Document 0vEXkO4RJ63jR3gdB0DeMNEd

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY BEFORE THE ADMINISTRATOR In the Matter cf: ) PROPOSED TONIC POLLUTANT EFFLUENT ) STANDARDS FOR POLYCHLORINATED BIPHENYLS ) FWPCA (307) (PCBs) ) Docket No. 4 ) OPENING BRIEF OF THE ELECTRONIC INDUSTRIES ASSOCIATION'S AD HOC PCB COMMITTEE December 22, 1976 PETER J. NICKLES STEVEN S. P.OSENTHAL JOHN MICHAEL CLEAR COVINGTON S. BURLING 888 Sixteenth Street, N.W. Washington, D. C. 20006 Attorneys for The Electronic Industries Association's Ad Hoc ' PCB Committee MONS 089908 CONTENTS . Page INTRODUCTION ... ................................................................................... 1 FACTUAL' BACKGROUND................................................................................... 6 A. The Chemistry of Polychlorinated Biphenyls ................................................................................... 6 B. The Chemistry ofAroclor 1016............................ 8 C. The Need for Aroclor 1016 in Capacitor Manufacturing ............................................. 12 ARGUMENT I. THE PROPOSED BAN ON PCBs UNDER THE FEDERAL WATER POLLUTION CONTROL .ACT SHOULD NOT BE . ADOPTED...................................................................................................15 A. The Toxic Substances Control Act Provides a Congressional Ban of PCBs Which Should Not Be By-Passed By Regulation Under the Water Pollution Control Act....... 15 B. National Effluent Discharge Limitations for Aroclor 1016 Represent an Abuse..of Discretion under the Water Pollution Control Act............................................................................22 II. AN END-OF-PIPE LIMITATION OF 100 PPB FOR AROCLOR 1016 WILL PROVIDE AN ADEQUATE MARGIN OF SAFETY TO THEENVIRONMENT.............................26 A. Ambient Concentrations of Aroclor 1016 Will Be 1000-Fold Smaller Than The . End-Of-Pipe Concentration ...................................... 29 B. Aroclor 1016 Has Not Been Shown To Have Any Toxic Effects on Aquatic Animals Except At Levels Greatly In Excess Of ' The Proposed Ambient Criterion of 100 | PPt.....................................................................................31 C. Aroclor 1016 Will Bioaccumulate In Aquatic Organisms By A Factor Not Greater Than 50,000 ............................................................................. 34 D. Aroclor 1016 Has Not Been Shown To Have Any Toxic Effects On Consumers of Aquatic Organisms At A Dietary Level Below 15 ppm.................................................................................................. 40 MONS 089909 ii E. A XQO. ppb Discharge Limitation for Aroclor 1016 Provides An Ample Margin of Safety to the Environment 48 III. A ONE PPB DISCHARGE LIMITATION FOR AROCLOR 1016 CANNOT BE FAIRLY ADMINISTERED................................ 50 A. The Lowest Discharge Limitation for Aroclor 1016 Which Can Be Accurately Measured Is 20 ppb...................................................... 51 B. Any Discharge Limitation Adopted Should Be a "Net" Discharge Limitation to Adjust for Preexisting PCB In InfluentWater ..... 55 CONCLUSION................................ 57 ' APPENDIX: Outline of Scientific Evidence Presented By the Environmental Protection Agency Concerning Aroclor 1016 huns 08991Q UNITED STATES ENVIRONMENTAL PROTECTION AGENCY BEFORE THE ADMINISTRATOR In the Matter of: PROPOSED TOXIC POLLUTANT EFFLUENT ) ) STANDARDS FOR POLYCHLORINATED BIPHENYLS ) FWPCA (307) (PCBs) ) Docket No. 4 ) OPENING'BRIEF OF THE ELECTRONIC INDUSTRIES ASSOCIATION'S . _________ AD HOC PCB COMMITTEE The issue presented in this proceeding is whether the Administrator should adopt proposed effluent standards for discharges of polychlorinated biphenyl (PCB or PCBs) into navigable waterways. Tne pertinent statute is Section 307(a) of the Federal Water Pollution Control Act, as amended by the Federal Water Pollution Control Act Amendments of 1972 (Pub.L. 92-500, 86 Stat. 816, 33 u.S.C. $1251 et seq.) In its Notice of Proposed Rulemaking, 41 Fed. Reg. 30468 (July 23, 1976), the Agency proposed a 1 part -per billion (ppb) discharge limitation on all "manufacturers of transformers and capacitors who use PCBs and who dis charge directly into the navigable waters." (41 Fed. Reg. 30468) The Electronic Industries Association's Ad Hoc PCB Committee filed objections to this proposed standard, and MONS 089911 2 participated as a party in the rulemaking proceeding. The Ad Hoc Committee is composed of the nine capacitor manu facturers who use Aroclor 1016, one of the many different varieties of the family of chemical compounds known generally 1/ as PCBs. Five of these companies would be directly and adversely affected by the proposed discharge limitation. Although the Agency has proposed PCB discharge regulations and has undertaken to prove that treatment technology exists which can reduce PCB effluent levels to 1 ppb as proposed, the practical effect of the Agency's proposed PCB discharge regulations.is to ban the use of Aroclor 1016 in capacitors and transformers. The evidence is undisputed that no capacitor or transformer manufacturer will invest the very substantial sums required by the pro posed discharge limitation to install and maintain effluent treatment facilities, (sea Tr. 2116; 2310-2312; EIA Exh. A at 2; EIA Exh. C at 7) The reasons can be traced to two developments which occurred after the Agency's issuance of its July 23, 1976 Notice of Proposed Rulemaking. Aorovox Industries, Inc., Comell-Dubilior Electronics, Inc., Jard Company, Sangamo Electric Company, Sprague Electric Company, and Universal Manufacturing Corporation discharge into navigable waters and their effluent arguably contains Aroclor 1016. HONS 089912 3 First, the Toxic Substances Control Act, f'ub.L. 94-469, 90 Stat. 2003, 15 U.S.C. 52601 et seq., passed by Congress this last session and signed into law by President Ford on October 11, 1976, will ban the use of PCB3 in the manufacture of capacitors and transformers after January 1, 1979. See 15 U.S.C. 52605(e) (3)(A). Thus, irrespective of the efflu ent standards adopted by the Agency, no manufacturer of capacitors will be per mitted to use Aroclor 1016 after 1978, unless exemptions are granted by the Administrator pursuant to the tsca. Second, the only U.S. manufacturer of Aroclor 1016, the Monsanto Chemical Co., recently announced that it will terminate all production of PCB, in cluding production of Aroclor 1016, by August 31, 1977 and that it will termi nate all shipments of PCB by October 31, 1977. It is estimated that with maximum use of stockpiles, capacitor manufacturers will cease all PCB use by the third quarter of 1978 because pcbs will not be imported to substitute for the Monsanto-oroduced Aroclor 1016 material. (E1A Exh. B at 9 10 [Hutzler]; EIA Exh. C at 10-11 [Clark]; Tr. 2086-2087) . The Agency should be aware that in undertaking to regulate PCB discharges, it is effectively banning the use of Aroclor 1016 prior to the PCB ban mandated by Congress in the TSCA. Indeed, the Agency's economic im pact assessment was expressly predicated on the assumption that all direct dischargers of PCB will end their use of tha material by the effective date of the proposed dis charge regulation rather than expend the several hundreds MONS 089913 T -4- of thousands, of dollars required for the treatment tech nology recommended by the Agency. (Tr. 67 of the Rearing on November 30, 1976; EPA Exh. 16 at vii-viii) The imposition of a ban on the use of Aroclor 1016 in capacitors poses serious risks. A ban on Aroclor 1016 will create the substantial risk of fire by forcing the industry to use highly flammable substitutes. (EIA Exh. B at 5-6) Such a ban also will result in a 20-30 percent increase in the costs of capacitors using the less desirable substitute materials. (EPA Exh. 16 at xi; see also Exhibit B to EIA Exh. B) In this brief, we will review the nature and use of Aroclor 1016 in capacitors and will then argue two alternative propositions. First, it is our position that no national standards should be established setting discharge limits on Aroclor 1016. The Toxic Substances Control Act preempts totally this area of regulation and establishes a Congressional scheme of FCB regulation leading to a ban on PCB use in capacitors after 197B. No further regulation under the FWPCA is warranted or sanctioned under TSCA. Further, national effluent standards are un wise in the circumstances here presented and an abuse of the Administrator's discretion under the FWPCA. Only on site regulation can properly evaluate local ecological con- MONS 089914 ditions and set appropriate discharge limits to correspond to varying local conditions. In the event the Administrator determines that a national effluent discharge limitation should be estab lished, we will urge that the proposed 1 ppb limit at the pipe for PCDs generally be modified substantially respecting Aroclor 1016. The record establishes sub stantial and important differences between the type of PCB used by the capacitor industry, Aroclor 1016, and all other PCBs. There is no basis for a uniform national standard for all PCB discharges. The maximum limitation justified by the record in this proceeding for Aroclor 1016, which at the same time provider the requisite ample margin of safety, is 100 ppb. The lower limit pro posed by the Agency is inappropriate for Aroclor 1016 in light of all the evidence of record. Further, the im position of a 1 ppb standard on Aroclor 1016 would create a system of regulation which could not be fairly administered. The 1 ppb limit cannot be accurately measured in industrial effluent and cannot be the basis for regulation save with allowable variations of 100 to 400 percent. Moreover, by providing only for an aggregate discharge limit, the Agency has failed to allow for the possibly substantial levels of PCB extant in each company's influent water. MONS 069915 6 Such an aggregate limit on PCB would serve only to penalize the capacitor and transformer companies, requiring them to attempt to treat water containing PCB discharged both in the post and currently by non-regulated companies. FACTUAL BACKGROUND A. The Chemistry of Polychlorinated Biphenyls The Agency has undertaken to regulate all "PCB" discharges, claiming that "PCBs have been conclusively demonstrated to produce lethal and sublethal toxic effects . . .."41 Fed. Reg. 30468. The Agency has sought to validate this sweeping indictment of "PCBs" by lumping the more than "209 separate compounds, or isomers, of the chlorinated biphenyl family," (Id.) under the umbrella label "PCB." There is no scientific basis for this failure to acknowledge the important chemical differences between different types of PCBs. As the Agency defined the term "PCB" in its Notice of Proposed Rulemaking: "PCBs are a class of organic com