Document YrEDjKrBNNzgBEBOvaawDRq78

! r-- *rVI - - - - Wednesday July 12, 1999 PLAINTIFF'S EXHIBIT CEL-1381 I Part til Environmental Protection Agency 40 CFR Part 763 Asbestos: Manufacture, Importation, Processing, and Distribution In Commerce Prohibitions; Final Rule HNA SH STEW 1485 KMVMOMMEMTAL PflOTfCT10M AQEMCY doempartm [orruamo; no.-r*-*] Aabaatoa; Manufacture, Importation, Proneaelngi and Ofatrtbution In Wwinmv npnBnioni MMCV: Environments! Protection Acnqr. acnoac Pinal rata. aiiilir EPA U issuing this final rale tmdar aactioa 6 #f the Toxic Sobstances Control Act (TSCA) to prohibit at staged Intervals, tba future manufacture. Importation, procesaing. and distribution in commarea of aibestoa in almoit all product*. as identified in the rule. EPA i issuing thia rale to reduce the unreasonable risks presented to human health by exposure to atbeitos during activities involving these products. The rule requires that asbestos-containing products that are subject to the bans be labeled to promote compliance with and enforcement of the rale. The rale provide* that exemption* from the rale'* hu ea ssaeufeoMre. importation.' processing, and distribution in commerce may be granted by EPA in very limited circumstances. BATCS: In scoordanct with SO CFR 23-5, thia rait sbali be promulgated for purpose* of judicial reeiaw at 1 pun. eastern time on July 21 net. The effective date of this ruls is August 25. I960. except far the information collection asqObuuHts of4DCFR 7M.171 faa.174. and 762.171 These information collection requirements have not bean approved by the Office of Management and BnrigffOhg) and are not affective until OMB has approved them. EPA will issue a notice in die future estabUtag an effective data tor the information collection requirements. non marmot nmorawnon contact: Michael M. Stahl. Director. TSCA Assistance Office (TS-799). Office of Toxic Substances. Environmental Protection Agency. Rm. E8-44. 401M Street SW, Washington, DC 20450. Telephone: (202-454-1404). TDD: (20264-0651). numjMDrTAnr BNOMtATioecThe preamble accompanying thle final rale la divided briothe Mowing Units: LAaAority JLTRCA Actions to Date IfmUwdlUbk A Geeerel heeWane 1 MiaafarWra. topertatiao. sad C. Seas an Dtstribettee teffeierre aiebeitai 1 tieeintlan Apogcatiaa Procaduws "pencrtstTig, distribution in commerce. P.MMscr bnpeooa ; <Ltscdkmfa* Tr- IV. Aareaiy ofAnalysts Supporting'Als Final Rule -'* V. Regulatory Aseeaaoent A. Health Effects and Magnitude ct ~ BAor disposal of tha chemical aobstanco. or any combination of such antivitiaa. present* or will present an smreasonaol* risk of injury to human baafth or tha environment. Section Sxpoaura to Asbestoa 6(a)(1) authorise* EPA to prohibit or B. Boviroomamal Effects gak the manufacture, processing, or C Asbestoa Substitutes 0. Economic Effects of the Rule 1 Other Option* Considered F. Summary of Individual Product Cattgonta VI Other EPA Stsrules __ VO. Analysts under Section 4(a) of TBCA A Other Authoribes Affecting Asbestos distribution In commerce of substance* or mixture* if EPA finds thaI these cffvlties pose an unraasonabls risk. Section 6(a)(2) authorize* EPA to prohibit or limit such activities for a particular us* of such substance* or mbetures. Section 6(a)(3) authorizes EPA 1 EPA'a Determination Under Section 9(a) !o require labels for such substances or of TSCA mixtures. Sections 6 and 8(a) authorize VOL Enforcement IX Confidentiality X Rulemaking Record XL Reference* XIL Regulatory Assessment Ra*ulrew*nu A Extcubve Order 12291 EPA in reouire the maintenance of records related to enforcement of EPA actions under section 6. These sections of TSCA provide EPA the authority to Iseue this rule. B. Regulatory Flexibility A0I C Paperwork Reduction Ad ft. TSCA Actions to Date This rule prohibits the manufacture, import processing, and distribution in commerce of certain asbestos- containing products. The rule also requires that asbestos-containing product* that are subject to this rule be " labeled to facilitate compliance with and enjoroameoi ef the rale. PtMlc reporting burden for this collection of information is estimated to average lea* than 2 hour* annually per firm over the 3-year period reviewed for the aaalywe of regulatory burden. This twdsn estimate iaeludes the time for reviewing instructions, searching mdsting data sauces, gathering and miimitating the data needed, and completing and reviewing the codection cf information- this estimate ofannua) burden is a relatively low figureWoeaes *f the souB number of firms affected by tha ramiiaiory actions taken during the period reviewed for the analysisof regnlotsiy bwdsa. Send comments regarding this burden estimate at any other aspect of this collection of. information, including suggetticAi for ' reducing this burden, to Chief, Information Branch. PM-223. UA, Environmental Protection Agenqy. 401M Street SW, Washington. DC 2040k sad to the Office of Information and j Regulatory Affairs, Office of EPA issued an Advance Notice of Proposed Rulemaking in the Federal Register of October 17.1979 (44 FR 60061). announcing it* Intent to explore ftw use of section 6 of TSCA to reduce A* risk to human health posed by exposure to asbestos. EPA then issued * asporting rule under section 6(a) of TSCA in the Federal Register of July 30. 12 (47 FR 33207.40 CFR 763.60). to collect information on industrial and commercial uses of aabestoa. Information collected under that rule, as wefi as analyses developed by EPA and other organizations, were evaluated and used to support a proposed rule, published in the Federal Register of Jamiary 29.1986 (51 PR 3736). fa the proposed rule EPA found that exposure to aabestoa pose* an msnasonabie risk to human health and dfacussed regulatory options for prohibiting or restricting the mining and Importation of bulk asbestos and the manufacturing, importation, and processing of asbestos-containing product* a* mean* of reducing the risk. Tba following options were discussed in A* proposed rale: - 6. Two options involving bans of some products soon after promulgation of the SmI rata and a phase out of others over Ig years by means of a permit aystem Management and Budget Washington. far asbestos us*. DC 20503, Attention: Desk Officer fv' >' A A 2-stag* ban. with A* first ban. on EPA asbestos ooostraction products and -'Nothing, to begin soon after I. Authority promulgation of As final rale and Ae Section 8(a) of TSCA authorises EPA" abroad ban. on Motion products, to to Impose certain regulatory t- baffn A Syeats. and after promulgation requirement* on actirlBa* Avolsfagn ' rgftbcAral rale, tha collection of chemical substance or mixture ff&A *TV ^yftitftmA date on other product*. find* that there ia a reasonable barista " - rj. A Pipage baa on all asbestos conduda that the manafaCtare. J'ppafatfls to begin toon after the HNA SH STEW 1486 raacrxj Register / Voi K Mo. in / Wednesday, July L2. 1969 / Rule* and Regulations 2S481 promulgation of the final rule, and I yean and 10 year* aftar promulgation. Requiring labeling of asbettoscantainln| product! waa aiao discussed. HPA received over 200 comment* In reaponaa to the prapoaed rule. Prior to issuing the propoaal. EPA received and granted two TSCA section 21 petition* (IS U.S.C. 2020). Under action 21 of TSCA. a peraon may petition E3*A to inidate a proceeding for tha iaauance of a rule under varioua sections of TSCA. One peddon requested the prohibition of the future aaa of aabeatoa in aabeatoa-cacent pipe thia petitiod waa granted in the Federal Retfetar of October 18.1979 (44 FR 80155). The other peddon requested the prohibition of the future uae of aabeatoa in motor vehicle braker. thia peddon waa granted in the Padaral Ragiatar of Decambar 111964 (49 FR 49311). In granting there peihtiona. EPA atated that It would, at part of the rulemaking proceeding and the final rule, conaider including prahibidona of the future uae of aabeatoa In aabeatoa-cement pipe and in motor vehicle brakea. Both uaea are prohibited by thia final rule. Purauant to aection 6(c)(2) of TSCA. EPA alao provided interested parties opporiunides to participate in a legislative bearing on the prapoaed rule in July 1981 and in extensive aosa- xamiaation of EPA personnel and contractors on factual issues relating to the rule in October 1981 Since the end of cross-examination in October 1981 EPA has updated the data collections and regulatory analyees uied to support the findings on which this rule U baaed. EPA believes that adequate daU and analyses existed in the rulemaking reoord for the propoaal to support the options discussed therein. The data collections and analytes were updated due to the passage of time since the publication of the propoaal and in response to specific public comments that the data bate supporting tha proposed rule, gathered largely in 1962. waa outdated. EPA has gathered updated data relating to: (1) Aabeatoa consumption. (2) manufacturing, import, and processing volume* of asbestoeoontaiainf products. (3) trends in the development of non-asbestos aabatitnte*. (4) costa of capital ooovarelon to the production of nooaabaatoe product^. (5) production, processing, us*, and disposal practices far asbestos-containing products, and (6) occupational and non-occupational releasa and exposure from the manufacture processing, installation, see. repair, rereoval, end disposal of aabeatoa containing products. These data were derived from, among other ources. (he 1987 EPA Asbestos Exposure survey, tha 1987 EPA Asbestos Market survey, end 1967 Occupational Health and Safety Administration (OSHA) complianct data. EPA ha* tlso modified and updated its Asbestos Regulatory Cost Model (ARCM). Health Benefits Model end asbestos exposure models which were usad to evsluate the coat* and benefits of various regulatory options. Additionally. EPA has furthered its analysis of the evailabiiity and possible hazard* posed by asbestos substitutes. . These updated data and analyses were reflected in documents released for public oommant in notices published in the Federal Ragister of April 1.1988 (53 FR 10548). and May 4,1988 (53 FR 15857). EPA received over 40 public comments In response to these notices. In addition. EPA allowed further crossexamination of EPA personnel and contractor* on factual issues related to the updated analytical data bass in September 1988. The materials released for public comment contain tha technical basis for tha actions taken in thia final rule. EPA afforded the opportunity for public comment on the updated documents and far further cross-examination as an exercise of its discretion and as a means of ensuring that any remaining disputed Issue* of material fact la the updated data and analysts oould be identified and resolved before promulgation of thia final rule. EPA has reviewed tha commenta received and the testimony alidted and has updated the record accordingly. Purauant to its procedural rules at 40 C7R 750.4(b), EPA alao announced to tntarestad parties in tha Federal Ragiatar of September 16.1968 (53 FR 36227). the opportunity to provide EPA with reply commenta relating to the rulemaking proceeding. EPA received reply comments from three commenters. The record which serves a* the basis for the action* taken in thia rule consists of over 45,000 pages of analyses, oommenta. testimony, correspondence, and other materials. The record for this rule also incorporates by reference the extensive record developed by OSHA in its rulemakinf to lower its Permissible Exposure Level (PEL) for asbestos, published In the Fedaral Reglatea of Jane 2a 1966 (51 FR 22812). EPA he* My considered these materials In developing thia final rule. In addition, all significant testimony or public comments mad* an the proposed rule, in conjunction with the legislative hearing, croaa-examination hearing, or reply comments, or in reaponaa to the material* announced In the April and May 1088 Fddarel Ragiatar notices, cited abova. ware considered In tha development of the final nil*. EPA'* responses to all significant comments are found either in this preamble or m a separate Response to Comments document that is available in the Public Docket (Ref. 40). Based on the numerous detailed nalyse* performed by EPA in support of this rule end after careful consideration of the extensive public comments received. EPA has concluded that the continued commercial manufacture, import processing, end distribution in commerce of the products identified in this rale poses an unreasonable risk of injury to human health under section 8 of TSCA. m. Provisions of the Rule A. General Provisions Consistent with an option described In the proposal, this rule imposes s 3stage ban on the manufacture, importation, processing, end distribution in commerce of various asbestoaconlaining products. The rul* also contain* a requirement that products subject to a manufacture, importation, and processing ban. but not yet subieet to ban on distribution tn commerce, be labeled tn the manner described at 1783.171, In addition. the rule include* procedure* for requesting an exemption from the rule's provisions. Tha effective dates of the various bans are aa Mow* (with exceptions as noted in Unit 1113 of this preamble for some asbestos friction products): Manufacture. Import and Processmg Ban: Stage 1--August 27.1990 Stage 2--August 25.1993 Stage 3--August 28.1996 Distribution in Commerce Bun: Stage 1--August 25.1982 Stage 2--August 25.1904 Stage I--August 25.1987 B. Manufacture. Importation, and Processing Bans As of the dates indicated below, the manufacture, importation, and processing of all asbestos-containing products within the categories listed must cease as follows for tach stage: Stage 1: Manufacture, importation, and processing of tha following product* most oaaae by Axgust 27.1980: Flooring Pelt Roofing Fait Pipeline Wrap Asbeatas/Cemanf (A/C) Flat Sheet A/C Corrugated Sheet Vinyl/Asbestos Floor Tile Asbestos Clothing HNA SH STEW 1487 t v^otai wym < vot. *. no. m i rreqoeaoay, July 12. Ides / Riue* aoc Keg ~a thins Stagt t Mwiiom faaponatian. and processing at fra teBowtag pradocto meat cross by Aagnst ts. ltnr rotro-AddCafretsjexoapt specialty indurtrial gaskets) Shrot Crokrt* (except specialty Industrial gaskets] Clutck Fdas Automatic Traroadsslixi Components Commercial md iadustrial Friction frstfrrati Orua Broke Linings (Original Equipment M*rfc*t(0M)| * Disc knits Pads far Light- and Medium- waught Vehsoto* (LMV) (OEM) * State t Maaafactuis. importation, and processing of tbs foliowing produets must cease by August IS. 19BS: A/C Pips Commercial Paper Corrugated Paper Rollboaid Millboard A/C Shingle Specialty Paper Roof Coatings Non-Roof Coatings Brake Blocks Drum Brake Linings {Aftermarket (AM}] Disc Brake Pad*. LMV (AM) Disc Brake Pads. HV (AM) in addition, any new aabaatoacootnining products for which oomanarctal manufacture, importation, or processing is Mbatad aftar the effective dale of this rule will be banned as of the affective data of Stage 1. unless EPA approves the use or product pursuant to an axemptioa application. In other words, if a person devises a new application for aabestoe that is not covered by the product categories defined in this rale, and the person wishes to commence commercial manufacture, importation, and processing of the product after August 25.19*0. manufacture, importation, and processing of tarn product must aeaae by August 27.1900. and distUbatwa io commerce of the product must aeasa by August 25.1902. Those bans oo manufacture, importation, processing, and distribution in oaamaroa may be avoided otdy if a person appbro to EPA for an sumption from the bane and the application to granted. ih*simtaiM arfas asSsI rsargstteu ssa r to a fmtatm la Octsbsr. nay be msS Is vaSMss ft *at prates* briars tbs tarotetes si odd iwiaw--Sirti nOcwfcsmm.ua--i igant hr InUi. <nn. tosoaiWa. rag rnrsulss m sf Asfwt as. isas. Pursuant to section l^eKI). SPA Bade fret the aieaufeetura or procroaing far export of fra asbestos-containing products fret art subject to this rale wfli prosent an anreasonable risk of injury to human health. Therefore. tfaa aianufactura and procesting of the oabostos-cmtatiting products for export is net exempted from this rale under section 12(sKl). and is subject to this rale's bens on manufacture, processing, and distribution in commerce bans. Much of the life cycle and a significant portion of risk posed by export products occurs in the United States. The most significant source of exposure that could be quantified by EPA for this rale is primary and aacondary manufacturing. During primary manufacture asbestos fibers are Introduced into the production prooeea. During secondary manufacture, an asbestos fiber-containing component Is used. EPA has concluded that these activities cause significant occupational and non-oceopstional exposures to workers and their CamHiee. populations surrounding plant rite*, and the general population. In tight of the high individual risk caused by exposure to asbestos. EPA has concluded that expuaures due to manufacturing or processing of these aabestoe-oantainisg products Tor export pose an unreasonable risk of Injury to human health In the United States. BPA hat not found that asbestoscontaining products imported into the United State* for the sole purpose of shipment to another country pose an unreasonable risk. Therefore, such activities are not subject to this rale's bans. However, for the reasons described above, imported products that are repackaged or otherwise processed tn the United States before shipment to another oountry are subject to tbe rule's bans. ' The proposal would hove exempted the import of imall quantities of otherwise banned asbestos-containing products for personal use from the rule's bans. EPA reoetvad comments indicating that many new automobile* are imported by individuals. However. EPA is ascertain about the extent of any risk reduction that would be achieved by a ban on these activities. Therefore, the final rule's ban on importation exdudes the act of bringing small quantities of artidae brio the United Statu for normal personal or business activities (not inrlnHiwg distribution of aSbestosaoptafarfng products in commerce] tnvoiying the use ofa banned product either alone oras a component orpart of larger object. Shnllariy, tbs definition of Import exehsde* activities such a* (he movement of outomoMes with asbrotoa-omttaMag products as Integral parts of the auto, tea and forth across the United States border during the norma! coune of personal or business activities. The final nil* bans the Import of products that in purchased or otherwise acquired outsids of the United Statts for the sole purpose of resale. For example, after the affective date of the ban oa OEM brake pads, a 1994 er later model year aulomobrla con taming banned ssbrotos-ooatainiAg part* cannot be purchased in Canada or another country and be transported by a perton to the United Stales for resale. However, the ml* doe* not ban the impart by a person of such a vehicle for personal use in the United State*. For purpose* of snforcing this provision. ERA will consider s vehicle to be Imported for personal tsa if the person importing the vehicle imports no mors than on* vehicle containing banned product* every s years. H a person import* a vehicle more frequently, EPA will presume that the activity is subject to the rule's bans. Other activities that ars excluded from the definition of import include driving across the US border in a 1994 or later model year automobile containing banned products during the course of transacting business or far rscrtsOousI purposes, or purchasing a used fie, pre-1994 model year) vahicl* containing asbssto* brakes in another emmtry and transporting tt into the United State*. C. Bobs on Distribution in Commerce Available evidence shows that the release of asbestos fiber* occurs not only in the manufacture and processing of asbestoa prodacts, bat also in their use and maintenance. EPA proposed to ban actvine* Involving asbestos product* because of this Ufe cycle risk. The proposed ban also implicitly would have prohibitad the aventnal distribution of these products is commerce because persons would not be permitted to manufacture. import, or process asbestos products. Consistent with the intent of the proposal, this final rui* explicitly prohibits the distribution in commerce of asbestos products within the specified timeframe after manufacture, importation, and processing bans for the products become effective. The time periods far distribution tn commerce ware established to afford affected parti** saflldent tin* to tell existing stocks and tbarefora Emit the likely economic impact of tbe ban. This was done after balancing the likely risks presented by oonttnued use of asbestos products with (he acaaomic impact of an outright ban on this activity. A* stated above. (his ruk bans the distribution in commerce of asbestos ti HIMA SH STEW 1488 r*4*al Easier /VilHfaia / WtAnfar. Mr li / Kales aad Kegalaffnsm irir,` irr **---------- ifirTiin Imf sruthm and processing baas far fa prod-- become affective. The baa oi rilasrihurtsa fa commerce far products sublet to the Slag* 1 manufactur*. Importation. and processing bao will became effective as August 23, 18B2. For Stap z product!, the bao on distribution to commerce orill become affective oa Aq--tgS, 1804. For Stag* 3 product*, the baooo distribution io commerce will became effective oc Angus! 23, ISB7. Remaining "etock-on-band" of an affected pcnrlart must be diapoead of within emaathe of the affective date of (be baa ao distribution la commerce Bwnainir^ stock* iicbide nil uatla at fa product In the possession or control of the penon tubject to the dietcibution in commerce ban. Disposal must be bp meaae that are la compliance with applicable local State, and Federal restriction*. The nile'i dietribuliaa ia commerce ben doee not cover ell ectkme taken with respect to aahntae-mntnining producte. Fee puipoaee of the rule, the term "distribution in commerce*' doee not cover end nst activities. for example, sale, resale, bedding, or delivery, with reaped to asbestos products by persons who ui the predact after It is manufactured, imparted, or processed. For example, the tens "distribution In commerce" does not include the meals of homes or motor vehicles that contain asbestoscontandng parts or products or the instaUetiea of aebestoo-oontaining brake pate in a paraoa'a automobile after the distribadoa in comperes of each brake pate is banned. (Htwsevar. Miss violation of Airrule far a person to engage la setting brake pads to anyone.) Tbits provision also does mot cover (he disposal of aabeetoe-coataining products. ETA recognises that some asbestoscontaining prodacts i4arh are eedaded from dm barn may be vary mmdar in form toed--iwiniWInwy p"wW that ass bamrod. Far snoopW. this rale's barm do aat cover dm manafaetsra. imported-- procamtag. and diatribothm in coassnsrot cf Ugh-grads electrical pepac. ^ndurt whscb may be ahnfler in to afUbomd or otem evrla dad pasdodte far uses lha< are banaad.ffate activities seoald vioiasa this min's bans be-- tote eon-teas of use wfll he ksampreSod by Q>A to be pmaaiag ar disSribatMB ia camraeme of toe banaed prediirte The daffatioss cffeecaeafag--ddieteCiatioBln Wepprated by SPA as amor activities which tnvaiva the eoovsrsioa at --"*-1*4 sshasda naiiihihsprrularts tO D. Labattng Products tool ass mbjact to a --root ~r future haa a* taanafiirftrinf processing, Impat. ar diafctbubon la comment matt be labeled es follows: Notes This predxi contains ASBSSTOS. Tbs US. Bufcaaaantri Aataettae Agaacy has bud lbs tetebaftoa ti US rimrswre af this product mteraae-- S at dw Tame Substancaa Control Act fit (JL&C.JB0Si a of (insert the effective data of has cn distribution In commerce). BuributWjc of (hi* prods'* to unuumes after fltis data snd iataiBanatiy isawvtef or tampering with ftrte fated aaa rthterlam afFederal hm. The purpoaa of this labeling requirement Is to fadfitete efforts by manufacturer*, importers, processors, snd distributors to comply with this rule's baa and EPA's efforts to enforce the rale. Labels most be applied by merafacturen. importer*, snd processors to specified products produced after the dates listed below, and to all stodr-on-band of these products in their possession or control at that time. The effective date* of the labeling requirement are a* follow*: Products twanad n Stag* 1_____ J Ai 37.1900 Product! banned Si Staga X. tu j Aug 24, 1*92 aftamartat 4k and aum cr*K J pTOttiCQk I AS o*ar praduro Uamad a team i As 2i taaS 1 Therefore. --imfectmir.importer, or processor of product banned In Stage 2 must label all stote-en-hand of the product a* sf Aagnet 23. itu. as vrol ea any tortbar stock of toat prodaot maredachwwd. Inqsmisl or pruotaaod after that fata, ftadacts mast be labeled at toe tames todfoeted to eaeare toat a date of the maaoiectes, importation. or processmg bans are labeled to fecRttet* enforcemaaal emd oqmpksnoe efforts. Asbettos-costtestog brake pads, drat brake Mteagt amd brake Modes must be labeled eariter toaa other producte becaue af fa saMvely tang potential ahaif bfe of brake prodact* and to facilitate oamphaooe with toe two pelt MB OI HMUI > WOB inXlBO^ For purpoaea of this labeling reqteramart. "atock-oo hand* siisw ell unite of the prodact te toe puaeAmluii or contest af toe amaafectmar, importer, or pnctHteflbbtodH ^odacte stored by e aspmate oo--nareisl aattty.bat still sritbte Ifw toredtoa or oontrol sf (he aamfsi-tw . testates, or processor. Maiwfectorvrs. Impwters. tod proceseors most Insert in toe label they apply to their products toe effective date of the baa on dletribslhre to commerce for toat prodact. Libels irest be ffspleyed prominently on product peckegtog. s* described below. Labels must be either ptkited on product packaging or in the form of either a sticker or teg made of toastie, paper, metal, or another durable material and aecurely adhered or attached to product packaging Label* must be securely attached so that lhay cannot be removed without being defaced or destroyed. They must be written in Ei^lisb to block tetter* and numeral*. TexI to other languages is permitted In addition to the English language text. The color of ihe taxt must contract with the background of (he label. Labels must be applied in visible location on (he exterior of the immediate packaging in which i product is distributed In commerce. However, if the product packaging has no visible surfaces larger than S square 'when & person subject to (he labeling requirement must either secilrsly attach a tag containing the required language to the product packaging or must label the next exile* container in which the smaller wrapped products ere packed for storage, transport, or distribution. Labels must be applied directly onto products which are stored, skipped, or distributed to coomwce without packaging or wrapping. However, if a product te otherwise properly labeled and is removed from the properly labeled perIraging only whan distributed to the and user, the product doe* not need to also be Ubried directly. Compliance with (hetebeltst requiremnab of thie rate does not fulfill labeling regain--ms astabbxkai mda the Federal Hazardowe Snbstances Ad (FHSA. 15 U-iC tll E- Exmpticm Applicaliae Procedures EPA belieres that exemptsoas from the rule's bans on future nwnufectnre. importstine. p-"-~and dutnbaocn in nwnmeroe wiii fail mao two different categories, to-- tovnteiag existing asbestos-containing products or exwtuig useeef oebesaos teprodooteend feoae invofvtag aam a-- of aebeeto* to products or aew eebetea* prodacts- Tht* nds pradki tee ^ipraucnes to obtaining an raaploi from these ban*. EPA haa already determined that activldaa invaMag moat asbesloacontaining products present unreasonable risks aif to(ary to human bealto. Therefore, pioeadures to (he ftsel HNA SH STEW 1489 tmi Jfafcfl KagUttr / VQl St No. ia> / Wednesday, }uly 13, tM / Kales and Hesitations applications Involving manufacture, importation. procatsing. tad distribution tn eommarca o/ asbestos-containing products In categories identified in this nils or uses of asbestos in these product* plac* the burden upon the applicant to show that ha or aba 1m* mad* dtaonatrable food faith effort* to develop aubafltute* for it* product and that granbn* tht exemption will not result In an unreasonable risk of injury to human health. EPA la uncertain about the fact* and cirraimtnce`that will attend any potential exemption involving new asbestos-containing products or new use* of asbestos. In view of this uncertainty about these product* or use*. EPA believe* that it la appropriate to employ a different process for reviewing exemptions for new asbestos product* or uses. Thus, requests for exemption for new product* or uses will be treated e* e petition to amend this rule pursuant to section 21 of TSCA. Such petition* should comply with the procedure* of section 21 end contain, at a minimum, the type of information set forth in this final rule for exemption applications. The remainder of this Unit discusses general exemption procedures for application* involving products identified in the rule. Exemptions for military uses are discussed in Unit m.F of this preamble. 1. Information requirements. This provision allows that EPA will exempt products from the rule's bens if an applicant can show that the activity described in the application will not result in tn unreasonable risk of injury to human health end that the applicant has made demonstrable good faith efforts to develop substitutes that do not pose n unreasonable risk. EPA will balance the various information received in an exemption application in determining whether the applicant has met the criteria for granting an exemption. Applicants far exemptions must submit to EPA data or discussions addressing each of the following itsue* regarding their product a. Data demonstrating the exposure level over the Ufe cycle of the product that ie the subject of the application. b. Data concerning: i. The extent to which noo-asbestoa tubedtotes for the product that is the subject of the application fall significantly abort in performance under necessary product standards or requirements, including laws or ordinances mandating product safety standards. it The costs of non-asbestot ubetitolas relative to the oosts^f the asbestos-contabling prodsct end. fat the case in which the product Is i component of another product the effect on tbe cost of the end use product of using the substitute component lii. Tbe extent to which tbe product or use serves s high-valued oss. c. Evidence of demonstrable good faith attempts by the applicant to develop and use a non-asbestot substance or product which may be substituted for the tsbestos-contsinmg product or tbe asbestos in the product or use that Is the subject of the application. d. An explanation of why the continued manufacture, importation, processing, distribution in commerce, and use. as applicable, of tbe product will not present an unreasonable nsk of injury to human health. Exemption applications which do not contain these items of in/ormstion and the other information required under f 783.173(d) will be considered Incomplete and will be returned to the applicant without further action by EPA. Exemption applications that sre returned as incomplete can be resubmitted with the additional required information. The resubmitted application will carry the resubmittal date is the date of receipt. 2. Procedures for submitting exemption applications. Exemption applications cannot be submitted for products subject to the following bans before the dates indicated, as follows: Manufacture. Importation, and Processing Stage 1--August 2S. 1988 Stage 2--February 28. 1992 Stage 3--February 27,1993 Distribution in Commerce Stage 1--February 2& 1990 Stage 2--February 28,1993 Stage 3--February 26.1996 EPA believe* that because of the ripid development of asbestos subsmvnes. decisions oo exemption applications made before these date* would be premature. However. EPA will consider, if appropriate, arguments made for an exemption from a ban on distribution in commerce for t product at tbs time and applicant submits an application for an exemption from a manufacture. Importation, or processing ban. Exemption applications must be addressed to: TSCA Document Processing Center (TS-790), Offioa of Toxic Substances, US. Environmental Protection Agency, 401 M Stmt SW. Washington. DC 20400. ATTN: Asbestos Exemption. i. EPA levies* and decision. S'A't review periods for exemption applications for existing products will vary, depending on the timettneee of their submission end the edeqnecy of the data that Is submitted. If s complete exemption application is submitted more than 1 year before the effective date of tbe applicable ban (or month* before the effective date of tbe ban In the case of Stage 1 manufacture. Importation, end processing bens). EPA will complete its review of the spplication and issue Its decision prior to the effective date of the ban. If E?A fails to meet this deadline, the applicant will be granted an automatic extension of up to 1 year, or until EPA decides whether to approve the application, during which the applicant can continue the activity thst is the subject of the spplication. EPA will render it* decision during the extension period. For example, if s ban becomes effective or. September 1.1994. an exemption application for a product subject to thst ban cannot be submitted to EPA before March 1.1993. To ensure a decision by EPA on an application before tbe ban's effective date, tbe applicant must submit the application to EPA before September 1.1993. If tn exemption application is submitted lets than 1 year before the effective date of the applicable ban or after the ban. EPA will issue s decision as soon as is feasible. The submitter of this "late" application must cease the banned activity at of the effective date of the ban unless EPA grants the exemption. For example, if a manufacture or importation ban bacomet effective on September 1.1994. and an application for product subject to the ban is received by EPA on April 1.1994 EPA will render its decision on the application as soon as is feasible. If EPA has not rendered t decision granting the exemption by September 1.1994. the applicant must cease manufacture or importation of tbe product If EPA denies an exemption application before the effective date of a ban. the applicant must cease the activity as of the effective date of the ban. or within 30 days after receipt of the denial if it it issued less than 30 days before the effective date of the ban. U a denial is rendered during an extension period, the applicant must oeaae the banned activity within 30 days after tbe issuance of the denial. For gvwp1* If the effective date of s ban It November t, 1981 and EPA renders a denial on funt 1.1984. the activity must caste by November 1. 1984. U the effective date of the ban is July 1.1994, and EPA renders a denial on june IS, 1991 the activity must caste by July IS, 1994. Further, if an extension period runs until December 1.1994. end I i y Eihtliti ill U HNA SH STEW 1490 Todsal Eagister / VoL H So. XSS / Wednesday. july a, IJW / Pule* sad Begulitinu* 39445 EPA lam denial on ]a* 1 IBM. ft* these risks by banning fte futare tee of activity most era** by Jutytisw. ashettos In many products la U The time frtma* discussed to ft* oocnmera*. Therefor*. exemptions will preceding paragraphs fbr EPA'i review be granted by EPA only fttnose of exempt]ub educations do not apply Instances where a dear showing la to eppBcrtlon* pertaining to new uses of made by an anplicant that the activity asMitua. Applications for new dki wIB described In fte exemption application b* subject to fte dratflinei fbr EPA meets fte criteria set out In (his review end decision specified hi section preamble end rule.The criteria require 21 of T9CA. the applicant to demonstrate that fte Oboe tecafot of a complete exemption activity described In fte application will application. EPA wffl (true * notice in not result in an unreasonable risk of ft* Federal Register announcing receipt injury to human health end tbit the of fte application and tartiinj applicant be* made demonstrable good oommetAa. ERA wfll oonaider any faith efforts to develop substitutes that commasto received ta determining do not pose a unreasonable risk. S*A whether ta fiat cr deny fta believe* that these criteria are applicatiea. 1PA may roquest further consistent with the finding* to this rule, information from the applicant to aaaiat yet provide applicants an opportunity to in datermtaiaf whether ft* iiwptioe demonstrate that they are emitted to an pptfawrtno Mete fte rale's criteria. exemption ta oertato non-routme Mftaa daayftf n applicaboa. IPA drcnmetanoaa. will and fte appttcaat copy of fte EPA'* evatastion of exemption deeiai via tapatnd wad. Ibis writttn application* will involve a balancing of denial ii a Anal Aguxj action far a amber af factors which go brio purpoeee of fadKiai tmritw. determining whether fte exemption IfSPA pnpoeaa to mat m criteria heve been met Thee* tactore appliestloa. EPA eedi iaene a aoticc ia include fte wettability af euitabte ilia Federal Bagiitar reqai itiiq substitute* end the feasibility of ootanMDU oa Me proposal or the substituting for asbestos in the prodert. sidaraas-- of e^pleaanUry asbestos exposure risk* posed by fta information. EPA will cnthior aay continued nee of fte asbestos product, commeata roosted wfraa prepense It* whether the asbestos use ia a high- final docHioo. A Aaol of oa vetoed am. aad ft* effort* af ft* axomptioa appliratina will be toaund by applicant to develop sebstitxto*. SPA Fedaaal Bofiatar notice and. likewise. U will gni aa aoaeetpdon only after a final Agracy dariaioa for purpose* of careUiy balaiu-iig all the lectors Judicial rvvirw. the notice will elate the presented ia an application. The length af the a--npixia period granted paragraphs that fallow provide by EPA. In addition, if an application ia guidelines which EPA eiifi follow hi approved. EPA may notify the applscaal applying the aboes-etatod txwapt-- that fta labeling naqaaramaate af criteria awfctog dene--s an 17BU71 have bon stayed nt2 a later exemption appheettoae. data fariiraSeri by EPA or often--* Generally. B>A da** aot ietand to modifiad la fta exemption application paot exetaptkau to applicants who are approval T.miyitM renewal application# merely --king to avoid tbetr ehere of fte Boats imposed by ft* ertmna taken cannot ba submitted earlier than IS to this tola. Ala*. EPA doe* aot totead to months before the end of the exemption great axemphoa* that wesld iaftdinitely period, unless to allowed Is fte notice extend fte see ef asbesto* in product*. granting fte original exemption. Notice* EPA ha* concluded that exposure to received between IS months end 1 year aahaatna during ft* life cycles cl fte before fta end of fte exemption period product* that are subject to this rule will be panted or denied before fte end potes an anreaaaneble risk of injury to of fte exemption period Renewal human health. Therefore. EPA doe* not applications received thereafter wtO be intend ft grant exemption applications granted or denied by EPA as soon as ia that are baaed solely on the rational* feasible. The activity that ta fte tubjed that relatively low levels of exposure of fte renewal application may not exist because exposure lavals may be cantina* beyond the aiglnal exnirption only oo* of eaveral factoa balanced in period mites BPA grant* the renewal. detominiag whether ft* uaa described in 4. Facton ccntidend in rrofuming an exemption application would poa* an exemption appkaatiaao. SPA has unreasonable dak. EPA has also Found concluded that fte future manufacture. that auitabla noo-aabaatousubatihiiaa Importation, pmrrashtg. end distribution exist for most seas of asbestos. in commerce of moat aabaatoa- Therefore, ff a aoo-aabesto* subatihile containing prodnt^ rescdts in an exist* for a product and lain ua* by oo* unreeecmMe rtek oftnjoy to hmsaa or mors of ft* producem in ft* market health.The ml* mb fte elimination of for ft* product EPA doe* not Intend to rant an axampdoo to on* producer baaed oo ft* cost or difSouby of modifying Us product-- procew *r af setting up a supply system for chanting the subaittui*. EPA has. ia eeabkahu^ the effective date* for if* bant, afforded sufficient time to allow producers and distributor* to develop and unpiement transit-- pleas. Therefore. EPA does not Intend to grant aa exemption becaua* an applicant has yet to purchase the oeoeesary equipment, to eet up system* of wuppiy for substitute*, or to ataka other trartaiboo plan*. Abo. ETA doe* not intend to pant or renew a exampooti if fte eppbcxnt has failed to make a tangible, documented effort to identify, develop, and use suitable ncm-asbestos tubsututee far fte product which is fta anbjad of fte exemption applies non. in addition, EPA doe* not intend to grant an exemption aterely because using a rabetitste t* somewhat more oasdy in fte production of a product than aatog asbeetoe. Howe rot. EPA mey grant an exemption tor an existing eabeetos product If. to addition to other factors a won-aabeetoe substitute fbr the product bei not been developed or adopted, despite fte best efforts of fte requestor. or If available substitutes ere umeeeoneWy expensive to purchasers. F. Military Exotoptmat EPA and the Department of Defense will develop Memorandum of Understanding establishing mediantsms for dealing with asbestos-containing products used for military purposes Along with fte uitena tor considerstine of general exemptions described in fte preceding Unit coneideration wit! be given to the military nature of such nses and the mission of fte Deportment of Defense. EPA and the Department of Defense will jointly develop procedures fbr exemption* from this role for asbestos-containing products used for military purposes. C- Reoortbeepms To ensure compliance with this rule, and to assiat enforcement efforts. EPA is requiring under fte authority of sections 0 and 6 of TSCA that all manufacturers. Importers, and processors of certain asbestos-containing products keep records. Section Ra) provides broad authority for EPA to require manufacturer*. Importers, and procaaaora ftkaap record*. Section 8[a) exempts small businesses from reporting in certain cates. However. EPA may require manufacturer*, importers, and processor* af a substance subject to a nil* under section 6 of TSCA to maintain records. Sine* asbestos ia " HNASH STEW 1491 29468 Federal Register [ VoL 54, No. 152 / Wednesday. fj> 15. !Sd9 / RJoi -. .. -'.-.zi already subject to rule* under section 8 end is alio subject to this one. the email business exemption of section 8(a) would not apply. EPA believes that these recordkeeping requirements represent very little burden and are necessary for the enforcement of this mla. EPA also has authority under section 6 to require recordkeeping and reporting related to tha other regulatory requirements Imposed by EPA under section l in this case, section 8 provides tha authority to apply the recordkeeping requirements to distributor* of asbestoscontaining products who are not also manufacturers, importers, or processors of these products subject to section 8(e). EPA hss used this section 6 recordkeeping and reporting authority previously in Its polychlorinated biphenyl and asbestos rules promulgated under TSGA section 6 in 40 CFR Parts 781 and 783. 1. Inventory. At of the effective date of e ban on manufacture, importation, or processing, all manufacturers, importers, and procaaaora of products subject to tha ban must taka an inventory of their stock-on-hand of tha banned products. This inventory must oonsist of a count of the number of product units in stock, in terms of the unit measure or form in which the product is used or sold, and the location of current stock. "Stock-on- hand" covers ell stock owned or controlled by the manufacturer, importer, or processor. This includes stock in a storage location owned by the person, as well as stock in storage locations owned by others if the stock remains within (he direction or control of the person. Results of this inventory must be retained by the manufacturer, importer, or processor for 8 years after the effective date of the ban. The purpose of this inventory is to serve as a baseline for EPA'a enforcement of the rale's bans on manufacture, importation, processing, and distribution in commerce. Inventory results will be compered by EPA inspectors with the business records maintained under 1783.178(b)(1) to determine compliance with this rale. 2. Reconit. Manufacturers, importers, and processors must maintain a copy of all labels used in compliance with 1783571 for 3 years after the effective date of the ben oo distribution in commerce to which the label applies. For example, tf the label la required for a product bemud from distribution in commeroe as ofOctober 1.1962, the records regarding the label must be maintained until October l, 1995. 'Manufacturers, importers, processors. ' end those persona aubjaet to bans on distribution in commaroe'must maintain normal business and sales records recording the dates and quantities uixbasad of eD products subject to ani. These records must be maintained for transactions from the effective date of the manufacture, importation, or processing ban for a product until tbe effective date of the ban on distribution in commerce for the product These records mu., .r maintained for 3 years after the effective date of the ban on distribution in commerce for a product. For example, if a manufacturer produce* an asbestos-contaming product that if subject to a manfacture ban that takes effect on September 1. 1993. the manufacturer mutt by that data, make an inventory of the stock-onband of the banned product as of that date. A record of the inventory must be maintained until September 1.1996. The manufacturer mutt alto keep records of all sales or transfer* of the product between September 1.1993. and the effective date of the ban on distribution in commerce (for purposes of this example, September 1,1964). These records must be maintained by tbe manufacturer until at least September 1. 1997. IV, Summary of Analysis Supporting This Final Rule EPA's basis for this rale, as described in the proposal remains largely unchanged. EPA's unreasonable risk findings under section 8 of TSCA are based on extensive data gathering, modeling, analysis, and review of public comments. EPA's findings are summarized briefly in this preamble. This preamble also addresses significant public comments raised during the course of this ralemaking. EPA has addressed other comments in a separate Response to Comments document, which is incorporated by reference in thia preamble end la included m the public docket The following documents are also contained in the public docket end terve ae the primary, although not exclusive, basis for th* action* taken in this rale. 1. Regulatory Impact Analysis, EPA. 1988. This document analyzes tbe coats and benefits of various options for regulating tbe ritks of exposure to asbestos. and indude* an analysis of available substitutes for aabeato*containing products, a regulatory flexibility analysis, and material* on tbe models and computational procedures eaad. survey result*, health affects and studies, costs of converting capital equipment from aabeatos-uaing procelli*, tha producer surplus lo** determination. economic impacts data and analyses, tnd sensitivity analyses. 