Initiatives of Chemical Industry to Modify TSCA ... - ACS Publications

By way of brief background, I would like to summarize how CMA has organized itself to deal with. TSCA, and describe some of the basic themes which we...
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7 I n i t i a t i v e s of C h e m i c a l I n d u s t r y t o M o d i f y

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TSCA

Regulations

STACIA DAVIS LE BLANC Chemical Manufacturers Association, Washington, DC 20037 By way of b r i e f background, I would l i k e to summarize how CMA has organized itself to deal with TSCA, and describe some of the basic themes which we have followed for v i r t u a l l y all of the issues raised by the Act. First of all, CMA conducts what are described as "Advocacy A c t i v i t i e s " -- a term which embraces all of our communications with Congress, the r e g u l a t o r y agencies, the courts, and the a d m i n i s t r a t i o n . These a c t i v i t i e s are multidisciplinary. Whenever an advocacy issue is i d e n t i f i e d , that matter is staffed by various disciplines in CMA including Technical, Legal, Government R e l a t i o n s and P u b l i c R e l a t i o n s where appropriate. CMA institutionalized the management of t o x i c substances control matters in the Chemical Regulations Advisory Committee (CRAC). This committee has a regime of task groups staffed by member company executives which deal with the various sections of TSCA. For instance, there is a testing committee for Section 4 matters, a reporting task group for S e c t i o n 8 and related matters, and so on. The coordination of these task groups is managed by CRAC. CRAC is the basic client organization within CMA. It consists of 15 company representatives, one-third of which are replaced each year by new representatives. This standing technical committee i s served by CMA s t a f f , outside consultants and outside c o u n s e l , as appropriate. While the various sections of the Toxic S u b s t a n c e s C o n t r o l Act are interrelated and interdependent this se c t i ο n - b y - s e c t i ο n task group structure has so far proved extremely e f f e c t i v e i n dealing with the v a r i o u s proposals which EPA has issued. Our key organizational theme, therefore, has been to utilize a m u l t i d i s e i p l i n a r y team concept to 0097-6156/83/0213-0095$06.00/0 © 1983 American Chemical Society Ingle; TSCA's Impact on Society and Chemical Industry ACS Symposium Series; American Chemical Society: Washington, DC, 1983.

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s e r v e a s p e c i f i c c l i e n t o r g a n i z a t i o n w i t h i n CMA, which i s responsible for addressing a l l TSCA r e l a t e d i s s u e s . The general CMA philosophy in addressing TSCA i s s u e s o v e r the p r e c e d i n g m o n t h s and years has been v e r y much a r e f l e c t i o n o f how EPA has addressed the Toxic Substances Control Act. U n f o r t u n a t e l y , u n d e r the p r e v i o u s A d m i n i s t r a t i o n , the p h i l o s o p h y of t h o s e w i t h i n t h e A g e n c y was t o p r o p o s e an i m p l e m e n t a t i o n of the s t a t u t e w h i c h i n CMA' s o p i n i o n e x c e e d e d t h e statutory l i m i t s of t h e p r o v i s i o n s of TSCA. We r e f e r t o t h i s as "statute busting." T h e r e may come a t i m e i n the h i s t o r y of t h e administration of a s t a t u t e , when extending the l i m i t s o f a u t h o r i t y w h i c h C o n g r e s s has b e s t o w e d u p o n an a g e n c y i s a p p r o p r i a t e . It clearly d o e s n o t seem t o be a p p r o p r i a t e , h o w e v e r , f o r a s t a t u t e i n w h i c h the g o v e r n m e n t has had l i t t l e o r no r e g u l a t o r y experience. In any e v e n t , t h i s i s c l e a r l y t h e case w i t h TSCA. Not o n l y d i d t h e p r e v i o u s Administration t r y to e x p a n d i t s a u t h o r i t y u n d e r TSCA, b u t the Agency further complicated the i m p l e m e n t a t i o n of TSCA by c r e a t i n g an e x t r e m e l y c o m p a r t m e n t a l i z e d o r g a n i z a t i o n a l structure. This resulted in S e c t i o n 4 people not t a l k i n g to S e c t i o n 5 p e o p l e , who i n turn d i d not talk to S e c t i o n 6 or S e c t i o n 8 p e o p l e — and so o n . What resulted was an i n e f f e c t i v e l y structured and u n n e c e s s a r i l y e x p a n s i o n i s t i c a t t i t u d e t o w a r d TSCA. T h i s A g e n c y a p p r o a c h , n e c e s s a r i l y , had a great d e a l t o do w i t h how our i n d u s t r y responded to the Agency's p r o p o s a l s . F i r s t of a l l , a m a j o r p o r t i o n o f our c o m m e n t s had to d e f i n e the r a t i o n a l limits and scope of the Agency's s t a t u t o r y a u t h o r i t y . Some p e o p l e t h o u g h t we w e r e e x c e s s i v e l y l e g a l i s t i c . We did not a p o l o g i z e , h o w e v e r , b e c a u s e i t a p p e a r e d c l e a r to us t h a t t h e A g e n c y was g o i n g b e y o n d t h e l a w i n b o t h fact and spirit. N e x t i n our r e s p o n s e to EPA's p r o p o s a l s was to p r e s e n t a d e t a i l e d c r i t i q u e of the p a r t i c u l a r p r o p o s a l w h i c h t h e A g e n c y was b r i n g i n g f o r t h , and i n a d d i t i o n -and t h i s i s most i m p o r t a n t — to o f f e r a c o n s t r u c t i v e , r a t i o n a l a l t e r n a t i v e to t h a t p r o p o s a l , w h i c h n o t only met t h e g o a l s o f the A c t , b u t was w i t h i n t h e l i m i t s and t h e s c o p e p r e s c r i b e d by C o n g r e s s . This three-part philosophy of our r e s p o n s e s — legal evaluations, policy c r i t i q u e s and technical e v a l u a t i o n s b a s e d on t h e need f o r "good s c i e n c e " a t a l l r e g u l a t o r y stages and presentation of constructive a l t e r n a t i v e s , l e d to o t h e r o p e r a t i n g philosophies. In g e n e r a l , because the Act i t s e l f i s i n t e r r e l a t e d , we had t o a d d r e s s v i r t u a l l y e v e r y TSCA proposal by t h e A g e n c y . We left product specific

