos-containingproducts. These iirni!s wculcf be L[is(;don previous I:o!wnes of the affected~ctii ii~ ar, d V., OUICIE~emani; ge d try asystci71 d issuing pcrrnits aliowing~r;,duiilly declining levc!s of theint!ic.~ted activities. “f%e permits wouldbe transferable. Thjs s:;siem would,o~:crtimw restrict the tctai amount ofasbestos Hvaiiable for use in the U.S.and iimit the amount used in importedproducts until the ru!e’s objective of acomplete phase out was achieved.

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In the analysis performed for thisrulemaking, EPA concluded that apermit system approach would not bethe least burdensome means of reducingthe unreasonable risk posed by asbestosfor all the products analyzed under therule. Most commenters who rendered anopinion on the issue opposed the permitsystem options. Commenters stated thatthe implementation of these optionscould create significant administrativeproblems for EPA and industry,particularly in the area of importedasbestos products. EPA found thatimplementing the proposal’s permitsystem options for all of the productcategories in the rule would result inhigh administrative costs. EPA alsobelieves that a permit system involving211of the products affected by this rulewould be difficult to enforce.

EPA concluded that some uses ofasbestos and some product life cyclestages pose a substantially greater riskthan others and that the permit systemsdescribed in the proposed rule wouldnot necessarily control the highest riskexposures (e.g., persons that producedor used products with high levels ofasbestos exposure could purchasepermits). Therefore, EPA concluded thatthe proposed rule’s permit system wouldnot adequately control asbestosexposure for the rule’s productcategories.

Despite EPA’s conclusion based oncurrently availab!e information that apermit system approach is not viable forregulating all of the products analyzedunder this rule, EPA recognizes thatthere are a number of inherentconceptual advantages to employing aneconomic incentive approach inregulating the risks posed by chemicals.Therefore, as a follow-up to EPA’sreview of the applicability of a permitsystem ~s a regulatory option in thisruIe, EPA will perform several extensiveanalyses uf the ad~antages andrlisadvant~ges of using variouseconomic incentive approaches,including marketable permit systemalternatives, as possible mechanisms forreducing human health andenvironmental risks from chemicals.These studies will review in greatwdetail the viabiiity of employing surhapproaches under regulatory authoriiicssuch as section 6 of TSCA.

One study will foctis on ecxmorricirtcentive prog~ams that could beapplied under ‘RCA and otherauthorities, rather than, for eY.arn;Ile,c(, r’ceritrating Oil alr-ef::is.)i!; ri ISSii?S. 3;does thte bulk of the avai!abletheoretical literature. The study willidentify and evaluate criteria fordetermining whi(.h chemicals or

Chemical products would be appropriatecandidates for the use of economicincentive approaches tinder TSCA andother authorities. Factors considered inidentifying these criteria will includedetermining the characteristics of achemical’s market, such as itsproduction and use, that would makethe chemical a viable candidate for npermit system rather than a depositsystem. The study will also examinethese criteria in the context of specificcandidate chemical substances.

Another study will analyzeadministrative problems associated witheconomic incentive approaches with theaim of devising methods that provideequitable and efficient regulation ofthese chemical substances. For example,the study will examine issues related toimports which complicateimplementation and enforcement ofeconomic incentive approaches. Thestudy will also examine mechanisms toovercome comp!ica!ions caused bythese factors and evaluate the type andlevel of assistance to EPA from otheragencies (e.g., U.S. Customs Service)that would be necessary to implementand enforce an economic incentivesapproach.

Based on the analyses performed(l\iring this and other rulemakings, thereis a continuum in the risks and benefitsassociated with product categories.Some product categories on thecontinuum have some characteristics(e.g., a large number of specialized usesor a lagging rate of substitutedevelopment) t!!at may make theproducts amenable to regulation throughuse of a economic incentive approachbased on the criteria developed in thestudies described in the precedingp,magraphs. Upon completion of thesestudies, EPA will review this rule andother rules, based on the identifiedcriteria and on then. availableixiformation about products andmarkets. For example, with respect tothis rule, this review could determinev:hether (I) any product categories notincluded within the rule’s bans shou!db~ phased out by use of an economicijlcen!ives approach, (2] any p!ocfuctsLanrred in Stage 3 for which a significantt?iXrlbCr of exemptions are likely tnigh!be more efficiently phased out via aneccnomic incentives approach, and [3)substitute development could Le moree!ficient!y compelled by an economicir. centive approach f~r any produc(s thatare the sl-ibj~’,ctox an active wwrnpticrn.U?,l.’s revi~,,~ JJi!l Je!errrriue ~}1..~~~,~rany of these products exhibitc!mracteristics that lead EPA toconclude that exposures could be rnorcefficiently phased out by use of an

economic incentive approach. If, afterreview of this or any other role, EPAdetermines that an economic incentiveregulatory approach is warranted forsome of the categories, EPA may in thefuture initiate rulemaking under sections6 and 6 of TSCA to amend such ru!es toimplement an economic incentiveapproach.

Even within the stage-ban approimh,EPA has considered a number ofpossible options for the number ofstages, the number of years between thestages, and the scheduling of productbans at various stages. The final rulefollows the 3-stage ban approach of theproposed rule. EPA has modified thetiming of the ban from soon after ~promulgation and 5 and 10 years afterthe effective date of the final rule, asdiscussed in the proposed rule, to 1,4,and 7 years, respectively, after theeffective date of the final rule. This wasdone because of the passage of timesince the proposed rule was publishedand because EPA’s analysis of avai!~bledata and comments indicates thatmarked advances have been made inthe development of and conversion tosuitable substitutes for asbestos in mostproduct areas. The timing for the stagesin the final rule are reasonable in termsof the current or anticipated availabilityof suitab!e substitutes, based on EPA’sanalyses. EPA rejected the option in theproposal of a limited 2-stage ban with aTSCA section 8(a) reporting requireincntbecause that option would notsufficiently reduce the unreasonable riskposed by asbestos exposure. In addition.the final rule does not iriclzde a ban oathe mining and import of bulk asbestosbecause not all asbestos-containingproducts are included within the banson manufacture, importation, processing,and distribution in commerce. However,the risks posed by these activities areexpected to decline as the demand forasbestos decreases due to the actionstaken in this rule.

Also, in scheduling products for thestaged-ban, EPA has analyzed thereiative risks posed by the diiferentasbestos-containing prodacts and thtiprobable availability of non-asbestossubstitutes. In the rule, the v~riousasbestos products are schedided to bebanned at times wi~en it is likely thatsuitable non-asbestos substitutes will beavai!ab!e. For example, bans on:isbcstos-containing brakes pads anddt um brake iinin~s arc divided jntu a. .

1 ent~!:)ge z ban on the orl,ym~. e:Iu:pwV.:}:ket ~Iid ~ Stage 3 tx{n d.] 1!:.tif{ermar%et kca’w; e s>lit<~’b!es~ibst:~i]!csmight not. be available for smne:iftemt:ir!wt products until Stage 3. T1.efinal ru!c’s approach im!c~nces the rw’~!

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for a reduction in the unreasonaLrle riskofexpnsure to asbestos with tll~:cwnrrmiceff~cks of bans on,manufacture, im~ortatirrrr, proce,s.siu,g,i+r,d distribution m commerce.

‘i”he inclusion in the final rule of apro~i~,i~!~ a!}~tn-i.lg fo:flxc,~.j;tit;:ls !!1ll:ni[edci~~ums(~n~es is a means ~fuiking into accoLln\ tk,a size rind

diversity of the asbestos industry. EPArealizes that, despite EPA’s projections,technology might not acii’imcesufficierrtly by the time cf a ban toproduce substitutes for a fewspecialized or limited uses of ssbestosin some product categories. In addition,other unforeseeable circumstances rmiyoccur that would make a ban on adiscrete product inappropriate at ihescheduled date. In these circumstances,an exemption from the ru!~’s bans may}}eappropriate if an applicant can showthat one is appropriate following theprocedures described in lJnit IH.E of thispreamble, However, EPA believes thatgranting exemptions will not be thenorm. The procedures should be usedon!y in exceptional cases and should notbe viewed as a means of attempting topostpone a person’s share of theeconomic consequences of the actionsdictated by the rule.

Another option considered wouldinvolve an immediate ban of themanufacture, importation, processing,importation, and distribution incommerce of all asbestos products.Section 6 of TSCA requires that a rangeof factors, including the availability ofsubstitutes and the relative costs ofregulatory options, be considered inaddressing the reasonable risks posedby a chemical substance, EPA rejectedan immediate ban option because itwould result in potentially severeeconomic and societal effects. Animmediate ban would not account forthe current unavailability of viablesubstitutes for some asbestos-containingproducts that provide significant benefitand would result in high costs in thosemarkets. Therefore, an immediate banwotdd not be the least hurdensornemeans to reduce the unrea:;onable riskposed by asbestos.

EPA also considered requiring.islwstos-conta inirrg products to belatrcled as a means cf redac.ing L}}eriskn[, sed by asbestos exposure. tIowcver,&}A has determined that the risL-redur;tjon benefits from a labelingrequirement for asLrestos-conta iningPro[iuCiS would fiot be subst:!nt;al. For

rximpie, many cf those that ~vollldpotentially be exposed to aslbestos fromthe labeled products would not haveaccess to the warning ]iib[;ls. 10

aodlllrrn, many aslbmtos prwlucls iirt:

used in c~ustic or dynaniicenvin>nmel~ts in which labels cannotsurvive. Crrm.merrters also argued tlia[Iabe!s diwci!y appljed to prurfucts caninhih]t product performance. Forexample, if~askets were reqliired to IwI:+be!td. ?hc~e lYAOc<,m~~i~to contactwitl) the proicct pack,: gin-g mtiiu l:ZVCIticcess to the l~bel. However, rrlany~{isk~ts ape too small to he ~;rt!c~ii”r:iy

labeled. In addition, it would be unljkelyth,it those exposed to Lhe protiuLt duringuse or removal would have access to thelabel because it might not sur~-ive in ahot, fluid envircmrnent. The aim of thefioal rule’s iabeling requirement is not t{]serve as a warning, but rather tmly infacilitate comp]iace with andeniorcemeut of !iie rule. The drawbacksof labeling described above rfo notaffect the use of kibelirrg as acompliance rind enforcement tool. Thelabels required by this rule are ap;)liedto product wrapping or packaging andare not intended to survive through theen(ire product life cycle.

Se~cral commenters suggested theconsitferation of options that wouldrequire “controlled use” of asbestosrather than bans on manufacture,importation, processing, or distrib~itionin commerce. These commenters argued~hat exposure to low levels of asbestosis not an unreasonable health hazardand that EPA should undertake actionsin a number of areas to require exposurecontrols fe.g., workplace controls forbrake replacement and repair) riithmihun enacting a product ban.Commenters also suggested thutchrysotile fibers pose a lower hrrzarxithan other asbestos fiber typesand thatcontrolled-use actions would be moreappropriate for chrysotile than would hesource reduction actions.

Contro!!rxi-use options were rejectedbecause they would be ineffective ii]reducing exposure at marry points in thelife cycle of asbestos prodacts. As isdiscussetf in Unit V.A of this preamble,EPA has found that exposure to even11.Jtvlevels of asbestos poses anunreasoniib]e health huzard. In addition.s~me Of t’he exposures of concern arenot anl~nahle to controls (e.g., ambient

rc;eas(’s from asbestos friction prodilcts

dlmili~ ~;se, from brake replac[’meni ijn Jr(~pirir ..s:jrk performed by consumezs, (Jr’

~:orn ~:ci:[i]cring of asbestos prodl:ctselp(,st,d !(I an outdcors cntir’onmtu!).

in ot!]er instances, contwlled use,Iproacht, s meate ne~v c,xposures ormo~e c~~i}qure from one stage of llzf,i,rui;u{:t lit{: (’y[;l(>[Clan(JlhcI. l’or(.~alnple, even if asbestos is ~,e:lte~i fr[>r::tr \Yo:i.pl:w, although workers aresc!>ji~(:t “o iofver exposure Ietfcls.

as Lt?stos is still released to the outsideaml)icnt air, thereby creating potentitilixposurrs for uess( rsby andsurrouri(!ing pi)plilati Gil S.

Fri TLhcr, man:~ engineering controlseithrr iail to reduce expasures to~i:!jP:.tc~ {:) lllYP!S t$at do rtcrt nme a~igr:i~icant r~>~ or Grea Ie workplace

inclficiencies that li:ad tErcm to not ile

L!sed. For exan-.ple, respiramrs aredifficult to fit properly and are oftenuncomfortable. Poor fit and intermittentuse because of discomfort lead tounprotected lvorkers. The problems areespecially prevalent in rmgativeprt,ssure respirators, the type mostcommonly used in workpk~ces becauseof [heir iow cost [R~f. 16).

Other agencies and EPA offices haveor are currcnt]y establishing asbestusexposure control requirements for theworkplace. Iiovvever, because of theextent and nature of the risks posed byasbestos and limitations on availabletechnology and the jurisdictions of thercgulaiory entiiies, EPA believes thate~’en those control standards that arebased on the best available technologyleave an unreasonable level of residualrisk in some occupational and norr-occupational settings.

Therefore, EPA has concluder thatsource reduction actions, like thosetaken in this rule, rather than controlleduse approaches are ~eccssary to reducethe unreasonable risk posed by asbestosexposure. In addition, pursuant to thediscussion in Unit V.A of this preambleregarding the rcltitive hazards posed bythe various asbestos fiber types, EPAhas also concluded that this rule’ssource reduction actions are moreappropriate than controlled use

approaches for products contair.ingch]-ysotile fibers.

Some commenters expressed aconcern that if FNA bans thenlanufacture, itrLportation, or processingof some asbestos-containing products,the go~jernments of other countrips ~vi!lbe compel!cd to take similar actions,although suittible non-asbestoss{ibstitutcs m:jy not be availab!e ilitilr~sc uoa[i~ries. The unreasonable riskfindins in t!lis rule is haswi on a detailedan:l!ysis of the risks posed t!woughoutt!;? entire !ifc cycle in th~’ u.S. of theflilure manufacture, importation,processing. distribution, use. aildcfisposal of the specified ashestos-conttiining products. The findings whichsui~port this rule arc not directly~{J]r!}l(;til)}eto other countries in which

facturs relatirig to risk and cost may hesi~nificant]y different.

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F. .Wnrnary of Individual Prod:mtCategories

This Unit describes EPA’sunreasonable risk finding for eachindividual category of asbestos-containing products identified for thisrule. It summarizes for each individualproduct category available informationregarding exposure, individual risklevels, the development of substitutes,the results of EPA’s analysis of the costsand benefits of a ban, and otherqualitative factors that were consideredin EPA’s unreasonable risk analysis foreach category. These discussions reflectpublic comments received on thesesubjects. Further responses to commentson these subjects can be found in theResponse to Comments document.

In the product category discussionsbelow, information regarding COS!S,benefits, and product substitutes isderived primarily from the RIA [Ref. ZI],which is discussed in Unit V.D of thispreamble. Information regardingexposure levels is derived from EPA’sAsbestos Exposure Assessment (Ref.z~], Asbestos Modeling Study (Ref. 30]*and Non-occupational AsbestosExposure Report (Ref. 31), which arediscussed in Unit V.A.3 of this preamble.

Based on available information, EPAfinds that the manufacture, importation,processing, and distribution incommerce of asbestos for use in each ofthe following product categories, exceptthose discussed in Unit V.F.1 of thispreamble, presents an unreasonable riskof i~.jury to human health. ‘l’hediscussions of EPA’s findings, below,summarize: (1) The estimated benefits ofthe actions taken in this rule for eachproduct category, (z) quantifiableasbestos exposure and !ifetime riskIc:.wls for the product, (3) the projec!eda’bailability of product substitutes, (4) adescrip:.ion of qualitative factors thatwere considered in reaching EPA’sunreasonable risk conclusion for theproduct, (5] tk,e estimated costs of theactions ti]ken, and (6) an explanation of

ary c~,:nges in EP.A’s approach torcgtilaling the product since theproposal.

The individual risk levels quiinLifietlfor the product categories that aresubject to this rule are ver-- high. Anindividual lifetime risk level of 10-3 orgreater has been quantified for manypersons who are exposed during theprimary and secondary rnanufackm ofmost of these products. Some otherphases of these produc!s’ life n~r:les ::Iso]esu!t in very high levels of individualrisk. An individual lifetime risk level of10-3 means that members of thepopulations exposed to this level of riskstand a 1 in l,Of?Ochance of developing

cancer during their lifetime as a result oft!~e exposure~. EP.4 considers the risklevels quantified for this rule forasbestos exposures to pose a substantialconcern. EPA also believes that the risklevels quantified for this rule represtmtan underestimate of the a~tui~l riskposed by asbestos exposure from theseproducts. A number of exposures tofisbestos and the resultant risks, forexample, the risks posed by incrementalincreases in environmental loadingcaused by the continued manufactureand importation of the asbestosproducts banned by this rule, arebelieved to be significant, but could notbe quantified for purposes of this rule,often because of limits in exposuremonitoring technology. Despite this“cautious” approach to estimating risk,the exposure and risk that can bcquantified are sufficient to make anunreasonable risk finding for purposesof this rule.

The costs and benefits cited belowinclude assumptions regarding -anticipated declines in substitute prices(discussed in Unit V,D of this preamble)and exposures estimated by analogy forrecognized, but unquantifiable,exposures (discussed in Unit V.A.3 ofthis preamble). EPA believes that thisapproach presents a prudent,representritive analysis of the costs andbenefits of the actions taken in this rulewith some reasonable adjustments madefor unquantifiable exposures or marketchanges. However, even if theseassumptions are not used, EPA hasconcluded that the continuedmanufacture, importation, andprocessing of the asbestos-containingproducts that are identified in the ruleposes an unreasonable risk of injury tohuman health.

a. Felt products. This groupingconsists of the flooring felt, roofing felt,and pipeline wrap product cate~ories.All of these categories will be banned inStage 1. ‘i’he benefits (in terms of cancer-cases-avoided) of the actions taken inthis rule on thew product categories areset forth in the following Table XI:

TABLE XI—CAFJCER-CASES-AVOIDED FOR

ASBESTOS FELT PROWCTS.. ————.

PfodLct

— b~-

F’!wxing felt Oli 01

Roofing felt.. ...................1 121 1.51Pipeline wrap ..... . ~ 2.31 2.85

—-————.—— 1.. ...— __] No currewt lJ.S. manufacl.ure or lmpcfi.

Ikimary routes of exposlire toasbestos from these products occurduring piimary manufacture, and

product installation, repair, remova!.and disposal. Quantifiable lifetime riskfor these products from occupationalexpos.uie rangf:s from an average 3f 7.4x 10-4 for secondary manufacture offlooring and roofing felt to an average of2.5 x 10-3 for the primary manufacture ofroofing felt. EPA estimates that as manyas 1,652 workers may be exposed t~asbestos during the installation andremoval of roofing felt, incurringindividual risks comparable to those formanufacturing. These exposureestimates do not take into account highpeak exposure to which homeowners orothers may be unknowingly subjectedduring removal or repair of theseproducts. EPA determined thataccurately quantifying these exposuresand the resultant risks would be difficultand that sufficient other exposure andrisk information is available regardingthese products to make a finding ofunreasonable risk.

Effective substitutes currently existfor all three of these product categories.These products are largely no longerproduced in the U. S., and flooring felt isno longer imported in this country. In theproposal, ffooring and roofing fe!t wouldhave been subject to the Stage I banand pipeline wrap would have beenbanned at Stage ~ or covered by thepermit system. kiowever, EPA receivedcomments indicating that the productcategories are not easily distinguishablefrom one another and that suitablesubstitutes are currently available forpipeline wrap. EPA therefore coilcludedthat a Stage I [s appropriate for all threeproduct categories.

The total cost of the actions taken onthese product categories are set forth inthe foiiowing Table XII:

TABLE XII—COST OF THE RULE FOR

ASBESTOS FELT PRODUCTS

——————.—.—— --+-”=--Flootiw feat...................................... 10Roofing felt . . 7.31Pipeline wrap ....................................[ 1.07

‘ No U.S. manufacture or import.

EPA has concluded that a Stage I banis appropriate for these productcategories for the following reasons: (I]Relatively high quantifiable exposureand indivirfu;il risk levels exist for !hw+eproducts: (~) these producis pww a highpotential for ambient release during anumber of life cycle stages, for example,during manufacture, installation,removal, and repair work: (3)homeowners and workers are

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Federal Register / Vol. 54, No. 132 / Wednesday, ]uly 12, 1989 / Rules and Regulations 29491

potentially subject to uncontrolledexposures during removal and repairwork (4) the cost of taking these actionsis reasonable because suitablesubstitutes exist for all of theseproducts; and (5) while the quantifiedbenefits of ban~ing these products arerelatively small, compared to Odierproduct categories banned by this rule,these products are likely both to lead toa number of serious exposures thatcould not be readily qua~tified for thisrule and to contribute significantly toenvironmental loading.

b. A/C sheet. This grouping consistsof the ffat arrd corrugated A/C sheetproduct categories. These categories willbe banned in Stage 1. These productswere proposed for a Stage 1 ban. Thebenefits (in terms of cancer-cases.avoided) of the actions taken in this ruleon these product categories are set forthin the following Table X111:

TABLE XI!I--CANCER-CASES-AVOIDED FOR

Ale stiEET

.57A

?~d~?

NC flat sheet .. . . ..

Primary routes of exposure toasbestos from these products occurduring manufacture, installation, andrepair. Approximately 53 workers areexposed to asbestos dining primarymanufacture of AIC flat sheet. EPAesfimates that as many as 735 workersmay be exposed to asbestos during theinstallation, repair, and disposal of A/Cfiat sheet, and that as many as 109workers may be exposed duringinstallation and repair of A/Ccorrugated sheet. Quantifiable riskposed for these products fmmoccupational exposure is estimated torange from an average of 0.2 X10-3forthe primary manufacture of A/C flatsheet to 13.7’x10-3 for repair and rfisposa]of flat and A/C corrugated sheet.Quantifiable risk from non-occupational,lifetime exposures to asbestos releasedduring the manufacture of A/C sheet isestimated at 1X10-4 for approximately4,500 people and at greater than 1 x 10–6for over 200,000 people.

EPA believes that the exposuresquantified for these product categoriesare tmderstated. Ambient release ofasbestos occurs due to weathering ofthese products during outdoor uses.C~,tting, drilling, and sanding take placedrming secondary processing,installation, repair, and maintenance ofthese products and result in significantrdease of asbestos. Homeowners or

others may be unknowingly exposed tosignificant levels of asbestos when theysand these products in preparation forrepainting or removing them. Workerexposure estimsites for this rule assumecompliance with OSHA restrictions, butEPA believer, baserf on some pi~blic

comments, [hat there may be someccttirrg of A/C products with powersaws in violation of OSHA restrictions.Asbestos releases to the ambient air dueto weathering of these materials duringoutdoor uses were not calculated andhigh peak exposures occurring duringcutting or scraping of these productswere not quantified for purposes of therule. EPA determined that acc~ratelyquantifying these exposures and theresultant risks would be difficu!t andthat sufficient other exposure and riskinformation is available regarding theseproducts to make a finding ofunreasonable risk.

