Document YzLwZEDr8VGY1Jb09vgmOzeO

before the united states ENVIRONMENTAL PROTECTION AGENCY +++ Haaring for tha Cloaad and Controllad Waata Proeaaa Rula Rood 3906 Watarsida Hall 401 M Straat, S.W. Washington, D.C. Monday, July It, 1912 Tha maating convanad at 9i07 a.a., Richard J. Guimond praaiding. EPA PANEL Richard J. Guimond Alan Carpian John Saith William Guntar David Radford Laura Caapball Danila Kaahnar Amy Moll For Distribution by CMA SPECIAL PROGRAMS DIVISION tmrrl P.T, r(. no Td-y-zy-f, Date__ , jEXECUTIVE COURT REPORTERS (M) MMM HONS 00365 7 2 ijbjx STATEMENT orl Or. Kenneth Burgee*, Chairman. Chamical Manufacturer* Aaan. Dr. Robert Kalay, marabar CMA. PCS Analytical Taak Group Dr. Geraldine Cox, CMA Jacqueline Karren, HRDC Bilan Silbargeld, HRDC Richard L. Bluma, Ganaral Electric, Divlaion Counael Or. Oanlal E. Sliva, Ganaral Electric, General Manager, Silicone PAGB NO. 29 g 112 119 144 144 MOMS EXECUTIVE COURT REPOaiuo (3m) m mi 003658 3 ?.52EE2ings M*. GUIMONDt Welcome to our hearing thia morning. My name 1* Richard Guinond. I'm chiaf of tha Chemical Regulation Branch in tha office of_Toxic Suhstancee. I'll be the chairman of this hearing panel. The other maabere of the panel and myaalf would like to give you a welcome to the hearing. Km you know, EPA propoaed a rule to control the releaae of PCBa encloaed in control waate proceaaaa. Thia action waa taken in raaponae to a daelaion from the U.s. court of Appeala for tha Diatrict of Columbia Circuit. Our goal for the hearing ia to learn aora about PCBa manufactured in low concantrationa, the impact that the propoaed axcluaion from the atatutory ban nay have, learn about the analytical methoda for monitoring PCBa and proceaaaa affected by tha rule, learn any problana aeaociatad with thia. Among tha iaeuaa in which tha agency haa requeeted ctaaaDt are the appropriateneea of the axcluaion, the need to apaeify criteria for determining tha abeenea of PCBa, tbe appropriateneea of uaing limit* of quantification vereue limit* of detection, and tbe auitability of allowing manufacturara to uae beat theoretical analyaia in lieu of actual monitoring. Aa moat of you are aware, the Federal Regiater EXECUTIVE COURT REPORTER! (m) la mi HONS 003659 Notice of June 8th included misprint concerning the date* for the cloeing of the mein content period and for this hearing. This misprint resulted in an error by the staff of the Governaant Printing Office that was unfortunately out of our control. we apologias for any inconveniences that this nay have caused and you will now have until August the >th for the close of reply concents. As with our actions to the extent feasible, the agency will consider other conents provided to it beyond that data within the constraints of our overall rulasiaklnq. ___ If, during the course of the hearing, any of you have any questions that you would like the hearing panel to ask the people that are testifying, I'd request that you write them down on a card or a sheet of paper and give than to the bearing clerk that's located up here in the front and she will pass them to the hearing panel to ask. In addition, if there are any other people that are not on the agenda for the hearing today that believe they have Information that is relevant to this rulemaking and would like to present it, we will consider that to the extent feasible within our time constraints of the hearing today. So if anyone does want to provide sons additional Information, I request that you sea me sometime during the EXBCimVB COURT RRPORIHIS (m) mmm HONS 003660 dy and I will talk with you and see if wa can make appropriate arrangements. Thara ara agendas for tha hearing located on the table Just as you cone in tha door -- excuse ae, it's outside tha door. At this tine, I'd like to introduce the remainder of the hearing panel for this informal hearing, way down at the and on my left is Amy Moll. Amy is one of tha economists with the Economics and Technology Division in the Office of Toxic Substances. Next to her is Laura Campbell. Laura is with the Office of Pesticides and Toxic Substances Enforcement and has bean working with us with respect to enforcement issues on the rule. Next to Laura is Bill Gunter. Bill is the team leader for the FCB Regulations Team in the Office of Toxic Substances. TO my laewdiate left la Alan Carpien. Alan is the attorney with tha office of General Counsel who has served as a legal advisor on these- PCB rulemaking. To my right is John Smith with the Exposure Evaluation Division of the Office of Toxic Substances. John has been tha principal chemist in the development of the guidance on tha methods for sample collection. To his right is Dave Radford, also of tha Exposure EXECUTIVE COURT REPORTERS (Ml) UUttt MOWS 003661 6 Evaluation Division.--Dava ia a project manager of the Midwest Raaaarch Institute contract that ia assisting ua in tha development of analytical methodology for tha rulemaking. To my far right ia Daniaa Keahner who ia a biologist on tha PCS Regulations Team and ia tha load ataff member for thia rulemaking. At thia time, i'll turn tha microphone ovar to Alan Carpian who hat boom remarka rawarding tha procedural aapacta of tha rulemaking in thia hearing. HR. CARPIBM$ I'd Ilka to stress, flrat of all, that thia ia an informal hearing and wa'ra going to try to remain aa flexible aa poaaibla aa a hearing panel. Bovevar, after paying that, I alao want to point out that wa have procedural rulea under Volume 40 of tha Code of Federal Regulations, Part 7S0, Subpart A, and there are copiee of thoae regulationa on tha table aa you cona in. I will be available for any questions about any of tha proeaduraa involved in thaaa rulea during any breaka. I believe Rich aaid that reply consents will be dee two weeks from the day tha hearing ends, under our currant schedule, we expect tha hearing to end today and that would mean that reply coaaaeata would be due by August *th. bet ea coaaaant briefly on how we are going to EXECUTIVE COURT REPORTERS () niww HONS 00366* dp 7 [proceed. We tlk *11 participant* to firat idantify themselves and thair affiliation to the court raportar before they bagin speaking. This ia in ordar to halp ua latar aa v* review tha tranacript. Any additional material you Hava, any additional written atafearial or any other matarial that the panel night request fron you ahould be given to tha hearing clerk for inaartion in the record. Although participants are not aworn, i would like to remind everyone thay are subject to II USC 10001 which is tha ralaa Reports to tha Government. Following aach speaker'a presentation, each amber of the panel will have an opportunity to ask questions and as Rich said before, we will ask any U reasonable questions subaittad by the audience. If anybody on the panel should ask a question or if any speaker has anything to say that is of a confidential business nature in the speaker's opinion, please note that. You can later present your response in a close session if that's necessary, but present the information in writing on a confidential basis under agency rules for tha submission of confidential material, tha agency regulations for submission of confidential material will found in Part 2 of Volume 40 of the Code of Federal EXECUTIVE COURT REPORTERS (M) MHW MONS 003663 Regulation*. That'* all 1 have. a MR. GUIMOND: Than X guaaa we'll begin with CM*? STATEMENT OF GERALDINE COX, CM* MS. COXi My nan* ia Geraldine Cox. X an vicePraaidant and Technical -- Director of th* Chemical Manufacturer* Asaociation. Th* Chemical Manufacturer* Aaaociation ia a trad* aaaociation representing th* manufacturer* of more than 90 percent of tha baaic induatrial chemical* in tha United State*. CMA and ita apeeial program* panel on POa welcome th* opportunity to diacuaa EPA'a proposed rule for cloaed and controlled waste manufacturing processes with you this morning. CMA shares EPA'a concern that PCBa do not pose unreasonable risk to man or to th* environment. As you know, in this country, intentional manufacture of PCBa ceased more than five years ago and we do not advocate such manufacture be reinstated. The chemical industry has worked diligently to develop substitutes for thee* use* for which PCBa were invaluable in the past. CMA further agrees with EPA that if the current uses of previously intentionally generated PC -- I'm sorry, if there era current uses of previously intentionally generated PCBa that pose unreasonable risk, adequate controls should be developed and if there are any specific circumstances where unreasonable risks are presented by EXECUTIVE COURT REPORTERS (Ml) J4I-4M4 HONS 003664 9 nail quantity of unintentionally generally PCBs found a* impurities in a wide variety of chemicals, control* to reduce human and environmental expoeure* would be appropriate. However, CMA cannot support EPA's present proposal for what it terms "closed and controlled waste manufacturing processes. * That proposal is preaiised on the scientifically and legally flawed assumption that any exposure to PCB is significant. Not only is this premise wrong, as a matter of science for any chemical, it also miacharaetarisea what we know about the toxicity of PCB*. Contrary to what might have been believed by some in the past. Including Congress, PCBa are not uniquely toxic. As the recent epidemiology studies of the -- incident and the heavily exposed capacitor worker have demonstrated significant health risks will not b* posed at the low lavsls from inadvertent generation that EPA is now considering regulating. Ones X?A reviews the health evidence in light of the exposure levels at issue, we are confidant that the agency will agree with us that inadvertent generation poses no significant risks to man or tha environment. CMA's special program panel has proposed a reasonable regulatory program for inadvartant generation of PCBs, although we do EXECUTIVE COURT REPORTERS (M) W-4M4 HONS 003665 10 not believe that likely -- believe the likely exposures that would occur 11 PCBs war* balow SO parta par million In product and wasta itraams would posa any significant riaka. wa would support a regulatory aehama basad on such a quantified cutoff. By amploylng this cutoff, fPA could asaura tha public that no raasonabla risks will bo posad and Industry, that it will ba allowed to continue to produce tha many valuable chemicals under reasonable regulations. Bara today to spall out in detail CMA's positions ara Or. Kenneth Burgess, chairman of our Special Program Panel on PCBs, and Dr. Robert Kaley of tha Panel's Analytical Task Korea. I encourage you to listen closaly to thair presentations and to ask them questions in order to assure that EPA clearly understands CMA's position on the issues raised by its closed and controlled proposal. Or. Burgess? STATBMEMT OP DR. KBHMBTH BURCRSS, CMA OR. SORSSSSi Thank you. Good morning. My name la Kenneth Burgess and I am Chairman of tha Chemical Manufacturers Association Special Program Panel on PCBs. With me today is Dr. Robert Kaley of tha Program Panel's Analytical Task Force who will also be presenting testimony and at the conclusion of Or. Xaley's testimony, I will be EXECUTIVE COURT REPORTERS (M) JIMSH MQNS 003666 11 glad to answer your quaations and rafar them to Dr. Kaley, aa appropriate. Also with ua today ar# Tia Hardy and John Jackriaon of tha firm of Kirkland t Ellia, eounaal to tha PCS Spacial Panel. CMA haa rapaatadly urged that SPA conduct a thorough review of potantial axpoauraa to substances containing inadvertently generated PCBa and tha ralativa eonaaquant health and environmental affacta of tha PCS content in raaponaa to the Court of Appeala remand of EPA'a 1979 PCS regulation#. With reapect to both intentionally manufactured PCBa still in uae in electrical equipment and inadvertently generated PCBa in a number of baaic chemicala, CMA acknovledgea any unraaaonable riak aa defined by TSCA Section 6(c) ahould be eliminated purauant to EPA'a authority under the Toxic Substance Control Act. However, SPA to date in both the electrical equipment propoaal and ite moat recent cloaad and controlled weate proposal, failed to review the exposure data or the health end environmental evidence. Both EPA proposals suffer from the absence of a straightforward description of the record evidence damonetrating that the trace quantities of PCB now entering the environment poee no significant, let alone unreasonable risks. EXECUTIVE COURT KfPORTZKS (mi) aum HONS 003667 12 In particular, these proposals fail to consider aavaral recently ralaasad atudias of PCB health effecti that demonstrate no signifleant risk will be posed by the trivial exposures the agency is now considering regulating. Such studies include, among others, the Raahimoto, at al. study, "Role of Polychlorinated Dlbenzofurans in Yuaho PCB Poisoning* published in Volume 36, Ho. 6 of the Archives of Environmental Health, and Brown and Jonas 'Mortality and Industrial Hygiene study of Workers Exposed to Chlorinated Biphenyls,* also in Volume 36, Ho. 3 of the Archives of Environmental Health. EPA's failure to address the de minimis risks ersatad by unintentional PCB generation explains in large part why CMA has urged the agency to withdraw its closed and controlled waste proposal. As our July Sth comments detailed, that proposal is of little value to anyone. It provides no assurance that public health will be protected. It never answers the court's questions in EBP v. EPA of whether any unreasonable risks are posed by inadvertent generation of PCBs and it will not provide industry any assurance in inadvertently generated PCBs in closed processes will be excluded from TSCA regulation, even though any release is trivial. The analytical guidelines are so uncertain that although we doubt any process will be excluded, this is EXECUTIVE COURT REPORTERS (m) MMNd HONS 003608 13 iptculttioiif * not 2ftct> In fict( tht ptopon^ rulo may er*t considerable opportunity for supplier-customer controvaray aa to whathar PCBa in customer plant* or plant waata war* generated by th* cuatomar or racaivad aa part of raw matarial from th* auppliar. H* hava thua urged EPA to pubilah a now propoaal that conform* with congraaaional intant in TSCA and th* mandat* of th* Court of Appaala to addraaa unraaaonabl* risks. that propoaal would recognise that no significant riaka ara poaad whan PCBa, in product* or waata atraama, ara in concantrationa balow 50 ppm. Such a propoaal would appropriately addraaa th* TSCA Section 6(e) criteria, health affects and exposure to humans and the environment, benefit of th* regulations and cost of regulating substances containing inadvertantly generated PCS*, and determine that inadvertently generated PCS* pose no unraaaonabl* risks. A 50 ppm cutoff has baan the law of the land for three years, although the exposure and health evidence would support a higher regulatory cutoff, CMA would not object to th* eomtinuanc* of such a regulation. ESA's closed and controlled waste proposal begins with the appropriate initial premise, namely, that there is no reasonable rationale for any regulatory concern about levels of PCS insider manufacturing equipment. Aa long a* [ EXECUTIVE COURT REPORTERS (*) wwmt MQNS 003669 inadvertently generated PCBs are within chenical plant 14 equipment, no environgiantal or human expoaure occur. The concentrations of concern are those to which humans and the environment might be exposed, in air, water, or products. However, the proposal's nonquantifiable approach is not a rational approach to the correctly perceived regulatory issue. This morning, 1 would like to provide toms background Information to explain further why CMA urges that EPA withdraw its nonquantifiable proposal. first, and most importantly, EPA's proposal bears no articulated relationship to protection of the public health as required under TSCA Section 6, and as requested l< by the court in SDF v. EPA. Although EPA justifies its proposal as being as close to sero ralaase as practically I* possible, the agency has not in fact sought to determine that levels -- what levels of PCB its proposal will allow in the various msdis. Moreover, the agency has made no attempt to It determine to what extent any such concentration will lead 21 to hiaan or environmental exposures, not to mention whether 22 tho likely trivial exposures pose any significant risks or n outweigh the cost of regulation that must be balance against 24 risk before making an unreasonable risk determination. n The proposal cannot withstand review under the EXECUTIVE COURT REPORTER! (m) in 4wi hONS 003670 IS ' statutory standards of TSCA which call for closa scrutiny of 2 risk and which wara in tha forafront of tha court's reversal 1 of SPA'S '79 PCB regulations. 4 Aa CMA damonstratad in its coananta, currant ( inadvartant generation of PCB doas not posa unreasonable 5 risks. Tha questions asked by tha Court of Appeals whether ; regulation of inadvartant PCBa has other than trivial health S and environmental banafits or whathar potential risks ara s unreasonable, can and should ba answered in tha negative. io EPA's currant proposal, however, has not anawarad It these quaationa and becauae it is not basad on a definite tg limit on PCB concentrations, it is- incapable of doing so. Second, tha nonquantifiable approach ia analytically unsound and administratively Impractical. FDA conaidarad usa of this approach to implamant tha "no-residue" requirement of tha Delaney clausa for animal faada, but rajactad it aa "unraaaonabla, unmanagaabla, and making no Sanaa from tha parspactiva of public health." CMA has for a long time recognised tha Importance of analytical chemistry iaauas -- developing reasonable PCB regulations. Nearly a year ago, wa submitted to EPA a report on "Analysis of Chlorinated Biphenyls" and have attempted to assist SPA in dsvaloping reasonable analytical appreachas to low-level PCB quantification in chemical matrices. j Na wara thus quits dismayed by tha serious EXECUTIVE COUBT REPOBTEBS (*t) MMM MOHS 003671 16 1 analytical inadequacies of the current proposal. We are also quite concerned about the continuing failure of EPA to make available the essential guidelines documents explaining its analytical proposals. The two docuaenta we have received were not aade available to the public until the week after consents on the proposal were due and the proaised guidelines for theoretical assessment has not been released to this day. Dr. xaley will further discuss the many scientific flaws in the analytical section of the current proposal. Third, the proposal's new requirement that any quantifiable PCS in a waste stress from closed and controlled proeeeses, even if concentrations below SO ppa be disposed of in an EFA-approved PCS disposal facility, is without justification. The existing SO ppsi cutoff for waste disposal haa never been challenged and no justification exists for ehangini it now. TO require any waste with less than 50 ppa but i* quantifiable PCSs to be handled by PCS disposal techniques would be tremendously expensive with no consequent meaningful reduction in risk. As such as a billion dollars annually a could be required for such disposal. a In promulgating the May 31st, 179 PCS rules, the M egency required PCI-approved disposal for substances containing SO ppm PCSs, rather than the previously proposed EXECUTIVE COURT REPORTERS (wi) in mu HONS 003672 17 SOO ppt PCBa. However, in taking thie step, the agency recognized the additional aconomic bordan and allaviatad it by allowing laaa stringent methods of disposal for substances containing more than 50 but laaa than SOO ppm PCBa. Tha agancy ahould now racognlza that a major part of that rallaf, high intanaity boilari, will not ba availabla for moat waata producta containing laaa than 50 ppm FCSa. High Intanaity boilara ara oparatad to ganarata ataam for a variaty of uaaa. Hinaral oil, containing traca quantitiaa of PCBa, may ba a auitabla fual for oparating aueh unita, but chamical waata atraama will not normally ba accaptabla ainca thay do not rapxaaant a conaiatant fual and may hava cemponanta othar than PCBa that could laad to unaccaptabla boilar oparationa. Bafora turning to Or. Xalay and tha iaauaa ralatad to tha analytical guidalinaa which ara at tha cora of EPh'a propoaal and of tha lnadaquacy of tha guidalinaa, I would Ilka to provide tha panal with a battar parapactiva on why PCM ara inadvertantly generated, aoma aapects of tha fata of aueh PCBa, and how tha chemicala in which thay ara contained ara handled. Traca polychlorinated blphanyla ara likely to ba termed in moat chemical procaaaaa where hydroeaxbone and EXECUTIVE COURT REPORTERS (m) hi mi HONS 003673 13 chlorine exist t high temperatures or if a catalyst such as iron chloride are present. Three basic types of reactions can yield chlorinated biphenyls. One, coupling reactions with chlorinated aromatiesi two, chlorination reactions where aromatic chemicals are present and temperature catalyst and/or chlorination is sufficiently intensive to cause aroMtization > and three, degradation reactions where conditions are such that hydrocarbon radicals are generated in the presence of chlorine radicals. In the first type of reaction, the point of coupling is well-defined and the number of chlorinated biphenyls are determined by the structure of the starting materials, for example, bis-2,4-dichlorobensoyl peroxide is decomposed under certain conditions to yield trsce quantities of 2,2',4.4'-tetrachlorobipheny1. Many variables will influence the relative yield of PCX versus the desired products, impurities, temperature, catalyst, -- effects, pressure, time, concentration, and other variables can change the relative keneties. Destruction or isomerization could occur under the conditions of various reactions. However, in coupling reactions, regardless of the concentration of FCBs, a single or limited number of congeners will dominate all others. In the second basic type when chlorinating EXKUTIVZ COURT REPORTERS (Ml) NMHI MOMS 00367^ 19 I aromatics, a substitution of chlocins for hydrogen on tha aromatic -- will follow a selectivity pattern that is wallknown. For example, whan nomal iron chlorida catalyzed chlorination of nonochlorobanzana will yield about 59 parcant paradiehlorobensene, 40 parcant orthodichlorobenzene, and only 5 parcant matadichlorobensane. Conditiona nay modify tha ratio slightly, but tha 1 basic salaction will continua to exist. Thus, several conganars may axist but a faw will dominata. To review tha analysis -- a review of tha analysis pravalant conganar ranges frost 32 parcant of tha total mixture in lower chlorinated biphenyls.to 1 percent of tha total sdxtura in highar chlorinated products. PCBs generated during incidental chlorination should have similar salactivity in tha ratio of total PCS to the nost prevalent congener should vary from 3 to 1 to 11 to 1. Fro* this, it is obvious that a 1 ppm par conganar sensitivity lialt naans that tha undetectable limit for total PCS is 3 to 11 ppm. Another chlorination of aromatic material yialdad PCS contamination with 26 identifiable congeners, but a ratio of ISO between tha moat and least prevalent conganar. Tha relative concentration of PCS versus desired chemical is EXECimVB COUHT KEPORTW (M) M14M, HONS 003075 213 subject to 11 tha iim vribl as listed bov and any single change will normally affect yiald of both tha Imparity and tha product and tha relative ratio muat than ba radatarminad. Tha third basic typo of reaction loading to chlorinated biphanyl is degradation. Catalyst, high temperature processes, or hot spots with any procass will yield a large number of chemicals and perhaps some PCBs. Those chemicals in turn degrade based on thermo dynamic stability since PCBs are quite stable, some aay survive. Sterlc and electronic effects dictate that different structures will have different thermodynamic stability. ' Tha relative concentration of reactants will dictate tha approximate degree of chlorination. Such generation may yiald many congeners but thermodynamic stability will determine that a few of these congeners will be prevalent probably in about the same ratio as it present in tha ohlorination reactions. If a chemical reaction yields trace quantities of PCBs, those impurities may end up in product, waste, or recycled stream and tha ratio of such distribution will depend on the separation technique. Ho separation technique is 100 percent affective, thus there will ^always be tome molecules in every stream. EXECUTIVE court reporters (Ml) MU--| MOMS OQlbJb 21 Th physical property difference*, namely, vapor praaaure and water solubility, will determine the ease of separation and to soma extent, the ratio of the constituents between the streams, whereas it is technically feasible to get good separation of decachlorobiphenyl from low boiling products, the same degree of separation may not be feasible for trichlorobiphanyl in products that boil between ISO and 200 degrees centigrade. Since these properties vary across the series of FCBs, separation techniques may change the congener distribution as well as the congener concentration. Xrseapaetive of separation, a few congeners will still predominate. Regardless of which of these three basic reaction types occur, the levels of PCB in final products are released to air and water during processing are in almost all substances -- instances -- very low, usually because some degree of separation has occurred and most of the PCS* are concentrated in the waste streams. As CMk has indicated in its coanents, a regulatory cutoff of 50 ppm for PCBs in products is frequently achievable, meaning that products will typically contain lese than 25 ppm. I am not sure many people recognize what a small quantity of PCBs are being discussed when I say 25 ppm. A 25 ppm concentration represents only one part EXECUTIVE COURT REPORTERS (m) sum* HONS 003677 oat of 40,000 or 0.0025 percent. 