Pesticide Regulation in Europe - ACS Symposium Series (ACS

33 Pesticide Regulation in Europe PETER DUBACH

Downloaded by NATL UNIV OF SINGAPORE on May 5, 2018 | https://pubs.acs.org Publication Date: August 10, 1981 | doi: 10.1021/bk-1981-0160.ch033

CIBA-GEIGY Limited, Basel, Switzerland

In the last decade many countries throughout the world have changed their relevant laws and regulations and, to be on the safe side, they have made the list of requirements an exhaustive one. This has happened also in Europe and requirements thus have become rather uniform today. While in daily practice an applicant still has a hard life to cope with the numerous country-specific different details of study protocols and in the preparing, launching and following up of an application for registering a product, I certainly would bore you if I tried to instruct you here on details. Although I have thus to stick to rather general terms, I do hope that some selected remarks on aspects of European Registration Requirements, on European Registration Policies and Procedures, and on Activities of the European Economic Community will find your interest. These recapitulative remarks are of course shaped by my eight years of industry experience in registration and contain some very personal opinions. European R e g i s t r a t i o n

Requirements

As i n d i c a t e d b r i e f l y i n t h e i n t r o d u c t i o n , r e q u i r e m e n t s i n E u r o p e t o d a y do n o t d i f f e r b a s i c a l l y f r o m t h o s e i n t h e U.S. o r elsewhere. Harmonizing e f f o r t s and s c i e n t i f i c and p o l i t i c a l e n v i r o n m e n t p r o t e c t i o n a c t i v i t i e s have l e d t o a s o r t o f m a x i mum r e q u i r e m e n t c h e c k l i s t s i n n e a r l y a l l c o u n t r i e s . O f t e n t h e r e q u i r e m e n t s a r e l i s t e d on a form which has t o be f i l l e d i n upon a p p l i c a t i o n . A l l i n a l l , t h e s e c h e c k l i s t s h a v e b e e n a p p l i e d so f a r r a t h e r r e a s o n a b l y i n Europe, i . e . t h e y a r e u s e d b y t h e a u t h o r i t i e s t o c h e c k t h a t no t e s t i n g a s p e c t i s o v e r l o o k e d w h i l e a c c e p t i n g v a l i d a r g u m e n t s t h a t i n many s p e c i f i c cases p a r t i c u l a r t e s t s on t h e c h e c k l i s t a r e n o t r e l e v a n t and need n o t be performed. I t i s u n d e r s t a n d a b l e t h a t t h e more e s t a b l i s h e d i n e x p e r t i s e a n a u t h o r i t y i s t h e more

0097-6156/81/0160-0513$05.00/0 © 1981 American Chemical Society

Bandal et al.; The Pesticide Chemist and Modern Toxicology ACS Symposium Series; American Chemical Society: Washington, DC, 1981.


