The Need for Risk Assessment of Chemicals in Corporate Decision

10 The Need for Risk Assessment of Chemicals in Corporate Decision Making FRED HOERGER

Downloaded by PURDUE UNIV on February 12, 2018 | https://pubs.acs.org Publication Date: January 13, 1984 | doi: 10.1021/bk-1984-0239.ch010

The Dow Chemical Company, Midland, MI 48640

Risk assessment is a complex and dynamic discipline, s t i l l in an evolutionary stage. The application of risk assessment within the chemical industry similarly has been evolutionary. Risk assessment is used in industry in several ways. Furthermore, industrial experience leads to several principles that are generally applicable in governmental and other sectors.

Chronology

o f t h e Growth o f R i s k

Concerns

In t h e e a r l y p e r i o d o f c h e m i c a l m a n u f a c t u r e , r o u g h l y f r o m 1900 t o 19^5, t h e i n d u s t r y f o c u s e d on u n d e r s t a n d i n g and c o n t r o l l i n g the r e a c t i v i t y o f chemicals. P r o p e r t i e s such as f l a m m a b i l i t y , s p o n t a n e o u s d e c o m p o s i t i o n , a u t o c a t a l y s i s , and a c u t e h a z a r d s such as c o r r o s i v e n e s s and o t h e r i r r e v e r s i b l e h e a l t h e f f e c t s f r o m s i n g l e e x p o s u r e s were c h a r a c t e r i z e d . R i s k management p r a c t i c e s were r e s p o n s i v e t o t h e s e t y p e s o f d a t a . During t h i s e a r l y p e r i o d , t h e cornerstones o f i n d u s t r i a l t o x i c o l o g y a n d e n v i r o n m e n t a l s c i e n c e were e s t a b l i s h e d . F o r e x a m p l e , Dow, du P o n t , and E a s t m a n Kodak e s t a b l i s h e d t o x i c o l o g y laboratories. And t h e u s e o f b i o l o g i c a l o x i d a t i o n f o r t r e a t m e n t o f i n d u s t r i a l w a s t e s was p i o n e e r e d i n t h e 1930s. In t h e m a j o r g r o w t h p e r i o d o f t h e c h e m i c a l i n d u s t r y , r o u g h l y f r o m 19^5 t o 1970, t h e a p p l i c a t i o n o f r i s k a s s e s s m e n t t o c h e m i c a l h a z a r d s a l s o grew r a p i d l y . In the f i e l d o f t o x i c o l o g y

0097-6156/ 84/ 0239-0147506.00/ 0 © 1984 American Chemical Society

Rodricks and Tardiff; Assessment and Management of Chemical Risks ACS Symposium Series; American Chemical Society: Washington, DC, 1984.


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A S S E S S M E N T A N D M A N A G E M E N T OF C H E M I C A L RISKS

the f i r s t two-year d i e t a r y study i n animals was completed i n 19^*6· Extensive animal studies on drugs, p e s t i c i d e s and food a d d i t i v e s became commonplace i n the 1960s. I n d u s t r i a l hygiene, a d i s c i p l i n e concerned with c o n t r o l of exposure p o t e n t i a l s and other hazards i n the workplace evolved as a new p r o f e s s i o n . Corporations i n s t i t u t e d occupational h e a l t h programs with medical s t a f f s and f a c i l i t i e s . And environmental science became a focus of a t t e n t i o n with the emergence of studies on aquatic t o x i c i t y , b i o c o n c e n t r a t i o n , and p e r s i s t e n c e of chemicals. During t h i s growth period of the i n d u s t r y , r i s k assessment was l a r g e l y formalized by corporate actions on a case-by-case b a s i s and a p r o f e s s i o n a l i s m i n v o l v i n g data generation and s c i e n t i f i c judgment. R e l a t i v e l y few p r o f e s s i o n a l s were i n v o l v e d , these coming from i n d u s t r y , academia, and government. As examples, a few of the groups c o n t r i b u t i n g to these formali z e d r i s k assessments were the American Conference of Governmental I n d u s t r i a l H y g i e n i s t s , f o r e s t a b l i s h i n g exposure l i m i t s for chemicals i n the workplace; The Food and Drug A d m i n i s t r a t i o n which e s t a b l i s h e d residue t o l e r a n c e s f o r p e s t i c i d e s ; and the American Society f o r T e s t i n g M a t e r i a l s which e s t a b l i s h e d a n a l y t i c a l methodology. Growth of the chemical i n d u s t r y has been more moderate s i n c e 1970. But during t h i s t h i r d p e r i o d , a combination of f a c t o r s has increased almost e x p o n e n t i a l l y the focus on r i s k s a s s o c i a t e d with chemicals, h e a l t h and the environment. These f a c t o r s include advances i n h e a l t h and environmental technology, an i n c r e a s i n g corporate r e s p o n s i b i l i t y toward h e a l t h and environmental concerns, media s p o t l i g h t i n g of new information and i n c i d e n t s , and i n c r e a s i n g government and p u b l i c involvement i n risk decisions. Advances i n h e a l t h and environmental technology during the 70s were t r u l y dramatic. A n a l y t i c a l technology which formerly f e r r e t e d out chemicals i n the ranges of tenths of a percent to parts per m i l l i o n now f i n d chemicals i n the parts per b i l l i o n and p a r t s per t r i l l i o n range on a r o u t i n e b a s i s . Carcinogenic bioassays have increased during the 70s and are now augmented by a v a r i e t y of short-term t e s t i n g methodologies. Mutagenicity, t e r a t o l o g y , reproductive e f f e c t s and b e h a v i o r a l t o x i c o l o g y are only a few of the s u b d i s c i p l i n e s of t o x i c o l o g y and c l i n i c a l medicine now r e c e i v i n g s o p h i s t i c a t e d a t t e n t i o n . Epidemiology has become a byword f o r both i n d u s t r y and government researchers. New information on the e f f e c t s of chemicals has received widespread media a t t e n t i o n . Bioconcentration of chemicals such as PCB and DDT i n f i s h , new f i n d i n g s of c a r c i n o g e n i c i t y , and the occurrence of reproductive h e a l t h e f f e c t s , to name only a few, are t o p i c s which have been p u b l i c i z e d i n media of every type. Incidents ranging from t r a n s p o r t a t i o n s p i l l s to the l e a c h i n g of chemicals i n t o ground water from waste d i s p o s a l s i t e s have



10.

