 ÐàÔ
à[Adjourn.]Ð	Ô” ÐàÔ
àMS.€WEGMAN:€€We€are€restarting€ourÐ	 ` Ðpublic€hearing€on€the€lead€„„€the€State€andÐ	l, ÐNational€Air€Quality€Standard€for€Lead€proposal.€Ð	8ø ÐJust€so€you€know€what€the€procedures€are,€my€nameÐ	Ä Ðis€Lydia€Wegman€and€the€other€two€panel€membersÐ	Ð Ðare€Zach€Pekar€and€David€Orlin.€€And€you€canÐ	œ\ Ðspeak€for€as€long€as€you€like€since€you€are€theÐ	h(	 Ðonly€speaker,€although€we€had€said€no€more€thanÐ	4!ô
 Ðten€minutes€for€others.Ð	#À	  ÐàÔ
àAnd€I€guess€maybe€Rebecca€here€will€keepÐ	Ì$Œ
" Ðtrack€of€time,€should€we€need€that.€€And€I€thinkÐ	˜&X $ Ðthat€is€really€all€I€wanted€to€say.Ð	d($"& ÐàÔ
àMS.€LINDQUIST:€€My€name€is€LindaÐ	0*ð#( ÐLindquist.€€I€am€a€registered€nurse€and€I€amÐ	ü+¼%* Ðrepresenting€being€an€American€citizen€today€hereÐ	@ Ðat€this€hearing.Ð	Ì ÐàÔ
àMS.€WEGMAN:€€And€can€you€speak€a€littleÐ	Ø	˜ Ðcloser€to€the€mike.Ð	¤d ÐàÔ
àMS.€LINDQUIST:€€Sure.Ð	p
0 ÐàÔ
àMS.€WEGMAN:€€So€that€our€court€reporterÐ	<ü
 Ðcan€hear.Ð	È
 ÐàÔ
àMS.€LINDQUIST:€€Thank€you.€€As€IÐ	Ô” Ðmentioned€I€am€a€registered€nurse€and€theÐ	 ` Ðinformation€that€I€am€going€to€talk€about€todayÐ	l, Ðdirectly€impacts€all€of€us€no€matter€what€age,Ð	8ø Ðbut€as€we€find,€the€lead€exposures€have€aÐ	Ä Ðneurotoxic€effect.Ð	Ð ÐàÔ
àSo€the€focus€I€want€to€focus€on€today€isÐ	œ\ Ðthat€neurotoxicity€in€the€exposures€and€bringingÐ	h(	 Ðit€down€to€the€cellular€level.Ð	4!ô
 ÐàÔ
àAs€you€can€imagine,€it€is€those€that€areÐ	#À	  Ðpregnant€and€young€children€and€the€growingÐ	Ì$Œ
" Ðfetuses€that€are€at€the€highest€risk€so€I€willÐ	˜&X $ Ðre„emphasize€that€later€on.Ð	d($"& ÐàÔ
àSo€for€the€most€part,€my€interest€inÐ	0*ð#( Ðthis€topic€is€to€really€look€at€how€is€thatÐ	ü+¼%* Ðexposure€affecting€the€brain€development,€howÐ	@ Ðdoes€that€translate€into€behavior€and€on€theÐ	Ì Ðcellular€level,€what€is€happening€and€some€of€theÐ	Ø	˜ Ðmitigating€factors.€€And€hopefully€I€will€touchÐ	¤d Ðon€all€of€them.Ð	p
0 ÐàÔ
àWith€research€being€one€of€the€key€areasÐ	<ü
 Ðto€truly€understand€the€complexity,€as€a€publicÐ	È
 Ðhealth€nurse€we€recognize€the€evidence€baseÐ	Ô” Ðbehind€the€work€that€we€do.€€We€are€growing€inÐ	 ` Ðthat€area€in€our€hospitals€and€our€communitiesÐ	l, Ðand€the€whole€direction€of€the€medical€field€isÐ	8ø Ðmoving€in€the€evidence€base€direction.Ð	Ä ÐàÔ
àLead€is€just€one€of€a€multitude€ofÐ	Ð Ðneurotoxins€along€with€other€areas€such€as€PCBs,Ð	œ\ Ðwhich€are€persistent€in€the€environment,€andÐ	h(	 Ðmercury,€which€are€the€more€common€ones€that€youÐ	4!ô
 Ðhear€more€on€a€daily€basis.Ð	#À	  ÐàÔ
àSo€what€is€neurotoxicity?€€It€is€theÐ	Ì$Œ
" Ðstate€of€having€a€poisonous€effect€on€the€neuronsÐ	˜&X $ Ðand€the€neuro€circuitry€of€your€brain€developmentÐ	d($"& Ðand€it€may€produce€changes€in€the€architectureÐ	0*ð#( Ðand€the€function€of€the€brain€as€it€results€fromÐ	ü+¼%* Ðincreased€exposure€or€minute€amounts€of€exposureÐ	@ Ðto€the€various€biological€and€chemical€agents.Ð	Ì ÐàÔ
àJust€to€emphasize,€I€probably€won'tÐ	Ø	˜ Ðbring€in€a€lot€of€statistics€but€my€goal€here€isÐ	¤d Ðfor€you€to€understand€more€or€less€the€impact€ofÐ	p
0 Ða€life„long€exposure€and€how€it€can€impair€humanÐ	<ü
 Ðdevelopment.€Ð	È
 ÐàÔ
àWhat€we€do€know€is€there€are€variousÐ	Ô” Ðfactors€that€contribute€to€neurotoxicity€andÐ	 ` Ðneuro€function.€€The€genes,€your€protein€makeupÐ	l, Ðcan€impair€your€growth€and€development€inÐ	8ø Ðgeneral.€€And€the€impairment€from€lead€exposureÐ	Ä Ðoccurs€before€birth,€meaning€in€the€pregnantÐ	Ð Ðfemale.€€So€she€can€have€lead€in€her€body€andÐ	œ\ Ðthat€can€be€transferred€through€the€umbilicalÐ	h(	 Ðcord€in€the€growth€and€development€process.Ð	4!ô
 ÐàÔ
àAnd€it€is€the€immature€brain€that€is€theÐ	#À	  Ðmost€vulnerable€because€the€brain€lacks€a€blood„Ð	Ì$Œ
" Ðbrain€barrier.€€And€as€an€adult,€you€and€I€areÐ	˜&X $ Ðprotected.€€The€blood„brain€barrier€doesn'tÐ	d($"& Ðdevelop€up€until€about€a€year€and€a€half,€twoÐ	0*ð#( Ðyears€into€the€growth€developmental€cycle.Ð	ü+¼%* ÐàÔ
àSo€what€does€that€do?€€That€really€opensÐ	@ Ðup€Pandora's€Box€for€the€toxins€that€are€bio„Ð	Ì Ðaccumulative€in€the€fatty€tissue€and€the€brainÐ	Ø	˜ Ðis,€I€don't€have€the€hard€core€statistics,€butÐ	¤d Ðthe€brain€consists€of€quite€a€bit€of€fat.€€So€weÐ	p
0 Ðdo€know€that€the€toxicity€is€getting€into€theÐ	<ü
 Ðbrain,€the€lead€exposures.Ð	È
 ÐàÔ
àAnd€the€other€point€here€is€that€it€isÐ	Ô” Ðthe€early€exposure€which€has€a€lasting€effect€onÐ	 ` Ðdevelopment€and€I€will€try€to€explain€that€in€aÐ	l, Ðlittle€bit€more€detail.Ð	8ø ÐàÔ
àWe€do€know€that€neurotoxins,€it€is€aÐ	Ä Ðbiochemical€process.€€It€is€a€disruption€of€theÐ	Ð Ðneural€cell€migration€from€one€part€of€the€brainÐ	œ\ Ðto€another€and€it€also€impairs€the€formation€ofÐ	h(	 Ðthe€synapse.€€So€I€like€to€use€the€analogy€of€aÐ	4!ô
 Ðbuilding€being€erected€and€constructed.Ð	#À	  ÐàÔ
àWhen€we€are€laying€the€foundation€of€theÐ	Ì$Œ
" Ðcement,€you€usually€have€to€have€the€rightÐ	˜&X $ Ðmoisture€content€for€that€concrete€to€harden€inÐ	d($"& Ðthe€right€time€sequence.€€If€you€have€too€muchÐ	0*ð#( Ðhumidity€or€not€enough€humidity,€the€concrete€canÐ	ü+¼%* Ðbecome€very€brittle€and€break€within€a€coupleÐ	@ Ðmonths€of€it€being€laid€down.€€And€it€affects€theÐ	Ì Ðwhole€foundation€that€is€built€on€top€of€it.Ð	Ø	˜ ÐàÔ
àThis€is€the€same€analogy€that€happensÐ	¤d Ðwith€lead€exposure€in€our€young,€growing€humans.€Ð	p
0 ÐIf€you€get€the€exposure,€even€at€the€fetus€level,Ð	<ü
 Ðwe€do€know€that€it€is€going€to€impair€the€synapseÐ	È
 Ðdevelopment€and€they€are€starting€already€on€aÐ	Ô” Ðvery€low€reserve€compared€to€somebody€that€is€notÐ	 ` Ðexposed€to€any€of€the€toxins.Ð	l, ÐàÔ
àSo€what€does€that€mean?€€It€means€thatÐ	8ø Ðyes,€the€brain€is€quite€resilient€but€we€also€doÐ	Ä Ðknow€that€that€child€is€not€going€to€be€startingÐ	Ð Ðfrom€the€very€same€spot€as€if€somebody€didn't€getÐ	œ\ Ðexposed.€€So€that€is€a€real€key€point,€thatÐ	h(	 Ðanything€that€develops€from€there€on€out€canÐ	4!ô
 Ðimpair€that€person.Ð	#À	  ÐàÔ
àAnd€yes,€there€are€other€environmentalÐ	Ì$Œ
" Ðvariables€in€that€individual's€upbringing€thatÐ	˜&X $ Ðcould€impair€it€even€further,€but€they€areÐ	d($"& Ðstarting€at€that€spot€with€limitations.€€So€itÐ	0*ð#( Ðinterferes€with€the€neurotransmitters,€theÐ	ü+¼%* Ðchemical€carrying€signal€throughout€the€body,Ð	@ Ðlearning,€control€of€emotions,€socialÐ	Ì Ðinteractions,€and€such€fundamental€issues€likeÐ	Ø	˜ Ðthat€are€impaired.Ð	¤d ÐàÔ
àThe€process€of€movement,€vision,€hearingÐ	p
0 Ðand€touch€are€also€directly€related€to€toxicityÐ	<ü
 Ðexposures.€€And€then€the€more€complex€humanÐ	È
 Ðdevelopments€that€are€impaired€and€susceptible€toÐ	Ô” Ðexposure€are€your€thinking€and€feelings.€€And€weÐ	 ` Ðknow€that€that€is€the€highest€cognitiveÐ	l, Ðfunctioning€part€of€a€human€being.Ð	8ø ÐàÔ
àSo€what€is€the€anatomy€of€a€brain?€Ð	Ä ÐReally€it€is€a€mixture€of€several€components.€Ð	Ð ÐThere€is€a€lot€going€on€in€the€brain€but€I€willÐ	œ\ Ðbreak€it€down.€€The€nerve€cells,€the€supportÐ	h(	 Ðcells,€which€are€your€astrocytes,€yourÐ	4!ô
 Ðoligodendrocytes,€etcetera.€€I€didn't€get€tooÐ	#À	  Ðinto€detail€with€that,€but€it€is€your€nerveÐ	Ì$Œ
" Ðendocrine€coordinating€functions€and€it€is€aÐ	˜&X $ Ðfeedback€network€that€is€all€interrupted,€such€asÐ	d($"& Ðyour€hypothalamus,€your€pituitary€gland;€itÐ	0*ð#( Ðaffects€human€behavior.€€So€it€does€even€impactÐ	ü+¼%* Ðyour€signals€when€you€are€hungry€or€you€are€upsetÐ	@ Ðand€that€learning€and€cognitive€reasoning€canÐ	Ì Ðalso€be€interfered€with.Ð	Ø	˜ ÐàÔ
àThe€central€nervous€system€is€like€aÐ	¤d Ðsuper€highway€of€the€United€States.€€It€reallyÐ	p
0 Ðconnects€everything€in€your€body€together.Ð	<ü
 ÐàÔ
àI€would€like€to€mention€again€the€blood„Ð	È
 Ðbrain€barrier.€€It€is€a€tightly€packed€set€ofÐ	Ô” Ðcapillaries€that€regulates€and€screens€solutesÐ	 ` Ðand€nutrients€in€and€out€of€your€brain.€€Lipid€„„Ð	l, Ðit€is€a€lipid€mediation€transport€system,€so€itÐ	8ø Ðdoes€transport€fat.€€Any€chemicals€attached€toÐ	Ä Ðfat€cells,€it€can€be€transported€into€the€brain.Ð	Ð ÐàÔ
àAll€right.€€As€far€as€neurotoxins€go,€weÐ	œ\ Ðdo€know€that€it€is€all€related€to€the€timing€ofÐ	h(	 Ðthe€exposure,€the€duration€of€the€exposure,€theÐ	4!ô
 Ðdistribution€in€the€central€nervous€system,Ð	#À	  Ðamount€and€concentration€in€the€central€nervousÐ	Ì$Œ
" Ðsystem€tissues€and€the€ability€of€agents€toÐ	˜&X $ Ðinterfere€with€developmental€process.€€So€forÐ	d($"& Ðexample,€my€„„€let's€say€I€am€exposed€to€the€sameÐ	0*ð#( Ðamount€of€lead€as€the€audience,€it€may€lodgeÐ	ü+¼%* Ðdifferently€in€my€brain€than€it€would€them€and€itÐ	@ Ðwould€affect€me€differently€than€it€would€them,Ð	Ì Ðbecause€the€brain€is€very€complex€and€where€itÐ	Ø	˜ Ðends€up€lodging€will€impair€that€part€of€yourÐ	¤d Ðbody€is€a€good€way€to€understand€how€that€works.Ð	p
0 ÐàÔ
àAnd€depending€upon€your€nutrition€andÐ	<ü
 Ðother€variables,€how€your€body€repairs€from€thatÐ	È
 Ðtoxicity€exposure€also€affects€how€it€will€playÐ	Ô” Ðout.€€But€the€key€point€is€that€if€I€get€too,Ð	 ` Ðwhat€is€the€exposure€level,€but€if€I€get€exposedÐ	l, Ðto€the€exact€same€amount,€it€is€not€going€toÐ	8ø Ðaffect€me€necessarily€the€same€as€it€will€affectÐ	Ä Ðsomebody€else.Ð	Ð ÐàÔ