pounds manufactured by the chlorination of biphenyl with anhydrous chlorine using iron filings or ferric chloride as a cata lyst. The biphenyl molecule has a total of ten carbon-hydrogen bonds at which chlorine substitution can be accommodated. In the manufacture of PCBs, anywhere from one to ten chlorine atoms may be located - on the biphenyl molecule. Depending upon I MQNS 089916 -7- the location of these substitutions, theoretically" as many as 209 separate compounds, or isomora, of the chlori nated biphenyl family can be manufacturcd." (emphasis added) (Id.) Some varieties of PCBs have been shown to be resistant to degradation in the environment, and have thus proved to be highly persistent. As these PCBs persist and accumulate in aquatic organisms, they move up the food chain--by fish-eating mammals ultimately to humans. It has been established that the degree of persistence is directly related to the degree of chlorination of the compound: the more highly chlorinated the PCB, the more likely it is to persist and pose a possible hazard to the environment. This fact became understood less than ten years ago. By that time PCBs had become a ubiquitous chemical, used in many thousands of industrial and business applica tions. The Agency has estimated that 1.4 billion pounds of different PCBs were produced in the United States over the past 45 years--of which 1.25 billion pounds were used in this country. (See 41 Ped. Reg. 30469; see also EIA Exh. 17 at p. Ill for more complete Monsanto-production data) The only remaining users of PCB arc the capacitor and transformer manufacturers. Their annual discharges of PCB do not exceed 10,000 pounds; PCB i3 now used only in 'closed-systems" which do not expose the vast bulk of the material to the environment, (l[d.) Aroclor 101G is tho only type of PCB used by tho capacitor industry. (EIA Exh. B at 2 [Ilutzlcr] ; EIA Exh. C at (Clark)) MONS 0B9917 -8- B. The Chemisty of Aroclor 1016 Aroclor 1016 bears little resemblance to the types of PCBs used previously. It is these earlier, nowabandoned types of PCB which presented the problems of persistence the Agency is belatedly undertaking to amelio rate, and which'for the most part form the basis for the v Agency's present "case" against Aroclor 1016. The many different PCB compounds vary substantially in their molecular composition, which affects directly their differing environmental characteristics. The. number of chlorine atoms in each molecule affects directly the ability of organisms to metabolize the material. Molecules with only a few chlorine atoms (e.g., -mono, di- and trichlorobiphenyl, also referred to as mono- and di- and tri-BP) have been found to be metabolized rapidly, with the rate of metabolism a function of the chlorine content of the mole cule. (EIA Exh. G at p. 4 [Mueller]) The following table, taken from the Criteria Document, gives the molecular compo sition of some of the Aroclor mixtures produced by Monsanto, as reported variously in three different studies. It reflects the very substantial differences between Aroclor 1016 and such highly chlorinated Aroclors such as A.1254 and V See Appendix One to this brief, which outlines the evidence presented by the Agency. This demonstrates that the vast bulk of the scientific evidence pertaining to PCBs is wholly irrelevant to Aroclor 1016. MQNS 089918 - 9- A. 1260, which are composed almost entirely of penta-, hexaand hepta-BP-molecules that are metabolized so slowly as to pose problems of persistence. Approximate Molecular Composition of Several Aroclors ____ ilorobiplionyl 1221 1232 1016 1242 1248 1254 1260 in fll m J1L 11] m [31 JIL [11 [21 [31 12] C12H10 ii 7 6 Tr Tr . Tr C12H9C11 C12H8C12 si 51 26 1 1 i Tr - Tr -- 32 38 29 20 16 17 4 l 0.5 - - - C12H7C13 4 3 24 57 49 40 39 23 1 - 0.5 - C12HC14 2 - 15 21 25 32 42 50 21 16 36 - C125C15 C12H4C16 0.5 - - 0.5 - '- 1 Tr 8 10 14 20 48 1 0.5 - 1 23 60 45 12 23 18 46 C12H3C17 - -- - Tr -' - - 6 1 1 35 C12M2C18 - -- - - - -- - - - 6 C12"lC19 C12C110 - - - - - - - - - '- - - - -- - - '- -- - -- Tr - Trace (less than 0.1 percent) II] Data from Criteria Document Ref. 13 (2) Data from Criteria Document Ref. 14 [3) ' Data from Criteria Document Ref. 15 Source: EPA Criteria Document Table II.3.1 MCNS 089919 10 Aroclor 1016 contains so few of the highly chlorinated molecules that the other materials have in high degree that its biological implications are entirely different from those of the materials which are no longer used--but from which the Agency has attempted to analogize 'V to establish afbasis for regulation of Aroclor 1016. Aroclor 1016 contains only 1 percent pentachloro BP and a trace of hexachloro-BP; 99 percent of Aroclor 1016 con sists of mono-, di~, tri- and tetrachloro-BP, which have been found to be rapidly metabolized and show lirtie accumulation tendencies. (EIA Exh.. D at 6-7 [Lauer] ; EIA Exh. G at 6 [Mueller])--^ It is no accident that Aroclor 1016 is virtually the only type of PCB in use today. In 1972 the capacitor industry converted to use of Aroclor 1016 due to its environ mental concern that more highly chlorinated varieties of PCB, being less biodegradable than Aroclor 1016, might pose unacceptable risks through their persistence in the environ- Strikingly, of all the Aroclors examined, A.1016 alone has been found to contain no detectable dibenzofurans which are impurities found in other PCB mixtures and which are them selves toxic. (EIA Exh. D at p. 7 [Lauer]; See also Criteria Document at p. 37) . **/ See also EPA Criteria Document at 277 and References 2 and 337] Doctor Nisbet, the author both of the Criteria Docu ment and the references cited above, in a 1976 oral presentation before the National Conference on Polychlorinated Biphenyls (cited as Reference 332 to the Criteria Document) stated "I think that we have had very adequate evidence here that tetrachloro isomers are indeed degraded rather rapidly, but not as rapidly as we would like." See also Criteria Document, page 306. The record establishes that mono-, di-, tri- and tetraBPs are all degradable, at varying speeds. HONS 089920 XI ment. (Tr. 2191-2X92; 2293-2294; EIA Exh. C at 4 [Clark]) Aroclor 1016 was developed by Monsanto to respond to these concerns and at the same time provide the needed quality of fire resistance required for use in capacitors. (EIA Exh. C at 4-5) In 1973 the Agency attempted to regulate PCBs. Then, as now, it was apparent that the Agency's evidence concerning the toxic effects of Aroclors such as A.1248, A.1254 or A.1260 was irrelevant to the regulation of Aroclor V 1016. The Agency has commissioned several studies con cerning Aroclor 1242 and a single study on Aroclor 1016 and has sought again to regulate Aroclor 1016 based on this slightly expanded data base. But now, as before, the alleged "conclusive" evidence of the toxicity of PCBs relates only to such highly chlorinated mixtures as A.1254 and A.1260, while the evidence concerning Aroclor 1016 is ambiguous and inconclusive. In its Notice of Proposed Rulemaking, the Agency ac knowledged that its earlier PCB regulatory efforts failed due to "certain gaps in the data base." (41 Fed. Reg. 30469) The Agency did not acknowledge that this "gap" turned on the critical differences betweeen Aroclor 1016 and other PCBs, differences which the Agency is again undertaking to ignore in favor of sweeping generalizations about "PCBs." 2/ The additional studies commissioned by the Agency added nothing to the data base on which to regulate Aroclor 1016. The only evidence pertaining to Aroclor 1016 in the record is a study by Dr. Ringer involving mink which produced no sta tistically significant toxic effects at low dose levels. See discussion infra. , pp. 45-47. The sole basis offered for regula ting Aroclor lOlG is an analogy between it and Aroclor 1242, drawn by a single witness without any credentials in the field of organic chemistry. See page 43, infra. The record thus reflects few (if any) improvements over the data base found to be inadequate in 1974. MUMS 089921 - 12 - C. The Need' for Aroclor 1016 In Capacitor Manufacturing . ' . Polychlorinated biphenyls have been used for capacitor impregnating fluids since the 1930s. Capacitors are a type of electrical instrument used in a wide variety of industrial and consumer applications. A capacitor (speaking most generally) -is composed of a metal container with a paper and foil core, impregnated with an oil (called a dielectric fluid) which permits the retention of an electrical charge until needed for use. The higher the so-called dielectric constant of the fluid, the greater the charge which can be held. The industry first used mineral oil as an impregnant, which was.both flammable and had a low dielectric constant thus requiring the use of relatively large capacitors to hold a suitable charge. (Tr. 2140-2141) After the introduction of PCB as an impregnant some forty years ago, the capacitor industry was able substantially to reduce the size of capacitors with a corresponding reduction in cost. (Tr. 2141; EXA Exh. B at 2 [Itutzler]) Some capacitors also use a type of polypropylene film in the core--although only a few of the film-type capacitors also use an impregnant such as Aroclor 1016. (See EXA Exh. B at 8-9 (Hutzlerl) */ ' While PCB was much more expensive than mineral oil, that did not affect the cost of the capacitor itself, since the largest costs of capacitor construction were for the paper and foil. Thus as more efficient capacitors were developed and tha size of capacitors decreased, so did their overall cost. See Tr. 2141. MQNS 089922 13 - Capacitors for alternating current applications are now in universal use in this country. AC capacitors include large capacitors known as power faction correction capacitors used by utilities companies efficiently to transmit electricity. Smaller types of power faction correction capacitors are also used by industry for similar purposes. AC capacitors are used in most lighting applications, ranging from mercury vapor lighting, high intensity discharge lighting and fluorescent lights. Finally, the so-called "small industrial" capacitors are used in a variety of motor-run operations--perhaps the most familiar being in the motors of home air conditioners. (ElA Exh. C at 1-3) At present, the vast majority of these AC capacitors contain PCB--and virtually all manufactured in the last four years contain Aroclor 1016. (Id. at 4) For over thirty years the capacitor industry haB conducted rigorous research and development in an attempt to locate a substitute for PCB as a dielectric fluid. (EIA Exh. B at 3) These efforts have proven un availing. (Id.) After these many years of R ( D, no known direct replacement for Aroclor 1016 exists. All suitable replacements present serious risks of flammability. (See generally EIA Exh. B at 5 and Exhibit B thereto) In *CNs 0899^3 14 use, such a .flammable material can be ignited in the event of a short circuit in the capacitor, causing rupture of the case and release of the dielectric fluid. The electrical arc present will then spark the fluid and fire will result. (Tr. 2161-2164) Tests conducted by the Underwriters Laboratory establish that the non-PCB substitutes w^.11 all ignite under these conditions, presenting the risk of catastrophic fire. (See Tr. 2179- */ - ------2182) 2236-2237) - The EPA's Notice of Proposed Rulemaking acknowleged the "unique physical and chemical properties of PCBs" which were said to include: low vapor pressure at ambient tempera tures, resistance to combustion, remark able chemical stability, high dielectric constant and high specific electrical resistivity .... 