2. Three documents evaluating the magnitude of potential route* of human exposure to asbestos: () Atbettot Exposure Attessmenl. EPA. 1988. This document analyzes the occupational exposure to asbestos end asbestos releases from manufacturing plants and commercial operations in the U.S. (b) Asbestos Modeling Study, EPA. 1988. This document analyze* the ambient exposure levels resulting from the release of asbestos to tha atmosphere from industrial and commerical sources. (c) Non-occupational Asbestos Exposure Report. EPA 1988. This document analyzes the level of consumer and ambient exposures to asbestos. 3. Three reports evaluating the extensive data base on human health hazards posed by asbestos: (a) Airborne Asbestos Health Assessment Update. EPA 1966. This document was prepared by EPA's Office of Research and Development and was reviewed, critiqued, and updated in response to peer review comments from tbe Environmental Health Committee of the EPA Science Advisory Board (SAB). The SAB advises the EPA Administrator on scientific matters. (b) Report to the U.S Consumer Product Safety Commission by the Chronic Hazard Advisory Panel on Asbestos. CPSC 1983. This document was written by a panel of seven scientists selected by CPSC from t list of nominees by the National Academy of Sciences after a nationwide solicitation. (c) Asbestiform Fibers: Nonoccupational Health Risks. National Academy of Science*. Committee on Non-occupational Health Risks of Asbestiform Fiber*. 1964. This document was written by an expert panel of 13 members. 4. Health HazardAssessment ofSonAsbestos Fibers. EPA 1988. This document evaluated the potential hazard posed by major non-asbestos fiber substitute* for aabeato*. This document was baaed in part on Recent Epidemiological investigations on Populations Exposed to Selected Non Asbestos Fibers, 13*A 1968. OtheT material* used in the development of this rale are died in the text of this preamble and listed in Unit XI of this preamble. V. Regulatory Aisaaiart 8*ctioa 6 of TSCA authorizes EPA to promulgate a rul* prohibiting orlimiting tbe amount of a chemical substance that may be manufactured, processed or distributed In commerce in the US. if HNA SH STEW 1492 Federal Register / Vol M. No. 132 / Wednesday, )uty 12. 1989 / Rule* and Rggvilstkms 29467 EPA find* that there is a reasonable bail* to conclude thet the manufacturer, processing, distribution la commerce. ur or disposal of the chemical eubetanca, or any combination of these activities, present* or will present an unreasonable risk of Injury to human health or the environment Section 8(c)(1) of TSCA requires EPA lo oonslder the following fectors when determining whether e chemical substance presents an unreasonable risk 1. The effects of eucb substance on human health and the magnitude of the exposure of human beings to such substance. 2. The effects of such substance on the environment and the magnitude of the exposure of the environment to such substance or mixture. J. The benefits of such substance for various uses and the availability of substitutes for such uses. 4. The reasonably ascertainable 'economic consequences of the rule, after consideration of the effect on the national economy, small businesses, technological innovation, the environment and public health. To determine whether a risk from activities involving asbestos-containing products presents an unreasonable risk. EPA must balance the probability that harm will occur from the activities against the effects of the proposed regulatory action on the availability to society of the benefits of esbestoe. EPA has considered these factors in conjunction with the extensive record gathered in the development of this rule. EPA has concluded that the continued manufacture, importation, processing, and distribution in commerce of most esbestoa-containing products poses an unreasonable risk to human health. This conclusion is based on information summarized fa the following paragraphs and discussed in the units that follow. EPA has concluded that exposure to asbestos during the life cycles of many asbestos-containing products poses an unreasonable risk of injury tohuman health. EPA has also concluded that action 8 of TSCA is the ideal statutory authority to regulate the risks posed by asbestos exposure. This rule's pollution prevention actions under TSCA are both the prefamble and the least burdensome means afponbeOingtha exposure risk* posed throughout the Hie cycle of sbeatne-onotainisg products. Findings supporting this cnadmirm include tht following; . L Exposure to asbestos causes msny painful preasature death* due to maanthafaoeie andhiay. gastrointestinal, and otfaar cancers, as *rcu as asbestoais and otftpr.diseases. Risks attribptable to. asbestos exposure and addressed by this rule are serious and art calculated for this rule using direct evidence from numerous human epidemiological studies. Studies show that asbestos is a highly potent carcinogen and thet severe health effects occur sfter sven short term. higb-leval or longer-term. low-level exposures to asbestos. Asbestos exposure is compatible with e linear, no threshold dose-response model for lung cancer, fat addition, there is no undisputed evidence of quantitative difference* in potency based on fiber size or type. For the quantitative risk assessment performed as part of this rulemaking. EPA used dose-response constants for lung cancer and mesothelioma that were the geometric means of the "best estimates" from a number of epidemiological studies. If EPA had instead used an upper bound estimate, as is normally done by the scientific community and in EPA regulatory nsk assessment whan only data from animal studies is available to extrapolate human health risk, predicted lung cancer deaths could increase by a factor of 10 and mesothelioma deaths could increase by a factor of 20 (Ref. 1). 2. People are frequently unknowingly exposed to asbestos and are rarely in position to protect themselves. Asbestos is generally invisible, odorless, very durable, and highly aerodynamic, ft can travel long distances and exist in the environment for extended periods. Therefore, exposure can take place long after the release of asbestos and at a distant location from the source of release. 3. Additions to the current stock of asbestos-containing products would contribute to the environmental loading of asbestos. This poaa* the potential for an increased risk to the general population of asbestos-related disease and an increased risk to future generations because of asbestos' longevity. 4. Asbestos fibers are released to the air at many stage* of the commercial life of the products thet are subject to this rule. Activities that nugh lead to the release of asbestos include mining of the substance. processing asbestos fibers into product*, and transport installation, use. maintenance. repair, removal and disposal at aabestoeoontaining products. EPA has found that the occupational and nos-occupational exposure existing over tbs sntirt life cycles of each of tbs banned asbestoscontaining products poses a Ugh level of Individual risk. EPA nas determined that thousands of persons involved in the Banafacture. processing, transport installation, use. repair, remove!, and disposal of the asbestos-containing products affected by this rult arv exposed to a serious lifetime asbestos exposure nsk. despite OSHA's relatively low workplace PEL. In addition, according to the EPA Asbestos Modeling Study, millions of members of the general U-S. population ere exposed to elevated levels of tifetims nsk due to asbestos released throughout the life cycle of asbettot-containing products K'A believes that the exposure quantified for the analyses supporting this rule represent an understatement of actual exposure. 5. Release of asbestos fibers from many products during life cycle activities can be substantial. OSKA stated in setting its PEL of 0.2 f/cc that remaining exposures pose * senous nsi. because of limitations on available exposure control technologies Even with OSHA's controls, thousands of workers involved in the manufacture and processing of asbestos-containing products are exposed to s lifetime nsk of 1 in 1.000 of developing cancer. Many other exposures addressed by this rule are not affected by engineenng controis required by OSHA's PEL or by other government regulation. Because asbestos u a highly potent carcinogen, the uncontrolled high peak episodic exposures that are faced by large populations pose t significant nsk- 6. Because of the life cycle or "cradieto-grave" nature of the nsk posed by asbestos, attempts by OSHA. the Consumer Product Safety Commission (CPSC). and other EPA offices to regulate the continued commercial use of asbestos still leave many persons unprotected from the hazards of asbestos exposure. Technological limitations inhibit the effectiveness o( existing or possible exposure control actions under non-TSCA authonties. Many routes of asbestos exposure posed by the products subject to this rule are outside the jurisdiction* of regulatory authorities other than TSCA. EPA has determined that the residual exposure to asbestos that exists despite the setions taken under other authorities poses a senous health nsk throughout the life cycle of many asbestos-containing products. This residual exposure can only he adequately controlled by the exposure prevention actions taken in thia rule. 7. Despite the proven risks of asbestos exposure and the eunsat or imminent existence of suitable substitute* for moat uses of asbestos, asbestos cootinuaa to be used in large quantities in the ILS. I* the manufacture or processing of a wide variety of commercial products. Total annual U.S. HNA SH STEW 1493 ehtmx federal lepster / Yot. 44, >o. u; / rtednesuiy, July 12, ISaa / jtiuci ooosuaptfon efubestoe dropped from * of Aa Me'* staged-ban of Aa identified Human healA elfset* A asbestos sad lflMtotsfef shoot MtttO metric ton* to ssbssfos-comahtlng products trill SPA'* cancer risk extrapolation are less tore KM metric low la Mtr. outweigh Ac resultant accnomic discussed A Units V.A.I sod V-A-2 of coorrfteg M A* US Dapsjuiient of consequences to consumers, producers, this preamble. Tb* extent of bums n Alerioc. Baron of MAe* dot*. This and users of Ae products. exposure to asbestos sod Ae resulting change suggest* (flat Are uao of subsStotsshas increased markedly luce the proposal. Hoeeaser. the T887 coitsampfion Mai todlcetes But significant expo*aw doe to (he conmwrdsl see of asbestos and the reaultant riak* wouid continue for Ae foraaeeabia fotare absent Ae action tafrao A fob Me. Evidence lupport* Ae conch(on Alt substitute* afready exist or wifi soon exiit for eeeh of Ae oroducti Aat ere eubject A Ae Me'* sens. b scheduling prodoet* fee Ae Afferent Mages of Ae ban*. EPA baa analysed Ae probable availability of non-asbestos substitutes. In Ae rale. Ae various asbestos products ere scheduled to be banned at times when R it Bkefy Aat suitable nonasbeatot substitute* will be available. However. Ae rufe tleo includes an exemption provision to account for Instances b which technology might not have advanced rrffhtiextiy by Ae Am of a ban to produce substitutes for certain apeciefaed or Bmitod uses of asbestos. 8. ERA bn eaiotletod Aat Aejirodoct bans A this role svffl result to Ae avoidance ofSB quantifiable cancer cases. ffbenefits ere not discounted, end 148 cases. ifbenefits are discounted at 3 percent Hie figures decrease to 184 8. EPA has determined Act. within As risks tre discussed AUoil VAJ of this finding* required by section 8 ef TSCA. only Ae siagad-ban approach employed A this final rule wti) adequate!# `xitrol As asbestos exposure risk poaed by Ae product categorise affected by thto rale. OAer options ttiktr (ail to adhui rigruficaat portion* ef As hfa cycle nek posed by products subject to the reis sr are anrenrmlilp kwrWmnaea EPA be*. Aerefore. conceded Am Ae action* takaa A Aa rtoa mpresent Ae team bardoraom* mean* of rodactog Aa riA posed by sxposare to asbestos during Ae life cycles af Aa products Aat are subject la Aa bai*. 10. Based on Ae rearms nmnnarized A this preamble. Ato rule ban* most preembte. Asbestos substiAtes are discussed A Unite VC. sad VS. of Ais preamble. EPA's avalustiao A A* viability A other eeguiatory options under TSCA is discussed A Unit VX. A Ais preamble. EPA't evaluation of Ae viability of u&dar auibor<Ua other than TSCA to control the nek posed by asbestos exposure it discussed A Units VT end VTi of Att preamble. EPA't estimate* ef the costs and benefits of At* rule are dwcussed in Unit VJX of Ai* preamble. EPA't eveluetions of Ae risks poaed by Ae different categories of ssbeslos- contaiaing products are tusnmarued us Unit VX of Ate preamble. asbestoa-contcinAg products A Ae U.S A. Health Effects and Magnitude of because they pose an unreasonable risk Exposure To Asbestos to human health. These banned products account for approximately M percent of U.S. asbestos uumumption. bused on 1889 cun*eruption figures, ^be actions taken will result to a substantial reduction A Ae mneasonsble risk caused by asbestos exposure A Ae U.S. A few minor uses of asbestos and 1. Health effects. The bmom besiA effects caused by expoawe to asbestos are well-dmrn--tried. Thu Hart reiterates tba aujcr beatih rilecw and Ae -- I risintie* that east regarding this (abject More coaprebewrive analytic can be faand A tba Airboree Asbestae Health A a earn if Update sbesta* products are not included A (Ref. 1). foe Repert to the LLS. Ceenater Ae ban. These uses, which account Cor Product Safety Cowantsslae by the less Aan 8 peresnt of U.S. asbs*As Chronic Henani Advisory Pam! art constanption baaed on U85 data, do sot Asbestos (Bet 2). aod Asbeetifono cases, ff benefits are not discounted, end pose an risk, based on Fibers: Nan-occvpoijoaal Health Risks 120 cases, ifbenefits are discounted at 9 current knowledge. For some product (Raf. 9). Furihar rvepnmee to emmeats percent if analogous exposures are not included to Ae analysis, in efl likelihood, Ae rofe wffl result in the categories. EPA was unable to find Aat Ae profomte paaa aa i--uaaooable risk becat-- nbasins siyosart is w on tbis aobjact cam be found to the Responea to ruia-- ate document Asbestos is chemical substanee as avoidance of a Inge number ef other cancer eases Aat camrat be quantified, over A* product's lito cycle retotive to tba axposHN* poaad by other paodacts. Aat term is defined in section 9f2j of TSCA. R Is weB-recogmted Ibet as weff as mstty ease* of asbestos- A oAer inslsacss EPA cwtseatiy baa asbestos is a human eercAegen and is related dbenes. Estimate* ofbenefits Asnffiriatit latsre--ina abeta eribea one ef foe moat baisrdou* substances to resaRtag bum Ae action taken to Ait asbestos u--irt aArtbatabto ta tks wAcb human* are exposed to both rule are baited to nesoAefeoma and product* sr Aa fotore availability af occupational and nou-occupational lung and M--ufalesfitisf canoer-caaes- suitable substitute* to make a fiarttaf A settings. As OSHA stited to its final avofcfed' and da not toeiude ease* of uniaa--Ids stofc. Exposes* hricnaaiian rule, pubfisbsd to the Fadera! tagistar of asbrototis and other dleetssi avoided June SB. MB (51 FR 22B12], estsbtishAg and avoldad casts from beating a 02 fibers pat-epbte-oentimeter (f/cc) asbestos diseases, tost productivity, or unavsftobto fcrtmei major stages A a PEL for asbestos. *OSHA is swmre of ao other factors. EPA hat estimated that paodaefa As eyed* --d too Uttie was instance to which exposure to a toxic As cost of Abide. for then-year known abet aipusmaa darttig Aaa* substance baa more dearly period of Ae analyses performed svill stages to sstimnto sxpasare by --eiagy demonstnrtcd detrimental health affects be appresfrsatelyMSSJtinHHon. or to Aom paaad fry ad-- products. Wbsn ob bamans fium has asbestos exposure.* B0&B1 wMkm ffa J percent tnneaj no Aformsttoti to avaiahto far a prodact Than tosridt agratmant that all type* decline to Ae price of substitutes la not of asbastoa ffi--s are aasodatsd trilh aaa--sfolfrfcseat wiBfre spread over --tot As asto--tod awt At predict puhwmaryflhreefo (aabestostsj, hmg time--iatoege papuladm so feat As ban to *sryhleaflaif fore* cases. oaaeer. aod maaofhafioma. coat tb --yasiaaa to tabs cmMquSESXTqaifctire^ Castrolatoattnal uaaear aod othar aagfigfMs.--aidM--At raid's ' cancan at --tMhmacfc sites, as atefi as s n map--pnalriun to e qaalitoffve aattocaSsac arreit ApaasAfe other lang dtoonfcra mi diseises, hav* factor Aat aanperto Aa action* token in regulatory adkei oaAd net be justified also bean sesodatod srith asbestos this rule. EM--caseladsd Aat As A light at AereaAtonl costs, under the txpoamu. rfthotEh the oooilstam? cud critaria A section tf efTBCA. msgnftiidsof the exes** risks of these HNA SH STEW 1494 toaertl Kepater / VoL H No. 132 / Wednesday, Juhy U. 19B / Rules and Regulations 29 i69 diseases era not a* artat u for hm| cancer and maaothelioma. All of the** eabestoa-related disease* an lifethreatening or disabling and cauM substantial pain and raftering. The conclusion* reached by EPA regarding tbe health affects of asbestos axpoaun npnacnt a widely accepted consensus of opinion) of health agencies, ecientifle otjanization). and independent expert*. The major health effects of aabeatoa an summarized below.......................... a. Lung cancer and meeothelioma. Lnnf cancertha* been reaponaible for the latgeri number of deatha attributable to occupational axpoaun to all of the principal commercial aabeatoa mineral types: chryaotila. amoaita, croddolite. and anthopbyllita. Excel) iunf cancan have bees documented amonj woricen involved in aabeatoa mininf and milling end in the manufacturing and uae of a variety of aabeatoa product). Lung cancer riak appear) to incnaae with both the level and duntion of cxpoaure. The latency period for diaeaae ia generally 20 yean or mon after axpoaun. Thie meana that lung cancer uaually doea not manifeat ttaetf until JO yean after the diaeaee-initiitin| axpoaun. Moat peraooa srho develop lung cancer die within X yean of diagnosis. While both aabeatoa and cigarette amoking can aeparately incnaae riak o( lung cancer, together they appear to interact syneigUtically to multiply lung cancer riak to humane. Commcnttrt have luggeeted that amoking ahould be controlled to reduce the eery high lung cancer risk due to combined aabeatoa exposure end amoking. However, even complete control of the amoking factor, if possible. would leave a substantial health riak tinea the aabeitoa-related riak of hmg cancer to nonamokera and of maaotbalionu (which la apparently not affected by amoking) would remain. Mesothelioma la a ran cancer of the lining of flu lung (pleural aeaothelioma) or abdominal cavity (peritoneal mesothelioma). Mesothelioma haa been aladdered with occupational axpoaun to chryaotfle. amoeite. and croddolite. Epidemiological stadias suggest that meaothelial risk rises rapidly with time 6um the onset of exposure. Risk also tpcreaaea with both intensity and deration sf exposure. The latency period for the dbssee is generally between 23 and 30 yean, b akoost all instancaa. the disease is rapidly fetal with aurvtral Haas ofless than 2 yean after diagnosis. There ta no evidence that dgauretta amoking tneraaaes tbe riak of devafopfog rtbeetoe-taduoed Moct tpldtmioloffc*] studies hsvs been conducted on occupational populations txposed to high alrboma concentrations of aabeatoa for relatively long periods of tune. However, short term occupational exposure! have been ahown to cause serious health effects. For example, one group of asbestos factory workers with less than 2 months of occupabonal exposure had a two-fold increase In lung cancer nsk (Kef. 4) Also, many documented cases of mesothelioma have been linked to extremely brief exposures to relatively high concentrations of aabeatoa (Kef. i). There is also direct evidence of adverse health effects from nonoccupational aabeatoa exposure. Increased riak of pleural abnormalities end mesothelioma havt been observed ia families of asbestos workers, presumably due to the dissemination of fibers in the home from contaminated work clothes. Mesotheliomas have also been documented in populations whose only identified exposure was living near asbestos mines or asbestos product factories, or shipyards with heavy eabeatoa uae (Kef. 1). Animal studies confirm the epidemiological findings regarding the health affecta of aabeatoa exposure. All commercial forma of aabeatoa have been shown to produce lung tumors and mesothelioma in laboratory animal* with no substantial differences between the form of aabeatoa forma in carcinogenic potency. b. Gaetrointestinal cancer. A number of epidemiological studies have documented significant increases In the incidence of gastrointestinal cancer due to occupational expoaure to aabeatoa. Gastrointestinal cancer* consiat largely of cancer* of tbe esophagus, stomach, colon, and rectum. However, tbe magnitude of gastrointestinal cancer nak ia lower than that of lung cancer or mesothelioma and no do**-response data are available. A number of commentsri argued that the evidence Indicating a positive association between gastrointestinal csuicer and aabeatoa exposure la waak and inconclusive. They indicated that unidentified fact* may aaeac the excel* gastrointtstinal cancer*. Commantar* . suggested that eiany of the axoaas cancer* attributed to gastrointestinal rites may be due to miadlig""*;* of pariUnseal mesothelioma*. Other commentate oositendad that in the abaenca of any poeitiva experimental evidence, the epidemiology data alone do not rapport the oonduaioa that exposure to aabeatoe can eauaa gastrointestinal cancer. EPA recognizes that the evidence supporting an association between gastrointestinal cancer and asbestos exposure is not as strong as that which is available to support an association between aabeetoe exposure and lung cancer and mesothelioma. However, after weighing available information. EPA believes that there ts evidence of a strong causal relationship between ssbestos exposure and gastrointestinal cancer excel*. This evidence includes the following-. (1) A statistically significant increase in gastrointestinal cancer was found in 10 of 23 epidemiological studies. (2) A consistent relationship exists between increased gastrointestinal cancer nsk and increased lung cancer nak (approximately 10 to 30 percent of the lung cancer excess). (3) it is biologically plausible that asbestos could be associated with these tumor utes. because it is conceivable that the majority of fibers inhaled are cleared from the respiratory tract and subsequently swallowed, allowing the fibers to enter the gastrointestinal tract (Kef. S). Additionally fibers may be swallowed directly. (4) One study demonstrated tome evidence of carcinogenicity in male rat* fed diets containing intermediate range aize chrysotile aabeatoa (At percent 10 microns in length) (Ref. A). Further. EPA doea not accept the argument that all gastrointestinal cancers identified m the epidemiology studies described above are the result of misdiagnosis. Cancer* of tome gastrointestinal cancer sites (s.g.. stomach and pancreas) could be the result of misdiagnosis of peritoneal meaothelioma*. However, this does not account for ail of the excess cancers seen at sites such as the colon or rectum. QSHA. in its final rule lowering the asbesto* PEL concluded that tbe etudies conducted to date "constitute substantial evidence of an association between aabestos exposure end e risk of incurring gastrointestinal caacer." EPA agrees with this conclusion. c. Concert at other titm. In(Teased riak of cancer* other then metothelioma and lung and gaatreintaatinal cancer* have been observed in populations occupationally exposed to aabeatoa. An *ciaes of laryngeal cancer ia asbestos workart haa been reported ia a comber of studies (Ret 2). Available data, however, iadsoet* that thera may be an interaction between amoking and asbestos exposure in tha etiology of laryngeal cancer. Elevated risk of kidney cancer kaa also been observed in two epidemiological studio* (Reft. 2 and ). In addition, an increased Incidence of HNA SH stew 1495 WCQ federal Ecgfaltr / Tol K Nt 18 / Ifadpecilaj. July U. i98 / Kufe* erf Eegnfagoa* vaston extern bn ha land unf tomato worker* it fare* stadia* (Ref*. ft la amd 11). Tbmrfarc, avid*-- nggeto an naacUtSM bvtw**a asbestos exponas nd emncmrt after than hag eastrelmcvtinto eenear. However, becuee af atsdy ttmJtatfcBa, ' too--ivlcnctos amcaj toadies. and (he potatoilityef mtodfagnneto to faeeaae. fta laiottootoftp betwvas esbeem expoaore Jcaar at (bare extrathoiacfc store ft ae< clear. Bacait 0/ ft* sacarimaSy. H>A <hd not calculate tba risk af concert at other tolas (or ptspoire to the qpantKeave rift imuHat far ftfa rale. d. AsbmtoM. Attirtoati t* a disabling Rbraftc tang dferese that baa bem areoefatad with Ugh levels of aecapatfaaal expat** la aabeatoa. ainlcal eigne aid symptom* aaaodated with Mbearaali toefede shortness of breath, paheonwy toictkmal changes, basal rales, and aiai. --iiity irregular, opacities on eboto radtogrepfee. Aabaaiaaft can both appear and progress awny years after fta termination of expoem*. All type* of aabeitea boat bean aaaodated with the deveiopareal af asbeatoataEpidemiological data indicate that (he incidence rata Inewaaea and fee dfaeaae becoraaa mere aeacre li facreoafag dust level and dunrtfea of expusmu. Thi* hat abo bon urfmal ia enknal atudiea via aftaftQon expoanre. h U act claar whether aa exponre threshold exists for aabaatoaia. However, there ft no available evidence (hot dftabftng aabeatoeie ia caned bp nenoccupational aabeeioa expuawe or relativtoy low levels of oooupatioaat expoaaca. Thectoore, ft* lift of disatotag aibestatos fare low ievaft of exposure la aabaatoe tea* aot oaloatotod far parpoaaa af the gaHitatrva rift anaaamant periarmeri tar 6sa fired nda. a. Effaat wff&tr typo. A anulur of coaurntm argued that do? aot8a. the aMfor co--aerial lorn of aabeatoa. ft tm ftat wcnoynic ftan fta aarpkiboft aabeatoa typaa (*-g_ amoetoe and crotodottta) aad reus. ftffarant Karl thclowaati ; Vftlndefte Bile be 1 of t rift factors abaarvad kfr to pradsreh--dy ftryatofls aabaatoe (Ref* ix aad m Mrererer. aaret of fta highest anil vetoes aaa dbe ban > to pftanfty ftbyaatfta (Kefa. naaftfaratwliad} Mgb risk of fang--car. Tbo eataa of (be observed varfabffity fa fang cancer artt rift tor chryioflto la different ifudle* is unknown, but some of <ht varitbffltie* can be aUribated fa dUferenew in tba fiber ckancterfatica eaaociatad with djfcraot processes. teenshrtlev dua to amal oaaabera in epidtattalogkrf atwhaa, and facorraot aetbaate* of the axpoaaraa of eoriier year* (Refe. 1 and *) For meaofteitoma. EPA recognizee that peritoneal awaotheffoaoea have largdy baea evvoclsted wtth croddoitte exporer* and ftat there ia some epidemiological evidence taggrsttng that croddobta b more potato than chryaotifa ia todaring ptoarto mesothelioma. iknerra, dfeflniore tmodusions concerning fta refaeva potency af vartooa fibre typaa to factoring meaothekoma caanot ba made on tba beat* of avsilabto epidemiological kifonrerttoa. Thia is because: (1) Mesotheliomas are difficult to dcagneerr (2) doaa-raeponaa informatioa far am*hello-- far individual fiber typw ia anavaitobie: (ft) exposure data a. : iaadequste; and (4) exposure to crocidolito Sbete could be higher becauaa they become airborne more easily than other fiber typaa. Further, atimrmaa --maftaa have demoaatraied that ebryaotito i at toast at potent aj amphibales m inducing both maaothelioma and lung cancer by inhalation, aa wall aa by in^criioa or implantation. Available information indicates that the combined epidemiological and animal evidence fail to establish conclusively differences is mesothelioma hazard for the various types ofasbestos fibers. In view of the incaniistenries and uncertainty regarding this issue, EPA believes that it ia prudent end in the public interest to consider all fiber types ss hsvtog comparable carcinogenic potency in its quandtsfive assessment of mesothelioma nsk. EPA does recognize ftat seme evidence exiets indicating that ampUbahs may ba mare ootent tn indvdng mesothelioma than chrysotfle. However, the need far further study to resolve (hie isvoe. and the leaiiftiug delay to EPA'a riak aasessment for aabotoa. emnpot be fartfled given the volume of data iliuwiug (he carrfeogealc potaacy of eg fter fyp6*Similar eonctotions were twaehtd ptavioufty by ofter adaatfflc bodies and ajenciev (ftda. t ft and Mf. . L Sfftet tf&brr diammkm. A smsber of eomMBterv atatod that sshlto faog fibers (>* miuuui) are asauioted with biological ecBstty. fibers fact than S ncrooa in length may ba Imauiuus. Acconfing fa these canrmenters, short flbati to not conefbuta to ssy significant risk to bnmans and therefore EPA should base Its cancer risk estimates on only fibers longer than S microns ia length. Infection or implantation studies in aitfaiab Indicate that iongsr. finer fibars of ft* same asbestoe fiber type appear to bars greater carcinogenic potential than shorter, thicker fibers (Refs. 1. 2, and 3}. Results of several recent inhalation studies also indicate that long fibers (> J microns) are more carcinogenic than sbort fibers (< 5 microns] (Ref*' V and 18). Howevar. studies performed to date have not established fiber dimensional thresholds for potency. Although animal atudiea have provided an indication of (ha'quaClative relationship between fiber dimension and carcinogenic potency, (hey are not used for quantifying dose-response relationships tor humans because EPA believes that extrapolation of data from human exposures to (he workplace 10 human exposure to non-occupational setting* is more appropriate. EPA based most of its estimate* of noa- occupatioaal exposure in term* of (he total mass of asbestos released to air. To estimate health risks from the noo- occupationaJ exposure, (he mass measurements need to be converted to (he equivalent optical fiber concentration (fibers longer than S microns and greater than 0.25 pm in diameter) (hat are used aa doss measurement* in workplace* far which dove-response relationship ba* been developed. Some data exist that relate optical fiber counts to the total mass of aabeatoa. Tba range ofconversion factor* between optical fiber oount mass concentration is Urge (5 to 150 pg/m'/i7 ml) because these vetoes vary with different envtrenments and sampling techniques, and any average value derived from thia range has a large uncertainty. Despite (he uncertainties, they are ftabeat data available for such assessment* and therefore EPA believes that for (ha purpose of extrapolating to low mass concentration from fiber count the approximate geometric mean. SO pg/m'/f/ml ia appropriate (Ret 1). . Additionally, uncertainty may be introduced is the assumption mads in ftis aavaamnrnt that the fiber etoe diatrfbufion ia fta same fa both oocapeOqnal and Ma-ocopa(tonal air aovfronmenls. Th* assumption b considered prudent to view althtfsci -that (giahlafivaly. abort fiber* are band more predominantly then long Bhere fa both oocupatfanaf and nm-arrgmtioaal tattings. The aama approach baa baea HNA SH STEW 1496 Fsttoral Regfrtto I VmL M, No. 132 / Wsdeesdsy. )ufy 11, 19M / Ratos ead EeguUtfac* 28471 adopted by the National Arartfy g| Sduco* {Rot 3) and the Ghratoc Hazard Advisory Pass! (CHAP] oa Asbestos (M 2) to MtiMtiai kimso kaahh ruk a asocial*d with low-Jevai noo^ccapatiooaj exposure to asbestos. I- Palmy raiuta. Commanten stated that cancer nika vary tram awe industry aegment to another and maintained that EPA (herald use different potency value* Jot different Industrie* in its quantitative cancer risk assessment for asbestos. Most ef the corneaenten singled out two sagnnts of the asbestos industry, manufacturers of chrysotile friction products and A/C products made from chrysonie. to which the lung cancer rules were considerably lower than those to chrysotile.textile production. EPA has oondoded that the data supporting this suggestion are not convincing because of signifies!! methodological or atabaticai uncertaintiea in theaa studies. Further, when the 86 percent confidence limit! on the potency factors for lung cancer are oonaidered along with the uncertainties associated with estimates of exposures, there ia considerable overlap of the anil nek estimates across industry segments and fiber types (Ret 1). Accordingly. EPA believaa that its use of a geometric mean unit risk derived from 11 studies that cover all industrial processes (with the exception of mining and milling) and that provida a dose-respoese relationship is reasonable. This approach recognizes that lower cancer risks may exist in some industry segments because of uncertainties in the measuremeal of exposure or statist]cal variabilities, but the potency factor for asbestos ia considered to be equivalent across industry segments, in fact, a follow-up study (Rat 24) reported a lung cancer unit risk of 00076 far A/C production workers who were exposed predominantly to ebrysooie. This value is closer to the beat estimate for the fractional increase in lung cancer. k*.. for asbestos exposure. 0.010. This study provide* further support for the use of a single potency factor for all asbestos exposure scenarios. 2. Quantitative Bitk Assessment. Risk assessment usually mqaim extrapolation between different routes of exposure, from atomsfs to tinman*, and fromfeat group* to tfa* population at large. Pspits asaaetaintias. risk sss*aimnt provide* an eetiaat* of the magnitude if risk far saktog dsaaisne about ootoralliag a^ocaie to a hazardous substance. Howrvet. because ' health risk fromaabatto*exposure i* astiautad using dtiootevidcaca from a large number apidmUokagieal stadias. the risk posed by asbestos exposure is far mors certain than that posed by exposure to other hazardous substances for which only animal data and/or fewer, less coocfuirve human data are available. ate from a study of US. insolation workers allow models to be developed for the time and age dependence of lung eencer and mesothelioma nsk (Ref. 4). Thirteen other epidemiological studies demonstrate a linear dose-response relationship between cammlstne occupational asbestos exposure and lung cancer. Although much lets datt are available regarding a dose-response relationship for mesothelioma, existing data suggest s linear response with dose and duration of expoaura. To obtain dose-response estimates for current occupational and noa-occupabooal exposures to asbestos, it ia necessary to extrapolate the effects observed in occupational settings with historically high exposure to anticipated affects st low levels of exposure. This is bssed on a no-threshold linear extrapolation. The assumption of no-threshold low dose linearity for asbestos carcinogenicity ia reasonable and well-supported because (1) cumdatfve dose-response relationship have been shown in several epidemiological studies over a wide range of exposure: (2} threshold dose has not been demonstrated: and (1) the concept ia coneletent with accepted theories of carcinogenesis. Both the lung cancer and mesothelioma models used for this final rule have been adopted by OSHA (Ref. 18). The National Academy of Sciences (Ref. 3) also adopted a similar no threshold model to estimate lung cancer risk to non-oceupabonal populations from exposure to asbestos. No-threshold linear models have widespread support (Refs. Z 3.16, 22. and 23). The derivation and validation of the models at well as the assumptions and uncertainties involved in the model, ere discussed in detail in Refs. 1. 2. and 21. dt, mi m dartban of exposure bum onset mbl 10 ysere (msatisssi Limey period) before promt (years). f -- smartjr of axposura to fiber equiveleati longer than 5 microns iliac). Ki > dost response constant - OJM0. (Refs. 1 and 21) Because mesotbabom is a my tar* fans of wear to tbs gwesi population, an tbsoltaa risk modal ta assd to estimate escaaa wtbttit toadtmes das to aabaitoa axpoaara. Accenting ta this modeMhe added rtek to nwothebow ts ptoportiooal to ttia cumulative axpoaara to aabaatoa sad tooeasae fa preoarttea to Iks third power aftitos after o--to af axpaiara. This model incorporates a delay of 10 years for the manifestation of disease (i.e., a minimum latency period of 10 yeers). Four epidemiological studies provided quantitative data suitable for calculation of potency factors for mesothelioma (K*). EPA (Ref. 1) selected an average value for K of l 0 x 10'* as the best estimate Cor environmental exposures. Although it was not possible to determine directly the 96 percent confidence tic. Is on K*. a multiplicative factor of 5 was estimated for the everage value of and a multiplicative factor of 20 was estimated for its epplication to any unstudied exposure circumstance. The absolute nsk node! for mesothelioma can be expressed as. Wt d. ft - K. 8Rt M) - ft. to. 4) ) for t >10 4-4 *t0 -K. gt-m'lorl* 4- 4 > t > Lamp cancer is best described by relative risk model. According to this model excess risk of Jung cancer from asbestos expoaura ia proportional to the crusalltive exposure (i.e, the duration of exposure time* the Intensity ef exposure, is terms of fiber-year/cc) and the background risk in (be ebsence of exposure. EPA used this mode) and data from 11 studies of workers exposed to asbestos in textile production, asbestos product manufacturing, and insuletion application to calculate potency factor* for lung cancer (K*, the fractional increase m risk per fiber-year/cc of exposure] (Ref. 1). The geometric mean value of K* for these studies. 0.010. was used ts the best estimate for environmental esbesto* exposure. The 95 percent confidence limits far this value are 0.0040 and 0.027 Imultipl'Cttive factor of 2.5) based on an analysis of variance* tn the 11 studies from which the 1C*, sets calculated. The SS percent confidence bahts for K* that might be applied in any unstudied exposure circumstances era estimated to be a multiplicative factor of approximately 10. The relative risk model (or lung cancer can be expressed it: k-W[i 4-k* f *.--) where: k > apt - specific hiag caaot* death rats with sxpoawi to aibtstoe k - ags -- spsdfie long canon death rata without exposure to asbestos, t - lima from onset ef exposure entO present lysartl i att HNA SH STEW 1497 2>*7> Redeem! Reglotaf / VoL H. No. 193 / Wednesday. July 12, 1989 / Rules and Regulationa K - iwrtiwnic powocy txprmtmi as to Inddsncs at anodMliocu pm nit at exposure Is Sbarfun Vac. f Intensity at txpoture to Sbtr squtvalsnts tagsr in S microat (f/ee). t Has aflat txposure In ysers. d m duntkm at exposure In yurt. (Rsfc. 1 and n) Is extrapolating rates of txceu eabaatae-ralated deeth* from gastrointestinal cancer, D>A adopted the approach used by OSHA (Ref. 16) In Miirntm that txceu gastrointestinal canoors wtU be equal to 10 percent of thoaa for huif cancer in each time period. However, thi* approach may actually understate the rate of gattroIntestinal concert. OSHA noted that this approach could reiult in an undamtimata. and EPA's analytii indicate* that the axotM gaitrointeatinal cancer rata could be at high at 90 percent of the lung cancer rate (Ref. 1). There art inconsistencies in finding* among different epidemiological ttudiat with regard to txceu mortality for concert at aitea other than the lung, meoothelial lining*, end goatrointestinai trad (eg. laryngeal, kidney, end ovary cancer*). Alto, there ere uncertaintie* about the development of disabling asbetioait at low axpoaurt. Therefor*. ETA ha* not made numerical tattmate* of the risk* for the** aabeetoa-related diaette* for purpoaa* of thi* anelyti*. Sine* eitimatet of theae diaeaae* are not included in the overall ritk eatimatet. EPA believe* that the total health risk poted by expoaure to aabeato* ia undereatimeted. A number of commenter* contended that it it inappropriate to adhere to a linear. no-thr*shold dose-response model for **timating lung cancer and mesothelioma riik from aabeato* expoourt. They dtod * number of epidemiological itudia* which they atatad (bow that that* la * threshold below which aabo*too-related diaeaae doe* not occur (Reft. 12. tt. 29. and 26). EPA has reviewed thoaa studio* and found that they are all insufficient to dated a threshold at low do*** (Rat 1). Other commonten expressed concam about tb* low-doo* linearity assumption because the shape of the dose-response curve at extremely low doaat i* subject to conjecture and that the so* of do threshold Unsar model greatly ovacwUmatee tn** risk. Others bolisv* that eoboeto* W a non ganatlc cardnagen. As discussed above. EPA baa OMWmfod (hat the tow-dose hnaarity assumption is rsasoswbla bacaoM direct evidence for linearity of ctrdangsnfc response associated with esbeetos exposure is found in several apidetaiefofieal studios over a arid* tertpt of exposure. Whether the response i* linear at very low do*** i* not known (Raf 1). In (be diicuaaion of tbs choic* of mathematical procedures In carcinogon risk assessment ths WhH* House Office of Science and Technology Policy (OSTP) atatad: "Whan data and information are limited, however, and when such uncertainty exist* regarding ths mechanism of , carcinogenic action, model* or procedure* which incorporate Iow-do*e linearity or* preferred when compatible with the limited inform*ttoa" (Raf. 27). HA generally concur* with this position a* reflected tn EPA'* Guideline* for Carcinogen Rifk Assessment (SI FR 33992). Thu*, given the lade of complete understendirg of the mechanism* by which asbestos induce* cancer, and the goal of protecting human health. EPA believe* that the choice of low-dose linearity is most prudent 3. Magnitude ofhuman exposure. Exposure to asbesto* is discussed in more detsil in the Asbestos Exposure Assessment (Ref. 29). the Asbestos Modeling Study (Ref. 30). and the Nonoccupational Asbestos Exposure Report (Ref. 31). Further responses to comment* on thi* subject can be found in th* Response to Comments document Most of the population of the United States is exposed to some level of airborne asbestos from asbestoscontaining products. Asbestos products have been in wide use in the U.S. for dfcades. Although U.S. asbestos consumption has declined in recent' years, thousands of ton* of asbestos are still used annually in the manufacture in the U.S. of the products that are subject to this rule (Ref. 21). Fiber* can b* released to the air and sxposur* can occur at ell stages of th* Ufa cycle of atbeatos products, including mining, processing, and th* transport installation. us*, repair, removal, and disposal of asbestos-containing products. Once released, asbesto* fiber* exhibit a number of characteristic* that tend to inrresse human exposure to them. They are ordorie** and fibers af respirable size are largely invisible, presenting risk to persons who ore not aware that they ore being exposed. They or* also extremely durable and posses* aerodynamic properties that allow them to remain suspended In tha air for t long dm* and to reenter th* air readily after settling out Aabeato*. therefore, can palmist for a very long time in th* environment and can trseol oxtaadod distances through the air. Tbaea factor* tnasase th* intensity, duration. and area of exposure and oompUcota attempts to control or reduce exposure. EPA ha* quantified many of ths Ufa cycl* exposure* anticipated from the continued manufacture, importation, processing, end us* of the asbesto* products that era subject to this rule. EPA estimate* that over 135.000 full-time equivalent (FTE] workers art exposed during th* Ufa cycle* of these products to levels of asbestos carrying lifetime nsks of between r tn 10400 end 7 in 1.000 (Ref. 29). At least 40 miUion consumers bee a potential hazard ** they install, us*, repair, and dispose of these products (Raf. 91). In addition, the general population is exposed to asbestos that is relessed into the ambient air during ail of these activities Both consumer* tnd members of the general population frequently incur individual lifetime risks of 1 tn t.000.000 or greater of developing cancer from these exposures (Ref. 31). There are other exposures associated with the continued production of asbestos products that cannot be readily quantified, but which could pose a significant risk to large populations. As discussed in more detail below, many releases of asbestos from asbestos products take place intermittently and over tong periods, making them difficult to measure. Because of the difficulty of obtaining accurate monitoring data for these release*, they have not been quantified for purposes of thi* rule's analyses, but qualitative evidence indicates that cumulatively, they are probably significant. Similarly, because it is difficult to quantify the tendency of asbestos to be resuspended in sir. EPA hat not quantified in its analyses the risk posed by asbestos that is repeated!;, reentrained after settling out. However, some reentrainment certainly occurs, and asbestos may pot* some threat years after its initial release from asbesto* product*. These exposures, although unquantified, have the potential to affect large numbers of people for long periods of tune. Thus, tn addition to the exposures quantified for this rule, they are a source of considerable concern. a. Occupational exposures. Since EPA's proposed rule was issued. OSHA has promulgated new occupational exposure sUindohd* for asbesto*. lowering the 6-bourTlme Weighted Average (TWA) PEL from 2.0 to 02 f/cc (51 FR 22612). OSHA has also set tn Excursion limit (EL) of 1 f/cc as t halfhour TWA in s September I960 amendment to the standards (S3 FR 35610). Th* probable impact of the 0.2 ll cc TO. on workers' exposure* to asbesto* was discussed In the proposal. As noted both tn that proposal and in OSHA's i uisoaking, exposures at the HNA SH STEW 1498 Fdrri Kegistee / Voi R Vp, 132 / Wedneaclsy, July tt 1989 / Ruin rad Regulation* 29471 mw PEL aril poasstfrificant risks, ae do txpomrt at tka EL OSHA octal tkat tha new HL and EL do aot represent "tala" Irrato of aabeatoa exposure. bat are the lowest levels that Industry can faatlMv achieve during currant control tachnologto*. EPA aatimatas that order the now PEL approximately 1U.OOO FTB woritan engaged in the manufacture, proceatoag. installation. repair, and difpoaal of the pradocta to be banned are exposed to'level* of airborne a*baato* between &0Z f/ce and 02 f/oc (Rsf. 29). Aseuming that worker* are exposed to tbtoa* level* over a tS-yur working Mafinie. they incur individual riak* of between T in 10.000 and 7 hi 1.000 of developing cancer (11 PR 22944). A number of comaantara oiticized the occupational expoaura data baa* uaed to support the propoaal as bains outdated and incomplete. Much of that data can* from tha 1982 TSCA section 8(a) reporting nd* (40 CF* 78320). In reaponaa to theaa coalmenti and because of tbs passage of time ainoatbe propoaal EPA ha* updated and expanded it* analyst* of occupational exposures, making naa of availsbla 11tarstors and data hate* and cooducting surreys of a*be*to* aae and expoaura level*. Materials ased by EPA in tb* updatad analyai* include OSHA and Mine Safety and Health Administration (MSHA) oooplianoe inspection reports. National Inidtnt* far Occupation! Safety and Health (NIOSH) studies, academic and industry studies, and public commanta. In 1988 and 1987, EPA condactad tha Aabetto* Expoaura Survey and gathered expoatoe and release Information on the manufacture of most of the major aabestna product categoric* from primary and secondary manufacturers of asbestos products. EPA gathated data on populations engaged in manufacturing in lb* 1986-87 Asbestos Market Survey. EPA was able to obtain extensive information an occupational exposure* during priaamy and secondary manufactaring far many product categories. Air monitoring data far primary and secondary manufacturing ware *variable far many prndsets from the 1988-87 EPA ifapoanre Survey. OSHA inspect)am. and aimwnxia studies. EPA has estimated that epproxtaataty 1300 worker* in tha U.S. are anpeaed In asbestos faofag the prinMuy and aaoandary menuhewing of tb* protest tbei are affactod by tbto rah (Rat. 29). the** arprawer art Mated in Table I of this Unit VA ala* gathered information an frioban and oonstnsction products. faa two predact pwp* for which exposure* art likaly to be highest during these Ufa cycle stage*. Forme installation and removal of construction products (roofing fait and A/C pipe, sheet, and shingle), air monitoring data were available from several studies. Oocapational population* (in tarns of FTEs) were estimated on the bails of crew site, productivity, end total manufacture and import volumes of the products. Exposures assodsted with the replacement and repair of friction materials wera estimated In * similar fashion. EPA estimates that 125.400 FTEs are exposed to asbestos during the installation, repair, and disposal of aabeatoa friction and construction products. More than 1Z5.400 workers are ctuaOy exposed to asbesto* during these processes (OSHA estimates that 558,320 persons are exposed), but many are expoaad on a leu than a full-time basis (Ret 29). FTE exposures are listed in Table 1 of this Unit Vary bttla monitoring data 00 occupational exposure* during installation, repair, and disposal were available far the other asbestos products that art subject to this rule, and EPA'* estimates therefor* do not include exposure* from tha installation, repair, and disposal of these products. However, oc tha basis of tb* limited data that exist far these products and on the basis of data for similar product* and processes. EPA believes that significant exposure* during installation, repair, and disposal of theta products do taks plao* (Sal (7). Therefore. EPA believe* that its analysis underestimate* expoaura* asaocistad with the** products. EPA conducted an analysts ha order to gauge (be possible impact of tbs abaanca of toot occupational axpoaur* data on calculations of tb* rule's benefit*; tb* wait* of this analysis appear ie Table D af this Unit and Table VU1 of Unit VA In geonreL when data relating to a certain type of exposer* oouid not be obtained IPA did not quantify that type of exposer*, reflecting what EPA considers ta b* a reasonable approach to risk assessment EPA find* the exposures quantified for this rule suffldsot tn themesIvs* to support EPA's risk aesevamsnt ooodusions far asbestos. However. EPA eotee that if *U exposure* to aabeatoa Irons the products affected by tfaaruUcauM have bean quantified tha benefits calculated far this nd* would probably hive been significantly greater thus noted In EPA'a risk ease*ament landing farther support to EPA's wsasonaMe risk finding far oabaitoa. Much of EPA's occupational exposure data bass for this rula represent* expotura that took placa before OSHA'* lowered PH. of 0.2 f/ce became effective In 1988. To estimate exposure* taking place after the lowering of the PH EPA fir*t lowered to 02 f/cc all data points which reported exposures above 02 f/cc. EPA then averaged these points with those points that were reported * lower than 02 f/cc for each job category In each product category. Far purposes of this analysis. EPA considered it appropriate to assume that previously high exposures will probsbly not be lowered significantly below tha PEL OSHA determined that 02 f/ec. which is 10 tunes lower than the previous PEL was the lowest PEL that most of the asbesto* industry could feasibly achieve using work practice* and engineering controls. The asbestos industry challenged OSHA'* standards, arguing that s PH of 0.5 f/cc was the lowest feasible standard and OSHA acknowledged that some industry sector* might not be able to coatrol exposure* to 02 f/cc without the use of respirator*. Thus, while EPA believe* that it is possible that tome companies era below the 02 f/ce PH by tome margin. U fa probable that other* are not and (hat aoraa of these actually exceed tb* PEL EPA behave* that adjusting previously high exposure points to 02 f/oc to a reasonable means of adjusting for fadkties that may be above the PEL In estimating the bauefit* of its 0.21/ cc PEL OSHA used somewhat different assumptions than EPA has in this rule to estimate the impact of the PH oo workplace expoaura level*. OSHA's analysis adjusted all exposure* in its data base that were at or above 0.2 f/ec to 0.11 f/ec in case* where OSHA assumed that engineering controls were used In eases where OSHA aseumed that re*pintors were ated OSHA reduced the exposure* by a factor equal to the affective protection factor of the . respirator. OSHA assumed that exposure* below 02 f/ce would be reduced by 90 percent due to engineering controls. OSHA's approach assume* not only general compliance with ft* fiber level standards, but also that on average, those subject to the PH will reduce their workplace exposure* significantly below the standards to ensure compliance. OSHA did not factor non-compliance Into Its analysis of tb* easts and benefits of th* PEL because both cotta and benefits dacfiM fa proporttoe to any noncomnfiance. fas ring cost-benefit ratio* forme OSHA tula unchanged HNA SH STEW 1499 28474 Federal Register / Vol. H No. 132 / Wedne*day, July 12. 