àThere€is€really€no€clear€path€is€what€IÐ	œ\ Ðam€saying€and€we€cannot€see€consistency€ofÐ	h(	 Ðpatterns€necessarily€in€each€individual€the€sameÐ	4!ô
 Ðway,€so€it€is€a€difficult€thing€to€measure€asÐ	#À	  Ðwell.Ð	Ì$Œ
" ÐàÔ
àI€will€also€mention€that€there€is€aÐ	˜&X $ Ðcalcium€regulation€interference€with€leadÐ	d($"& Ðexposure€during€your€circuitry€of€your€brainÐ	0*ð#( Ðdevelopment.Ð	ü+¼%* ÐàÔ
àMS.€WEGMAN:€€If€you€can€try€to€wrap€up.Ð	@ ÐàÔ
àMS.€LINDQUIST:€€Okay.Ð	Ì ÐàÔ
àMS.€WEGMAN:€€Okay.Ð	Ø	˜ ÐàÔ
àMS.€LINDQUIST:€€Yes.€€There€isÐ	¤d Ðinterference€with€several€important€neuroÐ	p
0 Ðtransmitters,€your€dopamine,€your€glutamate€andÐ	<ü
 Ðyour€acetyl€choline.€€And€these€happen€to€beÐ	È
 Ðsimilar€chemical€imbalances€that€we€are€treatingÐ	Ô” Ðdepression€for€today€in€our€healthcare€system.Ð	 ` ÐàÔ
àI€will€also€mention€a€host€of€otherÐ	l, Ðvariables.€€We€have€known€now€human€impacts€from,Ð	8ø Ðas€I€mentioned,€growth,€hearing,€IQ,€with€theÐ	Ä Ðdifferent€levels€of€exposure,€vitamin€DÐ	Ð Ðmetabolism,€nerve€conduction€velocity,€vitamin€DÐ	œ\ Ðmetabolism,€I€mentioned€that,€hemoglobinÐ	h(	 Ðsynthesis,€cholic,€anemia,€nephropathy,€which€isÐ	4!ô
 Ðin€your€kidneys,€high€exposures€haveÐ	#À	  Ðencephalopathy.€€We€also€have€blood€pressureÐ	Ì$Œ
" Ðregulation€complications,€systolic€blood€pressureÐ	˜&X $ Ðissues.€€I€mentioned€the€hearing.€€Red€cellÐ	d($"& Ðproduction€and€„„Ð	0*ð#( ÐàÔ
àMS.€WEGMAN:€€Can€you€wrap€up?Ð	ü+¼%* ÐàÔ
àMS.€LINDQUIST:€€Yes.€€All€right.€€IÐ	@ Ðthink€the€key€point€I€want€you€to€understand€isÐ	Ì Ðthat€it€impairs€human€growth€and€development€fromÐ	Ø	˜ Ðin€vitro,€even€a€pregnant€mother€under€stressÐ	¤d Ðincreases€her€lead€exposure€to€the€fetus,Ð	p
0 Ðalthough€her€blood€levels€may€before€pregnancy€beÐ	<ü
 Ðlow,€it€is€stored€in€your€bones€and€it€isÐ	È
 Ðreleased€into€the€fetus,€so€that€babies€gettingÐ	Ô” Ðan€IV€push€in€a€sense€of€a€neurotoxin,€whichÐ	 ` Ðimpairs€their€growth€and€development.Ð	l, ÐàÔ
àAnd€lead€is€just€one€of€the€very€„„€oneÐ	8ø Ðof€the€many€toxins€we€are€exposed€to€today,€asÐ	Ä Ðyou€well€know.€€Thank€you.Ð	Ð ÐàÔ
àMS.€WEGMAN:€€Thank€you.Ð	œ\ ÐàÔ
àMS.€LINDQUIST:€€Thanks.Ð	h(	 ÐàÔ
àMS.€WEGMAN:€€Do€you€have€any€commentsÐ	4!ô
 Ðspecifically€on€our€standard€that€we€proposed€toÐ	#À	  Ðtighten€the€„„€you€know€we€proposed€to€tightenÐ	Ì$Œ
" Ðthe€„„Ð	˜&X $ ÐàÔ
àMS.€LINDQUIST:€€No,€I€didn't.€€I€justÐ	d($"& Ðwant€to€talk€about€the€neurotoxicities.Ð	0*ð#( ÐàÔ
àMS.€WEGMAN:€€Okay.Ð	ü+¼%* ÐàÔ
àMS.€LINDQUIST:€€Exposures.Ð	@ ÐàÔ
àMS.€WEGMAN:€€Great.€€If€you€„„€if€thereÐ	Ì Ðare€any€specific€studies€that€you€have€there€thatÐ	Ø	˜ Ðyou€were€looking€at€to€offer€this€information,€weÐ	¤d Ðwould€certainly€be€happy€to€get€any€citations€youÐ	p
0 Ðmight€have,€just€to€make€sure.Ð	<ü
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àMS.€LINDQUIST:€€Okay.Ð	È
 ÐàÔ
àMS.€WEGMAN:€€We€have€a€document€that€isÐ	Ô” Ðprepared€to€support€this€rule€making€called€aÐ	 ` ÐCriteria€Document,€which€has€gone€over€aboutÐ	l, Ð6,000€studies,€but€there€are€always€new€onesÐ	8ø Ðpopping€up,€so€if€there€are€some€that€you€have,Ð	Ä Ðthat€would€be€useful.Ð	Ð ÐàÔ
àMS.€LINDQUIST:€€Okay.€€And€who€can€IÐ	œ\ Ðsend€that€to?Ð	h(	 ÐàÔ
àMS.€WEGMAN:€€I'm€sorry?Ð	4!ô
 ÐàÔ
àMS.€LINDQUIST:€€Who€can€I€send€that€to?Ð	#À	  ÐàÔ
àMS.€WEGMAN:€€You€can€send€it€to€theÐ	Ì$Œ
" ÐEnvironmental€Protection€Agency,€us,€and€I€willÐ	˜&X $ Ðgive€you€a€card.Ð	d($"& ÐàÔ
àMS.€LINDQUIST:€€Okay.Ð	0*ð#( ÐàÔ
àMS.€WEGMAN:€€You€can€send€it€to€me,Ð	ü+¼%* Ðokay?Ð	@ ÐàÔ
àMS.€LINDQUIST:€€Thank€you€for€your€time.Ð	Ì ÐàÔ
àMS.€WEGMAN:€€Okay,€thank€you€for€yourÐ	Ø	˜ Ðtime.€€We€very€much€appreciate€it.€€Jan,€I€wasÐ	¤d Ðjust€telling€Ms.€Lindquist€that€if€she€has€anyÐ	p
0 Ðstudies€she€could€let€us€know€about€them€so€I€amÐ	<ü
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 ÐàÔ
à[Break.]Ð	Ô” ÐàÔ
àMS.€CORTELYOU„LEE:€€Let's€go€ahead€andÐ	 ` Ðget€back€on€the€record.€€Mr.€White,€if€you€wouldÐ	l, Ðplease€just€state€your€name€and€who€you€are€with.€Ð	8ø ÐWe€have€been€holding€people€to€ten€minutes,€so€weÐ	Ä Ðwill€try€to€stay€within€that€range.Ð	Ð ÐàÔ
àMR.€WHITE:€€That's€not€a€problem.Ð	œ\ ÐàÔ
àMS.€CORTELYOU„LEE:€€Okay,€all€right.Ð	h(	 ÐàÔ
àMR.€WHITE:€€Thank€you.€€Good€afternoon.€Ð	4!ô
 ÐMy€name€is€Ronald€White€and€for€purposes€ofÐ	#À	  Ðidentification€I€am€an€associate€scientist€in€theÐ	Ì$Œ
" ÐDepartment€of€Epidemiology€at€the€Johns€HopkinsÐ	˜&X $ ÐBloomberg€School€of€Public€Health.€€I€present€myÐ	d($"& Ðtestimony€today€as€a€private€citizen€and€not€as€aÐ	0*ð#( Ðrepresentative€of€Johns€Hopkins€University.Ð	ü+¼%* ÐàÔ
àThe€scientific€and€medical€understandingÐ	@ Ðof€the€impact€on€human€health€from€exposure€toÐ	Ì Ðlead€in€the€ambient€air€has€grown€considerably€inÐ	Ø	˜ Ðthe€last€30€years€since€EPA€first€established€theÐ	¤d ÐNational€Ambient€Air€Quality€Standard€for€Lead.Ð	p
0 ÐàÔ
àThe€November€2007€EPA€Lead€Staff€PaperÐ	<ü
 Ðprovides€a€comprehensive€summary€and€assessmentÐ	È
 Ðof€this€more€recent€information,€which€supportsÐ	Ô” Ðincreasing€concern€regarding€both€the€scope€ofÐ	 ` Ðadverse€health€effects€and€the€substantiallyÐ	l, Ðlower€blood€lead€levels€at€which€these€effectsÐ	8ø Ðoccur.Ð	Ä ÐàÔ
àThese€health€effects€include€lowered€IQÐ	Ð Ðlevels,€increased€likelihood€of€attention€deficitÐ	œ\ Ðhyperactivity€disorder,€decreased€schoolÐ	h(	 Ðperformance€and€immune€system€effects,€forÐ	4!ô
 Ðexample€increased€IGE€production€in€children€andÐ	#À	  Ðincreased€risk€of€cardiovascular,€mortality,Ð	Ì$Œ
" Ðarterial€sclerosis€and€renal€disease€in€adults.Ð	˜&X $ ÐàÔ
àThe€blood€lead€levels€associated€withÐ	d($"& Ðthese€adverse€health€outcomes€occur€at€bloodÐ	0*ð#( Ðlevel€levels€that€are€well€below€the€Centers€forÐ	ü+¼%* ÐDisease€Control€and€Prevention€current€10Ð	@ Ðmicrograms€per€decimeter€action€level.Ð	Ì ÐàÔ
àGiven€the€issues€raised€in€EPA'sÐ	Ø	˜ Ðadvanced€notice€of€proposed€rule€making€for€leadÐ	¤d Ðregarding€the€appropriate€consideration€of€theÐ	p
0 ÐCDC€action€level,€it€is€important€to€note,€asÐ	<ü
 Ðdiscussed€in€the€January€2008€EPA€Clean€AirÐ	È
 ÐScientific€Advisory€Committee€letter€regardingÐ	Ô” Ðthe€lead€NAAQS€advanced€notice€of€proposed€ruleÐ	 ` Ðmaking,€that€the€CDC€action€level€is€set€forÐ	l, Ðpurposes€of€secondary€public€health€preventionÐ	8ø Ðinvolving€screening€for€potential€exposuresÐ	Ä Ðrequiring€remedial€action,€rather€than€serving€asÐ	Ð Ða€risk„based€level€for€primary€public€healthÐ	œ\ Ðprevention.Ð	h(	 ÐàÔ
àThe€August€2007€CDC€ATSDR€toxicologicalÐ	4!ô
 Ðprofile€for€lead€notes€that€adverse€healthÐ	#À	  Ðeffects€occur€in€children€and€adults€at€bloodÐ	Ì$Œ
" Ðlevels€below€10€micrograms€per€deciliter.€€Ð	˜&X $ ÐàÔ
àWith€respect€to€neural€behavioralÐ	d($"& Ðdeficits€in€children,€the€CDC€profile€indicatesÐ	0*ð#( Ðno€apparent€threshold€for€these€effects€have€beenÐ	ü+¼%* Ðfound€down€to€the€lowest€levels€observed€in€theÐ	@ Ðstudies€of€these€effects€and€states€that,€quote,Ð	Ì Ðno€safe€blood€level€„„€blood€lead€level€inÐ	Ø	˜ Ðchildren€has€been€determined,€end€quote,€with€theÐ	¤d Ðindication€that€these€relatively€low€levelÐ	p
0 Ðexposures€should€be€addressed€by€primary€ratherÐ	<ü
 Ðthan€secondary€prevention€approaches.Ð	È
 ÐàÔ
àEvidence€of€neurocognitive€impairment€inÐ	Ô” Ðchildren€that€the€EPA€Staff€Paper€characterizesÐ	 ` Ðas,€quote,€robust€effects,€end€quote,€have€beenÐ	l, Ðfound€at€blood€lead€levels€as€low€as€fiveÐ	8ø Ðmicrograms€per€deciliter€and€adverse€effects€onÐ	Ä Ðintellectual€attainment€in€young€children€haveÐ	Ð Ðbeen€associated€with€blood€lead€levels€as€low€asÐ	œ\ Ðtwo€micrograms€per€deciliter.Ð	h(	 ÐàÔ
àAs€noted€in€the€lead€staff€paper,€theseÐ	4!ô
 Ðneurological€effects€in€children€that€result€inÐ	#À	  Ðdeclines€in€cognitive€skills€can€haveÐ	Ì$Œ
" Ðsubstantially€adverse€effects€in€both€theÐ	˜&X $ Ðindividual€and€for€general€society,€with€lowerÐ	d($"& Ðacademic€achievement€limiting€the€potential€forÐ	0*ð#( Ðpersonal€success€and€increasing€the€risk€ofÐ	ü+¼%* Ðantisocial€and€delinquent€behavior.Ð	@ ÐàÔ
àChildren€in€poverty€are€particularly€atÐ	Ì Ðrisk€for€these€effects€due€to€both€increasedÐ	Ø	˜ Ðpotential€lead€exposure€from€ingestion€of€leadÐ	¤d Ðcontaminated€soil€in€the€roadways€and€flakingÐ	p
0 Ðlead„based€paint€as€well€as€social€factors€suchÐ	<ü
 Ðas€lack€of€access€to€healthcare€and€poorÐ	È
 Ðnutrition.Ð	Ô” ÐàÔ
àThe€2006€EPA€criteria€document€for€leadÐ	 ` Ðdocuments€the€increasing€and€consistent€body€ofÐ	l, Ðepidemiological€evidence€of€cardiovascularÐ	8ø Ðeffects€in€adults€with€blood€and€equivalent€boneÐ	Ä Ðlead€levels€below€10€micrograms€per€deciliter.€Ð	Ð ÐThese€effects€include€increased€blood€pressureÐ	œ\ Ðand€an€increased€incidence€of€hypertension€inÐ	h(	 Ðmiddle€aged€women.€€Of€particular€concern€is€theÐ	4!ô
 Ðevidence,€which€CASAC€termed€compelling,€quote„Ð	#À	  Ðunquote,€that€adults€with€blood€lead€levels€belowÐ	Ì$Œ
