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UBC Theses and Dissertations

Canadian toxic chemical policy Sturdy, John Robert 1980

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CANADIAN TOXIC CHEMICAL POLICY by JOHN ROBERT STURDY B.Sc., The U n i v e r s i t y Of B r i t i s h Columbia, 1975  A THESIS SUBMITTED IN PARTIAL FULFILMENT OF THE REQUIREMENTS FOR THE DEGREE OF MASTER OF SCIENCE IN BUSINESS ADMINISTRATION in THE FACULTY OF GRADUATE STUDIES (Department of Commerce  and Business A d m i n i s t r a t i o n )  We accept t h i s t h e s i s as conforming to the required  standard  THE UNIVERSITY OF BRITISH COLUMBIA April  1980  (c) John Robert Sturdy, 1980  In presenting this thesis in partial fulfilment of the requirements for an advanced degree at the University of B r i t i s h Columbia, I agree that the Library shall make i t freely available for reference and study. I further agree that permission for extensive copying of this thesis for scholarly purposes may be granted by the Head of my Department or by his representatives.  It is understood that copying or publication  of this thesis for financial gain shall not be allowed without my written permission.  Department of  /^~M  The University of B r i t i s h Columbia 2075 Wesbrook Place Vancouver, Canada V6T 1W5  E-6  BP  75-51 1 E  ABSTRACT  T h i s t h e s i s examines the e x i s t i n g c o n s t r a i n t s o p p o r t u n i t i e s t h a t shape present  and  f u t u r e chemical c o n t r o l .  I t argues that a l a c k of adequate and the l i m i t i n g Federal  f a c t o r and presents and  and  accessible information  steps  to expand those  is  limits.  p r o v i n c i a l j u r i s d i c t i o n s were examined.,  Governments were found to have adequate power to r e g u l a t e a l l aspects of the problem i n c l u d i n g e n a b l i n g r e g u l a t i o n s and  guidelines, information  compensation. The c o n s t i t u t i o n a l but  legislation,  access  and  impediments to r e g u l a t i o n are not  therefore,  r a t h e r the l a r g e number of chemicals and  the  l a c k of a method to choose c a n d i d a t e s f o r c o n t r o l . A pre-market s t r a t e g y i s necessary to e s t a b l i s h p r i o r i t i e s f o r c o n t r o l among the many chemicals posing Hazard was  described  chemical and  as a f u n c t i o n of the exposure to a  the consequences of t h a t exposure. Thus, c h e m i c a l s  with l a r g e exposure and  harmful consequences would  c a n d i d a t e s f o r c o n t r o l while, exposure and  a p o t e n t i a l hazard.  conversely,  chemicals with  n e g l i g i b l e consequences would not.  for information  be  The  little  necessity  on those i n between would be determined from  the extent o f exposure or of hazard known. Approaches t o transform  p u b l i c o p i n i o n and  scientific  knowledge i n t o standards f o r chosen c a n d i d a t e s was method of a r r i v i n g a t an optimal  standard  was  judgment i s necessary. To a i d i n a r r i v i n g at  examined.  found.  No  Therefore,  acceptable  standards a c o n s u l t a t i v e approach with government, i n d u s t r y  and  iii  the  p u b l i c as p a r t i c i p a n t s was suggested. R a t i o n a l  would be aided  by the a v a i l a b i l i t y of adequate  To provide  the necessary i n f o r m a t i o n  decisions  information.  an information  system  i s advocated. Three model systems were reviewed. D e f i c i e n c i e s were analyzed  and p r e s c r i p t i o n s f o r design  made. Some o f the key p o i n t s d i s c u s s e d s t a n d a r d i z a t i o n o f data, storage organization  and c o n f i d e n t i a l i t y .  improvements were  are c o m p a t i b i l i t y ,  and r e t r i e v a l  problems,  iv  TABLE OF CONTENTS  ABSTRACT ................ ... ...................•.......... i i INTRODUCTION ..... ....  ...... . . ..  ..... ........  1. INSTRUMENTS OF CONTROL 1.1 Current Canadian L e g i s l a t i o n 1.2 L e g i s l a t i v e C o n s t r a i n t s ...........................  1 7 7 13  1.2.1 F e d e r a l J u r i s d i c t i o n ........................ 14 1.2.2 P r o v i n c i a l J u r i s d i c t i o n  17  1.2.3 Summary o f F e d e r a l and P r o v i n c i a l Powers .... 17 1.3 I n f o r m a t i o n Access ........................  18  1.3.1 Summary o f Information Access ............... 21 1.4 Compensation  21  1.5 C o n c l u s i o n s .......... ............................. 23 2. ESTA BLISMENT OF PRIORITIES FOB REGULATION  28  2.1 Exposure Determination ............................ 29 2.2 Environmental Dynamics ............................ 32 2.3 Analogous Consequences ............................ 2.3.1 Common Sense ........................  37 33  2.3.2 O c c u p a t i o n a l Exposure ....................... 38 2.3.3 Epidemiology .........  39  2.3.4 E x t r a p o l a t i o n from Animal T e s t s ............. 40 2.3.5 E x t r a p o l a t i o n from In V i t r o T e s t s ........... 42 2.3.6 E x t r a p o l a t i o n from R a d i a t i o n Data ........... 43 2.4 Chemical Behavior ................................. 43 2.4.1 Atmospheric I n t e r a c t i o n s .................... 44 2.4.2 Aquatic I n t e r a c t i o n  46  2.4.3  Terrestrial Interaction  47  2.4.4 M i c r o b i a l I n t e r a c t i o n ....................... 48 2.4.5  P r e d i c t i o n C a p a b i l i t y ....................... 49  2.5 C o n c l u s i o n s  .......................................  51  3. STANDABD SETTING ............................. ......... 55 3.1 Standard S e t t i n g Approaches ....................... 55 3.1.1  The Delaney P r i n c i p l e ....................... 56  3.1.2 No Detectable Adverse E f f e c t ................ 60 3.1.3  Toxicologically  I n s i g n i f i c a n t L e v e l s ........ 62  3.1.4 The Threshold P r i n c i p l e ..................... 62 3.1.5  Standard o f Osage  63  3.1.6  P r a c t i c a l C o n s t r a i n t s ....................... 64  3.1.7 Degree of N e c e s s i t y of B e n e f i t  65  3.1.8 Reasonableness ...... .... . . ........ .. ........ 66 3.1.9  P r e v a i l i n g P r o f e s s i o n a l P r a c t i c e ............ 67  3.2 M o d i f i e r s of Standard S e t t i n g Approaches ..........68 3.2.1  Voluntary Versus I n v o l u n t a r y Bisk ........... 69  3.2.2 Temporal D i s t r i b u t i o n of Bisk 3.2.3  The C e r t a i n t y o f Risk • . . . w , , « > . w . •  70 •/!  1  3.2.4 N e c e s s i t y of Exposure ....................... 72 3.2.5  O c c u p a t i o n a l and Non-Occupational Risk ...... 72  3.2.6  Common Versus Dread Risk  73  3.2.7 Varying S u s c e p t i b i l i t y t o Risks ............. 74 3.2.8 Chemical P r o p e n s i t y f o r Misuse .............. 74 3.2.9  R e v e r s i b i l i t y o f E f f e c t s .................... 75  3.3 C o n c l u s i o n s ............................  76  4. INFORMATION SYSTEMS .............^.................. ... 82 4.1 Information Systems ...............................  82  vi  4.1.1 N e c e s s i t y ............ * ........... .. ...... ,.. 82 4.1.2  Systems Models .............................. 85 N a t i o n a l .................................. 86 European ..... ........ ... ..... ...... ........ 86 international  ................... .......... 87  Other Systems  90  4.1.3 Problem Areas ............................... 91 Data Q u a l i t y  ....,..,........,,...,.,..,...91  Design Problems ........................... 9 3 funding and Users ......................... 97 Technical Expertise 4.2 C o n c l u s i o n s  98  . ............. ............ ...... ....... 98  5. CONCLUSIONS  ..  .... ...... 10 4  BIBLI0G BAPHY ...................................v......... 108 APPENDIX  ... . ........ ., .•. . . ....... 11 8  A. OECD L e g i s l a t i v e Models  118  A. 1 United Kingdom . . . . . . . . . . . . . v . . . i . . . . . 118 A.2 United S t a t e s of America  121  A.3 Other OECD C o u n t r i e s  124  B. A n a l y s i s o f OECD Models  . . . . * i . . . . 1 2 7  1  INTBOPqCTION  There i s s t r o n g evidence of a problem chemical contamination of our environment. Agency f o r Besearch  The  from  International  on Cancer e s t i m a t e s that 80% of cancer i s  caused by environmental f a c t o r s p l e t h o r a of new  arising  (Higginson, 1968)  and  the  chemicals ranks a t l e a s t as a s i g n i f i c a n t  m i n o r i t y on the l i s t of p o t e n t i a l c a r c i n o g e n i c f a c t o r s (Bridges,  1976). In a d d i t i o n t o the c a r c i n o g e n s , there are a  host of chemicals with proven t o x i c a f f e c t s which cause d e t e r i o r a t i o n of nervous systems,  of pulmonary f u n c t i o n s , of  c a r d i o v a s c u l a r e f f i c i e n c y and of a c t i v i t y of v a r i o u s other organs. . The p o t e n t i a l h e a l t h r i s k from chemicals becomes of grave importance  when the number o f chemicals i s estimated.  The  American Chemical S o c i e t y (1978) i n d i c a t e s t h a t there are f o u r m i l l i o n chemicals i n e x i s t e n c e with 6000 new d i s c o v e r e d each week. About 1000  of these new  added t c the present 50,000 commercial  ones being chemicals are  chemicals each  year  (Devoret, 1979), circumstances i n d i c a t e that some form of government i n t e r v e n t i o n i s r e q u i r e d . Market mechanisms can l e a d t o e f f i c i e n t c h o i c e s i n some i n s t a n c e s but i n many cases the b a s i c assumptions  governing  e f f i c i e n t market c h o i c e s are v i o l a t e d . Some o f the r e l e v a n t assumptions  that are not met  s e v e r e l y i n h i b i t the f u n c t i o n of  the f r e e market process. For example, p o s s e s s i o n of adequate i n f o r m a t i o n by consumers i s assumed. But i n many i n s t a n c e s the  2  lay p u b l i c has l i t t l e  knowledge and l e s s understanding of  chemical s i d e - e f f e c t s . Indeed,  many times the s c i e n t i f i c  community i s only m a r g i n a l l y more e n l i g h t e n e d . The number and v a r i e t y of c h e m i c a l s produced  precludes exhaustive study o f  each i n d i v i d u a l new chemical. S y n e r g i s t i c and s t o c h i o m e t r i c i n t e r a c t i o n s between c h e m i c a l s which can o c c u r , i n an almost unimaginable  number of combinations makes a thorough  chemical e f f e c t s even more d i f f i c u l t .  study o f  Mercury, f o r example, was  found t c the s u r p r i s e of s c i e n t i s t s , t o be converted i n the presence o f the metabolic enzymes present i n c e r t a i n t o a more t o x i c form. A second assumption assumption  o f the independence  v i o l a t e d i s the  of the consumption  Negative e x t e r n a l i t i e s from the consumption group a r e imposed on other groups  bacteria  units.  o f chemicals by one  without t h e i r consent. For  i n s t a n c e , DDT found i t s way i n t o v i r t u a l l y every e a r t h l y place i n c l u d i n g mother's milk  (Lowrance,  1976). Because of the  e x t e r n a l i t i e s and the l a c k o f i n f o r m a t i o n , c o n s c i o u s c h o i c e between the l e v e l s of r i s k cannot be made. I t i s f u r t h e r aggravated by the h e t e r o g e n e i t y o f the r i s k l e v e l s of a p o p u l a t i o n . The l e v e l may vary a c c o r d i n g t o the s e n s i t i v i t y of the person exposed.  A f e t u s exposed  to t h a l i d o m i d e (a drug  used  f o r s l e e p i n g t a b l e t s and t r a n q u i l i z e r s ) i s a t f a r g r e a t e r r i s k than a a d u l t theoretical  (Lawless, 1977).,Thus, the free market system has f a i l i n g s which a r e borne out by the e m p i r i c a l  evidence of s u b s t a n t i a l chemical hazard. In a d d i t i o n , the present i n s t i t u t i o n a l s t r u c t u r e s and legislation  were s e t up to d e a l with p o l l u t i o n problems  recognized i n e a r l i e r  times. They grew i n a piecemeal way and  3  may  be unable  to cope with the new  p r o b l e m s . . E a r l i e r recognized  chemical p o l l u t a n t s , or c l a s s i c a l p o l l u t a n t s , as they are labeled  by Page (1978) tend to be v i s i b l e and immediate. They  i r r i t a t e eyes, burn t h r o a t s , t a i n t water and c l o u d the s k i e s among o t h e r e f f e c t s . S i n c e these p o l l u t a n t s c o u l d be t a s t e d and immediately obvious. T h i s acuteness  felt,  seen,  t h e i r presence and e f f e c t were  f a c i l i t a t e d the f o r m u l a t i o n and  public  acceptance o f measures to c o u n t e r a c t u n d e s i r a b l e c h a r a c t e r i s t i c s . Foam from d e t e r g e n t s , smog from c a r s , sewage i n potable water, a l l are examples of contaminants  t h a t are  c o n t r o l l e d by p o l l u t i o n l e g i s l a t i o n t h a t i s accepted by  the  public. But new  p o l l u t a n t s are d i f f e r e n t i n s e v e r a l r e s p e c t s  (Page, 1978) . F i r s t , they are very potent. .Concentrations measured i n p a r t s per b i l l i o n  (ppb)  or even p a r t s per  trillion  (ppt) can have d i s a s t r o u s consequences. For example, mercury at l e v e l s over f i f t y  ppb i s considered unacceptable  (World  Health  O r g a n i z a t i o n , 1967). Second, the time span between exposure  and  evidence o f e f f e c t can be very l o n g : S k i n cancer from c o a l t a r has a l a t e n c y p e r i o d of ten t o twenty years  (Heuper, 1959).  D e t e c t i o n i s o f t e n complicated because the e f f e c t may unique.  I t may  be manifested  number of anomalies epidemiology  not  be  simply as an i n c r e a s e i n the  which a l r e a d y occur. T h i s makes the  of d e t e c t i o n very d i f f i c u l t . Some chemicals  to be harmful were only d i s c o v e r e d because they  found  produced  p e c u l i a r , r a r e consequences. For example, the t e r r i b l e  effects  of t h a l i d o m i d e might have gone much l o n g e r without d e t e c t i o n except  f o r the c h a r a c t e r i s t i c and  unusual d e f o r m i t y which  4  resulted  (Lawless,  1577). Carcinogens o f t e n seem t o produce an  o v e r a l l , small increase  i n a common cancer r a t h e r than a new  tumor, a s p e c i f i c cancer or a marked i n c r e a s e area. T h i r d , the u n c e r t a i n t y  present  i n cancer of one  i n e x t r a p o l a t i n g from  a f f e c t s shown i n an animal or b a c t e r i o l o g i c a l t e s t system to an e s t i m a t e of the p o t e n t i a l danger to humans l e a v e s much room f o r a wide divergence o f o p i n i o n . The connection  between animal and  human c a n c e r i s only c i r c u m s t a n t i a l . Thus, a n i c e t y o f balance in  the t r a d e - o f f between r i s k and c o s t i s r e q u i r e d i n c l u d i n g  among other  t h i n g s , an i m p l i c i t value  on human l i f e .  Fourth,  many c h e m i c a l s have environmental and human a f f e c t s t h a t are e s s e n t i a l l y i r r e v e r s i b l e such as d e s t r u c t i o n of l a k e s by a c i d r a i n or some cancer forms. F i n a l l y , t r a d i t i o n a l mechanisms f o r dealing  with c o s t s , b e n e f i t s and r i s k s are not o p e r a t i n g  efficiently.  B e n e f i t s of c h e m i c a l s are t r a n s f e r r e d  by the market while c o s t s are d i s t r i b u t e d d i r e c t l y environmental hazards. Since standard  through  r i s k i s so u b i q u i t o u s , the  compensation methods f a i l .  ineffective  indirectly  Insurance, f o r example, i s  i n s i t u a t i o n s where many people are a f f e c t e d  simultaneously.  These f a c t o r s , potency, l a t e n c y ,  uncertainty,  i r r e v e r s i b i l i t y and market f a i l u r e , combine t o l i m i t the e f f e c t i v e n e s s o f c u r r e n t i n s t i t u t i o n a l s t r u c t u r e s and l e g i s l a t i o n . Some kind of government i n t e r v e n t i o n i s deemed necessary. The extent  and manner of the i n t e r v e n t i o n a r e t o be  examined. T h i s t h e s i s w i l l examine the e x i s t i n g c o n s t r a i n t s and o p p o r t u n i t i e s that may shape the f u t u r e chemical c o n t r o l r e g u l a t i o n s . I t w i l l argue t h a t a l a c k o f adequate and  5  accessible  information i s the l i m i t i n g  s t e p s t o expand t h e l i m i t s i m p o s e d The Existing  first  chapter  Canadian  reviews  legislation  b a c k g r o u n d . From t h i s  industrialized two s u g g e s t s  for regulation.  elements reviewed  interaction tests  with  of industry i n similarities  c o u n t r i e s are noted. „ and new  examination  of  to designate  I t t h e r e f o r e appraises the elements of priorities  f o r chemical r e g u l a t i o n s .  include determination o f  and d e t e r m i n a t i o n o f c h e m i c a l elements w i l l  t o make r a t i o n a l  t h e s i s next  exposure, various  behaviour.  &  r e q u i r e a c c u r a t e and  c h o i c e s among  candidates  e x a m i n e s a p p r o a c h e s t h a t may be  transforming public  standards  o p i n i o n and s c i e n t i f i c  f o r chosen c a n d i d a t e s . Chapter  two  s e c t i o n s . The f i r s t  for  c o n s t r u c t i n g standards.  on  access t o  regulation. The  in  to legislate  t h a t t h e number o f e x i s t i n g  composed o f t h e s e  comprehensive data for  futher l e g i s l a t i o n i s  t h e e n v i r o n m e n t , e x t r a p o l a t i o n from  and e v e n t s ,  strategy  and p r o v i n c i a l  & s c r e e n i n g system i s necessary  a strategy to establish The  to provide a general  i s t o o great t o allow a comprehensive  each substance. chemials  of control.  schemes i s c o v e r e d . . F i n a l l y , some  selected  chemicals  ability  1  and t o c c a p e l p a r t i c i p a t i o n  compensation  Chapter  i s surveyed  present  constraint.  the instruments  and need t o d r a f t  e x a m i n e d . The g o v e r n m e n t s  with  by t h i s  base, t h e f e d e r a l  governments' p o t e n t i a l  information  f a c t o r and w i l l  section  trade-off.  information  into  i s divided  into  presents a s e r i e s of techniques  These t e c h n i q u e s  a c o n c e p t u a l framework a s c e n d i n g  a risk-benefit  three  utilized  from  a r e superimposed  a n o - r i s k a p p r o a c h to  The f a c t o r s o f t h e s e c o n d  section  6  modify the techniques i n the f i r s t  s e c t i o n and i n t r o d u c e the  e f f e c t o f p u b l i c r i s k p e r c e p t i o n . Emphasis i s placed on the concept  of a c c e p t a b i l i t y as a necessary c o n d i t i o n f o r  s u c c e s s f u l standard  setting.  Chapter four i n t r o d u c e s the i n f o r m a t i o n system as a means of p r o v i d i n g the data needed f o r choosing c a n d i d a t e s and establishing  standards. Some systems c u r r e n t l y i n use a r e  d e s c r i b e d . T h e i r d e f i c i e n c i e s are analyzed and p r e s c r i p t i o n s f o r design improvements are made.  ;  The l a s t chapter p r o v i d e s a summary o f the analyses and recommendations o f the t h e s i s .  7  ii  IJSfJOHENfS OF CONTROL  1.1 CUBBENT CANADIAN LEGISLATION Given t h a t some change i n government c o n t r o l o f t o x i c chemicals i s necessary, i t i s u s e f u l to examine f e d e r a l and p r o v i n c i a l posers t o e f f e c t such change. In t h i s l i g h t , the Canadian  l e g i s l a t i o n r e g a r d i n g environmental  chemicals and drugs  and  commercial  w i l l be examined. In a d d i t i o n ,  limitations  on the a b i l i t y t o d r a f t new l e g i s l a t i o n such as p r o v i n c i a l federal  j u r i s d i c t i o n a l c o n s t r a i n t s w i l l be reviewed.  the approaches and Development (OS)  Finally,  of other O r g a n i z a t i o n f o r Economic Cooperation (OECD) c o u n t r i e s , n o t a b l y the United S t a t e s  and the u n i t e d Kingdom  (UK), to t o x i c c h e m i c a l c o n t r o l  w i l l be surveyed f o r a p p r o p r i a t e models a p p l i c a b l e t o the Canadian  arena. I n examining  present Canadian  statutes i t i s  convenient t c c a t e g o r i z e them a c c o r d i n g t o t h e i r The Canadian  purpose.  l e g i s l a t i o n t o c o n t r o l chemical hazards i s  c l a s s i f i e d by Franson et a l . (1977) i n t o t e n c a t e g o r i e s . (1) The  f i r s t c a t e g o r y . General P o l l u t i o n C o n t r o l S t a t u t e s ,  c o n t a i n s both f e d e r a l l e g i s l a t i o n and s t a t u t e s from a l l p r o v i n c e s . The p r o v i n c i a l r e g u l a t i o n systems use two main techniques: contaminants  (a) permits and a p p r o v a l s t o c o n t r o l d i s p o s a l of and p o l l u t i o n , the d e f i n i t i o n s being broad enough  to cover most s i t u a t i o n s of d i s c h a r g e i n t o the environment. For example, i n O n t a r i o , approvals u t i l i z i n g  standards d e r i v e d from  r e g u l a t i o n s concerning ambient a i r q u a l i t y a r e used t o c o n t r o l  8  a i r contaminants;  (b) the second technique  i s t h e a u t h o r i t y of  the Environment M i n i s t e r to use stop o r c o n t r o l orders when he e s t a b l i s h e s t o h i s s a t i s f a c t i o n t h a t a contaminant decrease  environmental  will  q u a l i t y . The main f e d e r a l p o l l u t i o n  c o n t r o l a c t s a r e the Canada Water a c t the Clean  A i r Act, and  the F i s h e r i e s Act. A l l three a c t s a r e g e n e r a l i n nature but because of incomplete limited  implementation,  i n practice.  the l a t t e r two a c t s are  (2) The second category  d e a l s with  I n d u s t r i a l S a f e t y , Workman's Compensation and O c c u p a t i o n a l Health S t a t u t e s . Although  a l l provinces have i n d u s t r i a l s a f e t y  l e g i s l a t i o n , the s t a t u t e s vary from g e n e r a l requirements common sense nature  (e.g. prevent  exposure t o t o x i c  l i m i t use or h a n d l i n g of dangerous substances, proper  chemicals,  and provide  v e n t i l a t i o n or p r o t e c t i v e c l o t h i n g ) , t o s p e c i f i c  t c c e r t a i n chemicals  of a  limits  (e.g. l e a d , v i n y l c h l o r i d e and a s b e s t o s ) .  (3) The t h i r d c o n t a i n s S p e c i a l S t a t u t e s Regulating  Particular  Contaminants. A s p e c i f i c contaminant per se may be r e g u l a t e d , (e.g. p r o v i n c i a l and f e d e r a l p e s t i c i d e c o n t r o l s ) or r e g u l a t i o n s may p e r t a i n t o a contaminant i n a substance leaded  g a s o l i n e ) . , ( 4 ) Category  (e.g. lead i n  f o u r d e a l s with Motor V e h i c l e  Standards and c o n t a i n s f e d e r a l and p r o v i n c i a l l e g i s l a t i o n on motor v e h i c l e emissions. Health  (5) The f i f t h encompasses P u b l i c  Acts. Here Franson e t a l . (1977) p e r c e i v e l i t t l e  overlap  between f e d e r a l and p r o v i n c i a l s t a t u t e s . F e d e r a l h e a l t h r e g u l a t i o n s are mainly  concerned with s p e c i f i c areas l i k e  s a f e t y and dangerous consumer products.  Health a c t s a f f e c t  other areas as w e l l as p u b l i c h e a l t h . Some p r o v i n c i a l p e r t a i n t o o c c u p a t i o n a l h e a l t h t o c o n t r o l the use of a  acts  food  9  p a r t i c u l a r contaminant pollution control.  and o t h e r acts c o n t a i n elements o f  (6) The s i x t h category covers the F e d e r a l  Food and Drug a c t which c o n t a i n s the fundamental c o n t r o l s f o r contaminants  i n food and drug products. S p e c i f i c standards d e a l  with q u a l i t y and q u a n t i t y of substances,  packaging  and t o x i c  chemicals such as l e a d . . (7) Only one p i e c e o f l e g i s l a t i o n i s i n the seventh c a t e g o r y . General Contaminants C o n t r o l s t a t u t e s , and t h a t i s the f e d e r a l Environmental Contaminants Act . I t i s used to supplement and r e e n f o r c e , the predominantly l e g i s l a t i o n i n the area  provincial  (OECD, 1976). For example, i t may  supplement the p r o v i n c i a l pharmacy a c t s which r e g u l a t e a more r e s t r i c t e d range o f chemicals. The  a c t allows f o r i n v e s t i g a t i o n of s u s p i c i o u s substances.  I f the s u s p i c i o n s are j u s t i f i e d , i . e " s i g n i f i c a n t danger t o h e a l t h or the environment" (p.,32) e x i s t s , then may be added to t h e Schedule  the chemical  of the Act a l l o w i n g r e s t r i c t i o n s  r e s p e c t i n g i m p o r t a t i o n , manufacture or use t o be a p p l i e d a f t e r c o n s u l t a t i o n with other a u t h o r i t i e s t o e s t a b l i s h the absence or presence  of other a p p l i c a b l e s t a t u t e s (OECD, 1976) o r i n some  other way. I t i s designed to a c t i n two ways. I t a l l o w s f o r the normal, measured flow c f process p r o v i d i n g due c o n s i d e r a t i o n during s i t u a t i o n s o f everyday  b u s i n e s s but, i s ready f o r  immediate a c t i o n i n emergency s i t u a t i o n s The  (Ince, 1976).  back-up nature of the l e g i s l a t i o n may present a  problem. As with the l e g i s l a t i o n o f the other OECD c o u n t r i e s , 1  1. A review and an a n a l y s i s of the l e g i s l a t i o n o f OECD c o u n t r i e s i s i n the appendix.  10  the act i s u s u a l l y a p p l i e d when other l e g i s l a t i o n w i l l not s u f f i c e . Thus, before a c t i o n can be taken Environmental  under the  Contaminants Act, c o n s i d e r a b l e d i s c u s s i o n between  f e d e r a l and p r o v i n c i a l departments i s necessary  to determine  whether other l e g i s l a t i o n i s a p p l i c a b l e (Ince, 1976). I f the j u r i s d i c t i o n s of the v a r i o u s departments are v i g o r o u s l y defended a s u b s t a n t i a l lapse of time can occur. The  Act r e p r e s e n t s a s h i f t  monitoring  i n emphasis from post-market  to pre-market s c r e e n i n g which i s common t o other  OECD c o u n t r i e s . However, a problem with the Act i n t h i s c a p a c i t y l i e s i n i t s l a c k of s e n s i t i v i t y t o s m a l l amounts. The e f f i c a c y o f the Act with regard t o pre-market s c r e e n i n g may be limited for  s i n c e the only n o t i f i c a t i o n o f chemicals  those  manufactured or imported  required are  i n q u a n t i t i e s over 500 kg.  Even then the Act can only be used when the c h a r a c t e r i s t i c s of a chemical  suggest  a potential  problem.  The o r g a n i z a t i o n a l aspects o f the Act allow a great of  f l e x i b i l i t y i n approach  substances The  deal  (OECD, 1 9 7 6 ) . E x p e r t s decide what  to investigate, gathering a l l available information.  a p p r o p r i a t e t e s t s a r e t o be c a r r i e d out ( a f t e r agreement  with i n d u s t r y i f p o s s i b l e ) a t i n d u s t r y expense and the r e s u l t s reviewed by the government. C o n d i t i o n s of s a l e are decided a f t e r c o n s u l t a t i o n with i n d u s t r y , other governments and f e d e r a l agencies  to decide on the method of c o n t r o l . . T h e  Environmental  Contaminant Act a l l o w s f o r whatever a c t i o n s are r e q u i r e d .  Ince  (1976) p o i n t s out that the advantages l i e i n the p o l i t i c a l convenience o f the s t a t u t e s and i n the p o t e n t i a l e f f i c i e n c y of the r e s u l t i n g r e g u l a t i o n s . The e x i s t e n c e o f the Act g i v e s the  11  appearance o f a s t r o n g stand to s a t i s f y environmental  interest  groups while a l l o w i n g input from  a f f e c t e d p a r t i e s before  a c t u a l r e g u l a t i o n s are designed.  (8)  P a r t i c u l a r Besource  the e i g h t h category i s  Statutes containing l e g i s l a t i o n f o r  management o f r e s o u r c e s . I t i s u s u a l l y g u i t e d e t a i l e d c o n t a i n s r e g u l a t i o n s to c o n t r o l p o l l u t i o n ; e.g.  Category  and  The  Saskatchewan P o l l u t i o n P r e v e n t i o n Regulation • f o r I n d u s t r y . (9)  the  the M i n e r a l  n i n e , S p e c i a l I n d u s t r y Regulation  S t a t u t e s , c o n t a i n s p r o v i n c i a l and f e d e r a l l e g i s l a t i o n .  The  p r o v i n c i a l l e g i s l a t i o n as noted by Franson e t a l . , tends  toward  the g e n e r a l , although laws d e a l i n g with areas such as mine s a f e t y , and p e s t i c i d e s are more s p e c i f i c . F e d e r a l s t a t u t e s of p r i n c i p l e i n t e r e s t are the P o l l u t i o n P r e v e n t i o n s B e q u l a t i o n s (part o f the Canada Shipping Act) and the F i s h e r i e s Act .dealing r e s p e c t i v e l y with discharge from i n t o water such as pulp and refineries.  (10)  s h i p s and i n d u s t r i a l d i s c h a r g e  paper m i l l e f f l u e n t  and  petroleum  The l a s t category, number ten, c o n t a i n s  Consumer S a f e t y S t a t u t e s . These range from those concerned food and  drug s a f e t y (the f e d e r a l Food and Drug Regulations  p r o v i n c i a l p u b l i c h e a l t h standards) poisons  with  (the f e d e r a l and  f i n a l l y , t o one  concerned  t o those concerned  and  with  p r o v i n c i a l p e s t i c i d e a c t s ) and with other aspects of consumer  s a f e t y , the f e d e r a l Hazardous Products Act ) . The l a t t e r  deals  with the s p e c i f i c standards, f o r example, l e a d and asbestos i n a myriad  cf consumer products i n c l u d i n g c h i l d r e n s toys.  In examining a l . i d e n t i f y two apparent  the c a t e g o r i e s presented above, Franson main c o n t r o l mechanisms. Both are used  randomness i n f e d e r a l and  et  with  p r o v i n c i a l s t a t u t e s and  12  sometimes i n the same s t a t u t e s , one approach to r e g u l a t i o n i s d i s t i n g u i s h e d by the use of agencies, to i s s u e l i c e n s e s or a p p r o v a l s .  officials  Guidelines  or departments  are e s t a b l i s h e d to  o u t l i n e procedures and q u a l i f i c a t i o n s necessary t o obtain governmental  sanction.  