198t / Rule* and Regulations Ob tlu other hand. EPA'i assessment might be above the PEL aomc of the Uowabla short-term exposure* to 1 f/cc '! of the costa end benefit* of this nil* U affected by non-compliance with the time, a finding of technological feasibility does not require that over a half-hour period. OSHA took this action after noting that controlling OSHA reL EPA's epproech uiumn employers be able to comply with a episodic exposure* to asbestos would general compliance with the PEL but standard constantly (51 FR 22653). lower the significant risk posed by also accommodate* the possibility that Moreover, data from recent OSHA asbestos in the workplace. However, some level of non-compliance with the inspection* do not support tha assertion while the EL will probably reduce atandard exists. A* it discussed further that c-rant exposures are significantly workplace exposures. EPA does not below, OSHA laaued many citations for below PEL OSHA cited employers believe that this reduction will be very violates* of the asbestos standards in for nearly 1.000 violations of its asbestos great EPA bases its judgment on t the first year after they went into effect standards io the first year after the number of observation* regarding the Using OSHA* fiber level adjustment standards went into effect, and the nature of and arcumstanee* aaaumptlon* in place of EPA't to violation most frequently cited was the surrounding episodic exposures. estimate the effects of this rule results in failure of employers to institute First many exposures that are an approximately 20 percent lower engineering controls to maintain episodic are also unpredictable, defying estimate of cancer-cases-tvoided for employee exposure at or below the PEL attempts to control them, in industrial occupational settings. However, tf a (Ref. 32). Personal monitoring date from settings, episodic exposure* ire likely to non-compliance rate of 2 percent (a recent Inspections showed that PI out of be associated with unexpected events relatively iow rate based on non- 655 establishment* inspected had such as equipment breakdown (53 FR compliance rates in other Federal health concentrations of airborne asbestos 35620) in the maintenance and repair and environmental regulatory settings) above the PEL and the average sector of the construction industry, is assumed in conjunction with the concentration level for all episodic exposures take piece when OSHA fiber level adjustments, the establishments inspected was 0.28 f/cc. individuals who only occasionally come resulting estimated benefits are virtually 45 percent higher than the PEL (Ref. 33). Into contact with asbestos materials and the same as those estimated using EPA's While respirators were in use in many of who may not recognize such materials assumption about fiber level average the establishment* with air disturb them accidentally or unwittingly exposure (Ret 21). Therefore. EPA concentrations higher than tha PEL 20 in the course of their work (53 FR 35624). believes that Kt assumptions are percent of these establishments were OSHA directs employers to conduct appropriate for purpose* of calculating cited for violations of respiratory initial monitoring of employees' the benefits of this rule. In practice, protection provisions or for violations of exposures where they "may reasonably given some level of noo-compliance with the PEL (Ref. 48). be expected'1 to exceed the excursion OSHA's asbestos regulations, actual On a related issue, tome commenters limit However, if peak exposures canaer case* that would havt occurred stated that EPA had ignored the effect of cannot reasonably be expected, they are as a raault of that non-compliance will using best available control technology unlikely to be either monitored for or now be prevented by this rule's product (BACT) to reduce exposures, arguing protected against bans. that industry-wide exposure values are Second, the initial monitoring required One commantar maintained that EPA "not relevant to determination of the to measure short-term, peak exposures should, base its analyses solely on the consequences of an effective PEL and where they are expected to occur is data collected before OSHA consistent use of good work practice." subject to error. To obtain accurate promnlgated its asbestos standard and As ia discussed more fuUv in Unit VE. estimate* of short-tarm exposure*, should not adjust the data to reflect and in the Response to Comments monitoring must be conducted using the compliance with the standard. However. document EPA has analysed the likely strictest sampling strategies and EPA considers it reasonable to assume effectiveness of mandating the use of analytical techniques. If the proper that previously high exposure level* BACT and has concluded that this protocol is not observed precisely, have bean reduced to some lower level regulatory option would not sufficiently violations of the EL can go undetected as a result of OSHA's action, and a* reduce exposures to asbestos from the (S3 FR 35616 and 35619). discussad abova, EPA ha* aalectad the products affected by this rule. For Third, where violations of the EL are PEL as a logical approximation of this calculating the cancer-caset-avoided detected and control measures are level Other commaotart contended that through regulation. EPA considers implemented, these control measures EPA't approximation of occupational existing rather than best-caa* exposures will frequently be ineffective. OSHA exposures taking place after the to be the appropriate baseline. The expects that for many of the employees lowering of tha PEL was too high, evidence discussed in the preoeding exposed to predictable burst* of arguing that beoauaa exposure level* paragraph* indicates that many airborne asbestos, including workers tn vary considerably from day to day. workplaces do not utilise BACT and Industry and tn building maintenance industry keep* average exposure* that the adjustments EPA has made to and repair, respirator use will prove the significantly below tha PEL to guarantee its exposure data account for the impact only feasible means of controlling constant ooaiplianc* These commenlera of tha 02 f/cc PEL Where BACT is exposure (63 FR 35616 and 35624). arte similar arguments during OSHA * utilized. EPA'* analysis has taken it into Unfortunately, respiratory protection rulemaking tatting tb* new PEL . account. For instance, io its analysis of has not bran found to be wry reliable. However, in that instance, tha exposures during brak* repair. EPA OSHA ranked respirator as* last tn it* commantan used tb* variability estimated that 06 parent of brake raeamaaadad hierarchy of controls in argument to support a claim that the FBL repair shop* usedBACT. and EPA it* 1M6 nefoian to tb* asbestos was infeasible Because average calculated an average of industry-wide standard*, observing: exposures could not b# kept low enough exposure* fnduding the relatively low to goarantaa constant compliance. oaMaam froBihimufis Ratpiraton an oapabia of providing adequate protection aety If they are property OEHA refuted this argument noting that On September 14,1M (S3 PR *5610). selected far tbe eoaoaitntiaoa of airborne ! day-to-day Variability can ha tpduGad OSHA amended it* Asbestos Standards iftaminsaH promt, property fitted to the by implsyaopad that while axpoaura* to Incorporate an EL which limits employee, property and oocscientioualy worn i i ! HNA SH STEW 1500 F>dar*l Ragistor / Vol. M. No. 132 / Wednesday. July 12. 1969 / Rules tnd Regulations 29475 by tbe Mpioyet. carefully maintained. end repiaead when they have cctied to provide adequate protection. While theoretically it it possible for ell of these conditions to be met. It (a mors often the case that they art not (51 HI 22602). The drawbacks cited above are aggravated if those using the respirators era not accuatomed to working with them or svith asbestos. OSHA states in Its amendment establishing the CL that it "is concerned about relying on respirator use to meet the EL in the maintenance and repair sector of the constraction'industry," where contact with asbestos is often only occasional (53 FR 35024). Finally, even if aU the conditions mentioned above are met. respirators will do nothing to reduce the quantity of asbestos released into the immediate environment of respirator wearers. Thus, during the activity that generates ths airborne asbestos, persons near the respirator wearer can be exposed to levels that are quite high even If they do not violate the EL acd after the activity. aU persons in the area, including those who have removed their respirstor*. can be exposed to dust that remains airborne or that is reentrained after settling out Like respirators, other control measures may reduce some short-term exposures without having much impact on long-term exposures. Some control messures replace one opportunity for exposure with another. For instance, to reduce short-term exposures during brake repair. OSHA recommends that mechanics utilize either a solvent spray or a vacuum enclosure equipped with s High Efficiency Particulate and Aerosol (HEPA) filter. While both of these controls can be affective in reducing short-term exposures during the brake fob. exposures can be high later if tne asbestos-contaminated solvent is allowed to ramain in the area to tvaporala. or if care is not taken during the removal of the HEPA filter from the vacuum device (Ref. 29). Because establishments using HEPA vacuum enclosures era exempt from monitoring under the OSHA standard, high exposures during filter removal may not be detected. Again, as is the cats for respirators, ths efiactivanasa of the brake repair control measures in reducing overall exposures depends heavily on the knowledge and conscientiousness of the user. This Is also true for shrouded tools the control tneesuT recommended by OSHA for reducing short-term exposures during the cutting of A/C pipe (53 FR 35622) Fourth, the implementation of additions! control messures will be difficult, expensive, end time-consuming for much of the regulated community, discouraging compliance with the EL For instance, although some brake repsir establishments servicing large government fleets utilize HEPA vacuum enclosures, smaller establishments repairing brakes less frequently are less likely to invest in these relatively expensive devices. Moreover, while employees in government brake repair shops are usually paid by the hour, employees in private establishments are often paid by the job. which discourages the use of time-consuming work practices and engineering controls (Ref. 50). A similar situation exists in the maintenance and repair sector of the construction industry where, as noted earlier many smaller building firm* may find it difficult to institute adequate respirator programs In these industry sectors and others, limitations on resources and time may discourage the diligent use of control measures that is required to achieve substantial reductions in occupational exposures to asbestos. The record of compliance with OSHA's 0.2 f/cc PEL supports this protection The provisions most frequently violated in the year after OSHA's 1966 PEL went into effect included the requirements to conduct initial and daily monitoring, to institute engineering controls, and to institute a respirator program, all of which, are as important to achieving the EL as the PEL In fact, achievement of the EL requires stricter application of these requirements than does achievement of the PEL making uniform compliance more difficult. Moreover, the structure of the brake repair and building maintenance and repair industries, in which numarout. small businesses art the norm, will also make enforcement of the EL difficult Lb summary, attempts to reduce short term exposure* are likely to hava only a limited effect in eliminating the exposure risks posed by asbestos. Peak exposures art both unpredictable and difficult to detect Efforts to control them must rely largely 00 respirators snd work prsctice controls, control measj-es whose elTectnenest 11 uneven, depending upon the conscientiousness of the user Implementation of these control measures also requires resources that employers snd employees may have difficulty investing, snd the record of compliance with the 0 2 f/cc PEL indicates that in many cases, the investment will not be made. For these reasons, occupations! exposures will probably not be greatly lowered as a result of the EL Although the estimates given below may slightly overestimate occupational exposures tn those cases where the impact of the EL is greatest. EPA believes that any overestimate is likely to be minor overall. The following table summarizes EPA s estimates of occupational exposu-es '0 asbestos by product category and process. This tabie and the other tables in this Unit present exposure levels in terms of millions of fiber* breathed per year (10* f/yr). an index of exposure that accounts for varying breathing rates an concentration levels, and frequencies and durations of exposure among workers, consumer*, and the genera! population. Assuming an S-hour workday, a 250-day work year (both conditions do not always hold in the industries below), and a breathing rate of 1.3 m*/hr. 100 x HP fibers/year = 0.038 f/cc. Assuming a 45-year working lifetime exposure, exposure to TOO * 10* Cbera/year cames 1 nsk of 1.29 < 10-' (1 29 tn 1.000) of developing cancer (51 FR 35610). In many cases, blank spaces in the table signify that information was not available not that no exposure takes place. The high fiber levels and relatively low populations given for dis repair and disposal of A/C shingle. A'C sheet, suid roofing felt are a result of the FTE approach to the calculation of benefits (cancer-cases-avoided). In reality, per person fiber levels are lower and populations are higher. Except as noted, all exposure information presented m this Unit of the preamble dates from 1985. the roost recent year fowhich a complete set of data was available in the Market and Exposure Surveys. In calculating the cancer-casesavoided through the rule, however. ETA ha* assumed that exposed populations would decline at the same rate as production volumes. p-|--- m 1 deduct Tasue I--OccuPATiOKAt Exposures !>) ramtacL fitoondvy iwutecL ** W'l/jf *0P- MU to f/yr fWptp/tfSQOMf 10 * 1/yr < 1 HNA SH STEW 1501 2frt7 Federal Register / Vat. S4, bb 132 J Wednesday. [aly 12, 1889 / Rule* aao Tabu i--Occupatio**. ExpomjmB--Cormtmd ____ gmem nniMjMi.. w/a AJr. A/r. flftfff A/r 1 J it ffmeM fW hemkm fm*m~i UV fW tara*m iamtEa >|l | MnUm v-1---MSsMala htf j 1 ill ...... j ! .. 1 Prwen Tisn WT *00 \ 10M^ asooeeer rmnttet 1 trmml te t/y Po* 10 t/ye 13 44$ as i zu tie i_zs* 57 07 430 1 aae S3 ti 1.506 ate is an zn it tat m 9L2 563 tit 140 07 CTO 470 471 ms 2.710 300 300 38S 377 19 400 44 H3 300 20 125 i*e 12? 194 105 108 aw m JT3 ( 220 M 000 40 723 7 723 3 130 |l f1 11 1i ii 0ir etas** Roe. ! W't/yr 1 | 1 303 i j | | * 1 j 9 2 1 A AM 1 2080 2000 944 270 1t7 3 935 73 1 390 388 125 43 i 'No U.*. mmatmo** at trpot. 'Cnoow mm mmoo Momutt ml mrrtw o< woom posse (Turns e pndueton of spsoafty nMW gssfcsa. *w. rt nor tonr b nis `Raps* mm depose Igura* mudi reOuiang ony EPA wit not able to quantify a occupational exposures to asbestos. At noted earlier, there are few data on exposures during the installation. use. repair, removal, and disposal of a number of products. although exposure it believed to take place during these precedes for many of these products. Moreover, existing exposure data do not reflect the elevated levels of airborne asbestos that can result from unpredictable episodic areata, such as the accidental disturbance of asbestos matsrial by t maintenance worker. As s mesns of representing part of this recognized but unmeasured exposure. Q'A estimated occupational exposures associated with ths Installation, repair, and disposal of certain products on the basts of the limited data that exist for these products and processes and on the basis of exposure data for similar products and processes. Populations (in terms of FTEi) were estimated on the basts of production volumes and tbc persoahourt typically required lot the acuviry of coocem. These estimates are presealed in the table below, aid are used as indicated is thu preamble to assess the possible impact of the abeeace of aome occupational expoeurt data on calculations of the ride's benefits. _____ rnai ldli a ... A/Com' |i * item am* m' Tasle n--Analogous Exposure Estimates piuOdbi *00000* Nil SUrn | tOMTyr 1 20 ! 272S 51*17 350 ' J (8 ! S.741 | 07 (2 V 57 n in Noptssss* J0 *.7as 53.417 350 i se <7* *.741 lOMTyr 57 23 57 S' *w 395 *7. Enm mm Itse msewy mm mrtm eS leoue pome OunnQ e momemr m ssotny mne ammo. Brnamm mm mam Rep* ana Dmatm mm m* mm m tamer e ram m*m mem mm* me Depone n Tan t vs oi Bsrwse ^ nme In view of the hiforaiatica presented to this Unit EPA oondedee that deepHe OSHA's recent promulgetion of new. stricter standards for exposure to ttcbcfttds Is MQffcplACG* occupttioul ntp--w mi risks remahi unacceptably high. As noted earlier. 06HA has eoeerved that nzki at the 0.C t/cc PEL remain significant but that fusibility aonstrainta prevent OSHA from setting the PH, any lower. EPA's extenetve data base on occupational exposures, including information collected after OSHA'i U f/cc PEL became effective, indicates that Individual risk remains higher then 1 in LOOO for lent of thousands of people who work with asbestos product*. b. Naa-ocaipational txpoturm. Outside of the work eavironmtai. moat of the U.S. population is exposed to aebeatoe tint is released during the life cycle of asbestos products. Some of these people are consumers who are exposed to asbestos te they install, use. repair, remove, and dispose of asbestos products that they have purchased, such at roofing materials and automotive brake*. Others are exposed In asbestos tsluttd tH* ishittt Air during thi d i i h -4 'i I HNA SH STEW 1502 Federal Register / Vol 54. No. 132 / "Wednesday, July 12. 19W / Rules and Regulation* 29477 manufacture, tasteDetion. use. repair, practices and engineering controls used concentrations within t factor of two and disposal of asbestos products. Risks by workers. (Ref. 47). from Qoo-occupatiooa! exposure art not The sbility of asbestos to persist and As explained in the Asbestos only incurred by very large populations to spread in the environment makes it s Exposure Assessment (Ref 29) EPA s but occasionally can be quite high. EPA hazard to millions of people who may methodology to estimate asbestos a-.r estimates that approximately 40 million consumers and IS million of those exposed to ambient asbestos incur risks of 1 in UOO.OOO or more of developing cancer bom their exposure. Approximately 223.000 of those exposed to ambient asbestos incur lifetime risks of 1 In 10,000 or greater of developing cancer (Ref. 90). Historically, consumer exposures to asbestos have not received a* much attention as occupational exposures to asbestos, but they are s source of significant concern. While consumer exposures are not likely to be a* frequent for individual oonsumers as occupational exposures art for workers, they are likely to be more intense than occupational exposures because consumer* generally lack the exposurereducing equipment and expertise available to protect worker*. For instance, consumer* replacing their brake* ar* not likely to use either solvent spray or a HEPA enclosure, the two pieces of equipment recommended by OSHA for ose in reducing exposures to asbestos during brake repair. Consumer* may in fact employ a shop or household vacuum cleaner to remove asbestos dust from braka assemblies. technique that can laad to very high exposures because most vacuum cleaners fail to capture asbestos dust and simply fores it back out into the air (Ref. 59). Consumer exposures are also txperienced by a much larger population than occupational exposures According to two recent, independent not have tny direct occupational or consumer contact with asbestos products. Several tons of asbes'os are released to the smbient sir during mining snd milling, during'the manufacture of asbestos products, during brake use and repair, and during construction and demolition (Ref. 29). Additional asbestos is released from asbestos products during other parts of their life cycles. Once released, this ssbestos accumulates and spreads in the environment Air monitoring studies have demonstrated that urban areas, with their high concentrations of motor vehicles, construction, and demolition, generally have levels of airborne asbestos one or two orders of magnitude higher than ruraJ areas. While rural background levels range between 0.01 and 0.1 Mg/n:*. readings in large cities range from 1 pg/m* upward (Ref. 3). Thus, asbestos released during the life cycle of asbestos products is capable of elevating smbient levels of asbestos to several times the background level. The release estimates and atmospheric modeling that EPA used to estimate ambient exposures capture at least part of the contribution of asbestos-containing products produced and used in the future to ambient levels. For this rulemaking. EPA calculated ambient exposures attributable to releases from mining and milling, the manufacture of asbestos products, brake use and repair, and construction with asbestos products. Since the proposal, these calculations have been expanded and refined to include ambient releases from manufacturing snd processing plants is presented in the March 3.1987 draft EPA report entitled National Emission Standards for Asbestos-Background Information for Proposed Standards (Ref 46). This document presents emission scenarios based on the only published stud.' on the efficiency of bsghouses in the asbestos industry. For each industry three emissions scenarios were presented for baghouses opera t.ng ir. normal, non-failure mode, minimum maximum, and "best estimate" emissions. These scenarios wee based upon three different assumptions regarding the sensitivity of the gravimetric analytical method used m. the study. For all three scenarios TWA efficiencies were also calculated taking into account occasional baghouse failures Time-weighted efficiencies for various asbestos product categories range from between 99.965 snd 99 659 percent under tbe maximum emission scenario with occasional baghouse failure assumed to 99.99 percent for si! products under the minimum emission scenario with no baghouse failure assumed. Under the "best estimate' emission scenario with occasional baghouse failure assumed, efficiencies range between 99.968 snd 99.933 For the maximum emission scenario with no baghouse failure assumed, a normal operating mode consisting of iko efficiencies. 99.95 percent for asbestos product categories with high inlet concentrations (greater than 0.1 gram cu ft) and 99 67 percent for product categories with low inlet concentra'.i.'-.i, consumer surveys, approximately 40 million consumer* repair their own exposures from brake repair, construction, and demolition. (less than 0.1 grain "cu ft) was. us<v. Trasbestos product categories with r.-.p'- brakes once every 3 years, and other To estimate smbient exposures inlet concentrations, for which an consumer surveys indicate that at least attributable to milling and product efficiency of 99.95 percent was usd are 840.000 consumers repsir their own roofs manufacturing. EPA first estimated air every 4 veer* (Ref. 31). These figures do emissions per facility in milling snd in not include consumer populations each product category, using production asbestos-cement sheet and pipe fr.-.:.or materials, and reinforced plastics. Trios, with low inlet concentrations, for w h 1 exposed to asbastos from the Installation, repair, and removal of gaskets. A/C sheet, and A/C shingle, other processing during which consumer volumes and the efficiency of pollution control equipment for each product category. EPA then used atmospheric dispersion modeling based on site- an efficiency of 99.67 percent was use J re paper, coatings and sealants, gaskets, and textiles. For purposes of comparison. EPA presents some reside expoenras are likely, bit not quantified. specific meteorological data to estimate in this preamble using both the Popalsboos annually qxposed to ambient concentrations and reposed maximum emissions scenario with r.u asbestos during brake and roof repair populations. Because the number of baghouse failure assumed and the "ben' are presented along with equivalent plants involved in the manufacture of estimate" emiseions scenario with lnfoemation for exposures to ambient asbettos products is quite large, occasional Eeghouse failure assumed. asbestos in Table IV of this Unit Air monitoring air concentrations around However, in many cases. EPA presents concentration levels were estimated tach plant is impractical. The rasults in this preamble using only the from occupational data. Thi* may result atmoapheric modeling used in EPA's maximum emissions scenario with no in underestimates because, as noted asbestos exposure analyses has been baghouse failure assumed. above, consumers are unlikely to have . tested on other pollutants and has been - EPA estimate* thxtT22 million people access to the exposure-reducing work * found generally to predict their- are exposed to ambient asbettos HNA SH STEW 1503 W7> Federal RsgUtar / Vol. 54. No. 132 / Wsrhiearley. frily 12. 1588 / Rules pd Regulations r8 rileiMd dwiag tattling and product concentration of a19 f/ac and half is Table m--Exposure* to Rmwcnt Ls- manufacturing. Under the maximum txposad to an asbestos concentreHoc of estob Fou fhwMAwv ano Second v i- amission scenario with so failure assumed number of people 0.21 f/cc th* expected incidence of cancer for the entire population can be ary MANUEACTuramj--Oortnued *1 would incur risks of et least 1 in 1.QQ0 of calculated by "movine." for the purposes h developing cancer from a lifetime of of the analysis. 0-01 f/cc of exposure exposure (ReL 90). Under the "best from the 0.21 f/cc population to the 0.18 Nona !TM ------- , (KP I'm estimate* assumption of baghouae e"idency with occasional baghouse failure atacy thousands of persons would incur risks of at least 1 in 10,000 ef developing cancer from ambient exposure to asbestos from plant emissions. Table IQ of due Unit, besed on the maximum emissions scenario with no baghouae failure assumed, lists the exposure levels and populations associsted with plant releases for each product category. For each category, f/cc population, yielding an average exposure level of 0.2 f/cc for the entire population. For populations of the same sue. the (L01 f/cc came* the same risk whether it is sssocisted with an additional exposure of 02 f/cc or a10.19 f/cc As long as th* cumulative population exposure (the sum of the products of the various exposure levels and the populations exposed to escb) remains constant. It can be distributed in any way among the population without affecting (he calculation of Dnjm briM tnkip | flV*___________ i MM2.W1 073 Ome brut o*di (LMV)__________ 1 I 240*9.022 1 0 0214 Osc &-XX4 aids (WV) _ L7p4.se} , c OOOOOOS27 Bum Moca*________ Tas 4 c striae Outer ______ 1 6,7r471 040*7 Automate 1 nnnuon oomoontnti.... . I 0 10 FiiHOB NVtfBFIriA ___ 12.122247 1 0 00234 An-- aaewg____ c. 0 Snsst gtstsw 1_____ 4&61241* 1 0<T6*1 Root ooasngs 64470.429 Q 3CuQ3 Non-mot ix--ttfs___ 7Q.3B.3H 0 0CKXX&4 exposure levels have been averaged over the entire population exposed. As detailed in Unit V.F and in the Asbestos Modeling Study, actual exposures are expected cancer cases. The following Table IQ. based on the maximum emissions scenario with no baghouse failure assumed, lists the exposure 1 Esxanns wws means * wMSn ns tonoar at cco*m oojmC amn$ n prouw o> rdus&W j****** wtocfi arv tenrwd Oy th* t\m much higher for some people and lower for others, but the total populations end avenge exposure* presented here levels and populations associated with To calculate exposures to asbestos plant releases far each product category. released into tbe ambient atr from i provide genera! gauge of exposure for each product category and were used to calculate the benefits (cancer-casessvoided) of thee rale. Table w--Exposure! to Ambient as bestos PROM PRIMARY AND SECONDAjrr Manufacturing mining and construction aim* and from brake repair fadlidea. EPA eatunatad emissions os th* basis of its information on occupational exposure* during I Averaging has no effect on EPA'* calculation of benefit! because EPA uses a Ikieer dose response model to Product PooUaton 0PQP0 Ah'f*g> mining, construction. and braka repair. Then EPA used atmospheric dispersion modelling to ralmlata ooactaXrUioa * protect cancer cases-evoided. A Sneer levels and axpoaad populations. 4* f } dose-response model assume* that an individuars risk of developing cancer increase* at a constant rate with his or Coflvnirsl most --... 00 Rotooam----------------- 1 00 WINDOW*. ___ S.747.S75 *0232 Postes wm_______l 4.S47J07 047* The following Table IV bats the exposure* and populations associated with releases from construction and her exposure to asbestos. Thus, for Bstts>-sdS gsmet1 _j 37.1S8JBI 0037} brake repair. The populations exposed i population* of equal sire, a given increment of exposure carries the same amount of risk regardless of any PSP*-------------------- RocAng Wl ,, , Floosnf IM________ ts*.m 040S 0 e are approximately equal to the urban population of the US. There are two exceptions: (1) brakes for light- and difference* that may exist between the populations m ths magnitude of the expoures that they axpesinxje in addition to H. For exasipl*. tf half of a population is txposad to an asbestos Conugswd psosr-- V/A fcvw * A/r A/C m M ___ A/C oorrugaud A/r-wesjan J o o 1913.002 21.232466 6 661.143 0 0 0.107 0021* 000301 medium-weight vehicle*, far which annual consumer exposures are added m. and (21 roof coatings, for which annual consumer exposures alone are counted Table N--Exposures to Ambient asbestos Prom Construction and Brake Repair and Exposures Prom Consumer brake mc Root Repair Av^if W Ao*ia Rooms IWBJtlJOW N40W sn* RmosR PooUston IOM/r ^Qputton 10M/f 171.138.37} 171.136473 1n.tss.379 171,136473 171.134979 0.00001* ,Q60034 *9000028* 040000643 <10218 1.161 171,1*973 0.00000*7 171.194X73 171,136473 T7l,m373 US.7IX7N imrum a0000173 A40000M 04000067 00123 6.00634 AA9AWW 4060171 Ti mb nilti rrf Hrnsitn idinl'ni - bote . VA Bret twfaxlaled th* toml fat eedb sf Aweriree dthsuBsing released Into the aslant air through ' asuant of asbestos Batted base hcakaa studies taaka **** id HNA SH STEW 1504 fadreai Register / Voi H, Kg. 5J2 / Wednesday, f\iy 13. 1M9 / Rules acd Refutations !75 estimates stalk* tootled by vehicle type (because rmfutons v) by vehicle type) In each city. Second, EPA performed atmospheric cfiipertfon madeheg sf thee* (mission* to estimate concentration* In each dty. Third EPA grouped the ctone topaths* by population, obtaining average cancantra bom (or each goup. To ' estimate the population* exposed ta each of the** average concentration* nationwide, EPA added np the population* living in the U S. cilia* similar in size to the cities at each group. Became non# af the eriginel M efttoe bad fewer than 25.000 inhabitant* and because vehicular traffic it kia concentrated in rural area* than at cJbe*. population* living in area* with fewer than 2&000 inhabitants were aaauaad to have no exposure to asbestos released during brake tie*. Finally, EPA averaged the estimated concentration* over att population group* from area* with more than 25.000 inhabitants, weighting each concantration by the population expoted to 1L Using thf* technique. EPA estimate* that 100 million people (the 1M0 U.S population living m aiaaa of more than 25.000 people) are exposed to 8.7 x 10** (ig/m* of ssbestus resulting from the use af asbestos hrale* (RaL 31). Th individual risk of developing cancer from a lifatima of exposure to this concentration of asbestos is estimated at approximately 1 in a million. level which is significant given the very large population exposed. Because populations living in trass with fewer than 25.000 people (53.5 percent of the U.S. population) probably eaa exposed to at least some asbestos km brake use. this estimate should be considered a lower bound. in addition to the rspnaiiraa quantified abavc. EPA believes that other significant ambient exposures occur that cannot be easily quantified. One type of unquantifled exposure results from rciecses of asbestos that are difficult to measure, sseb as the gradual sreathering and disintegration of constriction products aaad uutduura. A number of studies lndfctoe that these release* are probably significant indirect evidence ofweathering comes from soreraf studies of corrosion in A/C pipe soft add water has bean found to diaaoive A/C pipe to wtot instances (Ref.S). Became refn wafer is liksfy to be both ooft and add, tt is Bkaly to be aery uaiuslu to A/C matettato. Oirad svidanc* ofweathering supports this pryctioH. A study of aroaioa to A/C **"* bond vtsibte differences to wear between ana* ot shingle that m exposed to the elements snd areas that were paatened. and impaction of tba worn areas with * scanning electron mtaoecope rssealed a network of sfbestov fibers on (he sbrngfe surface. to addition, concentration* of asbestos ** high as . 543 miIB00 fiber* per filer (mfl.) were found in runoff collected from roofs covered to A/C sfngfe. Ten mfl. Is considered abnormally high (Ref 511 Another study detected ssbestos releases from construction malaria Is after a shingle storm: seven! air samples taken after s heavy rein at a school with A/C walkways and roof panels showed significantly elevated asbestos concentreSons (Ref. TJ. Thus, in areas where there is widespread cse of A/C sheet and A/C shingle, westherragis probably an important scarce of ambient asbestos. Another type of unquantifled exposure results from (bt tendencies of asbestos to persist in the environment and to reenter (he air after settling out. Bob the durability and aerodynamic properties of asbestos are well documented. The extraordinary ability of asbestos to survive for long periods under a variety of different condition* is often died * en important reason for its incorporation into a number of product*, including paper products used as insulation, friction materials, asbesto* cement product*, packings, and gaskets. Reentrainment is supported by studies finding high airborne asbestos concentrations not only near waste piles but opwind as well as downwind of point sources (Ref. 48), a finding most likely to result from the tesuspemion of asbestos deposfted earlier by wind* blowing in the opposite direction. This evidence indicates that over time, asbestos builds up to some degree in surface waters and soils and (hat some of this build-up Is continuously reemraroati in the air. This process of btofcd-up snd reentrainment to referred to at environmental loading. Because the likelihood of reentrainment in the environment depends upon a number of factors that are difficult to measure, inducting th* fraction of ulistoa* tital ia washed away by rainfall or touted under later sail deposits, reentrainment ba* not been included in EPA'a atmospheric modeling That EPA ha* not quantified exposures atoitoitable to environmental loading- Nonethafeks, EPA is very concerned about th* passible impact of this procaaa an exposures to atobieat ssbestoe. Given its durability, aabeetoe may persist to the environment for e decade or man after its original release, and aaeiroomentto leading to likefr to be most severe la urban areas, where large population* bath create tad come tote coatact with asbestos teietaes. to fact the elevated rearing*(tan* of asbestos found eumerou* studies to when areas probably result st West n pert from environmental loading. Th* pottaual longevity at the nak posed by envtiaoma&ulloading ui major factor tn EPA'* decision te eliminate that nak at lu *ourc* by banning most asbestos product*. Some coouneoters argued that exposure* to asbestos released into the ambient air by the aunufseturt. importation, processing snd use of asbestos-containing products are insignificant because (he risks associated with rich exposures are very small However, individual risks from asbesto* in the ambient *ir can be qor.e high for persona firing cear asbestos product plants, construction sites. 0: other sources of release. As noted earlier, under the maximum, emission scenario with no btghouse failure assumed, a number of people wouM incur risks af at toast 1 m tMO of developing cancer by firing n> such ares*. Under the "best estimate' emissions scenario, many thousand* of persona would still iocw a risk ef at leas' 1 in 10.900 front ambient exposure to asbestos from plant emresions Moreover. bile most psopie exposed to ambient asbestos from csbestoscantaining products incur individual risks smeller than 1 in 1.000. the number of people exposed is extremely Itrge. making the total risk 1 concent. c. Exposure front imported and exported asbestos products EPA has dete*mined that significant exposure is ltkeiv from imported asbestos products Although mu eeposura to U.S. populations is avoided when asbestos products era auBofactared abroad ana imported rather then manufactured in the U.S. (fareqsn exposures and resulting cancer casts are aat toctoded in the estimates far thi* ndet. significant exposure* still occmr after import at tee product* into this country. US. exposures occur during transport, instillation. w**. maintenance, removal end disposal of the product A* noted above, large numbers of people are exposed to aabasto* during thate activities and Ifaa level of exposure 1* .. , ......oftaa quite high. during Iho ILS. portion of the like cycle of esbestne -rnntsiatog product* manufactured in this coamry far export These exposure* occur dunng the mining and miUir^ of *he*lra fiber and the professing ef fiber in*o product* Families sf worker* and population* living near mining and manufacturing HNA SH STEW 1505 Federal Register / Voi Si No. 112 / Wednesday. July 13. 1989 / gale* and Regulations sit** m *lo sxpoeed to asbesto* result o{these activities. Therefor*. (i la discussed In Unit ID3 of this preamble. EPA find* under faction 12(a)(2) of TSCA tbat tha manufacture or processing for export of ssbestosoontainlns product! tbat art subject to tba rule will present an unreasonabla risk of injury to human health. Therefore, the manufacture and procession of asbestos-containing products for export is not exempted from this nils under section 12(a)(1)- and is subject to the rule's bans. d. Expotureiconclusions. In conclusion, EPA finds the Intensity, scope, and potential longevity of human exposure to asbestos released during the life cyoles of the products subject to this rule cause for serious concern. In spite of efforts to control exposure, asbestos is released and inhaled at all stages of the life cycles of asbestos products: extensive exposures have been quantified for workers, consumers, and the general population. EPA estimates that thousands of asbestos workers and member* of the general population incur individual risks near 1 in 1.000 from exposure to asbestos released from the products subject to this rule and that millions of people incur risks near 1 in 1.000,000 from such exposure. These risks are very large. Moreover, evidence indicates that significant exposures take place that cannot be quantified. EPA is especially concerned about exposures from environmental loading, which may occur long after the initial release of asbestos from a product B. Environmental Effects The unreasonable risk finding for this rule is based on tha risks to human health posed by axposure to asbestos. These risks are the most readily quantifiable consequences of the commercial use of aaboetoe and are sufficient to support the actions taken in this rule. However. EPA is concerned about the potential environmental fleets of ambient loading due to continued manufacture, importation, processing, and use of commercial asbestoc products. Exposure to csbestos fibers has been dearly shown in both human and animal studies to cause severe health effects. Effects on wildlife have not boon quantified for purpose* of this ink. Howevsr. because asbestos fiber* an extremely durable and transportable. SPA believe* that continued asbestos use will leave a legacy of serious health and environmental effects due to unnaturally high oopcantratioo* of aabesto* in the ambient air. . C Aebettoe Sabetitutet Table V. --projected Market Shares This Unit discusses tha relative or Current Substitutes--Continued availability of substitutes for asbestos in asbestos-containing products and the potential health hazards posed by such substitutes. EPA has found that suitable Ptodud and fcdcV%m Aaorownaw I <1 Maiflrmam* mSwnMare substitutes currently exist for most uses of asbestos. EPA believes that the benefits to society of asbestoscontaining products are relatively small because of the current availability of many substitutes and the expected development of others after promulgation of this final rule. I. Availability ofeubstitutes. This aubject is described in more detail in Volume QL Appendix F of the Regulatory Impact Analysis (RIA). Further responses to comments on these subjects can be found in the Response to Comments document. The availabdity of A/Cerae PoywyemaiM (PVO -......... -J Orcue -- --------------- Arc lei meat Cetoji* Wceu---------------------- Non<*teum mam___________ Ltaorattn, ane*_____________ ArC conugsied meee Ffeargnaa iwSoreed paeec____ AUnrun Steer_____________________ noyn-rcAgeonoa................... A/C mngtee- | wood_____________ j Vry-------------------------------------1 Asenalt ____________ aa/twuh_______ _____ J j 3 r ra < 20 32 11 S 32 v 20 19 substitutes for the various product groupings subject to this rule are discussed in Unit V.F. of this preamble. The following Table V lists currentlyavailable major substitutes far asbestoscontaining products that are banned by this rule and the market shares for each product category projected for the substitutes in the absence of asbestos This breakdown does not take into account the development of new substitutes or new applications of Onm erese Snetge. | Norvasoanaa organes_________ 1 SenwneteRe................... .......... Owe enne cedi (LMV end hmv) `Tana inenBr Brake aoefea Non eetwecie organa________ Sene-metafc Omen teoatge Eiaooaar amran-------------------- U.S ananj Monad ararroJ Molded t>7ui_____________ Amonwte Vanarreanon compo- 99 100 90 1 SO 30 10 10 existing substitutes since tbe preparation of the RIA. It also does not account for the likely development of new substitutes before the effective date of this rule's bans. EPA is aware that it may not have identified all substitutes for asbestos-containing products and tbat the costs of the rule may be overstated as a result. Table V. --Projected Market Shares of Current Substitutes faAAoaa______ Omar tneoon mannau. Ffearguss t pers-eraree......