Background, Goals, and Resultant Issues - ACS Publications

1 Background, Goals, and Resultant Issues GEORGE W. INGLE

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Chemical Manufacturers Association, Washington, DC 20037 At l e a s t two p a r t s of the h i s t o r y of TSCA have been prepared. The legislative h i s t o r y was prepared by the L i b r a r y of Congress, Congressional Research S e r v i c e , s h o r t l y a f t e r then President Ford signed the bill i n t o law, as P u b l i c Law 94-469. A s i g n i f i c a n t p a r t of t h i s summary i s Appendix I, of the April 1971 report, "Toxic Substances" prepared by the C o u n c i l on Environmental Q u a l i t y (CEQ). The nearly s i x years of l e g i s l a t i v e a c t i v i t y began when then President Nixon included the essence of t h i s report i n h i s State of the Union Message t o Congress i n February 1971. While t h i s CEQ report i s the legislative o r i g i n of TSCA, the conceptual o r i g i n , l i k e that of each of the s e v e r a l pieces of environmental l e g i s l a t i o n beginning i n the m i d - s i x t i e s , may well be Rachel Carson's "The S i l e n t Spring," published i n 1962. Several other r e l a t e d and heavily p u b l i c i z e d events created intensified i n t e r e s t ; these involved v i n y l c h l o r i d e monomer (VCM), p o l y c h l o r i n a t e d biphenyl (PCB's), mercury and other substances a s s o c i a t e d with b i o l o g i c a l damage. A second part of the h i s t o r y of TSCA was prepared by the Chemical Manufacturers A s s o c i a t i o n (CMA) — "The F i r s t Four Years of the Toxic Substances C o n t r o l Act — A Review of the Environmental Protection Agency's Progress i n Implementing TSCA." This review completed and summarized the " s i g n i f i c a n t developments i n the i n t e r p r e t a t i o n and implementation of TSCA since i t s enactment and CMA's assessment of them." There seems to be no corresponding a n a l y s i s by the initial proponents of TSCA, the group of environmentalist organizations i n c l u d i n g the Natural Resources Defense C o u n c i l , the Environmental Defense Fund, The Conservation Foundation, and others. In time, one expects that such a p e r s p e c t i v e w i l l be contributed. Each of these d i f f e r e n t views should be of concern to the broad spectrum of members of the American Chemical Society. It i s t h e i r d i s c i p l i n e s and t h e i r industry which are or w i l l be a f f e c t e d i n some way by the concepts, procedures and c o n t r o l s i n TSCA.

0097-6156/83/0213-0001$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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TSCA: IMPACT ON SOCIETY AND CHEMICAL INDUSTRY

While the e n t i r e CEQ Report of A p r i l 1971 i t s conclusions should be stressed:

should be read,

1. Toxic substances are e n t e r i n g the these substances can have severe e f f e c t s ;

environment

and

2. E x i s t i n g l e g a l a u t h o r i t i e s are inadequate and new l e g a l a u t h o r i z a t i o n s are required. Those a u t h o r i t i e s included i n the President's February '71 report were:


— EPA's a u t h o r i t y to r e s t r i c t or p r o h i b i t use or d i s t r i b u t i o n of a chemical substance, to p r o t e c t h e a l t h or the environment; not only adverse e f f e c t s but d e s i r e d b e n e f i t s must be considered; — I f the hazard were imminent, EPA could ask the courts to r e s t r a i n use or d i s t r i b u t i o n of the substance immediately; — EPA would be authorized to issue standards "or t e s t s to be performed and f o r r e s u l t s to be achieved f o r new substances, which could be marketed only a f t e r meeting these standards; — EPA could request from manufacturers information on potentially toxic substances — names, composition, production l e v e l , uses, and r e s u l t s of t e s t s to evaluate their effects; — The C o u n c i l on Environmental Q u a l i t y would be charged with c o o r d i n a t i n g e f f o r t s to e s t a b l i s h a uniform system for classifying and handling information on chemical substances. I t was f u r t h e r concluded that the Toxic Substances C o n t r o l Act i s a new way of l o o k i n g at environmental problems, a systematic and comprehensive approach, not l i m i t e d to p o l l u t a n t s classified by t h e i r occurrence, as i n a i r or water. TSCA contemplates the flow of p o t e n t i a l l y t o x i c substances from t h e i r o r i g i n , through use, to d i s p o s a l . In the f i v e and one-half years of ensuing Congressional a c t i v i t y , many a d d i t i o n a l aspects were considered and some were included i n the Act as f i n a l l y enacted. P o s s i b l y the most c o n t r o v e r s i a l had to do with the treatment of new substances. Were these to be t r e a t e d by r e g i s t r a t i o n , as i s the case i n the F e d e r a l I n s e c t i c i d e Fungicide and Rodenticide Act (FIFRA), or were they to be subject to a l e s s onerous notification procedure? T h i s would begin the attempt to assess t h e i r r i s k s more i n balance with the growth i n commercial volume of the substance, and hence with i t s c a p a c i t y to pay the costs f o r the frequently c o s t l y t e s t i n g r e q u i r e d . Without such a balance, the


