Document RJ15LNOmQQmQLQgKYK7vBGR6k

draft in the united states court or appeals FOR THE DISTRICT OF COLOMBIA CIRCUIT ) ) ENVIRONMENTAL DEFENSE FOHD, INC., ) ' ) Petitioner, ) v, . . ) ENVIRONMENTAL PROTECTION AGENCY, j Civ. So.. 7S-15B0 ) Respondent, ) ' ) AD HOC COMMITTEE ON LIQUID DIELECTRICS OF THE ) ELECTRONIC INDUSTRIES ASSOCIATION, eteK , ) ) EDISON ELECTRIC INSTITUTE, et al., and ) ) ALUMINUM COMPANY OF AMERICA, ) ) Intervener*. ) :) EPA REPORT IN ACCORDANCE WITH THIS COURT'S . APRIL 13, 19B1 ORDER CONCERNING EPA PROPOSAL FOR ACTION ON POLYCHLORINATED BIPHENYLS IN CONCENTRATIONS BELOW 50 PARTS PER MILLION RESULTING FROM "UNCONTROLLED FBhBAPfitf^l^ffs " AND MOTION FOR EXTENSION OF STAY OF MANDATE AS'TO EPA ACTrON cm UNCONTROLLED.R8LPABBC UNTIL DECEMBER 1, 1982 ' ' ~ ' Wgft : ' In accordance with paragraph 2.B. of this Court.' order of April 13, 19B1, the Bnvifconmental Protection Agency ("EPA"), hereby reports it* pl*n* for further regulatory action with respect to manufacturing, processing, distribution in commerce and use of polychlorinated biphenyls (PCS*) at concentration less than 50' part* per million (ppm), in other than closed 0543094 EX P-3324 Page 1 of 15 PCB-ARCH0754779 -2- manyfeaturing processes ("closed processes") and processes producing only controlled wastes ("controlled processes").*/ ftr tic pvrpefes of H,i dwcw^t, " <? have referred to this aspect of the PCB rulemaking as dealing rfiea*." with "uncontrolled /releases-. * j- 4, pre-fiWnaryof Hwl Afterjevalusting information submitted to EPA in response to reguests published in the Federal Register and other relevant data and consulting with all parties to this case, RPA determines L ,, , rPC&r imiiljt that completion of PCB rulemaking for uncontrolledj re leases rOfOn - largely dependent/os the resolution of issue* in the rulemaking on "closed* and "controlled" processes. A final PCB rule on "closed* and "controlled1! processes is scheduled for October 13, 1962, Therefore, EPA will need a short time after that date to further report to the Court on final plana for completing rulemaking on/the uncontrolled -reiearns of PCB*. EPA suggests that the further report of plans be made by November 1, 1962. Since the Court's present stay of its mandate empires on October 13, 1982, with respect to all PCB* at concentrations 1 less than 50 ppm, EPA also suggests that the stay be *tended r Pc*& * until December 1, 1982, with respect to unoontrol led/ralassas at those levels. During this extension of the stay, EPA can _ fUACcttrtlki PcjSj ' report its plans for suchJetlvmB on November 1, 1982 and ' the Court will have sufficient time to review these plena before the stay of the mandate erplrei-. --___ -- . - -------------------- dWUeJ lr+i# 'VLunc*" ft6t < e>V*r p^i^r er ,* Ctr\*U , / Sj>jcXk . <v'r _ > *. _ -- or_ ui.t1<-r cjb/aa. iIU. r#^ACiri. ^Pdda is. m.t. I , . a. ... , &(>. '\hatnte," of ll)______ S Mclosed manufacturing process* isjsna dined jsnsrases , --~~J pCDs bet from whieh no POBe aeesalssssd. in s "controlled ht psrfxyc-SX waste process," PCBs are released only as constituents of tVr wastes which are incinerated or disposed of in EPA approved landfills, or held for such disposal. EX P-3324 Page 2 of)153095 PCB-ARCH0754780 -3- The reasons for EPA's determination to suggest this course of action for further rulemsXing on uncontrolled ' PC0s ylese is explained below* X, BACKCROPTO. . A. GBHERAJ, BACKGROOND, ' Beetion 6(e) of TSCA, 15 D.S.C, 62605(e), required EPA, among other things, to adopt rules governing the manufacturing, processing, distribution in commerce, and uae of PCBs. On Hay 31, 1979, EPA promulgated such rules, called the *RCB Ban Regulations,* 4* Fed. Reg. 31542-58, 40 CPR