Editor's Note: The following speech was delivered at theApplied BioTreatment Association second annual meeting onNov. 28 in Washington, D.C. Giamporcaro is the section chief ofbiotechnology rules at the Office of Toxic Substances at the U.S.Environmental Protection Agency in Washington.


About a year and a half ago, I co-authored an article with BobNicholas titled "Nature's Prescription" on the state ofbioremediation. We concluded that despite its promise,bioremediation remained the poor stepchild of hazardous wastetreatment methods. We noted that there was an absence ofdata concerning the effectiveness of bioremediation in breakingdown hazardous waste, which in light of the technology-basednature of hazardous waste cleanup requirements, placedinnovative technologies such as bioremediation at adisadvantage. We cited the need for greater commitment ofresearch dollars to this field on the part of EPA. We also notedthat there were few, if any, signs that companies were usinggenetically engineered microorganisms in waste treatment.

I want to update you on developments in these areas. Whilethe litany of problems that I just recited continues to be anaccurate characterization of impediments to the developmentof this technology, they are problem areas which the EPA hasrecognized and is taking steps to address. As a result, futureprospects for the development of bioremediation appearconsiderably more promising than they did as recently as 18months ago.

I will address three areas, beginning with hazardous wasteregulatory developments. I will focus on the ResourceConservation and Recovery Act (RCRA), since that is the statutewhich is widely perceived as presenting the greatestimpediment to the use of biological systems in the degradationof PCBs and the accompanying regulatory process. Finally, I willprovide an update on the status of the biotechnologyregulations under the Toxic Substances Control Act (TSCA).

Hazardous Waste Regulatory Developments

There have been a number of significant recent developmentsin the area of hazardous waste cleanup. These includepromulgation of the final third-thirds list under the landdisposal restrictions of RCRA, promulgation of revisions to theToxicity Characteristics and the addition of 25 organicconstituents to the list of substances for which wastes must betested, and publication of the proposed RCRA corrective actionregulations.

These and other developments certainly have a bearing onbioremediation. Instead, I want to address the premise that theRCRA regulatory structure is not conducive to the use ofbioremediation, a premise which I suggest is in the process ofbeing refuted.

Let's look, for example, at the land disposal regulations. As youknow, when it enacted the Hazardous and Solid WasteAmendments to RCRA in 1984, Congress prohibited the landdisposal of hazardous waste unless it is first pre-treated to thelevel or by a method specified in implementing regulations, orunless it is demonstrated that there will be no migration of thewaste for as long as it remains hazardous. Treatment standardsfor each listed and characteristic hazardous waste are based onthe best demonstrated available technology (BDAT), and maybe established in two ways: by designating a specific method oftreatment or by establishing a specific treatment standard, thatis, a concentration level.

BDAT is often said to be a disincentive to the use of innovativetechnologies. It is certainly true that designated treatmentmethods and even treatment standards are based on theknown capabilities of existing technologies. However, under therecently promulgated third-thirds rule, biodegradation hasbeen designated as a method of treatment (along with othermethods) for 16 different wastes. Even where it has not beenso designated, there is a regulatory mechanism which aredemonstrated to be equivalent to the specified methods. Wherea specific concentration level has been designated, any methodof treatment which is capable of degrading the waste to thespecified standard may be used.

So there is certainly not an inherent disincentive to the use ofbioremediation in the land disposal regulations. The regulatorysystem does, however, place a premium on the development ofdata which demonstrate the effectiveness of innovativetechnologies -- including bioremediation -- in degradinghazardous waste.

The EPA has taken some important steps in helping to developthat data base. Organizationally, this is best exemplified by theestablishment less than a year ago of the TechnologyInnovation Office within the office of Solid Waste andEmergency Response (OSWER) and the formation of theBioremediation Action Committee.

The Technology Innovation Office's mandate is to examineways of promoting the uses of innovative technologies in thebreakdown of hazardous waste. One of the primary motivatingfactors on the agency's part in doing so is the potential toreduce the enormous costs associated with hazardous wastecleanup.

In February of last year, the EPA sponsored an all-day meetingin an effort to begin to map out what needed to be done tofoster innovative technologies. One of the outcomes of thatmeeting was the establishment of the Bioremediation ActionCommittee. The purposes of the committee are essentiallytwofold: to continue the dialogue among industry, academia,public interest groups and government in this area, and toimplement the recommendations which grew out of theFebruary meeting.