22 In ordar to dramatiza tha triviality of such concentration*, 1 vould lika to put tha nunbara in tarma more aaaily comprehended. For example, if 640 pounds at PCBa representing a total annual quantity found in comnarcial product* in tha CMA survey vara contained in a chemical at 50 *- at 23 ppm concentration and were dumped on somaone's doorstep, it might be considered by some that that person would have a PCB problem. That problem, hewavar, would ba trivial compared to the problem posed by the other 26,3(9,020 pounds of chemical on the doorstep, enough to fill ten olympie-sised avianing pools. Not only is 6(0 pounds trivial compared to the more than 26 million, but it would be almost impossible to get actual exposure to all of those 6(0 pounds given tha other 26 million that you would be faced with. Imagine for a moment that you were standing alone just outside an athletic stadium filled with (0,000 blindfolded fans. All (0,000 are trying desperately to get out of the stadium but they don't know where the axits are and two fan* ars ruffians, that's 2S parts per million, while the other 79,99( members of the mob are just trying to ,get out. You can see that tha ruffians' probability of a fast axit are minimal, but even if they did get out, the EXECUTIVE COUHT REPOATEM (*l) NHW HONS 003678 2] chance that tha ruffian wouid hava an advarsa affacc on you relative to tha probability of bain? trampled by tha othar 79,991 i na?libla. So it ia with PCBs containad at *uch low lavala in unintentionally -- in intentionally manufacture, chemicals. Carrying our example of tha tan swimming pools further, where those othar 26 million-plus pounds of non-PCX material water, there might be reason for concern about the 660 pounds of impurities. That is not the case. We are dealing with chemicals other than water. Yet, EPA totally ignores tha fact that chemicals containing inadvertantly generated PCBs have limits for handling because they are chemicals and often are also strictly regulated by the government. For example, carbon tetrachloride is one chemical for which PCX -- manufacturing ban exemption petitions have been filed. Carbon tetrachloride is already regulated by a myriad of agencies) the CPSC has banned -- its use in consumer products) contaminant levels have been set by DA for drinking water; disposal is regulated under KM; the Department of Transportation regulates its movement; OUk has sat workplace -- standards; and the Nine Safety Hasard Act regulates the chemical's use in mines. If PCBs exist in very low concentrations in carbon tetrachloride, human and environmental exposures to EXECUTIVE COURT REPORTER! (M>) MIJMl HONS 003679 24 the small amount of PCB will already b strictly controlled without a singla PCB regulation. Tha carbon tetrachloride Tabulations rapraaant an important point ignored by EPA in its proposal. Tha issus in tha currant EPA proceeding is antiraly diffarant than that addrassad by Congrass in TSCA Saetion 6(a). PCBs wara at ons tima intantionally manufacturad and millions of pounds par yaar antarad tha assassibla anvironaant. Tha absanca of adequate control on such antry was a problam worthy of concarn that should have baan and in fact, in tha last 15 yaars, has baan addrassad. Inadvertent generation is an issua of an entirely different strips. Tha issue of whether small amounts of inadvertently generated PCBs contained at very low levels in already controlled chemicals is worthy of further regulation -- of further regulatory concarn and an entirely different answer 1s warranted. Tha potential for worker exposure to PCBs inadvertantly generated at soma point within a chemical process facility is much lass than tha potential for workers servicing and rebuilding alectrical transformers. Tha low concentrations of such chemicals in process facilities automatically reduces exposure. A wide range or protection measures currently are EXECUTIVE COURT REPORTERS (J01) IIMW HONS 003600 IS 1 utilized by industry because of a need to protect against 2 toxic or corrosive primary chemicals. Food, drink, and 2 tobacco producta are frequently prohibited by the work areas, 4 employees may also be instructed to wash their hands and E faces prior to eating or smoking, , If eye contact with a toxic or corrosive chemicals . can occur, chemical showers and eye wash facilities are ( usually provided. Equipment or procaea engineering and t design considerations are also important in adnimizing the l0 potential for inadvertent releases in controlling intentional {1 removal of a chemical from a process. |2 For instance, sample points are generally designed l3 I to be easily asseasible and have appropriate purge systems. Drum filling stations generally provide for proper ventilation, pump seals and other likely leak points are generally shielded and drained to an appropriate point for clean-up and disposal. The chemical industry routinely employs spill prevention control and countermeasure eystems for storage and handling of toxic chamicale. These measures already address many of the primary chemicals with which inadvertentl; generated PCBs are associated. Moreover, the OSHA Act imposes a general duty on employers to provide safe workplaces regardless of other regulations. Therefore, additional requirements addressing EXECUTIVE COURT REPORTERS (Ml) MS4M4 MQNS 003601 i "I the low level* of inadvertantly generated PCB* art unneeeaaery. In addition, if thara bo any doubt that tha trivial quantitlea of inadvortantly gonaratod PCB* posa any riek, aavaral PCB apacific ragulatlona alraady axiat. Undar tha Claan watar Act, atrlct affluent limitation* axiat for PCB dlachargoa. OSHA ragulataa expoaura to PCB in tha workplace. PDA haa aat tolerance lavela for PCB in food, and of couraa, EPA haa eatabliahed undar TSCA ((a) apodal diapoaal 10 requirement* for PCB concontrationa of SO ppm or above. The caaa for additional regulation of inadvertantly generated PCS* thua cannot be made. The riaka poaad, if any, 13 ara trivial and not worthy of regulatory concern. It ia 14 alao worth pointing out that tha aubatantial economic coat 13 -- that aubatantial economic coat would bo poaad ware EPA to aeek -- to control unduly inadvertantly gonaratod -- 13 17 inadvertent generation of PCB*. 13 I have alraady mentioned tha tremendoua potential 13 eoat of BBA'a new propoaed requirement that any waata atraam with quantifiable PCB diapoaed in an EPA-approved manner. 30 at More aignificantly, it ia important that the agency 23 reeogniae the infeaaibility of producing of many important a chemical* without inadvertent PCB generation. The riaka poaad by inadvertent generation are to 34 (trivial aa to require no balancing of economic coat of n EXECUTIVE COUET REPORTERS (M) HI Ml HONS 003002 27 regulation against the risks to justify the absence of regulation. Nonetheless, it is worth noting that the potential economic impact of unreasonable regulations in light of TSCA's direction to determine unreasonable risk through such a balancing. Many chemicals from the complex reactions for I PCBs can be generated are engineered for unigue properties or for highly critical specialty applications. Substitution or replacement of these materials is often impossible or at best requires long-term expensive development prograau. For example, PCBs are generated in the production of phenyl-containing silicone products typically used in highly critical military and cosmwrcial aircraft, military equipment, space vehicles, nuclear reactor applications. Even if lower performance materials could be ^ substituted, such substitution would require long development programs. PCBs are also inadvertantly generated in production of bansene phosphorus dichlorida, an intermediate used in the production of a catalyst for nylon and carpeting. No substitute has been found for this Intermediate material and without it, carpet quality nylon cannot be manufactured. Withdrawal of that intermediate from the marketplace would require the producer of carpet nylong to shut down a large process line. In order to reestablish production, a producer EXECUTIVE COURT REPORTERS (Ml) MMM4 MOMS 003693 L 2a would be- forced to embark on fubitantlal and expenaive raacarch program for a aubatituta catalyat or a aubatituta for earpat nylon. A carpet manufacturar would in turn __ in turn would aithar ba foread to find a aubatituta fibar or go out of buainaaa. Thu eonaumar in turn would ba facad with raduead choica in carpat aalaction. Similar examples axiat for many othar ehamicala that contain traca PCB impuritiaa. In aach case, tha high coat of finding aubatitutaa not containing thia unintentional impurity cannot ba justified by tha minimal riaka poaad by ita praaanca. EPA'a failura to raviaw tha axpoaura and affacta data that damonatrata no riaka worthy of regulatory conearn -- that demonstrate that no riaka worthy of regulatoty conearn axiat from inadvertantly generated PCEa haa lad tha agency to propoae a rule that neither aaauraa the public that health and tha environment will ba protected nor aaauraa induatry that draatic regulationa will not hava a prohibitive impact on production of many important ehamicala. CMA thua urgaa tha cloaa and controlled waata propoaal ba withdraw and that EPA focua ita attention on an aehiawabla SO ppm regulatory cutoff that will bo more than adequate to aafeguard public health. I would now 1ika to turn tha floor over to or. Xalay who will diacuaa tha important scientific flawa in EXECUTIVE COUET MPOATEES () ui-mt ,,OHS 003684 29 the analytical guidelines lying behind EPA's proposed rule. STATEMENT OF ROBERT G. RALEY, II, MONSANTO COMPANY DR. RALEY: Good morning And thank you for this opportunity to tsstify. My nun* is Dr. Robert G. Raley. I am currently a senior Research Specialist with Monsanto Company and a member of CMA's PCS Analytical Task Group. I received my Ph.D. in analytical chemistry from the University of Illinois in 1974. Since that time, I have been employed at Monsanto in various analytical capacities. In particular, I have had over eight years experience in the analysis for PCBs. I have co-authored several journal articles and presentations dsaling with analyses for PCBs. In addition, I have served as Chairman of the PCB Task Group for ASTM Cossaittee D-19 on Mater. At Monsanto, I was initially involved in developing analytical methods for Monsanto's PCB Trademark Aroclor products in a variety of environmental and experimental matrices. More recently, I have been involved both actively and in a supervisory capacity in the development and implementation of analytical methods for the determination of inadvertently generated PCBs in various msdla. As ay testimony today should make clear, method development and analysis of inadvertantly generated PCBs is EXECUTIVE COURT REPORTERS (jm) m* HONS 003685 30 totally different and more arduoua time-consuming and analytically exacting taak than tha analyaia for conmiercially produced PC* mixtures in anvironnantal samples. In addition to developing thaaa in-houaa aathoda, our laboratory haa partlcipatad In lavaral intar-laboratory taata of PCS mathoda, including tha racant CM* round-robin. CM* has long considarad sound analytical principlas to ba cantral to tha davalopmant of appropriata PCS regulations, particularly In tha contaxt of inadvartantly ganaratad PCBa. For this raason, tha CM* PCS Analytical Task Group was formed and has developed and auhaittad substantial analytical coments on aavaral oeeaslona in conjunction with SPA'a rulemaking. ---- Wa hava appreciated thaaa opportunitias and look forward to providing additional analytical consents where appropriata. Mhila I hava included soma consents on MAI'S guideline protocols here, because of their complexity and bacausa full coanenta are not possible until tha methods hava been run on actual samples, wa hope to ba able to make more detailed eoanents later. Consistent with its past interest, CM*'a PCA Analytical Task Group has carefully evaluated ISA's proposed cloead and controlled waste rule. We conclude that EPA's proposal is analytically unsound and inappropriate. A nonquantiflabia cutoff using any analytical EXECUTIVE COURT REPORTERS (m) J4ISM4 HONS 003686 1 31 i I method will result in arbitrary and inconaiatant regulatory raaulta involving a moving ragulatory targat. Moraovar, EPA's propoaal doaa not aatabliah a validatad, workable method that can bo followed by tha analytical chemist aineo it laavaa critical analytical procedures to hia diacration. Tha only way to davalop a rule consiaeant with tha prineiplea of analytical chemistry ia to aatabliah a prevloualy determined ragulatory cutoff and davalop analytics;. methodology to enforce it. With unlimited financial and analytical resources, analytical techniquee can be rofinad to quantify lower and lower PCS amounta. Conaaquently, abaent a pravioualy specified cutoff, tha analytical .chemist has not way of determining when to stop seeking PCBa. In fact, EPA'a proposed rule and guidelines essentially specify an analytical aaarch for zaro. Using an analytical method to identify tha absence of a chemical as EPA'a proposal in reality is intended to do is an unsound use of analytical principles. The analytical chemist can never warrant that a substance is not present in a sample but only that its concentration doaa not exceed a given laval. Aa a result, a nonquantlfiabla cutoff constitutes no more than an indirect regulatory cutoff defined by the chemist himself. It ia imperative that EPA establish this cutoff EXECUTIVE COURT REPORTERS (mi) mew HOMS 003A7 directly presumably by examining the relevant hazard J2 infonaation and not indirectly through tha development of analytical methods which baar no relationship to that hazard evidence. EPA's proposed nonquantifiable cutoff reflects a lack of appreciation of both analytical chemistry's limits and the complexity of tha analytical problem posed by inadvertantly generated PCBa. For a variety of reasons which I will explore in more detail later in my testimony, a nonquantifiable cutoff provides no target for the analytical chemist. With enough analytical resources, a chemist would ultimately be able to quantify extremely low levels of PCle which may be present in matrices associated with processes unintentionally generating PCBs. Accordingly, the principles of analytical chainlatry do not and cannot tell the analytical chemist how extensively to analyze his samples as CPA seams to expect. But even if they could, because of the analytical complexity of inadvertently generated FCls, a nonquantifiable approach will have inconsistent, arbitrary, and unfair regulatory results. Substances having similar PCS level and similar exposure potentials will be regulated differently simply because of analytical peculiarities associated with EXECUTIVE COURT REPORTERS (m) hi mi HONS 003688 inadvertantly generated PCBs. 33 Moreover, a nonquantiflable approach will result in a mowing regulatory cutoff avan with tha MRI'a protocol guidelines. Our July Ith comments highlighted soma of tha irrational raaulta of a nonquantifiable rula. For example, dua to tha iaotopie propartiaa of chlorina in an alactzon impact ion aourca, monochlorinatad biphanyla will ba Bare conaiatantly quantifiable than dacachlorlnatad biphanyl and othar highar chlorinatad biphanyla. Upon alactron impact, monochloroblphanyla generate two pradoalnant ions, whila dacachloroblphanyl ganarata aix iona of 20 parcant or graatar ralativa lntanaity. This, in affact, dilutaa tha analytical aignal for dacachloroblphanyl. Aa a raault, an amount of mono will ganarata a mora intanaa aignal than tha aama amount of daca and ia consequently aora lilcaly to bo quantifiabla and thua ragulatad. Othar analytical problama exist undor a non quantifiabla ayatam. Nona of tha chromatographic ayatama doacribad by MIZ or yot dovalopad ia eapabla of aaparating all poaaibla KB oonganofa. Columna with different operational properties thus roaolwa congeners differently. For example, two different pentachlorinatad biphanyl iaomara will show two peaks on tha recomanded DB-5 EXECUTIVE COURT REPORTERS (JM) HI 0M< HONS QQ3689 34 capillary column, but only ona larger peak on a daxail 410 capillkzy. column which ia also permitted undar mm'a guidelinaa. Undar loma circumatancaa, tha larger euaralativa paak will ba quantifiable, wharaaa tha aama amount of PCBa dividad batwaan tha two paaks will not bo loading to a diffarant ragulatory raault. Evan if PCBa thamaalvaa wara analytically laaa complax, tha nonquantifiabla approach will inavltably load to inconaiatont raaulta. Sinca tha limit of quantitation ia a function of tha analytical noiaa laval of tha total aatbod which ia directly dapandant on the proportion of tha matrix, it would ba purely fortuitoua analytically if tha limit of quantitation turned out to ba the aama in any two different matricoa. Given the wide range of matricoa, liquid to aolid, aimple to complex, halogenatad to non-halogenated, limita of connotationa will atand aavaral ordara of magnitude undar IPA'a eloaad and control rula. Aa a raault, if EPA'a rule axclodaa any procoaaaa at all, it will atill include widely varying quantitiea of PCBa for regulation. Hot only will tha limita of quantitation vary widely among aubatancaa, it will alao vary over tima for any given aubatanca. That ia, tha approach aatabliahoa a moving ragulatory cutoff, significant improvement* in EXECUTIVE COURT REPORTERS (m) MMtM 003b9 *OH! 33 analytical hardware have occurred over the paat eeveral yeers. Take, for instance, the mass spectrometer. Some older models tuned for optimal operation as specified by the MK1 protocol exhibit more than an order of magnitude higher minimum detectable quantities than a newer instrument similarly tuned. Similar differences exist between older capillary columns and new ones with different bonded phases. Continued improvements axe inevitable, thus even if the protocols were precisely defined and these were no other source of analytics, variability, the regulatory cutoff would decrease as this analytical hardware is improved. Moreover, as methods and instruments are further improved, EPA's rule provides no assurance that the protocola will not be modified repeatedly to incorporate new methods with lower limits of quantitation. Such changes will nacassitata costly revaluation with aach incorporated improveswnt. The uncartainty and inavltabla inconsistency of a nonqunotifiable approach is greatly magnified under EPA's proposal since the-proposal faila-to establish a validated, workable, analytical method for the analytical chemist leaving him to datarmine the limit of quantitation on his M EPA'a proposal In the Fadaral Register, of course. EXECUTIVE COURT REPORTERS (m) MMOH MQNS 003b^1 36 does not more than *pacify the measurement technique to be used, capillary SC alactron impact, man apactromatry, leaving tha fall analytical method aa an unvalidated eeriee of nahuloua optiona. Even EPA's guideline as described in MUX's Interim protocols leava tha most critical decisions to tha individual analytical chemists and era largaly unworkable and still unvalidated. Ironically, in contrast to EPA's original proposal, these guidelines offer a choice of separation techniques, either peeked column or capillary column gas chromatography. While tha CMA approves this choice as scientificall;' justified, this new choice highlights tha great range of decisions left to tha individual analyst. This choice, like most of those left to the chemist, will affect ultimate quantiflability of certain isomara or isomer pairs. Xn addition to offering this choice of separation techniques, MXI's guidelines leave totally open the question of extraction, clean-up, or concentration procedures, max's guidelines permit dilution or direct injection, that is, no sample pretreatment at all or a choice of numerous extraction methods. The guidelines explicitly state in describing liquid-liquid extraction, the solvent -- number of extractions, solvent-to-sample ratio, and other parameters EXECUTIVE COURT REPORTERS (M) HHW HONS 003691 39 uniquely dependent on the nature of the original matrix. The other chemicals it may contain at various levels and similar factors and the limit of quantitation can only be specified after proper method validation. Indeed, in the analytical task group's experience, many.of the techniques described in MRI's guidelines have proven unworkable or impractical for inadvertently generated PCBs in organic matrices with analytical properties similar to those of PCBs themselves. The extraction and clean-up techniques suggested in the guidelines were designed for use on environanntal or other samples containing commercial PCS mixtures such aa Aroclor, Kaneclor, and other fluids. Such methods are not readily transferable to the types of analyses required under this rule. For example, an environmental matrices which normally contain a relatively small quantity of chemicals with properties similar to those of PCBs, the amount of absorbent and solvent needed in the recomsiended clean-ups to separate interferences is manageable, but in product or waste matrices in which the ratio of interferences to PCBs is orders of magnitude larger, the amount of needed absorbent and solvent is unmanagebly high. Similarly, none of the proposed extraction-clean-up techniques is applicable to tarry matrices which sometimes EXECUTIVE COURT REPORTERS (Ml) JU-4M4 HONS 003693 37 are chosen at the analyst's discretion. Similarly for clean-up, the guidelines describe sight alternative techniques but stata only that a lurrogata spiked sampla la to ba claanad up at tha diacration of tha analyat. Tha degree arid rigor or axtraction and elaan-up ara cantral both to tha ultimata parformanca and limits of quantitation of any PCB analytical mathod and to ita coat. In tha axparianca of tha mambara of tha taak group, thasa atapa in a procedure affact ultimata quantifiability by aavaral ordars of magnituda. Indaad, limits of dataction and quantitation for PCBs in anvironmantal samples hava fallan aavaral ordara of magnituda ovar tha past 10 to IS yaars bacausa of improvamanta in sampla claan-up which ramovad intarfaring pasticida rasiduas. Similar diffarancas in limits of quantitation ara likaly to axist batvaan thosa samples under this rula which ara subjected to clean-up and thosa which ara not. It is not surprising that EPA has baan unable to specify thasa mathod steps. No capillary GC electron impact maas spec method has yet baan validated for use on tha types of samples to which tha mathod pertains and many of tha suggested alternatives hava never baan triad with analyses for inadvertantly ganaratad PCBs. Proper axtraction and claan-up techniques ara EXECUTIVE COURT REPORTERS (Ml) MMM* MONS 003694 39 will have to b analyzed. Evan versa, soma of the matrices which contain inadvertently generated PCBs are themselves the best solvents for PCBs making any extraction or clean-up virtually impossible. In short, EPA's proposed nonquantifiable cutoff will have arbitrary and inconsistent results. A nonquantifiabla cutoff will result in substances with similar PCB levels being regulated differently, both because of the substantially differing matrices and because of the complexity of analyzing all 209 ehlorobiphenyl congeners. This inconsistency is compounded by EVA's failure and ultimate inability to specify the required analytical procedures. Host importantly, the nonquantifiable cutoff provides no analytical target at all thus requiring the analytical chemist himself to define the regulatory cutoff instead of the regulatory authority. The only analytically sensible way to define excluded processes is to specify in advance the regulatory cutoff, that is, tha performance standard or criteria the analyst must mast. Only a cutoff, determined primarily on the basis of appropriate health and exposure related factors gives the analytical chemist the guidance necessary to make decisions concerning necessary analytical procedures. Moreover, only a cutoff set at an analytically feasible level can eliminate tha irrational and EXECUTIVE COURT REPORTERS (Ml) MMM4 HONS 003695 40 irreconcilable results of ESA's nonquantifiabla approach. Of court*, *v*n a cutoff must b* accompanied by appropriata analytical guidelines to quid* compliance and anforcaraant. . As I suggested at tha output -- outaat -- a nonquantifiabla cutoff with no lowar limit praaanta th* analytical ehamist with an impoasibl* dilenma. As analytical tachniquas hav* improvad, analytical chemists hava concluded that it is virtually impossibla to atata that any chemical is absent from a particular matrix. In tha case of PCBs, by investing greater and graatar resources into th* analysis of any givan sample, lowar and lower amounts of PCS congeners will become quantifiable almost without limit. For example, by using sueoeasiva exhaustive and highly expensive chromatographic clean-up procedures, some samples could ba cleaned up and interfarencsa removed sufficiently to make low part par billion or part per trillion concentrations of some FCB congeners quantifiable. Since only a single congener need be quantifiable to eliminate the regulatory exclusion, tha limit of quantitation in this light is an extremely low threshold. Similarly, adjustments in tha mass spectrometer can be devised to further reduce tha limit of quantitation. Of course, tha coat in terms of time and resources become prohibitive for routine usage of such procedures. EXECUTIVE COURT REPORTERS (mi) mi m HONS 003696 41 In light of that* possibilities, whan can tha analyst atop analyzing his samplas and honastly say that PCS* are not quantifiable? Analytical chanistry itsalf provides no answer. Indeed, EPA's guidelines designed to answer this question suggest that the chemist must investigate available proceduraa and analyze hia samples until he quantifies FCBs without any limit. For example, MRI specified GC-M9 operating parameters are described as minimum suggesting that a sore sensitive parameter may, or perhaps should be used, mm's guidelines on Page B-13. The guidelines specify that simple volumetric dilution rather than extraction may be used where the PCS. concentration is high implying that alternate and continually more rigorous procedures must be chosen when low concentrations ara involved. Host significantly, in a somewhat ambiguous reference, the protocol states that upon an injection of a sample aliquot, if tha responses of any PCI ion are below the mass spectrometer's working range, recheck system performance, concentrate the sample, emphasized, and reanalyze. It is difficult to escape the conclusion that samplas ara to be analyzed using whatever procedures are necessary to detact and maasure PCSs. Indeed, EPA's proposal itself suggests the tame thing. It is apparently EXECUTIVE COURT REPORTERS () MMSH HONS 00369? 