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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 University 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 Administration) We accept this thesis as conforming to the required standard THE UNIVERSITY OF BRITISH COLUMBIA A p r i l 1980 (c) John Robert Sturdy, 1980 In presenting this thesis in partial fulfilment of the requirements for an advanced degree at the University of Brit ish 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 Br it ish Columbia 2075 Wesbrook Place Vancouver, Canada V6T 1W5 E-6 B P 75-51 1 E ABSTRACT This thesis examines the e x i s t i n g constraints and opportunities that shape present and future chemical cont r o l . I t argues that a lack of adequate and accessible information i s the l i m i t i n g factor and presents steps to expand those l i m i t s . Federal and 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 regulate a l l aspects of the problem including enabling l e g i s l a t i o n , regulations and guidelines, information access and compensation. The impediments to regulation are not therefore, c o n s t i t u t i o n a l but rather the large number of chemicals and the lack of a method to choose candidates f o r control. A pre-market strategy 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 control among the many chemicals posing a potential hazard. Hazard was described as a function of the exposure to a chemical and the consequences of that exposure. Thus, chemicals with large exposure and harmful consequences would be candidates f o r control while, conversely, chemicals with l i t t l e exposure and n e g l i g i b l e consequences would not. The necessity for information on those in between would be determined from the extent of exposure or of hazard known. Approaches to transform public opinion and s c i e n t i f i c knowledge into standards for chosen candidates was examined. No method of a r r i v i n g at an optimal standard was found. Therefore, judgment i s necessary. To aid i n a r r i v i n g at acceptable standards a consultative approach with government, industry and i i i the public as participants was suggested. Rational decisions would be aided by the a v a i l a b i l i t y of adequate information. To provide the necessary information an information system i s advocated. Three model systems were reviewed. Deficiencies were analyzed and prescriptions for design improvements were made. Some of the key points discussed are compatibility, standardization of data, storage and r e t r i e v a l problems, organization and c o n f i d e n t i a l i t y . iv TABLE OF CONTENTS ABSTRACT ................ ... ...................•.......... i i INTRODUCTION ..... .... ...... . . .. ..... ........ 1 1. INSTRUMENTS OF CONTROL 7 1.1 Current Canadian L e g i s l a t i o n 7 1.2 L e g i s l a t i v e Constraints ........................... 13 1.2.1 Federal J u r i s d i c t i o n ........................ 14 1.2.2 Provincial J u r i s d i c t i o n 17 1.2.3 Summary of Federal and P r o v i n c i a l Powers .... 17 1.3 Information Access ........................ 18 1.3.1 Summary of Information Access ............... 21 1.4 Compensation 21 1.5 Conclusions .......... ............................. 23 2. ESTA BLISMENT OF PRIORITIES FOB REGULATION 28 2.1 Exposure Determination ............................ 29 2.2 Environmental Dynamics ............................ 32 2.3 Analogous Consequences ............................ 37 2.3.1 Common Sense ........................ 33 2.3.2 Occupational Exposure ....................... 38 2.3.3 Epidemiology ......... 39 2.3.4 Extrapolation from Animal Tests ............. 40 2.3.5 Extrapolation from In Vitro Tests ........... 42 2.3.6 Extrapolation from Radiation Data ........... 43 2.4 Chemical Behavior ................................. 43 2.4.1 Atmospheric Interactions .................... 44 2.4.2 Aquatic Interaction 46 2.4.3 T e r r e s t r i a l Interaction 47 2.4.4 Microbial Interaction ....................... 48 2.4.5 Prediction Capability ....................... 49 2.5 Conclusions ....................................... 51 3. STANDABD SETTING ............................. ......... 55 3.1 Standard Setting Approaches ....................... 55 3.1.1 The Delaney P r i n c i p l e ....................... 56 3.1.2 No Detectable Adverse Eff e c t ................ 60 3.1.3 Toxicologically I n s i g n i f i c a n t Levels ........ 62 3.1.4 The Threshold P r i n c i p l e ..................... 62 3.1.5 Standard of Osage 63 3.1.6 P r a c t i c a l Constraints ....................... 64 3.1.7 Degree of Necessity of Benefit 65 3.1.8 Reasonableness ...... .... . . ........ .. ........ 66 3.1.9 Prevailing Professional Practice ............ 67 3.2 Modifiers of Standard Setting Approaches ..........68 3.2.1 Voluntary Versus Involuntary Bisk ........... 69 3.2.2 Temporal D i s t r i b u t i o n of Bisk 70 3.2.3 The Certainty of Risk • ...w,,«>.w. • •/! 1 3.2.4 Necessity of Exposure ....................... 72 3.2.5 Occupational 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 to Risks ............. 74 3.2.8 Chemical Propensity for Misuse .............. 74 3.2.9 R e v e r s i b i l i t y of Effects .................... 75 3.3 Conclusions ............................ 76 4. INFORMATION SYSTEMS .............^.................. ... 82 4.1 Information Systems ............................... 82 v i 4.1.1 Necessity ............ * ........... .. ...... ,.. 82 4.1.2 Systems Models .............................. 85 National .................................. 86 European ..... ........ ... ..... ...... ........ 86 international ................... .......... 87 Other Systems 90 4.1.3 Problem Areas ............................... 91 Data Quality ....,..,........,,...,.,..,...91 Design Problems ........................... 9 3 funding and Users ......................... 97 Technical Expertise 98 4.2 Conclusions . ............. ............ ...... ....... 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 States of America 121 A.3 Other OECD Countries 124 B. Analysis of OECD Models . . . . * i . . . . 1 2 7 1 INTBOPqCTION There i s strong evidence of a problem a r i s i n g from chemical contamination of our environment. The International Agency for Besearch on Cancer estimates that 80% of cancer i s caused by environmental factors (Higginson, 1968) and the plethora of new chemicals ranks at least as a s i g n i f i c a n t minority on the l i s t of potential carcinogenic factors (Bridges, 1976). In addition to the carcinogens, there are a host of chemicals with proven toxic a f f e c t s which cause deterioration of nervous systems, of pulmonary functions, of cardiovascular e f f i c i e n c y and of a c t i v i t y of various other organs. . The pot e n t i a l health r i s k from chemicals becomes of grave importance when the number of chemicals i s estimated. The American Chemical Society (1978) indicates that there are four mil l i o n chemicals i n existence with 6000 new ones being discovered each week. About 1000 of these new chemicals are added t c the present 50,000 commercial chemicals each year (Devoret, 1979), circumstances indicate that some form of government intervention i s required. Market mechanisms can lead to e f f i c i e n t choices in some instances but i n many cases the basic assumptions governing e f f i c i e n t market choices are violated. Some of the relevant assumptions that are not met severely i n h i b i t the function of the free market process. For example, possession of adequate information by consumers i s assumed. But i n many instances the 2 lay public 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 marginally more enlightened. The number and variety of chemicals produced precludes exhaustive study of each i n d i v i d u a l new chemical. Synergistic and stochiometric interactions between chemicals which can occur,in an almost unimaginable number of combinations makes a thorough study of chemical e f f e c t s even more d i f f i c u l t . Mercury, for example, was found tc the surprise of s c i e n t i s t s , to be converted i n the presence of the metabolic enzymes present in certa i n bacteria to a more toxic form. A second assumption violated i s the assumption of the independence of the consumption units. Negative e x t e r n a l i t i e s from the consumption of chemicals by one group are imposed on other groups without th e i r consent. For instance, DDT found i t s way into v i r t u a l l y every earthly place including mother's milk (Lowrance, 1976). Because of the e x t e r n a l i t i e s and the lack of information, conscious choice between the level s of r i s k cannot be made. It i s further aggravated by the heterogeneity of the ris k l e v e l s of a population. The l e v e l may vary according to the s e n s i t i v i t y of the person exposed. A fetus exposed to thalidomide (a drug used for sleeping tablets and tranquilizers) i s at f a r greater r i s k than a adult (Lawless, 1977).,Thus, the free market system has th e o r e t i c a l f a i l i n g s which are borne out by the empirical evidence of substantial chemical hazard. In addition, the present i n s t i t u t i o n a l structures and l e g i s l a t i o n were set up to deal with p o l l u t i o n problems recognized i n e a r l i e r times. They grew in a piecemeal way and 3 may be unable to cope with the new problems..Earlier recognized chemical pollutants, or c l a s s i c a l pollutants, 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 throats, t a i n t water and cloud the skies among other e f f e c t s . Since these pollutants could be seen, tasted and immediately f e l t , t h e i r presence and effect were obvious. This acuteness f a c i l i t a t e d the formulation and public acceptance of measures to counteract undesirable c h a r a c t e r i s t i c s . Foam from detergents, smog from cars, sewage i n potable water, a l l are examples of contaminants that are controlled by pollution l e g i s l a