" Ð10€micrograms€per€deciliter€are€at€increased€riskÐ	˜&X $ Ðof€cardiovascular€and€mortality€from€stroke€andÐ	d($"& Ðmyocardial€infarction.€€The€results€of€theseÐ	0*ð#( Ðepidemiological€studies€of€cardiovascular€effectsÐ	ü+¼%* Ðassociated€with€a€relatively€low€blood€and€boneÐ	@ Ðlead€levels€are€supported€by€results€from€animalÐ	Ì Ðtoxicological€studies€of€the€effects€of€lead€onÐ	Ø	˜ Ðcardiovascular€functions.Ð	¤d ÐàÔ
àIn€addition,€evidence€has€also€emergedÐ	p
0 Ðof€reduced€renal€function€in€adults€at€these€sameÐ	<ü
 Ðrelatively€low€lead€levels.Ð	È
 ÐàÔ
àBoth€EPA€Staff€and€the€CASAC€haveÐ	Ô” Ðrecommended€that€a€significant€tightening€of€theÐ	 ` Ðcurrent€lead€NAAQS€of€1.5€micrograms€per€cubicÐ	l, Ðmeter.€€EPA€Staff€has€recommended€in€the€leadÐ	8ø Ðstaff€paper,€revised€lead€NAAQS€within€the€rangeÐ	Ä Ðof€.02€to€.2€micrograms€per€cubic€meter,€howeverÐ	Ð Ðnoting,€based€on€the€risk€assessment€analysis,Ð	œ\ Ðthat€a€standard€of€.02€to€.05€micrograms€perÐ	h(	 Ðcubic€meter€would€provide€somewhat€greater€publicÐ	4!ô
 Ðhealth€protection€by€limiting€IQ€loss€in€theÐ	#À	  Ðpopulation€level€of€children€to€less€than€one€toÐ	Ì$Œ
" Ðtwo€points,€which€is€range€identified€by€CASAC€asÐ	˜&X $ Ðhighly€significant€from€a€public€healthÐ	d($"& Ðperspective.Ð	0*ð#( ÐàÔ
àCASAC€has€also€unanimously€endorsed€aÐ	ü+¼%* Ðrevised€standard€of€no€higher€than€.2€microgramsÐ	@ Ðper€cubic€meter€with€a€shift€from€a€quarterly€toÐ	Ì Ðmonthly€averaging€period.Ð	Ø	˜ ÐàÔ
àBased€on€this€robust€body€ofÐ	¤d Ðepidemiological€evidence€of€a€spectrum€of€adverseÐ	p
0 Ðhealth€effects€at€quite€low€levels€of€leadÐ	<ü
 Ðexposure,€which€is€supported€by€animalÐ	È
 Ðtoxicological€studies,€I€strongly€urge€EPA€toÐ	Ô” Ðstrengthen€the€lead€NAAQS€to€a€level€no€higherÐ	 ` Ðthan€.02€micrograms€per€cubic€meter.Ð	l, ÐàÔ
àI€support€this€level€of€the€standardÐ	8ø Ðbecause€of€the€need€for€a€substantial€margin€ofÐ	Ä Ðsafety€to€ensure€adequate€public€healthÐ	Ð Ðprotection,€given€both€the€requirements€of€theÐ	œ\ ÐClean€Air€Act€and€the€health€risks€posed€toÐ	h(	 Ðchildren€and€adults€potentially€exposed€to€evenÐ	4!ô
 Ðvery€low€levels€of€lead.Ð	#À	  ÐàÔ
àThe€most€recent€data€indicating€a€higherÐ	Ì$Œ
" Ðthan€previously€assumed€contribution€of€ambientÐ	˜&X $ Ðair€lead€exposures€to€blood€lead€levels€providesÐ	d($"& Ðfurther€support€for€adoption€of€a€.02€microgramsÐ	0*ð#( Ðper€cubic€meter€lead€NAAQS.Ð	ü+¼%* ÐàÔ
àFurther,€I€supported€the€option€of€anÐ	@ Ðaveraging€time€for€the€lead€NAAQS€of€no€longerÐ	Ì Ðthan€one€month€over€a€one„year€period.€€A€monthlyÐ	Ø	˜ Ðrather€than€the€current€quarterly€averaging€timeÐ	¤d Ðis€needed€to€more€adequately€protect€the€healthÐ	p
0 Ðof€children€for€whom€blood€lead€levels€have€beenÐ	<ü
 Ðshown€to€respond€to€monthly€variations€in€leadÐ	È
 Ðemissions.€€A€one€month€averaging€time€would€alsoÐ	Ô” Ðbetter€guard€against€short„term€exposures€duringÐ	 ` Ðpregnancy€and€early€life€that€evidence€suggestsÐ	l, Ðmay€be€critical€to€future€development.Ð	8ø ÐàÔ
àIn€addition,€establishing€a€monthlyÐ	Ä Ðaveraging€time€would€better€protect€against€shortÐ	Ð Ðsporadic€emission€bursts€and€would€ensure€thatÐ	œ\ Ðthe€lead€NAAQS€attainment€status€reflectsÐ	h(	 Ðpotentially€significant€localized€soil€and€dustÐ	4!ô
 Ðlead€loading€from€very€short€term€emissions.Ð	#À	  ÐàÔ
àFinally,€I€urge€EPA€to€expeditiouslyÐ	Ì$Œ
" Ðexpand€the€current€Lead€Ambient€Air€QualityÐ	˜&X $ ÐMonitoring€network,€which€has€declined€in€numberÐ	d($"& Ðby€almost€80€percent€over€the€past€25€years,€toÐ	0*ð#( Ðfewer€than€200€monitors€nationally.€€The€resultÐ	ü+¼%* Ðof€this€dramatic€reduction€in€the€National€LeadÐ	@ ÐMonitoring€network,€as€noted€in€the€lead€NAAQSÐ	Ì Ðadvanced€notice€of€proposed€rule€making€is€that,Ð	Ø	˜ Ðquote,€many€of€the€largest€lead€emitting€sourcesÐ	¤d Ðin€the€country€do€not€have€nearby€monitors€andÐ	p
0 Ðthere€is€substantial€uncertainty€about€ambientÐ	<ü
 Ðair€levels€resulting€from€historic€deposits€nearÐ	È
 Ðroadways,€end€quote.Ð	Ô” ÐàÔ
àThe€EPA€itself€has€noted€that€thisÐ	 ` Ðsituation€has€likely€resulted€in€anÐ	l, Ðunderestimation€of€the€extent€of€occurrences€ofÐ	8ø Ðrelatively€higher€ambient€air€lead€standards,Ð	Ä Ðconcentrations€rather.€€The€uncertaintiesÐ	Ð Ðassociated€with€the€lack€of€adequate€monitoringÐ	œ\ Ðand€the€resulting€potential€for€considerablyÐ	h(	 Ðhigher€lead€exposure€and€impacts€than€estimatedÐ	4!ô
 Ðin€the€Agency's€risk€analyses€is€yet€anotherÐ	#À	  Ðreason€for€adoption€of€a€lead€NAAQS€thatÐ	Ì$Œ
" Ðincorporates€a€substantial€margin€of€safety.Ð	˜&X $ ÐàÔ
àThe€implementation€of€a€revised€leadÐ	d($"& ÐNAAQS€provides€EPA€with€the€opportunity€toÐ	0*ð#( Ðaddress€the€current€poor€coverage€of€ambient€airÐ	ü+¼%* Ðmonitoring€for€lead.€€In€this€regard€I€supportÐ	@ Ðadoption€of€the€third€option€discussed€in€theÐ	Ì Ðadvanced€notice€of€proposed€rule€making,€whichÐ	Ø	˜ Ðwould€establish€a€minimum€number€of€requiredÐ	¤d Ðmonitors€in€urban€areas€based€on€population€andÐ	p
0 Ðambient€lead€concentrations€as€well€as€requireÐ	<ü
 Ðmonitors€near€large€lead€emission€sources,€unlessÐ	È
 Ðthere€is€strong€evidence€that€a€valid€lead€PM10Ð	Ô” Ðcorrelation€can€consistently€be€made€nationallyÐ	 ` Ðutilizing€the€current€PM10€monitoring€network.Ð	l, ÐàÔ
àI'd€be€happy€to€answer€any€questionsÐ	8ø Ðthat€you€have.Ð	Ä ÐàÔ
àMR.€ORLIN:€€I€actually€was€curious,€yourÐ	Ð Ðtestimony€indicates€that€you€support€adoption€onÐ	œ\ Ðaveraging€time€of€no€longer€than€one€month€over€aÐ	h(	 Ðone„year€period?Ð	4!ô
 ÐàÔ
àMR.€WHITE:€€Correct.Ð	#À	  ÐàÔ
àMR.€ORLIN:€€And€„„Ð	Ì$Œ
" ÐàÔ
àMR.€WHITE:€€Within€a€one€calendar€year.Ð	˜&X $ ÐàÔ
àMR.€ORLIN:€€Right,€and€the€proposalÐ	d($"& Ðwould€be€to€look€at€three€calendar€years,€whichÐ	0*ð#( Ðwould,€if€you€were,€I€guess€that€would€generallyÐ	ü+¼%* Ðbe€considered€more€protective€because€it€would€beÐ	@ Ðmore€likely€to€encompass€a€violating€monitor.€€SoÐ	Ì ÐI€guess€I€was€just€curious€if€you€had€a€reasonÐ	Ø	˜ Ðwhy€12€months€made€sense€over€„„Ð	¤d ÐàÔ
àMR.€WHITE:€€Within€„„€so€it€is€one€monthÐ	p
0 Ðwithin€a€calendar€year€as€opposed€to€any€oneÐ	<ü
 Ðmonth€over€a€longer€period€of€time€is€what€I€wasÐ	È
 Ðtrying€to€say.Ð	Ô” ÐàÔ
àMR.€ORLIN:€€Right,€right.€€Is€it€„„€forÐ	 ` Ða€max€quarterly€standard€it€would€be€the€highestÐ	l, Ðquarter€in€„„€any€quarter€within€a€12€monthÐ	8ø Ðperiod€or€any€quarter€in€a€36€month€period,Ð	Ä Ðviolating€would€mean€you€are€non„attainment€andÐ	Ð Ðfor€a€second€max€monthly€standard,€it€would€meanÐ	œ\ Ðthe€second€highest€month€in€a€year€or€the€secondÐ	h(	 Ðhighest€month€in€three€calendar€years.Ð	4!ô
 ÐàÔ
àMR.€WHITE:€€Right.€€So€what€I€amÐ	#À	  Ðsuggesting€is€that€rather€than€the€quarterly€timeÐ	Ì$Œ
" Ðframe€for€the€averaging€period,€we€are€looking€atÐ	˜&X $ Ða€monthly€averaging€period,€and€that€monthlyÐ	d($"& Ðaveraging€period€would€be€within€one€calendarÐ	0*ð#( Ðyear€as€opposed€to€potentially€some€other€periodÐ	ü+¼%* Ðof€time€that€the€Agency€might€designate€thatÐ	@ Ðmonthly€period.Ð	Ì ÐàÔ
àMR.€ORLIN:€€Okay.€€But,€so€that€would€beÐ	Ø	˜ Ðgenerally€less€protective€is€all€I€am€„„Ð	¤d ÐàÔ
àMR.€WHITE:€€No,€I€think€it€actuallyÐ	p
0 Ðwould€„„€well€it€is€certainly€more€protectiveÐ	<ü
 Ðthan€the€quarterly€standard.Ð	È
 ÐàÔ
àMR.€ORLIN:€€Well€then€the€quarter€„„€butÐ	Ô” Ða€one€year€time€frame€is€going€to€be€lessÐ	 ` Ðprotective€than€a€three€year€time€frame,€whetherÐ	l, Ðyou€are€doing€a€quarterly€or€a€monthly€average,Ð	8ø Ðwhich€is€all€I€was€saying.Ð	Ä ÐàÔ
àMR.€WHITE:€€If€you€were€going€to€sayÐ	Ð Ðthat€they€couldn't€violate€a€one€month€periodÐ	œ\ Ðover€any€three€year€period,€that€is€true.Ð	h(	 ÐàÔ
àMR.€ORLIN:€€Yes.Ð	4!ô
 ÐàÔ
àMR.€WHITE:€€And€all€I€was€saying€is€thatÐ	#À	  Ð„„€I€didn't€really€address€how€many€years.€€I€wasÐ	Ì$Œ
" Ðjust€pointing€out€that€it€should€be€within€oneÐ	˜&X $ Ðcalendar€year€as€opposed€to€some€year€that€mightÐ	d($"& Ðbe€designated€otherwise€so€that€the€year€might,Ð	0*ð#( Ðfor€example,€might€go€from€when€a€facility€firstÐ	ü+¼%* Ðstarts€monitoring€„„Ð	@ ÐàÔ
àMR.€ORLIN:€€Oh,€I€see.€€A€calendar€yearÐ	Ì Ðversus€a€rolling€year.Ð	Ø	˜ ÐàÔ
àMR.€WHITE:€€That€is€really€what€I€wasÐ	¤d Ðtrying€to€get€at,€a€calendar€versus€a€rolling.Ð	p
0 ÐàÔ
àMR.€ORLIN:€€That€is€helpful.Ð	<ü
 ÐàÔ
àMR.€WHITE:€€So€I€apologize€if€I€was€notÐ	È
 Ðmaking€that€clear,€which€I€clearly€wasn't.Ð	Ô” ÐàÔ
àMR.€ORLIN:€€Thank€you.Ð	 ` ÐàÔ
àMR.€WHITE:€€Yes.Ð	l, ÐàÔ
àMS.€CORTELYOU„LEE:€€Thank€you€forÐ	8ø Ðcoming.Ð	Ä ÐàÔ
àMR.€WHITE:€€Sure.€€Thank€you.Ð	Ð ÐàÔ
àMS.€CORTELYOU„LEE:€€Are€either€of€youÐ	œ\ Ðinterested€in€speaking?€€No.€€Ð	h(	 ÐàÔ
àWe€have€a€speaker€at€7:40€I€think,€rightÐ	4!ô
 Ðafter€the€dinner€break.€€And€we€are€going€to€takeÐ	#À	  Ða€dinner€break€from€6:00€to€7:30.€€Okay.Ð	Ì$Œ
" ÐàÔ
àThat€is€the€last€speaker€but€we€will€beÐ	˜&X $ Ðhere€until€9:00€tonight,€okay.€€All€right,€let'sÐ	d($"& Ðadjourn€for€dinner.Ð	0*ð#( ÐàÔ
àÔ_Ô[Break.]Ð	ü+¼%* ÐàÔ
àMS.€Ô_ÔCORTELYOUÔ_Ô„LEE:€€It€is€9:00.€Since€weÐ	@ Ðhave€no€further€speakers,€we€will€adjourn€theÐ	Ì ÐLead€Ô_ÔNAAQSÔ_Ô€public€hearing.€€Thank€you€all€forÐ	Ø	˜ Ðcoming.€Ð	¤d Ðà@%%'€à„€„€„ˆÐ	p
0 ÐÌÌÌÌÌÌÌÌÌÌÌÌÌÌÌÌ