41 Fed. Reg. 30468 Unhappily, the same reasons PCB persist in the environment make them uniquely suited to serve as a di electric fluid; the chlorine atoms provide strong chemical .bonds, which are resistant to degradation (either in capaci tors or in the environment), and provide stability in use in capacitors thus protecting against the dangers of fire One observer at these tests described the "blow torch" type fire which spurted from the ruptured capacitor case when the non-PCB material ignited. (Tr. 2237) MONS 089924 15 - which are always present when utilizing electrical current. (Tr. 2139) Aroclor 1016 was developed to balance these competing concerns. ARGUMENT I THE PROPOSED BAN ON PCBs UNDER THE FEDERAL WATER POLLUTION CONTROL ACT SHOULD NOT BE ADOPTED A. The Toxic Substances Control Act , Provides a Congressional' Ban of PCBs Which Should Not Be By-Passed By Regulation Under the Water Pollution Control Act The Toxic Substances Control Act, Pub.L. 94-469, 80 Stat. 2003, 15 U.S.C. $2601 et seq., signed into law on October 11, 1976, is a comprehensive statutory scheme for the regulation of virtually all' chemicals (with certain enumerated exceptions). It was passed pursuant to the Stated congressional policy that "adequate authority should exist to regulate chemical substances and mixtures which 'present an unreasonable risk of injury to health or the environment . . 15 U.S.C. S2601(b)(2). One type of chemical is singled out for individual treatment under the Act--polychlorinated biphenyls. Section 6(e) of the Act, 15 U.S.C. $2605(e), provides a detailed schedule for the MONS 089925 16 phase-out of all PCB use in this country, subject only */ to the grant of special exemption by the Administrator. The regulation of PCBs provided under TSCA is complete; it does not anticipate duplicative and ultimately incon sistent regulation in the same area by the Administrator pursuant to the authority previously granted under the Federal Mater Pollution Control Act. One year after the effective date of the Toxic Substances Control Act (by January 1, 1978) , all PCB use is forbidden "other than in a totally enclosed manner." 15 U.S.C. 52605 (e)(2)(A). One year .later, by January 1, 1979, the Act provides "no person may manufacture any polychlorinated biphenyl." Six months later, by July 1, 1979, "no person may process or distribute in commerce any polychlorinated biphenyl," subject only to the grant of exemptions by the Administrator. 15 U.S.C. 52605(e)(3)(A). 15 U.S.C. 52605(e)(3)(b) provides that the Administra tor may grant an exemption from the requirements of the Act, if he finds "(i) an unreasonable risk of injury to health or environment would not result, and (ii) good faith efforts have been made to develop a chemical substance which does not present an unreasonable risk of injury to health or the environment and which may be substituted for such poly chlorinated biphenyl." MONS 089926 17 The legislative history of TSCA reflects the unambiguous congressional intent to preempt fully the area of PCB regulation. The Toxic Substances Control Act's PCB ban was passed after the Agency's Notice of Proposed Rule making was promulgated, and indeed was passed only after the commencement of the hearing in this proceeding. Congress was fully aware of the Agency's actions under $307(a) of the FWPCA, and chose to supplant regulation under that statute with the comprehensive scheme of regulation contained in the 1976 Act. Despite differences betwe,en the House and Senate versions of the TSCA (which required ex tensive conference revisions), both bills contained vir tually identical provisions banning PCBs. Senator Nelson, who introduced the amendment to the Senate bill which banned PCBs, explained his dissatisfaction with the regulatory efforts of the EPA and the need for compre hensive congressional regulation of the material--stating his view that Congress should "no longer wait to regulate and eliminate this toxic substance." 122 Cong. Rec. S 4408 (daily ed., March 26, 1976) Senator Nelson emphasized that his amendment to the bill was the most desirable method of regulating PCBs, because "[ulnder this amendment, the continued use of PCBs would be allowed if the EPA Administrator finds that 'no unreasonable risk of injury MONS 069927 18 V to health or the environment' exists," and further be cause "[tjhis amendment would allow time for the phasing out of the manufacture and use of PCB's over 2-1/2 years." (Id.) Senator Tunney, one of the original sponsors of the bill, endorsed Nelson's amendment: "In my view, the amendment of the Senator from Wisconsin is indeed appro priate. It phases out PCB's by elimina ting nonclosed system uses within 1 year and eliminating PCB's altogether within 2 years. There are mechanisms for autho rizing uses of PCB's beyond these time - limits should that be appropriate so that we do not create worse problems than those we solve." 122 Cong. Rec. S4410 (daily ed., March 26, 1976) Some months later, the House adopted an amendment to its version of the TSCA banning PCBs. Strikingly, the House took this action only after promulgation of the Agency's Notice of Proposed Rulemaking under the Water Pollution Control Act. Congressional debate on the amend ment reflects express intent on the part of the House to substitute its regulatory scheme banning PCBs for the pro gram proposed by the Agency. Congressman Dingell, who introduced the amendment on August 23, 1976, emphasized Senator Nelson noted that "{i]n making such a finding, it is implicit that consideration be given to the availability of substitutes for PCBs, presumably having less risk." (Id.) HONS 089928 - 19 - that regulating PCBs under the Toxic Substances Control Act would fill a gap in the rwPCA and would provide the best solution to the problem: The amendment does not call, I want my colleagues to Know, for immediate prohibition but, rather, a gradual phase out to assure action within a reasonable period of time. As previously noted, the history . of EPA is not one of vigorous and quick action. ' This amendment defines PCB's to be bad, hazardous, and dangerous, and it man dates a program for their gradual removal, beginning with those uses which are out side of enclosed containers. 122 Cong. Rec. H 8829 (daily ed., August 23, 1976) The Congressional Record reflects vigorous debate over the merits of Congressman Dingell's proposal (which he co sponsored with Congressman Gude). Among the criticism leveled at the proposed 2-1/2 year ban on PCBs were: ' . (i) "the EPA may feel that the 2-1/2 . years the gentleman from Michigan (Mr. Dingell) suggests is too long and that more immediate action might be necessary;" (ii) that "(t]he Dingell amendment could in this case actually slow down the regulatory process;" (iii) that "there is no need for the amend ment, since the EPA has indicated a willingness to proceed expeditiously in this area;'1 (iv) and that "the agency may set up regu lations in which the treatment, of PCB's is specifically dealt with in a different way than the present pattern of control may ultimately seem the most desirable. Why carve MQNS 089929 - 20 - out one chemical to treat in this manner? There are many other chemicals that presently pose potential danger. I think that we would bo well advised to let the agency chart its own ' course in the same manner that we have let other agencies with like authority chart their courses, and not foist upon a preconceived manner of control before we find whether they will in due course address the question." (See 122 Cong. Rec. H 8830-31) (daily ed., Aug. 23, 1976) Congressman Leggett responded to these criticisms: "The flexibility of the Dingell-Gude amendment is shown by its exemption provisions, which recognize that some uses of PCB's outweigh safety con siderations ..." Cong. Rec, H 8832 (daily ed,, Aug, 23, 1976) Congressman Leggett supported the PCB ban because in light of the importance of mandating a final solution to the prob- blem posed by PCBs, ` . "[t)he Dingell-Gude amendment will give us a program immediately, setting the mandatory deadline for a phase-out Of PCB's." 122 Conct. Rec. 11 8832 (daily ed., Aug. 23, 1976) Congressman Murphy, one of the draftsmen of the bill in committee, also endorsed the amendment; "True, the substances are necessary at the present time for use in capacitors and transformers. We have heard the debate on what the Japanese have done and what they . have been forced to do because of the effects on their environment. This amendment seems reasonable. It gives at least 2 years to the industry to come up with substances other than PCB's. I think 2-1/2 years is certainly a rcason- able compromise and warning to the indus try. The EPA Administrator is given the MQNS 089930 - 21 flexibility to extend, if necessary, that period of time .... . Mr. Chairman, I hope we adopt this amendment." 122 Cong. Rec. H 8833 (daily ed., Aug. 23, 1976) This review of the legislative history of the PCB ban contained in the Toxic Substances Control Act demonstrates both that Congress intentionally undertook to pass comprehensive legislation on the subject, and that after considering the reasons for a phased with drawal of PCB use, Congress deliberately elected to establish a two and one-haif year time, frame in which to permit continued use of PCB in capacitors and transformers. The debate in the House over the proposal was quite unambiguous about the relationship between the ban under consideration and the Agency's regulation of PCBs under the Water Pollution Control Act. Despite claims that a fixed schedule of regulation imposed by Congress affected the Agency's freedom to act. Congress chose to adopt a specific and comprehensive program of PCB regula tion which permits no interference by the EPA--and which certainly does not permit the Agency effectively to ban the material prematurely, under the guise of regulating discharges. The Toxic Substances Control Act precludes regulation under the FWPCA--for the TSCA time table for termination of PCB use renders discharge regula tions a nullity. The very limited period of time por- MONS 089931 22 mitted under TSCA for continued PCD use makes installation of treatment facilities economically irrational. The two statutory regimes are ultimately inconsistent. In such circumstances the carefully prescribed congressional program of PCD control preempts the Agency's discretionary t/ authority under the Water Pollution Control Act. B. National Effluent Discharge Limitations for Aroclor 1016 Represent an Abuse of Discretion under the Water PollutioiControl Act._________________________________ _____ Section 307 of the Federal Water Pollution Control Act requires that the Administrator, in setting discharge standards, take into account "the toxicity of the pollutant, its persistence, degradability, the usual or potential presence of the affected organisms in any waters, the im portance of the affected organisms and the nature and extent of the effect of the toxic pollutant on such organisms . . .." 