Notification, 2011

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.

cft1 T,h,e Gozette of Slndio Rfic {rt ' EXTRAORDNARY

PUBLISHED BY AUTHORITY

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MINISTRY OFAGRICUUIURE

(Ihprftment of^grlculturc rd Coopcrstion)

NOTIFICANON

New Delhi, the lOth Ocrober, 201 I s.o. t39(l).- Wh€reas, a complaint was received that IWs S1.ng .nta Ind.ia Ltd., pune (hcreinafur referred to as SIL) had violated the Insecticides Acl, 1968 i-rereinafter referred to as the Act) by malpractices and misleading activities with regard to imp;;t of an insecticide formulation, namely, Emamectin Benzoate 5% SG (Soluble Granule), in India and the complaint was referred to the Directorate of Plant Protectiorq Quarantine & Storage, Faridabad (hereinafter rtferrcd to as DPPQ&S) for inquiry;

2. And whereas, pursunt to the preliminary inquiry conducted by DPPQ&S, the Regisration Commirtee @ereinafter referred to as RC), a statutory body set up under section 5 of the Act for reg',stration of insecticides, in is 3lqs meeting held on 24 & 27 Jan;ruy, 20ll constiruted a committee to inquire into the matt€r and the committee visited the manufacturing sites of the company located at Goa and Vadodara to verifr all the facts of the entire matter and conducted a detailed inquiry during 27ft February to 3'd March,20l l;

3. And whereas RC found that SIL appeared to have violated provisions of the Act in respect of import of the product Emamectin Benzoate 5% SG and, therefore, the RC called the rcpresentatives of SIL for personal hearing vide decision taken in its 3l8d meeting held on 27.M.20n;

4. And whereas, a personal hearing was given to the representatives of SIL by RC in its 3l9s meeting held on 26.05.2011, and they were asked to clarift the violations made by the company in respect of the product Emamectin Benzoate 5% SG with regard to import of two consignments of the product without valid certificate of registation during July, 2007 from rurapproved source and putting date of repackaging as date of manufactrue on label of the product in t}eir unit located at Coa instead of putting proper date of manufacture of formulation;

5. And whereas, the representatives of SIL informed RC that their application for regisua'ition of the product was considered in ttte 2776 meeting of RC held on 27.06.2007 and approved and upon publication of minutes of 2776 meeting of RC on website of the Cental Insecticides Board & Regisration Committee @ereinafter referred to as CIB&RC) they started the process of import with the hope that Certificate of Registration will be issued to them in due cou:r and acrordingly, SIL imported the poduct vide Bills of Entry datcd July 15 od l7' 2007 without Certificate of Registation in thcir physical possession; finthcr' regrrding import of the marerial from Syngent4 USA iDstead of SYngenta CroP Protection AG, Switzerland (hereinafter refened to as Spgent& SwiEerland), the sourcc aPProved by RC, theY informed thar the conslgnments were fomrulated by Smgentq USA (rr affilinc of Syngenta Switzerlan$ Aon the technical at manufacturcd by Syngenta Switzerland' Thc compony, in its dePositron to materi RC, amcpted its mistake on the issrrc of puning the dare of repacking in India as thc date of manufacture of the Producg

6. And whereas, thc RC formd that the Certificae of Regisradon was acnrally issued by Secretary, CIB&RC ot Zl-Ol iW, ie', after two consignmcnts were imported' and as such i*poiirrg/-.r,of""t*ing an insecticide u,ithout holding a valid certificate of Registration was was made by using trr" ".nii*rc that was isr,red for indigenous manufacture under seclion 9 (3B) for the same formulation in violation of sections 9 and l7(l) (d) of the Act; 1 . And whereas thc RC found t1s glnim of SIL with regard to the source of im-porr legally incorrect when compared *itn m details of the source (syngent4 Switzerland) fumished in Form I submitted earlier by tlle ;r.p*y along wittr their application and finther obsen'ed that SIL did not seek a proper *J"ttt'"" i'ot ttte ttuage of source which is a violation of section t. And whereas the RC noted that SIL accepted is misuke in putting the date of repacking

9. And u'hereas tfre RC was not satisfied with the explanation given by SIL in their support and after deliberations in detail, observed that these actions on the part of SIL, were in violation of section la(l) (a) a Gl ana s;n r7(l) (a), (c), (d) and l7(2) of the Act and Rules Famed

(c) of the Act;

there under;

following violations of the Act were noticed:

(l) Repacking, which is tantamount to manufacturing under the lnsecticides Act' 1968' was done by the company in rniia uguinst th" certificut" of Registration for import of formulation in violation of sections 9 and l7(2)' In several batches of repacling in Cou Unit' tle date of expiry preceded the date of manufacturing in violation of sections l7(l) (a) & (c)'

10. And whereas on funher perusal ofthe complain! the inquiry report and the deliberatiom of RC in Department "f A;:;lt*" Cooperation (hereinafter referred to as DAC) the

(3) Different batch numbers had been given to the repacked batches of the product at two difrerent plants. Ites€ numb€rs werc difierent from the batch numbers (lot numbels) ofthe imported consignment in violation of section l7 (l) (c) & (d).