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proposals to the a f f e c t e d g r o u p s o f m a n u f a c t u r e r s t o r a i s e matters s p e c i f i c to that p a r t i c u l a r p r o d u c t . We d i d take the o p p o r t u n i t y to a d d r e s s g e n e r i c issues in t h o s e p r o p o s a l s , h o w e v e r , i n an e f f o r t t o p r o t e c t t h e l a r g e r i n t e r e s t s of our i n d u s t r y i n f u t u r e rulemaking a c t i v i ties· Another p r a c t i c a l o p e r a t i n g philosophy w h i c h we f o l l o w e d was t o c a r e f u l l y and e x t e n s i v e l y c o m m u n i c a t e w i t h other trade a s s o c i a t i o n s and b u s i n e s s g r o u p s to a s s u r e t h e p o s i t i o n s we t o o k w e r e n o t i n a p p r o p r i a t e l y i n c o n s i s t e n t with p o s i t i o n s taken by those organizations. A considerable amount o f time and paperwork was d e v o t e d to t h i s i n t e r i n d u s t r y communications e f f o r t . A n o t h e r theme w h i c h we c o n s t a n t l y reiterated in a l l o f o u r c o m m u n i c a t i o n s w i t h EPA on TSCA, a n d i n d e e d in a l l other advocacy matters, was t h e n e e d f o r r e g u l a t o r y a c t i o n t o be b a s e d upon a d e q u a t e scientific d a t a and d e f e n s i b l e c o n c l u s i o n s . H i s t o r i c a l l y , the A g e n c y had b e e n t o o q u i c k t o i m p o s e r e q u i r e m e n t s on t h e basis of incomplete, c o n t r o v e r s i a l or ambiguous scientific evidence. We a l s o t a k e t h e a p p r o a c h i n o u r p r e s e n t a t i o n s t o t h e g o v e r n m e n t - - i n TSCA a s w e l l as i n o t h e r advocacy issues — to request less r e l i a n c e on formal r e q u i r e m e n t s and more e m p h a s i s on v o l u n t a r y a c t i o n and informal negotiation to a c h i e v e TSCA's objectives. Inflexible regulations are time-consuming, expensive and cumbersome t o i m p l e m e n t . Enforceable performance oriented standards c a n be d e s i g n e d . Unnecessary d i s p u t e s o v e r t h e l e g a l i t y o f E P A ' s a c t i o n s m i g h t be p r e v e n t e d , and n e e d e d r e g u l a t i o n s c a n be p u t i n p l a c e f as ter· W h i l e s e v e r a l EPA i n i t i a t i v e s under TSCA have become f i n a l , many more a r e i n t h e f o r m a t i v e stages. Under S e c t i o n s 4, 5, 6, 8 a n d 12 o f T S C A , EPA h a s d e v e l o p e d a l a r g e number o f p r o p o s a l s , some o f w h i c h await f i n a l a c t i o n . I f implemented i n a reasonable m a n n e r , many o f EPA's p e n d i n g p r o p o s a l s can provide a viable basis f o r implementing TSCA. I want to e m p h a s i z e , i n f a c t , t h a t CMA b e l i e v e s that TSCA as written i s workable. The f o l l o w i n g d i s c u s s i o n will d e m o n s t r a t e how i n d u s t r y h a s w o r k e d w i t h t h e EPA i n a p p l y i n g t h e m a j o r p r o v i s i o n s o f TSCA i n a m a n n e r that i s r e a s o n a b l e , c o s t - e f f e c t i v e and c o n s i s t e n t w i t h the o r i g i n a l i n t e n t of Congress. Section 4 o f TSCA a u t h o r i z e s EPA t o r e q u i r e manufacturers or processors to t e s t s p e c i f i e d e x i s t i n g c h e m i c a l s u b s t a n c e s when a v a i l a b l e d a t a a n d e x p e r i e n c e are i n s u f f i c i e n t to evaluate their h e a l t h and v