  SEQ CHAPTER \h \r 1              		United States Environmental
Protection Agency

			INFORMATION COLLECTION REQUEST (ICR)

Part A of the Supporting Statement

					(Draft - October 2006)

1. 	IDENTIFICATION OF THE INFORMATION COLLECTION

	1(a)	Title:	Registration of Fuels and Fuel Additives:

			Requirements for Manufacturers (40 CFR 79)

			EPA ICR Number 309.12, OMB Control Number 2060-0150

			Docket ID Number EPA-HQ-OAR-2006-0894

	1(b)	Abstract

	In accordance with the regulations at 40 CFR 79, Subparts A, B, C, D
and F, Registration of Fuels and Fuel Additives, manufacturers of (1)
motor vehicle gasoline, (2) motor vehicle diesel fuel, and (3) additives
for those fuels, are required to have their products registered by the
Environmental Protection Agency (EPA) prior to their introduction into
commerce.  Registration involves providing (1) a chemical description of
the fuel or additive, (2) certain technical and marketing information,
and (3) any health-effects information in company files.  (The portion
of Subpart F requiring the development of health-effects data is covered
by a separate information collection.)  Manufacturers are also required
to submit periodic reports on production and related information.  The
program is run by the Transportation and Regional Programs Division,
Office of Transportation and Air Quality, Office of Air and Radiation.
The information is used to (1) identify products whose evaporative or
exhaust emissions pose a particular threat to public health, thus
meriting further investigation and/or regulation, (2) ensure that EPA
compositional requirements for unleaded gasoline are met before a
product is registered and introduced into commerce, and (3) maintain a
comprehensive data base of motor vehicle fuel and additive composition.
Most of the compositional information is confidential.  Lists of
registered fuels and additives are available at
www.epa.gov/otaq/additive.htm.  The information is collected and stored
in hard copy, with most entered into a computer data base.  There are
approximately 300 fuel manufacturers, 750 additive manufacturers, 500
registered fuels,  and 5800 registered additives.  These numbers change
daily.  The annual cost to industry is estimated at $1.4 million.  The
annual cost to the government is estimated at $642,300.