(4) There wete variations in the label approved by RC and the label actually used by the company in tbat approved label had the categories (i) 'manufacared by'; and (ii) 'imported and marketed by' while the label actually used showed (i) 'manufactured by' and (ii)'tmported and repacked by'. Also the addresses of the factories approv€d for display on the label were not actually displayed in violation of sections l7(l) (a), I l. And whereas DAC issued a notice of even number datcd 15.07.201I to SIL for showing cause within 15 days of receipt of the notice as to uAy the Certificate of Regisuation issued to the company under section 9(3) of the Act for Emamecth B€nzoale 5olo SG sbould not be cancelled by the Central Government in exercise ofpowers under section 27(2) of the Act

12. And whereas SIL requested for extension of time upto two weeks vide their letter dated 03.08.201I and extension oftime upto 17.08.201 I was granted and also the date of hearing fixed on 23.08.201 I by DAC vide letter No. 13033/1712010-PP.I datd 10.08.201 l;

13. And whereas SIL filed a detailed. response dated 18.08.201 I to the show cause notice darcd 15.07.2011 and Shri S.S. Manhas and Shri Bhaskar Chan&an attended the hearing on 23.08.2011 as representati\/es of SIL and made the following substantive submissions made (Dr. B.S. Phogat, Additional Plant Protection Adviser & Secretary, CIB&RC attended the hearing on

(i) That SIL is an agri-business company *ith products in seeds, seed care, crop protection, crop nutrients and yield protection and is part of Syngenta AG, headguartered in Suitzerland. The company was granted provisional registration for import of Emamectin Berzoate technical and indigenous manufacftre of Emamectin Benzoate 5% SG formulation with commercialization vide Certificate of Registration dated 21.07.2O04. Regisration under section 9 is granted by RC only after it is satisfied about public safety of the product. Substantial use of Emamectin Benzoate 5% SG in cotton and vegetables is proof of its benefit to the farmers.

(ii) That power under section 27 ofthe Act can be exercised only in case the i.nsecticide is likely to involve such risks 1o human beings and animals so as to render it expedient or necessary to take immediate aclion. There has been no reported incident in respect of Emamectin Benzoate, however.

(iii) That ,mder section 27(2)' zuch Powa can be exercised only in cesc of a substaoce coBlng undcr section 3(c[iii) of the Act Fmamectin B€nzoate is not a subtaoce comrng rmder s.c'tion 3(e[fii) md as stch tbe Certificate of Registration issued to the CompanY c€nnot be cancelled under scction 27(2)' Government onlY on grormd

(iv) Th81 acuon rmder section 27Q) canb. talcen by Central of public safetY and after consrlution with the RC' The sbow cause notice does not raise anY concerns relating to public safetY. The findings of RC do not make ouit a case of risk to human beings or animals. Further, the notrce as well as minutes dated 26.05.201I do not reveal anY consultation of Central Government with Registration Committee. Even if Central Government has considered RC's report there ls no rn mention of public safetY element in such report/minutes and therefore' the notice question is not meintainable and is illegaVarbitrarY.

of investigation. s*t*iiizJ r,* no agplication \,r/here 27(I) does not apply. As the iDstant cas€ is not under-section 27(t), it is ouSide the purview of section27 (2)'

(vi) That with regard to the allegation of import of Emamectin Benzoate 5% SG without valid certificate or n.girt urtion, it is stated that rwo consignmens were imporred on 16.07 .2007 ana f Z'OziOOZ only after the decision of RC taken in its 277s meeting on27.06.2007 t'a U"i"* i"J of Certificate of Rrgistration on 24 07 2007 as the product \ryas in high d;J-i *"' to be used in themonths July/August 2007' No unauthorized *ptn ;;;; pJ"t toott place prior to decision of RC Imponed *a '*t to market only after 24 Oi '2007 ' i'e ' issuance of registration by RC and which would' in any event' relate back to the date uhen the insecticide was registered bY RC'

(vii) That u'ith regard ro the allegation of..'"I-ltt:,' different source' i1 is stated that while SIL had appried foi registration menlioning Syngenta. Swiuerrand as the manufacturer in roil i-of lf't application' in Certificate "l 24-07.2007 * '**"t "t trn*n' was stipulated' The tvvo consignments in questron were formulated by Syngenta' USA from tttlnlt^ul grade material manufacrured b1 'tt *"t ontv in April 2009 that the source of import u as mentioned u' S-'ngtn'-a' So'it"'t-i on Certificate of Registration and thereatler all imports have u"tn rn"i"-in compliance of this condition Thcrefore' no mistake or violation of the Act is admitted'

(viii) That tltough it has been alleged that reRacling is tanlamount 1o manufacturing' SI[- has only repacked ;;il; irnponti in bulk as per its application for rcgistration 2.4 THE GAZETTE OF INDIA : EXTRAORDNARY IP.rnr ll-Src.3(ir)] and in terms of Certificate of Registration dated.24.07.2007 highlighting packaging details.

(ix) That with reg:ud to the allegation that in repacking in Goa unit ofSIL date of expiry preceded date of manufacture, it is admitted that practice ofputting date ofrepacking as date of manufacture did occur at Goa unit inadvertently and was corrected. Since August 2008, there has been no repacking/manufacturing activity with respect to the product in Goa unit. There was no irregularity at Vadodara unit. As the shelf life of the product is two years and as the product is popular, there would not have been a single instance where the product actually violated provisions of the Act.

