Notification, 2013

Text

Reproduced from the document India Code holds for this instrument. The Gazette prints Hindi and English side by side and this is the English; the Department's own PDF remains the authority.

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EXTRAORDINARY

otd E 22s51 No.22561 NEW DELHI, FRIDAY, SEPTEMBER 27,20t3/ASV|NA 5, l9J5 sfoqrdr R**?" ffia 50 3i.

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MINISTRY OF AGRICULTURE

NclY Dclhi, the 20th Septenber, 2013.

&O. 293a(E).-D€ryfircnr of Agricultuc & Cmpsation in the Minisrry of Agricultu€ by a Notifica$on registration for Ac€tamiprid Tcchnicaf, Acctsmiprid 2096 SP Formulatioq Chlorpyiphos 1096 Granules Formulation and Chlorpyriphos 500/6 + Cypcrnethrin 5yo EC Famulation granted under Section 9(3) of the Ins€lticides Act, l 8 (th Acr) lo ll,l/s Dc-Nocil Crcp ProEcrion Ltd {now trr,t Dow Agro Scienoes (DAS)). The Notification dso orde|rrd cancellation ofall c€rtificales of rrgstrslion hcld unda Sedion 9(4) fc Chlcpyiptm 50/6 + Cypermethdn 5olo EC Formuluions. Th€ C-n2gue Nilification allowed fc a period of2 years towar& disposal of existing stocks hcld by companies. tt atso ord€red implementation ofthe Gazette Notificstion by the ReSisation Committ€€ as well &s Stalr Crovemments.

2. Gazete Notilicdioh NoS.O. 23 53(E) dared I 2u tuober, 20 I I was challengcd in the High Coun of Judicature at Bombay in I Writ Paition No.450 of 20f2 by lWs Ghrda Chenicsls Limit€(GCL) d another, !o the extsnt lhat the notification sought to cancel ertificole of Registration issued by Regisrrition Commifiee (RC) under Seclion 9(4) of the Act to Paitioner, GCL fa the combination p€sticid€ formulatioo Chlorpyriphm 50Yo + Cypqm€thrin 5% EC. High Court ofJudicatur€ at Bombay afler hearing p€titionen OCL and respordents Union oflndia thmugh Depanment of Agricultutr and Cooperation, the Central lnsccticides Board and Registration Committee, disposed off the Writ Petitiofl by an Order dstcd I lu July, 2012. Th€ operalivc Part ofthe Ordcr is as follows: 'Acccdingly, we dispose of the Petition in lhe following agreed teflns: iD We record thc statcm€nt made on behalfofthe Respondents by leamed senior counsel that the order revoking the r€gistration of the Petitionen under Section 9(4) of the lns€cticides Act' l96E is withdrawn in tclms of the stBtement of lesmed Senior Counsel r€corded above; The Petitionen would be ar libefty to file their replies within a P€riod oftwo.\ /eeks from today, on the basis thar the r€asons which have been contained in the impugned order dariiil 12 october 201I ftr the cancellation of tlrc regisEation under Section 9(4) constitute a noticc to show cause for the canctllation The Union Govcmment uould be at lib€rty to pass a fresh order upon the nctice issued in the aforesaid terms for the canc€llation of the regisrration under Section 9(4) afler fumishing to the Petitioners an opponunity of being had Fresh orders shall be passed within a period of eight weeks afrer the submission bf the reply refen€d to in clause (ii) above;

All the righB 8nd contentions of the panies are kept open to be urged before and decided by the Union Govemmenq The Petitionen shall not, in terfls ofthe statement msde before the court by learn€d s€nior counsel on insfucrions, manufacturt the combination in question, uotil a final order is Passed by the Union iiD D The paition is accordingly disposed of, sinc€ no oth€r point is pressed. There shall be no order as to costs'.

3. Bombey High Court h8d dirccted that DAC notificalion datcd l2t October,20ll for canccllation of regiseation under Sciion 9(4) shall constitutc a notice to sho\r cause for cancellation of rcgistsation. ln compliancc of thl said Arcction! GCL filed w tten submission to th€ Competcnt Authodty in DAC. S€cretary, Cenual Insectici&s Board snd Regists8rion Committee (Cts&RC) also liled wdtten r€sponse to sutnnissions made by GcL. Borh Secraz-y, CIB&RC and GCL werc invitcd by Compaent Authority in DAC for oral submissions, if they so desired GCL 8nd CIB&RC appeared befce compctent Authority ftr hearings on 24.0t-2012, 07 .09.2012, 12.10.2012 $d pr€sid€nt while CIB&RC was repescnted by Dr. Sushil K. Khuranq Medical Toxicologis! Dr. Vipin BhalnagarrJoint Dirccto(Chemistry) and Hariom Miglani, Law Officer .