A g u i d e l i n e i s defined a regulatory  as "an i n f o r m a l statement i s s u e d by  agency s e t t i n g f o r t h the standards of conduct that  i t expects those under i t s c o n t r o l to e x e r c i s e " al.,  (Franson e t  1977, p. 34). T h i s i s compared to a r e g u l a t i o n which i s  defined  as "a r u l e made by competent a u t h o r i t y r e l a t i n g to  a c t i o n s of those i n d i r e c t c o n t r o l  (Franson e t al.> 1977 p.  34). The l e g a l d i f f e r e n c e between g u i d e l i n e s and r e g u l a t i o n s i s that r e g u l a t i o n s a r e s p e c i f i c laws, and as such a r e e n f o r c e a b l e i n court  whereas g u i d e l i n e s a r e not enforceable  r e g u l a t i o n s have a higher Order-in-Council  i n court.  Also,  p r o f i l e , being g e n e r a l l y passed by  and published  i n the o f f i c i a l Gazette, whereas  g u i d e l i n e s a r e much l e s s obvious. To uncover g u i d e l i n e s i t i s o f t e n necessary f o r an o u t s i d e r t o check with agencies who might produce them. However, they are sometimes  considered  r e s t r i c t e d i n t e r n a l documents i n which case even d i r e c t i n q u i r y w i l l not u n v e i l them. The  second p r i n c i p a l mechanism i s d e s c r i b e d  by Franson e t  a l . as " o u t - r i g h t p r e s c r i p t i o n " (p. 46) i n which case a p a r t i c u l a r chemical has a s p e c i f i c and d e f i n i t e associated  with i t . To enforce  government has recourse  standard  compliance with the standard the  to q u a s i - c r i m i n a l s a n c t i o n s  which may  include c o n f i s c a t i o n . In some cases,  the p r e s c r i p t i v e r e g u l a t i o n s serve  as a  13  backup f o r the more common, d a i l y use of the l i c e n s i n g  and  approval mechanism. For example, the f e d e r a l Food and Drug. Act p r o v i d e s f o r standards and a l l o w s f o r g u a s i - c r i m i n a l proceedings i f the standards are not met. order of business u t i l i z e s warning  However, the  daily  l e t t e r s and other i n f o r m a l  methods such as n e g o t i a t i o n t o encourage v o l u n t a r y withdrawal of chemicals v i o l a t i n g standards. A l s o , i n p r a c t i c e , of product t e s t s and i n f o r m a t i o n f o r review r o u t i n e l y  submission results  i n " a p p r o v a l " f o r product manufacture and s a l e s . /In e s t a b l i s h i n g the r e g u l a t i o n s , a f a i r l y i n f o r m a l process i n v o l v i n g i n f o r m a t i o n c i r c u l a r s and  s o l i c i t i a t i o n of i n d u s t r y  views i s followed.,•  1.2  LEGISLATIVE CONSTRAINTS Having reviewed  present l e g i s l a t i o n , the a b i l i t i t y of the  government t o enable l e g i s l a t i o n concerning new  areas i s  analyzed. T h i s s e c t i o n d e a l s with the p o t e n t i a l of the f e d e r a l p r o v i n c i a l governments to produce  and  and enforce l e g i s l a t i o n  r e g u l a t i n g t o x i c c h e m i c a l s . I t w i l l cover the j u r i s d i c t i o n of the f e d e r a l and the governmental  p r o v i n c i a l governments, the posers  available,  versus i n d i v i d u a l r i g h t to i n f o r m a t i o n and  r i g h t t o compensation been harmed by t o x i c  of i n d i v i d u a l s and c o r p o r a t i o n s who substances.  the  have  14  1.2.1  Federal Jurisdiction The  federal  B r i t i s h North America Act (BNA Act) j u r i s d i c t i o n (Franson e t a l .  exclusive shipping  1977). Some areas of  j u r i s d i c t i o n s are l i s t e d , f o r example, f i s h e r i e s , and n a v i g a t i o n .  As w e l l , l e s s s p e c i f i c powers a r e  a l l o c a t e d f e d e r a l l y under S e c t i o n greatest  r  establishes  91. General powers with the  p o t e n t i a l f o r c o n t r o l of t o x i c substances e x i s t i n the  two  a r e a s of c r i m i n a l law and trade and commerce. These  two  w i l l be examined  Criminal The law  latter  first.,  Powers powers t h a t the f e d e r a l government has under c r i m i n a l  are very broad. In e f f e c t parliament has the power t o  r e c o g n i z e new crimes and enact l e g i s l a t i o n t o prevent them, f a c t , i t has been s a i d that any time Parliament  "in  prohibits  c e r t a i n conduct and attaches penal conseguences f o r engaging i n it,  that  l e g i s l a t i o n may be s u s t a i n e d  under the c r i m i n a l law  power" {Franson e t a l . 1977, p. ,14). Some l i m i t a t i o n s of the f e d e r a l use o f c r i m i n a l law power e x i s t i n p r a c t i c e and a r e summarized by Franson e t a l . (1977). F i r s t , t h e c o u r t s tend t o defend areas of p r o v i n c i a l j u r i s d i c t i o n . These areas, however, seem to be c o n f i n e d to regulation  of l o c a l trade which, i n any case, would not be  encroached upon by f e d e r a l r e g u l a t i o n sustances. Also,  concerning t o x i c  the p o t e n t i a l f o r f e d e r a l c r i m i n a l l e g i s l a t i o n  i s enhanced by a t r a d i t i o n a l posture o f crime p r e v e n t i o n . Legislation  governing the p r o d u c t i o n and d i s t r i b u t i o n of  15  chemicals t h a t  may  harm ethers f u l f i l s the d e f i n e d  i n t e n t i o n of  such laws q u i t e w e l l . In f a c t , some l e g a l precedent exists  (Franson e t a l . , 1977)  to support t h i s contention.,The  second problem i s t h a t because of strong area d e a l i n g with p o s s i b l e remedies and law,  some u s e f u l remedial a c t i o n may  t r a d i t i o n i n another sanction  the l e g i s l a t i o n should  imprisonment. Maintenance o f , and a c t i o n has  under c r i m i n a l  not be allowed. T r a d i t i o n  has e s t a b l i s h e d that persons found g u i l t y before of contravening  already  ordinary  Court  s u f f e r a f i n e or  limitation  to these modes of  been advocated. Franson et a l . (1977) note that  acceptance o f t h i s view would e f f e c t i v e l y negate the use  of  such b e n e f i c i a l a c t i o n s as s t o p o r d e r s and advance r u l i n g s . Given the c o u r t s ' i n c l i n a t i o n to l i m i t f e d e r a l use of c r i m i n a l law,  i t may  be  under t h i s area  Trade and  wise to r e l a t e f u t u r e t o x i c c h e m i c a l to crime prevention  and  regulations  c r i m i n a l punishment.  Commerce Powers  Federal  powers under t r a d e and  commerce law  may  somewhat l i m i t e d although a l a r g e p o t e n t i a l f o r the these powers e x i s t s because of the great chemicals involved d i r e c t l y  be use  of  number of t o x i c  with commercial  P r e v i o u s l y , the scope of f e d e r a l powers was  activities. interpreted quite  r e s t r i c t i v e l y , however, recent i n t e r p r e t a t i o n has  been  broadened to e f f e c t i v e l y i n c l u d e i n t e r p r o v i n c i a l t r a d e .  But  the  c o u r t s have remained undecided on the a b i l i t y of the f e d e r a l government to expand i t s i n t e r v e n t i o n from a economic focus to one  traditionally  i n c l u d i n g n a t i o n a l h e a l t h and  s a f e t y . In  16  p r a c t i c e , Franson et e l . a s s e r t , t h i s may consideration  f o r two  reasons. One,  not  s i n c e the  be an  important  very  uncertainty  which p r e v e n t s l e g a l a f f i r m a t i o n of such l e g i s l a t i o n p r o v i d e s a measure of p r o t e c t i o n the law  also  from attack.. A c h a l l e n g e  would be based on showing i t to be  to  unconstitutional,  making r e s o l u t i o n of the q u e s t i o n s c o n t i n g e n t upon the d e t e r m i n a t i o n cf the o r i g i n a l i n t e n t of the l e g i s l a t i o n ,  a  d i f f i c u l t task.  are  Two,  the  imported i n t o Canada and  majority  of new  importation  t o x i c chemicals  i s an acknowledged  federal  j u r i s d i c t ion.  General The  Ecwers g e n e r a l power l i k e l y t o be most important i n  r e g u l a t i o n o f t o x i c chemicals i s the ability  the  f e d e r a l government's  to d e a l with problems c r o s s i n g  p r o v i n c i a l borders  (Franson e t a l , , 1977) . Becent c o u r t d e c i s i o n s have added some credence t o the f e d e r a l argument f o r power over problems of n a t i o n a l dimensions. I n t e r p r o v i n c i a l p o l l u t i o n was  likened  to  i n t e r p r o v i n c i a l t r a d e with the i m p l i c a t i o n of s i m i l a r f e d e r a l j u r i s d i c t i o n . Franson e t a l . State made from such d e c i s i o n s the  that  the i n f e r e n c e  to  i s f u t u r e support from the Court  be on  i s s u e of f e d e r a l power over i n t e r p r o v i n c i a l contaminants.  17  1.2.2 P r o v i n c i a l J u r i s d i c i t o n  P r o v i n c i a l powers Franson  e t a l . p o i n t s out t h a t p r o v i n c i a l j u r i s d i c t i o n  granted by S e c t i o n 92 of the BNA  Act i s very broad  with r e s p e c t  to c o n t r o l o f t o x i c chemicals. Almost a l l a s p e c t s of domestic chemical  production are concerned  from manufacturing,  t o labour  r e l a t i o n s , t o work environment, and waste d i s p o s a l . . Although t h i s concerns  most c o n t i n g e n c i e s of i n t e r e s t some l i m i t a t i o n s  e x i s t , mostly  with regard t o f e d e r a l  p o w e r s . . P r o v i n c i a l powers  are c o n s t r a i n e d t o t h e i r r e s p e c t i v e t e r r i t o r i e s .  Federal  l e g i s l a t i o n takes precedence over c o n f l i c t i n g p r o v i n c i a l s t a t u t e s and f e d e r a l Crown property i s exempt from  provincial  c o n t r o l . F i n a l l y , the BNA Act g i v e s e x c l u s i v e r i g h t s over many areas t o the f e d e r a l government. Because of the amount of conflict  with f e d e r a l  l e g i s l a t i o n , delimiting  p r o v i n c i a l powers  implies d e f i n i t i o n of federal j u r i s d i c t i o n . ,  1.2.3 Summary o f F e d e r a l and P r o v i n c i a l In summary, f r u i t f u l f e d e r a l of c r i m i n a l  Powers  l e g a l powers l i e i n the areas  law, trade and commerce  law, s t a t u t e s ,  general  j u r i s d i c t i o n s and i n d i r e c t approaches. C r i m i n a l law has very broad uses and c o n t r o l fit  c f t o x i c c h e m i c a l s has t h e p o t e n t i a l to  t r a d i t i o n a l requirements  f o r such  law., one problem,  however, i s the nature of the t r a d i t i o n a l punishments attached  18  to  such  law. Compliance may  be b e t t e r achieved through  o r d e r s o r advance r u l i n g s r a t h e r than the f i n e s imprisonments p r e s e n t l y favoured t o x i c c h e m i c a l s are commercial, potentially useful.  stop  and  by c o u r t s . Because the bulk of trade and commerce law i s  Here again, the f o c u s has been  c h a r a c t e r i s t i c a l l y economic r a t h e r than h e a l t h and s a f e t y . However, enough ambiguity  may  e x i s t to cushion any laws from  the c h a l l e n g e of u n c o n s t i t u t i o n a l i t y . L e g i s l a t i v e power may l i e i n arguing the analogous  nature of i n t e r p r o v i n c i a l trade  i n t e r p r o v i n c i a l p o l l u t i o n . The c o u r t s seem i n c l i n e d  to  r e c o g n i z e the s i m i l a r i t y . F i n a l l y , the government may t a x a t i o n and  and  use  f i s c a l p o l i c y to provide i n d u s t r i e s with economic  i n c e n t i v e s t o comply. U n f o r t u n a t e l y , the p u b l i c may  view  such  i n d i r e c t methods with s u s p i c i o n , making such a p o l i c y politically  infeasible.  Provincial legislative  powers extend over the p r o d u c t i o n  process and are c o n s t r a i n e d mainly by r e g i o n a l l i m i t s  and  f e d e r a l - p r o v i n c i a l j u r i s d i c t i o n a l boundries. ...  1.3  INFOSMATION ACCESS Government appears  t o have ample power to enact  l e g i s l a t i o n c o n t r o l l i n g t o x i c c h e m i c a l s . A major r e s i d u a l c o n s i d e r a t i o n , i s c o l l e c t i o n of i n f o r m a t i o n t o guide of  selection  c a n d i d a t e s f o r c o n t r o l . In a d d i t i o n , the a b i l i t y t o o b t a i n  and use i n f o r m a t i o n f o r monitoring or p r o s e c u t i n g becomes very important. Both f e d e r a l and p r o v i n c i a l governments have wide  19  powers t o o b t a i n i n f o r m a t i o n , although take  a more c i r c u i t o u s route F e d e r a l powers to gather  the p r o v i n c e s  (Franson  must o f t e n  e t a l . , 1977).  i n f o r m a t i o n l i e i n the s e c t i o n of  the BNA Act d e a l i n g with census and s t a t i s t i c s and i n the ability  to pay f o r research and surveys  l i m i t s on spending. The l a t t e r a b i l i t y provinces  without c o n s t i t u t i o n a l i s shared  by the  as w e l l . I t i s i n the a b i l i t y t o f o r c e r e l e a s e o f  information  t h a t a divergence  of power occurs. The f e d e r a l  government has a d i r e c t method a v a i l a b l e i n the s t a t i s t i c s and census laws. As w e l l , i t can use the power of c r i m i n a l law t o compel the r e l e a s e o f i n f o r m a t i o n r e l a t i n g t o p r o s e c u t i o n f o r c r i m i n a l o f f e n s e . The p r o v i n c i a l governments must a c t more indirectly.  For example, they can make a p p r o v a l  of a l i c e n c e  contingent  on the proposed a c t i v i t i e s . Information  be l i m i t e d  to areas germane to the a p p l i c a t i o n .  access  might  Hide access t o i n f o r m a t i o n does not extend to the i n d i v i d u a l . In f a c t , many f a c t o r s m i l i t a t e a g a i n s t p u b l i c access  to government i n f o r m a t i o n about t o x i c substances. For  example, the f e d e r a l O f f i c i a l S e c r e t s Act and t h e c i v i l s e r v a n t s * Oath o f O f f i c e both encourage secrecy  (Franson e t  a l . , 1977). Canada takes an approach opposite t o t h a t o f the United S t a t e s . The US Freedom of Information  Act assumes i n f o r m a t i o n ,  except f o r t h a t noted, w i l l be open t o p u b l i c s c r u t i n y . The trend i n Canada i s t o resume i n f o r m a t i o n i s r e s t r i c t e d  except  f o r t h a t s p e c i f i c a l l y r e l e a s e d . G u i d e l i n e s f o r access to documents do e x i s t i n Canada, having  been s e t f o r t h by Cabinet,  but they are f o r i n t e r n a l government use o n l y . They are not  20  useful to a private c i t i z e n . In a d d i t i o n , Crown p r i v i l e g e  (the a b i l i t y o f a m i n i s t e r to  d e c l a r e documents secret) and the t h r e a t of a l i b e l  suit  should  an agency r e v e a l "defamatory" i n f o r m a t i o n f u r t h e r serves to i n c r e a s e a b a s i c government r e t i c e n c e t o d i s c l o s e i n f o r m a t i o n . Some v a l i d  reasons e x i s t t o support  a p o l i c y of non-  d i s c l o s u r e . F o r example, trade s e c r e t s r e g a r d i n g s t r u c t u r e and manufacturing techniques industry cooperation  chemical  must be s e c r e t or  w i l l be l o s t . Other arguments r e p o r t e d by  Franson e t a l . i n c l u d e a l o s s o f "working r a p p o r t " and our s o c i a l i n c l i n a t i o n f o r personal Some l i m i t e d  privacy.,  procedures e x i s t to compel r e l e a s e of  i n f o r m a t i o n , i . e . f o r j u d i c i a l proceedings  or r e g u l a t o r y  h e a r i n g s . I n g e n e r a l , however, p u b l i c access severely  to i n f o r m a t i o n i s  curtailed.  Once governments have the i n f o r m a t i o n , what can they do with i t ? In Canada, governments are not c o n s t r a i n e d by legislation  r e g a r d i n g p r i v a c y . But, even though Canadians have  no c o n s t i t u t i o n a l r i g h t there e x i s t c o m p e l l i n g  political  reasons f o r governments t o a c t as i f such an i n d i v i d u a l and c o r p o r a t e r i g h t t o privacy e x i s t e d  (Franson  e t a l . , 1977).  G e n e r a l l y they do s c . These p o l i t i c a l reasons a l s o tend to l i m i t t h e amount and kind of i n f o r m a t i o n c o l l e c t e d even i n the absence of c o n s t i t u t i o n a l c o n s t r a i n t s .  21  1.3.1  Summary of Information The  Access  f e d e r a l government has powerful  means of g a t h e r i n g  p r o c e s s i n g i n f o r m a t i o n . Besides the power of census t a k i n g s t a t i s t i c s procurement, c r i m i n a l law information  allows f o r access  and  to  r e l a t i n g to c r i m i n a l p r o s e c u t i o n s . A l s o , there  no c o n s t i t u t i o n a l r e s t r i c t i o n s on r e s e a r c h or survey  and  are  spending.  P r o v i n c i a l l y , more i n d i r e c t methods must be used f o r information  g a t h e r i n g . For example, a l i c e n s e may  be  withheld  pending i n f o r m a t i o n on i t s use. Information,  i s gathered  more r e a d i l y than i t i s  d i s p e r s e d . Broad access to i n f o r m a t i o n does not extend to the i n d i v i d u a l . Our p r i v i l e g e and  common law t r a d i t i o n combined with  ministerial  s e c r e c y laws s t r o n g l y i n h i b i t an outward  Often t h i s p r e d i s p o s i t i o n i s supported  with p o l i c y arguments.  An example o f such an argument i s that p u l i c access p o l l u t i o n i n f o r m a t i o n would destroy between r e g u l a t o r s and  1.4  flow.  to  the p r o f e s s i o n a l rapport  regulated.  COMPESSATIOH Another important  by f e d e r a l and  i s s u e r e l a t i n g to t o x i c chemical  p r o v i n c i a l governments i s compensation f o r  damages. Franson e t a l . (1977, p. 21) kinds:  control  l i s t s three  general  (1) compensation funds e s t a b l i s h e d from g e n e r a l  (2) s p e c i a l compensation funds maintained  by  revenue;  compulsory  c o n t r i b u t i o n s l e v i e d a g a i n s t the i n d u s t r i e s l i k e l y t o cause injury;  and  (.3) p r i v a t e r i g h t s of a c t i o n given t o an i n j u r e d  22  person to proceed d i r e c t l y a g a i n s t those causing the Both governments seem able to e s t a b l i s h the  injury.  compensation funds  p r o v i n c i a l governments, at l e a s t , have the  power to  and  levy  i n d u s t r y w i t h i n t h e i r r e s p e c t i v e borders. F e d e r a l power to r a i s e a c o n t r i b u t o r y fund i s probably l i m i t e d  to  industries  under i t s e x c l u s i v e j u r i s d i c t i o n . G e n e r a l l y , p r o v i n c i a l encompass p r i v a t e  r i g h t of a c t i o n  suggested P a r l i a m e n t may federal the  s t a t u t e s pay  but  powers  recent cases have  be a b l e to ensure that  violators  compensation to those i n j u r e d  of  as r e s u l t  violation. However, l e g a l r e s p o n s i b i l i t y of companies and  compensating those i n j u r e d  must be  s t i m u l a t e d such examinations. The  c o n s i d e r a t i o n of t h i s t o p i c  chlorine  a central  spill  at  s t i m u l a t e d government  where a c c i d e n t s have r e s u l t e d  acute h a z a r d . A p a r t i a l s o l u t i o n r e s p o n s i b i l i t y and  methods of  examined. Becent events have  H i s s i s s a u g a , O n t a r i o , f o r i n s t a n c e , has  to the  compensation may  in  q u e s t i o n s of  l i e i n the  fund with payments made i n t o i t on  p r o d u c t i o n l e v e l s . T h i s approach i s w e l l  establishment  the  b a s i s of  within f e d e r a l  and  p r o v i n c i a l powers. Another aspect i s r e s p o n s i b i l i t y f o r subacute damage. In the  of  case of l a t e n t  exists  (Ince,  damage o c c u r r i n g , some l e g i s l a t i o n a l r e a d y  1976)•  The  I n d u s t r i a l O p e r a t i o n s Damage  Compensation Act allows f o r an agreement f o r between the  owner of land and  negates f u r t h e r a r i s i n g from the  compensation  a p o l l u t i n g company. The  r e s p o n s i b i l i t y of a company f o r any  Act  damage  p o l l u t i o n . A l s o , should an agreement not  reached, agreement can  be  imposed on  an  owner by  a judge,  be  of  23  r e s u l t i n g i n the same l e s s of recourse to l e g a l a c t i o n should unexpected damages occur. In view of the l i m i t e d about long terra e f f e c t s of t o x i c chemicals and  knowledge  numerous  p o s s i b l e i n t e r a c t i o n s , the a b i l i t y of a judge t o decide  on  present adequate compensation f o r f u r t h e r damages seems g u e s t i o n a b l e . Although  Ince  (1976) p r e d i c t s t h a t judges  are  u n l i k e l y to use t h i s a c t to remove p e r s o n a l r i g h t s , i t may s i g n i f i c a n t l y reduce p r i v a t e access t o l e g a l a c t i o n a g a i n s t polluters. In any  case, a s s i g n i n g r e s p o n s i b i l i t y f o r any  environmental difficult  or h e a l t h damage done i n the past w i l l prove a  problem. The f i n a l  damage may  be caused  by a chemical  r e s u l t i n g from many i n t e r m e d i a t e r e a c t i o n s with other n a t u r a l or man-made chemicals over a long p e r i o d of time. Thus, the i n i t i a l c o n t r i b u t o r i s e f f e c t i v e l y d i s g u i s e d . Here a g a i n , some c e n t r a l n o - f a u l t fund, c o n t r i b u t e d to by i n d u s t r y and administered  by the governments, may  v i c t i m s of chemical  be r e q u i r e d t o compensate  hazards.,  1.5 CONCLUSIONS E x i s t i n g l e g i s l a t i o n i s broad and powerful. P o l l u t i o n C o n t r o l s t a t u t e s allow both the f e d e r a l  General and  p r o v i n c i a l governments to use permits and a p p r o v a l s t o c o n t r o l most s i t u a t i o n s of discharge i n t o the the environment.  The  s t a t u t e s a l s o allow the f e d e r a l use of stop or c o n t r o l  orders  i f contaminants are d e t r i m e n t a l to the environment.  24  Other e x i s t i n g  l e g i s l a t i o n d e a l s with s p e c i f i c areas.  p r o v i n c e s can r e g u l a t e p u b l i c h e a l t h , resource use and workplace, vehicle  The  the  while the f e d e r a l government can c o n t r o l motor  emissions, food and drugs, and consumer s a f e t y . Both  can r e g u l a t e s p e c i f i c chemicals or contaminants  and  specific  industries. Any  gaps i n environmental  l e g i s l a t i o n can be covered  by  the f e d e r a l Environmental Contaminants Act . I t supplements p r o v i n c i a l and other f e d e r a l l e g i s l a t i o n . By design i t i s very f l e x i b l e i n a p p l i c a t i o n and  effect.  In a d d i t i o n t o the e x i s t i n g have the a b i l i t y t o b r i n g i n new  l e g i s l a t i o n , both governments environmental  legislation  as  needed. , Such l e g i s l a t i o n can o r i g i n a t e i n any o f s e v e r a l areas. The  f e d e r a l government can c a l l almost anything a crime  and  enact l e g i s l a t i o n t o punish those engaged i n i t . A l s o , because many t o x i c chemicals are used commercially,  the  federal  government can apply the power of trade and commerce law. F i n a l l y , the f e d e r a l government has c o n t r o l over problems of national The  dimensions. p r o v i n c e s , except t h a t t h e i r powers are l i m i t e d  to  t h e i r r e s p e c t i v e t e r r i t o r i e s , can e x e r t c o n s i d e r a b l e i n f l u e n c e on c h e m i c a l production. T h i s c o n t r o l i s d e r i v e d from chemical i n d u s t r y * s a s s o c i a t i o n with at l e a s t one p r o v i n c i a l j u r i s d i c t i o n be i t manufacturing, workplace, f e d e r a l and  the  area of  l a b o u r , the  or c h e m i c a l waste d i s p o s a l . By working t o g e t h e r , p r o v i n c i a l governments should be a b l e t o cover most  s i t u a t i o n s with l i t t l e t r o u b l e . Between e x i s t i n g l e g i s l a t i o n and  the a b i l i t y to enact  new  25  l e g i s l a t i o n , introducing regulations to f i l l present  a gap should  no problems. However, c o n f l i c t betweeen f e d e r a l and  p r o v i n c i a l j u r i s d i c t i o n s may o c c u r . I n many c a s e s l e g i s l a t i o n o v e r l a p s . T h i s may be p r e f e r a b l e t o gaps s i n c e i f an emergency occurs i t i s advantageous to have the power t o a c t immediately. However, o v e r l a p s  a l s o mean d u p l i c a t i o n of e f f o r t , p o t e n t i a l  c o n f l i c t s between i n d i v i d u a l laws and added expense t o i n d u s t r y t c comply with d u p l i c a t e s t a t u t e s . C a r e f u l r a t i o n a l i z a t i o n o f c o n f l i c t s , such as d e s i g n a t i n g  which l e g i s l a t i o n has  precedence, may reduce the burden of o v e r l a p s . It i s e v i d e n t ,  upon reviewing  the e x i s t i n g l e g i s l a t i o n and  the powers e x i s t i n g to formulate new laws, t h a t few c o n s t i t u t i o n a l impediments r e s t r i c t the i n t r o d u c t i o n of t o x i c chemical r e g u l a t i o n s . Thus, the c o n s t r a i n t s on t h e promulgation of new p o l i c i e s a r e the l a r g e number o f c h e m i c a l s t o r e g u l a t e and  the d i f f i c u l t y  i n c o n t r o l l i n g them. The number and v a r i e t y  of chemicals i s so great and  that the determination  the e f f i c i e n t deployment of resources  i s d i f f i c u l t . In  essence, the development of new p o l i c y r e v o l v e s enabling  ability  not around  l e g i s l a t i o n but i n e s t a b l i s h i n g p r i o r i t i e s f o r  developing To  of p r i o r i t i e s  specific  legislation.  a i d i n developing  priorities,  both governments have the  to c o l l e c t n e a r l y any i n f o r m a t i o n  desired.  Federal  powers o r i g i n a t e with the census and s t a t i s t i c s s e c t i o n of the BNA Act and with c r i m i n a l law. I t a l s o has t h e a b i l i t y t o finance  the c o l l e c t i o n of data without c o n s t i t u t i o n a l  c o n s t r a i n t s . I t thus has d i r e c t a c c e s s to data and the power to f o r c e compliance. The provinces  t o o have few l i m i t s on  26  i n f o r m a t i o n c o l l e c t i o n posers  but must use a more i n d i r e c t  route i n some cases. L i c e n c e a p p r o v a l , f o r example, can be made contingent  upon p r o v i n c i a l access  to information.  P o t e n t i a l b l o c k s t o i n f o r m a t i o n c o l l e c t i o n are i n the nature  o f p o l i t i c a l and economic c o n s t r a i n t s . I n d u s t r y  wish to d i v u l g e i n f o r m a t i o n  i f competitors  may not  have access t o i t .  The use of government powers t o f o r c e compliance may have the undesirable  ccnseguence of reducing  the Canadian i n d u s t r y * s  economic c o n t r i b u t i o n s . .. However, governments need not r e v e a l i n f o r m a t i o n  collected  from i n d u s t r y . They can avoid the c o n f l i c t . The t r a d i t i o n of Canadian governments has been t o promote s e c r e c y . In a d d i t i o n to t r a d i t i o n there i s the O f f i c i a l S e c r e t s Act and the c i v i l s e r v a n t s ' Oath o f O f f i c e to ensure secrecy. Canadians have no c o n s t i t u t i o n a l r i g h t s to i n f o r m a t i o n so governments can assure i n d u s t r y of c o n f i d e n t i a l i t y i f r e q u i r e d . Both governments have t h e a b i l i t y t o ensure compensation f o r damage caused by chemials.  T h i s may be done i n s e v e r a l  ways. F e d e r a l and p r o v i n c i a l governments can provide funds from general revenue o r by l e v y o f i n d u s t r y . The f e d e r a l government can only l e v y i n d u s t r i e s d i r e c t l y  under i t s c o n t r o l whereas the  p r o v i n c e s can l e v y any i n d u s t r y w i t h i n i t s borders.  Finally,  both governments can ensure p r i v a t e r i g h t s of a c t i o n a g a i n s t r e s p o n s i b l e companies. Two problems e x i s t i n a d m i n i s t e r i n g a p o l i c y which includes a levy against industry. F i r s t , ascertaining r e p s o n s i b i l i t y f o r damage may be d i f f i c u l t i f t h e damage i s c h r o n i c and l a t e n t i n nature.  Time, environmental i n t e r a c t i o n s  27  and p e r s o n a l m o b i l i t y w i l l tend t o confuse areas of r e s p o n s i b i l i t y . In these cases, a g e n e r a l fund may  be needed. ,  The second problem a r i s e s because o f the nature o f the j u r i s d i c t i o n s . F e d e r a l and p r o v i n c i a l c o o p e r a t i o n may  be  e s s e n t i a l i f l e v i e s are to be a p p l i e d f a i r l y and e q u a l l y to i n d u s t r y , ftn i n t e r g o v e r n m e n t a l c o o r d i n a t i n g mechanism f a c i l i t a t e t h e a d m i n i s t r a t i o n of compensation  may  policies.  S e v e r a l p o i n t s are r a i s e d by an examination of OECD c o u n t r i e s ' l e g i s l a t i o n but the f o c u s here i s the change i n emphasis. The change i n emphasis  from post-market monitoring to  pre-market t e s t i n g i m p l i e s a form of t e s t system t o determine c a n d i d a t e s f o r c o n t r o l . Design of such a system may difficult and UK. will  be  as evidenced by the d i v e r g e n t approaches of the US  But, one p o i n t i s c l e a r : the pre-market  t e s t approach  r e q u i r e e f f i c i e n t and adequate i n f o r m a t i o n about  c h e m i c a l s , about t h e i r e f f e c t s and about p u b l i c p e r c e p t i o n s of t h e i r hazards. Governments have ample power to r e g u l a t e t o x i c c h e m i c a l s and to p r o v i d e compensation i s needed  f o r damages. However, i n f o r m a t i o n  to a i d i n the f o r m a t i o n o f a c t u a l r e g u l a t i o n s .  Governments have both the a b i l i t y  to f i n a n c e and c o l l e c t  i n f o r m a t i o n and to p r o v i d e i n d u s t r y with the assurance of c o n f i d e n t i a l i t y . The next step i s to examine c r i t e r i a f o r screening of candidates for c o n t r o l .  