Fart 761. The Environmental Defense Fund, Inc. ("RDF*) obtained judicial review of the PCB Bah Regulations. On October 30, 1980, this Court held, inter alia, that two aspects of the PCB Ban Regulations were invalid. EPF v. EPA, 636 F.2d 1267.. . This Court set aside, the portion of the PCB Ban Regulations that, generally, had limited the applicability of those rules to materials containing PCBs in concentrations of at least 50 ppm, 636 r.2d at 1279-1284.' In addition, the Court set aside EPA'a determination that certain uses of PCBs were totally enclosed* uses and, therefore, esempt from regulation under Section 6(e). 636 P.2d at 1284-6.2/ The rules were then remanded for further rulemsXing by EPA, consistent with the Court's opinion. 636 F2d at 1264. ' 27 The Court also upheld the PCB Ban Regulations* authorisation ' of eleven oon-enclosed uses of PCB*. 636 F2d at 1275-9. EX P-3324 Page,% 15 PCB-ARCH0754781 The Court'* decision placed industries that had relied upon the PCB Ban Regulations in a difficult position. BPA and EPF believed that issuance of the Court's mandate would have activated Section 6(e)'a broad prohibitions on the manufacture, processing, distribution in commerce and use of PCBs. TSif parties, therefore, filed a series of joint motions with the Court to seek a stay of the Court's mandate. During the period encompassed by the proposed stay; (1) EPA would conduct new rulemaking with respect to PCBsj (2) industry groups would undertake activities related to the new rulemaking; and (3) users of transformers containing PCBs would institute an interim inspection and reporting program. On February 12, 1981, this Court entered an order in """ response to the joint iaotion of January 21, 1981 <'February 12 Order*),1 This order is not relevant to the matters discussed in the instant report, but is described in a separate document submitted to the Court today titled 'Joint Motion For One Xeek Extension Of Stay Of This Court's Mandate,' On April 13, 1981, the Court entered a second order in EPF Vi EPA, in response to s joint motion that wss submitted on February 20, 1981 (the 'April 13 Order*). The April 13 Order stayed issuance of the Court's mandate with respect to activities relating to PCBs in concentrations below 50 ppm. The order also adopted a plan for further actions by EPA and EX P-3324 Page 4 of153097 PCB-ARCH0754782 -5 industry groups leading toward new PA rulemaking on the regulation of PCBs in concentrations below 50 ppm. The . April 13 Order required EPAt IX) to publish two Advance Notices of Proposed Rulemaking (ANPR*1) on developing rules to cover PCBs in concentrations below 50 ppmi (2) within 16 Months from the date of the order (i.e., October 13, 1982), to promulgate a final rule with respect to the exclusion - . from the prohibitions of Section 6(e)(3)'of the generation of PCBs in `closed manufacturing processes* or only ss contituents of `controlledwastes," or to explain the reasons for not proceeding with such s rule) and (3) within eleven month* after the date of the order (i.e., March 13. 1982>, to advise the Court of EPA's plana and schedule for further action on PCBs in concentrations below SO ppm generated other than' either in `dosed manufacturing processes* or as constituents of `controlled wastes,* i.e., for *uncontrolled/selesee.* ,-pCSs Por these "uncontrolled^release*. * described in item 3, BPA Reeded to collect a range of additional factual information in order to develop'an adequate'rulemaking-record consistent with the -Court's opinion of October 3D, 19B0. This need for - collection and evaluation of additional data accounts for the......... relatively greater difficulties EPA will face in completing rulemaking on `uncontrolled freiwmee* as compared with the closed* and "controlled* processes. ' 05*13098 EX P-3324 Page'5 of15........ PCB-ARCH0754783 -6~ B. IK76RHATX0K RELATING TO PCBs IN CONCENTRATIONS LESS TfiAN SO PPM. . 1 * Publication of ANPR's and Related Notices In deciding wbat further action it will take with respect ,, ' r<ud w.ll nsN to PCSs in concentrations lees than 50 ppm, EPA hasjs14*d heavily on information received in response to the two ANPRs published in'the Federal Register on May 20, 1981, 46 Fed. Reg. 21614, in accordance with the Court's April 13 Order. As set out above, the ANPR* established bifurcated rulemaking proceeding* with respect to PCB* in concentrations below 50 ppm. The first AKPR announced activities that EPA believed say lead to rulemaking on PCBs generated in the 'closed manufacturing processes' and 'controlled waste* processes. The second ANPF announced the framework.for the Agency's esploration of the scope of the problem presented by PCBs in concentrations below 50 ppm in uncontrolled PCBs s*laas. EPA there stated that it needed to develop a aukstintini factual basis to support rulemaking on these PCBs.'/ 46 Fed. Reg. '27619. . The comment period for both ARPRs expired on November 16, 1981. Approximately 50 public comments were submitted in response to the two ANPRs published on May 20th. The most significant submission was filed by the Cbemeial Manufacturers Association ("CMA") -- a trade association whose membership . *7 6n Kay 26, 19B1, EPA also bad published in the federal *" Register s summary and.the full text of the April 13 6rder. 46 Fed. Reg. 27615. . 0543099 EX P-3324 Page 6 of 15 PCB-ARCH0754784 ~1~ consist** of nearly 200 companies, including the nation's Or'('lt-ifAl majMiffcthjrers o f pnf/ t^hcm>'c*ls. foost-lmperlnn* ehemioal manufaetumeee. As explained further r u>i| I reiy below, BPA/selied on CMA's subaissionSto e significant extent, ' " rCII^ A.s ColkchU becausethe most comprehensive set of date gathered to date on generation of PCBs in concentrations below 50 ppm. 2, Information-Gathering by the Chemical ' Manufacturers Association ______ _ . On April 24, 1981, CMA distributed detailed questionnaires to its membership -- nearly two hundred companies. These questionnaires were designed to Provide a data base to oenerjv-fa determine the extent and|mSSinss- of the ganasatiea af^PCBs in concentrations below 50 ppm in chemical manufacturing processes! fWiH-< PcrnjUfoA for late/-------------------i-- After collecting and evaluating the. datar*cHA submittedjits .t>'uu>'- vrfr> \ f SUrUCY fAxi CDMMtMii ft flhAlJi^PortJto EPA on Bouember 30, 1981.^ The report is w iM ^titled, A Report of A Survey on the Incidental Manufacturing, >o Jau'W ^ ^ /Processing, Distribution, and Dae of Polychlorinated Biphenyl "Bit I at Concentrations Below SO PPM [hereafter CKA^REPORT -- a copy 'pfiki of the cm Report is attached as Appendix A], nn \ S *h> "tic L<0* Vtttr JITa^ Attack P^j)~t ft -d j'o a.tfl'ii) J7 Among other things, the questionnaires asked CKA members to describe the quantity and the environmental fate of PCBs generated in each process of each facility in which there was reason to believe PCBs were generated. The questionnaires also requested information with respect - to. potential human and environmental exposure to the PCBs generated and to controls employed to reduce the generation of PCBs, A copy of the questionnaire CKA distributed in connection with this survey was appended to the joint motion filed with the Court on February 20, 1981. ' 0543100 EX P-3324 Page 7 of 15 , PCB-ARCH0754785 7 A ATTACHMENT A In -a/lAition.