33 U.S.C. 51316(a)(2). The unrebutted evidence in the record TT--------------------------------------- . While 15 U.S.C. 52605(e)(5) provides that the TSCA's PCD ban "does not limit the authority of the Administrator, under any other provision of this Act or any other Federal law, to take action respecting any polychlorinated biphenyl," (emphasis supplied) this ambiguous provision cannot be con strued to permit the Administrator to take action inconsistent with the regulatory program prescribed by the Act. At most this provision relates to the preemption standards of Section 9 of the Act, which require the Administrator to "coordinate" all regulatory actions he might take under the statutes he is charged with administering.. Such "coordination" cannot be con strued to permit the Administrator to frustrate TSCA's regula tory scheme. 'It is noteworthy that the voluminous record in this proceeding will continue to be useful, notwithstanding the fact it may not. be used to promulgate discharge regulations. The Administrator may wish to rely in part on the record in promul gating the standards required under TSCA for disposal and labeling of PCDs (see 15 U.S.C. 52605(c)(1)) and may refer to the record in determining whether exemptions should be granted pursuant to 15 U.S.C. 52605(c)(3). MOWS 069932 - 23 in this proceeding establishes that each of these factors may only be evaluated based on varying local conditions. The effects of a pollutant in a water body depend on the specific chemical, hydrological and ecological characteristics of the water body into which the pollutant is being discharged. Dr. Gerald Lauer, an aquatic biologist with long experience both with the U.S. Public Health Service and as a private con sultant, testified that no national effluent standard for a pollutant such as Aroclor 1016 can properly take into account local conditions: "The toxicity of toxicants such as PCBs varies from species to species and for different life stages of the same species, and depends on a host of variables including the chemical con stituents and quality of the receiving water, the duration of exposure, the fate and physical-chemical state of the pollutant in the receiving water, the prior health of the exposed organisms, presence of other pollutants, previous history of exposure, etc." (EIA Exh. D at 2 [Lauer]) ' The need for such local regulation was also emphasized by one of the Agency's own witnesses. Dr. William Brungs, who testified that local conditions vary greatly in the dis persion effects of a pollutant in a mixing zone, and that It is thus difficult to assess the environmental implica- tions of a given discharge by means of a national effluent MOMS 089933 24 standard. (See EPA Exh. U at 4 (BrungsJ) It is for this rea- son that the National Academy of Sciences and the National Academy of Engineering, when advising EPA as to how to establish regulatory controls for the protection of aquatic ecosystems, emphasized the need to regulate based on differing "local conditions": "This caveat cannot bo over emphasized, because variabilities are encountered in different parts of the country. Specific local recommendations can be developed now in many instances, and more will be developed as experience grows."^/ The record contains no specific information concerning the bodies of water into which the capacitor and transformer plants affected by the proposed regulation discharge. These include plants in at least seven states, and discharges into at least ten different bodies of water. The Agency has failed to present any evidence concerning the "local conditions" affecting the environmental impli cations of these discharges. The record thus provides no basis for regulating the discharges of these plants--as Water Quality Criteria 1972, a Report of the Committee on Water Quality Criteria, 10 (1972). This EPA publication is plainly part of the Agency's body of specialized expertise, and is thus subject to notice pursuant to 40 C.F.R. $164.81(e). **/ The EPA's economic impact assessment lists eleven capacitor and transformer plants which would be affected by the regulations. See EPA Exh. 16 at 1-3) Incx- plicnbly, this assessment ignored Universal Manufacturing's Bridgeport plant, which is a direct discharger into the Bridgeport sewer system and ultimately into I.ong Island Sound (Tr. 2209) and also eliminated one other plant from consideration. (Tr. 118-119 of Hearing of November 30, 1976) MANS 089934 25 the national effluent standards proposed are without ade quate scientific foundation and thus improper as a matter of law. MONS 089935 - 26 - II. AN END-OF-PIPE LIMITATION OF 100 PPB FOR AROCLOR 1016 WILL PROVIDE AN ADEQUATE MARGIN OF SAFETY TO THE ENVIRONMENT_____ The Agency's proposed discharge regulations fail to distinguish among the various PCB mixtures, despite the overwhelming evidence that PCBs differ very substantially in their toxicity and persistence. See discussion pages 8-10, supra. The proposed regulations contain a single all-encompassing 1 ppb discharge standard applicable to all PCBs. (See also Tr. i881) There is no scientific basis for this attempt to regulate all PCBs as if they were a single chemical. Aroclor 1016 consists almost exclusively of lower-chlorinated homologs. It is far less persistent and is rapidly metabolized by predators. The record establishes conclusively that Aroclor 1016 bioaccumulates to a much lesser extent than the more-highly chlorinated mixtures. (EIA Exh. Dat 6-7 (LauerJ; EIA Exh. G at 6 [Mueller]) Accordingly, an end-of-pipe limitation of 100 ppb for Aroclor 1016 was established during the course of the hearing to be completely safe to the environment. This conclusion is based on the following five factors, each of which will be discussed in greater detail below: 1. The ambient concentration for Aroclor 1016 will be at least one thousand fold: less than the end-of-pipe MONS 089936 27 - concentration as a result of the dispersion and dilution of the outfall. Therefore, a 100 ppb end-of-pipe limitation for PCBs will produce an ambient concentration of 100 ppt. 2. Aroclor 1016 does not have any toxic effects on aquatic animals even at levels greatly in excess of 100 ppt. The great weight of the evidence demonstrates no adverse effects at levels approaching 100 ppb. Thus, a 100 ppb discharge limit for Aroclor 1016 would pose no threat what ever to aquatic organisms. . 3. Aroclor 1016 in the ambient water will bio accumulate in the lipid tissues of aquatic organisms by a factor not greater than 50,000. This figure is substantially lower than the bioaccumulation factor of 274,000 upon which the proposed regulations were based, which was derived for PCBs generally and which was shown to be lacking in any scientific basis. .4 Fish having a lipid concentration below 15 ppm of Aroclor 1016 will not have any adverse effects on regular consumers. A discharge limitation of 100 ppb will permit an accumulation of Aroclor 1016 in fish tissue of no more than 5 ppm and will be entirely safe for all fish consumers -- animal or human. Indeed, with regard to humans, no evidence exists that any level of Aroclor 1016 in the fish portion of the human diet would be injurious to human health. . MQNi 08993; 28 5. An end-of-pipe limitation of 100 ppb for Aroclor 1016 based upon the factors just discussed will provide "an ample margin of safety" to the environment. Adoption of a lower standard for Aroclor 1016 would be un justified. HUNS 089938 - 29 A. Ambient Concentrations of Aroclor 1016 Will Be 1000-Fold Smaller Than The EndOf-Pipe Concentration. It is impossible to establish meaningful ambient standards for Aroclor 1016 or any other PCB in this proceeding. The vast bulk of the PCB used in the past, which persists in the environment, will not be subject to the proposed regula tion. The capacitor and transformer industries which are subject to the proposed discharge regulations account for only a relatively trivial amount of PCB discharged currently into the environment. (See 41 Fed. Reg. 30469) Recognizing that the proposed'regulations will touch on only a minor fraction of the PCBs discharged currently, the Agency has focused its regulations on establishing a 1 ppb discharge limitation. In evaluating such discharge regulations, it is necessary to take into account the substantial dispersion that occurs immediately following discharge. In determining the potential toxic effects of such a discharge, it is necessary to calculate this dispersal effect. The Agency's proposed discharge regulations are premised on the fact that "effluent disperses following discharge and becomes greatly diluted." 41 Fed. Reg. at 30474 The Agency's 1 ppb dis charge regulation was thus calculated as producing an ambient standard of 1 ppt, inasmuch as dispersion and dilution "can result in a dispersion or dilution of the effluent of 1000-fold MONS 069939 - 30 - or more depending [on the discharge site]." (EPA Exh. G [Callaway] at 3.) Based on this same dispersal factor of at least 1000, a 100 ppb discharge limitation for Aroclor 1016 will produce concentrations of Aroclor 1016 in ambient waters of not less than 100 ppt. It is on this basis that the discharge level should be evaluated. There is no dispute that the existence of a mixing sone, in which dispersion occurs and which would be the only area where levels of Aroclor 1016 would be greater than 100 ppt if a 100 ppb discharge limit is adopted, poses no risk of harm. Exposures of aquatic organisms in such a mixing sone are not of sufficient duration to cause either chronic or acute effects in aquatic organisms. 