t i o n that i s accepted by the public. But new pollutants are d i f f e r e n t i n several respects (Page, 1978) . F i r s t , they are very potent. .Concentrations measured i n parts per b i l l i o n (ppb) or even parts per t r i l l i o n (ppt) can have disastrous consequences. For example, mercury at l e v e l s over f i f t y ppb i s considered unacceptable (World Health Organization, 1967). Second, the time span between exposure and evidence of e f f e c t can be very long: Skin cancer from coal tar has a latency period of ten to twenty years (Heuper, 1959). Detection i s often complicated because the e f f e c t may not be unique. It may be manifested simply as an increase i n the number of anomalies which already occur. This makes the epidemiology of detection very d i f f i c u l t . Some chemicals found to be harmful were only discovered because they produced peculiar, rare consequences. For example, the t e r r i b l e e f f e c t s of thalidomide might have gone much longer without detection except for the c h a r a c t e r i s t i c and unusual deformity which 4 resulted (Lawless, 1577). Carcinogens often seem to produce an o v e r a l l , small increase i n a common cancer rather than a new tumor, a s p e c i f i c cancer or a marked increase i n cancer of one area. Third, the uncertainty present i n extrapolating from aff 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 test system to an estimate of the potential danger to humans leaves much room for a wide divergence of opinion. The connection between animal and human cancer i s only circumstantial. Thus, a nicety of balance i n the trade-off between r i s k and cost i s required including among other things, an i m p l i c i t value on human l i f e . Fourth, many chemicals have environmental and human a f f e c t s that are es s e n t i a l l y i r r e v e r s i b l e such as destruction of lakes by acid rain or some cancer forms. F i n a l l y , t r a d i t i o n a l mechanisms for dealing with costs, benefits and r i s k s are not operating e f f i c i e n t l y . Benefits of chemicals are transferred i n d i r e c t l y by the market while costs are distributed d i r e c t l y through environmental hazards. Since r i s k i s so ubiquitous, the standard compensation methods f a i l . Insurance, for example, i s i n e f f e c t i v e in s i t u a t i o n s where many people are affected simultaneously. These fa c t o r s , potency, latency, 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 to l i m i t the effectiveness of current i n s t i t u t i o n a l structures and l e g i s l a t i o n . Some kind of government intervention i s deemed necessary. The extent and manner of the intervention are to be examined. This thesis w i l l examine the existing constraints and opportunities that may shape the future chemical control regulations. I t w i l l argue that a lack of adequate and 5 a c c e s s i b l e i n f o r m a t i o n i s the l i m i t i n g f a c t o r and w i l l present s t e p s t o expand the l i m i t s imposed by t h i s c o n s t r a i n t . The f i r s t chapter reviews the instruments of c o n t r o l . E x i s t i n g Canadian l e g i s l a t i o n i s surveyed to provide a g e n e r a l background. From t h i s base, the f e d e r a l and p r o v i n c i a l governments' p o t e n t i a l and need t o d r a f t f u t h e r l e g i s l a t i o n i s examined. The governments 1 a b i l i t y t o l e g i s l a t e access t o i n f o r m a t i o n and t o c c a p e l p a r t i c i p a t i o n of i n d u s t r y i n compensation schemes i s c o v e r e d . . F i n a l l y , some s i m i l a r i t i e s with s e l e c t e d i n d u s t r i a l i z e d c o u n t r i e s are noted. „ Chapter two suggests t h a t the number of e x i s t i n g and new chemicals i s too great to allow a comprehensive examination of each substance. & scr e e n i n g system i s necessary to designate chemials f o r r e g u l a t i o n . I t t h e r e f o r e a p p r a i s e s the elements of a s t r a t e g y t o 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 . The elements reviewed i n c l u d e determination o f exposure, i n t e r a c t i o n with the environment, e x t r a p o l a t i o n from v a r i o u s t e s t s and events, and determination o f chemical behaviour. & s t r a t e g y composed o f these elements w i l l r e q u i r e a c c u r a t e and comprehensive data to make r a t i o n a l c h o i c e s among ca n d i d a t e s f o r r e g u l a t i o n . The t h e s i s next examines approaches that may be u t i l i z e d i n t r a n s f o r m i n g p u b l i c o p i n i o n and s c i e n t i f i c i n f o r m a t i o n i n t o standards f o r chosen c a n d i d a t e s . Chapter three i s d i v i d e d i n t o two s e c t i o n s . The f i r s t s e c t i o n p r e s e n t s a s e r i e s of techniques f o r c o n s t r u c t i n g standards. These techniques are superimposed on a co n c e p t u a l framework ascending from a n o - r i s k approach to a r i s k - b e n e f i t t r a d e - o f f . The f a c t o r s of the second s e c t i o n 6 modify the techniques i n the f i r s t section and introduce the ef f e c t of public r i s k perception. Emphasis i s placed on the concept of acc e p t a b i l i t y as a necessary condition for successful standard setting. Chapter four introduces the information system as a means of providing the data needed for choosing candidates and establishing standards. Some systems currently i n use are described. Their d e f i c i e n c i e s are analyzed and prescriptions for design improvements are made.; The l a s t chapter provides a summary of the analyses and recommendations of the thesis. 7 i i IJSfJOHENfS OF CONTROL 1.1 CUBBENT CANADIAN LEGISLATION Given that some change in government control of toxic chemicals i s necessary, i t i s useful to examine federal and pr o v i n c i a l posers to ef 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 regarding environmental and commercial chemicals and drugs w i l l be examined. In addition, l i m i t a t i o n s on the a b i l i t y to draft 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 constraints w i l l be reviewed. F i n a l l y , the approaches of other Organization for Economic Cooperation and Development (OECD) countries, notably the United States (OS) and the united Kingdom (UK), to toxic chemical control w i l l be surveyed f o r appropriate models applicable to the Canadian arena. In examining present Canadian statutes i t i s convenient t c categorize them according to t h e i r purpose. The Canadian l e g i s l a t i o n to control chemical hazards i s c l a s s i f i e d by Franson et a l . (1977) into ten categories. (1) The f i r s t category. General Pollution Control Statutes, contains both federal l e g i s l a t i o n and statutes from a l l provinces. The p r o v i n c i a l regulation systems use two main techniques: (a) permits and approvals to control disposal of contaminants 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 si t u a t i o n s of discharge into the environment. For example, i n Ontario, approvals u t i l i z i n g standards derived from regulations concerning ambient a i r quality are used to control 8 air contaminants; (b) the second technique i s the authority of the Environment Minister to use stop or control orders when he establishes to his s a t i s f a c t i o n that a contaminant w i l l decrease environmental quality. The main federal pollution control acts are the Canada Water act the Clean Air Act, and the F i s h e r i e s Act. A l l three acts are general i n nature but because of incomplete implementation, the l a t t e r two acts are limited i n practice. (2) The second category deals with I n d u s t r i a l Safety, Workman's Compensation and Occupational Health Statutes. Although a l l provinces have i n d u s t r i a l safety l e g i s l a t i o n , the statutes vary from general requirements of a common sense nature (e.g. prevent exposure to tox i c chemicals, l i m i t use or handling of dangerous substances, and provide proper v e n t i l a t i o n or protective clothi n g ) , to s p e c i f i c l i m i t s t c c e r t a i n chemicals (e.g. lead, v i n y l chloride and asbestos). (3) The t h i r d contains Special Statutes Regulating P a r t i c u l a r Contaminants. A s p e c i f i c contaminant per se may be regulated, (e.g. p r o v i n c i a l and federal pesticide controls) or regulations may pertain to a contaminant i n a substance (e.g. lead i n leaded gasoline).,(4) Category four deals with Motor Vehicle Standards and contains federal and p r o v i n c i a l l e g i s l a t i o n on motor vehicle emissions. (5) The f i f t h encompasses Public Health Acts. Here Franson et a l . (1977) perceive l i t t l e overlap between federal and provincial statutes. Federal health regulations are mainly concerned with s p e c i f i c areas l i k e food safety and dangerous consumer products. Health acts a f f e c t other areas as well as public health. Some p r o v i n c i a l acts pertain to occupational health to control the use of a 9 p a r t i c u l a r contaminant and other acts contain elements of poll u t i o n control. (6) The sixth category covers the Federal Food and Drug act which contains the fundamental controls for contaminants i n food and drug products. S p e c i f i c standards deal with quality and quantity of substances, packaging and toxic chemicals such as lead. . (7) Only one piece of l e g i s l a t i o n i s in the seventh category. General Contaminants Control statutes, and that i s the federal Environmental Contaminants Act . I t i s used to supplement and reenforce, the predominantly p r o v i n c i a l l e g i s l a t i o n i n the area (OECD, 1976). For example, i t may supplement the pr o v i n c i a l pharmacy acts which regulate a more r e s t r i c t e d range of chemicals. The act allows for investigation of suspicious substances. I f the suspicions are j u s t i f i e d , i .e " s i g n i f i c a n t danger to health or the environment" (p.,32) e x i s t s , then the chemical may be added to the Schedule of the Act allowing r e s t r i c t i o n s respecting importation, manufacture or use to be applied a f t e r consultation with other authorities to establish the absence or presence of other applicable statutes (OECD, 1976) or in some other way. I t i s designed to act i n two ways. I t allows for the normal, measured flow cf process providing due consideration during situations of everyday business but, i s ready for immediate action i n emergency situ a t i o n s (Ince, 1976). The 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 of the other OECD c o u n t r i e s 1 , 1. A review and an analysis of the l e g i s l a t i o n of OECD countries i s in the appendix. 