The Bioremediation Action Committee, which has met twicesince its formation, has established four subcommittees todeveloping a set of protocols to determine the effectiveness ofbioremediation agents in spill response. The TreatabilityProtocol Subcommittee, as the name implies, is developingtreatability protocols for oil-spill cleanup and hazardous wasteremediation. The data Identification and CollectionSubcommittee is charged with identifying data sources on fieldapplications of bioremediation and for promoting the inclusionof such data in central databases. The Research & EducationSubcommittee is developing a list of research priorities inbioremediation.

We should not discuss organizational matters without raisingbudget concerns. While budgetary news is generally dismal,there is a silver lining, namely that the budget within EPA'sOffice of Research and Development (ORD) for bioremediationhas quadrupled. ORD's budget for its oil spill research program,which is focused primarily on bioremediation, has increasedfrom $1 million in fiscal year 1990 to $4 million for fiscal year1991.

In terms of actual data development, perhaps the mostsignificant development is the initiation of the BioremediationField Initiative, a joint project between ORD and OSWER. Foursites in which bioremediation is planned or is already in usehave been selected for the program from among a potentialpool of 114 RCRA, CERCLA and underground storage tank (UST)sites. For each of the sites, the EPA will undertake a full-scaleevaluation of bioremediation activities, with an emphasis oneffectiveness, operational reliability and cost. The secondcomponent of the program involves assistance on treatabilityand field pilot studies. This component of the program isdirected at offering support in the feasibility study andengineering evaluation phase to ensure adequate sitecharacterizations, proper design of the treatability studies andinterpretation of the results.

Three years ago, ORD initiated a major research program toassist in development of biological treatment technologies,known as the Biosystems Technology Development Program.The program consists of a consortium of five EPA laboratories.The goal of this research program is to develop new scientificknowledge to take bioremediation from the experimental stageto reasonably routine application status within five years. Theprogram consists of a basic research component and a field testdemonstration component. The basic research component hasemphasized characterization of biodegradation process, meansof enhancing such processes and methods of applications.Funding for the program during fiscal year 1991 has continuedat the same $4 million level as in previous years.

These efforts have been developed to supplement theSuperfund Innovative Technology Evaluation Program, or SITEProgram, which was established in response to Congress'mandate to establish a research program on alternative orinnovative technologies. The SITE Program consists of twoseparate components: a demonstration program and anemerging technology program. The demonstration program isintended to facilitate the application of innovative technologiesin the field, whereas the emerging technology program isdesigned to support remedial technologies that are still in theexperimental stage. Fifteen demonstration program trials havebeen completed, of which one involved the application ofbiological process. Four other biological process trials arepending under the demonstration program, while two othersare pending under the emerging technology program.

All of these efforts have begun to bear fruit. According to themost recent compilation of Records of Decision (RODs) preparedon Superfund sites between Fiscal Years 1982 and 1989,bioremediation had been selected as a remedial method in 21instances, representing slightly less than 10 percent of the totalnumber of RODs. It is significant to note, however, that of thistotal, 16 -- or 76 percent -- had been selected in fiscal years1988 and 1989. This is certainly a promising trend, and onewhich bodes well for future applications of this technology.

Biological Degradation of PCBs

When Congress passed TSCA in 1976, it expressly singled outone class of chemical substances for regulation --polychlorinated biphenyls (PCBs). Congress prohibited themanufacture of PCBs within 27 months of TSCA's enactment,prescribed the continued use of PCBs only in a totally enclosedmanner and required the EPA to promulgate regulations for thedisposal of PCBs.

The PCB disposal regulations prescribe the manner of disposalof PCBs at concentrations of 50 ppm or greater. The regulationsaddress the manner in which PCBs and PCB items can bedisposed.

PCBs include mineral oil dielectric fluid and other liquidscontaining PCB concentrations of 50 ppm or greater but lessthan 500 ppm, soils and other solid materials contaminatedwith PCBs and dredged materials and municipal sewagetreatment sludge. PCB items include transformers, capacitorsand manufactured items containing PCBs. Generally, theregulations prescribe that such materials can be disposed of inan incinerator, a chemical waste landfill or a high-efficiencyboiler.