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environmental effects. The EPA may, under certain c i r c u m s t a n c e s , p r e s c r i b e the m e t h o d o l o g y used to conduct the testing to a s s u r e reliable results. Testing costs are borne by manufacturers or processors. CMA has s t r e s s e d t h e need f o r EPA t o e s t a b l i s h an a d e q u a t e d a t a b a s e on p r o s p e c t i v e c h e m i c a l s before p u b l i s h i n g a proposed t e s t r u l e . The Agency needs to be f u l l y informed about the c h e m i c a l s under consideration for testing. The interagency Testing C o m m i t t e e ( I T C ) w h i c h recommends c h e m i c a l s f o r t e s t i n g t o t h e EPA, n e e d s to d e v e l o p a more c o m p l e t e p r o f i l e o f testing candidates. T h i s has b e e n a c c o m p l i s h e d to some e x t e n t by h a v i n g the ITC work more c l o s e l y with i n d u s t r y a t the e a r l y s t a g e s o f an a s s e s s m e n t o f a t e s t rule . T h i s a p p r o a c h i s a s i g n i f i c a n t i m p r o v e m e n t t o some of the i n i t i a l proposals. I n t h e p a s t , EPA devoted e x c e s s i v e t i m e and e f f o r t t o o v e r l y a m b i t i o u s testing approaches t h a t were q u e s t i o n a b l e on l e g a l as w e l l as s c i e n t i f i c grounds. F o r e x a m p l e , ITC h a d recommended several broad " c a t e g o r i e s " of c h e m i c a l s for EPA cοη s i d e r a t i ο η -f o r t e s t i n g that raised issues of d e f i n i n g t h e members o f t h e c a t e g o r y , a n d allocating c o s t s among t h e c o m p a n i e s who make the c h e m i c a l s w i t h i n that defined category. CMA has recommended t h a t ITC avoid broad d e s i g n a t i o n s and l i s t the s p e c i f i c chemicals i f appropriate. EPA's t e s t i n g p r o g r a m was initially excessively legalistic and f o r m a l i z e d . Recently, however, the A g e n c y has e n t e r e d i n t o d i a l o g u e w i t h i n d u s t r y . We have encouraged this development g e n e r a l l y , and s p e c i f i c a l l y promoted c o n s i d e r a t i o n of EPA/industry n e g o t i a t e d t e s t i n g programs. By e n s u r i n g t h a t i n d u s t r y is aware of EPA's testing p r i o r i t i e s and by c o m m u n i c a t i n g w i t h i n d u s t r y r e p r e s e n t a t i v e s a t an e a r l y s t a g e o f t h e t e s t r u l e d e v e l o p m e n t p r o c e s s , EPA can promote v o l u n t a r y t e s t i n g of c h e m i c a l s . R e c e n t l y , much o f t h e n e e d e d t e s t i n g i s b e i n g c o n d u c t e d by i n d u s t r y as a r e s u l t o f v o l u n t a r y n e g o t i a t i o n s b e t w e e n EPA a n d the affected manufacturers. As a r e s u l t , c h e m i c a l s of p r i o r i t y concern are b e i n g further evaluated more e f f i c i e n t l y t h a n i f EPA i n i t i a t e d a full rulemaking proceeding . CMA has a l s o u r g e d g r e a t e r r e l i a n c e on informed s c i e n t i f i c judgment of the t e s t s p o n s o r . This i s in l i n e w i t h our g e n e r a l theme t h a t r e g u l a t o r y d e c i s i o n s s h o u l d be made on t h e b a s i s o f "good s c i e n c e . " EPA had e x p r e s s e d g r e a t i n t e r e s t i n new and c o n t r o v e r s i a l a r e a s of t e s t i n g , s u c h as n e u r o t o x i c i t y and mutagenicity,