such  28  2. ESTABLISHMENT OF  It has  PSIOBITIES F08 REGOLATION  been e s t a b l i s h e d t h a t u t i l i z a t i o n o f  legislative  powers r e q u i r e s t h a t s u i t a b l e c a n d i d a t e s f o r c o n t r o l be i s o l a t e d from the thousands of new two  and  methods e x i s t , f i r e f i g h t i n g and  screening An  o l d c h e m i c a l s . At l e a s t  establishment  of a  system.  obvious s t r a t a g e y  p o l i c y of c o n c e n t r a t i n g  i s to focus  on h i g h  on f i r e f i g h t i n g . Such a  p r o f i l e chemicals has  good p o i n t s to recommend i t . F i r s t ,  several  p u b l i c acceptance of  r e s t r i c t i o n s i s l i k e l y t o be enhanced by the  l a r g e amount of  media hyperbole generated by a t o x i c chemical c r i s i s .  Two,  the  i n d u s t r y marketing or d i s t r i b u t i n g the chemical i s l i k e l y a t a disadvantage i n a c r i s i s s i t u a t i o n and  to  t h e r e f o r e more  amenable t c government r e g l a t i o n . F i n a l l y , the f a c t that  the  chemical i s drawing a t t e n t i o n suggests t h a t a s i g n i f i c a n t of information the design hazards can  already  exists..These  factors w i l l  be d e a l t  facilitate  with. s e v e r a l drawbacks a r i s e i f a more  comprehensive p o l i c y i s not implemented. F i r s t , r e c e p t i v e p u b l i c and  may  w e l l . Once a law  be  poorly conceived  placed  can  H a s t i l y composed  and  difficult  to enforce  e x i s t s , r e g u l a t i o n s must be designed  enforcement machinery must be Time can  even with a  a compliant i n d u s t r y , l e g i s l a t i o n  r e q u i r e a long time to pass i n t o law.  effect.  level  of s u i t a b l e c o n t r o l l i n g s t a t u t e s . Thus, known  Onfortunately,  legislation  be  i n motion before  be an important c o n s t r a i n t . , S e c o n d ,  as  and law the  takes nature  29  of contemporary commercial chemicals  allows them t o do much  damage before d i s c o v e r y i f they are not c l o s e l y Chemicals  monitored.  a r e o f t e n t o x i c a t low c o n c e n t r a t i o n s or may have  l a t e n t e f f e c t s . Once e s t a b l i s h e d i n the environment, p e r s i s t e n t chemicals  may take many years to d i s s i p a t e . Thus, there i s an  argument f o r t e s t i n g chemicals b e f o r e they a r e d i s t r i b u t e d i n l a r g e amounts (pre-market  control).  With the above p o i n t s i n mind, i t becomes important to choose candidates f o r c o n t r o l even before e x t e n s i v e i n f o r m a t i o n i s a v a i l a b l e . A s u i t a b l e s c r e e n i n g system must be developed t o e v a l u a t e the r e l a t i v e importance o f a p a r t i c u l a r chemical. Two f a c t o r s can be i n t e g r a t e d t o determine the p o t e n t i a l importance of a c h e m i c a l . These are expected  exposure t o a chemical and  the consequences of that exposure. Together determine the impact  these  factors  a chemical w i l l have on h e a l t h and the  environment and t h e r e f o r e , i t s importance as a candidate f o r regulation.  2.1 EXPOSURE DETERMINATION The  first  s t r a t e g y t o be examined i s exposure  d e t e r m i n a t i o n . I d e a l l y , exposure should be easy t o d e f i n e . The q u e s t i o n s to be answered a r e : Hho i s exposed? Sfhat a r e they exposed t o ? How long are they exposed? and What i s the s t r e n g t h o f exposure? To answer the q u e s t i o n s the p r o d u c t i o n process of a chemical i s examined. A t y p i c a l product s c e n a r i o might be as f o l l o w s . Raw  30  m a t e r i a l i s removed from the e a r t h i n some way, f o r i n s t a n c e , mining or pumping. I t i s t r a n s p o r t e d t o a r e f i n i n g  center,  r e f i n e d and sent t o a manufacturing p l a n t . & product or i n t e r m e d i a t e part i s produced which i s s o l d t o a consumer. The consumer uses the product u n t i l i t i s f i n i s h e d o r disposed o f , p o s s i b l y t c be degraded t o some b a s i c , n a t u r a l components. To d e f i n e the exposure the consumers are simply t r a c e d and catalogued. Obviously t h i s s c e n a r i o i s over s i m p l i f i e d .  Closer  examination r e v e a l s many p o s s i s i b i l i t i e s f o r i n a d v e r t e n t o r even r o u t i n e exposure. In the mining of a s b e s t o s , f o r example, miners are exposed t o the minute f i b e r s every workday. The h i t h e r t o ignored chendcal causes a c h r o n i c lung disease asbestosis  called  (Brodeur, 1979). Another example i s the accumulation  o f dust i n the lungs of c o a l miners which leads t o black lung d i s e a s e . Both are forms of o c c u p a t i o n a l exposure. During the mining process t a i l i n g s are d i s c a r d e d , some i n t o water used f o r other purposes. In 1973 the d r i n k i n g  water  of Duluth, Minnesota was found to have b i l l i o n s of a s b e s t o s l i k e f i b e r s suspended i n i t .  The d i s c h a r g e from the mine was  being d i s p o s e d of i n Lake S u p e r i o r  (the l o c a l water s u p p l y ) .  Animal t e s t s showed i t t o cause cancer (Lawless, 1979)..This i l l u s t r a t e s unintended exposure t o o t h e r s through i n d u s t r i a l d i s c h a r g e s and emissions..Other examples carbon-monoxide  abound: l e a d and  from c a r exhaust; s u l p h u r d i o x i d e s from c o a l -  burning e l e c t r i c a l p l a n t s ; and mercury compounds from the p l a s t i c s i n d u s t r y c o n c e n t r a t i n g i n f i s h and c a u s i n g the infamous Minamata tradgedy (Smith and Smith,  1970).  :  31  Another  point i n the s c e n a r i o where a c c i d e n t a l exposure  can occur i s during t r a n s p o r t between p r o c e s s o r s . C h l o r i n e , f o r example, shipped by truck or r a i l c a r has s p i l l e d  near  p o p u l a t i o n c e n t e r s i m p e r i l i n g whole c i t i e s with poisonous gas; d u r i n g a f i r e or f l o o d illegal  which  damages storage f a c i l i t i e s ; d u r i n g  use e i t h e r by a f i n a l consumer such as a drug a d d i c t or  by an i n t e r m e d i a t e user such as a farmer u s i n g the wrong p e s t i c i d e on crops; and during l e g i t i m a t e use o f substances which c o n t a i n i m p u r i t i e s such as flame r e t a r d a n t chemicals i n childrens clothing flavouring  (Blum and Ames, 1977)  (Strawberry Aldehyde)  F i n a l l y , unexpected Important  or strawberry  (Butterworth, 1978).  exposure can occur by c r i m i n a l design.  f a c t o r s t c c o n s i d e r i n e s t i m a t i n g exposure are the  very r e a l p r o b a b i l i t y of sabotage, s u b v e r s i o n or vandalism. These f a c t o r s can add s i g n i f i c a n t l y t o the u n c e r t a i n t y of both the occurrence and the extent of exposure. when the myriad o f p o t e n t i a l s o u r c e s of exposure  are  r e c o g n i z e d i t i s evident that the task of determining a c c u r a t e l y who  i s exposed  to what i s beyond reasonable means.  Rather than a c t u a l l y measuring index may  be used t o approximate  Economic Community  it.  or c a l c u l a t i n g exposure, an For example, the  European  (EEC) uses production l e v e l s as a proxy f o r  exposure. In the EEC scheme, as the p r o d u c t i o n l e v e l of a chemical passes c e r t a i n t h r e s h o l d s , thereby i n c r e a s i n g probable exposure, more s o p h i s t i c a t e d , complex and expensive t o x i c o l o g i c a l data are r e g u i r e d  (HcGinty, 1979).The use of  p r d u c t i o n l e v e l s as the s o l e index of exposure i s s u b j e c t to  32  s t r o n g c r i t i c i s m s s i n c e there are many cases where exposure i n t e n s i t y to man and the environment i s not r e f l e c t e d . Other systems use a more complex Testing Committee  ;  index. The OS Interagency  (ITC), f o r i n s t a n c e , d e r i v e d an index of  p o t e n t i a l exposure based on numerical s c a l e s f o r p r o d u c t i o n volume, e n v i r c m e n t a l r e l e a s e , o c c u p a t i o n a l exposure and nono c c u p a t i o n a l human exposure. Such an approach improves t h e index's s e n s i t i v i t y  to chemicals which may be h i g h l y t o x i c i n  s m a l l amounts o r , c o n v e r s e l y , only s l i g h t l y t o x i c i n very l a r g e doses.  2.2 ENVIfiONHENT&L DYNAMICS Another important c o n s i d e r a t i o n i n e s t i m a t i n g exposure i s environmental dynamics. Two main areas a r e of consequence, the n a t u r a l , e x t e r n a l environment and the environment o f the human body. The e x t e r n a l environment can have a powerful e f f e c t on chemicals. Substances d e p o s i t e d there a r e e v e n t u a l l y changed to some o t h e r form or compound. Some c h e m i c a l s l i k e DDT r e s i s t such changes and a r e c l a s s e d as p e r s i s t e n t  (Lawless, 1976).,  Others l i k e bicdegradeable soaps break down q u i c k l y . on t h e i r s o l u b i l i t y  Depending  i n water, the amount of s u n l i g h t and other  c o n d i t i o n s such as pfl, temperature and endemic  microorganisms,  chemicals may be degraded, d i s s i p a t e d o r c o n c e n t r a t e d . The end product o f d e g r a d a t i o n can be benign as i n the case of o r d i n a r y soap o r very t o x i c as i n the case of mercury. Mercury  was used i n chemical p l a n t s mainly i n t h e production of  33  c h l o r i n e and c a u s t i c soda  (Chemical and E n g i n e e r i n g News,  1971)  o r i n s m a l l e r amounts as a f u n g i c i d e with p u l p and paper o r a g r i c u l t u r e a p p l i c a t i o n s . I n 1969 consumption o f mercury  by  main u s e r s was almost 6 m i l l i o n pounds (Chemical and E n g i n e e r i n g News, 1971).,Host o f t h e mercury was i n a low t o x i c i t y form as a r y l mercury compounds ( o f t e n used i n p h a r m a c e u t i c a l s ) . However, a n a e r o b i c b a c t e r i a i n bottom sediment c o n v e r t the a r y l mercury compounds from  industrial  e f f l u e n t i n t o a f a r more t o x i c o r g a n i c form, a l k y l  mercury  (Bosen, Wood and Kennedy, 1968). In a d d i t i o n , mercury t e n d s t o accumulate i n a n i m a l s as the food pyramid i s ascended. F o r example, hawks f e d on c h i c k e n l i v e r s w i t h 3ppm, accumulated up t o 18 ppm  (Chemical  E n g i n e e r i n g , 1970) and f i s h have been found w i t h up t o 5 ppm i n the t o x i c methyl form ( l a w l e s s , 1977). Man i s a p r e d a t o r a t the top o f the f o o d c h a i n . Mercury i n g e s t e d a t low l e v e l s accumulates to h i g h e r t o x i c l e v e l s i n the f o o d t h a t man e a t s ( b i o m a g n i f i c a t i o n ) . I t tends t o c o n c e n t r a t e i n the b r a i n ( b i o a c c u m u l a t i o n ) a f f e c t i n g the c e n t r a l nervous system and l e a d i n g t o permanent, c r i p p l i n g b l i n d n e s s and even death ( n o r l a n d ' s I l l u s t r a t e d M e d i c a l D i c t i o n a r y , 1974). C h e m i c a l s can a l s o be d i s s i p a t e d as the n a t u r a l f l o w of the environment t r a n s p o r t s i t from p l a c e to p l a c e . Dust p a r t i c l e s a r e c a r r i e d by a n i m a l s and wind, streams c a r r y s o l u b l e s u b s t a n c e s o r suspended are condensed  matter and gaseous  materials  i n the a i r to r e t u r n as r a i n d r o p s . The end  result  i s a t h o r o u g h d i s p e r s i o n of the c h e m i c a l , an example of such a u b i q u i t o u s c h e m i c a l i s the p e s t i c i d e DDT.  Lowrance (1976, p.  34  162)  i n documenting  DDT  laments:  DDT was e v e r y w h e r e on t h e s u r f a c e o f the e a r t h . DDT was i n e v e r y body o f a i r and w a t e r . DDT was i n t h e b o d i e s o f v i r t u a l l y a l l l i v i n g c r e a t u r e s . DDT was i n man* s own flesh.  The  combination  allowed  i t t o permeate t h e  The  i t has  been i l l u s t r a t e d . arising  of the  physiology  from  on  To  mutagenicity  t h e s e two  or vice  with sodium botulinum  and  example of  used  to prevent  such  an  t h e growth  correlated from  (Council  of  of  the  occur  Clostridium  1977).  f o r i n s t a n c e , i n c r e a s e s the a c t i o n  Ames  into  Another  i s the s y n e r g i s t i c  McCann and  a  i n meat.,Microorganisms  which p o t e n t i a t e s t h e a c t i o n  1. See HcCann e t a l . ( 1 9 7 5 ) , P u r c h a s e e t a l . , (1978) .  they  influence  action could  which a r e c a r c i n o g e n i c ( L a w l e s s ,  some c h e m i c a l s  own  which  metabolized versa  the  transform the ingested n i t r i t e s  of p h y s i o l o g i c a l i n t e r a c t i o n  Caffeine,  be  other dangerous b a c t e r i a  i n t h e human g u t  nitrosamines  chemical  Mutagen S o c i e t y , 1975)  nitrites  with  (mutagenicity i s highly  non-mutagenically Environmental  man's  f a c t o r s can  can  and  and  be added  that  substances  with carcinogenicity)». Chemicals active  had  are deposited  f a c t o r s can  the e f f e c t  m i c r o b i o l o g y have on  of chemicals  that  the p o s s i b l e c o m b i n a t i o n s  human e n v i r o n m e n t :  and  chemicals  come i n c o n t a c t . F o r example, m e t a b o l i c  present  e x t e n s i v e use  world.  o f the environment  permutations action  p e r s i s t e n c e and  number o f s o u r c e s o f a c h e m i c a l have been shown,  the a c t i o n in  of mobility,  effect  o f a mutagen,  o f a mutagen  (1976),  and  by  35  inhibiting  the  T h u s , when a faulty  deoxyribonucleic acid  mutagen damages t h e  repair  Other cases  altered.  cf p o t e n t i a t i o n occur  Such c h a n g e s can  activation  o f a mutagen  individuals  Pigmentosum subjected external  (people  are  to  of  and  such  amounts o f c h e m i c a l s internally  to  t o a c t on  Men  and  from  and  gonads, a s u f f i c i e n t blood-testes  and  barrier.  Unfortunately,  surrounding  female has  no c o r r e s p o n d i n g  p r o t e c t i o n (Environmental  bearing  age  the  somatic  A child  developing  element  exposed  cancer  because t h e r e  passes prime  the Mutagen  child After  i t i s inconsequential..  mutations,  because of the time cancer.  immature o v a ,  importance o f such p r o t e c t i o n d i m i n i s h e s .  menopause, o f c o u r s e , For  the female  in  concentration of a c t i v e  follicular cells  1975). However, as  sex  genetic material.  other than  Society,  the  different  women d i f f e r  t o mutagens w h i c h a l t e r  pass the  people  body. ,  importance of exposure.  must  even  d e m o g r a p h i c f a c t o r s s u c h a s age  their susceptibility  1975)  g e n e t i c c o n d i t i o n Xeroderma  various transformations  p e c u l i a r t o h i s or her  change t h e  Mutagen S o c i e t y ,  the g e n e t i c p r e d i s p o s i t i o n  be e x p o s e d  the  are  enzymatic  more s u s c e p t i b l e t o c a r i c i n o g e n s )  result  Finally,  mutagen  with  the  t h e same k i n d s  d a n g e r s as a  In o r d e r  with  environment can  synergies  vary  p o s s i b l y to  when enzymes  i n c r e a s e the r a t e of  (Environmental  s i n c e s u c h r e a c t i o n s can  process.  s t r u c t u r e i t remains  l e a d i n g t o e r r o r s i n t r a n s c r i p t i o n s and  cancer.  of  DNA  (ONA)  to a  age  a l s o p l a y s an  inherent  i n the  carcinogen  t h a t a person  exposed  has  important  role  probability  of  a g r e a t e r chance  later  i s more t i m e f o r i t t o d e v e l o p .  in life  of  simply  T h u s , i t i s more  36  important  that  c h i d r e n n o t be e x p o s e d  nitrophenylenediamines mature  woman  (Searle,  When a l l t h e s e appears  found  i n hair  t o such c a r c i n o g e n s as dyes than  1975).  factors  a r e c o n s i d e r e d , exposure  very complicated. But, s e v e r a l  as i n t h e case  points stand out. P i r s t ,  with s u b t l e b i o l o g i c a l  mechanisms which a r e unknown o r t h o u g h t  of  events  Even  that  scientists.  i n known s y s t e m s ,  t o be o f  the p a r t i c u l a r  F o r example, C l a r k e  known a n d e v e r y  prepared  implies  sufficiently  controlled  capsule..Exposure  so t h a t  and t h e wide r a n g e  a considerable safety  for particular  with  f o r , a completely  o c c u r r e d which d e s t r o y e d t h e  of individuals that  combination  was c o m p l e t e l y  little  S e c o n d , t h e wide u n c o n t r o l l a b l e v a r i a t i o n  standards maximum  conceivable hazard  event  may be t h o u g h t  exposure  little  (1977) d e s c r i b e s a mishap t h e system  exists.  and c h e m i c a l  o c c u r s may n o t h a v e been p e r c e i v e d by  t h e A p o l l o 13 s p a c e c r a f t . .Although  unexpected  analysis  o f m e r c u r y , t h e d a n g e r o f many c h e m i c a l s i s n o t  r e a l i z e d . .They may i n t e r a c t  importance.  i t is fora  risk  i n the  of susceptibility  margin i s necessary i f  chemicals are s e t t o minimize the  risk.  What may be an i n s i g n i f i c a n t may be a l e t h a l  dose t o a n o t h e r  exposure  t o one i n d i v i d u a l  i f h i s genetic disposition or  metabolic s t a t e causes  potentiation  Unfortunately, setting  standards  of that  in this  chemical.  way  also  expense  t o consumers o f c h e m i c a l s a s i n c r e a s e d  control  c o s t s a r e passed  Finally,  pollution  i m p l i e s added  pollution  on from i n d u s t r y , that  i s insignificant  becomes o f paramount i m p o r t a n c e  i n small  when c o n t a m i n a n t s  doses  are i n  37  amounts beyond to  cope.  A long  capaility the  the capacity period  and h i g h  o r body and i r r e v e r s i b l e  a hazard i s recognized./The  overloaded  and permeated  c a n be done t o p r e d i c t  levels.  Extended  environment  rapid  necessitates  large tests  testing  protection  scale  the c a p a c i t y of  e n v i r o n m e n t may be s t u d y on low  the conseguences  of higher  sufficient  screening of chemicals  m a n u f a c t u r i n g i s p e r m i t t e d . Thus,  must be d e s i g n e d o r t h e p e r i o d between  i f protection  level  f o r t h e human and e x t e r n a l  a v a i l a b i l i t y and h i g h  lengthened  production  damage may be done  before s u f f i c i e n t  effects  before  volume  means t h a t c o n t a m i n a n t s may exceed  environment  before  latet  o f t h e body o r o f t h e e n v i r o n m e n t  volume  against  production  this  danger  either  initial  must be  i s t o be  established.  2.3  auaioGoos  CONSEQUENCES  I m p u t a t i o n s o f consequence premise  that  b y a n a l o g y i s b a s e d on t h e  i f two o r more t h i n g s a g r e e  i n f e r e n c e c a n be drawn t h a t  they w i l l  i n some r e s p e c t s t h e  probably agree  Mechanisms t o a i d i n t h e d i s c o v e r y and f o r m u l a t i o n analogous s i t u a t i o n  range from a s i m p l e a p p l i c a t i o n  sense t o the s o p h i s t i c a t e d  statistical  e p i d e m i o l o g i c a l s t u d i e s or mathematical  a n a l y s i s of models.  i n others.  o f an o f common  38  2.3.1  Common Sense A p p l i c a t i o n s of common sense  have occurred i n the food  i n d u s t r y . The Food P r o t e c t i o n Committee Research  C o u n c i l have developed  determining  (FPC)  o f the N a t i o n a l  g u i d e l i n e s as an a i d to  the a p p r o p r i a t e l e v e l s of chemicals  ( S c h l e g e l , 1978). One  of the c r i t e r i a  i n food  f o r determining  i n s i g n i f i c a n t l e v e l s i s based on the occurrence  of the chemical  i n t r a d i t i o n a l food. I f t h a t n a t u r a l l y o c c u r r i n g chemical i s recognized as s a f e , then by analogy,  the s y n t h e t i c chemical i s  c o n s i d e r e d s a f e i f consumed i n q u a n t i t i e s of the same order of magnitude. An example o f such an a p p l i c a t i o n i s the a d d i t i o n of g l y c e r i d e s t o processed foods t o improve t e x t u r e and c h a r a c t e r i s t i c s . Based on average  other  consumption of g l y c e r i d e s i n  t r a d t i o n a l foods, the a d d i t i o n a l g l y c e r i d e s were judged an i n s i g n i f i c a n t a d d i t o n a l hazard  2.3.2  (FPC,  to be  1965).  O c c u p a t i o n a l Exposure A second  use of analogy  i s the comparison of i n a d v e r t e n t  and o c c u p a t i o n a l exposure with expected  exposure of a  p o p u l a t i o n o v e r a l l . By i n f e r e n c e , an approximation consequences can be determined. high and continuous, i l l obvious  way.  of  expected  Because exposure i s r e l a t i v e l y  e f f e c t s o f t e n come to l i g h t i n a more  Such was the case with c o a l dust l e a d i n g t o black  lung d i s e a s e i n miners.  Information on p o s s i b l e e f f e c t s of  those r a r e l y exposed would be s e v e r e l y l i m i t e d without such analogy.  an  39  2.3.3  Epidemiology Epidemiological  who  studies  involve  the comparisons  of groups  have been exposed t o a substance with c o n t r o l groups  who  have not. They have been used with n o t a b l e success t o e s t a b l i s h the l i n k between cancer of the jaw and workers i n the watchmaking i n d u s t r y  (Castle et a l . 1925). .They have a l s o been  used,  although with l e s s success, to c o r r e l a t e lung cancer with c i g a r e t t e smoking. Such a method has the advantage human s u b j e c t s without the e t h i c a l c o n t r a i n t s of  of u t i l i z i n g  deliberate  exposure t o dangerous c h e m i c a l s . The major drawback i s t h a t epidemiological  s t u d i e s can only i n d i c a t e a r e l a t i o n s h i p . They  cannot prove cause and e f f e c t . For example, i f one were to study the r e l a t i o n s h i p between f o o t s i z e and success as a basketball  player,  correlation, skills.  one may  c o n c l u d e , from the h i g h p o s i t i v e  that a l a r g e f o o t c o n t r i b u t e s  to  basketball  However, t h i s i s an i n d i r e c t r e l a t i o n s h i p . The  c o r r e l a t i o n may  be b e t t e r e x p l a i n e d by the d i r e c t r e l a t i o n s h i p  between height and success i n the game./Thus, i n l e s s obvious c i r c u m s t a n c e s , i t i s c l e a r t h a t where the mechanisim i s not known, s p u r i o u s r e l a t i o n s h i p s may  of a c t i o n  be hypothesized. A  simple c o r r e l a t i o n cannot prove a cause and e f f e c t relationship. T h i s weakness of epidemiology has l e d to acrimonious debate between the tobacco i n d u s t r y  and advocates of heavy  r e s t r i c t i o n s on c i g a r e t t e s a l e s as w e l l as between the mining companies and advocates of more s t r i n g e n t s a f e t y compensation  status  f o r c e r t a i n miners  (Doren,  and 1978).  no McGarity  (1979) p o i n t s out t h a t secondary drawbacks e x i s t .  Since e p i d e m i o l o g i c a l s t u d i e s simply i n d i c a t e the  probability  of a r e l a t i o n s h i p , s c i e n t i s t s must judge the p o i n t at which data i s s t a t i s t i c a l l y s i g n i f i c a n t . Judgment i s a l s o e x e r c i s e d i n the d e s i g n i n g of experiments and i n choosing the c o n t r o l cohort.  ;  These methodological problems and o t h e r s , such as the difficulty  i n c o n t r o l l i n g f o r confounding, i r r e l e v a n t  events  d u r i n g the course o f the study pose s t r o n g t h r e a t s to v a l i d i t y . Meaningful e x t r a p o l a t i o n to other p o p u l a t i o n s becomes dubious. Despite  problems,  Sienstein  {1979), c o n s i d e r s e p i d e m i o l o g i c a l  s t u d i e s to be the source of best evidence to e s t a b l i s h an a s s o c i a t i o n between exposure  to a substance and a p a r t i c u l a r  human i l l n e s s .  2.3.4  E x t r a p o l a t i o n from Animal T e s t s Tenuous a n a l o g i e s can be drawn between animal t e s t s  p r e d i c t e d human consequences 1972)  from s i m i l a r exposure  and  (Storer  or p r e d i c t i o n c f chemical damage from data on the damage  caused by an  ' e q u i v a l e n t ' amount of r a d i a t i o n  Mutagen S o c i e t y ,  (Environmental  1975).,Both these a n a l o g i e s are more tenuous  as a n a t u r a l r e s u l t of the decrease i n s i m i l a r i t y on which to base the analogy. There are wide d i f f e r e n c e s i n the p h y s i c a l , p h y s i o l o g i c a l and metabolic s t r u c t u r e between v a r i o u s animal s p e c i e s and man.  A c a r c i n o g e n i c reponse  i n an animal i s not  wholly analogous t o a response i n a human. L i f e  spans are  41  d i f f e r e n t , i n t e s t i n a l f l o r a are d i f f e r e n t and body f u n c t i o n s are d i f f e r e n t animal  (Environmental Mutagen S o c i e t y , 1975). Thus  t e s t s cannot be d i r e c t l y e x t r a p o l a t e d to  However, the range of expected r e s u l t s can down. Crouch comparison  and H i l s o n  man. be narrowed  (1979) have developed a method of  t o allow e x t r a p o l a t i o n of consequences  within a  f a c t o r of ten as a good f i r s t approximation o f expected at  effect,  l e a s t one notable e x c e p t i o n e x i s t s , u n f o r t u n a t e l y , s i n c e  arsenic  (and p o s s i b l y other heavy elements)  by t e s t s with r a t s , as h i g h l y t o x i c to Animal t o man  were not d e t e c t e d  man.  t e s t s , as a means of determing a t o x i c o l o g i c a l  have other problems.  risk  F i r s t , they can be very expensive.  A common t e s t i n g methodology i n the OS uses a minimum of  600  animals, takes up to three years and c o s t s up t o $500,000 ( N a t i o n a l Research C o u n c i l (OS) result  , 1979). Second, t o o b t a i n a  with a p r a c t i c a b l e number of animals,  proportionately  l a r g e r doses of chemicals than man  would normally be exposed  are used. R e s u l t s may  i f dose response i s not  not be v a l i d  to  l i n e a r or i f a d e t o x i f i c a t i o n mechanism i s overwhelmed. In a d d i t i o n to these and other problems t h e r e remains t h e o r e t i c a l problems of e x t r a p o l a t i n g r e s u l t s from animals to man.  the  lower  Although the N a t i o n a l Research C o u n c i l  (OS)  (1979) f e e l s t h a t e x t r a p o l a t i o n u s i n g dose per body weight i s a reasonable approach, other r e s e a r c h e r s suggest the a l t e r n a t i v e of p r o p o r t i o n a l i t y of s u r f a c e area i s a more r e l i a b l e  approach.  Thus, t h e r e i s not agreement on the a p p r o p r i a t e methodology.  42  2.3.5 E x t r a p o l a t i o n from In V i t r o In v i t r o inexpensive chemicals. genetic  Tests  (short term) t e s t s c o n s t i t u t e a r a p i d and  means to determine the consequences of exposure to G e n e r a l l y , such t e s t s are based on the d e t e c t i o n of  mutation, damage, and growth t r a n s f o r m a t i o n s  i n micro-  organisms o r c u l t u r e d mamalian c e l l s . For example, changes i n DNA such as chromosome damage or mutations a r e known to be h i g h l y c o r r e l a t e d with the a b i l i t y t o cause cancer al.,  (HcCann e t  1975; McCann and Ames, 1976; and Purchase e t a l . , 1978) Over e i g h t y i n v i t r o t e s t s have been developed, o f t e n  s p e c i a l adaptations  with  to i n c r e a s e t h e i r a b i l i t y t o d e t e c t  p o t e n t i a l c a r c i n o g e n s . .By using b a t t e r i e s of t e s t s , the s e n s i t i v i t y t o carcinogens different  can be f u r t h e r i n c r e a s e d to  types of mutations or other anomalies. A b a t t e r y o f  t e s t s i s t h e r e f o r e , l i k e l y t o d e t e c t p o t e n t i a l carcinogens missed by a s i n g l e t e s t . U n f o r t u n a t e l y , sensitivity  i n c r e a s i n g the  i n c r e a s e s the p r o b a b i l i t y t h a t non-carcinogens  will  be l a b e l e d c a r c i n o g e n i c by mistake s i n c e the s p e c i f i c i t y o f the t e s t i s reduced. These t e s t systems have only a remote s i m i l a r i t y to human systems. T h e r e f o r e ,  t h e i r use i s g e n e r a l l y c o n f i n e d t o  p r e l i m i n a r y screening.„  43  2.3.6  Extrapolation  from B a d i a t i o n Data  The e x t e n s i v e data on r a d i a t i o n e f f e c t s c o u l d he very u s e f u l i n determining the p o t e n t i a l e f f e c t s of a new  chemical  on man.  developed  The Environmental Mutagen S o c i e t y (1975) has  the concept of a rem-equivalent-chemical  (BEC)  which i s the  dose of a chemical over some p e r i o d of time which produces e g u i v a l e n t amount of damage as one rem r e l i e s on the assumption  the  of c h r o n i c r a d i a t i o n . I t  that the r a t i o between chemical  and  r a d i a t i o n mutagenicity remains c o n s t a n t and l i n e a r which, when genetic and  metabolic f a c t o r s are i n c o r p o r a t e d , i s u n l i k e l y .  L i k e the e x t r a p o l a t i o n from animal t e s t s i t i s q u a n t i t a t i v e l y u s e f u l only as an  approximation.  2.4 CHEBICAL BEHAVIOB T h i s s e c t i o n d e a l s with the a b i l i t y to p r e d i c t the b e h a v i o r s of chemicals i n the environment  from  t h e i r chemical  structure. A f t e r r e l e a s e i n t o the environment,  a chemical becomes  d i s p e r s e d through a l l mediums; a i r , land and the complexity of the environment,  water. Because of  the behavior  and  c o n c e n t r a t i o n i n any geosphere depends on both chemical  and  geosphere p r o p e r t i e s ( N a t i o n a l Academy of S c i e n c e , 1975).  