Agriculture Reference
In-Depth Information
A MULTITUDE OF REGULATIONS EXIST AT NATIONAL
AND INTERNATIONAL LEVELS
The.problems.with.AP.and.consequent.trade.disruptions.described.above.also.remind.
us.that.we.have.not.one,.but.a.multitude.of.national.regulatory.regimes.that.can.vary.
widely.by.country,.as.well.as.an.overarching.international.regulatory.policy.in.the.
Cartagena.Protocol.of.the.Convention.on.Biological.Diversity.(CBD).
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.The.CBD's.
provisions.must.be.addressed.if.living.agricultural.products.such.as.seeds.are.traded,.
or.if.pollen,.seed.or.vegetative.propagules.can.move.across.country.boundaries..Such.
rules.are.critical.for.trade.in.many.horticultural.crops,.where.the.products.are.often.
living.(e.g.,.nuts,.fruits,.horticultural.varieties),.and.where.wind.and.insect.vectors.
often. can. move. pollen,. fruits,. and. sometimes. small. seeds. many. kilometers.. This.
network.of.regulations.means.that.making.changes.to.regulations.is.truly.a.glacial.
process;. it. involves. seeking. coordinated. changes. in. the.attitudes. of. highly.diverse.
societies,.as.well.as.through.fractious.and.highly.political.bureaucracies.such.as.the.
United.Nations..Given.the.negative.attitude.inherent.in.most.regulatory.regimes.con-
cerning.crop.biotechnology,.it.is.not.hyperbole.to.state.that.the.regulatory.challenges.
facing.horticultural.biotechnology.are.both.global.and.monumental.
REGULATORY COMPLIANCE IS ESPECIALLY
PROBLEMATIC FOR HORTICULTURAL CROPS
For. most. horticultural. crops,*. the. implications. of. the. stringent. regulatory. system.
are.even.more.grave.than.for.ield.crops..This.is.because.the.high.regulatory.costs
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.
per.gene.insertion.event.tend.to.be.spread.over.a.smaller.variety.base,.with.a.smaller.
economic.return,.and.with.a.longer.time.for.the.return.to.be.manifest..This.results.
because.these.crops.are.far.more.diverse.in.their.genetics.and.geography,.transfer-
ring. approved. biotech. traits. into. new. varieties. through. breeding. is. slow. due. to. a.
longer. generation. time. and. biological. limits. to. inbreeding,. and. because. valuable.
genotypes. tend.to.be. cloned. rather. than. sexually.propagated.. Thus,.it. is.expected.
that. individual. transgenic. events. from. elite. clones,. not. progeny. from. deregulated.
or.registered.events,.will.each.require.separate.regulatory.dossiers.and.decisions.
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Moreover,.these.crops.as.a.category.tend.to.be.less.domesticated.and.thus.can.
more. readily. mate. with. wild. or. feral. relatives,. and. spread. directly. via. seed. or.
vegetative. propagation. in. wild. or. feral. environments.. Because. of. their. large. size.
and. potential. for. wide. pollen. or. seed. dispersal. by. wind,. insect,. or. animal. vec-
tors,.containment.when.plants.are.old.enough.to.lower.and.are.producing.fruit.can.
be. very. dificult,. costly,. and. often. impossible. to. assure.. This. creates. a. situation.
where.gathering.needed.regulatory.data.on.environmental.effects,.under.the.very.
strong.coninement.mandated.by.regulations,.poses.a.kind.of.“Catch-22” situation.
(i.e., where.the.required.information,.at.a.high.level.of.scientiic.rigor.and.ecologi-
cal.relevance,.is.nearly.impossible.to.obtain.while.assuring.full.containment)..Even.
if. the. data. could. be. obtained,. the. required. depth. of. analyses. (e.g.,. of. nontarget.
*
.
Throughout.this.chapter.my.focus.is.on.woody.fruit,.shade,.and.ornamental.horticulture.species.
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