^CMA submitted the following reports to EPAs 1. ) The Analysis of Chlorobiphenyls, submitted August 21, 1981 (An analytical narrative on the problems and costs associated with analysing low level PCBs.) 2. ) Summary of the Health Effects of PCBs by Eoology and Environment, Inc., and associated reference material which contained five unpublished reviewB, draft report submitted November 16,1981) final report submitted November 25, 1981. 3. ) comments In Response to two Advance Notices of Pro posed Rulemafcing Relating to the Manufacture of PCBs below 50 parts per million published May 20, 1981 bv the Environmental Protection Agency (46 Fed. Reg. 27617, 27619), submitted November 25, 1981. 4. ) Statistical Analysis of Data From A Round Robin Experiment On PCB Samples by Beiden Pittaway Associates, draft report. (Report of an analytical round robin with EpA and industrial participants.) 0543101 .... EX. P-3324..... Page 8 of 15 PCB-ARCH0754786 C, PROBLEMS KITS DATA AND ANALYTICAL CAPABILITIES &&* believed that one hundred and thirty-five processes generate PCBs in concentration* below 50 ppm. CMA reporta these companies generate 13,800 pounds of PCBs, of which 13,100 pounds are L'Jpsit d f AS CO'i+rvlle A EPA has used the data presented by CHA and available data from some other sources to project PCS generation for the entire cheaioal Industry. Although the CMA data has been very helpful, as explained below it has not entirely put to rest certain questions about the generation of PCBa and the quantities being formed. , , (-Because rtseohijt*' r f*>e f SurOt/ rfr//w.jp&.{ h\ft.nUT.cTjntrs eT pr<ynn[j JJrlm* repaystivA tojCMAyreprescnt/arpnritlmeMly-'BB ptruiiil Cht.mic*ISj-CttA izlitilts tUt-He pW/jA(B(>ivfe) ,i repoucnfehueaf fLttofAl auiWl of all obaaioal industry sales, based on-i97t sales date%| . |M(TUrAiasVIrnef1iA1 Sil 'vliaanuaeirtpiirames Which iMii&Uiiy gf"yr~*tref-Tfit`i.s'-frci- /awl //**<; industry hi i Wnoie cannot be made on tala baslm without f* tf.^1 of Yneprificttl/j . I AefA+j/*yUJ aubatautleljuncertainty. JPCBjnay be formed when carbon, ' .-- Liji ttwpemitura. chlorine and a source offbeat are present, and aay therefore be present in many processes fundamental to the organic Mmbtr of pno/tstet int,J/y chemicals industry. ThejeS recpandenta te She CMA survey f^ 1V1 +h r- reported 135 preecesea generating PCpBAaa,f IS -At*h--iws appro*isiate -eetlo bolds tor She 11,000 chemical ./firms in the 0.6., -She- -number' of chonioal processes generating PCBa could be between . 10,000 and 20,000. 1 Of tkf.SC. 11 t PWrtJs, qtoo pO^/Wsftfe ptrctni) dhe i/iCirtArafei poods /|3 percent) & ^ 5alf ua+er ulM<> rfiScUfJ&l & S/* **'**'' reuo,r Swf*. w'^tr syitr*, /6po puUs ()A pec^ go +p 600 P01'^5 (j. percent) +0 groiud inj^fitvi. (See, CHA Survey fiefurf at P*Je 0543102 EX P-3324 Page 9 of 15 PCB-ARCH0754787 As a reseuulAt.ii*EPA f_a_c_e's8 suubbstantial uncertainty fCOJli fee neivil>itXSs~i_- determining how many 6T tcnnese processes/: generate ^ uncon . pees' " trolledf. The potential number of such processes could be relatively few or more than 10,000. Where the likely actual number falls will seriously affect how EPA can manage a rulemaking on "uncontrolled jraleatiea.* if there are relatively tmu ...........,........ r,'m-i H-ni'ScoCuaiu+exjoonrLmuiete PCB rul.eB - employing procedures that are simple, and the time needed for rulemaking will be relatively short. If the actual r fCGs 9<'*ra.