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where t h e r e i s s u b s t a n t i a l s c i e n t i f i c d i s a g r e e m e n t o v e r p r o p e r t e s t m e t h o d s and c o r r e c t i n t e r p r e t a t i o n o f t e s t results. CMA h a s s t r e s s e d t h a t t h e A g e n c y s h o u l d focus on d e v e l o p i n g straightforward t e s t r e q u i r e m e n t s t h a t do not r a i s e unresolved scientific issues. Section 5 o f TSCA i s another area o f much regulatory activity. Section 5 authorizes EPA t o s c r e e n "new" c h e m i c a l s , and " s i g n i f i c a n t new u s e s " o f e x i s t i n g c h e m i c a l s b e f o r e t h e y a r e m a n u f a c t u r e d so a s t o i d e n t i f y t h e i r p o t e n t i a l a d v e r s e e f f e c t s on h e a l t h or the environment. EPA's a c t i o n s u n d e r S e c t i o n 5 h a v e an i m p a c t on t h e f u t u r e d e v e l o p m e n t o f new c h e m i c a l s . C o n g r e s s was w e l l aware o f t h e p o t e n t i a l f o r s t i f l i n g i n n o v a t i o n and d e s i g n e d S e c t i o n 5 s o i t w o u l d impose minimum burdens on m a n u f a c t u r e r s while s t i l l i d e n t i f y i n g and e l i m i n a t i n g unreasonable r i s k s as r e q u i r e d under the A c t . Unfortunately, EPA i n i t i a l l y p r o p o s e d ambitious regulations t h a t c o u l d have expanded premanufacture notification ("PMN") r e q u i r e m e n t s well beyond the l i m i t s embodied i n t h e s t a t u t e . F o r e x a m p l e , EPA h a d t e s t i f i e d i n Congress that m a n u f a c t u r e r s would merely be r e q u i r e d t o c o m p l e t e and s u b m i t a two-page PMN f o r m . B u t t h e PMN t h a t EPA p r o p o s e d i n J a n u a r y o f 1979 was an e x t r e m e l y d e t a i l e d form which c a l l e d for nearly 40 pages of mandatory i n f o r m a t i o n , a n d 20 m o r e p a g e s o f optional information. CMA, a n d o t h e r industry commenters, urged drastic modifications i n EPA's proposal i n order to conform to the terms of the s t a t u t e and l e s s e n t h e b u r d e n on i n n o v a t i o n . In p a r t i c u l a r , CMA d e v e l o p e d and p r o v i d e d t o EPA, a d r a f t PMN form w h i c h c a l l e d f o r much l e s s i n f o r m a t i o n , b u t would s t i l l be a d e q u a t e t o f a c i l i t a t e EPA's review f u n c t i o n under S e c t i o n 5· EPA r e s p o n d e d t o i n d u s t r y c o n c e r n s b y p u b l i s h i n g reproposed regulations t h a t w e r e s u b s t a n t i a l l y more focused i n scope. Nevertheless, i n d u s t r y s t i l l had substantial reservations a b o u t many a s p e c t s o f E P A ' s reproposal. For example, CMA a r g u e d that EPA's r e p r o p o s e d PMN f o r m was s t i l l more e l a b o r a t e than n e c e s s a r y and c a l l e d f o rinformation t h a t EPA l a c k e d s t a t u t o r y a u t h o r i t y to r e q u i r e . In a d d i t i o n , industry e x p r e s s e d r e s e r v a t i o n s about EPA's c o n t i n u e d interest in p r e s c r i b i n g supplemental r e p o r t i n g requirements. F i n a l l y , CMA o b j e c t e d strenuously to h i g h l y elaborate p r o c e d u r e s t h a t EPA h a d d e v e l o p e d f o r a s s e r t i n g a n d substantiating confidentiality claims. Industry felt i t was h i g h l y u n n e c e s s a r y to r e q u i r e such s u b s t a n t i a t i o n a t t h e t i m e a PMN i s s u b m i t t e d , rather than after a request f o r the d i s c l o s u r e o f PMN

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information had been r e c e i v e d under the Freedom of I n f o r m a t i o n Act ( " F O I A " ) -- w h i c h i s how i t i s done u n d e r most o t h e r EPA regulations. While debate over the merits of i t s p r o p o s e d r e g u l a t i o n s has continued, EPA has simultaneously r e c e i v e d and r e v i e w e d a l m o s t 2,000 P M N s · The Agency's p r e m a n u f a c t u r e r e v i e w p r o g r a m has b e e n s h a p e d by the e x p l i c i t r e q u i r e m e n t s of the s t a t u t e , s u p p l e m e n t e d by informal A g e n c y g u i d a n c e , and t h u s has provided an opportunity t o t e s t the i n d u s t r y p o s i t i o n t h a t Section 5 c a n be i m p l e m e n t e d e f f e c t i v e l y without detailed regulations· I n CMA s judgment, EPA's e x p e r i e n c e largely c o n f i r m s the i n d u s t r y p o s i t i o n . In g e n e r a l , the PMN p r o g r a m has b e e n f u n c t i o n i n g s m o o t h l y and efficiently i n the a b s e n c e of r e g u l a t i o n s . M o s t PMN submitters have p r o v i d e d EPA with adequate i n f o r m a t i o n in their PMNs w h i c h r e f l e c t s t h e f a c t t h a t t h e c h e m i c a l s have generally presented l i t t l e o r no r i s k s . Submitters have a l m o s t always been r e s p o n s i v e to voluntary requests for follow-up information. In a d d i t i o n , where EPA has expressed concerns about the health and e n v i r o n m e n t a l e f f e c t s o f p a r t i c u l a r c h e m i c a l s , many submitters have t a k e n i n f o r m a l a c t i o n to a l l a y those concerns, including voluntary s u s p e n s i o n of the PMN r e v i e w p e r i o d o r w i t h d r a w a l o f the PMN. A t t h e same t i m e , h o w e v e r , there is emerging e v i d e n c e t h a t PMN requirements have significantly i n h i b i t e d i n n o v a t i o n i n the c h e m i c a l i n d u s t r y . Section 5 has i n e v i t a b l y had some i m p a c t on i n n o v a t i o n , and EPA regulations that add to the b a s i c s t a t u t o r y requirements are likely t o i m p o s e b u r d e n s on the chemical i n d u s t r y t h a t are u n n e c e s s a r y . That i s why CMA r e c o m m e n d s t h a t t h e Age ne y , a t a m i n i m u m , l i m i t those r e g u l a t i o n s to the c l e a r r e q u i r e m e n t s of the statute. R e q u i r e m e n t s s u c h as s u p p l e m e n t a l reporting o f PMN information, mandatory consumer contacts, a d v a n c e s u b s t a n t i a t i o n of c o n f i d e n t i a l i t y c l a i m s , and t h e " i n v a l i d a t i o n " o f i n c o m p l e t e PMNs, w i l l o n l y serve t o i n c r e a s e the c o s t s o f a p r o c e s s t h a t a l r e a d y imposes s u b s t a n t i a l burdens. S i n c e EPA c a n a d e q u a t e l y protect human h e a l t h and the environment without these r e q u i r e m e n t s , t h e y s h o u l d be eliminated. 1

