Environmental Engineering Reference
In-Depth Information
TSCA.does.not.require.the.PMN.submitter.to.test.a.new.chemical.substance.before.
submitting. a. PMN.. Health. and. safety. data. relating. to. a. new. chemical. substance's.
health.or.environmental.effects.that.are.in.a.submitter's.possession.or.control,.how-
ever,.must.be.submitted.along.with.the.PMN.to.the.extent.it.“is.known.to.or.reason-
ably.ascertainable.by”.the.submitter.
The.period.for.the.EPA.review.of.a.PMN.is.90.
days,.unless.extended.by.the.EPA.for.up.to.an.additional.90.days.
There.are.several.exemptions.from.the.PMN.requirements,.some.of.which.are.
relevant.to.engineered.nanoscale.materials.that.are.chemical.substances..The.TSCA.
exemptions. fall. into. one. of. two. categories:. (1). self-executing,. and. (2). those. that.
require.EPA.approval..Exemptions.are.considered.“self-executing”.because.they.do.
not.require.prior.EPA.approval;.and.once.a.manufacturer.determines.that.one.of.the.
self-executing.exemptions.applies,.the.new.chemical.substance.can.be.manufactured.
in.the.United.States.without.irst.submitting.a.PMN..However,.the.entity.must.comply.
with.certain.recordkeeping.and/or.other.requirements.for.the.particular.exemption.
to.apply..Self-executing.exemptions.include.the.exemption.for.chemical.substances.
having.no.separate.commercial.purpose,.the.polymer.exemption,.and.the.research.
and.development.(R&D).exemption.
Other.exemptions.from.PMN.requirements.require.EPA.prior.approval..In.these.
instances,. a. manufacturer. must. submit,. and. the. EPA. must. approve,. an. exemption.
application. before. a. company. can. commence. manufacture. of. the. new. chemical.
substance,. subject. to. compliance. with. any. associated. recordkeeping. and/or. other.
requirements. that. may. apply.. These. exemptions. are. for. low. volume. (LVE),. low.
release.and.low.exposure.(LoREX),.and.the.test.marketing.exemption.(TME).
The.self-executing.R&D.exemption.is.particularly.important.to.the.emerging.
nanotechnology. industry. [11,. 12].. To. qualify. as. an. R&D. substance,. the. chemi-
cal. substance. must. be. manufactured. or. imported. only. in. “small. quantities”. for.
purposes. of. scientiic. experimentation. or. analysis,. or. for. chemical. research. on.
or. analysis. of. such. substance. or. another. substance,. including. such. research. or.
analysis.for.the.development.of.a.product.[13]..The.term.“small.quantities”.is.not.
deined.quantitatively,.but.qualitatively,.as.those.“that.are.not.greater.than.reason-
ably. necessary”. for. R&D. purposes. [13,. 14].. Substances. that. satisfy. the. criteria.
for.an.R&D.substance.must.be.used.by.or.under.the.supervision.of.a.“technology.
qualiied.individual”.(TQI),.who.is.tasked.with.ensuring.compliance.with.volume,.
prescribed.uses,.labeling,.handling.and.distribution,.disposal,.and.recordkeeping.
requirements.
Two.other.exemptions.that.are.relevant.to.emerging.nanotechnology.industries.
—.the.LVE.and.LoREX.exemptions.—.are.not.self-executing.and.require.explicit.
EPA. approval.. These. exemptions. require. prior. EPA. review. and. approval,. and. the.
process.for.obtaining.EPA.approval.can.be.time.consuming.and.resource.intensive..
.See.EPA.40.C.F.R..§§.720.40(d),.720.50.(2007)..The.phrase.“known.to.or.reasonably.ascertainable.by”.
is.deined.at.EPA.40.C.F.R..§.720.3(p).(2007).
TSCA.§.5(a),.(c),.15.U.S.C..§.2604(a),.(c).(2006);.EPA.40.C.F.R..§.720.75..The.review.period.can.be.
extended.repeatedly.