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INGLE

Background,

Goals,

and

3

Resultant Issues


i n d u s t r y a s s e r t e d that excessive c o s t s f o r t e s t i n g new sub stances without established markets would frustrate their research and development. The notification view prevailed f i n a l l y i n the form of a f l e x i b l e and s e q u e n t i a l review of new substances, and of e x i s t i n g substances, i n c l u d i n g those new substances found to present no unreasonable r i s k and thus, i n time, added to the inventory of e x i s t i n g substances. This d e c i s i o n i s the source of s e v e r a l problems d i s c u s s e d i n t h i s symposium. Does t h i s multistage system of a s s e s s i n g the risks of new substances simultaneously p r o t e c t and nurture chemical i n n o v a t i o n , as S e c t i o n 2 of TSCA i n c l u d e s as part of Congressional P o l i c y and Intent? The papers by D. Bannerman and C.W. Umland deal explicitly with this issue and others i n d i r e c t l y . Has the European Economic Community's S i x t h Amend ment to i t s June 27, 1967, Directive (relating to the c l a s s i f i c a t i o n , packaging and l a b e l i n g of dangerous substances) created an i n t e r n a t i o n a l impasse by e s t a b l i s h i n g , f o r n o t i f y i n g new substances, a system nearer to r e g i s t r a t i o n ? B. B i l e s ' s chapter suggests t h i s has happened, and that i t w i l l take these groups of t r a d i n g partners years to r e s o l v e . T h i s problem i s aggravated f u r t h e r by OECD's (Organization f o r Economic Coopera t i o n and Development) proposal of i t s "Minimum Premarketing Data" requirement f o r assessing the r i s k s of new chemicals. Almost i d e n t i c a l to the EEC's "base s e t " of data f o r the same purpose, these two r i g i d systems are d i f f i c u l t to harmonize with TSCA on a sound risk-assessment b a s i s , but the e f f o r t w i l l continue. Another balance of f a c t o r s w i t h i n TSCA r i s k s and b e n e f i t s of the f a r l a r g e r number c a l s . E.H. B l a i r ' s c o n t r i b u t i o n examines the p r i o r i t i e s f o r t e s t i n g e x s i t i n g chemicals to i n a c o s t - e f f e c t i v e procedure.

has to do with the of e x i s t i n g chemi problem of s e t t i n g assess t h e i r r i s k s

Of a l l that which i s known about the r i s k s of these substances to h e a l t h and to the environment, how much i s s i g n i f i c a n t ? What are the f u r t h e r needs f o r information? How much of t h i s may e x i s t i n unpublished work elsewhere i n the new world? How can unnecessary d u p l i c a t i o n be eliminated? How f a r should the OECD Chemicals Programme go i n i n t e r n a t i o n a l i z i n g review and e v a l u a t i o n of e x i s t i n g chemicals f o r t h e i r r i s k s ? Is i t true, as Ε. H. Hurst a s s e r t s i n h i s chapter, that the costs of n o t i f y i n g new chemicals are so great, i n r e l a t i o n to t h e i r commercial value, t h a t USA research and development i n c r e a s i n g l y examines e x i s t i n g substances, or c l o s e l y r e l a t e d new substances, with minimal risks? These questions should be pondered by chemists i n research and development, because they bear on


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future of the chemical chemists* c a r e e r s .