(x) That as regards the allegation of giving different batch numbers to repacked batches of the produc! it is clarified that while exporting the product into India a reference batch number was put on t}re consignments and on repacking in lndia local batch number was mentioned to differentiate the repacking activities carried out at different units and this is not a violation of anv law.

(xi) That with regard to allegation of variations in label approved by RC [(i) 'manufactured by'; and (ii)'Imported and marketed by'] and label actually used by S[ [(i) 'manufactured by; and (ii) 'Imported and repacked by'], it is pointed out that Govemments of Gujarat and Goa had raised objections to the said labels [wherein SIL had mentioned (i) 'manufactured by; and (ii) 'Imported and repacked by'l whereupon SIL requested RC on 20.03.2009 to allow a comprehensive statement on label ['Imported repacked and marketed by'] and afler having come to know of RC's refusal of the request on 01.09.2009 SIL informed RC that it would follow label as approved by RC and has been following the same. Thus there is no violation of section 17.

(xii) No submission was made by SIL on the issue of not displaying addresses of the factories approved for display in violation of sections l7(l) (a), (c) and (d). Representatives of SIL staled that they would supply information after the hearing.

(xiii) That there are severa.l companies who are importing/manufacturing Emamectin Benzoate, but action is sought to be taken only against SIL.

(xiv) That invocation of section 14, which deals with licensing and not registration, is vitiated in law. For any alleged violation of section l4 and section 17, remedy is not under section 27(2).

t unintentional withour mala xv) That alleged violations are 8t best technical in nature and fide and therefore' action under scctton 27(2) cannot b€ taken against SIL(

(xvi) That allegations in question relate to a period *":#,3nff":i:tffitffT*:|; \^tr'' r"i"t it delayed action' Moreover' pti"'T*oL':t,it*;;;;;''s Crystal

(xvii) That due pocess of law has not b€€n followetl in that persons authorized' to take Antlvstl' t'a* iot tak"n the action' but gone into alleged violations and come out *,,hi"'Jto report/direction as per law' of Agriculture to uxt io, "ltion rurder section 27(2)' ional

(xix) rhat even if there has been a vioration'*'Y''-tl:Tl;;:l it-:;1]ll;;"1"1,"' '" and therefore' the proposed action of cancelling ( f.oportion to alleged violations' (xx ) beneficial for farmers: there are no public tllU;;;;

of commission/omission.

if anv' is *n"1".T-T:;J.r,La turther. notice under rherefore. SIL has not violared provisio"t "l.i:",:.";;in.r.*.. the notice mav be rturins the hearing held * following observations point-urse:

(i,fi Benzoare 5% SG is nor in dispute he: Y"l :":;';;.ther such commissions of commission anJ omissrrn alleged.on ry"1'# 10.0".,. hasis to conclude that and omtssions' in isolati'in c'r'r'ie\\ed "ogelher 3780 Gl/11---4 26 THE GAZETTE OF INDIA: EXTRAORDTNARY [Panr II-Src 3( ii)] (ii) SIL may have compromised safety aspects of the product to the extent which w rants action by Central Govemment under section 27.

Section 27 has two clauses reproduced below:

(1) If, on receipt { a repor! under section 26 or otheruise, the Centrol Government or lhe Stale Government is ofopinion. for reasons lo be recorded in u,riting, that use of any insecticide specified in clause (e) ofsection 3 or an1, speciJic balch thereofis likely to involve such risk to human beinls or animals as lo render il expedienl or necessary to take immediate action then that Governmenl may, by notificalion in the O/ficial Gazette, prohibit' the sale, distribution or use of the insecticide or batch, in such area, to such exlent and for such piriod (not exceeding sixly day, as may be specified in rhe noli./icalion pending investigalion inlo the ma er:

Prot'icied that vhere the inrestigation is not completed vithin the said perktri. the Central Goyernment or the Slate Gayernment. as the case mo); be, mo.r ex.lend il by such.further period or periods not exteeding thirty days in the oggrcgate as it may speclly in o like manner.

(21 I[. as o result of its ov n inw..stigction or on receipl rf the report -{rom the Stut? Goternment, and a.fter ccnsullation vith the Registration Commillte. the Central Goternment is sa[is.fied that the use o/ tlie said insecticide or barch ,: or it not likeh to (ause an) such risk. it mc) i,as! suth order fincludir,g ttn order reJusing to regi.gtLr the insectrcide i,r tantelling the rtrtiricate of regislration. rf any, granted in rcspect therec,.f1. as it deems lir. dcpending, on lhe circumstonces of the case.