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such f l e x i b i l i t y that a u t h o r i t y i s l i k e l y to show as long as i t s experts have a r e a l a d m i n i s t r a t i v e i n f l u e n c e . For example p r o v i s i o n a l o r , i n minor use s i t u a t i o n s , even f u l l r e g i s t r a t i o n s may be granted without chronic t o x i c i t y / c a r c i n o g e n i c i t y s t u d i e s , although contained i n every c h e c k l i s t , provided the other data i n c l u d i n g mutagenicity and residue data are f a v o r a b l e . This p o s s i b i l i t y a r i s e s a l s o from the f a c t that i n most instances the seasonal exposure o f a p p l i c a t o r s i n Europe l a s t s only a few days and t h a t r e - e n t r y problems l a r g e l y are nonexistent. In respect to mutagenicity many c o u n t r i e s request data from three independent t e s t systems, sometimes more t e s t s are r e quired. A pronounced harmonizing i n f l u e n c e i s being exerted by a C o u n c i l o f Europe p u b l i c a t i o n " P e s t i c i d e s " (formerly " A g r i c u l t u r a l P e s t i c i d e s " ) , which gives guidance to a u t h o r i t i e s r e s p o n s i b l e f o r r e g i s t r a t i o n and which soon w i l l go i n t o i t s 5 t h e d i t i o n ( l ) . In the C o u n c i l o f Europe, Europe's f i r s t embracing p o l i t i c a l i n s t i t u t i o n , which operates by r e commendations and agreements only, twenty member s t a t e s are represented. R e g i s t r a t i o n experts o f a great number o f these member s t a t e s are r e s p o n s i b l e f o r the d r a f t i n g and up-dating of t h i s booklet on r e g i s t r a t i o n guidance. In about f i f t y pages the requirements of s a f e t y t e s t i n g o f p e s t i c i d e s are d e s c r i b e d , i n c l u d i n g Chemical I d e n t i t y and P r o p e r t i e s , T o x i cology, Residues, Environment Phenomena, D i s p o s a l , C l a s s i f i c a t i o n , and L a b e l i n g . The s p i r i t o f the authors emerges by c i t i n g a few g e n e r a l , i n t r o d u c t o r y remarks: " I t (the booklet) does not deal with these questions (data requirements) exh a u s t i v e l y , nor are the v a r i o u s proposals t o be taken as f i n a l . Manufacturers must r e a l i z e that they can always be asked to supply a d d i t i o n a l information about t h e i r products. - A l though the features o f a chemical which may need i n v e s t i g a t i o n can be l i s t e d ..., i t must be r e a l i z e d that what i s needed i s an appropriate ... examination o f the substance and not the mere completion o f some predetermined l i s t o f t e s t s . - I t i s s t r o n g l y suggested t h a t manufacturers should d i s c u s s t h e i r program o f i n v e s t i g a t i o n with the r e s p o n s i b l e a u t h o r i t i e s at an e a r l y stage." This type of f l e x i b i l i t y i s r e f l e c t e d i n the laws and r e g u l a t i o n s o f a l l European c o u n t r i e s , which, o f course, has two s i d e s : i t can be a p p l i e d reasonably by experts but i t can a l s o be misused to ask f o r ever more data by non-experts or bureaucrats. I t i s p r a c t i c a l l y impossible f o r today's manuf a c t u r e r s o f new a c t i v e i n g r e d i e n t s to l i v e up to the proposal to i n v o l v e the r e s p o n s i b l e a u t h o r i t i e s i n a s p e c i f i c t e s t i n g program, because f o r economic reasons they have u s u a l l y to seek a quick market i n t r o d u c t i o n simultaneously i n many