Effective substitutes exist for all usesof these products. The total COS?Sof theactions taken in this rule for theseproduct categories are set forth in thefollowing Table XIV:

TABLE X! V—COST OF THE RULE FOR A/C

SHEET

Total cosf in $

Product I cftsc2%%at3

. EA/C flat shad ...................................A/c Corw@ed sheet ........ ........ ... 0.29

EPA has concluded that a Stage I banis appropriate for these productcategories for the following reasons: (1)Relatively high quantifiable exposureand individual risk levels exist for theseproducts; (2) these products pose a highpotential for ambient release during anumber of life cycle stages; (3)homeowners and workers arepotentially subject to uncontrolled, highpeak exposures during installation,repair, and removaI; (4) the cost oftaking these actions is reasonablebecause suitable substitutes exist for allof these products; and (5] while thequantified benefits of banning theseproducts are relatively small, comparedto other product categories banned bythis rule, these products are likely tolead to a number of serious exposuresthat could not be readily quantified forthis rule and to contribute significantlyto environmental loading.

c. A/C shirrgles. This product categorycovers roof shingles and sidingcomposed of a mixture of cement andasbestos fiber. This category will bebanned in Stage 3. This product wasproposed for a Stage 1 ban. The benefits

(in terms of cancer-cases-avoided] of theactions [aken in this rule on this productcategory is as foilows: 0.32 cases ifbenefits are no{ discounted and 0.23cases if benefits are discounted at 3percent.

Crrrrent!y, ATC shirrgles are rarelyused in n’elv building construction andare used primarily for replacement,maintenance, and historical restoration.Primary routes of exposure to asbestosfrom products in this category occurduring manufacture, installation, repair,removal, and disposal. Quantifiable riskposed by these products fromoccupational exposure is estimated torwge from a lower bound of 3.7 x 10-4for instal!atiorr to an average of6.1 X 10-3 for primary manufacturing.Quantifiable risk from non-occupational,iifetime exposure to asbestos emissionsreleased during manufacturing isestimated at 2.1 x 10-s forapproximately 1,500 people and atgreater than 1.0 x 10-s forapproximately 8,600 people. EPAbelieves that a number of factorscontributed to exposure beingunderestimated for this category.Ambient releases result from weatheringof these products and high peakexposures potentially occur duringcutting, sanding, scraping, andhammering of these products. EPA isconcerned about unknowing.inadvertent high peak exposures forhomeowners or others duringreplacement or repair of existingshingles and siding. Such exposures canresult from sanding, chipping, cutting. orother activities that result in substantialfiber release. Asbestos releases to theambient air due to weathering of thesematerials during outdoors uses were notcalculated and high peak exposuresoccurring during replacement or repairof these products were not quantified forpurposes of the rule. EPA determinedthat accurately quantifying theseexposures and the resultant risks wou!dbe difficult and that sufficient otherexposure and risk information isavailable regarding these products tomake a finding of unreasonable risk.

The traditional appeal of .4/Cproducts is their durability and theirability to be fabricated. A number ofnon-asbestos products are available thatare effective substitutes from theperspective of performance. Suitablesubstitutes, including wood, aluminum,and vinyl sidings and asphalt, cedarwood, and tile shingles, exist for manyapplications of the products in thiscategory. However, suitable substitutesare not currently available for someproducts in this category. Therefore,EPA has scheduled the ban of this

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29A92 Federal Register / Vol. 54, No. 132 j Wednesday, July 12, 1989 I Rules and Regulations

product for Stage 3 rather than Stage 1,as originally proposed, to allow for thedevelopment of cost-effectivesubstitutes while still addressing risks ina timely manner.

The total cost of the actions taken inthis rule for this product category is$23.57 million. EP.4 believes that thiscost estimate may be overstated. This isbecause the cost analysis for thisproduct category assumed that woodsubstitutes would capture 32 percent ofthe A/C shingle market if the asbestosproducts were banned. This assumptionwas made largely because wood is morephysically attractive than othersubstitutes, although it is much moreexpensive and does not performsignificantly better.

EPA has concluded that a Stage 3 banis appropriate for this product categoryfor the following reasons: (1) Relativelyhigh quantifiable exposure andindividual risk levels exist for theseproducts; (z) these prm!ncts pose a highpotential for ambient reIease during anumber of life cycle stages; (3]homeowners and workers arepotentially subject to uncontrolledexposures; (4) suitable substitutes existfor many of these products and arelikely to exist for others by the time ofthe baru (5] the cost of taking theseactions is reawmable, especially in lightof the assumption made regarding theportion of the market substituted for bywood shingles in the estimate of thecosts, the time provided for su?mtitituedevelopment, and the level of ambientexposure posed by products in thiscategory; and (6) while the quantifiedbenefits of banning these products arerelatively smal!, compared to otherproduct categories banned by this rule,these products are likc~~ to lead to anumber of serious exposures that couldnot be readily quantified for this ruleand to contribute significantly toenvironmental loading.

d. Other product cc?eymies L+et orecumen tly out of proc?ticti~~.q. This~roluping consists of the vin@/asL~estosfloor tile and asbestos c!oth]ngcategories. These categories wiil bsbanned in Stage 1. These products wereproposed for a Stage 1 ban.

These products are no Iongwproduced in the U.S. and are current!yimported in, at most, only smallquantities. In instances in which theseproducts are still imported, EPi\ isconcerned about the po!entiid fw-uncontrolled consumer e.xp~stire, forexample, the sanrimg, clltting, an~removal of vinyl/asbestos floor tile. Thefact that these products are no kmger incommerce in the US. indicates thateffective substitutes art? {~t’tjildh!e.

Therefore, the cost of banning t~eseproducts is minimal.

EPA has concluded that a State I banis appropriate for this product categoryfor the following reasons: (1) Relativelyhigh quantifiable individual risk levelswould exist for these products weresignificant U.S. manufacture orimportation to begin again; (z) theseproducts pose a high potential forambient release during a number of lifecycle states; (3) homeowners andworkers would be potentially subject touncontrolled exposures were significantU.S. manufacture or importation to beginagain; (4) the cost of banning theseproducts is negligible because there isno current significant manufacture orimport of these products and becausesuitable substitutes exist for them; and(5) these products are included withinthe ban to ensure that their U.S.manufacture, importation, processing, orimport does not resume.

e. Vehicular brakes. This groupingincludes drum brake lininss, disc brakepads and brake blocks used in new andexisting motor vehicles. Themanufacture or import of 1994 or latermodel year motor vehicles containingasbestos drum brake li~ings or asbestosdisc pads (hereafter referred to as theoriginal equipment market, or OEM) willbe banned in Stage 2. Asbestos brakefriction material manufactured,imported, or processed as replacementdrum brake linings or disc brake padsfor light- and medium-weight (LMV)motor vehicles with brake systemsdesigned to US9 non-asbestos f~iciion

material will also be banned in Stage Z.The manufacture, import, or processingof asbestos brake blocks for heavy-weight (HV) motor vehicles wili bebanned in Stage 3. In addition, a!lfliction material containing asbestosmanufactured, imported, or processed asreplacement parts for vehicles designedto use asbestos friction material(hereafter re~crred to as the aftermarht,or AM) will be banned in Stoge 3.

The benefits {in terms of cancer-cases-avoided) of the actions taken inthis rule on these product c~tegories areset forth in the following Table XV:

TABLE XV—CANCER-CAS:S-AVOiDED FORASBESTOS VEHICULARBFWIKES

———. —[_KWmmt F?rA3

Prod+)ct~ 3 pe~eX

.—. -—— _ . -.+ . . . .

1Drum make krings (OE)J) ......i fi.33 ! a,3sDrum br,j.ke lmmgs \AM) .........l 715.:J ; 106.26DISC brake pads, LMV

(OEM) .................. I 0?5 i 099DISCbrake pads, LMV (AM). .1 !1.5s I 15.95Disc brake pads, HV (OEM I

& AM) ............. 0.16 0.22

TABLE )(V-CANCEFt-CASES-AVOtDED FOR

ASBESTOS VEHICULAR BRAKEs—Con-

tinued

B

In the proposal, EPA discussed twoapproaches for regulating asbestosvehicular friction material, eitherbanning all swh material in Stage z orvia the operation of a permit system.EPA stated that it would consider a .class exemption for replacement partsunder the proposal’s staged-ban option.

Asbestos brake friction products aresome of the most widely-used asbestosproducts and are a source of broadlyranging exposures to asbestos. EPA hasquantified exposures to asbestos fromthe manufacture, installation, use, andrepair of brake friction products. Duringthe life cycle of these products, bothoccupational and non-occupationalexposures to asbestos post a lifetimerisk of cancer mortality. The popriiationat risk from these products is larger thanthat at risk from any other asbestosproduct category for which exposure hasbeen quantified for this rule.

Occupational exposure to asbestosfrom the primary and secondarymanufacture of friction products is highand affects many people. The 8-hourTWA exposure level quantified for theprimary manufacture of all frictionproducts is 0.145 f/cc (Ref. 29). Thelifetime risk from this exposure isestimak.d to be 5.0 x 10-3, with 2,779worke;s exposed. The exposure levelfrom secondary manufacture isconsiderably less than from primarymanufacture, because secondarymanufacture of friction products doesriot in(. olve cutting, grinding, and fittingof brake material. However, the TWAexposure level for secondarymanufacture is still high, rangingupward from 0.446 f/cc (Ref. 29). Thelifetime risk from secondarymanufacture ranges from an average of1.6 x 10-3 for drum brake linings to anaverage of 1,9 x 10-3 for disc brakepads, with 3,038 workers exposed.Quantifiable risk from non-occupational,liie !ime exposure to asbestos releasedduring the rnanuf~cturing of drrrmbrakes alor.e is estimated a! 1.0 X 10-4for WW08 people and greater than I x10-6 for 2 mil!ion people.

C)cu.ipaticmal expoure fi om theiris! allation and repair of asbestos brakepads/linings/blocks may result insignificant expos{lre. ‘1’fle 8-hour TWAexpos.Ise levei for the servicing of disc

II

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Federal Register / Vol. 54, No. 132 ) Wednesday, July 12, 1989 / Rules and Regulations 29493—.——— —.—-—__ .

f ~d toar. d drllm ‘or:~ke syste~rr,s is i?stin’,a Lavera~e 0.05 f/cc [fief, 29). The li!(, timerisk from this expos:~re is 1.68 x 10-”3.There are F.n esiinw!{:d 329,000 br:l~.f:rep:~;r L(iii:k:s where an FTF.pOp,l~ ii;(lll Of l,3~l,0W ;,lCjtl~ii~!.SCILIYbe e~-;,o=ed to asbestcrs d“.rringi:~s!aii:i!!sn and rep:iir of asbestos braLiefriction prod~cts. Exposwe :tnd. thus,ri.+k liave not been quanlifkf for thedisposal of .Ysbestos biakc f!icliofiJliilferi(+l.

EPA estimated that approximately 13mi!lion do-it-yourself brake irrs:alli{tion

and repair jobs are d~me annua!ly by~:o:lsunler~ (Ref. 31). ~~p~sur~ fro,m

rmnsumcr breke repair varies dependingLPOn the techniq,le used to repair thehrafies, whether tire repair is done in agarzge or outdoors, and other fact~rs.Release of asbestos fibers into theambient environment resulting from thebraking action of asbestos vehicularbrakes contributes to the significant riskof cancer mortality for members of thegenera] population. EPA has quantifiedthe non-occupational exposures from theuse of three friction materials: drumbrake linings, disc brake pads [LMV),and brake blocks. EPA estimates thatthe lifetime risk is one in one million for101 million Americans, on average.

EPA received a large number ofcommen&s concerning exposureassociated with the use of asbestos-containing brakes. Several commentersstated that there is very little risk ofexposure to asbestos fibers releasedfrom brakes, because the asbestos istransformed to forsterite by the highheat generated from the use of brakes.EPA recognizes that only a smallpercentage of the asbestos in brakes iseventually emitted into the air. Theremainder is either trapped in the brakeassembly or is transformed intominerals such as forstmite by the heat ofabrasion before release. However,asbestos is definitely released frombrakes during brake use. ‘f’he threestudies of brake emissions, which EPArelied upon in developing its exposureestimates, all used electron microscopyto obtain positive raineralegictilklentifica~lon of the emissions’components. The studies found thatbetween 0.017 and 0.216 percent of thew.:;terial released was ssbestos.l\ithoL@ these percentages arc qui{vsrna]!, the tcIttil amount of asbestosrrieased from brake use [approximately7 tuns per year] is large because theicinl volume of brake einissi(.]ns is I(+r:e.

There are devices which ~iin control

the release of asbestos during :he

ni]mial replacement of brakes. Thesedevices, the enciosed c~lindc~j] lEPAsacuum system and thf: {:[lm.pr[’ss{:d i{if’/

solvrnt s~r+v sv.ctwm, are recommended,hut not r[:qt:;re~, !Jy O$H.% as means forreducing exposures below 0SFL4”s WI.and action level [Ref. 16). The OSHA

.’ “ ‘f< tl~e use, of air h{;:;l:s.C.tand&l’d ]11,,i~:IJ:..dcri~lg l,wAc rr,!jdir. Unrfvr ic?c~lColi(!itions t!wse wntm]: m<:ysigrLificant{yrwi:w exposcre. I[owwvero~[in~rl;,]smus t he ussd col;siztent!y to heef~ective ii?ld arkdi!iwwrlexposures can

be cwalort dlrin~ the disposal of

asbestos-contaminated solvent or during

replacement of kiEPA vacuum fiiters.Ifthe devices are used propwiy andexposures are reduced to the PEL orlower, EPA believes t!lat the residualexposure can still result in anunwasonabie risk. The efficctcy ofcontrolled use HS an approach to riskreduction is discussed in more detuil inUnits V.A. 3 and V.E. of this preamble.

Several commenters stated that EP.4should not ban asbestos frictionproducts, arguing that engineeringcontrols can provide sufficientprotection from the risks of asbestosexposure. EPA believes that while thesecontrols, if used consistently, can reduceexposure to the OSHA PEL, EPA’sanalysis indicates that exposure atlevels e~en below OSHA’S 0.1 f/ccaction level still pose significant risk. Incomputing workplace exposures, EPAassumed compliance with the OSHAstandard w-hen actual monitoring datawas either unavailable or above theOSHA PEL. For examp!e, the EPAexposure data for brake repair facilitiesestimate asbestos exposure at 0.05 f/cc{Ref. 29). Even at this level, which is onehalf the OSHA action level of 0.1 f/cc,EPA, using the risk table in the 1986OSHA rule, calculates a lifetime risk of1,6 x 10-3, Given the substantial lifetimerisk and EPAs concern regarding theconsistent and proper use of thesecontrols by mechanics (Ref. 50), EPAdoes not beiieve that use of controlsduring brake repair will sufficientlyredrrce risk.

Additionally, a controlled useapproach as an alternative to a bun ofasbestos in friction material wouid notreduce general population exposures toasbestos originating from brake use, Inarfdiiion, these contro!s would noltypicdily !Je available to i!]e eslimatcd10 miii:on consumers w-ho arrnu:illy

If i~r:ike jo!)s (Kc-f.~erf[~rm rto-it-:,wurse,,,- ,JiJ.

EPA has assessed !hc c:.:rrentavail ahiiity of nor~-aslwstcrs friclicJllrn:]:er;ai for disc and drum brake svslemin v-ari(w!s vehicle weight c!asscs. lhisassessment can be found in Vcdulne iIIof the Kegu[atory Impact Ana]ysis (Rt:f.21). To summarize briefly, use of nm-as}ws*IJs friction malcria!s in recent !y-

manufactmed vehicles is increasingr~pid!j:. T!;ere is n.eady complete -subs~itfiticn for asbestos in disc pads

f \tlred motornsed m rwen!ly-manu ac.

h~,hicles..Wrwst 100 percent of disc~)ii(ls for ne;v?y ma:;!ufactured hea’.~-wei~ilt vehi(,!w ore ~.sLest~s.free. I’mIigfii- arid medium-weight vehic; t?s, 85percent of the disc pads used in newvehicles tire asbestos-free. Severalprodutxxs esiimate that by 1990, W to100 percent of the disc pads for newvehicles v{ill be asbestos-free.

Evidence also indicates thatsignificant progress is being made in thedevdcrprrwnt of substitutes for drumbrake linings used in recently-mwdactured motor vehicles. As notedby some commenters, substitution for~s}jestos in dmm brake linings and

brake bIocks in new model vehiclesappears to be more difficult than for discbrakes in new model vehicles. However.according to some commeniers, muchresearch is ongoing and somesubstitutes are currently available fordrum brakes in newly-manufacturedvehicles, Several commenters statedthat asbestos substitutes are morereadily available than EPA hasestimated and that full conversion toasbestos-free brakes in newly-manufactured vehicles would befeasible in the near future. Somecommenters pointed to the rapidconversion to asbestos-free brakefriction material in the European marketas proof of the technical feasibility ofbanning similar products in the U.S. Forexample, Swedem the Federal Republicof Germany, Switzerland, Austria,Denmark, and Norway have eitherbanned or are phasing out the use ofasbestos friction materiaL

Primary substitutes include semi-rnetallic materials for disc brakes andnon-asbestos organic materials(including fiberglass, para-aramid,mineral fibers, steel wool and fibers,and resins) for drums. Opinions fromccrmmenters vary greatly concerning theavailability of effective and economicalsubstitutes for brake friction products.While some commenters stated thatthere are substitutes currently avfiilablefor most, if fioI all, brake frictionproducts, other commentws feit thatsubstitutes vvou!d be available within 5to 10 years of tlc iime of the proposalfor most, if riot al!, broke frictionp~Odu~ts. s~~,erti! conlnlenters were

more pcssirnis!ic about the futureavaikfbili:y of substitutes. Othercommentem h~dicated that adequateasht:,tos-free brake blocks may bedifficult to chcvelop for new model!,(,.+ry-t.eig?lt Iwhid{$ because Ihe

weight of the vehicle puts ~reaterdemands on the braking system.

While many opinions were offc: d in. .1 ..l~e,~,~here ilb OUt t!lecomments a. IL: t..

progress bei:lg rwidz tow:ird the tise ofa!rbf!st~s-free bl’ak.e friCtion n~a!er~al,

EPA dirt not receive ana~ytical orquantitative data from comrnentersdocumeriting technicrrl difficultiescncrmntered regarding su’ostitutiorr forasbestos in b.~al<e friction rnateri a!. EPAacknowledges tfw inherel~t research anddevelopment variability associated withtechnological kmovation. As a result,EPA decided to delay the ban onasbestos disc brake pads and drumbrake linings in new light- and medlum-weight vehicles rind in replacement discpads and drum brake linings fm light-and medium-weigh! vehicles with brakesystems designed to use non-asbestosuntil Stage 2. Manufacture, import, andmarketing of brake blocks for use ineither new heavy-weight vehicles or asreplacements will not be banned untilStage 3. These dates are within therange of time frames suggested bycomments and the American Society ofMechanical Engineers (ASME) expertpanel’s rec~mmendations for newvehicles (Ref. 40). Specifically, ASMEstated that “‘ * ● at the present rate oftechn~cal progress, most new passengercars can be equipped with totally newncn-asbestos frictional systems by 1991,snd most light tracks and heavy truckswith S-cam brakes, by 1992. However, afew low-volume new vehicleapplications may not have acceptabler-ion-asbestos friction materials at thattime. Heavy trwck wedge brake blocks,medium drum brake linings and manyoff-road vehicle brake linings may notbe developed by 1992.” Commentssubmitted to EPA in 1986 in response toits p~oposai described various lead timeframes that would be necessary topermit !!lc transition to non-asbestosOEM friction rna!miais. These schedulesvaried betwee!l 2 and 10 years. Themost cormmon :i.me frame poirlted to was4 io 6 years for most frictirm proriu~b,with specia! consideraticms given tobrake blocks and disc pads for heavyvehicles. Severe! cmnmenfers requestedtime frames in excess of 10 years beconsidered for these heavy vehicles.Keeping in mind that these cwmmentswere made in 1’386, EPA believps :hat itis reasonable to assume that OEM brakefriction material for light- and mecfium-weight \ ehicles anti hesvy-weightvehi:ies can be astxstcs-fre: !2v tfie~;ites prescribed in the Pl]e.

Commenters generally agreed th~! i! iseasier to develop replacement asbes!os-free friction materials for use in vehiclesthat are inten!imral!y designed to tis.e

such maierials Wm it is to devuiupasbestos-free friction nlater’iti~s fl!r :132

as aftermarket? replacement products invehicles cwwnt)y in use that hi]vs brakesystems desi,g:l~d io use i+~besto~. A

number of cunlmmniers a~cll i:sw d ike

current av~iilability an~ efiicacy ofasbestos fzee aftermarket repiacem.entsfor vehii;~es designed w use usbest:Js

friction rnaterids. Son}: uf tiirxwcu,ilmenters maintained that stibstitvtcsale cnrrwltly available for all frictionmaterial aftermarket applications. Someof the major prorhicers oi brake frictimrproducis, including af!crmwket frictionmaterials, no longer produce asbestosbrake friction material. One con:menterstated that asbestos r~piacements forheavy-weight vehic!es are no lm:geravailable from reliable U.S. producers.On the other hand, some commentersstated that it would be infeasible,primarily for economic reasons, todevelop effective asbestos-freesubstitutes for the aftermarket, whileothers indicated, in 1986 comments. thatit wou!d take 10 years to developadequate aftermarket substitutes. Thesecomments about the technicalinfeasibility of replacing asbestosfriction material with asbestos-freefriction material were not based onperformance data, but rather theoreticaldiscussions and anecdotal information.Due to the lack of analyticalinformation, EPA cannot estinm!equantitatively t!le rate at whichasbestos-free substitution is ~ccurringfor the aftermarket prod Jsts. EP.% hasdelayed until Stage 3 tl,e km onaftermarket friction rnatmiakrmanufactured, irnporterf, or marketed foruse in brak; syste.rns designed to useasbestos. FYA beliew-s this deiay willpermit time to addrfss technologicaldifficulties in dwm!oping a%rnarketsubstitutes for vehicles d~:s+y ed to useasbestos, BY th~ effective date of theSt.~ge 3 ban, many of the vckicieti on theroad will b? asbest~s-free becuuse ofthe St,?go ? ban and the priormantif tc’ure of asbestos-free ~chicles.EPt4Xb ~i~~>~oth~]t it is il.

,. “-l~t>r~~~’{to f(jl’(;etechnr logy tc deve!op as&sios-freereplac :ments as rapirtiy’ as possib!epar!if A,ity in light of the fact thatmarry corn.menters have pointed to thecurrent availability of as bestos-flt!er~p!acement lir:i I;gs/b!ocks and havenoted rapid prw~ress in t}]e developmentof alternatives to L3~j S’+tOS frictionnm;eri:lls. EPA pl:lns :J moniwr theprog;ess of subsl:t:j:e a’walifibiiity faraP!ermarket products, t!rtus encour~gingsubstitute producers and aftermarketmanufact!l?ers to report progress mtechnological ciif’ficuit; es that may

IWWS~tdk ~iIJCf~fi:C~~~Oil(>f~~r!ai!}provisirms of fhe h:m.

Comments described technologicalrephcement ri~!fic’~l?ies cr eccmom~cdisinctintives associated wi:h(I:!vl;!opillg asbe:;ios-free frictionrnate~i. a!repiac:munt parts for older andsniique cars or for specifi).t~ r.ars suctr

Z13. “11ronslder a classas race cars. . .. /1 w’!,exemption f:>r such vebic.les if one isr~q~este~.

