pepper, hamilton scheetz · pepper, hamilton & scheetz attornelfs at law 13oo nineteenth...

PHILADELPHIA. PENNSYLVANIADETROIT. MICHIGAN

NEW YORK. NEW YORKPITTSBURGH. PENNSYLVANIAHARRISBURG, PENNSYLVANIA

PEPPER, HAMILTON & SCHEETZATTORNElfS AT LAW

13OO NINETEENTH STREET. N. w.WASHINGTON. D.C. 2OO36-I685

I2O2) 828-1 2OO

TELEX CABLE ADDRESS; A4O653 (ITT)FAX: (2O2) 828-1665

WILMINGTON. DELAWARE

BERWYN. PENNSYLVANIA

CHERRY HILL. NEW JERSEY

LONDON. ENGLAND

MOSCOW. RUSSIA

WRITER'S DIRECT NUMBER

coo of(202) 828-1452

July 2, 1996

VIA FACSIMILE

Michael Berman, Esq.U.S. Environmental Protection AgencyOffice of Regional CounselMail Code CS-29A77 West Jackson BoulevardChicago, IL 60604

Edward J. HanlonRemedial Project ManagerFields Brook Superfund SiteU.S. Environmental Protection AgencyRegion 5 (HSRM-6J)Ohio/Minnesota Remedial Response Branch77 West Jackson BoulevardChicago, IL 60604-3590

Re: Response To EPA's May 22, 1996 Letter, May 23, 1996Telephone Call and June 3,1996 Letter Concerning The RemedialAction Appropriate For the Floodplain/Wetlands Area

Dear Michael and Edward:

The purpose of this letter is to provide the Fields Brook Action Group's("FBAG") preliminary response to several conceptual issues raised in several EPAcommunications concerning the Floodplain/Wetlands Area ("FWA") and the sediment

PEPPER. HAMILTON & SCHEETZMessrs. Berman and HanlonJuly 2. 1996

operable unit ("SOU"). These communications include: (1) Michael German's June 3,1996 letter, re: Fields Brook Superfund Site Floodplain/Wetlands Alternative; (2) theletter from Edward Hanlon, Environmental Protection Agency ("EPA") to JosephHeimbuch of DeMaximis Re: Comments to FBAG's 12/15/95 Draft Feasibility Study,Floodplain/Wetlands Area (FWA))f Fields Brook Site (May 22, 1996) ("LetterCommenting On Draft FWA FS"); (3) Letter Re: Floodplains/Wetlands Area; FieldsBrook Site (May 22, 1996) ("Other FWA Letter"); (4) the May 23, 1996 telephone callbetween Joseph Heimbuch and Edward Hanlon; (5) the June 17, 1996 letter toJoseph Heimbuch; and (6) portions of the June 19,1996 letter from Michael Bermanto me.

While this letter is detailed, the FBAG is not attempting to engage in a"paper war." Rather this letter responds to several global negotiation issues andprovides our rationale (so that EPA will be able to understand our position). As notedbelow, we suggest the parties discuss how to proceed rather than generate morepaper responses.

In particular, the FBAG is responding to: (1) EPA's preferred alternativefor the FWA (i.e.. excavation of soil from industrial plants in Exposure Units 4, 6, and8 containing polychlorinated biphenyl ("PCB") concentrations greater than 50 ppm);(2) EPA's proposal that the FBAG place rip rap on the sediment in Fields Brook whichcontains chemical concentrations above the cleanup goal ("CUG"), but below theconfidence removal goal ("CRG"); (3) EPA's informal post-remedy monitoringproposals; (4) EPA's seeming departure from its own policies on "applicable orrelevant and appropriate requirements" (" ARARs") and remedies for PCB contaminatedsoil at industrial facilities; and (5) EPA's puzzling statement that a remedial alternativeestimated to cost between $11.3 million (CH2M Hill's estimate) and $14.8 million(Bechtel's estimate) is not different in cost from a remedial alternative that cost $6.9million (Bechtel's estimate of the cost of Alternative Ilia) (despite the 64% to 114%increase in costs) (see page 7 of the Letter Commenting On Draft FWA FS).

The FBAG has not preliminarily committed to any remedial alternativeother than Alternative Ilia and will not commit to EPA's suggested alternative,although we are willing to continue to discuss remedial alternatives and anyreasonable technical concerns. The administrative record demonstrates thatAlternative Ilia is consistent with the National Oil and Hazardous Substance PollutionContingency Plan ("NCP") and that EPA's suggested alternative is inconsistent withthe NCP (and not required by any policy or regulation),

EPA's proposed FWA alternative: (1) does not provide any incrementalrisk reduction and will increase the risk of construction related accidents (an actuarial

PEPPER. HAMILTON & SCHEETZMessrs. Berman and HanlonJuly 2, 1996

risk, not a theoretical risk); (2} does not provide a significantly greater degree ofeffectiveness (particularly since it significantly increases the environmental harm); (3)is not cost-effective; and (4) is contrary to ERA policies and guidance (including theSuperfund administrative reforms, EPA's proposed PCB disposal rules, and ERAproposed new cancer slope factors).

EPA's demand that the FBAG rip rap essentially all of the sediment whichERA heretofore has agreed need not be remedied repudiates a fundamental basis forthe negotiations over the last several years. Such a proposal can only be viewed asa profound "about face" at this point in the negotiations.

As described below, the rip rap is not necessary because the averageconcentration after implementing the sediment removal is less than the CUG.Additionally, the average concentration in the industrial exposure units ("Ells") is lessthan the residential CUG, therefore, the sediment from the industrial EUs cannot causethe residential EUs to exceed their CUGs. Further, as "noncontaminated" sedimentis added to the Brook from the watershed, the long term average concentration willdecrease far below the CUG. In fact, the highest concentration remaining in thesediment in the Brook (42 ppm of PCBs) represents a 10"6 risk level (which is an orderof magnitude below the level considered safe by EPA (see e.g.. National Commissionon Risk Assessment and Risk Management, Report on Risk Assessment and RiskManagement in Regulatory Decisionmakinq at 102 (June 13, 1996) (draft) ("NationalRisk Commission Report") (recommending a flexible bright line of 10"5 risk)). Thus,EPA's demand that the FBAG remedy the sediment containing concentrations abovethe CUGs but below the CRGs results in no meaningful decrease in risk. Similarly,EPA's monitoring proposal has little technical basis and a large cost.

Overall, the differences between the FBAG and EPA proposals are nottrivial. We estimate that as much as a total of $13.4 million in additional remedialcosts is being sought by EPA in the FWA and SOU.

Notwithstanding the FBAG's strong disagreement with and puzzlementover EPA's leanings concerning the remedial alternatives and our continued andgrowing frustration with the process which EPA is using in this negotiation, the FBAGremain committed to negotiating integrated FWA and SOU remedial actions and theindividual companies remain committed to integrating the separate plant sourcecontrol cleanups with the other remedial actions.

The FBAG welcomes and encourages early and forthright discussion ofthese significant issues rather than continued exchange of incredibly detailed commentletters which add to the transaction costs but do not improve the exchange of views.


It is preferable to discuss the major conceptual issues and leave the detailed responsesto a point in the process where there is agreement on the broader conceptual levels.Indeed, a pattern seems to have developed that whenever one group of EPA's expertsis favorably inclined towards a remedial proposal, new and different EPA personnel areasked to review the proposal until someone is found who objects. Such a proceduredooms the negotiation to failure. The FBAG recommends that the parties meet todetermine if there is a method of resolving these substantive and proceduraldifferences.

The remainder of this letter as divided into responses concerning theFWAand the SOU.

I. THE FLOODPLAIN/WETLANDS AREA

A. Introduction

The following: (1) summarizes the history of FWA negotiations; (2) brieflydiscusses the major ARARs issues; (3) described the reasons that EPA's preferredalternative (excavation of all soil containing PCBs greater than 50 ppm from industrialproperty) provides no significant incremental benefit at significantly greaterenvironmental costs; and (4) describes the reasons that selection of EPA's proposalis not consistent with EPA guidance and policy. The $3.8 million to $9.5 milliondifference in cost between EPA's proposed alternative and Alternative Ilia is a real andsignificant difference and is not cost-effective even using EPA guidance. In fact,selection of the EPA preferred alternative would also be contrary to recent Superfundand Toxic Substance Control ActC'TSCA") policy statements.