4. A close cxamination of thc DAC Notification daled l2th Octob€r, 2011, (hereinafter referred to as the shouf cause notioe) to cull out grounds fa cancellation of cenificate of r€gisration for the pesticide Chlorpyriphos 50% + Cypermetfyii 5olo EC forirularion in so fsr as it r€lat€s to th€ resporden! GCI- a registmnt under secdon 9(4) of th€ Aa ted to identification of following grounds for lhe show causc noticei D That int€grity of thc rcgistBtion prccess wlrs compromised oo acconnt of illegal gratificstion 8nd' pecuniary *ircfits cxt€nded to a key member oflhe RC. Since careful examination ofclaims madc Ly an applicant for registsstion ofa pesticide is sine qua non for validation of elficacy ofthe produa against-pess and diseascs and assurance of safety to human beings and animals, any circlrmstance t hich dllur.s rigour of scrutiny and compromises integrity of registration prc€ess is violative of the 10 THE GAZETTE OF INOIA : EXTRAOROINARY lPaRr ll-SEc.3(ii)l Act and csn have serious ramificatiom. Unahical behavior on the pafl of DAS and complicity ofa member ofRC has compronis€d iotegrity ofthe regist-ation process. ii) Th p..dcidc combfustioo Crhkrpytiphc 5096 + gypsn 6rit 5% EC fcmulaisr was approved fur registration in the l69th meeting held on 17.7.1997. Agends note ftr $e l69th meeting had clcarly slated ahat "ln vicw of above data submission on various loxicity Frameters 8s per guidelines of the RegisEation Commin€e it is evidert that the combination product is morc toxic Ihan the individual comporenti i.e., Chloryyriphos 500 and Cypqmethrin 50 EC in case of aculc oral toxicity Rat and acute oral toxicity Mic€. As per guidelines of th€ Registrarion Committee for the regisruion of combinarion ploducI' the evidence is requir€d in slpport dlat tbe combination is not more hazardous than individual insecticides." Toxicologr data provi&d by DAS showed cleady that scute cral toxicity (rar) of Cypermerhrin is !,562.62 mgikg and thar of Chlorpyriphos! 224.567 mglkg whercas toxicity for Cldspyriphos + Cypemetkitr combination is 159.4t mg^g. Fmm this it is evident thst thc combinalioo has a higher toxicity than eithei of its tu/o cofliponena. D€spite loolvledge of this facl, \xfiich was clcarly brorght out in the Agenda fo the l69P M€€ting, RC Foc€eded to apprcvc registration of the pestici& by ignoring guidelin€s which w6r€ in €xistEnc€ at thar tim€. It was in 2010 thal RC dir€cted I review to be caried out of lhe pesticide by an Expert Committce constituted undcr the Chairmanship of Dr. T.P. Rajendran, Assistant Direc{or CEn€ml (PP), ICAR and (Toxicologr), Shri A.K. Bandopadhyaya Deputy Dir€ctor (Ertomology) and Ms. Kamlesh Miglani, Assislant Direcltr (Chemistry). This Expert Commitsee came to th€ conclusion that'tilh regard !o Nurelle D formulation, there is a seriors apprehensioD about the toxicity of rhe mixturc of Chlorpyiphos and Clpermethrin is higher than that ofthe individual pe*icides." ln thc light ofthe above, an assenion was mad€ that RC's recommendations for withdrawaUcancellation of c€rtifrcate of registsation issued under section 9(3) for Chlorpyriphos 50olo + Cypemethrin 5o/o EC formulation !o DAS alongwith withdrawal/cancsllation of9(4) registrations on grounds of safety (higho oxicity) in 3l4t , 3l5s and 3lEh meetings were ba-sed on 'rational and valid criteria'. iiD lt was also averred that requirement of investigation', 'consultation with Registrdtion Committe€' and satisfaction of Central Govemm€nt as mandated before refusal to register an insecticide or cancellation ofa cstificate of registsation under Section 27(2) of the Act have been fulfilled. It uEs pointed out that inv€stigation in this case was canied out by Central Bureau of Investigation and process of consultation with RC was duly carried out and satisfaction of Competent Authority restcd on the findings and recommendations ofRC.

iu) That R€gistration Committe€ and the Central Governmcnt are competent !o carry out multiple rcviews ofan insecticidc under Provisions of Section 9(3Xc), s€ctioo I I and Section 27(2) ofthe Act and thal pow€r of r€view of registration is a logical corollary- to'power of grant of registration'.

5. GCL filed \r tten submission to the Show Caus€ Notice on 246 July, 2Ol3 in which they have iDformed that wrinen submissions filed by them are in addition to their submissions made in Writ Petitidn No.450 of2012. GCL, also filed s€veral documents in the couse of heuings and made detailed oral submissions before the Compctent Aulhority.

6. A summary of arguments offered by GCL though written and oral submissions and documents in response to Show Caus€ Notice is as follows:

(D Thal CrcL dis&ssocial€s ils€lf tom unethical conduct on th€ p6rt of DAS and that there are no allegarions of impropriety again$ GCL.

(ii) That the Act does not provid€ for a review or revision of regisu-uion process after expiry of one year and lhat aclion under Seclion 212) is permittrd undq the Act to deal with an emergent sitlation. The Acl provides fff sction under Scction 2(2) whff€ action under Sectioo 2(l) is required and has bcen taken. GCL has contended that DAC Notification has permitted liquidation of existing stock held by cornpanies over a priod oftwo years which in its€lfis demons:trative of the fact that the pesticidc posed no imminent thretl to humans and animals, Thus! in their opinion, a condition prec€dcnt for action under Sestion 27 ofthe Act is dcmonsEably abs€nt.