44  2.4.1  Atmospheric I n t e r a c t i o n s The  three main f a c t o r s a f f e c t i n g entry i n t o the a i r and  t r a n s p o r t o f chemicals through  i t are vapour pressure, heat of  v a p o u r i z a t i o n and the p a r t i t i o n c o e f f i c i e n t between the atmosphere and another flow  medium, and the c h a r a c t e r i s t i c s o f a i r  ( N a t i o n a l Academy of S c i e n c e ,  the probable  1975). I n order t o p r e d i c t  path and the f a t e of a chemical  a knowledge o f the  r a t e of exchange between the atmosphere and other geospheres i s e s s e n t i a l . The vapour pressure  (the maximum pressure a chemical  would e x e r t i n the gas phase i n a c l o s e d c o n t a i n e r (Porterfield,  1972) provides i n s i g h t i n t o the process  necessary  f o r e v a l u a t i o n . Using p e s t i c i d e s as an example, i t i s e v i d e n t t h a t vapour pressure values d i f f e r Kerlinger,  widely  (Hamaker and  1969). Values range from the extreme of gases  (oxygen, carbon  d i o x i d e and sulphur dioxide) to the v o l a t i l e  organophosphates and carbamates (Parathion and Sevin  with  vapour pressures of 0.03mm Hg and 0.005mm flg r e p e c t i v e l y ) the l e s s v o l a t i l e p e s t i c i d e s of 1 0  - 6  t o 10 mm _9  to  ( T r i a z i n e s have a vapour pressure  Hg) and f i n a l l y  t o the other extreme o f those  with n e g l i g i b l e vapour pressure. Any chemical  with a vapour pressure can be i n the  atmosphere but the r a t e and the extent are mediated by other f a c t o r s . Dust p a r t i c l e s i n c r e a s e the e n t r y r a t e by a b s o r p t i o n of vapour to the g r e a t l y i n c r e a s e d s u r f a c e area while a i r c u r r e n t s i n t e r a c t with the p a r t i t i o n c o e f f i c i e n t the r a t e o f d i f f u s i o n through concentration  (Hartly,  to increase  the p a r t i t i o n by d e c r e a s i n g the  1969). An important f a c t o r  influencing  45  the r a t e of chemical entry i n t o the atmosphere from the s o i l i s the pressure of moisture. The e v a p o r a t i o n r a t e o f many c h e m i c a l s , f o r example DDT, distillation  i s i n c r e a s e d through  with water (Acree e t a l . , 1963)  co-  so that l o s s  from  s o i l i s a c c e l e r a t e d when the s o i l i s damp (Freed et a l . , 1962). Other f a c t o r s mediating the i n f l u e n c e of vapour pressure are temperature,  humidity, pfl and p h y s i c a l p r o p e r t i e s of the  chemical. A c t i v i t y i n the atmosphere i s modified by g e n e r a l p h y s i c a l p r o p e r t i e s o f the chemical molecule. M o l e c u l a r weight  (MW)  tends t o l i m i t the d i s p e r s a l of molecules i n the atmosphere. Molecules over 200 t o 300 MH  tend to e x i s t as a e r o s o l s r a t h e r  than as random d i s p e r s i o n s . Molecules, such as  2,5-  d i n i t r o a n a l i n e , which are made of a b a s i c carbon framework with e l e c t r o n e g a t i v e atoms l i k e n i t r o g e n , oxygen, f l u o r i n e or c h l o r i n e i n c o r p o r a t e d i n the s t r u c t u r e tend t o have an d i p o l e moment. That i s , one end of the molecule n e g a t i v e than the other  (Porterfield,  electric  i s more  1972). T h i s  c h a r a c t e r i s t i c causes a c o n f i g u r a t i o n with a high degree s t a b i l i t y and  tends to lower the v o l a t i l i t y  of  l e a d i n g to l e s s  evaporation. Another  e f f e c t of the molecular d i p o l e moments pointed out  by the N a t i o n a l Academy of S c i e n c e i s the e f f e c t on  solubility.  P o l a r s o l v e n t s tend to d i s o l v e other p o l a r chemicals thus water, a p o l a r s o l v e n t , d i s s o l v e s p o l a r substances (table salt)  like  NaCl  an i o n i c c r y s t a l with s t r o n g charges, e a s i l y  and  c o v a l e n t or m e t a l l i c substances l e s s so. T h i s phenomenon l e a d s to s e l e c t i v e accumulation of p o l a r and i o n i c substances i n  46  aqueous clouds close proximity  through absorption  and d i s s o l u t i o n . As w e l l , the  o f the c h e m i c a l s i n t h i s s i t u a t i o n f a c i l i t a t e s  aqueous and heterogeneous chemistry r e s u l t i n g i n r e a c t i o n s transforming  the o r i g i n a l c o n s t i t u e n t s i n t o something q u i t e  different. Other chemical p r o p e r t i e s having atmospheric i m p l i c a t i o n s are c r y s t a l s t r u c t u r e , l i g h t s e n s i t i v i t y , r i n g s t r u c t u r e s and m u l t i p l e bonds ( N a t i o n a l Academy of Science,  1975). C r y s t a l  s t r u c t u r e , f o r example, can have profound e f f e c t s on weather s i n c e a substance with a s t r u c t u r e s i m i l a r t o t h a t of i c e can be i n c o r p o r a t e d  i n t o snow and h a i l or can provide  around which cloud  nucleus  d r o p l e t s o r i c e form. T h i s can l e a d to  p r e c i p i t a t i o n . Furthermore, many chemicals, depending on l i g h t sensitivity  and s t r u c t u r e a r e s u s c e p t i b l e t o photochemical  o x i d a t i o n sequences. Such c h e m i c a l s , c o n t a i n i n g  oxygen,  hydrogen or halogens can i n t e r a c t with u l t r a v i o l e t l i g h t (UV) t o form smog. Other c o n t r i b u t i n g chemicals a r e those with double bonds or aromatic and h e t r o c y c l i c r i n g s o r e s p e c i a l l y strained  2.4.2  3,4 or 7 member r i n g s .  Aquatic  Interaction  Many or the chemical a c t i v i t i e s i n the atmosphere a r e shared by t e r r e s t r i a l and a q u a t i c  ecosystems as w e l l . Of the  many chemical c h a r a c t e r i s t i c s a f f e c t i n g s o l u b i l i t y , of prime importance i n an a q u a t i c organic  system, the hydrophobic nature of many  compounds causes a unique r e s u l t . Besides the very low  47  s o l u b i l i t y which can  make accurate  measurement d i f f i c u l t ,  of the compounds are a t t r a c t e d to the air-water  some  i n t e r f a c e where  they c l u s t e r i n t o d i s c r e t e p a r t i c l e s (Bowman et a l . , 1959). As a r e s u l t of t h i s s e l e c t i v e process, p e s t i c i d e can occur at the  a marked accumulation of  surface.  Other f a c t o r s a f f e c t i n g s o l u b i l i t y and and  temperature. A decrease i n pH can  solubility: (Ward and  o f t e n l e a d to  Weber, 1968). Temperature has the opposite  mentioned, the other  such as p o l a r i t y , fl-W and  pH  increased  t r i a z i n e s o l u b i l i t y i s an i n v e r s e f u n c t i o n of  temperature i n c r e a s e s s o l u b i l i t y As  s t a b i l i t y are  pH  effect.  As  increases.  major c h a r a c t e r i s t i c s of chemicals  vapour pressure  have a s i m i l a r e f f e c t  i n water as i n a i r .  2.4.3  T e r r e s t r i a l Interaction The  N a t i o n a l Academy of Science  (1975) p o i n t s out t h a t  major i n f l u e n c i n g f a c t o r s on chemicals i n the s o i l  are  adsorption  strongly  and  l e a c h i n g . Those chemicals which are  i o n i c such as i n o r g a n i c s a l t s or organic  c a t i o n s tend to  the  be  adsorbed onto c l a y s e l l through an exchange mechanism making them l e s s mobile than n e u t r a l o r g a n i c s s o l u t i o n through a p h y s i c a l process. related leaching  to s o l u b i l i t y and decreases. ,,  adsorbed from an  Adsorbtion  aqueous  i s inversely  to l e a c h i n g . As a d s o r p t i o n  increases,  48  2.4.4  Microbial  Interaction  M i c r o b i a l a c t i o n on c h e m i c a l s i s probably the most important f a c t o r to c o n s i d e r i n the a q u a t i c and  terrestrial  geospheres and t h e i r i n t e r f a c e . The importance i s d e r i v e d from the a b i l i t y of microorganisms to cope with n a t u r a l l y  occurring  t o x i c compounds through s y n t h e s i s and d e g r a d a t i o n . An a n a e r o b i c bacterium  (Yamada and Tancmura, 1973)  (Landner, 1971) f o r example,  and a s t r a i n of fungus  were shown t o change i n o r g a n i c  mercury  to methlymercury  (a f a r more t o x i c form f o r humans). Of  further  importance i s the a b i l i t y of organisms t o reduce o r  o x i d i z e heavy metals to a l l valence s t a t e s . The  National  Academy of S c i e n c e (1975) uses the example o f mercury d e t o x i f i e d from Hg * t o methyl and d i m e t h y l mercury or t o Hg° 2  and methane. The i m p l i c a t i o n s of the a b i l i t y  to a l t e r metals  through t h e i r f u l l valence range are ominous to man.  The  valence s t a t e s have a s i g n i f i c a n t e f f e c t on the t o x i c i t y of substances. As pointed out above, mercurous  oxide has l i m i t e d  t o x i c p o t e n t i a l whereas methyl mercury i s very t o x i c i n comparison. The behavior of t o t a l l y s y n t h e t i c compounds may  be more  amenable to p r e d i c t i o n because the a b i l i t y of microorganisms to transform n a t u r a l t o x i n s comes from the s e l e c t i v e pressure o f exposure over many g e n e r a t i o n s ( N a t i o n a l Academy of S c i e n c e , 1S75). Since the organisms have not been exposed to s y n t h e t i c toxins,  there i s a strong chance that the microbes have not  evolved an e f f i c i e n t  means o f degrading them. However, i f a  s y n t h e t i c substance i s an analogue of a n a t u r a l m e t a b o l i t e , i t  49  may be a c t i v e l y accumulated  i n organisms.  In time,  organisms  can be expected to evolve the necessary enzymes and mechanisms to process s y n t h e t i c t o x i n s as w e l l . Jin approximation o f the time t h i s would take may be p o s s i b l e by i n c r e a s i n g  mutation  r a t e s under i n v i t r o l a b c o n d i t i o n s t o s i m u l a t e the n a t u r a l evolution  cn a compressed temporal s c a l e  (National academy o f  Science , 1975). Other f a c t o r s r e l a t i n g t o accumulation o f s y n t h e t i c c h e m i c a l s are a high degree  of l i p i d  s o l u b i l i t y causing the  c h e m i c a l to c o n c e n t r a t e i n f a t and the tendency  of m e t a l l i c  compounds t o form o r g a n o - m e t a l l i c complexes. These f a c t o r s can i n c r e a s e the exposure  of p r e d a t o r s to t o x i c substances.  2.4.5 P r e d i c t i o n C a p a b i l i t y The N a t i o n a l Academy of Science that the a b i l i t y environment  (1975, pp. 56-57) f e e l s  to p r e d i c t chemical r e a c t i o n s i n the  i s s u f f i c i e n t l y developed  how.  On the b a s i s o f e x i s t i n g knowledge, i t i s g e n e r a l l y p o s s i b l e f o r m i c r o b i o l o g i s t s , b i o c h e m i s t s and chemists working together t o determine metabolic sequences f o r both n a t u r a l and t o t a l l y s y n t h e t i c compounds and t o i d e n t i f y those t h a t may pose environmental problems. ,  A l a r g e assumption information commercial  i s implicit  i n t h e i r a t t i t u d e . Current  must be a v a i l a b l e . Chemicals p r e v i o u s l y used f o r purposes are probably f a m i l i a r enough t o s c i e n t i s t s  t o p r e d i c t t h e i r environmental r a t e s and b e h a v i o r s . However,  50  new,  complex chemicals  are produced at an astounding  rate.  Consequently, a l l s c i e n t i s t s w i l l not have s u f f i c i e n t information. It i s i m p e r a t i v e ,  i f f u l l use  i s to be made of a v a i l a b l e  e x p e r t i s e , t h a t i n f o r m a t i o n be a c c e s s i b l e . Necessary data cover:  oxidation; reduction; h y d r o l y s i s ; a l k y l a t i o n  d e a l k y l a t i o n ; conjugation polypeptides reactions  or s a c c h a r i d e s and the r a t e s and extent  ( N a t i o n a l Academy of S c i e n c e ,  s t a t e ; vapour pressure; and and  of  1975) . A l s o , b a s i c  must be known: melting  p o i n t ; decomposition temperature; f l a s h  monitoring  and  with m e t a b o l i t e s such as amino a c i d s ,  c h a r a c t e r i s t i c s o f the chemical boiling  would  point;  point; p h y s i c a l  c r y s t a l i n e form. F i n a l l y , f o r the  t e s t i n g of micro amounts, a b s o r p t i o n s p e c t r a f o r  the v a r i o u s l i g h t wave f r e q u e n c i e s must be known. One  f u r t h e r p o i n t must be made. Since commercial  chemicals  are not a s i n g l e , pure chemical,  i m p u r i t i e s may  s i g n i f i c a n t impact on behaviour.  The  matter through h a n d l i n g ,  or t r a n s p o r t a t i o n , the  storage  r e s i d u e s of r e a c t a n t s and r e a c t i o n s are a l l probable chemicals.  They may  have a  i n t r o d u c t i o n of f o r e i g n  s o l v e n t s and  the products  of s i d e  contaminants of i n d u s t r i a l  be more dangerous than the  principle  chemical. For example, t e t r a c h l o r o - p - d i b e n z o d i o x i n i n the p e s t i c i d e 2,4,5-T i s f a r more t o x i c than the p e s t i c i d e i t s e l f (Wilson;  1971). Thus, c a r e must be taken to t e s t both the c h i e f  chemical and  i t s i m p u r i t i e s . ..,  51  2.5 CONCLUSIONS A review of the f o r e g o i n g a n a l y s i s r e v e a l s that there seldom i s complete  i n f o r m a t i o n on any o f the elements  presented. Exposure i s a u s e f u l c r i t e r i o n f o r a s c r e e n i n g system  when used i n c o n c e r t with other c r i t e r i a . But, t h e  a n a l y s i s r e v e a l s the near i m p o s s i b i l i t y o f determining a c t u a l exposure a c c u r a t e l y by measurement or c a l c u l a t i o n . A c c i d e n t s , i n a d v e r t e n t exposure through misuse and environmental f a c t o r s such as p e r s i s t e n c e tend t o m i t i g a t e a g i n s t such an approach. A l s o , t h e e f f e c t of the exposure can d i f f e r because of s y n e r g i s t i c i n t e r a c t i o n s or v a r i a t i o n s i n p e r s o n a l s u s c e p t i b i l i t y . F i n a l l y , the c o s t i n time and d o l l a r s of o b t a i n i n g d e t a i l e d i n f o r m a t i o n may be p r o h i b i t i v e . The use of an esposure proxy, such as t h e ITC index, p a r t i a l l y s o l v e s the problems. I t i s r e l a t i v e l y i n e x p e n s i v e and s t r a i g h t f o r w a r d to use. As w e l l , necessary i n f o r m a t i o n i s a v a i l a b l e . I t does n o t , however, d e a l with the v a r i a t i o n i n i n d i v i d u a l s e n s i t i v i t y t o chemicals. The use of analogy as an a i d t o e s t a b l i s h i n g p r i o r i t i e s i s o f d i r e c t use i n many cases. A d i r e c t examination of the effects  of a n a t u r a l l y o c c u r r i n g chemical may y i e l d  sinnificant  i n f o r m a t i o n . Epidemiology and o c c u p a t i o n a l exposure p r o v i d e a check on c h r o n i c and acute hazard i n such c a s e s . However, i n most cases such approaches a r e l i m i t e d  to feedback  after  exposure t o new chemicals has o c c u r r e d . In s p i t e of t h e i r f a i l i n g s , animal and i n v i t r o t e s t s p r o v i d e the main source of i n f o r m a t i o n on the chemical e f f e c t s on l i v i n g  systems.,  52  The  N a t i o n a l Academy of S c i e n c e f e e l s that i t i s p o s s i b l e  to at l e a s t p r e d i c t the major a s p e c t s o f the environmental behavior of chemicals through  s t r u c t u r e and p h y s i c a l  c h a r a c t e r i s t i c s . The major f a c t o r s a f f e c t i n g chemical  behavior  are s t r o n g l y r e l a t e d t o a chemicals a t t r i b u t e s . F o r i n s t a n c e , the p r i n c i p a l f a c t o r s i n f l u e n c i n g chemicals i n s o i l are a d s o r p t i o n and l e a c h i n g which depend i n turn on the s o l u b i l i t y and charge o f a chemical. S i m i l a r i n f l u e n c i n g f a c t o r s i n other geospheres depend on other c h a r a c t e r i s t i c s . I t i s t h e r e f o r e important to o b t a i n b a s i c i n f o r m a t i o n about a p a r t i c u l a r c h e m i c a l . The N a t i o n a l Academy of Science suggests t h a t necessary data should cover a t l e a s t b a s i c r e a c t i o n s and b a s i c c h a r a ct e r i s t i cs . A r a t i o n a l approach to d e s i g n i n g a s c r e e n i n g system i n v o l v e s making the best use o f i n f o r m a t i o n . To t h i s end the f o l l o w i n g d e c i s i o n framework i s d i s c u s s e d . A major focus of concern should be the m i n i m i z a t i o n o f chemical hazard t o man and evironment imposed by l i m i t e d benefit  resources  within the c o n s t r a i n t s  (or maximization  o f the net  i f a c o s t / b e n e f i t approach i s taken). The impact  of a  chemical i s a f u n c t i o n of two v a r i a b l e s , exposure and consequences. Thus, an obvious candidate f o r r e g u l a t i o n i s a chemical with high exposure and d i s a s t r o u s consequences. C o n v e r s e l y , a chemical with low exposure and n e g l i g i b l e consequences i s of l i t t l e i n t e r e s t . These cases are straightforward. It clearly  i s the cases t h a t have i n s u f f i c i e n t  i n f o r m a t i o n to  c a t e g o r i z e a chemical t h a t cause d i f f i c u l t y . An  53  appropriate  s t r a t e g y f o r these cases would be t o examine the  information  t h a t i s a v a i l a b l e f o r i n d i c a t i o n s o f high exposure  or high  hazard. I f , f o r example, a chemical  l a r g e amounts, i s widely  d i s t r i b u t e d and  i s produced i n  i s persistent,  prudency d i c t a t e s a c l o s e examination of h e a l t h consequences. S i m i l a r l y , a h i g h l y t o x i c chemical  warrants f u t h e r  information  about exposure. In summing up,  a screening  composite of the three  system could  be a weighted  approaches. A r a t i o n a l approach to  c o n t r o l c o u l d i n v o l v e an index f o r exposure: a high index would mean s t r i c t e r t e s t i n g f o r t o x i c i t y . A scheme f o r the e f f e c t s of a chemical and  on l i v i n g t i s s u e would u t i l i z e animal  i n v i t r o t e s t s . Because of time and  screening  f o r h e a l t h e f f e c t s may  which a r e cheaper and of c a r c i n o g e n s , toxic chemicals.  determining  expense, p r e l i m i n a r y  be done with i n v i t r o t e s t s  f a s t e r . A b u i l t - i n bias  (toward d e t e c t i o n  f o r example) c o u l d reduce the chance of  missing  Those chemicals which t e s t as t o x i c would  be  tested further., S i m i l a r l y , knowledge t h a t a chemical  i s t o x i c would  i n d i c a t e the need f o r c a r e f u l review of e x i s t i n g i n f o r m a t i o n and  p o s s i b l y f u r t h e r research  to determine p e r s i s t e n c e  or  d i s t r i b ution etc.. E p i d e m i o l o g i c a l s t u d i e s could provide feedback on those potentially  t o x i c chemicals t e n t a t i v e l y c l e a r e d f o r l a r g e s c a l e  manufacture. T h i s would allow a check on the accuracy screening  system and  of i n d i v i d u a l t e s t s . ,0f  course,  of  the  chemicals  whose s t r u c t u r e i n d i c a t e d a p o t e n t i a l hazard would r e g u i r e c a r e f u l review as w e l l .  54  The  a n a l y s i s has i n d i c a t e d  the complexity of the two  v a r i a b l e s , exposure and consequences. To assess  probable  impact, the many a s p e c t s of each v a r i a b l e must be examined and weighed. Given the s i z e and complexity o f such a system, most chemicals cannot be d e a l t with by the use of a f o r m a l d e c i s i o n making model. Even though weights may be a s s i g n e d t o s p e c i f e d c r i t e r i a t o generate a formal d e c i s i o n model, knowledgeable s c i e n t i s t s w i l l be needed to i n t e g r a t e derived  and i n t e r p r e t data  from d i f f e r e n t sources and through d i f f e r e n t  methodologies. T h i s has two i m p l i c a t i o n s : one, an attempt to process l a r g e numbers o f chemicals w i l l n e c e s s a r i l y  require  many t r a i n e d s c i e n t i s t s and d e c i s i o n makers who may not be r e a d i l y a v a i l a b l e ; two, an e x t e n s i v e i n f o r m a t i o n needed t o provide r e l e v a n t  data t o a i d i n the d e c i s i o n  another major f a c t o r t o c o n s i d e r Heinstein great  system w i l l be  (1979) p o i n t s out that  process.  i s the c o s t of c o n t r o l .  the ITC, although  putting  e f f o r t i n t o e s t a b l i s h i n g "reasoned" p r i o r i t i e s has  c o n s i d e r e d " c o n t r o l c o s t only Consideration  implicitly  a t the end" (p.  371).  must be g i v e n t o e s t a b l i s h i n g the economic worth  of f u r t h e r i n f o r m a t i o n further research  so t h a t a r a t i o n a l d e c i s i o n about  and other i n f o r m a t i o n  c o s t s can be made.  55  I s . SfAND AHD SETTING  3.1 STANDABD SETTING APPROACHES Once a candidate f o r c o n t r o l i s chosen, the g u e s t i o n of what standards  to apply  must be answered. Burton  and Kbyte  (1S78) note t h a t i t i s through the design o f standards s c i e n t i f i c evidence  that  and p u b l i c o p i n i o n are melded i n t o laws and  r e g u l a t i o n s . Various methods e x i s t t o guide the development of standards. Acceptance o f such standards by both the p u b l i c i s important.  i n d u s t r y and  ;  U l t i m a t e l y , any u s e f u l standard p u b l i c r e j e c t i o n may have profound  must be " a c c e p t a b l e " s i n c e  e f f e c t s . In our s o c i e t y  r e j e c t i o n may range from p o l i t i c a l l o b b y i n g t o law s u i t s o r c i v i l disobedience.  Such r e s u l t s are g e n e r a l l y u n d e s i r a b l e t o a  p u b l i c d e c i s i o n maker. U n f o r t u n a t e l y , a problem becomes evident when an attempt i s made t o s u b s t a n t i a t e the e l u s i v e d e f i n i t i o n o f a c c e p t a b l e . Lcwrance  (1976, p. 78), i n s e a r c h i n g f o r a f u n c t i o n a l meaning,  quotes the OS Congress J o i n t Committee on Atomic Energy.  Acceptable i s used t o mean such d i f f e r e n t t h i n g s as (a) a c o n s c i o u s d e c i s i o n perhaps based on some b a l a n c i n g of good and bad or progress and r i s k , (b) a d e c i s i o n implying a comparison, p o s s i b l y s u b j e c t i v e , with hazards from other causes, these l a t t e r being • a c c e p t a b l e i n t u r n i n one of the senses given here, or perhaps j u s t h i s t o r i c a l l y and p o s s i b l y u n c o n s c i o u s l y , (c) the passive but s u b s t a n t i v e f a c t t h a t nothing has been done t o e l i m i n a t e or c u r t a i l the t h i n g deemed 'acceptable'. 1  1  56  Although f a i l i n g to d i s c o v e r a c i r c u m s c r i b e d  definition.  Lev ranee o f f e r s 'guides to a c c e p t a b i l i t y * augmented further  ' c o n s i d e r a t i o n s ' which are i n present  use.  with These  f a c t o r s are u t i l i z e d by d e c i s i o n makers i n v a r y i n g c i r c u m s t a n c e s as an a i d to choosing  an a p p r o p r i a t e  comparative a n a l y s i s of these a l t e r n a t i v e standard techniques  f o l l o w s . As a conceptual  w i l l be roughly risk-benefit  3.1.1  The The  ordered  standard.  A  setting  framework, the a n a l y s i s  between the two  extremes: no r i s k  and  trade o f f .  Delaney P r i n c i p l e Delaney p r i n c i p l e , which has been a p p l i e d to f o o d , i s  the embodiment of the n o - r i s k approach. ,.Its essence i s t h a t  "no  a d d i t i v e s h a l l be deemed safe i f i t i s found ... a f t e r t e s t s which are a p p r o p r i a t e  f o r the e v a l u a t i o n of the  a d d i t i v e s t o induce cancer i n man  s a f e t y of  food  or animal"(Lowrance, 1976,  p.  82) Although i t i s s u p e r f i c i a l l y a u s e f u l t o o l f o r d e c i s i o n makers s i n c e i t a u t o m a t i c a l l y bans c a r c i n o g e n i c food, i t has  been invoked s p a r i n g l y i n a c t u a l p r a c t i c e . I t s  main e f f e c t seems to be as a guide, r e p r e s e n t i n g the s p i r i t o f the law possible  a d d i t i v e s from  which i s to provide  as i t does,  food a t the lowest  risk.  Food i s accepted r e g u l a t o r y agencies.  as a s p e c i a l case by d e c i s i o n makers and Three of the main elements that make i t  unique are the f a c t s t h a t exposure i s u n i v e r s a l , i n v o l u n t a r y  57  and  without a l t e r n a t i v e s (Upton, 1 9 7 9 ) . G i v e n these f a c t o r s ,  there i s a s t r o n g p u b l i c f e e l i n g that confidence and  p u r i t y o f food  should  be  i n the  maintained even at high  quality  cost.  However, the same s t a t u s i s not granted to water. Implementing the Delaney p r i n c i p l e i s fraught d i f f i c u l t y and  with  c o n t r a d i c t i o n . F i r s t , Lowrance p o i n t s out  i t a p p l i e s only t o c a r c i n o g e n i c  food  that  a d d i t i v e s . Other t o x i c  agents are excepted. Second, c l o s e r examination r e v e a l s that requires  'appropriate*  T h i r d , i t precludes  it  t e s t s to i n d i c a t e c a r c i n o g e n i c i t y .  the e x p l i c i t  use  of c o s t - b e n e f i t  judgments  although t r a d e - o f f s are made i m p l i c i t l y . If  the o b j e c t i v e i s t o minimize hazard i n food,  why  i s the  Delaney p r i n c i p l e not a p p l i e d g e n e r a l l y , i n s t e a d of only carcinogenic a general  food a d d i t i v e s ? One  of the main arguments a g a i n s t  a p p l i c a t i o n i s that e v e r y t h i n g  of everything  to  seems t o have a  little  e l s e i n i t . , 4 s s c i e n t i s t s develop micro-  techniques t h a t can  detect and  measure p r o g r e s s i v e l y  smaller  amounts i t becomes i n f e a s i b l e to remove a l l known t o x i c c h e m i c a l s t h a t can only  be d e t e c t e d .  The  concept o f p u r i t y stands  u n t i l a more s e n s i t i v e d e t e c t i o n technology l e a d s to  discovery The  of i n f i n i t e s i m a l amounts of contaminant i n the second p o i n t mentioned questions  •appropriate*  t e s t s . The  the food.  the meaning of  wording, perhaps p u r p o s e f u l l y ,  leaves  the meaning open to d i s c u s s i o n , a r e f l e c t i o n of l i m i t e d knowledge i n t h i s area, t o what i s a p p r o p r i a t e  at  any  r a t e , much u n c e r t a i n t y  s i n c e many f a c t o r s can  r e s u l t s of a t e s t . K r a y b i l l  e x i s t s as  influence  (1979) l i s t s eleven  i n c l u d i n g route of a d m i n i s t r a t i o n , t e s t s p e c i e s  the  such f a c t o r s chosen,  58  i n f l u e n c e o f dose on metabolic pathways and contaminants t e s t chemicals, a l l  these elements are thought  the assessment of c a r c i n o g e n i c i t y and s i g n i f i c a n c e t o man.  in  t o impinge on  judgment of i t s  H i t h such a high l e v e l of u n c e r t a i n t y ,  j u s t s e l e c t i o n o f the r e q u i r e d t e s t by a d e c i s i o n maker r e q u i r e s a s i g n i f i c a n t l e v e l of e f f o r t . F i n a l l y , Lowrance Science  (1976, p. 83) quotes the P r e s i d e n t ' s  a d v i s o r y Committee r e g a r d i n g the e x c l u s i o n of c o s t -  b e n e f i t t r a d e - o f f s by the Delaney  principle.  The r i g i d s t i p u l a t i o n s of the Delaney C l a u s e , s p r i n g i n g from p r e s e n t l y inadequate b i o l o g i c a l knowledge, p l a c e s the a d m i n i s t r a t o r i n a very d i f f i c u l t p o s i t i o n . He i s not allowed, f o r example, to weigh any known b e n e f i t s to human h e a l t h , no matter how l a r g e , a g a i n s t the p o s s i b l e r i s k s of cancer p r o d u c t i o n , no matter how s m a l l .  Such a d e c i s i o n must be, i n r e a l i t y , d e a l t with i n some manner, the Delaney Clause not withstanding. In order t o contend  with  problems such as the use of n i t r i t e s i n meat (they are necessary t o reduce  the r i s k of b o t u l i s m from preserved meat)  the Delaney p r i n c i p l e must be subverted. N i t r i t e s i n combination and  with c e r t a i n amines become n i t r o s a m i n e s  E p s t e i n , 1970)  (Lijinsky  a known c a r c i n o g e n , so the dilemma e x i s t s . A  t r a d e - o f f must be made between the r i s k of cancer and the of b o t u l i s m . The f a c t t h a t n i t r i t e s are s t i l l  used  risk  turns on  the  f i n e p o i n t of l e g a l i n t e r p r e t a t i o n : The chemical i s deemed not to be a c a r c i n o g e n a t the time of a d d i t i o n and i t i s t h e r e f o r e permissible  ( K e s s l e r , 1977). Other c h e m i c a l s , p o s s i b l y  c a r c i n o g e n i c , remain i n food by v i r t u e of being ignored  59  (Lowrance, 1976). Contamination of water i s among the other  complications  t h a t e x i s t . , H a t e r meeting p u b l i c h e a l t h standards  i n other  r e s p e c t s does not meet the requirements of the Delaney c l a u s e when added t o food during p r o c e s s i n g . T h i s anomaly a r i s e s because of the  presence of complex organic compounds which are  c a r c i n o g e n i c i n t h e i r own  right  (Kraybill,  1979)  or become so  when combined with the c h l o r i n e added to reduce  bacterial  content..Thus, the context i n which a carcinogen  i s found  a f f e c t s the a p p l i c a t i o n of the Delaney c l a u s e . a l s o , some r i s k / b e n e f i t although  t r a d e - o f f may  a heterogeneous p o p u l a t i o n may  be p o s s i b l e ,  not have a t h r e s h o l d  below which a contaminant would not cause d e t r i m e n t a l  effects  (Calabrese,  Stokinger  1978)  i t i s p o s s i b l e t h a t i n d i v i d u a l s do.  (1972) shows that the body has enzymes which can d e t o x i f y some foreign  m a t e r i a l s . Orbach (1975) l i s t s three r e p a i r mechanisms  t h a t can reduce or remove the e f f e c t of DNa support  C o r n f i e l d (1977) who  t h r e s h o l d depends on  maintains  damage. These f a c t s  t h a t the e x i s t e n c e of a  whether or not d e t o x i f i c a t i o n and r e p a i r  mechanisms become s a t u r a t e d , a l e v e l which d i f f e r s from person to person. T h i s may contaminant may  imply  t h a t some s m a l l amount of t o x i c  be s a f e l y consumed by most people,  allowing  some l a t i t u d e f o r c o s t - b e n e f i t t r a d e - o f f s . , In summary, the Delaney c l a u s e appears t o be a myth, u n s u b s t a n t i v e Zeckhauser  in form, of the type  (1975) c o n f i r m i n g  postulated  the i d e a t h a t l i f e  comfortable by  cannot  be  traded o f f f o r other c o n s i d e r a t i o n s at any c o s t . T h i s may changing. Smith  (1979b, p. 1221)  be  r e p o r t s that a majority of  the  60  Institute  of Medicine and N a t i o n a l Academy o f Science  recommends t h a t " h e a l t h r i s k s of a hazardous food against  panel  be balanced  the economic b e n e f i t s to food s u p p l i e s and o t h e r s " .  