Environmental Engineering Reference
In-Depth Information
Section.5).engineered.nanoscale.materials.can.be.included.in.the.NMSP..Annex.A.
also.provides.examples.of.materials.that.the.EPA.believes.would.and.would.not.be.
appropriate.for.inclusion.in.the.program.
Consistent.with.the.NPPTAC.Interim.Ad.Hoc.Work.Group.on.Nanoscale.Mate-
rials'. recommendations,. the. EPA. is. considering. a. two-part. NMSP:. (1). a. “Basic”.
Program.that.would.request.the.reporting.of.“all.known.or.reasonably.ascertainable.
information.regarding.speciic.nanoscale.materials,”.and.(2).an.“In-Depth”.Program.
in.which.additional.data.would.be.developed.and.submitted.to.the.EPA.over.a.lon-
ger.timeframe.[21]..Annex.B.(Data.Elements).delineates.the.types.of.data.that.par-
ticipants. in. the. Basic. Program. would. be. expected. to. report.. Submitters. would. be.
encouraged,.but.not.required,.to.submit.their.data.through.a.data.submission.form.
that.the.EPA.has.prepared.
.Data.claimed.as.CBI.will.be.protected.“in.the.same.man-
ner.as.CBI.submitted.under.TSCA.in.accordance.with.procedures.in.40.CFR.parts.
2.and.720”.[21],.and.the.EPA.encourages.NMSP.participants.both.“to.give.careful.
consideration.to.what.they.will.and.will.not.claim.[as].CBI”.and.“to.make.as.much.
data.as.possible.available.to.the.public”.[21].
As. part. of. the. Basic. Program,. NMSP. participants. would. agree. to. implement.
a. risk. management. program,. as. well. as. “agree. to. consider. information. provided.
by.EPA.that.is.relevant.to.[nanoscale.material].risk.management.….and.to.provide.
information.about.the.risk.management.practices.and.other.aspects.of.their.risk.man-
agement.program.that.are.relevant.to.nanoscale.materials”.[21].
The.In-Depth.Program.would.be.informed.by.the.Basic.Program's.results,.and.
would.involve.a.subset.of.the.information.reported.under.the.Basic.Program.“in.a.
greater. amount. of. detail”. [21].. The. EPA. states. that. “[i]n-depth. data. development.
would.likely.apply.to.a.smaller.set.of.representative.nanoscale.materials.designated.
for.further.evaluation.by.mutual.agreement.of.EPA.and.participants,.with.input.from.
stakeholders”.[21].
The.EPA.will.use.the.data.from.the.NMSP.“to.gain.an.understanding.of.which.
nanoscale. materials. are. produced,. in. what. quantities,. how. they. are. used,. and. the.
data. that. is. available. for. such. materials”. [21].. The. data. will. assist. EPA. scientists.
in.making.human.health.and.environmental.risk.determinations,.and.may.be.used.
to. “[i]dentify. the. data. that. are. missing. to. conduct. an. informed. risk. assessment. of.
a.speciic.nanoscale.material”.and.“[i]dentify.nanoscale.materials.or.categories.of.
nanoscale.materials.that.may.not.warrant.future.concerns.or.actions,.or.should.oth-
erwise. be. treated. as. a. lower. priority. for. further. consideration”. [21].. Signiicantly,.
the.EPA.explains.that.if.data.submitted.by.an.NMSP.participant.“indicates.that.the.
participant.is.manufacturing.a.nanoscale.material.that.is.reportable.under.[TSCA].
Section.5.….as.a.new.chemical.substance,.EPA.will.immediately.inform.the.partici
-
pant.of.that.situation.and.the.applicable.TSCA.requirements”.[21].
Roughly.a.year.after.commencing.the.Basic.Program,.the.EPA.will.publish.an.
interim.report.summarizing.“the.types.of.data.available,.the.reasons.some.data.were.
reported.as.not.being.available,.additional.data.that.would.be.needed.for.a.better.risk.
assessment. and. any. activities. for. which. data. are. being. used.”. Two. years. after. the.
.The.draft.submission.form,.which.is.based.on.the.EPA's.Premanufacture.Notice.(PMN).form.(i.e.,.EPA.
Form.7710-25),.is.available.at.http://www.epa.gov/opptintr/nano/nmsp-icr-reportingform.pdf.
