Report No.:

INT EG RATED SAFEGUA IWS IJATAS II EET A PPRAI SA L STA( ;E

Date prepared/updated: NO\ ember 8. 2010

I. B<ls ic Inform.diun

I. Bas il' Projt.'t't I)"t;l

Country: Arg(.;nlina T projl.!cI II): P005920 ~~_ L Additiomill'rojccl II ) (1/ lilly): I"F220-'1"-3 ___ -I

Projec t Name: RcduCiion ofO/.o[1c DepIcting Substances Projl.:ct LMol1l1\.'al Protoc~'o~I~) ___ _ Task Team J .cader: Ih:nan A. Powdu ]':stimatcd Appraisal Dalc~N/A -=- -~~=rl :stirnal(,!d Board Dale. N/J\. ______ _ Managin!;2. Unit: I ,('SEN I I.!nding Instrument: Gran t _ ScclOr: Suslai nabll.! IJcvdoj)ll1cnl Environment: Pollutiun Control IBRIJ Amouo\ (US$m.): ==----­IDA Amount (LJSSm.): GI' F Amount (lJS$m.): PCF Amount (lJSSm.): Other linancing amounts b) SOUfCl': MOiHrCal Protocol USS 2.30 ... hn Environmental Cal ego!} : C

_.Is this a Irans lcrrcd 'project ~ Yl'S I J

Sin~lili i:d Processing _1 Simpli: jX1 Is Ihi s proj~'(;t proc(;ss~d under Oil 8.00 (Rap id Respon:-.e \0 Crises and Emergcm:ies)

2. I' rojc('t Objectivt,s;

j NolXl R,:£catcr Yos I I

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The ohjec ti ve or thl..' Pruject is to: (a) support Argcmin<l's program to phase out 07.one Depleting Substances (ODS) (;onsumption through the provision or tl:dmieal and technological assistance: and (b) stn:nglhi.:n Ihe inst itutional framcwork in Argentina \() betlcr ickntiry. prepare. evaluate, and administer subpt:ojects .

3. PrujN't Desc rip tion : The Project hus linnllced subprojec ts to red uce or \,.'liminale usc of ODS. Subprojec ts alread~ financed include cotl\l..'rsions o r industria l processes in :'I..'ctors slich as Hir conditioning (mobi le. domestic and cOlllmen: ial ). refrigeration (domestk. commen.:i'll. industrial and transport). compressor manuf~lcture. local production or ODS. industrial limms. and uthers, Subprojects financed to dati: hel\e..' c:liminah:d an estimated 2.778 tons 01" %ne dcpli:ting substances. meeting ,md far slirpussing the Project' s target of eliminating 1.(1I2 tons or ODS by the end of the Project. I'hl..' Prnjc:ct has also linanced technical assistance to strengthen Argentina's institutional capadt) to idcntil). prc:parc. evalume. and adminish .. ·r subprojl!ets.

Ih: Additional Finance \\Quld support the implementation of a new subproject 10 phase oul the usc or chlorofluorocarbons ((,FCs) in the production or rnctcn:d·dose inhalers (M Dls). an

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industrial seClor nOI previousl), addressed b) the Project through resl.!Hfch to develop a new MD I fo rm ulation based on isobutanc. rhe subproject \\oldd bt' I:arried oul b) the /,lIhOrlilorio Pahlo Cos.\(/rci, the nu~or MD I producer in Argentina, which \\ ould umkrtake rl.!seureh to test the usc of isobu tam:, dewlop and secure approval or the h.:t.:hnology by Argentina's Federal Drug Administration Agent.:y (ANMAT). Studies und technical assistancl.! on how 10 implement the CFe phase-out in the MDI production wou ld be extended to five additional laboratories. The Ministry of Industry and Tourism (through the Project Coordination Uni t) in collaboration ,,,,jth these laboratories \ ... auld also support a marketing and transition strategy to gain and monitor gradua l acccptancl.! or the nev,\) lonnulated MDl s among consumers o\l,,'r a thrce-y(.'ar period. This subproject is expected to contribute furthe r to Ihl.' Project' s objectives by eliminat ing approxima tely an additional 109 tons or ozone depicting substanCl's (ODS) .