(iii) The DAC Notilication of l2D October, 20ll was based on an erroneous undersianding that higher toxicity of th€ pesticide formulation Chlorplriphos 500/6 + Cypermethrin 5% EC rhar that of indivi&al constituents of the formulation viz, Chlorpyriphos and Cypermeihrin was in itself suffici€nt to rcnd€r it unfit for registsation under lhe RC guidelines. It has be€n pointed out that a review tras conducted in 2007 based on which RC came o the conclusion in is 277th metting thal no aspect of bio-efficacy or safety was overlooked while granting registrdtion to th€ product in question.. Moreover, guidelines in existcnce in 1997, when the p€sticide was registercd, specified categorically that'evidence is rcquired in support thar rhe combination is not mor€ hazzrdous than individual hsecticides,. GCL contends that there has been no finding to the eff€ct that thc pcsticide formulation is more hazardous than its constituents. As a consequenc.c. the order for with&au,all cancellation on ground of 'safcty of the formulation' is not €stsblished on the basis of any finding or credible evidcnc€ with rctdi&t to iisk oi ltaEd. Ir fr{t agurda for thc l69F RC Meeting had clcarfy mcntioned that the csnbinatisr pesicide Chlorpyiphm 5096 + Cyp€rmethrin 5% EC is morc toxic thar its constitu€nts, and this faa was considcred by RC before it decided !o grsnt apFoval to the formulation. RC al thc time had concctlyjudged the merits of thc case as per existing guidelines which refened to hazar4 not to(icity. It would be facile and erroneors to equlte hazsrd with loxicity simpliciter, sinc€ hrzrrd is a fimction ofnot only loxicity but equally of cxposure, packaging labeling precautions and safeguards in tsansportation, storage, usage, dosage etc. Had it not been so, far more ioxic pes-ticides, would never have been p€rmin€d !o be registerrd for use in India by the RC. Thus toxicity csnnot b€ the solc measure fG ass€ssrnex of hazard and safety, It is critical to und€rstand that guidelines which were in exist€nca in 1997 (when the pmduct wasr€gist€red by DAS) refenEd to 'hazard' md not 'loxicity'. It is also p€rtinent to note $al dats subrnitted by DAS at the time of r€gisEation has not beea impugnd ntr any inlirmity or deficiency in the data pertaining tio safay and hazard has been revealed in tlrc 'counsel of reviews of the pmduct wbich could have cast a shadow of doubt on the process of registraion. GCL bave 8lso ass€rtcd thal th€y themselves had generated and submitted data r€lated to scde oral todcity and &ut€ d€rmal toxicity as per requiremort undcr the then prevalent guidelines of RC in 199/2000. Tbe data submitted by GCL has not been challcnged either. That this very product vhich his,h€ea.in use-ia Iadia qnd. other cguoEics for m,r. .y y-cafs har beeo.foutd to b€ cfficacious sgainst p€sts and without any rcported adverse effects on health of humans and animals.

(iv) Th€ principl€ of natural justic€ has be€n violated in this case since no opponunity was granted [o GCL by either RC or Compet€nt Authority of being heand, before canctllation of cenificare of rcgistration.

7. Written and oral submission was also made on behalfofClB&RC in respons€ to rcpresentation liled by GCL. Repr€scrtatives ofClB&RC were present on all days when hearings were conducted, On the basis of wd en and oral submissions and documents CIB&RC has made following arguments io support of cancellation of regist-ation granted to GCL und€r Sedion 9(4):

D Ttd cgtification of rcgistration was granted ciginally uld€f, s€ction 9(3) of the Act ro DAS. The respondent, GCL, was granted ccrtificat€ of registration for the pesticide Chloryyriphos 5096 + Cypermethrin 5olo EC under "m€ too" provision for registration under section 9(4) ofthe said Act. The original data h8d b€en gerErated by DAS which RC had then found fit for grant of rcgistration under Seclion 9(3). Under provisions of the Act, an applicant under section 9(4) is granted rcgistration under the ssme conditions in which registration was granted to original r€Sislranl ii) The even6 which unfolded after disclosure of illegal pecuniary benefits to a key member of RC prompted a series ofreviews of pesticides registcr€d in the nsme of De-Nocil (nowDAS) in 197. The review in 2010 has established that RC guidelines rclating to safety of the product was ignored before rcgisralion. The Exp€rt Committee in 2010 concluded that *with regard to Nur€lle D formulatior; ' thire is a serious apprehensioo about the toxicity of the mixture of Chlorpyriphos + Cypermethrin is higher than that of the individual pesticides'. ln a situation when safety of prodrct could not be guarantee4 RC and DAC were well within rights and responsibiliti€s b€stowcd on them by the Act io &ncel all certificates of registration of the p€sticide in question granted under Section 9(4) of the Act, when thst granted to the original registrant was found fit for cancellation. ln the instant cas€, the decision foi cancellarion of rcgistuion ofthe Section 9(3) rcgistrant DAS had to be extend€d pad passu to 9(4) regisant slso, bccaus€ 9(4) appticants do not generate and submit original daE but rely wholly on that submitred by regisEarts under Section 9(3) of the Act. fie data submitted by DAS was found'on review to be oitically flawed on safety parameters. This also explains as m why registants under s€ction 9(4) of 3 othq pesticides wher€ left untouched, even though registrations Sranted to DAS under Section 9(3) ofthe Ad were canc.elled on account of unethical behaviour. Thes€ other pesticides did not posE any tkeat to human beings and animals from their continued use in tle assessment of th€ iii) RC.

