Agriculture Reference
In-Depth Information
through.outcrossing.with.conventional.crops.or.their.related.wild.species,.exposure.
of microorganisms.and.insects.or.other.herbivores.to.transgene.and.transgenic.prod-
ucts,.and.possible.immunological.tolerance.caused.by.edible.vaccines.
To.ultimately.address.these.public.concerns,.it.requires.the.diligent.stewardship.
by. the. PMP. community,. scientiic. and. technical. advancement. in. PMP. production.
platforms,.and.a.close.collaboration.between.different.regulatory.agencies.to.estab-
lish.clear.and.effective.policies.and.guidelines.for.transgenic.crops.and.PMPs.
b etter S tewardShIp of the pmp c ommunIty
One.of.the.embarrassing.lessons.learned.from.the.ProdiGene.incident.by.the.PMP.
community.was.the.need.to.improve.their.stewardship.on.PMPs..Practices.without.
consideration.and.common.sense.caused.several.incidents.and.controversies,.which.
are. unnecessary. and. avoidable.. For. example,. when. Ventria. Bioscience. planned. to.
test. their. PMP. carrying. transgenic. rice. in. ield. plots,. instead. of. growing. them. in.
containment.or.in.a.location.far.away.from.areas.of.major.food.rice.production,.it.
proposed.to.grow.them.in.California.Central.Valley.where.rice.production.for.human.
food.is.a.major.industry. 250 .This.proposal.angered.some.local.farmers,.and.the.con-
troversy. forced. Ventria. to. abandon. its.original. plan. and. moved. its.testing. plots. to.
Kansas.. The. ProdiGene. and. Ventria. controversies. have. alarmed. PMP. community.
to. develop. stricter. self-disciplinary. guidelines. on. PMP. containment.. As. a. result,.
the. Biotechnology. Industry. Organization. established. a. “Reference. Document. for.
Coninement.and.Development.of.Plant-Made.Pharmaceuticals.in.the.United.States”.
to. express. their. commitments. in. ensuring. the. safety. of. PMPs. during. all. stages. of.
development. and. production,. including. full. compliance. with. all. applicable. laws,.
regulations. and. guidance,. and.the. regulatory.framework.from. regulatory. agencies.
that.oversee.the.PMPs. 250 .This.document.also.provided.guidelines.for.practical.mea-
sures. in. preventing. inadvertent. human. exposure. to. the. transgenic. plants. and. their.
expression. product(s). through. food. and. feed. and. in. minimizing. occupational. and.
environmental.exposure..This.has.led.the.PMP.community.to.reconsider.the.risks.
associated.with.using.food.crops.as.PMP.hosts.and.to.develop.new.expression.plat-
forms.to.reduce.such.risks.
a lternatIve pmp p roductIon t echnoloGy and r ISk c ontrol
Nonbiological Containment
To.prevent.human.and.environmental.exposure.of.transgene.or.PMP.products,.the.
simplest. form. of. containment. would. be. having. a. physical. barrier. between. PMP.
host.plants.and.their.surroundings..The.barrier.can.be.green.houses.or.geographic.
distances.. For. example,. SemBioSys,. a. Canadian. PMP. company,. has. adopted. this.
approach.and.decided.to.grow.its.insulin-producing.transgenic.saflower.in.an.iso-
lated.geographical.area.of.Chile.far.away.from.any.food.or.feed.saflower.crops. 250.
Crops.such.as.tomato,.which.is.routinely.grown.in.large-scale.greenhouses.for.food.
production,. are. being. explored. as. expression. platforms. for. PMPs. as. they. can. be.
easily.adapted.for.PMP.production.in.containment. 240 .Other.physical.measures.can.
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