Some commel::ers si~?~d that a banon asbestos use in i$c aftermarket forbrake systems di:si~necf for asbestosfriction produc’s will compromise theperformance of braking sys!emsdesigned for asbestos brakes. Somecumrnenters went so far as to predictthat there may ix more deaths in vehicleaccidtm!s due to poo~ performancemused by prema krre substitution thanfrom the health risk posed by continueduse of asbestos in friction products.Several cormnenters stated that EPA hasignored the impact of an asbestosfriction product ban on highway safetyand that risks associated withsubstitution shouid have beenconsidered ~s part of the role’s analysisof costs ar.cl benefits. Clne commerrterurged EPA to confer with the NationalIiighway Traffic Safety Administration(N13TSP,) regarding possible motor

vehicles safety considerations ~associated with use of rron-asbestosfriction materials in vehicular brakesystems. EPA and NHTSA have met anddisc~lssed potential effects on vehiclesafeiy if asbestos friction materials werebanned (Refs. 61,62, and WJ). NHTSAhas no objection to the staged ban and

-$ adopted fortechnical revic;v approa,.,

this rl!le (Ref. 28~.-,Evaluation of the safety concern

regariiii~~ asbestos substitution voicedOy these corruneniers is cmnpiicated bythe fact that there are no federal safetys~ilndards governing me i)erformance ofaftermarket brake friction products.While the NHTSA promulgated safetyperformance standards in 1966 forbraks in new vehicles. no simiiarsiamfards exist for repldccm:e~.t parts.NHTSA received two petitionsrequesting i!ld t NH’i’5A prwnu!gaf.esj]!’e!y standards fur the aftermarket.‘rhe~e petitions rrotfid the present use 0!inferior grade asbestos and non-asbcstos friction ~]~i~~i:i!~ and theiwltivertent misrnai~hing of tifterm.arkctfriction material to i!:di;iduui brakes}stems; the petitioners aryued thaithere i3 a compl:~l~rv; :UIJ !0 cs::lhijsh~erformafiw stawiar:~s fur theafterw.arkei. Nlll’%\ ;r+:~ied a petitionrequesting that NEH%\ propose as!.andard requiring that ~i! heavy titi~kbr~lke linir:Ss be rated and marked in

I

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Federal Register / Vol. 54, No. 132 / Wednesday, July 12, 1989 / Rules and Regulations 29495h

to exist over the (iates wheir substituteswill be available for different vehicletypes, EPA believes that this ruleprovides sufficient lead t]me for thedevel{jpnlerlt of effecti~e rron-asbwtos

substitute fri:kes.ITI]it;ht OF!jlpse facts +,rrd [!IP

extensive risk posed by expcstire tuashl; stas from ~’ehicrr!ar brakes. EPAbelieves that it is appropriate andn(wcsswy to ban asbestos in vc!licularfriction material. Nonetheless, asdescril)ed above, EPA, in consrJtatiocr!vith NIfI’SA, Ivill monitor the pace ofsuhstiiute dt?~re;op!iif!nt and undwiake at~c}inical review 5 years after theef!eciive date of the rri!e, to ensure t!:cayai!a!)ility of sttitat)le non-asb, estusafterri~ar”k.c: brake prwfuc[s. Afterc[}l:side)ing a!l of these issues, EP~\bc~ievcs that tf-,is is the b(est ap~roach inli~!]t of the higil risk posed by asbestos,the rapid deve!opmerrt of rei]lacementfriction materials, the current use ofnon-asbestos brakes in Europeancrruntries, the controversy concernings~lhstitufe availability and perforrn:+n cc,and t!le current consideration, byNiiTS%, of af!crmarket safetystilndards.

“fl,etot,il costs of the actions t::ken int!;;s rule f{~rtk,e~e product categories are

set forih in the following Table XVI:

TABLE X\/1—COST OF THE RULE FOR

ASBESTOS VEHICULAR BR,4KES

————-–—– ——I Total CcstI (In $ mihw,

Produc[ dlscourlted,313

p+fcent)——-—-–-+.—.-—--–-—

Owm brake Itnmy (f2Eh’) ........ 7.12Drum b~~~e Immgs (At.4 )., . .. ... .. . , 8.7.9DISCbrake pads, IJ.4V (f3Eh!) .......... 356DISCbrake pads, LMV (AM).. ..... 394C%c brakepads, W (OEM & AM)......... 0.33

_-_-.__.__J-.u:Brake blocks(CEM & AM)......................-——

f. Other frictio~ pwdticts. Thisgi-cuping includes clutch facings,automatic Wmsmission components,i?nd the irrcf:lstriaI and commercial

‘f]iction products categories. Theseprodl[cts will all be banned at Sta~c zThe benefits (in terms of canrx!r-cases-uvoided) of the actions taken in this ruleon these product categories are set forthin the follo~~ing l’a~le XV1l:

TABLE XVW-QNCER-CASES-AVOIDECI

FOR @THEH FRICTIONPi=IODUCTS——

Prorl:lct ~j;:::y:ciii

. . ——+—-—-

Clu?ct? faclcg . ‘ 10!Y 1.38Autowa!]c Iransm!ss!on I

crmwwwnf~ ...........I <001 i <001

TABLE” XVII—CANCER-CASES-AVOIDED

FOR OTHER FRICTION PRoOucm--Con-tirwed

.—.-.. _ —.——.-——I Dwcount rate

Pr’Mutt

—[~~we;~ ~ O p.r,X\

——. .—1

!:!5 ,,JT3] and COmm$.l<12!\fnc!lon products ~ 040

1-G.52

.—..—.— — —.—

Primary routes of exposure toasljestos from these products occur(!:irirlg manufacture and repair.Quantified occupational risk posed bytki~ m~rtufacture und repair of thesep! uciucts ranges from an al’erage of1.45 >:10-3 fur the primary manufacturecf a~torr:alic JurLsJnissicm componentsto an avcwgc oi 5.2A 10-3 for thej;J ilniiry rnanufficture of friction:wi:criah. Approximately 517 workers inprimary and secondary manufach.rre andII G Fi’Es in instaii~tion, repair, anddisposal are exposed to asbestos. Inaddition to these occupational risks,EPA has quantified significant non-occupaticmal releases from the primaryman,d’i{cturin; of these three products.?vfunit(jring data are not avaiiable for the~>.p,;sil[.e Jcstlitir,~ from the use of theseproducts, alihough ETA does believeaddiiiorx+l exptrsures from ciutches andiw-hrs!riai and commercial frictionproducts are like!y.

After assessing the currentHv:~il,-:bi]ity of slihstitutes and expertopinicns co~ccrning the predictedavail tibility of s{~hstitutes, EPA believesthat suitable substitutes wili beiivfiil:~ble for clutch facings, automatici[-;,~]smi:;sion components, andconlnl.elci~l ai~d industrial frictionpr!,docts by ttre effective dates of thebins. Over ilie last-several year, EPAhas noted the increased use of non-asbestos parts for !hese products, andbelieves further development is hkeiy.

The total cost of the actions t~ken inthis rule for these product categories areset forth in ~he following Table XVIII:

TABLE XVIII—COST OF THE RULE FOROTHER FRICTION PRODUCTS

I Total Cost

Product in $ milhon,d!sccwnted

] at 3 parcent——

7——––rlutcb fac:ngs .. . . .. ... ... . ... .. .... . ... .. .. . .. ... ... . 12.s7

Automatic transmission COmpOn@S.. ..! 022Industrial and commercial frtd!on

~rcducls . ............. 2.11—— —

The economic impact cm this ban willbe limited by the fact that most majorprimary manufacturers of asbestosfriction products rrlso produce asbestos-

E

29496 Federal Register / Vo!. 54, No. 132 / Wednesday, July 1.2, 1909 / Rules and Regulations—. . .. . .

free substitute products, In fact, all ofthe U.S. manufacturers of asbestos-containing automatic transmissioncomponents also produce asbestos-freeproducts. Currently, asbestos-containingautomatic transmission componentscurrently comprise only one quarter ofthe present market. Considering therapid substitution in this area antirelatively low cost, EPA will ban themanufacture of automatic transmissioncomponents at Stage 2.

EPA has concluded that a Stage 2 banis appropriate for these productc~te,gories for the following reasons: (1)Relatively high quantifiable exposureand individual risk levels exist for theseproducts; (2) these products pose a highpotential for ambient release during anumber of life cycle stages; [3] workersand the general population arepotentially subject to uncontrolledexposures; (4) suitable substitutes existfor many of these products and arelikely to exist for others by the time ofthe ban; and (5) the cost of taking theseactions is reasonable.

g. Gaskets. This grouping includesmost of the beater-add and sheet gasketproduct categories. .These products,except for specialty industrialapplicati oris, will be banned in Stage Z.Specialty industrial g:iskets are notbmmcd under this rule [see discussionat Unit V.F.LX below). The benefits (interms of cancer-cases-avoided) of theactions taken in this rule on theseproduct categories are set forth in thefollowing Table XIX:

TABLE XIX—CANCER-CASES-AVOiDED

FOR GASKETS 1

1-

DISCOWXwtePrcduct .—.

3 p.3rcwM ~‘O->rcem+.—. —

~. .-3

B:>a!er-add ~askcts ................Sheet gaskets., ........................

1Does not inclixh specialty irrdwtrial gaskcls.

Gaskets are materials used to seal one

compartment of a device from another inapplications such as engine and exhacs!manifolds. Asbestos gaskets are usedmainly to seal connections and prwentleakage of ffuida between solid surfaces.

Primary routes of exposure toasbestos from these products occurduring manufacture, repair of machinerycontaining an asbestos gasket.replacement of the gaske! itself. and(iispos al, Exposure estimates [bit notcost or benefit est; nwte:) use,} iu thisUniL ref!ec~ cxpo ,ures ::uo.:t~~i!!:! F:II .I!l

gasket app~icxttions, inc]udirrg t!?i?s,mAlispecialty industrial gadwt seynmt ofthe gasket market that is not banned b:~this rule, An estimated 2,5s3 ~vorkrrs :~re

exposed to asbestos during primary andsecondary manufacturing of asbestosgaskets. Quantifiable risk ofoccupational exposure to these productsranges from an average of 7.35 x 10” forthe secondary manuf~cture of beater-add gaskets to an average of 3.56 x 10-3for the secondary manufacture of sheetgaskets. Quantifiable risk from non-occupational, lifetime exposures toasbestos released during themanufacture of beater-add gsskc!salone is estim~ted at 1 x 10-+ forapproximately 47,000 people and atgreater than 1 x 10-G for appwximatciy 6million people. EPA believes that theexposures quantified for these productsarc underestimated. Exposures thatoccur during gasket replacement andmachinery repair, including activitieslike scraping of gaskets or on-sitef~brication of gaskets, were notquantified by EPA. EPA determined thstaccurately quantifying these exprxmresand the resultant risks would be difficultand lhat sufficient other exposore andrisk information is ir~’ailable rcgiirdirigthese products !O make a finding ofunreasonable risk.

ilccording to comments, production oftis~)~~s!os-coll{:iinitlg sheet and bc(~ter-rrdd gaskets has dropped significtinily inmost applications in recent years ~li~dnon-asbestos substitutes alreilcfvpossess a large share of both gasketnlarkets. Also, commrmters indicatedthat the majority of the gasket marketwi!l be asbestos-free before the end of1989. The economic impact of this banwill be limited by the fii~t thatsignificant progress h~s been n~,~[ic inthe de~iciopmmrt and a~~ilahility of Po:w~sf.)estos sribstitutes for most gasketiipp!iciitiorrs and that rnnst, if nol ail,

Srlajar pr]mary manuf:~ctcrers ofasbestos g,iske[s diw prouuce nonrrsbestcrs substitute products. flue to :heinsufficiency of available price cfdta,

tblese recent Irends, and the resiilianic!wr(~.ism in the costs of binning thisproduct, arc not fully takerr into account

.~c ~):[;:::~~:;.:ik~the aria!ysis of lhc bcr.i,..,,

th~se categories.. Therefore, JW.-\beiievcs that the actual cost of ih~

actions taken on these catcgori, ~s is Icssthan that indicated below.

Gaskets were proposed for either aStage ~ tran or a ban via the oper-~~ion of: permit system. However, P.PA hasrsceived comments indicating that Ihc(!c~.~~lopmcnt of suitable substiiates h~sIwun Oloie rapirf ti:dn pr,je~hd f~r rno:;~

,.t$[l~.<!if:(!,,lo!:s, RI’* is i: ~? Cl,nf’!;?le! :~:lt(;:)ilSilITlZi5 and oihc:s IJldy he slilbj~:ct toijl]!,(,]}lrol]!~ley.fJ(]sures dl:iln~ the r(,p;iiranJ re~iticeinellt of cmmwvcr

a[)plic; llir, il.so f these PW:JW.!$;.

The total-costs of the actions tafwni.1this rule for these product ca!egorit’s areset forth in the following Trrb!e XX:

Tfl.BLEXX–COST OF THE FiLJLE%~GASKETS 1

-.. -.. -. ——..-Toial~Ostin S mi)lin

Product ~ (dyiwd

: py~enf).—.—. ———-- -- -

B?ater-add gaskzis .................................. 1“11.23Sheet g3skets ........................................... ~~~

JWA has concluded that a Stage 2 hi!nis upprcrpriate fur these productcategoi ies [except for specialtyindustrial gaskets) for the follow’in~reasons: (I) Relatively hi,gh qoanti~~.;!~iee~pos(lre and individual risk tcwe!.s ~xistfor these products: (2) these prrxjvctspose a high potential i~w ambient releasedzring a number of life qn:le stag:es: (3)hornrwwners and workers arepotentially subject to uncontrolhxic;..plmures during removal andreplacement of gaskets; (4] the ov(:i;~~i

cost calculated for taking therm actionsis relatively high, but is hke]y to be anovt;~cscimate because, according tocommenters, suitable substitutes existfor many of these oroducts aild arelikc]y lo exist for others by the time ofthe b,m; a~nd (s) the scheduling of Lfeseproducts for a Stage 2 ban allows for the(:[>~]tifiut:d development of substitutes.Kle!iiy irig the ban on these gaskets untilStage :~or not banning the use ofasb~wtw in these products could hiurtt!te etY:~rts cr,!the L:rgc :lu~ibc,.‘5 Of fi!; ll:l!lmt Live ahca~.iy m:]di? si@ficantJ)r[lRr,!ss ill dct’eiopii?g S1.lbStihlltJSbl;(X,USe S(,I1lIJ~l,iJStii.ti!~S drf; ml)f~,

,.. ] ~-,,cxpwlsive ih, m ~J,AS.OS-CC2t2: “Iiir.g:L. .:<eLs.

Spwi~iltj’ industrial ga3kets are

exc!oderf from this rule’s bans. Thesetipplicutions are rret banned h~~iiti~,~;,f

the high costs of a ban, d~~ LO~!:e ! ;of suitable substitutes for a number of

. ..S#2CldilZd irwus[iid i UWS, :hr2 rc!~i~;:!y

~ 1.smal[ bencflts dwvmf frwm a b:jrr. an, , .1’nLl:;l I(’Pof othi’rf;;rcturs <!tis~.;l,U...“;l’,~(; in

Ulll[ k’.r.l.x.h. A/Cp@e. This category wiil J-w

banned in Stage 3. The berwfi?s [interms of cancer-cases-avoided) of theiictions taken i.n this rmle on t}:is productcategory are as follows: 3.17 cases ifbene!ils are discounted at 3 pmccc? :11d-1.s8 casts if benefits :me not discoun::~t!.

A/C pi;w isJ ~roddc! COIYl!JfjS,,~l,]f

wIntint L~~I~J.]sbcr!os fibers :~nj US(.Jprim(trily to cw-:~.,eypu!ab!e w~?er i:{W$l!cr m:lin~, sewage in force .7rainSL:’rS:t;W and various rntt!erie!s in

.—

Federal Register / Vol. 54, No. 132 / Wednesday, July 12, 1989 / Rules and Regulations 29497

industrial process lines (pressure pipe. .aFPlicatlons], as Well as storm dr;]inpipes and sewer pipes (non-pressurepipe applications). Thousands of mi!csof A/C pipe are installed in the U.S.orrnually. A/C pipe comes in a widevqriety of diameters, forrnul+tions, an?weig,hts designed for differe~t.~jtplic~t ions.

Primary routes of exposure toasbestos from these products occurduring manufacture and installation. Atotal of 286 workers isestimated to beexposed to asbestos during the prirmsrymanufacture of A/C pipe and as manyas 14,944 workers may be exposedduri@ the installation and removal ofA/C pipe. Individual lifetime risks posedby these products from occupationalexposure are estimated to range from6.11 x 10”4 for installation and removal(a lower bound that assumes workersinstall and remove A/C pipe 16 percentof their working hours) to an average of3 X 10-3 for primary manufactureindividual risk from non-occupationallifetime exposure to asbestos releasedduring manufacturing is estimated at 1X 10-4 for approximately 30,000 peopleand at over 1 x 10-8 for approximately 2millionpeople. However, EPA believesthat the exposures quantified for thiscategory are underestimated. Workerexposures that occur due to the cutting,drilling, or machining of pipe in possibleviolation of OSHA requirements orgeneral population exposure because ofpossible erosion of A/C pipe are notaccounted for. U.S. production of A/Cpipe has decreased significantly inrecent years with the declines in sewersystem construction and other marketfactors, including the growing use ofnon-asbestos substitute products.

Some commenters have s~ated thatA/C pipe possesses a number of uniqueattributes, incIuding lower energyrequirements and friction loss, andgreater durability in certainenvironments than the substitutesidentified in the RIA, and that thereforeA/C pipe should not be banned in thenear term. Available evidence suggeststhat products are currently av:{ilable assubstitutes. The primary substitutes forA/C pipe are poiyvinylchloride (PVC)and ductile iron pipe. There are a~~riet~ of as!) S%tOS-frCeC(Jil Cr{; tC

prcducts, including prestresscd andreinforced concrete pipes that rn, iy alsobe used as substitutes. All prim:iiy lJ.S.p~oducers of A/C pipe also producedirect subshtutes made out of nomasbestos materials. A commcntwimiicated that a cenle]~t /s~]bsti t~ltt:-fil~t;rcompmition is under development andth:~t the substitute fiber rn~y repiiiceas!~cstos in A/C pipe. thus perrnittinp,

the continued use of capital equipmentcurrently used to produce A/C pipe.This ~vould substantially reduce thecosts nnd societal impact of banningA/C pipe.

Some commenters have argued that if,fla/c pipe i> bi:~ned, pressLIre may be

brought 10 repldce or discontinue rise ofexisiing A/C pipe. EPA does not believethat installed A/C pipe sholdd bereplaced or that its use should bediscontinued. EPA’s e~’aluation of therisk posed bv A/C pipe, and by allproducts su~ject to this rule, is ofabsolute risk posed over the entire lifecycle of products to be produced in thefuture, not just risk posed by existingproducts during product use. EPA’sprimary concern, for purposes of thisrule, is the risk posed by exposuresduring the life cycle stages of A/C pipefrom manufacture through installation.Expected risks later in the product lifecycle, for example those risksengendered from exposures due toeroding pipe, have not been quantified.Therefore, actions to remove ordiscontinue use of existing A/C pipe inresponse to this rule are not justified.

Other commenters argued that if A/Cpipe is banned in the U. S., othercountries, including those where viablesubstitutes for A/C pipe are not readilyavailable, would be pressured to ban theproduct. EPAs unreasonable riskanalysis for this rule for A/C pipe isbased not only on the risk posed duringthe life cycle of the product in the U. S.,but ~lso on the availability of viablesubstitutes in the U.S. and other factors.Therefore, the fact that EPA finds in thisrule that future A/C pipe production anduse in the U.S. poses an unreasonablerisk does not imply that a similar findingcould be made outside of the U.S.

A commenter argued that PVC andductile iron pipe as primary substitutesfor A/C pipe pose greater health risksthan those posed during the life cycle ofA/C pipe, EpA acknowledges that theindividual lifetime cancer riskassociated with the production of PVCmay be equivalent to that associatedwith the production of A/C pipe. EPAcould not calculate individual lifetimecancer risk for the production of ductileiron I)ipe. Instead EAP could onlycompu{c population cancer risk fordtlctile iro!i pipe production because oftile manner io which availoble risk dattiwere preserlted. The population cancerris’~ for tile production of ductile ironpipe could be comparaMe to thep~~puiaiitlil cancer risk for produc~ion ofA/C pipe. While available informationp(,rriiitit~d EPA to quantif’~ the risksassociated with the installation of A/Cpipe, cancer risks from installation of

ductile iron pipe or to PVC dust frominstallation of PVC pipe have not beerridentified. While individual hfetimerisks have been quantified for vinylchloride (VC) leachate in drinkingwater, individual lifetime risksassoci~tpd wi!h asbestos in drir. king

.11-vva+erhave no: been spccit’ic’t .yquantified. M bile the supporting datdare limited. based on a consideration oflife cycle risks, EPA believes that thea~’ailable evidence suggests thatsubstitution of A/C pipe wiih PVC andductile iron pipe will present lowerpopulation cancer risks.

i. Polavl’in~’lcllloridepi~>e.For theproposed rule, EPA concluded that PVCpipe does not appear to present a healthhazard comparable to asbestos,although VC, the monomer used toproduce PVC, is a carcinogen. EPA alsoconcluded that while VC is a humancarcinogen, it does not appear to presenta greater hazard than asbestos in theworkplace or ambient environment. ThePVC product itself presents little riskand workplace exposures areapparently adequately controlled (Ref.39).

EPA based this determination, for theproposed rule, on several factorsincluding the individual lifetime cancerrisk of 10-4 for occupational exposuredue to inhalation of VC in themanufacture of PVC pipe [Ref. 39). Inresponse to the proposal, a commenterstated that workers exposed viainhali~tion to VC at the OSIHA’S PEL of 1ppm would have a potential individuallifetime cancer risk of 4 x 10-3. Thecommenter noted that this individuallifetime cancer risk is based on EPA’sCarcinogen Assessment Group’s (CAG).published unit cancer risk of 2 X 10-2(mg/kg/day)-l for VC based on animalinhalation data. The commenterquestioned the discrepancy be!ween theindividual lifetime cancer riskestimation for VC of 4 x 10-3 and thelifetime cancer risk of 10-4 cited inEPA’s support document for theproposed rule.

The commenter is correct t!~at CAGhas published a unit risk number forinhalation exposure to VC. This unit risknumber was derived from animalinhalation data. The individual lifetimecancer risk number, 10–4, cited in !hesupport document for the prop~siil. Iviisderived from epidemiological dataanalyzed and reported by .Nicho]son etal. 198z (Ref. 39). In summary, EPAbelieves that the expected individuallifetime cancer risk associated with themanufacture of PVC pipe may beequivalent to ihe individual lifetimecancer risk posed by manufacture ofA/C pipe. However. as noted in

I

294!38 Federal Register / Vol. 54, No. 132 / Wednesday, ]UIY 12, 19S9 / Rules and Regulations——_—. _-—.. . .—— — _..__— ——— .——.

Ifwtirnooy presented by i] consultant ftlrt!ie Asbestos Institute at the “1986legislative hearing, production of A/Cpipe is significai~tly more labor intensivethan production of PVC pipe. Even if oneassumes that the lifetime cancer risk forproduction of .A/C pipe and inhalationof VC in the manufacture of PVC pipeare comparable, the number of expeGterfcancer cases (Poplllation risk) fromproduction ~f PVC pipe will most likelybe lower than the expected number ofcancer cases associated with theproduction of art equivalent amount ofA/C pipe.

EPA recognizes that VC inhalationexposure in the workplace, is the mostsignificant exposure. Other potentialexposures that could be present but aredifficult to evaluate include: (1) VCleachate in drinking water, (z) VCemissions from PVC plants, and (3)inhalation of PVC dust. A comrnenternoted that “exposure to VC by ingesfionin drinking water (via leaching from thePVC water pipe or as a contaminant inthe water supply from disposal of VC/PVC waste products) also occurs.”Additionally, the commenter noted thatEPA should update its unit cancer riskv,due for ingestion given a more recentci]lcula!ion by EPA’s Office of DrinkingV.’ater.