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c o u n t r i e s . This f a c t i s r e a l i z e d by European a u t h o r i t i e s and they are ready t o accept that there might be more than one sound approach t o i n v e s t i g a t e the s a f e t y o f a chemical. I t i s only r e c e n t l y that a few c o u n t r i e s i n Europe have become a c t i v e i n i s s u i n g r a t h e r d e t a i l e d t e s t i n g g u i d e l i n e s i n the f i e l d o f t o x i c o l o g y , environment and r e s i d u e s . These g u i d e l i n e s are not f u l l y harmonized with other c o u n t r i e s , which i s not a problem as long as they are a p p l i e d with f l e x i b i l i t y . However, i t seems unavoidable that the mere existence o f i s s u e d g u i d e l i n e s produces a l o s s o f f l e x i b i l i t y and i n v i t e s b u r e a u c r a t i c , u n s c i e n t i f i c formalism. This i s observable t o some extent even with a u t h o r i t i e s which i n the past have impressed by t h e i r pragmatic approach. I n t e g r a t i n g t h e data requirements i n European c o u n t r i e s , which concentrate a l t e r n a t i v e l y on d i f f e r e n t r e g i s t r a t i o n aspects, r e f l e c t i n g the i n f l u e n c e and i n t e r e s t o f i n d i v i d u a l o f f i c i a l s , I am not i n a p o s i t i o n t o say that they are l e s s exhaustive than i n the USA, as Hahn (g) d i d when he reviewed p e s t i c i d e r e g u l a t i o n i n Europe i n 1 9 7 2 . However, I f e e l that c e r t a i n l y the p o l i t i c a l and l e g a l p o s s i b i l i t i e s and perhaps the status o f t h e a u t h o r i t i e s t o apply the f l e x i b i l i t y o f the r e g u l a t i o n s i n i n d i v i d u a l cases are s t i l l more f a v o r a b l e i n Europe than e.g. p r e s e n t l y i n the U.S. In respect o f the extent o f data requirements i n the f i e l d o f e c o l o g i c a l t e s t i n g European a u t h o r i t i e s so f a r have been r a t h e r reasonable, but I f e e l that some are about t o develop a tendency t o go too f a r . Are we not going t o ask f o r the impossible, i f we r e q u i r e a p e s t i c i d e t o d i s p l a y e f f e c t i v e t o x i c i t y towards t a r g e t organisms, t o stay i n the area where i t i s a p p l i e d , t o degrade i n due time, not t o accumulate, and yet t o be harmless t o other organisms which o f t e n have no r e a l place i n that c u l t i v a t e d area anyway. Maybe we could allow mankind t o become again a l i t t l e more e g o c e n t r i c and be ready t o accept that a p e s t i c i d e , which i s considered t o be safe t o man based on favorable r e s u l t s i n today' s s o p h i s t i c a t e d t o x i c o l o g i c a l and biochemical t e s t i n g scheme, w i l l not be des t r u c t i v e t o eco-organisms. I t i s d o u b t f u l whether such a p e s t i c i d e which i m p l i c i t l y degrades at a reasonable r a t e and stays predominantly i n the place where i t i s a p p l i e d can m a t e r i a l l y o r permanently increase the e f f e c t s on the ecology produced by nonchemical a g r i c u l t u r a l p r a c t i c e s alone. I t i s accepted that such a p e s t i c i d e , according t o i t s use, i n d i cates t e s t i n g o f acute e f f e c t s on w i l d l i f e such as b i r d s and f i s h . However, t e s t s on organisms outside the c u l t i v a t e d area, e.g. on Daphnia, are not i n d i c a t e d , because adverse e f f e c t s could h a r d l y j u s t i f y the luxury t o ban or r e s t r i c t e s s e n t i a l uses o f such a unique compound without questioning 1