_.... Maooenr Sondera board.............. J Pratraan board............. .......... Speaelrr paper j Eerm and eeAraae___________ ' Looee oakeoee----- ------ J Root ooeenge. I Caraanee! BrwAjn^avLfjMwnnai ....... 1 I JI Omar-------------------- . Norwool coalmen Slnmaac tear*______________ CM) and nenerei---------------------) 100 IOC SO 20 SO so sr s s TO 30 Rradue and suoafttuw Approomaw Subamna SSefMi Snere (percent I Substitutes for asbestos products are steadily being developed and accepted in the marketplace It should be noted Seten (R)------------- ------- -------- Puregees (R)------------------- ---- Beeter-edd Jewess Cefcsoee------------------------- ---- i Aramd.------------------- -------- -- I>rrsa ........ PuNteveSucraefTiAene------------- Gnpta*------------------------------- Canme men Pen-ererad-----------Ftane peee_______ Onpnaa___________ CeSieoee___________ WpenSuese^Mfle Cannae___________ Boding Me BSiga s* nwmnna- that a number of products that are 32 I K subject to this rule's bans are no icir.gei manufactured or imported in the U.S. lr these cases, viable substitutes have 30 apparently forced asbestos-containing products from the US. market. An 10 10 s increasing rate of availability and acceptance of aubatitutes is evidenced by a more rapid decrease in asbestos 30 use in moat product categories than was as is predicted in the RIA for the proposal. 15 Public comments have identified new 10 snbsitutes and indicated that substitute 5 prices have decreased substantially 40 SO beyond the estimates generated in the RIA tor this final rule, in addition. EPA 10 believes that this rale will further spur Register f Vot 34. Wo. 132 f YVednegtfay. Inly H. 1389 / Rules and Regulstlooa 234S1 tht development of rabjfarate*. thereby increasing availability and decreasing OO*t*. 2. Health risk rcrtcir offibroot asbestos substitutes. Tlu* Unit addr***** Ore potential health risks caused by tapesus to mrioos fiber* pao^seted te replace atbeatoe in products beamed by this rate. This subject la dbeoeted in more detail te ft) "Review of Recast Epidenioiogical Investigations oh Pcpcie'ions Exposed to Selected Noe-esbesto* Fibers' (Ref. 33); (2) IteiUe Fiber Exposure Aiiiff' (Ref. 38); (3) "Dursbte Fiber ladany Profile and Market Oetiook" (Rat Vt and (4) Hesteh Hazard A sesssTBtot of Nan-asbeatoa Fiber*'' (Ref. a). Further reapoases to comments ca thi* wbject can be band in the Response te Cemaenta document Baaed an available information and a public health policy regarding asbestos. EPA has more concern aboot the continued uae and espoure to asbeatoe than it baa ter the fbtura replacement of asbestos in the products aabject te tern rate with otere fibrous substances. Available tefambon abort tbe fibrous aubatitutea under review for this rulemaking rapports the ceedarioa that the fibrous substitutes appear to pose a lower hums* health hazard than asbestos [Bet 3g). However. dae te limited date. EPA caaaot quantify tbe risk that stay he poaed by fibrous asbeatoe aubatitutea. EPA believes it is prudent public health policy to regulate asbestos rather than to delay regulation until all risks of substitute products are definitively datenained. Tins conclusion is baaed on a consideration of (1) Available data on the health hazards and exposures pnasd by asbestos and Its substitatar. (2) the {actor* that enhance or mitigate fiber pathogenicity. (3) an understand iag of the deficiencies of tbs data available on health hazards and expoeucaa of substitutes; and 14) EPA'a public health policy of reducing known, serines health risks, a. Background EPA. far the proposed nde. perfumed a review of the available hazard end exposure information on eight fibrous substances (bat could substitute for asbestos te 'Asbestos Substitutes sad Related Materials' (RaL M). in raapouete public comments recefvod an the proposal. EPA conducted tsi extensive review of available tefotmatton end apdated its hazard and exposure assessment of fibrous asbeatoe aubetitutaa (see Reft. 38.38.37. and ag. Specifically, tht* analysis Included six man-made or synthetic flbrou malarial* (aramid fiber*. caxbon fiber, ceramic fiber*, fteraaxgjna. ntinarel wootind polyotefls flLtna). aod two neturaffy* occurring fiber* (ettapulgfte and wofteifonire). The** efgbt fibers were individually telectad for review because (1) They are commercially important (2) they are potentially tbe major fibrous substitute* for tsbeftar (3) they represent fiber type* with broadly different physical and chemical characteristics: and f4) hazard and exposure date are available. Q'A chose to place its emphasis on the review of fibrous substitutes because their morphological similarity to asbestos suggested that they mey tetfuce cancer Other non-fibrous substitutes, specifically, wood and other cellulose produet*, cement end bricks, appear to pose littfe or no health hazard and. far this reason, their potential health effects have net been analyeed te detail for purpose* of this rule. b. ffeaftfi effects effibrous substitutes. EPA conducted a comprehensive review of the experimental and epidemiological hazard date ter the eight fibroua substitutes (Refs. 35 and 38). Available epidemiologic*) and toxtoeiogical data indicate that inhalation exposure to saaae fibrous substitute* nur be associated with maiignent aid notv malignaet disease* te banana. However, the evidence *f carcinogenicity and fibrogenidty of these substitutes r more limited than for asbestos. Based on available data. EPA bat concladed that, under suniUr experimental coruhtiaos. the fibroua substitute* are generally leu biologically active tad pathogenic than asbestos (Ref. 38). Uatikc tbe fibrous substitutes, asbestos it a weilrecognized potent hnetan carcnsogea. which also causes nog-malignant pulmonary effects. At tins CL te. EPA cannot make a definitive assessment of the biological activity and pathogenicity of fibrous substitutes te eacnpemae with asbestos because evaiabie date on the health effects of the substitutes are incomplete. EPA has not derived a carcinogenic potency ter any *f the fibrose asbestos (ubstitete* respected to pas* e carcinogenic concern. because either available epidamietogical date and/or animal tehaiatioe data are inadequate to eetabiieh a quaatitetiv* exposure-taapaose rotetinestep ar hiaaor response has only bees ahaavid is animals via noo-phyainlngtcte routes of administration. such as imraperitenaal inaction Pet, 38). One wmiminta cQaloodod that s potency usfue could he datertninad far fibrous glass aod niseis] wool based on epidemtologusl data and caneluded that the poteacy may be comparable to or exceed tee potency established far aibestos. EPA be* concluded that potency value cannot be derived Cur fibrous gtass because the epidemiologies/ evidence far carcinogenicity of these tibsunces it inadequate. The data c.ted by commenter* do oot show consistent eletation of hing cancer risks to exposed workers or provide tufiiaaot informatioa to demonstrate t doseresponse relationship (Ref. 3S). Further. It it not appropriate to compute potency values from the available experimental data because (he inhalation studies is animals did not produce tumorigenic responses (Ref. 38). Simla.-iy. carcinogenic potency cannot be determined far mineral wood beca-.se dose-response information is not available from existing epidemiological studies (Ref. 35) and no tumangemc response* were found te available inhalation itudles (Ref 38). The commenter alio dated that a uni; cancer risk could be developed far aramid fibers using results from an animal inhalation bioassay far ultrafuie para-aramd. Tbs commenter made use of the linearized multi-stage procedure to calculate nik. In calculating the un:t cancer risk vahie. the commenter only considered * subset of the hioassa) data (Ref. 58). Consequently, EPA does oot believe that the analysis presented by the commenter adeqaateliy reflects the results of the binassay (Ref. 58). EPA is continuing to gather additional information to evaluate potential cancer risk of respirable aramid fibrils. Additionally. EPA 1* assessing the appropriate model to use to extrapolate cancer risk (or aramid fibrils. Unprocessed commercial-grid* paraaramid. a type of araxiid fiber. 1* manufactured in sizes that are 100 Urge to be respirable (Ref. 36). to addition not all types of aramid fibers are expected to produce fibrils (s-g.. continuous pars-aramid) (Rel 36). Tbe pars-aramid used in tbe cited animal study was a highly respirable material made tprrifirally for the study (Rel. 38). Although the commercial-grad* of paraaramid is believad to have the potential to generate respirable fibers as the small fibrils peal off from the aoc-reiptreble core matrix, exposure date eca too limited to deters*me if fibril formation poses a significant concern. Limited monitoring data (meihined area samples aod personal samples) indicate that irpnoir-- to para-aranud Gbnle range from net detectable to a maximum of 73 f/cc (Refs. 38. M. sad 35). According to a commeatxt. during manufacture, a marimum fikaly 8-bcar TWA of Cl fifee was recorded. Acaording to tee tan* cetnatnlez. during production and proceising of HNA SH STEW 1507 .J.G. |=^-ieGay, July i*. / Ku.es friction mattriels. the maximum likely 8- future trends of the tight fibrous hour TWA was 1cm than 0.1 f/ce. Due to * substitutes (Ref- ST). EPA also developed the way that the monitoring data were n exposure profile of durable fibers precantcd It li difficult to determine If (Ref. 30). To this end. EPA conducted s theae data are representative of search of the literature and surveyed occupational exposure (Refs. S2 and 53). industry sources. This analysis focused In addition to the limited monitoring primarily on activities and applicanons data, exposures were only monitored at most likely to generate airborne fibers of a few industrial operations which are respirtble size. Exposure data for suspected of producing respirable fibers fibror ibititules. although very (Ref. SI). Additionally, it is not known if limited, were available for all fibers those operations are representative of except polyolefins. Most exposure data the Industry (Ref. 53). Based on available in the literature are for fiber available information. EPA believes that manufacture. Exposures during man neither commercial-grade aramid made end synthetic fiber production are products nor fibrils formed from such typically less than IB f/cc because products may pose major occupational, processes are highly automated and consumer, and ambient exposures often enclosed, meaning thst operators Generally, it appears thst aramid fibrils are rarely in contsci with the fiber (Ref. tend to curl and clump together, thus 38). Many of the packaging operations reducing their tendency to become or are also automated and ventilated, and remain airborne. Fibril formation the exhaust is sent to dust collection appears to be a by-product of aramid equipment (Ref. 38). Often the fiber size manufacture and processing. Fibrils are composition of s sample of airborne not expected to become an integral material is not noted. YVheo fiber size component of aramid products. In distinctions have been made, respirable contrast asbestos becomes airborne fibers can constitute 50 percent or more easily and can remain airborne for long of airborne fibers. However, as noted periods of tins*. above, airborne fibers typically c. Respirability. A basic property measured less than IB f/cc. Much of the which allows a fiber's potential toxicity airborne occupational exposure data to be expressed is its respirability. i.e.. available to EPA is outdated. Since the ability to penetrate into the lower many of these data were developed, the respiratory tract Respirable fibers are industry has become increasingly generally defined as fibers with actual automated (Ref. 38). Therefore, current diameters of less than about 3.S microns exposure levels may be iowet. or an aerodynamic diameter of less than Production of naturally-occurring about 10 microns. Once in the lower substitute fibers presents s different respiratory tract other factors such as exposure scenario than man-made fibers fiber length and diameter, surface, and since the former are mined and milled. chemical properties ire thought to Mining and milling have traditionally influence biological activity (Ref. 38). been "dusty'* operations where the use According to available information, a of engineering controls or personal large percentage of the production protective equipment are difficult to volume of these fibrous substitutes integrate into the routine operations of consists of non-respirable fibers (Ref the industry. Mining operations are 36). Because non-respirable fibers are labor intensive and exposures are likely, unlikely to enter and penetrate the hmg. however, most mining is performed in such fibers pose minimal risk of open pits which allows for some inhalation toxidty. However, some ventilation. Milling operations use portion of the production volume for mechanical grinding and screening many of these substitutes contains machines and exposure occurs to fibers of respirtble size. Such fibers are workers who run these machines. Both of concern to EPA. However, available dust and fiber concentrations have been information indicates that fibers tn the shown to significantly exceed OSHA's respirable size range are generally nuisance dust standards (Ref. 36) manufactured for specialty uses, such as During woilastonite milling, a limited high-temperature insulation materials, study found fiber concentrations ranging filtration media, tar defenders, from 30 to 80 fibere/cc (Ref. 38). ipacecrmft. and aircraft insulation (Rsf. While worker expoaure to attapulgite SB). Specialty weemsy be of concern b and woilastonite may be high during tareu of risk to individuals but do not certain mining and milling activities, have a* greets potential For broad available information indicates low population exposures. hazard for woilastonite or short fiber A Exposure-offibrous substitutes. attapulgite (Ref. 38). Attapulgite mined EPA conducted kn analysis of the in the UB. Is of the short fiber variety durable fibers industry which included' (RtL 16). The UB. supplies over 90 safomattonabont producers, uses, and percent of (be world-arid* demand for attapulgite (Ref. 37). Based on 'A'* analysis (See Unit V.C.1 of this preamble), neither sttspulgite or wollastomte are expected to be important aabestot subatitutea. Some comraenten a led exposure data for various fibrous products and concluded that the exposure* sometimes exceeded the asbestos PEL. These commenter* were concerned that expoaure* may pose a significant nik in general, production end uae of respirabie-atze man-made fiber* and mining and milling of the naturallyoccurring mineral fiber*, may potentially result tn some exposure* that exceed expoiures from asbestos (Ref. 361 While the date on certain fibrou* lubititute* indicate that occupational expoiure may range from not detectable to levels that exceed the asbestos PEL levels tn excess of the asbestos PEL alone will not lead to significant risks unless the substitutes present a health hazard of a magnitude approaching that of asoestos. As explained above, available Information on the hazards of the fibrous substitutes indicate that they are ten biologically active and pathogenic than asbestos. Given the scarcity of exposure data, the numerous types of processes or activities involved and the variable characteristics of the many fibrous materials. ETA hat concluded that reliable projections cannot be made about exposures to fibrous asbestos substitutes. This is contrasted with asbestos manufacturing, processing, and use practices about which much is known and such conclusions or reasonable projections about exposure can be made. e. Risk offibrous substitutes. Some commenter* stated that EPA should perform risk analyses of the same depth for the non-asbestos substitute* as EPA performed for asbestos. Commenter* also stated that EPA't substitute analysis should consider the entire life cycle of the substitute, including the r-.tV associated with non-asbestos raw materials, by-products, contaminants and energy production. Additionally, some commenter* stated that EPA should consider other health and environmental effects in addition to cancer assodatad with the substitutes, including silicosis and death due to trauma. For reasons described previously. EPA believes that tha available data base on the hazards and exposure to substitute fiber* is not sufficient for EPA to perform quantitative risk analysis. Whila EPA adopted a life cycle approach to tts risk analysis for asbe*tot. EPA did not Include in that 1 i 1 l 1 A \ i i a i i \ < tt i 1 Federal Register / Vol $4. No. 1S2 / Wednesday. July 12. 1969 / Rule* and Regulation* 29443 tnalysis additional risks that may result from: (1) Exposure to raw mstensls. byproducts, or contaminants associated with production and use of asbestoscontaining products: (2) accidents, or (3) energy production and consumption required to product asbestos products. EPA quantified, to the extent possible, only risk* of cancer associated with exposure to asbestos fibers EPA adopted a similar life cycle approach in ita review of substitutes and only evaluated the potential that the fiber itaelf may cause cancer or nonmalignant lung effects. In summary, the review epproach adopted for substitutes is comptrable to the approach used for asbestos and is only limited by the availability of data. Some commentert stated that EPA could not conclude, based on available data, that subatitutes pose lower risk than asbestos. EPA agrees that the data base is insufficient to quantify the risk of substitutes; however, in spite of the deficiencies of the duta base, information is available to indicate that (1] Some non-fibroua asbestos substitutes pose little or no health risk concern: (2} the inherent biological activity or pathogenicity of the substitute fibers sppear* to be less than asbestos; (3) large percentage of the total production volume of fibrous substitutes is non-respirable. and thus does not pose a risk concern: and (4) the diameter size of man-made and synthetic fibers may be controlled, thus enhancing efforts to reduce the presence of contaminants or unnecessary respirable fibers in substitute products. f. Policy approach to asbestos and asbestos substitutes. Regulatory decisions about asbestos which poses well-recognized, serious risks should not be delayed until the risk of all replacement materials are fully quantified. EPA believes that this is a prudent policy aince: (1) Asbestos is human cardngen and poses * serious risk to health: (2) substitute fibers appears to pos* lest hazard: (3) years are likely to pate before experimental toxicological data art available to quantify or adequately evaluate the poeaible health effects of substitutes; (41 a decade or more may pat* before epidemiological data of the quality that xists tot aabeatoa may be available to confirm any hazard* of aubstitutes identified in experimental data: (5) evolving fiber technology and the advances within the chemical industry ere likely to create nsw aubstitutes. thus meUng tt qnite difficult to evsr fully analyse tbt risks of all possible major substituiss; and (6} risks associated with man-mad# and synthetic fibers appears easier to control than the risks resulting from ssbestos use because fiber diameter size can be technologically oontrolled. EPA will control to evaluate hazards and exposures posed by fibrous materials tnd will determine appropriate regulatory action to mitigate any unreasonable nsks that may be identified. EPA may consider regulation of fiber diameter and length of substitute fibers if it is determined that such risk reduction action is needed. EPA recommends, that, whenever feasible, manufacturers, processors and users avoid the production and use of respirable fibers. EPA tlso strong!) encourages manufacturers and proceasor* of fibers to institute quality control practices that minimize if not eliminate the inadvertent production of respirable fiber*. D. Economic Effects of the Rule EPA has prepared a Reyuiatory Impact Analysis of Controls on Asbestos and Asbestos Products (Ref. 21) which analyzes the potential economic impact of the rule. EPA's assessment of the "reasonably ascertainable economic consequences of the rule." pursuant to section 0(c)(l)fD). is summarized below. The methodologies used by EPA to estimate .the costs and benefits of this rule comport with widely-accepted costbenefit techniques. The methodologies used snd the data on which costs and benefit estimates are based have been updated to reflect public comments. Further responses to comments on this subject can be found in the Response to Comments document. 1. Estimated costs. Estimated costs were derived using the Asbestos Regulatory Cost Model (ARCM). which is described in the R1A and which primarily used information collected during telephone surveys conducted by an EPA contractor during 1986 and 1967. EPA alto used tome data obtained under the TSCA taction S(a) atbetto* rule to estimate costs. Some information was adjusted to reflect more current data obtained through public comments and from other sources. The sources of Information are noted in the record for this rule. The costs represent the net present value of coats incurred doe to changes in asbestos production volume between the years 1967 and 2000. using a social rata of discount of 3 percent. The 13year time period serves as a reasonable endpoint for the analysis at a point well after all the actions taken in the rule have become affective. Tha percent rate used to discount aosts (and - benefits, as discussed below) Is a reasonable rate set by consensus by EPA economists This figure falls withm the range of social discount rates suggested by the economics bteraiure In estimating the costs of this role, tllowence is made by the economic model to estimate declines ic the pnr.es of substitutes. In practice, the ccs: of s product, in real terms, declines over its production as experience is ga-red in the manufacturing process In aoi,' ->n experience under other reg--!a:,c-.s has shown that the number of subsfres will increase es a result of proitic: regulation Some of the new subs'itu'es will be of lower cost than some of the existing lubstitutes or the) will no* capture market share from the exisfng substitutes. Both of these effects will lower the prices of substitutes Ne"icr of these effects can be full) quant.fied However as the cost of subs'.nu:es decreases, the overall cost of this roie will also decrease. The economic model does not take into account the cost reduction benefits of using substitutes which currently have lower costs than the asbestoscontaining products. In other words, the analysis assumes that the pnee of substitutes, after being adiusted for product life and performance, is slwau greater than or e;uai to the price of the comparable asbestos-containing product Thu was done to account for differences in the characteristics of asbestos and non-asbestos substitute products that cannot be captured in cost differences. For example, because asbestos-containing products have been traditionally used ui these markets, a bias ir.a) exist toward the use of asbestos products rather than simiUrh priced substitutes However, this assumption overstates the costs imposed by the rule whenever tn substitute actually costa less tnan me asbestos-containing product and there is no significant difference m product performance characteristics. EPA attempted to gauge the possible effects of expected declines in the prtcof substitutes on the overall cost of the rule. The analysis of costs of the boo:taken in this rule assumes that the prices of substitutes for asbestos products will decrease by 1 percent annually over the life of the 13-vear period analyzed in the ARCM. However, the analysis also assumes that the cost of individual substitute products will always remain greater than or equal to tha price of the comparable asbestoscontaining product for the reasons described in the preceding paragraph. EPA bebeves that tha assumption of a limited 1 percent decline in the price of substitute* is a reasonable "best HNA SH STEW 1509 2MM Federal Kegisfor / VoL 54. No. 132 / Wg<jr>cday, ]ujy n. 1*89 / K:.tes and estimatt* t tight of A* effect* of <S Table vt--Cost or "me time gr prod Table w--Cost of the Rule b* poo- growing markets for such product*. uct CATEGORY ASSUMING A 1 PERCENT uct Category Without the assump Increasing competition end production know-how tn these mtrketi. end the likely development of new, more costeffective substitutes that have not been quantified for the ARCM. Coat* ettimtted tn the IUA include cot* to consumer* and costs to Annual Oeojne in tw Price or SUB STITUTES Freduci Tote com (In t raon. SecnnwSN S paraanQ tion OF. A t PERCENT ANNUAL DECLINE in the Price of Substttutes--Contin ued r1 Tout co* On $ ITIftO* dKOtme m 9 producers. Consumer tones due to the rule result from increases in costs incurred for asbestos products or substitutes Cor asbestos products or from inferior performance of substitutes, to the extent that these Utter costs could be quantified. It ie estimated that AjowMvowwr* (A/Q NwN___ A/C nv____ _____ ___ .. A/C BO* ---------------------------- Produca not arvw u US. i proouctna |mc*wd ptmo- tot etottvig and lot floor _______________ Papar product! mum 2M 23 5? tara 0 Orw v --a> incton puouca imjiooiae rm.-*nwtten oorvpownt*. dmen Wonm wl etmwc* eto nsuuwl Be- Cottngt ifsot eotangt and norw r tec sa consumer* wiU incttr $375.4 million in eorrj9iad papv. m*3 warn- I losses a* a result of the actions taken ia this reie. for the period of the analysis, h psnso-----------------------F*A praducN (SdonnQ snd roo<- ng Ml snd ppwr* no|------ *.73 1 Ooaa net Mods wjNIi ram*I pewao S3* The costs is both of these tn*h ses spread acraa* tha retire consents population. Produoer losses dee to this rule would accrue when producers are forced to forego the portion of the return on their capital stock need to produce asbestos products. This occur* when the capital stock used far the production tnd processing of asbestos-containing product* either cannot be uted or cannot be used a* efficiently in the production of substitute products. It Is estimated that the rule wiQ result in S83.49 million in total producer costs. The nils will also result in aoma transition costs to workers who are displaced by product bans. Tlmse losses re incurred in the form of lost wages and job aearch costs. EPA believes that these ttansitiosi costs will be relatively low compared to consumer and prodooer costs because ofc (l) The Gutwu ----------------------------OUe tnd our Ortu pads lor I onpial aquonwm marts* .(OEM) and am Mows---------1 One and mu pads ta turn- ) marts* (SMI_____ _______ 307 7? tiA7 11.73 eommarew and rascal Beton praduas) Coatngs (mat laSip and non tsao 1 Ooaa not noun* apara*> roan gnus*. EPA also analyzed the costs of the rule without (he assumption about the declining price of substitutes that it described m the preceding paragraphs. Under this scenario, the total cost of the rule would rise from $458.39 million to $608.51 million. Estimated total costs of Individual product bant under this scenario ere set forth in the following Table VH: tre likely overstated far * number of reasoas. Tbs methodology used id this analysts for dealing with a lack of information tends by design towards overestimating costs and underestimating benefits. This "cautious" approach is taken to ensure that the analyse provides a strong basis for tbs refpdstary decision made in this rule. A commenter stated that ETA. in the analyses esed to support foe jwoposed rule, enderestiaated the costs of banning the toenufectwe. taportation. end processing of tsbestoe-cootaining products. The commerrter argued that EPA overestimated the rate of development of asbestos substitutes, underestimated future asbestos consumption rates, and erred in s number of other ways, discussed in more detail tn the Response to Comments document ia estimating the amount of time sHowed far companies to plan before the effective dates of most baas and (2) the already occurring Table VII--Cost of tvc Rule y Prod uct Category Without the assump cosB eaeocUted with (he venous options described in the proposed rule For the final rule. EPA hes updated transition to non-asbestos substitutes by tion of a i Percent Annual Decline the date base used to support its many former producers of esbestos M THE PraCE OF SuNSnTUTES analysis of the costs end benefits of the products. niie and ha* modified its analytical The total costs of the role were estimated first with costs discounted at 3 percent and benefits not discounted (hereafter 3 percent/0 percent) and then with both costs and benefits discounted at 3 percent (hereafter 3 psccaol/* percent). The results ofboth analytes will be died throughout the taxi of this preamble. Beth analytes support tha action* iaksa in this rule. Tbs total estimated eort of thsialo la MSU0 approach tn reepoase to comments In addition, the deidtne in the rote of consumption of asbestos in the U.S. has bean more rapid in recent year* than was predicted in ETA'i modeft. Total annual consumption of asbestos in the U.S. dropped from a 1904 total of 240.000 metric tons to less than 86.000 metric tons hi 1987. This chsmj* suggest* that the ase of asbestos sobiititvtes has increased markedly fcit the proposed rule wee published. miliaoa This cost will bt spread over U yearaamd a tar** population. Therefore, the impact aa moet persons will be tgl^lito EPA has adoptad several conservative assamptloos to ensure that the rate of substitution is not overstated In foe analysis of foe rule's costs. The anilysis Estteemd Mai ooats a# fcdMdael smbodies low-deefine baseline product baas are sat forth hi fin consumption approach. This approach followingTable Vfc assumes that substitutes hsve already feaSM>8MtUaift'S3llil<>in4i<afcllMAIaU, HNA SH STEW 1510 FWtfil Regular f Vot St, No. 132 / Wednesday, July 12. 196$ / Rules end Regulations 29485 been adopted for tboae market sector* for which substitution for asbestos was relatively uncomplicated. It also assumes a constant rate of asbestos consumption unless EPA is awar* of specific instances in which substitution has been mad*, in addition, the analysis assume* that the price of a substitute for an asbasto* product will not fall below the price of the asbestos product for which it is baing substituted. Therefore, the analysis adopts a number of assumptions that likely overestimate the coats of the actions taken in this rule rather than underestimate them. 2. Estimated benefit*. The costa described above will be offset to some extent by t number of avoided costs. Whils EPA did not attempt to place a value on the lost of life itself, or on associated coats such as "pain and suffering." "toss due to leisure time." or other similar factors. EPA has estimated that the actions taken in this rule will result in the avoidance nf at least 202 quantifiable cases of lung and gastrointestinal cancer and mesothelioma when benefits are not discounted and at least 143 cancer cases when benefits art discounted at 3 percent from the time of exposure. These estimates assume the occupational exposure levels based on other analogous exposure tcer.anos discussed in Unit V.A.3 of this preamble These estimates do not. for reasons discussed in Unit V.A of this preamble, include the number of asbeslosts cases and cases of other diseases avoided, in addition, EPA did not estimate losses due to lost work days or medical care costs. Thus the benefits of the rule (costs avoided by this rule] represent prudent esumates that like!) understate actual benefits. The cancer-cases-avoided by individual product category are set forth in the following Table VUI. Table VUI--Cancer-cases-avoided by Product Category Assuming Analo gous Exposure for Selected Prod uct Categories Pioaud Owooum am 0 pwevs Aaaaat/anaw - (A/C A/Caangwa vc (XP------------------------- Protfucft ndl wMif * \JS oSflnn issoassoB MM dsfsnf ana MsuaSoa. *)----------- Plptr products HwunmI paper. nfeosil maboant um ptaan poos., and a aaar paper)--------- --------- 09$ 0.23 3 IT 0 *2 1.1S 032 4 3a 0 OJ3 Table viii--Cancer-cases-avoided av Proouct Category Assuming Analo gous Exposure for Selected Prod uct Categories--Continued P>oduct Owcogtx TO S,0 omzmt i pru*nt Fa* products (floorng and nxj*"S not. and ptae&ne j -------1 Gaaaati1. - J Oac and iXum bnka pad* { Ax 0npnal aqupmant wa (OEMI and Irak. Mods__ ____1 Osc and on peoa tar at- ' wmanm (AMI--------------- - Otnar aaaatiaa taction proo- ucs (auiompoc tranairaa- aon oonpo-wmx duw 1 laonji. and oommarcwl and taouttnai taetton proo- , ueal -_____ ___________ Coaonga (roar coaonga anc nonuooi coating.)..... .... .1 1 1 3 S3 : UJ4 i j 43$ 42.54 14 55 M 37 1968 122 11 1 1 45 i 9* 241 333 ' Ooaa not raux aoaoany raara 9*aa Analogous exposure* could noi be assumed for a number of exposures. Therefore, benefits are understated to the extent that these exposures are not included. For example, some exposures result when asbestos fibers are released to air due to weathering of A/C products and other products used in exterior uses. Also, the analysis did noi quantify the increased risk due to high concentration, episodic exposures to asbestos for many products. Further, additions to ambient loading caused by tbe acUvmes affected by this rule and the resultant risk reduction from this rule's actions could no< be adequately quantified. The effect these factor* would have on the calculation of benefili i* difficult to determine because of technological difficulties in quantifying the extent of these releases and the resultant exposures. However, the effect could be significant because releases via these routes are frequent and. on aggregate, broad-ranging. EPA also analyzed the benefits that accrue due to the acUons taken in this rule if the analogous exposure analysis described in Unit V.A.3 of this preamble are not assumed. In this analysis, in all instances where exposure is believed to exist, but specific exposure data are not available. EPA assumed no exposureTbe figures in tbe following chart, therefore, understate the actual number of cancer-cases-avoided due to this rule to the extent that available monitoring data used in tbe exposure analysis understates actual exposure to asbestos. In this analysis, estimates of cancercases-avoided decrease from 202 cases to 164 cases if benefits are noi discounted and from 143 cases to 120 cases if benefits are discounted at 3 percent. The cancer-cases avc.Jed by individual product calegory us.-.g th s analysis are set forth in the following Table IX. Table IX--Cancer-Cases-A voided by Product Category Without ankd gous Exposure assumptions *90^: !3 ^ pr;*"1 AS6eS' (A Z`> A.Ctfwye* 4'C p** Proif cS ptoouttQf (*sr-e-5t^5 cry ftCUNt OOrv^ |oc vtnyi sottiot ftoo frc: ........ Paper prooucu tcor'maroai ; paoar rpHooara. mrtsoaro,' OOTjpatac dip* and apt* aany oapao................. fa* products tfto&vq and ; roofed and pcaune wrap. .............. GlS*tS 0**c and om** &'* oaas or ongna* aovomant maraa* tOeMi ane erpe txocm ..................... . . .. Osc ano pass <& a* ter"tanf* Or** is<sin neten prod* ucu n-jtiyruDc canvTMV oo cow\p>,`*ntj chjicr> t*o"*9S and co^wai' and tndusrta Motor proo ucn: Coatmo* (too* and non**30* coating*, C 96 0 23 2 2? C oy as: 5f u 5S , $ 3"* 1 29 o 3: 3 *' C&* 3 2i t* ' Ct*4 no< ndooc sd*ci***> rotjjna gtv r*. As sidled earlier ETA decidec for in.> rulemaung to estimate potential risk from plant emissions using an assumption of baghouse efficient of 99.9o percent for some product categories and 99.6" pe'rent for otne* product cate^r*.es |;h* me\:murr emission scenario with no baghouse failure a^sumeiil- However EV.A alsr esttma'ed the number of cancer-casesvoided using the assumptions of 99.966 to 99.986 percent efficiency (the best estimate scenario with occasional baghouse failure assumed) These estimates, assuming the occupations' exposure levels based or. other analogous exposure scenarios discussed above, are 163 cases if benefts are nc( discounted and 134 cases if benefits arrdiscounted at 3 percent. The cancer cases-avoided by individual product category using these estimates are set forth in the following Table X. HNA SH STEW 1511 2t4MW Fvdafel Register / VoL H. No. 132 / Wednesday, July It, 198t / Rule* end Reg-.dsHons l. Tams R--Cw*ee-c*$CT-Av<oDa> nr generally tveuft to death after relatively believe* feat felt rule wiD further Pwooucr Cattoowt assumixq Akal- abort period* of treatment or ttoralat* technological Innovation in the OOOUS EXPOSURES MO ALTERNATIVE Emissions Cottacx Rates hoapitafisaOoo. to addition, thi* total would be further lowered when discounted due to the fact that most development of substitutes for ssbestos and feat this strong trend toward use and acceptance of substitutes wfD {l l ONeount Raw S stream 1 0 stream ssbestoi-retated (Usenet appear only after a loaf latency period. Continued manufacture, importation, continoe. Different health benefits were estimated to support of fee proposal prorrsung, and use of the asbestos- than those development for the final containing product* banned by this rule rule. The number of eancer-casea- would result is environments! loading of a voided estimated for fee proposal asbestos The effect of environmental (approximately 1.000 case* and more, loading is discussed in store detail tn depending on the regulatory option) la Unit V.A.3 of thi* preamble. The actions higher than fee estimate for fee final taken under this rule will reduce the rule (202 and 148 cases ff analogous incremental increase in ambient exposures are assumed) for a Dumb of concentration* of aabeato* and thus reasons: (1) Several product categories reduce the risk of aabeato* exposure are not included m this final rule faced by the general population. EPA estimate* because they are no longer has not attempted to quantify theee manufactured or imported m tbr US benefits, due to the difficult! and (e.g.. vinyl-asbestos fioor tile). This probable imprecision of such an change accounts for approximately 4T3 analysis. However. EPA believes that of fee cancer-caaea-avoided quantified fee long-term benefits derived from this in the proposal rule. (2) The production incremental decrease tn ambtenl and exposure data supporting the concentrations of aabeato* will result in rulemaking ware updated for fee final substantial benefits because of fee large rule. U.S. asbestos consumption ku populations feat are affected. EPA baa decreased and substitute use had also concluded fea. feeae benefits can Increased autce fee publication of the be attained throngb fee source reduction proposed rule. Therefore, the proposal* ebons taken to fea* rule, rather then by estimates of cancer-caaes-avoided were use of other option* considered. higher than those for fee final rule Farther, doe to fee rule's bans, fee because consumption ratas and resulting substantial fature costs associated with exposure totals were higher at the time removal and disposal of asbestos- of fee proposal. (3) Updated exposure containing products that would have assessments were used in the health otherwise been produced and ased will benefits model. The updated data were be avoided. These included higher lower for some products than those used removal, demolition, and disposal costs for fee proposal meaning that fee for asbestos products than those for proposal estimates of cancer-cases- The different assumptions About Don-esbesto* product*, a* well a* higher avoided were higher than those for fee bagbouae efficiency do not have a health risk expenses for asbestos final rule. (4) The time frame used for eagmficaat effect on fee aatunatet at products. Putsre removal. demolition, estimating health benefit* for fee cancer-catet-avoided. Under both the and disposal of aobaatoe eoostractioo proposal was IS yeara: for fee final rule, beet estimate aoenerio with occasional products will likely be higher because the period ia 13 yeara. Therefore, the baghooa* fattnre asaomed and fee special precautions will probably be final rule analysts covered 2 fewer years maximum weiaion teenano with no necessary to meet OSHA. Clean Air Act of exposure, resulting m fewer estimeted bagboui* failure assumed. EPA believe* (CAA). or othea reqtosemsnf*. These health benefits. fS) Some modifications feat fee manufacture, importation, costa can be sebatenttaL but they have were made to fee health effects model prooeaemi and diatribotioa a not been estimated for purpose* of this uaed for the final rule (e.g.. minor commerce of feeae product* present* as rulemaking because estimates of the modification*, including quantification unreaaonafafe risk of miwy to bumaa timing and frequency of bufldmg of gestrointotfinal cancer risk, and the health. removal or rvoovatioc would be us* of a lower dose response constant The infa anil result m a namber of ofaar significant banafits. However, many of feaea beaafita aia either in the future aad are ralatfveiy ataaii in caireot trnni etbritemaelim nr an ififTimlt In quantity. Wat example. coat* avoided fedada fee aadatal coat of fee raaourcae eecaaaaiy fe heal asbestos-related flfeaaaaaaaid fee productivity laat a* a raaoft of aabeatna disease that will ba avoided doa toactions takas onda thi* tola. BPA baa not aettstetad feaae coat* speculative. Also, fee coBtmaad ase of asbestos win likely exacerbate fee heavy burden on cowl* and workman'* compensation beard* feat bow, to rvcerrt year*, been foliated with claims related to bans caused by aabeotoo exposure. Thi* nde. by redudag the occurrence of asbeetoeralated iMaaaaet. trill asaatoafly reduce tbo costs rotated to daks* arising wit of lllnassm d itoafes owned by asbootoe expoem. for mesothelioma (using an average of the doae response constants from a number of studies, rather than the constant from one large study)] that resulted in an estimate of benefits that was approximately SB percooi tower for fee final nde than for fee proposal. Several cammaiten stated that EPA underestimated fea assnristeri wife the product baas daacribed to fat proposad rule- These eoewaoter* asserted that the analysts of benefits avoided became (bay would be sstatisafy amal bacauae fee types of fence too proposal EPA has observed xferstanted risks because it did not a rapid (fcvehjyisiMl si substitutes for take Into account discsacs ether than cancers trrfewd to this analysis aitwolna rantsiniirg prodocta. gA hmg and gastrointsstiaal cancer end HNA SH STEW 1512 iA fe' Fadantl Register / Vpl 54. No. 132 / Wmtnreday. july VL 1889 / Rules aod Regufettoere 47 mesothelioma or exposure* to families of asbestos workers. cod failed to quantify (actors like avoided pain and suffartag and increuad worker productivity. EPA agree* that Use benefit* of (be rule may b* understated, poaaibly to a significant extant, in the supporting analysis due to techaologicaJ or other limitation*. These factor*, however, have been considered qualitatively in EPA's ana!} so. One coameatar argued that EPA Mnificaatiy ovarestimated Use benefit* of the rwl* by overstating asbestos potency and exposure ievtl*. The Ung cancer and mesothelioma potency value* nsod by EPA kn it* analysis of benefits at* wall-supported and are consistent with tboaa used by OSHA in reducing its PEL to 0.2 f/oc. The potency values for lung cancer represeat the mean of the resula of 11 human ' epidemiological studies on Use effects of asbestos expoaurt. The potency value* for meanthelmms represent Use mean of the results of 4 hitman epidemiological studies an Use effect* of asbestos exposure, la addition, the exposure estimates wed in this analysis understate actual exposure for a somber of reasons. a* explained m Unit V_A4 of this prsaobU. Therefore. EPA may have actually understated. not overstated. the benefits of this ruie. Sense oommeaters argued that EPA. m the proposal, improperly failed to discount benefits to be derived from Use rule, and in support documents for a final rale, only discounted benefits until the time of the expoaurt that results in tfas cancer rather than until the ocauisuKe of the disease. Other commantari arguad that EPA should not discount benefits, stating that discounting the benefit of saving humsa life is inappropriate methodology for this rulemaking. Tbs* final rale provides estimated benefits both with and without discounting. Arguments can be made that astunating benefits without discounting is preferable m caiaa tike this oae whet* the primary henefiu derivsd is iha avoidance of human cancar cases. However, arguments also can be articulated atfitpnrting the discounts* of hearfits EPA baliavas that if la the form of cancer- cnsaMvoidad are to be discounted, they art propedy ttiacnuiUd to the fiat what risk is reduced at avoided. Since tb* be*efit of a regulation to contra! a haxaedeaaaubetaaca occurs at the time of the island exposure EPA has coactodad that the appropriate period ov*r which in dismiss is until the data at expostn awkctica This approach was need to this east after cxtanmvt review of applicable hteramre and *n examinaboo of the inherent biases and features of other approaches. 