EPA acknowledges the presence ofdetectable levels of VC in drinkingw.ltw; however, the amount of VCexpected to leach into drinking waterfrom PVC pipe is considered to beminimal (Ref. 43]. It is estimated thatnearly all individuals (99 percent) usingptiblic water supplies are exposed to<1.0 ,ug/1 of VC from all sources. At 1.0yg/1, the excess lifetime cancer risk isabout 6 x 10-5 (Ref. 44). Since leachinguf VC from PVC drinking water pipe isestimated to be minimal, the risksassociated with any increase in theamount of VC !eachate in drinking waker~{sa result of a ban of A/C pipe k ~lsoexpected to be minimal.

Exposure to respirable PVC dusts tindfumes may mxasiona!ly be encounter,~din the prodw;tion of PVC or in theuv~nufticture of PVC pipe. Exposure toP\’C dust is associated with fibrotic lungchanges and nonfatal lung ccn~iitiorts,such as bronchitis and pneomccoccosis[Ref. 45).

Analogous to its analytical appJ eachto asbestos and fibrous substi!l:tes, EPAIi;niled its PVC assessment to healtheffects directly associated with VC m-pl-lC, F;ff~~~s from eYpo$ore 10 (Jth(3T

chemicals (such as solvents,bvproclucts.

intermediates, and adhesives) involved

in the nlanufacture, installation, use or

disposal of PVC pipe were notconsidered. For the proposal, EPAeva!uated hazard and exposure data onsome other chemicals associated withpipe production and use. However, asnoted by a commenter, the hazard and/or exposure data for these otherchemicals are too limited to assess risk.

On the basis of available evidence, onbi]lance, EPA believes that thepopu!aticm risk associated with A/Cpipe life cycle exposures are likely toexceed the population risks associatedwith life cycle exposures to PVC pipe.A/C pipe presents risks throughout itsproduct life cycle during manufacture,installation and repair, use and disposalbecause of the especially hazardousproperties inherent in asbestos, theenvironmental persistence of asbestosfibers, and the larger populationsexposed. In contrast, PVC pipe presentsrisks largely during the manufacturingphase of PVC pipe.

ii. Ductile iron pipe. For the proposedrule, EPA concluded that ductile ironpipe, as a substitute for A/C pipe, wouldnot present a health hazard comparableto that of asbestos (Ref. 39). Based onEPA’s revised analysis of lifetimeexposure associated with A/C pipe, onecou]d argue that the number of excesscancer deaths associated with theproduction of ductile iron pipe and A/Cpipe may be similar (Ref. 42). However,the excess cancer deaths that may beattributed to ductile iron pipe may beoverestimated (Ref. 42). The estimate ofexcess cancers was derived fromepidemiological data gathered on steeland iron foundry workers who may havehad more diverse and higher exposuresto toxic agents. Nevertheless, even if thecancer risk associated with ductile ironfoundries is similar to steel foundries,the estimate of cancer risk for ductileiron pipe is most likely an overestimatefor current exposure since historicalexposures upon which the risks werebased were probably much greater. Incontrast, ductile iron pipe ismanufactured from scrap metai which isnot expected to result in exposuressimilar in magrutude to those found inthe steel and iron foundries. [jiven thatthe number of workers exposed toparticular agents in particular jobctiiegories cannot be determined, aprecise occupational cancer riskcomparison cannot be made. inaddition, available evidwrce sugges?sthat risks during non-manufacturings:ages of the product life cycle aregleater for A/c pipe than for di~ctileir,-rn pipe. l’bus, Ei)A believes that fewercancer cases would be expected fromthe substitution of ductile iron pipe forA/C pipe than from the continued

manufact~ire, processing, and use of A/Cpipe.

iii. Re~ulot(wy approach. The totalcosts of the actions taken in this rule forthis product category is $128.03 million.This cost is likely an overestimate of

actual cost in that it does not quantifythe effect of the development ofsubstitute fibers in cement pipeproduction. Use of a substitute fiber isexpected to substantially reduce thecosts and societal impact of banning thisproduct.

EPA has concluded that a Stage 3 banis appropriate for this product categoryfor the following reasons: (1) relativelyhigh quantifiable exposure andindividual risk levels exist for theseproducts; (z) these products pose a highpotential for release of asbestos fibersduring a number of life cycle stages; (3)workers and surrounding populationsare potentially subject to uncontrolledexposures, especially duringinstallation; (4) while this category wasproposed for a Stage 1 ban, EPA hasconcluded that it is appropriate to delaythe ban until Stage 3 to allow more timefor further substitute developrnenti (5)the cost of taking these actions isreasonable because performance andprice suitable substitutes exist. Prior tothe effective date of the Stage 3 ban,EPA will undertake a tech~licid reviewto determine the availability of non-asbestos substitutes for A/C pipe, EPAbeiieves that this is the best approach inlight of the significant risk posed byasbestos; the possible risks posed by thecurrent major substitutes, PVC andductile iron pipe; and the developmentof’ further substitutes for A/C pipe.

i. Coatir~gs. This grouping includes theroof coatings and cements and non-roofing adhesives, sealants, andcoatings product categories. Theseproducts will be banned in Stage 3. Thebenefits (in terms of cancer-cases-avoided) of the actions taken in this ruleon these product categories are set forthin the following ‘i’able XXI:

TABLE XXI—CANCER-CASES-AVOIDED

FOR COATINGS

L

‘---— ,Fcen,7____ ---”-Dwourrt ratePcoduct

O percent__ —.--——.—. —.— , ——— ..— ._ ..——.- .

.___.___.._-i-EL_Roofcoa!irgs .. .. .. . ..... .Mn-roo! coatings . .. .

‘I”hese products are used for a widev,lri(?ty u! functions. Roof coatings W.CS~nc!ude waterproofing, sealing, andtcpair oi roofs. Non-roof cGatings usesinclude adhesives. sealants, andcoatings used in the building

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Federal Register / Vol. 54, No. 132 / Wednesday, ]uly 12, 1989 / Rules and Regulations 29499——.

cOnstructirm, autfm]o!iw, and af+r(wpaceilldustril;s.

[’rimary ~outes of exposure toasbestos from these products occurduring mfinufactrirc, installation or;ITplic.~tkm. end repair. A total of 5?,2.YO:k~~s is ~3ti:nU:{;C! to k t:A}W’S(:~k]~~b$:stos during primary r,anui;lctllre ofasbestos roof coatings, anff553 workersam exposecl during the primarymanufacture of asb~stos ncm-roufcoatings. Quantifiable risk posed bythese products is estimated to rangefrom 1.22 K10-3 for the removal of roofcoatings in built-up roofing (a lowerbound that assumes lCSS than full-timer~posure] to m averagf) of 3.52X 10”:’fm-itre primary manufacture of uori-ronfcoatings. QLiantihahle risk from nrrn-occu~ational, lifetime exposures toastwstos reieaswf during themanufacture of roof coatings isestimated at 6.27 x10-5 forapproximately 1,000 people and atgreater than I X10-6 for approximately450,000 people.

f+owe~’er,EPA has concluded that theexposure quantified for this grouping arf:underestimated. EPA did not quantifyexposures t?ia( occur clurirrg application,maintenance. and repair, includingactivities like spray application ofcoatings and sanding or removal ofexisting coatings or caulking. EPA alsodid not quantify releases to the ambientair due to the weathering of productsused in outdoor, sometimes harshenvironments. Many products in thiscategory that are used in outdoorenvironments eventually wear off orctri~ or fkike, resulting in difficult tomc.nitcjr am bierrt releases. If, as a nw3nsof representing the possible effect ofunderestimated exposure duringinstallation and removal, it wereassumed ihat as little as one-tent}] of Ipercent of asbestos consumed for theseuses were released over the life cycle ofthe products and exposure weretissumed based on analogous productoperations, the estimate of benefitswould more than double for roofcoatings (benefits wouid be 3.57 cases atO percent and 2.59 cases at 3 percent]and would inc:ease fox non-roofcotitings (benefits \vould be 2.07 cases tito percent and 1.50 cases at :j perc;ent),

Acci)rding io cornmmrts, norl-asbestos

suhstitt!tes possess gro~ving shares ofbo:h coatings markets. .As:t”ilablf:et idence suggests that suitablrsubstitutes should be ai’:~ihiblc for mosttipphcations by Stage 3. One comrnenter.a major producer of roof coatings,indicated that it had rep~aced asbestosin ail of its formuhiiions. Trends towardthe greater use of non-asbestossubstitutes anrf probaljle decreases in

the cost of substitutes are nut fully takeninto account in the analysis of tb.L!

berw!’lts of Lwnnmg these cate~(jriwtmcausc of the urxi~ aiiubi!i{y ofso bs!itu!c, rise i{lform ation at the timeple ~nalYsi~ ~%,asperform~cd ‘1’hereiore.

i-IPA t)e!iPL’eb thai the cCi!La\ (.OSt (;f the

‘1actions t~km on ,hese categories IS essthan that indicated Lreinw.

Both coat~ngs categories wrreproposed for either a Stage 3 ban or abdn via operation cf a permit system.EPA has received comrncn!s indicalin~that progress has been made in thedevelopment of soitahle substitutes.

“f%e total costs p! the actions taken inthis rule for these product categories iireset forth in the following ‘rable XXII:

TABLE XXII—COST OF THE RULE FOR

COATINGS

-. ——_-1

Total cost m $

Pmduclpercent

‘“ --t ‘-” ‘--””-Roofcoawqs .... ,. ....1 45.48

Non-root coating s.,... .. ... .... .. ...1 081

fWA has concluded that a Stage 3 banis rippropri~te for these productcategories for the following reasons: (I)Relatively high quantifiable exposureand individual risk levels [~xist for tht,seproducts: [2) these products pose a highpotential for ambient release during iinumber of life cycle stages, inc[udin~ambient releases cf:ie to }veatherirrgduring outdoor use: (3) homeowners andworkers ure pot~nti:i lly subject touncontrolled exposrires during productaPPlic[l~iCJrI, Ln.iiIltf?IiaLlcf!, and rernfjva];(4) the cost of taking these actions isreasonable because suit[ibk substitutesare expected to exist for all of theseploducts by (he time of the ban: and ~5)while the quantified benefits of banningthese products tiie re)itively small,c(unpared to other product categoriesbanned by this rule, t}~ese products arelike!y both to lead to a number ofserious exposures that could not bereadily quantified for this roie and tocontribute sigrlificaritly to environmentsloarfinf+

j. Jbpf?r /Jfl{~i/’i/CfS,‘i’his grrrupirlxincludes the con~merci,i] paper,corrugated paper, rnillboard, rollbot<rd.and specia]t~ paper product categories.‘llese producl~ will he bal)nwl in St+-y3, The benefits (in terms of cancer-cases-a i’oirfe(i) of the ac!iorrs taken inthis rule of these product ctitegories areset forth in tho fclllov:ir~g ‘r:ii)!f: XXIII:

TABLE XXI!! —CANCER-CASES-AVOIDED

FOR I%S8ESTOS PAFER PRODLJCTS

-l”– ““-

F’:OCiJC~ ~ , ~e :e’yt;::rLLnt.t} .>! .,.-< -– ..-; —--- .-

1!,!!! ltloe$d j 042~ 056Spec(a!ty paper . . .. . . . i 0101 014

. , - —.—.—..

Commercial i{nd corrugated pap[r androll boi+rd are no longer comnleccit~!lyimported or profiuced i!] the U.S.

l“he products in these catfygories LirI:

used for a wide variety of functions.l“hey are frquvn!ly \KYy sirniliii in formbut differ primarily by specific end use.pr{l(lllct US{:Sinclude ;hermai insukitiou.fireproofing, und fill for a Yariety ofapplications, such tis bevel-ay ~nd otherfilters. Asbestos paper products are a!suusual ii~ a component of other products.such as gaskets (discussed above].

Primtiry routes of exposure toasbestos from these products occurff!]rirfg fnanllfactbre, installation, repair,

removal, and Lfispo$al. A total of 668wrorkers is estimated to be exposecl toastms!{)s rturin: primary find secondarymanufacturing of iisbestos iiaperproducts. Quantifiable risk posed bythese products is estimated to rangefrom m average of 7.35 x 10-4 for thesecondary manufacturing of all paperproducts to an average of 1.87 x 10-~ for~he primary mantifacturing of millboard.There is potential for episodic, peakexposure during manufacturingactivities. Respirators and strictworkplace tirid cleaning practices mustbc observed to meet the existing OSHAPF,l. for these products, Qotintifiabic riskfrom non-occupational, iifetimeexposure to asbestos released dwi~ig themanufacture of millboard is estimated at1 x 10-4 fur approximately 2,256 peopleand at greater than I x 10-’ forapproximatc]:y 840,000 people. EPA }uisconcllidcd that the overall exposuresquantified for this grouping areunderestimated. E})A did no: quantify(>~posures that occur during installation,reptiir. and rc,moval, including activitieslike cutting, cfriliing, and tearingperfurmed by hand during installation,maintenance. remoral, and disposal ofexisting products. EPA determined thataccurately quantifying these exposuresand the resuilant risks would be difficultand that suffkient other e~xposu]e andrisk inforrn;lticln is available regardingihcse products to make a finding ofunreasonable risk.

A(;cordirrg to EP:\’s analysis andcornmcnts. three of the five paperproducts in this grouping, commercialand corrugated paper and rollboard, areno lon~er co~rrl~~cii~ll~ imported or

29509 Federal Register / Vol. 54, No. 132 / Wednesday, ]uly 12, 1989 / Rules and Regulations-—.- ..-. —— ———.

produced in the U.S. IrI addition, low-cost sribstitutes exist for products in themiilboard and the specialty papercategories. Therefore, availableevidence suggests that suitablesubstitutes should be available for mostapplications by the effective date of theStage 3 ban. The totaI costs of theactions taken in this rule for theseDrsduct categories are set iorti] in the~ollowing Table XXIV:

TABLE XXIV: —COST OF THE RULE FOR

AS8ESTOS PAPER PRODUCTS

——i Toki! cost in $

Product mdlwm, dtscourwd! at 3 percent)

.-.—

Wlboard . . .. .. .. .. . . ...........1 3.73Specialtypaper ... ... .. .. .. ... .. .. ...._. o

-J -

The paper product categories wereproposed for either a Stage 3 ban or aban via the operation of a permitsystem. Many of these products are nolonger used in the U.S. and suik+blesubstitutes are rapidly being developed.although the development of~ea~onably-priced substittltes for some

specialty uses rnig~bt take a number ofyears. EPA is also concerned t!ratconsumers may be subjwt touncontrolled exposures duringinstallation, maintenance, repair. andremoval of products such as miHboard.h-r addition, many of these paperproducts are very simiIar in form andbans would be difficult to enforce werethe products in this grouping banned atdifferent limes.

EPA has concluded tha? a S!Li~c 3 hdnis appwpria!e for these productcategories for the following reesons: [1)Relatively high qu,inti!iiit)le exposureand lndi~’idu~l risk Ierels exis! for theseproducts: [2) these products pirse a highpotential for anlbient release during anumfwr ~f !ife cyc!e s’Iages: (3]ccnsurn firs and wsrkew arr potent i:iilysub]e~! ;O LMCOntiYJi\Cd {?:. {I OS UIW.

especi~!!y di::ing installation.tnain!?i”’d~r<?, repair, ~~nd ~f’m!)~..::! oftbcst. ,)rm:u(>ts: [4) t!!e LiJS~ of ta;.ing?ilest, ,’ti::~$ }s if>ttSC?ldblF, f2C!C:lUSP

is~~~er:~i(!i ih.:SP prl!~ Uct$ ~~r(’ ::0 !Iongei’prmiuce(i w impcried in !he t!.S. andbeca~{s,’ suitnble suhstitriies ~reexpected :0 exis{ for :i!l of iheseprmaucis b} the ri:ne {jf !he b:J:?; ~nd [5)}v!]ile [he qi}antifie{i benefits of banning!’h=sp pr[,riljcts are rt:jCj~ivt,ly srna!l.~um;],?re~ t,; ot!if:r ilrmrftict co!ww>rivs

k,t:nnclf f?y !his r;]ic, f!!e:; p pro{l,gf;[s i;r[,

i:keiy ~~u!h !C lead to a ntl];:,.~t .!:,, .-,...

st31ious ex~osl~ros tirut COUIJ not be

read!ly quantified for this rule and to‘1contribute significant y to environmental

loading,

“One asbestos paper prmlcct chtegury,l:igh-grade electrical paper, is notincluded within the rule’s bans (see UnitV. F.1.V). This product is not included fora number of uses of the product, therebymaking the cost of a ban very highrelative to other products analyzed forthis ru!e. In additiorr, high-gradeelectrical pi~per is reasonablydiscernab]e from o!her paper products.

k. .h’ew conrme.rciol asbestos products.

This grouping covers all new asbestos-containirig products whose commercialmanufacture, importation, or processingcommences after the effective date ofthis rule. All such new uses will bebanned from manufacture, importation.processing. and distribution incommerce as of Stage 1, unless EPAgrants an exemption application for theproduct or use. In view of the followingfactors, EPA finds that the use ofasbestcw in new products whosecommercial manufacture, irnporta!ion,or processing is initiated after theeffective date of this rule’s bans posesan unreasonable risk of injury to humanhealth: (I) The develi~pment ofsubs[!r..ttti fibers, (?) the potential forhigh Iifehme risks reiated to e:. posure toasbestos due to the manufacture,importation. processing, and use of newasbestos products, [3) the !ikelyescalation of environmental loading ofasbestos if the manufacture,importation, processing, or distributionin commerce of new asbestos productswere allowed. (4) the specultitivebenefits of new uses of asbestos, and (5)the absence of cost related tomodification of existing capitalequipment. Thcrefcre, EPA fin[!s tba( thebenefits of bannicg new commercialushcstos products ollt~,veighs the costs ofsuch a ban. Should a new use ofasbestos be deveioped w-hictr mecis thecriteria applied to exemptions for~Ai~tillg ~5~estos products. sc~tCUI inUni! III,E of this pw:]mble ond \ 763.173.~n extimp:ion sbuuld he appiied for andmay be granted.

T [~of<~g{]fiesOfl[j Ol;[,!’p;f;{.,s:1[)/Sub,lt?!:f (() :}] j~ ,Pti!t,.,<~j(:i,, [’his grouping

+ii~f’s.incl~ijm acetylene c~!in!\fITs, .Jrc c,

-} .as ~i~sto~ (!i~’phrap,ms. I]at[e v,,

separators. high-grade electrica! p+per,missi’e [Incrs, packingy, reil~forc.edPlii$fi(;, se<i!dnt i:jpe, speci:,~~y industrialgaskets. cii;d textiles. These productswer,, ~enerdlly prcrpusml fur a thirdsttl~~: [Iiln ~,r ~ b,irj vi;] th:; opera ti.m ~~f’~

p,);rr,ii s:. ,:tem. Tilew prodlJ(; [s are

i?iernptet trom t!re firal ru!::’s bansilc(:au>,,, bdse~! II;L(:’dLlt’llt!,V-ti\’Clil:}lllein[orm. a(i~]n, EPA has not f’uund that

they pow an tmrvasorwble risk of injuryto hum;~:: he~!ih under the cri!eri~ of‘t%{; I w:tion 6. fW.\ vtii!l rf~v)nsi[l(~r its

decision whether to include theseproducts within the ban if moreinformation about them becomesavailable.

The following paragraphs discussEPA’s findings for the various productsin this grouping.

i,.4 cetylsne cylinder filler. Theseproducts are used as filler in steelcylinders used to store acetone inoxyacetylene torches. Benefits derivedby banning this product would total lessthan one-tenth of a cancer-case-avoided.Exposures during primary manufactureare low due to the enclosed nature ofthe product’s production process.Exposurss in stages of the product’s lifecycle beyond primary manufacture arelikely to be limited, rel~tive to otherproduct categories, because the prodtl~tis eric]c)sed and there is little exposureduring product repair or disposalcomparet.f to other products analyzed forthis rule.

EPA does not believe that a ban isappropriate fur this product category forthe following reasons: (I) Currentsluhstit, )tes are more expensive thanasbestos prod~!cts and lit!le inforrnatiunis availabie on the relative performancecharacteristics of substitutes; t?,erefure,reasonable cost, suitable substitutesmay not be available for all app!ica[ionsof these products; [z) this productcategory acco~mts for only a minuscule

portion of [J.S. asbestos consumption(approximately 584 tmrs in 1985]: and [3)a ban on this product category wouldresult in only minimal benefits becauseasbestos exposure is limited in most lifecycles stages. relative to other productsarli]iyzed for this rule.

ii. .,lrc chutes. These products are\iS!;i~ fn g:jideefectric arcs in productsincluding motor starter units in electricgenerating p~~nts. The bene:its derivedfrom H t):in on this pnxtuct would totalOn!y 2 Small fraction of a cilncer-case-avoided. A!though EPA has no data onex~rrsure for products in this category,exposures in product life cycle stagesbeyond primal-y n;anufacture are likely10 lie Iirnited, rel~tive to other productCo:pg,)ries, because the asbestos is

bou~Iti in ceramic in the end i.rse prmfuct.flPA does not believe that a ban is

i]ppr(l!]riate for this product category forthr foiio’wing re:+sons: (I) Insufficientinformation was available regardingexposure to Jetennine the benefits ofbanning this omduc!; [2) this productCii~i?~O~# LiC[;fJlliltS for O[ll:j a minuscu!eportion )( U.S. ~sbest[}s ronsumptio!](:lpDr(::.imdt21;; J15 t,jns in l[js5).

i I I ..1.;h/;.$!{A$ (/ilJ/>.;)IW#71S. Th t2SE

pr:J(il, cfs ar-~? used prin]ariiy in the chloi -

a!k~ii i~~[!osi~!, :‘n [ile production ufchio! ine, (:a:]s[it: sudd. and o!her

1

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Federal Register / Vol. 54, No. 132 / WednesdaV, IUIV 12, 1989 / Rules and Rew.dations 29!301.,.

products. Benefits derived by banningthis product would total approximatelythree-tenths of a cancer-case-avoided,Exposure to asbestos during the lifec!, cle of this product is limited becausethe product is gener!dly fa!~ricatecf onsii~, used satup:; !ec! -witl; solutic.n, ~iiddispcm~d of while wet. Asbestos it+notprone to be rele3serl into the ambient airduring stages after product fabrication.Further, insufficient information existsregarding the availability of substituteproducts for diaphragms in existingch!orine production plants to justify aban. The cost of modifying existingplants to accept new membrane cell:echnology in response to a ban onasbestos use in this product may be veryhigh. Based on available information,the total cost of banning this product isestimated to total more than $2 billion.However, suitable substitutes now existfor asbestos diaphragms for use in morerecently constructed chlorine productplants. Therefore, EPA specificallyrecommends that users of asbestosdiaphragms use non-asbestos diaphragmcells in facilities that will accept themand in the design of new facilities.

EPA does not be!ieve that a ban isappropriate for this product category forthe following reasons: (1) Insufficientinformation was available to determinewhether suitable product substituteswill soon be available for use in existingchlor;.ne production facilities; (z) thecost of baming this product categorywould be very high: (3) this productcategory accounts for only a minusculeportion of U.S. asbestos consumption(less than 1,000 tons in 1905); and (4) aban on this product category wouldresult in only minimal benefits becauseasbestos exposure is limited in most lifecycle stages, relative to other productsanalyzed for this rule.

iv. Battery separators, These productsare used to insulate or separate tbepolar terminals in batteries or fuel cells,primarily in highly-specialized militaryand aerospace applications, Thebenefits derived from a ban on thisproduct would total only a smallfraction of a cancer-case-avoided.Alt!lough EPA has no date on exposureto products in this category, exposuresin stages of the product’s ~fe cyclebeyond primary manufacture are Iike!yto be limited, relative to other productctitegories, because asbestos is enclosedduring use and disposal. In addition,because m~st uses are highlyspecialized and built to p.ovemrnentspecifications, it is doubtful thatsubstitutes will fJe developed or COSLSofa prospective ban will decreasesubs! antia]!y in the near foh~re.