42 deiigned to exclude from regulation only thoaa procaaaaa emitting taro PCBa or at cloaa to zero aa can bo maaaurad under the moat exacting procedurea. Aa our coimnanta point out, FDA conaidared and rejected an identical regulatory aearch for zero regime aa unreaaonable and unmanageable. EFA ahould do the eame. In ahort, analytical chamiatry cannot anaver the fundamental queetion of the level of PCBa the analytical chemiat ahould aeek in hia ampler. Moreover, were EFA to attempt to define precisely and unambiguoualy the required analytical procedure, it would face the eame queationa faced by the analytical chemiat under the rule* what procedurea are auffieient? Specification of a procedure will thua conetituta a da factor, albeit variable, regulatory cutoff. Only an independent determination of the acceptable FCB lavela can begin to provide the information neceaaary to anawar the quaation of what the cutoff ahould Ed Moreover, only a cutoff can eliminate the Irrationality and uncertainty whicb are inevitable under a nonquantiflabia approach. A known epecified cutoff providea the chemiat a target toward which ha can calibrate and develop hia method*. Knowing the general compoaition of hia aanplaa and performance of hia analytical techniquea on thoaa aamplea, EXECUTIVE COURT REPORTERS HONS 003698 43 h* can develop tachniquai sensitive enough to assure that tha u* of all poatibla congeners cannot axcaad tha cutoff if it is aat at an analytically faaaibla laval. If hia product contain* lower ehlorinatad biphanyla which ganarata fawar but more intanaa paaka than tha highar ehlorinatad conganara, ha may ba abla to uaa diffarant claan-up taohniguaa to aaaura that ha would ba abla to maaaura thaaa conganara at tha cutoff laval. Similarly, if two conganara eo-alluda on hi* column, hia calculation procadura would account for thia and would ba adaquat* to datarmina whathar ha maata tha cutoff. Of couraa, a regulatory cutoff can only ba anforcad uaing analytical method*. Accordingly, a cutoff must ba accompanied by appropriate analytical guideline* both to promote uniform compliance with the rule and to guide enforcement. CMA's PCS Analytical Taak Group will gladly aaaiat the agency in developing appropriate guideline*. Ha feel auch guideline* should contain, first, a description of tha analytical method to ba used for enforcement purpose*. GC-NS technique* are the preferred measurement techniques, though ae out previous comment* show, extraction and clean-up techniques ax* inevitably unique to the matrix under study. Secondly, a description of appropriate validation criteria. Svery method must ba validated according to such EXECUTIVE COURT REPORTERS (m) in mi HONS 003699 44 criteria before ite use for regulatory purposes to ensure data reliability, validation must be accomplished on the matrix to vrhieh the method is to be applied and be performed over a range of concentrations above and below the cutoff level. Thirdly, a description of appropriate quality assurance procedures to assure data reliability in ongoing analyses. Quality assurance procedures should be adopted to assure purity of standards, to establish the performance of laboratory equipment, and to aasaas method performance criteria. Most Importantly, guidelines accompanying any cutoff must recognise the uncertainty inherent in any analytical methodology. Validated methods include a measure of variability which must be acknowledged in making regulatory decisions. Recent commentators have reemphasised this important point and I'd like to quote the following from a statement which has appeared in Analytical Chemistry by L. I. Rogers, et al. "Analytical chemical data are central to governmental and industrial decisions relevant to regulations that can have far-reaching impacts on society. When the results of chemical analysis are used for regulatory purpose, the information must be reliable and creditable from EXECUTIVE COURT REPORTER! (m) sum MQNS 003700 a aciantific point of viaw. "Analytical chaniata muat alwaya amphaaiza to tha public that tha aingla moat important charactariatic of any analytical chamical raault obtainad ia an adaquata atatamant of ita uncartalnty intarval. It ia critical that tha public appraciata tha axiatanca and natura of uncartalnty in aciantific maaauramant.' In othar worda, avary mathod haa a daflnabla praciaion which dalinaataa how tha raaulta of rapatitiva analyaaa of a givan aaaipla will vary around tha aaaaurad valua. Thia rangaof variability-ia atatiatically charactarizad aa tha mathod atandard daviation oftan axpxaaaad aa ralativa atandard daviation or confidanca intarval. Bacauaa of thia variation, ona can navar hava parfact confidanca that ha haa idantifiad tha trua valua containad in a aaapla. Bvary maaauramant ia accompaniad by a confidanca intarval. Guidalinaa accompanying a ragulatory cutoff ahould raeogniaa thia variability and indieata that analyaaa muat provida at laaat 95 parcant confidanca that tha cutoff haa baon axcaadad bafora ragulatory action ia takan. In addition to thoaa pointa diacuaaad abova, EPA'a propoaal haa cartain taehnieal daficianciaa in othar aapocta which daaarva coaaaant. EXECUTIVE COURT REPORTERS (Ml) JU-MM HONS 003701 46 Flcie, 41 noted in our comments, EPA's rule appaars to be baaad on an ineorract eoncapt of limit of quantitation. To auamariza, tha propoaal appaara to baaa quantiflability on the noiaa laval generated by tha inatrumant itaalf in tha abaanca of tha matrix to ba analyxad. Such a definition ia not baaad on aound analytical principlaa and cannot ba justified. Tha American Chemical Society, in discussing method development and validation, has confirmed this point recognising that for soma samples, relative variation due to matrix effects ia substantial. The ACS committee concluded that, and I quota, "If the field blank, actual or simulated, is not properly defined in the protocol, than the results are invalid." EPA's protocol clearly must base tha limit of quantitation on tha ratio of the signal to tha noise from the total aethod run on the actual matrix. Second, I wish to emphasise that EPA's proposal will impoaa substantial analytical costa that have net bean considered in IPX's assessment. These costs are likely to be especially onerous for small businesses with processes potentially generating incidental PCBs because they often do not have the sophisticated analytical capability or sufficient analytical resources. Our consents mention that EPA's assessment omitted consideration of significant aethod developsMnt costs. In EXECUTIVE COURT REPORTERS [m) MMM* HONS 003702 47 addition, W atatad that MRI'a method was not routina and that tharafora, EPA's aatimate of monitoring eoati may ba underestimated aubstantially. Turthar caviaw of MRI'a guidelines confizma that ita protocol doaa not conatituta a routina aathod and will ba extremely coatly to operate, in particular, the guideline: i impose quality aaauranca criteria that far exceed routine monitoring requirements, particularly where one la monitoring a manufactured substance not subject to wide variability. Moat significantly, the method requires the laboratory demonstrate recoveries from SO to 120 percent with relative standard deviation of plus or minus 10 percent. For some matrices, these are exacting costly standards if they are attainable at all. In addition, the method contemplates daily docusmntation of performance criteria and requires that 10 percent of the qualitative determinations and 10 percent of the quantitative oMasuresMnts be checked by a second mass spectrometer. Indeed, many of the industries affected by this proposed rule do not even have one mass spectrometer. These and other requireaMnts will add drsmatically to costs incurred by both industrial and regulatory laboratories for analyses which already average about $1,000 a sample. Finally and most important, era's claim concerning EXECUTIVE COURT REPORTERS (m) HI4M HONS 003703 th validation of MAX'S protocol daaarvaa comment. EPA 49 suggests that MAI's preliminary validation taata indicata that tha propoaad tnathod is applicable and uaaful for tha analyaaa of PCBa in tha matrices study. Tha available data do not^demonstrate tha adequacy of MAX'S method. Indeed, based on those data, it is premature to conclude that MAI's protocol is workable and reliable for the matrices of concern here. Until vary recently, MAI's methods had never been tasted on any matrices like those to which it moat be applied under the rule. Hill attempted to validate selected clean-up steps by analysing a mixture of 11 calibration standard congeners in an appropriate solvent. As we have repeatedly stated, validation must taka place on actual matrices since it is tha similarity of matrices to PCI that makes analysis and clean-up for inadvertently generated PCBs so difficult. Accordingly, MUX's standard solution validation says little about the performance of the method in actual matrices. Indeed, MAX indicated that tha experiment should be repeated. In lata Hay, CMA sent MAX aliquots of the samples used in CHA's round-robin for further validation work. Mhile five samples were sent, analyses of only two are reported. The extraction and clean-up procedures used EXECUTIVE COUXT REPOATEAS () MMM4 HONS 00370* are not (pacified. 49 Recovery valuea for each anelyiia are not reported either. MRI reports the average PCS level it found in samples CMA-A as 400 parts per million. This average, during CMA's round-robin -- excuse me, the average during CMA's round-robin of 25 determinations in nine laboratories, eight of which used GC-MS on that sample, was 280 parts per million. The highest value reported in the round-robin from a single laboratory was 412 parts per million using the relatively nonspecific electron capture detector. HU'a validation results for sample CMA-E were similar. KU'a average was about parts par million, twice.that of the round-robin. These results raise significant concerns about the applicability of MRI'a methods as currently written to these types of samples, especially since these are not the seat difficult matrices encountered by the CMA task group laboratories. Whatever the procedures used, they resulted in values up to 100 percent higher than those of laboratories sere experienced in these types of analyses. Consequently, these data surely do not provide a basis for supporting the applicability of MU's methods and suggest that the methods as written have potential substantial high bias which is EXECUTIVH COURT REPORTERS (m) MMM HONS 003705 significant when dealing with a nonquantifiable cutoff. 50 Finally, MRl's validation fails to addrsss perhaps ths most important considaration for this rule. It doas not specify or even estimate the limit of quantitation for these or any other samples. Limit of quantitation is not even addressed in MRl's interim guidelines. Moreover, the guidelines provide no practical information how to determine LOQ for any particular sample. Since the limit of quantitation is clearly the moat critical performance parameter for this proposed rule, it must be experimentally determined in a statistically reliable way for each individual matrix. MXI has failed to provide information on how to determine LOQ or how to validate LOQ determination in any specific saisplea. Accordingly, EVA's proposed method is far from validated and is not practically usable to comply with ox enforce era's proposed rules. MRl's protocols are, by and large, technically competent though EPA cannot assume that they are suitable for asm with its rule. But this overall technical competence ehould not obecure the fundaamntal point that EVA's whole nonquantiflabia approach is analytically unsound. It will lead to inconsistent and irrational results. It does not provide a validated, workable, EXECUTIVE COURT REPORTERS (Ml) MMN HONS 003706 51 1 enforcement or compliance method and in essence, requires 2 ach individual analytical chemist to define the level of 2 PCBs that is quantifiable. 4 Only a specified regulatory cutoff can remedy B these problems. Indeed, only a prior determination of the B permissible PCB level allows sensible decisions concerning 7 necessary analytical procedures. EPA must make this determination directly. It is unfair and surely inappropriate to shift 10 this decision to the analytical chemist In the regulated 11 industry as ths current rule does. 12 1 appreciate this opportunity to testify and wish 13 to thank the msmbers of the CM* Analytical Task Group for 14 their assistance. Ken will be happy now to addreas any IB questions. If OK. BURG13S; Mr. Guimond, Or. Cox did have to leave but I think Or. Xaley and myself will at laast try to 17 15 answer whatever questions you have. If MX. GUZMOHDs Fine# thank you very much. I'm sure we'll have a number of questions from the various 30 members of the penel. I'd like to start off on my laft 21 22 with Alan carplen. MR. CAJtpXENs I only have two brief statements, questions# much of what we'll be discussing here obviously will be of a technical nature and Z'm sure -- by the way# EXECUTIVE COURT REPORTERS (m)j HONS 003707 52 thank you vary much for your highly competent technical aciantific teatimony. want to maka ona clarification. Savaral timaa during tha taatinony, tha statamanta wara mada -- aaa if I can find tha axact paga -- that thia regulation la daalgned to exclude from regulation only thoae procaaaaa emitting zero PCSs or aa cloaa to zaro aa can be meaaured under tha moat exacting procaduraa. I'd like to point out that while EPA haa atatad that wa'ra excluding thaaa procaaaaa, a claaa of procaaaaa within thia rule, I don't beliave -- it'a not a queation of not believing -- at no point in tha regulation or at any time during thia procedure have wa aver aaid that only thaaa procaaaaa will be excluded from regulation. EPA haa alwaya maintained that wa have a third rule -- you know, wa'va talked about tha electrical uaa rule, wo talk about thia rule, and wa know thara'a a third rule. While thia rule doer exclude certain procaaaaa, we have by no naane ever atatad that it ia tha only, thaaa are tha only pzoeoaaae, or that thia rule will eatabliah a regulatory cutoff. My only queation raally, I guaaa, that I could aak that -- it'a aort of related to that and that would be auppoaa thia rule went out aa ia or eubatantially aa ia with ehangaa baaed upon many of tha coznenta and in tha EXECUTIVE COURT REPORTERS (Ml) )IJ in HONS 00370b 53 i | third rule we wars to propose or consider a 50 part par j | million cutoff, would CMA, as an association, havs objections j to that? 4 DR. BURGESS: I think -- we'va got to look at tha , two things quits separately. We have haard about potantial Rule 3, ws'va saan nothing nor haard about tha specifics of ? Rule 3. As we have said, we think a SO ppm cutoff is a , reasonable, justifiable cutoff, and what resemblance it ( bears to this rule or why continue working on this rule " if such a thing is to be a part of Rule 3 is a little hard to comprehend. MR. CARVIEM: Again, thank you vary much for your testimony and let's gst on with tha technical aspects of this. Thank you,__' -------- MR. GUIMONDi Bill? MR. GUNTER: Dr. Burgaas, I'd like to follow-up on that question. It seems to me there are two possibilities with respect to this rule that ERA could go forward with it or they could do as CMA suggests, to withdraw it, and there are two possibilities with respect to Rule No. 3, that ERA could pursue the course that CMA recommends by promulgating a cutoff or we could pursue soma other regulatory approach and I'd like to look at the various combinations of those approaches. Case No. 1 would be if we want ahead and issued EXECUTIVE COURT REPORTERS (M) MMN4 MONS 003709 54 this rule and than eama out with a cutoff in Rule 3. Casa Ho. 2 would bo if wa did not proceed with this rula and cams out with a cutoff in Rula 3. Can you axplain to ma how anybody would ba any battar off undar Cats No. 2 than undar Caaa Ho. 1? DR. BURSESSt I'm not aura what you maan by anyona. Ho. 1, wa could got at tha raal iasuaa aarliar if wo discontinued Caaa No. 1. If Caaa No. 1, aa wa hava prasumad, and I must say again, as I did in my comments, that wa think there is no benefit to anyona from Rula 2 or whatever you want to call this rula, but tha analytical thing is so definite -- so indefinite -- that maybe there'a benefits there that I haven't soon. I've heard analytical chemists, pretty intelligent people, arguing at fairly great length aa to just what analytical procedure is and what limit of quantification relative to what has been proposed is going to ba and I hava to admit that as a non-analytical chemists, I can sit back and sey that the order of magnitude that Dr. Raley was talking about frightens me but from what I heard, it's not an an order of magnitude, it's several orders of nagnituda. MR. GUXMOND: Could you speak closer to tha microphone? DR. BURGESS: I'll aim it at my -- perhaps that EXECUTIVE COURT REPORTERS (Ml) JCI-tMd HONS 003710 will -- is it better in the back? 55 now? Tasting one, two, three, four -- can you haar ma It would dapand on tha timing, on tha sequence in what is Rule 3, You're asking a question to which raally thara is no dafinitiva answar. MX. GUNTERI If Rula 3 wara cut off, would anybody ba battar of by EVA not promulgating Rula 2 as a rasult? DR. BURGESSI It dapands on what tha cutoff is, it dapands on many factors. I guoss I can turn it around. Mould anyone -- would tha affort that's going into Rula 2 hava producad any rasulta? You know, you'ra spanding time, wa'ra spanding tima. MR. GUNTERt Let aa <fo back to soma of tha origins of this rula. This rula was suggastad originally by cma in discussions that followad tha daclsion of tha Court of Appaals and now CMA saama to ba almost totally ravarsing thamsalvas. Is it baeausa you'va rethought the nattar or is thara sums particular aspect of tha way EVA is implemanting this that troubles you? I think you hava identified two of thosa issues today, one being tha nonquantifiable approach tarsus sattlng soma limit and tha other being tha disposal cost. Is it that thosa aspects are aa different from Executive court reporters (m) mu HONS 003711 36 what you originally conceived that you no longar support tha idaa or hava you had aacond thoughta about tha eoneapt in ganaral7 DR. burgessi Tha eoneapt as I identified in my testimony, wa still agraa with. I think it's probably a casa of poor conaunicatiohs between oursalvaa and tha paopla in tha agancy whan wa originally proposad that thing, l think avaryona in tha induatry racogniaad that a limit of datsction or limit of quantification would bo totally unaecaptabla. That was tha worst thing in my estimation and 1 expressed it to many paopla many tlmas, that tha worst thing would ba a limit of detection or limit of quantification. TO go with a no-regulated quantity released, and by that in my mind, I was talking SO ppm, was what we were talking -- I think it was a case of very bad miscosanunicaticn between tha two groups. Certainly anyone who has aver worked with FDA and the Delaney clausa recognised tha problem of aero. MK. GUKTERi Would CMA's objection bo at least partially satisfiad if EFA specified for purposes of this rule only numerical values that would bo approximately equal to currently achievable LOO's? DR. BURGESS I I guess I would have to review that in some detail, number one, as Dr. Kalay has testified, numerical values limited to LOQ's is going to be considerably EXECUTIVE COURT REPORTERS (m) sue HONS 003712 different for different congeners and different matrices. So I'm not sure how you'ra going to do that. In ona caaa, you may b at 10 parta par billion and anothar caaa at 100 pacta pac million. MR. GUNTERi Dr. Kalay, your testimony indicatad that thia regulatory approach put quite a burdan on tha analytical chamiat and -- much battar from hia point of viaw if thara wara aoma valua aatabliahad and than a procadura daaiqnad to maat that valua and that's tha point I'm trying to gat at. DR. BURGESSi Wall, Hr. Guntar, I hava uaad an analogy -- I'm gatting a raputation for analogiaa, I guaaa -- I hava uaad an analogy that I think ia appropriata hara for tha analytical chamiat. It'a lika tailing an anginaar daaign a car to go 100 milaa an hour efficiently or daaign a car to go as fast as it will go afficianty. Those ara two different things, orders of magnitude difference in what you're asking tha anginaar or in this case, tha analytical chemist to do, and I think here whan you say liaiit of quantification, you're asking tha analytical chemist to design a process that will do tha bast it can. MR. GUNTER: But my question was that if EPA specified numbers that would give tha analytical chamist a specific target to shoot for such as tha 100 miles par hour EXECUTIVE COURT REPORTERS () IU40M HONS 003713 AM/DP 58-5* I in your analogy, would that maat at laast soma of CMA's objections? 3 DR, RALEYi Wall, first of all, I guass it's 4 obvious to both of us that that dapands on what thosa numbars 5 might ba. I think tha answar to tha cast of tha question is 6 in cartain caaas, 1 think that would ba a banafit. Tha 7 advantaga to us would ba that it would allow us to targat our rasourcas to thosa oatricas which wa do not foal wa ara - at present capabla of raaehing a cutoff analysis in. 10 So if wa had a raaaonabla analytical cutoff or a ragulatory cutoff, than wa would hava a fsal for whara thosa raaoureas naadad to ba aioad in ordar to elaar up tha quastions wa still hava. In tha currant proposad ruls, wa hava to aaauma that all of our rasoureoa hava to ba II II 17 End Tipi 2) II appliad to all of tha samples in ordar to datansina our limit of quantitation in avary particular sampla and it's just an aconomic and analytical impossibility. 21 22 a 24 25 EXECUTIVE COURT REPORTERS (m) MJ40M HONS 00371*1 60 NR. GUNTER! On* more follow up question. You don hav* to r**pond today, but you could giv* it some thought and parhap* giv* u* your answer in raply comments. In your opinion, what should that analytical bas* valu* b* for th* various madia? I would like to turn finally to on* last point, and that is th* disposal costs that you citad. Dr. Burgess, for th* wasta generated from thas* proeassas. And, you pointed out that whan E9A lowarsd the concentration cut off for tha disposal from 500 to SO parts par million, wa specified certain altarnata, lass stringent disposal methods. Could you suggest any altarnata, lass stringent disposal methods for thas* wastes that hav* under SO parts par million PCS'a? DR. BURGESS: Of course, many of thos* wastes contain, as do many chemical plant wastes, contain hasardous substances other than PCB'a and are currently being processed as such. To go into the limit -- the available PCB approved disposal, whereas many -- it would be a problem because as I say, many of them are already going to incine rators as tha CMA document indicated and if you are talking, as your end numbers came up with 100,000 pounds of material, if all of that were going to an incinerator, which were .B MONS 003715 61 versus the 99.999 on an Amex Ons incinerator that would be required if we went to PC8 approved incineration, you are talking the difference between one pound and 99 pounds or something such as that. I didn't -- I'm not sure of my numbers, but it's not very significantly different. And, yet, the 99.9 lncinverator is in general not going to be available to us. Many of those wastes should be incinerated. There is little doubt about that. Many of those wastes should be incinerated. Host of the incinerators where they are now going are perfectly competent to handle them, are probably over 99.9. Some of them, in this case it would not make the same degree of difference, could go to landfill and be handled that way. MR. GUNTER: Would it make much of a dent in that one million doller figure if EPA defined incineration to be in any RCRA approved facility for those that do fall in the category you mentioned of being hazardous wastes? DR. BURGESS: Certainly, if soma of the RCRA definitions were included in that and those incinerators, I'm not that familiar with RCRA. I know some of those are called process units, rather than incinerators, and there are a lot of different definitions. But, that type of thing would certainly help. (ip. GUNTER: That's all I have. Thank you. HONS 003716 62 DR. BURGESS: Before I laava today, I should point out that much of that waata, which is going to contributa significantly to tha larga numbar and wa ara trying to gat a mors dafinita fix on this numbar and hops to hava it by tha tima of tha raply constants, ona of tha big problans is watar. And tha incinaration of watar is an axpanaiva oparation. It can ba dona, but it is axpansiva. MS. CAMPBELL: My first quastion ralatas to tha lssua of watar which you just brought up, FCB contaminated water. I was wondering how the costs wars increased by this regulation, since the affluent guidelines limitations arti already lower than anything wa are proposing in this rule? OR. BURGESS: But you're requiring that waste ba disposed of by a PCS approved disposal facility. And those facilities ara different than RCRA or affluent guidelines or any other facility. _____ _ MS. CAMPBELL: Okay. Tha other question wa asked in the regulation, but I was wondering if you have any data related to the numbar of accidental or unplanned releases of PCS' a and, if so, what amount of PCB's would ba ralaasad during those events? DR. BURGESS: I think tha data that was submitted in the verear report is as accurate as anything that wa would hava. relative to that. Certainly, spills -- we don't HONS 00371^ 167 1 MR. GUNTER: How would ERA manage to get 4ll of tht 2 don* before December 1? 2 MR. CERAR: You h*v* got th* information in tha 4 racord. Thara has baan a good daal of haalth affact* inform 9 ation aubmtttad to you. Tha main problam with th* currant schadul* is that *v*n with an extension until Dacambar 1, ; what you ar* going to b* doing at that point is going back to tha court and asking for a further extension on tha basis of a plan that you will ba laying bafora it at that tie*. 10 MR. GUNTER: That was precisely th* point of my it question on credibility, wouldn't we be in much better shape 12 in getting that plan and further state of mandate approved if 11 we had done exactly what we had told the court earlier that v* 14 ware going to do then if we hadn't? 11 MR. CERAR: I think that's quite true. It's unfor 10 tunate that you can't^accomplish th*_whole thing by doing 17 something meaningful at th* same time. I'm not trying to be 10 facetious there. It seems to me it must be -- I mean, I hope 10 it's possible to anaylie all of that information by the time-- 20 by December 1, ideally. 21 ut th* thing that makes a company sitting here waiting for all of this so insecure is that the court may or 22 may not grant th* extension. They have granted -- the court 23 24 issued an opinion over two years ago, or almost two years ago 21 now, and they have allowed their mandate not to go into affact EXECUTIVE COURT REPORTERS (Ml) HONS 0038l6 168 1 II and to keep coining back and asking foe morn time in a bit 1 Ipracarioua. j I MR. BLUMEt I gather that ERA has no assurancas on 4 I that acorn. MX. GUNTERi Not from tha court. ( MR. CARPIEN: Obviously tha court doaan't say what I it is going to do, but in tha original ordar, tha court broka up tha incidantal manufacture of PCRe into two diffarant rulaa asking. Ona, of coursa, is tha ona wa ara doing now, and tha 10 other ona was tha so-called uncontrolled PCI regulation. It u saaas to aw tha court wouldn't have mada that statement, II wouldn't have allowed tha rule to be broken up into that other tj I rulemaking if it did not intend to grant soma kind of stay of 14 Hits aandata, given tha fact that wa could maka tha appropriate ,, I showing. It is certainly implicit in that stay of tha mandate 17 would be, I would imagine, at least a good chance of being able to hava that mandate extended. Tha guastlon would be It how long, I think, would be our main problem. MR. GUNTERi I have ona last question, laek in UTS, you said you became aware of the possibility, tha a likelihood of public concern ovar the presence of mono- and a dichlorophanyl in your products. How did you arrive at that M conclusion? | DR. SILVAi a Wall, from a quality assurance prospective EXECUTIVE COURT REPORTERS lie) MMM4 MONS 003817 16* 1 nd tom*, if you will, anaylsis of our upstraam procassas, wa 2 concluded that tha lavals wa wara currantly running with in 3 our finifthad products could ba raducsd and should b raducad. 