1 Stnall businesses. EPA has. pursuant to section 6fc)fl)(Dl of TSCA. also aaalyxad the anonoanc Impact of this rule on small businesses. The role will not have significant effect on small businesses because there are few such businesses affected by the rale and individual company producer losses are not expected to be substantial since capital eqwpment tor the prediction of ssbestos-coDtuning products has bttle remaining taaefui life, is inexpensive, or cam generally be converted at low cost to manufacture of alternative products A small fraction of the manufacturers, importers, and processors subject to tins rule are small producers and some couid be adversely affected by the rule, la addition, a number af snail governments may be affected by (he baa of some asbestos products, (or example A/C pipe. However, the economic impact of this rule is generally spread widely throughout the economy and any concentrated effect will not be focused on specific market sector* or on small businesses- 4 Evoluation of the rule's economic import. The overall oosls of this rule are significant. However, the overall benefits of the rule are also significant, although many of the benefits cannot be easi'y quantified. The analysis performed to ascertain the economic consequence* of the rule likelv overstates the costs of the scuoas. However, the ana'>u* points out several important facto's. (lj The societal benefit, or "essentiality." of asbestos has decreased, and continue! to do to. as asbestos consumption declines and substitutes for the mineral are developed for many applications: (2) most of the coats associated with the rule are short-ten* and spread over a relatively large popularton; (2) the contused development of price- and performance-comparable substitutes for asbestos indicates that the rule will not lead to either dramatic increases ia consumer price* or decrease* in the availability of products affected by this rule: and (4) the producer and consumer [ t'l eir~inf`~|r"~'~~~l---------*~T the rule's benefits (eg., canoer-caaesnvotded. medical oasts, and loot productivity avoided), although many of these benefits are af(her difficult to quantify at to express in monetary terms. EPA. therefore, finds feat, swdsr the standards of stetson fief TSCA. the costs of the rule ts bn sansnrahis in hgbl of tbs unreasonably large somber af asbestos-related deaths nmd writes illnesses that would occur If the srtiens In this rata were not taken. E. Other Options Considered Section I of TSCA requires EP\ to select (he lestCburder.iame means to reduce an onretsonable risk. Thn C'nit describes B>A's eraluaSon of opvor.i that would reduce or eliminate the unreasonable risk to human hrv'th posed by exposure to asbestos Fur'her responses to comments on this Si.b,rct can be found in the Response to Comments document. The options considered include the one selected for the final rule. siegedban of the manufacturing, importation, processing and distribution tc commerce of s number of categories of asbestos products. EPA selected s staged-ban for this final rule rather loan one of thr other regulatory options discussed in the proposal or identified jj comments because these other options would either fail to adequately reduce the unreasonable risk posed by tsbesio* exposure or impose an excessive burden. Conversely, the final rule s staged-bac approach prohibits, at different times, the manufacture, importation, processing or distnbuuor. in commerce for uses of asbestos Inal pose an unreasonable risk. Timing oi these bans is based largely on the availabibty of suitable available or anticipated non-asbestos substitutes for the banned products. Therefore, the staged-ban approach takes into aocount the potential economic effects of the vii-iou* bans, while *t:L' eUnunaurg the sources of the risk Oihcr opiums * ere discussed ir. the proposed rule or identified in comments, bu: were no: selected for the reason* described below. Under two proposed rule altemauiev some product categories would be banned soon after thr effective date of the rule and the remaining product categories would be "phased dewr." This would be accomplished cry instituting s permit system whicn would create limits on the U.S. mining of asbestos and the importation of asbestos and atbeetoa-containing product*. Thaaa hast* woaid be based ob pniwe vniianes of the affected activity and woaid ba managed by a system af Jaaefog permits allowing gradually dedinreg levels of the indicatad activities Thr permits would be traerficrmbfc. This system woaid. ovwr Use, reatrirt the total amount of asbestos avafiaUa far oae m toe U-S. and Until tot axvoant Bead is imported products unfit to* ale's objectors of a completa phase atot teas adaeved. hna SH STEW 1513 4 C 1, f-gS.>.e[ ; >l so. tj. , Meanasctav jj.v 12. 1999 , Rjcl j-j r- a- t In tfa analysis performed for tint rulemaking. tPA concluded that permit iytem approach would not be th# ltatt burdensome means of reducing the unreasonable risk posed by asbestos for all the products analysed under the rule. Most commenters who rendered an opinion on the Issue opposed the permit system options. Commenters stated that the Implementation of these options could oeete significant administrative problems foe EPA and industry, particularly In the area of imported sbestoe products. EPA found that implementing the proposal's permit system options-for all of the product catefories in the rule would result in high administrative costs. EPA also believes that a permit system involving all of the products affected by this rule would be difficult to enforce. ETA concluded that soma uses of asbestos and some product life cycle ttages pose a substantially greater risk than others and that the permit systems described in the proposed rule would not necessarily control the highest risk exposures (e.g.. persons that produced or used products with high levels of asbestos exposure could purchase permits). Therefore. EPA concluded that the proposed rule's permit system would not adequately control asbestos exposure for the rule's product categories. Despite EPA's conclusion based on currently available information that a permit system approach is not viable for regulating all of the products analyzed under this rule. EPA recognizes that there are e number of inherent conceptual advantages to employing an economic incentive approach in regulating the risks posed by chemicals. Therefore, as a follcw-up to EPA's review of the applicability of a permit vstem as a regulatory option in this rule. EPA will perform several extensive analyse* of the advantages and disadvantages of using various economic incentive approaches, including marketable permit system alternatives, a* possible mechanism* for reducing human health and environmental risks from chemical*. These studies will review m greater detail the viability of employing such approedi** under regulatory authorities such a* section of TSCA. One study will focus on economic tnoentlve program* that could be applied ante TSCA and other authorttaa. rather than, for example, concentrating oa air-emission iaauea, a* doe* the baft of tba available theoretical Utaratura. The study will identify sad avsduatt criteria for detarmiaing which chemicals or chemical products would be appropriate candidate* for the use of tcooomic Incentive approaches under TSCA tnd other authorities F*cton considered In Identifying these criteria will include determining the characteristics of t chemical's market, such as its production and uaa. that would make the chemical a viable candidate for a permit system rather than a deposit system. The study will also examine these criteria in the context of specific candidate chemical substances Another study will inalyz* administrative problems associated with economic incentive approaches with the aim of devising methods that provide equitable and efficient regulation of these chemical substances. For example, the study will examine issues related to imports which complicate Implementation ana enforcement of economic incentive approaches. The study will also examine mechanisms to overcome complications caused by these factors and evaluate the type and level of assistance to EPA from other agencies (eg.. U.S. Customs Service) that would be necessary to implement and enforce an economic incentives approach. Based on the analyses performed dunng this tnd other rulemakings, there it a continuum in the nskt and benefits associated with product categories. Some product categories on the continuum have tome characteristics (e.g.. s large number of,specialized uses or a lagging rate of substitute development) that may make the products amenable to regulation through use of,a economic incentive tpproach based on the criteria developed in the studies described in the preceding paragraphs. Upon completion of these studies. EPA will review this rule tnd other rules, bated on the identified criteria and on then-available information about products and market*. For example, with respect to this rule, this review could determine whether ft) any product categories not included within the rule'* bans should be phased out by use of an economic incentives approach. (2) any products banned in Stage 3 for which a significant number of exemptions are likely might be more efficiently phased out via an economic incentive* approach, and (3) substitute development could be more efficiently compelled by an economic incentive approach for any products that are the subject of an active exemption. EPA's review wifi determine whether any of thee# product! exhibit characteristic* that lead EPA to conclude that expoeares could be more efficiently phased out by ese of an economic incentive approach. If efler review of this or any other rule. EPA determines thst an economic Incentive regulatory approach la warranted for soma of the categories. EPA may In the future Initiate rulemaking under sections 8 and 6 of TSCA to amend such rules to implement so economic incentive approach. Even within the stage-ban approach EPA has considered a number of possible options for the number of stages, the number of year* between the stages, and the scheduling of product baas at various stages. The final rule follows the 3-stage baa approach of the proposed rule. EPA has modified the timing of the ban from soon after promulgation tnd S and 10 years after the effective date of the final rule, is discussed in tht proposed rule, to 1. 4 and 7 yean, respectively after the effective date of the final rule. This was done because of the passage of time since the proposed rule was published and because EPA's analysis of available data and comments indicates that marked advances have been made in the development of and conversion to suitable substitutes for asbestos in most product areas. The timing for the stages in the final rule are reasonable in terms of the current or anticipated availability of suitable substitutes, based on EPA's analyses. EPA rejected the option in the proposal of a limited 2-stage bin with a TSCA section 8(a) reporting requirement because that option would not sufficiently reduce the unreasonable risk posed by asbestos exposure. In addition the final rule does not include * ban on the mining and import of bulk asbestos because not all asbestos-containing products are included within the bans on manufacture, importation, processing and distribution in commerce. However the risks posed by these activities are expected to decline as the demand for asbestos decreases due to the action; taken in this rule. Also. It. scheduling products for tnsuged-ban. EPA hai analyzed the relahve risks posed by the different asbestos-containing products and the probable availability of non-asbestos substitutes. In the rule, the various asbestos products are scheduled to be banned at times when It it likely that suitable non-asbestos substitutes will be available. For example, bans on asbestoe-containing brakes pads snd drum brake linings era divided into s Stage 2 ban on the original equipment market and a Stage 3 ban on the aftermarket because euitable substitutes might not be available for tome aftermarket products until Stage 3. The final rale'* approach balance* the need 1 I k v-i HNA SH STEW 1514 Federal Register / Vgf, 54, No. H2 / Wednesday, July 12. 196R / Rules aod Regulations 294S9 for a reduction la the unressonabit riik of exposure to asbestos with the economic affects of bans on manufacture, importation. processing tod distribution in commerce. The inclusion in the final rule of frovision allowing for exemption! is halted circumstance* i* t mean* of taking into account the size and diversity of the asbestos induitr>'. EPA realize* thaL.despite EPA'* projection*, technology might not advance auffidently by the time of a ban to produce substitute* for a few specialized or limited use* of a*be*to* in some product categories. In addition, other unforaaaable circumstances may occur that would maka a ban on a diterete product inappropriate at the scheduled data. In these circumstance*, an exemption from the rule'* bans may be appropriate if as applicant can tbow that ona is appropriate following the procedure* described in Unit OLE of this preamble. However, EPA believe* that granting exemption* will not be the norm. The procedure* ihould be used only in exceptional case* and ahouid not be viewed as mean* of attempting to postpone a persoo'* share of the economic consequence* of the action* dictated by the rule. Another option considered would involve aa immediate bee of tha manufacture, importation, protesting, importation, and distribution in commerce of all asbestos products. Section of TSCA require* that a range of factors, including the availability of substitutes and the rdahrt costs of regulatory options, be considered in addressing the reasonable risks posed by a chemical substance EPA rejected an immediate ban option because it would result in potentially severe economic and societal effects. An immediate baa would not account for the current unavailability of viable eubatitutes for some asbestos-containing products that provide significant benefit and wcuH mult in high costs in those markets. Therefor*, aa immadiate ban would not be the least burdensome means to reduce tha unreasonable risk posed by asbestos. CPA aieo considered requiring aboto*-cnnt*inlng products to ba labeled a* a amass of rsdsciag the risk posed by asbealns exposme. Howovac, PA ha* ditansined that the riskrediirlina beanfits from a UbaUng lagulf--t far ashestns-ootitaiaiag prodarts weald not be aaharietial far example, many af those that weeid potantiallyba *rgunit to asbestos fcaaa the labeled paadactsemtddaot have , acosis tottaemmlagUbak. la addition. maay aabaatoa prodaots asa used In csastic or dynamic invirnmnu ia which labels cannot survive. Commenter* aiso argued that labei* directly applied to products can inhibit product performance. For example, if gsskets war* required to be labeled, those who came into contact with the product packaging could bav* access to the label. However, many gaskets art too small to be effectively labeled. In addition, it would be unlikely that those exposed to the product during use or removal would have access to the label because it might not survive in a hot. fluid environment. Tbt stm of the final rale'* labeling requirement it ool to serve as t warning, but rather only to facilitate compliance with and enforcement of the rule. The drawbacks of labeluig described above do not affect the use of labeling as a compliance and enforcement tooL The labels required by this rule are appbed to product wrapping or packaging and are not intended to lurm e through die entire product life cyd*. Several commenters suggested the consideration of options that would require "controlled use" of asbestos rather than bans on manufacture, importation, processing, or distribution in commerce. These commenter* argued that exposure to low levels of asbestos is not in unreasonable health hazard and tha! ETA should undertake actions In a number of areas to require exposure controls (e.g.. workplace controls for brake replacement and repair) rather than enacting a product ban. Commenter* also suggested that chrysotile fiber* pose a lower hazard than other asbestos fiber type* and that controOed-nre actions would be more appropriate for chrysotile thin would be source reduction action*. Controlkd-use options wars rejected because they would bs ineffective u reducing exposure at many points in the lift cycle of asbestos product*. As 1* discussed in Unit V.A af this preamble. EPA has found that exposure to eves low levab of asbestos poos* aa unreasonable health hazard. In addition, some of the exposures of cancers are not amenable to ooittrob (eg. ambient releases from asbestos friction products during me. from brake replacement and repair work performed by consumer*, or from weothermg of asbestos products exposed to an outdoor* environment). in other iattances. controlled use aproaches create new exposure* or movs exposure from on* st^e of tha product Ufa cyde to another. For example, eve* if asbastaa ia vented boas a workplace, sdthoagh esAes mt subject to lowar sapowns ievsb. asbestos is soil released la the outside smbient sir. thereby cresting potential exposures forpsssersby and surrounding populations. Further, naoy engineering co.itro.s ei'.hsr fill to reduce exposures to asbaato* to levels that do not pose s significant risk or create workplace inefTicienaet that lead them to not be used. For example, respirato'i are difficult to fit property and are of:e-' uncomfortable Poor fit and intermittent use because of discomfort lead to unprotected workers The problem' a-e especially prevalent m negative pressure respirators, the type most commonly used in workplaces be:a*>e of their low cost fRe/. 16) Other agencies and EPA off-cu have or are currently establishing exposure cootrol requirements fo- tilt workplace However, becauae o' :ne extent and natare of the nsxt posse b> asbestos and limitations on tvttitbi* technology and the jurisdictions of tee regulatory entities. EPA believe* tha: even Those control standards that are based on the best available technology leave an anreesonable Wvei trf residual nk in some occupational and nonoccopetional setting*. Therefore. EPA has concluded `bat source reduction actions, like those taken in this rule, rather than controlled use approaches are necessary'10 reduce the unreasonable risk posed by asbestos exposure In addition, pursuant to the discussion in linri VA of this preamble regarding the relative hazards posed by the various asbestos fiber type* EPA has also concluded that this rule's source reduction actiocs are more appropriate than controlled use approaches for products containing chrysotile fiber*. Some commenter* expressed a concern that if S*A bans the manafacture. importation, or processing of some atbestos-contaming products, the governments of other countries wii! be compelled to take similar actions, although suitable nan-asbestos substitutes may not be available in those countria*. The unreasonable nsk finding jo this rule is based on a detailed analysis of lb* risks posed throughout the entire lift cyd* ia the U-S. of the futare toastafarlure, Itoportation. processing, distribution, use. and disposal of lb* ^wailed aabestoscontasamg products. The findings which support this raft ar* not dwrdty applicable la cither cosntria* in which factors rrielitog to ride ad coat may be sigaficeatiy diSereaL ' 'v - V.-T- * U HNA SH STEW 1515 29490 Federal Register / Vol 5*. No. 132 / Wednesday, July 12. 1M9 / Rj|es and Regulations F.Summary fIndividual Product Categonti Thie Unit describes EPA's unreasonable risk finding for etch Individual category of asbestos- containing products identified tor this rule, h summarizes for etch individual product category available information regarding exposure. Individual risk levels, the development of substitutes, the results of EPA's analysis of the costs and benefits of a ban. and other qualitative factors that were considered in EPA's unreasonable risk analysts for each category. These discussions reflect public comments received on these subjects. Further responses to comments on these subjects can be found in the Response to Comments document. In the product category discussions below, information regarding costs, benefits, and product substitutes is derived primarily from the RXA (P.ef. 21), which is discussed in Unit VH of this preamble. Information regarding exposure levels is derived bom EPA's Asbestos Exposure Assessment (Ref. 29). Asbestos Modeling Study (Ref. 30). and Non-occupab'onal Asbestos Exposure Report (Ref. 31). which are discussed in Unit VA4 of this preamble. Based on available information. EPA finds that the manufacture, importation, processing, and distribution in commerce of asbestos for use in each of the following product categories, except those discussed in Unit V.F.l of this preamble, presents tn unreasonable risk of injury to human health. The discussions of EPA's findings, below, summarize: (1) The estimated benefits of the actions taken in this rule for each product category. (2) quantifiable aabestoa exposure and lifetime riak levels for the product. (3) the protected availability of product substitutes. (4) a description of qualitative factors that were considered in reaching EPA`a unreasonable riak conclusion for the product, (5) the estimated costs of the actions taken, and (S) an explanation of any changes in EPA's approach to regulating the product since the proposal. Ilia individual risk levels quantified for the product categories that are subject to this nils are vary high. An indMdaal Ufatima risk level of ltr* or graster has been quantified for many permone who are axpoaid daring the primary sod seooodiry manufacture of most of thaee products. Boot other phases of (aw products' Ufa cycles alto remit tn very high levels of Individual risk. An individual lifetime risk level of 10** moans that member*, of the. populations exposed to this Wei ef risk stand a 1 in 1.000 chance of developing cancer during their lifetime is s result of the exposures. EPA considers the risk levels quantified for this rule for asbestos exposures to pose a substantial concern. EPA also believes that the nsk levels quantified for this rule represent an underestimate of the actual nsk posed >" esbestoa exposure from these produu. A number of exposures to asbestos and the resultant risks, for example, the nsks posed by Incremental increases in environmental load ng caused by the continued manufacture end importation of the asbestos products binned by this rule, are believed to be eignificant. but could not be quantified for purposes of this rule, often because of limits in exposure monitoring technology. Despite this "cautious" approach to estimating risk, the exposure and nsk tha: can be quantified are sufficient to make an unreaaonable risk finding for purposes of this rule. The costs and benefiti cited below include assumptiona regarding anticipated declines in substitute prices (discussed in Unit VD of this preamble) and exposures estimated by analogy for recognized, but unquantifiable. exposures (discussed in Unit V A.3 of this preamble). EPA believes that this approach present! a prudent representative analysis of the costs and benefits of the actions taken in this rule with tome reisocable adjustments made for unquantifiable exposures or market changes. However, even if these assumptions are not used. EPA has concluded that the continued manufacture, importation, and processing of the asbestos-containing products that are identified in the rule poses an unreasonable risk of injur)' to human health. a. Felt products. This grouping consists of the flooring felt roofing felt and pipeline wrap product categories AD of these categories will be banned in Stage 1. The benefits (in terms of cancereases-evoided) of the actions taken in this rule on these product categories are eet forth in the following Table XI: Take Xi--Cancer-Cases-Avoided for Asbestos Felt Prooucts product ir.stsllelion. repair remet al. and disposal Quantifiable lifetime risk for these products from occjpafor.al exposure ranges from sn average of T 4 x 10"'for secondary manufacture of flooring and roofing felt to an average of 24 x 10'* for the primary manufacture of roofing felt. EPA estimates that as many as 1.3S2 workers may be exposed to asbestos during the installation arid removal of roofing felt incurring individual nsks comparable to those fo1, manufacturing These exposure estimates do not lake into account high peak exposure to which homeowners or others may be unknowingly subjected dunng removal or repair of these products EPA determined that accurately quantifying these exposures and the resultanl nsks would be d.fficu'' and that sufficient other exposure and nsk information is available regard.ng these products to make a finding of unreasonable nsk. Effective substitutes currently exist for all three of these product categories These products are largely no longer produced in the U.S.. and floonng felt is no longer imported in this country. In the proposal, flooring and roofing felt would have been subject to the Stage 1 ban and pipeline wrap would have been banned at Stage 3 or covered by the permit system. However. EPA received comments indicating that the product categones are not easily distinguishable from one another and that suitable substitutes are currently available for pipeline wrap. EPA therefore concluded that a Stage 1 is appropriate for all three product categones. The total coal of the ections taken on these product categones ere set forth in the following Table XU: Table xii--Cost of tvie Pule for Asbestos Felt Products Product Totof coat r t I intoon feeovnao v 3 ; paroara Zjfloonng to*..-------------- AooWiq tee----------------- J Poetne wnc ____ | 1 7J1 1.07 ' No U.S. menuttctn a erport. fnoxt Otoeasttm S percent . 0 percere noatigM________ ftoofr* toi__________ npeineerao----------- 01 ixi ZJ1 O' 1J1 LM Ne sums US. menAenn or import. Primary roetesof exposure to aabestoe from (base products occur during primary manufacture, and EPA has concluded that a Stage 1 bar. is appropriate far thaac product categories for the following reasons: (1) Relatively high quantifiable exposure and individual risk levels exist for these products: (2) these products pose a high potential for ambient release during a number of life cycle stages, for example, during manufacture, installation, removal, and repair work; (3) homeowners and workers are Federal Register / Vot M, No. 132 / Wednesday. July 12. 1989 / Rule* and Regulation* 29491 potentially (object to uncontrolled exposures during removal and repair work: (4) the cod of taking these action* U reasonable because suitable substitutes axis! for all of these products: and (S) while the quantified benefits of banning these products are relatively small compared to other product categories banned by this rule, these products are likely both to lead to a number of serious exposures that could not b* readily quantified for this rule and to oontribut* significantly to environmental loading. b. A/Cthaet. This grouping consists of the Oat and corrugated A/C sheet product categories. These categories will be banned in Stage 1. These products were proposed for e Stage 1 ban. The benefits fin terms of cancer-cases- avoided) of the actions taken in this rule on these product categories are set forth in the following Table XIII TABLE Xllt-CANCEft-CASES-AvOIOED FOU A/C Sheet A/T fftff# Arc osnugMM Mwal Oacxxm raw Spare** ! 0 pare** a0.*162 j 1.06 01* Primary routes of exposure to aabeatoe from these products occur during manufacture, installation, end repair. Approximately 53 workers are exposed to asbestos during primary manufacture of A/C flat iheet EPA estimates that ts many at 735 workers may be exposed to asbestos during the installation, repair, and disposal of A/C flat sheet and that as many as 109 workers may be exposed during installation end repair of A/C corrugated sheet Quantifieble nsk posed for these products from occupational exposure is estimated to range horn an average of 82X10*`for the primary manufacture of A/C fiat sheet to*JX10'4far repair end disposal of flat end A/C corrugated sheet Qiantillable risk fro non-occupational lifetime exposure# to aabeatoe released during the manufectsre of A/C sheet Is eetfcnaMi at lxiir* far approximately 4JQp people and at greater than 1 X10* fin earn MtMMB peiipfa .PA baHeras that the escposaraa doendfiadfar these product astagoriee erendsreteted. Ambient release of eheetoe occurs due to scattering of these products daring outdoor usee. Catting, drilling, end sending taka place durfae secondary pooeaafafc butauatioo. npait. end feaUfaaaaot af these products and nanlt in Significant release df asbestos. HcnedSmats or others may be unknowtngly exposed to significant levels of asbestos when they sand these products in preparation for repainting or removing them. Worker exposure estimates for this rule assume compliance with OSHA restrictions but EPA believe*, based on tome public comments, that there may be tome cutting of A/C products with power saws in violation of OSHA reUnctions. Asbestos releases to the ambient air due to weathering of these materials dunng outdoor uses were not calculated and high peak exposure* occurring dunng cutting or scraping of these products were not quantified for purpose' of the rule. Q>A determined that accurately quantifying these exposures and the resultant risks would be difficult and that sufficient other exposure and risk information ia available regarding these products to make a finding of unreasonable nsk. Effective substitutes exist for all uses of these products. The total costs of thr actions taken in this rule for these product categories are set forth in the following Table XTV: Table XIV--Cost of the Rule fob a/C Sheet *woua Tow coil v> f muter,. damsnad at 3 paroan A/C (1st snaaL________ ___ ___ A'C csnujaisO dwat................. 2 37 029 EPA has concluded that a Stage 3 ban is appropriate for these product categories for the following reasons: (1) Relatively high quantifiable exposure and individual risk levels exist for these products: (2) these products pose a high potential for ambient release dunng s number of life cycle stages: (3) homeowners and workers are potentially subject to uncontrolled, high peak exposures during installation, repair, and removal (4) the coat of taking these actions is reasonable because suitable substitutes exist for all of these products: and (5) while the quantified benefits of banning these products are relatively smalL compared to other product categories banned by this rule, those products are Ukely to tood to a number of serious exposures that could not be readily quantified for this rule and to cootribute significantly to environmental loading. c. A/C Wiing/e*. This product category covers roof shingles and tiding composed of a mixture of cement and asbestos fiber. This category will ba burned in Stage 3. This product was proposed tar a Stag* 1 ban. The benefits (in terms of cancer-caies-tvolded) of :he actions taken in this rule on this product category i ts follows 0 32 cases if benefits are not discounted and 0 23 cases if benefits are discounted at 3 percent Currently. A/C shingles are rare!) used In new building construction and art used primarily for replacement, maintenance, end historical restoration Primary route* of exposure to tsbestos from products in this category occur during manufacture. Installation repair removal, and disposal. Quantifiablr rci posed by these products from occupational exposure is estimated to range from a lower bound of 3.7 y 10'* for mstallabon to an average of 6.1 v 10"' for primary manufacturing Quantifiable nsk from non-occupanc--.!, lifetime exposure to asbestos emissions released dunng minufactunng is estimated at 2.1 x ltr'for approximately 1.500 people and at greater than 1.0 x 10*` for approximately 8.600 people EPA believes that a number of factors contributed to exposure being underestimated for this category Ambient releases result from weitht ~.ng of these products and high peak exposures potentially occur dunng cutting sanding, scraping, and hammering of these products. EPA is concerned about unknowing, inadvertent high peak exposures fo' homeowners or other* dunng replacement or repair of existing shingles and siding. Such exposures car. result from sanding, chipping cutting or other activities that result in subrlart:iii fiber release Asbestos releases to the ambient air due to weathering of these materials dunng outdoors uses were no' calculated and high peak exposures occurring dunng replacement or repa:of these products were not quantified f^r purposes of the rule. ETA determined that accurately quantifying these exposures and the resultant risks would be difficult and that sufficient other exposure and risk information is available regarding these products to make finding of unreasonable nsk The traditional appeal of A/C products is their durability and their ability to be fabricated. A number of oon-aabastoa products are available that are affective institutes from the perspective of performance. Suitable substitute*, including wood, aluminum, and vinyl tidings and asphalt cedar wood, and Ole shingles, exist for many applications of the products in this category. However, suitable substitutes are not currently available for some products in this category. Therefore. EPA has scheduled the ban of this HNA SH STEW 1517 product lor Stage 3 rather than Stag* 1. Therefor*, the coat of banning these a* originally proposed, to allow far A* development of ecst-affectfva producta is minimal, EPA has concluded that a State 1 ban substitutes while (till addressing riaka in 1* appropriate tot this product category a timely manner. for the following reason*: (l) Relatively The total coat of tha action! taken in high quantifiable individual risk levela thin rule for this product category ie would axial for (beat prodimta wer* S23.R7 million. n*A beliei ca that thia significant US. manufacture or coat eatimata may be overrated. Thia i* importation to begin again; (2) theaa because the coat analyiis for thia products post a high potential' product category aifumed that wood ambient release during a number of life aubitituiaa would capture 32 percent of cycle tUtec (3) homeowner* and the A/C thingls market if the asbestos worker* would be potentially subject to products were banned. Thia aaaumption uncontrolled exposure* war* significiant waa made largely becauae wood ie more U.S. manufacture or importation to begin phyiically attractive than other again: (4} tha cost of banning these substitutes, although U it mimh more producta ia negligible because there is expensive and doea not perform no current significant manufacture or significantly better. import of the** producta and because EPA hat concluded that a Stage * ban suitable aubetitutea exist for them; and ia appropriate far thia product category (S) these products art included within for the following reasons: (1) Relatively the ban to ensure that their U.S. high quantifiablt axpoaure and manufacture, importation, processing, or individual riak level* exiat for theta import doe* not resume product!: (2) Aue products poee a high a. Vehicular broket. This grouping potential for ambient release during a includes drum brake linings, disc brake number of lift cycle stages; (3) pads and brake blocks used in new end homeowner* and workers are existing motor vehicle*. The potentially subject to uncontrolled manufacture or import of 1994 or later exposurea; (4) suitable aubetitutea exiat model year motor vehicles containing for many of theaa producta and are asbestos drum brake Ruing* or asbestos likely to exiat for oihart by tha tune of disc pad* (beraefter referred to as the the ban: (5) the coat of taking theaa original equipment market, or OE3*f) will actiona ia reasonable, especially in light b banned u Stag* 2. Asbestos brake of the aaaumption made regarding tha frictiau material manufactured. portion at tha market substituted for by Imported, or processed at replacement wood ahinglaa ia tha aadmata of the dram brake lining* or disc brake pads cotta, the time provided for eubetititue for Hght- end medium-weight (LMV) development, and the level of ambient motor vehicles with brake systems exposure potad by producta in thia designed to use non-asbestos friction category; and (A] while the quantified material will alto b* banned in Stage 2. benefits of banning these producta are The manufacture, import, or processing relatively amalk compared to other af asbestos brake blocks far heavy product categories banned by thia rule, weight (HV) motor vehicles svill be these producta are likely to Wad to a harmed in Stage 3. fa addition, ell number of aarioua exposures that could friction material containing asbeatoa not bt readily quantified tor thia rule manufactured, imparted, ar processed es and to oootribute significantly In replacement parts far vahicfei environmental loadfag. to tme asbeatoa friction material d- Ock+rproduct mlryoriaa that art (hereafter referred to a* fat aftermarket, currtaUyout afproduction. Tbit or AM) will ba bennari in Stage S. grouping consists af the vinyl/eabeatoe The benefits (In terms of cancer- Door die and aahsetoe dothing caaea-aveidsd) of fat actions taken in categories. 7Vase categories wtii be this rule an these product categories are banntd in Huge 1. These products ware set forth is tha following Tahlt XV: proposed far a Stage 1 ban. Theaa product* am no koagn Table XV--CAMCBt-CASEs-AvooED con produced ia the US. and ar* currently AaacsTos VeeouLAR Bmmes imported hi. at moat, only --H qnantidae.!a instance* fa which these tlseaw* Haw prodnemwr atilt inyartad. PA ia conoamudjdjoet tha poteatial far * wax Oeareeni rrampU Ifc* starling. catting. and mmmral af wfayi/aabaataa floor Tha fact that theaa products art no isugar in cnmnimcafa the\IA indkatan that affactiauaubotititf rue aaatiabla Bum Pme **n CO*)__ own ana* tap (A*___ Otoreratat* pan Utf Oac anas peas. iv t*BQ. OKveMaawca I'M--------------------- (Si rue 0.7* n. am ua maja OJ* 14.14 Ut Table XV--Cancea-Cascs-akxoco ron asbestos vaecuu* Saaxes--Corv *noad Pvoduci Onovi Aew J paroars Sparer Brass Mocfci EM t Ml).... ?Jt <0.10 In the proposal. ffA discussed two approaches for regulating asbestos veh.cular friction material, either banning all auch material in Stage 2 or via the operation of a permit system EPA stated that it would consider a class exemption for replacement parts under the proposal's (taged-ban option. Asbeatos brake friction products are some of Ae most widely-used asbestos product* and are a tourer of broadly ranging exposures to asbestos EPA haj quantified exposures to aibestos from the manufacture, installation, use. aod repair of brake friction products. During Ae life cycle of Aete products, boA occupational and non-occupational exposures to asbeatoa post a lifetime risk of cancer mortality. The population at riak from Aete products it larger Aan Aat at risk from any other asbeatoa product category for which exposure bat been quantified for this rule. Occupational exposure to asbestos from the primary tad secondary mtnufacture of friction producta ia high and affects many people. The 4-hour TWA exposure level quantified for Ae primary manufacture of all friction products ia 0.14S f/ec (Ret. 29). The lifetime risk from this exposure is estimated to be 52) X 10'*. wiA 2.779 worker* exposed. The exposure level from secondary manufacture is considerably lea* Aan from primary manufacture, because secondary manufacture of friction products does not involve cutting, pending, and fitting of broke materiel. IJowarar. the TWA expos*** level for secondary manufacture is stiH high, ranging upward from 0.444 f/ec (Ref. 29). The Ul*time risk from secondary manufacture range* iron an average of 1.0 X 10`* far drum brake linings to an average of 1J x 10'* for disc brake pads. wiA &09B wodcais exposed. Quantifiable riak from Don-occupational lifetime exposers to anbeato* released during fan mnimfactariag of fanm brake* atom* fa nrim atari at 14 x 10** for 92009 people amd paster than 1 x 10'* for 2 mdfaan psrgif Oecnpeteml expose froae fa* installation and repair af eabeatoe brake peda/hslage/block* may reartt fa significant expo*are. Tba -hnar TWA axposare level far fat anrvidng of dtoc s>l HNA SH STEW 1518 F*dgr*) Register / VoL 54. No. 132 / Wednesday, July t2. 1989 / Rules and Regularion* 29493 ad drum brake systems Is estimated to average 0.06 f/cc [Ref. 29). The lifetime risk from this exposure la 1256 X 10`*. There are an estimated 329.000 brake repair facilities where an PTE population of 1.391,000 mechanic* may be exposed to asbestos during installation end repair of asbestos brake friction products. Exposure and. thus, risk have not been quantified for the disposal of asbestos brake friction matariaL 0A estimated that approximately 13 million do-lkyourseif brake installation and repair jobs are done annually by consumers (Ref. 31). Exposure from consumer brake repair variea depending upon the technique used lo repair the brakes, whether the repair i* dont in a garage or outdoors, and other factors. Release of esbestos fibers into (he ambient environment resulting from the braking action of asbestos vehicular brakes contributes to the aignficant risk of cancer mortality for members of the general population. EPA hat quantified die non-occupational exposures from the use of three friction materials: drum brake linings, disc brake pads (LMV). and brake blocks. EPA estimates that the lifetime risk it on* in one million for 101 million Americana, oo average. EPA received a large number of comments concerning exposure associated with the ate of asbestoscontaining brakes. Several commenters stated that there it very little risk of exposure to asbestos fibers released from brakes, because the asbestos is transformed to forsterite by the high beat generated from the use of brakes. EPA recognizes that only a small percentage of the asbeatoa in brakes is eventually emitted into the air. The remainder is either trapped in the brake assembly or la transformed into mineralt such at forsterite by the heat of abrasion before release. However, asbeatoa ts definitely released from brakes daring brake use. The three studies of brake emissions, which EPA relied upon in developing its exposure estimates, all used electron microscopy to obtain positive mineralogical identification of the amissions' components. IV studies found that between OjOIT end 0Jri percent of the material released teat asbeatoa. fl litii imTlTheea percentage* ere quite ctnaft me total amount of asbestos released from brake use (approximately 7 tons per year) la targe because the total veteme of brake emissions ts large. There are devices which can control the release of asbestos during the normal replacement of brake*. These devices, thehnclosed cylinder/HEPA vacuum system end the compressed atr/ solvent tpray system. are recommended, but not required by OSHA at tneeni for reducing exposure! below OSHA's PEL and action level (Ref. 16). The OSHA standard prohibits the use of air hoses during brake repair Under ideal conditions these controls may significantly reduce exposure However, controls must be used consistent!) to be effective and additional exposures can be created during the disposal of asbestos-contaminated solvent or during replacement of HEPA vacuum filters. If the devices are used properly and exposure* are reduced to the PEL or lower. EPA bellevea that the residual exposure can still result in an unreasonable risk. The efficacy of controlled uae as an approach to nsk reduction ia discussed in more detail in Unit* VA 3 and V.E. of this preamble. Several commenters atated that EPA should not ban asbeatoa friction product*, arguing that engineering controls can provide sufficient protection from the risks of asbestos exposure. EPA believes that while these controls, if used consistently, can reduce exposure to the OSHA PEL EPA's analyst* indicates that exposure at levels evan below OSHA'* 0.1 f/cc action level still pose significant risk. In computing workplace exposure*. EPA assumed compliance with the OSHA standard when actual monitoring data was either unavailable or above the OSHA PEL For example, the EPA exposure data for brake repair facilities estimate asbestos exposure at 0.05 f/cc (Ref. 29). Even at this level, which is one half the OSHA action level of 0.1 f/cc. EPA. using the risk table in the 1986 OSHA rule, calculates a lifetime risk of 1.6x10*'. Given the substantial lifetime risk and ISA's concern regarding the consistent and proper use of these controls by mechanica (Ref. SO). EPA does not believe that use of controls during brake repair will sufficiently reduce risk. Additionally. controlled use approach a* an alternative to a ben of asbestos in friction material would not reduce general population exposures to asbestos originating from brake use. In addition, these controls would not typically be available to the estimated 13 million consumers who annually perform do-it-yourself brake )obs (Ref. 31). EPA has assessed the current availability of non-asbestos friction material for disc and drum brake system In various vehicle weight classes. This assessment can be found in Volume HI of the Regulatory Impact Analysis (Ref. 21). To summarize briefly, use of nonasbeetos friction material* In recently- manufactured vehicles ts increasing repidly There is nearly complete substitution for asbestos in disc pads used in recently-manufactured motor vehicle* Almost 100 percent of dic pads for newlj manufactured heavy weight vehicle* are asbestos-free. For light- and medium-weight vehicles. 85 percent of the disc pads used in new vehicles are asbestos-free Several producers estimate that b) 1990. 90 lo 100 percent of the disc pads for new vehicles will be asbestos-free. Evidence also indicates that aignificam progreta ia being made in the development of substitutes for drum brake linings used in recently, manufactured motor vehicles As noted by some commenters. substitution for asbestos in drum brake Linings and brake blocks in new model vehicles appear* to be more difficult than for disc brake* in new model vehicles. However, according to some commenters. much research is ongoing end some substitutes are currently available for drum brakes in newly-manufsetured vehicles. Several commenters stated that asbestos substitute* are more < readily available than EPA baa * estimated and that full conversion to j asbestos-free brake* in newly- manufactured vehicles would be feasible in the near future. Some commenters pointed to the rapid conversion to asbestos-free brake friction material in the European market as proof of the technical feasibility of banning atmilar products in the U S For example. Sweden, the Federal Republic of Germany. Switzerland. Austria. Denmark, and Norway have either banned or are phasing out the use of asbestos friction material. Primary' substitutes include semimetallic materials for disc brakes and non-asbestoa organic materials (including fiberglass, para-aramid. mineral fibers, ateel wool and fibers, and resin*) for drums. Opinions from commenters vary greatly concerning the availability of effective end economical substitute* for brake friction products While some commenters stated that there are substitutes currently evailable for most If not eO. brake friction product*, other commenters fell that substitute* would be available within 5 to 10 yean at the time of the proposal for most If not alL brake friction products. Several commanten were more pessimistic about the future availability of substitute*. Other canuMOten Indicated that adequate *sbe*to*-fire* brake blocks may be difficult to develop for new mode! heavy-weight vehicles because the HNA SH STEW 1519 C- 1 -~s '/ -*- ) juiy 12. 