41 Fed. Reg. at 30475 This is all the more true for Aroclor 1016, which has virtually no acute toxic effects at levels below the proposed discharge limitation. (See pp. 31-32 infra.) By the same token, chronic effects for Aroclor 1016 have only been demonstrated at concentration levels slightly below the proposed dis charge limitation. (See pp. 32-33 infra.) A discharge limitation for Aroclor 1016 of 100 ppb will produce a concentration in the ambient water of 100 ppt, and any toxic effects of Aroclor 1016 must be evaluated accordingly. The record establishes that such an ambient standard poses no threat to the environment. . MOhS 069940 31 B. Aroclor 1016 Has Not Boon Shown To Have Any Toxic.Effects on Aquatic Animals Except At Levels Greatly In Excess Of The Proposed Ambient Criterion Of inn PPT. . */ ` Considerable testimony- and documentary evidence has been introduced on the toxic effects of PCD mixtures generally on aquatic animals. However, there is no evidence that Aroclor 1016 produces any adverse effects, except at levels greatly In excess of the 100 ppt ambient criterion proposed by the EIA. Virtually all of the data on the toxic effects of PCBs comes from laboratory bioassay experiments. Generally speaking, these bioassay experiments are divided into two general groups. The first group consists of acute (generally static) bioassays conducted for periods of approximately 96 hours. As the Criteria Document recognized, "PCBs do not appear very toxic in short-term static bioassasys. . .." **/ (EPA Exh. 2 at 114 and 119)--The acute bioassays conducted *7 In the area of toxic effects on aquatic organisms the principal witness for the EIA was Dr. Gerald J. Lauer. The principal witnesses for the EPA were Drs. Allan V. Nebeker, Gilman D. Veith and David J. Hansen. **/ Dr. Nebeker used these data as a basis for asserting Hint the toxicity of PCBs to fish was inversely related to chlorination. (EPA Exh. C at 8 [Nebeker]) The reliability of the data, however, are questionable because the concentra tions employed for all of the Aroclors tested greatly exceeded their solubility in water. (EIA Exh. D at 10-il [Lauer]; see also EPA Exh. 2 at 50 for the reported solubilities of the various Aroclor mixtures) Moreover, most of the recent data from chronic testing indicates a reverse pattern of increasing toxicity with increasing percentage of chlorine. (EIA Exh. D at 11 [Lauer] and attached References 3 and 6) MOWS 089941 32 with Aroclor 1016 produced data which showed significant short term toxic effects only at levels some two to three orders of magnitude above the ambient criterion being proposed by . */ the EIA. These bioassays produced 96-hour LC5Q values,--' for example, of from 48 to 650 ppb for blue gills, 750 ppb for channel catfish, 135 ppb for rainbow trout, 135 ppb for Atlantic salmon and 185 ppb for yellow perch. (EPA Exh. 2 at 119; see also EPA Exh. 12) The second type of bioassay experiment, the con tinuous flow bioassay, is conducted for considerably longer periods. In some experiments, the exposure time exceeds the generation time of the organism. Chronic toxicity data from these experiments "indicate that most species tested tolerate low part per billion (ug/1) concentrations in the water with no apparent adverse effects on survival, growth JJ/ The data produced by these studies is given in terms of LC.q values (the PCB level at which fifty percent mortality occurs) for a given length of time, usually 96 hours. HUNS 089942 33 or reproduction." (EIA Exh, D at 11 ILauerl) Quanti tatively, these experiments indicate that Aroclor 1016 ranges from slightly less toxic to one hundred times less toxic than the more highly chlorinated Aroclors such as Aroclor 1254. (Id. at 14 ) The chronic exposure data of Aroclor 1016 shows no adverse effects at levels below approximately 10 ppb. In fact, for most of the organisms tested, adverse effects were demonstrated only at levels substantially above 10 ppb. In a 42-day exposure study of pinfish, no significant mortality was. found at a measured concentration of 7 ppb. (EPA Exh. D at attached exhibit 7, p. 367.) No effects on reproduction occurred when sheepshead minnows were exposed to Aroclor 1016 at levels of from 0.3 to 3.0 ppb. (EPA Exh. 2 at 122) Exposures of rainbow trout for seventeen days produced an LC50 value of 40 ppb while a 35 day exposure of bluegills produced an LCS0 value of 43 ppb. (Id. at 120) It is apparent therefore that Aroclor 1016 has toxic effects only at levels that are between two and three orders of magnitude above the EIA's proposed ambient criterion of 100 ppt. ' V The Criteria Formulation chapter of the Criteria Document, on page 355, docs rely upon three low-level toxic effects of PCIls an a basis, in part, for the proposed ambient criterion. Each of those offects was exhibited in studies involvinq the effects of Aroclor 1254. (Tr. 1061-63, EPA Exh. 2 at 102, 108, 114) *GNS 089943 34 C. Aroclor 1016 Will Bioaccumulato In Aquatic Organisms By A Factor Not Greater Than 50,000,; In evaluating the environmental effects of Aroclor 1016 on non-aquatic organisms, it is necessary to consider the ability of aquatic organisms to uptake the mixture from the environment and accumulate that mixture in their tissues. (EPA Exh. 2 at 283) It is in this manner that Aroclor 1016 might present risks to fish-eating V mammals and other predators. PCBs have a tendency to accumulate in the lipid **/ (or fat) tissue of aquatic invertebrates and fish because PCBs are much more highly soluable in lipid tissue than they are in water. (Ibid.) This tendency has been referred to variously and interchangeably in these proceedings as "bio accumulation," "bioconcentration," and (to a lesser extent), "biomagnification." (Compare, e.g., EPA Exh. 2 at 283, EIA Exh. D at 14 [Lauer] (bioaccumulation) with EPA Exh. 2 at 296, EIA Exh. D at 13 (bioconcentration) and EPA Exh. 2 at 285, EIA Exh. D at 8 (biomagnification).) Aroclors bioaccumulatc in fish tissue in direct proportion to their concentration in the ambient water. A ratio can be established */ No evidence was adduced during these proceedings ns to the uptake, accumulation or toxic effects of PCBs by or upon plants. Our discussion, therefore, is limited to animal life. **/ It should bo noted that PCBs do not accumulate to the same degree in all tissues of an aquatic organism duo to this tendency to accumulate only in specific organs. Dr. Nisbet testified, for example, that three times as much PCD accumulated in whole fish as accumulated in the edible portion of the fish. (Tr. 1754 ; see a Iso EIA Exh. D at 13-14 (Lauer)) HONS 089944 - 35 ones equilibrium is reached ("the bioaccumulation factor") that relates the mixture's concentration in the organism to that pf the surrounding water. That ratio will be rela tively constant for a given organism and mixture over a wide range of PCB-water concentrations. (ElA Exh. D at 8 [Lauer]) A bioaccumulation-factor of 50,000 for Aroclor 1016 was the highest accumulation value found in the labora tory bioassay experiments of Mr. Hansen and Dr. Veith for the Agency. Dr. Gerald Lauer-, who reviewed the record in this proceeding carefully outlined these data in Exhibit E to his Affidavit (See EIA Exh. D at 9 [Lauer] and Exhibit E thereto) The laboratory bioassay results introduced into evidence support no higher bioaccumulation factor. Although the average of the bioaccumulation factors for Aroclor 1016 produced by these studies would be substantially lower than 50,000, this 50,000 figure provides the highest (and thus the most conservative) bioaccumulation ratio */ produced by an experiment.- */ The average of bioaccumulation factors found for Aroclor I01G is only 14,225 (See EIA Exh. D at 13). This factor has a sound scientific basis, but for the sake of providing an "ample margin of safety," wo will accept the 50,000 figure as appropriate for Aroclor 1016 for purposes of this proceeding. MONS 069945 36 The 50,000 bioaccumulation factor for Aroclor 1016 was taken from a bioassay study by Dr. Gilman Veith.-/ See EPA Exh. B at 24. In his testimony. Dr. Veith cal culated the 50,000 factor based upon a ratio between the level of Aroclor 1016 found in the fish studied and the concentration of Aroclor 1016 actually iniected into the water (called the "nominal water concentration"). (EPA Exh. B at attached exhibit 19) . Pr. Gerald Lauer explained in response to ques tions by EPA counsel, that it was mathematically pos sible to calculate a bioaccumulation factor using the fish tissue concentration and the actual measured con centration of Aroclor 1016 found in the water after the experiment was concluded (called the "measured water concentration"). However, Dr. Lauer did not recommend that calculating a bioaccumulation factor for Aroclor 1016, due to the unreliability of the measured water concentra tion data. (Tr. 2523-25, 2392, 2415-16) The studies giving measured water concentrations acknowledged only an 80 percent recovery of Aroclor 1016 in the water was ob tained -- and in some cases, even lower recoveries were accomplished. (See Tr. 2416-18) Due to uncertainties over the accuracy of the measured water concentrations */ Veith, Gilman D. and L. Kiwus. 1975. Uptake of Aroclor 1016 by fish. I. Laboratory bioaccumulation studies with fathead minnows. Unpublished report, U.S. Environmental Protection Agency, Environmental Research Laboratory, Duluth, Minn, (cited at Reference 338 in EPA Criteria Document) at pago 295. MOMS 089946 37 - Dr. Lauer testified he believed the nominal water con centration data should be used. (Tr. 2392)--^ This testimony stands unrebutted. Rather than presenting bioaccumulation factors for each of the different Aroclors, the Agency chose to Adopt a single bioaccumulation factor for PCBs generally -- 274 .000. This figure was shown to be most unreliable in Itself: it is based on a single experiment with four Cathead minnows which produced patently anomalous test results Of 477,000 for Aroclor 1242. Such data would normally be disregarded since they bear no relationship to any other test conducted (See EIA Exh. D at 10)., and indeed were anomalous within the experiment, since the other two minnows in the experiment showed much lower accumu lation. (Tr. 4162-67) y Dr. Lauer also gave other reasons he rejected use of the measured concentration data: 1) measured concentrations were not given in many instances (Tr. 2418 [Lauer]) and therefore the use of measured concentrations, would result in the ex clusion of the numerous observations where only nominal con centrations are available: and 2) even where measured figures are given, in many cases no information is available as to Analytical procedures and efficiencies of recovery and there fore no correction factor could bo applied to the measured concentrations to account for differences in analytical pro cedures and extraction efficiencies (Tr. 2392, 2416 (Lauer)). Strikingly, the authors of most of the Agency's bioaccumulation Studios used nominal concentrations which they considered a Useful and valid procedure. (Tr. 2421 (Lauer)) HONS 089947 30 But even if the unusually high 274,000 factor had oma rolovanco for the Aroclor