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o t h e r b a s i c e l e m e n t s o f o u r a g r i c u l t u r a l s y s t e m s . Of c o u r s e , one can a r g u e t h a t c a r e l e s s a p p l i c a t o r s c o u l d s t i l l contaminate s u r f a c e w a t e r s . C e r t a i n l y , c a r e must be t a k e n t h a t t h e p r e s e n t day's s o p h i s t i c a t e d , p r o d u c t s a f e t y e v a l u a t i o n i s m a t c h e d by an a d e q u a t e and m o n i t o r e d r e s p o n s i b i l i t y i n t h e a p p l i c a t i o n o f t h e p r o d u c t s . I t w o u l d seem t h a t o n l y f o r c h e m i c a l s w i t h p r o b l e m s i n m o b i l i t y and/or degradation, o r w i t h a q u a t i c u s e s , a d d i t i o n a l t e s t s w i t h o t h e r e c o - o r g a n i s m s , e.g. D a p h n i a , a r e i n d i c a t e d . I t i s hoped t h a t a f l e x i b l e s e q u e n t i a l a p p r o a c h w i l l be f o l l o w e d i n E u r o p e a l s o i n t e s t i n g f o r e f f e c t s on eco-organisms. The d a n g e r o f r e q u e s t i n g c h e c k l i s t d a t a w h i c h c a n n o t be c o n s i d e r e d i n t h e f i n a l e v a l u a t i o n and d e c i s i o n s h o u l d be more c a r e f u l l y r e c o g n i z e d by some E u r o p e a n a u t h o r i t i e s . T h i s d a n g e r seems t o be p a r t i c u l a r l y a p p a r e n t i n a r e a s w h i c h o f f e r f a s c i n a t i n g s c i e n t i f i c p l a y g r o u n d s , e.g. e n v i r o n m e n t a l s t u d i e s and a n a l y t i c a l w o r k , p a r t i c u l a r l y w i t h r a d i o l a b e l e d compounds. I admit t h a t e x t r e m e l y i n t e r e s t i n g redundant d a t a are not o n l y p r o d u c e d on r e q u e s t by a u t h o r i t i e s b u t o f t e n a l s o f r e e l y o f f e r e d by u n c r i t i c a l i n d u s t r i a l s c i e n t i s t s . One may have t o r e a l i z e t h a t d a t a r e q u i r i n g / p r o d u c i n g has r e a c h e d a s t a g e o f s e l f - p r o p e l l i n g d y n a m i c s as i t o f f e r s i n t e r e s t i n g b u s i n e s s o p p o r t u n i t i e s and h e l p s i n j o b e n l a r g e m e n t and j o b s e c u r i t y i n government and i n t h e i n d u s t r y . A c c e p t i n g t h a t t h e r e e x i s t s no a b s o l u t e s a f e t y and t h a t t h e r e i s a l i m i t g i v e n t o t h e number o f d a t a w h i c h r e a s o n a b l y need and c a n be c o n s i d e r e d i n a s a f e t y a s s e s s m e n t , t h e t i m e w i l l come, o r i s a l r e a d y h e r e , when a d d i n g new t e s t s t o t h e c h e c k l i s t has t o i m p l y t h e e l i m i n a t i o n o f o t h e r s . I am p o s i t i v e t h a t t h e a c c u m u l a t i o n o f e x p e r i e n c e i n t h e r a n k i n g o f t e s t s and i n t h e f u l l use o f data w i l l a l l o w a stop to the p r o l i f e r a t i o n o f t e s t s without l o s s o f e l e m e n t s f o r a d e q u a t e r e g u l a t o r y d e c i s i o n m a k i n g . An e n t r y i n t o t h e m o l e c u l a r b i o l o g y f i e l d opened w i t h mutag e n i c i t y s t u d i e s may be i n s t r u m e n t a l i n t h i s e n d e a v o r . E u r o p e a n R e g i s t r a t i o n P o l i c i e s and