Even the m i n o r i t y  d i s s e n t e r s tend  an i d e a l t o be s t r i v e d  to see i t more as a symbol of  f o r (Abramson, 1979) than as a r e a l i s t i c  p r i n c i p l e s i n c e i t was i n t r o d u c e d  when d e t e c t i o n o f minute  q u a n t i t i e s was not p o s s i b l e . Thus, as a s t a n d a r d - s e t t i n g it  provides  a symbolic  tool  i d e a l r a t h e r than a s c i e n t i f i c r e a l i t y .  However, i n t h a t sense, i t may serve as a guide f o r d e c i s i o n and  a r e s t r a i n t f o r hazardous a c t i o n s .  3.1.2 No Detectable The  next three  Adverse  Effect  standard  suggests have been l i n k e d  setting  together  guides t h a t Lowrance  f o r purposes o f a n a l y s i s on  the b a s i s o f t h e i r s i m i l a r i t y . They a r e : (1) no d e t e c t a b l e adverse e f f e c t ,  (2) t o x i c o l o g i c a l l y  i n s i g n i f i c a n t l e v e l , and  (3) the t h r e s h o l d p r i n c i p l e . These three guides admit some specific  l e v e l of a t o x i c substance but accept t h a t l e v e l as  benign..This c o n t r a s t s with the n o - r i s k approach o f the Delaney c l a u s e used as a benchmark., The applied  'no d e t e c t a b l e adverse e f f e c t ' approach i s l i b e r a l l y at present.„For example, the Onion of S o v i e t S o c i a l i s t  Republics  uses such a p r i n c i p l e i n s e t t i n g t h e i r maximum  permissible concentrations 1975  p. 32)  given a s :  (MPC)  (Roschin  and Timofeevaskaya,  f o r o c c u p a t i o n a l exposure. The d e f i n i t i o n of MPC i s  61  the c o n c e n t r a t i o n s which, with a workday of not more than 8 hours through the whole of the s e r v i c e r e c o r d , do not cause any d i s e a s e or have any other adverse e f f e c t s on the health s t a t u s of the workers t h a t c o u l d be detected by the modern methods of i n v e s t i g a t i o n e i t h e r d i r e c t l y i n the course of work or at l a t e r dates.  To i l l u s t r a t e some of the d i f f i c u l t i e s i n e s t a b l i s h i n g a l e v e l of no d e t e c t a b l e adverse e f f e c t i t i s noted t h a t there i s no consensus  on what the l e v e l i s . The  lower t h a t the OS t h r e s h o l d  S o v i e t HPC's are g e n e r a l l y  l i m i t v a l u e s (TLV) a p p l i e d t o the  same c h e m i c a l s , a major reason being t h a t most TLV's are weighted  mean c o n c e n t r a t i o n s r a t h e r than maximum s i n g l e  exposures  (Roschin and Timofeevskaya,  c o n s i d e r a t i o n i s the s e n s i t i v i t y  1975).Another  time  major  of those people t e s t e d .  N a t u r a l l y , i f those most s e n s i t i v e to the chemical are not t e s t e d , the p e r m i s s i b l e l e v e l w i l l be higher than i t would be otherwise, a l l o w i n g a s m a l l percentage of workers to s u f f e r adverse e f f e c t s . These p o i n t s show t h a t although the p r i n c i p l e may  be u s e f u l , i n o p e r a t i c n a l i z i n g i t ,  tested,  the type of exposure  f a c t o r s such as who i s  (average versus maximum s i n g l e  dose) and the s t a t e of development of the t e s t i n g technology employed can i n f l u e n c e the standard chosen.  62  3.1.3  Toxicologically Hany of the  Insignificant  criticisms  a p p l i c a b l e to the  principle  Levels  which apply to the of  above guide  •toxicologically  are  insignificant  l e v e l s ' , Lowrance comments t h a t t h i s approach i s sometimes taken with some types of food c h e m i c a l s . discretion  would be  Administrative  e x e r c i s e d i n s e t t i n g the  toxicologically  i n s i g n i f i c a n t l e v e l s . Chemicals s u b j e c t to t h i s might be:  those t h a t have e x i s t e d  regulation  commercially f o r an  adequate  p e r i o d of time without evidence of hazard; those about which little  i s known but  characteristics.  whose s t r u c t u r e has  Such an  approach c o n s i d e r s l a c k of negative  i n f o r m a t i o n as an i n d i c a t i o n the  certain  of a l a c k of negative e f f e c t s .  absence of knowlege about a mechanism of a c t i o n  c h e m i c a l t h i s assumption may c o u l d r e v o l v e around the expended on  for a  be dangerous. .Other c r i t i c i s m s  state  of the  technology, the  looking f o r t o x i c e f f e c t s , the  t o x i c e f f e c t s t o appear and  In  the  effort  time elapsed  arbitrariness  of the  for  standard  set.  3.1.4  The One  i s the As  Threshold of  the  Principle  most c o n t r o v e r s i a l  l a s t of t h i s group of  pointed "The  standard s e t t i n g  three, the  'threshold  techniques principle*.  t h r e s h o l d h y p o t h e s i s assumes t h a t there i s a  n o - e f f e c t dose of carcinogen below which i n d u c t i o n of cancer cannot occur or occurs with extremely low II,  1978,  p.  37).  As  pointed out  probability."  e a r l i e r and  reiterated  (Maugh by  63  Lowrance  (1976), the d e t e r m i n a t i o n  i n d i v i d u a l f o r c e r t a i n substances Kraybill  of a t h r e s h o l d f o r the seems p o s s i b l e . Indeed,  (1979) presents i n s t a n c e s where substances  present  n a t u r a l l y i n metabolic c y c l e s of the body become t o x i c at higher l e v e l s . However, because of the extreme v a r i a b i l i t y of a general  population  carcinogens  and  (Calabrese, 1978), t h r e s h o l d s f o r  other t o x i c chemicals  u s e f u l standard  setting  device.  I n f a c t , using standard the accepted  are not l i k e l y to be a  animal  method of • p r o v i n g  1  t e s t s , which are a t  c a r c i n o g e n c i t y , i t may  i m p o s s i b l e to r e s o l v e the t h r e s h o l d g u e s t i o n . The and  present be  experimental  human e r r o r i s too l a r g e to make such s t u d i e s u s e f u l f o r  d e f i n i n g the e x i s t e n c e or absence o f a t h r e s h o l d by  statistical  means (Maugh I I , 1978).  3.1.5  Standard The  of Osage  next standard  s e t t i n g technigue  •custom of usage'. T h i s technique  to be analyzed  i s of major importance to the  f l a v o u r i n d u s t r y ( S c h l e g e l , 1978). I t i s based on the t h a t i f a substance s a f e t y i s confirmed,  is  principle  i s consumed i n t r a d i t i o n a l food whose then an i d e n t i c a l s y n t h e t i c substance  can  be consumed s a f e l y i n other foods as long as i n g e s t i o n remains on the same order of magnitude. of food  (The FDA  reviewed the hundreds  a d d i t i v e s t h a t i t e s t a b l i s h e d as ' g e n e r a l l y recognized  as s a f e ' i n 1958 substances  but a s i d e from cyclamate had found  (Spiher, 1974)). There are two  no  toxic  main p o i n t s to be  64  made about t h i s approach. I t should be s u b j e c t t o p e r i o d i c review  (Lowrance, 1976) and although  no evidence  has yet come  to  l i g h t , there remains the p o t e n t i a l f o r a s y n t h e t i c chemical  to  be hazardous. T h i s may r e s u l t from a contaminant produced  d u r i n g the production process as occurred i n the manufacture of the f i r e  r e t a r d e n t t r i s - b p and i t s i m p u r i t y  chloropropane  1,2-dibromo-2-  a proven carcinogen i n r a t s and mice.  aldehyde f l a v o u r i n g was a l s o found  Strawberry  t o c o n t a i n an impurity  (suspected t o be the cause of p a r a l y s i s o f t h e hind limbs of rats)  (Butterworth,  1978).  3. 1.6 P r a c t i c a l C o n s t r a i n t s Next i n order o f i n c r e a s i n g acceptance  of r i s k trade-offs  i s Lowrance's guide: best a v a i l a b l e p r a c t i c e , h i g h e s t p r a c t i c a b l e p r o t e c t i o n and lowest p r a c t i c a b l e exposure. Here again t h e u t i l i t y  o f t h i s approach v a r i e s with the context o f  i t s use. In the context o f food where the aim i s t o reduce r i s k to  a minimal amount with l i t t l e  regard t o c o s t , i t s use has  s u b s t a n t i a l value. I t s adoption, however, must i n t e g r a t e with the enforcement technology and resources a v a i l a b l e s i n c e there is little  use i n promulgating  laws when i n f r a c t i o n s cannot be  d e t e c t e d . , (An exception t o t h i s may occur i f the o b j e c t i v e o f the d e c i s i o n maker i s t o decrease appearance o f a c t i o n without  p u b l i c pressure by the  a c t u a l l y attempting  t o change the  s i t u a t i o n . ) i t s main drawback i n t h i s i n s t a n c e i s that d e f i n i t i o n s of 'best' and ' p r a c t i c a b l e  1  are vague guides  f o r an  65  administrator  (Lowrance, 1976).  Such vagueness i n l e g i s l a t i o n t o i n t e r p r e t a t i o n . Burton and such  l e a v e s many q u e s t i o n s  Whyte (1978, p. 168)  list  open four  questions.  1. What f a c t o r s are to be i n c l u d e d i n the assessment? 2. .From whose p o i n t of view i s p r a c t i c a l i t y to be defined? 3. Who d e f i n e s what i s p r a c t i c a b l e ? 4. Does the 'best p r a c t i c a b l e means* i n c l u d e the extreme case of p r o h i b i t i o n of the cause i n order to reduce p o l l u t i o n t o zero?  Thus, t h i s approach p l a c e s the burden of i n t e r p r e t a t i o n on to the a d m i n i s t r a t o r  who  i s then f o r c e d t o make p o l i t i c a l  decisions..Companies d i s a g r e e i n g  with  the  r u l i n g may  go  to  the c o u r t s f o r c l a r i f i c a t i o n i s no other appeal system i s available.  3.1.7  Degree of N e c e s s i t y Be f l e c t i o n on  t h a t i n the context  of B e n e f i t  * degree of n e c e s s i t y of b e n e f i t ' r e v e a l s c f environmental p o l l u t i o n , e x p l i c i t  e v a l u a t i o n o f r i s k / b e n e f i t t r a d e - o f f s i s acknowledged. However, with  food, the connotation  o f e f f i c a c y i s added.  Environmental Mutagen S o c i e t y  (1970, p. 509)  The  states:  66  given a reasonable c a l c u l a t i o n of the g e n e t i c hazard posed by an environmental mutagen, i t then becomes necessary to c o n s i d e r how a c c e p t a b l e such a r i s k w i l l be to the population a t l a r g e . Guiding p r i n c i p l e i n a l l cases should be t h a t no r i s k whatsoever i s a c c e p t a b l e when the mutagenic compound p r e s e n t s no c l e a r b e n e f i t s , or when an a l t e r n a t i v e nonmutagenic compound i s a v a i l a b l e .  Lowrance  (1976) g i v e s an example of the a p p l i c a t i o n o f the  p r i n c i p l e r e l a t i v e to DDT. W i l l i a m Ruckelshaw o f the EPA reviewed the b e n e f i t s and c o s t s o f DDT and concluded that out  weighed b e n e f i t s with t h e e x i s t e n c e  of other  costs  "equally  e f f e c t i v e p e s t i c i d e s a v a i l a b l e " (Lowrance, 1976, p. 77) p l a y i n g a s i g n i f i c a n t r o l e i n the d e c i s i o n . With regard  to food, i n a d d i t i o n t o meeting the  requirements of s a f e t y , the a d d i t i v e must a l s o be e f f i c a c i o u s , l e s s t o x i c , improve supply o r n u t r i t i v e value,  or decrease  cost. T h i s c r i t e r i u m at l a s t o f f e r s the d e c i s i o n maker a sharp d e l i n e a t i o n of what i s a c c e p t a b l e and what i s n ' t . Onfortunately,  few chemicals a r e so o b l i g i n g as t o f a l l  within  t h i s narrow scope.  3.1.8 Reasonableness 'Reasonableness' i s c a l l e d by Lowrance (1976, p. 79) "the most commonly c i t e d and most unimpeachable p r i n c i p l e i n s a f e t y judgments". T h i s , with the l a s t of Lowrance's guides t o acceptability  'prevailing professional practice' i s  characterized  by s e r i o u s weakness. Lowrance p o i n t s out t h a t  67  reasonableness may  d i f f e r considerably  with the  point of view  of those d e c i d i n g .  What i s reasonable to i n d u s t r y may  not  be  reasonable to a community or a union. A l s o , such f a c t o r s as i g n o r a n c e , f a m i l i a r i t y , age  and  the  r i s k can i n f l u e n c e reasonableness Product S a f e t y ,  ( N a t i o n a l Commission  the on  1970). Thus, from the p o i n t of view of a  d e c i s i o n maker, t h i s guide has  3.1.9  necessity of taking  little  validity.  Prevailing Professional Practice The  p r e v a i l i n g p r o f e s s i o n a l p r a c t i c e guide s u f f e r s from  the l a c k of a r a t i o n a l b a s i s . Although i t i s i n growing unless the soundness of present  p r a c t i c e i s evaluated  j u s t i f i e d , such acceptance of c o n v e n t i o n a l guestionable  use,  and  wisdom i s  (Lowrance, 1976). In f a c t a tendency may  e x i s t to  r e s t r a i n from upgrading standards i f excess r e l i a n c e i s placed on t h i s  approach s i n c e the support t r a d i t i o n a l l y provided  by  employing a common p r a c t i c e i s l o s t i f i n n o v a t i v e methods are introduced.  I t s main appeal seems t o be i n the sense of  t h a t e s t a b l i s h e d procedures b r i n g about. T h i s may  be  as  important as e f f i c i e n c y t c a d e c i s i o n maker. Zeckhauser a s s e r t s that i t i s sometimes as important how as what you  do.  that can be  j u s t i f i e d and e x p l a i n e d  efficient obvious  Decision  you  do  process  (1975)  something  makers sometimes p r e f e r a procedure r a t h e r than a more  but e s o t e r i c approach whose methodology i s not  ( S l o v i c e t a l . , 1975).  68  3.2  MODIFIERS OF STANDARD SETTING APPROACHES The former standard s e t t i n g techniques r e p r e s e n t some of  the major approaches that have been used. D e c i s i o n s about a c c e p t a b l e l e v e l s may  be made on the b a s i s of these methods  alone but u s u a l l y the choice of a technique and  the f i n a l  d e t e r m i n a t i o n of the l e v e l i s modified by what Lowrance p. 86)  {1976,  terras "an array of c o n s i d e r a t i o n s " . These represent i n  p a r t a m a n i f e s t a t i o n of people's p e r c e p t i o n of r i s k which v a r i e s with the attendant circumstances and i n p a r t a measure o f the extent and  p r o b a b i l i t y of the consequences of a  p o t e n t i a l hazard. Although these f a c t o r s are known to  modify  the standard s e t t i n g techniques the amount o f t h e i r e f f e c t  and  t h e i r d i r e c t i o n i s sometimes u n c e r t a i n . For example, the p r o b a b i l i t y of an event,  perhaps a d i s a s t e r , i s o f t e n judged  a c c o r d i n g to our a b i l i t y  to r e c a l l a s i m i l a r event. However,  Newell  and Simon  (1972) p o i n t out t h a t our a b i l i t y t o  a s s i m i l a t e c o n c e p t u a l data i s l i m i t e d by the extent of our s h o r t term laid  memory and the speed a t which long term memory i s  down. Thus, when judging an improbable  event we  may  o v e r e s t i m a t e the p r o b a b i l i t y of i t s occurrence because the news media has r e c e n t l y brought  i t to our a t t e n t i o n . S l o v i c e t a l .  (1975) l a b e l s t h i s a v a i l a b i l i t y b i a s . I s sometimes r e v e r s e d , perhaps because of c u l t u r a l b i a s . A study comparing A u s t r i a n p e r c e p t i o n with Canadian p e r c e p t i o n of r i s k showed t h a t the A u s t r i a n s tended  t o i n c r e a s e t h e i r p e r c e p t i o n of p r o b a b i l i t y of  events they could not remember while Canadians decreased p e r c e p t i o n of p r o b a b i l i t y as memory of the experience  their  faded  69  (Otway and Pahner, 1876).  3.2.1  Voluntary The  Versus I n v o l u n t a r y  Risk  f i r s t consideration introduced  by Lowrance i s the  concept of i n v o l u n t a r y or v o l u n t a r y r i s k . S t a r r  (1969,  1972)  a s s e r t s t h a t r i s k assumed v o l u n t a r i l y i s deemed more a c c e p t a b l e than r i s k assumed i n v o l u n t a r i l y . participation  He g i v e s the example of p u b l i c  i n h i g h l y hazardous s p o r t s and  pastimes  c o n t r a s t i n g with p u b l i c r e s i s t a n c e to the n u c l e a r hazards which are c a l c u l a t e d to be l e s s r i s k y . The  concept of voluntary and  i n v o l u n t a r y r i s k i s more  complex than i s f i r s t apparent, Rowe (1977) r e c o g n i z e s a t l e a s t three important distribution,  elements: "(a) e q u i t y of r i s k and b e n e f i t (b) the a v o i d a b i l i t y of r i s k and  a l t e r n a t i v e s and risk taker"  (c) the  availability  manner n which r i s k i s imposed on  of the  (p. 119). In examining the e q u i t a b l e n e s s of r i s k  contends t h a t f o r a r i s k to be v o l u n t a r y the r e c i p i e n t of both r i s k and  he  the r i s k t a k e r must be  b e n e f i t . I f exposure to r i s k  b r i n g s no concomitant b e n e f i t , a l l o w i n g only the a l t e r n a t i v e of f l i g h t to avoid or reduce r i s k , then i t i s n e i t h e r e q u i t a b l e nor to  v o l u n t a r y . In a d d i t i o n , the extent  of knowledge a v a i l a b l e  the r i s k taker m o d i f i e s the s i t u a t i o n . I f a person at  risk  does not have s u f f i c i e n t i n f o r m a t i o n about the amount of  risk  exposure, then even i f b e n e f i t i s r e c e i v e d , the r i s k i s i n e q u i t a b l e and  i n v o l u n t a r y s i n c e no means to balance  b e n e f i t e x i s t s . The  l a c k of i n f o r m a t i o n may  risk  r e s u l t from  and  70  deliberate  w i t h h o l d i n g by an informed  (possibly  exploitative  party) or lack of i n t e r e s t i n a v a i l a b l e i n f o r m a t i o n on the part of the r i s k t a k e r .  Howe, i n e x p l a i n i n g  the s i g n i f i c a n c e o f the  manner i n which r i s k i s imposed, d i f f e r e n t i a t e s between imposed r i s k and e x t e r n a l l y inequitable  imposed r i s k . In some cases  r i s k can be self-imposed such a s the case o f a  person who r i s k s i n j u r y t o save a l i f e . can  a r i s e by f i a t  natural  self-  causes  Externally  imposed r i s k  (e.g. compulsory m i l i t a r y s e r v i c e ) , by  (e.g. earthquakes) or other c a u s e s . The l a s t  element posed by Howe and by Lowrance (1976) i s the a v a i l a b i l i t y of a l t e r n a t i v e s and the avoidance o f r i s k . In determining i f a r i s k i s v o l u n t a r y the presence o f v i a b l e alternatives  iscritical.  In addition  t o f l i g h t from r i s k ,  alternatives  with l e s s r i s k even a t higher c o s t  must be  available. Thus, a l l these f a c t o r s a c t to c h a r a c t e r i z e involuntary  r i s k . Howe c o n t e n t s t h a t  voluntary and  when a r i s k t a k e r i s  informed and a l t e r n a t i v e s e x i s t , r i s k , whether self-imposed or eguitable  and endogenously imposed i s v o l u n t a r y .  3.2.2 Temporal D i s t r i b u t i o n o f Bisk The  second c o n s i d e r a t i o n  i n t r o d u c e d by Lowrance i s the  temporal d i s t r i b u t i o n of r i s k . F i s c h h o f f that  et a l .  (1978) found  p e r c e p t i o n o f r i s k seemed l e s s when, among other f a c t o r s ,  consequences were immediate. This c o n t r a s t s of Howe  with the f i n d i n g s  (1977) who takes the view t h a t r i s k i s d i s c o u n t e d  over  71  time. That i s , the f u r t h e r away i n time the consequences are the g r e a t e r i s the discount e f f e c t .  An i l l u s t r a t i o n i s young  people's  penchant f o r smoking, knowing t h a t the  w i l l not  be manifest f o r many years. The  consequences  discrepancy  may  be at  l e a s t p a r t i a l l y e x p l a i n e d by the b u i l d i n g of a n x i e t y about consequences once a r i s k i s taken. Zeckhauser that a n x i e t y p l a y s a l a r g e p a r t i n r i s k the time between exposure and  the  (1975) s p e c u l a t e s  p e r c e p t i o n . The  longer  consequences the g r e a t e r the  anxiety can become. However, the l a r g e amount of apparent d i s c o u n t i n g behavior needs f u r t h e r examination  and  clarification.  3.2.3  The  C e r t a i n t y cf Bisk  The next c o n s i d e r a t i o n i n v o l v e s the extent  of our  knowledge about the c e r t a i n t y of r i s k . An example of t h i s i s the i n c r e a s e d p e r c e p t i o n the p u b l i c has e.g.  of new  technologies  nuclear e l e c t r i c p l a n t s versus b i c y c l e s , o l d r i s k s  o f t e n p e r c e i v e d as l e s s than the new  r i s k may  found f a m i l i a r i t y  u n f a m i l i a r new  are  ones even though  be s t a t i s t i c a l l y l e s s . F i s c h h o f f et a l . (1978) with the r i s k t o be one of the major f a c t o r s  i n f l u e n c i n g p e r c e p t i o n of  risk.  72  3.2.4  N e c e s s i t y of Exposure hn adaptive coping mechanism may  operate i n c o n j u n c t i o n  with t h i s next c o n s i d e r a t i o n , n e c e s s i t y of exposure. Otway and Pahner  (1976) p o i n t out that the p u b l i c o f t e n e x h i b i t s  d i c h o t o m i z a t i o n i n i t s behavior when e x c e s s i v e r i s k i s p e r c e i v e d . One  a c t i o n i s to withdraw and  ignore the t h r e a t . The  other i s to form i n t e r e s t groups g e n e r a l l y with the i n t e n t removing the source of the r i s k .  Withdrawal behavior may  of  be  a p p r o p r i a t e when r i s k i n unavoidable., Bowe (1977) supports  this  c o n t e n t i o n with o b s e r v a t i o n s of man's a b i l i t y t o r a t i o n a l i z e when confronted  with the i n e s c a p a b l e consequences of war  and  t e r m i n a l d i s e a s e . The p e r c e p t i o n of consequences i s reduced a manageable s i z e through  3.2.5  o c c u p a t i o n a l and The  divergence  exposure to hazard  to  the coping mechanism.  Bon-Occupational  Bisk  between o c c u p a t i o n a l and  non-occupational  has been j u s t i f i e d on the grounds t h a t the  e x t r a r i s k i s paid f o r (Lowrance, 1976) . .Indeed, many workers i n c u r r i n g high r i s k s are paid l a r g e amounts e.g... • h i g h - s t e e l ' workers on the s t e e l frame of s k y s c r a p e r s or d a r e d e v i l performers  performing improbable  f e a t s . U n f o r t u n a t e l y , the  economics of the work place o f t e n encourage poorer workers t o accept high r i s k f o r low pay.  Economic theory suggests t h a t the  r i s k r e j e c t e d by the r i c h i s accepted marginal u t i l i t y  by the poor because t h e i r  f o r the b e n e f i t i s much h i g h e r . E m p i r i c a l  s t u d i e s show t h a t the job r i s k a worker w i l l accept i s  73  n e g a t i v e l y r e l a t e d t o wealth and supports i n c r e a s e d pay f o r i n c r e a s e d r i s k The and  (Viscusi,  the concept of 1978).  OSSB s t a t e s t h e i r i n t e n t i o n to e q u a l i z e  occupational  common p u b l i c exposure (Roschin and Timofeevkaya, 1975)  even with t h e best o f i n t e n t i o n s , the extent  but  and complexity o f  o c c u p a t i o n a l environments combined with t r a d i t i o n a l a t t i t u d e s means t h a t attainment foreseeable  of such a g o a l i s improbable i n the  future.  3.2.6 Common Versus Dread B i s k When the comparison between common and dread hazards are considered  t h e i n f l u e n c e of p e r c e p t i o n becomes o f major  importance. News media b u i l d - u p o f p a r t i c u l a r l y a c c i d e n t s or f e a r e d diseases  terrible  l i k e cancer can cause resources to  be expended out. of p r o p o r t i o n t o i t s a c t u a l b e n e f i t t o s o c i e t y . As Lowrance  (1976) observes,  this inefficiency  means that  hazards more e f f i c i e n t l y reduced go unattended r e s u l t i n g i n an overall  r i s k that i s unnecessarily high.  d i s e a s e s take more l i v e s than cancer Health  Statistics  Cardiovascular  (National Center f o r  (US), 1S79). But cancer  i s o f t e n p e r c e i v e d as  being t h e more hazardous and t h e r e f o r e r e c e i v e s more a t t e n t i o n . The  p e r c e p t i o n of dread hazards as having  s e r i o u s l y skew our approach t o r i s k  g r e a t e r r i s k can  management.  74  3.2.7  Varying The  S u s c e p t i b i l i t y to  sensitivity  particularly  of the  Bisks  persons a f f e c t e d i s a f a c t o r  important when c o n s i d e r i n g  agents. As pointed  out p r e v i o u s l y and  supported by Lowrance  (1976), the v a r i a b i l i t y of a p o p u l a t i o n impossible  standards f o r t o x i c  makes i t v i r t u a l l y  to p r o t e c t everyone. C a l a b r e s e  s e n s i t i v i t y i s modified  (1978) s t a t e s  by e x o t i c f a c t o r s l i k e blood  (e.g. .Methemoglobinemia), h o m e o s t a t i c - r e g u l a t o r y (e. g. C y s t i n u r i a ) f a c t o r s as age,  3.2.8  and  magnesium d e f i c i e n c y , and  sex and  disorders  disorders by such common  living habits. .  Chemical Propensity Other c o n s i d e r a t i o n s  f o r Misuse such as the propensity  the r e v e r s i b i l i t y of the consequences can acceptable  that  s t a n d a r d . Some of the  include  the amount of e x t r a  f o r the  few  f o r misuse  and  help t o a r r i v e at  points discussed  an  by Lowrance  p r o t e c t i o n that must be  built-in  t h a t might misuse a product compared t o the  cost  imposed on the r e s t cf s o c i e t y . Flame-retardants i n f a b r i c s , f o r example, may  p r o t e c t people smoking i n t h e i r  at the expense of e x p l o i t i n g o t h e r s ' Blum and  l i f e threatening  retardants who  s e n s i t i v i t y t o cancer.  f o r c e s must be balanced. Must flame  expcse others  go?  in  to mice. Here i s a s i t u a t i o n i n which  to the r i s k of cancer t o p r o t e c t those  choose to abuse f i r e i n t h e i r homes? How  trade-off  fire  Ames (1977) have shown that a major f i r e r e t a r d a n t  f a b r i c i s carcinogenic two  beds from  f a r should  such a  75  3.2.9  R e v e r s i b i l i t y of E f f e c t s In examining  the p o t e n t i a l hazard  from a chemical,  the  r e v e r s i b i l i t y of i t s e f f e c t s and i t s p e r s i s t e n c e are of major i n t e r e s t . To i l l u s t r a t e a worst case, suppose a chemical u t i l i z e d i n l a r g e q u a n t i t i e s i n a way throughout  that allowed d i s p e r s i o n  the environment. I f the chemical were found  cause i r r e v e r s i b l e e f f e c t s , e.g. cancer, and double  was  l a t e r to  persistent, a  bind would e x i s t . Such a chemical would not only cause  i r r e p a r a b l e harm by  would be a c t i v e l y  present f o r g e n e r a t i o n s  a f t e r i t s use has been d i s c o n t i n u e d . Such a s i t u a t i o n f e a r e d with DDT  was  (Lowrance, 1976). Because of i t s great  p e r s i s t e n c e t h i s u b i q u i t o u s chemical was on the b a s i s of merely  serverely restricted  suspected d e l e t e r i o u s long term  D e c i s i o n makers f e l t t h a t the consequences would c a t a s t r o p h i c i f DDT  caused t o x i c e f f e c t s and  effects.  be  judged the  too g r e a t i n l i g h t of the a v a i l a b i l i t y of s u i t a b l e  risk  substitutes.  On the other hand, a s i t u a t i o n i n which a widely used was  was  chemical  t r a n s i e n t i n nature would l i k e l y l e a v e d e c i s i o n makers more  amenable to c o n t r o l l e d use. In t h i s case i t i s c l e a r t h a t i f post market monitoring r e v e a l e d c h r o n i c e f f e c t s , removal o f the chemical from the market would c o n s t i t u t e e f f e c t i v e c o n t r o l not p o s s i b l e i n the case of a p e r s i s t e n t  immediate  chemical.  Thus, t h e t h r e a t of i r r e v e r s i b l e damage perpetuated by a p e r s i s t e n t c h e m i c a l must be c o n s i d e r e d . a second  view of r e v e r s i b i l i t y c o n s i d e r s acute e f f e c t s .  In  t h i s case r e v e r s i b i l i t y can be e f f e c t i v e l y coupled with the p o t e n t i a l f o r misuse. An agent which may  cause an ailment which  76  i s p a s s i n g or t r e a t a b l e may be marketed with l e s s  stringent  standards and with g r e a t e r p o t e n t i a l f o r misuse than an agent causing permanent harm,  3.3 CONCLUSIONS A l l of these c o n s i d e r a t i o n s and others such as people's cognizance o f a hazard and the f a m i l i a r i t y o f t h e technology of a hazard, have a sense o f s c a l e i n them. At one end of the s c a l e a hazard i s unacceptable but, at the o t h e r , i t i s l i k e l y t o be accepted. D e c i s i o n makers t r y t o assess the point on the s c a l e a t which a hazard i s p e r c e i v e d as a c c e p t a b l e . T h i s p o i n t o f t e n has l i t t l e  connection with the a c t u a l r i s k o f any given  hazard because of the i n f l u e n c e of a v a r i e t y of p s y c h o l o g i c a l and p h y s i o l o g i c a l c o n s t r a i n t s which d i s t o r t p e r c e p t i o n . Methodology t o e s t a b l i s h the p o i n t of acceptance being r e s e a r c h e d . Two o f the approaches h i s t o r i c a l behavior preferences  i s currently  used are d e r i v e d from  ( S t a r r , 1969) and from a survey of present  ( S l c v i c e t a l . , 1S75).  Other i n f l u e n c i n g f a c t o r s can e x i s t . To i l l u s t r a t e , the e v o l u t i o n c f the US P u b l i c Health S e r v i c e water standards be examined. Borchard and Walton  will  (1971) point o u t that the  composition of the a d v i s o r y body a f f e c t s the s u b s t a n t i v e nature of the recommendation. P e r s o n a l l i m i t a t i o n s and views of the p a r t i c i p a n t s o f t e n d i c t a t e t h e outcome o f a meeting.  