	This program also serves as a vehicle for the administration of the
program for the certification of deposit control/detergent gasoline
additives at 40 CFR 80.  By using this existing registration program the
EPA avoided having to establish an additional registration program for
gasoline detergent additives.  The reporting and recordkeeping
requirements unique to this certification program are covered by a
separate information collection.

	In addition, per 30 CFR 75.1901(c), only registered diesel fuel
additives may be used in diesel-powered equipment for underground coal
mining.  Thus the Mine Safety and Health Administration of the
Department of Labor is able to utilize this program.

2.	NEED FOR AND USE OF THE COLLECTION

	2(a)	Need/Authority for the Collection

	Motor vehicles comprise the major source of air pollution in most urban
areas, and account for about half the toxic air emissions in the United
States.  Congress demonstrated its strong concern for the protection of
public health by providing broad legislative authority to monitor and
regulate fuels, fuel additives, and their emissions.  This registration
program was established by the Air Quality Act of 1967, carried forward
into the Clean Air Act (Act) of 1970, and strengthened in the Act’s
1977 and 1990 reauthorizations.

	Section 211(a) of the Act provides EPA with the authority to designate
any mobile source fuel or additive for registration.  Any fuel or
additive with the potential for a significant emissions impact on the
public would be an appropriate candidate.  Once designated, it may not
be introduced into commerce until it has been registered by EPA.
Section 211(b) requires, for the purpose of registration, that the
manufacturer provide certain compositional and related information, and
available health-effects data.  Section 211(b) also provides EPA with
the authority to require health-effects testing.  The original
regulations were promulgated by the Department of Health, Education, and
Welfare in 1970, and transferred to the EPA shortly thereafter.  They
ultimately resided at 40 CFR 79 (available at     HYPERLINK
"http://www.access.gpo.gov"  www.access.gpo.gov/nara ) and were revised
in 1975, 1976, and 1978.  Due to their broad public emissions exposure,
motor vehicle gasolines and diesel fuels, and their additives, were
designated.  Section 211(e) (1977 amendments) directs EPA to establish
health-effects testing requirements, and those regulations were
promulgated in 1994 as Subpart F of 40 CFR 79.  (Changes to the
regulations have reduced the burdens, particularly for small
businesses.)  They are structured into three tiers of requirements for
specific fuel/additive categories.  Tier 1, due in May 1997, required an
emissions characterization and a literature search for health-effects
information on those emissions.  Tier 2, due in May 2000,  required
short-term inhalation exposures of laboratory animals to emissions to
screen for adverse health effects.  The regulations also allow for
alternative Tier 2 testing if more appropriate.  The major gasoline
oxygenates and a manganese additive for gasoline are undergoing such
alternative testing.  Follow-up studies, if required, would occur under
Tier 3.  (The reporting and recordkeeping requirements of these tiers
are covered by a separate information collection.)  The objective of the
program is to determine if there are any fuels and/or additives whose
evaporative emissions or products of combustion pose a particular danger
to public health or welfare.  Section 211(c) of the Act provides EPA
with the authority to regulate such fuels and additives.  For example,
the use of lead additives in gasoline, gasoline volatility, and the
sulfur content of gasoline and diesel fuel, have been regulated.  In
order to assist the EPA in assessing the extent of public exposure to a
given fuel or additive, the regulations require additive manufacturers
to submit annual reports on production.  Fuel manufacturers are required
to submit quarterly production reports.  The manufacturers are also
required to report annually on any new health effects data they may have
acquired.  Copies of the sections of the Act mentioned above are
available at www.epa.gov/otaq.

	Another objective of the program is the review of an unleaded gasoline
additive’s composition for compliance with EPA restrictions.  In order
to protect catalytic converters and other emission control devices,
there are specific compositional limitations.  On a number of occasions
the EPA has informed a manufacturer that its additive could not be
registered until the formulation was modified to comply with those
requirements.

	An added benefit of the program has been the development of a
comprehensive data base of gasoline and diesel fuel/additive
composition.  These data have proven useful in a number of fuels issues,
such as the identification of additives with a high sulfur content.

	2(b)	Practical Utility/Users of the Data

	The lists of registered fuels and additives are available to the public
at www.epa.gov/otaq/additive.htm.  The fuel, additive, and motor vehicle
industries are well aware that gasolines, diesel fuels, and their
additives, must be registered before they may be introduced into
commerce for use in motor vehicles.  A separate list of registered
gasoline detergent additives is also available.  These lists are
frequently requested by consumers and the manufacturers in order to
maintain an awareness of competing products.  In accordance with
regulations promulgated by the Mine Safety and Health Administration,
only registered diesel additives may be used in diesel-powered equipment
for underground coal mining.

	Most of the data have been claimed as business confidential by the
manufacturers.   Thus access is restricted to authorized EPA personnel
and contractors.  The data have been extremely valuable in EPA’s
evaluation of certain fuels issues.  Most notably, the compositional
data required since the program’s inception were instrumental in
establishing the fuel/additive testing categories in the 1994
health-effects testing rules (Subpart F, 40 CFR 79).  If  these data
indicate a particular threat to public health from the evaporative or
exhaust emissions of a fuel or additive, they will be used to support
regulatory action under section 211(c) of the Act.

	Section 211(f) of the Act prohibits the introduction into commerce of
fuels and additives which are not “substantially similar” to those
used by the vehicle manufacturers in emissions certification (unless a
waiver is granted).  The objective is to protect emission controls from
potentially damaging fuels and additives.  The term “substantially
similar” for unleaded gasoline has been defined via interpretive rule.
 Elemental composition is restricted to carbon, hydrogen, oxygen,
nitrogen, and sulphur.  On a number of occasions additive manufacturers
have attempted to register additives for unleaded gasoline which did not
meet these requirements.  Thus, the registration program has been
instrumental in enforcing requirements that were established
independently of the registration regulations at 40 CFR 79.

	The fuel/additive data base has proven extremely useful in the analysis
of other fuels issues.  For example, the data have been used to assess
the development and use of gasoline detergent additives.

3.	NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

	3(a)	Nonduplication

	To our knowledge, this is the only program which requires additive
manufacturers to report the composition of their additives, and gasoline
and diesel fuel manufacturers to report the usage of additives in their
fuels.  It is the only program under which these manufacturers must
develop information on the emissions health effects of their products.
Production volumes for additives are not reported elsewhere.  Nowhere
else are the production volumes for gasoline and diesel fuels reported
in conjunction with additive usage in those fuels.  Such data are
necessary in order to gauge the extent of public exposure to the
emissions of a fuel, additive, or particular fuel/additive combinations.

	3(b)	Public Notice

	A notice will be placed in the Federal Register requesting public
comment on this draft ICR.

	3(c)	Consultations

	The Agency has routinely consulted with the manufacturers on the effort
to comply with the reporting requirements.  See section 6.

	The Mine Safety and Health Administration (MSHA), U. S. Department of
Labor, views this program as beneficial in that it will provide
information on the diesel emissions to which underground coal miners are
exposed.  MSHA regulations limit the diesel additives used in
underground coal mining to those that have been registered by EPA.

	3(d)	Effects of Less Frequent Collection

	Registration of a designated fuel or additive is required only once,
although the manufacturer is required to notify EPA if changes occur in
the information provided.  The quarterly and annual reports for fuel
manufacturers, and annual reports for additive manufacturers, are
appropriate in order to monitor patterns of fuel and additive usage in a
timely manner.  Should the health-effects data indicate that certain
fuel/additive combinations are of concern, their history of usage would
be necessary in order to assess the extent of public exposure.  If these
fuel/additive combinations were to experience a significant increase in
usage, it would be important to know that on a quarterly basis.

	For the current clearance, the Office of Management and Budget
suggested that EPA should consider amending the regulations to change
this quarterly report to an annual report.  EPA still believes that a
quarterly report is appropriate.  For example, The states of New York
and Connecticut will be banning the popular gasoline additive methyl
tertiary butyl ether (MTBE), effective January 1, 2004.  Other states
are also planning to ban MTBE, and a ban is being considered in the new
national energy bill.  Refiners and importers will be using other
additives to replace MTBE.  The Agency believes that with this
significant change in gasoline, the ability to monitor replacement
additives on a quarterly basis is very important, and that only an
annual report would not allow the Agency to monitor trends in a timely
fashion.

	With refiners and importers reporting their usage of additives
quarterly, the annual production report from the additive manufacturers
remains adequate. If an additive were to experience a dramatic increase
in production, it would be important to have that reported on at least
an annual basis.

	3(e)	General Guidelines

	All Office of Management and Budget (OMB) guidelines are met.  With
respect to the Government Paperwork Elimination Act (GPEA), issues
concerning confidential business information have not been resolved.
Most of the information in this collection is confidential.  Once these
issues are resolved, this collection will be brought into compliance
with the GPEA.

	3(f)	Confidentiality

	The availability to the public of information submitted for this
program is governed by the Freedom of Information Act (FOIA) regulations
for EPA at 40 CFR 2, with the exception that all health and safety test
data and other information concerning health and welfare effects,
submitted pursuant to Subpart F, shall be public.  Lists of the
registered fuels and additives are publicly available.

	The majority of the manufacturers consider, for competitive reasons,
the compositional information for their fuels and additives to be
confidential.  EPA’s Office of General Counsel has consistently ruled
that confidentiality is justified when such information has been
requested under the FOIA.

	Because most of the information is confidential, this program is housed
in a separate office protected by a multi-sensor alarm system with
24-hour monitoring.  Access is via a keyfob system for authorized
personnel only.  Paper files are secured in combination lock, fireproof
cabinets with each cabinet requiring its own unique sequence to be
unlocked.

	Data processing is performed solely on computers in the secure area.
These computers have no connections outside the secure area and employ
password security measures.

	Contractor personnel handle routine administrative tasks, data input,
and data analysis.

EPA personnel work closely with contractor personnel and handle the
technical review of the data and questions involving regulatory
interpretation.

	3(g)	Sensitive Questions

	There are no sensitive questions.

4.	THE RESPONDENTS AND THE INFORMATION COLLECTED

	4(a)	Respondents/NAICS Codes

	The fuel and fuel additive manufacturers are related to the following
major group North American Industry Classification System (NAICS) codes:

324110 - Petroleum Refineries

324199 - All Other Petroleum and Coal Products Manufacturing

325110 - Petrochemical Manufacturing

325193 - Ethyl Alcohol Manufacturing

325199 - All Other Basic Organic Chemical Manufacturing

	4(b)	Information Requested

	(i)       	Data Items

	The following definitions at 40 CFR 79.2 are important to the
understanding of the reporting requirements:

	“Fuel manufacturer” means any person who, for sale or introduction
into commerce, produces, manufacturers, or imports a fuel or causes or
directs the alteration of the chemical composition of a bulk fuel, or
the mixture of chemical compounds in a bulk fuel, by adding to it an
additive, except:

	(1)  A party (other than a fuel refiner or importer) who adds a
quantity of additive(s) amounting to less than 1.0 percent by volume of
the resultant additive(s)/fuel mixture is not thereby considered a fuel
manufacturer.

	(2) A party (other than a fuel refiner or importer) who adds an
oxygenate compound to fuel in any otherwise allowable amount is not
thereby considered a fuel manufacturer.