1 0 the act i s usually applied 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 action can be taken under the Environmental Contaminants Act, considerable discussion between federal and pr 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 applicable (Ince, 1976). I f the j u r i s d i c t i o n s of the various departments are vigorously defended a substantial lapse of time can occur. The Act represents a s h i f t i n emphasis from post-market monitoring to pre-market screening which i s common to other OECD countries. However, a problem with the Act i n thi s capacity l i e s i n i t s lack of s e n s i t i v i t y to small amounts. The ef f i c a c y of the Act with regard to pre-market screening may be limited since the only n o t i f i c a t i o n of chemicals required are for those manufactured or imported i n quantities 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 organizational aspects of the Act allow a great deal of f l e x i b i l i t y i n approach (OECD, 1976).Experts decide what substances to investigate, gathering a l l available information. The appropriate tests are to be carr i e d out (after agreement with industry i f possible) at industry expense and the r e s u l t s reviewed by the government. Conditions of sale are decided after consultation with industry, other governments and federal agencies to decide on the method of control..The Environmental Contaminant Act allows for whatever actions are required. Ince (1976) points out that the advantages l i e i n the p o l i t i c a l convenience of the statutes and i n the potential e f f i c i e n c y of the r e s u l t i n g regulations. The existence of the Act gives the 11 appearance of a strong stand to s a t i s f y environmental i n t e r e s t groups while allowing input from affected parties before the actual regulations are designed. (8) the eighth category i s Parti c u l a r Besource Statutes containing l e g i s l a t i o n for management of resources. It i s usually guite detailed and contains regulations to c o n t r o l p o l l u t i o n ; e.g. The Saskatchewan Pollution Prevention Regulation • for the Mineral Industry . (9) Category nine, Special Industry Regulation Statutes, contains pro v i n c i a l and federal l e g i s l a t i o n . The pr o v i n c i a l l e g i s l a t i o n as noted by Franson et a l . , tends toward the general, although laws dealing with areas such as mine safety, and pesticides are more s p e c i f i c . Federal statutes 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 Preventions Bequlations (part of the Canada Shipping Act) and the F i s h e r i e s Act .dealing respectively with discharge from ships and i n d u s t r i a l discharge in t o water such as pulp and paper m i l l effluent and petroleum r e f i n e r i e s . (10) The l a s t category, number ten, contains Consumer Safety Statutes. These range from those concerned with food and drug safety (the f e d e r a l Food and Drug Regulations and p r o v i n c i a l public health standards) to those concerned with poisons (the federal and p r o v i n c i a l pesticide acts) and f i n a l l y , to one concerned with other aspects of consumer safety, the federal Hazardous Products Act ) . The l a t t e r deals with the s p e c i f i c standards, for example, lead and asbestos in a myriad cf consumer products including childrens toys. In examining the categories presented above, Franson et a l . i d e n t i f y two main control mechanisms. Both are used with apparent randomness in federal and p r o v i n c i a l statutes and 12 sometimes i n the same statutes, one approach to regulation i s distinguished by the use of agencies, o f f i c i a l s or departments to issue licenses or approvals. Guidelines are established to outline procedures and q u a l i f i c a t i o n s necessary to obtain governmental sanction. A guideline i s defined as "an informal statement issued by a regulatory agency setting forth the standards of conduct that i t expects those under i t s control to exercise" (Franson et a l . , 1977, p. 34). This i s compared to a regulation which i s defined as "a rule made by competent authority r e l a t i n g to actions of those i n direct control (Franson et al.> 1977 p. 34). The l e g a l difference between guidelines and regulations i s that regulations are s p e c i f i c laws, and as such are enforceable i n court whereas guidelines are not enforceable i n court. Also, regulations have a higher p r o f i l e , being generally passed by Order-in-Council and published i n the o f f i c i a l Gazette, whereas guidelines are much les s obvious. To uncover guidelines i t i s often necessary for an outsider to 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 in which case even dir e c t inquiry w i l l not unveil them. The second p r i n c i p a l mechanism i s described by Franson et a l . as "out-right prescription" (p. 46) in which case a pa 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 standard associated with i t . To enforce compliance with the standard the government has recourse to quasi-criminal sanctions which may include c o n f i s c a t i o n . In some cases, the prescriptive regulations serve as a 13 backup for the more common, dail y use of the l i c e n s i n g and approval mechanism. For example, the federal Food and Drug. Act provides for standards and allows f o r guasi-criminal proceedings i f the standards are not met. However, the d a i l y order of business u t i l i z e s warning l e t t e r s and other informal methods such as negotiation to encourage voluntary withdrawal of chemicals v i o l a t i n g standards. Also, i n practice, submission of product tests and information for review routinely r e s u l t s in "approval" for product manufacture and sales. /In estab l i s h i n g the regulations, a f a i r l y informal process involving information c i r c u l a r s and s o l i c i t i a t i o n of industry 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 to enable l e g i s l a t i o n concerning new areas i s analyzed. This section deals with the potential of the federal and p r o v i n c i a l governments to produce and enforce l e g i s l a t i o n regulating t o x i c chemicals. I t w i l l cover the j u r i s d i c t i o n of the federal and p r o v i n c i a l governments, the posers avai l a b l e , the governmental versus i n d i v i d u a l r i g h t to information and the right to compensation of individuals and corporations who have been harmed by toxic substances. 14 1.2.1 Federal J u r i s d i c t i o n The B r i t i s h North America Act (BNA Act) establishes federal j u r i s d i c t i o n (Franson et a l . r 1977). Some areas of exclusive 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 , shipping and navigation. As well, l e s s s p e c i f i c powers are allocated f e d e r a l l y under Section 91. General powers with the greatest potential for control of tox i c substances exist i n the two areas of criminal law and trade and commerce. These l a t t e r two w i l l be examined f i r s t . , Criminal Powers The powers that the federal government has under criminal law are very broad. In e f f e c t parliament has the power to recognize new crimes and enact l e g i s l a t i o n to prevent them, " i n fact , i t has been said that any time Parliament prohibits certain conduct and attaches penal conseguences for engaging i n i t , that l e g i s l a t i o n may be sustained under the criminal law power" {Franson et a l . 1977, p. ,14). Some l i m i t a t i o n s of the federal use of criminal law power exi s t i n practice and are summarized by Franson et a l . (1977). F i r s t , the courts tend to defend areas of pr 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 confined to regulation of l o c a l trade which, in any case, would not be encroached upon by federal regulation concerning toxic sustances. Also, the potential for federal 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 of crime prevention. Le g i s l a t i o n governing the production and d i s t r i b u t i o n of 15 chemicals that may harm ethers f u l f i l s the defined intention of such laws quite well. In f a c t , some l e g a l precedent already e x i s t s (Franson et a l . , 1977) to support t h i s contention.,The second problem i s that because of strong t r a d i t i o n i n another area dealing with possible remedies and sanction under criminal law, some useful remedial action may not be allowed. Tradition has established that persons found g u i l t y before ordinary Court of contravening the l e g i s l a t i o n should suffer a fine or imprisonment. Maintenance of, and l i m i t a t i o n to these modes of action has been advocated. Franson et a l . (1977) note that acceptance of this 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 actions as stop orders and advance ru l i n g s . Given the courts' i n c l i n a t i o n to l i m i t federal use of criminal law, i t may be wise to r e l a t e future toxic chemical regulations under t h i s area to crime prevention and criminal punishment. Trade and Commerce Powers Federal powers under trade and commerce law may be somewhat limited although a large p o t e n t i a l