Borchard  and Walton  committees  (1971, p. 17) comment on one of t h e f i r s t  to s e t water g u a l i t y  standards.  77  I t i s a l s o e v i d e n t that the recommended and accepted standards were l i m i t e d t c the b a c t e r i o l o g i c a l q u a l i t y only because the commissioners had been unable t o agree on s p e c i f i c p h y s i c a l and chemical requirements.  & second  factor influencing  what standards a r e s e t and a t what  l e v e l , i s the simple f a c t of awareness o f a hazard. For example, standards f o r lead were s e t very e a r l y  while o t h e r s  were i n c l u d e d l a t e r as s c i e n t i s t s became cognizant of a new t h r e a t and gathered enough i n f o r m a t i o n t o i n i t i a t e a c t i o n . T h i s awareness of r i s k i s t i e d d i r e c t l y t o technology. Technology  i s important i n two r e s p e c t s . . F i r s t , the  technology f o r reproduceable and s e n s i t i v e t e s t i n g must be a v a i l a b l e . I f the standard i s more r i g o r o u s than can be reliably  t e s t e d by c u r r e n t technigues then the standard i s  u s e l e s s . Second, i n some cases, water i n p a r t i c u l a r , the necessary technology t o meet s t r i n g e n t standards was simply not a v a i l a b l e . Here a g a i n i t was not p r a c t i c a b l e to s e t standards at a lower l e v e l than c o u l d be met by the i n d u s t r y s i n c e the water was needed. The answer was to t o l e t standards become p r o g e s s i v e l y more s t r i n g e n t as technology was developed  and the  i n d u s t r y became more s o p h i s t i c a t e d . Such a s t r a t e g y i s s t i l l being implemented with time l i m i t s being imposed to encourage the use of the best a v a i l a b l e technology  (Environment  Beporter,  1978). a t h i r d i n f l u e n c e i s the l o g i s t i c s of t e s t i n g . I t may not be p o s s i b l e t o t e s t f o r every p o t e n t i a l contaminant.  Borchard  and Walton p o i n t out that when b a c t e r i a l l e v e l s i n water were being developed i t was not f e a s i b l e t c t e s t f o r the presence of  78  every organism. The s t r a t e g y f i n a l l y adopted was t o use the presence o f the most numerous, robust I f these organisms were not detected  organism as an i n d i c a t o r . i t was assumed that the  other more v i r u l e n t but l a b i l e organisms were a l s o absent. Such a s t r a t e g y may work f o r chemicals a l s o i f a production always produces a c e r t a i n group o f chemicals together  process so t h a t a  r e l i a b l e i n d i c a t o r e x i s t s . I n any case, with the multitude o f d i f f e r e n t chemicals present  i n water, i t i s not p o s s i b l e t o  t e s t f o r a l l of them t h a t may be harmful. F i n a l l y , r e a c t i o n s t o a standard  must be c o n s i d e r e d . The  r e a c t i o n of the p u b l i c and the i n d u s t r y are important. r e a c t i o n to r e g u l a t i o n s intended increase  Public  to p r o t e c t i t may, i n f a c t ,  the r i s k t o which they a r e exposed. The c o n s t r u c t i o n  of dams t o c o n t r o l f l o o d waters i s an example o f such an occurrence. Since t h e dam was perceived  by i n h a b i t a n t s o f t h e  f l o o d p l a i n t o c o n t r o l the water and reduce r i s k , and  develpment on the f l o o d p l a i n i n c r e a s e d .  f l o o d , beyond the c a p a c i t y o f the dam occurs, and  property  population  When a major the l o s s o f l i f e  w i l l be l a r g e r than the p o t e n t i a l l o s s before the  c o n s t r u c t i o n of the dam ( S l o v i c e t a l . , 1975). I f an i n c r e a s e d sense o f s a f e t y l e a d s t o i n c r e a s e d a hazardous product, a standard  p u b l i c use or consumption of  may c o s t more than i t b e n e f i t s  society. Industry  a c t i o n s can a l s o negate the purpose of a  standard. Eorchard and Walton f a c t o r s considered was  (1971) p o i n t out that one of the  i n the s e t t i n g o f water g u a l i t y standards  i n d u s t r y ' s r e a c t i o n t o i t . The f e a r was t h a t a standard  limiting  p o l l u t i o n t o amounts below a c e r t a i n l e v e l would cause  79  i n d u s t r y t o j u s t meet the maximum l e v e l allowed, e f f o r t s t o reduce contamination experience  slowing  below t h a t l e v e l . Present day  shews that t h i s sometimes occurs. L a r g e r , more  e s t a b l i s h e d f i r m s with, perhaps, t h e i r r e p u t a t i o n s i n mind, tend to meet and exceed minimal requirements standards  so that company  may be more r i g o r o u s than government  requirements  (John Wessel, FDA, 1979). However, s m a l l e r f i r m s , with a more tenuous e x i s t e n c e , have l e s s to l o s e and may tend t o j u s t meet government  standards.  Many f a c t o r s , c o n s i d e r a t i o n s and methods impinge on standard s e t t i n g d e c i s i o n s . These i n c l u d e : t h e people  setting  the standards as w e l l as the b e n e f i c i a r i e s , the technology f o r d e t e c t i n g t r a n s g r e s s i o n s of standards and the technology f o r complying  t o them, and the many moral and p h i l o s o p h i c a l  approaches t o e s t a b l i s h i n g an o p e r a t i n g p r i n c i p l e . Some p r o v i d e more guidance  than others but most serve simply  to increase  awareness of the r a m i f i c a t i o n s of any p a r t i c u l a r d e c i s i o n made. Few of the approaches and m o d i f i e r s are d e f i n i t e a d m i n i s t r a t i v e a i d s to the c o n t r o l of t o x i c c h e m i c a l s . Modern a n a l y t i c a l methods have c h a l l e n g e d the e f f e c t i v e n e s s of the Delaney p r i n c i p l e and turned i t i n t o only a u s e f u l myth. The v a l i d i t y of other approaches such as 'no d e t e c t a b l e  adverse  e f f e c t ' and ' t o x i c o l o g i c a l l y i n s i g n i f i c a n t l e v e l s ' , which depend on technology,  are being c h a l l e n g e d as w e l l . Often, what  i s a c c e p t a b l e i n one country i s not a c c e p t a b l e i n another. In f a c t , with the e x c e p t i o n of 'degree o f n e c e s s i t y o f b e n e f i t ' and perhaps, • r e v e r s i b i l i t y o f e f f e c t s ' , which provide  fairly  o b j e c t i v e g u i d e l i n e s , a l l o f the approaches and m o d i f i e r s r e l y  80  on  judgment. If  •judgment' i s the only  u s e f u l method to combine  s c i e n t i f i c knowledge of chemical hazard with p u b l i c o p i n i o n s of t o l e r a b l e l e v e l s of hazard, s t r a t e g i e s t o ensure an a c c e p t a b l e judgment should be implemented. A r a t i o n a l approach could  utilize risk/benefit  methodology. The end r e s u l t could r i s k and i n c r e a s e d  benefits.  be the r e d u c t i o n  of o v e r a l l  U n f o r t u n a t e l y , the methodology  necessary t o apply r i s k / b e n e f i t a n a l y s i s t o q u e s t i o n s i n v o l v i n g human m o r b i d i t y and m o r t a l i t y  i s not f u l l y developed.  Public  m i s p e r c e p t i o n s caused by f a c t o r s such as temporal d i s t r i b u t i o n , c e r t a i n t y , and dreadness of r i s k make i t d i f f i c u l t t o d e f i n e the elements of r i s k / b e n e f i t a n a l y s i s . For example, what discount  rate  would make a death i n the f u t u r e equal to a death  a t present? Should a l i n g e r i n g death by cancer have the same value a s a sudden f a t a l a c c i d e n t ? These d e f i c i e n c i e s prevent a t o t a l a p p l i c a t i o n of t h i s method o f a n a l y s i s but r i s k / b e n e f i t a n a l y s i s may s t i l l be used as a guide to a i d r a t i o n l  decision  making. A second approach to standard s e t t i n g emphasises the need f o r a p r o c e s s t o a s s i s t the judgment procedure./The  objective  of the process would be the accumulation of as much of the relevant  information  as p o s s i b l e  as an a i d t o r a t i o n a l i z i n g  decisions.  An important c o n s i d e r a t i o n  regulation  versus the b e n e f i t s . A f u l l  here i s the c o s t of study may not be  p o s s i b l e , however, even a p a r t i a l examination o f the c o s t s and b e n e f i t s of v a r i o u s  methods of c o n t r o l may be h e l p f u l i n  choosing the best a v a i l a b l e approach. Submissions from  81  i n d u s t r y , from the sought. The  p u b l i c and  from government agencies would  accumulation of i n f o r m a t i o n  would ensure at l e a s t  t h a t d e c i s i o n makers were exposed t o r e l e v a n t data. independent body, acceptable  be  to the three  An  p a r t i c i p a t i n g sectors  could review appeals where p a r t i c i a n t s were not  satisfied  with  an o r i g i n a l d e c i s i o n . The  success of such a process would depend on  a v a i l a b i l i t y of i n f o r m a t i o n already  e x i s t t o present  to the  participants.„Organizations  i n d u s t r y ' s p o i n t of view  Canadian Chemical P r o d u c e r s  1  the  A s s o c i a t i o n and  The  (e.g.  The  Manufacturers'  of Chemical S p e c i a l t i e s A s s o c i a t i o n ) . Such a s s o c i a t i o n s have access t o i n d u s t r y ' s i n f o r m a t i o n case. The  and  the resources  to argue a  p u b l i c , having more d i f f u s e i n t e r e s t s , has  difficulty information  i n assembling the resources or to present  a case. The  more  necessary to gather success of  this  c o n s u l t a t i v e process t h e r e f o r e , would r e q u i r e government a s s i s t a n c e . Both i n f o r m a t i o n reguired.  and  f i n a n c i a l help  may  be  82  4. INFORMATION SYSTEMS  4.1  INFOBMATION SYSTEMS  4.1.1  Necessity The  foregoing a n a l y s i s i n d i c a t e s that d e c i s i o n s  the r e g u l a t i o n of t o x i c chemicals  r e q u i r e s access  concerning  to a  s t r u c t u r e d and e f f i c i e n t data base. Economical i n f o r m a t i o n development and access information The  r e q u i r e s the c r e a t i o n of an  system. ,  problem f a c i n g chemical  i n f o r m a t i o n systems i s o f t e n  not a l a c k o f i n f o r m a t i o n but r a t h e r a l a c k of the i n f o r m a t i o n . Burton and  right  Whyte (1979) p o i n t out t h a t we  being overwhelmed by data and of choosing  appropriate  are  t h a t what i s needed i s a method  pertinent information  from the g l u t of i r r e l e v a n t  data. The  word " i n f o r m a t i o n " i s used r a t h e r l o o s e l y as a synonym  f o r data. However, s t r i c t l y u n t i l a user has l o c a t e d and  speaking,  data are not  information  a s s i m i l a t e d them. In many c a s e s ,  p o t e n t i a l users are not even aware of the e x i s t e n c e of  data.  Adams (1978) p o i n t s out that not only are p o t e n t i a l users aware o f the data  not  'universe* of data but they cannot l o c a t e s p e c i f i c  w i t h i n the  'universe'.  I t seems t h i s i s not only a contempory problem. F i f t y - t w o years ago  s c i e n t i s t s were lamenting  the lack of an  efficient  83  data system as t h i s quote from, December 15, 1928 ( J o u r n a l of Information S c i e n c e ,  1978,  p.  illustrates  3).  The p r e c i s e extent t o which r e s e a r c h workers are wasting energy r e p e a t i n g experiments t h a t have already been made i s d i f f i c u l t t o estimate; but those who have given much a t t e n t i o n to the study of the l i t e r a t u r e o f t h e i r s p e c i a l s u b j e c t s are aware that the p r o p o r t i o n of labour which i s wasted f o r l a c k of i n f o r m a t i o n on previous work i s very high. ... perhaps i t i s l e s s w e l l p e r c e i v e d t h a t the same p r o p o r t i o n of u s e f u l work i s p u b l i s h e d o n l y t o be b u r i e d out of s i g h t . . . . a t t e n t i o n should be concentrated on the i n d e x i n g of recorded i n f o r m a t i o n so t h a t hard won data may be found a t need and p l a y t h e i r p a r t as a basis f o r further progress.  It  i s obvious  are expensive  that d u p l i c a t i o n and  i n a c c e s s a b i l i t y of data  i n terms of time, money and l o s t o p p o r t u n i t y .  The  e x i s t i n g multitude of data s o u r c e s have many f a u l t s which c o n t r i b u t e t o t h a t e x c e s s i v e expense. Data are o f t e n s t o r e d i n i n f o r m a t i o n systems which are incompatible i n t h e i r methodology. A l s o , d i f f e r e n t systems were b u i l t  access  to meet  d i f f e r e n t needs. T h e r e f o r e , no common nomenclature i s used. Chemicals  are s t o r e d under d i f f e r e n t names and,  indeed, i n  completely d i f f e r e n t ways. For example, c h e m i c a l s may  be s t o r e d  a c c o r d i n g t o chemical s t r u c t u r e i n c o n t r a s t t o storage by commercial or common name (TSSC, 1979). T h i s heterogeneity makes e f f i c i e n t data exchange very There are important  difficult.  s o c i a l consequences of  inefficient  data systems as w e l l . For example, i t i s u s u a l i n Canada f o r the Department of N a t i o n a l Health and p h y s i c i a n s t o food and drug to  Welfare t o a l e r t  problems. T h i s has not c a r r i e d  the d i s s e m i n a t i o n of i n f o r m a t i o n about carcinomas  of  over  84  chemical  origin  r e c e n t data cancer,  (Science C o u n c i l of Canada, 1977) i n t h i s  l i n k e d v i n y l c h l o r i d e to a s p e c i f i c  case,  type of l i v e r  yet the Department o f N a t i o n a l H e a l t h and Welfare  f a i l e d to alert  p a t h o l o g i s t s t o these  f i n d i n g s . Given t h i s  i n f o r m a t i o n , i t i s p o s s i b l e t h a t much could have been done t o reduce the v i n y l c h o r i d e hazard Information such hazards.  t o Canadians.  d i s s e m i n a t i o n i s an important  t o o l to combat  The l a t e n t and s u b t l e e f f e c t s o f some  chemicals  r e q u i r e s a comprehensive data base as one of the few e f f e c t i v e means o f d e t e c t i n g and d i s t r i b u t i n g i n f o r m a t i o n hazards as v i n y l c h l o r i d e . Data from medical  t o c o n t r o l such  research,  workers  compensation, o c c u p a t i o n a l s e t t i n g s and v a r i o u s a p p l i c a b l e p r o v i n c i a l agencies  must be known to e x i s t and be a c c e s s i b l e t o  other r e l e v a n t users i f i t i s t o be e x p l o i t e d t o i t s p o t e n t i a l . A p r o p e r l y programmed and e f f i c i e n t data system could be an important  and s i g n i f i c a n t s t e p toward such a g o a l .  E f f i c i e n t chemical  data  systems can o f f e r many advantages  to government and p r i v a t e s e c t o r s . Seduced d u p l i c a t i o n o f r e s e a r c h and data r e p o r t i n g save time and money. Not only i s i n f o r m a t i o n a v a i l a b l e f a s t e r , but i n some cases,  uncertainty  can  be reduced and new ideas s t i m u l a t e d by the new combinations  and  a s s o c i a t i o n s p o s s i b l e through computer use (TSSC,  Information  1979).  systems could do f o r s c i e n t i s t s and r e g u l a t o r s what  the P o l a r o i d camera system d i d f o r photographers. I t c o u l d decrease the time spent  on r e s e a r c h and allow e f f o r t and  c r e a t i v i t y t o focus on s y n t h e s i z i n g and developing  innovative  ideas. I n t e r n a t i o n a l c o o p e r a t i o n can improve  information  85  d i s s e m i n a t i o n and hazard utilization  d e t e c t i o n by i n c r e a s i n g the  of present i n f o r m a t i o n . Dse  of computers to search  and c r o s s - r e f e r e n c e the expanded data base should to  p r i v a t e and  p u b l i c agencies both n a t i o n a l l y  prove u s e f u l  and  internationally. V a r i o u s methods of chemical retrieval  data c o m p i l a t i o n , storage  have been t r i e d . These systems, r a n g i n g from standard  manual methods to s o p h i s t i c a t e d computer models  (some even able  t o t r a n s l a t e data from f o r e i g n languages (Dubois, designed  and  1979)) are  t o minimize c e r t a i n problems and maximize c e r t a i n  advantages t o a p a r t i c u l a r user. Depending on the user's needs, parameters such as access methods, c o s t , speed of  retrieval,  type of i n f o r m a t i o n and system c a p a c i t y can be a d j u s t e d . Three example models i n v a r i o u s s t a g e s of development w i l l o u t l i n e d and t h e i r common and illustrate  4.1.2  be  unique problems d i s c u s s e d t o  the present s t a t e of the i n f o r m a t i o n systems f i e l d .  Systems Models Port  (1978) o u t l i n e s t h r e e i n f o r m a t i o n systems as  examples, d e s c r i b i n g methods of a c c e s s , c a p a c i t y , p o t e n t i a l users and  information  handled.  86  Nationa1 The  n a t i o n a l system has the acronym DESCNET s t a n d i n g f o r  Network Of Data On Environmentally S i g n i f i c a n t chemicals. I t was  originally  designed by t h e Department of the Environment of  the O K to provide the government and others with i n f o r m a t i o n on c h e m i c a l s . The  s t r u c t u r e resembles  a s p i d e r ' s web  i n that i t i s  organized as a network around a c e n t r e . The p e r i p h e r a l nodes s t o r e data on chemicals i n a common format t o f a c i l i t a t e i n f o r m a t i o n exchange with each other and with other i n f o r m a t i o n systems. The c e n t r e would a c t as a reference f o r sources g u e s t i o n s . A p i l o t p r o j e c t has been i n i t i a t e d t o answers to g u e s t i o n s of f e a s i b i l i t y  and  determine  and of the needs of users. ,.  European The developed  European system d e s c r i b e d by Port (1978) i s being at the J o i n t Research  Communities  (Norager e t a l . ,  1978). I t s name, ECDIN i s the  acronym f o r European Chemicals The  Centre of the European  Data and Information Network.  i n f o r m a t i o n system can be v i s u a l i z e d  more as a spoked wheel  than as a network s i n c e i t s t o r e s i t s data i n a s i n g l e data bank at the hub of the wheel. Osers t e r m i n a l s w i l l have access through users through  phone l i n e s a t post  with compatible  computer  the EUBONET which l i n k s offices.  Data on about 30,000 c h e m i c a l s w i l l be segmented i n t o ten c a t e g o r i e s of i n f o r m a t i o n on each chemical and each category w i l l be d i v i d e d 200  f u r t h e r i n t o f i e l d s and s u b f i e l d s to a t o t a l  p r o p e r t i e s . Each w i l l be r e t r i e v a b l e s e p a r a t e l y . The  of  87  c a t e g o r i e s i n c l u d e s c i e n t i f i c i n f o r m a t i o n on s t r u c t u r e and p r o p e r t i e s as w e l l as production  information  such as use,  t r a n s p o r t a t i o n methods and d i s p e r s i o n i n the environment. The design of t h e data base i s such t h a t simple  i n f o r m a t i o n such as  s o l u b i l i t y can be r e t r i e v e d or a s o p h i s t i c a t e d r e t r i e v a l progam c a l l e d ADABAS can oversee t h e r e t r i e v a l of c r o s s - r e f e r e n c e d information  such as a breakdown o f chemicals  pesticides;  (2) a r e found i n milk and; (3) a r e c a r c i n o g e n i c to  rats  that:  (1)  are  (Port, 1978) . As part of the p i l o t p r o j e c t a p o r t i o n o f the R e g i s t r y of  T o x i c E f f e c t s o f Chemical Substances data from NIOSH ( N a t i o n a l I n s t i t u t e of O c c u p a t i o n a l  S a f e t y and Health) was i n c o r p o r a t e d  i n t o the data base  (Norager e t a l . , 1978). The data on the  approximately  chemicals  5000  (Johnson, 1978) were taken at f a c e  value from t h e B e g i s t r y : t h e i r i n t e g r i t y unquestioned, "of n e c e s s i t y we r e l y on e d i t i n g  provided  by the s c i e n t i f i c  community before p u b l i s h i n g . " (Norager e t a j . . , 1978, p. 135) . 1  International The Port  i n t e r n a t i o n a l i n f o r m a t i o n system model d e s c r i b e d by  (1978) i s under the auspice of the United  Environmental Program Monitoring  System  s t r u c t u r e of IBPTC  Nations  (UNEP) and i s t i e d i n t o t h e UNEP G l o b a l  ( 0 * S u l l i v a n , 1976). The o r g a n i z a t i o n a l (International Begistry of P o t e n t i a l l y  Toxic  1. The q u e s t i o n o f v a l i d i t y and c r o s s c e r t i f i c a t i o n o f data and i n f e r e n c e s i s addressed l a t e r i n t h i s t h e s i s .  88  Chemicals) i s a network with a c e n t r e but i t has more emphasis on secondary data bases than the OK DESCNET. although the c e n t r e a t Geneva w i l l c a r r y out a d m i n i s t r a t i v e d u t i e s such  as  p r o v i d i n g r e f e r r a l s and answering q u e s t i o n s as well as a c t i n g as a computer data storage c e n t r e , the p e r i p h e r a l nodes of the network named • N a t i o n a l Correspondents' w i l l  be encouraged  b u i l d up a s e l e c t i v e semi-autonomous data base. This  to  will  develop a c a p a c i t y to answer q u e s t i o n s p e r t i n e n t to a p a r t i c u l a r geographic area (Huismans,  1978)  without going  through the c e n t r e a t Geneva. IBPTC w i l l cover a g e o g r a p h i c a l l y l a r g e r a r e a and have a somewhat broader mandate than most other i n f o r m a t i o n systems. Users w i l l be g l o b a l l y d i s t r i b u t e d and  w i l l i n c l u d e such  i n s t i t u t e s as the World H e a l t h O r g a n i z a t i o n and the I n t e r n a t i o n a l agency  f o r Research on Cancer as w e l l as d i v e r s  member c o u n t r i e s , as a r e s u l ^ o f t h i s width and breadth IBPTC has unique g o a l s and c o n s t r a i n t s . Huismans (1978) p o i n t s out f o u r f u n c t i o n a l o b j e c t i v e s o f IBPTC. IBPTC w i l l not attempt may  to c e n t r a l i z e a l l data but r a t h e r  r e f e r r e q u e s t s f o r i n f o r m a t i o n to the a p p r o p r i a t e N a t i o n a l  Correspondent. Thus, a N a t i o n a l Correspondent may i n two  ways: the data base may  participate  be s t o r e d c e n t r a l l y a t the  Progam a c t i v i t y Centre as has occurred with data from NIOSH i n the  US;  i n f o r m a t i o n may  be r e l e a s e d d i r e c t l y  from  individual  f i l e s on r e g u e s t . In any case, an a d d i t i o n a l f u n c t i o n of each N a t i o n a l Correspondent w i l l be to s e a r c h out  required  i n f o r m a t i o n from h i s s p e c i f i c s e c t o r and to make i t a v a i l a b l e throughout the network.  89  A second f u n c t i o n of IRPTC takes advantage of the extensiveness  of the network to i n order to r e v e a l g l o b a l  i n f o r m a t i o n d e f i c i e n c i e s i n t o x i c chemical research  data and  to d i r e c t  to reduce the gaps. T h i s w i l l be accomplished through  the c o o p e r a t i o n  and  c o l l a b o r a t i o n of v a r i o u s programs world  wide. The  t h i r d f u n c t i o n w i l l r e v o l v e around the  of p o t e n t i a l chemical the network to achieve hazards and  hazards.  identification  Here the agencies  a fan-out  will  of data on c u r r e n t  utilize  chemical  c o n t r o l s of g l o b a l i n t e r e s t . Members w i l l  be  a l e r t e d t c c u r r e n t chemical  r i s k s throughout the world and  s t e p s taken t o c o n t r o l such  risks.  F i n a l l y , Huismans (1978) expects t h a t IBPTC disseminate  to  will  data on the r e g u l a o r y approaches and  p o l i c i e s of  member c o u n t r i e s by whatever means seem a p p r o p r i a t e . T h i s might range from r e g u l a r b u l l e t i n s f o r r o u t i n e i n f o r m a t i o n to s p e c i a l a l e r t s f o r more urgent According  to Port  information. , (1975) the a c t u a l chemical  expected to be s m a l l e r than the 30,000 chemical ECDIN. The  data base i s  c a p a c i t y of  o r g a n i z a t i o n of the f i l e s a l s o w i l l be  slightly  d i f f e r e n t . They w i l l be comprised of only e i g h t c a t e g o r i e s divided chemical  i n t o 140  a t t r i b u t e s . The  characteristics  and  t o x i c dose) and  and  regulations)  information  (molecular formula,  regulatory information  will  include  molecular (reviews,  weight standards  (Huismans, 1978). To a i d i d e n t i f i c a t i o n  c r o s s - r e f e r e n c i n g of c h e m i c a l s , w i l l be s t o r e d i n the  files.  approximately  and  80,000 synonyms  90  Other Systems Other systems have been developed  i n response  s p e c i f i c needs of a p a r t i c u l a r user. The Environmental  to the  US C o u n c i l on  Q u a l i t y has formed CSIN (Chemical  Substances  Information Network) (TSSC, 1979) . I t w i l l have a l a r g e capacity  (about 500,000 chemicals)  and i s expected  t o serve  f e d e r a l agencies as w e l l as p r i v a t e groups i n i n d u s t r y and p u b l i c i n t e r e s t groups.  Software,  seme of the areas with g u e s t i o n s The  management and  funding are  pending.  US has s e v e r a l other systems which p r o v i d e s p e c i a l i z e d  data bases.  Merian  (1978) mentions: MEDLABS, TOXLINE, CHEMLINE  and TOX BANK administered by the N a t i o n a l L i b r a r y of data banks maintained  Medicine;  by NIOSH, CPSC (Consumer Product S a f e t y  Commission) and EMIC (Environmental  Mutagens Information  C e n t r e ) ; and a l s o the e x t e n s i v e f i l e s of the  EPA.  Other e x i s t i n g systems are the German UMPLIS (Omweltplanungsinforffiationssystem), DABAWAS (Dataenbank f u r wassergefahrdeude s t e f f e ) and DIMI-systems (Deutsches fur  m e d i z i n i s c h e Dokumentation und Information)  Institut  (Merian, 1978).  These are but a few of the many systems i n the chemical i n f o r m a t i o n system f i e l d . As mentioned, most are not  compatible  with others and so r e p r e s e n t not only d u p l i c a t i o n of e f f o r t a l s o l i m i t e d access to unique data. However, r a t i o n a l i z i n g systems presents s e v e r a l problem a r e a s .  but such  91  4.1.3  Problem  Areas  Hany of the advantages and disadvantages data systems are the same as those brought  o f computerized  by a computer to any  system. ,A computer can scan a tremendous amount of data i n a s h o r t time with g r e a t e r accuracy than a manual searcher can. However, the computer adage 'garbage i n garbage out*  still  applies. S e v e r a l problem areas a r e e v i d e n t when a system design i s attempted. to  handle  The data i t s e l f must be of good q u a l i t y . The program the f i l e s  must be sound and e f f i c i e n t . .The needs o f  the p o t e n t i a l users must be met i n such areas as access, s t r u c t u r e , funding and c o n f i d e n t i a l i t y . F i n a l l y , e x p e r t s must be a v a i l a b l e to prepare data and run the system.  Data Q u a l i t y D i f f e r e n t data are important a profound e f f e c t on the c r i t e r i a  t o d i f f e r e n t users. T h i s has used  to develop a  comprehensive, c u r r e n t and a c c u r a t e data base. For example, a user seeking only i n f o r m a t i o n to p h y s i c a l l y c h a r a c t e r i z e a chemical r e q u i r e s s t a b l e data which i s f a i r l y easy to o b t a i n . The  accuracy i s simple t o v e r i f y and not s u b j e c t t o e x c e s s i v e  d i s t o r t i o n as i t passes through the data g a t h e r i n g system. Such data may i n c l u d e molecular weight,  melting p o i n t , s t r u c t u r a l  formula  and other 'hard' f a c t s . Since these data are obtained  through  the p h y s i c a l s c i e n c e s using e s t a b l i s h e d procedures,  there i s l i t t l e  judgment i n v o l v e d . .The f i e l d i s l i m i t e d  can be covered comprehensively  and data can be gathered  so i t easily  92  on thousands of chemicals  (Port,  1978) . However, other  data  users such as a r e g u l a t o r y a g e n c i e s or p u b l i c i n t e r e s t groups are i n t e r e s t e d i n the i m p l i c a t i o n s of data. out  that i n these cases summaries and  Port  (1978)  points  i n t e r p r e t a t i o n s are  needed. What are to be t r e a t e d as r e l e v a n t data becomes a p o l i c y guestion  i n v o l v i n g judgment. Because o f  this  s u b j e c t i v i t y , a complete coverage o f the f i e l d i s d i f f i c u l t i f not  impossible  to  obtain.  another problem i s the d i f f i c u l t y current  s i n c e l i m i t e d resources  i n keeping  information  c o n s t r a i n the f i e l d s  of  new  data t h a t can be examined, as w e l l as the s e l e c t i o n and  the  e n t r y speed f o r t h a t data t h a t i s considered bibliography  and  ways. One,  journals  (Port 1978) . So i n a d d i t i o n to reduced  comprehensiveness, accuracy may  s i n c e much of the  d e c i s i o n s and  p u b l i c use  information  for  suffer i n  data base. The  two  regulatory  r e q u i r e s i n t e r p r e t a t i o n of data,  s u b s t a n t i a l amount of judgment b i a s can be introduced the f i n a l  The  data base, TOXLINE, f o r example, l a g s months  behind c u r r e n t currency  relevant.  into  and  Academy of S c i e n c e ,  s u b j e c t to h i s p r o c l i v i t i e s  1975). Two,  y e t , any  s u b j e c t i v i t y and  vary with the  volume of the data  product  e r r o r s made i n  data to be covered makes e r r o r s unavoidable. The data q u a l i t y w i l l  as  (National  t r a n s c r i b i n g the data are d i f f i c u l t t o d e t e c t . The  maintaining  the  data chosen f o r e n t r y or e x c l u s i o n  well as the manner i n which data i s worded becomes the of the r e s e a r c h e r  a  volume of  difficulty  of  complexity,  stored.  Some suggestions have been developed to improve data quality  and  to reduce the impact of e r r o r s and  omissions.  