Biotechnology Regulation - ACS Symposium Series (ACS Publications)

Chapter 30

Biotechnology

Regulation

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An Environmentalist's View Jack Doyle Environmental Policy Institute, 218 D Street, SE, Washington, DC 20003 Environmentalists do not intend to be the enemy of the biotechnology industry. Rather, they recognize the great potentials and desire to help move biotechnology forward without unduly endangering the environment. Environmentalists contend that regulation of the release of genetically-altered organisms must be given to EPA. They cite illegal release incidents and problems with the management within the coordinated framwork. They believe new legislation is needed to clarify the present situation legally, to protect the environment, and to insure a "local playing field" for all participants. Despite what many have heard, or are inclined to believe, environmentalists are not shutting down the biotechnology industry. One need only look as far as Wall Street and the recent public offerings by biotechnology companies to know that this industry is robust indeed. Investors continue to be interested, even though the pay-off is years away in many cases, Agracetus has tested genetically engineered tobacco plants in the field; Ciba-Geigy has field tested herbicide tolerant plants; Advanced Genetic Sciences has tested "ice minus" in the field, as has University of California researcher Steven Lindow, Secondly, it is important to mention the fact that some environmentalists think a great deal about economic impacts as well as ecological concerns. Too often, it seems, environmentalists are thought of as only concerned with the picture-book environment, with the cosmetic side of the outdoors, derisively referred to as "bugs and bunny" people or "tree buggers". However, most environmentalists are very concerned with economic health and, particularly, economic opportunity, fair pricing, and genuine competition in the marketplace, And third, The Environmental Policy Institute (EPI) does not oppose biotechnology, but rather we believe that these are 0097-6156/88/0379-0394$06.00/0 « 1988 American Chemical Society

Hedin et al.; Biotechnology for Crop Protection ACS Symposium Series; American Chemical Society: Washington, DC, 1988.

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Biotechnology Regulation

e x c i t i n g times f o r b i o l o g i c a l r e s e a r c h . The r e v o l u t i o n t h a t i s o c c u r r i n g i n the b i o l o g i c a l s c i e n c e s a t the c e l l u l a r and m o l e c u l a r l e v e l s i s awesome and i t i s a s t o u n d i n g . The c o n c e r n s w i t h b i o t e c h n o l o g y have more t o do w i t h how t h i s new knowledge w i l l be used, what knowledge w i l l be pursued and c a p i t a l i z e d , and the economic as w e l l as e n v i r o n m e n t a l consequences o f u s i n g b i o t e c h n o l o g y merely t o c o n t i n u e o l d and damaging p a c t i c e s . B i o t e c h n o l o g y As A Knowledge O p p o r t u n i t y B i o t e c h n o l o g y needs t o be approached as a knowledge o p p o r t u n i t y , not s i m p l y as a manufacturing o p p o r t u n i t y . What i s happening today i n the b i o l o g i c a l s c i e n c e s a t the m o l e c u l a r and c e l l u l a r l e v e l s i s t r u l y astounding. We are on the verge o f u n d e r s t a n d i n g the b i o l o g i c a l r e a l m i n fundamentally new ways; i n ways t h a t s h o u l d h e l p a g r i c u l t u r e become p r o f i t a b l e as w e l l as environmentally responsible. But i f t h i s new b i o l o g y i s used o n l y t o d i v i d e up the n a t u r a l w o r l d i n t o i t s s m a l l e s t p o s s i b l e commercial p a r t s , r a t h e r than improve our a b i l i t y t o work w i t h the b i o l o g i c a l r e a l m , the r e s u l t may be f u r t h e r economic and e n v i r o n m e n t a l problems f o r the f u t u r e . Government's R o l e I n B i o t e c h n o l o g y Government's r o l e i n b i o t e c h n o l o g y i s a m u l t i f a c e t e d r o l e , one t h a t i s c o m p l i c a t e d by d i f f e r e n t t a s k s and d i f f e r e n t constituencies. There are a t l e a s t t h r e e d i s t i n c t r o l e s — and they are o f t e n found a t the s t a t e l e v e l as w e l l . F i r s t , there i s one r o l e t h a t i n c l u d e s b e i n g a funder o f b i o t e c h n o l o g y r e s e a r c h , a t s e v e r a l l e v e l s , such as through the N a t i o n a l I n s t i t u t e s o f H e a l t h , the N a t i o n a l S c i e n c e F o u n d a t i o n , the USDA, and the l a n d g r a n t u n i v e r s i t i e s . Second, t h e r e i s another r o l e t h a t i n c l u d e s b e i n g a b o o s t e r and promoter o f b i o t e c h n o l o g y f o r the o s t e n s i b l e purpose o f m a i n t a i n i n g a c o m p e t i t i v e advantage, o r i n the case of the s t a t e s , t o a t t r a c t new i n d u s t r y . And t h i r d , t h e r e i s the r o l e of r e g u l a t o r f o r reasons o f p u b l i c h e a l t h and s a f e t y , product e f f i c a c y , and e n v i r o n m e n t a l protection. I t i s p o s s i b l e t h a t these t h r e e government r o l e s — f u n d i n g , promotion and r e g u l a t i o n — may not always r e c e i v e e q u a l a t t e n t i o n by government a g e n c i e s , and may i n f a c t come i n t o c o n f l i c t w i t h one a n o t h e r . EPI i s i n f a v o r o f new l e g i s l a t i o n f o r r e g u l a t i n g the environmental release of g e n e t i c a l l y - a l t e r e d organisms. The c u r r e n t r e g u l a t o r y framework i s i n a d e q u a t e , and p r o b a b l y o v e r the l o n g r u n , unworkable and fraught w i t h l e g a l p i t f a l l s . On a p u r e l y e n v i r o n m e n t a l l e v e l — w i t h r e s p e c t t o d e l i b e r a t e r e l e a s e — the r e g u l a t o r y p r o c e s s , as c u r r e n t l y c r a f t e d , i s l o d g e d i n a l l the wrong p l a c e s , w i t h the e x c e p t i o n o f some o f EPA's a u t h o r i t i e s . B i o t e c h n o l o g y - d e r i v e d p r o d u c t s w i l l be used f o r a l l k i n d s o f purposes i n the environment i n the y e a r s ahead; f o r t o x i c waste c l e a n - u p , f o r enhanced o i l r e c o v e r , f o r c l e a n i n g