B. The History Of The FWA Negotiations

As you know, for several years the FBAG has engaged in accelerateddata gathering and remedy negotiations to determine if the FBAG and EPA could agreeupon a remedial action that: (1) both parties believe is consistent with the NCP; (2)the FBAG could agree to implement; and (3) EPA could propose for public comment.The FBAG has preliminarily committed to implement Alternative Ilia from the draftFWA Feasibility Study. This alternative reduces the risk in the residential EUs to the10"6 risk level (based on EPA's deterministic risk assessment) by excavation of soilcontaining, inter alia, above 30 ppm of PCBs and covering soil containing PCBsbetween 8 ppm and 30 ppm. This alternative also reduces the risk in the industrialareas to less than 4 x 10'a (again based on EPA's deterministic risk assessment) bycovering soil containing concentrations above 50 ppm with a six or twelve inch soil


cover). Finally, this alternative also reduces the ecological risk to acceptable levelsusing the ERA ecological screening risk formula.

Alternative Ilia in the draft FWA FS: (1) protects human health and theenvironment; (2) satisfies ail ARARs (see below); (3) balances permanence against thewholesale destruction of a thriving ecosystem; and (4) costs in excess of $6.9 million{a substantial commitment by any standard, unless one uses the mathematics citedby EPA in its May 22nd letter, see discussion below).1

The FBAG recognizes that EPA never formally (or even informally! agreedto Alternative Ilia. However, at the November 2, 1995 meeting, there seemed to bea positive reception to the FBAG proposal, especially from the EPA wetlands andecological experts. Since that meeting, however, a series of questions have beenraised and the FBAG believes that different personnel have become involved in thedecisionmaking. The emphasis has shifted away from protecting the ecosystem toconcern about the "long-term effectiveness after the remedy is implemented" in theareas on industrial property where PCB concentrations will remain at or above 50Ppm (see May 22nd Letter Commenting On Draft FWA FS at 4). Although some ofthe specific questions that have recently been raised have surprised and confused ofthe technical experts utilized by the FBAG, we have expended considerable costsresponding to these concerns. This letter also communicates additional technicalsupport for the FBAG position.

C. ARARS

The Letter Commenting On Draft FWA FS requests an "analysisindicating why the 6" cover and 12" cover alternatives meet the requirements ofTSCA's § 761.75 for any cover over any total PCB areas above 50 ppm," adiscussion regarding compliance with TSCA § 761.60, and a discussion of whethera TSCA waiver is needed (id- At 5). Elsewhere in the EPA letter (M- at 3), EPAacknowledges that this analysis "will be submitted" as part of the source controldiscussion on the SCM plant. On March 7, 1996, a forty-four page discussion ofARARs was submitted to EPA (notwithstanding the confusion in dates, this is themore detailed discussion of ARARs mentioned in EPA's May 22d letter). In any case,the discussion in this March 7th submission concerning the SCM facility is equallyapplicable to the FWA and thus this letter only summarizes the conclusions (A copy

1. Cost estimates vary depending upon whether the damage to the FWA ismitigated in place or offsite.


of the SCM submission is Attachment 1, which is included for the FWA administrativerecord).

The conclusion is that the TSCA regulations are not legally applicable,but, in certain circumstances, may be relevant and appropriate. Even the TSCA officehas concluded that they do "not anticipate that the provisions relating to the remedialapproach and residual levels permitted will significantly affect CERCLA cleanups,because "[generally, EPA would be likely to select the risk-based option."2 EPA, infact, concluded in a 1995 memorandum concerning another Region V PCB sedimentsite that "[ujnder any reading of the regulations/1 EPA "is empowered to leave thesediments in-place in a manner that will not present an unreasonable risk to humanhealth and the environment."3 Most of the logic is equally applicable for thesediments/soils in the FWA. In any case, TSCA waivers may be granted for soil if arisk assessment demonstrates that the disposal is safe.4 Thus, the question pursuantto Superfund or TSCA is whether covering the soil on industrial plant property withsix to twelve inches of soil is protective (see discussion below).

A response to the other specific ARAR questions raised in MichaelGerman's June 17th letter will be sent to you by separate cover. It is worth noting,however, that most of the alleged continuing ARAR disagreements seem to be amistaken reading by EPA (in most cases involving EPA's failure to note an unequivocalprior acceptance) or misapplication of an ARAR (e.g.. EPA request that the FBAGfollow EPA acquisition regulations despite the fact that the FBAG is not part of theFederal government).

2. Disposal of Polvchlorinated Biphenvls: Manufacturing, Processing, and Distribution inCommerce: Proposed Decision on Exemption Petitions: Proposed Rules. 59 Fed. Reg. 62,788,62,799 (1994) ("Proposed PCB Disposal Rule").

3. Memorandum form J. Carra, Office of Pollution Prevention, to Stephen Luftig, Acting Director,Office of Emergency and Remedial Response, Re: Disposal of PCBs Contaminated Sediments (April3. 1995).

4. 40 CFR S 761.75(c)(4) and Interim Guidance on Non-Liquid PCB Disposal Methods to be Usedas Alternatives to a 40 C.F.R. 761.75 Chemical Waste LandfillfCWLl (July 3, 1990).

PEPPER. HAMILTON fit SCHEETZMessrs. Berman and HanlonJuly 2, 1996

D. EPA's Proposed Alternative Provides No Significant Benefits. On Balance.Over Alternative Ilia

1. Introduction

The following: (1) addresses generally some of the comments raised byEPA in its June 17, 1996 letter on the FWA Human Health and Ecological RiskAssessment ("FWA Risk Assessment"); and (2) evaluates the reasons that there is nosignificant risk presented by leaving soil containing PCB concentrations between 50ppm and the highest concentration in the FWA (approximately 600 ppm) covered withbetween six and twelve inches of soil in the FWA.

Regardless of which risk assessment is used, there is no significant riskpresented by soil containing PCB covered with six inches to twelve inches of soil (seeAttachment 2: Gradient Report, assessing the potential for contaminant migration andexposure on the SCM property. Much of this analysis is equally valid for the FWA.We will submit a new Gradient Report for the FWA shortly}. Note, however, theprimary reason for using a six inch soil cover rather than a ten or twelve inch coverwas to prevent harm to the ecosystem.

2. The FWA Human Health and Ecological Risk Assessment

a. Introduction

EPA's June 17, 1996 letter concerning the FWA Human Health andEcological Risk Assessment is puzzling. Generally, that letter either misstates EPA'spolicy or is simply wrong. Each point is addressed below.

b. The Delay In Raising Substantive Concerns Suggests ThePurpose of the Comments Is Record Building Rather ThanSubstantive Disagreement

EPA and FBAG risk assessors agreed at the November 1995 FWAmeeting upon cleanup and removal levels (even though they agreed to continue todisagree about the derivation of these levels). The unanimous impression of the FBAGrepresentatives was that EPA was inclined to accept the FBAG's proposed alternative.