This ciause provides for invtstigation' a;ltd 'totisultation vith XC' for delermir,;r,g uhether an insecticide 'is or is nol liluly to cause irsk to human beings and aninia,ls and passing of such order by the Central Govemment 'as il deems ./il, depending on thc cir(umstonces of the case'. It is imponant to rinderline that it is nol onl)* the basic technical ingredients of rhe insecticide but also rhe marurer in uhich the insecticide is manufaclured. packed.i repacked, transponed, sold and disposed of ''rhich determines its safety. Thus absence ofa report under section 26, uhich relares to insecrjcjde poisoning. does not bar action under clause (2) of section 27. Prcrceedir,gs undcr clause (2) of section 2'7 can be initiated if on rhe bas;s of ;r:r esl.ip;rlion or repon there is Iikelihooci ofrisk. lhe exrenl of likelihood of r;sI: r,r abst,nce cf it u ill be detern;:reJ bv lhe Cei-rtral Gcvernment as a res'...:lt of cri"r in'rcstication or on receipt of report fronr State Gcvemment and afier consulkticn .,.r. R( Furtrel ,( L entra! Gcr.err"'i,er.. uill pass suer o:der as it deernr fit oepending on the orrc'rnstances of the case.

(iii) Section 3(e) defines insecticides and is rcproduced below:

(i) any substance specified in the Schedule; or

(ii) such other substonce (including fungicides and insecticides) as the Central Government may, after consullotion v'ith the Board, by notifrcation in the OfJlcial Gazcrre . include in the Schedule from time to time; ot

(iii) any- pre paration contaming an)) one or more of such substances,' During the hearing representatives of SIL provided the follou,ing inlerpretation of section 3(e): 'Once a substance is specifed in the Schcdule as contemplated under S. 3(e)(i), then there is no pov,er for cancelling the registration certificate issued in respect of the same sbslance elen if on sciefiific study, it appedrs thal the substance in question is grossly detrimental to.the htman health. This is a lacuno in the legislatictn itse$ and therefore, steps should be taken for appropriate amerulment to rhe legislarion: Dr. Ashok r,. Union of India A.l.R. 1997. ' Further: 'The pov,cr of ,,.ancellation of certi.ficate of registation conferred upon th( Cental Got'crnment under sub-S.(2) o/ S. 27 can be exercised only in respect of ary ia5sg1iti4. speLified in sub-Cl.(iii) of Cl (e) of 5.3, i.e,, a preparation or formularion of one or more suhstonces specified in the Schedule but the said power cannot be ixercised in respect of an insecticide which is specified in the Schedule itself by the Porliament. Thus, in respect of Benzene Hexachloride vhich is one of the substances specified in the Schedule and as such is an insecticide v ithin the meaning of S.j(e1fi), rhere is no pouer u'ilh the Central Governmenl under sub-S.(2) of S. 27 to canccl the cerrifcole o.[ registration: Dr. Ashokv. L'nion of lndia A.l.R. 1997.' The answer 1o issue raised b1 representatives of SIL is available in the same judgment of Hon'ble Supreme Coun relevanl extract of u'hich is reproduced hereafter: 'The Scheme of sub-section (l) and sub-section (2) of section 27 is lhal in respect of a .formulation vhich is also an insecticide u'ithin the meaning of section 3 klftii) the Cen.tral Governmcfi for reasons lo be recorded in v'riting and pending intesligarion into the marler can imme dialell' prohibit sale, di,stribution or use und after -further investigation can cancel rhe ('ertificate o.f Registation in respecl thercqf uruler sub- section (2) oJ section 27. That being the Position in exercise of suth powcr uttder sub- seclion (2) of section 27 a certificale of Registralion in re:;Pecl t,.f dn insecticide under sttb-seclion 3(e)(il cannot be cancelled under sub-seclion (21 ,tf rccrion 21 This is also in consonunce vith the logic that an insecticide uhich i-' tht.iinmui:;ti"n qf un-v one or more of the subslances specified in the schedule an,l is citn:itnt," 2E oriented Power ofcancellation of rcgistration certainly lus becn conler?cd ugm tfu Central Governmcnt bul in resPecl ol an insecticide which does ,tol co"E rc a consumet ard is a substance specified in thz schadule itselt ard tlvreforc an insecticide ut&r section' 3(e)(i), tln pwer han not been confened upn tle Central Government since the sPecitled sttbstarce in thc schedule has been spccified by the Parliament itself,, In view of the $oiesald cottcluslon ol ws we vould lpld tlut rhose of the Certifcates ol Registralion granled to the Petilionet in respect of any lorm ulations rumely BHC I f/6 VP, tle order of the Central Government cancelling Certificate of Registration is vell within the jurisdiction and there is ra legal inJirmity in the same. But in resrycl of Beruene Hexoe&oride which is orc of the substance s specified in the schedule and as such is an iwecticide within the meaing of seition 3 (e)(i) rhere is no power with the Central Governm,, ttt wtder sub' section