+.4" projected number of "uncontrolled! vein ana* processes is very large (l.ev several thousand or more), resources for formulating and administering PCB rules could be severely strained, larger numbers of processes will make it more difficult to develop definitions of terms or recordkeeping and reporting requirements that can uniformly apply to tits persons subject to the' rule. Horeover, the larger the number of processes covered by an rPCfis" "uncontrolled/salaasaa* rule, the more difficult it will be to fashion a rational exemption procedure under eactlon 6(e)(3) of T8CA, 15 O.6.C. 62605(e)(3). EPA will have to ' perform considerable analyeea to reduee the large number of' : (MlfUiil ptOMisit Into manageable categories for purposes " of determlnlho eroosure to JBfai; miatiiabriltV'of'sub.titut.."" fihAnVtWtfvnhj/, procCi&hy sol diitnttoriQfi) and, ultimately, whether thejtpao.eemmes present unreasonable . rltke. . Bee 66(e)(3)(0) ot WtA,15 O.8.C. *2605{e)(S)(B). EPA might find.lt administratively lmpoaasible to make such findings bnan individual plant or even process basts, if the 05't3103 EX P-3324 Page 10 of 15 PCB-ARCH0754788 -10- number of processes covered by a rule Is large. Resolution of technical and legal issues for formulating the rules would require a considerable effort on EPA'* part. Particularly, d irec-t care must be taken to fashion a scheme that would>poee' regoUhw -Hose available EPA resources end public attention on (processes (- vfcitA preterit Ht~ jgreatest environmental or health concern. After completion of the rulemaking on "closed* and controlled" processes, EPA can better estimate the number of rpCBSj " the remaining, `uncontrolled^release, processes. When EPA fPC-Qi/' refines the estimate of "uncontrol ledil,m /ro-leaeeay* it will be able to submit to the Court a plan reflecting the expenditure of resources and time needed to complete additional rulemaking. Until then SPA will continue to evaluate and eventually resolve, in the context of the "closed" and "controlled" process rulemaking, issues necessary to decide what aualifiaa a process as "closed" or "controlled." Among these issues are* (1) how wastes from a process must be handled! (2) whether there will be a limit to the amount of PCBs generated within, but not released from, e system considered "closed* or "con trolled (3) what, if any, worker protection requirements are necessary; HM/tfl (4) what analytical techniques should be used to determine that a process Is "closed" or "controlled^"^ and e^alu.tron of He. mL concerns? "*/ his issue will have a bearing on the risks associated . with accidental release of PCBs. 0543104 ____EX P-3324 Page 11 of 15 PCB-ARCH0754789 tt pnoblan of ebooaing analytical techniques is a particularly good exsapla of the problem m fm in deter Mining tbe amber of pnoWNt that trill be considered"eloeedf asd "controlled" nd. consequently, the scope of tbs ruleaaXing on "Cftoontrollsd/rsil.esse* of rat in oonoentxation* below SO ppm. tbmxm is substantial uncertainty in th* accuracy of PCS analytical techniques at low concentrations. These . questions itn ftm tbt fact that controlled and closed processes are defined by the "absence* of PCS* either in tbs . final product ox in oertain releases, wdi sa air ssisaiona or water discharges. because of- scientific and other practical limitations oo the detection and quantification of PCS* in releases, tba "attoenos* of Pda oannot saan litarally solscules. COoaaqaantly, tba agency Must apeoify bow tbs abesass of POBs is to ba datsminsd in nriw releases. aealfteal oyjk> - noat oftan to atnitorfia KMjia a gas abroaatograph (OCK V Tberrare 200 different sbsnioel cvnjtmrs . fprns (toiam) of PCOa which oas be present in various processes, products', -and rslsasas in differing proportions. tba idsntlfioation of total uonta of PCBa is eeapliested by difficulties in determining which of tba 209 Com are . wyat. further, the settsltlsltr of analysis for PCOa by to? ` a "-tbaWaamStjesalysey a atoms of ebasieal oompoande- fiy^arawriig tin length of tine it feikM for each obsnleal ' epapound to