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up o i l s p i l l s , f o r a p p l i c a t i o n s i n f o r e s t r y , f o r sewage waste t r e a t m e n t , and f o r a range o f uses i n a g r i c u l t u r e . I t seems r e a s o n a b l e t h e n , when c o n s i d e r i n g the p o t e n t i a l e n v i r o n m e n t a l e f f e c t s t h a t engineered organisms c o u l d have when r e l e a s e d i n t o the a i r , water and s o i l , t h a t e n v i r o n m e n t a l s c i e n c e and e n v i r o n m e n t a l p r o t e c t i o n be the paramount c o n s i d e r a t i o n i n any r e g u l a t o r y scheme. But t h a t i s not the c a s e w i t h the p r e s e n t r e g u l a t o r y framework. As e a r l y as 1982, c o n c e r n a b o u t , and c o n t r o l o v e r , the r e g u l a t i o n o f e n v i r o n m e n t a l b i o t e c h n o l o g y began t o emerge i n the White House O f f i c e o f S c i e n c e & Technology P o l i c y (OSTP). T h i s began i n i t i a l l y as an i n q u i r y i n t o the U . S. b i o t e c h n o l o g y i n d u s t r y ' s c o m p e t i t i v e i n t e r n a t i o n a l p o s i t i o n , and soon i n c l u d e d a l o n g l i s t o f concerns r e l a t e d t o the A d m i n i s t r a t i o n ' s i n t e r e s t i n competitiveness. I n a d d i t i o n t o OSTP, o t h e r a g e n c i e s , i n c l u d i n g the S t a t e and Commerce d e p a r t m e n t s , and l a t e r 0MB, a l s o became i n v o l v e d i n the q u e s t i o n . Industry representatives were brought i n t o the A d m i n i s t r a t i o n ' s process e a r l y o n . After the c o m p l e t i o n o f t h i s r e v i e w o f the new b i o t e c h n o l o g y i n d u s t r y , the s t a t e d i n t e n t i o n o f the A d m i n i s t r a t i o n became c l e a r : maximize the U . S. c o m p e t i t i v e p o s i t i o n i n b i o t e c h n o l o g y , m i n i m i z e r e g u l a t i o n , and d e r e g u l a t e any e x i s t i n g laws thought t o encumber the p r o g r e s s o f h i g h t e c h n o l o g y g e n e r a l l y — from drug e x p o r t laws t o a n t i t r u s t l a w s . I n October 1982, the White House O f f i c e o f S c i e n c e and Technology P o l i c y (OSTP), under the d i r e c t i o n o f George K e y w o r t h , commissioned an i n q u i r y i n t o the c o m p e t i t i v e n e s s o f the U . S. b i o t e c h n o l o g y i n d u s t r y . That e f f o r t was o r g a n i z e d as a w o r k i n g group headed by W i l l i a m J . Walsh o f the S t a t e Department. I n A p r i l 1983, a s m a l l e r group o f i n d i v i d u a l s i n v o l v e d w i t h the study met w i t h n i n e key r e p r e s e n t a t i v e s o f b i o t e c h n o l o g y companies and major c o r p o r a t i o n s a t a V i r g i n i a r e t r e a t f o r two days t o f i n a l i z e the r e p o r t ' s recommendations. Walsh d e s c r i b e d t h a t d r a f t — w h i c h was s u b m i t t e d t o OSTP on May 2 7 , 1983— as "a d a t a base w i t h s u g g e s t i o n s on how government a g e n c i e s s h o u l d change t h e i r ways i n such areas as p a t e n t s , l i c e n s e s , e x p o r t c o n t r o l s and FDA r e g u l a t i o n s , so as not t o l e n d themselves t o s e l l i n g out s t a t e - o f - t h e a r t c h e a p l y , and to u n s h a c k l e i n d u s t r y i n p u r s u i t o f b i o t e c h n o l o g y " . The r e p o r t recommended, f o r example, removing c e r t a i n d i s i n c e n t i v e s t o b i o t e c h n o l o g y i n the t a x , p a t e n t , and a n t i t r u s t a r e a . "The c u r r e n t s i t u a t i o n " , wrote Walsh i n h i s l e t t e r t o Keyworth t r a n s m i t t i n g the s t u d y , "does not warrant more r e s t r i c t i v e c o n t r o l measures, which c o u l d be c o u n t e r - p r o d u c t i v e " . Then i n June 1983, t h e r e came the f i r s t s i g n s o f government i n t e r e s t i n the r e g u l a t i o n o f g e n e t i c a l l y e n g i n e e r e d organisms proposed f o r r e l e a s e i n t o the environment. At t h a t t i m e , E P A ' s A s s i s t a n t A d m i n i s t r a t o r Don C l a y , t h e n a p p e a r i n g b e f o r e Rep. A l b e r t G o r e ' s House S c i e n c e & Technology subcommittee, a s s e r t e d t h a t EPA had a u t h o r i t y t o r e g u l a t e c e r t a i n p r o d u c t s o f b i o t e c h n o l o g y under FIFRA and TSCA. C l a y ' s t e s t i m o n y a l s o r a i s e d the f i r s t o f f i c i a l s i g n s o f u n c e r t a i n t y w i t h r e g a r d t o the a v a i l a b l e p r e d i c t i v e c a p a b i l i t i e s and d a t a base needed f o r a s s e s s i n g the r i s k o f g e n e t i c a l l y


