Environmental Engineering Reference
In-Depth Information
includes.importation.
This.deinition.brings.importers.of.chemical.substances.within.
TSCA's.jurisdictional.reach,.even.though.actual.chemical.manufacturing.activities.
occur.outside.of.the.United.States.
TSCA. governs. both. the. manufacture. of. “new”. chemical. substances. and. reg-
ulates. uses. of. “existing”. chemical. substances. that. the. EPA. has. determined. to. be.
“signiicant.new”.uses.[3]..TSCA.Section.8(b)(1).directs.the.EPA.to.“compile,.keep.
current,.and.publish.a.list.of.each.chemical.substance.….manufactured.or.processed.
in.the.United.States.”.[4].The.majority.of.the.chemicals.included.on.the.TSCA.Inven-
tory.are.substances.that.were.in.commerce.prior.to.December.1979,.and.are.so.listed.
because.entities.included.them.on.the.Inventory.when.it.was.irst.published.on.June.
1,.1979.[5]..Under.TSCA,.these.substances.are.considered.“existing”.chemical.sub-
stances.by.virtue.of.their.listing.on.the.Inventory.[6,.7]..The.Inventory.is.updated.
with. chemical. substances. that. have. been. added. since. the. original. Inventory. was.
issued.in.1979,.including.those.chemicals.the.EPA.has.more.recently.reviewed.and.
approved.as.“new”.chemicals.subject.to.the.premanufacture.notiication.(PMN).pro-
visions.under.TSCA.Section.5..Thus,.under.TSCA,.a.chemical.substance.is.consid-
ered.either.an.“existing”.chemical.substance.(because.it.is.included.on.the.Inventory).
for.TSCA.purposes,.or.a.“new”.chemical.substance.(because.it.is.not.and.must.be.
approved. by. the. EPA. prior. to. manufacture).. For. engineered. nanoscale. materials,.
the. distinction. is. particularly. signiicant.
. A. “signiicant. new”. use. of. a. chemical.
substance.already.listed.on.the.TSCA.Inventory.is.treated.much.like.a.new.chemical.
substance,.and.the.new.use.is.subject.to.EPA.review.in.much.the.same.way.that.the.
EPA.reviews.a.new.chemical.
To.ensure.compliance.with.TSCA,.prior.to.the.commercial.manufacture.of.a.
chemical.substance.for.a.non-exempt.purpose,.the.manufacturer.must.irst.deter-
mine.its.TSCA.Inventory.status..There.are.two.Inventories:.(1).the.Public.Inven-
tory.and.(2).the.Conidential.Inventory..If.a.search.of.the.Public.Inventory.(which.
is.included.on.a.publicly.available,.searchable.database).[8].does.not.yield.a.listing,.
the.next.step.is.to.determine.whether.the.substance.is.included.on.the.Coniden-
tial.Inventory..If.the.identity.of.a.chemical.substance.has.been.claimed.as.a.trade.
secret,.or.otherwise.it.is.not.listed.on.the.Public.Inventory,.it.may.be.listed.on.the.
TSCA.Conidential.Inventory..To.determine.if.it.is.listed,.a.
bona ide
.intent.(BFI).
request.must.be.submitted.to.the.EPA.so.that.the.EPA.can.search.the.Conidential.
Inventory.[9].
If. a. chemical. substance. is. not. listed. on. either. portion. of. the. TSCA.Inventory,.
manufacturers.must.submit.a.PMN.for.any.chemical.substance.to.be.manufactured.
and. that. is. not. eligible. for. a. PMN. exemption.. The. PMN. form. itself. is. straightfor-
ward.and.seeks.information.only.on.the.submitter's.identity,.and.the.chemical.sub-
stance's.identity,.production.volume,.uses,.exposures,.and.environmental.fate.[10]..
.TSCA.§.3(7),.15.U.S.C..§.2602(7).(2007)..Under.the.implementing.regulations.for.TSCA.Sections.5.and.
8,.“manufacture”.is.deined.to.mean.“to.manufacture,.produce,.or.import.for.commercial.purposes,”.
which.in.turn.is.deined.to.mean.“to.manufacture,.produce,.or.import.with.the.purpose.of.obtaining.an.
immediate.or.eventual.commercial.advantage.”.See,.e.g.,.EPA.40.C.F.R..§.710.3(d).(2007).
.The.PMN.regulations.are.at.EPA.40.C.F.R..pt..720.(2007),.and.PMN.exemptions.are.at.EPA.40.C.F.R..
pt..723.(2007)..Existing.chemical.substances.already.listed.on.the.TSCA.Inventory.may.be.subject.to.a.
Signiicant.New.Use.Rule.(SNUR),.which.also.is.authorized.under.TSCA.Section.5.and.EPA.40.C.F.R..
pt..721,.subpart.E,.and.is.discussed.below.