CIB&RC asserts that hazard is directly related !o toxicity since "hazld = toxicity x exposure". .Since DAS d8la has clearly rcv€aled that LDro of both rar and mice wer€ higher in the combination pesticide formulation as opposed to LDro values for its solo constituent Pesticides, RC should have ascribed reasons for ignoring iS oum guidelines. Since the Act mandates that pesticides need to be evsluated inter-alia with relilion to assurance of safety to human bein$ and animals, thereforc grant of registration manifestly by flouting gUidelines which RC had itself fomulated to assu€ safety csnnot bG condoned and as such jusification for necessary conective stePs is self-evident' CIB&RC has refrrt€d ihe claim made by GCL thst the comPary was not wholly dePender[ on toxicity data provided by DAs but had generarcd its own data on loxicity of the p€sticidc conbination on rais and micr. CIB&RC comends that Form I of the applicaion for registration merely requires informarion on toxicity available in the public domsin and not generation of original dala from calefully conducred supervised scientific trials as in the case of 8n applicant for original registration under

Section 9(3).

iv) t2 v) cIB&Rc assefls thar rhc pns€nt casc is one of cancellation-of re?*gj*^g,g {:S '' g,a;;gi'E"tion' The cancellatioa was warranted as soon 8s Report ofExpert commiuee rsvealeo non ailrcnnoc of -r-p""J-J"y grroaine * ttc time or grant of re6*ation- This artion of.the RC is rdrrm8rr *o in n'inrri"rioiis-rcepl mrndalr und('' ft; Ad whidr is to cnsur! sefety, and thcrcfore That RC slrould have r"t I^t r"grt ,io1 on a hii assessment of dara during prc-registration- scrutiny ,rb;{r*t ,""ir", in zoto i-rtiilry an-exercise in scrutiny aad eva.luation prior to rcgistra.tior of th€ Produd.

t. Now having examined in detail, contenls of Show cause l'Iotice, Britten and oral submissions of th€ two i;p..d;; cci ;i crsanc, -a J;r.*o presented before comp€tenr Authoriry, following inferencs can be &awn:

I"girt""rion for ttris ctremicat *"t iart"a t6 CCt under Fovisions of Scctioo 9(4) of $e Act. lt is slso not cont€sted that ill"guigrutin".t-- and pecuniary benifits wcre extended to a member of the RC by -6iS.

O,cC nodn"dii, SIO. ZfSffD; arid l2.to.i0r0 Noticc to Show Carsc) is hcd inttr alis, oo "t maf;ices -nriuut"o to compmmis€ of integrity of scrutiny, evaluation 8nd "xtent rhal safety of products could no longer be vouchsafed.

This provided "a.q*r! j*tinom fc cancellari_on of regisrarions for pcsticides A@tamiprid and Cfriorpyriptos 50olo i Cypermethrin 5% E€ formulation granted to DAS under Section.9(3). Howbver, no dher concomitan, ,"gl'ttr"ri* *Oo ,roion 9(4) of thi Act was sought to be cancelled- excets those ""r,"d 'n" formulation.

after due deliberation the Cimmince decided to withdrad cancel c€nificates of r€gistration held by DAS for AceAmiprid iechnical (pfide), Acetamiprid 20% sp formulstion and chlorpyriphos I @/o granules formulation (Dursban IOG) for adopting unethical practices withgT {*'l:S^Jl^:l ""v iuUr"qr-t 9(4) registrations. However, the minutis went on to add that 'registration of Chlorpyriphos g(3) be withdraldcrncelbd Lcause of unethical pracric€s adopted by the r€gisfant and.safety of the formulation as well as due to avaitability ofaltematives. The RC further deci6 that the subsequenr 9(4) i"gitrotiont issued for this producl (cl'lopyriphos 50"/i + cyPermahrin 50lo EC)- shall alv' be *ith&"rrr,/"*".lled.' However this agenda iiern of Slath RC meering did not ga confirmed.and was taken up as agenda item 1.0 in the 3l5ih me€tirlg o122-02-2|rl fcn amendment. The amended minule! while retainifi the core etemcnts of the decision taken in thc Prcrious RC.meeting (3l4th) added that 'Acctamiprid iboth technical and its 20% fomulation) has useful Ptsc€ in lhe managemert ot saP sucking insects of cotton at present tm' Hence, this will not' in any way' affect the- sutssquent recistrations of these productsi- The malter was orce again takan up for consideration-in the 318th ;;;il; ,h" nC fia on 2?-w2oll for further clarificarion on recomm€ndations of Registration (prio"l nc held thar decisiin was taken in rhe 3l5rh meaing ro canc€l rcgistrsrio of Ac€ramiprid iect ni"a ana ia formulations because of unethical practices adopled by DAs and 'nor lug to any advers€ asp€cts of thes€ products. Since the Registratiod Committ€€ of rhe CIB is satisfied on the Tcchnical and is iormulation, th€re is no jusiificalion tJo cqnpletely eliminate th€ producs from tlrc couno-y. It is noted that this is widely used-in coton crop in thi country. It is also r€levant to mentiofl out no adverse impact of these producs has been reportid in agriculrure from any country. yh": ,h.y lroauJs, ir any, wirt "oninue'.