The FBAG, therefore, is surprised and concerned at EPA's presentposition. These comments arrive nine months after the submission of the October1995 FWA Risk Assessment (and over a year since the original draft of the FWA RiskAssessment was submitted in June 1995). It was the FBAG understanding (based

PEPPER. HAMILTON & SCHEETZ

Messrs. Berman and HantonJuly 2, 1996

on the November 1995 meeting) that there were no significant differences, except thedegree to which the FBAG relied upon the probabilistic exposure analysis. The factthat these issues are being raised suggests that they are related to EPA's withdrawalits apparent acceptance of the FBAG proposed remedial alternative. Nonetheless, werespond to these comments (Responses concerning alleged mathematical errors arebeing checked and will be included in a subsequent submission from Gradient).

c. EPA's Risk Assessment Fails To Follow EPA Guidance ToTreat Industrial Land Use Differently Than Residential LandUse

All of the soil that EPA suggests should be excavated and landfilledoffsite is located on industrial plants (most of which are owned and operated bymembers of the FBAG). Thus, the actual likelihood of exposure is remote. Localcitizens would need to trespass on private property to be exposed. The hypotheticalrisk assessed in both the FBAG and EPA risk assessments is an artifact of theassumption that workers regularly and repeatedly visit the areas with contaminatedsoil. A survey of the actual workers indicates no such behavior (and, therefore, norisk) (see further discussion of the survey below).

d. Probabilistic Exposure Assessment Is Required Bv EPAGuidance and Recommended By The National RiskAssessment Commission

The probabilistic risk assessment performed by the FBAG demonstratesthat the existing levels of PCBs present a risk less than 10"6 in the occupationalexposure units. Notwithstanding EPA's attempt at this site to ignore the probabilisticrisk assessment because of alleged uncertainties, the probabilistic exposure analysisprovides valuable insight into the risks at this Site.5 EPA guidance and policyencourage, if not require, probabilistic risk assessment. In fact, not only are the EPARegional offices encouraged, if not commanded, to use probabilistic risk assessmentsby EPA written guidance (which we cited in our prior letters), but on May 14-16,1996, EPA Superfund Headquarters recently held a workshop on probabilistic risk

5. As the FBAG understand it, EPA intends to issue a risk assessment purged of all references toprobabilistic risk assessment. Even if ultimately EPA decided to rely upon the deterministic riskassessment to set cleanup goals and confidence removal goals, it would be more appropriatescientifically and more honest administratively to include the probabilistic risk assessment in anappendix as part of the risk assessment's evaluation of uncertainties in the risk. In any case, theFBAG's probabilistic risk assessment remains in the administrative record and EPA cannot expungeit.


Messrs. Berman and HanlonJuly 2, 1996

assessment to further encourage the use of such techniques. The author ofGradient's two-phase probabilistic risk assessment was an invited participant in thisworkshop.

The Commission on Risk Assessment and Risk Management ("NationalRisk Assessment Commission") (an expert panel specifically tasked withrecommending improvements to the risk assessment process) recommended that EPAuse probabilistic exposure assessment in the Suoerfund program.6 In fact, the RiskCommission pointedly noted that EPA guidance requires use of probabilistic exposureassessments but that "implementation of those guidelines among regional offices isuneven; some continue to use point estimates."7

If EPA completely ignores the probabilistic risk assessment, such anaction can could only be characterized as "arbitrary."

6. National Risk Assessment Commission Report at 29-30. The National Risk AssessmentCommission also endorsed using the 90th percentile and 10* risk management goal. Id., at 29 and74.

7. Id. 29.



e. EPA's Claim That The Accuracy Of the FBAG DistributionsAre Questionable Is Generic. Unsupported Bv Anv TechnicalAnalysis And Simply Wrong

EPA's complaint that the accuracy of the FBAG distributions isquestionable applies to any probabilistic analysis and any deterministic analysis.Contrary to statements made by ERA, a probabilistic risk does not and cannot createuncertainty in a risk assessment. At worst, it makes apparent and explicit theuncertainties inherent in the deterministic risk assessment used by ERA. If adistribution of exposure values is uncertain, then a point estimate is even moreuncertain.

The FBAG's consultant proposed reasonable distributions for allparameters. Where the distributions were known, the real distributions were used.Where less information was available, the consultant used distributions reflecting bestprofessional judgment (in some cases triangular or rectangular shapes) which variedgenerally as the true distributions are expected to vary (e.g.. low values of exposurerising to high values and dropping to low values through the distribution). Based onour review of probabilistic risk assessments used by other ERA Regions at Superfundsites and even probabilistic exposure assessments prepared for ERA program offices,the FBAG's two-phase probabilistic risk assessment is state-of-the-art for this type ofassessment and addresses forthrightly all of the legitimate technical issues raised byERA. A paper describing this two-phase probabilistic risk assessment has beenaccepted for publication by the Human and Ecological Risk Assessment journal andthe ERA probabilistic risk assessment workshop panel members will be given thispaper as a "case study". Clearly, independent scientific reviewers did not find thesame level of problems as ERA Region V.

It is not relevant that these distributions may not be a perfect reflectionof the true distribution. This argument undercuts all probabilistic analyses. Rather,these arguments seem to stem from a disagreement between ERA Region V and ERAheadquarters and virtually every expert body which has examined the issue (e.g.. theNational Risk Assessment Commission).

The uncertainties in these distributions (which are openly acknowledgedin the October 1995 FWA Risk Assessment) do not significantly affect the risk.Perhaps EPA's real concern with the probabilistic exposure assessment is that itresults in lower risks for the measured concentrations (which is precisely the reasonthat it has been adopted by ERA Headquarters and recommended by national expertbodies).



It should be noted that the many comments about probabilistic versusdeterministic exposure assessment are taken (in some cases with quotation marks andin other case without the quotation marks} from EPA national guidance, learned texts,and national expert recommendations and reports.

f- EPA's Claim That The Surveys Performed By The FBAG AreUnreliable Are Overstated and Unsupported Bv AnvTechnical Analysis And Simply Wrong

The October 1995 FWA Risk Assessment carefully qualifies the surveyscited. The Gradient risk assessment, in fact, does not use the actual exposuredetermined from the survey. Rather the survey is used to assess the properdistribution and to anchor the distribution. Margins of safety were added in eachcase, i.e.. higher exposure is used in the probabilistic risk assessment than indicatedin the survey.

It is not fruitful to reiterate all of the points previously made, but thecompany that performed the residential survey was a professional organization andhas been used by EPA to perform similar surveys. This type of survey is inherentlydifficult to perform and interpret. However, repeated EPA Region V's refusal toconsider it at all, is unscientific and contrary to EPA policy on maximizing the use ofreal data.

The industrial worker survey was administered by the companies, but theresults confirm the intuitively obvious — most workers do not walk long distancesduring their lunch hour to sit in a wetland/floodplain so that they can eat dirt.

PEPPER, HAMILTON & SCHEETZ


g. EPA's Attempt To Censor The Record Bv Removing AnyReference To EPA's Own Professional Judgment That PCBsAre Much less Toxic Than Was Assumed In the October1995 Risk Assessment Is Contrary To Two legally BindingConsent Decrees and National Guidances That RequireConsideration Of New ToxicoloQical Information AtSuoerfund Site and Sound Principles Of Administrative Law

EPA's June 17th Letter states that the discussion of EPA's decision tochange the cancer slope factor for PCB: (1) is based on a document not publiclyavailable; (2) is a draft document and therefore cannot be followed as policy untilissued in final; and (3) inaccurately characterizes the impact of the change in cancerslope factors. These points are either factually incorrect or based on amisunderstanding.

First, the Settlement Agreement in General Electric Company v. CarolBrowner and EPA. Civ. Act. No. 93-1251 (D.C.Cir. October 26, 1993) (Attachment3) ("GE Settlement") requires EPA to "consider ail credible and relevant informationbefore it" in a Superfund risk assessment, "if any outside party questions IRIS valuesduring the course of an EPA proceeding (for example, during the course of a riskassessment or selection of the remedy at a particular site)" (lei- at 2). Although thelanguage is broad, the lawsuit was filed specifically concerning EPA's cancer potencyfactor for PCBs in the Integrated Risk Information System ("IRIS") (as you know, IRISis used as the source of cancer potencies for Superfund risk assessments). Further,the GE Settlement requires EPA personnel to recognize that "entry of a value on IRISdoes not constitute rulemaking, is not entitled to conclusive weight, and does notmake the value legally binding." (Id., at 2).

On December 21,1993, in response to this Settlement Agreement, EPAissued a national guidance, which makes the same points (Attachment 4:Memorandum from William Farland, Director, Office of Health and EnvironmentalAssessment, and H. Longest, Director, Office of Emergency and Remedial Response,to Directors, Regional Offices (December 21, 1993). In fact, EPA (in response toanother lawsuit) issued a memorandum to EPA Regions stating the EPA Regions haveauthority to approve human health water quality standards for PCBs that use a cancerslope factor less stringent than 7.7 (mg/kg/day)-1 (Attachment 5: American ForestAnd Paper Association. Inc. v. EPA. Consolid. Case No. 93-0697 RMU (D.C. Cir.Nov. 7, 1995).