for the use of these powers exists because of the great number of toxic chemicals involved d i r e c t l y with commercial a c t i v i t i e s . Previously, the scope of federal powers was 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 include i n t e r p r o v i n c i a l trade. But the courts have remained undecided on the a b i l i t y of the federal government to expand i t s intervention from a t r a d i t i o n a l l y economic focus to one including national health and safety. In 16 practice, Franson et e l . assert, t h i s may not be an important consideration for two reasons. One, since the very uncertainty which prevents l e g a l affirmation of such l e g i s l a t i o n also provides a measure of protection from attack.. A challenge to the law would be based on showing i t to be unconstitutional, making resolution of the questions contingent upon the determination cf the o r i g i n a l intent of the l e g i s l a t i o n , a d i f f i c u l t task. Two, the majority of new toxic chemicals are imported into Canada and importation i s an acknowledged federal j u r i s d i c t ion. General Ecwers The general power l i k e l y to be most important i n the regulation of toxic chemicals i s the federal government's a b i l i t y to deal with problems crossing p r o v i n c i a l borders (Franson et a l , , 1977) . Becent court decisions have added some credence to the federal argument f o r power over problems of national 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 trade with the implication of s i m i l a r federal j u r i s d i c t i o n . Franson et a l . State that the inference to be made from such decisions i s future support from the Court on the issue of federal 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 et a l . points out that p r o v i n c i a l j u r i s d i c t i o n granted by Section 92 of the BNA Act i s very broad with respect to control of toxic chemicals. Almost a l l aspects of domestic chemical production are concerned from manufacturing, to labour r e l a t i o n s , to work environment, and waste disposal. . Although t h i s concerns most contingencies of inter e s t some l i m i t a t i o n s e x i s t , mostly with regard to federal powers..Provincial powers are constrained to th e i r respective 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 statutes and federal Crown property i s exempt from p r o v i n c i a l c o n t r o l . F i n a l l y , the BNA Act gives exclusive r i g h t s over many areas to the federal government. Because of the amount of c o n f l i c t with federal 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 of Federal and P r o v i n c i a l Powers In summary, f r u i t f u l f e deral l e g a l powers l i e i n the areas of criminal law, trade and commerce law, statutes, general j u r i s d i c t i o n s and i n d i r e c t approaches. Criminal law has very broad uses and control cf to x i c chemicals has the potential to f i t t r a d i t i o n a l requirements for 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 better achieved through stop orders or advance rulings rather than the fin e s and imprisonments presently favoured by courts. Because the bulk of toxic chemicals are commercial, trade and commerce law i s p o t e n t i a l l y useful. Here again, the focus has been c h a r a c t e r i s t i c a l l y economic rather than health and safety. However, enough ambiguity may ex i s t to cushion any laws from the challenge of unconstitutionality. 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 and 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 courts seem i n c l i n e d to recognize the s i m i l a r i t y . F i n a l l y , the government may use taxation and f i s c a l policy to provide industries with economic incentives to comply. Unfortunately, the public may view such i n d i r e c t methods with suspicion, making such a policy p o l i t i c a l l y i n f e a s i b l e . P r o v i n c i a l l e g i s l a t i v e powers extend over the production process and are constrained mainly by regional 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 to 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 toxic chemicals. A major residual consideration, i s c o l l e c t i o n of information to guide s e l e c t i o n of candidates for c o n t r o l . In addition, the a b i l i t y to obtain and use information for monitoring or prosecuting becomes very important. Both federal and p r o v i n c i a l governments have wide 1 9 powers to obtain information, although the provinces must often take a more circuitous route (Franson et a l . , 1977). Federal powers to gather information l i e in the section of the BNA Act dealing with census and s t a t i s t i c s and i n the a b i l i t y to pay f o r research and surveys without c o n s t i t u t i o n a l l i m i t s on spending. The l a t t e r a b i l i t y i s shared by the provinces as well. I t i s i n the a b i l i t y to force release of information that a divergence of power occurs. The federal government has a di r e c t method available in the s t a t i s t i c s and census laws. As well, i t can use the power of criminal law to compel the release of information r e l a t i n g to prosecution for criminal offense. The provincial governments must act more i n d i r e c t l y . For example, they can make approval of a licence contingent on the proposed a c t i v i t i e s . Information access might be limited to areas germane to the application. Hide access to information does not extend to the in d i v i d u a l . In f a c t , many factors militate against public access to government information about toxic substances. For example, the federal O f f i c i a l Secrets Act and the c i v i l servants* Oath of Office both encourage secrecy (Franson et a l . , 1977). Canada takes an approach opposite to that of the United States. The US Freedom of Information Act assumes information, except for that noted, w i l l be open to public scrutiny. The trend i n Canada i s to resume information i s r e s t r i c t e d except for that s p e c i f i c a l l y released. Guidelines f o r access to documents do ex i s t in Canada, having been set fo r t h by Cabinet, but they are for internal government use only. They are not 20 useful to a private c i t i z e n . In addition, Crown p r i v i l e g e (the a b i l i t y of a minister to declare documents secret) and the threat of a l i b e l suit should an agency reveal "defamatory" information further serves to increase a basic government reticence to disclose information. Some v a l i d reasons exi s t to support a policy of non-disclosure. For example, trade secrets regarding chemical structure and manufacturing techniques must be secret or industry cooperation w i l l be l o s t . Other arguments reported by Franson et a l . include a loss of "working rapport" and our s o c i a l i n c l i n a t i o n for personal privacy., Some limited procedures e x i s t to compel release of information, i . e . f o r j u d i c i a l proceedings or regulatory hearings. In general, however, public access to information i s severely c u r t a i l e d . Once governments have the information, what can they do with i t ? In Canada, governments are not constrained by l e g i s l a t i o n regarding privacy. 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 exist compelling p o l i t i c a l reasons for governments to act as i f such an individual and corporate right to privacy existed (Franson et a l . , 1977). Generally they do sc. These p o l i t i c a l reasons also tend to l i m i t the amount and kind of information collected even i n the absence of c o n s t i t u t i o n a l constraints. 21 1.3.1 Summary of Information Access The federal government has powerful means of gathering and processing information. Besides the power of census taking and s t a t i s t i c s procurement, criminal law allows for access to information r e l a t i n g to criminal prosecutions. Also, there are 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 research or survey spending. P r o v i n c i a l l y , more ind i r e c t methods must be used for information gathering. For example, a license may be withheld pending information on i t s use. Information, i s gathered more readily than i t i s dispersed. Broad access to information does not extend to the i n d i v i d u a l . Our common law t r a d i t i o n combined with m i n i s t e r i a l p r i v i l e g e and secrecy laws strongly i n h i b i t an outward flow. Often t h i s predisposition i s supported with policy arguments. An example of such an argument i s that pulic access to p o l l u t i o n information would destroy the professional rapport between regulators and regulated. 