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Corporate Decision Making

149

s i m i l a r l y been p u b l i c i z e d . The p u b l i c has developed perceptions of r i s k based upon fragments of information rather than comprehensive r i s k determinations. The government's r o l e i n r i s k determination has p a r a l l e l e d the concerns of the media and the p u b l i c . Frequently, percept i o n s of r i s k r a t h e r than o b j e c t i v e fact c o l l e c t i o n and r i s k assessment have been paramount i n Congressional enactment o f laws and i n government r e g u l a t o r y d e c i s i o n s . C a r c i n o g e n i c i t y has been the t r i g g e r f o r a whole host of government d e c i s i o n s , for example, c o n t r o l s on DDT, asbestos, benzene, s a c c h a r i n ; and even t o enactment of the Clean Drinking Water A c t . S i g n i f i c a n t l y , a strong trend toward government r e l i a n c e on r i s k assessment occurred s i n c e 1 9 7 6 . The Toxic Substances C o n t r o l Act o f 1976 s t i p u l a t e s that r e g u l a t o r y c o n t r o l over chemicals s h a l l involve d e c i s i o n s based upon a balancing o f h e a l t h and environmental r i s k s with economic and s o c i a l impacts. Congress, responding t o a changing p u b l i c mood, deferred FDA's proposals t o ban s a c c h a r i n . The Supreme Court, i n o v e r t u r n i n g OSHA's standard f o r benzene, s t i p u l a t e d that OSHA must make a t h r e s h o l d f i n d i n g of s i g n i f i c a n t r i s k . FDA was d i r e c t e d to a l l o w de minimis q u a n t i t i e s o f a c r y l o n i t r i l e i n polymers r a t h e r than i n s i s t upon zero c o n c e n t r a t i o n . F i n a l l y i t should be mentioned that an i n c r e a s i n g number o f corporations have continued t o expand t h e i r corporate p o l i c i e s toward the knowledge and perceptions of h e a l t h and environmental concerns. For example, many company p o l i c i e s r e l a t e , i n a comprehensive way, t o product s a f e t y , workplace h e a l t h and s a f e t y , and t o d i s p o s a l of chemicals. Broad P r i n c i p l e s o f t h e Risk Assessment Process i n the Corporation Based upon the events c i t e d i n the preceding b r i e f chronology, I b e l i e v e there are two p r i n c i p l e s that i n f l u e n c e the r i s k assessment process i n c o r p o r a t i o n s . The f i r s t p r i n c i p l e i s that a combination of data and experienced judgment are necessary t o assess r i s k s i n a r a t i o n a l way. The need f o r data on the i n t r i n s i c p r o p e r t i e s o f a chemical i s s e l f - e v i d e n t . The experienced judgment i s perhaps l e s s obvious. The seventies became the era of r i s k s p e c u l a t i o n . The p u b l i c , government r e g u l a t o r s , and p l a i n t i f f attorneys a r e f a m i l i a r with the lengthy l i s t o f p o s s i b l e hazards from broad generic c l a s s e s o f chemicals. For a given chemical, the l i k e l y r i s k s must be separated from the long s p e c u l a t i v e r i s k l i s t s . The experienced Judgment must i n t e g r a t e chemical and p h y s i c a l p r o p e r t i e s , use/exposure p o t e n t i a l , t o x i c i t y and environmental f a t e information i n order t o t a r g e t the r i s k assessment process toward r e a l r i s k s i n s t e a d of t r i v i a l r i s k s .


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ASSESSMENT A N D M A N A G E M E N T OF C H E M I C A L RISKS

The s e c o n d p r i n c i p l e o f t h e r i s k a s s e s s m e n t p r o c e s s i n t h e c o r p o r a t i o n i s that i t i s a staged and r e c y c l i n g process. G e n e r a t i o n o f new d a t a l e a d s t o new c o n c l u s i o n s a n d interpretations.

An o n c o g e n i c i t y s t u d y may p r o v i d e a n e g a t i v e

i n d i c a t i o n o f c a n c e r p o t e n t i a l and t h u s v a l i d a t e p r e s e n t exposure c o n t r o l s . On t h e o t h e r h a n d , a p o s i t i v e i n d i c a t i o n o f c a r c i n o g e n i c p o t e n t i a l may t r i g g e r b o t h a r é é v a l u a t i o n o f e x p o s u r e c o n t r o l s and t h e need f o r f u r t h e r d a t a g e n e r a t i o n .


Another major source o f t h e r e c y c l i n g o f r i s k assessments comes f r o m g e n e r i c a d v a n c e s b e i n g made i n o u r m e t h o d o l o g i e s . As o n c o g e n i c i t y s t u d i e s h a v e p r o g r e s s e d , we h a v e seen a t h r u s t f r o m a n i m a l s t u d i e s o f 6 months e x p o s u r e t o s t u d i e s i n v o l v i n g l i f e time exposure t o q u a l i t a t i v e s h o r t - t e r m t e s t s . And t o d a y , we s e e a n e m e r g i n g e m p h a s i s on m e c h a n i s m s t u d i e s t o d i f f e r e n t i a t e g e n e t i c from n o n - g e n e t i c c a r c i n o g e n e s i s . As each methodology d e v e l o p s , i t may b e n e c e s s a r y t o f i l l d a t a g a p s , a n d t o u p d a t e or r e v i s e t h e r i s k assessment o f a g i v e n c h e m i c a l . The

point

i s , a risk

assessment

i s a snapshot

i n a time

frame s u b j e c t t o a n e x p a n d i n g d a t a b a s e and a d v a n c e s i n s c i e n t i f i c methodology, t h e o r y , and i n s i g h t . E x p e r i e n c e d judgment i s a n e c e s s a r y component t o t a r g e t r e s o u r c e s a n d t o a r t i c u l a t e p r i o r i t i e s a g a i n s t t h e i n d i s c r i m i n a t e background o f s p e c u l a t i v e risks. Types o f C o r p o r a t e Relating t o Risk