EPA does not believd that a ban isappropriate for this product category forthe fcllowing reaswrs: [Y) Insufficientinformation was ai’aiiable rqardirlgproduct substitutes to dctermi~e tlwcosts of banning this pro.-tuct. althou{{hai’aila!l!e infmm.ation mc!ica!m tli:il Ibccosts of a btiil wouid be high: (2) thisproduct category ac~oufits for only aminuscule portion of U.S. asbestosconsumption (appmxirnately 1 ton in1985): and (3) a ban on this productcategory would resu!t in only minimtdbenefits because asbestos exposure islimited in most life cycle stages, relativeto other products analyzed for this rule.

v. High-grade electrical paper. Theseproducts are used as electrical paperinsulation, primariiy for high-temperature, low-voltage applicationssuch as motors, generators,transformers, and other heavy electricalapparatuses. The benefits derived froma ban on this product would totalapproximately 0.4 of a cancer-case-avoided. The cost of banning thisproduct would be high becausereasonably priced suitable substitutesdo not exist for all applications and anumber of existing substitutes are veryexpensive. The total cost of banning thisproduct is estimated to total over $51million.

EPA does not believe that a ban isappropriate for this product category forthe following reasons: [I) This productcategory accounts for only a minusculepor!ion of U.S. asbestos consumption(approximately 744 tons in 1985); (2) thecosts of baming this product would bevery high, due to the absence ofreasonably priced substitutes; and (3) nban on this product category wouldresult in minimal benefits.

vi. Missile Liners. These products areused to coat the interiors of rocketchambers, primarily in highly-specialized military and aerospaceapplications. Benefits derived bybanning this product would totalapproximately four tenths of a cancer-case-avoided. EPA has no informationindicating that suitable substitutes areavailable. The total cost of banning thisproduct is estimated at almost $2 billion.Because most uses are highlyspecialized military uses.. it is doubtfulthat substitutes will be developed andhe certified for these uses or that CUS:Sof a prospective ban will decreasesu!jstaniially in the nwir future,

EPA does not believe that a ban isappropriate for this product cfitegory forthe follov;ing reasons: (1) This productcategory accounts for only a minusculeportion of U.S. asbestos consumption(approximately 700 tons in 1985); (2] tbecm~s of lmnning this product would be

veiy hi#r, because most uses are highlyspecialized military uses; and (3) il banuc this prmiut,t ctitegory wou!d wsu[t inm~nima~ txm<fits.

\, ii. J~UCJLiIIgS.FticAi:lgs are used ioi fi,l,~d~ i~i ~~vic<!> }fjil>f’l?r,lo(i(jf! isSf;!,

,; , ,tr,:,~: J,, ~~k;:fifs ~,,~i,.};~ !i?)c:

~!{{[!~ti~~ihls p!’(J{ib!;t ~ak’~:jry \’JfdLit!):ii~ ;[SS thdn one teinth of a cancer-

13 pr(jtiactcttw-a rokded. F,.xpilsures in L.sIif{, cyr,ie stages beyond priin::ry andscccmciary rwmufactore are likely to beiirnite<i, wititivc to other productctitegnries, because [Jsbestos in packingsis ~(:n[~raily.sti!tlratcd wiiil lubricantduring parwmg forrrwtion dwl witi) flui(iduriri use and removal. In addition.there are many specialized uses ofashcstos packings. including ~dvanccdtechnology and mi!itary applications.The cost of Lanning this product wo{fldbe relatively high on a per unil basisbecause suitaMe substitutes do not existand are unlikely to soon be developedfor a significant number of packingsapplications and a number of existingsubstitutes are very expensive. I%c totalcost of banning this product is estim, +itedat $0.55 million.

EPA does not believe that a ban isappropriate for this product category forthe following reasons: [1) this productcategory accotints for only a smallportion of U.S. asbestos consumption(approximately 125 tons in 1985); (2) thecosts pcr unit of banning this pruductwould be relatively high for the amountof benefits derived, due to the absenceof substitutes of similar cost orperformance characteristics for anumber of applications; and (3] a ban cmthis product category would result inminimal benefits because asbestosexposure is limited in most life cyclestages, relative to other productsanalyzed for this rule.

vii i. Reinforced plastic, Theseproducts are used primarily for electro-magnetic parts in the automotive andappliance industries and high-perforrnance specialty plastics. Benefitsderived by banning this productcategory would total approximately fourtenths of a cancer-case-avoided.Exposures in product life cycle stagesbeyond primary manufacture are likelyto be limited, relative to other productcategories, because asbestos is encasedin piastic in the end use products. Inaddition, the cost of banning thisproduct would be high because suitablesubstitutes do not exist for a significantnum!x+r of plastics applications and ancmbcr of existing substitutes are veryexpensive. The total cost of banning thisprodijct is estimated at almost $35million.

29522 Fedcrak Register / Vol. 54, No. 132 / Wednesday, July 12, lgEt9 / Rules and Regulations—. —,.

EPA cioe~ not believe that a ban isappropriate for this product category forthe following reasons: (1) This productcategcry accounts for only a minuscuieportion of U.S. asbestos consumption(zpploximately 812 tons in 1985]; [2) thecosts of banning this prciduct would behigh, due to the absence for a number ofapplications of substitutes of sim,ilarcost or performance characteristics; and[3) a ban on this product category wouldresult in minimai benefits becauseasbestos exposure is limited in most lifecyc!e stages, relative to other productsanalyzed for this rule.

ix. Sealant tape. These products areused pri,narily to seal windows andautomotive windshields, in aerospaceapplications, and in the manufacture ofinsulated glass. Benefits derived bybanning this product would total lessthan one tenth of a cancer-case-avoided.Exposures in the product’s life cyclestages beyond primary manufacture arelikely to be limited, relative to otherproduct categories, because asbestos iscontained in rutrber in the end useproducts. In addition, the cost ofbanning this product would be highbecause suitable substi~tes do not existfor a number of non-automotiveapplications. A number of existingsubstitutes are very expensive andethers do not perform as well asasbestos-containing products. The to!alcost of banning this product is estimatedat almost $35 million.

EPA does not believe that a ban isappropriate for this product category forthe following reasons: (I) This productcategory accounts for on!y a minusculeportion of US. asbeslos consumption(approximately 700 tons in 1985]; (2) thetotal cost of banning this product wouldbe significant because of the absence ofsuitable substitutes for some uses; and(3) a ban on this product category wouldresult in minimal benefits becauseasbestos exposure is limited in most lifecycle stages, relati we to other p:oductsanalyzed for this rule.

Speciaity industriui gc~kets. Theproduction of most asbestos-containinggaskets is banned in Stage 2 (see IJnitV.F.g). Excluded from the rule’s bans aregaskets that are manufactured,imported, processed, or distrib,~itid incommerce for specialty incktria! uses.This exclusion is limited to asbestos-containing gaskets that are iiesigned forindustrial uses in either (a)environments where temperatures are?50 degrees Fammheit or greater, m [h]corrosive erivirorunents. An incfustri~lgasket is one dcsigr-ied for use in anarticle which is not u “cm:somerproduct” within the mearrin~ of !heConsumer Product SLlfet:; A,.i (CPS<I),

15 L’.S.C. 2052 or for use in a “motorvehicle” or “motor vehicle equipment”within the meaning of the NationalTraffic and Motor Vehicle Safety Act of1%8, as amended, 15 U.S.C. 1381. Acorrosive environmental is one in whichthe gasket is exposed to concentrated(pI-i less than 2), highly oxidizingmineral acids (e.g., sulfuric, nitric, orchromic acid) at temperatures aboveamb;ent. For example, gaskets used inai(tomobiles or consumer productswould not be excluded from the rule’sbans, even if a particular applicationwas designed for use in a corrosiveenvironment or an environment ofgreater than 75o degrees Fahrenheit. Onthe other hand, gaskets used inindustrial machinery would be excludedfrom the rule’s bans if the gasketapjrlica!ion were designed for use in acorrosive environment or in one ofgreater than 75o degrees Fahrenheit.

Gaskets are used ta seal onecompartment of a device from another instatic applications. This portion of thebeater-add an~ sheet gasket productcategories is not being banned because:(’l) According to commenters and theRIA, industrial applications above 75odegrees Fahrenheit and industrial usesin corrosive envircmments contain manyspecialized uses of asbestos gaskets,including advanced technology andmilitary applications, and avai!ableinformation indicates that substitutes forthrse industrial applications are lesslikely to be available tffan for lowertemperature, non-corrosive, or consu,mer[e.g., automotive) applications, (2) due tothe nature of their applications, thepotential hazards created by failure ofspecialty industrial gaskets might begreater than for other categories, [3]these applications accorint f~i only asmaIl portion of the gasket productCategories and a very srmdi portion ofUS. asbestos consumption, (4j i~dus!rialapplications have relatively lov~eroverali exposure levels and smallerexposed populations than do uses withpotential consurrer exposures, (5j thebenefits resulting from a ba~ of theseapplications (approximately 6.6 cancercases] would be small re!ative to d~ebenefits derived f~om including the restof the gasket categories in the ban. Thecost of trtilming these portions of thegasket categories would be high bwauseavai!ab!e evidence indicates !hatsuitable substitutes do not e~isi ar,d areunlikely to wren bp develope, i for asignificant number of applicat~ons and anumber of existing substitritcs ilre veryexpensive. The total cost of b~nningthese applications is estknatcd ut(ajlproxi~ma:e l-v$9J mi}ii~~n.

xi. Textile products. These procluc!sare primarily intermediate textileproducts used in end products coveredby other categories banned by this rule,including friction products and gaskets,Etecar.rse exposures related to t!!eproduction of these products are largelyeliminated by other actions taken in thisrule, EPA has determined that separateacticm on this category to beunnecessary.

W. Other EPA S!atutes

Section c(c) of TSCA requires that ifEPA determines that a risk of injury tohealth or the enviromnent could beeliminated or reduced to a sufficientextent by actions taken under anotherstatute adrni.nktered by EPA, EPA maynot promulgate a rule under section 6(a)of TSCA unless EPA finds that it is inthe public interest to protect against therisk by action under TSCA. EPA findsthat no other !aw administered by EPAwill eliminate or reduce to a sufficientextent the risks posed by asbestosexposure and that it is in the publicinterest to use TSCA.

Several EPA statutes have been usedto limit asbestos exposure. On April 16,1973, EPA used the authority of theClean Air Act (CAA) to list asbestos asa hazardous air pollutant, establish a“no visible emission” standard formanufacturers, and ban the use ofspray-applied, asbestos-containingmaterial as insulation in buildings. EPAamended this regulation to banasbestos-containing pipe lagging, by arule published in the Federal Register ofOctober 12,1975 (4o FR 48292); and in1978, extended the ban to a}] uses ofsprayed-on asbestos by a rule publishedin the Federal Register of June 19, 1978[43 FR 26372). The CAA rule, which waslast amended on April 5,1964 (49 FR13658), aiso regulates the removal ofasbestos from buildings and the disposslof w:lstes generated by removal. EPAproposed amendments to the rule in theFcderai Register of Jtwwary 10,1989 (54FR 912j to enhance and promotecompliance with the current standard.

However, the CAA has limitations.The CAA does not apply directly toindoor air in the workplace or home.Cow.equently, some adcfitional uses ofthat statute may leave many workplaceor hoine exposures inadequatelycoutrol}ed.

Arw?!.m EPA statute that could beused tc}reduce asbestos exposure is t~,e%fe Urinkil)g ~rater Act [SEW.%).L’mlcr the 1986 SDWA .Amendmen?s,EF.4 is required to set a NationalPrimwy Drinking Water Regulation forasbestos. In {he Federal Register of hlay22, 1989, ITi\ proposed an SDWA

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maximum contaniimmt led goa! andN~tional Primary Drinking WaterRegulation maximum contaminant levelfor asbestos in drinking water of 7mihion asbcsios fibers excmxiin~ 10microns in hms~h. This re:gula:ionshortiy. However, this rcgulaiion WCUMnecessarily ignore the mhalatian riskposed by asbestos from sources otbmthan drinking water and would tliereforeaffect only a small portion of overallexposure.

An addi!ionzl EPA statute that couldbe used tc l~ri,i~.asbestos expssure is theResrjurce Consw\ation and RecoveryAct (RCRA). Under RCRA, EPA ccuicflist osbwkw as a hazardous waste afidsubject d’sposa[ of asbes!os to gene:alRCRA requirements designed to reduceexposure. However, such action underRCRA would only reduce exposureduring the disposal of asbestos andasbestos products.

VU. Analysis Under Section 9(R) ofTSCA

Under section 9[a)(l) of TSCA, EPA isrequired to submit a report to anotherFederal agency when twodeterminations are made. The firstdetermination is that EPA has areasonable basis to conclude that achemical substance or mixture presentsor will present an unreasonable risk ofinjury to hea!th or the environment. Thesecond determination is that theunreasonable risk may be prevented orreduced to a sufficient extent by sctiontaken by another Federal agency undwa Federal law not administered by EPA.Secitn 9(a)(l) provides that when theAdministrator makes these twodeterminations, EPA must provide anopportunity to the other Federal agencyto assess the risk described in the”report, to interpret its own statutoryauthorities, and to init; ate an actionunder the Federal laws that itadministers. Section 9(a) of TSCA thusrequires EPA to review other Federalauthorities not administered by EPA todetermine whether action under thoseauthorities may prevent or sufficientlyreduce the unreasonable risk. Thefollowing Unit summarizes past andcontemplated actions by other agencies

and then discusses why those ~genciesare not able to ~mevent m sufricier, tiyreduce the unreasonable risk presentedby asbestos.

A. O!herAuthorities A~Jeding As.bes[os

Under the authority of the (lmsurnerProduct Safety Act (CPSA, 15 U,S.C.2051), the Consumer Product SafetyCommission (CPSC) has issued ruiesbanning consumer patching compoi]ncfs(16 CFR Part 1304) and artificialemberizing materials (16 CFR Part Y305]

containing respirable asbestos. TheCI+C took these actions based onfindings that the use of those prodt]c(s inthe household would result in anincreased risk of cancer. Earlier. theFond and Drug Administration ~n[der theF?ricral HazardGus %bs!imces Act(F! !S,% 15 U.S.C. 1261) banner! “gerleral-use garmenb containing asbestos otherth:jn garments having a bma fideapplication for persona} protcc?icmag,. inst therm.a] injury and soconstructed that the asbestos fibers willnot become airborne under reasonablyforeseeable conditions of use-’ (16 CFR1500.17). The FHSA is now administeredh-y the CPSC.

In 1980, CPSG issued a general orderrequiring persons to submit informationon the use of asbestos in cwt:iinconsumer product categories. CPSC hasalso measured potential consumerexposure to asbestos from such productsas asbestos millboard, asbestos p~p~rproducts, and stove door gaskets. CPSCsubmitted those data to EPA as par! ofthis rulemaking. On Septsxnber 24, 1236(51 FR 33911), CPSC issued labti]ingrequirements for “household produrfscontaining in!entional!y added as’bestost}]at, under any reasonable foreseeableconditions of handling and use are like!yto release asbestos fibers.” In 1986, inlight of the EPA propose rule to bancertain asbestos products immediatelyand phase out others over 10 years,

CPSC decided not to ban any additionalconsumer products containing asbestosunder statutes that it administers.

GSH_A began to re@ate asbestos in

the wcrkplace in 1971 under theOccupational Safety and Heaith Act (19U.S.C. 51, OSHAct), Since the firstworkplace standard setting a Iimi! of 12f/cc was promulgated in May 19-1, theworkplace standard has beenperiodically lowered, to 5 f/cc in 19TZand to 2 f/cc in 1976. An Emergex:ryTemporary Standard [FTC) establisllii~g

a PEL of 0.5 f/cc was published iii theFederal Register of No~’ember 4, 1983 [48FR 5’1086), but the ETS was foundinva!id by a court. OSHA proposed are-{ised standard in the Federai Registerof April 10, 1964 (49 FR 14116). OSIL%is~ued a final rule on June 20, 198C [51FR 22512], lowering the PEL to 0.2 ffrcar:d establishing new work practicer{~quirements f,cirboth general indt!?ir:y~i}d (he construction sector. Bethasbestos industry groups and unionschallenged various provisions of thenew 0S13A ru!e. On February Z, 1988,the United States Court of AppeaIs forthe District of Columbia Circuit issuedits decision in the consolidated appea?s.The court upheld OSHA’S finding thatasbestos expmsure poses a significant

risk and the feasibility of the new PELand spncificaily rejected the asbestosixiclvstr-y grolips’ challenges to OSHA’Srisk assessment, However, the courtfound th:+? there was rm{ substantialevidence s:ipporiing 0S}!.%’s: (1) Eh?non

t;;e spraying of asbestos-conid ini:.gproducts, (z) rejec!im of a lower FT1. forc:>~[ain maji~r subgroups of industry, [3]r~jection of a short-term exposure limit(STEL). and (4) rejection of certainspecific provisions recommended byparticipants in the rulemaking [e.g.smcking controi provisions, bilin~~aiiabds, and more stringent respiratwyprotection requirements]. The courtordered OSHA to establish a STEL, toconsider a Iowcr PEL for certainiildustry sectors w-here it may befeasible, and to consider several o!hcrspecific changes suggested byru!emaking participants. In response !0this court decision, OSHA amended itsAsbestos Standard to incorporate anExcursion Limit (EL). This amendment,which was published in the FederalRegister of September 14,1988 (53 FR33610), limits short-term exposures toI f/cc over a half-hour period. OSHAhas not either finalized or propcsed anyother changes in its Asbestos Standards.

The Lfine Safety and Heal!hAdn-ministration (MSi !A), acting underthe hline Safety and !Ieaith Act. hzsadopted workplace standards designedts protect workers engaged in pit andunderground minin~ and milling {30 CFP.71..202]. The fv!SHA standard was lastamcndk:d in 1976 and calls for a PEii of~ f/’cc.

State and Iocai puh!ic employees aregenerally excluded from coverage underthe OSHAct. However, under section 19of the OSHAct, OSHA has approvedState plans for 23 Statea and 2trriitories, ihus effectively extending0S: IA protections to State and localp~jblic ~mployees in these jurisdictions.EPA has promulgated a rule to establishri-quirements similar to those of theOSHA Asbestos Construction Stacdardfor State and local puMic employees notco; ered under a S~ate plan who c.ondu~tas’besios abate me~.t v.-ork. liowevw,o~her public e.mpk~yees, such as fire

fi<;h~ms, are not covwed by that ~uie.

8. EP.4 k Determixmtion Under Sec!ion9(0) of TSC.4

EPA is not required under section 9[s]to submit a report to other agencies onthe asbestos risks described in thisdocument since EPA has determirwdthat such risks cannot be prevented m-reduced to a sufficient extent takenunder a Federal; law not administeredby EPA. Certain activities involvingas bcsto~ present risks that fall under the

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jurisdiction of a number of differentFederal laws such as the OSFiAct, theCPSA, and the CAA, but no one statute,other than TSCA, can adequatelytiddress all the risks posed throughoutthe life cycle of asbestos. Referral wouldresult in fragmented assessment andcontrol of risks and potentiallyduplicative regulatory efforts.Furthermore, even if EPA were to referasbestos exposure risks to otheragencies, taken by those other agencieswotdd still leave a substantial residualrisk, resulting in an adverse effect onpublic health. Only EPA under TSCAcan stop the build up of asbestos in theenvironment. EPA’s reasons for reachingthese conclusion are set forth below.

1. Interpretation of section 9(u) ofTSCA. The comprehensive nature cfTSCA has long been reccrgnized. TSCAallows regulation of a c~emicalsubstance based on all of its risks and,thereby, allows the Government toremedy the deficiencies in other statutesthat can deal oniy with parts of the risk.(Statement of the President on signing S.3149 Into Law, October 12, 1976, WeeklyCompilation of Presidential Documents,vol. 12, No. 42, Oct. 18, 1976, at 1469; S,Rep. No. 94-698, 94th Cong. 2d Sess. at2]. The need for a total exposure, nmlti-rnedia approach to chemical regulationand the dangers of a fragmentedregulatory approach were recognizedeven during the early Congressionalhearings on TSCA. See, for example, the1973 Senate Hearings at 212-214 and the1972 Iiouse Hearings at 65-67. No othersingle law provides authority to dealcomprehensively with multi-mediahazards.

In particular, Congress designedTSCA to deal with chemical substancesfor which the most appropriate remedywould be a total ban on theirmanufacture, importation, processing,and distribution in commerce. In thisregard, Congress focused on the risk of

asbestos and the dangers of fragmentedregulation of asbestos driring tirelegislative hearings. See the IY71 SenateHearings and 1973 Hearings, Asbestostisks were described h the workplaceact! in over 3,OOOuses that could presentrisks to the general population [fi.R.Rep. No. 94-1341, 94th Cong., 2d Sess., at5 [1976). lvfembers of Congress believedit intolerable that no agency could dealcomprehensively with chemical risks,~nc]lic]ing the risk frcm asbtstos. See1973 Senate Hf;arings a! 319-320 [f,ettt,r!!,cqmsen:~tor TIlnney to Dow Chrxnic::lCompany]; 1975 Senate Hearings at 131-133 (Remark of Senator Turmey-).

2. Ccrpability o,f other FederalUutho,-ities to dea] with the!CO,?ibiUUtiUIl

ofosbestos activities. EPA’s analytiis of

the jurisdiction over the risks presentedby asbestos among a number ofagencies and statutory authorities is setout below. OSHA has authority underthe OSHAct to control risk presented toprivate sector manufacturing,construction, and service employeesfrom workplace exposures, and mayapprove State plans covering State andlocal public employees. CPSC hasarrthority under the CPS.4 and FHSA tocontrol risk presented to consumersfrom consumer products. The MineSafety and Health Administration hasauthority under the Mine Safety andHealth Act concerning risk presentedduring the mining and milling ofasbestos. Sti+!e and local publicercployees in about half the States (suchas fire fighters who may wear asbestosclothing) are not covered by eitherOSHA regulations or OSHA-approvedState plans.

EPA has concluded that asbestos isappropriate for TSCA action rather thanreferral to other agencies. It is asubstance for which there is broadexposure to populations in numeroussituations—in the workplace, throughlong- and short-term ambientconcentrations, and from consumersproducts. With the exception of TSCA,there is no single authority to deal withaIl of these multiple exposures. NTOoneof the other potential Federal regulatoryauthorities, in looking at its specific partof the overall exposures, can eitherevaluate or deal with the totality of therisk presented, OSHA may set exposurelimits for workers, but there may beventing of asbestos from the workplaceinto the atr-nosphere. EPA, under theC.AA, may regula!e ambient emissions,but not workplace or consumerexposures, In each case, only a fractionc~fthe risk is controlled. Only EPA underTSCA can look across the range ofasLestos use to evaluate \shetherexposilre presents an un;easonab]e risk.There is no other Act that affords SLICh

authority. Further, cnl~ action underTSGA can stop the build up of asbeslosin the envirrmn:ent.