.t. 1)I'ojccI L(H.'alion and Salient Ph)lsical C hl.lnlctcristics RdcvlInt to the Sltfeguanl Analysis: J>roj~ct activitit.'s to substitutc C FCs will take plm;c in the l.(lho/"{/lOrj{) Jlah/() Cassunl (being the largest producer or MDls in Argen tina ). I"h is laborator~ has !.!'\pl.'rience in handling gas propellants agents in their products. I"herc arc no !o r!.!sccn risks or impacts rclt-van! to safc.·guards ana lysis. No physical. cm ironmental or social impacts arl.' expected from the implementation of this subproject.

s. Environmcnt;.tland Sociul Saf('gullrcls Specia li sts on Ih(' Team: Marcelo Acerbi (LCSI :N). Lilian Pcdcrsetl (LCSSO)

6. Safeguard Polic ies Triggered (please r!xplain II'lIy)

Envi rolllllcntaJ Asscssment (01)181' 4,0 1l. Nlltunill-l.tbit.l ts (OPIBP .t.04) -Fun'sts (OP/BP .... 36) Pest Manaoementj OP .t.09) Phys ie .. J C ultu!":11 J~esourees iOPII!..!~ .... 11 ) Indi~('n()us Pcol>lcs lO I'/HI) 4.10) luvolul1tar,' Resettlement (OI)IHI) ... .J1) Safety of I)ams (OI'IIl I' 4.37) Ilroj ('cts on Il1t(' l"Illitionlll Watcr\nl,vs (OP/BP 7.50) Projects in Disputed An'as «)!l/ lll' 7.60)

II. Key Saf(.'gu:lnl Poli('Y Issues and Their Manllgellwnt

A . Summary of Key Safeguard [!iSues

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I Yes No X X

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X X X

t X X X X

i X

I. Desnih(' ,lilY sllfeguard issues 1111(1 imp:lcts associ:-Ited with the proposed project. Identify and describt.' an)' potential large sc.lle, sign ilil'an t li nd/or irre"crsible imp:lcts:

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rhe subproject 10 be lin"need under the proposed c."ensiGn in.olves the phase-out 01" CIT consumption in the manu!~leturing of aerosol MIJI by s\\ itching to an isobutane-based fonnula tion. This substitution of propellant docs not flm:sce a changt' in tcchnolog~ nor in the currc.:n1 production line. but an adaptation in th(.' l.:urrCI1I equipment that \\(lldd dcli\cr thl,..' isoblllanc propellant into thc MDI. It is expected that th(.· slIbprojl.'ct \\ill contribute to thc

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elimination or 109,1 tons of ODS. further strengthening the Project's already satisfactory outcomes. There arc no expected ad\ erse environmental or social impacts: isobutane is a we!! known substance. has a vel") [ow !Oxicity: and then.: is a long history of human cxposure to hydrocarbon propellants (such as isobutam:) in cosmdics, deodorants and mcdicinal products. In addition . an MDI lorlllulalcd with isobulane propellant would be beneficial in reducing greenhouse gas emissions and in line with a worldwide trend aiming to substitute the use of CFCs in MDl s. 1

While isobutane IS a tlammable substance, it is not considered to pose a sign ificant risk/drawback since: (i) the Laborcllorio Pablo Cassurel is experienced in handling Ilammable substances such as CFe prope!!ants: Oi) prel.:<lutionary measures in the use or isobutanc arc well known sinec it is extensively used as a propel lan t in the aerosol industry lor domestic, cosmetic and medicinal products by both consumers and indust ry: and (iii) in the casc of MDls. each unit delivers a metered dose or less than 50 mg per shot of "hich isobutane is only a vel") small fraelion.

2. I)escl'ibt.' any potenti.t1 indiret.'t and/or long It.' rlll impads due to anticipated future a ctivitit.~s in the projet.·t arc.a:

Neither adverse long+tcnn nor cllillulativl..' impacts art: /orcseen as a result or future PI;ojeet activities.

3. Describe any IlI'oject alternatiVt.'s (if rclev.lOl) considered 10 hdp avoid or minimize adverse impacts:

Other possibk lonnulations lor M])[s indudc the usc of 111:C<?:17ca and Nllr!1urane (IIFA 134a). These options were rl..'jccted bascd Ull l:osts and pt:I"Cl:iveu liabilities concerning health impacts . For instance. exposure to gas leaks in the case of I [F;\. 134a have been associated with cardiovascular irregularities (heart thumping). Likewise. this propellant can cause irritation as wcll as skin and eye i"rl..'ezing ir directly exposed. Tht:se sid!.! crfects have not been detected in the usc or isobutane.