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engineered organisms i n the e n v i r o n m e n t . In h i s testimony. Clay p o i n t e d t o the t e c h n i c a l problems o f s c i e n t i f i c a l l y g e a r i n g up t o do e n v i r o n m e n t a l assessments o f g e n e t i c a l l y - e n g i n e e r e d organisms. "There are almost no a c c e p t e d methodologies f o r e v a l u a t i n g the s a f e t y o f g e n e t i c a l l y - e n g i n e e r e d p r o d u c t s " , he e x p l a i n e d , adding t h a t the r i s k - a s s e s s m e n t t o o l s and d a t a used f o r c h e m i c a l substances c o u l d not a p p l y i n the case o f organisms. C l a y then e x p l a i n e d t h a t the EPA needed t o develop methodologies t o e v a l u a t e e n v i r o n m e n t a l f a t e , human e x p o s u r e , and the p o t e n t i a l e n v i r o n m e n t a l and h e a l t h hazards o f g e n e t i c a l l y - e n g i n e e r e d o r g a n i s m s , but t h a t such t e s t s were " s t i l l s e v e r a l y e a r s away". In e a r l y 1984, a f t e r EPA had c i r c u l a t e d a d r a f t b i o t e c h n o l o g y r e g u l a t i o n f o r p u b l i c a t i o n i n the F e d e r a l R e g i s t e r w i t h r e g a r d t o i t s p e r c e i v e d r e s p o n s i b i l i t i e s under FIFRA and TSCA, C h r i s t o p h e r DeMuth, an 0MB o f f i c i a l , o b j e c t e d . I n a March 1 2 t h , 1984 memo d r a f t e d f o r the C a b i n e t C o u n c i l on Economic A f f a i r s , DeMuth argued t h a t the c o u n c i l , not EPA, s h o u l d d e c i d e how t o r e g u l a t e b i o t e c h n o l o g y . I n the memo, DeMuth r e f e r r e d t o E P A ' s p r o p o s a l as a "gambit", and v o i c e d concerns t h a t too much r e g u l a t i o n would h u r t b i o t e c h n o l o g y companies, which he viewed as " e x t r a o r d i n a r i l y i n n o v a t i v e " but " u n u s u a l l y s e n s i t i v e t o r e g u l a t o r y c o s t s and d e l a y s " . He a l s o o u t l i n e d s e v e r a l o p t i o n s : d o i n g n o t h i n g , a s k i n g the N a t i o n a l Academy o f S c i e n c e s to study the m a t t e r , and k e e p i n g the s t a t u s quo i n t a c t under N I H , among others. One r e p o r t a t the time charged t h a t 0MB and DeMuth were under p r e s s u r e from the Department o f Commerce and Commerce S e c r e t a r y Malcolm B a l d r i d g e , who was concerned t h a t EPA r e g u l a t i o n would h i n d e r U . S . b i o t e c h n o l o g y companies i n c o m p e t i t i o n w i t h Japan. Meanwhile, w i t h i n the White House Domestic C o u n c i l , a l l o f t h i s a g i t a t i n g over E P A ' s move t o r e g u l a t e b i o t e c h n o l o g y , l e d t o the demise o f E P A ' s and W i l l i a m R u c k e l s h a u s ' l e a d on biotechnology i s s u e . On A p r i l 30, 1984, the Working Group on B i o t e c h n o l o g y o f the C a b i n e t C o u n c i l on N a t u r a l Resouces was c r e a t e d under the c h a i r m a n s h i p o f OSTP's George K e y w o r t h . On May 9 t h , t h i s newly c o n s t i t u t e d group h e l d i t s f i r s t m e e t i n g , w i t h Keyworth as c h a i r m a n . A c c o r d i n g t o E P A ' s Jack Moore, a t l e a s t p a r t o f K e y w o r t h ' s message was: " L e t ' s m a i n t a i n our competitiveness. D o n ' t u n w i t t i n g l y do a n y t h i n g t o s t i f l e the technology". I t was t h i s OSTP-led w o r k i n g group t h a t f o r m u l a t e d the f i r s t c o o r d i n a t e d framework approach t o f e d e r a l b i o t e c h n o l o g y r e g u l a t i o n , f i r s t p u b l i s h e d i n the F e d e r a l R e g i s t e r December 3 1 . 1984. Throughout e a r l y 1985, the r e g u l a t o r y framwork was c r i t i c i z e d on a number o f f r o n t s , and the i s s u e o f e n v i r o n m e n t a l r i s k c o n t i n e d t o be d i s c u s s e d . I n February 1985, the C o r n e l l U n i v e r s i t y Ecosystems R e s e a r c h Center i s s u e d one o f the f i r s t comprehensive o v e r v i e w s o f what was p o s s i b l e and what was l a c k i n g t o a d e q u a t e l y a s s e s s the e n v i r o n m e n t a l r i s k s o f new b i o t e c h n o l o g y p r o d u c t s . The f i n d i n g s o f t h a t r e p o r t are s t i l l q u i t e r e m a r k a b l e , and u n d e r s c o r e how l i t t l e we know about microorganisms—how they s u r v i v e , how they are d i s p e r s e d i n the environment, why some grow r a p i d l y , and why o t h e r s do n o t .


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The most i m p o r t a n t c o n c l u s i o n o f the C o r n e l l study i s what i t s a i d about the a b i l i t y t o make p r e d i c t i o n s about the b e h a v i o r o f organisms i n the environment: "Methods f o r p r e d i c t i n g the l i k e l i h o o d o f s u r v i a l and p r o l i f e r a t i o n o f a g i v e n organism i n the environment are c r u d e . . . Methods are a v a i l a b l e f o r a s s e s s i n g some p o t e n t i a l e f f e c t s , but t h e r e are many d e f i c i e n c i e s i n c u r r e n t knowledge and t h e o r y . G e n e r a l l y , we l a c k any t r u e d a t a base a g a i n s t which to compare t e s t r e s u l t s o r p r e d i c t e n v i r o n m e n t a l consequences." I n June 1985, f o l l o w i n g the C o r n e l l s t u d y , i n P h i l a d e l p h i a , m o l e c u l a r b i o l o g i s t s and e c o l o g i s t s g a t h e r e d f o r the f i r s t time i n a p u b l i c formum to d i s c u s s some of the q u e s t i o n s s u r r o u n d i n g deliberate release. Not much agreement was reached a t t h a t m e e t i n g , but more e c o l o g i s t s d i d become i n v o l v e d . In November 1985, the B i o t e c h n o l o g y S c i e n c e C o o r d i n a t i n g Committee was formed t o h e l p guide and c o o r d i n a t e the r e g u l a t o r y p r o c e s s among f e d e r a l a g e n c i e s . By t h i s time EPA had announced the a p p r o v a l o f Advanced G e n e t i c S c i e n c e s ' (AGS) f i e l d t e s t f o r " i c e m i n u s " . Then i n December 1985, Senator Durenberger i n t r o d u c e d S . 1 9 6 7 . The B i o s a f e t y A c t , aimed a t amending TSCA t o r e q u i r e t h a t EPA r e v i e w and approve g e n e t i c a l l y e n g i n e e r e d microorganisms b e f o r e they c o u l d be r e l e a s e d i n t o the environment. H e a r i n g s were never h e l d , and the b i l l d i e d i n the l a s t Congress. The f i r s t q u a r t e r o f 1986 was not a good p e r i o d f o r the b i o t e c h n o l o g y i n d u s t r y . On February 1 1 t h , the Monterey County ( C a l i f o r n i a ) Board passed a moratorium on the r e l e a s e o f g e n e t i c a l l y engineered organisms w i t h i n t h a t l o c a l j u r i s d i c t i o n . Monterey County was the s i t e chosen by AGS t o f i e l d t e s t i c e minus. On February 2 6 t h , i t was r e v e a l e d i n news accounts t h a t AGS had i l l e g a l l y t e s t e d i c e - m i n u s i n the open a i r a year e a r l i e r w i t h o u t i n f o r m i n g EPA. A month l a t e r , EPA f i n e d AGS $20,000 and suspended t h e i r p e r m i t to t e s t i c e minus, which the agency had approved j u s t four months e a r l i e r . Less than t h r e e weeks a f t e r the r e v e l a t i o n s about AGS' i l l e g a l a c t i v i t i e s , i t was s u b s e q u e n t l y r e v e a l e d t h a t USDA had approved a g e n e t i c a l l y e n g i n e e r e d v a c c i n e w i t h o u t the r e v i e w o f i t s own R A C USDA then suspended the l i c e n s e i t i s s u e d f o r the v a c c i n e and began an e n v i r o n m e n t a l r e v i e w . Meanwhile, back i n C o n g r e s s , the Fuqua/Volkmer b i l l — T h e B i o t e c h n o l o g y S c i e n c e C o o r d i n a t i o n A c t o f 1986— was i n t r o d u c e d i n March 1986. T h i s b i l l took a more comprehensive approach than d i d the Durenberger b i l l , but i t d i e d t o o . One h e a r i n g was held. In June 1986, the f i n a l r e v i s i o n o f the A d m i n i s t r a t i o n ' s C o o r d i n a t e d framework f o r the r e g u l a t i o n o f B i o t e c h n o l o g y was p u b l i s h e d i n the F e d e r a l R e g i s t e r . T h i s now c o n s t i t u t e s the g u i d e l i n e s but they l a c k adequate o r agreed upon d e f i n i t i o n s o f some v e r y i m p o r t a n t t h r e s h o l d t e r m s , such as " r e l e a s e i n t o the environment" and "pathogen". W i t h t h i s new package o f r e g u l a t i o n s c o n c e r n i n g b i o t e c h n o l o g y , t h e r e a r o s e some c o n t r o v e r s y s u r r o u n d i n g some