1.4 COMPESSATIOH Another important issue r e l a t i n g to toxic chemical control by federal and p r o v i n c i a l governments i s compensation f o r damages. Franson et a l . (1977, p. 21) l i s t s three general kinds: (1) compensation funds established from general revenue; (2) s p e c i a l compensation funds maintained by compulsory contributions le v i e d against the industries l i k e l y to cause injury; and (.3) private r i g h t s of action given to an injured 22 person to proceed d i r e c t l y against those causing the injury. Both governments seem able to e s t a b l i s h compensation funds and the p r o v i n c i a l governments, at l e a s t , have the power to levy industry within t h e i r respective borders. Federal power to raise a contributory fund i s probably limited to industries under i t s exclusive j u r i s d i c t i o n . Generally, p r o v i n c i a l powers encompass private r i g h t of action but recent cases have suggested Parliament may be able to ensure that v i o l a t o r s of federal statutes pay compensation to those injured as r e s u l t of the v i o l a t i o n . However, legal r e s p o n s i b i l i t y of companies and methods of compensating those injured must be examined. Becent events have stimulated such examinations. The chlorine s p i l l at Hississauga, Ontario, for instance, has stimulated government consideration of t h i s topic where accidents have resulted i n acute hazard. A p a r t i a l solution to the questions of r e s p o n s i b i l i t y and compensation may l i e i n the establishment of a c e n t r a l fund with payments made into i t on the basis of production l e v e l s . This approach i s well within federal 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 case of latent damage occurring, some l e g i s l a t i o n already e x i s t s (Ince, 1 9 7 6 ) • The I n d u s t r i a l Operations Damage Compensation Act allows fo r an agreement for compensation between the owner of land and a p o l l u t i n g company. The Act negates further r e s p o n s i b i l i t y of a company for any damage ari s i n g from the pollution. Also, should an agreement not be reached, agreement can be imposed on an owner by a judge, 23 r e s u l t i n g i n the same less of recourse to l e g a l action should unexpected damages occur. In view of the limited knowledge about long terra e f f e c t s of t o x i c chemicals and numerous possible interactions, the a b i l i t y of a judge to decide on present adequate compensation for further damages seems guestionable. Although Ince (1976) predicts that judges are unlikel y to use t h i s act to remove personal r i g h t s , i t may s i g n i f i c a n t l y reduce private access to l e g a l action against polluters. In any case, assigning r e s p o n s i b i l i t y f o r any environmental or health damage done i n the past w i l l prove a d i f f i c u l t 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 intermediate reactions with other natural or man-made chemicals over a long period of time. Thus, the i n i t i a l contributor i s e f f e c t i v e l y disguised. Here again, some central no-fault fund, contributed to by industry and administered by the governments, may be required to compensate victims of chemical hazards., 1.5 CONCLUSIONS Existing l e g i s l a t i o n i s broad and powerful. General Po l l u t i o n Control statutes allow both the federal and p r o v i n c i a l governments to use permits and approvals to control most s i t u a t i o n s of discharge into the the environment. The statutes also allow the federal use of stop or control orders i f contaminants are detrimental to the environment. 24 Other existing l e g i s l a t i o n deals with s p e c i f i c areas. The provinces can regulate public health, resource use and the workplace, while the federal government can control motor vehicle emissions, food and drugs, and consumer safety. Both can regulate s p e c i f i c chemicals or contaminants and s p e c i f i c i n d u s t r i e s . Any gaps in 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 . It supplements prov i n c i a l and other federal 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 in application and e f f e c t . In addition to the exi s t i n g l e g i s l a t i o n , both governments have the a b i l i t y to bring in new environmental l e g i s l a t i o n as needed. , Such l e g i s l a t i o n can originate i n any of several areas. The federal government can c a l l almost anything a crime and enact l e g i s l a t i o n to punish those engaged in i t . Also, because many toxic chemicals are used commercially, the federal government can apply the power of trade and commerce law. F i n a l l y , the federal government has control over problems of national dimensions. The provinces, except that t h e i r powers are limited to t h e i r respective t e r r i t o r i e s , can exert considerable influence on chemical production. This control i s derived from the chemical industry*s association with at least one area of 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, labour, the workplace, or chemical waste disposal. By working together, federal and pro v i n c i a l governments should be able to cover most situa t i o n s with l i t t l e trouble. Between ex 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 a gap should present no problems. However, c o n f l i c t betweeen federal and pr o v i n c i a l j u r i s d i c t i o n s may occur. In many cases l e g i s l a t i o n overlaps. This may be preferable to gaps since i f an emergency occurs i t i s advantageous to have the power to act immediately. However, overlaps also mean duplication of e f f o r t , potential c o n f l i c t s between i n d i v i d u a l laws and added expense to industry tc comply with duplicate statutes. Careful r a t i o n a l i z a t i o n of c o n f l i c t s , such as designating which l e g i s l a t i o n has precedence, may reduce the burden of overlaps. It i s evident, upon reviewing the existing 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, that few co n s t i t u t i o n a l impediments r e s t r i c t the introduction of toxic chemical regulations. Thus, the constraints on the promulgation of new p o l i c i e s are the large number of chemicals to regulate and the d i f f i c u l t y in c o n t r o l l i n g them. The number and variety of chemicals i s so great that the determination of p r i o r i t i e s and 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 policy revolves not around enabling l e g i s l a t i o n but i n establishing p r i o r i t i e s f or developing s p e c i f i c l e g i s l a t i o n . To aid i n developing p r i o r i t i e s , both governments have the a b i l i t y to c o l l e c t nearly any information desired. Federal powers originate with the census and s t a t i s t i c s section of the BNA Act and with criminal law. It also has the a b i l i t y to 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 constraints. I t thus has dire c t access to data and the power to force compliance. The provinces too have few l i m i t s on 26 information 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. Licence approval, f o r example, can be made contingent upon pr o v i n c i a l access to information. Potential blocks to information c o l l e c t i o n are i n the nature of p o l i t i c a l and economic constraints. Industry may not wish to divulge information i f competitors have access to i t . The use of government powers to force compliance may have the undesirable ccnseguence of reducing the Canadian industry*s economic contributions. .. However, governments need not reveal information collected from industry. 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 to promote secrecy. In addition to t r a d i t i o n there i s the O f f i c i a l Secrets Act and the c i v i l servants' Oath of Off i c e to ensure secrecy. Canadians have no co n s t i t u t i o n a l r i g h t s to information so governments can assure industry of c o n f i d e n t i a l i t y i f required. Both governments have the a b i l i t y to ensure compensation for damage caused by chemials. This may be done in several ways. Federal and pr o v i n c i a l governments can provide funds from general revenue or by levy of industry. The federal government can only levy industries d i r e c t l y under i t s c o n t r o l whereas the provinces can levy any industry within i t s borders. F i n a l l y , both governments can ensure private r i g h t s of action against responsible companies. Two problems exist i n administering a policy 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 or damage may be d i f f i c u l t i f the damage i s chronic and latent i n nature. Time, environmental in t e r a c t i o n s 2 7 and personal mobility w i l l tend to confuse areas of r e s p o n s i b i l i t y . In these cases, a general fund may be needed. , The second problem arises because of the nature of the j u r i s d i c t i o n s . Federal and p r o v i n c i a l cooperation may be e s s e n t i a l i f l e v i e s are to be applied f a i r l y and equally to industry, ftn intergovernmental coordinating mechanism may f a c i l i t a t e the administration of compensation p o l i c i e s . Several points are raised by an examination of OECD countries' l e g i s l a t i o n but the focus here i s the change i n emphasis. The change i n emphasis from post-market monitoring to pre-market te s t i n g implies a form of test system to determine candidates for control. Design of such a system may be d i f f i c u l t as evidenced by the divergent approaches of the US and UK. But, one point i s cl e a r : the pre-market test approach w i l l require e f f i c i e n t and adequate information about chemicals, about their e f f e c t s and about public perceptions of th e i r hazards. Governments have ample power to regulate t o x i c chemicals and to provide compensation for damages. However, information i s needed to aid i n the formation of actual regulations. Governments have both the a b i l i t y to finance and c o l l e c t such information and to provide industry 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 control. 