Second, PCBs Cancer Dose-Response Assessment and Application ToEnvironmental Mixtures (NCEA-W-059. Jan. 1996) ("EPA's PCB Cancer AssessmentDocument") is an external review draft and, therefore, by definition is publiclyavailable. In fact, EPA held a public workshop on its new proposed cancer potencieson May 21-22, 1996 and is soliciting public comment.

The FBAG agrees that EPA's final policy (and the final cancer slope factorfor PCBs) cannot be known to a certainty now. The FBAG believes that many of thepolicy aspects of the EPA Cancer Assessment Document are scientificallyinsupportable and not sound policy and, therefore, they should be changed in the finaldocument. This acknowledgement does not alleviate EPA from its obligation toconsider this new lexicological information on a site-specific basis. In fact, ithighlights the need to do so.

EPA is also obligated by the American Forest and Paper Associationsettlement agreement to issue a final cancer slope factor by the end of the year(Attachment 5 indicates September 1, 1996). EPA confirmed to the participants atthe PCB cancer slope factor workshop that a final PCB cancer slope factor would beissued by September 1996. Even if a short extension is obtained, a new cancer slopefactor will be known well before a remedy for the FWA is designed or implemented.It would be cost-ineffective to proceed without considering this new information.

Third, the FBAG did not cite the EPA PCB Cancer Assessment Documentas "policy" that EPA Region V should follow. Rather, this EPA report is new scientificinformation on the cancer slope factor for PCBs that EPA must consider in its site-specific risk assessment of PCBs at this specific Superfund Site. The new informationincludes EPA's Office of Research and Development's best professional judgmentconcerning the cancer slope factor for PCBs and the new General Electric rat studies{see below).

As you know, the re-evaluation of the original rat studies by EPA is basedon a re-read of the original tumor slides performed by independent experts of thehighest caliber, which demonstrates few tumors in the rats. That information wassubmitted to EPA.

General Electric voluntarily performed additional animal exposure studiesand has submitted those studies to EPA (they are summarized in the EPA report).Based on this new lexicological information, EPA and all of the members of EPA'sscience advisory panel have concluded indicates that PCBs are less potent than wasassumed in the October 1995 risk assessment. The General Electric studies may

PEPPER. HAMILTON & SGHEETZ

Messrs. Herman and HanlonJuly 2, 1996

support even lower levels than listed in the EPA PCB Cancer Assessment Document.

The F6AG are concerned that EPA may be considering not including adiscussion of this scientific uncertainty in its risk assessment for the FWA. EPA isrequired to consider this information and has already allowed the use of less stringentcancer slope factors prior to the issuance of a final revised cancer slope factor.Clearly, EPA guidance, a legally binding settlement agreement, and general principlesof administrative law mandate that EPA consider this information.

The analysis of the potential impact of the change in cancer slope factorsstated in the June 17th letter is not well founded. The aroclor present in the FieldsBrook soil and sediment is overwhelmingly 1 248 (based on the Monsanto salesrecords and examination of the chromatographs from soils taken from the area).Since it is not possible to predict which cancer slope factor the final guidance willproposed for aroclor 1248, we use the range of new slope factors from EPA's ownbest estimate.

The cancer slope factor recommended by the EPA toxicological expertsfor lower chlorinated PCBs is 0.3 (mg/kg/day)"1 and for higher chlorinated PCBs is 2.0(mg/kg/day}"1 (approximately one fourth to one thirtieth the value used in the October1995 FWA Risk Assessment). Thus, use of a cancer slope factor recommended byEPA Research and Development staff for this type of aroclor would result in anincrease in the cleanup goal by a factor of approximately 4 to 30.

Many other Federal agencies have issued more reasonable assessmentsof the toxicity of PCBs. Table 1 compares the average daily exposure (ug/kg/day) ofPCBs estimated using: (1) the cancer slope factor in October 1995 FWA RiskAssessment (at the 10"9 risk level); (2) the cancer slope factors proposed for lowerand higher chlorinated PCBs in EPA PCB Cancer Assessment Document; (3) the FDAadvisory for PCBs in fish; (4) the Agency for Toxic Substances and Disease Registryminimal risk level; and (5) the Great lakes Governors Special Fish Advisory Sciencepanel recommended exposure. This comparison indicates that these othergovernmental PCB toxicity values are many times higher than the level which wouldbe allowed using even the highest proposed cancer potency factor recommended byEPA's own experts in EPA PCB Cancer Assessment Document.

Gradient representatives also attended the PCB cancer slope factorworkshop. The Gradient personnel concluded that a substantial lowering of thecancer slope factor is inevitable. This opinion is consistent with the unanimousconclusions expressed in environmental trade press about the PCB cancer slope



reassessment process. The FBAG strongly believes that no one can conclude that thePCB cancer slope factor will not change.

In summary, there is no basis in the law or science for ignoring theaccumulated new scientific information. The cancer slope factor for aroclor 1248 iscertain to be lowered. Even if there is uncertainty in the final cancer slope factor thatmay be chosen, it is absolutely clear that a significantly lower cancer slope factor iswarranted at this Site.

If the final risk assessment for this Site does not consider thisinformation, it will be deficient as a matter of law and fact. Instead, ERA should avoidmaking a cost-ineffective decision based on dated information.

3. Ecological Risks

The ecological studies of the area do not reveal significant ecosystemimpacts from the presence of chemicals. Every visit to the Site reveals a healthy andrelatively diverse ecosystem. The ecological hazard quotient methodology used to setecological cleanup goals is a screening methodology. As a result, this methodologyoverstates potential impacts and should not be used to set ecological cleanup levels(see our prior letters). Until recently, EPA's major concern has been that theecological harm caused by the remedial alternatives might cause more ecological harmthan good.

The FWA Alternative Ilia (particularly the use of six inch cover in certainareas) recognizes the tradeoff between the long-term effectiveness of the cover andthe impact of excavation in the FWA. Until relatively recently, the EPA expertsinvolved in the decisionmaking were ecological experts and seemed more concernedabout the harm to viable natural ecosystem. Of late, other {as yet unidentified) EPAreviewers (apparently less concerned about the ecological impacts on the FWA) haveexpressed concerns about long-term effectiveness. This factor now seems to havebeen elevated above all other factors (which as noted below is contrary to EPApolicy). Such an emphasis is not warranted factually nor based on EPA's regulationsand policy.



4. Conclusion

EPA's approach to decisionmaking at this Site is troubling. The FBAGhas raised issues in a respectful and scientific manner. EPA's recent unanticipatedtermination of the previous dialogue on these issues is unfortunate and unjustified.The administrative record contains the FBAG's submissions. Attempts to excludeinformation and science from the negotiation process endangers the entire negotiationprocess.

E. Comparison of Alternative Ilia Compared To EPA's Proposal

1. Introduction

Regardless of the disputes concerning the risk assessment, EPA'sproposal results in little or no additional benefit for significantly greater costs. Thefollowing summarizes this information.

2. There Is No Significant Difference In the Risk Reduction

There are no significant pathways of exposure once the soil in the FWAis covered. The following summarizes the major pathways.

a. Groundwater Pathway Presents No Significant Risk

EPA's TSCA office has proposed to allow a ten inch soil cover to be usedto dispose of soil containing PCB concentrations up to 100 ppm genericallythroughout the U.S.8 Thus, on its face, any soil containing PCB concentrations upto 100 ppm can be safely covered with 10 inches of soil.