30. DOYLE


exemptions of g e n e t i c a l l y a l t e r e d organisms the A d m i n i s t r a t i o n had p r o p o s e d . For example, one p r o p o s a l o f f e r e d t o exempt g e n e t i c a l l y engineered organisms t h a t had a gene o r genes deleted. Some s c i e n t i s t s i m m e d i a t e l y o b j e c t e d t o t h i s e x e m p t i o n . For example, MIT b i o l o g i s t Jonathan K i n g s t a t e d : " I t i s a m e d i e v a l s c i e n t i f i c view t h a t a d e l e t i o n i s automatically less risky". The d e l e t i o n o f a gene, he s a i d , can have a wide range o f e f f e c t s . Similarly, Cornell University b i o c h e m i s t L i e b e C a v a l i e r i s t a t e d t h a t the d e l e t i o n o f DNA segments does not n e c e s s a r i l y mean t h a t you have changed j u s t one c h a r a c t e r i s t i c . The A d m i n i s t r a t i o n a l s o proposed exempting organisms t h a t had o n l y changes i n r e g u l a t o r y genes; t h a t i s , genes t h a t r e g u l a t e or c o n t r o l the a c t i v i t y o f o t h e r genes. Some e c o l o g i s t s o b j e c t e d on t h i s p o i n t too because the a l t e r n a t i o n o f r e g u l a t o r y sequences can a f f e c t the c h a r a c t e r i s t i c s o f organisms i n ways t h a t a f f e c t t h e i r s u r v i v a l , r e p r o d u c t i o n and e f f e c t s on e c o l o g i c a l systems. Stated E l l i o t t N o r s e , then r e p r e s e n t i n g the E c o l o g i c a l S o c i e t y o f A m e r i c a : R e g u l a t o r y sequences t h a t change growth o r r e p r o d u c t i v e r a t e s by j u s t a few p e r c e n t c o u l d d r a m a t i c a l l y a l t e r c o m p e t i t i v e b a l a n c e s among m i c r o o r g a n i s m s , p l a n t s , o r a n i m a l s i n n a t u r e . In f a c t , s t a t e d N o r s e , "exempting any o f the p r o c e s s e s of a l t e r i n g genomes t h a t have developed i n the l a s t 10-15 y e a r s from r i g o r o u s r e v i e w seems p r e m a t u r e " . In December 1986, the "Volkmer r e p o r t " was i s s u e d by the House S c i e n c e & Technology Committee's O v e r s i g h t and I n v e s t i g a t i o n s Subcommittee, e n t i t l e d : " I s s u e s i n the F e d e r a l R e g u l a t i o n o f B i o t e c h n o l o g y : From Research t o R e l e a s e " . T h i s r e p o r t t r a c k e d the h a n d l i n g o f the i l l e g a l AGS and USDA r e l e a s e i n c i d e n t s , and a l s o e x p l o r e d the problems apparent w i t h the management o f the C o o r d i n a t e d Framework. From an e n v i r o n m e n t a l i s t ' s p r e s p e c t i v e , t h e r e are a number of i m p o r t a n t problems t o be c o n s i d e r e d . F i r s t and foremost i s the q u e s t i o n o f l e g a l a u t h o r i t y . Is the C o o r d i n a t e d R e g u l a t o r y Framework f o r B i o t e c h n o l o g y l e g a l l y sound? Does i t p r o v i d e clear l e g a l authority? S e c o n d l y , t h e r e i s a l s o the c r i t i c a l m a t t e r o f d e f i n i t i o n s . I t seems t h a t a s e t of b a s i c , o p e r a t i v e , and s c i e n t i f i c a l l y sound d e f i n i t i o n s must be i n p l a c e before a r e g u l a t o r y system can be e s t a b l i s h e d . Y e t , the A d m i n i s t r a t i o n ' s C o o r d i n a t e d framework i s j u s t the r e v e r s e . C u r r e n t l y , we are b a c k - t r a c k i n g on d e f i n i t i o n s where they e x i s t a t a l l ; t r y i n g t o make them f i t the package. I n EPA, some key r u l e - m a k i n g s needed t o make t h e i r p a r t of the package work under TSCA are dependent on d e f i n i t i o n s such as those f o r "pathogen", " r e l e a s e i n t o the e n v i r o n m e n t " , and " c o n t a i n m e n t " , none o f which y e t e x i s t . T h i r d l y , the i s s u e o f d e t e r m i n i n g r i s k t o the environment from g e n e t i c a l l y a l t e r e d organisms i s a matter f o r e n v i r o n m e n t a l s c i e n t i s t s and e c o l o g i s t s , not m o l e c u l a r b i o l o g i s t s and m e d i c a l scientists. Yet the p r i n c i p a l a r c h i t e c t s o f the c u r r e n t framework have been the m o l e c u l a r b i o l o g i s t s , m e d i c a l s c i e n t i s t s , and i n d u s t r i a l b i o t e c h n o l o g i s t s . E c o l o g i s t s , f o r the most p a r t , have been e x c l u d e d from t h i s p r o c e s s . As the r e g u l a t o r y framwork has emerged under the guidance of the BSCC, t h e r e has been a c l e a r b i a s toward the m e d i c a l


