SEATTLE H In a year of proposed big changes in federalregulation of biotechnology, biopesticide developers are feelingoverlooked.
With proposals to reduce permit requirements for field-testinggenetically altered plants and to accord no special treatment tobiotechnology foods, "it's been a year of landmarks forbiotechnology," Joseph D. Panetta, biopesticide-maker MycogenCorp.'s director of regulatory affairs, said Friday."Unfortunately, we haven't seen anything."
What biopesticide developers want to see is a set ofEnvironmental Protection Agency (EPA) guidelines coveringfield tests of genetically altered organisms that reduce farmand garden pests, replacing the case-by-case permit approachEPA uses now.
"We need to get together on this," Panetta told a session of theIndustrial Biotechnology Association's (IBA) annualcommittees' conference here. "Otherwise, it'll be very difficultto get our companies to invest in these genetically engineeredmicrobes." San Diego-based Mycogen, one of the leadingbiopesticide developers, has six approved products, two ofwhich are genetically engineered.
Others suggested that the EPA adopt an approach suggestedrecently by the Animal and Plant Health Inspection Service(APHIS) of the U.S. Department of Agriculture. APHIS suggestedthat companies could merely notify the government if theyplan to run field trials, as long as the plants they aredeveloping produce substances the USDA has already reviewed.
The EPA has worked six years on guidelines for biopesticidefield tests, said Panetta. One of its objectives is to reduce mostenvironmental pollutants. It also wants to promote the use ofreduced-risk pesticide alternatives. Biopesticide developers seetheir approach as a means to reduce the use of chemicalpesticides, which can't be easily targeted against specific pests.
"We've been following the rules, as we've been asked by theEPA," Panetta said after the session. Now, what's needed is "aconcerted effort on the part of industry to persuade the EPAand executive branch to get these field test regulations out."
Providing that a biopesticide clears the field-test hurdles,product registration by the EPA is comparatively easy, Panettasaid.
The EPA is considering three approaches for the regulation ofbiopesticides:
-- One that would require a filing on any organism thatcontains a genetically modified component;
-- One only for biopesticides in which the pesticide propertieshave been genetically changed;
-- Another, which is the most lenient and has support of theOffice of Management and Budget, would leave to developersthe decision to file with the EPA if a biopesticide posed apotential risk to health or the environment.
The IBA has not taken an official position on the options;historically, it has supported EPA notification of any plannedrelease of a modified organism, Panetta said.
As far as state and local government regulations of pesticides,one of the provisions of the Federal Insecticide, Fungicide andRodenticide Act H which said that the Federal governmentcould preempt state and local authorities H was struck down ina court involving a Wisconsin case.
An industry-backed Senate bill to overrule the court's decisionhas gone nowhere, but could likely be reintroduced in the newCongress, Frederick A. Provorny, an attorney who representsthe biotechnology companies, told the session. However, 13states have now passed legislation restricting localgovernments from regulating pesticide use.
A 14th, Utah, enacted even more sweeping legislation in Marchthat prevents its local governments from regulatingbiotechnology in general, Provorny said. "As far as I can tell,it's the only case of a state that specifically preempts localgovernment in regulations of biotechnology."
The 13 states that have preempted local government inpesticide regulation are Florida, Georgia, Indiana, Kansas,Kentucky, Mississippi, Missouri, New Mexico, Oklahoma, SouthCarolina, South Dakota, Tennessee and Virginia. n
-- Ray Potter Senior Editor
(c) 1997 American Health Consultants. All rights reserved.