The site-specific factors indicate that high concentrations of PCBs maybe safely disposed of with a six or twelve inch cover because of the virtual absenceof groundwater in the region coupled with low permeability and high soil partitioningby PCBs (ssfithe March 7, 1996 submission concerning the SCM plant source controlproposal, which demonstrates that there is very little risk of the migration of PCBs ingroundwater in this area generally (including in the FWA).9 Based on the model usedin this assessment, it will take thousands of years for any PCBs to migrate even short

8. Proposed PCB Disposal Rule, supra note 2, at 62,863-64.

9- See soon to be submitted Gradient Report.


distances. Gradient will submit a technical report to EPA by separate cover once itis completed).

b. The Inhalation Pathway Presents No Significant Risk

EPA's 1987 assessment of the inhalation risk to local residents from PCSon industrial soil which is uncovered concluded that "PCB levels in [outdoor] soilbetween 220 and 1,300 ppm presents a 1 x 10"7 carcinogenic risk."10 Thus, the 10'a risk level is 1,144 ppm to 6,760 ppm using this risk assessment. If EPA's proposedcancer slope factors were used, the concentrations that correspond to a 10'6 risk levelwould be 17,290 ppm to 29,260 ppm. All soil containing PCBs greater than 50 ppmin occupational areas will be covered pursuant to Alternative Ilia. Virtually noemission of PCBs would occur. Therefore, the inhalation risk from leaving some onthe FWA uncovered would be significantly lower than estimated above. The risk aftercovering is virtually zero.

c. The Cover Eliminates Dermal and Inqestion Exposure. ToThe Extent Any Exposure Occurs

By definition, any remedial action or institutional control that preventsdirect contact with the contaminated soil eliminates the risk of dermal or ingestionexposure. The only difference between EPA's proposed alternative and Alternative Iliais whether the soil containing PCB concentrations are maintained on-site or whethersuch soils are excavated and maintained off-site in a TSCA landfill.

First, the FWA is a floodplain and wetland because, by definition, waterand sediment deposit in these areas during normal flow conditions and during storms.Thus, it is inconsistent with the nature of the soils for there to be substantial erosioninto the Brook.

Second, even if "normal" erosion of soil from the FWA to the Brook isassumed, it would take 150 to 300 years for the 6 inch cover and 300 to 600 yearsfor the twelve inch cover to erode completely away (using the same erosionparameters provided to EPA in the submission on the SCM mining residuals pileanalysis).

10. Polvchlorinated Biohenvls Spill Cleanup Policy. 42 Fed. Reg. 10,688, 10.698 (1987) ("PCBCleanup Policy"I• The cancer slope factor used in 1987 was 4.0 (mg/kg/dav)'1, as opposed to thecurrent cancer slope factor of 7.7 (mg/kg/dayH. EPA's PCB Cancer Assessment Documents listscancer slope factor of 2 and 0.3 (mg/kg/day}'1 for the higher and lower chlorinated PCBs,respectively. Thus, the risk would be 2 to 13 times lower than the risk estimated in 1987.


Third, covers can and this cover will be inspected and maintained. Therewill be yearly inspections and inspections whenever a 25 year or greater storm occurs.If the cover erodes, the cover will be replaced. Since this cover will be located onprivate property and the FBAG will be obligated to inspect and maintain the cover, thecover, by definition, will provide long-term protection. As part of an integratedmonitoring proposal (for the sediment operable unit, the FWA remedy, and the sourcecontrol operable units), the FBAG will propose a one time post-remedial actionsampling program to ensure that exposure to the sediment in the Brook does notpresent an unacceptable risk.

Fourth, the FBAG have repeatedly answered EPA's unusual request toassess the likelihood that worms will transport PCB contaminated soil to the top ofthe cover over time. As indicated in the submissions from EA Engineering, there isno ecological rationale for such an assumption. It is simply biologically infeasible forworms to transport sufficient PCBs to the surface in any reasonable time period.

If such worm transport of PCBs is a legitimate concern at this Site, itmust be a concern at all PCBs sites. Therefore, to be consistent. EPA must withdrawits proposed PCB disposal rule (which allows a ten inch soil cover) and withdraw thePCB Spill rule which has allowed ten inch covers at thousands of PCB spill locations.Since EPA has no intention of withdrawing these rules, it is clear that the wormtransport theory is not only scientifically invalid, but more of an excuse than aconcern.


d. Conclusion

As this review indicates, even without considering the new EPA cancerslope factor and the probabilistic exposure, there is no significant risk to human healthand the environment if the soil in the industrial areas within the FWA are coveredrather than removed.

3. The Cost Difference Between EPA's Alternative Ilia And EPA'sAlternative Are Significant (Even According To EPA Policy) And.Therefore. EPA's Proposed Alternative Is Not Cost-Effective

The FBAG are particularly concerned with EPA's statement that

Alternative V's excavation and off-site disposal of allmaterial above 50 ppm PCBs is $11.3 million [a disputedfigure since the draft FWA FS indicates a realistic cost of$17 million], whereas the Alternative 111 A excavation witha cover is $7.5 million, with a difference in cost betweenEPA's proposed Alternative V and II [sic] of $3.8 million.... the costs [between these alternatives] are notoverwhelmingly different... and that the $11.3 million totalcosts would not generally be considered 'inordinate/(Comments On Draft FWA FS Letter at 7).

This statement is contrary to EPA's own published statementsconcerning costs. The difference in costs between Alternative Ilia and EPA proposedalternative (approximately $4.4 million to $7.9 million)11 means that EPA's proposedalternative is between 65% to 114% higher in costs than Alternative Ilia. This costdifference is: (1) an amount that would be considered a serious cost overrun in anynormal construction project; (2) greater than the difference in the maximum annualfunding for Superfund and the current 1996 funding level (i.e.. a 20% difference); and(3) greater than the difference in the estimated average remedy cost using the currentSuperfund remedy selection criteria and the cost estimated by ChemicalManufacturers' Association if all of the remedy selection reforms are enacted (a 30%difference).

EPA Superfund policy (explicitly stated in the preamble to the currentNCP and upheld by the District of Columbia Court of Appeals) is that, if two or more

11. The difference between $11.3 million to $14.8 million versus $6.9 million is $4.4 million to$7.9 million.


remedial alternatives are determined to be comparably effective, "the least-costly ofthe comparably effective alternatives would be identified as cost-effective while theothers would not."12 Even where the effectiveness of the alternatives is notidentical, but the difference is" small but the difference in costs is very large, aproportional relationship does not exist."13 The D.C. Court of Appeals directlyaddressed the issue raised by EPA in the FWA when it held that there is "nothing" inSuperfund to "suggest that selecting permanent remedies is more important thanselecting cost-effective remedies."14 In fact, the Court noted that if "EPA were torequire the selection of permanent remedies whenever possible, it would be ignoringthe statutory mandate to select cost-effective remedies."15

Even the TSCA office referred to a 100% difference in costs of attainingcleanup levels as dramatically higher.10 EPA is developing guidance on cost-effectiveness. The First Circuit specifically held that lowering the PCB cleanup levelat a Superfund site from 50 ppm to 20 ppm at an increased cost of $6.7 million (afactor of 3.6) was not cost-effective.17

When these factors are applied to the FWA remedial alternatives, thereis no question that EPA proposed alternative is not cost-effective. Further, there is nodifference whatsoever between the effectiveness of the FWA Alternative Ilia and theproposed PCB disposal rules. The site-specific risk assessment demonstrates thatthere is no meaningful difference between the effectiveness of a well maintained soilcover and disposal in a TSCA landfill.

Thus, the difference of between $4.4 million and $7.9 million (which isalmost certain to be toward the higher end) is out of proportion to any meaningfulincrease in effectiveness.

12. National Oil and Hazardous Substances Pollution Contingency Plan. 59 Fed. Reg. 8,666, 8,727(1990) C1990 NCR*). See Ohio v. U.S. Environmental Protection Agency. 997 F.2d 1520, 1532(D.C.Cir. 1993).

13. 1990 NCP. supra note 12. at 8.727.

14. Ohio v. U.S. EPA. 997 F.2d at 1532.

15. id. at 1532.

16. PCB Spill Cleanup Policy, supra note 10, at 10,699.

17. U.S. v. Ottati & Goss. Inc.. 900 F.2d 429, 441 (1st Cir. 1990) (noted that such increasedcost "amounts to a very high cost for very little extra safety." Id.).