Procedures

P r a c t i c a l l y i n a l l European c o u n t r i e s the key r o l e i n the administrative handling of applications for registration l i e s w i t h o f f i c e s o f t h e M i n i s t r i e s o f A g r i c u l t u r e . They a c c e p t t h e a p p l i c a t i o n s , organize the involvement o f experts o f the M i n i s t r i e s o f H e a l t h and M i n i s t r i e s o r A g e n c i e s o f E n v i r o n ment, and t h e y i s s u e t h e f i n a l r e g i s t r a t i o n d e c i s i o n s . These d e c i s i o n s a r e o f t e n r e a c h e d i n an i n t e r m i n i s t e r i a l s p e c i a l c o m m i s s i o n w h i c h may i n c l u d e e x p e r t s f r o m a c a d e m i a , o r even industry. N o t e w o r t h y and u n i q u e i s t h e n o n s t a t u t o r y r e g i s t r a t i o n scheme i n t h e U.K. The P e s t i c i d e S a f e t y P r e c a u t i o n s Scheme,



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as i t i s c a l l e d , was drawn up i n 1957 between the i n t e r e s t e d M i n i s t r i e s and I n d u s t r i a l A s s o c i a t i o n s . I f agreements are t o stay i n such a f i e l d they have to have the same enforcement power i n p r a c t i c e as corresponding laws. But the n e g o t i a t i o n and up-dating o f agreements may create a climate f o r more easy understanding among partners with divergent i n t e r e s t s . Because o f the key involvement o f the M i n i s t r i e s o f A g r i c u l t u r e i n the r e g i s t r a t i o n process t h e i r experimental s t a t i o n s are e x t e n s i v e l y i n v o l v e d i n the e v a l u a t i o n o f the b i o l o g i c a l e f f i c a c y and the p r a c t i c a l usefulness o f the products. In t h i s e v a l u a t i o n aspects o f i n t e g r a t e d pest c o n t r o l are being i n c r e a s i n g l y considered and t h i s proves t o be not the l e a s t hurdle t o take i n r e g i s t e r i n g a new product. Although e f f i c a c y i s not a r e g i s t r a t i o n aspect i n the U.K., a corresponding approval by o f f i c i a l t e s t i n g i s needed f o r s u c c e s s f u l marketing. While the data a c t u a l l y r e q u i r e d i n p r a c t i c e vary from country t o country according to s p e c i f i c l o c a l i n t e r e s t s and the p o s s i b i l i t y or readiness f o r f l e x i b i l i t y , the b a s i c concepts o f laws and r e g u l a t i o n s are homogeneous and not s u b s t a n t i a l l y d i f f e r e n t from those o f the U.S. The g e n e r a l l y p r e v a i l i n g conciseness o f European p e s t i c i d e laws and regul a t i o n s would i n d i c a t e that only a r a t h e r l i m i t e d number o f government lawyers have found a f u l l - t i m e engagement i n p e s t i c i d e r e g u l a t o r y a f f a i r s . P r i v a t e lawyers may not earn an a p p r e c i a b l e amount o f money i n t h a t domain s i n c e suing the a u t h o r i t i e s i s only r a r e l y done by companies or i n d u s t r y associations. R e g i s t r a t i o n o f f i c i a l s i n the v a r i o u s European c o u n t r i e s have r a t h e r c l o s e contacts with each other. Although some aspects may be reviewed l e s s thoroughly than others by i n d i v i d u a l a u t h o r i t i e s , t h e i r d i f f e r e n t l y o r i e n t e d primary i n t e r e s t s coupled w i t h t h e i r b i l a t e r a l contacts f i n a l l y r e s u l t i n a r a t h e r thorough e v a l u a t i o n . I t i s i n t e r e s t i n g t o note that i n a given case requests f o r f u r t h e r i n f o r m a t i o n or data u s u a l l y do not focus on the same question but may r e l a t e to as many areas as c o u n t r i e s are i n v o l v e d . A standard request i n the a p p l i c a t i o n f o r r e g i s t r a t i o n i s t o s t a t e where e l s e r e g i s t r a t i o n has been asked f o r , has been already granted, or has been denied. A l s o the a p p l i c a n t must r e p o r t when data or f a c t s become known which may put those submitted i n doubt. European a u t h o r i t i e s have so f a r been prudent i n not t r y i n g to handle t h i s domain f o r m a l i s t i c a l l y as t h i s can e a s i l y l e a d to a voluminous bureaucracy. They consider t h a t f i n a l l y i t i s the manufacturer who has to cope with a severe, r a t h e r consumer-friendly product l i a b i l i t y and t h a t he w i l l be f r e e l y ready t o i n v o l v e them i n cases o f a c e r t a i n importance.