4 C think it was a culmination, of soma atudias wa had s going on intarnally and I think cartainly soma public raports 6 concarning tha affacts of PCBs on a largar seals. Wa took tha 7 initiative bacausa wa fait it was appropriata to ramova tha ft moi}Q* and dichlorobiphanyls that wars peasant in our procass. ft Z would lika to point out that wa do not hava any 10 trichloro or highar chloronatad PCBs in our phanyclchloro11 silanas procass and that tha mono- and dichlorobiphanyl 13 matarials ara not as long livad in tha anvironmant as soma of 13 tha vary highly chloronatad biphanyls ara. 14 However, we felt that wa could do something about 1ft tha problem and wa took that action in 197*. tft MR. GUMTERt It haa baan G.E.'s position, I baliava 17 consistently throughout all thasa proceedings, that tha 1ft Incidental manufacture of PCS should not bo subject to 1ft Section 6(e) of TSCA. If you were aware of this problam back 30 aa early as 1975 whan TSCA was being considered, why didn't 21 you try and get Congress to maka clarification that would hava 33 helped that position? OR. SILVA I think I will aak Jeff here to comment 23 24 on that. Lat me just tay that I quoted in the text, that we 2ft always viewed incidental by products whara wa had a closed EXECUTIVE COURT REPORTERS (Ml) MMM< MQNS 003810 170 system and we do have an integrated cloaad ayatan involving both incinaration and some absorption type of procaaaaa* Wa did net anticipate a ban baaad on incidental by producta. MR. BLUMS: I can anewer that guaation to the extent wo are able. Neither Mr. Cerar nor myself were around in that era and w can only epeculate at this juncture, ao I don't know that we can give you any kind of meaningful response. MR. GUNTER* If there are others around who were around during that time, perhaps you could give somathing during the reply consents. That's all I have now. Alan? MR. CARFIEN* I have no questions. MR. SMITH* Since I am Involved withsampling, sampling relies quite a bit on the variability of the system and I have heard statements this morning about folks feel that you gat relatively the same isomers in patterns. My question is, from your analytical experience with your system, do you see homogehiety in your, if you will call it contamination or side reactions, or as you get slugs, what I would call slugs of VCBs? DR. SILVA* Well, as I mentioned earlier, we have spent a considerable amount of time and money understanding the chasdcal reaction with the intent of trying to reduce the amount of PCBs generated. Wa have obtained information which indicates that in our particular system it's essentially e steady rate of production and that the isomer content does not EXECUTIVE COURT REPORTERS (m) im mi MQNS 003819 1 chang* appreciably. 17'. 2 As I mentioned, w hava moncchloro and dichloro- byphanyls. Thar* la no triehloro matarlal. Tha monochloro- . nd dlchloroblphanyla I an aura you could gat out of a atandarc f taxtbook, would tharafora glva you nlna poaaibla laomara. Wa aaa all of thoaa nlna laomara. Wa undaratand tha ratio* of 7 aach on* to tha othar. Wa routlnaly analyz* for aaeh ona of thoaa nlna laomara. t MR. REDFORDt I would juat Ilka to gat your raaetlon 10 to tha analytical mathods that SPA la proposing as In tha MR! 11 docuaiant. 13 OR. SILVA: You ara talking about SC Mass Spac, Is 13 that corract? 14 MX. REDFORDt Yaa. IS DR. SILVAt w* currently us* GC Mass Spac to do many 10 of our analysas. I think It's what I would faal comfortable 1? with In tarma of soma of tha analysas that w* do In cur 10 facility. I think, contrary to soma of tha comments that war* IS made earlier, that the level of detection or, if you will, tha 30 L00, or whatever you want to call it la going to change 31 continually over tha next decade. It haa over tha past dacad*. 33 I think GC Mass Spac givas us soma vary good answers 23 now and I axpact to aaa more techniques coming along that will 34 taka that even further. I think that's tha real concern on 2S LOO or laval of detection. In a sans*, if you go by level of EXECUTIVE COURT REPORTERS (Ml) IU-MU HONS 003820 172 detection, you are going down even lower Chan loo, becauee oat analytical chamiata will tall you they naad a little bit ora laval of detection to be able to quantify what you have. I think we are aakinq a lot of our ehaaical engin eering people aa we move down and become more eophietieated in our analytical techniquea. MR. REOFOROi Thank you. II 1* It 21 21 22 2* EXECUTIVE COURT REPORTERS -- () JM~- MONS 003821 173 MS. KEEHHER: If ERA modified it* definition of controlled w*te procees and *et the cut-off for product* at SO part* per million, could you qualify for the exclusion? pleaae? MR. BLUMEt Repeat the question one more time, MS. XEEHNER: If ERA modified its definition of a controlled waste manufacturing process and set the level for no PCBs at SO parts per million in the product, could you qualify for exclusion under this rule? MR. BLUMEi It's still zero quantifiable with respect to the manufacturing process and waste streams? MS. XEEHNER: Zero in air and zero in -- well, no quantifiable in air and no quantifiable in water releases. OR. SUVA: I think the definition of no quantifiable would get us into a discussion immediately. I think that's, again, the problem. Zero is a very low number and maybe that's the intent. However, from a reality position, I think we need a definition of what zero means. MR. BL0M1: And I gathered, Or. Silva, you are referring not only to the GE system, but virtually any aysttm if you are going to test it in terms of zero quantifiable. OR. SUVA: That's correct. I believe that EXECUTIVE COURT REPORTERS (Ml) )U40M HONS 003822 174 whenever you can talk about ona molecule escaping from a system, you'va violated zero. I think thara ara paopla who try to intarprat tha law in that aanaa. avan though it might not ba tha intant of tha law to count tha molaculaa that laava from a procaaa. I think that would ba tha difficulty that induatry and'General Electric would have with a atataaiont of no quantifiable from a cloaad ayeteai. MS. XXIHMZA: How would you dafina manufacturing procaaa, a product and a ralaaaa for purposes of your system? DR. SLTVAi Hew would I dafina -- lat me taka tha first ona, a product. ` MS. XHZHMSRi A process, could wa try that first? DR. SUVA: A procaaa. MS. XnHXSRi Right. DR. SLIVA: How would I dafina a procaaa which would ba inadvertantly producing PCRs, is that -- MS. RZtHMERi Yea, I am concerned about, for instance, maybe you have more than oris building on a site or a plant and you are moving things from building to building. What is the process? Is tha process tha first step in a multi-stage, or would you consider everything -- DR. SUVA: Most chanleal processes do not taka EXECUTIVE COURT REPORTERS (mi) mss HONS 003823 173 t*k* pltc* in on* particular vsl and ara connactad by pipes. In some eaaas they ara connactad by the movwant of bank wagon*. Our procaaa doaa con*lit of savaral steps. It doaa taka plaea in ona or more buildings and is connactad by a piping ayatan. MS. KZZHNERi So you would eonsidar that to ba your proeasa. OH. slivai I would call that tha intagratad procaaa for tha manufactura and control of phenyJLchlorosilane. MS. KZZHNSRi How about ralaaaas such as to watar and air? Do you conaidar ralaaaas -- DR. SliIVAi All our vants and all our points of ralaaaa ara catagorizad and hava undargona both a theoretical analyaia, and I'll connent on that in a minute, and an actual empirical analyaia of what those amissions ara over a pariod of time. Thare ara protocols for those teat procedure*. I do not knew what the results ara, ether than that wa did present in a If79 exemption petition soma data relating to workplace monitoring. In regards to tha theoretical calculations, ona can calculate -- can quantitatively measure with QC mass spec what tha concentration of FCBs ara in the materials EXECUTIVE COURT REPORTERS (Ml) MMN4 MONS OOidi'* 17* join? to tha vents. We call that theoretical bacausa we back-calculata based on what va'va found in tha environment and ask ourselves ia that reasonable. In moat easaa tha matarlal balanca did check. ms. KEEHNEXi I hava no furthar questions. MX. GUNTEXi Follow, up anyone?. Thank you vary much, gentlemen. ' This couplets* tha achadulad agenda of partleipanta and, ainea thaxa ia tin* remaining bafora tha and of tha day, is anyona alsa prasant who would lika to mako a atatenant for tha record? Ho hava an opportunity to hava that at this tlma. (No response.) - MX. GOWTEXi This hearing is closed. (Whereupon, at 2:52 p.m. tha hearing in tha ahova-entitied matter was concluded.) + ++ EXECUTIVE COUXT REPOKTEXS (m) NHM* HONS 003825 WORTS*11 C1RT1MCATI DOCKS? HUKRSRl CASS TITLSi Closed and Controllad Waste Process Rule HSARIWC DATS i July 2, 1911 LOCATION I Washington, D.C. I hereby certify that tha proceedings and evidence haraln ara centainad fully and aeeurataly on tha tapaa and netaa raportad by mu at tha hearing in tha abovo case bafora tha Onitad States environmental Protaction Agancy . and thut this la a trua and cermet transcript of tha same. Datai July 27, 1912 Official Reporter executive Court Repertara IS2S Colasvilla Read Silver Spring, Md. 20110 HONS 0030^6 63 have any hard data, but -- and, I think they treat that quite fairly. They didn't really deal with explosions. Those are such infrequent thing* that we don't have good itatittic* on it. Certainly, it'* something we try to avoid rather vigorously and when we have an explosion, the problem is usually not the PCS'*, the explosion of PCB's: if you have an explosion, you have a number of elements that you have to take care of, people injured by shrapnel, people burned, something such as that, and you have a clean up procedure that you have to go through, whether there are PCB's there or not. But, the frequency of such things is so de minimis that I don't have good data on that. MS. CAMPBELL: I would also be interested in the type of proteetive clothing and the kind of material in the clothing used during the times of worker exposure that were indicated in the CMA submission. DR. BURGESS: It will vary with different plants and different chemicals. If -- and, it i* primarily aimed at the primary chemical. The protection will be aimed at the primary chemicals. Most plants will have procedures for so-callsd hazardous operations as line opening", if you are going to dn a maintenance job and have to open the line. MOMS 003718 Tha normal requirement there would be fact shield, as wall at, in most, just common working, you would hava aya protaction and probably gloves. If you act handling waats streams, normally you ara going to hava glovas on. Varsar, avan though thay found tha axpoaura quite small, did atsuma that that axposura cams from tha fact that anyona handling wasta had both hands constantly wat on both sidas during tha antira oparation of handling wastaa. I would cartainly hopa no ona would praetica that, whathar you wara doing it yoursalf or asking seasons alas. That typa of thing would not ba dona. Cartainly, soma nomax clothing in seaa casas, if thara is hasard from firs from tha primary chamicali, but vary littla of that would ba aimad at tha PCS. It would ba aimad at tha primary chamicals. MX. GPNTEXt Amy Moll? MS. MOLL! You continually cits in your analysis tha fact that EPA should call for a mathod valldiation and also that EPA undarastimatad its costs bacausa it did not lncluds tha cost of mathod davalopmant and mathod validation. You probably don't hava figuras on tha tip of your tongua, but if you could provids ua with soma astimatas of tha coats of mathod davalopmant and mathod MOMS 003V19 validation, that would b helpful to ua. 65 DR. BURGESS: Wall, obviously, tha mora validation: you do on tha mora streams, tha aacond ona ia not going to ba aa expensive aa tha first, but it ia atill an axpansiva procedure. Rob, did you want to hava any comment or should wa juat commant in raply commonts? DR. RALEY: Wall, I think primarily anything mora apaciflc that wa might hava to aay will hava to ba in tha raply connanta. I think wa did maka aOaa limitad information availabla in conjunction with both our first submission, "Tha Analysis of Chlorinatad Biphanyls* and in tha raport on tha round robin axparimant. And, I'm not aura wa'va raally got anything battar than that. Wa hava diacuasad thasa issuas at our various maatings and it bacomaa difficult bacausa, frankly, wa don't know what it is going to taka to validata a raathod such aa proposed in tha variety of matrixes that wo will hava to encounter. And, tha limitad quantitation issue just makes even mora critical, because our validation, instead of being soma relatively workable level, like SO parts par million, has to -- essentially, to bo dona right, extend below our limit of quantitation and we're raally not sura how to HONS 003720 address that at this point. 6f I will taka down your question. w will do our baat to gat soma mora -- gat soma firm anawart to you In tha raply constants. MS. MOIXi Oo you feel that tha method will have to ba validated on every single different process that wa encounter? DR. RALEY: Yes, wa definitely do faal that. MS. MOLL: Okay. DR. RALEYi That's one of the primary issues of my testimony, is that validation must bo on tha matrix of intarast. So, for ovary regulated or excluded matrix, wa will have to have a validated method. DR. BURGESS: Your question there, you use tha term process; wa usa tha term matrix. They may be analogous, but thara may be situations where they aren't also. MS. MOLL: Okay. You cited. Dr. Raley, you cited tha potentially large burden on small businasaes, that could result from this rule. Do you have any idea as to tha number of small businesses that might bo affected? DR. BURGESS; I think it would bo pure speculation. Versar has listed tha processes that, although I'm not sura that that is comprehensive, but it MQNS 003721 67 would be pure apeculation to 90 beyond that liat chat Versar ha alraady compllad. MS. MOLit Okay. And, I hava ona mora follow up on Bill'* quaation. Ha askad you about auggeationa foe dastructlon of PCB'a In concentrationa balow SO parta par million. Onca you'va coma up with that auggeation, can you giva ua any idaa aa to tha diffarancaa in coata batwaan tha methoda that diacharga aaeh of thaaa in concantrationa graatar than SO pazta par million and thoaa that you might auggaat ara laaa than 50 parta par million? DR. BURGESS) Hall, I think tha main thing thae wa ara looking at, tha laat figure that 1 heard for daatruetion of PCB'a in an Anex One incinerator waa around 60 canta a pound and that ia what ia quoted in our conmanta. That certainly ia a figure that ia much higher and whether it'a 5 tinea higher or 10 timea higher than incineration of normal waetaa, but I think wa'ra talking in that ballpark, that moat waataa can be incinaratad for -- maybe it's aomawhare batwaan 5 and 20 canta a pound, although water ia unique again. Whareaa, tha Amex One commercial inclnaratora ara, tha laat I knew, were quoting about 60 canta a pound. MS. MOIXi Okay. That'a all I hava. MR. GUIMONni Okay. I hava a few quaationa. HONS 003722 6S It I understand your testimony today and soma of the comments that you made pravioualy, you'd prefer that we withdrew this and then went out and said that inadvertent PCB's ere not covered and, therefore, exclude everythin? on that basis. And, in the alternative, withdraw this and put a SO pom cut off. Am I correct? os. BURCtsS' Yes, 1 think w feel that thin proposal is -- you are takina your reeourees and ours awav from the real issue of what is the risk to incidental generated PCB's. MR. GUIMOND: Okav. If I take that first option or proposal of yours and withdraw this and propose that Inadvertent PCB's not covered by TOSCA. how would vou define inadvertent PCB's? DR. BURGESS: I haven't oiven specific thought to that. We are having a eenel meeting tomorrow. Basically, it i those PCB's generated -- maybe vou oouid ue something like th* PDA has in their constituent pollcv that have no function in the oroduct. They ere not there for any preferred properties. They are unintentional, thev are unwanted in aeneral. we would be glad to ait down and work out some kind of -- MR. GUIHOHD: Would you envision something that was regardless of concentration or amount or something, -tust HONS 003723 69 a I0119 aa you don't want it, it would oualifv aa uninrsntional? I DR. BURGESS' I think that thos* eaaaa that wo ara awara o today, concentrations ara extremely low. I know -- at ieat that T know of. I know of no aituation whara wa'ra talkinn percents of prB'a. Certainly, in that aituation, if aomaona eonaa alon9 and ia going to aall a product that ia 49 parcant and call that inadvertent, 1 guaaa probably wa ought to dafina that out obviously. HR. GUIMOHDi Okay. That, I think, ia ona potential problem, is a definitional issue. But, in any avent, -- okay. Than, if I -- your second altarnativa than, which was, okav; withdraw this, out a 50 ppm cut off or somehow pul one 50 ppm out off, wherever possible- then on paea 8. in your comments. I noted the last paraaranh on the pace, it says, "Due to unique circumstances of this procaading, however, another course is open to ERA. CHA would be prepared to support an approach permitting PCB's and eloaad processes and in waste streams, disposed of under era's PCB disposal requirement, providing that there were a regulatory cut off of at least SO ppm for products in waste streams*. Am I to interpret that, that you mean that you -- HONS 00372"* 70 is thia the same alternative as your overall 30 ppm or ia It third altarnativa in which you would aay if va wara to daflna cloaad ayatama ao that it was defined at 30 ppm and products and waata straams qualifiad you, that that would ba accaptabla to you? DR. BURGISS: Basically, it*a going back to tha original coneapt which waa diaeuasad with with obvious miaundaratandlng. Tha currant rula, if you havs in a racycla atraam, a thousand pasta par million, you must gat an axamption for that procass. It is still, I think -- as long as that's in a racycla atraam, it's going around a pips, it novar gats out. So, if tha product and tha waata ara bales so, you don't have any raal concern about what's in that racycla atraam. Ha maintain no, that those isn't. So that wa ara still intaraatad in getting that racycla atraam or any at tha bottcai of a atill or acne -- MR. OUlMOHDi I guess what I'm driving at here is that if you recall tha proposal that now slta, it sits that it la non-quantifiabla for affluents, amissions, for wests products, waste straams to ba closed and controlled. And, than, for control, you can dispose of tha waste, as you have said in there, and than you could qualify 0037/5 HONS A* I read this, if you're sayin? that if va change j tha products and wastas portions of that dafinition, to stats that 50 ppm numbar for thosa two portions of tha dafinition. that would ba accaptabla to you, is that corract? OR. BURGESSi Basically, wa ara saying no, if tha amissions ara not abova a ragulatad laval, whathar thay ara in product or wasta of air or water; tha amissions ara not abova a ragulatad laval. That is what wa hava thought wa wara talking about a yaar and a half ago. MX. GUIMONOt So, wasta straams, too, means mors than just wasta; it maans affluants and amissions, too, is that corract? DR. BURGESSt I think wa'va got to look at tha antira -- whatavar is coming out, ralativo to sxposura. MR. GUIMONDi Okay, okay. So, you maan 50 ppm all ovar, this is not a subsat. what I was trying to dataxmina was whathar you wara talking about a subsat products and wastas as opposad to affluants and amissions. You maan tha whola shabang? DR. BURGESSt I'm talking about ragulatad guantitias baing dissipatad into tha environment or for exposura. . MR. GUIMONDi Okay. Thank you. I guess I'va bear a little bit puszled and trying to answer the guestion MOMS 003726 72 myself, as to this mlsunderstanding that we apparently have, and I want back and took a look at tone of the historical information that ve'va had hara relative to this,, and if you taka a look at tha EFA submission to the Court back in January, I guess, of '81, on page 18 of that, there la a saction that atatas, this was dona subsequent to discussions wo had with yourselves and a variety of other groups, "The industry representatives participating in the discussions of the SPA and SOP believe that most of the PCS's which are generated in concentrations below SO ppm are generated eithat in closed chemical processes in which the PCS'a are both generated and destroyed, to tha present levels of detectability, within the processesv without ever leaving ( the closed process (closed system) or in chemical processes where any PCS'a are removed from tha process as wastes which are either incinerated or disposed of in EPA approved landfills or stored for such disposal (controlled wastes).' "Same chemical processes may produce low concentretione of PCS's which are released to the environment, appear in the final product, are disposed of in non-SPA approved landfills or by other disposal means (un controlled releases). These are thought to account for a much smaller portion of the total generation of PCB's below 50 ppa". You know, wo hovo sort of boon oporotlng for Ion; OO*1*1 73 period of time that that'* tha way w thought tha world was and so. from tha standpoint of what I haar you saying in your conmants today, you ara indicating to us that, in fact, tha ravarsa is trua, vary faw procassas would qualify for closad or eontrollad wastas as prasantad thara and most would fit into tha othar catagory. Is that corract? DR. BURGESS I I think two things hava happened; wa hava laarnad mora about our procassas. also, tha fact that you hava baan working on tha analytical nathoda and wa hava baan working on tha analytical methods, and as Dr. Kalsy has indicated, analytical, methods move, I think wa know a lot mora how to analyse for things today than wo did IS months ago whan wa were talking. I don't know whether the limit of quantification has baan cut by a factor of 2 or 10 or 100, but I'm sure that tha limit of quantification has gone down and wa certainly know how to quantify at lower lavals today. wa also laarnad mora about our procassas and I guess, again, I think thara is soma misunderstanding and I can't argue with what you hava written because I haven't read it. But, thara certainly was considerable emphasis that we could not go to a detectable limit. At tha time one of the orders was to be written or was being written for the Court, the word datactabla PCB showed up in tha thing and MOMS 003728 74 r a I wa had a considerable emergency in trying to gat some of tha 1 CM* paopla to go talk with tha paopia, your paopla who wara 1 3 writing that to try and gat tha word datactabla out of tha 1 4 document. 1 8 I think, aa I say, it'* an unfortunate eaaa of 1 miaundaratending. 1 7 MR. GUXMONDt Okay. If, again, I understand your 1 a testimony, you indicated that you fait vary few -- this 1 i exclusion proposed rule would have vary little good ainca 10 few, if any, people would likely qualify. n OR. BURGESS> If we understand tha analytical, I 13 think it ia technology forcing, if wo undaratand it - correctly and that the limit of quantification is going to ha t 14 considerably different. 1C As Dr. Raley said, you give those analytical 1C chemists enough money and enough time and they can change the 1 limit of quantification. 1s 17 MR. GUIMOHDi Me have received soma comments, that I" 1 soma people have fait that they baliava they may Qualify for i | this. But, to pursue your question, than you did indicate j * further that the costs associated with tha proposed rule woul. 1 i ,, be very high. a If few people are going to qualify, obviously, them would be no reason for them to try to take advantage of the H a exclusion, so they would have no cost in doing that, would tin1 HONS 00311^ ba corract? 75 DR. BURGESS I E x cuaa ma. I don't -- MR. GUXMOND: Mall, if you don't think you qualify for thia, you'ra not going to undartaka an axtanalva monitoring program or thaoratical aiaaaamant or what hava you, whara you anticipata tha coat ara going to ba, to ahow that you qualify for thia. So, in fact, thara would not ba high coata if, aa you indicata, that thara would ba faw paopla qualifying for tha thing. DR. BURGESS: Hall, if you ara raady to aay wa will fila for an annual axamption, thara ia graat lncantiva to not hava to fila for an annual axamption. Cartainly, if you wara raady to aay wa ara juat going to fila for an annual axamption, than all your coata ara involvad with filing for tha annual axamption. Thara again, wa gat back to what ia Rula 3 going to aay? And, I hava no idaa. I hopa at aoma point wa find out. MR. SUIMONDi So, you'ra aaying a lot of paopla would raally lika to ba abla to qualify for thia and ao tha eoafea would ba involvad in trying to aaa if thay can poaaiblj dataralna whathar thay could qualify? DR. BURGESS: An annual axamption for an on-going chamlcal procaaa la vary onaroua. MR. GUIMOND: Okay. So, again, if I intarprat HONS 003730 76 that, you would indicate that a lot of paopla, bacausa of tha onarouanaaa of tha annual axanption and tha uncartainty aaaoelatad with Rule 3 at thla a tag*, would vary much like to try to qualify for^thla axcluaioju If thay fgaaibly could, and, tharafora, would undartaka a conaldarabla monitoring affort to aaaura thamaalvaa or to try to qualify? OR. B0RGES8: Right. Again, it'a dapandant on what happana with Rula 3. You could gat halfway through it and find Rula 3 took cara of you. HR. GUIMOND: Tha -- thla is a quaation for aithor you or Dr. Xalay, I'm not quita aura which ona of you would want to taka it. Right now, you had indicatad torn* problaai aaaoclatai i with -- throughout your tastimony, problaata aaaoelatad with tha dataetion of tha PCS'a in difficult madia, tar, aolvanta, what hava you, and what I'm wondaring right now la what tachniquaa ara paopla uaing to inaura complianca with SO ppm? Ara thay having any problama with datacting tha SO ppm datactabla avarywhara? OR. RALEY: I can anauar tha laat part of your quaation, and than I will lat Ran addraaa tha_aacond part, bacauaa I, frankly, don't know tha anawar. Tha trua ia that no, 30 parta par million ara not datactabla in aoma matricaa. Tha aubmiaaion wa gava EPA HONS 003731 77 1 concerning the "Analytic of Chlorinated Biphenyls* showed an 2 example of actual chromatogram* where, I believe It was one 3 hundred parts per million spike into one of these tarry. 4 crumby matrices that in essence showed no detectable peaks 1 above baseline for the PCB's. Thie was 100 parts per million total PCB's. 1 7 don't frankly know what the individual congener concentratioi 1 might have been. There certainly are matrices where these 1 problems exist, and what is done with these matrices, to frankly, I don't know, after the numbers are reported. 