Fufther, ceflificlte of regisffation with respect to chlorpyriphos lOyo G was also allowid to be continued for 9(4) regist,r6 bccausc the RC was satisfied with the bieeflicacy "s no "&"tse impad of this formulation in agriculture. 'ln respoct of chlo;yi'phos 50% + Cypcrme$rin 57o EC (Nurelle) fonnuldion, the position of higher loxicity of tlrc fo.-riation over that oI individual suHances of this mbture formulation, unequivocally, made tlrc Regiskation Comminee of CIB to d.cide upon withdrawing certificat€s mder Section 9' sub'section 3 and S€ction 9, sub-s6tion 4 of th€ fodud' .

Ifthat be the case, thcn decision to canccl 9(4) regi$rations for only on€ ofrhe four agro-chemicals, viz inherJnt flaw in the rationale for arriving at this decision. tt is a contradiction in terms rvhen an argument b) is madc out that RC recommcnded csnc"llation of registation of thc 9(3) registrant alone for rnd not o(trnd tbc csrccllation trdrr !o 9(4) ,€gistrants for thes€ products on account of unethical practices by the 9(3) rcgistant, DAS 6nd "rot because it found theses products unsaf€" and th€n to go on to ass€n in thc Show Causc Notic€ olgt 'cancellation of cstificat€ of rcgistration for these poducs is bss€d on adoptim of uncthical pracrices by the registrant which comFomised ass€ssmcnt of safety of the products 8nd ther€by created a likelihod of risk to humens atd animals which cgnnot b€ ignored". lf cvidencr of malpractice had raised douhs on issues of safcty in the minds of the RC, then that apprehension could not have remsined mnfined tojust one product, Chlorplriphos 507o + Cypcrmethrin 5% EC alone but to all thrEe rEmaining Foducts.

The specific rcason givm for car$€llatron of 9(4) rcgistralion of GCL for Chlorpyrihos 5@/o + Cypermahrin 5% EC h thst it k mo]! toxic thsn its constitucnts Chlorpfihos and Cyperm€thdn which was incoNist€nt vith gurdctines fc rcgistraio. A rcvicw of the pcgici& codl.redja 2010 rweelod that LDe value for ca.l toiicity for both micr 8nd rat in case of the cornbination product is lower than that of individual constitu€nts. This signifie{ lh81 thc combinstion product uas morc toxic thaD its solo constitu€nts and hcncs the Foduct could nct have been rcgistcred under the extant guidelines. That this critical ha which was dcety bMrght out in fhe agcnda fc thc RC rncedng was ignored, hes boen cttcd as evi&rc8 of thc extcnt to which decision-making in thc RC had got compromised. CCL howevcr, has vdEmently contestcd this ground for cancelluion citing gui&lincs which rcfer€d nor !o toxicity, but to an assessnent of hazrd of the combinarion vis-a-vis is solo constituents. It was argued that toxicity is one of the constitucnts of hazan4 not hazard per se. Therc are scversl othcr faciors rhat contsibute to the degree of hazard posed by a pesticid€ e.g. expooure, method of handlin& slorage, Iransporration etc. Thercfore, it would bc facile to conclude thu a poduct is more hazardous merely on th€ basis of one parameter viz toxicity, and by ignoring othen u,hich m8y have an €4ually stsong b€aring or hazrd pdential. CIB&RC however, has ass€rted that higher th€ toxicity the great€f, Ote hazard and thercfore toxicity has a direc{ c6nelation with hazard.

The Suidelin€s p€rlaining to Data RequiEflenls for Combination Products specified that for toxicological dsta 'cvidencc in suppon that thc combination is not more hazardou than individual ins€cticid€s should be submitted. For thig the dat8 ar€ need€d both on individual omponens of Oe combinuion Froducts rnd on the final combinaion. For generation of data the annexr!€s prescribed in th€ Gailond€ Commiuee Repon will be followed as may be requircd for the technical or the respective formulations.' From this it may be infentd thu fiamers of the guidelines wer€ lookinE at the totsliry of risk pot€ntial of a Foduct with respect !o humans and environment and that for loxicological asp€cts associated with the hazar4 prolocols of tests prescriM by the Gaitonde Commin€e Repofi shall be followed. While toxicity of I product is carainly an imporunt d€terminant of its risk status, it is not th€ only one. Had it not b€m so, RC whilc framing guidelincs would ccrtainly have sub6titut€d thc t€rm 'hazsrd' with 'toxicity'. It is nc[ contested that lhere are several far more toxic chcmicals which have been rcgistered by RC after laying doun conditions for their usagg packaging, storagc, precautions and safeguards ac. In the inslant cas€, it Ms not been eslsblished thst the combination pesticide is mor€ hazardous,. but only that it is more toxic than its constituent pesricides. GCL has provided a list of morc toxic chemicals on the bosis of LDJo values for acute oral toxicity Rat which have been registered by RC. This claim has not been contadict€d by CIB&RC.