The chemical i n d u s t r y also encourages EPA to r e e x a m i n e and rescind i t s Premanufacture Testing P o l i c y . Wh i 1 e ostensibly voluntary, this po1i c y e m b o d i e s the A g e n c y ' s p o s i t i o n t h a t a l l , o r n e a r l y a l l , new chemicals should und e r g o a mi n i m um "base s e t " of t e s t s o r , i n OECD t e r m s , a "Minimum P r e m a r k e t i n g S e t o f D a t a " (MPD), w h i c h c o u l d g r e a t l y i n c r e a s e t h e c o s t s of

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m o s t PMN submittals. As C o n g r e s s drafted TSCA, t h e d e c i s i o n w h e t h e r t o t e s t a new c h e m i c a l , a n d how much t e s t i n g t o do, r e s i d e s i n i t i a l l y w i t h t h e PMN submitter and must be t a i l o r e d t o t h e p a r t i c u l a r c i r c u m s t a n c e s o f e a c h new c h e m i c a l . Any a c t i o n by EPA w h i c h r e s u l t s i n u n n e c e s s a r y t e s t i n g , o r p r e v e n t s PMN submitters from b a l a n c i n g t h e e c o n o m i c and s a f e t y f a c t o r s u n i q u e to t h e i r p a r t i c u l a r c h e m i c a l s , w i l l add u n j u s t i f i a b l y to PMN c o s t s , and n e e d l e s s l y i n h i b i t i n n o v a t i o n w i t h o u t a commensurate b e n e f i t . As a f o o t n o t e , t h i s p h i l o s o p h y t o w a r d s chemical t e s t i n g i s i n c o n t r a s t w i t h t h a t of the Europeans* " S i x t h Amendment." The S i x t h Amendment r e q u i r e s t h e development of "base set" data through mandatory t e s t i n g c o n d u c t e d b e f o r e t h e c h e m i c a l may be marketed. The U.S. has had much more e x p e r i e n c e i n i m p l e m e n t i n g a r e g u l a t o r y scheme t o e v a l u a t e t h e e f f e c t s o f c h e m i c a l s , and recognizes the great costs and burdens of performing unnecessary t e s t s . A l s o i n t h e U.S., much d a t a has a l r e a d y b e e n d e v e l o p e d that i s available for e v a l u a t i o n o f many c h e m i c a l s . F u r t h e r t e s t i n g w o u l d be s u p e r f l u o u s i n many i n s t a n c e s . T h a t i s why the EPA m u s t f i r s t make a s h o w i n g t h a t a p a r t i c u l a r chemical may p r e s e n t an u n r e a s o n a b l e r i s k o r c a u s e significant human o r e n v i r o n m e n t a l e x p o s u r e before designating i t for further testing. In addition, CMA has petitioned the EPA to e s t a b 1 i sh e x e m p t i o n s under S e c t i o n 5 of TSCA f o r c e r t a i n chemical s· The s e e x e m p t i o n s f a l l i n t o t h r e e c a t e g o r i e s — exemptions for s i t e - l i m i t e d i n t e r m e d i a t e s ; low volume c h e m i c a l s ; and p o l y m e r s . For i n s t a n c e , a s u b s t a n t i a1 po r t i o n o f t h e PMN filings r e c e i v e d by EPA t o da t e have b e e n f o r i n t e r m e d i a t e s and h i g h m o l e c u l a r we i g h t p o l y m e r s · The r i s k p o t e n t i a l of t h e s e chem i c a l s i s u n u s u a l l y low and the y rarely require careful e v a l u a t i o n s by the Agency. Iη a d d i t i o n , many new s it e - l i m i t e d intermediates are t y p i c a l l y manufactured i n s m a l l volume s and a r e unable to a b s o r b t h e c o s t s o f PMN submissions. For these r e a s o n s , CMA pe t i t i o n e d EPA to g r a n t e x e m p t i o n s as p e r m i t t e d u n d e r S e c t i o n 5 ( h ) ( 4 ) o f TSCA. EPA recently p r o p o s e d s u c h e x e m p t i o n s i n Au g u s t . Al though some p r o b l e m s we r e r a i s e d r e g a r d i ng E P A ' s p r o p o s a l s d u r i n g t h e comment p e r i o d , i t i s l i k e l y t h a t by 1983 t h e f i n a l e x e m p t i o n r e g u l a t i o n s wi11 be i n p i a c e · Ano t h e r im po r t a η t p r o v i s i o n und e r S e c t i o n 5 o f TSCA i s the "significant new use" n o t i f i c a t i o n r e q u i r e m e n t ( c a l l e d "SNUR"). A "SNUR" i s d e s i g n e d to n o t i f y EPA when a c h e m i c a l , t h a t h a s u n d e r g o n e PMN r e v i e w , p r e s e η t s a s i g n i f i c a n t new distribution in