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s c i e n c e s i n t r y i n g t o d e f i n e the e n v i r o n m e n t a l and e c o l o g i c a l r i s k s faced w i t h b i o t e c h n o l o g y . EPI does not b e l i e v e , f o r example, t h a t c o n s u l t i n g w i t h i n f e c t i o u s c o n t r o l o f f i c e r s a t h o s p i t a l s , the N a t i o n a l L i b r a r y o f M e d i c i n e , o r u s i n g the TOXLINE and MEDLINE d a t a bases w i l l h e l p s i g n i f i c a n t l y w i t h p r e d i c t i n g e c o l o g i c a l consequences o f g e n e t i c a l l y e n g i n e e r e d v i r u s e s , b a c t e r i a , and i n s e c t s d e s t i n e d f o r use i n the e n v i r o n m e n t . There may be some p a r a l l e l s , and t h e s e data bases may be somewhat h e l p f u l , but i n the m a i n , d i s e a s e e t i o l o g y / e p i d e m i o l o g y and environmenmtal e c o l o g y are d i f f e r e n t phenomena, w i t h d i f f e r e n t t h r e s h o l d s and consequences. So t h e r e needs t o be much more a t t e n t i o n p a i d t o the s c i e n c e o f e c o l o g y i n the a d m i n i s t r a t i o n o f r e g u l a t i o n . Yet another q u e s t i o n i s t o whether t h e r e w i l l be more o r less l i t i g a t i o n . Based on the i n t r a - a g e n c y t u g - o f - w a r i n the h a n d l i n g o f b i o t e c h n o l o g y r e g u l a t i o n so f a r , i t i s p r o b a b l e t h a t we w i l l see over the next few y e a r s , a never e n d i n g t a n g l e o f new d e f i n i t i o n s , amended d e f i n i t i o n s , ad-hoc r u l e - m a k i n g s , BSCC subcommittee m e e t i n g s , s c i e n t i f i c a d v i s o r y committee m e e t i n g s , exemption l i s t i n g s and d e - l i s t i n g s , a p p e a l s , and f i n a l l y , litigation. Some o f t h i s l i t i g a t i o n w i l l be based on p r o c e d u r a l f l a w s t h a t are guaranteed t o come w i t h a p r o c e s s t h a t attempts t o c o v e r f i v e a g e n c i e s ; i t c a n ' t h e l p but make more g r a y a r e a s as i t moves f o r w a r d . And some o f t h i s l i t i g a t i o n may w e l l come from e n v i r o n m e n t a l o r g a n i z a t i o n s o r consumer g r o u p s . But some may a l s o come from i n d u s t r i e s f r u s t r a t e d w i t h the p r o c e s s . EPI supports the view t h a t new l e g i s l a t i o n i s needed t o c l a r i f y the p r e s e n t s i t u a t i o n l e g a l l y , t o p r o t e c t the e n v i r o n m e n t , and t o i n s u r e a l e v e l p l a y i n g f i e l d f o r a l l p a r t i c i p a n t s . T h i s i s i n i n d u s t r y ' s i n t e r e s t t o o , because i t w i l l s t r e a m l i n e the r e v i e w p r o c e s s . For both e n v i r o n m e n t a l i s t s and businessmen, t h e r e i s a need t o s t r a i g h t e n out t h i s c o n v o l u t e d framework i n o r d e r t o a v o i d unnecessary b u r e a u c r a c y and l i t i g a t i o n i n the y e a r s ahead. EPI has c a l l e d on Congress t o r e v i e w and e v a l u a t e the p r e s e n t r e g u l a t o r y s i t u a t i o n , and t o c l e a r l y a r t i c u l a t e what laws s h o u l d a p p l y , whether those be o l d laws c l a r i f i e d w i t h new amendments, o r the c r a f t i n g o f an e n t i r e l y new p i e c e o f legislation. From time t o time i n the p a s t , o t h e r s have a l s o c a l l e d f o r Congress to become i n v o l v e d l e g i s l a t i v e l y . Others have recommended l e g i s l a t i o n on the d e l i b e r a t e r e l e a s e s i t u a t i o n as e a r l y as 1981. New l e g i s l a t i o n was one o f the o p t i o n s o u t l i n e d by OTA i n i t s 1981 r e p o r t Impact o f A p p l i e d G e n e t i c s : M i c r o - O r g a n i s m s , P l a n t s , and A n i m a l s : Congress c o u l d pass l e g i s l a t i o n r e g u l a t i n g a l l types and phases o f g e n e t i c e n g i n e e r i n g from r e s e a r c h through commercial p r o d u c t i o n . T h i s o p t i o n would d e a l c o m p r e h e n s i v e l y and d i r e c t l y w i t h the r i s k s o f n o v e l m o l e c u l a r g e n e t i c t e c h n i q i u e s . A s p e c i f i c s t a t u t e would e l i m i n a t e the u n c e r t a i n t i e s over the e x t e n t t o which p r e s e n t law c o v e r s p a r t i c u l a r a p p l i c a t i o n s . Rep. John D i n g e l l c a l l e d f o r new l e g i s l a t i o n i n a September 1985 l e t t e r t o the e d i t o r o f I s s u e s i n S c i e n c e & T e c h n o l o g y . "New s t a t u t o r y p r o v i s i o n s seem e s s e n t i a l ^ t o p r o v i d e a s e n s i b l e and f a i r s e t o f r u l e s f o r a l l a s p e c t s o f t h i s new f i e l d " , he