D e c i s i o n s B a s e d on o r Assessment

From a n a n a l y t i c a l health

the

viewpoint, corporate decisions

and e n v i r o n m e n t a l

risk

assessment

1)

those i n v o l v i n g business decisions i n v e s t m e n t s and v e n t u r e s ; and

2)

those

involving

policy

long-term

staffing

community

relations.

reflecting

a r e o f two t y p e s : on p r o j e c t s ,

c o n s i d e r a t i o n s such as

p l a n s , and employee, customer and

The d e g r e e o f i m p o r t a n c e o f r i s k a s s e s s m e n t depends u p o n s p e c i f i c circumstances. I t d e p e n d s u p o n t h e p r o d u c t mix o f

t h e company a n d t h e t y p e o f a c t i v i t y w h i c h i s c a r r i e d o n , t h a t i s , w h e t h e r t h e company i s a m a n u f a c t u r e r , a p r o c e s s o r o r a distributor. A l m o s t e v e r y company a t some t i m e i s f a c e d w i t h t h e q u e s t i o n o f whether t o c o n t i n u e o r d i s c o n t i n u e a product o r a c t i v i t y b a s e d upon new f i n d i n g s o r p e r c e p t i o n s o f r i s k . The more common p r o b l e m i s f r e q u e n t l y f a c e d i n d e c i s i o n s on w h e t h e r t o a d o p t more s t r i n g e n t p r a c t i c e s o r s t a n d a r d s i n o r d e r t o m i n i mize r i s k s . F r e q u e n t l y an i n v e s t m e n t d e c i s i o n i s c l o u d e d b y


10.

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u n c e r t a i n t i e s , o r perceptions o fu n c e r t a i n t i e s i nrisk assessment, o r b y g a p s i n r i s k i n f o r m a t i o n . Commercial development o f a new p r o d u c t o r a new v e n t u r e o f t e n h i n g e s on a r i s k a s s e s s m e n t and an e v a l u a t i o n o f t h e p o t e n t i a l f o r l i a b i l i t y c l a i m s a n d l i t i g a t i o n costs. T h e s e l e c t i o n o f a new p l a n t s i t e must b e i n f l u e n c e d by the determination o f s e v e r a l kinds o f r i s k s .


D i f f i c u l t d e c i s i o n s a r e o f t e n f a c e d b y management i n d e t e r m i n i n g t h e optimum d e g r e e o f c o m m u n i c a t i o n f o r new r i s k i n f o r m a tion. U s u a l l y new i n f o r m a t i o n on h e a l t h e f f e c t s comes i n f r a g m e n t s so t h a t p e r s p e c t i v e on r i s k i s d i f f i c u l t t o m a i n t a i n , whether communicating t o employees, t o customers, t o the government o r t o o t h e r p u b l i c s e c t o r s . Company P o l i c y on R i s k D e t e r m i n a t i o n . E i t h e r by c a r e f u l design, b y a n e v o l u t i o n a r y p r o c e s s o r b y d e f a u l t , a g i v e n company u s u a l l y a r r i v e s a t a number o f s i g n i f i c a n t p o l i c i e s a n d p r a c t i c e s involving risk. C o n s i d e r i n g t h e e v e n t s o f t h e p a s t decade a n d the continuing trends i n r i s k concerns, an e s s e n t i a l p o l i c y d e c i s i o n i n v o l v e s the assessment o f s t a f f i n g needs. A company must develop the t e c h n i c a l and s p e c i a l i s t r e s o u r c e s : t o m a i n t a i n a c u r r e n t awareness o f a l l i n f o r m a t i o n t o t h e r i s k s o f i t s p r o d u c t s and a c t i v i t i e s ;

-

to

determine a p p r o p r i a t e

to

disseminate

practices for minimizing

appropriate

t o work w i t h c u s t o m e r s and bodies i n t h e i r assessment

relating

risks;

customer i n f o r m a t i o n ; and v a r i o u s government a n d p u b l i c o f p r a c t i c e s and s t a n d a r d s .

A l m o s t a s i m p o r t a n t i s t h e d e c i s i o n on w h e t h e r t o d e v e l o p r e s o u r c e s f o r r e s e a r c h and t e s t i n g t o o b t a i n a d d i t i o n a l r i s k information. A company c a n r e s p o n d t o i n f o r m a t i o n g e n e r a t e d b y t h e v a r i o u s i n d u s t r y , a c a d e m i c and g o v e r n m e n t s e c t o r s , o r i t c a n p a r t i c i p a t e i n the development o f i n f o r m a t i o n . The l a t t e r c o u r s e p e r m i t s a more i n - d e p t h a w a r e n e s s o f s o p h i s t i c a t e d technology a t the p r o f e s s i o n a l i n t e r a c t i o n l e v e l . E m p l o y e e s , c u s t o m e r s , a n d members o f l o c a l c o m m u n i t i e s a r e aware o f , a n d o f t e n h i g h l y s e n s i t i v e t o , i n f o r m a t i o n on t h e e f f e c t s o f chemicals. P o l i c i e s t e n d i n g toward candor, d i r e c t d i a l o g u e and m u t u a l p r o b l e m s o l v i n g emerged d u r i n g t h e 70s a n d w i l l probably continue i n the f u t u r e . The I n t e r r e l a t i o n s h i p o f R i s k w i t h O t h e r C o r p o r a t e C ons i de r a t i o n s . F o r p u r p o s e s o f t h i s d i s c u s s i o n , assume t h a t the a c t u a l r i s k s i n v o l v e d with a substance o r a given a c t i v i t y a r e o b j e c t i v e l y j u d g e d t o b e q u i t e low. E v e n s o , a number o f o t h e r f a c t o r s must b e t a k e n i n t o a c c o u n t .