Repon of the committc€ ut|del Dr. T.P. Rajendran clnstituted by the RC to 'Re-review the facts of rcgiso'atioa process in respect of four poducs by M/S. Dc,Nocil Crop Protcction Ltd., fr€sently known as Dow Agro Scicnes lndia Pvt. Ltd, Mumbai, a subsidiary of ivllS. Dow Chemicals Co., U.S.A.' was submiBed to the RC on 20.12.2010. The report concluded that 'inspite of imp€rfect aDd inadequatc availability of vadous files, that the regisbation of these four products in India by M/S De- Nocil...........may havc had the imperfections, in the proc€ss of accelerat€d r€gistrarion of Acetamiprid Technical and Formulation, th€ desired drta requirements in regard to toxicity is not fully met. The Repon furlher go€s on to strte that'with r€gard to Nurelle D formulation there is serious apprehE;sion about the loxicity of the mixture Chlorplriphos and C),permethrin is higher than that of the individual constituents'. Howevcr, what the commi[ee did not evaluate is the implication ofthis higho roxicity on the haz$d potential of the pesticide. Nor was there any evidence thal the Committee had re-looked at thc data to makc an overall cvaluation and assessment of thc product. Rather, it appe{s that th€ Re-r€view Committee look€d at just one sct of dat8 related to LD5o values for oral toxicity Rat and Mice only. Thc Committe€ also failed to make rn overall assessment of other toxicology r€lated data which had also be€n provided to the RC at the time of regisration as per Gaitonde Commitlee R€commendations on Pesticide Toxicology. lt is wonh notin8 that this Comminee did not make any €valuation on how the higher toxicity of the pesticide formulation would impacl on ssfety of the product. This is significant in the light of the faa that thcre arc chcmical3 which hsvc bcen rcgistercd with hiShcr toxicity thsn thc product in question. It is obvious that factors other than loxicity like exposue, storage, handlin& Fecautions, safeguards elc have also been tak€n into account by the RC before agreeing to register more thereby sofety of th€ chemical. A reading of the Act also shows thal it is safety which has been refened to and not toxicity.

It wilt not b€ out ofplace to mentior that the Agenda for t 69th meeting of fi€ RC dated 1741'1997 placed a summary of the evaluation of the pegicide dossier related ro. ChlorPyriphos 5@/o + Cypermethrin 5o/o EC alllsm 6.1. After providing a technicsl synopsis on toxicology of the chemic€I, it concluded that .in view of data submission on various toxicity parameters as per the guidelines of the Registration Committee it is evident that the combination product is more toxic than the individual *.ponerrts i.e. Chlorpyrophos 500 and C)?€rmethrin 50 EC in case of oral toxicity Rat and acute oIal toxicity Mic€. As per the guidelines of the Registration Committee for the regisration of the . combination plIoduct, the evidence is required in support thal the combination is not more hazardous than individual insecticides.' Minutes of the l69th meeting of the RC dated 17-07-1997 r€corded thal the 'agenda was deliberated in detail and th€ committee appmved the same'. Thus agenda notes r,fiile pointing out that the poduct is more toxic than its solo constituents also informed the Committee about ielevant guidelines which refcr to hazard associated with a pesticide being considered for registration. It is also relervanr to note thal in the 277th meeting hcld on 2746-2@'l, RC 'critically evaluated informatior/data in the agenda of the relevant meetings' of the RC on regislrations of and Chlorpyriphos 10% Granules formulation and concluded that 'no information rrith reference to safety and efficacy of this product were overlooked al the time of grart of registration and the applications were complete as per guidelines of the RC in vogue'. CIB&RC has itself ass€Ited that h;ard is a function of both safety and exposue (hazard=oxicity x exposure). This affirms that hazard is directly rclated to toxicity but then by that same logic, hazard is also dirEctly Eoponional to exposure. Thus rationale for justification that hazard is dcpendent only on toxicity is misconstrue4 inaccurate and disingenuous, c) GCL has stared tbat it was not provided an opportunity to rEpresent its case before the Comp€tent Authority decided to cancel certificate of registration grdnted to it for Chlotpyriphos 50olo + Cyp€metfuin 5% EC. This has been argued as a b,reach of well established pdnciple of Datural justice. CIB&RC has held that Competent Authority had issued show cause notice to DAS and ganted it opportunity to answer charges drawn up in the show cause. It has been argued that DAS has availed of the opportunity to represent its side before the Competent Authority and that the latt€r after hearing parti€s and after due examinatior of facls passed an order mmmunicated through DAC notification

S.O. 2353 (E) dated l2.lo-2010. CIB&RC also holds that Comp€tent Authority had nghtly called upon DAS to show cause aDd not to ally other regisbant by viftue ofDAS being an original registrant under s€ction 9(3) ofth€ Ac1" GCL happens to be a 'Me Too' registrant uder section 9(4) and as such reliant on data, generated by the original registrant, DAS.