30. DOYLE


w r o t e . And i n 1986, the background paper f o r B r o o k i n g s ' Second Annual Conference on B i o t e c h n o l o g y i n c l u d e d an o p t i o n f o r "a new i n t e g r a t e d law t o r e g u l a t e b i o t e c h n o l o g y " . I n C o n g r e s s i o n a l t e s t i m o n y i n June 1987, and i n comments t o the BSCC i n September 1986, EPI advocated t h a t Congress g i v e EPA the l e a d i n r e v i e w i n g a l l proposed r e l e a s e s o f g e n e t i c a l l y a l t e r e d o r g a n i s m s , whether f o r academic t e s t - p l o t experiments o r f u l l - b l o w n commercial r e l e a s e s . I t was proposed t h a t a B i o t e c h n o l o g y r e v i e w Board be c r e a t e d w i t h i n EPA charged w i t h r e v i e w i n g and a p p r o v i n g a l l a p p l i c a t i o n s f o r outdoor t e s t i n g . A d d i t i o n a l l y , a p e r m i t system was proposed as an i n t e g r a l p a r t of t h i s system, w i t h EPA h a v i n g f i n a l a u t h o r i t y f o r a p p r o v i n g o r v e t o i n g i n d i v i d u a l a p p l i c a t i o n s f o r r e l e a s e on the b a s i s o f e c o l o g i c a l a n d / o r p u b l i c h e a l t h r i s k s . Some l e g i s l a t o r s a r e now t a l k i n g more s e r i o u s l y about the need f o r l e g i s l a t i o n . R e c e n t l y , Senator A l b e r t Gore, i n a May 19, 1987 speech b e f o r e the Keystone Center Forum on B i o t e c h n o l o g y h e l d i n Washington, D . C , i s s u e d the f o l l o w i n g e x c e r p t e d s t a t e m e n t : L o o k i n g back over the p a s t f i v e y e a r s s i n c e I h e l d my f i r s t h e a r i n g on b i o t e c h n o l o g y , I ' m a f r a i d t h a t many o f the q u e s t i o n s r a i s e d remain u n r e s o l v e d . . • Back i n 1983, f o r example, the Subcommittee on I n v e s t i g a t i o n s and O v e r s i g h t c o n c l u d e d t h a t one o f the major r i s k s a s s o c i a t e d w i t h the r e l e a s e o f g e n e t i c a l l y a l t e r e d organisms was not n e c e s s a r i l y the r e l e a s e s t h e m s e l v e s , but our i n a b i l i t y and f a i l u r e t o make r i s k assessments. Four y e a r s l a t e r , we s t i l l h a v e n ' t developed adequate standards f o r r i s k assessment... . . . I have always f e l t t h a t government s h o u l d encourage t h i s new s c i e n c e , not stand i n i t s way. But we d i d see the need f o r new i n p u t and c a l l e d f o r development of a " p r e d i c t i v e e c o l o g y " t o h e l p shed l i g h t on some o f the nagging u n c e r t a i n t i e s . Yet those u n c e r t a i n t i e s have o n l y m u l t i p l i e d . • • I t i s the j o b o f government and the Congress not o n l y t o reduce r i s k , but t o reduce f e a r . B i o t e c h n o l o g y w i l l not r e a l i z e i t s promise u n t i l we have a b i o t e c h n o l o g y i n d u s t r y t h a t t r u s t s our governmental p r o c e s s and i s w i l l i n g t o s i t down w i t h the e l e c t e d r e p r e s e n t a t i v e s o f the p u b l i c , the C o n g r e s s , t o d r a f t comprehensive l e g i s l a t i o n t o d i s p e l the p u b l i c ' s f e a r s and t h u s , insure a s o l i d foundation for i t s future. I do not understand the r e l u c t a n c e ( o f i n d u s t r y t o do this). I t was Congress t h a t passed the Drug E x p o r t B i l l , the P a t e n t Terra R e s t o r a t i o n B i l l , and the r e s e a r c h and development s e c t i o n s o f Superfund. Y e t , d e s p i t e t h i s t r a c k r e c o r d o f s u p p o r t , i n d u s t r y c o n t i n u e s t o r e a c t w i t h f e a r whenever t a l k o f biotechnology l e g i s l a t i o n a r i s e s . I ' v e been t o l d i t ' s f e a r o f the unknown t h a t l e a d s i n d u s t r y t o oppose new b i o t e c h l e g i s l a t i o n . But the i n d u s t r y must r e a l i z e t h a t a f u l l , v i g o r o u s p u b l i c debate now, when t h i n g s are g o i n g w e l l , w i l l o n l y h e l p i n the l o n g - r u n . N o t h i n g i s more dangerous t o the f u t u r e o f b i o t e c h n o l o g y than t o pospone the debate u n t i l a c r i s i s o c c u r s . . . EPI p r e d i c t s t h a t more members o f Congress w i l l c a l l f o r l e g i s l a t i o n t o c l a r i f y the s i t u a t i o n .