11 But, certainly, we still report numbers, non12 detected, less thairlOO parts per million. That type of IS thing, okay. Let me -- our plea for a cut off is that 14 let us have our resources to go after those hard problems, 11 so that wo can try different waye of cleaning up or separati> It or whatever for those difficult problems, so that we can holt 17 our engineers or our environmental people make those It decisions wisely. It MM. GUIMONDt Okay. How, -- so, 50 ppm is not -- 20 you cannot detect it in certain difficult media at the 21 22 OR. 8URGISS: I think that's true. 23 DR. KALETi That's true. Tou are basically 24 dealing with waste etreame when you are -- 21 MR. OTIMONDi Processes, too? HONS 003732 79 DR. BURGESS i 7hr m*y b om -- i*ra n0 familiar with th*m, hut thara may ba soma fairly complax processes where it's inside the equipment. Certainly, the 5^ ppm cut off has baan technology forcing and continues to ba. MR, GUIMONDt Than, but if I understand you correctly, you are willing to accept that? DR. BURGESS: That's what wa have proposed, yes. MR. GUIMONDt In which case, you -- what would be the net result, either now you would have to develop method ology to ba able to achieve that or, secondly, you would Jua^ well, we can't find it, it's not there, SO ppm? DR. RALEY: Well, there is another alternative in which -- you know, hopefully -- I don't want to apeak for anybody, but at certain points, you would assume that th^ PCB's might be at a higher level and treat that material as if they were PCS contaminated. I don't know. MR. GUIMONDt Okay. On some kind of a theoretical basis or something? DR. KALE?: Well, if you would expect that PCB's might be in that type of matrix. MR. GUIMONDt Okay. DR. RALEYi i mean, in general, we signals, if we cannot define whether that signal is or is not a PCB, then, you know, we have to almost assume that the PCB's could be in there, up to that limit of quantification. HONS 003733 79 DR. BURGESS: I think I would like to juat add to what Dr. Kalay haa aaid. I think tha product straams and anythin? that ia bain? diatributad haa baan pratty wall workad out. Wa mayba daalin? in tha question of 50 ppn which is fairly conplax waata atraama, most of which ara bain? handlad accordin? and to tha bast of my knowlad?a -- obviously thay ara all complyin? with tha law, ao thay would ba handlad, whathar thay ara 50 ppm or not. Thay would ba handlad as a PCB straam. Stuff in tha proeass, for thoaa paopla who hava not -- who hava filad for an axamption patition, thay may hava filad not knowin? whathar thay wara at 40 or 400 and still fila for tha axamption patition. A?ain, I can't spaak to that typa of thin?. But, aa Dr. Kalay has indieatad, that ia an option that you hava, rathar than tryin? to pin down ara you at 40 or SO or 60. You could cartainly fila for tha axamption patition, rathar than -- bacausa -- parhapa tha likalihood is hi?h that you ara ?oin? to ba thara anyhow. NX. GUIMOND: Okay. You indieatad in your taatianny today that you did not baliava that tha propoaal wa had provided any additional public haalth protaction. I ?uass my question is how would your proposed solutions provida additional public health protection than ours does now? MONS 003734 90 DR. BURGESS: I think our comment, ac least what j I meant to say, la that wa hava not justified -- thia propoaal doesn't do any calculation as to whether the public health is protected to a greater extant or not. what we need to do is to do a risk assessment on the incidental manufactured material and what happens to it, what the exposures are, what the health affects frost such environmental effects are, and determine what Is an unreasonable risk. MR. GUIMOND: Okay. Also, in comments, written comments, you indicated that you did not believe anyone would take advantage of the theoretical analysis that we have made optionable. Everybody would go out and monitor. In fact, today, aren't a lot of people taking advantage of the theoretical analysis as opposed to SO ppm? Everybody going out and measuring to see if they are under 50 ppm? It was my impression from talking to a lot ol industry people that a lot of people axe saying 1 or SO PPm- So, in essence, they are doing that theoretical type of thing as opposed to anything more than that. I mean, as an example, your own data -- an example of your own data from the survey that you sent to us, much of the data in there was not data reported from monitoring results, but was data reported from theoretical calculations that HONS 003735 81 people did indicating that thay, in fact, fait that thay nay vary wall generate aoma PCD'*, but thay did a calculation and it vat, you know, wall undar 50 or vhatavar. I'm trying to aaa what -- OR. BURGESSi Calculating aa to whathar you ara moating SO ppm requirement* or whathar you are moating a quantifiable limit, ia two different thing*. I *u*pact also that your definition of a theoretical calculation may b different than our* and wa have not aaan yours, so wa can't compare them. A* to whether or not anyone would taka advantage of it, ia certainly going to depend on what ara the limits of such a theoretical calculation. MX. GUIMOND: X would anticipate that the Individual procassos would probably be as noted in your particular data you submitted to us, ara in the best position to run their own etychiora*try and their own calculations out -- OX. BOXGSSSt Whan you ara dealing with quantifiable level* in tha part par million range, stychiomatry isn't of much halp. You know, I can account for 9*0,000 pounds, 999,999 pounds and I've still got a hundred pounds, a hundred plus million out there. You can't even pump liquids with that kind of accuracy. MX. GUIMOHD: But, wouldn't that give you the MOMS 003736 ' same problem at SO ppm than tha other? 82 I 2 OR. BURGESSi But, we hava a tool than, we have 3 tha analytical chemist has (aid with some effort, wa can cat 4 theaa analytical thinga worked down to where wa can determine S SO part per million. 9 MX. GUIMOND: okay. Then, to pursue Just a little 7 bit more one point that Bill was talking about earlier, is that you do make a very significant push for quantifying 9 something, getting you a target, seme number to shoot at 10 here. And, do I hear that as, you know, SO or not, some n particular number other than a real embarrassment in trying 12 to go and find a specific number that we can give you that 13 is going to give you not necessarily a 100 percent assurance C 14 that you're going to beat it all the time, but a target to 19 shoot at frequently, since even SO ppa doesn't give you the 19 100 percent assurance? ! 1 17 OR. BURGESS: From an analytical standpoint, if you havm -- if tha analytical chemist is assigned the Job !* of coming up with a method which ia sensitive to some t i . limit, that is vastly different than being assigned the job of defining what is quantifiable. - a MX. GUIMONDi You don't mind working hard to find a the stuff, you just like to make sure how hard you've got to look or exactly what you're got to look for, is that right? 24 "... a DR. BURGESSi Well, I think if we look at the MONS 003737 S3 definition of significance, perhaps that's -- we hata to keep looking at something that Is insignificant. Obviously, at some level, PCB's, like most other chemicals, the exposure is insignificant. Let's find out vhat is significant and what isn't. Let's find out what represents an unreasonable risk and aim our efforts at controlling those unreasonable risks. MX. CUIMONDi Okay. I think I asked you this question during our lunch period, but I'll ask it again relative to this. You just mentioned significance here. With respect to the type of things we're talking about, what are -- are there any significant exposures? DR. BURGESSi Of the chemicals that I'm aware of, I don't know of any that I consider to be a significant exposure, to the PCB. Again, you've got -- in this situation, you have two separate risk factors involved, one is the exposure to PCB, does it exist in the toxicity and that tvp< of thing, but you also have the relative hasards of exposure to the primary chemical. And, you know, drinking chlorobensene with or without PCB is not my choice regard less. MR. CUIMONDi So, you're saying that the fact the ; PCB is in most of the stuff, doesn't change the hazard HONS 003738 84 associated with on* iota and, therefore, forgat tha PCB'a. DR. BURGESSt I'm aura that in moat ot tha situations, PCB'a ara wall balow SO ppm. But, chlorobanaana, carbon tatraehlorida, tha chamicala that wa'ra talking about, at S00 ppm, PCB doaa not rapraaant a riak. Tha chamical -- we'va got all kinda of handling techniques for thoaa chamicala and tha chamicala ara tha problam, tha ralativa riak from tha PCB is axtramaly small, da minimis, whatavar you want to call thoaa vary small numbera. MR. GUXMONDi Okay. Thank you vary amch. John? MR. SMITH) No ona has raally spokan that much about aaaqpling hara. My quaations ara related to sampling and since no ona has raally spokan about thaai, you needn't answer now, but perhaps in the reply comments. EPA has proposed a sequential sampling schema whiel involves sample collection from randomly selected locations, at randomly selected times, within tha nrocesa cycle. Could you describe the procedure you would use to select samples to represent a process? Include the maximum number of samples that you would select to rapraaant a process and why you selected this number, exactly how you would select the sites and times for collecting these samples, and the sample volume or waste you would collect for air, water and other matrices. DR. BURGESS) Could -- in late late week, in tryimr 003739 MONS to discuss tha sampling documents that we received, thara waa obviously soma misunderstandings and questions aa to what it really maant, and wa dacidad wa could not addraaa it at this tima bacausa wa just didn't hava it taaolvad. Your quastion sounds rathar compla* to me, at laaat. Ha can cartainly attempt to anawar that quastion; wa could hava it in writing, it would ba vary helpful. MR, SMITH; Fina. That's all I hava. MR. GUNTER; Okay. Dava? MR. REDFORDi Before I attampt to varbalisa my quastion, 1st ma clarify an issua you brought up bafora, thjt in tha Fsdaral Ragistar, it spoka about noisa balng determined just by using caxriar gas. That that was a misprint, I would lika to lat you| know. Naithsr mysalf nor MIR would agraa with what was statad in tha Fadaral Ragistar. It has to ba dona with tha| matrix. Ha agraa with you. Okay. In your tastimony, you pointad out that sosm of tha MIR protocols ara a littla too loosa and you spoka about elaan up and you said it was a littla loosa aad it was lsft up to tha analysts, a lot of tha things. (ater on, in your oonelusion, you recommend that wa davalop an analytical mathod and laava tha elaan up up to tha analysts. That, I think, was your final racommandation, sinca it's madia specific, matric specific.I MONS 003740 86 Could you clarify what you moan by that* two 2 atatamanta? They don't aaam to agree with ona another. 1 OR. kaixy: Those two statements ara made in what we 4 feel are diffarant contexts. The first statement is made in I the context that a non-quantifiable limit, in which the analytical chemist is askad to define at what limit his 7. chemical or his PCB's are going to be regulated. I So that we feel that if we are given a series of options, we have no guarantee that someone in an enforcement 10 position won't make a diffarant series of options that come up II with a different quantifiable limit and, thus, we will be found 12 in violation. 13 The second recoamiandatlon for leaving clean up 14 and separation options open to the chemist is made in the 11 context of regulatory cut offs, at which point we know the 11 target level that we must be able to measure our PCI'a and in 17 that case, we can design our experiments in the way we find 10 nost affective to clean up our particular matrix and still be 10 assured that somebody else using a different methodology will 20 till find us in complianes at that cut off. 21 MS. KEDrORO: So, if you'rs -- you're saying that 22 Lf we use -- stick with the limit of quantification, you 23 fault us to coma up with some kind of a very strict protocol 24 diet would need to be followed. :hing is feasible? 21 Do you think that sort of * I MONS 003V-*! DR. KALEY: I think that for ua to ba sura of compliance, wa naad tha agency to coma up with a vary strict protocol that they will follow. MX. BEDFORD: You yourself have stated that, in a different matrix, though, that tHfft's not possible. DX. KALEY: I agree. That is the basis of our concern with this non-quantlfiable approach. He don't know whan to stop locking and we don't know when anybody else is going to stop looking. DX. BURGESS: I think it's important to note that tha difference between enforcement and the analytical group is also going to be a difference between supplier and customer. And, it can lead to all kinds of problems if the custoswr analyzes his product and finds quantifiable PCS'*. His first reaction is going to be, it must have bean supplied to him from the supplier, who said it did not have quantifiable FOB'S. And, he's going to go back and with a little work ha may well find it in the supplier's company. You are going to have all kinds of customer/supplier relationships. MX. BEDFORD: All right. Ha came out with a numbei that was SO and we only came out with, say, an analytical method to clean up and we left all that loose, wouldn't tha same situation exist as far as when ERA comes in to check you7 If they went in and used a different method, it would MONS sa b th same situation as if it was limit of quantification. Thay could do whatavtr thay fait and you could hava dona something completely different. OR. KALEY: I know. But, at that point, wa'ra talking about axcaading a previously astablishad limit. If wa do tha bast job that wa hava dona, we are confidant that wa hava dona a sufficient job to datarmina that tha PCB's in any givan particular sample era lass than 50 parts per million. Wa can be confidant that EFA or anyone else coming in, a supplier, competitor, whatever, will also find that tha PCB's in that particular sample era lass than 50 parts par million. Okay? In tha case of non-quantifiables, wa may datarmina that our limit of quantification is 10 parts par million. Somebody alsa may coma in, do something different with tha sample, spend 6 months trying to lower their limit of quantification, and, say, ah, but, now, I'va found that my limit of quantification is ona part par million on those samples and look, you've got 5. Okay? So, wa'va got an ordar of magnitude different. I say I lowar my limit of quantification to 10, somebody alsa says, you're above my limit of quantification at 1 and thay are both telling tha truth. There is no disputing of facts. But, if tha cut off is sat at 50 or whatever number, than I think there would bo agreement that both are mqnS below that point. 89 MR. REDFORDi But, they both could cotta out with different number* avan if thara.waa a limit; OR. RALEYt I think our round robin experience, our individual laboratory experience, haa ahovn that claarly two paopla analyzing tha aame aamplea of tha typaa wa'ra talking about, will gat diffarant numbara. Tha analytical variability wa'ra talking about, I think, our rourtd robin raaulta hava ahown variabilitiaa of plua or minua 70 parcant. But, wo noad -- avan with that, wa ahouli ba aura wa art atill balow 30 parta par aiilllon, baaad on our analytical variability and what tha trua valua waa. OR. BORGESSi Wa hava a targat whieh ia vary difficult to hit and if you atart awinging it around and moving it all ovar tha plaea or don't tall ua what tha targat ia, it makaa it avan mora difficult to hit. MR. REDFORD: Okay. All right. Thara haa boon a lot of eoananta made from youraaIf and othara in tha written coaaaanta wa'va rocalvad talking about tha MRX matho< not being validatad. If -- I'm going to hava to go to two diffarant poaalbilitiaa. If wa aither atuck with tha limit of quantitation or if wo caaia out with a number, what do you think would ba an acceptable laval of validation work bafori you would aay that tha method waa validated? Row much HONS 003?'*'* ?0 ffort would you think would b needed before wa could lay that tha method was validatad? - I raaliza you'ra saying that wa can't validata tha elaan up mathods bacausa wa hava to do it tor a particular matrix, what about just tha analytical, just tha instrumantal? What laval do you think would ba naadai just for that part? DR. RALEY: I don't think - HR. REDFORD: Whara ara you going to draw tha lina, and stop saying that EFA hasn't validata tha mathod? DR. RALEY: okay. This gats back to our basic question and I'm not sura. I think it doas mattar whether it's a cut off or a non-quantifiable limit. I think validation must Include the total mathod run on an actual sample. And, I know that you agraa with that. At that point, I think that tha validation burden rests with tha industry on their particular samples. I think tha agency can giva guidelines on what is suitable validation, so that wo hava soma idea of what kind of statistics tha agency feels wa need to develop for our samplaa. Okay. This gats back to tha question, your very first question. In terms -- you know, wa want the HONS OOSJ'fS 91 option# for clean up end separation and measurement in tarn# 1 of a cut off type regulation, and we, speaking for myself, 2 certainly In our laboratory and I know that at least some 3 members of tha group were willing to accept thoee burdens of 4 validation, va'ra going to have to do than anyway. 9 Okay. It we talk in tarma of a limit of quantitatio^ ayatam, frankly, I don't havo an anawor to your quaation. 7 That'* ona of our eoncarna. I don't aao how wa can validata a avaryona of our mathoda aa a limit of quantitation tor all tha 6 matrlcaa givan a apeeifie protocol and i don't aaa how tha to agancy can aithar. n Ha both, aa analytical ehamiata, wo all hava tha 12 aaae problama with thia rula. 13 OR. BURGESSi Your ... analytical chamiata, if thay 14 go to anforcamant, aran't going to hava tha aaaa kind of IB problam of whatavar mathod you'ra uaing ia going to hava to bo 16 validatad for that apacifie madia matrix alao. 17 MR. REDFORD: Sura, okay. If wa did go to tha 16 aatabliahad limit, to tha numbar, do you think that tha 16 guidalinaa, tha analytical guidalinaa that MRI had in thair 20 docuaanta, do you think thay ara aceaptabla to that tort of 21 a mathod? 22 OR. RALEYs Okay. I can't apaak in total, but I 23 think I mada a atatamant, I certainly agraa with it, that I 24 think MRI people hava dona a fine job aa far aa thay hava 28 HONS 003740 92 gon. They have certainly studied the field of analysis of ; * PCB'a and whatever matrices were available and literature references. I think they have identified some options which have worked in the past. Our experience is that soaie of these options do not work in the matrices we`re talking about, but MM has no way of knowing that because they haven't tried them on those matrices. I think the MM documents stands as a fine starting point fox any laboratory which needs to comply with the regulatory limit. However, I don't think that the docuattnta should necessarily be considered complete by the EPA. I think the industrial laboratories* who have more experience in these types of systems, should be allowed to modify and/or use alternative techniques to reach the regulatory cut off as long as those techniques ere documented and the quality of assurance and method performance criteria are documented in that industrial laboratory. In other words, I don't think, because something ie mentioned in the MRI -- is not mentioned in the MM doctosents, it should be excluded from useage for methods to comply with the regulatory cut off. However, I think the MM documents does serve as a very fine starting point for somebody that is going to have tc comply with this cut off. OQiV*1 mons 92 MK. REDFORDt Ml right. In -- if epa has to stabliah a sat analytical procedure, as you are recommending, analytically, not clean up, do you think we should stay with the GC MS or do you think we should leave that open like the way the MRI documents is, that you can use packed or capillary column, or -- I mean, if you want us to narrow it down, we have to narrow it down. Just how loose are you saying? OK. KALEYi Okay. I think -MK. REDFORDI I'm asking you to bo explicit as to what method you think ERA should follow. OR. KA1XI: 1 think everything we have suppliad to tha agency, expresses our preference for electronic impact, mass spectrometry as tha preferred enforcement or compliance method. Me feel that in the matrices we're talking about, that is, in many cases, the only instrument which will allow you to determine PCB's at SO parts per million, if you can do them at all, at that point, we would -- we feel that the agency should have a reference method which they feel will work on tha samples, absent clean up procedures, so that we know what standard we are going to be judged against. But, we also feel that the agency ought to allow the use of equivalent methods if the industry, the regulated industry, cen develop information showing the equivalency HONS 0037*# 1 of thoa* mothoda to tha primary mathod. 94 j In other word*, we don't particularly object to havir to analyse a let number of aamples by GCMS, but certain of the regulated laboratories, for certain of the products, can do an excellent job with a short packed column and an electron. captured detector. We don't feel that those groups, who now have validated methods and are doing that to meat the SO part par million cut off, ought to be -- ought to have to go out and buy a mass spectrometer or send all of their sample* to a contract laboratory. Does that answer your question? MR. REDroRD: Yes. Ml right. In one of the comments that we had received, it was suggested that we acquire a specific minimum extraction recovery percentage efficiency, and that was something like 90 percent. In whichever way ws go, do you think that specifying 17 what we require to be the extraction efficiency is a good IS idea, of the surrogates that MRI has prepared, that we require It someone to have a specific extraction efficiency? SO DR. RALEYt I would hate to see it in terms of a 21 requirement. Certainly, we feel that guidelines are useful in a giving us a target, but there are matrices in which SO to 70 a percent recoveries must be considered good. 24 Thera are matrices in which plus or minus 50 percent a relative standard deviations must be considered good. MOWS 003^49 So, certainly, we don't want to ba told that we hava to do something which la going to ba a virtual impossibility. ' I think ona of the point! wa made, plua or minua 10 relative atandard deviation on some of theae matrices, we work with is an extremely exacting thing. Aa long aa we know our analytical variability and know the projected value given our recovery and preciaion, then I feel we can operate effectively below a~cut off. MR. BEDFORD: No matter which way EPA should go, what forms of QA and QC and what intensity QA and QC do you think EPA should require? Such aa interlaboratory studies, laboratory certification, the use of surrogates, blanks, dupes? DR. RALEYi Could we addresa that -- could1 i address that in the reply coirments, in the group's reply comments? MR. REDFORDi Sure. I think I'm about questioned out. MR. GUNTER: You're done? Okay. Denise? MS. KZZ1TNER: I'd like to direct this to Dr. Burgess. In your testimony here today, you coosnantad that you doubt that any processes will qualify for this exclusion. Do you have any information on what criteria under the definitions of closed and controlled waste MOMS 003750 96 processes will be least likely met? In other words, are rslesses in air most likely to disqualify people from excluding or releases in water or the releases in products? DR, BURGESS: Again, it would be speculation on my part. I think as the Industry has become more familiar vith these things, there are unique situations that have come up, vacuum pump problems which would give some release in air. Very low levels, very low quantities, but fairly high concentrations would be detectable in air, because a vacuum pump doesn't move that much air. Water, per se, I don't -- I'm not sure. It would depend a great deal on which PCB you ware talking of because the partition coefficient is such that decachlorobiphenyl is exceedingly insolube, has very low solubility in water. So, I can't visualize very much deeachloro getting in water if the water is in contact with soma organic stream. But, there again, in soma of the other materials that have soma water solubility, you could get problems. A year ago, we were looking monthly at the product consideration. I think as we have moved through this, we have realized there are some air and water concerns and the extant of them or the ratio of them, I don't know. MS. KEEITNER: One of the comments received in response to the proposal suggested that we define process. HONS 0031*1 97 release, product and waata mora carefully in tha proposal so that paopla know whara exactly tha sampling should occur. Tor example, do wa mean affluents from some type of water treatment, on-sita water treatment, or do we mean water effluent directly from the process. 00 you have any suggestions on how that should be defined or some recommendations, on those four? DR. BURGESS> I've debated some on that within our group. Is hsat exchanger water included or not included? Is a vater aspirator included or not included? And, 1 think we would have to sit down and work on these definitions in order to get anything specific. He can try tc address scan of that in our reply comment. MS. XZSITNZRt In your main comments, you state that the quantities of PCS'a inadvertently produced in the United States today is miniscule. You use that information to a great degree to support your contention that tha risks proposed are de minimis. The data on the PCS levels are the amounts of PCS'a produced as reported in the survey, were gathered by different analytical methods and by best theoretical estimates by each CMA member firm that responded to the survey. The survey did not require actual analysis, did not specify analytical schemes as a standard and did not 003751 moms 98 define sample alia, extraction procedure, the clean up procadura. Is It possibla that tha data_reported in the survey ara inaccurate and tha actual amounts of ?CB's praaant could vary by savaral ordara of magnitude? OR. BURGESS: X don't think by orders of magnitude. Ara they inaceurata Certainly, they ara estimates and any estimate is subject to consideration. Is i' a factor of two. Certainly, some people were reporting high, some people were reporting low. I don't know what the inaccuracy figure is. Is it 50 percent, 100 percent, S00 percent? I don't think we're orders of magnitude and I think the work that you have done it looking at tha exemption petition, where we are dealing with materials over SO ppm, would confirm that, that we are in tha right ballpark, whether it's 13,600, I'm -- I like to use statistically significant numbers, even to say 13,600 makes me shudder a little bit, but that's what we need to say in order to get the things to add up. How, somewhere -- I guess I'd say somewhere around IS,000, plus or minus some number, and I worry about saying 13,600, but it -- but, that is, I think, the limit of our technology at the present time in saying that. MS. EEEIZNERi Are you aware of the analytical method that EVA compliance monitoring personnel are currently using to enforce the SO part par million cut off it has set HONS 003753 on manufacture? 