industry,

here and

abroad, and

thus

on


These e f f e c t s and those of other r e g u l a t i o n s proposed or implemented by EPA have stimulated a flow of i n i t i a t i v e s by the chemical i n d u s t r y and i t s major trade a s s o c i a t i o n s to propose changes i n these or new concepts f o r other, r e g u l a t i o n s , as described by S. Davis, Esq., i n her a n a l y s i s . Many of these changes and concepts are of p a r t i c u l a r i n t e r e s t to the smaller chemical manufacturer. T h e i r l i m i t e d f i n a n c i a l and manpower resources are f a r l e s s able to cope with the requirements of TSCA, with the r e s u l t that t h i s s i g n i f i c a n t source of chemical innovation i s at a s e r i o u s disadvantage. In i t s f u l l reach, TSCA r e q u i r e s the r e c e i p t , production and management of a vast amount of information. As C. Elmer and D. Harlow i n d i c a t e , major new i n c e n t i v e s f o r l a r g e r and b e t t e r information management systems w i t h i n the corporate s t r u c t u r e s of most chemical manufacturers have r e s u l t e d . The r o l e of EPA i t s e l f , i n amassing such information, maintaining i t s q u a l i t y , and making i t a v a i l a b l e w i t h i n the l i m i t s of c o n f i d e n t i a l i t y c o n t r o l s , needs c r i t i c a l examination. The s i g n i f i c a n c e of those elements of t h i s information that are trade secrets i s discussed by J . O ' R e i l l y . He s t r e s s e s s i g n i f i c a n t d i f f e r e n c e s between the u n t r i e d EEC system under the S i x t h Amendment to the 67/548/EEC D i r e c t i v e , and the f u n c t i o n i n g TSCA System — d i f f e r e n c e s which need r e s o l u t i o n . The u t i l i t y of TSCA's information banks to people i n chemical market research, f o r example, was not described i n t h i s Symposium, but i t would seem to be only a matter of time before t h i s major compilation w i l l attract workers i n t h i s and other p a r t s of the chemical i n d u s t r y , as w e l l as workers i n the government i t s e l f and people representing public interests. The impacts of TSCA, such as those on two s p e c i f i c exemp l a r y i n d u s t r i e s , surface c o a t i n g polymers and metal-cutting f l u i d s , by S.Oslosky and H.Fribush, r e s p e c t i v e l y , are implied but a c t u a l l y not e x p l i c i t w i t h i n TSCA. Consider the required assessment of r i s k s , the need f o r t e s t - d a t a d e s c r i b i n g e f f e c t s on h e a l t h and the environment, a s i d e from p l a n t i n s p e c t i o n s , subpoenas, p r o h i b i t e d acts, penalties for prohibited acts, enforcement and seizure, judicial review, citizens' civil a c t i o n s and p e t i t i o n s , and employee p r o t e c t i o n p r o v i s i o n s i n the Act. Thus, i t ' s i n e v i t a b l e that the a l e r t manufacturer w i l l adjust h i s product research, development and s e l e c t i o n processes to i d e n t i f y and use substances with reduced r i s k to h e a l t h and the environment wherever p o s s i b l e . As s t r u c t u r e - ( b i o l o g i c a l ) activity relationships become more reliable, the alert


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and Resultant Issues

synthesizer of new substances should r e l y i n c r e a s i n g l y on t h i s d i s c i p l i n e to help reduce c o s t s i n sharpening h i s s e l e c t i o n of p r e f e r r e d s t r u c t u r e s . These f a c t o r s d i r e c t the chemical industry toward substances, uses and c o n t r o l s which should be g e n e r a l l y preventive of i n s u l t t o h e a l t h and environment. Aside from the a c t i o n s already i n i t i a t e d by EPA under S e c t i o n 6 to r e s t r i c t exposures to p o l y c h l o r i n a t e d biphenyls and to chlorofluorocarbons i n c e r t a i n uses, no other a c t i o n s have been taken against s p e c i f i c chemical substances, nor has an imminent hazard been i d e n t i f i e d f o r appropriate a c t i o n . Less than a dozen proposed orders have been issued under S e c t i o n 5(e) requesting further information to assess the r i s k s of as many new substances. Perhaps 80 informal requests f o r f u r t h e r information on such substances have been made and s a t i s f i e d v o l u n t a r i l y . T e s t i n g programs f o r a s u b s t a n t i a l number of e x i s t i n g substances have been s t a r t e d and more are planned. In a d d i t i o n , of course, the monumental task of c r e a t i n g an inventory of some 55,000 e x i s t i n g chemicals was completed.