4. I)escrilll' measures taken by Iht.' borrower to itddrcss silfeguard policy issues. I'rovidt.' an ass t.·ssment of borrower cllpacity 10 plan and implement the mt.'asurcs desnihcd:

No adverse impacts or risks arc expected under the proposed aeti\ ities. The '-oho/"(I{()/";o f'ah/o CassaNI requircs its \\orkcrs to usc protei.:livc equipment and has aceidl..'nt prc\'l..'lltion procedures to whid its \\orkers must adhere, Moreover. the ne\d) -dl.!\'duped isoblitanl.!+MDI formulation will have to be n:gistl..'red. clinically analyzl..'d and appro\l'd h) ;\.NM/\ [" prior to being marketed .

I For insttllKl'. in April. 2010 Ihe US Food ~lIld llrug Administration annuunced Ihm il \\Uldd be phasillg-oullhl' producliol1 and sale of asthma inhalers using chloroi1uorOCllrnons as a propd lanl.

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5. Identify thc kcy stakeholdcrs ,lnd describe the Illl' l'h :lIlis IllS fo r l'unsult:ltion and disclosure 0 11 s:lfeguunl po licies, with an emphasis 0 11 potenti a lly affected people:

Not applicable.

H. OL'ie/muIr(' Reqlliremel1b Oate

En "il"Ollmen la I Assessm ell II A ud it/M ,I nu "em ent Pia nlOth cr: Was the document disclosed prio! to ..!!l!£raisal? Date orreceiEt by the Bank Date or "in~coun lry" disc losure Date or subm ission to In roShop For ca tegury A projects. dat<-' o r distributin g the J ~ xl'cutive Summary o r the EA to the Execllli vc Din.:ctors

Rl'settlement Actio n 1)lan/FrumewurkiPolicy PI'Ul' l'SS: Was the document disclosed prior to appraisal? Dale or receipt by the Bank ____ ---Dale of "in~eountry" disclus~e

Dale or submission to JnroSh~ Indlg,l' nous Peo.Q h.'s PhllllPhlOnin.,g F'nullework:

WClS thc documen t discloscd prior 10 appraisal? Dale ()r n':cl'ipt b) the Bank Date of "ill-eoullln" disclosure

~ -DatI: or submissiun to inroShop

Pes t M anJ.l gcml·nt I' hln : Was thl' dOClllTI elll disclosed l!.rjor to appraisal? _ Date or recci£.!. by the BaJ~ Date of "in-country" disclosure

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N/A N/A N/A N/A

N/A

N/A N/A N/A N/A

I N/A \1 '/\

I N/A N/A

1 N/A N/A N/A N/A

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Dm\: of submission 10 InfoSh,oo"p,-O-,-___ _ * Ifthc projl'l'( t r iggers the Pest Management andlor Physical C l the res pl'cli\'C iss lies :In to be mldrcsscd lind disl'iosrd li S pa ri of

l!tural Resources policies, thl' Ellvironllll'n tal

Asscss men llA udit/o r EM I). If in -l'ount)"y di sl'l osure of lIny of !pc .tbon do('ulllcnt s is nut l'X P l' l't l'd.please ex p lain wh,':

C. Compliance Monitoring Indicators allhe Corporale Level (10 b/!filled ill wltellthe ISOS is finalized by Ihe project decision meetil1g)

O PIB P .. l.01 ~ F. 1I" iI"O IIOlcnt Assessment Docs the project require a stand -alone EA (including Yes I EM P) rcporl'? It')cs.lhen did the Regional Environmcm Uni t or Sector N/A Manager (SM) reviev. and approve the EA report?

No[XI N/A I I

Are the cost and the accountabiliti~s for the EMP inc~!I'0ralCd in thl' trc~it/loan'? OP/BP 4.04 - NlltunlJ I-Iabitats Would the project result in any significant conversion or degradat ion or critical natural habitats? If the project would result in si"g~n7ili"I=C,=tn=t-c-'o-n-\-'c-r"Csi~o-n-or degradation or other (non-critical) natural habitats. docs the projcct include mitigation measures acceptable to the Uank?