99 DR. BURGESS: I'm not, but I'm sura I can find an analytical chaniat who la. MS. KEEITNER: Aren't you concarnad about not bain? In compliance? DR. BURGESS: Am I concerned about not being in compliance? For three years, I have bean concerned about not beinq in compliance. A great deal -- but, aa far as -- if that is being derived from your other question about the analytical chemistry, irrespective of how concerned I was about being in compliance, I would not spend much tiara on the analytical method because I have analytical chemists who are much more profound at reading those things and doing it than I am. MS. KEEITNER: Than* you. That's all the question I I have. MR. GUIMOND: Thank you, Denise. There are follow up questions. If there are any from the panel, I've got a couple myself I would like to ask, and than move on. On your written testimony, page IS and then again on page S2, you note that all these processes that we're talking about -- I guess if we don't accept any of the other alternatives, all these processes should be considered as totally enclosed usee of PCB's as opposed to manufacturing, and I guess I would like to expand a little MOWS 003754 lc: bit on that, as to why you believe this is a totally enclosed use. DR. Bl'RGESS:. Wall, csrtainly, wa hava not intended to manufaetura, ptoeass or distribute PCB's. This is not a commercial venture. It is something which the PCS is an inadvertent thing that occurs in the usa of the chemical itself. I think we can develop those arguments further, if you are interested, certainly 1 would like to get a legal counsel more vitally involved in it. MR. GDIHONDi Yes, I -- that was an interesting concept to me, too. Let me just expound on another question here that you were talking with Dave Redford. If I understood you correctly. Dr. Raley, you indicated that if we specified a specific number, you felt that it would be-up to individual companies to accept the burden for individual validation? DR. rir.rv; Well, in the climate today of good laboratory practices and things like that, I think that is a perfectly reasonable expectation and that, certainly in our laboratory, I know of many others, feel that we cannot use methods for regulatory purposes or for any purposes at all unless they have been fully validated in our laboratory and we know at what level they are able to perform. MOHS 003755 101 MR. CUIM0N91 Okay. , I DR. BURGESS: But, simultaneously, we would expect J you to have your method validated. DR. RALEY: Right. He would like -- MR. GUIHOMD: But, if I heard you correctly, not neeeaaarily to the extent that you would. You would not expect ua to validate our method for each and every possi bility. DR. RALEY: If it's going to be used for enforcement on that matrix, I think -- yes, sir. Certainly, it would need to be demonstrated that it gave reliable results by some statistically significant manner. MR. GUIMQND: Even with respect to enforcement action, but I gather from the standpoint of promulgation of the regulation, 1n the first place, you would not antiaipate that we would have to validate it for each and every posaibli -- DR. RALEY: He realize that's an impossibility. MR. GUXMOND: Okay. DR. RALEY: That's one of our points with non- quantifiabls being a problem. MR. GUIMOND: I see. Any other follow up questions? Bill? ------- MR. GUNTER: I'd like to follow up on a point that Denise raised about the data in the-CMA survey and it also relates to an exchange that you had with Rich about the UQNS 00VJ56 102 1 information that was given to th Court ovr a year ago. 2 In raading th inatruction* that ware mailed out 3 with th quaationnaira that waa uaad for that aurvay, in 4 defining what a cloned ayitem was, you indicated "thia ia a S special case and raquiree estimating pounds produced in manufacturing operations without detectable PCS concentratio: 7 in any output strain". Now, your discussion related to Rich's question. 1 you indicated that you might not have communicated the 10 concept very well, but what you really had in mind was 11 something lass than the 50 part per million regulatory cut 12 off or -- is that correct? 13 DR. BURGESS: Yes, it is. 14 HR. GUNTER: Do you think that there were errors 1> made in responding to tha survey based on that some mis- 10 communication, with this kind of language in the instruction: 17 DR. BURGESS: I think most of the people responding IS to the survey hod telephone eosenunication which would have IS straightened that out. 3D 21 22 23 24 2S I Is it possible there were errors? Yes, it certainly is possible, but I think, again, this kind of a survey that we ware doing, we were ballpark numbering. But, most people were basically looking at is it a PCB by rule, SO part per million. HR. GUNTER: Even with the language like without 003757 HONS IZ2 detectable PCB concentration in the instructions, do you j 1 think that's what happened? j 2 DR. BURGESS: I certainly -- I guess I -- it's 3 somewhat speculation as 1 try to remember back, but I 4 think most of the people did call in and that we were talkin' 5 pretty much 50 part per million. 6 MR. GUNTER: That's all X have. 1 MR. GUIMOND: Any additional questions? 9 MR. REDFOPD: Yes, X have another one. This is 9 alonq the tame vein as one of my questions before. IS If you had a new product* a new matrix# could you 11 explain what types of things you would do with that 12 product to validate your analytical method to say -- to maki 13 you comfortable now, say yes or no, this is what the 14 concentration of PCS's is? 10 Could you just explain what kind of validation 10 ! procedures you would go through? ! 17 DR. KALEY: Well, X can't -- X cannot speak for I 15 the panel on this point, but let me juat give an example of 3 It whet -- maybe how X would etert. Okay. 20 A sample comae in and the guy says X went to know i 21 I if you've got SO ppm PCB'a in it. So, X look at it, you 22 know# pick a matrix. Well, sey, it's pretty bed. If I 22 sey well, first thing I'm going to try to do is dilute it 24 and shoot it. Okay. So# we dilute it. Okay. Let's say 28 MQNS 003753 104 il 1 that work*. w can dilute it by a factor of 10 to 50 or 2 something sod it looks like the baseline is going to be ' clean enough, we can do pcb's. 1 .1 At that point, we establish the working range we an 5 going to need for standards to quantify 30 parts per million or less PCB's in that system. We run a series of at least 1 three standards, in replicates of S, to determine our linear range, the reproduceability of our stnadard. I We try to then spike -- first of all, hopefully, we can have a blank sample. Somehow, either we've got generate one or we've got to hope that we can somehow -- one of the samples la truly clean, gets no PCB signal or a very small PCB signal under those circumstances. At that point, we spike the sample at three different levels in repliactea of 5 determinations each to determine our recovery and precision of the PCB's in that matrix at those various levels. And, then, that presumably I would give us at least a baseline validation. f Than, from that point on, on-going checks of standard responses and spiked samples and replicate samples 20 run and compared against those previously established 21 performance criteria in either a controlled chart system or at 23 least some sort of documented system to tell when we were 23 exceeding our specified limit of precision and accuracy. 24 Basically, we're talking about three levels in 23 HOMS 003759 Ill rsplicatas of S to establish our statistic* in our laboratory. Tha othar members may agree or disagrs*. MR. REDFORD: Okay. Thank you. MR. OUIMOND: No mora questions? Thank you vary much. Dr. Burgess, Dr. Kalay. Art thara any quastions from tha floor that w* didn't gat? I don't think v* got any yat. (No raaponsa) Okay. Thank you vary much. At this tins, rathar than starting on NRDC. although wa hava finishad up a littla aarliar than I had antlcipatad, I think wa will braak for lunch and plan on coming back -- I think wa'll plan on coming back at 1 o'clock rathar than 1:30 and gat on a bit aarly. (Whereupon, at 11:40 o'clock a.m., tha haaring was recessed, to raconvana this sama day, Monday, July 26, 1982, at 1:00 p.m.) MQNS 003760 Ill afternoon session 1:10 p.n. MR. GBIMOND: The first testimony this sfttrnoon will bs by ths Environmental Defense Fund and NRDC. Jackie. STATEMENT OF JACQUELINE WARREN, t ELLEN SILBERGELO, ENVIRONMENTAL DEFENSE FUND, NRDC MS. WARREN: Thank you, we don't have extensive testimony prepered for this afternoon. MR. CUIMONDi Would you identify yoursalf, please? MS. WARREN: I'm sorry. Jacqueline Warren with Natural Resources Defense Council and Ellen Silbergeld who is a scientist with Environmental Defense Fund. I wrote in the request to testify at the hearing that we would address five particular subjects. I really think we are only going to speak to four of them because with the proposed guidelines, there seems still ton confusion with -- VOICE: Louder, please. MS. WARREN: The change to now saying that packed coltasn, GS Mass Spec is acceptable aa capillary wise. We have been talking about, I received a vary small guidelines docmaent In the mail and I didn't see any particular difficulties with it. But I am not going to speak to it this afternoon. The first thing, in our testimony we started out by saying that we didn't think the LQQ was an appropriate EXECUTIVE COURT REPORTERS (m) Hi mt MOMS 003761 113 point to diffar.nti.f between PCB, wMch woul(J b< in ^ category for further conaldaratlon In the naxt rulemaking, aa oppoaad to PCBa that wouldn't ba. And afear conaidering tha varloua problem*, many of which war* diaeuaaad thia morning and which hava baan in tha written taatimony, wo raally hava coma to tha point to agrae that it la a moving targat and it would ba battar to apecify a number. X hava never baan oppoaad to a number in the to flrat place. The objactiona that we had with tha SO parte par million limitation had everything to do with tha apparently vary arbitrary choice of it. tha applicability of it to all PCBa regardleea of tha medium and tha pathway 14 to tha environment and any conaldaratlon of what tha health to affacta would bo. 1 What wo would really Ilka to tee ia tha agency 17 atarting from tha point that tha atatuta waa intended to 15 addraaa, which la tha prevention of tha addition of PCBa IS to tha environment. Tha court opinion epoke about reaching as point aoureoa of PCBa and wo think that you can do that by 21 Betting a ntabor which ia in tha range of what tha limit of 23 detection would ba. ____ 23 Since tha atatuta aaya no ona may manufatura any 24 PCBa, obviously you are going to ba concarnad about tha n pretence of any PCBa. Once you find them, you hava another EXECUTIVE COURT REPORTERS (m) mwi MOI>*S qq3761 IU problem and that, obviously, is whsthsr you art going to do 2 anything about that or do aonathing about sons aspscts of thosa PCBa. But tha first quastion you hava to ask is ara thara any, which is why wa said start with tha LOO. But if it is aasisr for psopla to look for, in tha product and waata straam, a nunbaz which is approximately in tha ranga of where the LOO would ba, I think that might clarify sons of tha difficultias. 1 raalixa tha ranga can diffar, but it doesn't differ by orders of magnitude in what you ara looking for, <2 presence. Ha would lika tha number to ba at tha low and of tha spectrum, obviously, because we ara concerned about tha health affects. Evan though thara has bean a lot introduced in this record purporting to show that PCBs ara not hazardous, since they ara persistant bio-accumulating compounds, tha question is not what risk does this molecule of FCB pose, but what rlak is going to ba posed- to a. parson at tha point 1* of actual exposure whara that PCS is no longer one molecule. Having said that, wa do stand bahind tha position 21 wa took in tha written testimony, with tha exception of a saying, rather than specifying LOO, wa would rather see you a coma up with a number that everybody can than attsmpt to M gear their analytical proceduraa to finding. I think you would ba heading in that direction EXECUTIVE COUXT REPORTERS (Ml) MI.MM MOWS 003263 U3 I aome point anyway because of tha variability of what LOO or LOQ naans to tha various haarars and it was vary claar to ma hara that, sines CMA's survay was asking paopla for no datactabla PCB and paopla wars interpreting that as 50 parts par million, tha opportunities for mistakes, misunder standings and variability are graat unless you do sat a number. So I think you should. With respect to tha deaionatration of eligibility for an exception, I have a graat daal of concern about tha approach that is taken in tha proposal because, first of all, this is an exception from a statutory prohibition. Whsravsr you draw tha line, you era still going to be -- if you era going to ba accepting paopla as da minimis risk, paopla who qualify for saying that thair releases ara da minimis, tha agency, I think, has to understand tha basis for that claim of eligibility and if a manufacturer simply announces to himself that ha is eligible and files tha paper signed on tha bottom lina in tha drawer, you don't know about it. Tha full burden is on tha agency to find out who those paopla may ba. which out of the group deservea the 10 expenditure of your vary limited, and every increasing limited, enforcement resources. n I think it would be much more appropriate for tha a paopla who are claiming eligibility to come forward and show M you they are eligible and how they got there. Xnd we will EXECUTIVB COURT REPORTERS (Ml) JW4M4 HOhS 003764 IIS bs speaking in a nonant to tha queation of the appropriatanaaa of tha thaoratical calculation to gat thara. But I think at tha vary minimum tha agancy should hava tha information prasantad to it aa to who thoaa paepla ara who claim to ba allgibla and what that claim la baaad on. Thara wasn't any dascription of vKat enforcement atratagy tha agancy plana to follow. I don't know whathsr you ara avar going to publicist what that anforcamant atratagy la, but I find it practically an unenforceable proposal tha way it ia worded now. Not only that, but tha statute doas allow for citizan anforcamant actions and that kind of proposal where tha relevant information remains in the file of tha company moans that tha public is completely excluded from accaaa to that information, which, wore it in your filaa, would be It available under the Freedom of Information Act. It completely 17 defeats tha ability of anyone to enforce -- you or a member IS of the public, who I believe is entitled to know that I* somebody is still producing PCBs, even though the statutory intent wee that that be, either entirely eliminated or >1 only permitted when BPA was aware of it and could make a a finding aa to no unraaaonabla risk. a I don't think tha no unraaaonabla riak finding a is applicabla to da minimis axcaptions from the law. If you reed the court's opinion, they weren't telking about EXECUTIVE COURT REPORTERS (mi) su mi MONS 003765 u? balancing risks and benefits, having found that tha banafit is thara at a mattar of law. You would hava to find that tha ragulation was trivial or of no valua, but It is not strictly an unraasonabla risk tast, although tha unrsaaonabla risk tast cartainly comas into play with tha exemption procaaa. I fully understand tha difficulty of an annual application from thousands of producers and I am not advocating that you gat involved in that. I think that a da minimis risk approach is an appropriate way to ba proceeding. But I do hava a lot of problem with starting from SO parts per million as has bean advocated. The SO parts par million levsl, as far as I can see, has no magic about it. It was-an arbitrary choice to begin with. It was navar justified by an rationale that I could understand and it is being promoted here as if it has some rationale inherent in it, which I don't believe to be the case. A previous witness testified that the fact that 50 parts per adlllon was drawn as tha limitation has been a technology rorelng -- a fact of lifa and many companies have changed their processes and fine-tuned their analytical procedures to be able to comply with that. If that is the case, it is within the intent of the statute for you to be forcing further action on it. By analogy to the example of dioxin of 2,4,5T where dioxin EXECUTIVE COURT REPORTERS () hi mi HONS 003766 ua if an inadvertent contaminanc in the manufacture of 2,4,5T bacausa of Cha concarn about tha toxicological propartiat of dioxin, companiaa have iaarnad to look for it at lovar lavals than thay ever thought thay would ba abla to and manufacturing procaaaaa hava baan changad in ordar to minimixa tha praaanca of tha contaminant. And I think wa ihould ba looking for tha sama rasult with thii. For that raaton, if and whan you do tat a numbar for thia, I think you ahould ba baaring in mind that it ia daairabla for companiaa to bo changing thoir procaaaaa in ordar to minimixa tha praaanca of tha contaminant. Conattering how many procaaaaa thara ara and how ahaky tha data ara on tha numbar of PCBa that ara actually being genera i. ted and being ralaaaad into tha environment, I think it bahoovaa all of ua to be working toward a reduction in tha it production of that quantity. I alao think it would be appropriate for you to hava a ntabar of different limita ao that if you ara concernet if about tha ralaaaa of PCBa into the air, it would be appropri W ate to hava one number for that and tha ralaaaa of PCBa into 11 tha water, another numbar for that, if tha ability of the a analytical methodolgiaa to gat down to diffareit nianbera a dapending on tha medium ia aa variable aa it ia. And tha M hardaat part ia dealing with the complicated matricea auch aa EXECUTIVE COURT REPORTERS (mi) in a--i HONS 003707 119 tarry matrices that peopl* war* talking about. But on* number, 1 think, haa inharant difficulties with it and you ought to ba looking at variatiaa so that thay ara madia pacific and always kaap to tha haalth affacts that you found as a matter of findings of fact in tha pravious procaading and in tha affluent discharge procaading that tha FDA has also found and which ramain tha currant paar raviswad and unrabuttad findings of fact with raapact to tha haalth affacts of PCBs. Bilan will speak to tha quastion of thaoratical analysas. MS. SILBERGIXD: Ha undarstand that soma burden has baan plaead on tha usa of thaoratical rathar than actual analysas of materials in ordar to determine axaaiptions W* hava soma concarn about this as a procass to ba raliad upon. For tha most part in anvironmantal and other typos of regulation, thaoratical analyses ara usually invoked whan it ia difficult, if not impossible, to do empirical analysis. Far example, in air pollution whan oaleulations based on models of dispersion, entrainment and other phenomena ara obviously appropriate because tha cost of doing adequate empirical studios would be enormous and of dubious reliability In this instance wa ara not convinced, however, that the barriers to actual empirical chemical analysis of EXECUTIVE COURT REPORTERS (Ml) MMM4 HONS 003768 120 product, process, streams or waste streams ere so great, 2 the barriers to doing this are so great as to encourage 3 theoretical analysis. We are, moreover, concerned that the agency and 5 others be satisfied of the errors inherent in theoretical 4 analysis so as to determine, really, the bounds to which 1 these types of analyses can be used in regulation. I For example, I would assume that the way these analyses are going to be conducted will be to set up a 10 chemical engineering flow diagram of the varioue reaction* II that are thought to occur in producing a certain product 12 and, therefore, demonstrate how many molecules of FCBs 13 would be produced per molecule of product or other such 14 factors. However, in most chemical engineering streams, IB chemical processing streams, one is usually dealing with It great excesses of precursors or catalysts because yields 17 II ere considerably below 100 percent, even under optimum II conditions Small changes in the conditions under which those 20 processes oceur, such as temperature, aerobic or anaerobic 31 conditions end the like, can, of course, drive chemical 33 reactions in dlffarent ways by considerable factors. 23 Therefore, we would have to obtain e very clear 34 understanding of what the likely range of error in the final 21 EXECUTIVE COURT REPORTERS (Ml) MJ-0M4 MONS 003769 121 calculation based on thaoratical analyaia of PCBa. Indeed, If ona vara to do such analysas thoroughly and carafully, we wondar if much affort or time would ha aavad ovar doing actual empirical analysas, and, Indaad, whathar tha reliability would bo such that both companies and tha public would be satisfied by that approach. MS. WARRENt I wanted to speak to one other isaua. In our written comments for July 9th wa addressed a number of statements that SPA made with raapact to the risks of inadvertantly manufactured PCBs. On page 11 of tha testimony I quoted ona statement in the Preamble about exposure levels during routine operations are not expected to result in significant exposure, presumably to workers, because of measures already instituted in the industry to reduce exposures.- With respect to that, I wanted to call your attention to a document that NIOSH published in January of 19(1 where they were evaluating the permeation of protective garment material by liquid halogenated ethanes and PCBS. With respect to PCBs, with the exception of one material, the PCBs permeated the protective material in under three minutes and most of them in less than a minute. So there is a real question about how affective thorn protective materials really are. I will submit that EXECUTIVE COURT REPORTERS (m) HONS 003770 122 1 for the rtcord with the rtply comments, but I wanted you 2 to be aware of it. 3 Wt have haard a lot of ttstimony. rapraaantetions 4 about how protactiva thoaa protective gannente actually 9 are and have not heard a lot from the unions on it. I assume and understand that some testimony is going to be 7 submitted by them, but 1 wanted to get that into the a record because that's a very significant difference from a what we have heard if it is in fact true that ?CBs come 10 through in less than a minute through most of the materials. ii 13 13 ( 14 That's all. HR. GUIMONO: Thank you, Jackie, Ellen. . Why don' t we start the questioning at my far right. Denise. 10 MS. KEEHNERi In your testimony you spoke of 10 limited detection. What do you believe is limited 17 detection for PCBs? ia MS. WARRENt 1 think it depends on the medium it you are looking at. 30 MS. KEEHNERi In products. 31 MS. WARRENi In products? I think what we've n heard today is that it depends on the particular matrix 33 that it's in. But I think a range of what the likely 34 PCB concentrations are is something that could be 21 identified. EXECUTIVE COURT REPORTERS (Ml) MI4M H0I*S 123 ! I'm not in a position to say what that limited 2 detection would ba. 3 MS. XEEHNER: If EPA wara to withdraw this 4 proposal and not procaad with tha third rulemaking and 1st 8 tha TSCA Saction 6-E ban go into affact, what typa of i analytical method would you propoaa that EPA would usa to 7 anforca tha total ban? MS. WARRENi I don't think it's raalistic for tha aganey to raally conaidar tlat aa an altamativa, aftar ,0 avarything that has baan haard about tha nunbar of 11 procassas. Otharwisa you just wouldn't bo enforcing it. 12 I can't imagine that tha aganey is going to taka a stop 13 that would ba as economically disruptive as that. 14 MS. REEHNERi That's all tha questions I have. IS MR. OTIMOHDi Dave. IS MS. REDFORDi I guess I have, raally, ona question. 17 If wo wara to pick a number near the dataction limit or IS whatever, do-you think wa should just usa dataction limit IS aa soaiathing to find it, to dafina that number? ' 30 Lika you are saying that it would ba a good idea 21 to have different numbers for different madia, air, water. 22 ate. What do you think wa should usa to determine that 23 number? 24 MS. SILBERGELDi Wall, obviously, if you go to 2S sotting a number, and I think for many reasons wa endorse EXECUTIVE COURT REPORTERS (Ml) HS-mt HONS 0037^2 124 tht at a procadura rathar than tha rathar murky concaptt that ara baaad on currant technologlea which may or may not rapraaant tha baat availtbla technologiee, or currant average practicaa in analytic laboratoriaa which may or may not rapraaant tha baat poaaibla practicaa uaing a apecific technology, onca you go to a number aeveral tliinga inform tha choica of that number. One ia, obvioualy, tha ability to detect the eubatance. But the other, and which moat be an overriding factor, are knowledge and aatimataa of tha adveraa health and environmental affacta of any given amount or preaence of tha compound. It may wall be, aa in tha caaa of dioxina and other aubetancee, that there may ba raaaon to believe that in aoma inatancaa tha levela of a toxic aubatance known or auapactad to have advaraa health affacta may, indeed, ba lower than a generally aatabliahad level of detection currently available. In thoae inatancaa, than, tha health concern la overriding and really drivea the analytic technology to develop mathoda leneltiva enough to reflect that concern. That certainly haa been the eaae with dioxina and probably ia alao tha caaa with tha dibenaofurana. MR. RZOrORB: Thank you. MR. SMITH: I have no quaationa. EXECUTIVE COURT REPORTERS (Ml) J4J-0M4 MOWS 003773 125 I MR. GUXMONDt Okay, I have jujt a coup1a. In your written teatimony you indicate that you don't think tha control waste ahould ba axcludad. Could you axpand on that a littla bit more? MS. WARXBN: Yes, tha major thrust of tha taction 6-1 that daala with manufacturing la that manufacturing of PCBa waa to and. If you ara going to allow unlimitad manufacture of PCBa aa long aa tha waata it going to soma sort of controlled disposal source, than I think you ara just ignoring tha initial statutory requirement. I am not persuaded that any of tha diaposal technologies available ara all that adequate in dealing with tha PCBa. Certainly landfilling-and things like that ^ ara not and thara ara a lot of questions about incineration, about whether it ia being dona right and what the by products and combustion products of it ara. Just to allow any amount of PCBa to go out as long as it ia what you ara calling controlled waata saoma to ma to ba gatting around tha basic point of Section 61. a MX. GOXMORD: You would not saa, than, any advantage to tha environment or public health from, perhaps, a tha incentive that might create. That ia someone that a alternately might have what you would call uncotrollad PCBa, M but could coneeivably, via the test of an exemption, not have an unreasonable risk, that there would be an incentive EXECUTIVE COURT REPORTERS (JM) HONS 003774 125 1 for than to try to qualify for an exclusion by taking their 2 wastes and getting rid of them in this manner as opposed 1 to some other way and thus actually presenting less risk 4 than might otherwise be done if you handled -- i MS. WARRENt There are a lot of ifs and maybes in that and it is clear to ne that the final rule has any 7 guarantee whatsoever that the waste is going to have to go to an appropriate facility. I There was a question raised this morning about, 10 what if it ia a RCRA facility as opposed to a PCI facility, II wall, RCRA leaves the control of PCS disposal to TSCA so 12 I don't know what sort of RCRA requirements would apply II that would be appropriate for PCIs. 14 With that uncertainty, I don't like the idea I* that the quantity of PCBs could be increasing in the waste 10 or in a process and that that would be all right as long 17 as it goes to the right facility. It I would rather have a cap on the amount. It MR. CUIMONBt Okay, let me see if I can understand M your proposal. You would suggest that we go with a closed 21 system exclusion, with the definition, basically, being that 22 we would establish some kind of numerical value, probably 21 near the general level of detector limit -- limit of 24 detection that might be applicable to these things for air, Iwater, products, waste, is that correct? EXECUTIVE COURT REPORTERS (W) MM4M *0NS 127 1 MS. SILSEROEO, Not necessarily, if I didn't mate* that claar. whan X said if you go towards setting a apacific nunbar, than tha overriding eonearn must ba tha valuation of tha actual ptantial and adverse affects to human health and environment, you cannot than soley rely upon level of detection or level of quantification as tha criterion for setting a number. Insofar as what you stata about varying levels for varying sources of PCS'a, that may wall ba appropriate. MR. OUXMONDi Okay. As you know, there probably is son* dissension among a variety of people relative to how serious the health effects are, environmental effects seefi 1 at el with PCB's. I guess 1 am trying to translate if I was to practically try to taka your reccemiendations today and translate [those into .some kind of regulatory requirements, how would I go about changing what X currently have in the rule as proposed. IS And if I translate them right, one thing X would do ! is that X would either eliminate the control waste 10 exclusion, or, if I was going to include it, X would have to It include it with some kind of a total quantity amount and, a X gather, and/or a concentration value for it, too. a And then fox the close waste exclusion, x would a* put in a numerical limit fox air, water, product, waste and a X would select that limit by looking at sometlhg around tha EXECUTIVE COURT REPORTERS (M) J4J4M4 HONS 00377b 123 lvX of detection, assuming that I convlnca myialf that at that level i am not going to have aarioua health affacta. Am I correct, it that what you ara advocating? MS. WAXXENi I think if you go back to tha statutory statamant that no ona should ba doing any, you ara going to want to ba aomawhara naar tha limit of dataction in satting tha numbar. That doesn't maan that_you ara than going to ba ragulating and imposing a ban on what you maasurad. Sue it maans that you hava now diffarantiatad tha catagory for purpoaaa of this rulamaking that you ara not going to worry about any mora or that you ara going to worry about furthar. For purposas of making that' kind of diffarantiation I think tha numbar would hava to ba aomawhara around tha limit of dataction. MX. GUIMONDi As it axists today prasantly? MS. WAXXENi I think you can updata it as appropriata. I don't think tha limits of dataction ehanga that fraguantly. Or you could laava it as it is. Thara ara othar ragulatory procedures where numbers are sat. They tend to got angravad in atono, even though tha ability to deal with than batter. MX. COlMOMCi Wall, lot me use aa an example, if -- EXECUTIVE COURT REPORTERS (J0) ))4H4 mons ' .... < * 129 1 and I an just using this as an example. a If, for axanpla, a limit of dstsction in 3 products -- ws lookad at a bunch of products and wa found 4 that it lookad lika it was 50 parts par million for S claarly a majority of tha products, 75 parcant or mors. and vs did tha saaa thing for wastes. Ha lookad at air and 7 watar and found it was, nayba, a factor of 100 lass for 1 air and watar, nayba svan mors. You could liva with that kind of approach? 