BIOREMEDIATION WASTE CONTROL MORE PROMISINGThe proposed scope in the TSCA rule currently underdevelopment will differ from both of these prior approaches.The scope of oversight will be based on the guidance providedby the Office of Science and Technology Policy (OSTP) in its"Principles for Federal Oversight of Biotechnology," which werepublished in the Federal Register on July 31 of last year."

On Sept. 7, the EPA presented its proposed definition of thosemicroorganisms which would be subject to oversight underTSCA to the Biotechnology Science Advisory Committee.(Editors note: Giamporcaro made available to speech attendeesa single-page handout which includes the proposed definition.)Microorganisms which would be subject to notification underSection 5 of TSCA would include those with deliberatelymodified hereditary traits, with the exception of thosemicroorganisms which fall into one or more of the listedexclusions.

Before discussing some of the elements of the current proposalwhich may not have the most direct bearing on bioremediation,I want to address the 1988 draft proposed rule. In thatdocument, the EPA proposed to require reporting of allcommercial uses involving environmental release of naturallyoccurring microorganisms ongoing as of or since Dec. 1, 1985.The agency's intention was to establish a list of such uses whichwould not be subject to reporting. People intending to use anymicroorganism for a commercial use which was not listedwould have been required to submit a significant new usenotice to the EPA before doing so. Under this scheme, all uses ofnaturally occurring microorganisms for bioremediationpurposes would have been reported to the agency, and any useof a microorganism not included on the list, or use of a listedmicroorganism for an unlisted use, would have requiredsubmission of a significant new use notice.

We are no longer planning to pursue that approach in thecurrent proposal. In fact, we are not proposing to regulatenaturally occurring microorganisms in this current rule.Moreover, in the definition of a "new microorganism," certainmodifications to naturally occurring microorganisms broughtabout by chemical or physical processes, such as chemicalmutation, transduction or transformation, would not be subjectto reporting under the TSCA rule. Thus, many of the processeswhich you may be using or may use in the future to enhancethe biodegradative capabilities of microorganisms would not bewithin the scope of the TSCA rule.

I should note, however, that if it comes to the agency'sattention in the future that the use of a naturally occurringmicroorganism may present an unreasonable risk to health orthe environment, the EPA may use its authority under Section5 to designate such a use as a significant new use or take actionwith respect to that microorganism under other sections of theAct.

Finally, I want to address two specific elements on the proposalwhich may have particular relevance to you to the extent thatyou may in the future be using a microorganism which wouldfall within the scope of the rule. We are planning to proposethat new microorganisms used for commercial R&D purposewhich are not intentionally tested outside of a structure wouldbe exempt from the notification requirements of the rule. Theexemption would apply to microorganisms used in structuresdesigned and operated to impede the release ofmicroorganisms and which comply with the following generalconditions:

-- Access is restricted to perople who require access;

-- validated inactivation procedures are implemented prior todisposal of liquid and solid wastes containing themicroorganism;

-- features to minimize microbial releases in aerosols and gasesfrom the structure, and systems for controlling disseminationof the microorganisms through other plausible routes ofdissemination are included.

In addition, the research must be under the supervision of atechnically qualified individual who would be responsible forensuring that the above criteria are met.

It is our intention that this exemption apply to various types offacilities in which research may occur, such as fermentationpilot plants, greenhouses and laboratories. We also intendedthe exemption to apply to R&D involving the use ofmicroorganisms in bioreactors used for on-site wastetreatment.

We are proposing a similar exemption for new microorganismsmanufactured for general commercial use. The EPA is in theprocess of reviewing approximately 40 microorganisms todetermine which may be eligible for a full or partial exemptionfrom notification requirements. Once the final rule ispromulgated, persons will be able to petition the EPA to havemicroorganisms added to the full or partial exemption lists.

New microorganisms created from any of these hostmicroorganisms would be subject to certain restrictions. Theintroduced DNA used to modify the host microorganism mustbe well-characterized, free of harmful sequences, limited insize to the DNA required to perform the intended function andpoorly mobilizable. In addition, the new microorganisms mustbe used in structures which comply with inactivationrequirements and containment criteria specified in theproposal. New microorganisms which would be eligible for afull exemption would need to be inactivated by at least a six-log reduction prior to disposal. The rule would not specify aninactivation level for new microorganisms eligible for a partialexemption because such microorganisms would be reviewed bythe agency on an expedited basis prior to their use incommerce. Finally, the containment criteria for the commercialexemption are similar to those I previously listed for the R&Dexemption.

These criteria are designed to be consistent with the provisionsin RCRA regulations which allow accumulation and treatment ofhazardous waste in tanks or containers. We have attempted todesign a system which will allow these practices to continuewithout imposing regulatory requirements where nonecurrently exist.

With this proposed regulatory structure, it is hoped that theimpact of the TSCA biotechnology rule on the bioremediationindustry will be minimal. In order to be subject to the rule, youwould need to be working a microorganism which met thedefinition of a "new microorganism." If you are, you maynevertheless be exempt from notification at the R&D stage ifyou use the microorganism in accordance with the criteria setout in the rule. Once you have progressed to the generalcommercial stage, you may still be exempt from notificationrequirements if the microorganism has been listed as eligibleor an exemption by the EPA, and you comply with the othereligibility criteria.

In closing, I would like to note that within the past severalmonths our office has been contacted by two differentcompanies which may be developing genetically engineeredmicroorganisms for bioremediation purposes. The day may notbe far off when the EPA receives its first PMN formicroorganism intended to be used for bioremediationpurposes.

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

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