involved in that experiment, it is plain that Aroclor 1016 would be expected to have a substantially lower bioaccumulation tendency since 99 percent of Aroclor 1016 is composed of rapidly metabolized homologs. See discussion pages 8-10, Bupra; EPA Exh. B [Veith] at 24; EPA Exh. M [Nist-et] at 8; EIA Exh. O [Lauer] at 10; Tr. 586, Bee also EIA Exh. G [Mueller] at 3-4. Each Aroclor persists in direct relationship to the degree of chlorination of the mixture and the type of chlorine molecules involved; and Aroclor 1016 would have entirely different persistence characteristics than any other PCB mixture for which bio accumulation data was presented. The record is plain that Aroclor 1242 and 1016 have quite different bioaccumulation tendencies. . Although there is some surface similarity in the overall chlorine contents of Aroclor 1016 and Aroclor 1242 (41 and 42 percent respectively. See Criteria Document, Table II.2.2, page 8), the similarity ends when the actual chemical compositions of the two mixtures are considered. Because "1242 has approximately 30 percent more tetra-CBs and 10.times more penta- and higher CBs ..." than Aroclor 1016, "more of the Aroclor 1242 would be expected to persist and be bioaccumulated than Aroclor 1016." (EIA MONS 089948 39 Exh. D [hauer] at 10; see also EIA Exh. G [MuellcrJ at 3-4.) There is no scientific basis to excuse the Agency's failure to take into account this undeniable differ ence between the two Aroclors in arriving at appropriate bioaccumulation factors by which to evaluate appropriate discharge criteria. MONS 089949 40 - D. Aroclor 10X6 has Not Been Shown To Have Any Toxic Effects on Con sumers of Aquatic Organisms At A , Dietary I.evcl Holow 15 ppm. Just as there was no evidence that Aroclor 1016 could have any toxic effects on aquatic organisms at levels below 100 ppt, there is no evidence that this concentration of Aroclor 1016 would pose any hazard to fish consumers. Assuming a bioaccurnulation factor of 50,000/ a 100 ppb discharge limitation on Aroclor i016 would produce maximum levels of Aroclor 1016 in fish tissues of 5 ppm. (EIA Exh. D. at 13) This level is entirely safe for all fish consumers. The EPA's evidence concerning the alleged risks of Aroclor 1016 to predators is marked throughout by two basic flaws. The first is its failure or inability to demonstrate that the toxicological effects exhibited by othef PCB mixtures may be used to assess the toxicity of Aroclor 1016. Indeed, the substantial evidence in the record establishes conclusively that Aroclor 1016, because it consists almost exclusively of lower chlorinated PCB isomers, has few if any of the toxic effects found to result from the more highly Chlorinated Aroclor mixtures. Second, the EPA has failed / to dovclop specific 1016 studies.--' Only one study -- that conducted by Dr. Robert K. Ringer on mink -- even The absence of studios conducted on Aroclor 1016 is aptly illustrated in the Criteria Document. In the con cluding chapter of the Criteria Document (page 356) there is a list of the specific adverse effects which EPA used ns.a basis for the proposed ambient criterion together with the levels of PCD in tho diet at which these effects nro exhibited. None of these effects are based upon studios that were conducted with Aroclor 101G, 0S66B0 SNOW 41 - arguably demonstrates adverse effects by Aroclor 1016 at levels below 15 ppm in the diet, and that study was shown to. have produced wholly insignificant test results. 1. The Results of Studies On More Highly Chlorinated PCB Mixtures May Not Be Applied to Aroclor 1016 Almost all of the 'evidence allegedly demonstrating adverse effects to mammals from low level doses of PCB resulted from studies on PCB mixtures other than Aroclor 101G. The Agency has based its proposed regulation of Aro clor 1016 discharges almost entirely on the supposed analogy between Aroclor 1016 and the other PCB compounds studied. Thus, although the few studies actually conducted with Aroclor 1016 produced no similar adverse effects, the Agency takes the position that the same low level effects resulting from studies on other mixtures, such as Aroclors 1260, 1254 and 1242, are likely to result from exposure to Aroclor 1016. In fact, the record provides no support whatever for this theory. Aroclor 1016 was shown to be substantially lens toxic than the other PCB mixtures because it bioaccumulatcs in consumers of aquatic organisms to a much lesser extent than does Aroclor 1242 or any other of the more highly chlorinated PCB mixtures. Thus, mammals and birds, as well an fluh and aquatic invertebrates, are able easily and rapidly MOWS 089951 42 to metabolize and excrete the lower chlorinated isomers of PCD and prevent their accumulation in the tissues. Dr. Wolfgang F. Mueller summarized the available information on bioaccumulation an follows: "The fact that; only very small amounts of di-, tri- and tetra-CH are found in living organisms, however, cannot be explained by selective enrich ment alone. It must be assumed that those quan tities of lower chlorinated isomers which are taken up by organisms, can be actively eliminated. It has indeed been shown in numerous studies, re viewed in Appendix E to the Criteria'Document, that bacteria, invertebrates, fish, birds, and mammals are able to metabolize PCB, i.e., alter their struc ture to make them more water soluble and thus ex ' cretable. The ability of PCB to be metabolized decreases in all investigated organisms with in creasing chlorine content: mono- and dichloro BP are generally metabolized very rapidly, trichloro BP somewhat more slowly. Although the metabolism rate for tetrachloro BP is considerably lower in all species than for mono- to trichloro BP, resi due data presented by Nisbet and Sarofim indicate that it is still sufficient to prevent accumulation under environmental conditions. Biphenyls with five or more chlorine atoms, however, are metabo lized so slowly that they are found to be accumu lated in many species, including mammals and man. (EIA Exh. G at 3-4 [Mueller] (Footnote omitted)) The Agency made no effort to rebut Dr. Mueller's conclusions. Indeed, none of the six scientists who testi fied for EPA on the mammalian toxicology issues undertook to analyze the chemistry of Aroclor 1016 or, with a single xception, to make any claim that Aroclor 1016 has been proven */ to have toxic effects at low dose levels.-- These EPA scientists merely-assumed PCBs were a single category of "*7 Dr"! Ringer related the results of his 1016 study dis cussed below, see pp. 45-47 supra, to the results of his 1254 study and concluded that Aroclor 1016 "docs not appear to be as toxic to mink as Aroclor 1254 ...." (EPA Exh. S at 5-6 [Ringer]) MOMS 009952 43 - chemical, no matter how different their chemical composi tion. The record provides no support whatever for this assumption. The only witness for the Agency who expressly claimed that test results for other PCB compounds could be analogized to Aroclor 1016 was Dr. Ian Nisbet, the author of the Agency's Criteria Document. Dr. Nisbet broadly asserted that "there appears no convincing basis for setting different [ambient water] standards for the various isomers or Aroclor mixtures." (EPA Exh. M at 10) Dr. Nisbet made this assertion based on his understanding that the molecular composition of Aroclor 1016 and 1242 were so similar that similar toxic effects must be pre sumed to result. Dr. Nisbet is a physicist, with no background in biology or organic chemistry -- as author of the Criteria Document he reviewed the extensive litera ture on the molecular composition of different PCU com pounds, but could make no claim of individual expertise in evaluating those data. (EPA Exh. M at 5) His con clusions were evaluated and rejected by Dr. Wolfgang Mueller, an organic chemist with years of experience in conducting tests on the metabolism of different PCB isomers. Dr. Mueller reviewed the evidence contained in the Critaria Document and in the record of this proceeding, and stated flatly:"Aroclor 1016 differs in its chemical composi tion significantly from more highly chlorinated mixtures HONS 069951 44 including 1242 in that it consists to nearly 80 percent Of mono-, di-, and trichlorobiphenyls, and contains only 1 percent of pentachloro DP and a trace of hexachloro BP." As a result, Dr. Mueller concluded that "Aroclor 1016 can be metabolized relatively rapidly and much more completely than . . , 1242." (EIA Exh. G at 14) Dr. Mueller rejected the claim by Dr. Nisbet that results from 1242 studies could be extrapolated to Aroclor 1016: Due to the high accumulation tendency and slow metabolism of the hexa-, penta-, and to some degree also the tetrachloro-BP, these components will build up to much higher levels in the test animals upon chronic treatment with 1242 than would be expected with 1016. Con sequently, prolonged intake of Aroclor 1242 will result in elevated liver concentrations of tetra-, penta- and hexachloro BP, which will eventually cause similar hepatic changes as have been found with lower levels of Aroclor 1248 and 1254. Due to its lower content of tetrachloro BP and the virtual absence of higher chlorinated isomers, 1016 will not produce these effectsT (Id. at 6-7) (Emphasis supplied) 2. The Record Is Devoid of Credible Evidence Demonstrating That Aroclor 1016 Causes Adverse Effects at a Level Below 15 ppm in the Diet. The lowest level at which the Criteria Document notes any purported toxic effect of Aroclor 1016 is at 15 ppm. At that level, one study demonstrates small in creases in the weight of the liver (9% increase over con trol) and in two liver enzyme functions of rats (12% and 361 increase over control) who received a daily oral dosage MUNS 089954 for 21 days. 45 This same study showed no significant effects at a daily dosage of either 1.5 ppm or .15 ppm. (EPA Exh. 2 at 227-30, Reference 243.) The purported adverse effects demonstrated by this single study are of equivocal significance inasmuch as two similar studies produced no similar effect.-* / Taken for whatever limited significance this single study might have, it represents the lowest arguable adverse effect noted in the Criteria Document for Aroclor 1016. Only one study introduced independently of the Criteria Document purports to demonstrate adverse effects by Aroclor 1016 at levels below 15 ppm. That study was one undertaken under contract with EPA by Dr. Robert K. Ringer and purports to demonstrate that Aroclor 1016 ad versely affects the reproduction of mink. (EPA Exh. 5 at 5 [Ringer) and supporting Exhibit F to that affidavit.) The study consisted of feeding four groups of standard ranch mink with a basic mink diet supplemented with zero, 2, 10, and 25 ppm of Aroclor 1016. Each group consisted of three males and 12 females. Mating was begun approxi mately two months after the study began and whelping occurred approximately two months later. Feeding continued for ap MONS 0 8 9 9 5 5 proximately eight weeks post-whelping. *7 One similar study involving six daily doses of 375 ppm of Jiroclor 1016 to male rats, showed no significant effects on two liver enzyme functions, one of which was the same enzyme function noted in the above experiment. (P.PA Exh. at . 