Agriculture Reference
In-Depth Information
12 Why Are Regulatory
Requirements a
Major Impediment
to Genetic Engineering
of Horticultural Crops?
Steven H. Strauss
CONTENTS
Need.for.Biotechnology.Scientists.to.Be.Informed.and.to.Inform.Regulations..... 250
Consequences.of.Failure.to.Comply.with.Regulations.Are.Large......................... 252
A.Multitude.of.Regulations.Exist.at.National.and.International.Levels................. 253
Regulatory.Compliance.Is.Especially.Problematic.for.Horticultural.Crops.......... 253
Deregulated.Horticultural.Varieties.Do.Not.Provide.General.Models................... 254
Causes.of.Our.Stringent.Regulatory.System.......................................................... 254
Presumption.of.Harm.from.Transgenic.Methods.............................................. 255
Environmental.Concerns.Prompt.Strong.Regulations....................................... 256
Familiar.Genes.Meet.Same.Regulatory.Review................................................ 256
Environmental.Studies.Are.Seriously.Compromised.by.Regulations.................... 258
Presumption.That.Stasis.Is.Desirable..................................................................... 258
Consequences.of.Simple.Deinitions.of.Clean.and.Green...................................... 259
Conclusions............................................................................................................ 260
References.............................................................................................................. 260
Regulations.in.the.United.States.and.in.most.other.countries.treat.all.plants.produced.
using.recombinant. DNA.methods. (genetic.engineering.or.genetic.modiication). as.
illegal.for.use.in.the.environment.or.in.commercial.products.until.their.safety.and.
acceptability.has.been.speciically.authorized..The.costs.of.complying.with.regula-
tions. and. the. legal. risks. of. not. complying. place. severe. constraints. on. the. use. of.
recombinant. DNA. breeding. methods. at. both. research. and. commercial. phases.. In.
particular,.the.limitations.to.gene.release.in.the.environment.pose.severe.constraints.
for.required.ield.research,.development,.and.commercial.applications.for.most.hor-
ticultural. crops,. a. problem. that. is. exacerbated. in. many. cases. by. their. incomplete.
249
 
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