(2) of section 27 to cance! rhe Cerrificate of Registation The chernical molecule, which is the active ingredient baving ;:sccticidal proPerty, is included in the Schedule to the Act. In concentraled form, suc': hemjcal substance is called 'technical msterial'' Preparations (or forrr''ulations) of ' .ious Linds are made with the technical material of active ingredient to render it sti',abi( lcr pest control by adding inert substances such as clays and solvents to 'mprove application .ff""tiu.ner., safety, handling, and storage' 'Technical' and 'fi'rnulation" including formulations containing various active ingredients, are registered by RC under the Act under section 9. In the instant case, Emamectin-benzoate [4 "-epimethylamino- 4" deoxyavermectin B' benzoate (A mixnue of min' 90% of 4"-deoxy-aver-mectin B substance inctuded in rhe Schedule to the Act, Emamectin Benmate is the technical material and Emamectin Benzoate 5% SG is the formulation registered by RC The (Emamectin Benzoate 5% SG) which goes to the consumer and not the technical (E.urn..tin Benzoate). Therefore, it is disingenuous for SIL to claim that Emamectin Benzoate 5% SG, a preparation made out of Emamectin Benzoate Schedule. does not fall under the purview of section 3(eXiii)' It may be added that at the tirne the Act was passed by the Parliament there weie few substances included in the Schedule to the Act' Over the years' by virtue of powers conferred upon Central Government vide sub-clause (ii) of clause (e) of section 3' many substances, including Emameclin Benzoate have been added to the Schedule' It is also noteworthy that Benzene Hexachloride is an old substance which was in the Supreme Court refer to substances included in the Schedule in the Act as passed by (iv) nt an<i not to thcse substances ui:ir'h have beeo 'i!']'|uoei aheni arc: r" the Parllame Cental Govsmment within the ambit of Powers conferred uPon it lide sectlttt' 3(eXii). Be thst as it rlsy' the issue under consideration is whether Central Government has the Powcr to cancel Certificate of Reglstration in respect of a prcpuation or formulation' iDpluding Emamectin Benzoate 5% SG, within the ambit of section 27(2), rnd the ans*er, following fro above, is in affirmative'm It would also bc relevant to add that the exprcssion 'sub'-cl'ause (inl o/ was de'leted from ttre phrase 'use "1"';;;n;';;litino * sub''ct'ause (iii) of ctause (e ) of secrion 3 ' ilr clsusc tf I of '"ciJli uiat ttt t**a-ent in the year 2000' The Central Govemment directed tre Plaot Protection Adviser (PPA) heading the part of sll in import E ;;;-i;*-5olo' coo'rn** on the mstter were orovided by PPA in F"bnr"y;;' -fn tit* o-f 'confuine atlegations' matter was refened to PPA acain t" M#;;; rJ' uto""a inquirv' iu'as reported bv PPA in ewsive reply lo the quenes tn tn: "u':::,vr i-^,.-' ,", submined the requtsirc _u.e olri. "Tne obave mentioned "Xtll, ***" crs&nc' on 306 iulv' 2010 inter t rec'ltrds '{ terms of penal provisiors'Jtt";;" it;reaftert Rc deci'led in 'Ianriar)' 201i to constitute a committee '"- tn""t into the matter' T'liis cornniflee r isited rhe erifi all the fac"s of ii'e resurtsof thisin*oigu,i",i"*l,ii*:;;.i::l:j":T:,1"#,5i^i,lillilli;l have violated the provtsrons c'r" '* represenhrives :t-t].1:trl;r'ffi; -a *n.tua"a that actions t'f SIL uere .in satisfied bY exPlanatton I violation of section 'o *i'ii "i *t ot'. on frrther perusal of the complaint' :hc inquiry report tr'o *t atil*"'*-"r Ri ln oac' the shou'cause notice \\as )5s"rcd whrclr- when riewed in isolation or togerher, may have had the effect of serio,.rsly compromising the safety aspect of the product. It is not only the basic technica.l ingrediens of the insecticide but also the manner in which the insecticide is mmufachre4 packe.d/repacked tramporte4 sold and disposed of which determines its safety. There hai,e been instances where Certificates of Regisfation of those manufacturers of insecticides who did nol possess adeguate facilities for manufacture of such insecticides as per guidelines of RC uere canceiled in exercise of pou,ers under section 27(2).

(v) It is not necessary that process under clause (l) of section 27 of the Act precede process under clause (2). Clause (l) provides for imhediaie action to prohibir the sale, disribution or use of the insecticide if circumstances so warant in terms of Iikely risk to humEtl beings and anirnals. There may be, aDd iode€d are, situations where based on specific inquiry or a technical review based on fresh scientilic information, it is decided to ban or restrict an insecticide. In such cases, immediate action under clause (i) does nol uke place. but reieva:il and appropnare acuon ma) be taken under clause (2). Several insecticides stand banned or re,stricted in India on the basis of orders issued ',urder section 27(2) afier fulfilting the requirements under clau-se (2) u,ithout frrst resorting to imrnediare action under clause it1. Ttie jnsra-',r case is an example of a case uhere the complaint u'as received b1, Cenral Govemment. investigation carried out RC consuited and notice issued under secrion (..i) Undisputed facts are that case of SIL for regiscatiorr for impon of Erna-mectin Benzoate 59'o SG u'as approved by RC on 27 .06.2007 , aird rw.-o consi6::ments of the product werr imported by SlL. on 16.07.2011 and 't7.07.2007 u'hile Clertificate of Regisu'arion u,as issuol on21.07.2N7. Thus rhe impons of ru,o consignments rook place af,er approval of RC but before issue of Cedficate of Registration. While SIL could have initiated preparations for import of the product after its approval by RC at its or+n rislq the actual import should not have been made before issue of Cenificate of Registration as this is the document which describes product characteristics and is pr€seoted to Customs authorities for allouing import. Instead, as the inquiry report has brought ou! imports were made againsl provisional registration under section 9(3B) issued to SIL 21.07.2004 u,ith validity of trt o years. Thus imporl u,as made agahst in\alid Certificate of Registration. In the hearing representatives af SIL explained that import of the pioduct u,as' expedited because of seasonal demand, but expressed ignorance on iniport of tu'o consigr,rnents against invalid doc'.rments stating that employees resp<;nsible for impon \\'ere no longer in the company. This ,- ,i S,r (r'ii) does not absolve SIL from lapse of imports against invalid Certificate of Registration and violating section l7(d) in the process.

