Report of the Biotechnology Science Advisory Committee of the U.S. Environmental Protection Agency / the Committee.

  • United States. Environmental Protection Agency. Biotechnology Science Advisory Committee.
Date:
1987
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Licence: Public Domain Mark

Credit: Report of the Biotechnology Science Advisory Committee of the U.S. Environmental Protection Agency / the Committee. Source: Wellcome Collection.

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    Comments by Meeting Participants. The following obser- vations were made concerning this approach. ¢ EPA would have to choose the control methods and determine the point values to be assigned to each method. e The point system would have to be based on objec- tive measurable values as opposed to subjective criteria. This is particularly true in choosing biological contain- ment criteria since such criteria are more subjective. However, under this scheme the number of points as- signed to any criterion could reflect the degree of con- fidence associated with the control method. e The trigger point for EPA review could be a single number or could vary with the use or industry. e This approach requires further development but from a scientific point of view has certain inherent attrac- tions; the criteria are quantifiable and the scheme offers flexibility to both industry and the Agency. Release as Opposite of Containment This approach, which is based on a concept of contain- ment, specifies that EPA notification and review will oc- cur prior to conducting any testing or procedure in an “‘unrestricted environment”’ regardless of the size of the test or procedure. The following language was offered for discussion: “‘For organisms defined as pathogens, EPA notification and review will precede growth chamber, growth room and/or greenhouse tests, and such growth facilities shall include a level of containment from which no greater than 10° organisms per day are emitted. ‘‘For intra-generic and non-pathogenic organisms, EPA notification and review will [occur] prior to conducting any level of evaluation in an unrestricted environment re- gardless of the size. “*This includes tests on biologically contained organisms until the efficacy of the genetic containment has been demonstrated to be acceptable.’ The term ‘“‘unrestricted environment’’ is used rather than the term ‘‘field’’ because some uses would not be in a ‘‘field’’ type of application. This approach would not recognize any difference be- tween ‘‘biologically contained’’ and organisms not con- structed to be ‘‘biologically contained”’ since the efficacy of such containment could not be evaluated prior to ac- tual testing in the field. Two triggers are included in the definition: (1) use of pathogens, and (2) use of nonpathogenic organisms con- structed from source organisms from different genera; this is consistent with EPA’s current policy. A list of exemptions could be developed for small scale field tests. Comments by Meeting Participants. The following obser- vations were made concerning this approach. e The term ‘‘unrestricted environment’’ would have to be defined. It might prove difficult to define an ‘‘unrestricted environment.’ Report of the Biotechnology Science Advisory Committee This approach is based on an evaluation of risk as a trig- ger for EPA review. Under the risk based approach, low, medium and high risk ratings would be applied to criteria in three categories: (1) biological factors; (2) applica- tions/use factors; and (3) environmental factors. Examples of biological factors offered include: number of organisms released (this would vary with the type of organism); genetic stability; pathogenicity; survivability; controllability; host range; and indigenous versus exotic origin. Examples of the application/use criteria include: manufacturing; biorational (biocontrol); oil recovery; agricultural (pesticide or fertilizer); and metal reclama- tion. Examples of environmental criteria include: labora- tory; greenhouse; field; commercial production facility; fresh water systems; and marine water systems. The subcommittee did not have sufficient time to develop all the criteria they thought would be appropriate for this approach. They did, however, rate some criteria and classify them in three categories. Items in category C correlate with risk, are relatively easy to measure and are objective; items in category I are intermediate in cor- relating with risk, ease of measurement and objectiveness; items in category P correlate poorly with risk, are not easi- ly measured, and are not objective. Of the biological factors, pathogenicity and con- trollability fall into category C; genetic stability, sur- vivability, ability to monitor, competitiveness with non- target organisms fall into category I; host range and bioproducts released fall into category P. All of the application/use factors rated by the group fall into category C. These include: aerosol, liquid, above ground, below ground, enclosed/open, growing, non- growing, numbers/volume (concentration). The three environmental factors rated by the group, site suitability, species, hydrology, fall into category I. Comments by Meeting Participants. The following obser- vations were made concerning this approach. e The concept of a point scheme could be applied to this approach. The criteria used in the point scheme would be different, however, from those used in a control- based approach. It is difficult to assign numerical values to criteria listed in arisk approach, such as pathogenicity and survivabili- ty, many of which are subjective and context dependent. e The approach is data intensive for both industry and EPA. e The amount of testing necessary for industry to determine whether a procedure is a release would be high. Standardized tests would probably be required to permit comparison between companies and to offer industry some solid criteria on which to determine the status of a procedure. e Who would evaluate the criteria in order to know a procedure would be a release? Would the company per- form such a review itself? Would EPA be involved?
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