2 at 227 and Refer ence 244) The other study involved feeding female rats 100 and 500 ppm of Aroclor 101G for six months. After one week of Aro clor 1016 fit 100 ppm, none of the ten liver paramo tors tested wnr> significantly different from control. Even after six months at. 100 ppm, only limited effects were noted. (ERA Exh. 2 at 231, Figures III.10.7 and III. 10.(1 and Reference 245). 46 The data produced by the Ringer study is set forth in three tables. One table lists the reproduction performance of female mink fed either a control diet or one of the PCB-supplemented diets. The second table con sists of the average body weight at birth and at four weeks and survival of the kits fed a control diet or one of the PCB-supplemented diets. The third table lists average body weight at four points during the experiment and hemo globin and hematocrit values for the various female mink four weeks post-whelping. The first point to be made is .that the data pre sented does not demonstrate that AroClor 1016 impairs the reproduction of mink at the 2 ppm and 10 ppm feeding levels. Looking first at Table 1, the author concedes that no tests for mathematical significance were conducted on the data presented in the table despite the fact that it was possible to conduct such tests. (Tr. 1028-29 [Ringer]) Therefore, there is no way to know whether the data were the product of chance or the result of PCB in the diet. More over, an examination of the data indicates no discernable effects at the 2 ppm and 10 ppm feeding level. For example, the number of live births per whelp and the average number of kits per whelp at the 10 ppm feeding level were above tho comparable figures for the control group. Similarly, the number of dead births at 2 ppm wore below the number of dead birth per whelp of the control. Although live births per whelp and average number of kits per female who whelped at the 2 ppm feeding level was slightly below the HUNS 0 8 9 9 5 b 47 control group, there is no indication that such minor variations have any significance. Turning to Table 2, the data on weight at birth, weight at four weeks and kit mortality between birth and four weeks were subject to tests for mathematical significance. (Tr. 1035-36 [Ringer]) On the basis of these tests it was determined that none of the data values at the 2 ppm, 10 ppm and 25 ppm feeding levels were significantly different from the comparable figures for control. (Tr. 1036-1040) Accordingly, there is no reason to believe that the data produced at each of the levels resulted from PCB in the diet. (Tr. 1044 1045) The same is true for the data on Table 3. Only two figures on this chart raise any implication of statis tical significance and both of these figures were produced at the 25 ppm feeding level. (Tr. 1041-1046). The second point to be emphasized is Dr. Ringer's testimony that a prior study he had conducted on various Aroclor mixtures demonstrated that a diet of 2 ppm of either Aroclor 1016, 1221 or 1242 had no adverse effects on mink. (Tr. 1025-26) Dr. Ringer failed to attach the results of his oarlier study to his affidavit and he failed to refer to it anywhere in the study of 1016 performed under con tract with EPA. Thus, Dr. Ringer's study, as well as his personal bias, are subject to serious question. M0NS 089957 I - 40 - B. A XOO ppb Discharge Limitation for Aroclor 1016 Provides An Ample Margin of Safety to the Environment.; We have shown that a 100 ppb discharge limitation for Aroclor 1016 presents no risks whatever to aquatic or mammalian organisms. With normal dispersion, the 100 ppb discharge immediately dilutes into concentrations no greater than 100 ppt. Laboratory studies introduced by the Agency in this proceeding conclusively established that Aroclor 1016 in this concentration has no acute or chronic toxic effects on aquatic life. Given the highest bioaccumulation factor for Aroclor 1016 which has been produced in the labora tory and which was shown to be a generally reliable datum (50,000), the 100 ppt ambient concentration will produce con centrations no greater than 5 ppm in fish consumed by predators or man. This 5 ppm level is entirely safe for all fish con sumers -- it is 3 times smaller than the lowest dose level of Aroclor 1016 which produced any adverse effects in test animals, and even assuming that these rat studies can be extrapolated to man, or other mahnals, the 5 ppm food level for Aroclor 1016 was established as entirely safe. The 100 ppb discharge limitation is both entirely safe to the environment and provides the requisite "ample margin of safety." First, it assumes only a 1000 dispersion factor while dispersion and dilution could be substantially greater. (See EPA Exh. G ' (Callaway) at 2.) HONS 089950 49 Second, it is based on a 50,000 bio- accumulation factor for Aroclor 1016, which is 3 times greater than the average of the bioaccumulation factors found for Aroclor 1016 in the laboratory -- and indeed, was a factor substantially higher than any other reported. Use of this highest value is the most conservative approach which can be taken. Third, it is 3 times lower than the 15 ppm minimum feeding dosage which had any adverse effects on test animals. The 5 ppm food standard is thus sub stantially lower than the feeding dosage which could possibly be harmful to rats, much less to man or other mammals. Taken together, these three safety factors establish that a 100 ppb discharge limitation recommended by the EIA should bo adopted by the Administrator.' Any lower standard is unrea sonable as being unsupported by the substantial weight of the scientific evidence in the record. MCNS 0ti9959 - 50 - IH A ONE Prn DISCHARGE LIMITATION FOR AROCLOR 1016 CANNOT BE FAIRLY ADMINISTERED The record in this proceeding establishes that a 1 ppb discharge limitation for Aroclor 1016 is impossible to regulate fairly and accurately. Arbitrary enforcement must necessarily result should the Administrator elect to adopt the 1 ppb standard for two reasons. (1) It is impossible utilizing current testing methods reliably and accurately to determine PCB levels in industrial effluent to 1 ppb. If that low level is adopted, companies subject to the regulation will be unable to determine whether they are in compliance with the law. (2) PCB exists in most in fluent water used by capacitor manufacturers. If the discharge limitation is not modified to adjust for pre existing PCB levels, capacitor manufacturers who dis charge no Aroclor 1016 into their waste water may none theless be subject to sanctions for failure to treat their effluent. As a matter of elementary fairness, the proposed discharge limitations should be modified to take these factors into account. HONS 089960 51 - A. The Lowest Discharge ' Limitation for Aroclor 1D1C Which Can De Accurately Measured Is 20 pph There can be no dispute that the Agency may not set discharge standards which cannot be measured accurately and reliably. Discharge limits set below the point at which accurate measurements can be taken a fortiori expose all companies subject to the regulation to arbitrary enforcement actions, as neither the Agency nor the companies themselves can be certain whether their discharges comply with the law. The record in this proceeding establishes conclusively that it is impossible to measure PCD levels in industrial effluent accurately and reliably to 1 ppb. Mr. James Laubscher, the director of the Woodson- Tenent Laboratory of Memphis, Tennessee, with long experience both in testing for pesticide and other pollutants in industrial effluent and other water, testified: X do not believe that my labora tory can produce accurate test results . of PCB levels in industrial effluent water at 1 part per billion at the pipe. This level is too low for reliable test ing. EIA Exh. F at 5 [Laubscher] Mr. Laubscher explained the many obstacles to testing for PCD levels in industrial effluent. Industrial effluent may contain many different constituents, which may or may mons 089961 - 52 - not be extracted by use of a solvent. These other con stituents may create substantial confusion on instrumental and biological test systems. If clean-up procedures are used to cope with this problem, those procedures reduce the efficiency of the test procedure. PCBs adsorb onto sample containers, and pose potentially critical problems of analysis. (Id. at 2-3) For these reasons, and others, Mr. Laubschor testified that 1 ppb is an impossibly low level at which to test for PCB. But Mr. Laubscher did not rely solely on his own experience in testing. He also relied on the results of a round-robin test conducted by Monsanto and the American Society for Testing and Materials in 1975. Twelve labora tories participated in this testing program, designed to determine whether PCB levels in river water could be accurately determined. The results of this Monsanto/ASTM round-robin are provided as Exhibit B to Mr. Laubscher's affidavit (EIA Exh. F), and reflect "substantial variations in the range of 1 ppb to 23 ppb." (EIA Exh. F at 5 iLaubscher]) After reviewing these results, Mr. Laubschor testified: Results which show variations of this magnitude are not reliable and es tablish that one laboratory's results aro not readily reproducible by other . laboratories using essentially identical testing techniques. (Id.) MONS 089962 53 The experience of the capacitor industry with testing for PCB levels in plant effluent rein forces this conclusion. Dr. Eunice Moore conducted a survey of nine capacitor companies which are members of the Ad Hoc PCD Committee. The detailed results of her survey are presented as Exhibit B to her affidavit. (EIA y' Exh. E) The test results contained in Dr. Moore's survey vividly demonstrate the disparity between measur*e*- / jnents of as nearly identical samples as could be taken. To preserve the confidentiality of company data, Dr. Moore did not identify the companies by name--but did iden tify the six independent laboratories involved in the survey, and the four EPA regional laboratories whose test results are also reported, as follows: (Tr. 2548-2551) Laboratory 1 Laboratory 2 Laboratory 3 Laboratory 4 Laboratory 5 EPA Region I EPA Region II EPA Region IV EPA Region V Baron Consulting Laboratory Laboratory C Laboratory 7 Laboratory 8 Laboratory 9 Galbraithe Laboratory [Company's Own Laboratory] New England Analytical Testing Stewart Laboratories Laboratory 10 Warf Institute **/ Laboratory 11 Laboratory 12 [Company's Own Laboratory] Woodson-Tenent