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commerce. The c r i t e r i a d e f i n i n g a s i g n i f i c a n t new use includes projected production volume, p r o j e c t e d uses and p r o j e c t e d e x p o s u r e . A disturbing development last y e a r was EPA's i n t e r e s t i n u s i n g SNURs t o m o n i t o r the c o m m e r c i a l d e v e l o p m e n t o f new chemicals that have completed the PMN review process. CMA submitted c o m m e n t s on the first "significant new use rule" d i r e c t e d at a s p e c i f i c chemical. A l t h o u g h SNURs may be appropriate in certain circumstances, CMA objected to t h e i n d i s c r i m i n a t e u s e o f SNURs t o f o l l o w - u p on new chemicals after i n i t i a l manufacture because i t could s u b j e c t such c h e m i c a l s to a b u r d e n s o m e s e r i e s of n o t i f i c a t i o n requirements throughout t h e i r life-cycles. S u c h r e c u r r i n g PMN r e q u i r e m e n t s would i n c r e a s e the short-term and l o n g - t e r m c o s t s o f c o m m e r c i a l i z i n g new chemicals, e s p e c i a l l y when more e f f e c t i v e o p t i o n s are available. I w o u l d l i k e now to d i s c u s s a t h i r d m a j o r a r e a of TSCA -- t h e r e c o r d k e e p i n g , r e t e n t i o n , and r e p o r t i n g o f i n f o r m a t i o n u n d e r S e c t i o n 8 o f TSCA. The b a s i c p u r p o s e o f t h i s i n f o r m a t i o n g a t h e r i n g m e c h a n i s m o f TSCA i s t o a s s i s t EPA i n a c q u i r i n g i n f o r m a t i o n n e c e s s a r y for the Agency's v a r i o u s r e g u l a t o r y a c t i v i t i e s under the Act. S e c t i o n 8 i s not a s u b s t a n t i v e regulatory provision. I t f u n c t i o n s as an a d j u n c t to o t h e r provisions to provide EPA with the information relevant to the e v a l u a t i o n of t h e h e a l t h o r e n v i r o n m e n t a l e f f e c t s of chemical substances. An o b v i o u s and a l l - i m p o r t a n t a s p e c t o f S e c t i o n 8 i s t h a t i t i s a m e c h a n i s m to f a c i l i t a t e t h e a c q u i s i t i o n o f i n f o r m a t i o n t h a t EPA n e e d s . A c c o r d i n g l y , the proper t e s t of EPA's p e r f o r m a n c e u n d e r S e c t i o n 8 i s n o t the amount of i n f o r m a t i o n t h a t EPA a c q u i r e s o r t h e number o f c o m p a n i e s r e q u i r e d to r e p o r t , b u t the Agency's success in b u i l d i n g a data-base f o r a c c o m p l i s h i n g its s p e c i f i c r i s k a s s e s s m e n t , t e s t i n g and c h e m i c a l control r e s p o n s i b i l i t i e s u n d e r S e c t i o n s 4, 5, 6 and 7 of TSCA. In v i e w o f t h i s p u r p o s e , i t was of g r e a t c o n c e r n that EPA has r e p e a t e d l y f a i l e d to d e f i n e c a r e f u l l y , and then articulate fully, the c o n n e c t i o n between a proposal u n d e r S e c t i o n 8, and a specific regulatory objective u n d e r some o t h e r p r o v i s i o n of TSCA. A l l t o o o f t e n , the A g e n c y ' s p r o p o s a l s appeared to s e e k i n f o r m a t i o n f o r i t s own sake. As a r e s u l t , EPA's reporting proposals o f t e n r e q u i r e d the s u b m i s s i o n of data t h a t are of q u e s t i o n a b l e validity or limited relevance i n EPA's r i s k a s s e s s m e n t a c t i v i t i e s under o t h e r TSCA p r o v i s i o n s . They a l s o c a l l e d f o r f a r more i n f o r m a t i o n t h a n EPA had the c a p a b i l i t y to p r o c e s s and evaluate in a reasonable p e r i o d of t i m e .

