Document rpoBjop169O2ZXwgK91oopZx7

Monsanto tt O' i t> IJM 00 N. Si. Mimow S3t07 oo*: 014) 14-1000 February 3, 1984 Document Control Officer (TS-793) Office of Toxic Subetancee U.S. ENVIRONMENTAL PROTECTION AGENCY Rooei E-409 401 "M" Street, Southwest Washington, D.C. 20460 Deer Sir: Re: Docket No. OPTS-62032 * Proposed Rule - Polychlorinated Biphenyls (PCBa); Exclusions, Exceptions and Use Authorizations (48 FA 53076) Monsanto Company, a broad-based nenufacturer of chealcalo, welcomes the opportunity to coamnt on the proposed rule Indicated. General Co--nts While Monsanto Coapany continues to believe that TSCA Section 6(e) was not Intended by Congress to eover inadvertently generated PCBs, Monsanto Co^any generally supports the proposed rule and believes that It will provlda a partial resolution of remitting Issues concerning Inadvertently generated and recycled PCls. In addition, Monsanto supports the proposed use authorisations for PCBs In hydraulic and heat transfer eye teas, includiaLJpA's consideration to aaend Its proposal for heat transfer system to NgrrlOO ppa Halt. As a apitlclpaat la developing the "consensus rule" proposal last April by thd Chaaleal Manufacturers Association (CMA), the Eavlronaaatal Defense had (I9f), and the Natural Resources Defease Council (MRDC), Monsanto believes that the proposed rule is fully supportable by available scientific and eeoaoalc data and places tight, practicable cost effective lluitatlons and controls on Inadvertent PCS releases and certain other uses that assure no unreasonable risks will be posed to health aad~the environment. However, Monsanto Coapany fully supports the Inclusion of recycled PCBs in the proposed rule in order to insure that manufacturing operations having products contslnlng Inadvertent PCB contamination due to recycle operations receive fair and equitable regulatory treatment as other in advertently PCB contaminated products. unn ftl Cmnv HONS 003607 U.S. ENVIRONMENTAL PROTECTION ACENCT -2- JKC 2/3/84 While generally supporting the proposed rule, Monsanto Coapeny does not egret with certeia devistions by EPA in seversl septets of the consensus proposal. Monsanto questions the validity and value of the untried, unproven, non-peer reviewed aaehodologies employed by EPA In attempting to perform scientific risk assessment evaluations as background documents la support of the proposed rule making. Specific items are discussed In detail below. Specific Issues Monsanto Company submits the following comments relevant to specific Issues: I. Deviations From Consensus Proposal Monsanto disagrees with EPA deviations from tha recowndstlons of the consensus proposal in the following areas: e Establishment of lover 5 ppm concentration limits for certain eonstser products, specifically, deodorant bars end eoepe and plastic building materials and products. e Deletion of the "upset provision" providing for an affirmative defense in enforcement actions. A. Consumer Products EPA'a singling out of the two consumer product cstegorlee (1) deodor ant bars and aoepa, and (2) plastic building materials and products is arbitrary and capricious and totally unnecessary. EPA states that they are not evert of any evidence that PCBs are fowd in eoepe or pleatlc building materials and seates (1) "In fact, PCBa are only hypothesised to occur in soaps and may not be present" (aphasia added), end (2) "Evidence euggeets thet PCS# ere present la plestlc only as a contaminant in pigments at a maximum weight percent of plastic of Imes than 2 ppm..." (emphasis added). Singling out of such products on a purely erbitrary end vhlaslcel basis serves no useful purpose In protecting the consumer or the environment. Furthermore, EPA't explanation of the besle of their Justification merely serves to confuse the general public and leads to a general loss of credibility. Such arbitrary classification can also cauae unjust and irreparable harm to businesses that raly on these product sales end could result In severe financial loaaea from such allegations dua to customars' isifounded faara. Finally, use of EPA's pseudo-acltntlflc risk assassment evaluations and worst case axpoeure scenarios ere totally unrealistic and msanlnglesa and detract from tha Agency's scianeific credibility. This will be discussed in detail later. MONS 003600 < U.S. ENVIRONMENTAL PROTECTION AGENCY -3- j'riC 2/J/84 B. Upset Provision EPA rejected and deleted the "upset provision'' reconended by the consensus proposal on ths basis chat "high lavsls of ralaasas ...should noc bt excluded from regulations." Obviously EPA did not fully understand the consensus proposal upset provision which was modeled after the similar provision In Clean Water Act NPDES regulations. That provision was Intended to provide r'feguards and prevent misunderstandings. The pro posed upset provision required notification of an upset within 72 hours of occurrence. It did not "exclude" from regulation "high levels" of releasee nor did It excuse any factors within the control of the generators. It was solely applicable to an "exceptional incident in which there is unintentional and temporary non-compliance" because of factors beyond the control of the generetor. The provision only provided an affirmative defense In an enforcement action for unintentional and temporary non compliance provided detailed notification was given to EPA within 72 hours. As a result of the provision EPA would be quickly notified of any