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Fundamental d i f f e r e n c e s e x i s t between European c o u n t r i e s i n respect of the a d m i n i s t r a t i v e handling of crop residues : Some a u t h o r i t i e s have d e l i b e r a t e l y n o t i n t r o d u c e d a r e s i d u e t o l e r a n c e - s e t t i n g system, a r g u i n g t h a t c a r e f u l e v a l u a t i o n o f t h e r e s i d u e s i t u a t i o n a t t h e t i m e o f r e g i s t r a t i o n and s u b sequent p e r i o d i c a l m o n i t o r i n g o f t h e p r a c t i c a l s i t u a t i o n w i l l take care o f the problem. Others, m a i n l y the c o u n t r i e s which import a g r i c u l t u r a l produce, operate s y s t e m a t i c a l l y a t o l e r a n c e s y s t e m v e r y much l i k e t h a t o f t h e U.S. The r e m a i n i n g c o u n t r i e s o p e r a t e t o l e r a n c e s y s t e m s o n l y f o r p r o d u c e t o be e x p o r t e d , f o r c e r t a i n p r o d u c t c a t e g o r i e s , o r on a c a s e - b y - c a s e b a s i s a f t e r o v e r a l l judgment o f t h e p r o d u c t and i t s u s e . I n a number o f i m p o r t a n t c o u n t r i e s r e g i s t r a t i o n s o f new products are i n p r i n c i p l e granted o n l y f o r a l i m i t e d t i m e , m o s t l y f o r t h r e e y e a r s , w i t h o r w i t h o u t an a c c o m p a n y i n g r e q u e s t for a d d i t i o n a l data f o r r e - r e g i s t r a t i o n a f t e r that period. Some c o u n t r i e s o p e r a t e a p h a s e d r e g i s t r a t i o n scheme g i v i n g p r o v i s i o n a l r e g i s t r a t i o n s on a r e d u c e d b u t f a v o r a b l e d a t a b a s e t o a l l o w e a r l y m a r k e t i n t r o d u c t i o n o f new p r o d u c t s . As an e x a m p l e , p h a s e d r e g i s t r a t i o n schemes have a l l o w e d CIBA-GEIGY t o s t a r t s e l l i n g TILT®, a new f u n g i c i d e , t h i s y e a r i n F r a n c e and t h e U.K., b u t i t w i l l be I98U when i t w i l l be a v a i l a b l e t o U.S. f a r m e r s . The d a t a w h i c h may p o s s i b l y be d e v e l o p e d d u r i n g a p r o v i s i o n a l r e g i s t r a t i o n phase i n v o l v e c h r o n i c t o x i c i t y , s o i l m e t a b o l i s m , and o t h e r e n v i r o n m e n t a l s t u d i e s . As mentioned e a r l i e r , f i n a l r e g i s t r a t i o n s are granted w i t h o u t c h r o n i c t o x i c i t y s t u d i e s i n m i n o r use s i t u a t i o n s . European a u t h o r i t i e s are i n p r i n c i p l e sympathetic t o i n d u s t r y ' s p l e a t o p r o t e c t t h e p r o p e r t y r i g h t s o f companies w i t h r e s p e c t t o t h e d a t a d e v e l o p e d and s u b m i t t e d d u r i n g t h e r e g i s t r a t i o n p r o c e d u r e and n o t t o use them i n f a v o r o f f o l l o w i n g r e g i s t r a n t s . They a r e aware o f t h e l a r g e and c o n t i n u o u s i n v e s t m e n t i n p e r s o n n e l , s p a c e , e q u i p m e n t and t i m e n e c e s s a r y t o p r o d u c e r e g i s t r a t i o n d a t a . However, u n l i k e i n d u s t r y , which f e e l s t h a t t h i s p l e a i s w e l l covered by the v a r i o u s c o n s t i t u t i o n a l l a w s i n E u r o p e a n c o u n t r i e s , most a u t h o r i t i e s s t r e s s t h a t c o r r e s p o n d i n g r e g u l a t i o n s need f i r s t t o be c r e a t e d , w h i c h so f a r has n o t b e e n done i n E u r o p e . P r e s e n t l y some a u t h o r i t i e s seem t o r e s p e c t i n f o r m a l l y , a t l e a s t p a r t l y , p r o p e r t y r i g h t s on d a t a , o t h e r s a r e r e a d y t o use d a t a i n f a v o r o f s e c o n d r e g i s t r a n t s o n l y when t h e y c a n d e m o n s t r a t e t h a t t h e i r t e c h n i c a l a c t i v e i n g r e d i e n t has t h e same s p e c i f i c a t i o n s as t h a t o f t h e f i r s t r e g i s t r a n t ; and t h e r e s t o f t h e a u t h o r i t i e s a r e n o t a b l e o r w i l l i n g t o pay a t t e n t i o n t o t h a t problem. A l t h o u g h s a f e t y and e n v i r o n m e n t a l q u e s t i o n s h a v e r e a c h e d and do r e a c h h i g h and sometimes e x p l o s i v e momentum i n E u r o p e