m

With very few short-term exceptions, these a c t i o n s may lead h o p e f u l l y t o long-term improvement, l a r g e l y by preventive measures, and by broad education of manufacturers, processors and users, to reduce h e a l t h and environmental i n s u l t s . How can such meaningful progress, i f any, be measured, aside from numbers of r e g u l a t i o n s i s s u e d , or chemical compounds tested? How can i t be determined i f t h i s noble experiment i s s u c c e s s f u l , l e t alone c o s t - e f f e c t i v e ? M.J. L i p s e t t ' s paper suggests that impacts of TSCA on p u b l i c and occupational h e a l t h may take a long time to d e t e c t , i f ever, simply because TSCA i s only one i n a spectrum of r e l a t e d laws. How, then, can d e c i s i o n s be made under TSCA i f the e f f e c t s are so d i f f i c u l t to d i s c e r n ? Some i n s i g h t i n t o u s e f u l and q u a n t i t a t i v e methodology i s given by D.W. North. E q u a l l y or more important f o r the long term, i s the supply of t a l e n t to use t h i s or other methodology to make such decisions, whether i n the r e g u l a t o r y agencies or i n the i n d u s t r y . To the extent t h a t relevant s e c t o r s of i n d u s t r y take the f u l l range of i n i t i a t i v e s t o reduce adverse b i o l o g i c a l e f f e c t s , aside from complying with e x i s t i n g and forthcoming r e g u l a t o r y requirements — the r e g u l a t o r y agencies' r o l e s may be minimized. To t h i s e s s e n t i a l g o a l , R.L. P e r r i n e ' s comments on educating the Ph.D. environmental chemist f o r careers i n government, i n d u s t r y , and i n education a r e d i r e c t e d . Having asked a l l these questions, and made analyses and drawn c o n c l u s i o n s from observing implementation of TSCA to date, how can one sum i t s o v e r a l l costs and i t s b e n e f i t s ? On balance,


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do the b e n e f i t s equal the costs? The costs are c o n s i s t e n t l y more evident than the b e n e f i t s , but i s t h i s simply because the l a t t e r are so d i f f i c u l t to q u a n t i f y ? Much i n f o r m a t i o n has been generated about new and e x i s t i n g chemical substances, but EPA's c o n t r o l of unreasonable r i s k s r e l a t e d to these has been very much l e s s i n evidence. Does t h i s r e f l e c t the use of other laws, EPA's i n a c t i o n , i n d u s t r y ' s s e l f - c o n t r o l or i n d u s t r y ' s o p p o s i t i o n to any c o n t r o l by EPA? The Conservation Foundation's J.C. Davies, who had a s i g n i f i c a n t r o l e i n CEQ's i n i t i a l c r e a t i o n of TSCA, commented, "there have been almost no s i g n i f i c a n t b e n e f i t s of TSCA r e s u l t i n g from c o n t r o l s on e x i s t i n g chemicals. The costs of a d m i n i s t r a t i o n of TSCA i n '81 approximated $85 m i l l i o n , and i n d u s t r y and p u b l i c costs f o r compliance i n '80 were estimated by CEQ to be roughly 3.5x t h i s l e v e l . " Are the i n d i r e c t costs more important than these d i r e c t c o s t s ? Has innovation i n the chemical i n d u s t r y been supressed by TSCA? How r e l i a b l e are the assumptions that such suppression has occurred? Can TSCA's effects be separated from those of inflation, tax r a t e , i n d u s t r i a l R/D budgets, and long-term maturation of the industry? Davies suggests that the u n c e r t a i n t i e s i n costs and i n b e n e f i t s are so great as to f r u s t r a t e t h e i r comparison. Aside from t h i s i s the philosophy that the p u b l i c , through TSCA, has a role i n decision-making with regard to chemicals. In t h i s context, the p u b l i c might w e l l ask i f experience to date i n implementing TSCA i n d i c a t e s areas of i n e f f i c i e n c y . Are a l l parts of TSCA workable? What i s the most e f f e c t i v e balance between regulatory a c t i o n and voluntary compliance? Does TSCA provide a "due-process" f o r i n d u s t r y and the p u b l i c i n determining i f a substance poses unreasonable risks? Does TSCA gather more information than i s needed f o r appropriate c o n t r o l of chemicals? Does TSCA provide a reasonable framework f o r d e c i d i n g qut _ ions of p o l i c y , i f not of science, as t o how much r i s k s o c i e t y w i l l t o l e r a t e i n using chemical substances? Few of these questions are easy t o answer. The e f f o r t has begun i n these papers. A l l members of the American Chemical Society should be concerned that progress i s made toward t h e i r answers. RECEIVED August 10,

1982


Background, Goals, and Resultant Issues - ACS Publications

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