	“Additive” means any substance, other than one composed solely of
carbon and/or hydrogen, that is intentionally added to a fuel named in
the designation (including any added to a motor vehicle’s fuel system)
and that is not intentionally removed prior to sale or use.

	“Additive manufacturer” means any person who produces,
manufacturers, or imports an additive for use as an additive and/or
sells or imports for sale such additive under the person’s own name.

	Motor vehicle gasolines, motor vehicle diesel fuels, and additives to
those fuels, have been designated at 40 CFR 79.  For the purpose of
registration, the following is required to be submitted by each
manufacturer of a designated fuel (40 CFR 79.11): (See EPA Form 3520-12,
Fuel Manufacturer Notification for Motor Vehicle Fuel, Attachment 1, and
instructions, Attachment 2)

Brand name(s) of the fuel:

2.	Company name;

Company identification number (issued by EPA);

4.	Address;

5.	Type of fuel;

6.	Fuel properties as specified in the regulations;

7.	A list of additives the manufacturer intends to use, additive
manufacturer names,

	purpose-in-use of each additive, and range of additive concentration;

8.	To the extent known, information on analytical techniques that can be
used to detect the 	presence of the additives listed above in the fuel;

9.	To the extent known to the manufacturer, information on the
mechanisms of action of the 	additives listed, reactions between the
additives and the fuel, emission products, additive 	effects on
emissions, health or welfare effects of additive emission products, and
effects  	of additive emission products on emission controls;

10.	Anticipated sales, in percent, by Petroleum Administration for
Defense Districts;

Yes/no response on if fuel is derived only from conventional petroleum,
heavy oil deposits, coal, tar sands, and/or oil sands:

12.	If applying for a small business provision, annual sales revenue for
the past three years and identification of any parent company;

13.	If not applicable for a small business provision, identification of
membership in a testing group:

Indication of which portions of the form are confidential:

List of attachments:

Assurances that the information is correct, EPA will be notified in
writing if certain information were to change, and that registration
will not be used in advertising to imply government approval;

Signature, date, printed name, title, phone number, fax number, and
e-mail address of signer.

	Note that in item 16 above the manufacturer is required to notify EPA
in writing if certain information, listed in the regulations, were to
change.  This usually involves updating the list of additives being
used, and is accomplished with a brief letter.  This will be referred to
later in this ICR as a “fuel notification update.”

	For the purpose of registration, the following is required to be
submitted by each manufacturer of a designated fuel additive (40 CFR
79.21): (See EPA Form 3520-13, Fuel Additive Manufacturer Notification,
Attachment 3, and instructions, Attachment 4)

1.	Commercial name(s) of the additive;

2.	Company name and company identification number (issued by EPA);

3.	Address;

4.	Method of use (bulk and/or aftermarket);

5.	Fuels for which the additive is recommended and range of
concentration;

6.	Recommended purpose-in-use of the additive;

7.	Chemical composition of the additive;

8.	Chemical structure of the additive;

9.	To the extent known, impurities at greater 0.1% by weight;

10.	To the extent known, information on analytical techniques that can
be used to detect the 	additive in fuel;

11.	To the extent known to the manufacturer, information on additive
mechanisms of action, 	reactions between the additive and fuel,
identification and measurement of additive 	emission products, effects
of the additive on emissions, toxicity or any other health  	effects of
the additive emission products, and effects on emission controls;

Yes/no response on if the additive is a relable of a currently
registered additive;

Estimated annual production during the third year of production;

Estimated market distribution for the third year of production;

Yes/no response on if the additive is derived only from conventional
petroleum, heavy oil deposits, coal, tar sands, and/or oil sands;

If applying for a small business provision, annual sales revenue for the
past three years and identification of any parent company;

Yes/no response on if the additive is an aerosol, and if so, if applying
for the aerosol provision;

If not applicable for a small business or aerosol provision,
identification of membership in a testing group;

19.	Indication of which portions of the form are confidential;

List of attachments;

21.	Assurances that the information is correct, EPA will be notified in
writing if certain 	information were to change, and that registration
will not be used in advertising to imply 	government approval;

22.	Signature, date, printed name, title, phone number, fax number, and
e-mail address of signer.

 	Note that in item 21 above, the EPA would be notified in writing if
certain information, listed in the regulations, were to change.  This is
accomplished by a brief letter, and involves minor issues such as an
additional name under which the additive will be sold.  This will be
referred to later in this ICR as an “additive notification update.”

	Additive manufacturers are also required to report annually the
following information for each registered additive (40 CFR 79.5(b)):
(See EPA Form 3520-13A, Fuel Additive Manufacturer Annual Report,
Attachment 5, and instructions, Attachment 6, and, if reporting for more
than 16 additives, EPA Form 3520-13B, Supplemental Additive Manufacturer
Annual Report, Attachment 7)

1.	Company name and company identification number;

2.	Report year;

3.	Type of report (original or resubmission);

4.	Impurities, if greater than 0.1% by weight, to the extent known;

5.	Any information known to the manufacturer and not previously reported
on mechanisms 	of action, reactions with fuels, emission products, or
emission effects;

6.	Production (volume or weight) for the year for the additive(s);

7.	Indication of which portions of the form are confidential;

8.	Signature, date, printed name, title, phone, fax, e-mail;

9.         Indication if a supplemental report is attached.

	Additive manufacturers who are merely relabeling a registered additive
or blend of registered additives are not required to submit an annual
report, since the information would be covered by the original
manufacturer(s).

	Fuel manufacturers are also required to report quarterly the following
information for each registered gasoline and diesel fuel (40 CFR
79.5(a)(1)): (See EPA Form 3520-12Q, Fuel Manufacturer Quarterly Report
for Motor Vehicle Gasoline or Diesel Fuel, Attachment 8, and
instructions, Attachment 9)

1.	Company name and identification number;

2.	Address;

3.	Fuel identification number;

4.	Report year;

5 	Quarterly production volume;

6.	Quarter;

7.	Brand name of the fuel;

8.	Range of concentration during the quarter for each additive
previously reported for use in the fuel;

9.	Indication of which items are confidential;

10.       Signature, date, printed name, title, phone, fax, e-mail.

	Fuel manufacturers are also required to report annually the following
information for each registered gasoline and diesel fuel (40 CFR
79.5(a)(2)): (See EPA Form 3520-12A,  Fuel Manufacturer Annual Report
for Motor Vehicle Gasoline or Diesel Fuel, Attachment 10, and
instructions, Attachment 11)

1.	Company name and identification number;

2.	Address;

3.	Fuel identification number;

4.	Report year;

5.	Brand names(s);

6.	Fuel properties, to the extent known by the manufacturer;

7.	If not previously reported, information known by the manufacturer on
mechanisms of 	action, reactions between additives and fuels, emission
products, and emission effects;

8.	Indication of which items are confidential;

9.	Signature, date, printed name, title, phone, fax, and e-mail.

There are no recordkeeping requirements.

	 (ii)	Respondent Activities

	The following activities are required:

1.	Read or hear the regulations at 40 CFR 79 and the instructions for
each of the

	applicable forms;

2.	Gather information from company files;

3.	Review the information;

4.	Enter information onto the forms and sign;

5.	If indicated on the forms that additional information is attached,
copy such information;

6.	Transmit the information.

5.	THE INFORMATION COLLECTED--AGENCY ACTIVITIES, COLLECTION METHODOLOGY,
AND INFORMATION MANAGEMENT

	5(a)	Agency Activities

	The following activities are required:

1.	Respond to inquiries on the reporting requirements;

2.	Mail copies of the forms/instructions, regulations, list of all
registered additives, list of 	registered gasoline detergent additives,
list of registered diesel additives, and/or list of 	registered fuels
upon request;

3.	Review the forms and other submitted data;

4.	Contact the manufacturer when the information has not been submitted
in accordance  	with the regulations and discuss how the problem can be
resolved;

5.	Store the information in hard copy;

6.	Enter the data submitted on the forms into the database.

7.	Issue a letter to the manufacturer for each fuel and additive that is
registered;

8.	Administer a contract for the day-to-day operation of the
registration program;

9.	Maintain rigorous security for the protection of confidential
business information;

10.	Maintain a record of all confidential business information provided
to the contractor;

11.	Maintain computer hardware and software;

12.	Provide general program oversight.

	5(b)	Collection Methodology and Management

	The manufacturers are completing forms which are very straightforward
and whose basic structure dates back to 1975.  We have not had
complaints on the design of the forms.

Much of the information is maintained in the normal course of business,
such as the chemical composition of an additive and its annual
production.  For information which may not normally be maintained, such
as mechanisms of reaction, the manufacturer is not required to search
beyond its company files.  EPA and its contractor review the forms and
in some cases the manufacturer must be contacted for clarification or
additional information.  Since most of the information is confidential,
the data are handled exclusively on a physically and electronically
isolated IBM/PC-based local area network using Novell NetWare as an
operating system and running FOXPRO database software as the database
platform.  Data are input and reports generated on workstations located
entirely within the locked facility and connected to the network through
direct connections.  EPA personnel routinely compare the data that have
been entered into the database with hard copy.  The network is not
connected to the Agency’s LAN backbone and has no modem connections.
The facility is protected by an advanced security system described
earlier.

	All of the forms are available for downloading at:     HYPERLINK
"http://www.epa.gov/otaq/regs/fuels/ffarsfrms.htm."
http://www.epa.gov/otaq/regs/fuels/ffarsfrms.htm.   Manufacturers may
also submit the quarterly and annual reports in the format of their
choice, including on diskette, if they prefer not to use the forms.

	5(c)	Small Entity Flexibility

	The reporting requirements have been kept as simple as possible to
minimize the burden on all manufacturers.  EPA is not aware of any
simpler format to provide the chemical descriptions and related
information.  Changes to the regulations in 1997 removed many small
businesses from the program, by excluding those who only add oxygenates
or small amounts of additives to fuels from the definition of a fuel
manufacturer.  For manufacturers who merely relabel additives, which are
usually small businesses, the one-time notification is very simple, and
there are no periodic reporting requirements.

	5(d)	Collection Schedule

	For the manufacturer of a fuel, there is a one-time registration for
the fuel, and an on-occasion requirement to inform the Agency if the
information provided for registration were to change.  There are also
quarterly and annual reports that a fuel manufacturer is required to
submit for the registered fuel.

	For the manufacturer of a fuel additive, there is a one-time
registration for the additive, and an on-occasion requirement to inform
the Agency if the information provided for registration were to change.
There is also an annual report that the additive manufacturer is
required to submit for the registered additive.

6.	ESTIMATING THE BURDEN AND THE COST OF THE COLLECTION

	6(a) and (b)	Estimating Respondent Burden and Costs

	Estimating the burden is straightforward.  For the most part, the
manufacturer is collecting and reporting information that is available
in the normal conduct of business, such as product composition and
production volume.  Other information, such as health effects data, only
have to be reported if they reside in the company files.  No searching
beyond company files is required.  There are no recordkeeping
requirements.  There are no third party activities.  Thus, there are no
capital/start-up costs.  The only operating and maintenance (O&M) cost
is for copying and postage for each submission.  Instead of including
this in each burden table, a cost of $5.00 per submission will be
included in the total burden estimate.