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It has become i n c r e a s i n g l y c l e a r t h a t the p u b l i c percept i o n s of r i s k do not n e c e s s a r i l y f o l l o w o b j e c t i v e s t a t i s t i c a l assessments of r i s k . For example, s e v e r a l surveys have been conducted i n which the p u b l i c was asked to rank according to r e l a t i v e r i s k various i n d u s t r i e s or a c t i v i t i e s such as p e s t i c i d e s , nuclear power, a i r p l a n e t r a v e l , smoking, skin d i v i n g and others. The p u b l i c ranking d i d not c o r r e l a t e very w e l l with s t a t i s t i c a l evidence and the expert Judgment of engineers and scientists. I t i s i n t e r e s t i n g to note that use of asbestos i n s u l a t i o n i n h a i r dryers probably presents a t r i v i a l r i s k s i t u a t i o n ; however, i t i s u n l i k e l y t h a t any company would today consider a r e i n t r o d u c t i o n of such a p r a c t i c e . Frequently the amount of e f f o r t required to demonstrate that a r i s k i s t r i v i a l becomes very l a r g e . For example, one can hypothesize that any g a s o l i n e a d d i t i v e might have the same h e a l t h e f f e c t c h a r a c t e r i s t i c s as benzene. I f t h i s was being considered as a new chemical venture, the e f f o r t to put the low r i s k i n t o perspective might be almost insurmountable. In 1971 NTA was v o l u n t a r i l y withdrawn from the market by major detergent manufacturers because concerns were r a i s e d about the safety of the m a t e r i a l . L a t e r studies resolved these concerns. In 1973, NTA-containing detergents were reintroduced i n t o Canada and l a t e r approved f o r use i n s e v e r a l European and South American c o u n t r i e s . In the U.S., s i g n i f i c a n t l y more research and t e s t i n g were done on OTA. F i n a l l y i n 1980, a f t e r a 2-1/2 y e a r review o f NTA s a f e t y , EPA concluded that there was no reason to take regul a t o r y a c t i o n against the resumed production and use of NTA i n laundry detergents. It seems apparent that smaller volume products with l e s s market p o t e n t i a l than NTA or benzene and g a s o l i n e cannot J u s t i f y the e f f o r t required when p u b l i c perceptions of r i s k are g r e a t l y d i f f e r e n t from o b j e c t i v e l y determined r i s k s . The D i s t i n c t i o n Between Risk Assessment and Acceptable Risk. Both corporate and government decisions on r i s k u l t i m a t e l y focus on l e v e l s of r i s k t h a t are acceptable to s o c i e t y . Because of the widespread i n c o n s i s t e n c i e s i n r i s k l e v e l s achieved by the i n c l u s i o n of p o l i t i c a l f a c t o r s i n the r e g u l a t o r y process and because of d i f f e r e n c e s i n laws, regulatory d e c i s i o n s show a p a t t e r n of inconsistency i n the l e v e l of r i s k c o n t r o l a c t u a l l y achieved. These i n c o n s i s t e n c i e s have increased the focus on methodology f o r estimating r i s k s from various s o c i e t a l and industrial activities. I t i s important t o emphasize that the desired goal of o b j e c t i v e r i s k assessment should be that i t i s viewed as one of the t o o l s f o r the decisionmaker and that no s p e c i f i c methodology leads to a s i n g l e formula f o r a d e c i s i o n . Within the corporate s e t t i n g , i t i s f e l t that management needs the best assessment of r i s k a s s o c i a t e d with the various uses of a chemical. The r i s k a n a l y s i s can then be i n t e g r a t e d with the other business and p u b l i c p o l i c y c o n s i d e r a t i o n s .


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HOERGER


153


Data G e n e r a t i o n and R i s k Assessment I n t e g r a t e d i n t o t h e R e s e a r c h , Development, and C o m m e r c i a l i z a t i o n C y c l e o f a P r o d u c t As r e s e a r c h p r o g r e s s e s t o w a r d a c o m m e r c i a l v e n t u r e , t h e r e a r e p o i n t s i n t i m e when t h e i m p o r t a n c e o f t h e c h e m i c a l substance, f o r m u l a t i o n o r t h e f a b r i c a t e d i t e m must be e v a l u a t e d . Although e a c h company may have i t s own s y s t e m f o r e v a l u a t i o n , more a n d more i n d i v i d u a l s become i n v o l v e d a s t h e c y c l e p r o g r e s s e s . M u l t i - d i s c i p l i n a r y r e s o u r c e s a n d t a l e n t s a r e needed t o d e a l w i t h procurement, w i t h t h e b i o l o g i c a l impact o r p o t e n t i a l hazards from t h e m a t e r i a l , w i t h t h e f o r m u l a t i o n o r f a b r i c a t i o n methodo l o g y t h a t may b e n e e d e d , a n d e v e n w i t h how i t w i l l b e m a r k e t e d and what segments o f s o c i e t y w i l l f i n d i t u s e f u l . Thus, i n d u s t r i a l R&D i n v o l v e s m a n a g i n g a b r o a d r a n g e o f r e s o u r c e s — d o l l a r s , p r o f e s s i o n a l s k i l l s ( p e o p l e ) and f a c i l i t i e s (analytical equipment, p i l o t p l a n t s , e t c . ) . are

I n d u s t r i a l r e s e a r c h and commercial development o f a p r o d u c t f r e q u e n t l y v i e w e d a s b e i n g segmented i n t o f o u r s t a g e s : Stage Stage Stage Stage

I — E x p l o r a t o r y and S y n t h e s i s I I — P r o d u c t and Use C h a r a c t e r i z a t i o n I I I — P i l o t P r o c e s s and F i e l d D e v e l o p m e n t TV — Commercialization