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too, I f e e l t h a t o f f i c i a l s s t i l l can reach r e g i s t r a t i o n dec i s i o n s i n a c l i m a t e w i t h o u t t o o much p o l i t i c a l p r e s s u r e . They can demonstrate r a t h e r severe l e g i s l a t i o n and a r e thus p r e s e n t l y n o t f o r c e d t o make p u b l i c t h e d e t a i l e d a r g u m e n t s o n which they base i n d i v i d u a l r e g i s t r a t i o n d e c i s i o n s .


A c t i v i t i e s o f t h e E u r o p e a n E c o n o m i c Community (EEC) W i t h i n t h e g e n e r a l endeavor o f removing b a r r i e r s t o t r a d e b e t w e e n t h e n i n e p r e s e n t member s t a t e s o f t h e Community, t h e EEC C o m m i s s i o n h a s s t a r t e d t o become a c t i v e i n h a r m o n i z i n g laws i n t h e f i e l d o f c h e m i c a l s and p e s t i c i d e s . A C o u n c i l D i r e c t i v e o f t h e y e a r 1967 o n t h e a p p r o x i m a t i o n o f t h e l a w s o f member s t a t e s r e l a t i n g t o t h e c l a s s i f i c a t i o n , p a c k a g i n g , a n d l a b e l i n g o f dangerous substances b a s i c a l l y covers a l l c h e m i c a l and h a s b e e n e x t e n d e d w i t h s i x m o d i f i c a t i o n s t o a n e q u i v a l e n t o f t h e U.S. T o x i c S u b s t a n c e s C o n t r o l A c t ( 3 . ) . T h i s d i r e c t i v e w i l l i n v o l v e a n o t i f i c a t i o n o f a u t h o r i t i e s on t h e market i n t r o d u c t i o n o f new c h e m i c a l s , e x c l u d i n g c h e m i c a l s r e g u l a t e d o t h e r w i s e , s u c h a s p e s t i c i d e s . However, t h e h a r m o n i z a t i o n o f t h e e x i s t i n g p e s t i c i d e l a w s w i t h i n t h e Community p r o v e s t o be a p a r t i c u l a r l y d e l i c a t e a f f a i r , much i n t h e same manner a s other questions r e l a t e d t o a g r i c u l t u r e , b u t p a r t i c u l a r l y so because n a t i o n a l p e s t i c i d e l e g i s l a t i o n s and r e g i s t r a t i o n a u t h o r i t i e s i n t h e member s t a t e s have b e e n w e l l e s t a b l i s h e d since a rather long time. Based on t h e above-mentioned d i r e c t i v e on c l a s s i f i c a t i o n , p a c k a g i n g a n d l a b e l i n g o f c h e m i c a l s , a s p e c i a l d i r e c t i v e (k) t o harmonize t h e s e a s p e c t s f o r p e s t i c i d e f o r m u l a t i o n s as s o l d t o t h e u s e r has been adopted b y t h e C o u n c i l o f M i n i s t e r s o f t h e member s t a t e s a n d w i l l b e i n f o r c e a s o f J a n u a r y 1 , 1 9 8 1 . A t t h e same t i m e , a n a d d i t i o n a l d i r e c t i v e (5.) w i l l b e i n f o r c e p r o h i b i t i n g o r r e s t r i c t i n g t h e use o f c e r t a i n p e s t i c i d e s i n a l l member s t a t e s . The d i s c r e p a n c i e s m e n t i o n e d e a r l i e r i n t h e a p p r o a c h f o l l o w e d by European c o u n t r i e s i n r e g u l a t i n g p e s t i c i d e r e s i d u e s i n a g r i c u l t u r a l produce i s r e f l e c t e d b y t h e d i f f i c u l t i e s e n c o u n t e r e d i n h a r m o n i z i n g t h i s domain. So f a r o n l y a d i r e c t i v e r e l a t i n g t o r e s i d u e s i n f r u i t and v e g e t a b l e s has b e e n a d o p t e d . T h r e e o t h e r s on r e s i d u e s i n c e r e a l s f o r human consumption, on r e s i d u e s i n products o f animal o r i g i n , and on r e s i d u e s i n a n i m a l f e e d s have r e m a i n e d i n t h e p r o p o s a l stage f o rq u i t e a l o n g time. I n 1976 a f i r s t a t t e m p t t o h a r m o n i z e p e s t i c i d e r e g i s t r a t i o n p r o c e d u r e s was made i n t h e f o r m o f a p r o p o s a l o f a d i r e c t i v e which would c r e a t e t h e p o s s i b i l i t y o f a type o f EEC-accepted p l a n t p r o t e c t i o n product w i t h t h e aim o f h a v i n g