upset and would be Informed and able to Insure future compliance with all regulations at such sites. Thus the upset provision would have served to call out any sudden high releases to EPA's attention and would have encouraged more vigilant surveillance of Inadvertent generation activity. Since precedent for use of such upset provisions has been estab lished by EPA in other environmental regulations and it offers significant benefits and safeguards to both the EPA end industry at essentially no cost, Monsanto Company urges EPA to reconsider the consensus proposal upset provision for incorporation into the final rule. II. Risk Assessment Evaluation Methodologies & Assumptions Monsanto and others have maintained for many years, based upon evalua tion of the beat available scientific data on animals, humans and the environment, that EPA has grossly over-estimated the toxic potential of PCBs. Major differences In interpretation of findings of PCB health effects, especially related to carcinogenicity studies in animals and human health effects (epidemiology) studies, heve been published as a part of this and other PCB rulemakings by the Agency and Industry groups. Including Monsanto, and will not ba reiterated here. We will focus our comments on the recent methodologies used by the Agency in this rulemaking to astlmata risk and sxposure assessments. In the consensus proposal of April 13, 1983, the parties - CMA, CDF, end NRDC - although having different views on the toxicology of PCBs, believed that their recommendation would assure an absence of un reasonable risk of injury to the health or environment based upon evaluation of all available aciantific Information. Although peer-ravievad scientific methodologies heve not been developed to provide accurate unequivocal quantitative risk end hazard asstsamants that could ba placed on a numarlcal acala, the parties' belief and reconmandatlon was baaed upon the beat scientific Judgments avail abla to all parties. MONS 003609  U.S. ENVIRONMENTAL PROTECTION AGENCY -4- JV.C 2/3/84 EPA, however, in e zealous attempt to resolve the inadvertent generation rulemaking to a simple numerical choice, conducted a new round of risk assessment and exposure assessment using ehe talents of certain in-house scientists and consultants. Tha result of the latest nu&trical risk and exposure assessments by EPA is confusion, contradiction and credulity chat totally strain the bounds of scientific credibility. _ Although EPA uses the documents to arrive at tha same point to support the consensus proposal and states, "Based on the risk assessment for carcinogenicity as well as information on reproductlve/deveiopmencal effects, environmental effects and costs, EPA has determined that the manufacture, processing, distribution in commerce, and use of PCBs below the limits proposed In the consensus proposal would not otssent so unreasonable risk of inlurv to human health or tha environment (48 FR 55079)," because of thepoor factual aciantific basis these document* should be withdrawn from the rulemaking propoaal and be rtavaluatad. (Emphasis added.) Tha documents generally fall to rely on factual information and generally accepted scientific principles and concepts. In all cases tha documents rely on and compound worse csss assumptions which cause the numerical estimates to vary by factors of 1,000,000 or more In many calculations. EPA recognises these shortcomings and points out in saveral discussions of human health risks that "The actual exposure level will be significantly lover than the estimated exposure; therefore tha actual risk will be lower than tha worst case estimate presented in tha quantitative risk assess ment" (48 FR 55081-55085). Again, such pseudo-scientific calcula tions end methodologies merely serve to confuse the public end strain the credibility of the Agency. A detailed critique and review of the scientific aspects of the carcinogenicity and reproductive health effects risk assessments was conducted for Monsanto by independent consultants in toxicology having expertise in evaluation of PCB health effects and la attached as Appendix I. However, the most critical review of tha validity and utility of the EPA risk assessment documents comas from ths EPA HERO sclaetlsts/ authors themselves who stats In their opening paragraph of tha executive summery of the Cercinogenic Risk Assessment: "This docu ment presents the HERD risk assessment for carcinogenicity of PCBe sod suMirisss ths rssults of four previous PCB risk assessments for cancer conducted by FDA, OTA, end CAG/EPA, and 0TS. Unfor tunately, no consolidated assessment can be developed from these sources bseauss of ths different units and dlffsrsnt techniques used, the results from these various risk assessments are not directly comparable, though they ere consistent." The most serious flaws with these documents are that they don't conform in style end/or content to that recommended by the National NUNS 003610 < C.S. ENVIRONMENTAL PROTECTION AGENCY -5- JHC 2/3/84 Academy of Sciences (1983) which have bean accepted by oehar EPA official! and working groups including the Administrator and eha Carcinogan Assessment Croup. In addition, the documents obviously suffer from lack of outside scientific peer review. Monsanto Company racosssends that the carcinogenicity and reproduc tive health effect risk assessment documents and generic exposure scenario documents be withdrawn as part of this rulemaking