1983 / R;.lej ac.: Srj.Ui.v.u weight of the vehicle pun greater ech material* than U la to develop demand* on the brsi.ng system. eibeitce-free friction me tensl* for us* While many opinion* were offered la a* aftermarket replacement product* la comment* end elsewhere about the vehicle* caRsntlv in us* that kev* brake progress being msde toward the use of lystem* designed lo see asbestos. A eibestos-fre* brake friction materiel. umber of commenter* addressed the EPA did not receive analytical or current availability and efficacy of quantitative data from commenter* asbestos free aftermarket replacement* documenting technical difliculties for vehicles designed to use asbestos encountered regarding substitution for friction materials. Some of the** asbestos in brake friction material. EPA commenter* maintained (hat substitute* acknowledges the inherent research and tie currently *tellable for all friction development variability associated with technological innovation. As a result EPA decided to delay the ben on aebeatos disc brake pads end drum brake fining* in new fight- and mediumweight vehicle* and in replacement disc padf and drum brake linings for lightand medium-weight vehicles with brake systems designed to use non-esbestoe until Stage 1 Manufacture, import end marketing of brake blocks for use is either new beevy-weigbt vehicles or as repiacetneats will not be banned until Stage 3- Theae dates are within the range of time frame* suggested by comments end the American Society' of Mechanical Engineers (ASME) expert panel's recommendations for new vehicles (Ref. 4fl). Specifically. ASME stated that.......... at the present rate of technical progrea*. most new passenger care can be equipped with totally new non-aebeeto* Uricbocal eysteoa by 1981. and most light truck* and heavy trucks with S-cam brake*, by 1902. However, a few low-volume new vehicle application* may not have acceptable non-asbestos friction malarial* at that time. Heavy truck wedge brake block*, medium drum brake linings and many off-road vehicle brake linings may not be developed by 1992." Comments submitted to EPA in 1986 in response to it* proposal described various lead time frames that would be necessary to material aftermarket application*. Some of the major producer* of brake friction products, taduding aftermarket friction material*, no longer produce esbesto* brake frictioo material. One coounenter stated that asbestos replacements tor heavy-weight vehide* are no longer available from refaabl* U.S. producers. On the other hand some coBtateotert stated that it would be infeasible, primarily for economic reasons, to develop effective asbestos-free substitutes for the aftermarket, while others inchested, to 1988 comments, that it would take 10 yean to develop adequate aftermarket substitute*. These comments about tb* technical infeasibiliry of replacing esbesto* friction materiel with asbestos-free frictioo material were not baaed on performance data, but rather theoretical discussions and anecdotal information. Due to the lack of analytic*) information. ETA cannot estimate quantitatively the rate et which asbestos-free substitution is /coining for the sftermarket predicts. EPA has delayed antil Stage 3 the San on sftermarket friction materials manufactured, imported or marketed for use in brek: system* designed to use asbestos. EPA believes this delay will permit time to address technological difficulties in developing aftermarket permit the transition to non-asbestos substitute* for vehicle* designed to use OEM friction materials. These schedules eebeeto*. By the effective date of the varied between 2 and 10 years. The Stage 3 ban. many of the vehicles on the most common time frame pointed to was road will be eebaetoe-free because of 4 to 8 yean for moat friction products, the Stage 2 ban end the prior with spedel consideration* given to menu! tCure of atbestoe-frec vehiclri. brake Mocks tad disc pads for heavy EPA b iheve* that It is important to fore* vehicles. Several commenters requested technr logy to develop asbestos-free time frames in excess of 10 years be replec -ment* as rapidly as possible considered far thee* heavy vehicles. partii atarity in light of the fact that Keeping in mind that these Moments many commenter* have pointed to the wen aade to IfBtvEPA behaves that it current availability et asbeatoa-free is reasonable to atsmne that OEM brake replacement linings/blocks and have fricttoB material (be fight- and median* noted rapid progress in the developmeat weight tdUidii ami heavy-weight of alternatives to asbestos ftictioa vehicles one ha Obrstos-free by the materials. IPA plane to monitor the dates ptawaited to the nds. progress of eubstttute availability tor Commenter* generally agreed that it 1* aftermarket products, thus encouraging eailer to develop replacement asbestoe- . substitute peodaoari and aftermarket free friefcn materials for tse to vehiebs manufacturers to report progrea* or that are intent!oneBy dadgned to use technological difficulties Qiet may necessitate modification ofcertain provisions ol the bam Commecu described lechnolcgjcel replacement difficulties or economic disincentive* associated with developing asbeetoa-frev friction material replacement parts for older and antique care or for epecialty cars such as race can. EPA will ooasider a das* exemption for such vehicles if one is requested. Some commenters stated that a ban on esbesto* use in the aftermarket (or brake systems designed for esbesto* friction products will compromise ttie performance of braking systems designed Cor asbestos brake*. Some commenters went to far as to predict that there may be more death* m vebteie accidents due to poor performance caused by prematura substitution than from the health nsk posed by continued use of asbestos m friction products. Several commenter* stated that EPA bat ignored the impact of an asbestos friction product ban on highway safety and that nsk* associated with substitution should have been considered a* part of the rale's analysis of coats and benefits. One commenter urged EPA to confer with the National Highway Traffic Safety Administration (NHTSA) regarding possible motor vehicles safety considerations associated with use of non-asbestos friction material* m vehicular brake system*. EPA end NHTSA have met and dismissed potential eflect* on vehicle safety if asbestos frictioo materials were banned (Reis. 61. 62. and 83). NHTSA has ao objection to the staged ban and technical review approach adopted for this rule (Ref. 26). Evaluation of the safety concern regarding asbestos substitutioc voiced by these commenter* is complicated by the fact that there are do federal safety standards governing the pariotmanct of aftermarket brake friction product*. While the NHTSA promulgated safety performance standards in 1966 for braka* in aaw vehicles, ao sunilai standards exist for replacement parts. NHTSA received two petitions requesting that NHTSA promulgate safety standard* for the aftermarket. These petitions noted tb* present use of inferior grad* asbestoe aad aooesbesto# frictioo matariala and the inadvertent mismatching of aftermarket friction osatarial to individual brake eystema; tha petitions!* argued that titan is a eoapsUiog need to establish parfnretann* standards tar tha aftermarket. NHTSA panted a petition requesting that NHTSA propose a standard requiring that all heavy truck braka finings be rated and marked in HNA SH STEW 1520 f Easfafal Re*gisiar / Vol. 54. No. 132 / Wednesday. July 12. 1999 / Rale* snd Regulation* JS49S accordance with the requirements of such a standard. Aaotbit petitioner requested that NHTSA vstablish nitty standards for motor vehicle aftermarket brake*. WhUa NHTSA denied portions of thet petition. NHTSA announced its intent to keep abreast of development* by (be Society of Automotive Engineer*, a* wel as other developments in the ana* of brake lining performance the relationship to traffic safety, and the netd* of the nlotoring public. NHTSA entt continue to examine these issues es resource* permit and review and adjust ft* position, ft appropriate. EPA believes that without safety standard* for the aftermarket commercially available aftermarket friction material may continue to be of incooatsssol quality, regardless of whether asbestos or asbestos-free friction products are need. EPA also acknowledge* that a ban on aabestos m the beak* friction product categories may rnrreaae tha uncertainty about brake performsn. in light of the controversy suroe-tding the availability of effective aubatituma for aftermarket frictioo proAicts. coupled with the rapid development and current me of tom* a*beatos-fraa substitutes and the lack of definitive evidence to resolve Cte conpovy. EPA bus tincsrird to delay the ban oa aabestos in aftermarket brake friction ptuducts until Stage 3 to allow sufficient time ts develop adequate substitute*, fat spits of the relatively low economic impact associated with an lnanediate ban of asbestos in the beak* frictioo products category and the high risk associated with aabestos exposure originating from aabestos friction products. EPA believe* that it is isspartant le provide this 7-year lead tiaa for the industry to develop tad produce safe and effective asbestos-free substitutes. Such sn approach u consistant with some oonunetta received by H'A. The baa on areata* friction product* will buocats effective ia two stages: the OQ4 far can aad ti^tt trades wtft ha in Stage 2 aad the OEM for heavy vufaddes and tha AM far sB vehidet w8i banned at Stage 3. Thus sequential ban aocoomodatea the variable rntoaf develops* nf antad by stages than EPA is this Am! rale. DA that a ceagdicatad wnddhabetdtnscna without any real bspsAtTW 2 stage baa for aabaatna bruhaajdagtod ia <a* tula tayusaato tiainaa that * Kh dutaaprapaaarl by < Whflei to exist over the dates when substitutes will be available for different vehicle types. EPA believes thsl this rule provides sufficient lesd time for tbe development of effoctivs non-esbesto* substitute brakes. In light of these facts and tha extensive risk posed by exposure to asbestos from vehicular brakes EPA believes that it (a appropriate and necessary to ban asbestos in vehicular friction material. Nonetheless, as described above. EPA. In consultation with NHTSA, will monitor the pace of substitute development and undertake a technical review S year* after the effective date of the rule, to ensure the availability of suitable ooo-esbeato* aftermarket brake products. After considering *0 of those issue*. EPA believe* that this is the besJ tpproach in light of tiw high risk posed by asbestos, the rapid development of replacement friction material*, the current use of oon-asbestou brakes in European countries, the controversy concerning substitute availability and performance, and the ctureal consideration, by NHTSA. of aftermarket safety standards. The total cost* of the actions taken in this rule for these product categories are aet forth tn the following Table XVI: Table XVt--Cost of the Role fob asbestos vehicular Brakes Product 1 TOW Cost I In * mdhen. | ascrxsxsd el Onn t>W> tong* CB I PutlwiWuiU*| Due MM pLMV lOEUl---------- Dec Brakv pads LMV (AW,... ........... OeC BrsM Beds. HV (OEM 4 AAfl J Brake CtoOa OEM 4 ASAII r 13 *7* 3.5* 3M 033 __' *6I f. Otherfriction products. This grouping include* clutch facing*, automatic transmission components, and the industrial and commercial friction products categories. These products will all be banned at Stage 2. The benefits [in terms of cancer-casesvoidedl of the actions taken in this rule on these product categories are set forth tn the following Table XVtt Table CascEwOtscs-Avcto fob Other Dhctos Prooucts Table XVII--GwcEn-CASES-Avo-oeo SOB OTHER FRtCHO* PSOO'JCTS--Corbrtuod Wudwl j *itc | J pwiMiv 0 pran i mouirat fncflOfa m wwiw| ----- ~1 1 1 04C| a Primary routes of exposure to asbestos from these products occur during manufacture end repair Quantified occupational risk pored bj the manufacture and repair of these products range* from an average of 1 4Bx JO-*for (he primary manufacture of automatic transmission components to in sverige of 5 2xltr* for the primary manufacture of friction materials Approximately SI* wo-in-s :> primary end secondary mar.jfic'i.-e at d 116 FTE* m installation, repair and disposal are exposed to asbestos In addition to these occupational risks EPA haa quantified significant nonoccupationul release* from the primary manufacturing of these three products Monitoring data are not available for the exposure resulting from the use of these products, although EPA does believe additional exposures from clutches and industrial and commercial friction products sre likely. After assessing the current availability of substitutes and expert opinions concerning the predicted availability of substitutes. EPA believes that suitable substitutes will be available for dutch facing*, automatic transmission components, snd commercial snd industrial friction products by the effective data* of the bens. Over the las! several yea: EPA bai noted the increased use of nonssbestos part* for these products end beheves further development i* likely The total coit or the actions taken is this rule for these product categories art set forth in the following Table XVUl. Table xvw--Cost of the Rule fob Otheb Fmcno* Pbooucts* i Tow CoS' i r l mrfux i axnt*c 'trie 12.87 0J22 2.11 The ooomamic tepect cm this ben will be teitad by the fact thet moat tua)or primary manufacturer* of asbestos HHina aVan ferarfuce MheatOft- HNA SH STEW 1521 ..a-, Jv rev-c.. r.ez.z.'ii i v gi. >4. >a lu<; / W jcn'-vday. /:;.'> 12. 199 / R..' ; a~~ S,,:-.s free substitute products. la fact. si) of the U.S. manufacturers of esbestoscontaiainf automatic transmission components also produce asbestos-free products. Currently, asbestos-containing automatic transmission components currently comprise only one quarter of the present market. Considering the rapid substitution in this area and relatively low cost. EPA will ban the manufacture of automatic transmission components at Stage 2. EPA hae concluded that a Stage 2 ban ie appropriate for these product categories for the following reasons: (1) Relatively high.quanUfiable exposure and individual nsk levels exist for these products: (2) these products pose a high potential for ambient release during a number of life cycle stages: (3) workers and the general population are potentially subject to uncontrolled exposures; (4) suitable substitutes exist for many of these products und are likely to exist for other* by the time of the ban: and (5] the cost of taking these actions is reasonable. g. Gaskets. This grouping includes most of the beater-add and sheet gasket product categories. These products, except for specialty industrial applications, will be banned in Stage 2. Specialty industrial gaskets are not banned under this rule (see discussion at Unit VF-Lx below). The benefits (in terms of cancar-casea-svoided) of the actions taken in this rule on these product categories are set forth in the following Table XIX: Table XIX--Cancer-Cases-Avoioed fob Gaskets 1 - Produel Oseev* -ate 3 potmt 0 imunt Shaei ari---------------- <14i 29 34 10 76 14.20 'Oos* not rduot specialty rdunna: getua Gaskets are materials used to seal one compartment of a device from another in applications tucb as engine and exhaust manifold*. Atbesto* gaskets are used mainly to ttal connections end prevent leakage of fluids between solid surfaces. Primary routs* of exposure to asbestos from these products occur during manufacture, repair of machinery containing an aibeato* gasket, wgdansmant af Ifce festal Uself and disposal Bxposare estimate* (but not coet or benefit estimates) used in this Unit feflndl exposures quantified for all safest applications, including the stnsll specialty industrial gasket segment of the pssktt market that is not banned by this mis. An sntlmstsd 2.583 workers are exposed to asbestos during primary and secondary manufacturing of asbestos gaskets. Quantifiable risk of occupational exposure to these products ranges from tn sverage of 7.35 x 10" * for the secondary manufacture of beateradd gaskets to an average of 3.56 x 10'1 for the secondary manufacture of sheet gaskets. Quantifiable risk from nonoccupational lifetime exposures to asbestos released during the manufacture of beater-add gaskets alone is estimated at 1 x 10' ` for approximately 47.000 people and at greater than 1 x I0"`fo: approximately 6 million people. EPA believes that the exposures quantified for these products are underestimated. Exposures that occur during gasket replacement and machinery repair, including activities like scraping of gaskets or on-site fabrication of gaskets, were not quantified by EPA. EPA determined that accurately quantifying these exposures and the resultant nskt would be difficult and that sufficient other exposure and risk information it available regarding these products to make a finding of unreasonable risk. According to comments, production of asbestos-containing sheet and beateradd gaskets has dropped significantly in most applications in recent years and non-asbestos substitutes already possess a large share of both gasket markets. Also, commentert indicated that the majority of the gasket market will be asbestos-free before the end of 1989. The economic impact of this ban will be limited by the fact that significant progress has been made in the development and availability of non asbestos substitutes for most gasket applications and that most if not all. major primary manufacturers of asbestos gaskets also produce non asbestos substitute product*. Due to the insufficiency of available pnee data, tbese recent trends, and the resultant decreases in the coats of banning this product, are not fully taken into acuoun1 in the analysis of the benefits of banning these categories. Therefore. EPA believes that the actual cost of the actions taken on these categories is less than that indicated below. Gaskets wart proposed for either a Stage 3 ban or a ban via the operation of a permit system. However, EPA bss racsivsd comments indiesdug that the development of suitable substitutes has bssa mors rapid than projected for most applications. EPA is also concerned that consumers and others may be subject to uncontrolled exposures during the repair sad rsplacsaent of consumer application* of these products. - The total cos'.* of the ec::on teketi in this rule for these product rategor.es a"r set forth ui the following Table XX. Table xx--Cost Of The Rule Fo> Gaskets 1 Baste- eoe )n________ ____ S"*r easMts _________ ___________ 1 Oom rot rdude ! Tot to** , r $ njiiyt , i^vrtvr-.tiQ ; r. 3 * poc/rti i * u ?c ka pute:* EPA has concluded that e Stage 2 bar is appropriate for these product categories (except for specialty industrial gaskets) for the follow,ng reasons (II Relatively high quart.f.-abie exposure and individual risk levels ex:t>: for these products: (2) these products pose a high potential for ambient release during a number of life cycle stages: (31 homeowners and workers art potentially subject to uncontrolled exposures during removal and replacement of gaskets: (4) the overall cost calculated for taking these actions is relatively high, but n likely to be an overestimate because, according to commentert. suitable substitutes exist for many of these products snd are likely to exist for others by the tune of the ban: snd (5) the scheduling of these products for t Stage 2 ban allows for the continued development of substitutes. Delaying the ban on these gaskets until Stage 3 or not banning the use of asbestos in these products could hurt the efforts of the large numbers of firms that have already made aigmficant progress in developing substitutes because tome substitutes are more expensive than asbeatoa-contamir.g gaskets. Specialty industrial gaskets are excluded from this rule's bans. These applications are oot banned because of the high costs of a ban. due to the lack of suitable substitutes for a number of specialized industrial uses, the relatively small benefits derived from bar. and number of other factors described ir. Unit V.F.I.X. h. A/C pipe. This category will be banned in Stage 3. The benefit* (in term* of canotr-casea-svoided) of the actions tsksa in this rale on this product category an as follows: 3.17 cates if benefits art discounted st 3 percent and 4.38 cases if benefits are not discounted A/C pipe fa a product composed of cement and asbestos fibers and used primarily to convey potable water in water mains, aewage is force main sewer*. and various materials In HNA SH STEW 1522 . . Federal Register / VoL 54, No. 122 / Wedaesday, fuly 12. 1989 / Rule* sod Regulation* 29497 Industrial process line* (pressure pip* applications), i well * storm drain pipe* tad sewer pipe* (nan-pressure pip* application*). Thousand* of mil** of A/C pipe are installed in the U.S. annually. A/C pipe comes in a wide variety of diameter*, formulations, and weight* designed for different applications. Primary route* of exposure to tsbeato* from these products occur during manufacture and installation. A total of 280 workers is estimated to be exposed to asbestos during the primary manufacture of A/C pipe and a* many a* 14.944 workers may be exposed during the installation and removal of A/C pipe. Individual lifetime risks posed by these products from occupational exposure are estimated to range from 6.11 X ltr'for instails hoc and removal (a lower bound that assumes workers install and remove A/C pipe 16 percent of tbau working hour*) to an average of 3 x 10"'for primary autoufaciur*. Individual risk from nos-occupetiaaal lifetime exposure to asbestos released during manufacturing it estimated at 1 X 1(T* for approximately 30.000 people and at over 1 x 10** for approximately 2 million people. Howevitr. EPA believes that the exposure* quantified tor this category are underestimated. Worker exposures that occur due to the cutting, drilling, or machining of pipe in possible violation of OSHA requirement* or general population exposure because of possible erosion of A/C pipe an not accounted for. U.S. production of A/C pipe baa deereased significantly in recant yean with tbs dnrJinas in sawar system construction and other market factor*, including the growing us* of non-asbestos substitute products. Some commenter* have stated that A/C pipe poeaessts a number of uniqa* attribute*, including lower energy requirements and friction loss, and greater durability in certain environments then the substitute* identified in the RIA. and that therefor* A/C pipe should aot be burned fn the near term. Avadabl* evidence suggests that products sn currently available a* subatitoias. Tbs primary substitutes for A/C pip* art polyvinylchloride (PVC) wd dwetfle iroo pipe. There era e variety of asbestos-free concrete peeducts.tackding prastrasaed end ratafaroed concrete pip** that may *ko be seed |i substitute*. All primary ILS. producers ofA/C pipe also prodsc* direct mb*brutes made out of sonasbestos malarial*. A comment*? indicated flint a cemanl/aubatitute-fiber pomposttlon Is under development and that the Mbetftnte fiber may replace asbeetoe to A/C pip*, thus permitting (he continued use of capital equipment cuijently ued to produce A/C pipe. This would iubstantially reduce the cot:* end societal impact of banning A/C pipe. Some coomenters have argued that if A'C pipe is banned pressure may b* brought to replace or diacootmue use of existing A/C pipe. EPA does rot believe that installed A/C pipe should be replaced or that its use should be discontinued SPA* evsJcabofl of the risk poaed by A/C pipe, and by all product* subject to this nil*, ts of absolute risk poaed over the entire life cycle of product* to be produced In the future, not fust risk poaed by existing product* during product use. EPA's primary concern, for purpose* of this rule, is the risk poaed by exposure* during the life cycle stages of A/C pipe from manufacture through installation. Expected risks later in the product life cycle. for example those risk* engendered from exposures doe to eroding pip*, have not b*en quantified Therefore, actions to remove or discontinue nae of existing A/C pipe In response to this rule are not justified Other commenter* argued that if A/C pipe is banned in the U.S., other countries, including those where viable substitute* foe A/C pipe ere not readily available, would be pressured to ben the product. EPA't unreasonable risk analysis for this rale for A/C pipe is based not only on the risk posed during the life cycle of the product in the U.S.. but also on the availability of viable sobttitstea in the U.S. and other factors. Therefore, the fad that EPA finds in this rule that future A/C pipe production and use to the U.S. poses an unreasonable risk does not Imply that a similar finding could be made outside of the U.S. A commenter argued that PVC and ductile iron pipe a* primary substitute* for A/C pipe pose greater health risks than those poeed daring the life cycle of A/C pipe. EPA acknowledges that the Individual lifetime cancer nsk associated with the production of PVC may be equivalent to that associated with the production of A/C pipe. EPA could not calculate Individual lifetime cancer risk for the production of ductile iron pipe. Instead EAP could only compute population caacer risk for ductile iron pip* production because of tba manner in which available risk data were presented. Tb* population cancer riak for the production of ductile iron pipe could be comparable to th* population cancer riak for production of A/C pipe. While available information permitted EPA to quantify the risks associated with th* installation of A/C pipe, cancer risks from installation of ductile Iron pip* or to PVC dust from Installation of PVC pipe have not been identified. While Individual 'ifedme risks have been quantified for v.r.yi chJonde (VC) leachate ui dn-.k.ng water, individual lifetime risks associated with asbestos in drilling water have not bean specifically quantified. While the fuppcr.ag data are limited, based on a consideration of life cycle risks. EPA believes tha> the available evidence suggests that substitution of A/C pipe with PVC and ductile iron pipe will present lower population cancer risks t. Polyvinylchloride pipe For the proposed rule. EPA concluded !ha' PVC pipe does not appear to preseo' a health hazard comparable to asbestos although VC. the monomer used ro produce PVC is s carcinogen EPA also concluded that while VC Is a human carcinogen, it does not appear sc present a greater hazard than asbefos ir. t.be workplace or ambient environment The PVC product itself presents little r.sk and workplace exposures are apparently adequately controlled (Ret. 39). ETA based this determine tier- for the proposed rule, on several factors including the individual lifetime cancer nsk of 10'* for occupational exposure due to inhalation of VC in the manufacture of PVC pipe fRef. 39) In response to the proposal, s commenter stated that workers exposed via inhalation to VC at the OSHA's PEI. of 1 ppm would have a potential individual lifetime cancer risk of 4 x 1<T *. The commenter noted that this mdividua! lifetime cancer risk is based or EPA's Carcinogen Assessment Group's (CAG) published unit cancer risk of Z x 10'* (mg/kg/day)'1 for VC based on sntmal inhalation data. The commenter questioned the discrepancy between the individual fifetime cancer risk estimation for VC of 4 x 10"' and the lifetime cancer nsk of 10** cited in EPA's cuppari docemrnt for the proposed rale. The commenter Is comet that CAG bas published a unit riak number for inhalation exposure to VC This unit nsk number was derived from animal Inhaladoa data. The individual lifetime cancer risk number. 10**. cited in the support document for the proposal was derived from epidemiological data analysed aad reported by Nicholson et al. 1962 (Ref. 39). Is summary. EPA believes that the expected individual lifetime cancer riak associated with the manufacture of PVC pipe may be equivalent to tb* Individual lifetime cancer risk posed by manufacture of A/C pip*. However, a* noted in HNA SH STEW 1523 29498 Federal Register / VoL 54. No. 132 / Wednesday. July 12. 198V / Rules and Regulations testimony presented by i consultant for disposal of PVC nips were not the Asbestos Institute at the 1900 considered. For the proposal. EPA legislative hearing, production of A/C evaluated hazard and exposure data on pipe is significantly more tabor Intensive some other chemicals associated with than production of PVC pipe. Even if one pipe production and uae. However, as assumes that the lifetime cancer risk for noted by a commenter. the hazard and/ production of A/C pipe and inhalation or exposure data for these other of VC in the manufacture of PVC pipe chemicals are too limited to assess nsk. are comparable, the number of expected C -e basis of available evidence, on cancer cases (population risk) from balance. EPA believes that the production of PVC pipe will most likely population risk associated with A/C be lower than the.expected number of pipe life cycle exposures are likely to cancer cases associated with the exceed the population nsks associated production of an equivalent amount of with life cycle exposures to PVC pipe. A/C pipe. A/C pipe presents risks throughout iu EPA recognize! that VC inhalation exposure in the workplace, is the most significant exposure. Other potential exposures that could be present but are difficult to evaluate include: (1) VC leachate in drinking water. (2) VC emissions from PVC plants, and (3) inhalation of PVC dual. A commer.ter noted that "exposure to VC by ingestion in drinking water (via leaching from the PVC water pipe or at a contaminant in the water aupply from disposal of VC/ PVC waste products) also occurs." Additionally, the commenter noted that EPA should update its unit cancer risk valne for ingestion given e more recent calculation by EPA's Office of Drinking Water. product life cycle during manufacture, installation and repair, use and disposal because of the especially hazardous properties inherent in asbestos, the environmental persistence of asbestos fibers, and the larger populations exposed, In contrast. PVC pipe presents risks largely during the manufactunng phase of PVC pipe. ii. Ductile iron pipe. For the proposed rule. EPA concluded that ductile iron pipe, as a substitute for A/C pipe, would not present a health hazard comparable to that of asbestos (Ref. 39). Based on EPA's revised analysis of lifetime exposure associated with A/C pipe, one could argue that the number of excess cancer deaths associated with the production of ductile iron pipe and A/C EPA acknowledges the presence of pipe may be similar (Ref. 42). However, detectable levels of V'C in drinking the excess cancer deaths that may be water however, the amount of VC attributed to ductile iron pipe may be expected to leach into drinking water overestimated (Ref. 42). The estimate of from PVC pipe is considered to be excess cancers was derived from minimal (Ref. 43). It is estimated that epidemiological data gathered on steel nearly all individuals (96 percent) using and iron foundry workers who may have public water supplies are exposed to had more diverse and higher exposures <1.0 ng/l of VC from all sources. At IX) to toxic agents. Nevertheless, even if the pg/L the excess lifetime cancer risk is cancer risk associated with ductile iron about 6 x 10'* (Ref. 44). Since leaching foundries is similar to steel foundries, of VC from PVC drinking water pipe is the estimate of cancer nsk for ductile estimated to be minimal the nsks iron pipe is most likely an overestimate associated with any increase in the for current exposure since histoncal amount of VC leachate in drinking water exposures upon which the risks were as a result of a ban of A/C ptpa is also based were probably much greater. In expected to be minimal. contrast, ductile iron pipe is Exposure to respirable PVC dusts and fumes may occasionally be encountered in the production of PVC or in the manufacture of PVC pipe. Exposure to PVC duet is associated with nbrotic lung changes and aoafatal lung ooaditiosa. suafa as bronchitis and pneumococcosis manufactured from scrap metal which is not expected to result in exposures similar In magnitude to those found in the steel and iron foundries. Given that the number of workers exposed to particular agants in particular fob categories cannot be determined, a precise occupational cancer risk comparison cannot be made. In AsUoftas >6 its analytical approach addition, available evidence suggests to asbestos and fibrous substitutes. EPA that risks during non-manufacturing limited itsTVC assessment to health stages of the product life cycle are effects directly aisocisted with VC or greater for A/C pipe than for ductile PVC Effects from exposure to other iron pipe. Thus. EPA believes that fewer chemicals (sndi as solvents, byproducts, cancer cases would be expected from intermtdiats*. andedhcsivss) involved ' die substitution of ductile bon pipe for in the manufacture, Installation, use or A/C pjpe than from tha continued manufacture processing, and us* ofA /C Pipe. tii. Regulatory approach The total costs of the actions taken in this rule for this product category is St28 03 million Thu cost it likely an overestimate of tctual cost (n that it does not quantify the effect of the development of substitute fibers in cement pipe production. Use of a substitute fiber is expected to substantially reduce the costs and societal impact of banning this product. ETA has concluded that a Stage 3 ban is appropriate for this product category for the following reasons: (1) relatively high quantifiable exposure and individual risk levels exist for these products; (2) these products pose a hig.n potential for release of asbestos fibers dunng number of Life cycle stages (3; workers and surrounding populations are potentially subject to uncontrolled exposures, especially during installation: (4) while this category was proposed for a Stage 1 ban. EPA has concluded that It is appropriate to delay the ban until Siage 3 to allow more lime for further substitute development: (5) the cost of taking these actions is reasonable because performance and price suitable substitutes exist Prior lo the effective date of the Stage 3 ban. EPA will undertake a technical review to determine the availability of non asbestos substitutes for A/C pipe. EPA believes that this is the best approach in tight of the significant risk posed by asbestos: the possible risks posed by the current major substitutes. PVC and ductile iron pipe: and the development of further substitutes for A/C pipe. L Coatings. This grouping includes the roof coatings and cements and non roofing adhesives, sealants, and coanngt product categories. These products will be banned in Stage 3 Tne benefits tin terms of concer-ctsesavoided) of the actions taken in this rule on these product categories are set forth in the following Table XXI: Take XXI--Cawceh-Cases-Avoioed FoaCOATmas Pnajea Daaxrft ma 9 pmxmn 0 p#Ft*rr Morwvot coisaoi_____ 1JB 1 49 tM These products are used for s wide variety of functions. Roof coatings uses include waterproof!^. Mating, and repair of roofs. Non-roof costings uses tndude adhesives, sealants, and postings used tat the building i ariat/to.! HNA SH STEW 1524 construction. automotive. *nd aerospace Industrie*. Primary routes of exposure to asbestos from these products occur during manufacture, installation or application, and repair. A total of 582 workers i estimated to be exposed to asbestos during primary manufacture of asbestos roof coatings, and S53 workers are exposed during the primary manufacture of asbestos nor.-roof coatings Quantifiable risl posed by these products is estimated to range from 1-22x10*' for the removal of roof' coating* in built-up roofing [a lower bound that assumes less than full-time exposure] to an average of 3.52 x 10 * for the primary manufacture of non-roof coatings. Quantifiable risk from nonoccupationaL lifetime exposures to asbestos released during the mantificture of roof coatings is estimated at 6.27 x 10*` for approximately 1.000 people and at greater than 1 X'10**for approximately 450000 people. However. EPA baa concluded that the exposure quantified for this grouping are underestimated. EPA did not quantify exposures that occur during applicationmaintenance. and repair, including activities like spray application oi coatings and sanding or removal of axisting coatings or caulking. EPA also did not quantify releases to the imbfent air due to the weathering of products used in outdoor, sometimes harsh environments. Many products in this category' that are used in outdoor environmenta eventually wear off or chip or flake, resulting in difficult to monitor ambient releases. If. as a means of representing the possible effect of underestimated exposure during installation and removal it were assumed that as little as one-tenth of l percent of asbestos consumed for these uses were released over the life cycle of the products and exposure were assumed based on analogous product operations, the estimate of benefits would more than double for roof onetings [benefits,would be 3JS7 cases at 0 percent and 2.59 cases at 3 percent) end would increase for non-roof coatings [benefits would be 2JJ7 cases at 0 percent end 1SO cases at 3 percent). According to comments, non-asbestos substitute* possess growing shares of both coatings markets. Available evidence sasgesls that suitable sabsrttwtas mould be available for most application* by Stag* 1 One coamenter. a major producer of roof coatings, indicated that ti had replaced asbestos to all of tts formulations. Trends toward the peatar oae of noe-sbesto* substitutes and probable decreases in the cost of substitutes ars not fully taken into account in the analysis of iht benefits of banning these categories because of the unavailability of substitute use information at the time the analysis wes performed. Therefore. ETA believes that the actual cost of the actions taken on these categories is less than that indicated below. Both coatings categories were proposed for either a Stage 3 ban or a bar. via operation of a permit system. EPA has received comments indicating that progress has been made in the development of suitable substitutes. The total costs of the actions taken in this rule for these product categories are ae: forth in the following Table XXII- Table xxii--Cost of the Rule fo Coatings Product , Tote cost e S . n*on. 1 iteccuxnu st 3 | psreare 1 ttod oosanoa----------------_______ 1 Sowooi coaSne*______ _______ j $ 41 0 8'. EPA hat concluded that a Stage 3 ban is appropriate for these product categories for the following reasons: (1) Relatively high quantifiable exposure and individual risk levels exist for these products: (Z) these products pose a high potential for ambient release during a number of life cycle stages, including ambient releases due to weathering during outdoor use: (3) homeowners and workers are potentially sublet to uncontrolled exposures during product application, maintenance, and removal. (4) the cost of taking these actions is reaaonable because suitable substitutes are expected to exist for all of these products by the time of the ban: and (5j while the quantified banefita of banning the** products are relatively small, compared to other product categories banned by this rule, these products sre likely both to lead to a number of aerious exposure* that could not be readily quantified for this rule and to contribute significantly to environmental loading. j. Paperproduct*. This grouping ksedude* the commercial paper, corrugated paper, millboard, rollboard. and specialty paper product categories. These products will be banned in Stage X The banefita (in -tarns of cancercases-svotded) of tba actions taken in tUa rule of these product categories are aet forth in the following Table XXIU: Table XXilt--Cancer-Cases *vooeo fo* Asbestos Paper Prooucts teteoeW______ _______I Sosoafty pspsr ... _. j 0' 0 '0 0 54 cn Comme-cial and cor-.-gs'ed p'pe- -~,l rollboard ere no longe- u'lr.-.f: imported or produced in the l' S The products in these categor es a.-tused for a wide variety of functions They are frequently very tim-lar ir. fu-m but differ primarily by specific end use Product uses include thermal insulation fireproofing and fill for a variety of applications, such as beverage anti other fillers. Asbestos paper products are also used as a component of other products such as gaskets (discussed abot e! Primary routes of exposure to asbestos from these products occur during manufacture, installation, repair removal, and disposal. A total of 668 workers is estimated tc be exposed to asbestos during primary and secondary manufacturing of asbestos paper products Quantifiable risk posed by these products is estimated to range from an aversge of 7.35 < 10* for the secondary manufacturing of all paper products to an average of 1.87 x 10 1 fur the primary manufacturing of millboard There is potential for episodic peak exposure during manufacturing activities Respirators and strict workplace and cleaning practices must be observed to meet the existing OSHA PEL for these products. Quantifiable risk from non-ocr.upational. Iifenme exposure tc asbestos released dunrg :he manufacture of millboard is estimatec a1 r, 10'*for approximately Z.2S6 pc-c-f li and at greater than 1 x 10*'for approximately 840.000 people EPA hof concluded that the overall exposures quantified for this grouping are underestimated. EPA did not quantify exposures that occur during installation repair, and removal including activities like cutting, drilling, and tearing performed by hand during installation, maintenance, removal, and disposal of existing products- EPA determined tha: accurately quantifying these exposures and the resultant risks would be difficult and that sufficient other exposure and risk information is available regarding that* product* to make a finding of unreaaonable risk. According to EPA'* analysis and comments, three of (he five peper product* in this grouping, commercial and corrugated paper and rollboard. are no longer commercially imported or HNA SH STEW 1525 I^rs-nor / y. . >o. 132 / W^dr.evijy. July 12. 1369 / Rjes i. - Rr*. produced in the U.l In addition. low cost rubstltale* rxjt for products In (he millboard aod the specialty peper categories. Therefore, aveilabte evidence suggest* that suitsble substitute* should be tvtllsble for most applications by the effective date of the Stage 3 ban. The total costs of the actions taken In this rule for these product categories are set forth in the following Table XXIV: Table XXIV:--Cost of tv* Rule for Asbestos Paper Products L Prefect Tow cost e f reMan. etvnrtart m 3 parent) Wtlbo*iU.... ... _ 371 &aea*y paear .. 0 _________________ __________ The paper product categories were proposed for either t Stage 3 ban or a ban via the operation of a permit system. Many of these products are no longer used in the U.S. and suitable substitutes are rapidly being developed, although the development of reasonably-priced substitutes for some specialty uses might take a number of years. EPA Is also concerned that consumers may be subject to uncontrolled exposures during installation, maintenance, repair, and removal of products such as millboard. In addition, many of these paper products are very similar in form and bans would be difficult to enforce were the products in this grouping banned at different times. EPA has concluded that a Stage 3 ban is appropriate foe these product categories for the following reasons. (1) Relatively high quantifiable exposure and Individual risk levels exist for these products: (2) these products pose s high potential for ambient release during a number of life cycle stages: (3) consumers and workers are potentially subject to uncontrolled exposures, especially during Installation, maintenance, repair, and removal of these products: (<} the coal of taking these actions la reasonable beceust several of these products are no longer produced or Imparted in the U.S. and because suitable substitutes are expected to exist for all of these product* by the time of the ban; and (5] white be quantified benefits of hashing theee projects are relatively small compared to other product categories banned by (Us rule, these products are likely bets to lead to a number of serious exposure* that could not be readily quantified for this rule and to contribute significantly to environmental loading. One Asbestos psper product category, high-grade electrical paper. I* not included within the rule's bans (see Unit VJ.l.v). This product is not included for s number of uses of the product, thereby making the cost of a ban very high relative to other products analyzed for this rule In addition. high-grede electrical paper is reaeonah'y discernible from other pap.: products. 1l New commercial asbestos products This grouping covers ail new asbestos- containing products whose commerc;*! manufacture, importation, or processing commence* after the effectiva date of this rule. All such new uses wtll be banned from manufacture, importation, processing, and distribution m commerce si of Stsge 1. unless EPA grants an exemption application for the product or use. tn view of the following factori. EPA finda that the use of asbestos in new products whose commercial manufacture, importation, or processing is initiated after the effective date of this rule's bans poses an unreasonable risk of injury to human health: (1) The development of substitute fiberi. (2) the potential for high lifetime risks related to exposure to asbestos due to the manufacture, importation, processing, and use of aew asbestos products. (3) the likely escalation of environmental loading of asbestos if the manufacture, importation, processing or distribution in commerce of new asbestos products were allowed. (4) the speculative benefits of new uses of asbestos, and (5) the absence of cost related to modification of existing capital equipment Therefore. EPA finds that the benefits of banning new commercial asbestos products outweighs the costs of such s ban Should a new use of asbestos be developed which meets the crrterii applied to exemptions for existing asbestos products, set out tn Unit HUE of this preamble and J 783.173, an exemption should be applied for and may be panted. 