F. Selection Of EPA's Proposed Alternative Is Contrary To RecentSuoerfund And TSCA Policy and Regulations And Other Developments

In recognition of the substantial concern that Superfund remedies werenot cost-effective, ERA has announced a number of new policies to guide the site-specific remedy selection process in Superfund and TSCA. Specifically, EPA'sAdministrator has repeatedly stated that the Superfund program would make more"common-sense; cost-effective [remediation] choices" than in the past.18 TheAssistant Administrators for Solid Waste and Emergency Response (i.e.. Superfund)and TSCA jointly issued a directive to Region V explaining how the Superfund andTSCA cleanup policies are moving "towards increased consideration of containmentas a appropriate remedy for many sites."19

EPA's proposed PCB Disposal rule allows covering of soil containing upto 100 ppm of PCBs with ten inches of clean soil at any low exposure (i.e.. industrial)location in the country and containment of soil containing higher concentrations atspecific sites, if supported by a risk assessment.20 Commenters urged EPA toexplicitly authorize covering soil containing up to 500 ppm of PCBs and the final rules(which have not yet been promulgated) may contain such an option. Additionally,EPA just proposed a new rule for disposal of media contaminated with RCRA wastes.The proposed rule uses a 1,000 ppm concentration of PCBs in soil as the "bright-line"level which allows site-specific remedial management plans to address contaminatedsoil on site without treatment.21

18. 20 New Reforms Cap Two-Year Effort To Reform Suoerfund: EPA Administrator Calls forLegislative Changes. Environmental News 23 (October 2, 1995).

19. Memorandum from E. Laws, Assistant Administrator, Office of Solid Waste and EmergencyResponse, and Lynn Goldman, Assistant Administrator, Office of Pollution Prevention. Pesticides,and Toxic Substances, to Valdas V. Adamkas, Administrator, Region V, Re: Transmittal of theTechnical Review Team Report for the Manistioue Michigan River and Harbor Area of Concern at 2(April 11, 1995).

20. Proposed PCB Disposal Rule, supra note 2, at 62,798-99, 62,863-64.

21. Requirements for Management of Hazardous Contaminated Media (HWIR-Media). 61 Fed. Reg.18,780(1996). This proposed rule applies to soils contaminated by RCRA wastes, which is not thesituation in Fields Brook. This proposal, however, illustrates the unequivocal direction of cleanuppolicy at EPA.


Furthermore, the level of review in this case also runs directly counter tothe trend in EPA programs. The PCB New Spill policy is self-implementing. EPA hasproposed to make all PCB remediation disposal Resource Conservation and RecfDoverAct corrective actions self-implementation. (See Corrective Action for Releases FromSolid Waste Management Units A Hazardous Waste Management Facilities. 61 Fed.Reg. 19,432, 19443 (1996) (advanced notice of rulemaking) EPA also nowemphasizes use of performance standards rather than strict regulatory oversight. id.In fact, EPA is encouraging program manager to "focus on the desired result of thecleanup rather than a mechanistic cleanup process." ]Q. at 19,443, and See Id. at1,447.

In summary, EPA guidance favors containment of PCBs in the FWA soilon industrial property and use of less detailed reviews.

G. Conclusion

EPA's statements that excavation of soil containing greater than 50 ppmof PCBs from industrial private property and offsite disposal are not based on cost-effectiveness. No other basis or benefit has been suggested.

The FBAG has extensively cited EPA policy and guidance (sfifi above), inlarge part, because it often reflects the experience of EPA in implementing theprogram. Also, generally and in this case, citing such guidance is useful to EPApersonnel because it demonstrates that decisions are within a range of acceptableoutcomes. The FBAG and its members have never been involved in a Superfund orother environmental project where departures from the Agency's national policy hasbeen so widespread and explanations of the discrepancies so limited.

In light of the clear inconsistencies with the NCP, the FBAG cannot andwill not commit to implement or agree with EPA's proposed remedy.


II. THE SEDIMENT OPERABLE UNIT ISSUES

A. Introduction

EPA's May 14th and June 19th letters reflect a continuing confusion andmisapprehension concerning the CRG concept, scour, and the normal dynamics ofFields Brook, and a resistance to EPA national guidance. The following outlinesFBAG's response to EPA's rip rap proposal and outlines a reasonable remedialproposal.

B. The Distinctions Between The Confidence Removal Goal Concent. Scour.And Movement Of Sediment Containing Concentrations Above The CUGWithin An Exposure Unit

1. Introduction

EPA's June 19th letter evidences the CRG concept. Thus, we need todefine (once again) the CRG concept and distinguish between the scour analysis(performed by Woodward-Clyde and agreed to by the Army Corps of Engineers andEPA) and the concept articulated in the letter of "dirty" sediment migratingdownstream and becoming deposited on previously clean sediment.

2. Confidence Removal Goals

Initially, it should be stated that all CRG calculations have alwaysassumed that no rip rap is placed on the sediment containing chemicals atconcentrations above CUG, and below CRG. That is, the whole point of the CRGconcept. This sediment need not be remedied (i.e.. neither excavated nor rip rapped).The FBAG are puzzled that this point is not yet understood after all of these years andtechnical discussions.

Since the concept of CRGs has been repeatedly explained in submissionsto EPA and is described in EPA Superfund guidance, this submission will only brieflydiscuss it. The CRG concept is founded on EPA's method of selecting cleanup levelsto protect human health and the environment.22 The cancer risk assessmentestimates the average lifetime exposure to either a residential or occupationalpopulation to chemicals in a particular media — sediment in this case. Compliance

22. SQQ e.q,. USEPA, Supplemental Guidance to RAGS: Calculating The Source Term (IntermittentBulletin, May 1992).


with the cleanup level is determined by examining the average concentration after theremedy is implemented.

Hence, the CRG approach requires removing the sediment containing thehigher concentrations until the average concentration after the remedy is at or belowthe CUG. Thus, by definition soil or sediment containing chemical concentrationsabove the CUG, but below the CRG are not remediated. Furthermore, at the Site, theFBAG agreed to remove sediment in areas where sampling measured concentrationscorresponding to a 10"4 risk level. Since the highest CRG concentrations are lowerthan the 10*4 risk level (e.g.. the highest CRG for PCBs is 42 ppm or approximately10"* risk), this has not driven any excavation.

Notwithstanding the lack of need, the FBAG agreed to place rip rap inareas where sediment is excavated because it exceeds a CRG and bedrock is notencountered).

3. Scour Analysis

EPA's May 14th letter confuses the scour analysis with normal in streammovement of sediment. Woodward-Clyde, under EPA's and the Army Corps ofEngineers' direction performed a scour analysis. The purpose of this analysis was toidentify areas where the flow of water might be so high that contaminated sedimentbelow the top two feet might become uncovered. As a result, the water wouldbecome a source of recontamination of the stream and a potential exposure route.Scour, therefore, focusses on storm events, not normal flow.

At EPA 's insistence, many unrealistic assumptions were used in thisanalysis to ensure that any conceivable scour area was identified and the FBAGagreed to place rip rap on that sediment. It is this analysts that was referred to in themany misquotes cited in EPA's May 14, 1996 Letter. None of the areas that EPAnow requests to be covered with rip rap were identified by this scour analysis.

4. Movement Of Sediment Within An Exposure Unit

a. Introduction

Inherent in the CRG concept is the fact that sediment containingchemicals of concern at concentrations above the CUG, but at or below the CRGconcentration, will remain on-site after the remedy is implemented. For sedimentcleanups, an implicit fact is that the sediment in Fields Brook (whether it contains


concentrations in excess of CUG concentrations or not) will continue to migrate afterthe implementation of the remedy (as it has prior the remedy).

Sediment containing chemicals at concentrations above the CUG,however, are not glued to their present location on Fields Brook. All of the sedimentin the top several feet of the Brook may move down stream within an exposure unitand the top portion of the sediment will constantly be moving.

However, this sediment does not move intact, but mixes with otherbottom sediment from the Brook containing concentrations less than the CRG,noncontaminated sediment (i.e.. sediment containing concentrations less than theCUG concentrations) from the Brook and noncontaminated sediment migrating fromthe drainage basin. An assumption that sediment moves downstream intact is not aworst-case assumption but an impossible assumption.

b. Since No Additional loading Of Chemicals Of Concern AreAdded To the Brook. The Concentration Cannot Increase.Even If The Impact Of Noncontaminated Sediment IsConsidered

The FBAG have not, and do not, argue that sediment containingchemicals above the CUG will not move, just that such movement is irrelevant sinceit does not change the average exposure (and, therefore, does not change the risk).