401

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Another development o c c u r r i n g on the r e g u l a t o r y f r o n t i s the a c t i v i t y a t the s t a t e and l o c a l l e v e l . New J e r s e y , Texas C a l i f o r n i a , W i s c o n s i n , and N o r t h C a r o l i n a have a l l c o n s i d e r e d new o r s p e c i a l approaches t o b i o t e c h n o l o g y r e g u l a t i o n , some w i t h new l e g i s l a t i o n . I n New J e r s e y , a moratorium measure was i n t r o d u c e d i n 1986, which l a t e r , as a compromise b i l l i n c o r p o r a t i n g a r e v i e w c o m m i s s i o n , passed unanimously i n the s t a t e Senate. That b i l l i s s t i l l w a i t i n g a vote i n the New Jersey assembly. I t i s l i k e l y t h a t as more and more f i e l d t e s t s o c c u r i n more and more s t a t e s , t h e r e w i l l be more c o n c e r n i n s t a t e legislatures. I t s h o u l d be i n the s t a t e s ' i n t e r e s t t o b e g i n a s s e m b l i n g t h e i r r e g u l a t o r y and e c o l o g i c a l e x p e r t i s e i n these a r e a s , and not t o r e l y on Washington o r assume t h a t the c u r r e n t r e g u l a t o r y framwork i s g o i n g t o s u r v i v e . I t appears t h a t a f i n a l r e s o l u t i o n w i l l not be soon i n coming. I n many ways, the debate i s j u s t b e g i n n i n g , both around the c o u n t r y and i n the U . S. C o n g r e s s . The advent o f b i o t e c h n o l o g y may p r o v i d e a fundamental o p p o r t u n i t y t o phase out c h e m i c a l p e s t i c i d e use i n a g r i c u l t u r e . I t may be an o p p o r t u n i t y whose time has come, and t h e r e f o r e i t needs t o be pushed h a r d , and e l e v a t e d t o a n a t i o n a l g o a l . C o n s i d e r f o r a moment some o f the o p i n i o n s and a c t i v i t i e s i n t h i s country with regard to p e s t i c i d e s : P u b l i c O p i n i o n . A January 1984 consumer s u r v e y conducted by the Food M a r k e t i n g I n s t i t u t e , 77 p e r c e n t o f those p o l l e d e x p r e s s e d c o n c e r n o v e r p e s t i c i d e and h e r b i c i d e r e s i d u e s i n f o o d , i n d i c a t i n g the problem t o be a " s e r i o u s h a z a r d " . (Hammonds, 1984). P u b l i c O p i n i o n . A September 1986 Pes Moines R e g i s t e r p o l l t a k e n i n Iowa shows t h a t 58% o f those surveyed b e l i e v e farm c h e m i c a l s are the b i g g e s t t h r e a t t o water q u a l i t y , and t h a t 78% f a v o r l i m i t s on farm c h e m i c a l s . Consumer P r e s s u r e . I n May 1986, the c e n t e r f o r S c i e n c e i n the P u b l i c I n t e r e s t began a n a t i o n a l campaign c a l l e d "Americans f o r Safe F o o d " , w i t h a 5 - p o i n t p l a n o f a c t i o n t h a t c a l l e d f o r , among o t h e r t h i n g s : laws t h a t r e q u i r e d i s c l o s u r e o f p e s t i c i d e s , d r u g s , and o t h e r c h e m i c a l s used i n the p r o d u c t i o n o f f o o d s ; a ban on p e s t i c i d e s and a n i m a l drugs known t o pose a s e r i o u s r i s k t o consumers; and n a t i o n a l standards f o r " o r g a n i c " , " n a t u r a l " , and " p e s t i c i d e - f r e e " f o o d s . B u s i n e s s R e a c t i o n . I n J u l y 1986, Safeway S t o r e s , I n c . , the n a t i o n ' s l a r g e s t g r o c e r y c h a i n , announced t h a t i t would stop b u y i n g a p p l e s t r e a t e d w i t h the c h e m i c a l growth r e g u l a t o r A l a r , d e s p i t e E P A ' s d e c i s i o n i n January t o a l l o w i t s use w h i l e f u r t h e r s t u d i e s are done. I n a d d i t i o n , the s t a t e o f Maine proposed a n o n - d e t e c t a b l e s t a n d a r d f o r daminozide t o be reached t h i s y e a r , and the s t a t e o f M a s s a c h u s e t t s has enacted r e g u l a t i o n t o reduce A l a r i n baby foods and h e a t - p r o c e s s e d foods to a n o n d e t e c t a b l e l e v e l by 1988. (Wall S t r e e t J o u r n a l , 1986). B u s i n e s s R e a c t i o n . I n November 1986, the H . J . Heinz Co. announced t h a t i t was p l a n n i n g t o r e s t r i c t the purchase o f crops used i n the manufacture o f baby foods t h a t had been t r e a t e d w i t h c e r t a i n p e s t i c i d e s . Heinz l i s t e d 12 c h e m i c a l s : a l a c h l o r ,


30. DOYLE


a l d i c a r b , c a p t a n , c a p t a f o l , c a r b o f u r a n , carbon t e t r a c h l o r i d e , c y a n a z i n e , d a m i n o z i d e , d i n o c a p , e t h y l e n e o x i d e , l i n u r o n , and TPTH. Heinz t o l d farmers t h a t i t would l i k e l y t e s t crops f o r the absence o f these c h e m i c a l s — a l l o f which were then s t i l l l e g a l , but under r e v i e w by EPA as p o s s i b l e h e a l t h h a z a r d s . (Meier, 1986). Farmworker H e a l t h . I n May 1986, U n i t e d Farmworkers l e a d e r , Caesar Chavez sent out a mass m a i l i n g a p p e a l t o Americans n a t i o n w i d e , announcing a new grape b o y c o t t aimed a t e l i m i n a t i n g f i v e p e s t i c i d e s t h a t endanger farmworker h e a l t h . In h i s appeal, Chavez asked consumers not t o buy f r e s h C a l i f o r n i a t a b l e grapes u n t i l growers agree t o ban the f i v e most dangerous p e s t i c i d e s used i n grape p r o d u c t i o n — c a p t a n , d i n o s e b , p a r a t h i o n , p h o s d r i n , and m e t h y l b r o m i d e . (Chavez, 1 9 8 6 ) . Farmer & Farm F a m i l y E x p o s u r e . L a s t y e a r , the U . S. E n v i r o n m e n t a l P r o t e c t i o n Agency warned women o f c h i l d b e a r i n g age t o a v o i d farm f i e l d s r e c e n t l y t r e a t e d w i t h the h e r b i c i d e d i n o s e b because the c h e m i c a l might cause b i r t h d e f e c t s . Another s t u d y , conducted by a team o f m e d i c a l s c i e n t i s t s , found t h a t Kansas farmers exposed t o a w i d e l y - u s e d c o r n and wheat h e r b i c i d e f o r 20 days o r more a year had a s i x f o l d i n c r e a s e i n a c e r t a i n k i n d o f lymph c a n c e r s compared t o n o n - f a r m e r s . And a t h i r d study from W i s c o n s i n noted p o s s i b l e immune-system s u p p r e s s i o n due t o a l d i c a r b exposure. With b i o t e c h n o l o g y , i t may be c o n c e i v a b l e t o b e g i n a n a t i o n a l r e s e a r c h program t h a t has as i t s g o a l the p h a s i n g o u t of pesticides i n a g r i c u l t u r e . At the v e r y l e a s t , i t s h o u l d be p o s s i b l e t o d r a s t i c a l l y reduce the use o f p e s t i c i d e s by " b u i l d i n g i n " d i s e a s e and i n s e c t r e s i s t a n c e i n t o c r o p s and l i v e s t o c k , and making t h a t a major p r i o r i t y i n USDA and the l a n d grant system. I n - f a c t , such a program c o u l d be t a r g e t e d as a n a t i o n a l g o a l — a g o a l no l e s s i m p o r t a n t than p u t t i n g a man on t h e moon, o r N I H ' s war on c a n c e r . C e r t a i n l y , e l i m i n a t i n g the source o f one o f our g r e a t e s t p u b l i c h e a l t h t h r e a t s , as w e l l as a c o n t i n u i n g source o f groundwater p o l l u t i o n , and a p r i m a r y source o f farmer, and farmworker p o i s o n i n g s — w o u l d be a l a u d a b l e national goal. Such a program would e l i c i t widespread support and a c c o m p l i s h s e v e r a l t h i n g s s i m u l t a n e o u s l y . F i r s t , i t would reduce p u b l i c , farmer, and farmworker exposure t o p e s t i c i d e s . Second, i t would reduce the c o s t o f p r o d u c t i o n f o r farmers and t h e r e b y improve farm income and p r o f i t a b i l i t y . Farmers c u r r e n t l y spend an e s t i m a t e d $18 b i l l i o n a n n u a l l y f o r purchased f e e d , $ 7 . 4 b i l l i o n f o r f e r t i l i z e r , $4 b i l l i o n f o r p e s t i c i d e s and $4 b i l l i o n f o r seed. That adds up t o n a t i o n a l c o s t - o f p r o d u c t i o n b i l l o f a t l e a s t $33 b i l l i o n , w i t h o u t i n c l u d i n g o t h e r related input costs. Any r e d u c t i o n i n t h e s e c o s t s would c e r t a i n l y improve farm income, and presumably, U . S. a g r i c u l t u r a l competitiveness. Moreover, the p u b l i c h e a l t h and e n v i r o n m e n t a l c o s t s o f u s i n g many o f these farm i n p u t s are a l s o h i g h , and c o u l d be decreased a c c o r d i n g l y w i t h a r e d u c t i o n i n use. T h i r d , i t s h o u l d improve consumer f a i t h i n t h e a g r i c u l t u r a l