With regard to the allegation of import from a different source, SIL has s"ated that it did not violate the 'Act as (a) in Certificate of Registration daled 24.A7 2007 no 'source of import' was stipulated; and @) the two consignments in queslion were formulated by Syngenta USA from technical grade material manufactured by Syngenta, Switzerland, the latter being the approved source. In this regard, APPA & Secretary CIB&RC submitted thal RC has a procedure for approving registration for import of insecticides from specified source(s). It is observed that the procedure is based on the fact that a technical grade material of a pesticide is manufactured from its raw materials by adopting a methotl oT iynthesis ThE technical grade pesticide is then mixed in certain proportion with inert substances such as clays or solvents and adjuvants'lo improve application effectiveness. safet,v' handling, and storage. Every chemical compound, including a pesticide, has several methods (routes) cf syrthesis' *'hich give different purilv and associated irr^p'.rities in the final product ln certain cases. the impurities can be different. in narure or quantit)', if the process of syrrbesis has not been efficientll performed. Fur'.her. '.he formulation is prepared using rau' materials - diluents and adjuvants. The active ingredient in the synthesized product used in manufacturing a formulation is responsible for toxicitv to the target pesl (bic- efficacy) while impurities present in such fomrularion coming from the s1'rrthesized technical product as well as the raw materials used for manufacturing its formulation may be responsible fcrr adverse effects ttoxicitl I of a pesricide in hurr,ans, animals and the environment. Thus, a pesticide, tech,'iical or formulation. mar-1 ufactured b1 different manufacturers or a1 different places (sou:ces) ma)r have differer,t chemical due to use of raw rnaterials obtained fiom <iifllerent sources for marufacture of technical as well as formulation. Therefore. the source of import is of utmost importance. If a pesticide is imported ficm a different manufacturel or place of manufacture or pesticide manufactured using d ilferent raw materials. it shall have different set of technical dara, uhen generated usirig that material. The technical dala submitted by the registrant at the time of registration for the material from one source may not hold good for another source or place or raw'materials. Due to this reason. the Registration committee requires submission of technical data from each source source to ensure its efficacy and safety. Given the fact that S{L kneu that it had applied for registration *ith Slngenta Su'itzerla;:d as the manufacrurer and the certificate of Registration $'as issued al1er inipons lock place, it is disingenuous cn pa,t of SIL to claim that source of ir."p:rt u,as no1 mentioned on Ce(ificate of Registration. Further- ri'hile source cf iir',p.rn u'as not menlioncd on the firsl page cf THE g^ZET-TE OF INDIA; EXTMONDNARY [Panr II-Sec. 3(ii)l i2 (r'iii) certificate of Regisuation (it was added llfior on 23.04.2009 by secr€t8ry cIBlft'RC a1 the request oi Slt y, it is a fact tt't Syngenta, Switzerland was mentioned as manufacturer in label/leaflet wluch forms part of certiEcate of Registation In view of RC's specification of source for import and the importance of the souce not only for maintaining characteristics of technical but also for formulation, it is difficult to accept SIL's claim that as technical material was sourced from approved source (Syngent4 Switzerland), manufacture of formulation by Syngenta' USA did not violate the Act. Thus, import of two consignments from Syngenta, USA was not only in violation of section l7(c) of the Act but also created likelihood of material alterations in efiicacy and safety of the product thereby posrng risk to human and a-nimal health and the environment.