	In discussions with fewer than ten fuel and fuel additive
manufacturers, four labor categories were identified as having
involvement: managerial, legal, technical, and clerical.  According to
the Bureau of Labor Statistics, Employer Costs for Employee Compensation
 (December 2005), for private industry, wages and benefits were:

Wages and Benefits

Managerial 	$43.48 per hour

Professional	$43.48 per hour

Technical	$43.48 per hour

Clerical	$19.61 per hour

	Assuming that professional and legal rates are comparable, doubling for
company overhead beyond wages and benefits, employing a 2% annual
inflation factor to bring the rates to the year 2006, and, for
convenience, rounding up to the nearest dollar, gives the follow rates
that will be used in this ICR:

Total Employer Cost

Managerial	$90 per hour

Legal		$90 per hour

Technical	$90 per hour

Clerical	$40 per hour

	The labor mix for the activities above will be about the same for each.
 It is assumed that for each hour of activity the mix will be about 0.05
hour managerial, 0.05 hour legal, 0.7 hour technical, and 0.2 hour
clerical.  This gives an average labor cost of about $80 per hour, which
will be used in this ICR.  The burden estimates for each activity are
the same as for the previous ICR.  That is, a fuel manufacturer
notification will require 8 hours on average to complete.    Likewise,
the fuel additive manufacturer notification will require 8 hours to
complete.  The additive update, fuel update, and additive annual report
each require one hour on average to complete.  The fuel annual and fuel
quarterly reports each require 3 hours on average to complete.

Cost per Report

Fuel Manufacturer Notification - 8 hours @ $80 = $640

Fuel Notification Update - 1 hour @ $80 = $80

Fuel Additive Manufacturer Notification - 8 hours @ $80 = $640

Additive Notification Update - 1 hour @ $80 = $80

Additive Manufacturer Annual Report - 1 hour @ $80 = $80

Fuel Manufacturer Quarterly Report - 3 hours @ $80 = $240

Fuel Manufacturer Annual Report - 3 hours @ $80 = $240

6(c)	Estimating Agency Burden and Cost

	The Agency activities listed in section 5(a) are handled primarily by
contractor personnel for $396,000 per year.  A part time Senior
Environmental Employee (SEE) is employed at $14,000 per year for data
entry.  Eight hundred twenty square feet of space are leased at $25,000
per year.  Security monitoring is $5,000 per year.  Portions of the
following EPA personnel are involved (with 1.6 overhead factor):

	GS -14 Environmental Engineer (EE), $106K x 1.6=$170K

	GS-13 Chemical Engineer (CE), $86K x 1.6=$138K

	GS-13 Program Analyst (PA), $86K x 1.6=$138K

	GS-13 Computer Specialist (CS), $86K x 1.6=$138K

Worksheet 9: Annual Agency Burden in Full Time Equivalents (FTE’s)

activity		EE		CE		PA		CS

respond to

inquiries		0.1/$17000	0.1/$13800	0		0

mail info		by contractor

review data		0.1/$17000	0.2/$27600	0		0

contact manu.		0		0.1/$13800	0		0

store info		by contractor

enter data		by contractor and Senior Environmental Employee

issue letters		by contractor

contract ad.		0.1/$17000	0		0.2/$27600	0

security		0		0		0.1/$13800	0

record cbi		division clerical support

maintain computer	by contractor 					0.05/$6900

program oversight	0.2/$34000	0.1/$13800	0		0

totals			0.5/$85000	0.5/$69000	0.3/$41400	0.05/$6900

total			1.35 FTE/$202,300

Total Annual Cost to the Government

Contract		$ 396,000

Part time SEE		$  14,000

Lease			$  25,000

Security		$    5,000

FTE’s			$202,300

Total			$642,300

	Thus, the annual estimated cost to the government is $642,300.  The
total hours are 1.35 FTE x 2080 hours/FTE=2808.

	6(d) and (e)	Estimating the Respondent Universe and Total Burden and
Costs, and 			Bottom Line Burden Hours and Costs

	The following worksheet is based on an inventory of 500 registered
fuels (up from 350 in the previous ICR) and 5800 registered additives
(same as in the previous ICR).  Of the additives, about 1500 are merely
relabels, so only 5800-1500 = 4300 additives will require annual
reports.  Data for 2006 indicate that EPA is receiving approximately 100
new fuel notifications (up from 70), 250 fuel notification updates (down
from 500), 500 new additive notifications (unchanged), and 300 additive
notification updates (up from 200) annually.

Worksheet 10: Annual Industry Burden

Form			Number		Hours/Cost			Total Hours/Cost

Additive

Notification		500			8.0/$640			4000/$320,000

Additive Update	300			1.0/$80			300/$24,000

Additive Annual	4300			1.0/$80			4300/$344,000

Fuel Notification	100			8.0/$640			800/$64,000

Fuel Update		250			1.0/$80			250/$20,000

Fuel Annual		500			3.0/$240			1500/$120,000

Fuel Quarterly		2000			3.0/$240			6000/$480,000

Totals			7,950						17,150/$1,372,000

	Thus, the net burden to industry is 17,150 hours and $1,372,000, plus
7,950 submissions x $5.00 each for copying and postage, or
$39,750+$1,372,000=$1,411,750.  (The net burden for the previous ICR was
$1,006,740.)  The burden is gauged per form.  Some manufacturers have
hundreds of products, some have only one or two.  Per section 6(c), the
annual burden to the government is 2808 hours and $642,300.  It is
recommended that the above costs be increased 3% annually for inflation.

	6(f)	Reasons for Change in Burden

	The net burden has increased due to an increase in the number of fuels
and an increase in labor rates.  The following worksheet summarizes the
changes:

Worksheet 11: Changes in Burden - Hours

Form		Previous 	Requested	Change	Reason

additive

notification	4000		4000		0

additive

update		200		300		+100		adjustment

additive

annual		4300		4300		0

fuel

notification	560		800		+240		adjustment

fuel

annual		1050		1500		+450		adjustment

fuel

quarterly	4200		6000		+1800		adjustment

fuel

update		500		250		-250		adjustment

totals		14,810		17,150		+2,340

	6(g)	Burden Statements

	For the two notification forms, the statement is proposed to read as
follows:

	Burden Statement:  The annual public reporting and recordkeeping burden
for this collection of information is estimated to average 8 hours per
response.  Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency.  This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to comply
with any previously applicable instructions and requirements; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.  An agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.  The OMB control numbers for EPA's regulations are
listed in 40 CFR part 9 and 48 CFR chapter 15.

	To comment on the Agency's need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including the use of automated collection techniques,
EPA has established a public docket for this ICR under Docket ID No.
EPA-HQ-OAR-2006-0894, which is available for public viewing at the
Office of Air and Radiation Docket in the EPA Docket Center (EPA/DC),
EPA West, Room B102, 1301 Constitution Ave., NW, Washington, DC. The EPA
Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal holidays.  The telephone number
for the Reading Room is<PHONE_NUMBER>, and the telephone number for the
Office of Air and radiation Docket is<PHONE_NUMBER>.  An electronic
version of the public docket is available through www.regulations.gov.
Use the to submit or view public comments, access the index listing of
the contents of the public docket, and to access those documents in the
public docket that are available electronically.  Once in the system,
follow the on-line instructions.  Also, you can send comments to the
Office of Information and Regulatory Affairs, Office of Management and
Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk
Office for EPA.  Please include the EPA Docket ID No.
EPA-HQ-OAR-2006-0894 and OMB control number (2060-0150) in any
correspondence.

	For the additive annual report form, the statement would be identical,
with the exception that the burden estimate would be one hour.  For the
quarterly and annual fuel report forms, the statement would be
identical, with the exception that the burden estimate would be three
hours.

Attachments

Attachment 1 - EPA Form 3520-12

Attachment 2 - Instructions for EPA Form 3520-12

Attachment 3 - EPA Form 3520-13

Attachment 4 - Instructions for EPA Form 3520-13

Attachment 5 - EPA Form 3520-13A

Attachment 6 - Instructions for EPA Form 3520-13A

Attachment 7 - EPA Form 3520-13B

Attachment 8 - EPA Form 3520-12Q

Attachment 9 - Instructions for EPA Form 3520-12Q

Attachment 10 - EPA Form 3520-12A

Attachment 11 - Instructions for EPA Form 3520-12A

 PAGE

 PAGE   1


[Federal Register Volume 86, Number 245 (Monday, December 27, 2021)]
[Notices]
[Pages 73310-73311]
[FR Doc No: 2021-28036]

-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2021-0002; Internal Agency Docket No. FEMA-B-2172]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency; Department of Homeland
Security.

ACTION: Notice; correction.

-----------------------------------------------------------------------

SUMMARY: On October 13, 2021, FEMA published in the Federal Register a
proposed flood hazard determination notice that contained an erroneous
table. This notice provides corrections to that table to be used in
lieu of the erroneous information. The table provided here represents
the proposed flood hazard determinations and communities affected for
Prince Edward County, Virginia and Incorporated Areas.

DATES: Comments are to be submitted on or before March 28, 2022.

ADDRESSES: The Preliminary Flood Insurance Rate Map (FIRM), and where
applicable, the Flood Insurance Study (FIS) report for each community
are available for inspection at both the online location and the
respective Community Map Repository address listed in the table below.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
https://msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-2172, to
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance
and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC
20472,<PHONE_NUMBER>, or (email) [email protected].

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
[email protected]; or visit the FEMA Mapping and Insurance
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed in the table below, in
accordance with Section 110 of the Flood Disaster Protection Act of
1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own, or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP may only be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a

mutually acceptable resolution of an appeal. Additional information
regarding the SRP process can be found online at https://floodsrp.org/pdfs/srp_fact_sheet.pdf.
    The communities affected by the flood hazard determinations are
provided in the table below. Any request for reconsideration of the
revised flood hazard determinations shown on the Preliminary FIRM and
FIS report that satisfies the data requirements outlined in 44 CFR
67.6(b) is considered an appeal. Comments unrelated to the flood hazard
determinations will also be considered before the FIRM and FIS report
are made final.

Correction

    In the proposed flood hazard determination notice published at 86
FR 56972 in the October 13, 2021, issue of the Federal Register, FEMA
published a table titled Prince Edward County, Virginia and
Incorporated Areas. This table contained inaccurate information as to
the community map repository for the Unincorporated Areas of Prince
Edward County featured in the table. In this document, FEMA is
publishing a table containing the accurate information. The information
provided below should be used in lieu of that previously published.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
          Prince Edward County, Virginia and Incorporated Areas
          Project: 19-03-0018S Preliminary Date: April 14, 2021
------------------------------------------------------------------------
Unincorporated Areas of Prince Edward    Prince Edward County
 County.                                  Administrator's Office, 111
                                          North South Street, Farmville,
                                          VA 23901.
------------------------------------------------------------------------

[FR Doc. 2021-28036 Filed 12-23-21; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33312-33313]
[FR Doc No: 2021-13371]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0512]

Considerations for Progressive Multifocal Leukoencephalopathy
Clinical Trial Designs; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the following public workshop entitled ``Considerations for Progressive
Multifocal Leukoencephalopathy Clinical Trial Designs.'' The purpose of
the public workshop is to discuss the challenges and clinical trial
design considerations for developing therapeutic products for the
treatment of progressive multifocal leukoencephalopathy (PML).

DATES: The public workshop will be held virtually on September 21,
2021, from 10 a.m. to 4:15 p.m., Eastern Time. Submit either electronic
or written comments on this public workshop by November 1, 2021. See
the SUPPLEMENTARY INFORMATION section for registration date and
information.

ADDRESSES: The public workshop will be held in virtual format only.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before November 1, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 1, 2021. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-N-0512 for ``Considerations for Progressive Multifocal
Leukoencephalopathy Clinical Trial Designs.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments

received, go to https://www.regulations.gov and insert the docket
number, found in brackets in the heading of this document, into the
``Search'' box and follow the prompts and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852,
240-402-7500.