I t i s i n Stage I — t h e e x p l o r a t o r y stage — t h a t s c i e n t i s t s i n i t i a t e e f f o r t on a p r o b l e m , t h e s o l u t i o n t o w h i c h w i l l c o n t r i b u t e an e c o n o m i c b e n e f i t t o t h e company a n d f i l l a n e e d t h a t t h e u s e r i s a b l e t o i d e n t i f y a n d f o r w h i c h he i s w i l l i n g t o pay. T h e s c i e n t i s t w i l l b e l o o k i n g f o r new c o n c e p t s , p o t e n t i a l l y u s e f u l compounds a n d new ways o f m o d i f y i n g e x i s t i n g p r o d u c t s , a n d he w i l l b e e x e r c i s i n g t h e p r o c e s s e s o f i n n o v a t i o n and i n v e n t i o n . S t a g e I I r e p r e s e n t s a s e l e c t i o n p o i n t . More r e s o u r c e s a r e t a r g e t e d on a g i v e n p r o d u c t a n d / o r t e c h n o l o g y . Stage I I I i s f u r t h e r t a r g e t i n g o f r e s o u r c e s — more f a c i l i t i e s , more d i s c i p l i n e s , a n d i n v o l v e m e n t o f t h o s e o u t s i d e t h e company — l e a d i n g t o c o m m e r c i a l i z a t i o n i n Stage IV. L e t ' s examine s e v e r a l d i f f e r e n t a s p e c t s o f t h i s f o u r - s t a g e process. P r o g r e s s i v e l y , t h e c o r p o r a t i o n p r o c e e d s f r o m many i d e a s a n d c h e m i c a l s t o one c h e m i c a l c o n t a i n e d i n one o r a few f o r m u l a t i o n s f o r o n e o r a few u s e s . T h e knowledge o f t h e p o t e n t i a l u s e becomes more s o p h i s t i c a t e d t h r o u g h t h i s p r o g r e s s i o n . F o r example, from a concern f o r t h e simple p r o p e r t y o f t e n s i l e s t r e n g t h i n a p o l y m e r t h e c o r p o r a t i o n w i l l become more s o p h i s t i c a t e d a n d i n t u r n examine o t h e r p a r a m e t e r s s u c h a s b r i t t l e n e s s , a d h e s i v e c h a r a c t e r i s t i c s , l i g h t s t a b i l i t y , and many more. T h e q u e s t f o r a b r o a d - u s e p r o d u c t f r e q u e n t l y n a r r o w s down t o a s p e c i f i c use.



154

A S S E S S M E N T A N D M A N A G E M E N T O F C H E M I C A L RISKS

Generation of t o x i c o l o g i c a l data s i m i l a r l y goes through a progression. Newly synthesized compounds may be c h a r a c t e r i z e d o n l y as t o acute t o x i c i t y t o t h e r a t o r be screened only f o r unique drug or p e s t i c i d a l a c t i v i t y . But as the p r o g r e s s i o n proceeds and commercial success becomes more l i k e l y , the t o x i c o l o g i c a l data base and p o t e n t i a l exposure are f u r t h e r considered and, where needed, more species a r e t e s t e d and longer range t e s t s may be commenced. For example, e a r l y i n Stage I I , mammalian t o x i c o l o g i c a l range-finding t e s t s f r e q u e n t l y a r e i n s t i t u t e d . These s t u d i e s are designed to determine the c a p a c i t y o f the m a t e r i a l t o cause i n j u r y from acute exposure i f i n g e s t e d , makes contact with the eyes or s k i n , or i s i n h a l e d . These types of s t u d i e s a r e done to determine any s i g n i f i c a n t degree of danger from i n c i d e n t a l exposure t o the compound. This informat i o n i s needed f o r safe handling by chemists and chemical engineers, and i s u s e f u l i n the design o f p i l o t p l a n t s . T h i s information a l s o w i l l become part o f the data package made a v a i l able t o the customer, t o the government and t o other segments of society. Environmental data s i m i l a r l y goes through a sequence. Considerable i n s i g h t on t r a n s p o r t and f a t e c h a r a c t e r i s t i c s can be gained from simple chemical and p h y s i c a l data c o l l e c t e d i n Stages I and I I . Vapor pressure, water s o l u b i l i t y , d i s s o c i a t i o n constants, h y d r o l y s i s and o x i d a t i o n h a l f - l i v e s , along with a simple t e s t f o r b i o l o g i c a l o x i d a t i o n , permit informed Judgments on environmental c h a r a c t e r i s t i c s . Modeling s t u d i e s , k i n e t i c a n a l y s i s of degradation processes and aquatic t o x i c i t y s t u d i e s w i l l be considered f o r those few l a r g e volume chemicals which have p o t e n t i a l f o r large environmental r e l e a s e , are r e l a t i v e l y p e r s i s t e n t and e x h i b i t r e l a t i v e l y high t o x i c i t y . Group Decisions on Product Review. In the l a t t e r p a r t o f Stage I I , the f i r s t key product review i n v o l v i n g many i n d i v i duals takes p l a c e . Up t o t h i s p o i n t , d e c i s i o n s have g e n e r a l l y been made by i n d i v i d u a l s p e r s o n a l l y i n v o l v e d i n the product development. As a product becomes more i d e n t i f i a b l e , group review takes place and a management d e c i s i o n i s made on whether to begin i n t e n s i v e development a c t i v i t y . Suppose the compound shows l i t t l e p o t e n t i a l f o r e n v i r o n mental i n s u l t and has a l s o proved t o be very low i n t o x i c i t y . In such a case, there i s an opportunity t o move more r a p i d l y toward commercialization without f u r t h e r extensive t e s t i n g , e s p e c i a l l y i f the product i s s i t e - l i m i t e d , i s u s e f u l as an i n t e r mediate f o r the p r e p a r a t i o n o f other types of m a t e r i a l s , o r i f i t has only minimal contact with man and the environment. I f , however, t h e r e i s opportunity f o r high exposure t o the compound or i t has a high p r o b a b i l i t y o f e n t e r i n g i n t o the environment, i t may be necessary t o do sub-chronic t o x i c i t y t e s t s . Such s t u d i e s may be of the i n g e s t i o n type or of the



10.