10 MS. WASREM: I would lika to know whara tha 11 products arc going, what routs into tha environment are 13 those PCSs really taking. 13 MRSUIMONDi So you ara saying, not only limit u of dataction, but limit of dataction with sons kind of It risk assessment, if you will, that assures us that these It ara not intaracting in tha environment directly or 17 exposing humans diractly. It MS. mUUUD) i Aid what quantity tha product is being It produced every year. at MX. GCIMONDt Do you see an overall quantity 31 Unit established to this whole thing, too? 33 MS. MMtXXMi I think so because, first of all, 33 just drawing the lino at any one number doesn't taka into 34 account tha kind of concerns that wa wars expressing all at tha way along with the 50 parts per million cutoff. EXECUTIVE COURT REPORTERS (mi) )U<an HONS 00 3?TM ;3o th# rout* into tha environment it getting out into th# water, getting into fiih which is ths major rout# into th# di#t, th# number should b# a lot low#r than SO. It ought to b# a numbar that corrasponds to what wa know about PCBa and how much of th* parcantaga of diat is raally involvad with tha aating of fish, that kind of thing. You can do tha sama thing with axposura ralaasas into tha air, but to do that you hav* to know whar* th* product is going or how much of it is coning out, not only in tazas of parts par million or parts par billion, but ovar th# couraa of a yaar what is th* total quantity as wall. I'm just saying that it is a difficult problan baeausa you don't want to just say tha Sana thing goas for any PCS as long as it is balow a cartain laval. I havs tha Sana difficulty with any laval that you could com* up with. That's why I suggastad that you hav* diffarant onas that ara gaarad mora to tha madiun that you ara conearnad about. I am lass conearnad about PCBa found within a matrix whar* they ara not vary likaly to gat out and, dapaadiag on what tha us# of tha product is, or if it is in tha waystraam and tha wasta is going to a controlled disposal, ths fact that tha nvaabar is higher than a numbar that would ba going out into tha water or going into tha air doesn't bother ma so much. MR. GUIMOHDi Obviously, w* can't hav# an infinite EXECUTIVE COURT REPORTERS (Ml) JIS4M4 HONS 003779 131 1 numbc of limit*, w* hav* to hava soma finita numb of limits. MS. WARRENi How about ona for air, ona for w*t*r for .tartar.. MR. GUXMONDt Okay, on. for product., all product. -- MS. WARRZNi Wall, th.r. ar. dlff.rant kind, of -- wall. If you can catagoriza th. product. Into ..parata, daacrat subsats ao that you wouldn't hava too many of thi. MR. GUIMONDi Sana thing for waata, parhapa, dapanding on what happana to tha waata. MS. WARRXNi i think probably tha waata you don't naad to diffarantiat. tha aama way. MR. GUXMONDi I'd lik. to talk juat . littla about your polnta ralatlva to aligibllity, how aoaiobody dataminaa aliglbility, how thay ahould cartify or aalf-cartify. Again, if I intarprat whay you ara saying, you baliava that whatavar -- whathar thia waa dona, on an analytical basia or whathar it waa dona on a thaoratical 30 baaia, that tha agancy ahould raquira r.porting of that 21 information, ia that corract7 23 MS. MASXSNi Initially, yaa. 22 MX. GUIMONDi For axampla, In tha propoaad rul. 34 wa lndicata that ona must aalf-cartify aach time your 31 aalf - cartification bacomaa no longar - EXECUTIVE COURT REPORTERS (J) )I4M MOWS 00378 MS. WARREN: It's a quali.tati.va diffarance. 132 MR. GUIMONDI Right. MS. WARREN: But thay'ra not tailing you that, thay'ra tailing thaotaalvaa that. That's tha problaai that I have with It, I think ERA should know. MR. GUIMOND: So you would aay wa should hava than certify to ua aach tins that occurs. MS. WARRENt Yes. MR. GUIMONDt And -- MS. warreni That's an altarnatlva to an annual axasiption petition ao, unlasa thair procaaa changaa more frequently than that, I would lnaglne It la not going to be aa often aa annually tha first tiaa and then whenever the process changes qualitatively enough that the quantity of PCBs that's being generated changaa. MR. GUIMONDi I guaas somewhat on a philosophical plane relative to thia, if you create this thing as an exclusion, it is supposedly an exclusion, as you pointed out, from the court's language, is because there is da minimis risk or littla benefit associated with regulation of the thing. Than, via that sane thing, you are then saying that, basically, these things I an excluding because I an not concerned about them, I don't have that much interest in than. So, philosophically, wouldn't you also think that EXECUTIVE COURT REPORTERS (Mt) MHM MQNS 003781 1 you would not want to craata a major effort on eheaa 133 2 people'* part or our part, for example, to determine that 3 you, in fact are eligible for something that the agency 4 doesn't care that much bacausa of tha health risk. S MS. WARREN1 Wall I Juat wanted you to know that you don't car*. I don't trust them because they don't 7 think it's haxardous. So I think you can gat a lot of theoretical calculations that are don* by just putting your hands over your ayes and theorizing about it. 10 Where tha nimbere could be quite high and, unless 11 you happened to discover than through enforcement which 13 I also don't think ia that likely, you are not going to 13 know about it. 14 11 everything, do you have any suggestions for a strategy? If For example, whan w* approached -- whan you take a look 17 at some of this, we've got tha information from the 10 exemption petitions that we have and, as w* note in the TO proposed rule, we utilize that as dh*~*ffort in developing 20 an anforoaaMnt strategy. 21 You would see this other information as sort of, 22 in addition to that, it would help us focus on people that 23 may have, in fact, not even provided an exemption petition? 34 MS. WARRENi I don't understand the second part. a MR. GUlMONOi I am trying to get at what extra EXECUTIVE COURT REPORTERS (mi) Mi-om HONS 003782 134 1 piacea of information you think you might gat from all of 2 these paopla. Potentially wa could hava a lot of papar 3 coning in here, right, if wa aakad for a lot of tha paopla 4 who qualify -- thay actually qualify for thia axcluiion 9 how thay did it. Wa could hava a lot of papar in hara and 6 I'm ganarally aomawhat concarnad about having a lot of papar 7 coming to ua from raporta that may or may not bo uaaful for ua in doing aomalthing. Than thara ara tha burdana 9 aaaociated with having that papar craatad and, of couraa. 10 tha burdana of ua doing aomathing with it, too. 11 I'm not 100 poreant elaar -- 13 MS. warrent how many piocoa of papar ara wa 13 talking about! 14 MR. SUIMONOi Wall, if you mada everybody -- 11 MS. WARRENi You already hava tha group that m i producing inadvertantly about 50 parta par million. If you 17 confinad youraelf to tha group that waa below that -- m MR. SUIMONOi I don't know how many pieces of 19 papar wa may hava, I hava had estimated coning in from 30 various paopla ranging from a faw hundred to thousands. 31 22 23 24 29 executive court Reporters || (Ml) JM-0M4 MOMS 00373 /vh | 135 MS. WARREN: The alternative is to soy we just trust the Industry to do It nd given thoir concerns or lack of eoncorna about FCBs, it doasn't saan to ma that It Is resson- abla to just assume that It's going to ba adequately dona. MR. GUIMOND: Okay, so this is basically a safaguard You faal it would put mora prassura on than to do it right and u to do it in tha first placa, is that corract? MS. WARREN: Yas. MR. GUXMOND: Thank you. I don't hava any mora questions. Alan? I MR. CARFXEN: I don't hava any quastions. MR. GUNTER: I'd like to follow up on Rich's last 13 ona. Xn your comments you indicatad that era should than, aftar thasa piacas of papar coma in, do somathing to varify tha information. Raading your daseription of what EPA should do, X got tha idaa that wa would ba craating anothar kind of axamption procadura, albait on a ona tima basis. What did you raally hava in mind hara that wa should 1* do with tha papers whan they coma in? 30 Ml. WARREN: X thought that you would look through 31 thaw and than sea which out of tha group of people that are 33 inadvertantly producing PCBa look like candidates for enforce 33 ment. Tha likeliest ones to ba producing lavels that oughtn't 3* bo excluded. At least it will tall you who they are. You 30 don't avan really know who they are. EXECUTIVE COURT REPORTERS (Mi) jo-oo*> MOMS 003784 136 MR. GUNTER* So the verification you really had in mind was roily enforcement of tha rule? ' MS> WARREN: Yea. z don't ... how you art gain? to nfore. thi* by -- with no information about what procaaaaa and what companies, axcapt for tha onaa -- you Know about tha onaa ovar fifty who hava alraady appliad to you for axamptiona You hava no idaa raaliy who tha onaa undar fifty ara. MR. GUNTER: With ragard to tha aatabliahmant of a aariaa of eutoffa for varioua madia, you hava auggaatad that H thaia should ba in tha naighborhood of tha LOO. Wouldn't thaan numbara of nacaaaity hava to ba around tha LOQa, ainca otharwiaa you wouldn't ba able to make quantatatlve mee.urertent*, it would ba balow what you would ba abla to quantify. MS. WARREN: My undaratanding is that thara ara ways to figura out how to quantify onca you hava datactad tham. That might not ba corraot, but I undaratood that it's poaaibls It IJ to davalop a procadura ao that you could msaaura what you It raaliy hava. It ut it's sera than just maasuring what you hava. Tha other questions ara, how much of this product contains 30 21 whatever it is that you hava measured that you hava. and whsra a is it going! Which ara tha things that I am mors eonesrnad a about. I am raaliy less concerned about whatever point you M pich and what the ultimata environmental fata of it would be a and what tha exposures involved in it ara. EXECUTIVE COURT REPORTERS (Ml) J4J4M4 "S,`5 137 MB. GUNTER: Turning to the question of controlled waste processes, when this concept was originally introduced by CMA and submitted to the court in paperwork that we init iated: EOF did not object to that concept then and now you are raising soma objections. What about it has changed your mind? MS. WARREN: I think we didn't realize that the amount of FCBs could really keep increasing and that pro duction could -- as you have even acknowledged in your Preambli , that production could increase significantly as long as it goei to a controlled disposal site. I didn't envision any conclusion to this proceeding that allowed the amount of FCBs that are being produced to increase. That's really the main reason I changed my mind about it. HR. GUNTER: Turning now to the disposal of waste from controlled waste processes, it's true that FCBs are not a listed waste under RCRA but would there be any legal problem or other problem with specifying in the PCB regulations that disposal of wastes be done in a facility approved under the RCRA regulations as an incinerator of organic waste? 30 MS. DARREN: The problem is that if FCBs ara not 31 incinerated at the right temperature for the right amount of 23 time, you get Dibensofuran and other toxic Intermediate com 23 bustion products. You still get them as long as there are 24 a FCBs, and I think if you are not going to control the EXECUTIVE COURT REPORTERS (W) MMM4 HONS 0037S6 US 1 incineration of them proparly that'* going to be a problem. If that could be taken care of by some specification! in the RCRA regs than I have lass problem with it. But I am concerned about the PCBs still getting out into the environ ment and to the extent that they go into landfills that aren't appropriate for them or are incinerated under inproper conditions for them, you are not solving the problem that you set out to solve. MR. GUNTER: That's all the questions I have, thank to you. MR. GUIMOND! Laura. MS. CAMPBELL: I don't have any quaations. 13 MR. GUIMOND: Amy. MS. MOLL: I don't have any either. MR. GUIMOND: I have a few questions from the 10 floor, let me take care of. One of them is regarding, I 13 think this is a comment, and Jackie, you can respond to it if II you would like, regarding Me. Warren's statement on the II protection -- worker protection and clothing barriers. NIOSH document by Dr. Weeks has since published an errata stateawnt. 31 11 Are you aware of this? The errata shows Dr. Weeks was in 22 error in his PCBs -- in that his PCB sample was not PCBs, but contained over fifty percent of a highly chlorinated aromatic 23 24 compound known to permeate rubber. 21 MS. WARREN: Well, unless that condition could never EXECUTIVE COURT REPORTERS (in) MI-WM HONS 139 occur in the manufacturing procasta* in which the protective clothing vaa being used, where PCSe ware present ai a contamin ate, I think what he said was still relevant. MR. GUXMONDi Okay. Second one, it an exposure and health effects assessment demonstrates no significant risks from PCBs with a one hundred PPM cutoff, would you be satisfie< with a cutoff of one hundred PPM? MS. WARMS! Depending on how you reach the deter mination that no significant exposure could occur. If you change your definition of what is a significant exposure, probably I will have a problem with that. MR. GUIMORDs Do you mean a BPA change from no 13 detectable? ' . MS. WARMN: No, from what your determination of what constitutes a significant exposure, which you are pro 1 posing to keep the same definition of significant exposure IT that you had in the previous rulemaking. I* MR. GDIMONDi Okay. Por the record, would If Me. Silbergeld please state her education and possible exper iences with industry practices or alternatively, your qual 39 31 ifications to give testimony today on engineering and analy 33 tical technology. 33 MS. SILBERGELD: Okay. I am the chief toxic 1 scientist of the Environmental Defense Fund. I have a Ph.D. 31 in environmental engineering from Johns Hopkins University, MOMS 00398 EXECUTIVE COURT REPORTERS (XI) SUM 14a 1 | and post-doctural training in toxicology and biochemistry. For 2 Ithrss years I was ths Kennedy fellow in neuro-sciences at 2 I Johns Hopkins Medical School and for seven years a scientist at the National Institutes of Health, ending up as chief of the Naurotoxicology Section. I have also been trained in GCMS and other aspects of chamical engineering and analysis. MR. GUIMOND: Thank you. This is another point relative to the errata sheet that I just mentioned in the other consent frost NIOSH. This is question that I will read and if you would like to comment on it you can. I am not quite sure exactly how it would fit in. The question is, doatn11_ rwpCA preempt the regulatioi, of PCBs by TSCA in the control of liquid waste streams or how will the proposed rule effect the regulation of liquid waste streams by FWPCA? IS MS. WARRENi I don't think that the Clean Water Act 17 does preempt it. In fact, in the Claan Water proceeding back IS in 1977, where SPA was reaching to direct charges of PCS IS stanufacture and had a very narrow category of sources, at that as time it was just PCS manufacturers, deliberate PCS manufactur 21 ers, transformer and capacitor manufacturers, some parties 21 in the proceeding including the EDF, for which I was employed a at the time, argued that there were many other sources of 24 PCS discharge which weren't being included and the answer wes a we will reach them under other statutes and under tha permit EXECUTIVE COURT REPORTERS (Ml) JH m4 NUNS 003789 141 program. So, at that point, tha agency wasn't considarlng 2 tha Claan water Act to preempt it. 1 Thia statute allows tha administrator to daal with 4 any problam undar tha atatuta or anothar statuta if ona or 5 tha othsr saams mora approprlata and it's antirsly discra 1 tionary. 1 don't think that it is praamptad. 7 HR. GUXMONDi Okay. Oo you raally baliava, as ERA said in tha past -- MS. WARREN: Yes. to HR. GUIMONDt Okay. Oo you raally baliava, as ERA 11 said in tha past, that any axposura to RCBs is significant? 12 Is not such a statamant incorract as a matter of seianca? 13 MS. SXLBERCELDi I will bo glad to answar it as a 14 matter of science. Jackie, perhaps, can answar it in its 18 historical context. I think one of tha major problems with a 15 substance like RCBs, as Jackie mentioned, is that it doesn't 17 occur in a vacuum. Both its entrance into tha environment is ia into a context that is already considerably contaminated by a its presence, and certainly its uptake and residence time in 20 humans or any othar organism is for a vary long period of 21 tla. 23 So, it's vary difficult to say would ona part par 23 billion of RCBs in my tuna fish sandwich today rapreaant a 24 significant event. It would depend very largely what I was 2* doing physiologically in my Ufa at that time. For example, EXECUTIVE COURT REPORTERS (Ml) IU-4M4 HONS 003790 142 if I were involved in reproduction, it night be very signifi cant. It would also depend very much as to my historical encounters with PCBs. HR, GUIMONDt Anything to add? MS. warren I already answered the question. MR. GOIMONDi Are there any other comments from the floor7 Questions? MR. BEDFORDs I have two. MR. GOIMONDi Go ahead. MR. RIDFORDi In regard to the setting of limits using the LOD, Dr. Kailey, earlier this morning, spoke about the LOD for some pruducts being far greeter than fifty parts per million. What would be your reaction to a rule that re flected this type of a limit, well above the fifty? MS. WARRINi I think that we would find that un acceptable but on the basis of the potential health effects of it and the LOD itself is just not enough, you need to know more about where the product is going, how much of it -- if you know there are PCBS there -- They know there are PCBS there even though the limit of detection because of the nature of what they are trying to detect it in, doesn't permit them to find it except at relatively high levels but they know it's there. It seems to me that that information plus the answers to those other questions about where is it going. EXECUTIVE COURT REPORTERS (Ml) M)4W HONS 003791 143 hould determine what the regulatory response i* going to ba. LOO by itself, or a numarical aquivalant of LOD, ia not adequate all by itialf. MR. BEDFORD My othar question it on back to tha thaoratical analyaia part. Thara ara a lot of products out thara that, I think, will fall into tha category that wa ara talking about, and wa will have to, tha way I understand it with your suggestion, is sand in something saying that they have looked at it and have determined that it doesn't have PCBs. ' What about products that -- I mean, how far are we going to go? How far do you suggest we go? Should OS Steel have to check steel parts, steel I beams -- I mean, where do we draw our line on the amount of paper work that we are going It to accept? Virtually anybody out there who makes s product |could end up having to send us in something saying wa don't It think we have PCBs. Where do we draw our line? MS. WAJUIZNi The drawing of lines is something -- It it's necessarily arbitrary and it's something that regulatory M agencies have to do and that is what they are in business to J1 do. I am not going to be able to sit hare and say to you this n is where you do it. You have some inherent authority on the a basis of administrative necessity to draw the line at a point M that I might be unhappy with, but which you, for Justifiable a reasons, can't deal with beyond that point. EXECUTIVE COURT REPORTERS (Ml) MI4M HONS 003792 144 I That'* something that you ara going to hav* to do j on your own. But it'* impo**ibl* -- it'* something that you 1 fact in avaryday -- 4 MR. REDFORD: What would you sugg*st7 I main, what 5 could wa usa to even attompt to coma to that hind of a line? * I hava no idaa. You don't hava to *n*war if you don't want 7 to. Hava you got a (uggastion? I MS. WARREN: 1 don't think I hava an answer off tha * top of my haad right now. 0 MX. GUIMONDi Any othar followup question*? Okay, , thank you vary much. U Elactric hara? Ara tha rapraiantativa* from Ganaral 13 MR. BLUMEt Wa ara hara today to rapraaant Ganaral 14 Elactric Company' a Silicon* Product* Division. I m Richard 15 Blum*, our Division Coun**l. To my right i* Dr. Dsn Silva, .- Ganaral Manager of our Tachnology Development Department. To Dr. Silva'* right 1* Mika Scarbal, our Managar of Quality Aaaurane*. To my left la JaffrayCarar, our outaida litigation counaal, with tha Washington law firm of Sguiror*, Sander* and Dampsay. Dr. Silva will l*ad off our presentation today. DR. SILVAi Thank you for tha opportunity to part icipate in this informal haaring. The Ganaral Elactric Company raquaatad this opportunity so that wa make axplain tha affect that ERA'S recant proposal for the regulation of PCS* enclosed and controlled wasta manufacturing systems will hav* on G.E., EXECUTIVE COURT REPORTERS (W) J4I44M HONS 003793 1 iti customers, and the public. 145 G.E. hot invaotad a considarabl# amount of time and axpenaa in afforta to reapond to the PCB iaaue. Individually, and aa a member of the Chemical Manufacturera Association, we recently aubmitted comments on EPA's June 8, 1982 proposal for the regulation of PCBa and inadvertently generated enclosed manufacturing systems with controlled waste processes. 1 direct your attention to those commenst as a statement of G.E.'s concerns with the overall regulatory ap proach that EPA haa chosen to follow respecting incidential PCBa. Those cossaents explain that as currently formulated, the EPA proposal does not provide relief from the ban for G.E.'s carefully controlled process. Today, I would like to concentrate on a number of aspects of this subject. Number one, the nature of the G.E. process within which Incidental PCBs are generated. Number two, the importance of G.E.'s manufactured products to U.S. industry and national security. Three, G.E.'s efforts to eliminate incidental generated PCBs. Four, General Electric's '20 efforts to develop alternative processes and reformulate its 21 produets. And five, the economic impact of the EPA proposal. 22 G.E.'s involvement in this proceeding stems from cur 23 phenylchlorosilane production process at General Electric's 24 Silicone Products Division in Waterford, New York. An unwanted 3 biproduct, monochlorobiphenyl and dichlorobiphenyl, unavoidabl EXECUTIVE COURT REPORTERS (Ml) MJ4M4 HONS 003294 146 | result from the chemical reaction by which phenylchlorosilaneel I art produced. These unwanted by-products occur within General Elsctrlc's process equipment and ace removed for dastruetion in an incinaration facility approved by EPA, Region II, in compliance with the PCS disposal and marking regulations. This integrated process releases PCBs well below the EPA permitted values to the air and water and only trace amounts of mono- Iand dichlorobiphenyl in concentrations below the fifty part per million level and up in the products. Phonylchlorosllanes are essential precursors in the production of certain highly engineered silicone products due 13 to their superior high and low tamperatue performance, radia tion resistance, clarity and flexibility. Silicone products are used extensively in the aerospace, automotive, construc tion, defense equipment, electrical, electronic, and energy 17 industries. Typical uses for silicone products containing phenyli 1* ehloroailanes include seals, hoses, insulation, adhesives, at coatings, lubricants and fluids where properties of high and >1 low temperature performance are required. Phenylchlorosilane a based silicone products are used for thermal insulation and a sealants in aircraft, spacecraft and communication satellites. M Our Versilube F-50 silicone fluid is the only fluid available a for use in the constant speed drive of the A-4 aircraft flown EXECUTIVE COURT"REPORTERS (Ml) Ht Ml HONS 003795 147 by th Navy, a G.B. product* in the RTV-500 series arc uaad in 3 rocket motor* and r#-*ntry body assemblies of tha Tridant 4 flaat balliatic missis, and ara tha only matarials which ara I qualified for auch us*. Phanylchlorosilan* based ailicona f product* ara uaad a* an adhasiv* for tha thermal tila* of tha 7 paca ahuttla dua to thair ability to withatand axtrama tan* 9 paratura* upon ra-antry to tha atmosphere. Thay ara alao an aaaantial part of our daily Ufa 10 a* aaalanta and aa coolant* in car angina* aa wall aa waathar11 proof coating* for conatruction matariala and inkulators for 12 alactrical talaviaion components. 