28 2. ESTABLISHMENT OF PSIOBITIES F08 REGOLATION It has been established that u t i l i z a t i o n of l e g i s l a t i v e powers requires that suitable candidates for control be i s o l a t e d from the thousands of new and old chemicals. At l e a s t two methods e x i s t , f i r e f i g h t i n g and establishment of a screening system. An obvious stratagey i s to focus on f i r e f i g h t i n g . Such a policy of concentrating on high p r o f i l e chemicals has several good points to recommend i t . F i r s t , public acceptance of r e s t r i c t i o n s i s l i k e l y to be enhanced by the large amount of media hyperbole generated by a toxic chemical c r i s i s . Two, the industry marketing or d i s t r i b u t i n g the chemical i s l i k e l y to be at a disadvantage i n a c r i s i s s i t u a t i o n and therefore more amenable tc government reglation. F i n a l l y , the f a c t that the chemical i s drawing attention suggests that a s i g n i f i c a n t l e v e l of information already exists..These factors w i l l f a c i l i t a t e the design of suitable c o n t r o l l i n g statutes. Thus, known hazards can be dealt with. Onfortunately, several drawbacks arise i f a more comprehensive policy i s not implemented. F i r s t , even with a receptive public and a compliant industry, l e g i s l a t i o n can require a long time to pass into law. Hastily composed l e g i s l a t i o n may be poorly conceived and d i f f i c u l t to enforce as well. Once a law e x i s t s , regulations must be designed and enforcement machinery must be placed in motion before law takes effect. Time can be an important constraint.,Second, the nature 29 of contemporary commercial chemicals allows them to do much damage before discovery i f they are not closely monitored. Chemicals are often toxic at low concentrations or may have latent e f f e c t s . Once established i n the environment, persistent chemicals may take many years to dissipate. Thus, there i s an argument for testing chemicals before they are distributed i n large amounts (pre-market c o n t r o l ) . With the above points i n mind, i t becomes important to choose candidates f o r control even before extensive information i s available. A suitable screening system must be developed to evaluate the r e l a t i v e importance of a pa r t i c u l a r chemical. Two factors can be integrated to determine the poten t i a l importance of a chemical. These are expected exposure to a chemical and the consequences of that exposure. Together these factors determine the impact a chemical w i l l have on health and the environment and therefore, i t s importance as a candidate for regulation. 2 .1 EXPOSURE DETERMINATION The f i r s t strategy to be examined i s exposure determination. Ideally, exposure should be easy to define. The questions to be answered are: Hho i s exposed? Sfhat are they exposed to? How long are they exposed? and What i s the strength of exposure? To answer the questions the production process of a chemical i s examined. A t y p i c a l product scenario might be as follows. Raw 30 material i s removed from the earth i n some way, for instance, mining or pumping. I t i s transported to a r e f i n i n g center, refined and sent to a manufacturing plant. & product or intermediate part i s produced which i s sold to a consumer. The consumer uses the product u n t i l i t i s fini s h e d or disposed of, possibly tc be degraded to some basic, natural components. To define the exposure the consumers are simply traced and catalogued. Obviously this scenario i s over s i m p l i f i e d . Closer examination reveals many p o s s i s i b i l i t i e s for inadvertent or even routine exposure. In the mining of asbestos, f o r example, miners are exposed to the minute f i b e r s every workday. The hitherto ignored chendcal causes a chronic lung disease c a l l e d asbestosis (Brodeur, 1979). Another example i s the accumulation of dust i n the lungs of coal miners which leads to black lung disease. Both are forms of occupational exposure. During the mining process t a i l i n g s are discarded, some into water used for other purposes. In 1973 the drinking water of Duluth, Minnesota was found to have b i l l i o n s of asbestos-l i k e f i b e r s suspended i n i t . The discharge from the mine was being disposed of i n Lake Superior (the l o c a l water supply). Animal tests showed i t to cause cancer (Lawless, 1979)..This i l l u s t r a t e s unintended exposure to others through i n d u s t r i a l discharges and emissions..Other examples abound: lead and carbon-monoxide from car exhaust; sulphur dioxides from c o a l -burning e l e c t r i c a l plants; and mercury compounds from the p l a s t i c s industry concentrating i n f i s h and causing the infamous Minamata tradgedy (Smith and Smith, 1970). : 31 Another point i n the scenario where accidental exposure can occur i s during transport between processors. Chlorine, for example, shipped by truck or r a i l c a r has s p i l l e d near population centers imperiling whole c i t i e s with poisonous gas; during a f i r e or flood which damages storage f a c i l i t i e s ; during i l l e g a l use either by a f i n a l consumer such as a drug addict or by an intermediate user such as a farmer using the wrong pesticide on crops; and during legitimate use of substances which contain impurities such as flame retardant chemicals i n childrens clothing (Blum and Ames, 1977) or strawberry flavouring (Strawberry Aldehyde) (Butterworth, 1978). F i n a l l y , unexpected exposure can occur by criminal design. Important factors t c consider in estimating exposure are the very r e a l probability of sabotage, subversion 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 to the uncertainty of both the occurrence and the extent of exposure. when the myriad of potential sources of exposure are recognized i t i s evident that the task of determining accurately who i s exposed to what i s beyond reasonable means. Rather than actually measuring or c a l c u l a t i n g exposure, an index may be used to approximate i t . For example, the European Economic Community (EEC) uses production levels as a proxy f o r exposure. In the EEC scheme, as the production l e v e l of a chemical passes certain thresholds, thereby increasing probable exposure, more sophisticated, complex and expensive t o x i c o l o g i c a l data are reguired (HcGinty, 1979).The use of prduction lev e l s as the sole index of exposure i s subject to 32 strong c r i t i c i s m s since 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 index. The OS Interagency Testing Committee (ITC), for instance, derived an index of potential exposure based on numerical scales for production volume, envircmental release, occupational exposure and non-occupational human exposure. Such an approach improves the index's s e n s i t i v i t y to chemicals which may be highly toxic i n small amounts or, conversely, only s l i g h t l y t o x i c i n very large doses. 2.2 ENVIfiONHENT&L DYNAMICS Another important consideration i n estimating exposure i s environmental dynamics. Two main areas are of consequence, the natural, external environment and the environment of the human body. The external environment can have a powerful e f f e c t on chemicals. Substances deposited there are eventually changed to some other form or compound. Some chemicals l i k e DDT r e s i s t such changes and are classed as persistent (Lawless, 1976)., Others l i k e bicdegradeable soaps break down quickly. Depending on their s o l u b i l i t y in water, the amount of sunlight and other conditions such as pfl, temperature and endemic microorganisms, chemicals may be degraded, dissipated or concentrated. The end product of degradation can be benign as i n the case of ordinary soap or very toxic as i n the case of mercury. Mercury was used in chemical plants mainly i n the production of 33 c h l o r i n e and c a u s t i c soda (Chemical and Engineering News, 1971) or i n s m a l l e r amounts as a f u n g i c i d e with pulp and paper or a g r i c u l t u r e a p p l i c a t i o n s . In 1969 consumption of mercury by main users was almost 6 m i l l i o n pounds (Chemical and Engineering News, 1971).,Host of the mercury was i n a low t o x i c i t y form as a r y l mercury compounds (often used i n pharmaceuticals). However, anaerobic b a c t e r i a i n bottom sediment convert the a r y l mercury compounds from i n d u s t r i a l e f f l u e n t i n t o a f a r more t o x i c organic form, a l k y l mercury (Bosen, Wood and Kennedy, 1968). In a d d i t i o n , mercury tends t o accumulate i n animals as the food pyramid i s ascended. For example, hawks fed on chicken l i v e r s with 3ppm, accumulated up to 18 ppm (Chemical Engineering, 1970) and f i s h have been found with up to 5 ppm i n the t o x i c methyl form ( l a w l e s s , 1977). Man i s a predator at the top of the food chain. Mercury ingested at low l e v e l s accumulates to higher t o x i c l e v e l s i n the food t h a t man eats ( b i o m a g n i f i c a t i o n ) . I t tends to concentrate i n the b r a i n (bioaccumulation) a f f e c t i n g the c e n t r a l nervous system and leading to permanent, c r i p p l i n g b l i n d n e s s and even death (norland's I l l u s t r a t e d Medical D i c t i o n a r y , 1974). Chemicals can also be d i s s i p a t e d as the n a t u r a l flow of the environment t r a n s p o r t s i t from place to p l a c e . Dust p a r t i c l e s are c a r r i e d by animals and wind, streams c a r r y s o l u b l e substances or suspended matter and gaseous m a t e r i a l s are condensed i n the a i r to ret u r n as raindrops. The end r e s u l t i s a thorough d i s p e r s i o n of the chemical, an example of such a ubiquitous chemical 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 everywhere on the s u r f a c e of the e a r t h . DDT was i n every body of a i r and water. DDT was i n the bodies of 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 f l e s h . The combination of m o b i l i t y , p e r s i s t e n c e and e x t e n s i v e use had allowed i t t o permeate the world. The number of sources of a c h e m i c a l have been shown, and the a c t i o n of the environment on chemicals that are d e p o s i t e d i n i t has been i l l u s t r a t e d . To the p o s s i b l e combinations and permutations a r i s i n g from these two f a c t o r s can be added the a c t i o n o f the human environment: the e f f e c t t h a t man's own p h y s i o l o g y and microbiology have on substances with which they come i n c o n t a c t . For example, metabolic f a c t o r s can i n f l u e n c e mutagenicity of chemicals (mutagenicity i s h i g h l y c o r r e l a t e d with carcinogenicity)». Chemicals can be metabolized from a non-mutagenically a c t i v e chemical or v i c e versa (Council of the Environmental Mutagen S o c i e t y , 1975) such an a c t i o n c o u l d occur with sodium n i t r i t e s used to prevent the growth of C l o s t r i d i u m botulinum and other dangerous b a c t e r i a i n meat.,Microorganisms present i n the human gut transform the ingested n i t r i t e s i n t o n i t r o s a m i n e s which are c a r c i n o g e n i c (Lawless, 1977). Another example 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 i s the s y n e r g i s t i c e f f e c t of some chemicals which p o t e n t i a t e s the a c t i o n of a mutagen, C a f f e i n e , 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 of a mutagen by 1. See HcCann e t a l . (1975), McCann and Ames (1976), and Purchase et a l . , (1978) . 