0·P4.09 ---.:--pcstMallitgcmcnt __ --- -Docs the EA adequately address the pest management issues? F=~-=~~c-c~~--~-· --­Is~ s~arate PMP r~Jired? I r yes . has the PMP be~n reviewed and approved by a sareguards specialist or Sector Managcr? Are PMP requirements included in project d~sign'! lryes. docs the

_proj~ct team include a Pest Mm~ement S~cialist'? o I' /BI'_4. !.!. -:. Physical C ultur..!.11 Reso urces _ Does the EA include adequate measures related to

c L!ltural~roJ?en)"! Does the credit/ loan incorporate m~chanisms \ 0 mitigate the potential adverse impacts on physical cultural resources? OP/BP 4.10 - Indigenous Peoples Has a separate Indigenous Peoples Plan/Plann ing Framework (as appropriate) been prepared in consultation with afrected ! nd~nous Peoples'? II' yes. then did the Regional unit responsible for sa tcouards or Sect~Mam~r l~view l~e plan? If the whole project is designed to benclitlP. has th~ design been reviewed and approved by the Regional Soci~cvelopment Unit? __ _ ___ _

Yes I I

N/A

Yes I I

Yes I J N/A

N/A

Yes I I

N/;\

N/A

No IXI N/A I I -

No I I N/A IXI - -- ~----co.,,--,~--I

Noll N/A lX]

No I I N/A IXI

No I I N/A IX]

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OPIBP 4.11- IIl\,olulltary_ Rcsettlemen t __ lIas a f<.,'senlcment plan/abbreviated plan/policy rramework/proeess framework (as appropriate) been jlrcjlarcd?

- - ----;-;--;-;------c;~vc;--I Yes I I No I I N/A IX]

I r yes. then did the Regional unit responsible lor sareguards or Sector Manager review and approve the plan~oli':2' f~nK'work/proeess framl.'\vork? OP/HP 4.36 ~ Forests

N/A

lias the sector-wide aml1ysis of policy and institutional Yes I I issues and constraints been carried OUI? - -Does the project design include satisractory measures to N/J\ overcome these constraints?

[ )OC5 the projecllinance commercial harvesting. and if NIJ\ so, docs it include provisiuns for certilication system'? __

No I I N/A IXI

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OP~BP -1 .37 - Saf~ of Ihms llavc dam salety plans been pn:.'pared,,?~_~ lime the rORs as weI! as composition ror the independent Panel or Experts (POE) been rev iewed and <l roved hi' the Bank '! l ias an Emergency Pn:paredncss Plan (EPP) been prepan:d and arnmgements been made for public awareness an~ trainin.1:\'! OP/ BP 7.50 - Projects on Intermllion<ll W<ltcrways I lave the other ri£.arians been notified or the ~ect? I r the project l~ll!S under one of the exceptions IU the notilieation n:quin':lllent. has this been cleared \\·ith the Legal Department. unci the memo to the RVP prepared and sent? What ure the reasons len thl' l'xeept~n? Please l'xplain: lias the RVP approved such an exception?

OI'/ UP 7.60 - Projects in Disputed Areas l ias the melllO com eying all pertinent information on the international aspects of the project. including the procedures to be fotlO\\Cd, and the recommendations for dealing \\ith the issue. been preJ?ared Docs the PAD/MOP incllJde thl' staCOn~d'a~r'd~d"i~se"laimer rclcrred to in the OP? The World Blink Polic2' on Disclosure of Informatio n I lave relevan t safeguard pol ides documents been sent to the World Banh.' s Inf()shop? 'Ia\~ rdcvant dOl.:Lllnellls been disclosed in-COUlHr) in a public place in a form and language that an.: understandable and aCl.:cssible to proj ect-a fleeted groups and local NGOs'!

A II S .. feg u ard Po ' ,i ''c'' i"es,-' ,--,---c---,--,-~ I lave satisfactory calendar. budget and clear institutional responsibilities becn prepared for the implementation of measun.:s related to sa leguard policies? I la\c costs relah:d to safeguard policy measures bccn included in the project cost? ~_~

Docs the Monitoring and E\ alumion system or the project include the monitoring of saleguard impacts and ll1eaSll r~s n.'IHted to sall~guard policies? Ilave sat is lac tory implementation arrangements Ix'en agreed \\ith the borro\\er and the same been adequ<ltd) rellectcci in the projcl.:t I~gal document,~s-," __ _

Yes I N/A

N/A

Yeti 1 N/A

N/A N/A

Yes I I

N/A

I Yes I

N/A

r YeS I

N/A

I N/A

~ N/A

Nol N/A IXI

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No I I N/A IXl ~

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No I I N/A IXI

No I I N/A IXI

No I I N/A IXI

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