1. Categories and activities not subfect to this rule i ban. This grouping Includes acctyten* cylinder*, arc chute*, aebesto* diaphragms, battery separators, high-grade electrical paper. tateaUe imers. packing*, reinforced plastic, sealant tape, specialty indastrial gaskets, and textile*. These products wert generally prapoasd far a third stage ban or a ban via the operation of a permit system. Thau products art exempted from the final rule's baas because, based on curranily-evaitebte information. EPA has not found that they pose an unreasonable risk of injury tohuman health under the criteria of TSCA taction 8. H>A wifi reconsider its decision whether to include these product* w.thin the ban if more Information about them becomes available. The following par*graphs discuss EPA's findings for the various products in this grouping. I. Acetylene cylinder filler These products are used a* filler in steel cylinders used to store acetone in oxyacetylene torches. Benefits deriv ed by banning this product would total less than one-ter.tb of t cancar-case-svoided. Exposure* during primary manufacture are low due to the enclosed nature of the product's production process. Exposures in stages of the product s life cycle beyond primary manufacture are likely to be limited, relative to other product categories, because the product is enclosed and there is bale exposure during product repair or disposal compared to other products analyzed for this ruie. ETA does not believe that a bar is appropriate for this product category for the following reasoos: (lj Current substitutes are more expensive than asbestos products and little informs lion is available on the relative performance characteristics of substitutes, therefore, reasonable cost, suitable substitutes may not be available for all appbeatians of these products; (2] this product category accounts far only a minuscule portion of U.S. asbestos consumption (approximately 584 tons in 1985). and (3) s ban on this product category would result in only minimal benefits because asbestos exposure is limited in most life cycles stages, relative to other products analyzed for this rule. ii. Arc chutes. These products are used to guide electric arcs in products including motor starter units in electric generating plants. The benefits derived from a ban on this product would total only a small fraction of a cancer-caseavoided. Although EPA baa no data on exposure tor products is this category, exposures in product Life cyclt suges beyond primary manufacture are Ukeiv to be limited, relative to'other product categories, because the asbestos is bound in oaramic in the end use product. EPA does not bebeve that a ban is appropriate for this product category fo' the following reasons: (1) Insufficient information was available regarding exposure to determine the benefits of banning this product; (2} this product category account* far only a minuscule portion oT Uix asbestos coossmpuon (approximately tans in 1985k iii. Asbeatos dicphrogsis These products ate used primarily in the chloraikali industry in ths production of chlorine, caustic sod*, and other 1 HNA SH STEW 1526 1 fs I'* "X Federal Register / VoL H Na 133 / Wednesday. July 12. 198* / Rules nd Reyjldtioa* 29001 product*. Benefit* derived by banning this product would totel approximately three-tenth* of a cancer-case-*voided. Expoiure to asbestos during the life cycle of thi* product Is limited because the product l* generally fabricated on sit*. u*ed saturated with solution. and disposad of while wet. Asbestos t* not proa* to be releaied into the ambient air during stage* after product fabrication. Further. Insufficient Information exists regarding the availability of substitute product* for diaphragm* in existing chlorine production plant* to justify a baa. The coat of modifying exiating plant* to aocept new membrane cefi technology in response to e ben oo asbestos use in this product may be very high. Bated on evailablc information, the totel cost of banning this product is estimated to total more than 52 bilhon. However, suitable aubetltutet now exist for asbestos diaphragm* for use in more recently constructed chlorine product plants. Therefore. EPA specifically recommend* that user* of asbestos diaphragms use non-asbestos diaphragm cells in facilities that will accept them and in tha design of new facilities. EPA does not believe that ban is appropriate for thi* product category for the following reasons: (1) Insufficient information waa available to determine whether suitable product substitutes will soon be available for use tn existing chlorine production facilities: (2) the cost of banning this product category would be very high: (3) this product category accounts for only a minuscule portion ofU-S. asbestos consumption (less than 1.000 tons in 1985); and (4) a ban on this product category would result in Only minimal benefits because asbestos exposure is limited in most life cycle stages, relative to other products analyzed for this rule. hr. Battery separators. These products are used to insulate or separata die polar terminals in batteries or fuel calls, primarily in highly-specialized military and aerospace applications. Tha benefits derived from a bam on thi* product would total only a small fraction of a cancer-care avoided. Although EPA baa no data oo exposure to products (n Ibis category, exposure* to stags* of tha product's life cycle beyond primary manufacture an Ukefy to noJMtadl relative to other product catoporie*.because asbestos is enclosed mnA dlgpOMl. b ldditi(Nu baoMM gfcet saw are highly pada&red and built So aovsromant spadSaattona.it is doubtful that rehottttoi* jri&jbe.developed or costa of *J o to*tjftoi18 will decrease.. Jan near future. -. EPA does not believe that a ban Is tppropriatt for this product category for the following reasons: (1) insufficient information was svailsbie regarding product substitutes to determine the costs of banning this product, although available information indicates that the cost* of a ban would be high: (2) thi* product category account i for only a minuscule portion of U.3. tsbesios consumption (approximately 1 too in 1985): and (3) a nan on this product category would result in only minimal benefits because asbestos exposure is limited in most life cycle stages, relttive to other product* analyzed for this rule. v. High-grade electrical paper These products are used as electrical paper insulation, primarily for hightemperature. low-voltage applications such ** motor*, generators, transformer*, and other betvy electrical apparatuses. The benefits derived from a ban on this product would total approximately 0.4 of a cancer-case- evolded The cost of binning this product would be btgh because reasonably priced suitable substitutes do not exist for all applications and * number of existing substitutes are very expensive. Tbe total cost of banning this product it estimated to total over SSI million. EPA does not believe that a ban it appropriate for this product category for the following reasons: (1) This product category accounts for only * minuscule portion of U.S. asbestos consumption (approximately 744 tons in 1985): (2) the oosls of banning this product would b* very high, due to the absence of reasonably priced substitutes; and (3) ban oa thi* product category would result in minimal benefits. vi Missile Linere. These products are used to coat the interiors of rocket chambers, primarily in highlyspeaalired military and aerospace applications. Benefits derived by banning this product would total approximately four tenths of a cancer esse-svoided. EPA baa oo information indicating that suitable substitutes are available. The total cost of banning this product is *tunatad at almost 52 billion. Because most uses are highly tpacializad military os**, it to doubtful that substitute* will be devetojsad and b* certified tor there uses or that ooeta at a prospective baa wtil dscnxtre substantial]y fat the near future. EPA doe* not believe that ban to appropriate for thi* product category for tha MLnmriKf reason*: (1) Tha* product category aooovmta for only a mfauacui* porttou of UA asbasto* ooaaanptioa japproximately TOO ton* to 1985k tf) tha oosts of banning this product would be very high, because most uses are highly specialized military uses: and (3) s ban on thi* product category would result in minimal benefits. vfl Packings. Packings are used to teal fluids tn devices where motion is necessary Benefits derived from banning thi* product category w ould total less than one tenth of a cancer- case-avoided. Exposures In the prodjc: life cycle stages beyond pnrr.a-y and secondary manufacture are likely to be limited, relative to other product categories, because asbestos in packing* is generally saturated with lubncac during packing formation and with Pjid during us# and removal. In addition there are many specialized uses of asbestos packings, tncludjig advanced technology and military applications The coat of banning this product wo^ld be relatively high on a per unf bas.s because suitable substitutes do not tes' and are unlikely to soon be developed for significant number of packings application* and a number of existing substitutes sre very expensive The to'.a! cost of banning thi* product is estimated at 50.55 million. B'A does not believe that t ban is appropriate for this product category for the following reasons: (1) this product category' accounts for only t small portion of U.S. asbestos consumption (approximately 125 tons in 1985): (2) the costs per unit of banning this product would be relatively high for the amount of benefits derived due to the absence of substitutes of similar cost or performance characteristics for a number of applications: and (3) a bar. on this product category' would result in mimical benefits because asbestos exposure is limited in moat fife cycit ttsges. relative to other products analyzed for this rule. via Reinforced plastic. These products are used primarily for electro magnetic parts tn the automotive and appliance industries end high- performance specialty plastic*. Benefits derived by banning this product category would total approximately four tenuis of s cancer-case-avoided. Exposures m product life cycle stages beyond primary manufacture art likely to be limited, relative to other product categories, because asbestos is encased bi plastic in tha and use products. In addition, tha ooat of banning this product would be high because suitable aubstitntre do Dot exist tor significant ninitnf of plastics applications and a timber of existing substitutes an very expensive. TV* total cost of banning this product to estimated at almost 533 ailUoa. . HNA SH STEW 1527 2*681 Federal Register / Vol. M. No. 133 / Wednesday, )ufy 11 1389 / Ridas r:d Regu!a'; ns tPA do** wX believe that baa to IS U-S.G 3032 or for use to a "motor appropriate for this product category far vehicle" or "motor vehicla equipment* the fauowfag reason*: (1) Thl* prodart within the meaning of the National category account* for only a mtauaeule Traffic and Motor Vehicle Safety Act of portioa of 113. asbestos consumption 1980. as amended, 18 U.S.C. 1381. A (approximately (12 too* to 1385): (2) tha corrosive environmental I* one to which coat* of banning Lfaia product would b th* gasket ft exposed to concentrated .high, do* to th* absence for a number of [pH lest than 2). highly oxidizing application* of lubatitute* of atmilar mineral acids (e g., sulfuric, nitric, or coet or performance characteristics; and chromic acid) it temperature* sbeve (3) a boa ob this product category would ambient. For example, gsske's used in result (n minimal beneCU because asbestos exposure is limited ir. most life cycle stagss. reistivs to other product* analyzed for tk'l rule. to. Sealant tape. These product* are used primarily to seal windows and automotive windshields, in aerospace application!, and in the manufacture of insulated {lass. Benefits derived by banning this product would total less than one tooth of a canoer-case-avoided. Exposures In the product's life cycle stages beyond primary manufacture are likely to b* limited, relative to other produet categories, because asbestos is contained to rubber to the end use' products. In addition, the cost of banning this product would be high beesuse suitable substitutes do not exist for s number of non-automotiva appfieations. A number of existing substitute* ere very expensive and other* do not perform at well at asbestos-containing products. The total coat of banning this product is estimated at almost $33 million. automobiles or cor jumer produfi would not be excluded from th* rult'i bent, even If a particular application seat designed for use to a corrosive environment or an environment of greater than 750 degrees Fahrenheit On the other hand, gaskets used to Industrial machinery would be excluded from the rule's bans If the gesket application were designed for use in a eorraaive environment or ir. one of greater than 750 degrees Fahrenheit. Gaskets are used to seal ana compartment of a device from soother to static applications. This pertioo of the beator-edd and sheet gasket product categories is not being banned because: (1) According to commenter* and the RLA. industrial applications tbcvt 750 degrees Fahrenheit and industrial uses to corrosive environments contain many specialized u*q* of asbestos gaskets. Including advanced technology end 'military applications, and available information indicates that substitutes for EPA doe* not believe that a ban is appropriate for this product category far the following reasons: (1) This product category accounts for only a minuscule portion of U3. asbestos consumption [approximately 700 tons in 1985): (2) the total oort of burning this product would be significant because of the absence of these Industrial applications are leas likely to be available than far lower temperature, doc-corrosive, or consumer (eg., automotive) applications. (2) due to the aabtre of their application*, the potential hazards aeatad by failure of specialty industrial gaskets might be peaMr than for ether categories. (3) suitable abstftotes for some uses; and these applications account for only a (3) a ban on this product category would small portion of (he gasket product result in mwitoial. benefits because categorise and a vary amafi portion of aabaatos exposure to limited to most life US. asbestos consumption. (4) Industrial cycle stages, rslativs to other products application* have relatively lower analyzed far this nil*. overall exposure levels and smaller Specialty industrialgaskets. Tbs expoaad populations than do uei with production #f most asbestos-containing potential consumer axpoaur**. (S) the peeked to banned to Stage * (see Unit benefits reaalring from a ban of these VTg). Barimtod boas tba rule'* bens are gppbcstions (approximately 4.6 esneer gaskets that see manufactured. cases) would be amall relative to th* tmpertod.proe*veed. or distributed to benefits derived feoao Including th* reel nn--wci far specialty tedustrialeee*. of the gsdot categories in fa* ben. Tbe ats SMbmtoB to Bmitod to aabestee ooetef barmlag thee* portion* *f fa* cQBts^faggMtoattfaat ass designed far ukad categorise woald be high because available evidence (states fast '' anefaammMtotebcre temperatares are editable aabatMntee do not nto and an 710 AapnesFaUnbafeer pester, or (b) fakaly to eoon be developed far a l^fli iiS aiiaitm ttapiifii atl an sail i gefamtoew* iaetgneri far awe to -- amnharaf existing aubatitetes are vary rtcfattorich to mat "oaneamer axpantova. Th# total oast oTbaanfag prodacT atofaia toe meaning *f fa* - 1 ponwerProduct Safety Act (CPSAj. . ri. Textile product*. These product* are primarily intermediate textile product* oacd to end product! covered by other categories banned by this rule. Including friction product* and gaskets. Because exposure* related to the production of these product* are largely eliminated by other action! taken to thii rule. EPA hat determined that iepinte action oa this category to be unnecessary. VI Other EPA Statute* Section 6(c| of TSCA require! that if EPA determine* that a rttk of truun to health or the environment could bt eliminated or reduced to a sufficient extent by actions takes under soother statute administered by EPA. EPA may not promulgate a rule ander section 6(a) of TSCA orlett EPA find* that it is to the public interest to protect again!! the nsk by action ander TSCA. E?A Gods that no other law admauatered by EPA will eliminat* or redac* to a sufficient extent th* riaka poaed by tabeato* axpoaur* and that it is to the public totereat to ua* TSCA. Several EPA statute* have been used to Limit atbeatos axpoaur*. On Apnl 16. 1971 EPA usad th* authority of the Clean Air Act (CAA) to list asbestos at a hazardous air pollutant, establish a "no visible emission" standard fa* manufacturers, and ban the use of apray-epplied. asbestos-containing material as insulation to buildings. EPA amended this regulation to ban asbestos-containing pipe lagging, by a rule published to the Federal Register of October IX 1975 (40 FR 48282): and in 1978. extended the ban to all uaei of iprived-on asbestos by a rule published to the Federal Register of June 19.1978 (43 FR 26372). The CAA nil*, which w<u last amended on April 5.1984 (43 FR 13658). also regulate* the removal of asbestos from buildings and the dispose! of waste* generated by removal. EPA proposed amendments to the rule to thr Federal Register of Janaary m 1989 (54 FR 912) to enhance and promote compliance with the current standard However, the CAA has limitations. The CAA does oat apply directly to indoor air in the workplace or borne. Consequently, scan* additional uses of that statute may Uert many workplace ar home exposui* Inadequately uuatiofled. - Anofaer H*A etatute that amid be used to redact adbaftss exposure is the Safe Drinking Water Act (SDWA). Under fa* 1MB SDWA Amendments, EPA to required to aot a National Primary Drinking Water Regulation for aabaato*. to fat Padeaal Ragitoar of May 22.1880, EPA proposed an SOWA HNA SH STEW 1528 rs: z. ;g * . Federal Register / Vol M. Vo. 152 / Wedrieadey, JuIyttWM / Rules snd Rey.-taMoas 29503 <--ggr^e^^w-- maxbcafa coatewfnant level goal and National Primary Drinking Water Regulation maximum contaminant lcwl for asbestos in drinkiag wsttr of 7 million asbestos fiber* exceeding 10 aioma in length. Thi* regulation shortly. However. thi* regulatioa would necessarily ignon the Inhalation ritk ' poeed by asbestos from tource* other than drinking water and would therefor* affect only q small portion of overall exposure. An additional EPA statute that could be used toiimit asbestos exposure Is the Resource Conservation and Recovery Act (RCRA). Under RCRA. EPA could list asbeetoa as a hazardous waste and subject disposal of asbestos to general RCRA requirements designed to redaoa exposure. However, such action under RCRA would only reduce exposure during'the disposal of asbestos and asbestos products. VO. Analysts Under Sadism 1(a) o( TSCA ' Undsr sacfiod Bfa)(i} of TSCA, EPA ie required"to submit a report to another federal agency when two determinations are made. The first determinatios is that EPA has a reasonable basis to conclude that a chemical substance or mixture presents ar vriH present an treasonable risk of injury to health or the environment The coed determination is fits! the unteaaoaabl* risk may be prevented or reduced to a sufficient extent by ection taken by another Federal agency under a Federal law not administered by EPA Sedtn 1(a)(1) provides (hat when the Administrator makes theta two determinetiocs. EPA mast provide an opportunity to the other Federal agency to aetata the risk described in the report to interpret its own statutory authorities, and to initiate an action under the Federal law* that it adminfctara. Section 1(a) of TSCA fires require* EPA to review other Federal enthtettss not administered by EPA to detsrmtaw whether action ander those authorities auy prevent or euffictentiy reduce to* seasonable risk. The fallowing Unit snaarfm past and eoatsafHBted actions by other agendas and then dfacssseS'vHby thee agencies n apt Me fa prwent or ecdBcfsmfiy radons fiMBsmssooebte riafc presented _ * 0 lit .* *. y +- ' . A. OUmrMutharitmt Affectiag Asbmtae Predate Maty AatfCPSA 16 UAC ~ liftsG--aearFradaetSafety patelfeC compounds awd artificial t6 CFR Fart UK) containing reeptrablc asbestos- The CPSC took these actions based on findings that the as* of those products In the household woold result In an increased risk of cancer. Earlier, the Food and Drag Administration under the Federal Hazardous Substances Act fFHSA 15 U.S C 1251) banned generaluse garments containing asbestos other than garments having a bona fide application for personal protection against thermal Injury and so constructed that the asbestos fibers will not become tlrbome under reasonably foreseeable oondltiont of use* (15 CFR 1500.17). The FHSA Is now administered by the CPSC In I960. CPSC Issued a general order requiring persons to submit informstlon on the use of asbestos In certain consumer product categories. CPSC has also measured potential consumer exposure to asbestos from such products as asbestos millboard, asbestos paper products, end stove door gasket*. CPSC submitted those deta to EPA as pari of this rulemaking. On September 24.1956 (51 FR 53911), CPSC issued labeling requirements for 'household products containing intentionally added asbestos that, ander any reasonable foreseeable condition* of handling end ase are likely to release asbestos fiber*.' In 1966. In light of the EPA propose rule to ban certain asbestos products immediately and phase out others over 10 years. CPSC decided not to ban any additional consumtr products containing asbestos under statutes that it administers OSHA began to regulate asbestos In the workplace in 1971 under the Occupational Safety and Health Act (29 U.S.C. 51. OSHAct}. Since the first workpiece standard setting a limit of 12 f/ce was promulgated in May 1S7L the workpiece standard has been periodically lowered, to 5 f/ec In 1972 , and to 2 f/ce in 197*. An Emergency Temporary Standard fETS) establishing a PEL of 0.5 f/cc was published in the Fader*! legistar of November 4.1963 (46 FR 51066). but fire ETS wee found Invalid by a court. OSHA proposed a revised standard in the Federal lagistsr of April 10.1964 (49 PR14116). OSHA Issued a final rale on June SB, 1965 (31 FR 23612). lowering the KL to 02 f/cc and estabfcsking new work practice require--its tor both general Industry* end the construction rector. Both asbeeto* tadaatry po^e and unkma draganged varlou* provmtooa of the new OSHA rate. Oe February 2.1996. (he United States Cowl of Appeals for flfa District ofCefufabia Qrerit issued He dedtioa fa the consolidated appeals. TVe apart Upheld OSHA's finding that asbeetoa exposw poses a efafficsnt nsk and the fessibfTity of the new PEL and specifically rejected the asbestos industry groups' challenges to OSHA's risk asseasovenL However, the court found that there was not substantial evidence supporting OSHA's: (1) Han on the spraying of esbestoscor^airor.g products. (2) rejection of s lower PEL for certain major subgroups of Industry (3) reiaetioo of a short-term exposure i'm.t (STEL). snd (4) rejection of certain specific provisions recommended by participants in the rulemaking (e g smoking coatrul provisions mfi.-goat labels, and more stringent respiratory protection requirements). The court ' ordered OSHA to establish STEL to consider a lower PEL for certain industry sector* where It may be feasible, and to consider several other specific change* suggested by rulemaktng participants. 1b response tc this court decision. OSHA amended Its Asbestos Standard to incorporate an Excursion Limit (EL). Thit amendment which was published in the Federal Register of September 14.1988 (53 FR 35610). limits sbort-terro exposure; to 1 f/ce over * half-hour period. OSHA has not either finalized or proposed sr.v other changes fa Its Asbestos Standards. The Mine Safety and Health Administration (MSHA). acting under the Mine Safety and Health Act. has adopted workplace standards des:gned to protect worker* engaged in ptt and underground mining and milling (30 CFR 71.202)- The MSHA standard was last amended in 1975 and calls for PEL of 2 f/cc. State and local pubtic employees are generally excluded from coverage under the OSHAct. However, under section 19 of the OSHAct. OSHA has approv ed Stats plans for 23 States and 2 territories, thus effectively extending OSHA protections to State and local public employee* in three jurisdictions. EPA has promulgated a rale to establish requirements similar to those of the OSHA Asbestos Construction Standard for State and local public employees not covered under a State plan who conduct asbestos abatement work. However, -other public employees, such as lire fighter*, are not covered by that rule. 8. SPA i DeUtmixatiom UederSection 0(aj4 TSCA .. ... SPA I* not required under section 9(e) to submit a report to other agencies on the asbeeto* risks described In this docuaat since EPA has determined that such iteks cannot be prevented or reduced fa a sufficient extent taken under *Fsd*kkw net administered by ERA- Certain activities tovoMng asbeeto* preamt risk* that tsO under the HNA SH STEW 1529 a - -r ,'itV T i w ^ r c ?* :, W -s -t. toueri r\c.iM / VOL H No. 112 / '\-dr.?sday. July 12. V3C") / ?.-_.'e4 r.J R j'J- -< Jurisdiction of number of different the Jurisdiction over the risks presented during tbe manufacture, processing, use. Federal Uwi uch u tbe OSHAct. the by isbettos tmong * number of repair, and disposal of asbestos CPSA. end the CAA but no one statute, tgendes and statutory authorities 1* set products. As discussed more fully In : other then TSCA. can adequate!)' out below. OSHA has authority under Unit VA4 of this preamble, asbestos < address all the risks posed throughout the OSHAct to control risk presented to released into the ambient air can build the life cycle of asbestos. Referral would private sector manufacturing, up in the environment Q>A Is concerned remit in fragmented assessment and construction, and sendee employees about this environmental loading. oootrol of risk* and potentially duplicative regulatory effort*. Furthermore, even if EPA were to refer eabeetoa exposure risk* to other from workplace exposures, and may approve State plana covering State and local public employee*. CPSC ba authority under the CPSA and FHSA to Further, even if OSHA achieves strict compliance with tta PEL of 0.2 f/cc and its new EL of 1 f/cc. substantia! and unreasonable residual risk would agenda*, taken by those other agenda* would *U11 leave a substantia! res.dual risk, resulting In an adverse effect on public health. Only EPA under TSCA can etop the build up of asbestos in the environment EPA's reasons for reaching control risk presented to consumer* from consumer products. The Sima Safety and Health Administration ha* authority under tbe Mine Safety and Health Act concerning risk presented during tbe mining and milling of remain. OSHA recognized that a substantial risk remained with a PEL of 0.2 f/oc OSHA estimated that person* exposed to this level over a working lifetime of 4S years would face t risk of 7 in 1.000 of developing cancer. these conclusion are set forth below. asbesto*. State and local public However. OSHA concluded that this 1. Interpretation oflection 9(oJ of employee* in about ball the State* (such was the lowest exposure level that was TSCA. lie comprehensive nature of as fire fighters who may wear asbesto* technologically feasible in asbestos TSCA has long oeeo recognized. TSCA clothing) art not covered by either workplace* A* ststed sbov*. OSHA has allows regulation of a chemical OSHA regulations or OSHA-approved been ordered to consider s lower PEL substance based oo all of Its risks and. State plena. for certain general industry' sectors thereby, allows the Government to EPA bat concluded that asbestos it where It may be feasible. However, remedy die deficiencies in other statutes appropriate for TSCA action rather than technical limitations on asbestos that can daal only with parts of the risk. referral to other agencies. It is a exposure monitoring seem to limit (Statement of the President on signing & substance for which there is broad OSHA from establishing a PEL lower 3149 Into Law, October 12.1976, Weekly exposure to populations in numerous than 0.1 f/cc. Indeed, tbe union groups Compilation of Presidential Documents. situations--in the workplace, through that asked tbe court to order OSHA to voL 12. No. 42. Oct16. 1978, at 1489: S. long- and abort-term ambient adopt a lower PEL only requested a PEL Rep. No. 94-808. 94th Cong. 2d Sess. at concentrations, and from consumer* of 0.1 f/cc- Workart exposed to level 2). The seed for a total exposure, multi- products. With th* exception of TSCA. of 0.1 f/cc still face a substantial risk. media approach to chemical regulation there is no single authority to deal with OSHA calculates that such workers face and the dangers of a fragmented ah of thaae multiple exposures. No one a risk of 3 In 1,000 of developing cancer regulatory approach were recognized of the other potential Federal regulatory when exposed over a 45-year working even during the early Congressional authorities, in looking at its specific part lifetime. hearings on TSCA. See. for example, the of die overall exposurea, can either In addition, it i* likely that the OSHA 1973 Senate Hearings at 212-214 and tbe evaluate or deal with the totality of the PEL of 0.2 f/cc and EL of 1 f/cc will be 1972 House Hearings at 83-67. No other risk presented. OSHA may set exposure exceeded in many cases since tt is single law provides authority to deal limit* for workers, but there msy be particularly difficult to apply the PEL in comprehensively with multi-media venting of asbestos from the workplace the construction and service sectors. hazards.. . into the atmosphere. EPA under the Many of the workplaot exposures to In particular. Congress designed CAA. may regulate ambient emission*, asbestos occur downstream in tbe TSCA to deal with chemical substances but not workplace or consumer construction and service sector* rather for which the moat appopriate remedy exposure*. In each case, only a fraction than the manufacturing sector. Over 80 ? would be a total ban on their of the risk is controlled. Only EPA under percent of workers exposed to asbestos manufacture, importation, processing, TSCA can look across the range of are in the construction and aervic* and distribution In commerce. In this asbestos use to evaluate whether sectors. Employee* in those sector* *? regard. Congress focused on tbe risk of exposure present* an unreasonable risk. often do not know when they are asbestos and (ha dangers of fragmented There is no othsr Act that afford* such exposed to asbesto* because they do regulation of asbestos during tbe authority. Further, only action nnder not know that they are working with legislative bearings. See the 1971 Senate TSCA can stop the build up of asbestos asbestos product* (Ref. 34). Attempts at Hearings and 1973 Htarings. Asbestos in the environment. compliance and OHSA's compliance X risks were described in the workplace 3. Refidual risks. Even IT other inspections trs also difficult in the and in over MOO usat that could presant Federal agencies took additional action construction and service sections sines risks to the general population (HJL. to reduce tbe risk associated with employees frequently do not have a Rep. No. 94-1341.94th Cong* 2d Seas, at asbestos during the various stage* of th* fixed work sits. Between July 1.1988 8 (1971). Iinhere at Coopese believed life cycle of asbestos products, a and June 30.1987. OSHA dted 534 tt Intolerable that no agency oould deal substantial and unreaaonabl* residual alleged violation* of the asbesto* rule '' with chemical risks, riak would still remain. for general industry and 427 alleged [from asbestos. See Largs populations outside of OSHA violations of the rule for the I at 319-320 (Uttar Jurisdiction are at riak from exposurs to construction seek*. OSHA inspection .. r to Dow Chemical tsbeeioe. State end local pebiic - data show Sait VI of fc* MS araesto* t^TS Senate Hearings at 131- employee*, such as fir* fighters, mm not - Benitaring sample* ttkeo by OSHA l of.Stnator Tunney). . ^ .... protected by OSHA regulations in about from fn^y 3, ISM through April 30.19M. yafotherFederal ,. . half of the SutseTTb# general had exposure value* above the.OSHA ., Jwiik the combination popelation is exposed to esbestoe into . PEL Of02 f/cc. White fMpfratsra *r* ofatbeetoe eotrUiee. EPA's analyeU of th# ambient sir** a result of release in one in many of (he eetabUahmenta 4 1 2 if HNA SH STEW 1530 federal Redgier / VoL K No. 132 / Wednesday, July 12, 1989 / Rules and Regulation* 2S...05 with afr concentrations higher then the provision of section 18 of TSCA. any PEL 20 percent of these establishments person who violates sectioo IS could be were died for violations of respiratory subject to i civil penalty of up to $25,000 protection guidelines or for violations at for each violation. Each day of operation the PEL (R*f. 49k As stated earlier. in violation of this rule oould constitute OSHA amended its Asbestos Standards a separate violation. Knowing or willful to Incorporate an EX oo September 14. violations of this rale could lead to ths 1989. EPA doe* not believe that the EL imposition of criminal penalties of up to wtl have a significant effect on the S25.000 for each day of violation ana aigniflnant risk poaed by asbestos in the imprisonment of up to 1 year. In workplace. A more detailed discussion addition, other remedies are avaitabla to of this may be found In Unit V.A.3 of EPA under sections 7 and 17 of TSCA. this preamble. Finally, many asbestos such as seeking an injunction to restrain control measures, In particular, the use violations of this rule and seizing any at respirators or increased workplace chemical enbstance or mixture rantilstio& only shift the asbeeto* manufactured or Imparted In violation of exposure to another population for this rale. which no exposure oootrots exist For example. If vactuation is used, substantial quantities of asbestos would be released to ths ambient environment where It would continue to present a risk bod to other workers and the. genera] population. SimUariy, CPSC cannot evaluate or deal with the totality of the risk presentad by asbestos. CPSC may bam or require safety standards for asbestoeooutatoiog consumer products based individuals, u well as corporations, could be subject to enforcement actions. Section* 15 end 18 of TSCA apply to "any person" who violate* various provisions of TSCA. EPA may. at Its ' discretion, proceed against Individuals ' at well as companies. In particular. EPA may proceed against individuals who report false information or cause it So be reported. DC. Confidentiality exclusively oo risk to consumers. CPSC Is unable to consider risk to other groups from releases at asbestos daring tbs life cycle of those products. In addition. CPSC baa indicated that it does not pin to enact further bans oo asbestoscontaining products. After carefully analyzing other Federal authorities. EPA concludes that action under TSCA is appropriate to reduce the unreasonable risk to health poked by asbeetoe. Use of other Federal authorities oannot reduce risk to a reasonable level because: (l) Even together, they cannot reduce tbe total volume of asbestos or asbestos products in-commerce or limit (he ongoing buildup at asbestos in the environment (X) Even together, they cannot protect aS of the Barry population puups at risk, and (I) They all have jurisdictional gaps, both mdhriduatty and aoliactiveiy. Section 14(a) of TSCA allows a person who submits Information to EPA to assert a data of eonfidentialltv If release of ths information would reveal bade secrets or confidential commercial or financial Information. Under this rule, claims of confidantiality can be asaerted only at the time information ie submitted in an examption application and only in tha mmnnar ^verified is | 783.178. EPA't procedures for processing and reviewing confidentiality deists ere set forth at 40 CFR Part 1 Subpart & Any person who claims information contained in an exemption application as confidential is required to provide two copies of its application: a complete copy of the application tosiudlng H information claimed ae confidential and a "sanifiaed' eepy bam wfehA aH confidential information has bees deleted. EPA will pitas the applicant's VEUnaamt ~ sanitized copy in me public file. EPA Section U makes it anlawful to fail ar will also iaaut a notice in the Federal refare to comply with say provision at tegieur requesting ontnmenta an the a rale pramtonatod mdm Motion at exemption request - TSCA. Therefore, any failure to comply Persons deimtng information e* wtth this rule weuid be a violation of confidential should do to by tiding, aectian U. la addMaa. section 15 of bracketing, or anderitolng Hand TSCA makes tX anlateM for any person marking it ~GONRDH4TlAL.*.EPA will t* cyMlpHqfose to.gstabiUb and ... dtodoee information subject to a daim rrrtirn records ae required by (his at confidentiality only to the extant itdctthBerminM to permit amass te psraribad by section 14 at TSCA and 48 m liuisH at nnants, as required by CF* Part 2. Subpart B. If e person does TSCA: M Fag ar tafese to permit sb*7 not assart a data ef am&fontialHy foe oriMpaeiteaas (squired bqr Motion M tofomatisn at the time M is sdbmltied to at TKA.-:it*,' b-:- B>A may make tie Information 1 Ykiatoasfaay lb offset to both etvti - ybUe wtthout fcrtherwattes tothet amd atmiaal liability. Under dm penalty - pttiim In sddition. persons claiming information as confidential in exemption applications must respood In dcteil to the substantiation questions In - I 783.179((f) at the time the eppllcatlon is submitted to EPA. if s dahn Is unaccompanied by the required substantiation at the time it is subm.. ' J to EPA. ths company wifi b* notified that the unsanitized oopy of the application will be placed la the public file. EPA is committed to the public , disclosure of ts much noaconfidential Information submitted in exemption applications is possible. Requiring up front substantiation of confidentiality claims and continued close scrutiny of such daims throagh tha established daim review process wifi ensure that as much fnformstion as possible It released. Public Interest hi tha information in exemption applications and ths need for public participation in the review of applications jastifies this approach. Up-front substantiation obviates the need for follow-up substantiation by subositten resulting from EPA review or Freedom of Informatioa Act requests and thereby facilitates public participation in the process of reviewing exemption j 1 applications. X. KnlewiHeg Recced EPA hat established record for this rulemaking (docket oontrol number OPTS-oaJ38). A public version of the record, without any confidential business Information. Is available In ths TSCA Public Docket Office, from B am. to 4 p.nu Monday through Friday, except legal holidays. Tbe TSCA Public Docket Office is located to Room NEC004.401 M Street. SW,, Washington. DC This record contains information considered by EPA in developing this rule. The record includes: (1) All Federal Register notices, (2) relevant support documents. (3) reports. (4) memoranda and lettace. and (5) hearing transcripts, rseponm to oocamwits. and ether docaraeot* related to this rulemaking. 1 XL Rafereoca* (1) USEPA OttD, OHEA. 19BB. Airborne j Ash--las HaaJtjt A--smewt Vpdata. Qune IMS): ns pp. VS. ghwtranmental Aesocy. WtshSqriB. DC- XFA/eOD/a-St/OOJF- (3) 09CFSC SB. QuaaJc Hmntd Advisory fhaa/eeAsh--loa Qafr 1SCJ: 1 ISOpptfj Csa--bw Ptodacl SoJsty Coaatakto'W--hiagiab. ELC (Q HAS, WRC. m MbmUfon f&w Afan-occBpatfaoaf&aiATfob. (UMk K3pp Nsti--el ArefsaqcfSd--c--Mstional Xsnild ComdL WastoqglpB tUL. National Acadmey ft--e. HNA SH STEW 1531 2950> Fodarml Renter / Vol 54. No. iSZ / Wodnaatlay. July IX tMS / Rule* and Regulation* (4) Saidmaa. K. SeUkoft LJ_ Hammond,. SC. 187*. "Short-Urn aabaatoa work expoawt tod loot-ton* obaarvatton.* Annals of the New York Aoodsmy ofSciences, txtet-tt. - (3) Morpu. A. Evana. XJ,, Hocnca. ILF. HoIbm A. Dcyi*. SC. 1978 "Sludie* oo th* depoaition af Inhtltd fibrou* materia) in th* reepiratary (red of th* nt tod It* aubeaquaot daaranca taint radioactive tracer technique*. X DeaoaWoa oit th* U1CC atandard reference attaplaa of aabaatoa.' Environmental Rematch 1OU9-907. () U30HHS NT?. 1963 Toxicology and Carcinagentiii Studies of Chrysoole Asbestos h Rgg/X Rato--(FhedStudies!. Tactaioel Report Saria* No. SI NIH Pub No. WHl (November 1996): 362pp. UA Deportment at Health tod Human Sendee*. National Toricoiofy Profnun. Reaetrch TrlaaeU Park. North fewili-- . (7) SaUkoO, U. Hammond. SC. Saidma*. H. 1971. "Mortality experience of intulatiaa worker* la &* United 3UU* and Canada, 1949-1*78'Anna/io/th# New York . . Academy ofSciences. 98M1-118 (I) Pantoni, X, VacotOL hC Mario. F,, Vaiario. F. tad Stoti. L187*. *MortaIitr soom ahipyard wortnr* la Genoa. Italy.' AonabcftnsNsgrYaA Aoodsmy of Schticm. *30339-977. - {) Nawboea*. hlL. Bmiy. C. W*|n*r.-f. Tarot MX 187*. *A atady af th* mortafity of few*!* aabaatoa wotkara." BritishJournal of IndustrialMedicine. 281J4-14L (10) Wlpwll.tX.FcK.A4.1982.'Mortality af ftraala fu maak taaambiata.* British Journal sfIndustrialMndiams 9*44-38 (II) Adwtoo. U. Cardaar MX Plppatri SC. Grim* LF. 1912. *TW mortality of two roapa af waa who manufecterad ft* maak* froacfcryaotil* aod aocfdoUtt aabeatoa: a 40-jrtar follow-up." British Journal ifindustrial Medium. MJII ill. (12) Barry. C. Nawboaaa. MX. 19*1 "Mortality of --trim mandrrbirtini friction ' material* using aabaatoa.' British Journo!4 IndustrialMedicine. 4(21-7. (U) McDonald. AD. Fry. (X. WaoBay. (It) Davtai )ACC. (oaa* AO. Sotth T. 1987. Comparison ofthe pothotenkity of bnj and short flhtrs ofchrysolite asbestos In rats. Qua* 1987). 90pp. Inatitata of Occupational Madleln*. Edlnburth. UX (19) USEPA198* Aabaatoa: propoaad mInina aod faspott taatrictiocu tod propoaad etanufactarina. inportaHoa. and procaaalnt prohibition*. January 1981. *1 Ft J73*97*8 (X) Platek. SX Croth. 0>L Ulrich. C. Scectiar. L. TjuieU. M. Skill. M. 1963. Xhronic Inhalation of abort aabeatoa tibora." Fundamentals ofApplied Toxicology kS3JM (It) US3*A OPTS ETO. 1981. Regulatory Impact Analyte of Controls oe Asbmtm and Asbestos Products. Final Report. Volumes /-- IV. January 18 IBM. Addendum. Junt 26. 1918 (22) DoS X. Fata X UN. Asbestos; Effects on the Health ofExposure to Asbestos. (198$)83p*. London. UX Htahh and Safety Coouniaaioa. (29) OoB. X1987. "The tuntitativt aitnifleanoa af aabaatoa fibre* ta tb* anbiaot air.* In: Advancea in Aerobiology. Bukhauaar Variaa. Btaal pp. 219-&8 ' m Hughe*. JM. Wsm. K_ Kaomad. Y.r. 1987. "Mortafity of ardrkan amployad Intwo aabeatoa oatnanl oasufacturlnt plant*.* British Journal afIndustrial Medicine. 44:191-174. (23) Weill. H_ Huthaa. J- Waftenapack. C 1878 `Tnfiuaooe af data aod fiber type oe reaptratory mtUtnancy nak In aabaatoa cacsent manufacturiot.* American Review of Respiratory Disease*. 120-J43-15*. (26) TVynaa KF. Beniamin. LT. Elmwood. Pa. Sareetnam. PX. 1981 *Furthar follow^ip atudy of worker* from to aabeatoa oamant factory." British Journal ofIndustrial Medians. 39379-278 (27) OSTP. 1988 Cbtaicel cardnofena: rataew of the acieoct and it* aaaodatad petndptan 10 FX18972-M441 Offica of Sdanoa and Ttcfmolofy Folky. Raaculiva Offiot of tb* PraaidenL (29) USOOT. NHT81M8 Can* boo Barry asbestos Fiber*. Final Report. (March 2L 19Wj 66pp. (36) USEPA OPTS. ETO. 1996 Durable Fiber Exposure Assessment Final Report (September 81999) 488pp (37) USEPA OPTS ETO 1998 Durable Fiber tndmtry FrsfUe and Martlet Outlook. (Aufuat 97. lMih3iapp (99) US8FA OPTS HBUX 1998 Health Hoard Assessment ofNotratbettoe Fibers. (March 2L 1B**)-M0pp (39) USEPA OPTS ECAO. 1993 Asbestos Subilitvtet and Related Materials. (April 24. 1995) :*6pp (40) USEPA OPTS ETO-18*7 Anal)*is of the Feasibility ofReplacing Asbestos in Automobile and Truck Brake*. Final Report April 181997. Prepared undar eontraet by the American Sodaty of Mechanical Enfineara. (41) USEPA OPTS CCD. 18*8 Response ta Public Comments Document for the Rulemaking Process Concerning Asbestos; Manufacture. Importation. Processing, aod Distribution in Commerce. Prohibitions. Quae 1988). (42) USEPA OPTS ECAD. Memorandum from Franco* TenEyck to Lynda Pnddj, CCD. OTS USEPA eatitiad "Potentiel lunt canoer riak for doctil* troa manufactur* a* a aabatitute for aabeatoa/oMMnt pip*.' (Deeaabar 181998k2an. (43) USEPA OIUkWBn. 1999. Plumbing materials anddrinking water quality; Proceedings afs Seminar. Cuiannau. Ohio. Hey lh-17. IBM (February I993)rl00pp. Office of Raaearch and Development. Water Eafioearint Raaearch Labarelory. Q'A 600/ 9-93-007. (44) USEPA OOW, CS& 1*83. Drinking water criteria document on vinyl chloride. Final Draft (January. 19*S)ri40pp, (43) WHO. IARC1978 "Vinyl chlorid*. polyvinyl cbioridt and vinyl dilonde-ncyi acetate copolymera." IARC Monographs on the Evaluation ofCarcinogenic Risk of Chemicals to Humans. VaL tg. {Ptbniary 1979):aQ2-411 Intareational Aftney lor Reaaatch on Cancer. Wartd Health AJ- McDonald. J/C. MM. rOoat expoour* and mortality la at Amartrna ehtyaotila aabaatoa trtortaa product* plant.* British>m amiof Industrial Medicine C391-UF. (14) Dammd, (hf Karri* XL. Bynonhv~l MJ. tky, CM. an. fcpoaarea md ortaBty aaont ehryaotlla aabeato* arerkara. Part 0; amrtahty." Aomriaa* Jommm!of MiMrW MVOCOM. f* l (U| hieOaoakl AiX. Fry. IX. Waol^. ' ' A4. McO*mU. 1C TSmI aapoava ad BortalMy to a* Aaaieaa AryaatOa tenia plaa<* MMJkoaf^MMHalMMgha aajti nr. C*J) 0*001. OtHA. 199*. Ocaar i.*aad Falrlo* 4o John W. Katana. Obeetor. CCD. OTS. US?A Novtmbtr 981988 UX O^artmret af Tbantporlallon. National IBttiwaj Tladbc Safety fideilekitratina jm dBMfh OPT8m 1Sm._A*beeCo* I1M(w90e)faUXSLEPI --A8W1 Ulnnara. 1968 Asbestos Modeling Stmly. FinalReport. Qdarcfc 18 (81) U99A. OPTS BED. S988 ffensooupationat Asbastas Exposers. Revised Draft Report. (Saptembar a tBHJMpp (92) law OoaspmJoaai Health and Ssfsty (99) U98PA. OFT8 8SD. 19(8 lliNirinh booDe. Ida Want tojoh* JUtby.OOB.OmUSH'Aanaid-OBKA Camjillaerf Beta fat Adbaatoa.* ^ag*8t L ' 'tN)OBDOllO(KA19M. OtfeNSafionaT W6|J|JBa>A. OAQPS ESED. 1987. Natrsaal Emission Standards for Asbestos-- Background Isforssatios fee Proposed Standards. Draft (March 819*7(311pp. (47) AXAF. LewaBan. WX Syka*. RJ. Cereaoli. CF. Fukar, 5X 1**6 Comparison of the tSB! Seeds* dispersion derm with results from s number ofdifferent models. (Ftbraary 19H)rU3p^ Mnoatoa NJ: Aeronautical Reiiirrh Aaaodataon of Mnoaton. Frapared far Oak tidgr National Laboratory aBdarconoact thxmil V. AJtAF rapartaa. 378 (49) USSPA OPTS BID. 19*8 Exposure Aeeessmsei fer Asbeerm Draft Fmal Report (January 8 UMfcJKi* (i usra. arrs cm. nM. MaBaenndaB bam Dr. Ck Want to Dabble Otth^K CCRrOTX UWPA eetiflad >Adflaari Made af (XHA Coa^Uenoe ooieBe WMBheBa. NasalNn ' --* ` Pet8ffli ! hi> ii IMNHtp (*b) oyRAon cca tm UaaarendeB feaa Jahn Ugby la (ha laoord aMfdadldaattatwtihtvaitiAaalyda.lnc.' an Weak Panc&oaadarint brake Repair" *+ rr tr. - : 0*a8*ryS.iBM)ri9pp. :.VlA. ( ifr i i HNA SH STEW 1532 Federal Register / Vol S4. No. 133 / Wednesday. July tZ. 1969 / Rules and Regulations 23507 (51) USEPA. ORD. MlDslta. J.R.. Boom. R, Rosenthal M. IMS. Asbeetoe in Cistern Water. (February 1980)4pp. (52) USEPA OPTS. ETD. last. Msroorandua from Cathy Pshranbackar to Lynda Pnddy. CCD. OPTS. USEPA sobtitd "Monitoring Data Availsbi* on Occupational Exposure to Aranud Flbsra." (October 7. 