HOFRGER


155

i n h a l a t i o n type, o r both, and may take three to s i x months. In a d d i t i o n , s k i n s e n s i t i z a t i o n t e s t s may be performed on guinea p i g s . Concurrently, product e v a l u a t i o n research i s i n t e n s i f i e d i n the l a b o r a t o r i e s , and f r e q u e n t l y p o t e n t i a l customers are encouraged to evaluate the product i n t h e i r s e l e c t e d uses. As the chemical product moves toward commercialization, other major key review conferences are conducted. Committees o f research, development and marketing people review the a d d i t i o n a l data and decide whether t o obtain a d d i t i o n a l i n f o r m a t i o n , i n c l u d i n g h e a l t h and environmental data, or go d i r e c t l y to the marketplace· With a r e l a t i v e l y few new chemicals, there may be p o t e n t i a l for wide exposure to humans or the environment, and i f the i n i t i a l t o x i c i t y and environmental p r o f i l e data i n d i c a t e s concern f o r c e r t a i n e f f e c t s , there may be need f o r an in-depth s e r i e s of studies which c o u l d take t h r e e years or longer to complete. These studies would be chosen from a spectrum of animal t e s t s such as s t u d i e s of metabolic pathways, pharmacok i n e t i c parameters, t e r a t o g e n i c , mutagenic and c a r c i n o g e n i c p o t e n t i a l and reproductive competency. Normally the necessary t e s t s are chosen by c o n s i d e r i n g p o t e n t i a l use and s i m i l a r i t y to a l r e a d y c h a r a c t e r i z e d compounds. These d e c i s i o n s r e q u i r e p r o f e s s i o n a l judgment by h i g h l y experienced experts. While the a d d i t i o n a l h e a l t h and environmental t e s t i n g i s going on, much work i n advanced product and process development i s a l s o being c a r r i e d out. The h e a l t h and environmental data c o l l e c t e d i n the l a b o r a t o r y becomes the b a s i s f o r d e f i n i n g operating c o n t r o l s and pract i c e s and f o r manufacture and use. T y p i c a l l y , the chemical manufacturer, and many u s e r s , i n i t i a t e i n d u s t r i a l hygiene monitoring and medical s u r v e i l l a n c e programs i n the commercial phase· It can be seen t h a t data generation f o r r i s k assessment i s an on-going process during development and commercialization of a new product. Once commercialized, a few chemicals grow t o l a r g e volume ( m u l t i - m i l l i o n to m u l t i - b i l l i o n pounds per year) and f r e q u e n t l y t h e i r u t i l i t y r e s u l t s i n uses not envisioned a t product launch. Risk assessment continues with t h i s growth. Risk Assessment on E x i s t i n g Chemicals — Data Gaps, Exposure Assessment and P r i o r i t i e s The inventory of e x i s t i n g chemicals, compiled i n 1978 under the Toxic Substances C o n t r o l A c t , l i s t s more than 55*000 chemicals i n commerce. ( P e s t i c i d e s , drugs and food a d d i t i v e s are excluded). Considering the rapid advances i n h e a l t h and environmental sciences during the past two decades, and the l i m i t a t i o n s on f a c i l i t i e s , p r o f e s s i o n a l s s k i l l e d i n t e s t i n g , and monetary resources, i t i s obvious that not a l l of these e x i s t i n g


156


chemicals

c a n be t e s t e d and e v a l u a t e d

prescription. A s a g e n e r a l i z a t i o n , most the

i n f o r m a t i o n b a s e on t h e i r

by a u n i v e r s a l t e s t i n g

large chemical chemicals

companies

on a p e r i o d i c

review

basis i n

o r d e r t o e s t a b l i s h r e s e a r c h and t e s t i n g p r i o r i t i e s . Absence o f data, s t r u c t u r e / a c t i v i t y s i m i l a r i t y t o chemicals with potent a d v e r s e e f f e c t s , and p o t e n t i a l f o r e x p o s u r e a r e i m p o r t a n t considerations i n setting p r i o r i t i e s . Usually, a dossier of a v a i l a b l e information i s prepared p r i o r t o e s t a b l i s h i n g a t e s t i n g program.


S i m i l a r p r a c t i c e s have b e e n u t i l i z e d b y t h e C h e m i c a l Industry I n s t i t u t e of Toxicology i n e s t a b l i s h i n g t h e i r t e s t i n g p r o g r a m s and b y t h e F e d e r a l I n t e r a g e n c y T e s t i n g C o m m i t t e e w h i c h functions It

under

TSCA.

i s becoming

increasingly

clear

that

estimates of

exposure p o t e n t i a l a r e important i n d e v e l o p i n g t e s t i n g priorities. Screening o f groups o f chemicals t o s e l e c t c a n d i d a t e s f o r p o s s i b l e t e s t i n g c a n r e l y on s u r r o g a t e s f o r exposure data: -

Volume o f p r o d u c t i o n Amount o f e n v i r o n m e n t a l r e l e a s e T y p e o f m a n u f a c t u r e and u s e : on-site chemical -

intermediate

o r consumption use

Handled i n c l o s e systems. Dispersion uses.

Environmental

Fate

Characteristics

Persistence Bioconcentration Media Transport B l a i r and Bowman* have a n a l y z e d t h e v o l u m e p r o f i l e s o f t h e universe o f chemicals. T h e y f o u n d t h a t 10% (3,796 s u b s t a n c e s ) a r e produced i n q u a n t i t i e s over 1 m i l l i o n pounds, p e r y e a r , b u t t h a t 8l% (31,699 s u b s t a n c e s ) a r e p r o d u c e d i n q u a n t i t i e s l e s s t h a n 100,000 l b s / y r . They a l s o r e p o r t e d t h a t s i g n i f i c a n t h e a l t h and e n v i r o n m e n t a l d a t a e x i s t , o r i s c u r r e n t l y b e i n g generated, on 21 o f t h e 50 l a r g e s t v o l u m e c h e m i c a l s . C u r r e n t l y , much o f t h e t e s t i n g t o f i l l d a t a g a p s i s t a r g e t e d a t t h e l a r g e v o l u m e o r commodity c h e m i c a l s . Consider ing that r i s k i s a f u n c t i o n o f the t o x i c i t y (or other hazard) and t h e e x p o s u r e , i t i s a p p a r e n t t h a t g r e a t e r r e l i a n c e on e x p o s u r e a s s e s s m e n t w i l l be n e c e s s a r y a s p r i o r i t i e s a r e e s t a b l i s h e d f o r medium and s m a l l v o l u m e c h e m i c a l s .