3. Res;cfoal n’s~s. Even Ii o:herFwfera! ti.gencies took additional actionto redluce ihe risk associated \vithasbestos during the various stages of [helife cycie of asbestos products, asubstantial Rnd unreasonable residualrisk would still re,main.

iar,ge ~opulatimls outsic!e of OHMjurisdichon are at risk fro~il exposiire toastwstos. state ar!r!10:?1p’.lblic

employees, such as fire fighters, are notprotecked by OStiA rcgula+ions in ~t)oiithalf of the States, The generalpopulation is exposed to asbestos intothe ambient air as a r<:sult of wleasf:

during the manufacture, processing, use,repair, and disposal of asbestosproducts. As discussed more fully inUnit V.A.3 of this preamble, twbestosreleased irrto the ambient air can buildup in the environment. EPA is concerned~bout this environmental loading.

Further, even if OSHA achieves strictcompliance with its PEL of 0.2 f/cc andits new EL of 1 f/cc, a substantial andunreasonable residual risk wouldremain. OSHA recognized that asubstantial risk remained with a PEL of0.2 f/cc. OSHA estimated that personsexposed to this level over a workinglifetime of 45 years would face a risk of7 in 1,000 of developing cancer.However, OSHA concluded that thiswas the lowest exposure level that wastechnologically feasible in asbestosworkplaces. As stated above, OSHA hasbeen ordered to consider a lower PELfor certain general industry sectorswhere it may be feasible. However,technical limitations on asbestosexposure monitoring seem to limitOSHA from establishing a PEL lowerthan 0.1 f[cc. Indeed, the union groupsthat asked the court to order OSHA toadopt a lower PEL onfy requested a PELof 0.1 f/cc. Workers exposed to a levelof 0.1 f/cc still face a substmrtial risk.OSHA calculates that such workers facea risk of 3 in 1,000 of developing cancerwhen exposed over a 45-year workinglifetime.

in addition, it is likely that the OSHAPEL of 0.2 f/cc and EL of 1 f/cc will beexceeded in many cases since it isparticularly difficult to apply the PEL inthe construction and service sectors.kfany of the workplace exposures toasbestos occur downstream in theconstruction and service sectors ratherthan the manufacturing sector. Over 80percent of workers exposed to asbestosare in the construction and servicesectors. Employees in those sectorsofton do not know when they aree~posed to asbestos becriuse they donc]t k~ow that they are working withasiwstm products (Ref. 34). Attempts atcomp!ia nce and OHSA’S complianceii]spections are SISO difficult in theco[istructicn and service sections sincecm.plo}tws frequently do not have afixed \vork site. Between July 1, 1986and June 30, 1067, OSHA cited 534ri!!egeci vi~laticms of the asbestos ruk:for general irrdus!ry and 427 a!legedViolations of the rde km thecunskuctiw: sector. OSFL4 iuspecdon.d<t;l show t+:tt Qi of the &55 lrsbes!wmoc{!c)ririg s~:mp!es taken by OSHAfronl ju!y I, 1986 through April 30, WM.h:~d exposure val[!es above the OSHAPEf. of (].? f/cc. While respirators werein use in many of the establishments

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with air concentrations higher than theFEL, 20 percent of these establishmentswere cited for violations of respiratoryprotection guidelines or for ~’iolations ofthe PEL (Ref. 49). As sta?ed earlier,OSFfA amended its Asbestos Standardsto incorporate an EL on SeEternbcr 14,me. EPA does not believe that [he ELwill have a significant effect on thesignificant risk posed by asbestos in the

workplace. A more detailed discussionof this maybe found in Unit V.A.3 ofthis preamble. Finally, mtiny asbestoscontrol measures, in particular, the useof respirators or increased workplaceventilation, only shift the asbestosexposure to another population forwhich no exposure contro!s exist. Forexample, if ventilation is used,substantial quantities of asbestos wouldbe released to the ambient environmentwhere it would continue to present arisk boih to other workers and thegeneral population.

Similarly, CPSC cannot evaluate ordeal with the totality of the riskpresentccf by asbestos. CPSC may banor require safety standards for asbestos-containing consumer products basedexclusively on risk to consumers. CPSCis unable to consider risk to other groupsfrom releases of asbestos during the lifecycle of those products. In addition,CPSC has indicated that it does not planto enact further bans on asbestos-coctaining products.

After carefully analyzing otherFederal authorities, EPA concludes thataction under TSCA is appropriate toreduce the unreasonable risk to humanhealth posed by asbestos. Use of otherFederal authorities cannot reduce risk toa reasonable level because: (1) Eventogether, they cannot reduce the totalvolume of asbestos or asbestos productsin commerce or limit the ongoingbuildup of asbestos in the environment,(z) Even together, they cannot protect allof thz many population groups at risk,and (3) They all have jurisdictional gaps,both individually and collectively.

WIL Enforcement

Section IS makes it unlawful to fail orrefuse to comply with any provisions ofa rule promulgated under section 6 ofTSCA, Therefore, any failure to complywith this rule would be a viclation ofsection 15. In addition, section 15 ofTSCA makes it unlawful for any personto: [1) Fail or refuse to estabIish andmaintain records as required by thisrule; (2) Fail or refuse to permit access toor ccpying of records, as required byTSC,% (3] Fail or refuse to permit entryor inspection as required by section IIof ‘llSCA.

Violators may be subject to both civiland criminal liability. [Jnder the penalty

provision of section 16 of TSC.4, anyperson who violates section 15 cou~d besubject to a civil penalty of up to $25,000for each violation. Each day of operationin violation of this rule could constitutea separate violation. Knowing or willftilviv!alion.s of this rule could le2d io theimposition of criminal penalties of up to$25,000 for each day of \~iolation andimprisonment of up to I year. Inaddition, other remedies are available toEPA under sections 7 and 17 of TSCA,SIJCh as seeking an injunction to restrain\,iolations of this rule and seizing anychemical substance or mixturen-mnufactured or imported in violation ofthis ruie.

hdiviciuals, as weil as corporaiiom,could be subject to enforcement actkms.Sections 15 and 16 of TSCA apply to“any person” who violates variousprovisions of TSCA. EPA may, at itsdiscretion, proceed against iiidividualsas well as companies. In particular, EPAmay proceed against individuals whoreport false information or cause it to bereported.

IX. Confidentiality

Section 14(a) of TSCA allows a personwho submits information to EPA toassert a claim of confidentiality ifrelease of the information would revealtrade secrets or confidential commercialor financial information. Under this r-de,claims of confidentiality can be assertedonly at the time information is submittedin an exemption application and only inthe manner specified in $763.179. EPA’sprocedures for processing and reviewingconfidentiality claims are set forth at 40CFR Part 2, Subpart B.

Any person who claims informationcontained in an exemption applicationas confidential is required to providetwo copies of its application: a completecopy of the application including aHinformation claimed as confidential anda “sanitized” copy from which allconfidential information has beendeleted. EPA will place the applicant’ssariitized copy in the public file. EPAwill a!so issue a notice in the FederalRegister requesting comments on theexempiion request.

Persons claiming information asconfidential should do so by circling.braeketiug. or underlining it andmmrking it “CCINFIDENTIAL.” EPA wiildiscl~se ir}forrnation subject to a c!aimof confidentiality only to the extentpermitted by section 14 of TSCA and 40CFR Pm-t Z, Subpart B. If a person doesn,ot assert a claim of confidentiality for

information at the time it is submitted toEPA, EPA may make the informationpub!ic without further notice to thatperwn.

In addition, persons claiminginformation as confidential in excmplionappiicilticns must respond in detail tothe substantiation questions in$ 7(i3.179(d) at the time the applicationis s{ibmitte~ to EpA. If a cl~jM kunaccompanied by the requiredsubstantiation at the time it is submittedto EP.4, the company will be notifiedthat the unsanitized copy of theapplicaticm will be placed in the publicfile.

EPA is committed to the publicdisclosure of as much nonconfidential!in?imnation submitted in exemptionapplications as possible, Requiring up-front substantiation of confidentialityclaims and continued close scrutiny ofsuch claims through the establishedclaim. review process will ensure that asmuch information as possible isreleased. Public interest in theinformation in exemption applicationsand the need for public participation inthe review of applications justifies thisapproach. Up-front substantiationobviates the need for follow-upsubstantiation by submitters resultingfrom EPA review or Freedom ofInformation Act requests and therebyfacilitates public participation in theprocess of reviewing exemptionapplications.

X. Rulemaking Record

EPA has established a record for thisrulemaking (docket control numberOPTS-62036). A public version of therecord, without any confidentialbusiness information, is available in theTSCA Public Docket Office, from 8 a.m.to 4 p.m., .Monday through Friday,except legal holidays. The TSCA PublicDocket Office is located in Room NE-Go04, 401 M Street, SW., Washington,DC.

This record contains informationconsidered by EPA in developing thisrule. The record includes: (1) Ail FederalRegister notices, (2) relevant supportdocuments, (3] reports, (41 memorandaand letters, and (5) hearing transcripts,responses to comments, and otherdocuments related to this rulemaking.

XL References

[I) USIU?A,ORD, OHEA. 1X%.AirborneAsbestos Health Assessment L~date. [June1986):215 pp. U.S. Environmental Agency,Washington, DC.: EPA/lXX7/&84/IM3F.

(2] USCPSC. 1983. Chronic Hazard

Advisory Panel on Asbestos. [July 1983):MOpp. U.S. Consumer Product SafetyCommission, Washington, D.C.

(3) NAS, NRC. 1984. Asbest@m Fibers.’Non-occupational Health risks. [I!x34):353pp.LNaiiona!Academy of Sciences, NationalR~search council, Washington. D.C.:National Academy Press.

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(4) Seidman, }1., %likoff. I.J., tfammomlE.C. 1979. “Short-term ~sbestos workexposure and long-term observation.’” A nnuko,f the New York Academy of .kiences.330:61-69.

(5) Morgan, A.. Evans, R.J., I lounarn. R.F.,Hrrhnes, A., Doyle, S.G. 1975. ‘“Studies on thedeposition of inhaled fibrous mateiial in therespiratory tract of the rat and its subseqrrentclearance using radioactive tracer techniques.IL Deposition of the UICC standard referencesamples of asbestos.’” ErrvirorrmentnlResearch. 1OXII3-2O7.

(6) USDHHS, NTP. 1985. TOXiCO@ andCorcinogenesis Studies of CbrysotileAsbestos in F344/N Rats—{Feed Studies).Technical Report Series No. 295, NIH Pub hro.8&2551. (November 1985): 392pp. U.S.Department of Health and Human services.National Toxicology Program. ResearchTriangle Park, North Carolina.

(7) SeIikoff, I.J., Hammond. B.C., Seidma@H. 1679. “Mortality experience of insulationworkers in the United States and Canada.1943-1978.” Annals of the New YorkAcademy of Sciences. 33091-116.

(8) Funtorrf, R, Vercellii M., Medo, F.,Valerfo, F., and Santi, L 1979, “Mortalityamong shipyard workers fn Genoa, Italy,’”Annals of the New York Academy ofSciences. 330:353-377.

(9) Newhouse, M.L., Berry, G., Wagner, J.C..Turok, M.E. lWZ, “A study of the mortality offemale asbestos workers.” Brilish Journal ofIndustrial Medicine. .29134-141.

(10) Wignall, B.K., FOX A.J. 1982. “Mortalityof female gas mask assemblers.” BritishJournal of Industrial Medicine 3934-38.

(11) Achesom E.D., Gardner M.J., PippardE.C.. Grime LP. 1982. ‘“Themortality of twogroups of women who manufactured gasmasks from chryaotiie and crocidoliteasbestos a M-year follow-up.” BritishJournal of IndustrioI Medicine. 3%344-346,

(12) Berry, G., Newhouse, M.L. 1963.Wlortality of workers manufacturing frictionmaterials using aebestos.” British Journal ofIndustrial Medicine. 4&l-7.

(13) McDonald, A.D., Fry, ].S., W’ordley,A.J., McDonald, J.C. 1964. “Dust exposure andmortality in an American chrysotile asbestosfriction products plant.” British Journal ofindustrial Medicine. 41:151-157.

(14) Demerit, J.M., Harris, R.L., Syrnoms,M.J., Shy, C.M. 1963. “Exposures andmortality among chrysotile asbestos workers.Part 11 mortality.” American Journal qfIndustrial Medicine. 4:421+33.

(15) McDonald, A.D., Fry, J.S., Woolley.A.J., McDonald, J.C. 1963. “Dust exposure andmortality in an American chryso[ile textileplant.” British Journal of Industrial llfedicine.40i361-367.

(16) USDOL, OSHA. 1980 Occupationalexposure to asbestos, tremolite,anthophyIlite, and actincriite; final rules. June20.1966.51 FR 22612-22790. U.S. Departmentof Labor, Occupational Safety and I IealthAdministration.

(17) Devis, J.M.G., Adciison. j., 1301tun,R,Donaldson, K., Jones, A., %nith, T. 1985. ‘Thepathogenicity of long versus short filmsamples of amosite asbestos administered torats by inhalation and intraperitonealinjection.” British Journal of E.~perimenkdPathology. 67415-430.

~Itt) lhvis, J.M.C., Jones A.D., Smi’thT.1987. Comparisons of the pothosenicity oflong and short fibers of chysott[e osbestos inrots. (June 1987). 60pp. Institute ofOccupational hledicine, Edinburgh, U.K.

(19) USEPA. 1566. Asbestorx proposedmining and import restrictions and proposedmanufacturing, importation, and processingprohibitions. January 29,1986.51 FR 3xNl--3759.

(20) Platek. S.F., Groth, D.IL, Ulrich, C.,Stettler, L, Finnell, M., Stoll, M. 1985.‘-Chronic inhalation of short asbestos fibers.’”Funcbnentals of Applied Toxicology. 5:327-340.

(21) USEPA. OHS, ETD. 1989. RE@7tO~Impoc! Analysis of Controls on Asbestos andAsbestos Products. Final Report, Volumes I—IV. January 19,1969. Addendum. June 26,1989.

(22) Doll. R., Pt+o, R. 1985. Asbestos: Effectson the Health of Exposure to Asbestos.(1965):63pp. London, UK: Health and SafetyCommission.

(23) Doll, R. 1967. “The quantitativesignificance of asbestos fibres in the ambientair.” frx Advances in Aerobio/ogy. BirkhauserVedag. Basal pp. 213-219.

(24) Hughes, J.M., Weill, H., Harnmad, Y.Y.1987. ‘“Mortality of workera employed in twoasbestos cement manufacturing plants.”British Journal of Industrial Medicine.44:161-174.

[25) Weill, H., Hughes, J., Waggenspack, C.1979. “Influence of dose and fiber type onrespiratory malignancy risk in asbestoscement manufacturing.” American Review ofRespiratory Diseases. 12034S354.

(26) Thomas, H.F., Benjamin, LT., ElmwoorLP.C., Sweetnam, P.M. 1982. “Further follow-upstudy of workers from an asbestos cementfactory.” British }ourna] of lndmstr/alMedicine. 39273-276.

(27) OSTP. 1985. Chemical carcinogens:review of the science and its associatedprinciples. 30 FR 10372-10442. Office ofScience and Technology Policy, ExecutiveOffice of the President,

[28) USDOT, NHTS. 1988. Letter from BarryFelrice to John W. Melone, Director, CCD,OTS, USEPA, November 30,1966. U.S.Department of Transportation, NationrdHighwey Traffic Safety Administration.

(29) USEPA, OPTS, ETD. 1966.AsbestosExposure Assessment. Revised Report.(March 21,196&J):281pp

[30]L!SF~A, OPTS, EED.1988.ilshesfosModeling Sfudy. Final Report. (March 18.lY86):78pp.

(31] USf?Pf\ OPTS, EED. 1988. Norf-occupotiona] Asbestos Exposure. Revisc~dDraft Report. (September 25, 1988):68pp

(32?]Item. Occ!,pational Health and SafetyIIfpork?r. X987.(September 16,1987):822pp.

[33) USEP.&.OPTS, EIUI. 1966.Memorandum from Dr. Kin WOng 10JohnRigby, CCD, 0W5, USEPA, erititlcd “0S} L4Compliance Data for Asbestos.’s August 1,~:)8&

[34) LJSCOL.0S} iA. IW8. Occi]paliorrnlexposure to n?tresto.fi. kemolite.unthophylhte, and actinolitti final rulee:a mendmrmt. September ]4, 1966. .s3 FR 3cA1O.

(35) USEPA, OPTS, EE3J. 1986. Review ofIlecent Epidemiulogicul invest igot[ons onPit{i(//OliOrW EYOtJSfYf tOSP{W’?ed!<on-

asbes[os Fib~rs. Final Report. [March 21,1986):66PP.

(36] USEPA, OPTS, ETD. 1966.Durab/eFiber E.~posure Assessment Fined Report.(September 9, 1986):466pp

(37) USEPA. OPTS, ETD. 1968. Dumb/eFiber IndustryProfile and Market Outlook.(August 27>IW36):31OPP

[38) b’SEPA, OPTS, HERD. 1988. HealthHazard Assessment of Non-asbestos Fibers.(March 21, 1988):2fK3pp

(39) USEPA, OTf’S, ECAD. 1985. AsbestosSubstitutes and Related Materials. [April 24,1985):246pp

(40] USEPA, OPTS, ETD. 1987.Ana/y!sis ofthe Feasibility of Replacing Asbestos in

Automobile and Truck Bmkes. Final Report,

April 15,1987. Prepared under contract by theAmerican Society of Mechanical Engineers.

(41) USEPA, OPTS, CCD. 1969. Response toPublic Comments Document for theRulemoki.~g Process Concerning Asbestos:Manuj’octure, Importation, Processing, ondDistribution in Commerce, Prohibitions.(June 1989).

(42) USEFA, OPTS, ECAD. Memorandumfrom Francine TenEyck to Lynda Priddy,CCD, OTS, USEPA, entitled “Potential lungcancer risk for ductile iron manufacture as asubstitute for asbestos/cement pipe.”[December 15, 1968):2pp.

(43) USEPA. ORD, WERL 1965.Pkaabingmateriels and drinking water qualit~Proceedings of a Seminar. Cincinnati, Ohio.Moy 16-17, 1984. (February 1965]:1OOPP.Office of Research and Development WaterEngineering Research Laboratory. EPA 600/a-65-oo7.

(44] USEPA, ODW, CSD. 1985. Drinkingwater criteria document on vinyl chloride.Finol Draft. [January, 1985):140pp.

(45) WEiO, IARC. 1979. “Vinyl chloride,polyvinyl chloride and vinyl chloride-vinyiacetate copolymers.” IARCMonographs onthe Evaluation of Carcinogenic Risk OfC!remicals to [irrnrans, Vol. 19. (February1979):402+12.International Agency forResearch on Cancer, World HealthOrganization.

(46] USEPA, OAQPS, ESt3D.1987.Nationa/Emission Standards for Asbestos—Background Information ,for ProposedStandards. Draft [hlarch 5, 1967):311pJr.

(47] ARAP. Lewellen, W.S., Sykes, R.I..Cer~soli, C.P., Parker, S.F. 1966. Comparisonof the i9t7z Seadtw dispemion data withrasu[ts from a number of different models.(February 1986):133pp. Princeton, NJ:Aeronautical Research Association ofPrinceton. Prepared for Oak Ridge NationalLaboratory under contract 19X8P811V. ARApreport no. 575.

(48) USEPA, OPTS. EED. 1504. .!LpesureAssessment ,for Asbestos. Draft Find Report.(Januury 9, 1904):2Lt2pp.

(49) USEPA, OPTS, ETD. 1980.Memorandum from Dr. Kin WOW to DebbieOttin~cr. CCD, OTS, USFJA, entitled“Adclltional Analysis of OSHA ComplianceQ:\t~i.” f Nnvemher2, l@f18j:4pp.

[rf)] LfSltPA. OFTS, CCD. 1988.hiomorarrdum from }ohn Rigby to ihe Recordentitied “Meeting with Events Analysis. Inc.,on Work Practices during Brake Repnir.”[Jtimiory 22. 1988) :l:Jpp.

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(51] USEPA, ORD. Millette, J.R., Boone, k.,Rosenthal, M. 1960. Asbestos in CLst~~mL1’otec (February 1960) :4pp.

(52) USEPA, OPTS, ETU. 1988.,\femorandunr from Cathy Fehrenbocker toL:{nda Priddy, CCI), OPTS. USF~’A. entitled“.Monitoring Data Avtiilahle on Om:or)ationalrxpos~re to Aramid Fib[.rs.’” (Oc!ober 7,1988):2PP.

(53) USEPA, OPTS, ET’t).1988.Memorandum from Cathy Fehrenlxicker toLynda Priddy, CCD, OPTS, USEPA, entitled“Review of the Recent Data Submit!ed byDupont on Aramid Fibers. (dated March 15,1988).” [flecember 9, 1YS6):2pp,

(54] USEPA, OPTS, ETD. 1966. I.)umhkFiber Exposure Assessment: Addendum.(October IL 1966):14pp.

[55) USEPA, OPTS, ETD. 1988. Durub/e

Fiber EXPOSUrSAssessment: Attachment toAddendum. [Post] (October 11, 1988]:2pp.

(56] USEPA, OPTS, EED. 1988.Memorandum from Karen Milne and GeryGrindstaff to Dr. Barbara Mandula, ECAD,OPTS, lJSEPA, entitled “Risk Assessment ofAramid Fibers.” (June 16, 1968):zpp.

(57] lCF, Inc. 1988. Memorandum from NoraZirps and Maravene Edelstein to Dr. KinWong, ETD, OPTS, USEPA, e~titled“Numeric Data for Summary of Asbes[osExposure Information.” [May 20. 1908) :12pp.

(58) USDHHS, NIOSH. 1987c. In-depthsurvey reporb control technology for drumbrake service operations at Ohio Departmentof Transportation maintenance facility,Lebanon, OH. (February 198i’):35pp.NationalInstitute for Occupational Safety and HealthCincinnati, OH: NIOSH. Report No. ECTB152-18b,

(59) USEPA, Asbestos Action Program.1986. Guidance for Preventing AsbestosDisease Among Auto A4echanics. (JunelWO):14pp.

[80) USEPA, OPTS, CCD. 1989.Memorandum from Deborah Ottirrger to theRetard entitled “Upper bound population andlower baund risk estimates-revisions.” (May31, 1989) :llpp.

(61] USEPA, OPTS, CCD. 1987.Memorandum from John Rigby to the Recordentitled “July 23, 1987 Meeting BetweenNHTSA and EPA.” (September 15, 1987):3pp.

(62) USEPA, OPTS, CCD. 1966.Memorandum from John Rigby to the Recordentitled “Ianuarv 12, 1988 Meetirm BetwernEPA and NHTSA,” (Septeml~er 9,-1983]:2pp.

(63) USEPA, OPTS, CCD. 1988.Memorandum from John Rigby to the Rw;ordentitled “July 12, 1988 Meeting Between EPAand NHTSA.” (September 8, 1988):3pp.

(64) USEPA, ODW. 1966. Estin]atedNational Occurrence and Exposure toA sbesios in Public Drinking Water Supplies.(December 23, 1986):72pp. plus appendices.

XII. Regulatory AssessmentRequirements

A. Execative Order 1.?,?91

Under Executive Order 12291, EPAhas determined that this rule is a “MajorRule” and has prepared an RIA. TheIUA estimates that this ru!e will costapproximately $458.89 rni]lion, or $808.51million if a 1 percent annual decrease inthe pri(:e of substitutes is not assurm?d.