13 Hiatorically, in 197?, tha Ganaral Elactrie Silicon* 14 Product* Department coneludad that tha praaanc* of mono15 and dichlorobiphanyl product* in silicon* products darlvad IS from phanylchloroailanas, avan at low lavals, was likaly to 17 bacon* a public concarn. IS Without waiting for legislative or ragulatory action, If Ganaral Elactrie voluntarily undertook an extensive and com30 prahanaiv* technical program with tha objaetlv* of ensuring 21 that PCI materials war* not distributed in commerce and did 22 not aiitar tha environment^** a result of phanylehloroailan* 22 manufacturing. 24 In 1975, no one for aaw that unintentional forma 9 tion of PCB byproducts enclosed in controlled ayatama would ba EXECUTIVE COURT REPORTERS (Ml) J4JMM4 MOWS 00379b UB subjact to s regulatory ban. Bstwsan 197S and 1979, General Cltctric devoted substantial, highly sophistieatad aciantifie facilities and human raaourcas to tha affort to raduca PCS ganaration. Ovar thesa four yaara va attamptad to find a sub- stituta procass for phanylchlorosilana production that would not produca by-product PCBs, and to modify our currant diract procass to raduca tha parcantaga of by-product PCBs producad, to davalop substitute products for phanylchlorosilanas and to davalop procatsas which would remove and destroy unwanted by product PCBs from tha phanylchlorosilana procesa. Since 1979, General Electric has had an ongoing program to identify substitute products and to attempt to discover a now procass that would not involve by-product PCBs. Tha specifics of that program ware supplied in a confidential submittal to EPA on July 31, 1979. To data, this IT program haa resulted in only limited improvement in Ganaral 1* Electric'a ability to substitute products or to develop a new It procass. x> Wa have baan successful, howavar, in removing PCBs from our- current process and destroying than. As early as a 197C, Ganaral Electric's Silicone Products Division reduced a tha PCBs in tha procass to a sufficient degree that by-product Ia PCB concentrations in products ara below fifty parts par a million. Moreover, our on-site disposal facility, which wa EXECUTIVE COURT REPORTERS (M) JU4M4 MOWS 003797 149 imtillid At a cost of tons of millions of dollars, Assures the ssfs end sfficiAnt incineration of PCBs. EPa's ban on incidental by-products in 1979 came as an unpleasant surprise to Ganaral Electric, particularly because it applied to PCBS generated inside process equipment, where there is no exposure. EPA must have assumed that the number of processes generating an incidental by-product was smail and intended to use the annuel exemptions to deal with the phenomenon. I G.E. filed a request for a manufacturing exemption in order to continue operating the phenylchlorosilanes process, Because the 1979 regulation defined PCBs to include only those substances that contain PCBs in concentrations of fifty parts 21 per million or greeter, the processors, distributors, and end a users of our products did not require exemptions. a General Elactric filed a law suit challenging the M regulation on the basis that Section CE of the Toxic Substance! Control Act did not apply to incidental by-products. However, when the EOf court decision necessitated a new rulemaking. General Electric choEsXeECtUoTIVpEosCtpOoUnReT IRtEsPORlaTwERSsuit in the belief (JM) MMM4 that EPA would formulate an appropriate, re-OgNuSlatory solution for incidental by-products in that rulemaking. One final avenue of relief General Elactric hat sought is the exclusion of mono- and dichlorobiphanyl from 150 amp la justification for that action, General Elactric peti tioned EPA on July 14, 1982, to amend the PCS regulation in that reepact. Thif ii what the picture looks like in 1982 for General Electric Company* Our exemption request, originally filed in 1978, has never been acted upon by EPA. On Auguat 2, Ganaral Electric will file, at EPA'a request, a renewal application for exemption. The fifty part per million cutoff in now in doubt, meaning that even if General Electric geta a one year manufacturing exemption, the processing, distribution and uae of our phenylchlorosilane based silicone products may still be prohibited. What General Electric is hoping for is that EPA will recognize the strong justification for excluding our system and products from the ban. However, EPA has been working j since November of 1980 on developing a rule to deal with the incidental PCBs and other PCBs in low concentrations, and no relief is yet in sight. Given the history of this rulemaking, it is clear that EPA's notice of proposed rulemaking of June 8, 1982, is an attesqpt :o come to grips with incidental by-products. In that proposal, EPA announced its conclusion that excluding from the ban incidental PCBs produced in closed and controlled waate manufacturing systems would not pose unreasonable risk to health or the environment. I HONS EXECUTIVE COURT REPORTERS (M) fJ OWE 003799 LSI Hovvr, epa failed to establish a meaningful, di minimis standard by which incidentally generated PCBs can be regulated. The current proposal therefore offers no relief to General Electric and others who can quantify PCBs of their end products. As the June 8, 1982 proposal is structured, regardless of whether trace amounts of PCBs found in endproducts of these processes cause minimal or no risk to health or the environment, all proc.aaaa and and products in which Itraca PCBa can be found, will b banned. We at General Electric tr very concerned. The date which the court's mandate goes back Into effect la laea than three months away. EFA waa to have completed work on a 13 dl minlmla standard by than, yet EPA has given no Indication when, if at all, it will propose a di minimis standard by which companies in our position continue to operate. Unless the court once more extends the stay of its mandate, companies such as General Electric, who can quantify trace amounts of PCB impurities in their end product will tee It their products banned. Even if EPA publishes the regulation 20 as currently proposed, industrial usara and supplies of these 21 products will also be prohibited from using or distributing 22 products containing trace amounts of PCBs after this dats. 23 If this ban continues. General Elsctric will have 24 only one alternative to ceasing production of phenylchloro1 silane based silicone products. It will have to rely upon EPA 28 EXECUTIVE COURT REPORTERS MI4N4 MONS 003800 action on it* axamption request. 1:1 As Ganaral Eisctric has alraady pointed out in its connMnt of November 16, 1981, submitted in rssponsa to tha May 20, 1981 advanca notica at proposad rulemaking in this proceeding, tha axamption procass is an inadaquata solution to tha problem, dua to tha unjustified axpanaa and administrativa burdan that it placaa upon industry and EVA alike. Il Ganaral Elactric's only hops is to raly upon submitting its axamption request to epa aaeh yaar in ordar to continua producing phanylehloroailanas, than Ganaral Elactrie must considar tha likalihood that it will hava to discontinue production of phanylchloroailana basad silicona products. Tha loss of its phanylchlorosilana basad product lina will not toppla G.E. Howavar, tha impact of this avant upon Ganaral Elactrie, ita employees, consumers, and indeed our national defense, will be severe. Currently General Elactrie sails hundreds of pro ducts derived from the precursor phanylchlorosilana* to thou sands of direct customers. Tha immediate economic effects to general Electric of discontinuing its phanylchlorosilana based ao *t products include tha immediate loss of tans of millions of a dollars par year in sales and tha estimated direct loss of a mora than 200 jobs at its Waterford, Maw York facility. aI In addition, this would rapraaaat a loss of our a substantial investment in developing a process for removal of EXECUTIVE COURT REPORTERS (M) JCMM4 MQNS 003801 151 by product PCBi from phanylchloroailana -- from th phanylchlorotiUnt procass, along with tha lots of praaant facilitiai for tha production of phanylchloroailana and ramoval of by products, mono- and dichloroaiphanyla. Tha combinad valua of thaaa facilitiaa ia aatimatad in tha tana of millions of dollars. Tha majority of tha capacity of thasa facilitiaa can not ba usad for any othar applications. Furthar, tha unavailability of phanylchloroailana basad silicona products would hava a asvara, advarsa aconoraic Impact on diract customars and othar usars. As indieatad abova, phanyl containing siliconas ara typically usad in tha highly critical applications such as military, coaawrcial aircraft, military aguipmant, and our nations' highly vlsibla spaca shuttla. In many applications, phonylchlorosilana containing |silicona products ara SpOcifically raguirad by custoswr opacifications. Tha consaguancas to commarcial customars would ba substantial, both in tarma of lost profits and salas, It and tha inability to find substitutas. Ivan if lowar parformanca materials for substitution il could ba found, this would raguiro davalopmant programs astia matad to ranga in duration from ona to tan yaars. Tha most a critical applications would tand to raguira longar davalopmant 24 and avaluation tima. Humorous General Electric customars hava a writtan to EPA to amphasiza tha importanca of our products to EXECUTIVE COURT REPORTERS U (Ml) Jll-MM HONE 003802 thorn. 15-t Mot recently, on July 12, 1982, the Department of tha Navy wrote to EPA that a ban would ground tha A-4 aircraft and would nacaaaitata a aavaral yaar program to raplaca tha conatant speed drlvaa on all affactad aircraft at a coat of r.ora than $16 million. Othar advaraa affacta of tha diacontinuanca of General Elactric'a phanylchloroailana baaad ailicona product., includa tha aubatantial loaa of aalaa and joba for auppliara of good! and aarvica to tha Watarford plant. Tha diacon tinuanca of General Elactric'a phanylchloroailana procaaa will 1 hava an impact, not only on tha Watarford, Now York araa, but 13 on tha national aeonomy as wall. Usa of tha annual axamption procaaa to daal with tha larga numbar of proeassas and products involving inci dental PCB by products would ba moat unfortunata aa a mattar of public policy. Such a aolution to tha problem would ba 1C illuaionary. Not only tha adminiatrativa burdana that it 1C plaeas upon EPA and industry alike, but bacausa it fails to 20 addrass tha raal issua posed by incidental PCBa. Tha raal iaaua in this entire proceeding is whathar II regulating PCBa aa a dafinad regulatory cutoff would adequate a ly balance tha interests of industry, government, and con a sumers. Tha exemption process is cumbersoma and time-consuming 34 n and is daaignad to daal with case by case issues. It is not EXECUTIVE COURT REPORTERS (mi) wan HONS 003803 155 the propor forum to address major issues that cut across all 2 tho interests involved. 3 Such an ad hoc approach will necessarily make a 4 sham of the exemption mechanism. Either the annual exemption s will be pending for years, at has already happened, or EPA will rush through applications with a cursory view that does 7 not address anybody's interests. Meanwhile, the applicants are left hanging in the balance wondering when an adverse decision will put them out of business. 10 I have attempted to emphasise to you today the 11 efforts that have been made by General Electric to solve the 12 PCS problem. So far, theta efforts have not guaranteed us 13 the right to operate our process nor has the substantial 14 amount of time and money invested in the administrative pro It cess by private industry and government achieved such a It guarantee. 17 I have outlined the severe economic impact EPA'a It most recent proposal will have on General Electric and its It customers. He have no doubt that the proposal equally affects 20 many other companies. EPA itself recognised in its June 1, 21 1913 proposal, that a ban on incidental by products would cost a billions of dollars and cause the elimination of a wide variety a of products with great social value. If this is the ultimate result of BPA's efforts on 34 PCBs, we submit a major public policy mistake will have been EXECUTIVE COURT REPORTERS (m) le-aoM HONS 003804 15 1 road*. w must reach a aolution to the dilemma of incidental 2 by products as soon as possible. October is already close at 3 hand for EPA to ba equivical on this issue. If EPA is not 4 prepared to agree that the statute does not ban incidental S PCB by products, then it must achieve a practical compromise. 6 setting a meaningful regulatory cutoff for the manufacture. 7 processing, distribution and end use of incidental PCBs, can I adequately balance tha interest involved in this proceeding. Until EPA takes action to resolve the current 10 dilestna, the uncertainty and confusion will continue. Thank 11 you. 12 HR. GU1MOND: Thank you. If I understand your pre13 sentatlon here you, of course, are particularly concerned 14 that G.8. is not going to make the proposal as it is now IS structured, right? IS DR. SILVA: Correct. 17 HR. GUINOND: Do you also believe that your products IS present little human exposure, environmental exposure? If DR. SILVA: To the beat of our knowledge, that's 20 correct. 21 HR. GUIHOND: You have done some kind of analysis 22 and you feel that people are not coming in contact directly or 23 they don't get into the environment or whatever, is that 24 correct? 20 DR. SILVA: He have a wide variety of products, end EXECUTIVE COURT REPORTERS () 14J-40S4 HONS 003305 157 products. Many of thoss materials havs tracs levels of pcBs 2 in a matrix which doas not allow movamant of that matarial 3 from tha matrix. I could give you a mora dafinitiva answar 4 on that if you would submit that question to us in writing. ft wa possibly could giva you a spactrum on soma of our products. MB. QUIMONDi Okay. Lat ma ask a hypothetical 7 question. You have already identified your concern that you right now do not fall into this proposed exclusion, therefore ara up in tha air as to what might happen in the future. 10 whether you have to just rely on tha exemption petition pro 11 cess, if subsequent to this rulamaking, if EPA want ahead with 12 this currant rulemaking and tha way it's sat up now, want 13 final with it, and you did not qualify, and in tha following 14 rulemaking which wo are currently planning to undertake, we 11 than proposed to exclude products that presented little risk. 1ft and assuming that your's fall into that, would tharo bo any 17 economic impact or any problem to you at that stage? Would 1ft that be reasonable solution for you? Could you live with that? 1ft DU. SILVAi If you ara talking about, again, an annual exemption procedure, and we would have to verify the 30 21 levels -- 22 NX. OUINONDi I am not talking about an annual ex 23 emption procedure, I am talking about -- DU. SILVAi You are talking about a permanent -- 24 2S MX. GUIHQNDt Let's just hypothetieelly assume that EXECUTIVE COURT REPORTERS (Ml) MJ4M* .. HONS 003806 138 w cam* up with a third rulemaking and th* third rulamaking 2 conaiatad of, part of it in any ovant, wa propoaad to exclude I cartain procaaaaa that praaantad di minimi* riak or m*n riak, that war* ovar and abov*, that wara diffarant kind* of I procasaa* from cioaad and eontroilad wait* procaasas. Lat'a hypothatically aaaum* that your'* fall into it 7 What would ba your problam with thi* rulamaking in that event? DR. SILVA) My opinion ia that it would b* of * minimal impact, aaauming that w* had quantativ* limit* on 10 what you ara talking about in tarn* of riak. Wa would want a ! quantative aat of apacificationa. 11 MR. BLUMXi I am not cartain to what you ara refer 13 ring with raapaet to tha naxt phaaa of th* rulaawking rela 14 tive to a procaa* othar than that which ia baing r* farrad to II today. II MR. GUIMONDi Alan Carpian rafarrad to it aarliar 17 whan wa talkad thia morning, ia that wa ara doing thia cioaad II and eontroilad rulamaking raaponaa to tha court and than w* II hava aehadulaa to do a third rulamaking that daala with un- controllad PCBa, and it haa alwaya baan our lntant in tha n eloaad and eontroilad ona to daal with a category which wa* a daacribad from -- atartad from original diaeuaaion* with a induatry and than waa ultimataly -- a daal, if you will, waa 14 out in an ordar with tha court. a What I am aaying ia that that doaa not preclude ua EXECUTIVE COURT REPORTERS (Ml) J4J4M8 MOMS 003807 159 from excluding additional procasaaa bacauia thay prasant di minimi* riak although thay may not ba cloaad and controlled waata procaaaaa. what X am juat trying to find out la that if you faal -- Lot'* aaauma you don't qualify for thia, and wa fix thia go you gtill don't qualify, in tha third rulamakinq you atill coneaivably might qualify for an axelualon dapanding upon tha riak aaaociatad with what you art doing and how that gata craftad. If, in fact, you did qualify in that third rulamaking, would thara ba any particular impact or nagativa problem* created for General Electric by thia currant rulamaking? What I am trying to gat at, it aaama that you ara calling thia one a large impediment, thia it a problem beeauaa |you ara not included in it. Tha raaponaa, I guaaa, or tha thing ia that tha rule may not have bean craftad for incluaion of your kind* of thing*. It doaa not mean that your kind* of procaaaaa would ba banned. I am trying to find out, given that aa an aaaumpl tion, do you have any additional problem* with thia rule making? ME. SLUMSi At the riak of reducing tha quaation to 21 a baaiea, I gather the quaation ia, that if a further phaae of ' a tha rulemaking warn to coma up with parameter* ba faahionad M along linaa which would axcluda our procaaa, would wa ba warn a and happy? EXECUTIVE COURT REPORTERS (W) MMOW HONS 003808 MR. CUIMOND: Yea, you have got it. ISO MR. BLUME: The anawar to that it definitely yas. MR. GUIMOND: A raal fuzzy fatling. MR. BLUMEj Jaff, did you hava something? MR. CERARi Yea. I'm Jaff Carar. I am counaal to G.E. on thia rulamaking. Tha thing that troublaa ma about tha guaation it that it waa praeiaaly our kind of procees that thia daal that waa atruck waa auppoaad to ba addraaaing. That ia why wo hava difficulty with it. Whan wa llatanad to your guaationa thia morning of CMA, whara you raad from a January 1981 aubmlaaion to tha court, I think it'a a miataka to characterize our poaitiona today aa inconaiatant with what I] waa aaid back than. For example, tha cloaad ayatam, aa dafinad in that aubmiaalon, and dafinad in aoma of our dlacuaaiona, wa had l troubla with tha concapt of any datactibla PCBa, but aa a matter of fact, tha cloaad ayatam waa auppoaad to ba -- tha attempt waa being made there to define eomathing that waa it almoat a theoretical poaeibility. That waa a ayatam in which FCla coma and go and they ara created and disappear and never >1 go anywhare. a Nobody haa ever boliavad, tha CMA people have never a baliavad that there would ba vary many ayataaw falling into M that category. Tha controlled waata ayatam, aa you hava called a it, and aa waa part of tha diacuaaion back in 1981, 1980, ia EXECUTIVE COURT REPORTERS (Ml) JCJ.OOM HONS 003009 161 1 rwlly thm on* thst w *r talking about and it's tha ona that G.E. would hopa to qualify for. That'* ona whara thara ara PCli that coma out of tha syatam in tha products and in tha wait.. The problem with the mechanism that you fashioned hero la that it goaa down to level* that ara to low that no body can qualify for It. If there are people who can qualify for it, then our aurmiae la in error, but G.E. can quantify at auch low levela that the ayatam, aa aat up, la of no practical value. Sure, it would make G.E. very happy to be excluded one way or tha other from thia, and in that aenee, thla proposal wouldn't poae an impediment. But, thia pcopoeal waa auppoaed to deal with preclaely the kind of problem that we have brought to your attention. NX. GUIMOND: Okay, thank you. I am, unfortunately, 17 going to have to leave for a few minute* to go to a maeting ! 1 can't avoid. In my abeence. Bill Gunter will be tha It Chairman of the panel. ao NX. GOMTEKt Amy Noll. 21 NS. NOLL: Would you aay that moat of the proceaaaa n that you say would not be excluded under thia rulee^king, a would not be excluded on tha baaia of the concentration of H PCBs in their product*, like in G.E.'a case? n DR. SILVA: If I can repeat tha question a little EXECUTIVE COURT REPORTERS __ (m) mi-ww----- NOhS 003810 162 1 | nd fee if I understood whst you are saying, you are saying 2 I the exclusion would not be grented based on the levels in the 3 B final products, is that correct? 4 MS. MOLLi Yes. 5 OR. SILVA: I, speaking for our own proeess, I believe that's correct and l think for many other processes 7 (that I am familiar with I would also agree. I I MS. MOLL: You mentioned that G.E. has filed ex- t eaption petitions in the past. Can you give us any idea as 10 to what the costs of filing those exemptions has been for II your company? Or if you could submit that information. t2 OR. SILVAi Hell, the coat is -- if you want to try II to calculate the direct costs, you might want to try to look 14 at xeroxing. I am trying to be a little facetious here, but 15 it's the indirect costs that gat you on these proposals. For 10 instance, the exhaustive analysis of our product line and the 17 precursors in many of our product lines are the type of in IS direct costs that are built into these exemption petitions. 10 Having to do this yearly would mean we would have 30 to update our anaylsia every year and, in fact, I would put the coat in the range of several -- tans of thousands of a dollars -- certainly over one hundred thousand dollars cumu a lative for preparing just our petition. a MS. MOLL: Does that include doing all the research to find alternative -- EXECUTIVE COURT REPORTERS ()! MANS 003811 if j 1 DR. SILVAi No, no. That's why I say, if you want 2 to include the actual tatting, at catara, that want into 3 bain? abla to prepare tha patition, it'a in tha rang* of 4 hundrada of thouaanda of dollars, ha wa gat into tha afforts 8 t outlined regarding alternative processes, wa ara talking millions of dollars, and that did not include thosa efforts. 7 MS. MOLLi What would you say ara tha closast substitutes for phanylchlorosllanas at this point? DR. SILVAi I wiah I know. I think wa have looked i10 at soom materials which coma close, but having tha right mix 11 of overall properties is tha issue, flexibility, low tamper12 ature, high temperature, electrical rasistanea, radiation 13 rasistanca, having all thosa things in tha right molecule is r 14 pretty tough to coma by. It It'a many of thosa problems that have caused many 10 of our customers to coma to us for thasa specific materials. 17 The space shuttle is a good example. Thera it no material 10 that has bean able to achieve the type of adhesion and thermal It resistance to date. 30 MS. MOLLi That's all I have. 21 MR. GUNTERI Laura. 21 MS. ,CAMPBELL: My first question relates to worker 23 24 avoid worker exposure or deal with this problem to PCBs during the production of phenylchlorosilanea? EXECUTIVE COURT REPORTERS (Ml) J4J4M4 HONS 0038X2 164 1 DR. SILVA: Okay. Phanylchloroiil*nM arc produced in a cloaad systwn. Tha work placa monitoring is-dona routing ly at Watarford and has lookad at vary low lavala of PCBs in tha air. All thosa anaylsas hava baanr if you will, analyxad and proc.is.d and ara don. coutin.ly. I an not axactly aura of tha tima ftam. in which wa ara doing than now, but it ia aaaantialiy an air sampling typa of tachniqua. Soma procaduraa involv. tha oparators waaring actual sampling davicas which ara than analyiad as part of tha whola sita survay. Mika haa coatnantod thatsoma of that data is peasant in tha 1979 oxanption patition. NS. CAMPBELL: Ha also asbad for information in tha f notica of proposad rulanaking and I was wondaring if you hava any data indicating both tha numbar of accidantal or unplannad ralaasas of PCBs, and if so, tha amount of PCBs ralaasad during such avants? DB. SILVA: I an not faailiar with what information 19 wa hava submittad to data. Dick, would you Ilka to -- 30 MB. BLOME: Ho eartainly don't hava that information at with us today, but to tha axtant that such incidants ara at raquirad to ba raportad, thoy of coursa ara, and that inform, a ation it availabla to you. 34 MS. CAMPBELL: Okay, X am intarastadparticularly a in if thosa incidanta hava occurrad, what maasuras hava baan EXECUTIVE COURT REPORTERS (Ml) MQNS 003813 165 tolcon to protoct tho workers or to prevent environmental ex posure, clean-up procedures. OR. SILVA; We have standard procedures for all the processes that involve phenylchloroslianas which contain PCBs. Those are documented procedures in terms of how operators and various other workers can-- must, if you will, handle the materials which are spilled or whatever. Dick pointed out that there is a notification procedure involving PCS releases, and to my knowledge we have been following that procedure. I do not have the specific Information relating to how much or if there have been any releases. MS. CAMPBELL; Thank you. MR. SUMTER; Dr. Silva, in your prepared statmaent, you Indicated that the date on which -- on page 7, you cossninicated that the date on which the court's mandate goes back into effect is less than three months away. Are you not 17 aware that that mandate has been extended -- that the mandate has been extended to December 17 DR. SILVA; No, I was -- MX. CARRIER; It is stated in the Preamble. It has JO been requested in the Preamble and the court granted the a request and gave the date. It is April IS or 9, I can't a remember exactly the date. a DR. SILVA: Okay, so we have an additional month. a It doesn't help us -- it would be nice for a Christmas present EXECUTIVE COURT REPORTERS (301) MMO04 HONS 003814 isc I MR. GUNTERi I would like to addrosi till* noxt 1 queation to the two ottornoyo. If EPA li to go back to tho s court, ao wo aro currently ichadulad to do on Novambar 1, with a plan at to how wo aro going to addroaa tho third part at tho rulemaking, wouldn't our credibility with the court bo im proved if wo had gono forward with tho promulgation of a 1 final rule on cloaod and controlled tyatema ao tho court had ordorod ua to do, rather than to withdraw that and report to the court that we are aimply dropping back to rethink the 10 whole aituation? II MR. CERARi I agree with your baaic praadae that it 12 ia alwaya batter to ahow aoma action when you are going back 13 to the court, particularly action that you aaid you wore going 14 to taka. But, if we are correct that it doean't do anything, 10 that ian't a vary aatiafactory kind of action. Maybe at thia 10 point we ought to aay that we haven't naked you to withdraw 17 thia propoaal. General Electric haa not. II What General Electric would like would be thia pro10 Jpoaal with an acceptable cutoff aubetituted for the level of detection criteria and that la doable within the period direeted by the court. a MR. GUNTERI You would like to aee an acceptable a cutoff baaed on the higheat di minimia atandard which could I14 be aupported, ia that correct? a MR. BLUMSi That'a correct. MQNS 003815 EXECUTIVE COURT REPORTERS (wt) ni m