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An e x a m p l e o f t h e s e p r o b l e m s was E P A ' s p r o p o s e d " p r e l i m i n a r y a s s e s s m e n t " r u l e under S e c t i o n 8 ( a ) . This r u l e would have c o v e r e d 2 , 300 c h e m i c a l s a n d a f f e c t s a very l a r g e number o f m a n u f a c t u r e r s a n d processors. Nevertheless, EPA's p r o p o s a l f a i l e d t o e x p l a i n why t h e Agency b e l i e v e d i t c o u l d p r o m p t l y p r o c e s s information on t h i s many c h e m i c a l s , what p r e c i s e c r i t e r i a were u s e d to s e l e c t c h e m i c a l s f o r i n c l u s i o n i n EPA's r e p o r t i n g p r o g r a m , and e x a c t l y how EPA i n t e n d e d to use the i n f o r mation submitted to r e a c h c o n c l u s i o n s concerning the risk p o t e n t i a l o f t h e 2,300 c h e m i c a l s involved. Fortunately, i n t h e f i n a l r u l e , EPA h a s r e j e c t e d a generic approach to S e c t i o n 8(a) follow-up o f new c h e m i c a l s and r e q u i r e s r e p o r t i n g o n l y where i t h a s identified specific concerns. The l i s t o f 2*, 3 0 0 c h e m i c a l s has been r e d u c e d t o 250 . T h e r u l e s a r e now s t r u c t u r e d to r e q u i r e r e p o r t i n g by m a n u f a c t u r e r s and importers, with f o l l o w - u p processor r e p o r t i n g , which s i g n i f i c a n t l y r e d u c e s t h e b u r d e n on s u b m i t t e r s . A n o t h e r example o f e x c e s s i v e l y b r o a d regulations is EPA's r e q u i r e m e n t of reporting a l l e g a t i o n s of " s i g n i f i c a n t a d v e r s e r e a c t i o n s " under S e c t i o n 8(c). F i r s t o f a l l , t h e s e " a l l e g a t i o n s " a r e by d e f i n i t i o n unsubstantiated, and t h e y o f t e n w i l l be i n a c c u r a t e o r misleading. Moreover, broad r e p o r t i n g requirements might encompass many thousands of a l l e g a t i o n s throughout industry. S e c o n d l y , as w r i t t e n i n the statute, this i s a recordkeeping provision, not a reporting requirement. This proposal, again, goes beyond the s t a t u t o r y r e q u i r e m e n t s o f TSCA and h a s little value i n achieving i t s objectives. We a r e e n c o u r a g e d t h a t EPA i s r e c o n s i d e r i n g some o f i t s b a s i c c o n c e p t s under the p r o p o s a l b e f o r e p u b l i s h i n g the f i n a l r ule . EPA's p r e v i o u s e f f o r t s to expand i t s a u t h o r i t y would have r e s u l t e d i n the submission of data of questionable q u a l i t y , and t h e i m p o s i t i o n o f u n n e c e s s a r y b u r d e n s on i n d u s t r y . Industry h a s r e c o m m e n d e d a more focused a p p r o a c h u n d e r w h i c h EPA c o u l d still obtain more t h a n enough sound i n f o r m a t i o n to support i t s regulatory activities under TSCA. The r e p o r t i n g p r o v i s i o n s of S e c t i o n 8 a r e s u f f i c i e n t l y broad to a l l o w EPA t o a c c o m p l i s h i t s o b j e c t i v e s w i t h o u t d e p a r t i n g from t h e b a s i c s t a t u t o r y f r a m e w o r k e s t a b l i s h e d by C o n g r e s s . S e c t i o n 8 ( d ) g o v e r n s EPA a c q u i s i t i o n o f h e a l t h and safety studies. i t a u t h o r i z e s EPA t o p r o m u l g a t e rules r e q u i r i n g a n y p e r s o n who m a n u f a c t u r e s , p r o c e s s e s o r d i s t r i b u t e s i n commerce a n y c h e m i c a l substance or m i x t u r e , o r p r o p o s e s t o do s o , t o s u b m i t l i s t s and/or c o p i e s o f h e a l t h and s a f e t y s t u d i e s . EPA may e x c l u d e