txsssl through a peeked tubs of snail dlan*tei> ' At IdMtKieitisi of individual eosponanta of tbs sistors la aeoanpliebedtfoy fionpsrlng tbs retention tias of tb* compound is tba aanls bains analysed to tba retention tine of a Known standard aolrtiowp^f^jet <ymfog) 05<,31o5 ----------- EX P-3324------Page 12 of 15 PCB-ARCH0754790 12- OC methods may he adversely iHteUd by the (num of . other organic oospoand* in wvml way"-*/ So <Ml rtth these ptobitn th* analytical chemist must find appropriate procedures to extract the PCS* and to naovt tha intarfaring oompounda. Different procedure* are.auliable for solving thaae problaas in air emissions, in ester discharges, in waste stream* and in and product* . Moreover, difference* in the physical and ehaaical natora of processes add ooaplexlty to the analytical chamistry Issue*. Accordingly, a number of procedure* of varying complexity will base to be oealuatod before KPA decides ' bow reasonably to determine the "absence* of PCBa. . Za specifying bow the "absence* of PCBs is to be dater*load, the Agency is feoed with the problem of deciding the level of sophistication that should be need in. analytical taobnipwic because tie siete. of tie tyrPcfi ontlycs gUMtiftsatua /***y see asphiatiaasiaa ic regained-#or mxaaxiriag BCSs in easy espeohg #-0 i/mprodt. - lamawrtwii-->i tha umbxe a* presses** as* gaslltying- a Taloaad* or eeaetamllsd* stit Inert*** aal eltf-iwsd , ha traatad lathe taaeamfcssMad sel*ae swl--ahlng. | malarial* are/aot suitable for direct injection 'samples aucb as solids, tars, sad corrosive j. . mater***^art essaWy dimsolved in a suitable solventFre{>ilttyamd axe attracted into ajdUferes* solvent prior to fir1-> analysis ,JlCertain organic oomnoenda may bind tha PCBa ^icrceier^. ana oraviant their antiartiwY^ ^|r tro of procedure. TlUP^iittirr- are oome org*nld~oompounds vnoae oc retea tlmas are the asms or wiyaasllr-bh* aaae-ao ehoafCBa- (Simil Such compounds mev^ ln-ter-fere witthh the detection ooxTP5C^ Bl ^ EX P-3324 3106 t . Page 13 of 15 PCB-ARCH0754791 13 Zb sua,^ EPA cannot dtttniM Its plans for tbs uncon trolled Jsslaass^ rulmaking until It Jum nttonibl* sstlisats of tbs water of pnwtmi that will bs subject to web ruleaaking. Chat enter cannot bs dstsrwinsd until spa has decided tbs enter of processes that will bs considered closed" or "controlled." Meanwhile. SPA nuat resolve a r nawbsr of issues in tbs "dosed* and "controlled* process ruleaaklng. Including tbs nstars of tbs analytical techniques to bs used. 05^3107 EX P-3324 Page 14 of 15 PCB-ARCH0754792 -14 . COWCtOSlOB Mmmb mw and Hovenber 1, 1982, EPA will work toward revolving th* aforemsntloned question* as expeditiously a* possible. On that dates BP* will report to this Court on the agency's plans for proposing and promulgating a rule on /cfl," "uncontrolledUselessas" of PCBs in concentrations below SO ppe. tbs plans will provide an adequate period for public ooamen't and review within the Pedexal govern--wt. - BP* --geests an extension until December 1, 1982, of this Court's atey of its --ndate issued with respect to PCBs in ocnoentretions below 50 ppe other than in closed masufeetutring processes or in processes producing only controlled west--. Counsel for all parties to this proceeding have authorised --. to represent that they do wot oppose the report or the . extension of the sthy bf mandate. . Respectfully subeitted, . post bbspokdbht* . - bsvid Suent*, Attorney D.6. Department of Justice, Boom 1724 Tenth and Pennsylvania *ve., M.W. Hashington, D.C. 20530 (202) <33-2807 . Alan V. Itarpien* attorney ` 0.8. Environmental Protection Agency 401 Street, S.V. Hashingtoo, D.C. 204*0 <202) 424-3248 . EX p_3,,4 Page 15 of1S3i08 PCB-ARCH0754793