Environmental Engineering Reference
In-Depth Information
to. assess. data. needs. to. better. regulate. nanotechnology. products;. develop. in-house.
expertise;.ensure.consideration.of.relevant.new.information.on.nanotechnology.as.it.
becomes.available;.and.evaluate.the.adequacy.of.current.testing.approaches.to.assess.
safety,. effectiveness,. and. quality. of. nanoscale. materials.. The. Task. Force. report. is.
available.at.http://www.fda.gov/nanotechnology/taskforce/report2007.pdf.
Importantly,.the.Task.Force.recommended.that.the.FDA.continue.to.pursue.regu-
latory. approaches. that. take. into. account. the. potential. importance. of. material. size.
and.the.evolving.state.of.the.science..Because.one.deinition.for.“nanotechnology,”.
“nanoscale.material,”.or.a.related.term.or.concept.“may.offer.meaningful.guidance.in.
one.context,.the.Task.Force.recommended.that.deinition.may.be.too.narrow.or.broad.
to. be. of. use. in. another.”. The. Task. Force. thus. “does. not. recommend. attempting. to.
adopt.formal,.ixed.deinitions.for.such.terms.for.regulatory.purposes.at.this.time.”
The.Task.Force's.initial.indings.and.recommendations.are.divided.into.two.sec-
tions:.(1).a.review.of.the.scientiic.knowledge.of.the.potential.effects.of.nanoscale.
materials.relevant.to.the.FDA's.regulation.of.products,.with.an.assessment.of.scien-
tiic.issues.relating.to.the.FDA's.regulation.of.products.using.nanoscale.materials;.
and.(2).an.assessment.of.the.FDA's.regulatory.authorities.as.they.apply.to.FDA-regu-
lated.products.using.nanoscale.materials..Each.is.described.below.
4.7.1  s CienCe  i ssues
The. Task. Force's. initial. recommendations. relating. to. scientiic. issues. focus. on.
improving.scientiic.knowledge.of.nanotechnology.to.help.ensure.the.FDA's.regula-
tory. effectiveness,. particularly. with. regard. to. products. not. subject. to. pre-market.
authorization. requirements.. The. Task. Force. also. addresses. the. need. to. evaluate.
whether. the. tools. available. to. describe. and. evaluate. nanoscale. materials. are. suf-
icient,.and.the.development.of.additional.tools.where.necessary.
... 
issue: understanding interactions of nanoscale 
Materials with biological systems
The.Task.Force.recommends.strengthening.the.FDA's.promotion.of,.and.participa-
tion. in,. research. and. other. efforts. to. increase. scientiic. understanding. to. facilitate.
assessment.of.data.needs.for.regulated.products,.including:
Promoting. efforts,. and. participating. in. collaborative. efforts,. to. further.
understanding.of.biological.interactions.of.nanoscale.materials,.including,.
as. appropriate,. the. development. of. data. to. assess. the. likelihood. of. long-
term.health.effects.from.exposure.to.speciic.nanoscale.materials
Assessing.data.on.general.particle.interactions.with.biological.systems.and.
on.speciic.particles.of.concern.to.the.FDA
Promoting.and.participating.in.collaborative.efforts.to.further.understand -
ing.of.the.science.of.novel.properties.that.might.contribute.to.toxicity,.such.
as.surface.area.or.surface.charge
Promoting.and.participating.in.collaborative.efforts.to.further.understand-
ing.of.measurement.and.detection.methods.for.nanoscale.materials
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