19esk2pp. (U) LfSEPA. OPTS, ETD. IBM. Memorandum from Cathy Fshranbscker to Lynda Priddy. CCD. OPTS. USEPA. rneiled "Renew of tie Rrcea: Data Submitted by Dupoot oa Aramid Fibvr*. (dated March IS. 1888)." (Daeambar a 19BS):2pp. (54) USEPA.OPTS. ETD. last. Duroblt Fiber Exposure Assessment: Addendum. (October U. lMSJ-.iepp. (55) USEPA. OPTS. ETD. 1984. Durable Fiber Exposure Assessment Attachment to Addendum. (Poet) (October II. 1988Jt2pp. (58) USEPA. OPTS BED. 1984 Memorandum from Karas Milne and Cary Crindataff to Dr. Barbara Mandnia. ECAD. OPTS. USEPA. entitled "Rule Assessment of The R1A also ssdnste* tKai (he rule arllL over the 15-yew period analyzed, tvold at leaat 202 cancw cases, u benefit! are not discounted. and 148 cancer ceaea. if beneflta are diacounted at 3 percent If analogous exposure* are not assumed, the estimate* of cancer casei-evoided are 194 cases. If benefit* are not discounted, and 120 cases, if benefits are diacounted at 3 percent. Aj la stated in Unit V.D. of thii preamble. EPA believes that these costa are reasonable and that tbe rule 1* the least burdensome way of reducing the unreasonable risk posed by exposure to asbestos from the manufacture. Importation, processing, use. and disposal of asbestos-containing product! This rule was submitted to the Office of Management and Budget (OMB) for review, a* required by Executive Order Aramid Ptban.' (June 141988)2pp. 12291. (37) ICF. Inc 1984 Memorandum from Nora Zfrpe and Maravane Edelateia to Dt. Kin B. Regulatory Flexibility Act Won* ETD. OPTS. USE?A. antitied "Nameric Data for St-jnaary of Aabettoa Exposure biform*tiou.* (May 241988(.12pp. (58) USOHKS. NIOSH. 1887c b-depth rurrey report oootrol technology for drum brake service operatiaoa at Otuo Department Under section 805{b] of the Regulatory Flexibility Act 5 VS.C 009(b). the Administrator may certify that a rule will not if promulgated, have a significant Impact on a substantial of TMnaportation maintasance-iedbtjr, number of small entities and. therefore, Lebanon. OH. (Ftbraary 1987)-2Spp. National ioatltuta far Oecupstianel Safety and Health Ondmsti. 0*i NX3SH. Raport No. BCI 152-tab. (58) USEPA Aabeatoa Action Program. 1984 Guidance for Frerentmt Aebeetoe Dieeaee Among Auto Mechanics. Quna 1988pl4pp. (80) USEPA, OPTS. CCD. 1984 Memorandum boa Deborah Othnpet to the Record entitled "Upper bound population and lower bound risk estimates--revision!* (May It 198B)nipp. m USEPA. OPTS. CCD. 1ST. Memorandum bon )oha Rigby to the Record endtied "July 241M7 Hi swig Bsrwsse NHTSA and SPA." (September 1419S7)Jpp. (2) usepa. opts, cay we! Memorandme bom John Rigby to the Reooed entitled "lanuary 141M Masting Betwe en aad NKTSA.* (September! U8l)2pp (81) USBPA. OPTS. CCD. 1(84 Memorandum boa )ohn Rigby to fee Rooord eotitted "July 141888 Mnetfeg Batwaa VA gad WTBA.* (1a>tombar 4 lSMfcapp. . does not require a regulatory flexibility analysis. EPA has analyzed (be economic Impact of this final rule on small businesses. A summary of this analysis appear* in the RIA and Unit VO of this preamble. Based on tbe discussion in that Unit EPA certifies that this rale will not have a significant economic impact on a substantial number of small antitie! C Paperwork Reduction Act Th# reporting and recordkeeping provisions of this final rule havt iwen submitted to OMB (or approval under the Paperwork Reduction Act 48 U.&C 1S01 at mg. Them requirements art not effective antil OMB approvee them and a technical amendment to that effect is published in tbe Federal Register. Public reporting burden for this (04) USOA OOW. 1888 Banmnaed collection of information is estimated to National Oeaaroaoe mei btpooure to AebeetaetaFebticDeiakjimWamSuppbee. pa aggsumoa! average leas than 2 hours amraally par firm osar the 5-yew patlod reviewed for the analysis of regulatory burden. This Iranian astiaate inductee tbe time for rsetewtag testrectioc! sasrthfag ILMmeotNe Order 131B1 ; existing data source! gathering and maintaining lbs data naadad. and -Uodar Sxeottivs Outer 11291. EPA . oaapkting aad reviewing fee ooDeetioo baa tWerrairied that this rate is a "Major -of information. This estimate of aanal Kate" gad W8.pnpaiBdaaUA.Thn - burdaste a relatively low figure because KIA eetiraatea tWtthterW* arid-port aftea araaB amber af firms effected bp -j-r--"Vy fiff *t m2han,or MOBS} tbe ragalilory antinrn taken during the inffilandf 8 S paraaot saanai daemsait'; period reviewed fat tbe anafrits of " (harpden of eubetitstea la not aammad regulatory bardad. -,- ' Send any comments regarding the burdeo estimate or any other aspect of this collection of Information, including suggestions for reducing this burden, to Chief Information Policy Branch. PM224 UJL Environmental Protection Agency, 401 M Street. SW,, Washington. DC 29490; and to the Office of Information sod Regulatory Affair*. Office of Mansgement and Budget Washington. DC 20SC3. Atte.V;on Desk Officer for EPA. Cist of Subjects in 40 CFK Part 755 Asbestos, Environmental protection. Hazardous substance! Dtted July 4 2988. Wini.m K. RalOy. Administrator. Therefore. 40 OK Part 763 is amended as follows. PART 743--(AMENDED ] L The authority citation for Part 763 is revised to read as follows: Authority 15 UAC 2805 and 2807(c). '2. By reserving Subpart H and adding new Subpart 1 to read as follow*; Subcart I PratebWon ot fee Manufacture. npoRno^ noonanii wo imu juulmjii vi Commerce eA Certain Asbastoe-ConteMng Rooura; LaDseg nsqtasRwns Sec. 741180 Scope. 745.143 Definition! 743.148 Memtfsotors tad importation prohibiooat. 744167 Processing prohibition! 744189 Dittribuboa is eoaunsree prohibit)an! 783.171 Ltbshni raqulrsmeni! 784172 Caosnl txtmpuan! 7*457* SnforosmsnL 784178 hwpection! 784178 Raoardkeeplng. 784178 ConfldsnBel basint** Inform*boo duns gubpertl ProWWtton at ttra Manutactira, Importation, Pwwealng. and Otetributton In Commarca of Cartain Aabaato^Contalning Product*; Labalng Requirements { 784180 Seep! This subpart prohibits the anufactm. hopactatian. processing, and dtetribetioa in oosnmwoe of the Babastoe-eaBteiidng products identified aad at tbe dates indicated in f 1794166. 7941V. emi 784188. This subpart requires (bat products safefecl to tide rate's ban! but not yet subject to a ban so distribution in commerce, be labeled. TUdsdbpart uleo indudn general exemptions and procedures far HNA SH STEW 1533 895W Federal Register / Vot 54. No. 133 / Wednesday, fuly 12. 1 / Ru'o and Ri'g-Vinns requesting axaapfioo* from the pwiBoaa of dds subpart f m.tU DafMJon* For purpose* of thi tubparh "Acetylene cylinder fillef'moan* to asbestos-containing product which ta lo(coded lor use ej a fiber (or acetylene cylrndm* . "Act" means the Toxic Substances Control Act U U.S.C. 2fOl et teq. "Aftermarket pert" means eay pert offered far sale fir installation in or on e motor rehide after such vehicle hai left the aunadscturar's production Into. "Agency" mean* the United Stetea Environmental Protection Agency. "Arc chute" meena an eabeitoscontaining product that acta ta chute or guidance device and ia intended to guide electric area in applloebon* each aa motor etarter unite in electric generating plant* "Asbeatoe" tneam the asbestifonn varfetiea at. chryaotilt (terpentine); croddoHte (riebeddte): emoifte (cummingtonitt-grunerfte): tmnolftr anthophftVtK and acttaollt*. "Asbeatoe-cement (A/Q corrugated beer means an aabeiioi-containing product made of cement and In the form of a run ^ta latitat oaad sat aari-fltSavfaoad totafsrciag or taerfattag material Major opphcafloce of tfata product Jadodr. bending tiding or roofing; linings for waterway* and componanta in 000ling tower* "Aabastoa-camant (A/C) fiat aboot" meant aa aahattoa mntainlng prodact mada of camant and In tha form of a flat abeet uaad primarily aa a fiat-earfaced reinforcing or teatdating material Major pplicationa of this product Include: wall lining* partitions; soffit matariafc electrical barrierboards. busbar nm separator* reactance coll partition* laboratory work surface* and oompoaaaia of vmiB* avma* aate* and broiler* "Asbaatoa-cemant (A/C) pipe and "Attwetoa-containing product" mesne sny product to which sabeatos is deliberstely added in any concantritian or which coataint more than in percent aabeatoa' by weight or are* "Aabeatoa diaphragm" meant an asbestos-containing product that is made of paper and Intended for etc as a filter in the production of eh -ine and other chemicala. and which acts aa 1 mechanic*1 barrier between the ' cathodic and anodic chambers of aa electrolytic cell. `Automated transmit jiod componenl" meant an asbestos-containing product used st a friction material is vehicular automatic transmission*. "Battery separator" means an asbestos-containing product used as an insulator or separator between the negative and positive Unaiaalt in batteries and fuel cell* "Beater-add gasket" means an asbestos-containing product that ia made of paper intended for use at 1 gasket, and designed to prevent leakage of liquid* solid* or gases and to esal the space between two tertirvia of a oomponent in circumstance* not involving rotary, reciprocating and helical modem* Major application* af beatar-add gaskets include: gaskets for internal combustion engines; carburetor* exhaust manifold* compressor* reactor* dtatflUrion column* and other apparatu* TJriVe block" means an asbestoscontaining product intended for use as a friction material in drum braka systama for vehicles ratsd at 26.001 pounds gross veWde weight rating (CVWR) or more. "Chemical substance." has the same meaning as in section 9 of the Act "Clutch facing' means an aabeatoacontaining product Intended for use as a frictioa material or Biting ta the dutch maebatritna or manual transmission vehidaa. "Commerce" bei the same meaning aa in aecfao I of the Act - "Ooemettid aad industrial Irictioo prodaoT means an taheatot-ccBtatatag product which ta sHhar omided ar woven. Intended for aaa aa a tridtoo material la brafctag and gear changing oomponeota ta ridaatrial aad oaaaMNril machinery and oonamoar appMaaca* Major appficafloaa oMUa prodact ridede.' braka iatags , rtap aad dot dnita ioduairtal aad conmarcia! maddnsry prwdwcl tshicfc ta fora** at transfer, and corrosion In circumsii-.-ea that require a thm. bu! durable, barrier. "Corrugated paper" means an asbestos-containing product made of corrugated paper, which ts often cemented to a Oat baclurg. may be laminated with foils or other ma'enal* and has a corrugated surface Major application* of asbestos comig.'ed paper Include, thermal insult hoc for pipe covering* block bsuV-ion. panel L-.vujt.on Is elevators. Insj'.obo'' in .appl.inres. and insulation w low- pressure steam, hot water, and process lines. "Customs territory of the United Slates" meant the 50 States. Puerio Rico, and the District of Columbia. "Disc brake pad for heavy-weight vehicles" meant as asbesloa-cocteuung product intended for us* as a friction maternal in disc brake systems for vehicles rated at 28.001 pounds grots vehicle weight rating (CVWR) or more. "Disc brake pad for light- and mediiuB-weighl vehicle*" mm an asbestos-containing produm intended for naa aa a friction matarial to disc braka systems for vehicle* ratsd et lees than 20JQ01 pooitdt pom vshick weight rating (GVWR). TJisiribut* to commerce* has the same moaning as in taction 3 of the Act but the term ooei not include actions taken with rasped to an aabastoe- contaioing product (to aall reaata. deliver, or bold) ta connection with tha end use of the product by persons who are users (persons who ase the prodact for ft* farteeded pmpose after it is manufactured or prooessad). The term also does not include distribution by manufacturer* importer* and proceatar* and other persons solely for purpose* of disposal of as asbestoa- oootaintag prodact "Drum brake lining" mean* any asbestoa-ooBtaiafog prodact Intended for ase aa a friction matarial In drum brake systems for vehicle* raiad at las* than 2*001 pounds groat vahlcla weight rating (CVWR). "Flooring fab" manat aa asbestos- containing prodact which ta mada of paper fait tatanded for esa at an , undeilayw for floor covtring* or to be bonded ta flat underside of vtnyi sheet . flooring. ! "Cros* vehicle sreight rating j (CVWR)" meant tha vain* specified by ! Am maamaetanr aa tha amxtmum I design It 1 hi swri#l af a atagta aafrids. . "IRgh grade dtacritatl paper" metna 1 aa ti> mtm ttalitaltg prodact that ta made af paper arid oonetabagaf Mb stria -- be worn by papar. Major agpRcaaans af c papsrs arm tasolattan agate* fee. hast wtta al1 L<rtad drvteot tar pmpoaaa af i S HNA SH STEW 1534 u Federal Register / Vol 54, No. 132 / Wednesday, July 12. 1989 / Rules and Regulations 29!09 Insulation or protection. Major applications of this product include Insulation for high-temperature, low voltage applications>such as in motors, generators, transformers, switch gears, and other heavy electrical apparatus. "Import" means to bring into the customs territory of the United Slates, except for (1) Shipment through the customs territory of the United States for export without any use. processing, or disposal vrithin the customs territory of the United States, or (2) entering the customs territory of the United States as a oomponeht of a product during normal personal or business activities involving use of tbe product "Importer'' means anyone who Imports a chemical substance, including a chemical substance as part of a mixture or article, into tbe customs territory of the United States. "Importer" includes the person primarily liable for the payment of any duties oc the merchandise or an authorized agent acting on hit or her behalf. The term Includes as appropriate: (1) The consignee. (2) The importer of record. (3) The actual owner if an actual owner's declaration and superseding bond has been filed in accordance with 19 CFR 141.20. (4) The transferee. ff the right to withdraw merchandise in a bonded warehouse has been transferred in accordance with Subpart C of 19 Git Part 144. "Manufacture" means to produce or manufacture in the United State*. "Manufacturer- means a person who produces or manufacture* in the United State*. "Millboard" means an asbestos* containing product made of paper sod similar in consistency to cardboard produced in sections rather than as i continuous sheet. Major application* of this product Include: thermal protection for large circuit breakers; barrier* from flam* or heat lining* in floor*, partitions, and fire doom linings for atovas and heaters: gaskatr. table padr trough liners: aovara far oparationt Involving molten matal: and stove mats. "Missile frnar" means an asbestos* containing product used as a Unar for coating the interior surfaces of rocket motors. .. . "Model year" mean# the manufactmer'a annual production parted which tedudce January 1 of such calendar yestr. provided that if the manufacturer has ao production period, 1b* tarm "model year" shell mean tier calendar year. *9lew uses *f aimaatea" means commercial pare of asbestos not Identified inj .7(348$ the manufacture. importation or processing of which would be initiated for the first time sfter August 25.1989. The following products art also not new uses of asbestos: acetylene cylinders, arc chutes, asbestos diaphragms, battery separators, high grade electrical paper, missile Uner. reinforced plastic, sealant tap*, and textiles. "Non-roof coating" means an asbestos-contair.ing product intended for use a* a coating, cement adhesive, or sealant and not intended for use on roofs. Major applications of this product include: liquid sealants: semi-liquid glazing, caulking and patching compounds: asphalt-based compounds: epoxy adhesives: butyl rubber sealants: vehicle anderco*ting*; vinyl sealants; and compounds containing asbesto* fibers that are used for bonding, weather proofing, sound deadening, sealing, coating: and other such applications. "Original equipment market part" meant any part installed in or on a motor vehicle in the manufacturer'* production line. "Packing" meant an asbestoscontaining product Intended for use it a mechanical seal in circumstances involving rotary, reciprocating, and helical motions, and which art intended to restrict fluid or gas leakage between moving and stationary surfaces. Major applications of this product include: teals in pumps: seals In valver. teals in compressors: seals in mixers: seals in swing joints: and seals m hydraulic cylinders. "Person" means any natural person, firm, company, corporation, jointventure, partnership, sole proprietorship, association, or any other business entity, any State or political subdivision thereof, or any municipality: any interstate body and anv department agency, or instrumentality of the Pederal Government "Pipeline wrap" means an asbestoscontaining product made of paper felt Intended for use in wrapping at coating pipes for insulation purposes. "Process" has the tarn* meaning a* in ectioo 3 of the Act "Processor" ha* the same meaning at in section 3 of the Act "Reinforced plastic" means an asbestos-containing product made of plastic. Major application* of this product mdodt: alactro-aachaaical parts in the automotive and appliance industries; components of printing platas; and as high-performance plastic* in the aerospace industry. "RoUboard" maans an aabeatoa- contauring product mada of paper that is produced te a contlnooa* sheet it flexible, and is rolled to achieve a desired thickness. Aab**4oa roitboard consists of two sheets of asbestos p=per laminated together Major appKca:- ir.i of this product Include: office partitioning: garage paneling, lining; for stoves end electric switch boxes: snd fire-proofinj agent for security boxes, safes, and files. "Roof coatint' meant so asbestoscontaining product intended for use as * coating, cement adhesive, or s' ilan: on roofs Major applications of this JC* include; wati-proofing. weather resistance: sealing, repair and surface rejuvenation. "Roofing felt" mean* tn asbestoscontaining product that it made of paper felt intended for use on building roofs as a covering or underlayer for other roof coverings. "Sealsnt tape" means an asbestos- containing product which it imtiall) a semi-liquid mixture of butyl rubber and asbestos, but which solidifies when exposed to air. and which it intended for use as a sealing agent Major applications of this product include: sealants for building and automotive windows, sealants for aerospace equipment components, and sealants for insulated glass. "Sheet gasket' meant either fV) an asbestos-containing product consisting of asbesto* and elastomeric or other binders rofled tn homogeneous sheets t tome point in its manufacture and intended for use as a gasket or (21 sny asbestos-containing product made from braided or twisted rope, slit or woven tape. yam. or other textile products intended for use at gasket. Sheet gaskets are used to seal the space between two sections of a component and thereby prevent leakage in such applications at: exhaust cylinder head, and intake manifolds: pipe flanges: autoclaves: vulcamzers: pressure vessels: cooling towers: turbochargers and gear cat**. This category includes flange, tpiralwound. tadpole, manhole, handhole, door, and other gaskets or teals. "Specialty industrial gaskets' means sheet or beatar-add gaskets designed for industrial uses tn either (1) environments where temperatures are 750 decree* Fahrenheit or greater, or (2) corrosive environments. An industrial gatkal it eat designed for use in an article which ts not a "consumer product" within tbe meaning of the Consumer Product Safety Act (GPSA) 15 U.&C 3062. or for use in a "motor vehicle' or "motor vehicle equipment" within the meaning of the National Traffic and Motor Vehicle Safety Act of 1986. a* amended, 15 VS.C. 1381. A corrosive environment is one in which the gasket la exposed to concentrated A HNA SH STEW 1535 29518 Federal Reyetar / Vot No. 112 / Wednesday. July 12. 1969 / Rule; irvd Beg-1, lions (pH leu than 2j. highly oxidizing mineral tad* (e.g^ tulfuric, nitric or chromic acid) *< lempsnlure* ebove tm bieat. "Spedifly paper" mean* in asbestoscontaining product that ia made of paper intended for uae ai filter* for bet eragee or other fluid* or a* paper fill for ooolit^ lever*. CooStg tower fill consists of asbestos paper that ia used as a cooling agent for nqiids from Industrial procesa** and air qonditiocirg system*. "State" hai the same meaning at in section 3 of the Act "Stock-on-hiDtj" means the product* which are la the possession. direction, or control of a per*on and are Intended for dlatrfbetion In commerce. "Textile*" mean* an asbestos- containing product aucfa a*: yam: thread, wick cart braided and twiited rope: braided and woven tubing mat rovingcloth: ifit and woven tape, lap: felt and other bonded or nan-wovsn fabric*. "United States" bai the same meaning a* in aection 3 of die Act "Vinj4-asbesh>* floor tile* mean* an asbestos-containing product compoied of vuivi roatas and uaed as floor tile. i 7CX1M Manufacture site tayoctMine prrihnytiima (a* AAar August 27.1990. do peraoo (ball manufacture or import the following aabeatoe-caoteining product*. either for use* the United State* or foT export; A/C carragated aheet A/C flat sheet aabeeto* clothing. flooring felt pipeline wrap roofing felt vinyl/ sbestaa floor tile. and sew uses of asbestoe. (b) After August 2S. UM. an peraoo (hall manufacture or import the following asbeetoe-containing products, either Cor uea in the United State* or for export automatic transmiatiaa components. oluich facing*, oomnerdol nd industrial asbestos friction product*, and sheet end beater-odd gaskets (exnepi apectelty iodttrthai gisketek (c) After August 2S. 1993. no person hell naaufactars or import, larluriing as part of a motor vehicle, isheslot containing disc brake pod* for light*, medium*, end heavy-weight vehicle*, and drum broke linings far the following uses ia the Doited States or for export ft] As ot%faBl ogupoMBt in 19M or totw modal poor motor vehicle* er (2) Amaftermaths* raplaraaasnt porta lo breke^atmas dashed far oae with ann wheat** teglaaaaeafa part*. (d AlfaA^afa fa. 1996. no peraoo ahafl moortMSm sr hnport dm toflowfag aahaatoe-oanteinfag producte. eitherTar aoe fa the Uaitad 8tala* or far export 4*e brake pad* far oea in tight*. BedfuKodheavy-weight nhtdaa and drum brake lining* manufactured, imported, or markettd for use as fVertsarket replacement pans in broke rystems designed far usa with ssbestoscontauiing friction products A/C pipe. A/C shingle. brake blocks commercial paper, corrugated piper, millboard, aooroofing costings, roilboard. roof coatings and specialty paper. (e) The import prohibition* of this subpart do not prohibit (1) The Import into the custom* territory of the United States of product* imported solely for shipment outside the customs territory of the United States, unless further repackaging or processing of the product is performed is the United State* or (2) Activities amoving purchases or acquisitions of small quantities of products made outside the cuMoms territory of the United Stetes far personal at in the United States. { 7(3.197 Proe**** protfMtona. (a) After August 27.1990. no peraoo sball process for any use. either m the United Stale* or far export, an; of the ashesioe-coatataie^ products bated at f 763.165(a). fb) After Anguat 23.1991 no person shall process far any use. either to the United States or far export, any of the asbestoa-containing product* luted at i 763495 (b) and (cf. (c) After August 29.1999. no person shall process faT any ase. either in the United State* or far export any of the asbestos-containing products listed at i 763.165(d). 793.199 Otetributioo to oomoarcu prohMSon*. (a) After August 25.1992. oo person shall distribute in commerce, either for uae U! the United Stales or for export, any of the eahestoa-coolaming products listed at | 783.16S(a). fb) AAar August 25.1994. oo person shall distribute so aommoro*. either far use in the United State* or far export, any of the asbestos-containing products listed at { 763491 (b) and (c). (c) After August 25.1997. no person shall distribute ia commerce, either for use in the United Stetes or for export, any of the aabestoe-conumiag products listed *11 713.195(d). (d) A tneaufacbinr. importer, processor, nr any other person who a subject to a baa on distribution ia commerce m paragraph fa), (b). er (c| of this section must, within 9 months of the effective date of the ben of a (pacific asbestos-dnotafnlng product from diaOrtbotion lo omemorre. dtepoas ef el tibefrrtmofafag stock eo belief flat product by means that mo fa . . compbaaee with applicable food. State. and Federal restriction* which an current at that tuna. 793.171 labeling requirement* (a) After August 27.199a manufacturer* importers, and processors of all asbestos-containing products thet er* identified m i 76348S(a} shall label the producii specified In this subpart at the time of manufacture. Import, or processing This requirement include* labeling ail manufacturers', importers', and processors' stock-oo-hand as of August 27.1990. fb) After August 2S. 1992. manufacturer* importers, end processors of all asbestos-contami-'p products that are Identified m 7C3 165(b) and (c). and disc brake pads for use In ligfct-. medium-, and heavyweight vehicles ind drum brake linings manufactured, imported, or marketed fur use as aftermarket replacement parts tn brake systems designed for use with asbestos-containing friction products shall tabel the products ss specified ia this subpart at the time of manufacture, import, or processing This requirement includes labeling alt manufacturers', importers', and processors' stock-onhand as of August 35.1992. (c) A/tar August 211995. manufacturers, importer* and processors of ail asbestos-containing products that are identified in 763.165(d). except disc brake pads for use m light*, medium*, and heavy-weight vehicles and drum brake linings manufactured, imported, or marketed for use as aftermarket replacement parts m brake systems designed for use with asbestos-oootaa<uag frtettoe product* shall label the product* as speciftad u> this subpart at the dm* of manufacture, import, or processing. This requirement tndudaa labehng all manufacturers. importers', and proceaaors' stock-onhand a* of Aqgusl 25.1995. (d) The labal shall be placed direcuy on the visible exterior of the wrappings and packaging m which the product a placed far aale. ahipaam. or storage. If the product hat more than oae layer of external wrapping or padcapng. the label eras! be attached tn the innermost . layer adjacael lo the producL If the innermost layer of product wrapping or packaging don aot base a visible extenor surface larger then 5 aqoera incha* atthar a teg raaonag the ruiquii eiaoora af paragraph (a) of tide aactioo aaoat ha saowtey attached ts the product** famaanoat layer ci product wrapping or packaging, ar a label exist be attached fa 1b* Stefa outer layer o( product portaging or wrapping. Any pnxfacte that an distributed fa Federal Key liar / Voi K No. 132 / Wednesday. ]tdy 12. 1589 / tufas and Regulations 29311 --1--nr^MU----^iujm--11--r~Ttiw rr--wr----i------r~i------------------------r nw^rn t - r^*w^M^aaap commerce to oowone other this the or the applicant recetra* an extension end ueer. ahfpped. or etored without under paragraph (h)(8) or (9) of this packaging or wrapping mutt be labeled sacdon. or tagged directly oo a vxible exterior fb) Application filing date*. (1) surface of the product a* described in paragraph (e) of thJe section. Applications for products affsetid by the prohibitions under {|?63.165<aJ and (e) (1) Label* mutt be either printed 765.167(e) tsuy be submitted after directly on product packaging or In the August 25. 1980. Complete application* forte ot a aticl.tr or tug ci.idt of plastic, received after that data but before paper, metal or other durable substances. Ltib-is tr..<: be j'*eched m November 27.3S#9. will be either granted or denied by tbe Agf'jv.y prior to uch a manner that they :r.- o: be removed without defacing or destroying them. Product labels ahull appear at m paragraph (e)(2) o! (hi* aecoon and consttt of block letters and numeral* of color that contrast* w ith the background of tbe label or tag Labels shall be sufTicieutlj durable to equal or exceed the life, including storage cod disposal of the product packaging or wrapping. The size of the label or tag must be at least 13.25 an (* iacns) or each side. If the product packaging is too small te accommodate a label of this size, the label may be reduced In size proportionately to the size of the product packaging nr wrapping down to a minimum 2.5 cm ft inch) on each side if the product wrapping or packaging has a visible extenor surface larger than 5 square Inches. (2) Products subieci to this subpart shall be labeled to English as follows: the effective date of the bun for the product. Application* received after November 27.1900. will be either granted or denied by EPA a* toon as is feasible. 12) Applications for products affected by the ban under ( 7.ifWat may not be submitted prior to February 20 1980. Complete appbeations received after that data bat before August 26.1901. will he either granted or dented by the Agency prior to the effective date of the ban for tbe product Applications received after August 26.1901. will be either granted os denied by EPA s* won as is feasible. (3) Applications for prodacti effected by the biut under f f 763.165(b) or (c) end 763.167(5) or (c) may not be submitted prior te February 201902. Complete applications received after that date, but before August 201M2. will be either granted or denied by tbe Agency prior to tbe effective date of the NOTICE This product contains ASBESTOS. The U.S. Environmental Protection Agency has banned tbe dtstribause id U.S. commerce of tbs . product under locuan a of tba Toxic ban for die product. Application* received after Angus! 25.1992. will be either granted or dented by EPA as soon as is feasible. (4) Applications far products affected Substances Control Act (15 U-S.C. 25051 aa of by the ban ender f 793.188(b) or (c| may (insert effective date o! baa on distnbutioo r not be submitted prior to February 20 - commerce). Distribution of this product in commerce after this dsie and :eoiisaal<> removing or tampering with ;i..i iabei annotation* ofFudtrol tew 1993. Complete applications received after that date, but befree August 20 1993. will be either granted or denied by the Agency prior to the effective date of (f) No one may intentionally remove, the ban for tbe probed. Applications deface, cover, or otherwise obscure or received after Aegon 20 ISOS, will be tamper with a label or sticker that hat either granted or denied by EPA as soon bees applied in compliance with this as is feasible section, except when the product is used (5) Application* for prodacw sSsctad or disposed of. |7ltin IbwimU stssnoeqna. by the ban wider f | 7901&(d] end 763JC(d) may not be submitted prior to February 27,1995. Complete (a) Persons who are subject to the applications received after that date, bat prohibitions Imposed by I! 763.195, before August 201980 will be either 783.107, *r 70.180 may file an granted or denied by the Agency prior to application for an exemption. Persons tbe effective dele of the ban for the whore exemption applications are product Applications received after approved by foe Agency may August 201980 wfll he after granted sr maaafacBs, import. precast, or denied by EPA aa noon aa te feasible. distribute tecomoMroe dw batmad (8) Applications far ptndncse effected product aa specified hi the Agency's by the baa wader 17.IM(d) way not approval of the application. No beanburitiedprtaeio Fehruny M. Q0 applicant far an exea^rean may Complete apptlimtionB received tfot ooatiam At beared activity flaat it Ibc that dale, lad bafwa Aaguti M B0 subjact afanrxanpbisieppbcatiuB will be eithw granted er dented by tbe aftar tbe tifcotivedata afthe ban uaiere' Agency prior to tbe effective dote efffw' the Agency baa granted the exemption ben for tbe product. Appbeatimw received after Augus' 20 :390 will be either granted or denied by EPA ei soon it it feasible. (7) The agency will consider an tppticatoo for an exempnen from s b*n under f 763.169 for produc* at the same time the applicant subrr.i's an application for so exemption from > h*n under f 763.165 or f 763 167 for that product EPA will grant *n ex<rmp"o<i at that time tom a bar. t-.-iar I 761i*.9 if the Agency determines it eppr.ip-> to do so. (8) If the agency denies an apeticaii'-vi less than 30 days before the effective date of e ben for a product, the applicant can continue the activity for 30 days after receipt of the denial (mm the Agency. (9) If the Agency fails to meet the deadlines stated in paragraphs (oKH through (6) of this section for grtntir; or denying e complete application in instances in which the deadline 1* before the effective date of the ben to which tbe application applies, the applicant will be granted an extension of 1 year from the Agency's deadline date. Dumtg this extension period the pplictm may eesitlnoe the activity that is the sabject of the exemption application. Tbe Agency will either grant or deny the application during the extension period The extension period will terminate either on the date the Agency grants the application or X dtvt after the applicant receives the Agency s denial of the application. However, no pxlensxxi will be granted if the Agency is scheduled to grant or deny an application at tome date after the effective date of tbe ban. puraoan1 to the deadlines stated in paragraphs (b)'ll through (8) of this section. (c) Where to file. Alt applications must be nibmittvd to the following location: TSCA Document Proceu.ng Center (TS-7901. Office of Toxic Substances. US. Environmental Protection Agency. 40! M St~ SW.. Washington DC. 20460. ATTENTION Asbestos Exemption. (d) Content of application end criteria for decisionmaking. (11 Content of application. Each application meet contain the following- (i) Name, address, end telephone number of tbe applicant <U) Psscrtptiiei f the manufacturing import. preoseting. and/or distribution in commaroe activity for which wt exemption is requested, htdodbtg a description of tiw anbeetoe-oontainmg product to bn manufactured. Imported. puiLsmod. or dUtitbuted bt ooanuerce. (iiff Identffication of focatioc* at which die exempted activity would take place. HNA SH STEW 1537 29511 Federal Registar / Vol $< N'g 132 / Wcfoesd4y, July 12. 1989 / Rules and Res'jiation* (fv) Laagth of da* requested tot exemption (msjdmum length of u exemption ie 4 yean). (v) Estimated amount of asbestos to be used is the activity that ia the subject of the exemption application. (vt) Data demonstrating the exposure level ovat the life cycle of the product that ft tha sublet of the application. (viij Defo concerning: (A) The extent to which non-asbestos substitute* for the product that is the subject of the application fall significantly abort to performance under nternary product rtandards or requirement*. Including lawa or ordinances mandating product safety standards. (B) The costs of non-esbestof substitutes relative to the coats of the asbestos-containing product and. in the case in which the product is a component of another product, the effect on the coat of the end use product of using the substitute component (C) The extent to which the product or use serves e high-valued use. (viii) Evidence of demonstrable good faith attempts by the applicant to develop and use a non-asbeatoa substance or product which may be substituted for the asbestos-containing product or foe asbestos in the product or use that ia the subject to the application. fix) Evidence, in addition to that provided in foe other information required with the application, showing that foe continued manufacture, importation, processing, distribution in commerce, and use. as applicable of foe product will not present an unreasonable risk of injury to human health. (2) Criteria for decision (existing products). Aftar considering ail foe information provided by an applicant under paragraphs (dHI 1 and (#) of this section, and any other information available to EPA. EPA will grant an exemption from foe prohibitions in f 1783.1*. 783.187. or 783.180 for an applicant's asbaatos-contafniag product only if EPA determines both of the Mlowing; (i) The applicant hat mad* good faith attempt* to develop and use a non- asbestos atfbatanoa or product which may4* substituted for foe aabeatoe- . containing prodact nr the aabeatoe in the proinetarena, end those ettaaapta have foiled to prahaoe a substitute or a substitute foal raaidts in a product that can be economically prodeoad (10 Cthnaad manufacturing, processing, attribution in oommerca. and naa. a* applicable, of the eroded will ant peasant an acressopabi.rik of injury to human health. (3) Criteria for decision (new exemption period will be either g*anted products). Requests to develop and us* or denied by the Agency befort the end an asbestos substance or proauct will be of the exemption period. Application* treated as a petition pursuant to Section received after the date 1 year prior to nofTSCA. (e| The Agency reserve* the right to request further information from an exemption applicant if necessary to complete the Agency's evaluation of an application. (f) Upon receipt of e complete application, the Agency will issue a the end of the exemption period will be either granted or denied by the .Agency as soon as is feasible Applicant; may not continue the activity that is the subiect of the renewal application after the date of the end of the exemption period. notice in the Federal Register |7M.t7S Enforcement announcing its receipt and invite public comments on foe merits of foe application. (g) if the application doe* not include all of the information required in paragraph (d) of this section, foe Agency will return it to the applicant as incomplete and any reaubmission of the application wii] be considered a new application for purpose* of the availability of any extension period. If foe application it substantially inadequate to allow foe Agency to make a reasoned judgment on any of the (a) Failure to comply with any provision of this subpart is a notation of section IS of the Act (IS U.S.C. 2614) (bj Failure or refusal to establish and maintain record*, or to permit access to or copying of records as required by section 11 of the Act (IS U S C. 26101 is a violation of section 15 of the Act (IS U.S.C 2814). (c) Failure or refusal to permit entry or inspection as required by section H ol the Act (IS U.S.C. 2610) is s violation of section IS of the Act (IS U.S.C. 2614). information required in paragraph (d) of (d) Violator* may be subject to the this section and the Agency chooses to civil and cnminal penalties in section 16 request additional information from the of the Act (15 U.S.C. 2815) for each applicant the Agency may also notation. determine that an extension period (e) The Agency may seek to enioin the provided for in paragraph (b)(7) of this manufacture, import, prooeumg. or section it unavaiiabit to the applicant diftributioc in commerce of asbestos- (b) Whan denying an application, foe containing products in violation of this Agency will notify the applicant by subpart, or act to seize any asbestos- registered mail of it* decision and containing product* manufactured, rationale. Whenever possible, the Agency will send this letter prior to the imported, processed, or distributed m commerce in violation of this subpart or appropriate bait Thii letter will be considered a final Agency action for purposes of judicial review. A notice announcing the Agency'* denial of the take any other actions under the authority of section 7 or 17 of the act (15 U.SC. 2606 or 2816) that are appropriate application will be publtahed in the 17*3.178 Inspections. Federal Register. (ij If the Agency propose* to approve an exemption, it will iaaue a notice in the Federal Register announcing this intent and invite public comments. If. The Agency will conduct inspection; under section 11 of the Act (15 U.S C. 2810) to ensure compliance with this subpart. after considering any timely comments 17*3.17* Hecorda--pmq. received, foe Agency approve* an exemption, its decision will be pubHihed in the Federal Register. This notice will be considered a final Agency action for purposes of Judicial review. (j) The length of an exemption period wiU be specified by the agency when it approve* the exemption. To extend an exemption period beyond the period stipulated by EPA. applicants must submit a new application to foe Agency, following the application procedures (a) Inventory. |1! Each person who i; subiect to the prohibition* imposed by fi 763.166 and 783.167 must perform ar inventory of the stock-on-hand of each banned product as ol the effective date of the ban for that product for the applicable activity. (2) The invaototy shall be in writing and shall include foe type of product, the number at product units currently in the stock-on4and of the person described in till* section. Application* performing foe inventory, and foe may not be submitted prior to IS months location of foe stock. before foe expiration of the exemption - (3) Resuit* of the inventory for a period smite* stated otherwiee In the banned product mast be maintained by notice punting foe exemption. foe person for 3 year* aftar the effective Application# received between IS - data of fo* f 763.165 or f 763.167 ban on asonth* and 1 year before the end of foe theprodoct. HNA SH stew 1538 Foclera] Register / Voi. 54. No. 133 / Wednesday, July 13, 1989 / Rules and Regulation* 29313 (b) Records. (1) Each person whose activities art lubfcct to tha bana Impotad by f| 763.165. 763.167. and 783.169 for a product mutt, berween tha affective date of the i 763.105 or I 763.167 ban on tha product and tha I 763.160 ban on the product, keep records of all commercial transactions regarding tha product. Including tha dates of purchases and sales and the quantities purchased or sold. These records must be ma.r.teined for 3 years after tha effective date of the | 763.160 ban for the.product (2) Each person who is subject to tha requirements of } 763.171 must for etch product required to be labeled, maintain copy of the label used in compliance with 1 763.171. These records must be maintained for 3 years after the effective date of the ban on distribution in commerce for the product for which the I 763.171 requirement! apply. 1763.176 Confidential buatnaaa rformanon deans. (s) Applicants for exemptions under i 763.173 msy sssert s Confidentisi Business Information (CBI) claim for information in an exemption application or supplement submitted to the Agency under this subpart only If the claim is asserted in accordance with this section, and release of the information would reveal trade secrets or confidential commercial or financial information, as provided in section 14(a) of the Act Information covered by s CBI claim will be treated in accordance with the procedures set forth in 40 CFR Part 1 Subpart & The Agency will plaoe ell information not claimed as CBI in the manner described in this section in e public file without further notice to the applicant (b) Applicants may assert CBI claims only at the time they submit e completed exemption application and only in the specified manner. If no such claim accompanies the information when it it received by the Agency, the information may be made available to the public without further notice to the applicant Submitters that claim information as business confidential must do to by writing the word "Confidential" at tha top of the page on which the information appears tnd by underlining, circling, or placing brackets ((I) around the information claimed CBI. (c) Applicants who sssert e CBI claim for submitted information muat provide ths Agency with two copies of their exemption application. The first copy must be complete and contain all Information being claimed as CBI. The second copy must coctain only Information not claimed as CBL The Agency will place the second copy of the submission in a public file. Failure to furnish s second copy of the submission when information is claimed as CBI in the first copy will be considered a presumptive waiver of the claim of confidentiality. The Agency will notify the applicant by certified mail the! a finding of e presumptive waiver of the claim of confidentiality bat been made. The applicant has 30 days from tha date of receipt of notification to submit the required second copy. Failure to submit the second copy will cause the Agency to place the first copy in t public file. (d) Applicants must substantiate ell claims of CBI at the time the applicant asserts the claim, t-e.. when the exemption application or supplement is submitted, by responding to the questions in paragraph fe) of this section. Failure to provide substantiation of a claim at the time the applicant submits the application will result in t waiver of the CBI claim, and the information may be disclosed to the public without further notice to the applicant. (e) Applicants who assert anyCBI claims must substantiate all claims by providing detailed responses to the following: (1) Is this information subject to a patent or patent application m fire United States or elsewhere? if so. why is confidentiality necessary? (2) For whet period do you assert e data of confidentiality? If the claim Is to extend until a certain event or point far time, pieese indicate that event or Hn* period. Explain why such information should remain confidential until such point (3) Has the information that you are claiming as confidentisi been disclosed to persons outside of your company? Will it be disclosed to such persons in the future? if so. what restrictions, if any. apply to use or further disclosure of the information? (4) Briefly describe measures ta' - by your company to guard against undeslred disclosure of the uifo'ma'.ion you are claiming si confidential to others. (5) Does the Information claimed as confidential appear or is it referred to m advertising or promotions! materials for the product or the resulting end product, safety dats sheets or other similar materials for the product or the resulting end product, professional or trade publications, or any other media available to the public or to your competitors? If you answered yes. indicate where the information appears. (6) If the Agency disclosed the information you are claiming as confidential to the public, how difficult would it be for the competitor to enter the market for your product? Consider in your answer sucb constraints as capita! and marketing cost, specialized technical expertise, or unusual processes. (7) Has the Agency, another Federal agency, or a Federal court made any confidentiality determination regarding this information? If so. provide copies of such determinations. (8) How would your company's competitive position be harmed if the Agency disclosed this information? Whyshould such harm be considered substantial? Describe the causal relationship between the disclosure and barm. (9) In light of section 14(b) of TSCA. if you have claimed information from a health and safety study as confidential do you assert that disclosure of this information would disclose a process used in the manufacturing or processing of a product or information unrelated to the effects of asbestos on human health and tha environment? If your answer is yea. explain. (PR Doc.'w-l(262 Filed 7-7-a* 0:44 am) aamacooc --i HNA SH STEW 1539