FOR FURTHER INFORMATION CONTACT: Lori Benner and/or Antoinette
Ziolkowski, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6221, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Progressive Multifocal Leukoencephalopathy (PML) is a rare, often
fatal viral disease of the central nervous system that affects patients
with immunosuppressive conditions and those treated with
immunomodulatory agents. No products are approved for the treatment of
PML and no therapeutic development pathway is established for PML. FDA
seeks to discuss scientific and regulatory challenges associated with
designing clinical trials evaluating PML treatments, and to develop PML
clinical trial designs that are feasible, adequate to establish
substantial evidence of effectiveness, adequate to characterize the
safety profile of investigational treatments, and acceptable to PML
patients, clinicians, regulators, and industry.
    The Agency encourages healthcare providers, employees of other U.S.
Government agencies, academic experts, industry experts, patients and
patient advocates, and other stakeholders to attend this public
workshop.

II. Topics for Discussion at the Public Workshop

    Discussions are planned around the following topics areas:
     Unmet need for PML therapeutics.
     Key trial design considerations, including feasibility,
trial populations, selection of control groups, endpoints, adaptive
designs, and master protocols.

III. Participating in the Public Workshop

    Registration: Persons interested in attending this public workshop
must register online by September 20, 2021, midnight Eastern Time using
the weblink for this workshop noted in the Transcripts section below.
Please provide complete contact information for each attendee,
including name, title, affiliation, address, email, and telephone.
    Requests for Oral Presentations: During online registration, you
may indicate if you wish to present during the virtual public comment
session and which topic(s) you wish to address. We will do our best to
accommodate requests to make public comments. Individuals and
organizations with common interests are urged to consolidate or
coordinate their presentations, and request time for a joint
presentation, or submit requests for designated representatives to
participate in the focused sessions. We will determine the amount of
time allotted to each presenter and the approximate time each oral
presentation is to begin, and will select and notify participants by
September 10, 2021. All requests to make oral presentations must be
received by September 3, 2021. If selected for presentation, any
presentation materials must be emailed to the
<EMAIL_ADDRESS>no later than September 16, 2021. No
commercial or promotional material will be permitted to be presented or
distributed at the public workshop.
    Streaming webcast of the public workshop: This public workshop will
be webcast at the following site: https://collaboration.fda.gov/fdaworkshop092121.
    If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the website addresses in this document, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
    Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at https://www.fda.gov/drugs/news-events-human-drugs/considerations-progressive-multifocal-leukoencephalopathy-clinical-trial-designs-09212021-09212021.

    Dated: June 15, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13371 Filed 6-23-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: March 18, 2010 (Volume 75, Number 52)]
[Notices]
[Page 13170-13172]
[DOCID:fr18mr10-109]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61694; File No. SR-NYSE-2010-18]

Self-Regulatory Organizations; Notice of Filing of Proposed Rule
Change by New York Stock Exchange LLC To Amend the Bylaws of NYSE
Euronext To Adopt a Majority Voting Standard in Uncontested Elections
of Directors

March 11, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on March 5, 2010, New York Stock Exchange LLC (``NYSE'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is submitting this rule filing in connection with the
proposal of its ultimate parent, NYSE Euronext (the
``Corporation''),\3\ to amend its bylaws (``Bylaws'') to replace the
plurality vote standard for election of directors in uncontested
elections that is currently in the Bylaws with a majority vote standard
for such elections. The existing plurality vote standard will be
retained in connection with contested elections for directors. The text
of the proposed rule change is available at the Exchange, at the
Commission's Public Reference Room, and on the Exchange's Web site at
http://www.nyse.com.
---------------------------------------------------------------------------

    \3\ NYSE, a New York limited liability company, is an indirect
wholly-owned subsidiary of NYSE Euronext.
---------------------------------------------------------------------------

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of and basis for the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of these statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in Sections A, B, and C below, of the most
significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange is submitting this rule filing in connection with the
Corporation's proposal to amend its Bylaws to replace the plurality
vote standard for election of directors in uncontested elections that
is currently in the Bylaws with a majority vote standard for such
elections. Specifically, the Bylaws currently provide that ``directors
shall be elected by a plurality of the votes of the shares present in
person or represented by proxy at the meeting and entitled to vote on
the election of directors.'' Under the Corporation's corporate
governance

guidelines previously adopted by the Board, however, any director
nominee in an uncontested election (being an election in which the
number of nominees equals the number of directors to be elected) who
receives a greater number of ``withheld'' votes than ``for'' votes
(including any ``against'' votes if that option were to be made
available on the proxy card) must immediately tender his or her
resignation from the Board. The Board will then decide, through a
process managed by the Nominating and Governance Committee and
excluding the nominee in question, whether to accept the resignation.
In a contested election (being an election in which the number of
nominees exceeds the number of directors to be elected), the
unqualified plurality vote standard controls.
Uncontested Election
    The Corporation is proposing to add an explicit majority voting
provision for uncontested director elections to the Bylaws, thereby
replacing the plurality vote standard for election of directors in such
elections that is currently in the Bylaws. The existing plurality vote
standard will be retained in connection with contested elections for
directors. Under the proposed amendment to the Bylaws, the proxy card
would change for an uncontested election, and the stockholders would be
given the choice to vote ``for,'' ``against'' or ``abstain'' with
respect to each director nominee individually.\4\ In such an election,
each director would be elected by the vote of the majority of the votes
cast with respect to such director's election, meaning that the number
of votes cast ``for'' such director's election exceeded the number of
votes cast ``against'' that director's election (with ``abstentions''
not counted as a vote cast either ``for'' or ``against'' such
director's election). In the event that any incumbent director fails to
receive a majority of the votes cast, such director would be required
to tender his or her resignation to the Nominating and Governance
Committee of the Board (or another committee designated by the Board),
and such committee would make a recommendation to the Board as to
whether to accept or reject such resignation or whether other action
should be taken. The Board would then act on the recommendation of such
committee and publicly disclose its decision regarding the tendered
resignation and the rationale behind the decision.
---------------------------------------------------------------------------

    \4\ Stockholders are currently given three choices when voting
for a slate of director nominees: They can vote (1) ``for'' all
nominees, (2) ``withheld'' for all nominees or (3) ``withheld'' for
certain nominees and ``for'' the remaining nominees.
---------------------------------------------------------------------------

    The proposed amendment to the Bylaws also provides that a director
who tenders his or her resignation as described above will not
participate in the recommendation by the Nominating and Governance
Committee or the Board of Directors action regarding whether to accept
the tendered resignation. In the event that each member of the
Nominating and Governance Committee fails to receive a majority of the
votes cast in the same uncontested election, then the independent
directors who received a majority of the votes cast in such election
must appoint a committee among themselves to consider the tendered
resignation and recommend to the Board whether to accept it. However,
if the only directors who received a majority of the votes cast in such
election constitute three or fewer directors, all directors may
participate in the action regarding whether to accept the tendered
resignation.
    Pursuant to the proposed amendment to the Bylaws, if the Board
accepts a director's resignation as part of the process described above
for uncontested elections, or if a nominee for director is not elected
and the nominee is not an incumbent director, the Board may (i) fill
the remaining vacancy as provided in Section 3.6 of the Bylaws and
Article VI, Section 6 of the Certificate of Incorporation (involving a
majority vote of the remaining directors then in office, though less
than a quorum, or by the sole remaining director) or (ii) decrease the
size of the Board as provided in Section 3.1 of the Bylaws and Article
VI, Section 3 of the Certificate of Incorporation (involving adoption
of a resolution by two-thirds of the directors then in office).
General Election Requirements
    The following applies to elections of directors and is not being
amended. Section 2.7 of the Bylaws provides that, unless otherwise
provided in the Certificate of Incorporation of the Corporation, each
stockholder entitled to vote at any meeting of stockholders shall be
entitled to one vote for each share of stock held by such stockholder
that has voting power upon the matter in question. This entitlement,
however, is subject to the voting limitation in the Certificate of
Incorporation that generally prohibits a beneficial owner, either alone
or together with related parties, from voting or causing the voting of
shares of stock of the corporation, in person or by proxy or through
any voting agreement or other arrangement, to the extent that such
shares represent in the aggregate more than 10% of the then outstanding
votes entitled to be cast on such matter. Any votes purported to be
cast in excess of this limitation will be disregarded.\5\
---------------------------------------------------------------------------

    \5\ See NYSE Euronext Amended and Restated Certificate of
Incorporation at Article V, Section 1(A).
---------------------------------------------------------------------------

    Relative to the foregoing, if any beneficial owner of the
Corporation's stock, either alone or together with related parties, is
party to any agreement, plan or other arrangement with any other person
or entity relating to shares of stock of the Corporation entitled to
vote on any matter under circumstances in which (i) the result would be
that shares of stock of the Corporation that would be subject to such
agreement, plan or other arrangement would not be voted on any matter,
or any proxy relating thereto would be withheld and (ii) the effect of
the agreement, plan or arrangement would be to enable a beneficial
owner (but for these provisions), either alone or together with related
parties, to vote, possess the right to vote or cause the voting of
shares of the Corporation's stock to exceed 10% of the then outstanding
votes entitled to be cast (assuming that all shares of stock of the
Corporation that are subject to the agreement, plan or other
arrangement are not outstanding votes entitled to be cast on such
matter), then this recalculated 10% voting limitation will be
applicable. Any votes purported to be cast in excess of this
recalculated voting limitation will be disregarded.\6\
---------------------------------------------------------------------------

    \6\ See id.
---------------------------------------------------------------------------

    At each meeting of stockholders of the Corporation, except as
otherwise provided by law or the Certificate of Incorporation of the
Corporation, the holders of a majority of the voting power of the
outstanding shares of stock of the Corporation entitled to vote on a
matter at the meeting, present in person or represented by proxy, will
constitute a quorum (it being understood that any shares in excess of
the applicable voting limitation discussed above will not be counted as
present at the meeting and will not be counted as outstanding shares of
stock of the Corporation for purposes of determining whether there is a
quorum, unless and only to the extent that such voting limitation shall
have been duly waived as provided in the Certificate of
Incorporation).\7\
---------------------------------------------------------------------------

    \7\ See NYSE Euronext Amended and Restated Certificate of
Incorporation at Article VIII, Section 2.
---------------------------------------------------------------------------

2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) \8\ of the
Act,

in general, and furthers the objectives of Section 6(b)(1) \9\ of the
Act, which requires a national securities exchange to be so organized
and have the capacity to carry out the purposes of the Act and to
comply, and to enforce compliance by its members and persons associated
with its members, with the provisions of the Act. The proposed rule
change is also consistent with, and furthers the objectives of, Section
6(b)(5) \10\ of the Act, in that it is designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, to foster cooperation and coordination with
persons engaged in facilitating transactions in securities, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system and, in general, to protect investors and the
public interest. Specifically, the Exchange believes that the proposed
rule change will protect investors and the public interest by codifying
in the Bylaws the existing policy of the Corporation aimed at ensuring
better corporate governance and accountability to stockholders by means
of a voting procedure leading to election results that more accurately
reflect the views of stockholders on the qualifications and suitability
of individual director nominees, even if there are no alternative
director nominees to vote for on the ballot.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(1).
    \10\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which NYSE consents, the Commission will:
    (A) By order approve such proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change, as amended, is consistent with the Act. Comments may be
submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2010-18 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSE-2010-18. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room on official business
days between the hours of 10 a.m. and 3 p.m. Copies of such filing also
will be available for inspection and copying at the principal offices
of the Exchange. All comments received will be posted without change;
the Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
NYSE-2010-18, and should be submitted on or before April 8, 2010.
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-5916 Filed 3-17-10; 8:45 am]
BILLING CODE 8011-01-P