The RIA also estimates that the rulewill, over the 13-year period analyzed,avoid at least zoz cancer cases, ifbenefits are not discounted, and 148cancer cases, if benefits are discountedat 3 percent. If analogous exposures arenot cssumed, the estimates of cancer-cases-avoided arc 184 cases, if benefitsare not discounted, and 120 cases, ifbenefits are discounted at 3 percent. Asis stated in Unit V.D. of this preamble,EPA believes that these costs arereasonable and that the rule is the leastburdensome way of reducing theunreasonable risk posed by exposure toasbestos from the manufacture,importation, processing. use, anddisposal of asbestos-contain~ngproducts.

This rule was submitted to the Officeof Management and Budget (OMB) forreview, as required by Execu!ive Order12291.

B. Regulatory Flexibility Act

Under section 805[b) of the RegulatoryFlexibility Act, 5 U.S.C. 605(b), theAdministrator may certify that a rdewill not, if promulgated, have asignificant impact on a substantialnumber of small entities and, therefore,does not require a regulatory flexibilityanalysis.

EPA has analyzed the economicimpact of this final rule on smallbusinesses. A summary of this ~nalysisappears in the RIA and Unit V.D of thispreamble. Based on the discussion inthat Unit, EPA certifies that this rule willnot have a significant economic impacton a substantial number of smallentities.

C. Paperwork Reduction Act

The reporting and recordkeepingprovisions of this final rule have beensubmitted to OMB for approval underthe Paperwork Reduction Act, 44 U.S.C.35OI et seq. These requirements are noteffective until OMB approves them anda technical amendment to that effect ispublished in the Federal Register.

Public reporting burden for thiscollection of information is estimated toaverage less than 2 hours annually perfirm over the 3-year period reviewed fortbe analysis of regulatory burden. Thisburden estimate includes the time forreviewing instructions, searchingexisting data sources, gathering andmaintaining the data needed, andcompleting and reviewing the collectionof information. This estimate of annualburden ia a relatively low figure becauseof the small number of firms affected bythe mglilatory actions taken during theperiod reviewed for the analysis ofregulatory burden.

Send any comments regarding theburden estimate or any other aspect ofthis collection of information, includingsuggestions for reducing this burden, toChief, Information Policy Branch, PM-223, us< Environmental protection

Agency, 401 M Street., SW.,~)ashington, DC 204m and to the Officeof Information and Regulatory Affairs,Office of Management and Budget,Washington, DC 20503, Attention: DeskOfficer for EPA.

List of Subjects in 40 CFR Part 763

Asbestos, Environmental protection.Hazardous substances.

DatedJuly6,1989.WMiamK. Reilly,Administmtor.

Therefore, 40 CFR Part 763 isamended as follows,

PART 763+AMENDED]

1. The authority citation for Part 763 isrevised to read as follows:

Authority 15 U.S.C. 2805 and 2607(c).

2. By reserving Subpart H and addingnew Subpart I to read as follows:

Subpart I—Prohibition of the Manufacture,lmportatio~ Processing, end DletributioninCommerce of Certain Aabestoa-ContainingProduc~ LebetingRequirements

sec.763.180 Scope.763.103 Definitions.763.165 Manufacture and importation

prohibitiona.763.167 Processing prohibitions.783.169 Distribution in commerce

prohibitions.763.171 Labeling requirements.763.173 General exemptions.763.175 Enforcement.763.176 Inspections.783.178 Recordkeeping.763.179 Confidential business information

claims.

Subpart i-Prohibition of theManufacture, Importation, Processing,and Distribution in Commerce ofCertain Asbestos-Containing Products;Labeling Requirements

$763.160 6COFN?.

This subpart prohibits themanufacture, importation, processing,and distribution in commerce of theasbeatos-containing products identifiedand at the dates indicated in ~$763.165,763,167, and 763.169. This subpartrequires that products subject to thisrule’s bans, but not yet sobject to a banon distribution in commerce, be laiwlefi.‘Ibis subpart also includes generalexernptiorrs and procedures for

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2.9508 Federal Register j Vol. 54, No. 132 / Wednesday, July 12, 1989 / Rules and Regulations-—— —

req~lcstirrg exernptlrms from theprovisions of this subpart.

~ 763.163 Definitions.

For purposes of this subpart:“Acetylene cylinder filler’’means an

astxx,tos-conta ining product which isintended for use as a filler for acetylenecylinders.

“Act” means the Toxic SubstancesControl Act, 15 L!.S.C. 2601 et seq.

“Aftermarket part” means any partoffered for sale for installation in or on amotor vehicle after such vehicle has leftthe manufacturer’s production hue.

“Agency” means the United StatesEnvironmental Protection Agency.

“Arc chute” means an asbestos-containing product that acts as a chuteor guidance device and is intended toguide electric arcs in applications suchas motor starter units in electricgenerating plants.

“Asbestos”’ means the asbestiforrnvarieties ofi chrysotile (serpentine);crocidolite (riebeckitel amrmite[cummingtonite-grtxnerite); tremolitmanthophyilite; and actinolite.

“Asbestos-cement (A/C) corrugatedsheet” means an asbestos-containingproduct made of cement and in \he formof a corrugated sheet used as a non-flat-surfaced reinforcing or insulatingmaterial. Major applications of thisproduct include IxiIding siding orroofing liningsfor waterways; andcomponents in cooling towers.

“Asbestos-cement (A/C] flat sheet”means an asbestos-conhdning productmade of cement and in the form of a flatsheet used primarily as a flat-surfacedreinforcing or insulating material. Majorapplications of this product include: walllinings; partitions; soffit materiakelectrical barrier boards; bus bar runseparators; reactance coil partitions;laboratory work surfaces; andcomponents of vaults, ovens. safes. andbroilers. -

“Asbestos-cement (A/C) pipe andfittings” means an asbestos-containingproduct made of cement and intendedfor use as pipe or fittings for joiningpipe. Major applications of this productinclude: pipe used for transmitting wateror sewage; conduit pipe for protection ofutility or t#[ephone cablw and pipesused for air ducts.

“Asbestos-cement (A/C] shingle”means an asbestos-containing productmade of cement and intended for use asa siding, roofing, or construction shingleserving the purpose of covering a~duisrrlutiog the surkice of building wallsand roofs.

“Asbestos clothing” means anasbestos-containing product designed 10be worn by persons.

“Asbestos-containirlg product’’ ”rrw:insany product to which asbestos isdeliberately added in any concentl-iitionor which contains more than 1.0 percentasbestos by weight or area.

“Asbestos diaphragm” means anasbestos-containing product that is

made of paper and intended for use as afilter in the production of chlorine andother chemicals, and whic}l acts :s amechanical barrier between thecathodic and anodic chambers of anelectrolytic cell.

“Automated transmission component”means an asbes!o~containing productused as a friction material in vehicularautomatic transmissions.

“Battery separator” means anasbestos-containing product used as aninsulator or separator between thenegative and positive terminals inbatteries and fuel celIs.

“’Beater-add gasket” means anasbestos-containing product that ismade of paper intended for use as agasket. and designed to prevent leakageof Iiquids, solids, or gases and ~0 sealthe space between two sections of acomponent in circumstances notinvolving rotary, recipmcatingt andhelical motions. Major applications ofbeater-add gaskets inch.rde: gaskets forinternal combustion engines;carburetors; exhaust manifolds;compressor reactors distillationcolumn% and other apparatus.

“Brake block” means an asbestos-containing product intended for use as afriction material in drum brake systemsfor vehicles rated at z6,001 pounds grossvehicle weight rating [GVWR) or more.

“ChemicrrIsubstance,” has the samemeaning as in section 3 of the Act.

“Clutch facing” means an asbestos-containing product intended for use as afriction material or lining fn the clutchmechanisms or marmet transmissionvehicles.

“Commerce” has the same meaning asin section 3 of the Act.

“commercial and industrial frictionproduct” means an asbestos-containingproduct, which is either motded orwoven, intended for use as a frictionmaterial in braking and gear changingcomponents in industrial andcommercial machinery ancl consumerappliances. Major applications of thisproduct include: hand brake% segment%blocks; and other components used asbrake linings, rings and clutches inindustrial and commercial machineryarrd consumer appliances.

“Cor,lrnercial paper” means aniisbesios-collt aiilirlg product l.’klich ismade of paper intended for use asgeneral insulation paper or mufflerpaper. Major applications of commercialrm~ers are insulation agairrst fire. heat

transfer, and corrosion in circumstai:ct;sthat require a thin, but dowbie, barrier.

“CorrugateLt paper” means anasbestos-containing product made ofcorrugated paper, which is oftencemented to a flat backing, may beIaminateci with foils or other maletials.and has a corrugated surface. Majorapplications of asbestos corrugatedpaper include: thermal insulation forpipe coverings; block insulation: panelinsulation in elevators; insulatioil inappliances: and insulation in 10W-pressure steam, hot water. and process

lines.“Custonls territory of the United

States” means the 50 States, PuertoRico, and the District of Columbia.

“Disc brake pad for heavy-weightvehicles” means an asbestos-containingproduct intended for use as a frictionmaterial in disc brake systems forvehicles rated at z6,001 pounds grossvehicle weight rating [GVWR) m more.

“Disc brake pad for light- andmedium-weight vehicles” means anasbestos-containing product intendedfor use as a friction maternid in discbrake systems for vehicles rated at lessthan z6,001 pounds gross vehicle weightrating (GVWR).

“Distribute in commerce” has thesame meaning as in section 3 of the Act,but the term does not include actionstaken with respect to an asbestos-con taining product (to sell. resale,deliver, or hold) in comection with theend use of the product by persons whoare users (persons who use the productfor its intended purpose after it ismanufactured or processed). The termalso does not include distribution bymanufacturers, importer% andprocessors, and other persons ~leIy forpurposes of disposal of an asbestos-containing product.

“Drum brake lining” means anyasbestos-containing product intendedfor use as a friction material in drumbrake systems for vehicles rated at lessthan 26,001 pounds gross vehicIe weightrating (GVWR).

“Flooring felt” means an asbestos-containing product which is made ofpaper felt intended for use as anunderlayer for floor coverings. or to bebonded to the underside of vinyl sheetflooring.

“Gross vehicle weight rating(GVWR)” means the value specified bythe manufacturer as the maximumdesign loaded weight of a single vehicle.

‘“High-grade electrical paper” means::n rAcst, ~s-cor.!ai::ii:g prod’uc! tha t ismade of paper and consisting ofasbestos fibers and high-temperatureresistant organic binders and used in or\vith electrid devices for purposes of

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Federal Register [ Vol. 54, No. 132 / Wednesday, ]uly 12, 1989 / Rules and Regulations 29509——

icsulalion or protcctioir. Ma@:;k)piictitio!ls of this p:CdU~t ]nciudl~insal,iti~:~ for }Iigh-tc,]lpjrat:)]e, 1(;1..,volta{:e appliciriior?s such as in :IIctors.

gcneraturs, trans(crm,;rs, s.r.,,jt~~ ~t,;irs.

and o(her Eieavy elcc~rlcal appctrattis“’IillI~OI’1” n’ea~;s to i>rin; ir-,!(j :tIU

,;i, stems trmitury of the Uciteti States.

except for: (1) shipment through thecustoms territory crf the United St:i!esfor export without any use. procwsin~.or disposal within the customs !m riioryof the United States; or (z] ente~ing thecustoms territory of the United States asa component of a product duririg normalpersonal or business activities invoivinguse of the product.

“Importer” means anyone whoimports a chemical substance, inciudinge chemical substance as part of amix ture or article, into the custmnsterritory of the United States. %nporter”includes the person primarily liable forthe payment of any duties on themerchandise or an authorized agentacting on his or her behalf. The termincludes as appropriate:

(1) The consignee.(z) The importer of record.(3) The actual owner if an actual

owner’s declaration and supersedingbond has been filed in accordance with19 cm 141.20.

(4) The transferee, if the right towithdraw merchandise in a bondedwarehouse has been transferred inaccordance with Subpart C of J 9 CFRPart 144.

“Manufacture” means to produce ormanufacture in the United States.

“Manufacturer” means a person whoproduces or monufactw-es in ihe UnitedStates.

“Millboard” means an asbestos-containing product made of paper andsimilar in consistency to cardboardproduced in sections rather than as accn!inuous sheet. Major applications ofthis product include: thermal protectionfor large circuit breakers; barriers frrr:nflame or heat; linings in floors,pmtitions, and fire doors; linings forstoves and heaters; gaskets; table pads:trough liners; covers for rrperafionsinvolving molten metal; and sto~.e milt S.

“Missi!e liner” mc.scs an aslwst~Js-comtaining product used as a liner ff)rccating the interior surfaces of nxketmotors.

“klmfe! year”” means themlanufactorcr’s annual productionperiod which inciudw January 1 of suchCa!endar year, providerJ that if thc

manufacturer has no annoai pro~d[[ctionpcriml, the term “mod,:] year” Sh(:llme~rr the calend:tr year.

‘dNew uses of asbesios’” meanscommercial uses of asbestos notidrmt itled in $ 763.165 [he manufa(;ture,

importation or proccssing”of whichv.,ould be initi~ted for the first time afterAugust 25, 19W. Tile fo!iowing productsare also not new uscs of as bestcs::;cetylene cylinders, arc chutes, asbestosdiaphragms, battery separators, high~lfii~~ el?ciriwl pa~::r, I;Li:;sile li:ler,reinforced pidsiic, sealant tape. andtrxti!es.

“Non-roof coating” means anasfwstos-containing product intendedfor use as a coating, cement, adhesive,or sealant and not intended for use onroofs. Major applications of this productinclude: liquid sealants; semi-liquifiglazing, caulking and patchingcompounds; asphalt-based compounds;epoxy adhesives; butyl rubber sealants;vehicle undercoatings; vinyl sealants;and compounds containing asbestosfibers that are used for bonding, weatherproofing, sound deadening, sealing,coating; and other such applications.

“Original equipment marke! part”means an? part insta!led in or on amotor vehicle in the manufacturer’sproduction line.

“Packing” means an asbestos-containing product intended for use as amechanical seal in circumstancesinvolving rotary, reciprocating, andhelical motions, and which are intendedto restrict fluid or gas leakage betweenmoving and stationary surfaces. Majorapplications of this product include:seals in pumps; seals in valves; seals incompressors; seals in mixers; seals inswing joints: and seals in hydrauliccylinders.

“Person” means any natural person.firm, company, corporation, joint-venture, partnership. sole propric!orship,association, or any other businessentity: any Siate or political subdivisionthereof, or any municipality; anyinterstate body and any department,agency, or instrumentality of the FederalGovernment,

“Pipe!ine wrap” means an asbestos-curitaining product made of paper feltintended for use in wr~pping or coatingFipes for insulation purposes.

“pr-o[;ess” has the same meaning as insection 3 of the Act.

“processor” has the same meaning asin section 3 of t’ne Act.

“Reinforced plastic” JIIPil~S an;j:;lccstos -coll(air:iil~ product nlclde ofplastic, NI.)jor upplic.~tions of thisprodut:i includt~:elect ro-mcwh:inic~ip,+rts io the automotive and applii~nceiridustrics: components of printingplates; and as high-performance pl:isticsin the aerospace industry.

“Rolii)oard”’ means an asbcstos-containing product rmde of paper that isprwfuceci in a continuous sheet, isflexible, ai?<i is rolled to achieve a(iesii-cd thickness. Asbestos roll board

consists of two sheets of asbestos pap(’rlaminated tcrgcther. Major applicationsof this product include: officepartitioning; garage paneling; linings forstoves ami electric switch boxes; ;i~)(ifire-proofing agent for security boxrs.Siif(?S, &Ild f;;CS.

‘“Roof zcatirg” means an asbes!os-containing product intended for use as acoating, cement, adhesive, or sealant oilroofs. Major applications of this productinclude: waterproofing; wea!herresistance; sealing; repain and surfacerejuvenation.

‘&Roofing felt” means an asbeslos-containing product that is made of paperfelt intended for use on building roofs asa covering or underplayer for other rocfcoverings.

‘Sealant tape” means an asbestos-containing product which is initially asemi-liquid mixture of butyl rubber andasbestos, but which solidifies whenexposed to air, and which is intendedfor use as a sealing agent. Majorapplications of this product include:sealants for building and automotivewindows, sealants for aerospaceequipment components, and sealants forinsulated glass.

“Sheet gasket” means either (1) anasbestos-containing product consistingof asbestos and elastomeric or otherbinders rolled in homogeneous sheets atsome point in its manufacture andintended for use as a gasket, or (z) anyasbestos-containing product made frombraided or twisted rope, slit or woventape, yarn, or other textile productsintended for use as a gasket. Sheetgtiskets are used to seal the spacebetween two sections of a componentand thereby prevent leakage in suchapplications as: exhaust, cylinder head,arid intuke manifolds; pipe flanges:autoclaves; vulcanizers; pressurevessels; coo!ing towers; turbochargers;and gear cases. This category includesf!an~e, spiralwound, tadpole, manhole.harrdho!e, door, and other gaskets orseals.

‘(Specialty industrial g~skets” meansslie~l or beeter-add gaskets designed forindustria! rises in either (I)en\:ironments where temperatures arc750 de~rees Fahrenheit or grea!er, or (3)corrosive t?i?vironments. An inr!ustriaigasket is one designed for use in anarticle which is not a “consumerpro[Juct”’ tvithin the meaning of theConsumer Product Safety Act [CPSA).15 U.S. C. 2052, or for use in a “motor~e]lic~e” or “m.r)tor vehicle equipment”within t!]e mcarring of the Na!ionalTraffic and Nlotor Vehicle Safety Act of1966, as amended, 15 U.S.C, 1381. Acorrosive environment is one in whicht!~e gasket is exposed to concentratrxi

(pit less than z], highiy o,i.i[lizi:~};

Iilit:(:ral acids [e.g., sulfuric, liitric, tlrchromicacirf]at temperatures dbovcam bifmt.

“Sprcialty paper” means an :is5es LL)s-corrtaining procfuc! that is made ofjraperintended for-use as filters for beveragesor other fluids was paper fill foi-coo!ingtowers. Cooling tower fill consists ofasbestos paper that is used as a cooIingagent for liquids from industrialprocesses and air conditioning systerrls.

“State” has the same meaning as insection 3 of the Act.

“Stock-on-hand” means the products\vhich are in the possession, direction,or control of a person and are intendedfor distribution in commerce.

‘“TexfiIes” means an asbestos-containing prOLiUGt such as: yarn; thread:wick; cod braided and twisted rope;braided and woven tubing mat; roving;cloth; slit and woven tape; lajx felt; mrrfother bondeti or non-woven fabrics.

“United States” has the same meaningas in section 3 of the Act.

“Vi@-asbestos floor tile” means anasi]estos-contairring produst composeclof vinyi resins and used as tlcror tile.

~ 763.165 Manufacture and importationprohibitions.

(a) After August 27, 1990, no personshaII manufacture or import thefollowing asbestos-containing prrxJucts.either for use h-rthe United States or forexpo~t: A/C corrugated sheet, A/C flaisheet, asbestos clothing, flooring felt,pipeline wrap, roofing fell, vinyl~asbestos floor tile. and new- uses ofaslx?stos.

(b] After August 25.1993, no personshall manufacture or import thefollowing asbestos-containing products,either for use in the United States or forexport: automatic transmissioncomponents, clutch fticings, commercialand industrial asbestos fri(tionproducts. and sheet and bzaier-addgaskets {excep~ specialty irldustlial~~skets].

(c) After August 25, 1993, no personsh~ll manufacture or import, inclwiingas part of a motor vehicie, ashestos-containing disc trrakc pads for light-,me(iium . and heavy -~vei; kt \ ehiclcs.anti drum brake linings for tile followingMCS in the United St:ites or lur cx.port:

(1) As original equip mer:l tn “1994uclater model year motor vchicies, or

(2) As aftermarket replacement p.trtsi;I br~lke systems designed fur use wilh

non-asbestos replacenLent parts,{(i) After AUr USt 26, 1995, [IO pL!USO:I.

si:all marjufacture or import tiicio!!owirrg asbestos-containing prm!ucts,either for use in tire United Stc. (es or forexport: disc brake pads for rise in Iigilt-,~il[:diij m-, arrci trea~,y-~vei~}:t v[, hic!cs

onci urum br~ke llrrln~s :Oil Oli[:l(. . .t“rt, [i,impurtecf, or marketed for use :is

aftermaricet replacement parts ill brake

systems designed for use with as bestw-co[~iaining friction plOdiiCtS: A/C pipe.A/C shingie, br~ke Moths. comnlercialpaper, corrugated p:+per, mdib(mrd, rlon-ruofin: coatings, rollboarcf, roofcoatings. and sprwialt~ paper.

(e) The import prohibitions of this

subpart do nut prohibi!:(I} The import into the customs

lerritory of the United States of productsimported soiely for shipment ootsicie the(;ilstorris territory of the iJnited States,uniess further repackaging or processingof the prodllct is periormed in the UnitedStiiteS; or

(z) Activities involving purchases or

acquisitions of smail quantities ofprcducts made outside the customsterritory of the United States forpersonal use in the United States.

~ 763.167 Processing prohibitlona

(a) After August 27,1990, no personshaii process for any use, either in theUnited States or for export, any of theasbestos-containing products listed at$ 7tj3.165(a).

(b) After August 25,1993, no personshall process for any use, either in thel!nited States or for export, any of theasbestos-containing products l~sitxf a t$763.155 [b) and [c).

(c) After August 26, 1396, no personshall process for any use, either in theUnited States or for export, any of theasbestos-containing pro(iucts listed at$ 7fXJ.165(d).

$763.169 Distribution in commerceprohibi?tons.

(a) After August 25,1992. no peisolls},:ti] distribute in commerce, eitht:r fO1use in the United States or for export.any of the as bes!os-cor, itiining productsIiste(i at $ 76:1.”165(a).

(1)] After Auglst 25, 1!w4, no personSll:-fil distribute in comrncrce, eiiher for[Is!: in the I!niteci St~:tcs or for export,an,v of ih[! [Isl)cslos-(;orlt:lining pro(!ucts

Iiste[l at $ 76:j.l&5 (b) dnLf {C).

((, ) After A(, gll:; i 25, 1:/{)7, [IL) pel son

sihill distribute in conlmcrce, eit!:er for~];e ir) [ilf: [Jni!rd St:itvs or Ff)rexport,:!ny IJI Iht:asi~cs[os.c(>nliiinin[; productsIls:((i a? $ 76$lf55\d).

(d) A nulnuf:l(:lurer. iil)Il)ltL!i’.procew,ur, or any othf;r person tviIo issilt)ject to a b~~nLJ[ldistril)ution incommerce in paragraph [ii), (b], or (( }ofthis sectiurL must. within 6 mo~lth,s of lile:,ftr,:ti!e dale f.)!I;e b~il of a S;)ec!fitzsht~stos-coi:t{~i:lin< ;~md:lcl frwndl~trilru! ion in coiumerce, (iispose Ji titlitheir mrnaining s!ock-un-hand ot’ thatpro(iuct. by mt?ans that are in

compliance with applica!)le local, Stute.

i J>..)- .h ,haric FC(,t.iti re.stric:iorts m 1(. ik ,Ire

(: Lirrt:r:t at that tijme.

$763.171 Labeling requirements.

(a) After Ati:ust 27, IWKJ,manufacturers, importers, andprocessors of all asbestos-c(]nttlinin~pro(iucts tha! are identified in\ 763.165(:1) shall label the products ;~sspecified in this subpart at the time ofmanufacture, import, or processing. Thisrequire ruent inclu(ies liri)ciiri~ ,111manufacturers’, importers’, arrdpr[JCeSSOrS’ stock-on-h i]nri its of Augits[

27, 1990.