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c e r t a i n t y p e s of s t u d i e s i f i t f i n d s t h e i r submission t o be u n n e c e s s a r y to c a r r y o u t the p u r p o s e s o f TSCA. EPA p r o p o s e d and r e p r o p o s e d i t s S e c t i o n 8 ( d ) rule and CMA submitted extensive comments. CMA expressed concern t h a t the proposal applied to a b r o a d and i n d i s c r i m i n a t e s e l e c t i o n of c h e m i c a l s with l i t t l e a t t e m p t to e x p l a i n why r e p o r t i n g on t h e s e c h e m i c a l s is needed. The l e g i s l a t i v e h i s t o r y a n d S e c t i o n s 2 and 9 o f TSCA r e q u i r e EPA t o m i n i m i z e t h e b u r d e n on r e p o r t e r s by s e e k i n g o n l y i n f o r m a t i o n n e c e s s a r y to a c h i e v e i t s o b j e c t i v e s u n d e r TSCA. Many o f CMA s c o n c e r n s were addressed by EPA i n the final Section 8(d) rule p u b l i s h e d i n September. A l t h o u g h t h e i n t e r n a t i o n a l a s p e c t s o f TSCA w i l l be a d d r e s s e d i n d e t a i l by a n o t h e r s p e a k e r , I t h o u g h t i t appropriate to m e n t i o n t h a t CMA and industry are p a r t i c i p a t i n g i n the d e v e l o p m e n t o f t h o s e i s s u e s r a i s e d by t h e v a r i o u s s e c t i o n s o f TSCA. For i n s t a n c e , i n the a r e a of t e s t i n g c h e m i c a l s u n d e r S e c t i o n 5, t h e r e are differences between the U.S. and the European a p p r o a c h e s r e g a r d i n g when t e s t i n g s h o u l d be required, w h i c h I have a l r e a d y m e n t i o n e d . A n o t h e r a r e a of i n t e r n a t i o n a l c o n t r o v e r s y i s the export n o t i f i c a t i o n requirements under S e c t i o n 12(b). EPA's r e g u l a t i o n r e q u i r e s t h a t (1) e x p o r t e r s n o t i f y t h e EPA of t h e i r i n t e n t to e x p o r t chemicals that are s u b j e c t to c e r t a i n l i s t e d r e g u l a t o r y a c t i v i t i e s under TSCA, ( 2 ) t h a t EPA n o t i f y t h e f o r e i g n g o v e r n m e n t o f t h e i m p o r t a t i o n o f s u c h c h e m i c a l s , and (3) t h a t EPA provide TSCA-related information to t h o s e governments. CMA submitted a p e t i t i o n t o EPA proposing an a l t e r n a t i v e which provides f o r an annual dissemination of information concerning a l l relevant regulatory activities, listed in Section 12(b), to a l l f o r e i g n governments. This comprehensive mechanism would p r o v i d e a l l r e l e v a n t i n f o r m a t i o n to f o r e i g n g o v e r n m e n t s in a timely fashion. I f i n t h e i n t e r i m t h e r e was a f i n d i n g that a chemical presented an i m m i n e n t h a z a r d , a s p e c i a l n o t i c e c o u l d be s e n t . In t h i s m a n n e r each g o v e r n m e n t c o u l d e m p l o y i t s own a u t h o r i t y to regulate chemicals i m p o r t e d from a n y w h e r e i n the w o r l d , n o t j u s t from the U n i t e d S t a t e s . F u r t h e r m o r e , to the e x t e n t a S e c t i o n 12(b) n o t i c e m i g h t a d v e r s e l y a f f e c t commerce involving a regulated chemical, a l l exporters operate under similar c o n s t r a i n t s . We also suggested procedures designed to p r o t e c t c o n f i d e n t i a l information a s r e q u i r e d u n d e r S e c t i o n 14 o f TSCA. 1

The i n t e r n a t i o n a l i s s u e s r a i s e d by TSCA i n t e r f a c e with s e v e r a l arenas i n c l u d i n g the S t a t e Department, Commerce D e p a r t m e n t , EPA, the O r g a n i z a t i o n f o r Economic

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Cooperation and Development (OECD), the European E c o n o m i c Community ( E E C ) and t h e U n i t e d N a t i o n s . CMA c o n t i n u e s t o k e e p u p - t o - d a t e on t h e l a t e s t d e v e l o p m e n t s in these areas a n d i s an a c t i v e p a r t i c i p a n t i n d e v e l o p i n g r e a s o n a b l e and p r a c t i c a l international policies· As y o u c a n s e e , d u r i n g t h e r e g u l a t o r y d e v e l o p m e n t o f TSCA, t h e c h e m i c a l i n d u s t r y h a s b e e n a l e r t t o t h e p r a c t i c a l impacts o f t h e law and i t s e n s u i n g r e g u l a t i o n s . Represen ta t i v e s of i n d i v i d u a l m a n u f a c t u r e r s , CMA and o t h e r t r a d e a s s o c i a t i o n s , have p a r t i c i p a t e d a t e v e r y o p p o r t u n i t y t o p r o v i d e EPA w i t h t h e f a c t u a l d a t a i t r e q u i r e s and t o show t h e p r a c t i c a l i m p l i c a t i o n s o f i t s p r o p o s a l s i n o r d e r t o p r e v e n t EPA f r o m o v e r - e x t e n d i n g i t s power beyond i t s s t a t u t o r y authority. CMA h a s a s k e d EPA t o be m o r e s e n s i t i v e t o the impact of these regulatory requirements on innovation and o t h e r economic aspects of this i ndus t r y . EPA b e g a n w i t h o v e r l y a m b i t i o u s p l a n s w h i c h h a v e r e q u i r e d r e e x a m i n a t i o n i n l i g h t of p r a c t i c a l and l e g a l considerations that i t first overlooked. I f EPA f o c u s e s and m o d i f i e s i t s p r o p o s a l s i n a c c o r d a n c e with i n d u s t r y r e c o m m e n d a t i o n s , i t w i l l be a b l e t o i m p l e m e n t TSCA i n a r e a s o n a b l e , c o s t - e f f e c t i v e , y e t e f f i c i e n t and t i m e l y , manner. RECEIVED

December 23, 1982

Ingle; TSCA's Impact on Society and Chemical Industry ACS Symposium Series; American Chemical Society: Washington, DC, 1983.