The regulations also provide for the use of alternative methodsof destroying PCBs and PCB items. The alternative methods arerequired to achieve a level of performance equivalent toincineration or high-efficiency boilers. What this means inpractice is that the alternative method must achieve a final PCBconcentration of less than 2 ppm per PCB congener. (Congenersare the different chemical structures of PCBs. There are 209PCB congeners.) Thus, depending upon the number of PCBcongeners remaining after treatment, the actual concentrationof PCBs in a sample which is considered to have been destroyedcould number several parts per million. This flexibility isconducive to permitting the use of alternative methods, such asbiological degradation, which generally do not achieve totaldestruction of Al PCBs. The EPA has approved one commercialoperating permit for PCB disposal using biological methods.

The PCB regulations also provide for the issuance of R&Dpermits for PCB disposal methods. Permits involving the use offewer than 500 pounds of PCB materials are reviewed on theregional level, whereas those involving 500 pounds or more arereviewed at headquarters.

To date, EPA headquarters has approved three PCB researchand development permits involving the use of microbiologicalprocesses to break down PCBs. The first was issued in August1988 and involved the use of white-rot fungus to treat PCB-contaminated soil. This permit has been renewed twice, and thework at the site is ongoing.

Two permits have been approved thus far this year. On July 23,the EPA approved a permit involving in situ biodegradation ofPCB-contaminated pond sediments. The study is beingundertaken to determined whether biodegradation is a feasibleremedy for corrective active at the site.

On Nov. 1, the PCB Disposal Permitting Section at the EPAapproved an R&D permit involving degradation ofcontaminated soil and sediment in a pilot scale bioreactor.Approval of a fourth R&D permit is pending. This involves atwo-stage process that will combine biodegradation withphotolysis to treat PCB-contaminated soils.

Two other PCB R&D permits are under review. One involves theuse of naturally occurring microorganisms to treat PCB-contaminated soils in situ. The second also involves an in situstudy of anaerobic and oxidation degradation of PCBs in riversediments.

The final point I would like to make concerning the PCBprogram involves the interface between the PCB disposalprogram and the RCRA and CERCLA programs. The PCBregulations under TSCA govern the destruction of this class ofchemical substances. Thus, the cleanup of PCB contamination ata RCRA facility or a CERCLA site must be done pursuant to aTSCA permit. However, the fact that an owner or operator of aRCRA facility or CERCLA site has obtained a PCB commercialoperating permit or an R&D permit to use a particulartechnology to degrade PCB-contaminated materials does notforeclose the selection of some other technology under RCRAcorrective action or CERCLA remedial or response actions.Several of the sites for which PCB R&D permits have beenissued are in the RCRA corrective action process. These permitscontain a statement that the PCB permit cannot be used to biasor predetermine the selection of corrective measures underRCRA.

The TSCA Biotechnology Regulations

As most of you who have followed biotechnology regulatorypolicy over the past several years know, the area of greatestcontroversy concerns the scope of federal oversights. So let'sbegin by discussing the proposed scope of oversight of theTSCA biotechnology proposal.

The EPA will be proposing its biotechnology regulations underSection 5 of TSCA. Section 5 requires that "new chemicalsubstances" undergo review by the EPA before beingintroduced into commerce. Manufacturers of new chemicalsubstances must submit a Pre-manufacture Notification (PMN)to the EPA to enable the agency to review the substance priorto its introduction into commerce. In 1984, the EPA adoptedthe position that its authority to regulate new chemicalsubstances under TSCA extended to living organisms.

Over the years, the EPA has proposed two different approachesto defining the scope of oversight under TSCA. In its 1984proposed policy statement, the EPA adopted a "process"approach. It defined microorganisms produced through specifictechniques as "new chemical substances" subject to PMNreporting requirements."

The agency was roundly criticized for this approach, and as aresult, in the 1986 policy statement, the EPA adopted anapproach which it felt was more risk-oriented. This approachwas based on two principles: that intergeneric microorganisms-- those exhibiting generic combinations from source organismsof different genera, and microorganisms which are pathogenicor contain genetic material from pathogens -- warrant reviewprior to their release into the environment because of theirpotential to exhibit new traits or to cause adverse effects in theenvironment.


-- David E. Giamporcaro Special to BioWorld

(c) 1997 American Health Consultants. All rights reserved.