Port  93  (1978) advocates  the establishment of data bases i n c o n j u n c t i o n  with i n s t i t u t e s doing r e s e a r c h i n the same s u b j e c t a r e a . T h i s would i n c r e a s e data q u a l i t y by p r o v i d i n g expert advice on  the  i n t e r p r e t a t i o n and the i n c l u s i o n or e x c l u s i o n of data f o r the bank. Adams (1978), i n summarizing the r e s u l t s of the N a t i o n a l Forum on S c i e n t i f i c and T e c h n i c a l Communications, s t r e s s e s the need to educate  those concerned  with the system  (from data  generator through data p r o v i d e r to data user) about the standards of the system. Adams a l s o p o i n t s out the need f o r the people e n t e r i n g the data t o understand i n v o l v e d and  Design  both the s c i e n t i f i c  the i n f o r m a t i o n system being  area  used.  Problems  Much work i s being done on data storage and  retrieval  methods with the r e s u l t t h a t systems are improving, problems remain. systems are:  However,  Some of the b l o c k s i n the c h e m i c a l data  (1) a u n i v e r s a l method of r e f e r r i n g t o a  p a r t i c u l a r chemical does not e x i s t ;  (2) the o p t i m a l  o r g a n i z a t i o n a l s t r u c t u r e of a system i s u n c e r t a i n . (3) t h e r e i s a problem i n c h a r a c t e r i z i n g the uses of c h e m i c a l s ; and  (4)  methods a v a i l a b l e t o t i e other f i l e s to computer systems r a i s e other g u e s t i o n s . . A s t a n d a r d i z e d method of r e f e r r i n g  to a chemical must be  e s t a b l i s h e d i f i n t e r - s y s t e m and i n t e r - a g e n c y data exchange i s t o occur. At p r e s e n t , a chemical may  be r e f e r r e d  to by  formula,  by commercial or trade name, by common name or by any of s e v e r a l chemical names i n E n g l i s h or a f o r e i g n language.  To  94  r a t i o n a l i z e chemical  data systems i t i s important  information  to v a r i o u s names be r e t r i e v e d when only  attached  one chemical  name i s given. One  s o l u t i o n to the  to a s s i g n a unique number to each chemical synonym i s used. The  the problem i s  no matter what  American Chemical S o c i e t y has been using  such a system f o r i t s Chemical A b s t r a c t s S e r v i c e already  assigned  that a l l the  (CAS)  numbers to f o u r m i l l i o n chemicals.  such a plan seems f e a s i b l e  has  Adoption of  (TSSC, 1979)^  A p o r t i o n of the problem not  addressed by the  numbering system i s that r a i s e d by mixtures./TSSC out the d i f f i c u l t y  and  of i d e n t i f y i n g and  CAS (1979) p o i n t s  c a t e g o r i z i n g mixes such  as t a r . ,Hany other complex o r g a n i c mixes such as f l a v o u r i n g chemicals The  may  f a l l i n t o t h i s problem area  ( S c h l e g e l , 1978).  problem of system o r g a n i z a t i o n i s u n l i k e l y to  be  s o l v e d u n t i l the p o t e n t i a l u s e r s are i d e n t i f i e d . However, some of the c o n s i d e r a t i o n s may One  be d e l i n e a t e d . ,  c o n s i d e r a t i o n i s whether to use a data c e n t r e or a  network approach to o r a g a n i z a t i o n . Each has i t s advantages. A network a l l o w s a base to be g e o g r a p h i c a l l y c l o s e r to major users o r data generators.  Proximity  to data generators  may  improve data g u a l i t y by i n c r e a s i n g the a v a i l a b i l i t y of s u b j e c t e x p e r t i s e , as mentioned e a r l i e r , while p r o x i m i t y t o users  may  reduce c o s t of access. A s i n g l e data c e n t r e , on the other hand, a l l o w s g r e a t e r u t i l i z a t i o n o f the computer's c a p a b i l i t y manipulate data f o r c r c s s - r e f e r e n c i n g and l i n k i n g Such a system conserves s c a r c e e x p e r t i s e and  to  (Port, 1978).  provides a more  s t i m u l a t i n g and s u p p o r t i v e enviroment. In a d d i t i o n , g r e a t e r c o n t r o l over the data g e n e r a l l y i s p o s s i b l e .  95  The t h i r d problem use i n a s t a n d a r d way.  i n v o l v e s a method to c a t e g o r i z e c h e m i c a l At p r e s e n t the TSSC (1979) p o i n t s out  t h a t a Standard I n d u s t r i a l C l a s s i f i c a t i o n code e x i s t s but i t f a i l s t o p r o v i d e enough d e t a i l . However, they r e p o r t an a l t e r n a t i v e method developed  by the EPA  which uses c h e m i c a l  f u n c t i o n and a p p l i c a t i o n t o g e n e r a t e about 800 terms. Used s i n g l y or t o g e t h e r , the terms can c h a r a c t e r i z e a c h e m i c a l i n a u n i f o r m and unique  way.  One  use  example i s the f u n c t i o n  •adhesive* which i s s u b d i v i d e d i n t o s i x t e e n a p p l i c a t i o n s of •adhesi v e s . f  F i n a l l y , a method i s needed t o t i e e x i s t i n g and f u t u r e f i l e s t o g e t h e r . Techniques  l i k e epidemiology  need methods of  r e l a t i n g e x t e n s i v e p e r s o n a l f i l e s c o n t a i n i n g demographic, m e d i c a l and o c c u p a t i o n a l data on i n d i v i d u a l s t o c h e m i c a l and exposure  d a t a . .This i s d i f f i c u l t  use  because of p e r s o n a l  m o b i l i t y and name changes. An obvious answer i s the use of the S o c i a l I n s u r a n c e Number (SIN)• U n f o r t u n a t e l y , i t i s f e l t  by  many t h a t use of the SIN p r e s e n t s s e v e r e t h r e a t s t o p e r s o n a l privacy since i t represents a p o t e n t i a l l y powerful t o o l to s u r p p r e s s p e r s o n a l freedom by b o t h government and  private  p a r t i e s . P o s s i b l e use and p o t e n t i a l e f f e c t s are now  under s t u d y  i n Canada by a f e d e r a l commission. P r i v a t e companies have expressed c o n c e r n about the c o n f i d e n t i a l i t y o f computer d a t a . , D u e l t g e n a p r i v a t e company i n the US,  (1979), s p e a k i n g f o r  r e c o g n i z e s the v a l u e of computer  i n f o r m a t i o n t o the p r i v a t e s e c t o r , but emphasizes the c o s t of u n a u t h o r i z e d d i s c l o s e r e of p r o p r i e t a r y d a t a . He p o i n t s out t h a t  96  possession  o f manufacturing  significant industry. as  chemical  market a d v a n t a g e  He q u e s t i o n s  accuracy  A similar  1980). The C a n a d i a n  EPA  r e s o l u t i o n of the  p r o b l e m may be compounded  ( H e r d e l and S t e e l e ,  greater r i s k  refused  information  confidentiality  the problem  of p r o p r i e t a r y o r other  i s t o segment a f i l e f o r TOSCA i s s p l i t  s y s t e m a s t h e EPA  into  a v a i l a b l e t o a l l and i n f o r m a t i o n  public a v a i l a b l e t o the  (TSSC, 1 9 7 9 ) . , T h u s , t h e p u b l i c and o t h e r l e g a l access  i n US  of disclosure.  done. I n f o r m a t i o n  only  1978).  their information  banks i f t h e A m e r i c a n a t t i t u d e t o d a t a  information  that the  i n t h e US s i n c e Canada d e p e n d s h e a v i l y on US  One method o f h a n d l i n g  has  areas  to non-disclosure of  c o m p a n i e s may n o t w i s h t o r i s k  restricted  i n such  f e e l s at present,  satisfactory  bases and i n f o r m a t i o n s e r v i c e s  creates  i n the  i n d u s t r y a t t i t u d e a p p e a r s t o e x i s t i n Canada  circumstances  Canadian  companies  be a  question.  (Neff and Mutton,  data  pending  may  s t a t u s o f data  use..Dueltgen  information  confidentiality  data  to other  the l e g a l  and p r o p e r  on c h e m i c a l s  i n d u s t r y i n t h e OS i n c l i n e s  sensitive  by  data  to p r o p r i e t a r y data  through  companies a r e security  mechanisms. Such mechanisms r e s t r i c t three broad authorized  methods d e s i g n e d user  (Lowe,  physical  possession  property  o f the user  access  t o computer f i l e s  to verify  the i d e n t i t y  1976) . V e r i f i c a t i o n  of questions.  on some  some  or signature, or  some knowledge o f t h e u s e r s u c h a s a password series  o f an  may be b a s e d  s u c h as a key o r m a g n e t i c c a r d , such as a f i n g e r p r i n t  through  o r answers t o a  However, no s e c u r i t y s y s t e m  i s p e r f e c t . At  97  best  these  f e a t u r e s , when c o m b i n e d  degree o f s e c u r i t y " difficulty security  with  others provide "a high  (p. ,17). A t r a d e - o f f between c o s t and  o f o p e r a t i o n on one hand and t h e i m p o r t a n c e  on t h e o t h e r  must be made, k e e p i n g  r e l u c t a n c e t o r e v e a l t r a d e - s e c r e t s without  Funding  and  system cannot  scientists  demands o f a s y s t e m  meet a l l t h e needs o f d i v e r s e  u s e r s such  as government,  and t h e p u b l i c  sources  l a r g e amounts o f p u b l i c  economic b e n e f i t exploit  of  be l o s t  different  evident.  i f the p r i v a t e  existence i n the f i r s t needs o f p r i v a t e  t o use  much o f t h e  sector  t o advantage. Furthermore,  and a p r i n c i p a l  I f the  the system. Yet, i f a  reason  cannot  private  i n v o l v e d i n the i n f o r m a t i o n system, being  much o f t h e d a t a  private  money t o f u n d  users  private  i ti s unfair  o n l y f o r government use then  will  the system  integrally  have  reconciliation  makes c o n f l i c t  n e e d s o f t h e p r i v a t e s e c t o r a r e met t h e n  i s designed  a l l make  ( P o r t , 1978). The a t t e m p t e d  u s e r ' s n e e d s a n d fund  system  security.  methods o f f u n d i n g i n f o r m a t i o n s y s t e m s  1979). P o t e n t i a l  corporations,  of  adequate  developed.  A given (Adams,  i n mind i n d u s t r y ' s  Users  Satisfactory y e t t o be  o f data  users are the source  f o r the system's  p l a c e . I f a s y s t e m d o e s n o t meet t h e  users then  s e c t o r may n o t be  t h e c o o p e r a t i o n r e q u i r e d from t h e  forthcoming.  E v e n i f government i s t h e main u s e r government, s c i e n t i s t s and r e g u l a t i n g  problems e x i s t .  agencies  have  Within  different  98  requirements. regulators  S c i e n t i s t s need  need  Given l i m i t e d neither  and r e f e r e n c e s  while  summaries and i n t e r p r e t a t i o n s o f r e l e v a n t  resources,  a system  may be compromised  data.  so t h a t  Expertise  i s obvious that a great  required  deal of t e c h n i c a l expertise i s  to e x t r a c t a f a i r r e t u r n from  expenditures. to  data  group i s s a t i s i f i e d .  Technical It  full  (1978)  Krentz  p o i n t s o u t t h e need  be w e l l t r a i n e d i n b o t h i n f o r m a t i o n  clients•  subject  area  information  i f data  system  f o r operators  systems and i n a  i s t o be e n t e r e d  and r e t r i e v e d  effectively.  As w e l l , t h e demands f o r d a t a  in  o f i n t e r p r e t a t i o n and s u m m a r i z a t i o n , h i g h l i g h t t h e  the areas  need the  f o r expert various  trained  reviewers  able t o s e l e c t ,  relevant fields.  professionals w i l l  of information  quality, especially  and e v a l u a t e  data i n  Thus, a requirement f o r h i g h l y  be g e n e r a t e d  with  the i n t r o d u c t i o n  systems.,  t».2 CONCLUSIONS Computerized information  information  necessary  chemical  screening  chemical  candidates  questions The  remain  systems can p r o v i d e the  t o a i d i n d e c i s i o n s about  and a b o u t a c c e p t a b l e chosen. Although  priorities for  standards  f o r the  t h e r e a r e a d v a n t a g e s , some  t o be a n s w e r e d .  main a d v a n t a g e s o f i n f o r m a t i o n  systems a r e those  99  derived  from  computer u s e . The s p e e d  user t o scan relevant, speed  available  data  quickly  avoiding duplication  also  f o r those  which a r e  o f p r e v i o u s r e s e a r c h . The h i g h  a l l o w s f o r i n c r e a s e d u s e o f d a t a and a b r o a d e r  base. I n t u r n , the enlarged information Finally,  o f the computer a l l o w s a  f o r decision  t h e unique  data  base c a n p r o v i d e  making t h e r e b y  characteristics  data  more r e l e v a n t  reducing uncertainty.  o f c o m p u t e r s o f f e r two  o t h e r f e a t u r e s ; by a l l o w i n g c r o s s r e f e r e n c e s and new associations  o f d a t a , i n o v a t i o n c a n be s t i m u l a t e d .  Difficulties typically question  concerned i s data  provide data judgment and  with computerized with  t h e human e l e m e n t s .  validity.  T o be v e r y  that iscurrnet  must be used  produces a s u b s t a n t i a l  a system  must  Dnfortunately,  Such  judgment c a n i n t r o d u c e a  potential  with e n t r y  errors,  f o r m i s r e p r e s e n t a t i o n . Thus,  must be i n t r o d u c e d t o m a i n t a i n  approach t o improving  important  i n d e c i d i n g what i s t o be p l a c e d i n f i l e s  t o t h e d a t a . B i a s when combined  techniques  One  useful,  and c o r r e c t .  how i t i s t o be r e c o r d e d .  bias  i n f o r m a t i o n systems a r e  data v a l i d i t y  data  validity.  One  i s the establishment of  data e n t r y p o i n t s a t research c e n t r e s whereexpertise i s available  t o monitor  A second of  data.  entries.  major c o n c e r n  Storage  i s the categorization  and r e t r i e v a l  many synonyms c a n be a c h i e v e d numbers. U n f o r t u n a t e l y , t h i s the c a t e g o r i z a t i o n categorizing approach  through approach  of chemical  chemical  of chemical  mixes.  data  and r e t r i e v a l  entered  t h e use o f common does n o t a p p l y  under CAS  w e l l to  However, t h e p r o b l e m o f  u s e s c a n be r e d u c e d  o f f u n c t i o n s and a p p l i c a t i o n s .  by u t i l i z i n g  t h e EPA  100  a l s o , unanswered q u e s t i o n s about data exchange and  a system  remain. D i f f e r e n t users have c o n f l i c t i n g reguirements. that e f f i c i e n t l y The  meets one s e t of needs may  c o s t of p r o v i d i n g d u p l i c a t e data i n two  forms may users  be  not  use  meet o t h e r s . ,  or more d i f f e r e n t  very high. Thus, i n meeting the needs of d i f f e r e n t  (e.g. r e g u l a t o r s and s c i e n t i s t s ) a compromise may  be  needed. To  reduce t h i s c o n f l i c t  a network approach may  system o r g a n i z a t i o n s i m i l a r to that of IBPTC may  be taken,  a  be used. A  f e d e r a l system would s e r v e as the c e n t r e of the network providing a centralized systems would serve as  data base while p r o v i n c i a l computer • N a t i o n a l correspondents'  t o meet  s p e c i a l i z e d needs and provide r e g i o n a l i n f o r m a t i o n . C o n f i d e n t i a l i t y i s a f o u r t h major concern. setting  and  Standard  s c r e e n i n g w i l l r e g u i r e i n d u s t r y t o provide  the  f e d e r a l government with p r o p r i e t a r y i n f o r m a t i o n i t wishes to keep c o n f i d e n t i a l . , . However, the r e g u l a t i o n of  chemicals  r e q u i r e s f e d e r a l and p r o v i n c i a l c o o p e r a t i o n and  information  exchange as w e l l as i n t e r a c t i o n with p u b l i c i n t e r e s t C o n f i d e n t i a l i t y w i l l be threatened. Thus, although government may  the f e d e r a l  share most i n f o r m a t i o n , some i n f o r m a t i o n must  remain r e s t r i c t e d . One and  groups.  method to do so i s u t i l i z e d  i n v o l v e s s p l i t t i n g the data base. Data i n one  base would be r e s t r i c t e d  by the  EPa  p a r t of  the  f o r the use of a u t h o r i z e d users only,  a second element of c o n f i d e n t i a l i t y r e v o l v e s around the s t a t u s of Canadian i n f o r m a t i o n i n American data banks. Canadian i n f o r m a t i o n i n the OS may  be s u b j e c t to american freedom of  101  i n f o r m a t i o n laws i n which case  industrial prorietary  i n f o r m a t i o n may be d i v u l g e d . Understandably, Canadian i n d u s t r i e s may not y i e l d c o n f i d e n t i a l i n f o r m a t i o n under circumstances.  F u r t h e r i m p l i c a t i o n s of t r a n s f e r r i n g  these  information  a c r o s s i n t e r n a t i o n a l borders must be examined. C o m p a t i b i l i t y among i n f o r m a t i o n systems, both i n t e r n a t i o n a l i s important.  Since most p r o v i n c e s maintain  own computer systems i s important compatible  n a t i o n a l and their  t h a t t h e i r systems be  with a f e d e r a l system. The o v e r l a p p i n g and i n t e g a t e d  f e d e r a l and p r o v i n c i a l environmental  l e g i s l a t i o n necessitates  c o o p e r a t i o n among governments. E f f i c i e n t i n f o r m a t i o n exchange i s a s i g n i f i c a n t step toward such an o b j e c t i v e . Information  systems improve d e c i s i o n s only i f t h e i r , d a t a  are v a l i d . To ensure v a l i d i t y , systems must have a means o f c r o s s v e r i f i c a t i o n and v a l i d a t i o n . T h i s i m p l i e s t h a t data from d i f f e r e n t sources  w i l l be compatible  f o r exchange and  comparison among systems. Thus, methods o f data c o l l e c t i o n and storage  must be s t a n d a r d i z e d .  Besides the steps taken  t o r a t i o n a l i z e the i n f o r m a t i o n  systems themselves, attempts a r e being made t o s t a n d a r d i z e n a t i o n a l and i n t e r n a t i o n a l r e s e a r c h techniques  to f a c i l i t a t e  data comparison. For example, the OECD i s c u r r e n t l y engaged i n r e a c h i n g i n t e r n a t i o n a l agreement on uniform p r a c t i c e s . I n any case, i t i s important  laboratory  that i n f o r m a t i o n  systems i n c l u d e a mechanism t o i d e n t i f y data t h a t has been proven r o b u s t , i e .  has been v a l i d a t e d by comparison with  from d i f f e r e n t sources. Conversely, be designated  as such.  l e s s r e l i a b l e data  data  should  Users of the data would then be a b l e to  102  give a datum the proper  weight i n a d e c i s i o n .  I n t e r n a t i o n a l c o m p a t i b i l i t y may be as important t o a f u n c t i o n i n g system as n a t i o n a l c o m p a t i b i l i t y . The US, f o r example, i n a d d i t i o n t o p r o v i d i n g much r e l e v a n t , g e n e r a l scientific  i n f o r m a t i o n , i s a l s o a major e x p o r t e r of c h e m i c a l s  to Canada. S p e c i f i c  i n f o r m a t i o n from US t e s t s o f imported  chemicals w i l l a i d i n s c r e e n i n g and standard s e t t i n g d e c i s i o n s . T h e r e f o r e , t h e design o f any Canadian i n f o r m a t i o n system should c o n s i d e r c o m p a t i b i l i t y a t l e a s t with the American system. An important aspect of s c r e e n i n g and standard s e t t i n g i s feedback  about t h e e f f e c t s of p r e v i o u s d e c i s i o n s . Epidemiology,  the main method o f d e t e c t i n g and t r a c i n g chemical  effects  depends on e x t e n s i v e , c u r r e n t d a t a . These data are obtained from sources i n c l u d i n g o c c u p a t i o n a l and medical records. Modern m o b i l i t y makes the maintenance of such data bases d i f f i c u l t . Although  the use of the S o c i a l Insurance  Number to t i e p e r s o n a l  f i l e s t o g e t h e r i s not p r e s e n t l y accepted, procedures  t o reduce  the danger o f misuse and ensure p r i v a c y must be developed t o improve a c c e p t a b i l i t y o r a substitute.method One  must be found.  f u r t h e r aspect o f t h e o p e r a t i o n os a Canadian  i n f o r m a t i o n system remains f o r d i s c u s s i o n . The e f f i c i e n t f u n c t i o n i n g of such a system depends on t r a i n e d  people a b l e t o  make knowledgeable judgments about i n t e r p r e t a t i o n , s e l e c t i o n , r e l e v a n c e and r e t r i e v a l of data. .Without v a l i d data and proper use, c o r r e c t d e c i s i o n s cannot  be made. The users of the system  must be f a m i l i a r with i t s s t r e n g t h s , weaknesses and o p e r a t i o n and be able t o i n t e r f a c e with s c i e n t i s t s from many d i s c i p l i n e s . The t r a i n i n g c f s u f f i c i e n t numbers of s c i e n t i s t s and other  103  p r o f e s s i o n a l s a s s o c i a t e d with the i n f o r m a t i o n system must be encouraged and potential.  facilitated  i f a Canadian system i s t o reach i t s  104  5i COHCJ.UglOlS  The  instruments  of c o n t r o l have been reviewed and  Canadian l e g i s l a t i o n surveyed  to provide a g e n e r a l  existing  background.  Such l e g i s l a t i o n provides f o r f e d e r a l and/or p r o v i n c i a l c o n t r o l of most general and  s p e c i f i c contaminants. The  Environmental  Contaminants Act supplements the l e g i s l a t i o n of both governments and necessary,  covers  most gaps. L i t t l e new  ;  c o n s t i t u t i o n a l impediments r e s t r i c t  of t o x i c chemical  regulations. Instead,  the i n t r o d u c t i o n  c o n s t r a i n t s on  r e g u l a t i o n s a r i s e from the l a r g e number of chemicals r e g u l a t e and  the p a u c i t y of i n f o r m a t i o n . The  p o l i c y r e v o l v e s not  gathering  to  development of  around d e s i g n i n g l e g i s l a t i o n  e s t a b l i s h i n g p r i o r i t i e s and developing  new  but i n  information f o r  specific regulations.  Both governments have the c o n s t i t u t i o n a l a b i l t i t y collect  seems  however both governments have e x t e n s i v e powers to  enact needed l e g i s l a t i o n . Few  legislation  n e a r l y any  i n f o r m a t i o n or to f i n a n c e any  to  research  r e q u i r e d . C o n s t r a i n t s on i n f o r m a t i o n g a t h e r i n g are of a p o l i t i a l or economic  nature.  Some c o n s t r a i n t s can be avoided  by the governments  1  power  to r e s t r i c t p u b l i c access to government i n f o r m a t i o n . Thus, i n d u s t r y ' s r e l u c t a n c e to y i e l d governments may  proprietary information  to  be reduced.  Governments have powers to ensure compensation f o r damages from chemicals.  Compensation funds may  be s e t up and  financed  105  e i t h e r from general  revenue or from l e v i e s on i n d u s t r y . In  a d d i t i o n , governments can a s s i s t ensuring  those harmed by chemicals by  p r i v a t e r i g h t s of a c t i o n a g a i n s t  responsible  companies. f o ensure e f f e c t i v e chemical c o n t r o l p o l i c y , f e d e r a l and p r o v i n c i a l cooperation  i s needed s i n c e much o f the l e g i s l a t i o n  o v e r l a p s . C o o p e r a t i o n would be a s s i s t e d by i n f o r m a t i o n exchange. A l s o , pre-market s c r e e n i n g r e g u i r e adeguate The  and r e g u l a t i o n s  will  information.  elements o f a s t r a t e g y to e s t a b l i s h p r i o r i t i e s f o r  chemical r e g u l a t i o n s were a p p r a i s e d .  Exposure t o chemicals and  the consequences of that exposure a r e found t o determine the extent  o f the impact on h e a l t h and the environment. Adequate  information  on both elements would make s c r e e n i n g  e x e r c i s e . However, such i n f o r m a t i o n  a trivial  seldom e x i s t s ; t h e r e f o r e ,  judgment must be used. The complexity o f the system makes the use o f a formal placed  d e c i s i o n model u n l i k e l y . I f r e l i a n c e i s to be  on the judgment of s c i e n t i s t s and r e g u l a t o r s , then  c a r e f u l t r a i n i n g and as much r e l e v a n t i n f o r m a t i o n are necessary t o reduce The  as p o s s i b l e  uncertainty..  approaches to transform  p u b l i c opinion  and s c i e n t i f i c  knowledge i n t o standards f o r chemical r e g u l a t i o n s have been presented. The f a c t o r s a f f e c t i n g the standard  s e t t i n g procedure  have been reviewed as w e l l . These i n c l u d e p e r s o n a l l i m i t a t i o n s of standard  s e t t i n g bodies,  technology a v a i l a b l e ,  resources  a v a i l a b l e , l o g i s t i c a l c o n s t r a i n t s and r e a c t i o n t o p o l i c i e s . No c l e a r method i s a v a i l a b l e t o e s t a b l i s h optimum standards. Therefore,  a c o n s u l t a t i v e process and p a r t i c i p a t i o n of t h e  106  three s e c t o r s  ( p u b l i c , government, and i n d u s t r y )  t o ensure a c c e p t a b i l i t y . be necessary provide  An appeal  i s necessary  to an independent board may  t o r e s o l v e some i s s u e s . Governments may a l s o  a s s i s t a n c e i n the form of i n f o r m a t i o n and f i n a n c e s t o  p u b l i c i n t e r e s t groups to i n c r e a s e meaningful p a r i c i p a t i o n . F i n a l l y , i n f o r m a t i o n systems were reviewed as a means o f p r o v i d i n g data The  f o r screening and standard  setting  processes.  main advantages of a computerized i n f o r m a t i o n system a r e  speed, c a p a c i t y and c r o s s r e f e r e n c i n g a b i l i t y . „ Disadvantages such as problems with data v a l i d i t y and currentness  a r i s e p r i n c i p a l l y from human l i m i t a t i o n s .  Considerations same chemical can  must be given t o c r o s s indexing synonyms f o r the and c a t e g o r i z i n g chemical  be reduced by adoption  uses. These problems  o f the CAS unique numbering method  and the EPA f u n c t i o n s and a p p l i c a t i o n s approach t o categorization respectively., A system o r g a n i z a t i o n must be decided on. ,,A Canadian system may i n c o r p o r a t e a network approach s i m i l a r t o the IBPTC organization  with the f e d e r a l government a c t i n g as a c e n t r a l  data base and the p r o v i n c e s as p e r i p h e r a l nodes c a t e r i n g t o s p e c i a l i z e d , r e g i o n a l needs. T h i s compromise u t i l i z e s the computer a b i l i t y  to c r o s s r e f e r e n c e data while  allowing  s p e c i a l i z e d needs t o be met. However, the s h a r i n g of c o s t , c o m p a t i b i l i t y and methods of m a i n t a i n i n g  confidentiality  requires f e d e r a l / p r o v i n c i a l cooperation. Compatibility compatibility  with other systems i s s t r e s s e d *  National  i s a n e c e s s i t y . A l s o , c o m p a t i b i l i t y with the  systems i n other c o u n t r i e s , notably t h a t o f the OS, must be  1.07  given thorough c o n s i d e r a t i o n . Such i n f o r m a t i o n exchange i m p l i e s examination  of the s t a t u s of Canadian i n f o r m a t i o n i n other  c o u n t r i e s and s t a n d a r d i z a t i o n of i n t e r n a t i o n a l t e s t i n g  and  r e s e a r c h methodology. Such an approach t o chemical trained  regulation w i l l require  peronnel. To b e n e f i t from the system o p e r a t o r s  users must understand c a p a b i l i t e s and disseminate i n d u s t r y and  each o t h e r ' s f i e l d s and  and  the system's  weaknesses, .also, they must be a b l e to  a p p r o p r i a t e e d u c a t i o n a l i n f o r m a t i o n to government, public participants.  Without adequate i n f o r m a t i o n , r a t i o n a l d e c i s i o n s cannot made about s c r e e n i n g and standards. efficient process.  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S l o v i c , P a u l ; Baruch F i s c h h o f f and Sarah L e c h t e n s t e i n (1977), " B e h a v i o r a l D e c i s i o n Theory", American Beview of Psychology. 28:1-39.  116  S l o v i c , P a u l ; Baruch Fisc.hho.ff and Sarah L i c h t e n s t e i n (1979) , "Rating the R i s k s " , Environment. 21 (no. 3) : 14-20, 36-39. Smith, R. J e f f r e y (1979a), " I n s t i t u t e of Medicine Report Recommends Complete Overhaul of Food S a f e t y Laws", S c i e n c e . 203:1221-1222, 1224. Smith, R. J e f f r e y (1979b), "NCI Bioassay Y i e l d s a T r a i l of Blunders", S c i e n c e . 204:1287-1292., Smith, W. Eugene and A i l e e n M. Smith (1975), Minamata. York: Holt Rinehart and Winston.  New  Spiher, Alan T. J r . (1974), "Food I n g r e d i e n t Review: Where I t Stand Now", FDA Consumer. June 1974, pp. 23-26. S t a r r , Chauncey (1969), " S o c i a l B e n e f i t Versus T e c h n o l g i c a l R i s k " , S c i e n c e . 165(no. 3899):1232-1238. S t a r r , Chauncey (1972), P e r s p e c t i v e s on R i s k - B e n g f i t D e c i s i o n Making. N a t i o n a l Academy of E n g i n e e r i n g . S t a r r , C.; R. Rudman and C. Whipple (1976), " P h i l o s o p h i c a l B a s i s f o r Risk A n a l y s i s " . Annual Review of Energy. 1:62966 2. S t o k i n g e r , H . E. (1972), "Concepts of Thresholds i n Standard S e t t i n g " , A r c h i v e s o f Environmental H e a l t h . 25:155. S t o r e r , John B. (1972), "The Low L e v e l Experiment", Oak N a t i o n a l Laboratory Review. 5 (no. 4):1-5.  Ridge  Sub Committe on Oversight and I n v e s t i g a t i o n s (OS) (1978), Cancer Causing Chemicals i n Food. Committee on I n t e r s t a t e and F o r e i g n Commerce 95th Congress, Second Session. T o x i c Substances S t r a t e g y Committee (1979), Report to the P r e s i s d e n t by. the Toxic Substances S t r a t e g y Committee. C o u n c i l on Environmental Q u a l i t y , Executive O f f i c e of the P r e s i d e n t , No. CEQ - EHTS - 03, August 1979. Tversky and Kahneman (1974), "Judgment Under U n c e r t a i n t y : H e u r i s t i c s and B i a s e s " , S c i e n c e . 183:1124-1125. Upton, Arthur (1979), D i r e c t o r , N a t i o n a l Cancer I n s t i t u t e , P e r s o n a l Communications, September, 1979. , V i s c u s i , W. Kip (1978), "Wealth E f f e c t s and Earnings Premiums f o r Job Hazards", Review o f Economics and S t a t i s t i c s , 60:no. 3):408-4T6. Ward, T. M. and J . B. Weber (1968), "Aqueous S o l u b i l i t y of A l k y a m i n o - s - t r i a z i n e s as a F u n c t i o n of pH and M o l e c u l a r S t r u c t u r e " , J o u r n a l of A g r i c u l t u r a l and Food Chemistry,  117  16 :959-961. Weinstain, M i l t o n C. (1979), " D e c i s i o n Making f o r T o x i c Substances C o n t r o l : C o s t - e f f e c t i v e Information Development f o r the C o n t r o l of Environmental Carcinogens", P u b l i c P o l i c y . 27{no. 3):333-383. Werdel, J u d i t h A. amd R i c h a r d A. S t e e l e (1978), "The Information Age: World Wide Data Warfare?", B u l l e t i n of the American S o c i e t y f o r I n f o r m a t i o n S c i e n c e . 