repacking is tantamount to manufacturing, SIL stated that it had oniy repacked the p^dr.t impon.d in bulk as per irs application for registration and ir ''erms of cenrficare cf Eegistration datec 24.07.2007. 1'rt certificate of Registration specifies r* o rypes of pack-ing - (i) import for bulk in po\'ethylene bag/liner f.rther insene<i jn fiber board <irun of 55 kgs': and tii) I-IDPF' conuiner of suitable dimensic,ns and altematell, wSP pouches fierther packed in triJaminated pouches of 10g. 50g. i 00g. 2509, 5009 1 kg and 5kg' A ciarificarion on this matier was issued to Djr'eclorate o{' Agicuiture. Cou t'y S"ttt'ul1'' CIB&RC on 22^d April' 2009' SII- r iolaieC 'Jiese condjlions bv repacking the product in lndia' SIL adrritted thar practice cf p;rlr'g clale of repackirrg as date of ma-rufacture did occur at Goa unit. but jt clairr,ed that it rl'as inadi enent. unintentional and v'as co,-,.ecled. SIL also claime,j that as the producl is poruiar. there u'ould not have been of na1ufa..:r.:re r-,n product js cnricai as expiry js aher an appror ed fixed period' ie shelf life. (in thjs case - 2 ;'ears) reckoned iii'n' ''he date cf r'''anufacture' \4a:rufaciure took pJace earlier in Si'rgenta' USA cut date of repacking ialer in Goa u,as recorded as dare of manufacture. This lapse c:"eated rhe iikelihood of product violateJ secticll 1 7(a) and (c) of ihe .{ct ard alsc crealei rhe likeiihood of the product becorning unsale for use durirg jis si;elf life as irtdlca;ed 'r the label' SIL srated ihat v-'hile exportir,g the Frcducl intc lr:cia a re{erence baich rrumber u'as iix) ( )j-,r put on the consignments and on repacking in India local batch number was mentiotred to differentide the repacking activities caried out at differcnt units and this is not a violation of any law. Drring tbe hearing representatives of SIL were asked their views to describ€ the indusry/company practice- ln a subscquent submission on 27.08.201 I by SIL, it was stated that " SIL follows a standod Practice for allocation of buch mmber to its imported formulation bulk Normolly an imported butk batch nwy be stored and rewked al differcnt dates based on lhe markct requirement qnd operarional activities, hence allocation of dffirent batch numbers to particular imported bulk product are provided. To track it back lo original imporred bulk moterial batcfu proper slock regkter vith all the deloils and records of original and revised balch numbers are maiwained at factory site. This is a standard .practice that has been adopted acloss crop prolection industry for repacfing anl granting lhe revised batch numbers lor ease of tracHng through proper record ond stock iegisten." In this regard, it is observed tlat section 27 refers to 'batch'. The batch number identifies the material produced as result of one operation. It has a certair, date of manufacture as uell as of exp[r-' It is given ar the time of manufacture and before packhg. The same number remains on the prduct throughout its life. A batch can be sub-divided but the batch number cannot be changed. As per nrle 19(lxvi) ofthe Insecticides Rules, 1971, batcb number must be mentioned on the label. As per rule 17(2\, '.Before putting any insecticide into the primary package, every batch thereof slatt be analysed as per lhe relevont specificatiors of the manufacture thereof, in accordance with lhe approwd methods of analysis and the resulr of such an analysis shall be recorfud in lhe register sample of pesticide is collected by Insecticide Inspector and sent for analysis for quality control. If there are issues with regard to a product's compliance u'ith irovisions of, the Act and the Rules, it has implications for entire batch. The lnsecticide Inspector, under sub-clause (d) of clause(l) of section 2l of the Act has the power ,,tu srop the disiibution, sale or use of an insecticifu which he has reason to ielieve is being disyibuted, sold or used in confiavenlion of the provisions of the Acl or the rules made thereunder, for a specified period not exceeding thiily days' or unless the alleged contravention is such lhat the defect may be removed by the possessor of the insecticide, seize the stock of such insecticide'" Such 'reason to believe, could be arrived at with reference to a sample draun from a particular batch. Unlessthemarketedproductmanufacturedinasinglebatchbearsthesamebatch ,r'r-^ -r-- +L-. L-r^h -,,alrar rwr.c chanserl to differentiate packing units is not tenable as such differeotiation should be achieved in terms of Rule l9(1[i) which provides that on the tabel of the insecticide tnter aliothe followiag shall be printed or written: " Name of manufactwer (if the manufacturer is not the Wrson in whose name the insecticide is rcgistered under the Act, the relationship between the prson in vthose name lhe insecticide has been registered snd lhc person wla manufactures, packs or disrributes or sells shall be sloteQ. " As per the International Code of Conduct on Distribution and Use oi Pesticides - Guidelines on Quality confol of Pesticides (20f 1) brought out by WHOffAO, the irdustry 'should use labels that identify each lot or batch of the product in numbers and letters that cqn be understood without the need for additional code references and labels should clearly show the release date (mottth ond yew) of thc lot or batch and contain relevant informaiiu'i aii slgr4ge stability of prodact. ' In view of this position, giving different batch numbers to repacked batches of rhe product by SIL was not proper and created likelihood of product of ldefective batch contiruing to be sold even if the Insedigiqe Inspector had reason to believe that the batch contravened provisions of the Act. To that exten! giving different balch numbers created a likelihood of an ursafe product continuing to be sold in the market.

(xi) [n regard to variations in label approved by RC and label actually used by SIL. the explanation of SIL indhectly admits that variations took place and gives a convoluted explanation which does not absolve the company of varying the label and thus rendering the product liable as 'misbranded' in terms of section 3(kxi) & (iv) and in violation of section 17(1)(a) of the Act'