The simplest method of evaluating the impact of the movement ofcontaminated sediment within an exposure unit is to consider the following. Forsimplicity sake, we assume that the exposure unit is, in essence, a box containing100 kilograms of surface sediment with an average concentration 1 ppm of PCBs.Thus, there is 1/10,000 (0.0001) kilogram of PCBs (0.1 grams or 100 milligrams) and99.9999 kilogram of sediment (0.0001/99.9999 - 1 ppm). No matter how thechemicals are distributed on this sediment and the sediment distributed within thebox, the average concentration remains the same — 1 ppm. Prior to the remedialaction, there is a particular distribution of PCBs on the sediment within the exposureunit.23

23. Another visual analogy would be a very long oblong box containing different colored ping pongballs. If the red balls were the high concentration sediment and the low concentration balls weregreen, there would be an initial distribution. As the ping pong balls moved within the long oblongbox, the number of red and green balls would not change. If the average concentration of red andgreen balls is fixed, there never can be a situation were all of the balls to which a person might be

(continued...)


EPA's examples of how movement of sediment within an exposure unitcould result in an increased risk that either violates the laws of physics (i.e.. increasingconcentration of PCBs without increasing the mass of PCBs in the box or exposureunit), ignoring the average concentration, and/or only look at what is happening inwhat occurs in a portion of the box {thereby violating EPA's guidance on how toassess risks).

As far as we can understand, the EPA's "worst-case" scenario24

assumes that sediment containing the highest CRG level (42 ppm in exposure unit 8)moves intact within an exposure unit. It Is physically impossible for sediment tomigrate intact, as hypothesized by EPA. Rather, the sediment containing 42 ppm ofPCBs must mix with less contaminated sediment (since by definition, all othersediment in the Exposure Unit contains lower concentrations of PCBs). Even if thishigher concentration sediment is temporarily deposited on clean sediment, the riskdoes not change, because other sediment containing concentrations above the CUGwill be covered with clean sediment that has migrated. One can only create a risk byfixating only on one half of what is happening within the exposure unit.

c. After The Implementation of the Sediment Operable Unit.Source Control Operable Units, and the FWA Remedy. TheAverage Concentration Must Decrease BecauseNoncontaminated Sediment Continues To Be Added To TheBrook And The Mass Of Chemicals Of Concern RemainsConstant Or Decreases In Fields Brook

In reality, every day, there is additional mass added to the Brook (ourhypothetical "box"), I.e.. soil and sediment runoff enter Fields Brook. Currently, littleof this sediment is contaminated. After implementation of the Source ControlOperable Unit and the FWA remedies, this new sediment entering the Brook will notbe contaminated (i.e.. it will contain between zero and concentrations lower than theCUGs). By definition, the volume of sediment increases and the mass of chemicals

23. (...continued)exposed over the lono term la lifetime) were red. Rather there would be a constantly changingpattern of red and green balls at any given location, but the same number and, therefore, the same•likelihood of exposure overall.

24. EPA policy, however, is to use "reasonable" exposure assumptions, not worst-caseassumption. See also Risk Commission Report at 28-29, which strongly recommends against theuse of maximum exposure and supports probabilistic exposure.

PEPPER. HAMILTON & SCHEETZMessrs. German and HanlonJuly 2, 1996

of concern does not. Thus, the average concentration of chemicals on thecontaminated sediment must decrease over time.

There is no doubt that the exact location of a given portion of sedimentwill vary over time after the remedy is implemented. At some locations,concentrations may temporarily increase, but at others, the concentration, bydefinition, must decrease (because no new mass of contaminants is being added tothe Brook and more sediment).

This result is generally confirmed by the existing sampling data. Thesource of all the chemicals of concern are from historic discharges and the residualsoil contamination on the source areas. The pattern of chemical concentrations in thesoils and sediment confirms this model. For example, virtually all of the PCBs arelocated in two hot spots. The bulk of the length of Fields Brook contains PCBconcentrations below 50 ppm (50% nondetects and only 2% with concentrationsabove 50 ppm}.

5. Movement Of Sediment From The Occupational Exposure Units ToExposure Unit 2. The Residential Exposure Unit

For simplicity of calculating risks and because it does not alter the result,the FBAG and EPA have assumed that no sediment is transported down stream fromone exposure unit to another. The basis of EPA's request that the Army Corps ofEngineers model the sources of contaminated sediment entering the Ashtabula Riveris EPA's assumption that Fields Brook is a significant source of contaminated sedimentnow found in the Ashtabula River. Without admitting or denying this claim, it is clearthat to the extent that existing sediment in Fields Brook is contaminated and thissediment migrates down Fields Brook into the Ashtabula River, this assumption simplyserves to remove contaminated sediment from Fields Brook. Thus, the net impact isto reduce the risk in Fields Brook overtime.

6. The Sediment Remedy Is "Safe" Even if Sediment ContainingConcentrations Equal To The Confidence Removal Goals RemainAfter Excavation

The risk from exposure to the Fields Brook sediment after excavation is"safe* regardless of how the sediment migrates. First, the CUGs are set at the lowestend of risk management range (10'6 risk level). As the D.C. Court of Appeals noted

PEPPER. HAMILTON & SCHEETZMessrs. German and HanlonJuly 2, 1996

in upholding EPA's long-held policy and practice the "10"* [risk level] represents a safelevel of exposures" to average concentrations at a Superfund site.25

Second, the risk assessment methodology used to set the CUGs is veryoverpredictive of risk. For example, the National Risk Assessment Commissionrecently noted several deficiencies in the risk assessment, many of whichoverestimate the risk.28 More importantly for the SOU, the National RiskAssessment Commission recommends the use of probabilistic exposure estimates(with a 90th percentile as the goal), and criticized EPA Regional offices for notimplementing EPA national guidance.27 Therefore, as the probabilistic exposureassessment performed for the FWA indicated that, even higher CRGs would beappropriate, if probabilistic exposures were used.

Furthermore, as discussed above in Section I, EPA has announced thatits best toxicological judgment is that the cancer slope factor for lower chlorinatedPCBs approximately 1/4th with the value currently in EPA's Integrated RiskInformation System (and which was used in the sediment CUG calculation}. Thus, theCUG for PCBs should be at least a factor of 4 and perhaps an order of magnitudehigher, if this new cancer slope factor is used. As result, the CRGs would increase andthe volume of sediment to be excavated decrease.

Thus, the residual risk level for sediments containing the CUGconcentrations is probably much lower than EPA's deterministic risk assessmentassumes.

Third, because sediment is being excavated for multiple chemicals, theactual average concentration per exposure unit of PCBs and other chemicals ofconcern after the remediation of the sediment will be less than the CUG. Forexample, the volume weighted average concentration of PCBs for all industrialexposure units is 0.6 ppm (compared to the CUG concentration for residential areasof 1 ppm and the occupational CUG of 3.1 ppm).28

25. Ohio v. USEPA. 997 F.2d 1520, 1533 (D.C. Cir. 1993).

26. Id. at 29-30.

27. See Risk Commission Report at 29-30 and Appendices, which compare toxicity factorsestimates using the techniques recommended by the Risk Commission with existing toxicityestimates.

28. Since clean fill should contain no PCBs, the true concentration is likely to be zero.


Even if one ignores all of EPA risk assessment guidance and simplyestimates the lifetime risk if a person was exposure to the highest remainingconcentrations, the highest risk is 10* using EPA's deterministic risk assessment, arisk level an order of magnitude lower than the level EPA considers safe for PCBs (10**risk level) and about equal to the average risk after regulation in the U.S. (see aboveand prior submissions).

Fourth, since only "clean" sediment will migrate into the Brook afterremediation of the source areas, the average will be even lower. Over time, all of thesediment in the Brook will be replaced by "clean" sediment, which should be anaverage concentration that is much lower than the post-remedy concentration of 0.6ppm). If the Fields Brook sediment replacement time is less than the 30 year lifetimeexposure period used to estimate lifetime risk in the residential EUs, the residual riskover a lifetime would decrease even further. In any case, the risk ends, once all ofthe "contaminated sediment in the Brook is replaced with "clean" sediment (wheneverreplacement occurs). Therefore, the sediment concentrations after excavation cannotcause the risk to exceed the 10*° risk level.