as being unnecessary and of little scientific value. III. Listing Of "Organic Chemical Product Claasas Potentially Containing Inadvertently Generated PCBt" EPA's mere listing of "Organic Chemical Product Clasaee Potentially Containing Inadvertantly Generated PCBt" (48 FR 55080) is misleading In certain aapects and has alrtady caused considerable confusion and misunderstanding. Certain chemical process classes and subsequently product classes have been mistakenly identified in EPA's support dociawnts on lists of processes and products that could laad to significant Inadvertent generation of PCBa. The published listing le scientifically Incorrect. It is not only the class of chemical product or process that gives rise to the implication that inadvertent PCB contamination is a possibility. The possibility of contamination occurs because the process of manufacture involves the uee of several key ingredients all of which art necessary to cause the alleged Inadvertent PCB con tamination. These key ingredients are (1) hydrocarbon sources, end (2) active chlorine sources as has been pointed out previously In this rulemaking by others, including EPA consultants. Thus the allegation that a certain compound or proceas can be con taminated by inadvertent PCBs is incorrect unless it is stated specifically and succinctly that the route to this product or the process itself Involves ell of the key Ingredients. ?or example, "diphenyl oxide" and "linear alkyl benzenes" are classi fied by EPA ae part of "seventy chemical processes (that) were deter mined to have a high potential for PCB generation.'* EPA co^oundad the problem by employing the downstream usee of these produets to dsvslop further "worst cast" gsnerlc exposure scenarios, i.s., linear alkyl benzenes sra used In the manufacture of detergents, a consumer product. Significant quantities of both diphenyl oxide and linear alkyl bentene, both in excess of about 30E of total U.S. production, ere produced annually la the U.S. by chemical routes which involve absolutely no chlorine. Thus the necessary and sufficient conditions for lnadverteot PCB generation requiring both hydrocarbon sources and aeelve chlorine are not fulfilled. However, the casual raadar of this information and HONS 003611 U.S. ENVIRONMENTAL PROTECTION AGENCY -6- JHC 2/3/84 these liftings who Is not technically sophisticated and trained In chemistry would not understand that these chemicals should not be listed as alleged PCB contaminated produccs/processes because It is scientifically lnpossible. Such e casual listing and allegation has the potential eo cause Irreparable harm to buslnaaaas due to loss of sales due to consumer/ purchaser misunderstanding and fears. EPA should clarify the list ing end explicitly state the minimum conditions necessary for alleging possible PCB contamination by Inadvertent generation. IV. Heat Transfer Use Authorisation EPA has proposed a use authorisation for PCBe in heat transfer syetems in a manner other then totally enclosed at a concentration level of less then 50 ppm. The Agency stated that they are also considering the option of raising the standard to the 100 ppm concentration level. The regulatory Impact analysis conducted by the Agency indicates that the total quantity of PCBe controlled if the standard vara relaxed would vary by only about 4,000 pounds from that of the lover proposed 50 ppm level. However, the cost saving par pound of PCB removed would be substantial, changing from $18,000 to only $300 per pound. From verbal contacts with many owners of heat transfer systems that once contained concentrated PCB materials, Monsanto has learned that design, construction, and operating characteristics of some equip ment meke difficult. If not a practical Impossibility, to achieve the 50 ppm level or lower. The old heat exchanger plpea/syateme can have many turns, twists and recesses where smell quantities of resinous and sludge-like materials caused by localised heat stress can build up and coat the internal surfaces of the heat exchangers. After multiple drainings and flushings use of fresh heat transfer fluid at elevated temperatures sometimes leads to some dissolving of more of ehate solid materials resulting in e gradual increase io levels of PCB greater than 50 ppm over a period of time. Because hast transfer systems generally operate at elevated tempera tures they are designed to operate at some positive pressure and are thus sealed. Leakage, if any, la minimal and usually occurs at pumps or similar locations where It can be collected and controlled. In its generic exposure assessment, EPA assumed worse-case situations that art totally unrealistic In the workplace, as pointed out in the aaaeeassnt. Monsanto Company urges EPA to carefully reconsider the proposed heat transfer use authorisation standard, taking into account coet/beneflc and overstated risk assumption and to propose the 100 ppm standard in the final rule. MONS 003612 U.S. ENVIRONMENTAL PROTECTION AGENCY -7- JHC 2/3/84 Aa a CMA aeaber, Honaanto contributed data and tachnleal expertlae to tha coaanta aubalttad In this rulemaking by CMA for tha lnduatry. Therefore, Mmaanto Coa>any aupporca and adopca othar coanenta aubalttad on chla aubject by tha Chaalcal Manufacturara Aaaoclaclon. Raapactfully aubalttad. / d* Attachaanc bcc: J. R. J. P. R. Condray A. Tenaterhela G. Haaalf S. Park/P. H. Salts John H. Craddock Product and Environmental Safety Director HONS 003613