* B l a i r , Ε . Η . , and Bowman, C., C o n t r o l o f E x i s t i n g Chemicals. Presented a t t h e American Chemical S o c i e t y N a t i o n a l Meeting, Las Vegas, Nevada. March 3 1 - A p r i l 1, 1982.


10.

HOFRCïER


Sound Risk Assessment:

157

M u I t i d i s c i p l i n a r y and Staged


As can be seen from my comments so f a r , r i s k assessment i n t h e c o r p o r a t i o n i s f r e q u e n t l y an informal process integrated i n t o other aspects of p r o j e c t s , programs, and d e c i s i o n s . I t i s , however, becoming more f o r m a l i z e d , along with needs f o r more widespread communication. I t seems worthwhile to elaborate on two key aspects f o r sound r i s k assessment — t h e i r m u l t i d i s c i p l i n a r y and staged nature. These key features have evolved from experience and seem e q u a l l y a p p l i c a b l e t o the government and other sectors making assessments. Risk Assessment — A M u l t i d i s c i p l i n a r y Process. Sound r i s k assessment must be considered as a m u l t i d i s c i p l i n a r y f u n c t i o n r e l y i n g upon data and experience from t o x i c o l o g y , epidemiology, c l i n i c a l medicine and i n d u s t r i a l hygiene or engineering representing exposure aspects of substances or agents. The r i s k assessment should be c a r r i e d out by a group o f experts i n these f i e l d s , making up a science panel. The h e a l t h p r o f e s s i o n a l s who make up t h i s panel may be employees of the company and may be c a l l e d an i n d u s t r i a l h e a l t h board. In other cases, the panel may be employees of an outside c o n s u l t i n g f i r m or may be academic c o n s u l t a n t s . O p e r a t i o n a l l y , the simplest v e r s i o n o f m u l t i d i s c i p l i n a r y r i s k assessment would involve t h e p r e p a r a t i o n o f a d r a f t r i s k assessment by one or two s c i e n t i s t s which would then be subjected t o c r i t i c a l review by an academic consultant knowledgeable i n the subject area. Risk Assessment — A Staged Process. Risk assessment i s obviously complex. I f the goal i s to have a reasonably o b j e c t i v e determination o f r i s k , i t i s u s e f u l t o view the determination as a s e q u e n t i a l process and as itemized i n Table I .

Table I . Risk Assessment Is a Staged

1. 2. 3. hm 5· 6.

Process

Perception of r i s k Preliminary r i s k assessment Proposed fact c o l l e c t i o n and research program Peer review Implementation of fact c o l l e c t i o n and research Comprehensive r i s k assessment


158

ASSESSMENT AND

Some e v e n t t r i g g e r s a p e r c e p t i o n

MANAGEMENT OF C H E M I C A L RISKS

of

risk:


a new t o x i c o l o g i c a l f i n d i n g , a p a t t e r n o f a s s o c i a t i o n e v e n t s s u c h as d i s e a s e o r w i l d l i f e i n j u r y , an a n a l y s i s of data fragments, o r a s e r i e s o f customer i n q u i r i e s or complaints. Such p e r c e p t i o n s u s u a l l y l e a d t o a p r e l i m i n a r y r i s k a s s e s s ment w h i c h may be made on t h e b a s i s o f r e a d i l y a v a i l a b l e f a c t s . Frequently the a v a i l a b l e data are l i m i t e d r e s u l t i n g i n high degrees of u n c e r t a i n t y i n the p r e l i m i n a r y assessment. If i t is deemed d e s i r a b l e t o r e d u c e s u c h u n c e r t a i n t i e s , t h e n a f a c t c o l l e c t i o n a n d / o r r e s e a r c h p r o g r a m must be p l a n n e d . It i s i m p o r t a n t t o e m p h a s i z e t h a t any more r e f i n e d r i s k a s s e s s m e n t w i l l depend upon t h e q u a l i t y o f judgment i n v o l v e d i n t h e d e s i g n o f r e s e a r c h and f a c t - f i n d i n g p r o j e c t s . I n t e r a c t i o n of s e v e r a l d i s c i p l i n e s i s important t o maximize the u t i l i t y o f the r e s u l t s . A t t e n t i o n t o t h e p u r p o s e and d e t a i l o f p r o t o c o l s , a n t i c i p a t i o n o f e n v i r o n m e n t a l c o n c e n t r a t i o n l e v e l s , and a h o s t o f p r a g m a t i c q u e s t i o n s a r e e s s e n t i a l . T y p i c a l l y , one o r more e x p e r i m e n t a l i s t s and a s p o n s o r w i l l d r a f t t h e r e s e a r c h p r o g r a m . Peer review b y one o r s e v e r a l e x p e r t s c a n t h e n u p g r a d e t h e d r a f t e d p r o g r a m . F a c t c o l l e c t i o n and r e s e a r c h r e s u l t s t h e n s e t t h e s t a g e f o r a comprehensive r i s k assessment. Some w o u l d a r g u e t h a t t h e s t a g e d p r o c e s s o u t l i n e d h e r e w o u l d d e l a y management d e c i s i o n s . I t may be t h a t t h e f a c t c o l l e c t i o n s t a g e w o u l d be l o n g e r ; however, the g r e a t e r c l a r i t y of the r i s k estimate would p r o v i d e more p r e c i s i o n i n a d d r e s s i n g a l t e r n a t i v e s and i n many c a s e s would a v o i d waste o f r e s o u r c e s , reduce the c o n f u s i o n and i n c r e a s e t h e d e g r e e o f c o n f i d e n c e and v a l i d i t y o f t h e d e c i s i o n . P r e l i m i n a r y e m p h a s i s upon t h e s t a g i n g n e e d e d t o d e v e l o p good s c i e n c e and f a c t w o u l d i n r e a l i t y work t o s h o r t e n t h e t i m e u s e d i n w h e e l - s p i n n i n g and c o u r s e c h a n g e s and t h e p r o v i d i n g o f c o n t i n g e n c i e s due t o u n c e r t a i n t i e s . Anticipation

