Environmental Engineering Reference
In-Depth Information
the.European.Union.and.Canada,.and.initiatives.by.the.Organization.for.Economic.
Cooperation.and.Development.
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The. federal. law. implemented. and. enforced. by. the. EPA. most. often. cited. in. con-
nection.with.regulating.nanoscale.substances.that.are.intentionally.manipulated.by.
human. activity,. and. not. on. naturally. occurring. nanoscale. particles. (volcanic. ash).
or.incidental.nanoscale.materials.(combustion.byproducts),.is.the.Toxic.Substances.
Control.Act.(TSCA).[1]..TSCA.regulates.new.and.existing.chemical.substances.and.
provides.a.regulatory.framework.to.address.chemicals.throughout.their.production,.
use,.and.disposal.
Enacted.by.the.U.S..Congress.in.1976.to.protect.human.health.and.the.environ-
ment.from.the.effects.of.exposure.to.potentially.harmful.chemical.substances.and.
mixtures,.TSCA.is.the.federal.statute.that.authorizes.the.EPA.to.regulate.engineered.
nanoscale.materials.that.are.chemical.substances..TSCA.is.interpreted.broadly.and.
is.directed.toward.regulating.“chemical.substances”.[2].through.their.manufacture,.
use,.and.disposal..The.term.“chemical.substance”.means.“any.organic.or.inorganic.
substance.of.a.particular.molecular.identity,.including.—.any.combination.of.such.
substances.occurring.in.whole.or.in.part.as.a.result.of.a.chemical.reaction.or.occur-
ring.in.nature,.and.any.element.or.uncombined.radical.”
TSCA. applies. broadly. to. “any. person”. who. manufactures,. processes,. distrib-
utes. in. commerce,. uses,. or. disposes. of. a. chemical. substance.. TSCA. requirements.
fall.most. heavily. on. chemical. manufacturers..For. TSCA.purposes,.“manufacture”.
.Other. articles. on. this. subject. include:. Bergeson,. L.L.. and. J.E.. Plamondon.. 2007.. TSCA. and. Engi-
neered. Nanoscale. Substances.. Nanotechnol.,. Law. &. Bus.,. 4(1):. 51;. Bergeson,. L.. and. B.. Auerbach..
2004.. Reading. the. Small. Print.. Env't. Forum,. 30-41;. Breggin,. L.K.. 2005.. Securing. the. Promise. of.
Nanotechnology:.Is.the.U.S..Environmental.Law.up.to.the.Job?.A.Dialogue..Envtl..Law.Inst..(Wood-
row.Wilson.Int..Ctr..for.Scholars.Project.on.Emerging.Nanotech.)..October..Available.at.http://www.
elistore.org/reports. detail.asp?ID=11116;. American. Bar. Association. (ABA).. 2006.. Regulation. of.
Nanoscale.Materials.under.the.Toxic.Substances.Control.Act,.Section.of.Environment,.Energy,.and.
Resources.(SEER)..June..Available.at.http://www.abanet.org/environ/nanotech/pdf/TSCA.pdf.
.TSCA.§.3(2)(A),.15.U.S.C..§.2602(2)(A).(2007);.See.also.EPA.40.C.F.R..§§.710.3(d),.720.3(e).(2007)..
TSCA. Section. 3(2)(B). excludes. from. the. deinition. of. “chemical. substance”. mixtures,. pesticides,.
tobacco.and.tobacco.products,.certain.nuclear.materials,.irearms.and.ammunition,.and.foods,.food.
additives,.drugs,.cosmetics,.and.devices..15.U.S.C..§.2602(2)(B).(2007);.see.also.EPA.40.C.F.R..§§.
710.3(d),.720.3(e).(2007)..All.of.these.categories,.with.the.exception.of.mixtures,.are.regulated.under.
other. federal. laws.. The. TSCA. deines. a. “mixture”. as. “any. combination. of. two. or. more. chemical.
substances.if.the.combination.does.not.occur.in.nature.and.is.not,.in.whole.or.in.part,.the.result.of.a.
chemical.reaction.”.Also.included.within.the.deinition.is.any.chemical.substance.that.is.the.result.of.
a.chemical.reaction,.but.that.could.have.been.manufactured.for.commercial.purposes.without.a.reac-
tion..TSCA.§.3(8),.15.U.S.C..§.2602(8).(2007);.see.also.EPA.40.C.F.R..§§.710.3(d),.720.3(u).(2007)..
In.addition.to.these.statutory.exclusions,.the.EPA's.regulations.exclude.“articles”.and.other.types.of.
substances.(e.g.,.certain.impurities.and.by-products).for.purposes.of.various.TSCA.provisions..See,.
e.g.,.EPA.40.C.F.R..§§.704.5,.710.4(d),.720.30.(2007).