Section 9(4) provides that 'where an insecticide has been registered on th€ spplication of any person, any other person desiring to import or manufacture the insecticide............shall on applicatioD and on payment of prescribed fee be allotted a registration number and graDted a certificate of registration in rcspect thereof on the same conditions on which the insecticide was originally registered'. CIB&RC h&s argued that it was the DAS dala which formed the basis for grant of registratioD to GCL on an analogous basis. Competent Authority 8fter hearing the original registrant DAS and after taking in to account recommendation ofthe RC and other relevant facts, decided to cancel registration ofChlorpyriphos 50% + Cypemethrin 5% EC becaus€ the process of registation has been shourn to b€ in non-c.oDformity of the norms set by the RC therefore there was no conceivable gtound for affording an oPportunity for being heard !o GCL becaus€ GCL could not have referred to any other data thsn what had been submined by DAS at the time ofregistration.

It has been argued by CIB&RC that being a'Me Too' registrant under se{tion 9(4) ofthe Ac! GCL was not required to gcnerate and submit original data to the RC for registration of Chlorpyriphos 50% + C,?ermethdn 5% EC. GCL has however, contested this claim and stated that the then Suidelines of RC had enjoined applicants for regislration under section 9 (4) of the Act to provide cenain data related to toxicity and that GcL had ensured compliance by submiuing requisite data. Guidelines issued by Secretary RC vide F.No. 8088-F dated 19.10.1993 state that l40h meeting of the RC held on 23.9.1993 require an applicant under section 9(4) to provide ioformation on acute dermal for Rat or Rabbit in Form-l of application. This uas funher clarified vide CIB&RC letter F.No.80E&F dated 3.11.1993 wherein it was mentioned that information on AcutE oral toxicity Rat (LD56) and Acute d€mal roxicity Rat or Rabbit (LD5o) need to be provided in the column "Toxicity ofthe product to human beings, wild life, aquatic animals (adequate roxicological dala concerning the active ingredjent to be enclosed) of d) t Form-l. GCL has claimed that data was generated by them in complianc.e of guidelines and submitled to however, hes been refutcd by GIB&RC oD the grounds that the guidelines rcfer to information and not g€n€ration of original dalA. tn 8ny case the law only allows for registrUion undcr 'same coflditions' for section S(l) t€gist"anS as $e originrl regisssnt under section 9(3). Thereforc, there is no plausible basis for an applicani under s€ction 9(4) to generat ciginal data. The contention of GCL in this regad is not wtrolly iub*antiated on the basis of record plac8d on file that original data on toxicity was Seneratcd and submitted to RC for consideration and therefore merits a separate consideration Th€ show cause Nolic€ has also been assailed on Point of law. GcL ass€rts that cancellstion of regisration by invoking Section 27(2) of O_le Act is misconceived. It has b€en pointed out thar Section ZZ\Z) wtrictr proriacs felt Uosis to ttie Ciiltal Crovemment to cance I rcgistration of an ins€cticide if it is .likeiy to involve suctr rish to humao beingS c onimals as to Elrd€r it €)q€(lient G nec€ssary !o tsk€ immcdiatc action', is a ccollary to section 2?(l) of thc AcL Sectioo 27(t) has been described as an emcrgency provision to prohibit salq disEibulion or use widr immediate effect to obviate any risk !o t uman UeirUS or animals for a period of 60 days initially, extendable furttel by a period of 30 mors davs. Wher;s Section 27(l) provides for an immediale prohibition ifthe situation so warrants, S€ction ,h) of m na ar;s Central Govemment with legal authon'ty to refr.lsc dr cancel regisiratlon.' GCL has argued that sinc.e no eyidence h8s been povided to eslablish that th€re was a situation which rcquired immediafe actioq therefore punitive action under Section 2(2) of the Act lacks leg8l baSiS for aeion. Even if it is pr€sumed thaf integrity of the process of rtgistration *as compomised on account of charges of bribery, neither was r€commendatiu made by the Rc nor did the comp€tent Authority come io any finding that pesticide was so unsafe as to warant 8n imPosition of Pmhibition on sale, distribution and us€ with immediate effect. That a p€riod of two years was granted to companies to dispos€ stocks held by them is proof enough that the product is not hazardous enough to pose immediate 0reat !o human beings or animals. However, this argument has been contested by clB&RC which has argued that rhcr€ may not be a necessary link or conclation between Sections 27( l) and (2) ofthc AcL ln or a legally presffib€d time limit on validity of the prohibitcy older, or areas of activities that 8n old€r unaer !""iio, 27(l) msy impact upon viz. sale, distribution and use. Section 27(2) on lhe other hand provides legal authority to refus€ or cancel registarion of an insecticide and is not ried down in any way with an ord-eI under section 27(l). Therefore the contention made by clB&Rc that no sooner th€ fact of inegular registration of the product in disregard of norms on safety came to ligbt that actiol was taken undir Sectiin 27(2) of the Act is correct, and as such invocation of section 27(2) in the order uas legal and appropriete.