35 i n h i b i t i n g the d e o x y r i b o n u c l e i c a c i d (ONA) r e p a i r process. Thus, when a mutagen damages the DNA s t r u c t u r e i t remains f a u l t y l e a d i n g to e r r o r s i n t r a n s c r i p t i o n s and p o s s i b l y to cancer. Other cases cf p o t e n t i a t i o n occur when enzymes are a l t e r e d . Such changes can i n c r e a s e the r a t e o f enzymatic a c t i v a t i o n of a mutagen (Environmental Mutagen S o c i e t y , 1975) s i n c e such r e a c t i o n s can vary with the g e n e t i c p r e d i s p o s i t i o n of i n d i v i d u a l s (people with the g e n e t i c c o n d i t i o n Xeroderma Pigmentosum are more s u s c e p t i b l e to c a r i c i n o g e n s ) even people s u b j e c t e d to the same kinds and amounts of chemicals from the e x t e r n a l environment can be exposed i n t e r n a l l y t o d i f f e r e n t dangers as a r e s u l t of the v a r i o u s t r a n s f o r m a t i o n s and s y n e r g i e s p e c u l i a r to h i s or her body. , F i n a l l y , such demographic f a c t o r s such as age and sex change the importance of exposure. Men and women d i f f e r i n t h e i r s u s c e p t i b i l i t y to mutagens which a l t e r g e n e t i c m a t e r i a l . In o r d e r to a c t on gonads, a s u f f i c i e n t c o n c e n t r a t i o n of a c t i v e mutagen must pass the b l o o d - t e s t e s b a r r i e r . U n f o r t u n a t e l y , other than f o l l i c u l a r c e l l s surrounding immature ova, the female has no corresponding p r o t e c t i o n (Environmental Mutagen S o c i e t y , 1975). However, as the female passes prime c h i l d b earing age the importance o f such p r o t e c t i o n d i m i n i s h e s . A f t e r menopause, of c o u r s e , i t i s i n c o n s e q u e n t i a l . . For somatic mutations, age a l s o p l a y s an important r o l e because of the time element i n h e r e n t i n the p r o b a b i l i t y of cancer. A c h i l d exposed to a c a r c i n o g e n has a g r e a t e r chance of developing cancer t h a t a person exposed l a t e r i n l i f e simply because there i s more time f o r i t to develop. Thus, i t i s more 36 important t h a t c h i d r e n not be exposed to such c a r c i n o g e n s as nitrophenylenediamines found i n h a i r dyes than i t i s f o r a mature woman (S e a r l e , 1975). When a l l these f a c t o r s are c o n s i d e r e d , exposure a n a l y s i s appears very complicated. But, s e v e r a l p o i n t s stand out. P i r s t , as i n the case of mercury, the danger of many chemicals i s not r e a l i z e d . .They may i n t e r a c t with s u b t l e b i o l o g i c a l and chemical mechanisms which are unknown or thought t o be of l i t t l e importance. Even i n known systems, the p a r t i c u l a r combination of events t h a t occurs may not have been p e r c e i v e d by s c i e n t i s t s . For example, C l a r k e (1977) d e s c r i b e s a mishap with the A p o l l o 13 s p a c e c r a f t . .Although the system was completely known and every c o n c e i v a b l e hazard prepared f o r , a completely unexpected event occurred which destroyed the capsule..Exposure may be thought s u f f i c i e n t l y c o n t r o l l e d so t h a t l i t t l e r i s k e x i s t s . Second, the wide u n c o n t r o l l a b l e v a r i a t i o n i n the exposure of i n d i v i d u a l s and the wide range o f s u s c e p t i b i l i t y i m p l i e s t h a t a c o n s i d e r a b l e s a f e t y margin i s necessary i f standards f o r p a r t i c u l a r chemicals are s e t t o minimize the maximum r i s k . What may be an i n s i g n i f i c a n t exposure t o one i n d i v i d u a l may be a l e t h a l dose to another i f h i s g e n e t i c d i s p o s i t i o n or metabolic s t a t e causes p o t e n t i a t i o n of that c h e m i c a l . U n f o r t u n a t e l y , s e t t i n g standards i n t h i s way a l s o i m p l i e s added expense to consumers of chemicals as i n c r e a s e d p o l l u t i o n c o n t r o l c o s t s are passed on from i n d u s t r y , F i n a l l y , p o l l u t i o n t h a t i s i n s i g n i f i c a n t i n s m a l l doses becomes of paramount importance when contaminants are i n 37 amounts beyond the c a p a c i t y o f the body or of the environment to cope. A l o n g l a t e t p e r i o d and high volume production c a p a i l i t y means t h a t contaminants may exceed the c a p a c i t y of the environment or body and i r r e v e r s i b l e damage may be done bef o r e a hazard i s recognized./The environment may be overloaded and permeated before s u f f i c i e n t study on low l e v e l e f f e c t s can be done to p r e d i c t the conseguences of higher l e v e l s . Extended p r o t e c t i o n f o r the human and e x t e r n a l environment n e c e s s i t a t e s s u f f i c i e n t s c r e e n i n g o f chemicals before l a r g e s c a l e manufacturing i s per m i t t e d . Thus, e i t h e r r a p i d t e s t s must be designed or the p e r i o d between i n i t i a l t e s t i n g a v a i l a b i l i t y and high volume production must be lengthened i f p r o t e c t i o n a g a i n s t t h i s danger i s to be e s t a b l i s h e d . 2 . 3 auaioGoos CONSEQUENCES Imputations of consequence by analogy i s based on the premise t h a t i f two or more t h i n g s agree i n some r e s p e c t s the i n f e r e n c e can be drawn that they w i l l probably agree i n ot h e r s . Mechanisms to a i d i n the d i s c o v e r y and f o r m u l a t i o n of an analogous s i t u a t i o n range from a simple a p p l i c a t i o n of common sense t o the s o p h i s t i c a t e d s t a t i s t i c a l a n a l y s i s of e p i d e m i o l o g i c a l s t u d i e s or mathematical models. 38 2.3.1 Common Sense Applications of common sense have occurred i n the food industry. The Food Protection Committee (FPC) of the National Research Council have developed guidelines as an aid to determining the appropriate l e v e l s of chemicals in food (Schlegel, 1978). One of the c r i t e r i a 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 that naturally occurring chemical i s recognized as safe, then by analogy, the synthetic chemical i s considered safe i f consumed i n quantities of the same order of magnitude. An example of such an application i s the addition of glycerides to processed foods to improve texture and other c h a r a c t e r i s t i c s . Based on average consumption of glycerides i n tr a d t i o n a l foods, the additional glycerides were judged to be an i n s i g n i f i c a n t additonal hazard (FPC, 1965). 2.3.2 Occupational Exposure A second use of analogy i s the comparison of inadvertent and occupational exposure with expected exposure of a population o v e r a l l . By inference, an approximation of expected consequences can be determined. Because exposure i s r e l a t i v e l y high and continuous, i l l e f f e c t s often come to l i g h t in a more obvious way. Such was the case with coal dust leading to black lung disease in miners. Information on possible effects of those r a r e l y exposed would be severely li m i t e d without such an analogy. 39 2.3.3 Epidemiology Epidemiological studies involve the comparisons of groups who have been exposed to a substance with control groups who have not. They have been used with notable success to establish the l i n k between cancer of the jaw and workers i n the watch-making industry (Castle et a l . 1925). .They have also been used, although with less success, to correlate lung cancer with cigarette smoking. Such a method has the advantage of u t i l i z i n g human subjects without the e t h i c a l contraints of deliberate exposure to dangerous chemicals. The major drawback i s that epidemiological studies can only indicate 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 rela t i o n s h i p between foot size and success as a basketball player, one may conclude, from the high positive c o r r e l a t i o n , that a large foot contributes to basketball s k i l l s . However, t h i s i s an i n d i r e c t relationship. The co r r e l a t i o n may be better explained 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 less obvious circumstances, i t i s c l e a r that where the mechanisim of action i s not known, spurious relationships may 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 r e l a t i o n s h i p . This weakness of epidemiology has led to acrimonious debate between the tobacco industry and advocates of heavy r e s t r i c t i o n s on cigarette sales as well as between the mining companies and advocates of more stringent safety and compensation status for c e r t a i n miners (Doren, 1978). no McGarity (1979) points out that secondary drawbacks e x i s t . Since epidemiological studies simply indicate 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 point 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 also exercised i n the designing of experiments and i n choosing the control cohort. ; These methodological problems and others, such as the d i f f i c u l t y 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 during the course of the study pose strong threats to v a l i d i t y . Meaningful extrapolation to other populations becomes dubious. Despite problems, Sienstein {1979), considers epidemiological studies to be the source of best evidence to establish an