(xii) when shown photographs of labels of SIL's product submitted by complainant which showed that addresses of the factories approved by RC were not displayed on label in violation of sections 17(1) (a), (c) and (d), representatives of SIL stated that tbey would supply information. ln a subsequent submission on 27.08.2011 by SIL, it was stated that the certificare of Registration issued to slL on 24.07 .2007 had the factory addresses on it, but the approved label and leaIlet provided by registration authority did not have factory address on them. Therefore, SIL was printing label and leaflet with registered ofEce address of SIL without mentioning factory address on the label. Later, in 303'd meeting of RC held on 05.08.2009, Iabel expansion of SIL for more crops was approved. The revised label and leaflets with addition of these crops also had factory address endorsed on the label and leaflet and were granted to SIL on 20.10.2009. It was claimed fiat sIL has been printinc label and leaflet with factory addresses as approved by RC since. It was also stated that as this allegation was made by IWs crystal Phosphate vide their letter dated 29.12.2008, the annexure showing label without factory address relates to the period prior to 20'10'20019- Thicc obser';ations need to be made on this issue' First, the Certificate of Registation including the label and the leaflet is prepared by Secretariat of CIB&RC on the basis of the material submitted by the registrant. Second, the Certificate of J i I RcdsEdim idudcs re fOef dd tbe leaflet and the uihole document has to b€ consider€d in its €iltircty' and mt in Psrts! in terms of comPliance with the Acr and 6c Rules. Ttird' o cilun€rded in srbparagPPh (x) above of this Psagtraph" Rule le(1xi) makes it mandarory that relationshiP betwc€n packer, manufacM€r ard rcgistraot is brouglt orn on thc lah€l' There is m escaPe from mentioning the factry addrEss utherc Foduct ls packed It is also noteworthY that hbel and leallA were lerlfucd itr Octobd 2OO9 incorporattng factorY addrtss aftcr the complaint ,nas maae w ivils CrYstat PhosPbates Ltd- While omission of factory addr€ss in label and hafla sr4Plied to SIL with C€rtificde of Registradon in JulY 2007 is a mitigating circunstltlc€r rt is not srfrcient to ab6olve SIL of violating P(ovrsror of RuIe

(xiv) Viotrnion of p'ovisions of the Act' tnclud'ns' :moi:#,ffi"uiTg,ffi(ruY' ,tili"* rilder section 27(2) if the nature ol vror of Pcstici& into quesEolt" uniL altering batch numoers on dare of Eanu,i*hr€ on tbe prodrrt in- SIL's Y"H:J;;f*r factorv ad'lress ssf€ty csDnot be termed as 'technical- in nalure ^ne were to acc€pt tlat-lapses. rvefe T iil}l;* iack of attention to .,intEotioo.l "" "rri-a to huoall beitrgp or aoinab or the enviromcu:

rmder sectio 27@' I oo @F nmrtrctrriry sitca of the compey !o vEriry a[ fu frcts of ttc cntir Eef ed fu conductitrg a detailed inquiry. souce of complaint aad Eodvrtffi bchtfit it ir not a rclevant consideration.

(xvii) Due process of law has f6s1 followed by conducting F,elinirury inqdry folleurcd by detailed investigation, consideration of the macet by Re md examimtion of all issues by DAC. The inqu,y team consdtutod as per docision of Re in iB 3146 Director (wecd Science) and bad Ms. Kanlesh Miglodii Ausinatu Director (chemistry) as a member. Both of tbegc officei.s havc been notitred as lnsecticide lqryEptor uqder ssjiqn 20 of the Ast vide gazettc mtifdot c-s-R- x(E) dared

(xviii) Findings of RC and subsequenr examitrstion in DAc, by raising scrious concems regarding efficacy and safety of the podtrct res'lting aom multiple violations in process of manufacture, imporq affixing date of manufachur atrd batch irumber and not displaying address of factory on the laber, provide edeqruE basis for goceedings under section 27(2). T',trc,€ proceedingo nE EDarat€ fiob, aod in addition to, action that is warranted on part of conc€med State oovernment for vioration of other provisions of the Act.

(xix) In the certificate of registation issued to sIL br imporq the firs condition stipuldes thx "the registration is subject to srricr compliance qf various povisions of tre Insecricides Acl, 1968 os amended {rom aimo to time and rures, bye-ravs franed ond notilications issued thereunder and as amended from iime to tirrre." viorations of various provisions of the Act, in isolation and also in their entirety, read to the conclusion that sIL could not have, in arr reasonableness, ensured mfety of the product in the market and consequently crcated likelihood of risk to human beings, animals and the envimnment particuiarly due ro scrious eircrs in so.rcing the product, display of date of manufacture and display of batch number as far as two co[lignments in question are coneerned. fho intent of the legislation to focus on sqfety as the pararnourrt c{irtideiation is cleai as biowht out in the pneamble to the Act: "An Act to rcgulate the import, manufacture, sale, transporl, distribution and tse of ircecticides with a view ro prevent risk to human beings or aninbrs, and for wllers connected therewith. " Therefote, while the material may no longer exist in the market and also keeping in view submissions made by SIL inclirding submission as $ated in sub-paragraph (xx) of preceding paragraph, it would not serve the ends of justice to not hold SIL accountable for these grave lapses.

15. ma mrv, therefsc, hadng codidercd the reply dated lt.0E'2011 filed by t'l/s Spgenta lndia l,td. m rEsponse to the notice dated 15.07'2011' submissions made drring the hearing on Certificae of Regisuation issued to lvt/s Syngenta India Ltd. for import of Emamectin Betrzoate 5% SG is wlled- Horrever the comPonY will be dlowed to disPose of srrch stocks of Fql,lrl€c.titr BfDmtc 5olo SG as it may have in the country in accordance with provisions of the

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