Agriculture Reference
In-Depth Information
and.grant.agencies.choosing.among.research.and.technology.transfer.options..They.
have.little.idea.what.the.cost.and.time.delays.will.really.be,.and.agencies.provide.no.
guarantees.up.front.
ENVIRONMENTAL STUDIES ARE SERIOUSLY
COMPROMISED BY REGULATIONS
From. an. environmental. viewpoint,. the. presumption. of. harm. creates. even. larger.
problems. and. regulatory. obstacles.. As. discussed. above,. it. is. very. dificult. to. pre-
dict. ecological. impact. from. small. studies. that. are. performed. under. containment..
Although. simple. extrapolations. are. possible. when. the. toxicology. model. applies.
(as.with.a.pest.toxin.whose.effects.on.wild.species.can.be.roughly.estimated.in.the.
greenhouse.or.short-term.ield.study),.even.this.simple.case.is.fraught.with.dificulty..
Such.studies.say.little.about.the.effect.of.such.genes.under.varying.abiotic.and.biotic.
environments.in.the.ield,.and.they.cannot.predict.in.any.meaningful.way.what.might.
happen.in.a.future.dominated.by.climate.change,.nor.can.assess.how.biological.com-
munities.will.adapt.and.evolve.in.response.to.the.new.gene.product.and.phenotype.
In.other.words,.under.current.regulatory.constraints.we.are.unable.to.adequately.
answer. any. of.the.big. questions. about. transgene. impacts.. For. example,. how. will.
the. myriad. species. that. might. be. exposed. to. a. naturalized. transgene-expressing.
plant.be.affected.over.time?.Can.the.novel.gene/toxin.have.so.strong.an.effect.as.to.
drive.an.herbivorous.species.to. extinction,.or.will. most.species,.or.other.ecosys-
tem.adjustments,.attenuate.such.effects.over.evolutionary.time?.Do.the.perturba-
tions.matter.given.the.very.large.effects.of.agriculture,.breeding,.climate-induced.
variation,. anthropogenic. change,. and. exotic. species. in. general?. How. often. will.
genes.of.value.in.the.management.of.simple.agricultural.systems,.or.as.a.result.of.
crop.domestication.for.human.tastes.in.food.and.iber,.be.ecologically.powerful.in.
diverse.wild.or.feral.systems?.The.point.is.that.while.the.goal.of.regulations.is.to.
force.informed.and.wise.decisions,.the.reality.is.that.the. process .imposed,.with.its.
high.costs.and.legal.risks,.appears.to.do.more.harm.than.good.by.impeding.most.
forms. of. transgenic. research. and. development. with. horticultural. crops.. A  more.
eficient.option.might.be.to.exempt.the.transgenic.method.and.small.or.contained.
ield. trials. from. regulation,. but. require. substantially. novel. gene. products—such.
as. phylogenetically. novel. and. broadly. effective. toxins,. or. pharmacologically.
active. molecules.that. result. from.synthetic.biology. or. long.distance. phylogenetic.
transfers—to. undergo. regulatory. review. prior. to. large. scale,. uncontained. ield.
research.or.commercial.use..We.have.provided.more.speciic.recommendations.for.
regulatory.reform.elsewhere. 3,4,14
PRESUMPTION THAT STASIS IS DESIRABLE
The. USDA. regulations. for. transgenic. biotechnology. treat. all. transgenic. innova-
tions. as. risks.. The. beneits. of. transgenic. plants. are. not. formally. considered.. This.
framework. is. not. surprising. given. the. evolution. of. the. current. regulatory. scheme.
from. a. plant. pest. oriented. system. 17 . The. framework. therefore. implicitly. assumes.
that.crop.species.and.their.wild.relatives.that.might.receive.transgenes.via.gene.low.
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