519

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i n t h e f u t u r e a c a t a l o g u e o f EEC-accepted products b e s i d e s t h e n a t i o n a l l y r e g i s t e r e d o n e s . As t h e EEC C o m m i s s i o n does a c c e p t t h a t most p e s t i c i d e s h a v e s p e c i f i c i m p o r t a n c e f o r l o c a l o r r e g i o n a l a g r i c u l t u r a l n e e d s a n d t h a t t h e y do h a v e t o correspond t o l o c a l o r r e g i o n a l e c o l o g i c a l and e n v i r o n m e n t a l s i t u a t i o n s , t h e C o m m i s s i o n a l s o a c c e p t s t h a t member s t a t e s s h o u l d s t a y f r e e t o r e g u l a t e p e s t i c i d e s f o r t h e i r own t e r r i t o r i e s i n accordance w i t h t h e i r n a t i o n a l laws. T h e r e f o r e , i n t h i s p r o p o s e d d i r e c t i v e on p u t t i n g i n t o c i r c u l a t i o n EECa c c e p t e d p l a n t p r o t e c t i o n p r o d u c t s (6_), due f l e x i b i l i t y h a s b e e n i n c o r p o r a t e d . The o p t i o n i s l e f t open t o s e e k e i t h e r , a s up t o now, n a t i o n a l r e g i s t r a t i o n s i n t h e v a r i o u s c o u n t r i e s o r t o a p p l y f o r EEC a c c e p t a n c e o f a p r o d u c t i n a member s t a t e o f f r e e c h o i c e . T h a t member s t a t e w o u l d have t o n o t i f y t h e o t h e r member s t a t e s a n d t h e C o m m i s s i o n on t h e r e c e i p t o f s u c h an a p p l i c a t i o n and r e s p e c t a r e l a t e d d i r e c t i v e i n d r a f t s t a g e on u n i f o r m p r i n c i p l e s ( i . e . t h e t e s t s r e q u i r e d ) f o r c h e c k i n g c o m p l i a n c e w i t h t h e r e q u i r e m e n t s f o r EEC a c c e p t a n c e o f a p l a n t p r o t e c t i o n p r o d u c t . I f t h e member s t a t e g r a n t s EEC a c c e p t a n c e t o a p r o d u c t i t h a s t o i n f o r m t h e o t h e r member s t a t e s a n d t h e C o m m i s s i o n on t h e e l e m e n t s o f t h a t d e c i s i o n documented w i t h a l a b e l c o p y . Member s t a t e s a n d t h e C o m m i s s i o n may r e q u e s t a f u l l c o p y o f t h e a p p l i c a t i o n s u b m i s s i o n f o r t h e i r own r e v i e w a n d make known p o s s i b l e r e s e r v a t i o n s w i t h i n one y e a r ' s t i m e . A f t e r w a r d s no r e s t r i c t i o n s o n t h e f r e e c i r c u l a t i o n o f t h e p r o d u c t may be i m p o s e d b y member s t a t e s . I t i s r e q u i r e d t h a t EEC-accepted p l a n t p r o t e c t i o n products contain exclusively active ingredients l i s t e d i n a corresponding appendix o f t h e d i r e c t i v e . A S c i e n t i f i c Committee f o r P e s t i c i d e s e s t a b l i s h e d i n 1978 c o n s i s t i n g o f h i g h l y q u a l i f i e d s c i e n t i s t s i s t o b e m e n t i o n e d , w h i c h may be c o n s u l t e d b y t h e C o m m i s s i o n on s c i e n t i f i c and t e c h n i c a l p r o b l e m s r e l a t i n g t o t h e u s e a n d m a r k e t i n g o f p e s t i c i d e s and t o t h e i r r e s i d u e s . C o n c l u d i n g Remarks No f u n d a m e n t a l d i f f e r e n c e s i s p e s t i c i d e r e g u l a t i o n b e t w e e n t h e U.S. a n d E u r o p e a n c o u n t r i e s c a n be n o t e d . Howe v e r , due a t t e n t i o n h a s t o be drawn t o some r e l e v a n t d i f f e r e n c e s i n f l e x i b i l i t y o f l a w s , g u i d e l i n e s and r e q u i r e m e n t s , as w e l l as i n t h e p o l i t i c a l r e g u l a t o r y environment. A l t h o u g h i t s t i l l may t a k e a l o n g t i m e u n t i l a c e n t r a l p e s t i c i d e r e g i s t r a t i o n becomes a p r a c t i c a l r e a l i t y i n t h e E u r o p e a n Economic Community, t h e i n i t i a t e d a c t i v i t i e s w i l l c e r t a i n l y s p e e d up t h e h a r m o n i z a t i o n o f r e g u l a t i o n s a n d d e c i s i o n m a k i n g i n t h e member s t a t e s .



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O f f i c i a l s from European c o u n t r i e s , supported by e x p e r t s f r o m i n d u s t r y , a r e a c t i v e l y c o o p e r a t i n g i n t h e OECD e f f o r t s t o h a r m o n i z e t h e t e s t i n g o f c h e m i c a l s . The n e e d f o r a g r e e d t e s t s a n d f o r g u i d e l i n e s i n Good L a b o r a t o r y P r a c t i c e i s w e l l r e c o g n i z e d . Most E u r o p e a n d e l e g a t e s w i l l be a c t i v e t o s e c u r e o p t i m a l f l e x i b i l i t y i n emerging g u i d e l i n e s . The p r o l i f e r a t i o n o f d a t a r e q u e s t e d f o r r e g i s t r a t i o n , s p e c i f i c a l l y i n t h e f i e l d o f e n v i r o n m e n t a l a s p e c t s , may s t i l l c o n t i n u e f o r some t i m e . B u t i t i s h o p e d t h a t f i n a l l y e x p e r i e n c e i n i n t e g r a t e d human a n d e n v i r o n m e n t a l s a f e t y t e s t i n g w i l l make i t p o s s i b l e t o r e a c h b e t t e r d e c i s i o n s on a s m a l l e r number o f relevant key data.

Literature Cited 1. Council of Europe, Ed. "Pesticides"; 4th ed., Strasbourg, France, 1977. 2. Hahn, S.; Proc. 11th Br. Weed Control Conf., 1972, 1028. 3. Off. J. of the Europ. Comm., 1967, No 196, 1. 4. Off. J. of the Europ. Comm., 1978, No L206, 13. 5. Off. J. of the Europ. Comm., 1979, No L33, 36. 6. Off. J. of the Europ. Comm., 1976, No C212, 3. RECEIVED February 2,

1981.


Pesticide Regulation in Europe - ACS Symposium Series (ACS

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