403

404


system and p o s s i b l y reduce p r i c e s once a l l a s s o c i a t e d " p e s t i c i d e c o s t s " were reduced throughout the system. And f o u r t h , i t c o u l d p r o v i d e a p o w e r f u l b a s i s f o r r e j u v e n a t i n g the l a n d g r a n t u n i v e r s i t i e s and a g r i c u l t u r a l experiment s t a t i o n s . In f a c t , i t s h o u l d be the USDA, the l a n d g r a n t u n i v e r s i t i e s , and the a g r i c u l t u r a l experiment s t a t i o n s t h a t are charged w i t h p u r s u i n g and a c h i e v i n g t h i s n a t i o n a l g o a l . The i d e a here i s not t o e x c l u d e the p r i v a t e s e c t o r , but f o r the p u b l i c s e c t o r t o "prime and pump", t o take l e a d e r s h i p i n , and absorb the r i s k s o f , a major r e o r i e n t a t i o n i n a g r i c u l t u r a l p r o d u c t i o n r e s e a r c h t h a t p o t e n t i a l l y c o u l d have wide p u b l i c benefit. However, w i t h such a program, the d e f i n i t i o n o f b i o t e c h n o l o g y and what i s pursued i n the name o f n o n - c h e m i c a l a n d / o r b i o l o g i c a l a l t e r n a t i v e s w i l l be a b s o l u t e l y c r u c i a l . What i s needed i s a b i o t e c h n o l o g y t h a t embraces "common sense b i o l o g y " and "common sense g e n e t i c s " , y e t eschews the g e n e t i c e n g i n e e r i n g o f organisms s i m p l y f o r the sake o f making new products. What t h i s means, however, i s t h a t gene s p l i c i n g and o t h e r b i o t e c h n o l o g y t e c h n i q u e s s h o u l d be used, w i t h i n r e a s o n , but t h a t what we a l r e a d y know s h o u l d not be d i s r e g a r e d o r overlooked. There i s a l r e a d y a l o t o f good b i o l o g y ' o n the s h e l f " , so t o speak. And t h e r e i s a l o t o f good, i n n o v a t i v e work g o i n g on throughout the c o u n t r y by r e s e a r c h e r s a t our l a n d g r a n t u n i v e r s i t i e s and a g r i c u l t u r a l experiment s t a t i o n s . For example, Donald B a r n e s , a p l a n t b r e e d e r a t USDA's r e s e a r c h c e n t e r a t the U n i v e r s i t y o f M i n n e s o t a , has developed a new v a r i e t y o f a l f a l f a c a l l e d N i t r o t h a t produces good l i v e s t o c k fodder and puts h i g h amounts o f n i t r o g e n back i n t o the s o i l . When plowed back i n t o the s o i l , N i t r o puts 94 l b s . o f n i t r o g e n i n t o the ground compared w i t h 59 l b s . f o r the top s t a n d a r d v a r i e t y . Nitro r e p r e s e n t s the k i n d o f g e n e t i c improvement i n a g r i c u l t u r e t h a t can save growers money on the i n p u t s i d e o f t h e i r o p e r a t i o n , and thus, increase t h e i r p r o f i t a b i l i t y . Extensive information i s a v a i l a b l e about s o i l t i l t h , p l a n t b r e e d i n g , c r o p r o t a t i o n s , intercropping, multilining, insect adaptability, agricultural d i v e r s i f i c a t i o n , and o t h e r f i e l d s — a l l o f which has a p p l i c a t i o n today. However, we s h o u l d not become so enamored o f b i o t e c h n o l o g y t h a t we go out o f our way f o r a h i g h - t e c h s o l u t i o n when a common-sense a l t e r n a t i v e i s r i g h t i n f r o n t o f u s . I f b i o t e c h n o l o g y i s used o n l y t o d i v i d e up the n a t u r a l w o r l d i n t o i t s most numerous product p o s s i b i l i t i e s , r a t h e r than u s i n g i t t o improve our a b i l i t y t o work w i t h the b i o l o g i c a l r e a l m , f u r t h e r economic and e n v i r o n m e n t a l problems f o r the f u t u r e w i l l s u r e l y be c r e a t e d , and a t r u l y g o l d e n o p p o r t u n i t y f o r r i g h t i n g some o f the m i s t a k e s o f the p a s t w i l l be m i s s e d . RECEIVED

June 7,1988


Biotechnology Regulation - ACS Symposium Series (ACS Publications)

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