4(no. 6):10-12. , Wessel, John (1979), R e p r e s e n t a t i v e o f FDA, P e r s o n a l Communications, September, 1979. Wilson, J . G. . (1971), Report of the Advisory Committee on 2.4.5-T t o the A d m i n i s t r a t o r of the Environmental P r o t e c t i o n Agency. O f f i c e of P e s t i c i d e s , Environmental P r o t e c t i o n Agency, Washington D. C.. World H e a l t h O r g a n i z a t i o n (1967), Mercury Contamination of Man and H i s Environment. Food and A g r i c u l t u r e O r g a n i z a t i o n / I n t e r n a t i o n a l Atomic Energy Agency International Discussion. Yamada, M. and K. Tonomura (1973), J o u r n a l o f Fermentation Technology. 50: 159. Zeckhauser, Richard (1975), "Procedures f o r V a l u i n g L i v e s " , P u b l i c P o l i c y . 23:419-46 3.  118  APPENDIX  A. .OECD LEGISLATIVE MODELS To a i d i n developing a f o c u s f o r p o t e n t i a l legislation, reviewed. (UK)  Canadian  the l e g i s l a t i o n o f other OECD c o u n t r i e s i s  A t t e n t i o n w i l l c e n t r e mainly on t h e United Kingdom  and the United S t a t e s (US). The UK i s important because o f  Canada's h i s t o r i c a l , c o n s t i t u t i o n a l and l e g a l commonalities. As a r e s u l t , both Canada and the UK have adopted a s i m i a l r c o n s u l t a t i v e approach consensus.  t o chemical c o n t r o l with an emphasis on  T h i s i s i n c o n t r a s t t o the approach  o f the US which  uses adversary proceedings and r e l i e s h e a v i l y on the c o u r t s to r e s o l v e c o n f l i c t s . However, c u l t u r a l s i m i l a r i t e s , g r o g r a p h i c a l p r o x i m i t y and economic t i e s make examination  of US l e g i s l a t i o n  important. The l e g i s l a t i o n enacted by other i n d u s t r i a l i z e d OECD c o u n t r i e s w i l l be reviewed as w e l l t o provide a more  complete  overview.  A.I United Kingdom The C o n t r o l of P o l l u t i o n Act of 1974 was enacted to cover s i t u a t i o n s where e x i s t i n g l e g i s l a t i o n i s not a p p l i c a b l e , e s p e c i a l l y where emergency a c t i o n i s r e q u i r e d (OECD, 1976). I t enables the a d m i n i s t r a t o r , the Department of the Environment , to c o n t r o l o r ban t h e import, commercial  use or d i s t r i b u t i o n of  any chemical t o prevent environmental or human damage. Before  119  r e g u l a t i o n s are promulgated, c o n s u l t a t i o n occurs with  those  affected. , To c o n t r o l p e s t i c i d e s , the OK has i n s t i t u t e d a nons t a t u t o r y agreement between manufacturers  and government  a g e n c i e s . The agreement a l l o w s f o r government n o t i f i c a t i o n o f new p e s t i c i d e s . Recommendations, i n c o n j u n c t i o n with an Advisory Committee, are made with r e s p e c t t o r e s t r i c t i o n s on marketing  and use. The t i t l e  i s P e s t i c i d e s Safety  Precautions  Scheme. The OECD r e p o r t p o i n t s out t h a t the c o n t r o l of environmental  contaminants has o c c u r r e d i n three main a r e a s ,  g e n e r a l p o l l u t a n t s , s p e c i f i c c h e m i c a l s , and c e r t a i n uses. The control  approach to g e n e r a l p o l l u t a n t s o f a i r and water and t o  waste d i s p o s a l has been t o allow l o c a l autonomy. A u t h o r i t i e s c o n s i d e r a l l f a c t o r s , l o c a l c o n d i t i o n s not excepted, set type and l e v e l of c o n t r o l s t o s u i t . i n d i f f e r e n t areas o f the country  and then  As a r e s u l t , c o n t r o l s  vary c o n s i d e r a b l y . The  c o n t r o l of s p e c i f i c chemicals i s achieved through  a mix of  s t a t u t e s and agreements.,For i n s t a n c e , on the one hand, detergents a r e r e g u l a t e d by a v o l u n t a r y agreement c o v e r i n g the s c r e e n i n g of new chemicals t o be used i n domestic  detergents.  Sulphur, on the other hand, i s r e g u l a t e d under S e c t i o n 76 o f the C o n t r o l of P o l l u t i o n Act which provides f o r l i m i t s on the amount of s u l f u r i n f u e l o i l . F i n a l l y , c e r t a i n uses are covered, f o r example, i n the work p l a c e the manufacturer i s bound t o ensure t h a t only chemicals s a f e under normal c o n d i t i o n s a r e used. Under the Health and S a f e t y At Work Act (1974),  constant  monitoring  by t h e Health and S a f e t y  Executive  120  (HSE) i s aimed at r e g u l a t i n g  p o t e n t i a l l y harmful chemicals.  These c h e m i c a l s are c o n t r o l l e d  by o f f i c i a l  guidelines  r e i n f o r c e d by h e a l t h and s a f e t y s t a t u t e s as r e q u i r e d . In a r e c e n t r e l e a s e , desiqned t o e l i c i t  industry  response.  N o t i f i c a t i o n Scheme f o r T o x i c Substances, HSE o u t l i n e d i t s approach  (Hay, 19 79). The philosophy i s to keep t e s t c o s t s down  by r e q u i r i n g the minimum amount o f i n f o r m a t i o n necessary t o move to the next step of chemical development i f more than 100 kg/yr i s marketed. The i d e a i s t h a t p r e l i m i n a r y  toxicity  t e s t i n g w i l l be c a r r i e d out a t a sub-acute l e v e l f o r 20 days. Should t h i s r a i s e s u s p i c i o n s , l o n g term r e s e a r c h must be implemented. T h i s c o n t r a s t s with the US Environmental P r o t e c t i o n Agency  (EPA) requirements f o r a r i g i d  t e s t s b e f o r e a chemical i s r e g i s t e r e d for  s e r i e s of  (registration i s required  marketing). The UK changed i t s approach  t o the c o n t r o l of  p h a r m a c e u t i c a l s with the i n t r o d u c t i o n o f the Medicines Act o f 1971. The Act i n t r o d u c e d f o r m a l procedures f o r pre-market s c r e e n i n g o f new drugs proof o f e f f i c a c y  (Grabowski  and an approved  et a l . ,  1978).These i n c l u d e d  plan f o r t e s t i n g i n animals  and humans. T h i s represented a major s h i f t i n emphasis from a post-market, screening.  l a r g e l y v o l u n t a r y program t o pre-market  formal  121  A.2  United S t a t e s of In  1976,  C o n t r o l Act  America  a f t e r s i x years of e f f o r t , the T o x i c (TOSCA.) was  Substances  passed. The reason f o r i t s i n c e p t i o n i s  summed up by P r e s i d e n t C a r t e r  (1977).  ...the presence of t o x i c chemicals i n our environment i s one of the grimmest d i s c o v e r i e s of the i n d u s t r i a l e r a . Rather than coping with these hazards a f t e r they have escaped i n t o cur environment, our primary o b j e c t i v e must be to prevent them from e n t e r i n g the environment i n the f i r s t p l a c e . The  act g i v e s the SPA an e x t e n s i v e range of a u t h o r i t y t o  i n s t i t u t e pre-market  controls  (Cleary e t a l . ,  1978): E x i s t i n g  chemicals are being catalogued and the EPA r e c e i v e s n o t i c e of a l l new  chemical and e x i s t i n g chemicals with new  uses; I n d u s t r y  t e s t s o f chemical and chemical mixes can be r e q u i r e d ; Chemicals with i n s u f f i c i e n t  i n f o r m a t i o n and s i g n i f i c a n t exposure  withheld from the market; Chemicals, new p r e s e n t i n g unreasonable  can  be  or e x i s t i n g ,  r i s k can be banned or r e s t r i c t e d  and;  The act r e g u i r e s extensive r e c o r d keeping and r e p o r t production. Already i n d u s t r y i s o b j e c t i n g t o EPA Act  (Hay,  1979). The proposed  approach  p r o p o s a l s under the  requires a r i g i d battery  of s p e c i f i c t e s t s , long and s h o r t term, b e f o r e a l l o w i n g a chemical t o be marketed. Industry a n t i c i p a t e s high c o s t , decreased i n n o v a t i o n and a shortage o f s k i l l e d  t e c h n i c i a n s to  c a r r y out the work as a r e s u l t of such a p o l i c y . The  OS has s p e c i f i c l e g i s l a t i o n designed t o c o n t r o l  p e s t i c i d e s although TOSCA may  be a p p l i e d  i f the a d m i n i s t r a t o r  122  f e e l s i t i s i n the p u b l i c ' s best i n t e r e s t  (Cleary g t a l , ,  1978), The l e g i s l a t i o n r e q u i r e s the r e g i s t r a t i o n of a l l p e s t i c i d e s with the EPA and t h e i r examination  f o r e f f i c a c y and  f o r s a f e t y t o man and environment. Present r e g u l a t i o n s p e r t a i n to c l a s s i f i c a t i o n and provide g u i d e l i n e s concerning safety,  user  proper procedures and permits f o r experimental use. As  with TOSCA, p o t e n t i a l hazard i s emphasised. Various other laws are germane t o the c o n t r o l of t o x i c c h e m i c a l s . Some o f the major l e g i s l a t i o n administered by the EPA f o l l o w s . The Clean A i r A c t and amendments r e q u i r e s the e s t a b l i s h m e n t of n a t i o n a l e m i s s i o n standards contaminants.  f o r various  The Hater P o l l u t i o n C o n t r o l Act and amendments  has s t a t e d g o a l s : "(1) t o o b t a i n , by 1983, an i n t e r i m l e v e l of water q u a l i t y t h a t provides f o r the p r o t e c t i o n o f f i s h , s h e l l f i s h and w i l d l f e and r e c r e a t i o n ; and (2) t o achieve the e l i m i n a t i o n of the discharge of a l l p o l l u t a n t s i n t o the waters o f the United S t a t e s by 1985" (OECD, 1976, p. 8 2 ) . A s i g n i f i c a n t point made by t h e OECD r e p o r t i s t h a t standards are based on f u t u r e technology and not on p r e s e n t l y a v a i l a b l e technology. The Marine P r o t e c t i o n Research  and S a n c t u a r i e s Act  l i m i t s or p r o h i b i t s the d i s p o s a l of harmful m a t e r i a l s i n t o the ocean e.g. c h e m i c a l s , b i o l o g i c a l warfare agents and r a d i o a c t i v e wastes.„It s p e c i f i c a l l y i n c l u d e s c o n s i d e r a t i o n of p o t e n t i a l environmental  damage as well as danger to human h e a l t h and  welfare. F i n a l l y , the Resources C o n s e r v a t i o n and Recovery Act d e a l s with the dumping of t o x i c c h e m i c a l s or other dangerous m a t e r i a l i n l a n d f i l l s , d i s p o s a l through means. Introduced  i n c i n e r a t i o n and other  i n 1970, t h e A c t was t o encourage  recycling  123  of waste m a t e r i a l . The and  designs The  guidelines for recycling  Drug A d m i n i s t r a t i o n  (FDA)  law.  administers  an  p i e c e o f l e g i s l a t i o n , the Food, Drujg and Cosmetic  •Containing any  provides  programs f o r waste management under the  Food and  important  EPA  Act  the Delany c l a u s e , i t p r o h i b i t s the a d d i t i o n of  carcinogens  to foods and  cosmetics,  although  h a i r dyes are  s p e c i f i c a l l y exempt from i t s p r o v i s i o n s . A l s o , i n f o l l o w i n g the Thalidomide tragedy,  the  1962,  Kefauver-Harris  Amendments were i n t r o d u c e d r e q u i r i n g f i r m s t o s u b s t a n t i a t e the e f f i c a c y and s a f e t y of new  drugs. Some economists have claimed  a s u b s t a n t i a l l o s s c f i n n o v a t i o n and c o n c e n t r a t i o n as i n c r e a s e d product c l o s i n g of the s m a l l e r f i r m s Various designed  a r i s e i n industry  c o s t and r i s k f o r c e the  (Grabowski and  Vernon, 1977).  laws under the Department of Transport  t o promote the safe t r a n s p o r t of t o x i c  (DOT)  are  chemicals  (OECD, 1976). Chemical and o i l s p i l l s from s h i p s are covered the O i l P o l l u t i o n Act of  1976.  t r a n s p o r t a t i o n are covered  e.g.  packaging and The  of  by the Dangerous Cargo Act,  T r a n s p o r t a t i o n Safety Act of S e c r e t a r y of Transport  Host other a s p e c t s  by  1974  and  o t h e r s . They give  the  power over a l l f a c e t s of t r a n s p o r t  labelling.  use o f chemicals  through the O c c u p a t i o n a l  i n the work place i s r e g u l a t e d Safety and  Health  Administration  (OSHA) (OECD, 1976). Broad powers are given the S e c r e t a r y  of  Labour through the O c c u p a t i o n a l  1970.  I t has  S a f e t y and H e a l t h Act of  p r o v i s i o n s f o r the s e t t i n g of standards,  r e c o r d i n g of  employee exposure, i n s p e c t i o n s and i n v e s t i g a t i o n s . Immediate c o r r e c t i v e a c t i o n may  be taken i f danger e x i s t s . A l s o , i n  124  c o n s u l t a t i o n with Health, Education and welfare of  o c c u p a t i o n a l s a f e t y and h e a l t h f a c t o r s may  (HEW), r e s e a r c h  be c a r r i e d  out  l e a d i n g t o the formation of c r i t e r i a and standards f o r handing t o x i c c h e m i c a l s . Examples of a c t i o n s taken are the emergency v i n y l c h l o r i d e u n i t standards s e t i n 1974  and  the a r s e n i c  standards i n 19 75. laws f o r the p r o t e c t i o n of consumers are a d m i n i s t e r e d the Consumer Product S a f e t y Commision  by  (CPSC). Four major a c t s  allow f o r the c o n t r o l of products and the enforcement of earlier  laws. The Consumer Product S a f e t y Act of 1972,  although  i t excludes tobacco, foods, drugs and cosmetics, has the a u t h o r i t y t o s e t standards on a v a r i e t y of products as w e l l as the mandate to e n f o r c e p r e v i o u s laws. Other a c t s are the F e d e r a l Hazardous Substances Act of 1953  Act of 1927,  the Flammable F a b r i c s  and the Poison P r e v e n t i o n Packaging  Act which  r e s p e c t i v e l y r e g u l a t e dangerous or i r r i t a t i n g chemicals i n consumer p r o d u c t s , domestic  f a b r i c s and c l o t h i n g , and  child-  proof caps.  A.3  Other OECD C o u n t r i e s  France The  purpose of the C o n t r o l of Chemicals  Environment B i l l  Disjgersed i n the  i s t o complement e x i s t i n g l e g i s l a t i o n which  governs only post-market  use of c h e m i c a l s . The b i l l  introduces  s c r e e n i n g of chemicals before l a r g e s c a l e manufacture i s  125  commenced chemical  (OECD, 1976).,Under the E i l l ,  a manufacturer of a  new  or an e x i s t i n g chemical coming under s u s p i c i o n must  provide i n f o r m a t i o n t o allow an e s t i m a t i o n o f p o t e n t i a l hazards. The  e v a l u a t i o n uses s p e c i f i c c r i t e r i a e.g. LD50  dose l e t h a l to h a l f c f the t e s t animals) man  and  environment. On  Category  II  I  i n Category  I may  to  chemical  (absolute e c o l o g i c a l danger) or  ( p o t e n t i a l e c o l o g i c a l danger). V a r i o u s  r e g a r d i n g s a l e , use, storage chemicals  to a s s e s s the r i s k  the b a s i s of the r i s k , the  w i l l be placed i n Category  (the  and  d i s p o s a l may  restrictions  be a p p l i e d and  be t o t a l l y banned. Expenses  i n c u r r e d i n p r o v i d i n g the i n f o r m a t i o n are borne by manufacturer i n the case of new  the  chemicals but i n the case  of  e x i s t i n g chemicals are shared among producers i n p r o p o r t i o n to the amount marketed i n the preceding two  years.,  A s i m i l a r c l a s s i f i c a t i o n system p r o v i d e s f o r the  control  of a g r i c u l t u r a l p e s t i c i d e s under the a d m i n i s t r a t i o n o f the m i n i s t r y of A g r i c u l t u r e (OECD, 1976), v a r i o u s commissions: s e t and r e v i s e standards i n c o n s u l t a t i o n with i n d u s t r y ; examine data in order to s e t r e s t r i c t o n s ; and c l a s s i f y and the e f f i c a c y of the chemical. The  determine  i n t e n t of the l e g i s l a t i o n  broadened to i n c l u d e p r o t e c t i o n of the g e n e r a l p u b l i c and  has  the  general environment from i t s p r e v i o u s narrower focus on efficacy  and  user p r o t e c t i o n .  According to the OECD r e p o r t other French l e g i s l a t i o n  has  organized c o n t r o l s a c c o r d i n g to the p o i n t of d i s t r i b u t i o n i n the environment, type of i n d u s t r y , method of t r a n s p o r t and forms o f use. The drawback of t h i s l e g i s l a t i o n i s that i t i s d i r e c t e d at s p e c i f i c substances  thereby l e a v i n g p o s s i b l e gaps  126  i n coverage. For example, i n d u s t r i a l discharges are c h e m i c a l l y complex whereas r e g u l a t i o n s are enacted only f o r a few s p e c i f i e d substances such as a s m a l l number of the many e l e c t r o - p l a t e p l a n t chemicals d i s c h a r g e d . A more general approach  i s being  developed.,  Japan The Chemical Substances  C o n t r o l Act was  enacted i n 1973  answer the need f o r c o n t r o l of p e r s i s t e n t chemicals by such  to  dramatized  d i s a s t e r s as the Minamata d i s e a s e (caused by mercury)  and the Kanemi r i c e bran o i l d i s e a s e (caused by p o l y chlcrinated act was  biphenyls)  (PCB)  (OECD, 1976). The i n t e n t of the  to allow f o r pre-market  examination and  c o n t r o l of  new  c h e m i c a l s . I t s p r o v i s i o n s i n c l u d e submission of i n f o r m a t i o n and review  with regard t o p e r s i s t e n c e , accumulation  and  toxicity  before production or i m p o r t a t i o n i s p e r m i t t e d . T e s t i n g i s q u i t e thorough, i n v o l v i n g  micro-organisms,  rate in f i s h , t o x i c i t y  solubility,  condensing  (broadly and s p e c i f i c a l l y ) using i n v i v o  t e s t s on m e t a b o l i c d e f e c t s , and pharmaco-dynamics. Those chemicals c o n s i d e r e d dangerous are l a b e l l e d  "specified  substances" and are l i a b l e t o be banned or r e s t r i c t e d i n use as w e l l as i n manufacture and i m p o r t a t i o n . The c o s t of the r e s e a r c h i s d i s t r i b u t e d under the P o l l u t i o n C o n t r o l P u b l i c works Cost A l l o c a t i o n Law The  .  aim of the A g r i c u l t u r a l Chemicals R e g u l a t i o n Law  provide s t a b l e p r o d u c t i o n and human and evironmental through  i s to  safety  s t a n d a r d i z a t i o n of chemical q u a l i t y and ensurance  of  127  proper use. B e g u l a t i o n s cover r e s t r i c t i o n s , p r o h i b i t i o n s , safety  criteria  concerning t o x i c i t y and p e r s i s t e n c e ,  and  d e t a i l e d i n s t r u c t i o n s on the use t o which c e r t a i n chemicals are to be put. A l l a g r i c u l t u r a l chemicals must be a v a i l a b l e f o r inspection  before  marketing.  Other r e g u l a t i o n s  allow f o r post-market  monitoring (OECD, 1S76). The B a s i c Law Protection  and  pollution  f o r Environmental  a l l o w s the use of broad powers t o implement measures  necessary to c o n t r o l p o l l u t i o n . More s p e c i f i c laws are i n the areas o f : p o l l u t i o n c o n t r o l establishing  with r e s p o n s i b i l i t y f o r  and r e v i s i n g s t a n d a r d s , monitoring and  p o l l u t i o n c o n t r o l programs; a i r p o l l u t i o n c o n t r o l r e s p o n s i b i l i t y to designate and e n f o r c e c o n t r o l s from combustion,  introducing  with on a l l gases  c e r t a i n t o x i c chemicals and auto  exhaust;  water p o l l u t i o n ; marine p o l l u t i o n ; and o t h e r s .  B. A n a l y s i s  of OECD Hodels  The two  approaches  i n t o x i c chemical c o n t r o l most apparent  over the l a s t few years have been i n j u r i s d i c t i o n o f l e g i s l a t i o n and from post-market respect  (1) l e g i s l a t i o n to cover gaps (2) the s h i f t i n emphasis  monitoring to pre-market  c o n t r o l . In t h i s  Canada has taken s i m i l a r a c t i o n . The  Contaminants Act i s designed t o f u l f i l l In c o n t r a s t  those two  to the US TOSCA, but i n accordance  approach, c o n s u l t a t i o n This contrast  Environmental  with i n d u s t r y  between US and Canadian  i s explicitly  functions. with the included.  l e g i s l a t i o n i s perhaps  UK  128  due  to the d i f f e r e n c e i n l e g a l s t r u c t u r e s i n c e , i n g e n e r a l ,  Canadian c o u r t s do not serve the same purpose as OS c o u r t s do i n t e s t i n g agency d e c i s i o n s . C o n f r o n t a t i o n s between government agencies and i n d u s t r y are avoided  as much as p o s s i b l e by the  c o n s u l t a t i v e process. Thus, the approach i s p o l i t i c a l l y accommodating while e x t e n s i v e i n t e r a c t i o n with a f f e c t e d  groups  should enable the design of a c c e p t a b l e and e f f i c i e n t legislation. &s mentioned, a l l of the s e l e c t e d OECD c o u n t r i e s have implemented some form of pre-market c o n t r o l t o d e t e c t  hazards  b e f o r e p r o d u c t i o n . T h i s i s , perhaps, i n r e c o g n i t i o n of the i n s i d i o u s nature of many of the t o x i c chemicals  produced (as  mentioned e a r l i e r , they are o f t e n t o x i c i n very s m a l l amounts, p e r s i s t e n t and have l a t e n t e f f e c t s ) . I t i s the implementation of the r e g u l a t i o n s attached to t h e a c t s which have caused c o n t r o v e r s y . The r e g u l a t i o n s accompanying TOSCA f o r example, have caused  an acrimonious  debate between the EPA and the  chemical i n d u s t r y (Hay, 1979)• The EPa proposes a r i g i d and e x t e n s i v e s e r i e s of t e s t s conducted p e r m i t t e d . The chemical companies  before r e g i s t r a t i o n i s (who bear the cost) f e e l the  c o s t of t h i s approach i s e x o r b i t a n t and much favour the UK approach which i n c l u d e s a more f l e x i b l e schedule  o f t e s t s . In  the UK, i f p r e l i m i n a r y r e s u l t s prove a c c e p t a b l e , the chemical can be marketed. Only i f s u s p i c i o n s a r e aroused tests  are long term  necessary. The  p r i n c i p l e drawback of pre-market t e s t i n g i s the c o s t  i n c u r r e d i n processing each of the l a r g e number of chemicals i n t r o d u c e d . The US has committed  vast resources to simply  129  establishing a l i s t  of chemicals f o r r e g i s t r a t i o n . In a d d i t i o n  to d i r e c t c o s t s of t e s t i n g , r e p o r t i n g and may  be i n d i r e c t i n t e r n a t i o n a l c o s t and  1S78). The which may  OS has  record  keeping,  domestic c o s t s  (Ross,  a $6 b i l l i o n d o l l a r chemical export  be j e o p a r d i z e d .  there  industy  TOSCA could f o r c e f o r e i g n companies  to t e s t t h e i r products to meet American reguirements j u s t to r e t a i n the US  market, making TOSCA i n e f f e c t , a n o n - t a r r i f  b a r r i e r . I f other c o u n t r i e s were to r e a c t by  banning US  the American i n d u s t r y ^ export b u s i n e s s could be But, Canadian e x p o r t s are not as e x t e n s i v e l e s s r e f i n e d i n nature reducing  the  and  destroyed.  are  generally  importance o f such f a c t o r s .  However, some agreement on i n t e r n a t i o n a l standards may step toward r e s o l u t i o n of the problem f o r the Domestic c o s t that may innovation  and  be a  future.  occur are the decrease i n  the l o s s of s m a l l e r companies l e a d i n g  decreased competition.  imports  to  Grabowski et a l . (1977,1978)  i n v e s t i g a t e d the e f f e c t of l e g i s l a t i o n r e g u i r i n g pre-market proof o f e f f i c a c y and  s a f e t y on the  They contend that the i n c r e a s e d failure  American drug  industry..  c o s t o f t e s t i n g and  r e s u l t e d i n fewer u s e f u l new  number of companies i n the i n d u s t r y  drugs and  of r i s k  reduced  the  without a b a l a n c i n g  rise in  s o c i a l b e n e f i t . In the chemical i n d u s t r y , the d i r e c t c o s t t e s t i n g , r e p o r t i n g , record keeping and  time delay  s i m i l a r r e s u l t . In a d d i t i o n , the r i s k of f a i l u r e competitive  edge could  money spent on research research  may  lead t c a r e d u c t i o n and  may  of  have a  or l o s s of a  i n the amount of  development. Extensive  and  go i n t o a chemical t h a t i s then designated  r e q u i r i n g more t e s t i n g . Not  of  costly as  only i s i t s i n t r o d u c t i o n delayed.  130  perhaps f o r years,  but each agency handling  p o s s i b l e l e a k of trade " c o s t s " may  i t represents  s e c r e t s t o competitors.  f o r c e otherwise competitive  a  These e x t r a  companies from  the  industry. a l s o , t h i s domestic c o s t may  be s u f f i c i e n t  to i n h i b i t  the  growth of secondary chemical i n d u s t r y i n Canada. But because research not  and  development i n the Canadian chemical i n d u s t r y i s  as e x t e n s i v e  effect  may  not  at that of i t s american c o u n t e r p a r t ,  be as s t r o n g . Canada's i n d u s t r y d e a l s l a r g e l y i n  bulk c h e m i c a l s which i n v o l v e s only a s m a l l amount of and  innovation,  of the  with regard  be  to standard  OK,  s e t t i n g , s t a t e g i e s employed can areas:  uses g u i d e l i n e s  by s t a t u t e s as necessary. T h i s approach allows procedure with the  r e g u l a t i o n s should  (3)  versus f u t u r e technology.  i n an o c c u p a t i o n a l c o n t e x t ,  i n content and  be  ( 1 ) g u i d e l i n e s versus  (2) c e n t r a l versus l o c a l c o n t r o l , and  meeting standards by present The  part  inhibited.  i n t o at l e a s t three  fixed statues,  research  however, expansion of the more i n n o v a t i v e  i n d u s t r y may  categorized  the  for  backed  flexibility  h i n t of more r i g i d  they be n e c e s s a r y . A weakness with t h i s  approach i s the i n a b i l i t y  of independent t h i r d p a r t i e s to  monitor the compliance of i n d u s t r y . S i n c e , i n Canada, information  i s d i f f i c u l t f o r the p u b l i c to o b t a i n , there  a tendency f o r e n f o r c e r s  to i d e n t i f y with the r e g u l a t e d  than the r e g u l a t o r s . The  p u b l i c may  perceive  are: f i r s t , the d i f f i c u l t y i n p r o v i d i n g  wording to guide a d m i n i s t r a t o r s ;  second,the  be  rather  t h i s as l a x  enforcement. ,.0n the other hand, problems with standards i n t o law  may  written  precise  inflexibility  131  should change be r e q u i r e d ; and necessary  to pass such  laws.  i n t e r e s t groups are l i k e l y  finally,  the amount of  Both environmental  time  and i n d u s t r y  t o to c o n f r o n t government with  s t r o n g l o b b i e s on each issue c a u s i n g delay and  increased court  costs. In c o n s i d e r i n g the b e n e f i t s and c o s t s of l o c a l c e n t r a l c o n t r o l o f environmental  versus  standards, a compromise seems  p o s s i b l e . There i s much v a r i a t i o n i n l o c a l c o n d i t i o n s a c r o s s Canada and  t h e r e f o r e , much v a r i a t i o n i n each area's a b i l i t y  to  absorb p o l l u t i o n without e x c e s s i v e damage. A l s o , the b e n e f i t s t c l o c a l areas may likely  vary c o n s i d e r a b l y . Economic i n e f f i c i e n c y i s  to r e s u l t i f strong standards prevent  a d j u s t i n g t h e i r own  r e g i o n s from  l e v e l s . However, some minimal g u i d e l i n e s  seem d e s i r a b l e to prevent i r r e v e r s i b l e damage to s o c i a l l y g e o g r a p h i c a l l y i s o l a t e d areas. Thus, minimal f e d e r a l  or  standards  could be a p p l i c a b l e i n the absence of other more r i g o r o u s standards. An unusual "territorial  aspect of t h i s area l i e s i n the e x i s t e n c e of a  i m p e r a t i v e " . The  present p o l i t i c a l  seems t o be away from c e n t r a l c o n t r o l and autonomy. The  toward  trend i n Canada provincial  t e r r i t o r i a l i m p e r a t i v e s of both the f e d e r a l  and  p r o v i n c i a l governments can l e a d t o a competition to c o n t r o l p o l l u t i n g companies. Such a c o m p e t i t i o n can be manifest  as  a l t e r n a t i n g i n c r e a s e s i n standards as each government v i e s with the o t h e r t o have the most s t r i n g e n t and t h e r e f o r e c o n t r o l l i n g standards. One  of the f e a r s of s e t t i n g standards i s t h a t they become  maximum as w e l l as minimum requirements  (Borchard and  Walton,  132  1571). As mentioned l a t e r , t h i s tends to occur more with smaller,  l e s s permanent companies than with  companies who by  have a r e p u t a t i o n  the f a c t t h a t the s m a l l e r  terms o f c a p i t a l and liability  more to l o s e and One  way  OS  companies have l e s s to l o s e i n  greater  therefore,  have l i m i t e d  liability.  of i n s u r i n g against  has  such abuse i s to write more  ahead of a v a i l a b l e technology such  done with i t s water a c t . The  t h a t the technology w i l l not  danger of course i s  evolve r a p i d l y enough to meet  standards or that i t w i l l prove uneconomical. Such reguire  c o n s t a n t s u r v e i l l a n c e to ensure that an  over or under r e g u l a t e d . e f f e c t i v e i s the  would then c a r r y such p o l i c y and damages and  industry  of p e r s o n a l l i a b i l i t y  Knowledge and  with i t the  the  stategies  A second approach which may  introduction  corporate executives.  explained  l a r g e r companies have c o r r e s p o n d i n g l y  s t r i n g e n t standards i n t o law as the  to protect. This i s  business and  f o r damage. The  established  i s not  be for  c o n t r o l of company p o l i c y  r e s p o n s i b i l i t y f o r the r e s u l t s of  make s e n i o r e x e c u t i v e s p e r s o n a l l y  liable for  p e n a l t i e s . Drawbacks to such a p o l i c y could  be  the  d i f f i c u l t y i n e s t a b l i s h i n g the degree of c o n t r o l each e x e c u t i v e might have (hence the amount of r e s p o n s i b i l i t y ) and d i f f i c u l t y i n providing Such a p o l i c y may  i n s u r a n c e to r e s p o n s i b l e  then a c t t o c o n s t r a i n  the  executives.  entrepreneurial  a c t i v i t i e s as w e l l as decreasing p u b l i c r i s k . A net l o s s of s o c i a l b e n e f i t may  occur.  

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