According to EPA's ecological experts, removal of PCBs to an averageconcentration of 50 ppm (a level higher than the highest PCB CRG) would not presenta significant environmental risk.29 Thus, the residual levels cannot result in anunacceptable risk, even if averaging and probabilistic exposure are ignored.

Thus, EPA's concern that sediment containing chemicals above the CUG,but below the CRG, is irrelevant from a human health and environmental risk point ofview, even assuming the impossible occurs and the high concentration sedimentmigrates down the Brook intact. In the interest of time, we summarize this technicalassessment. The technical submission will be provided to EPA by separate cover.

29. This is based on the ecological risk assessment and discussions at the and conclusionsreached at the November 2, 1995 meeting.


7. The Confidence Removal Goal Concent Is Even More Imbedded InEPA Guidance Than When It Was Originally Approved And HasUndergone Vigorous Scientific Scrutiny Purina Scientific PeerReview

The concept of the CRGs, which was accepted by EPA in this case fouryears ago, has long been adopted in general EPA guidance.30 This approach is nowspecifically required by Superfund's draft soil screening level guidance.31 Just assignificant to the scientific validity of the approach is the acceptance of the approachby the peer reviewers selected by the Environmental Science & Technology (publishedby the American Chemical Society).

8. Conclusion

The foregoing demonstrates that: (1) the CRG method attains CUGsunder all conditions; and (2) movement of contaminated sediment cannot cause asignificant risk. Therefore, rejection of this technique and the demand to use rip rapto prevent migration of sediment containing sediments with concentrations above theCUG, but below the CRG, is arbitrary and capricious.

30. USEPA, Methods For Evaluating the Attainment of Cleanup Standards: Volume t: Soils andSolid Media (EPA 230/02-89-042, 1989).

31. EPA, Soil Screening Guidance 14-16 (EPA/540/R-94/101) and EPA, Soil Screening Guidance:User's Guide at 33 (EPA/540/R-961098, April 1996).


C. LONG TERM MONITORING OF THE BROOK

1. Introduction

EPA is apparently seeking periodic sampling (approximately 20 samplesper exposure unit) every six months during at least the initial few years after theimplementation of the SOU and the FWA remedial actions. This sampling would costmillions of dollars per year for many years. Some members of the FBAG negotiatingteam believe that EPA has indicated that this sampling must demonstrate no changein distribution of sediment concentrations within exposure units and if the distributionchanges (even if the average does not change}, more remediation would be required.

EPA's proposal: (1) is scientifically inconsistent; (2) is contrary to EPA'slong established policy concerning when to require additional remedial action; (3)evidences absolutely no comprehension of or agreement in the fundamental principlesunderlying the remedial proposal that has been discussion over the last four years.

2. Confirming The Excavation Was Performed As Designed AndVisually Observing the Brook Is The Only Monitoring That IsNecessary

EPA has expressed concern that the soil covers used in the FWA willerode. General soil loss equations indicated that it would take 150 to 300 years toerode a six inch cover. To ensure that erosion does not occur, the FBAG woulddevelop and submit to EPA a plan for visual inspection of FWA covers. This planwould ensure that the cover has not eroded and would require maintenance of thecover if excess erosion occurs.

3. EPA Clear. Unequivocal. And Long Term Policy Is Not To RequireAdditional Remedial Work Unless The Risks From The Site Exceed10* Risk Level

As noted above, this remedy is stringent, with risk beingreduced to below 10"a. Neither the statute, the new NCP, EPA guidance nor commonsense require remedies to be changed after implementation of the remedy.Requirements normally are determined and "frozen" in the ROD.32 It is EPA policynot to add new requirements "unless the new or modified requirement calls into

32. 1990 NCP suflra note 12. at 8,757.

PEPPER. HAMILTON & SCHEETZMessrs.Berman and HanionJuly 2, 1996

question the protectiveness of the remedy.33 Requirements "promulgated ormodified after ROD signature," are only required if they are "necessary to ensure thatthe remedy is protective of human health and the environment."34

ERA clearly stated in the preamble to the NCR,

Once a ROD is signed and a remedy chosen, EPA will not reopen thatdecision unless the new or modified requirement calls into question theprotectiveness of the selected remedy. EPA believes ... continuallychanging remedies to accommodate new or modified requirements would... disrupt CERCLA cleanups. ... The policy will help avoid constantinterruption, re-evaluation, and redesign during the implementation ofselected remedies.35 (emphasis added)

As a practical matter, private parties must have finality. The history ofconstantly changing requirements for the Fields Brook SOU stands testament to thedisruptive effects and delay caused by moving the target.

The District of Columbia Court of Appeals affirmed EPA's interpretationof the statute when it noted that new remedial actions will only occur at Superfundsites when the "the remedy is no longer protective."36 Where the remedy attainshealth-based cleanup levels (as in the case of the Fields Brook sediment operableunit), the Court specific upheld EPA's policy that "five year reviews will not occur atsites deemed safe under the standards prevailing at the time of the determination,"against the argument raised by several States (including Ohio) that even sites cleanedup to CUGs should be reviewed every five years.37 Thus, no five year review isnecessary at the Fields Brook Site for the SOU.

As noted in several prior submissions, a remedy is not protective if therisk exceeds the 10"4 risk level, i.e.. only if the remedy "would result in exposures

33. ££&40 C.F.R. § 300.430{f)(1)(ii)(B).

34. See 40 C.F.R. 5 300.430{f)(1)(ii){B)(1).

35. 1990 NCP. suora note 12. at 8.757.

36. Ohio v. U.S.E.P.A.. 997 F.2d 1520, 1535 (D.C.Cir. 1993).

37. id. at 1535.


outside the acceptable range that generally defines what is protective."M Theexample provided in the preamble to the NCR is when a remedy that is thought topresent a 10"B risk level after implementation of the remedy is later found to presenta 10'2.39

111. CONCLUSION

It is impossible after considering the above not to conclude that thereremain serious problems, not just with the substantive proposal recently made EPA,but with the process. While the FBAG has welcomed the additional expertise (throughthe FBAG or EPA) to solve problems, recently it almost seems as if the FBAGsubmissions are circulated until someone is found to object to a provision.

The effort to expedite the remediation at the Site, however, is not anacademic issue nor can it be reviewed in isolation. The FBAG has already spent theincredible sum of the more than $22 million in sampling, analysis, reports, and designwork. AH too much of this incredible sum has been misspent answering academic orirrelevant questions. The FBAG has preliminary committed substantial sums to performthe SOU design and the FWA Alternative Ilia remedy. A portion of these costs alsoinvolve costs not required by science or EPA policy, but committed to in order toavoid litigation. Various individual companies are committing millions more to performsource control remedies. Many of the companies in the FBAG are participants in theAshtabula River Partnership, which seeks cleanup of the Ashtabula River. Thesepreliminary commitments individually, no less in the aggregate, are huge.

Suddenly, in disregard of these offers and numerous prior agreements onissues, EPA is seeking up to $14 million more than the FBAG are willing to commit toimplement cost-ineffective measures. As a result, the negotiation are at a de factostand still. We urge EPA to respond to the FBAG's substantive and proceduralconcerns.

38. NCP, supia note 12. at 8,758; Sfifiajgp.40 C.F.R. 300.430(e)(2(i)(A}(2) and Ohio v. USEPA.997 F.2d at 1549, EPA's drinking water regulations specifically refer to the 10-4 risk level forPCBs as a level that "is associated with little to none" of the risks of "cancer or other adversehealth effects which have been observed in laboratory animals" and "should be considered safe."40 C.F.R. S 141.32(eH45) (emphasis added).

39. 1990 NCP, suora note 12, at 8,758


If EPA has any questions concerning the issues discussed in this letter,please call me at the number listed above and I will endeavor to clarify any questionsthat you may have.

ephen M. Truitt

cc: FBAG Negotiating CommitteeConnie Puchalski, EPAW. Carney, EPAB. Bolen, EPAL. Gelman. DOJRegan Williams, OEPAJ. Hurdley, OEPAWayne Reiber, CabotGeraldine Scoll, Cabot