Laboratory In eight of the nine studies presented in Dr. Moore's survey, the EPA took duplicate samples in separate containers and left tho sample with the company for comparison testing. (Sec Tr. 2558-2559) MQNS 089963 54 The tost results in the following table were also introduced into evidence by Mr. N. Ray Clark of Universal Manufacturing, who had personally conducted or supervised the sampling (producing grab samples taken simultaneously or consecutively from the same stream): TEST RESULTS OF UNIVERSAL MANUFACTURING CORPORATION Woodson-Tenent Baron Consulting ID 8.40 ppb None detected (less than 1 ppb) 12] 24.7 ppb None detected (less than 1 ppb) 13] 0.43 ppb None detected (loss than 1 ppb) 14] 11.3 ppb None detected (less than 1 ppb) 15] 4.99 ppb None detected (less than 1 ppb) Source: EIA Exhs. 9-12. ** * The results of these different testing programs all reflect the same fact: Reputable testing laboratories, using recognized and accepted measurement techniques, "are unable in most cases to produce even approximately similar test results on PCB levels in identical samples of industrial effluent." (EIA Exh. E at 2) Accordingly, the discharge limitation for Aroclor 1016 must be modified. Mr. Laubscher testified the allowable limits which could be tested accurately would bo between 10 MOWS 0B9964 - 55 and 20 ppb, with a 100 to 400 percent range of reasonable variations. (EIA Exh. F at 6) This testimony is unrebutted, and requires modification in the proposed 1 ppb standard. In view of the substantial range of variations which must be expected, a 20 ppb discharge limitation is the lowest standard which could be properly enforced. B. Any Discharge Limitation Adopted Should Be a "Net" Discharge Limitation to Adjust for Preexisting PCB In Influent Water Over the past forty years, over one billion pounds of PCB have been used by many different industries in this country (see 41 Fed. Reg. 30469)--and to the extent that the more highly chlorinated mixtures have persisted in the envi ronment, they can be found in many different bodies of water. Tests of influent water at capacitor plants have disclosed the presence of PCB--at times exceeding the proposed effluent limitations of 1 ppb. But the proposed regulations do not take this factor into account in regulating capacitor discharges. (EIA Exh. C at 8-10) Thus, capacitor manufac turers who discharge little (if any) Aroclor 1016 in their plant effluent and whose discharges without any pre treatment would meet the 1 ppb limitation, may be obliged to treat the water under the proposed regulations due solely to PCB for which they boar no responsibility and over which M0NS 089965 56 they had no control. Such a result is both unfair and improper under the Federal Water Pollution Control Act which provides only for the regulation of discharges actually made by each company subject to a discharge limitation. Accordingly, the proposed standards should be modified to adjust for preexisting PCB levels in influent water by regulating only the discharges actually made by capacitor companies. MONS 089966 - 57 - ' CONCLUSION There is no basis for the Agency's decision to regulate all "PCBs" as if the many different PCB. mixtures were a single chemical, presenting identical hazards to the environment. PCBs vary substantially in their chemistry and molecular ccnposition. As a matter of elementary organic chemistry, the persistence tendency of each compound and thus .its potential for toxic effect varies directly with the number of chlorine atoms in each molecule. This is a non-controversial scientific fact. Yet the significance of this fact has been ignored by the Agency, which has undertaken to regulate "PCBs" with little attention to the differences in the materials used by the two industries subject to the discharge regulations involved in this proceeding. . The capacitor industry, represented by the Electronic Industries Association's Ad Hoc PCB Committee, has long recog nized the substantial differences between Aroclor mixtures. Five years ago the industry made the decision to convert to the use of a material which was shown to be biologically safe and non-persistent. Aroclor 101G was developed by Monsanto for the sole purpose of eliminating those highly chlorinated isomers which have been found to persist in the environment; the capacitor industry converted to its use solely out of environmental concerns. Yet despite all this, the Agency has MONi> 0d9967 58 chosen to regulate Aroclor 1016 as if it were essentially identical to such highly chlorinated PCB mixtures as Aroclor 1254 or Aroclor 1260. The record is silent when it comes to a justification for the Agency's proposal to regulate Aroclor 1016 at the same discharge lfevel proposed for such Aroclors as 1254 and 1260. Accordingly, the Agency's proposed 1 ppb discharge limitations for all polychlorinated biphenyls should be modi fied with respect to Aroclor 10.16. The following arguments justify such needed modifications. . First, the Toxic Substances Control Act preempts totally this area of regulation. Inasmuch as no capacitor manufacturer will invest the substantial sums required for treatment facilities to comply with the proposed 1 ppb dis charge limit, such regulation is tantamount to a premature ban on the use of Aroclor 1016 and is thus inconsistent with the 2-1/2 year gradual phase-out of PCBs mandated by TSCA. Further, the imposition of national effluent limitations Is inconsistent with the requirement of the Water Pollution Control Act that the Administrator consider specifically tho effects of a pollutant on the specific body of water into which it is discharged. Only, local on-site regulation of discharges can fulfill this statutory requirement. ' ; V.'.. MONS 089968 - 59 Second, if national effluent discharge limitations are to be set for Aroclor 1016, the 1 ppb limitation should be modified to 100 ppb. Such a discharge limitation would be entirely free from risk to the environment, and would provide a very substantial and "ample" margin of safety for all aquatic and non-aquatic life. Adoption of any lower standard would be inconsistent with the vast bulk of the scientific evidence introduced into the record, and would be based on a failure to recognize the characteristics of Aroclor 1016 which make it materially different in chemistry and environ mental effects from all other PCBs which have been studied. Finally, if the Administrator elects to adopt a discharge limitation for Aroclor 1016 lower than 100 ppb, the lowest criteria which can be fairly administered is 20 ppb. At any lower level, companies subject to the regulation will unavoidably be exposed to arbitrary and unfair enforcement. It is impossible accurately to measure Aroclor 1016 in industrial effluent to 1 ppb as proposed. Even at higher levels such as 10 ppb, measurements would be subject to very substantial variations. Only a 20 ppb limitation provides a reasonable basis for regulation. Further, the discharge regulation must be modified to account for the substantial levels of PCB extant in mostcapacitor plants' influent water-- which in some cases would exceed the 1 ppb limit. Unless the discharge criteria ia modified to regulate only those discharges actually made by each company, the capacitor industry will bo penalized for past use of PCBs by other, non-rogulatcd companies--a result nowhere sanctioned or HONS 0 0 9 9 6 9 60 authorized by the Water Pollution Control Act. Respectfully submitted. Steven S. Rosenthal December 22, 1976 COVINGTON & BURLING 888 Sixteenth Street, N.W. Washington, D. C. 20006 Attorneys for The Electronic Industries Association's Ad Hoc PCB Committee MON8 0899 70 APPENDIX Outline Of Scientific Evidence Presented By the Environmental Protection Agency Concerning Aroclor 1016 The following outlines the scientific evidence presented by the Agency concerning the toxicity or persistence of Aroclor 1016. EPA Exhibit A and 24 exhibits thereto Donald I . Mount, Ph.D. No testimony concerning studies on the toxicity or persistence of Aroclor 1016. EPA Exhibits B and 3D exhibits thereto Gilman D . Veith, Ph.D. Four studies presented on the bioaccumulation of Aroclor 1016. EPA Exhibit C and 9 exhibits thereto Alan V. :Nebeker, Ph.D. Two studies presented on the toxicity of Aroclor 1016. EPA Exhibit D and 19 exhibits thereto David J. Hansen Four studies presented on the bioaccumulation of Aroclor 1016. EPA Exhibit E and one exhibit thereto Thomas 0 . Munson, Ph.D. No testimony concerning studies on the toxicity or persistence of Aroclo. 1016. EPA Exhibit F and two exhibits thereto Donald Sargent No testimony concerning studies on the toxicity or persistence of Aroclo: 1016. EPA Exhibit G Richard J. Callaway No testimony concerning studies on the toxicity or persistence of Aroclor 1016. EPA Exhibit X and Wilbur McNulty, four exhibits thereto M.D. No testimony concerning studies on the toxicity or persistence of Aroclm 1016. HONS 089971 2- EPA Exhibit J and 9 exhibits thereto EPA Exhibit K and seven exhibits there to EPA Exhibit L and 11 exhibits thereto EPA Exhibit M and exhibit thereto EPA Exhibit N and four exhibits thereto EPA Exhibit 0 and 10 exhibits thereto EPA Exhibit P and 10 exhibits thereto EPA Exhibit Q and 9 exhibits thereto EPA Exhibit R and one exhibit thereto EPA Exhibit S and 6 exhibits thereto Ronate Kimbrough, M.D. No testimony concerning studies on the toxicity or persistence of Aroclor 1016. Joseph Rizzo No testimony concerning studies on the toxiciIy or persistence of Aroclor 1016. Delwayne Nimmo, Ph.D. No testimony concerning studies on the toxicity or persistence of Aroclor 1016. Ian C.T. Nisbet, Ph.D. Testimony concerning the Criteria Document. Robert Squire, D.V.M., Ph.D. No testimony concerning studies on the toxicity or persistence of Aroclor 1016. Harry V. Gelboin, Ph.D. No testimony concerning studies on the toxicity or persistence of Aroclor 1016. David R. Young, Ph.D. No testimony concerning studies on the toxicity or persistence of Aroclor 1016. James R. Allen, D.V.M., Ph.D. No testimony concerning studies on the toxicity or persistence of Aroclor 1016. David E. Ph.D. Armstrong, No testimony concerning studies on the toxicity or persistence of Aroclor 1016. Robert Ringer, Ph.D. One study presented on the toxicity of Aroclor 1016 in mink. NUNS 0899 72 EPA Exhibit T and 4 exhibits thereto EPA Exhibit U.and 4 exhibits thereto EPA Exhibit V and 12 exhibits thereto EPA Exhibit W Robert Risebrouqh Ph.D. No testimony concerning studies on the toxicity or persistence of Aroci.o> 1016. William A. Br ungs, Ph.D. No testimony concerning studios on the toxicity or persistence of AroeUi:' 1016. Charles E. Mauk, Ph.D. No testimony concerning studies on the toxicity or persistence of Aroclo:: 1016. Leonard J. Ph.D. Guarraia, Testimony concerning the formulation of the Agency's proposed criteri M0Ns 009973