9. After ccreful and cornprehensive evaluation of the evidence and averments made by both resPondents to the Show €ause Notice, Compeknt Aulhority is of the vicw that decision to selectively cancel only certificales of registration granted unier Section 9(4) of the Act for the p€sticide ChlorPlriphos 50% + Cyperm-ethrin 5olo EC foinulation is not sustainable, especiaily when lhe corc cont€ntion behind cancellation of regisuation of four pcsicide dtJ; DA,i is tnat ethicat misdemeanor compromised integrity of registmtion to an extent where safety of the fioducts could no longer bc established The ground cited to justify- seleclive cancellstion of Chlorpyriphos 50',{ + eyp.r-"lhrt" 5% EC-is the dstr which r"u"ated t igha toxicity of the combination product compared to its solo constitueno. Hoo,ever, it has bee[ clearly shown thaf guidelines in vogue at the time of registration rcquired assessroent of hazard and not mer€ly toxicity. Therefore, it h8s not b€en proved beyond all reasonable douh that thcre wEs a violation ofguidelines by nC in granting registsation to GCL under Section 9(4) and as such the product is not srfe to human beinfi and animals. On the other hand, GCL has not been ablc to show that RC required data on some aspects ;ia*i"it;"", from applicans for Section 9(4) regisrants. The exlanl guidelines merely call for toxicity relared information and do not expect generation of data from applicants for registration in conformity uith provision of law under Section 9(4). Thus toxicily related data on the basii of which registration was granted to GCL was tie same that OeS n"a rrUlnlaiO for the registration. SincE this data was not found to be consistent with guidelines therefore as a --Urry to canccllation of relistration granted to DAS, gdcr i€cJi9n 9(3) that gRnted !o GCL was also can-c€lled compctent Authority trad grantea oppon--unity to DAS and the decision to cancel registration was taken 1ft9 f:aring rf," purty. ffrer"fo"i, no fiitth". n".i was found lo give a seParate opportunity for h€aring to GCL. And-fin8lly' th€ .onLrtion put fonh by GCL that canc€llstion of registation under Section 2?(2) of the Act is miscorceived' is not sustainable. As has bein shown above that pow6 to exercise jurisdiction under this Section is not contingent upon, or as a corollary io, Section 27( l). Whereas, cases r,vhere prohibition has already be€n imposcd under Section 27(l) will' if rhc facrs so;ecessitate, invite funher action under Section 27(2), but this does not in any uay preclude oth€I cascs uhere action under Section 27(1) hes not b€en initiated at 8ll' Thercforc, in tlre Frnal analysis, whereas competelt Authority was legally on a sound footing in_inv-oking 27(2) of th€ Ac{ atrd that an opportuility had b€€n affold€d to DAS, and byanalogy to GcL, because it was DAS dali trai *as impugned, yetthe very basis ofthe order dated 12.t0.201I sulTers fiom serious deficiencies- Facts ofthe cas€ have shoun rh-ar registrarion oi the pesticide Chlorpfiphos 50% + Cypermethrin 5olo EC was not in violstion or non- cotrfonnity of loxicity relst€d guidelines and requiremens. Since non-conformity of toxicity deted guidelines was tbe jnstifrc*ion fc thc decision is misconceived and withoul basis. Thus the Order dated 12.10.2011 suffen from e seriors facural infirmity which would rEquir€ c6rEcti6n and slEuld be rcctificd by making nec€ssary amendmcnt in the

10. And now thereforE, in compliance of di.rccioos of $c High Coun of Jrdicattrc 8l Bonbay dated 11.07 2012 in Writ Paition no. 450 of 2012 Ghar& Chcmicals Limited and othen verss lhe Union of Indis ard olhers, and aftt' a crreful examinaioo of rvritlen and oral subrissions end documents filed on behalf of Respondentf GCL and CIB&RC on 24.0t.2012,07.09.2012, 12.10.2012 ard 1t.102012, it is hqeby sdered thu notificstior No. S.O. 2353 datcd 12.10.2011of the Depanment ofAgriq tu€ and Cooperation in the Ministry ofAgriculture published in the Gazcuc of India is amelded only to the exte thal C€rtificale of R€gistration no. E. No. 1374-Fl99 issued in favour of lv{/S Gharda Chemicals Limited under Serrion 9(4) of The Insecticides Act, l96E ftr Chlorpyriphos 50% + Cvoennetbrin 57o EC shall not be cancelled and is restored from tbe dafe of noificrrion in the Gazitrc of India- Thar Ms Ghardi Chemicals Limite{ the Regisration Commitee ard $atr govcrnments sh8[ abide by terms and conditions of the Cdtificate of Registration E. No. 1374-F/99 for Chlorpyiphc 59o + Cyperrnethrin 5% EC in toto. Thal Registration Commitlee is hereby direcred to r€hlrn original copy of the Certificate of Regi*ration for Chlorpyriphos Notification no. 2353 of the D€partment of Agriculturc and Cmperation in the Minisry of Agriculture published in Gazeue of lndia on 12.10.201t shall bc implemented by th€ Rcgist-ation Committee and the state govemments It shall be opgr to Registation Committ€€ !o carry out fresh review of the product Chlorpyriphos 50olo + Cypcrmethrin 5% EC, if it dcems necGsary, under rclevant provisions of the lnsecticides Act 196E, The Insecticides Rulcs l97l and guidelines framed by Registration Committee in exercis€ of powers confened u;nn it by Section 5 of the Act. ffi Printld by fie Mrnaget, Govemment of lDdia PrEs$ RiDg Road, Mayapuri, New Delhi-l10064

Provisions this notification answers to

Read out of the instrument itself: an enabling provision is one it says it was made under, which is the power it rests on. The rest it names without resting on.

Other instruments under the same Act

All of the The Insecticides Act, 1968