of Regulatory

Decision

As f e d e r a l and s t a t e i n v o l v e m e n t i n s e t t i n g h e a l t h and environm e n t a l s t a n d a r d s has i n c r e a s e d d u r i n g t h e s e v e n t i e s , c o r p o r a t i o n s i n c r e a s i n g l y h a v e had t o a n t i c i p a t e t h e outcome o f regulatory proceedings. F o r e x a m p l e , i f new p l a n t s must be r e t r o f i t t e d t o meet new s t a n d a r d s , c o m p l i a n c e c o s t s e s c a l a t e ; o r , t h e demise o f a m a j o r use f o r a c h e m i c a l may i d l e a p l a n t and i t s w o r k f o r c e . P r e d i c t i n g r e g u l a t i o n s i s not an e a s y f o r e c a s t t o make, b u t the zones o f u n c e r t a i n t y are d e c r e a s i n g . Some s t a t u t o r y g u i d ance a p p l i e s . F o r e x a m p l e , t h e D e l a n e y Amendment r e q u i r e s a s i m p l i s t i c r i s k a s s e s s m e n t , c e n t e r i n g s o l e l y on t h e q u e s t i o n s of



10.

HOERGER


159

whether a m a t e r i a l i s a food a d d i t i v e and whether i t i s c a r cinogenic i n humans or i n appropriate animal t e s t s . A recent Supreme Court d e c i s i o n i n the benzene case s t i p u l a t e s that OSHA must show a s i g n i f i c a n t reduction i n r i s k i n order to j u s t i f y a workplace standard. This i n f e r s r e l i a n c e on r i s k assessment, but leaves open the question of s i g n i f i c a n c e . The Toxic Substances C o n t r o l A c t , i n c o n t r a s t , s t i p u l a t e s c o n s i d e r a t i o n of r i s k s , but balances r i s k s with costs and b e n e f i t s . During the 1977 to 1980 p e r i o d , OSHA, the CPSC and to some extent FDA and EPA adopted generic r e g u l a t o r y p o l i c i e s f o r evalu-J a t i n g carcinogenic r i s k s . These p o l i c i e s permitted us to p r e d i c t the f i n a l outcome. But they had a major shortcoming — they p r e s c r i b e d a recipe approach t o r i s k assessment which precluded an e v a l u a t i o n of a l l the a v a i l a b l e data and an expert judgmental i n t e r p r e t a t i o n of the i n t e r r e l a t i n g f a c t o r s and t h e i r consistency with u n d e r l y i n g s c i e n t i f i c theory. The author b e l i e v e s that r i s k assessment by a m u l t i d i s c i p l i n a r y group can r e l a t e a given r i s k s i t u a t i o n to other r i s k s i t u a t i o n s t h a t have been dealt with by r e g u l a t o r y agencies. However, the r i s k assessment i s , at best, only one of numerous inputs to r e g u l a t o r y d e c i s i o n s . Perspective f o r the Future During the past few years considerable debate has focused on the u n c e r t a i n t i e s of r i s k assessments, the concept of making prudent assumptions, the concept of upper l i m i t estimates, 95Î c o n f i dence l e v e l s and other f a c t o r s r e l a t i n g to the u n c e r t a i n t y of the data. Despite these debates, i t has been necessary t o make many d e c i s i o n s i n both company r i s k management p r a c t i c e s and the p u b l i c r e g u l a t o r y arena. I t i s important that r i s k assessment aim at determining the most probable estimate of r i s k . U t i l i z a t i o n of a s e q u e n t i a l process of m u l t i - d i s c i p l i n a r y r i s k assessment, with a focus on a comprehensive data base, w i l l go a long way toward a c h i e v i n g t h i s goal. The decisions from top management, both i n corporations and agencies, which commit to the development and use of sound r i s k determinations w i l l become i n c r e a s i n g l y important. As i n d i c a t e d e a r l i e r , our needs are sound data and t e c h nology f o r a p p r o p r i a t e l y minimizing h e a l t h and environmental r i s k s . To accomplish t h i s we need s p e c i a l i z e d s k i l l s , i n t e r d i s c i p l i n a r y i n t e r p r e t a t i o n and judgment. Laws, r e g u l a t i o n s and the a u t h o r i t y vested i n government are now superimposed on our chemical development scheme. L e g a l i s t i c and b u r e a u c r a t i c processes have a tendency to p l a c e burdens of proof f o r e i g n to the normal processes of s c i e n t i f i c i n t e r p r e t a t i o n and the t e s t s of consistency of the data as a whole·


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ASSESSMENT A N D M A N A G E M E N T OF CHEMICAL RISKS

G o v e r n m e n t s h a v e a r t i c u l a t e d s c e n a r i o s t h a t i n v o l v e new requirements f o r t e s t i n g and c r i t e r i a f o r d e c i s i o n - m a k i n g . Many o f t h e s e s c e n a r i o s , when c a r e f u l l y e x a m i n e d , r a i s e s p e c t e r s o f testing ourselves to e x t i n c t i o n . We a r e t o d a y p a r t o f a g r e a t d e b a t e i n r i s k management. T h i s a r e n a r e q u i r e s p e r s p e c t i v e on i t s c o m p l e x i t i e s a n d t h e b a l a n c i n g o f o u r i m p o r t a n t human, e c o n o m i c and n a t u r a l resources. 1983


RECEIVED N o v e m b e r ^


The Need for Risk Assessment of Chemicals in Corporate Decision

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