(h) After August 25, 1992.

rnarrufacturers, importers, and

processors of al} asbestos-cor~~.ili!lir~gproducts that are identified in

$ ~6S.165(b) and [c], and disc brake padsfor ose in light-, medium-, and heavy-weight vehicles and drum brake liningsmanuftictured, imported, or marketed foruse as aftermarket replacement parts inbrake systems designed for use \vithastwstos-corttai ning frirlion prrxiuctsshall label the products as speci~itxi inthis subpart ~t the time of rnanufar;turw.import, or processing. This requirementinclucim labeling ali manufacturers’,importers’, and processors’ stock-on-harrd as of August 25, 199z.

(c) After August 25,1995,rrtanufacturers, imporlers, andprocessors of aIi asbestos-containingproducts that are identified in$ 763.”165(d), except disc brake pads furuse in light-, medium-, and hea~ry-wei~tvehicles and drum brake liningsmanufactured. imported, or marketed foruse tis afterrn<irket replacement parts iabrake systems designed for use witi~asbestos-containing friction products,shall Iabci the products as specified intil:s subpart at the time cd manufacture,import, or processin~. This requirementinciudos labeling all manufacturers’.importers’, and pror,essors’ sto(; k-oi~-hand as of’ August 25, 19%+.

[:;) ‘1’t,~l~bpi shall ~)e pia(:eti directiyun the visible exterior of the wrappin,manti ~~~hit~)[ig in wilic. h ihe produict isp;aced fur sale, shipmeoi. ur skr!age. ifl!Ie pr(xiuct l~as more than one layer of(Jitt,rr.al wrappiny of p~:cka; :inj;, t!; f!

I:li,(!l Illost k)f! ai:dc hwl to the i~>nermost

!;:!,Ic F adiac~.nl 10 t!]t? pnxi:[!t. i] !I]e,r)~~[:rrn~,,s: !(i!,.,:~ of ~,r~]d~c:i il”r:lppi:ig Or

p[lcka~ing ~i&:s not have a visibie

fxif:rior sLL:~acf! Idrger than 5 squareiot:hes, either a @ nweting thercriuirr. iaeo~s 0! p:Jrdg:ilI!h [[?} of th.iSs~,(:licjn nlhs; ije Seuure!j. attaci-ed to jhepr[Jd L:cl”s in:]etmost Iaycr of prmfb:ivwr:ipp, ng or p[ickf]*ing. r,r a luWI rndst!)(: zi(tachccf to tile next ou!er layer ofpJ’OfiLIC/ packiging or ‘wrapping Anyprf)ducts th:il are distributed in

I

n ..

I

I

Federal Register / Vol. 54, No. 132 / Wednesday, July 12, 1989 / Rules and Regulations 29511&—— —- ———

or the app!icant receives an extensionunder paragmph (i))[8) or (9) of thissection.

[bj Application filingdates. [I),lpplic~:ions for products aff’ectcd h:,)th? proilibi’ions under $ $763.16G(a) tirjd753,]07[8) m3y Lrcsukrmittcd iiiIcrAlugust 23.1989. Corcplete application,;received after that date. but beforefiiov emher :27,1s[19. wi!l be ei~her

.nted or denied by the Agency prior togf’,.the e~~ecti~~e date of the ban for- th.?product. Applications received ~f!er.Novl:mber 27, 1989. n ili !x? eithergmn[ed or denied by H’:! as socn as isfrasiblc.

(2) App!ica!icmi for ptwd!:cts aff~?ctedhy the }>an ~lnder $763 159(()) iilti~ I?)!

he sub:ni!ted prior 10 F~!)~~ijr~ L6, i!)~).

thmplcte applications received after

thnt date, but before August 26, 1391,W~]l he either granted or der.ied h~ the

Agency plier to the effective date of theb~i~ for the product. Applicationsreel; ived after August 26.1991, will beeiiher &ranted or denied b~yE1}A as soon,as is feasible.

(2) Applications for products affecfedby ihe ban under $$ 763.165 [b] or (c]dfii~ 763.? 67(!?) or (c) may not besubrnit!ecl prior to February 26, 1992.Conlj)lete applications received a!!erthat date, but before August 25, 19!)2,

w’ill be either granted or denied by ?he

Agmlcy prior to the effective date of thebdn for the product. Application:rt?cci~~cc]a[t e: At)f+~si 25, 1992, w’1]1 he

cit?lcr ~m~]ted or denied hy El>A as soon

as is feasible.[4) Applications for product< afftctwi

by the ban under $ 763.169 [b] or (c) maynot be submitted prior to February 26.1W3. Complete applications receivedafter that date, but before tltigiist X,1933, will be either gran:ed or denied bythe Agericy prior to the effective date uftho ban for the product. Applicationsreceived after August 25, 19!KI.will be~>~thergr~lited or cfeni~d h~ EPA ~S soon~i~is fe:~si’b!e.

iii) ,.’ipplications for prod\tr;ts aff[!;t~>dh:y [he ban under $$ 763.165(d) a,-,:.]763.16T(d] may not be su!~mittcd p;-ior 10Fei;ruary 22, 1995. Complete{+i]~)iic,,qtitj!:s recei~, ed dfter !hat date. hotb~f[)ie AUgUSt 25, IW!5. wili b? eiiher

~wnte~ UT d~i:ied hy the ~\p,i,nry prior to

d::’ effwciivr (iate of the b:in for I!Wpi!>!; llct ,A,:~p]l:,i]ticfis rpct~it:cd ;ifil’i~\11~,05f ZS, ‘Iqj.~, -Nj]l be cit}; er ~ra:’t,:d or

cieliit?d by i+[)il as soon as is fetis;b!t;.(bj Applications f’or prorfuc;ts i] f!(;cted

by Ihe han under $ 7tij.16{j[d} mav notIx; submi!tcd ~wior to Fe!mlary 26, 19!1S.C[mplete ;Ipplicatirrns receivet-f aftertil:it date, !Jilt tmfore ,Iugust 2fj, 19!ki.

w!li be eiihi;r ,grantmf or denied by th~~Agcnc]~ prior !O the effective da!c of theI]:,n for !he product, Applicti!i(>ns

rccei’ied after August 20. I%%, will be. .rx?her granted or di:~’ie~ !,y EPA a.s soonas is feasi~]e.

[7) The agency Wi!i consider dn

app!i~aticm ~~r an cxel;i~tion from :i }mng~der $763,169 for a pr!) iflct at ihc’same time the apniicar, ~ slrfmits anapplication for an ~exemption from a banunder $ 763. Ifi5 or f 763.lW For tha!

pro:l~(;t. EPA will gr3r~! an Pxcmption al

that time from a ban under $ 7ti3.Ifi9 ifthe Agency deiernlines it appropriate to.(in 50.

[o,i it’the agency dei~ies an applicati:m!CSSthan 30 days befow the effectivecfatc CFa ban for a pmdu~t. the:~pp]icant can Continui> the ac.tivit~~ i’orso days after reccipf of !!l~-rfcmlal fro; ~

!bn ,Igcncy,

(9] !f !he Agency fails to meet tbe

~ctl~]lnes stated in paragraphs (b](l)

tilroligh [6J of this section for granting or

denying a complete application ini:wl~nces in which the deadiine istwfore [he effective date of the ban tow’hicb the application applies, theaj?piiuar.t vJil] be granted an extensionof 1 year from the Agency’s deadlinedtitt?. Dlwing this extension period thetipp!icant may continue the activity thatis ths subject of the exemptionapplication. ‘lile Agency will eithergrant or deny the application during theultwtsion period. The ex~ension period~;ii) terminate either on the date the.Agrncv gr~:li~ the application or 30 daysa~.cr the apFiicant receives the Agency.sdcniai of the application. However, nocxtensiorr wiji be granted if the A,qrmcyis sc!mdulcd to gr;~~t or deny anLlppiiC,l:iOll at some date after thevffc{;tlve date of the ban, pursuant to thecieodlines st,]ted in pera:;raphs (b)(~]{!lrolkg!l {[j) of this section.

[c) Where to fiie. Ali applicationsmo~t be submitted to the followingIor,ation: TSCA Uoclumen{ Process irigCcnier [“f%790J, Office of “roxicSIIb:.\ances, U.S. Environmentallh:t:>,:tion Agency. 401 M St., SW.,~, ,j;hingron. DC. 2046{?, ATTENTi(}N:Asiwstos Lxemption.

{,JJ f~ontellt of application anff criteriaf~>r(,!(,cibl O: ~.l;ik~:jg.

(i! Content ofapplication. Each:Jppii(:ation ml)st contain the foik}wing:

(I; ?i:~rne. ad~iress, arid tcle!]hon~:ll]li,l~,:r ::f:t-ie a pp!icarrt.

[ii! i~:lwriptinn of :h*: manufticturing,Import, l~rocessing, drrd/or fiistribotiunin commerce activity for which ancx{m~plion is requrxtcd. inci:lding sdr~.riptiun of the a:>!~esfl)s-conta ining!)J[M!::(.( to he .~]~]i~ufijrtured, imported,

p,,j,;t>$~~d. or rfistribuicd in commerce.[iii) lden~ii’ica!ion of iocations al

}~,!;i(:hthe exempted activity would take1,:?.$>.

2!3512 Federal Register / Vol. 54, No, 132 / Wednesday, July 12, 1989 / Rules and Regulations.—..—_____ .. .. .

(iv) Length of time requesled forexemption [maximum length of anexemption is 4 years).

(v] Estimated amount of tisbestos tobe used in the activity that is the subjectof the exemption afrpiication.

(vi) Data demonstrating the exposurelevel over the life cycle of the productthat is the subject of the application.

(vii) Data concerning:(A) The extent to which non-asbestos

substitutes for the product that is thesubject of the application fallsigrrificantiy short in performance umiernecessary product standards orrequirements, including laws orordinances mandating product safetystandards.

[B) The costs of non-asbestossubstitutes relative to the costs of theasbestos-containing product and, in thecase in which the product is acomponent of another product, the effecton the cost of the end use product ofusing the substitute component.

(C) The extent to which the product oruse serves a high-valued use.

(viii) Evidence of demonstrable goodfaith attempts by the applicant todevelop and use a non-asbestossubstance or product which may besuLrstituted for the asbestos-containingproduct or the asbestos in the product oruse that is the subject to the application.

(ix) Evidence, in uddition to thatprovided in the other informationrequired with the application, showingthat the continued manufacture,importation, processing, distribution incommerce, and use, as applicable, of theproduct will not present anunreasonable risk of injury to h~mmnhealth,

(z) Criteria for decision [existingproducts). After considering all theinformrttion pro~~irif.d by an ripp!icarrtunder paragraphs (dj(l] and [e) of thissection. and any other information

a w ila’dle to WA, I?P:I will grant an

e.wmp!io.n frwrn the probibitioits in$$ 7~3.165, 763.167, rrr 7W.IW [or anapp!i(; n.nt”s as[>e.s[:js-c:ort ttii{>i?lgproc!u t;!oolv if’EPA detwmirws both of [! Is,

Wi)v;:nfy

[i) ‘ll!~: app!irxint haS nl:(dC ~[){)([ Fi{iti]i$!tCl12pt$ to Cf(VP!il~ ;:n(l uS(: ~<rlo!j

}iisbcfit(~s subs M7,cc trr prociuci fshic Inl:iy t:{, S1.!bstitrr!+.;J for tbf: aslwst{os-cw. i;:iuing pi’odiii;! ~rr ihc :js[)cs[~:,s if: t~lt:

f)r[:cit:C: O; LIS$. ~!ild t!lUS[! ;\l!i(Tli!t5 kliiVf!f’[?!~i:(! lo prorfii(;f: :i }i!!l)sli!ill( ~); ;1

s!l!,s!itut~. [ha~ ies LI\ts in ;I ~)P,I(!,!i t tb({t

““ 1’1 ~rr’f~iitf4.1C:in h,. <.rm[:!!, --,1<, .! !.,

(i;) ~“~!’i?i,il:~.(l !:::iilll;:*i:!iifi;i[:.~l”+.l{:f!$:.l!!~<, Li:Si~~!.lii!l(l[l irl (:(llllli:tl(;C,ilrld !Iiif,, :1s appii(::ji)! t,. ()[ ~}11: pr(](!l~(:!

wil! !Io[ present an !;rjrcos(lrwl)~(, risk t)fi[l~<,:+;~:~!:;{nl;[:, !lt:ti~,}!.

(3) Criteria for r]e~ision (n~,wprorfucts]. Requests to develop iind use

arr asbestos substance or proc!tict will betreated as a petition pursrrant irr Section21 of TSCA.

(c) The Agency reserves the right trrrequest further information from anexemption applicrtnt if necessary tocomplete the Agency’s evaluation of finapplication.

(fJ Upon receipt of a completeapplication, the Agency will issue anotice in the Federal Registerannouncing its receipt and invite pubhccomments on the merits of theapplication,

(g) If the application does not inchrdeall of !he information required inparagraph (d) of this section, the Agencywill return it to the applicant asincomplete and any resubmission of theapplication will be considered a newapplication for purposes of theavailability of any extension period. Ifthe application is substantiallyinadequate to allow the Agency to makea reasoned judgment on any of theinformittion required in paragraph (d) ofthis section and the Agency chooses torequest additional information from theapplicant, the Agency may alsodetermine that an extension periodprovided for in paragraph (b)(i) of thissection is unavailable to the applicant.

(h] LVhen denying an application, theAgency wii] notify the applicant byregistered mail of its decision andratiouale. Whenever possible, theAgency will senrJ this letter prior to theap!)ropriatc ban. This letter will beconsidered a final Agency action forpurposes of judicial review. A ~oticearmouncing the Agency’s denia] of th(ltipplication will be published in theFederal Register.

(i) If the Agency proposes to approvean exemp!irrrr, it wili issue a notice inthe Federal Register announcing thisintent and invite public comments. If.after uorisi(ierins tip.y timel}- rx.x,ml(~nkircceivd. the tlgency approves {ii]e~cn~pti(ln, its decision will t)cPi~~~iifihi:din the Federal Register. ‘I”!lisnc?ir.~. ~~ii! [~t. cons! c!ercd[I fi[ial .Agenc.yii(tlo{l r[)f ,puqposes of j:idici: ii rt~~iew.

(i! “[he {t;n~th Ui iin exump[ior~ p{,ri(}d“FW’7\l[)C p;ltt:i{lei! ilj . IL ,lgf!rlC~ ‘,~I!t..,~ it

iii!jl!i:!+cs I\ic exdnlptiorl. To l,~le(l(.i ar7

~it:!!,~~i!,l?: m:riod lwjona [h(. periu{i

S[l:ldi<i[t,(i by WA, :i~![jlic;lrr~s n!ris!Sli:; ;r:it .,,: ,7(:;v ii[)[l~l(:ati(;n Iu ltl~ ?i~(,[l(y

f::~~(,f,.,j ,, .1..b ~<it+ app!!utirm pro(,t, duv:s

fl(;~(:r:l,v:.j irl !Ilis si, [;tif :() ~J)i)li{::{rl(,r:$

1P;.-. ( ,.. ! f .S.lk)3*:!tf., (! ~ nor l{, I.r} 7:!’.:! ith.51}( l!)it ilii c’,[;i?(tli,,:l (}f til[: [.~:.:j,[,tio!~

~J1. ;(?.!, 1. !(SS Stiit(:(! Ul}terwise (if Ikl(;

[l(~}i(.t, ~r,,r~ting Ih(: ek(:rnptiu ii.

/Ai:,p!{(;i; l( r]~ rtJ(f,i\ PLI l)t:t:yt.{rl Ir,

~:,<,r:?~ ,, ,, :,:: -1 J{’Llr bf,for~ [110(.:1(!(;[ 1~(,

exemption peii Od will he either griilltf!d

or denied by the Agency before the endof !he exemption period. Applicationsreceived after the cla!e 1 year prior to

the enrf of the exemption periorf will bt!

either granted or rfenied Lry the Agrmcy

ris soon as is feasible. .Applicants niay

not continue the activity that is the

subject of the renewal application aftet

the cfa!e of the end of the exemptionperimi.

~ 763.”175 Enforcement.

(a) Failure to compiy with anyprovision of this subpart is a violation ofsection 15 of the Act (15 U.S.C. 2614).

(b] Failure or refusal to establish andmaintt:in records, or to permit atxxws toor copying of records as required bysection 11 of the Act (I5 U.S.C. 2610) is aviohttirxr of section 15 of the Act (IsU.S.C. 2614).

(c) Failure or refusal to permit entry orinspection as required by section II ofthe Act (15 USC. 2610) is a violation ofsection 15 of the Act (15 U.S.C. 2614).

(d) Violators may be subject to thecivil and criminal penalties in section 16of the Act (15 LJ.S.C.2615) for eachviolation.

(e] The Agency r-my seek to enjoin themanufacture, import, processing, ordistribution in commerce of asbestos-containing products in violation of thissubpart, or act to seize any asbestos-containing products manufactured.imported, processed, or distributed incommerrx in violation of this subpart. ortake any other actions under theauthority of secticm ~ or IT of the act (IsU. SC. 2506 or 2616) that are appropriate.

$763.176 Inspections.

The Agen(;y will corrrflict inspectionsm?(ier suction 11 of the Act (15 LJ.S.C.2610] tcl ensure compliance wi!h thissubpart.

$763.178 RecorrMeeping.

(a) /.IIterrfoIy. (I) Each per+x>n whtr issubiect !:; thu prohil]i!irrrrs irnpowd by$ S 7K~.lti5 ftn(i 7W.167 must perform ani~iseni[)r~ of’ the siock-un-hanrf of eachbam IPIi {m>dw! :1Sof the effective (idleOf lhl? h:tr: f(~r tli;+; ;j~t,K\II/;t r(lr the

[j[;[~[i::;fl)lc activity.

[2) “{”I?v in%eiltury Sh;,l; f_I.ein wri?ingi ‘~ t}lc type uf product.<:~i({$I!,,i,f iii{ !,(,..

Iijf, vum[:(,r (If prodncl units rv.lrrertl]y i~l~lit ..;.7{:h-(1~-}l:t[ici,;f ti}c p::;w.rllp[:!f~rrtli:fg !llf: i!,},~[!t(}ry an, i liIF,!’;(’’!!:..~: (.!-Lb,; :?i)(. o.,

,,f ’~’;; t.?$~>~!ifsor ti:f! !:lf.,f~f:t[)r’vor iibiImi(:Li \JIU~M:t must iw mairltt!irlcd t]yiil[ ptf S(lil for Oyt,ars ;If!cr the effpctilc(!,:[(, of l}~t,$ 76:+.165or $ 763. iti7 I)iirl (1[1!I)t O:(}(!,:CI.

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Federal Register I Vol. 54, No. 132 I Wednesday, IUIY 12, 1989 1 Rules and Regulations 29513

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(b] Records. (1) Each person whoseactivities are su!)ject to the bansimposed by $5763.165.763.167, arid763.169 fcrr a product must, between theeffecti~’e date of the $ 763.165 or~ 713.3.10~ban On the piOdUGtand t!re$763.169 ban on the product, keeprecords of all commercial transactionsregarding the product, including thedates of purchases and sales iind thequantities purchased or sold. Theserecords must be maintained for 3 yearsafter the effective date of the $ 763.16!3ban for the product.

(2) Each person who is subject tc therequirements of $763.171 must, for eachproduct required to be labeled, maintaina copy of the label used in compliancewith $763.171. These records must bemci~~tained for 3 years after the effectivedate of the ban on distribution incommerce for the product for which the~ 763.171 requirements apply.

$763.179 Confidential businessinformation claims.

(a] Applicants for exemptions under~ 763.173 may assert a ConfidentialBusiness Information (CBI) claim forinformation in an exemption applicationor supplement submitted to the Agencyunder this subpart only if the claim isasserted in accordance with this section,and release of the information wouldreveal trade secrets or confidentialcommercial or financial information, asprovided in section 14(a) of the Act.Information covered by a CBI claim willbe treated in accordance with theprocedures set forth in 40 CFR Part Z,Subpart B. The Agency will place allinformation not claimed as CBI in themanner described in this section in apublic file without further notice to theapplicant.

(b) Applicants may assert CBI claimsonly at the time they submit a completedexemption application and only in thespecified manner. if no such claimaccompanies the information when it isreceived by the Agency, the informationmay be made available to the publicwithout further notice to the applicant.Submitters that claim information asbusiness confidential must do so bywriting the word “onfidential” at the

top of the page on which the informationoppears am] by underlining, circling. or

placing bnckets [[ ]) around theinformation claimed CBL

[c) Applicants who assert a CBI claimfur su!,n~itted iuformaticm must providethe Agency with two copies of theirexemption application. The first copymust be complete and contain allinform:ition being claimed as CB~. Thesecond copy must contain on!yinformation not claimed as CBI. TheAgency wi!l place the second copy ofthe submission in a public file. Failure tofurnish a second cupy of the submissionwhen information is c!aimed as CBI inthe first copy will be considered apresumptive waiver of the claim ofconfidentiality. The Agency will notifythe applicant by certified mail that afinding of a presumptive waiver of theclaim of confidentiality has been made.The applicant has 30 days lrmn the dateof receipt of notification to submit therequired second copy. Faiiure to submit

the second copy will cause the Agencyto place the first copy in a public file.

[d) Applicants must substantiate allcl~ims of CBI at the time the applicantasserts the claim, i.e., when theexemption application or supplemrmt issubmitted, by responding to ihequestions in paragraph (e) of thissection. Failure to providesubstantiation of a claim at the time theapplicant submits the application willresult in a waiver of the CBI claim, andthe information may be disclosed to thepublic without further notice to theapplicant.

(e) Applicants who assert any CBIclaims must substantiate all claims byproviding detailed responses to thefollowing:

[I] Is this information subject to apatent or patent application in theUnited States or elsewhere? If so, why isconfidentiality necessary?

(z) For what period do you assert aclaim of confidentiality? If the claim isto extend until a certain event or pointin time, please indicate that event ortime period. Explain why suchh: forma !imr should rermin confidentialuntil such point.

(3) EIas the information that you are(:laimi;lg as confidential bw-m disclosedto pwsolls outside of your company?Will it be disclosed to such persons in

the fature? If so, what restrictions, if:iny, app!y to usc ar fur!hm d!sdm:tre ofthe information?

(~] B1ieRY dcscl-ibe measures tti~.cn “bY

your company to Suard againstundesired disclosure of the informationyou are clai:nirrg as confidential toothers.

[:,} noes the information claimed asconfidential appear or is it referred to inildverti sing or promotional materials forthe product or the resulting end prodrict,sa!ety data sheets or other similarmateriais for the product or the resultingend product, professional or tradepublications, or any other mediaavailable to the public or to yourcompetitors? If’YOUanswered yes,indicate where the information appears.

(6) if the Agency disclosed theinformation you are claiming asconfidential to the public, how difficultwould it be for the competitor to enterthe market for your product? Consider inyour answer such constraints as capitaland marketing cost, specializedtechnical expertise, or unusualprocesses.

(7’)Has the Agency, another Federalagency. or a Federal court made anyconfidentiality determination regardingthis information? If so, provide copies ofsuch determinations.

(8) I iow would your company’scompetitive position be harmed if theAgency disclosed this information? Whyshould such harm be consideredsubstantial? Describe the causalrelationship between the disclosure andharm.

(9) In light of section 14(b) of TSCA, ifyou have claimed information from ahealth and safety study as confidential,do you assert that disclosure of thisinformation wou[d disclose a processused in the manufacturing or processingof a product or information unrelated tothe effects of asbestos on human healthand the environment? If your answer isyes, explain.

[FR Dec. &3-lfiz62 Filed 7-7-&9; 9:44 am)

E!ILLNG CODE 6S60-504