association 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 Extrapolation from Animal Tests Tenuous analogies can be drawn between animal tests and predicted human consequences from s i m i l a r exposure (Storer 1972) or prediction cf chemical damage from data on the damage caused by an 'equivalent' amount of radiation (Environmental Mutagen Society, 1975).,Both these analogies are more tenuous as a natural result of the decrease in s i m i l a r i t y on which to base the analogy. There are wide differences in the physical, physiological and metabolic structure between various animal species and man. A carcinogenic reponse i n an animal i s not wholly analogous to 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 functions are d i f f e r e n t (Environmental Mutagen Society, 1975). Thus animal tests cannot be d i r e c t l y extrapolated to man. However, the range of expected r e s u l t s can be narrowed down. Crouch and Hilson (1979) have developed a method of comparison to allow extrapolation of consequences within a factor of ten as a good f i r s t approximation of expected e f f e c t , at l e a s t one notable exception e x i s t s , unfortunately, since arsenic (and possibly other heavy elements) were not detected by tests with r a t s , as highly toxic to man. Animal tests, as a means of determing a t o x i c o l o g i c a l r i s k to man have other problems. F i r s t , they can be very expensive. A common testing methodology in the OS uses a minimum of 600 animals, takes up to three years and costs up to $500,000 (National Research Council (OS) , 1979). Second, to obtain a r e s u l t with a practicable number of animals, proportionately larger doses of chemicals than man would normally be exposed to are used. Results may not be v a l i d i f dose response i s not l i n e a r or i f a det o x i f i c a t i o n mechanism i s overwhelmed. In addition to these and other problems there remains the t h e o r e t i c a l problems of extrapolating results from lower animals to man. Although the National Research Council (OS) (1979) fe e l s that extrapolation using dose per body weight i s a reasonable approach, other researchers suggest the alternative of proportionality of surface area i s a more r e l i a b l e approach. Thus, there i s not agreement on the appropriate methodology. 42 2.3.5 Extrapolation from In Vitro Tests In v i t r o (short term) t e s t s constitute a rapid and inexpensive means to determine the consequences of exposure to chemicals. Generally, such tests are based on the detection of genetic mutation, damage, and growth transformations i n micro-organisms or cultured mamalian c e l l s . For example, changes i n DNA such as chromosome damage or mutations are known to be highly correlated with the a b i l i t y to cause cancer (HcCann et a l . , 1975; McCann and Ames, 1976; and Purchase et a l . , 1978) Over eighty in v i t r o t e s t s have been developed, often with special adaptations to increase t h e i r a b i l i t y to detect potential carcinogens. .By using batteries of tests, the s e n s i t i v i t y to carcinogens can be further increased to di f f e r e n t types of mutations or other anomalies. A battery of tests i s therefore, l i k e l y to detect p o t e n t i a l carcinogens missed by a single t e s t . Unfortunately, increasing the s e n s i t i v i t y increases the probability that non-carcinogens w i l l be labeled carcinogenic by mistake since the s p e c i f i c i t y of the test is reduced. These te s t systems have only a remote s i m i l a r i t y to human systems. Therefore, t h e i r use i s generally confined to preliminary screening.„ 4 3 2 . 3 . 6 Extrapolation from Badiation Data The extensive data on radiation effects could he very useful in determining the potential e f f e c t s of a new chemical on man. The Environmental Mutagen Society (1975) has developed the concept of a rem-equivalent-chemical (BEC) which i s the dose of a chemical over some period of time which produces the eguivalent amount of damage as one rem of chronic radi a t i o n . It r e l i e s on the assumption that the r a t i o between chemical and radiation mutagenicity remains constant and l i n e a r which, when genetic and metabolic factors are incorporated, i s unlikely. Like the extrapolation from animal tests i t i s quant i t a t i v e l y useful only as an approximation. 2.4 CHEBICAL BEHAVIOB This section deals with the a b i l i t y to predict the behaviors of chemicals i n the environment from their chemical structure. After release into the environment, a chemical becomes dispersed through a l l mediums; a i r , land and water. Because of the complexity of the environment, the behavior and concentration i n any geosphere depends on both chemical and geosphere properties (National Academy of Science, 1975). 44 2.4.1 Atmospheric Interactions The three main factors a f f e c t i n g entry into the a i r and transport of chemicals through i t are vapour pressure, heat of vapourization 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 medium, and the c h a r a c t e r i s t i c s of a i r flow (National Academy of Science, 1975). In order to predict the probable path and the fate of a chemical a knowledge of the rate of exchange between the atmosphere and other geospheres i s ess e n t i a l . The vapour pressure (the maximum pressure a chemical would exert i n the gas phase i n a closed container ( P o r t e r f i e l d , 1972) provides insight into the process necessary for evaluation. Using pesticides as an example, i t i s evident that vapour pressure values d i f f e r widely (Hamaker and Kerlinger, 1969). Values range from the extreme of gases (oxygen, carbon dioxide 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 repectively) to the less v o l a t i l e pesticides (Triazines have a vapour pressure of 10 - 6 to 10_9mm Hg) and f i n a l l y to the other extreme of those with neg l i g i b l e vapour pressure. Any chemical with a vapour pressure can be in the atmosphere but the rate and the extent are mediated by other factors. Dust p a r t i c l e s increase the entry rate by absorption of vapour to the greatly increased surface area while a i r currents 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 to increase the rate of d i f f u s i o n through the p a r t i t i o n by decreasing the concentration (Hartly, 1969). An important factor influencing 45 the rate of chemical entry into the atmosphere from the s o i l i s the pressure of moisture. The evaporation rate of many chemicals, for example DDT, i s increased through co-d i s t i l l a t i o n with water (Acree et a l . , 1963) so that loss from s o i l i s accelerated when the s o i l i s damp (Freed et a l . , 1962). Other f a c t o r s mediating the influence of vapour pressure are temperature, humidity, pfl and physical properties of the chemical. A c t i v i t y i n the atmosphere i s modified by general physical properties of the chemical molecule. Molecular weight (MW) tends to l i m i t the dispersal of molecules in the atmosphere. Molecules over 200 to 300 MH tend to exist as aerosols rather than as random dispersions. Molecules, such as 2,5-dinitroanaline, which are made of a basic carbon framework with electronegative atoms l i k e nitrogen, oxygen, flu o r i n e or chlorine incorporated i n the structure tend to have an e l e c t r i c dipole moment. That i s , one end of the molecule i s more negative than the other ( P o r t e r f i e l d , 1972). This c h a r a c t e r i s t i c causes a configuration with a high degree of s t a b i l i t y and tends to lower the v o l a t i l i t y leading to less evaporation. Another ef f e c t of the molecular dipole moments pointed out by the National Academy of Science i s the e f f e c t on s o l u b i l i t y . Polar solvents tend to disolve other polar chemicals thus water, a polar solvent, dissolves polar substances l i k e NaCl (table salt) an i o n i c c r y s t a l with strong charges, e a s i l y and covalent or metallic substances l e s s so. This phenomenon leads to sel e c t i v e accumulation of polar and i o n i c substances in 46 aqueous clouds through absorption and di s s o l u t i o n . As well, the close proximity of the chemicals 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 reactions transforming the o r i g i n a l constituents into something quite d i f f e r e n t . Other chemical properties having atmospheric implications are c r y s t a l structure, l i g h t s e n s i t i v i t y , r i n g structures and multiple bonds (National Academy of Science, 1975). Crys t a l structure, f o r example, can have profound e f f e c t s on weather since a substance with a structure s i m i l a r to that of ice can be incorporated into snow and h a i l or can provide nucleus around which cloud droplets or i c e form. This can lead to p r e c i p i t a t i o n . Furthermore, many chemicals, depending on l i g h t s e n s i t i v i t y and structure are susceptible to photochemical oxidation sequences. Such chemicals, containing oxygen, hydrogen or halogens can in t e r a c t with u l t r a v i o l e t l i g h t (UV) to form smog. Other contributing chemicals are those with double bonds or aromatic and hetrocyclic rings or es p e c i a l l y strained 3,4 or 7 member rings. 2.4.2 Aquatic Interaction Many or the chemical a c t i v i t i e s in the atmosphere are shared by t e r r e s t r i a l and aquatic ecosystems as well. 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 aquatic system, the hydrophobic nature of many organic 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 , some of the compounds are attracted to the air-water interface where they c l u s t e r into discrete 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, a marked accumulation of pes t i c i d e can occur at the surface. Other factors affecting s o l u b i l i t y and s t a b i l i t y are pH and temperature. A decrease i n pH can often lead to increased s o l u b i l i t y : t r i a z i n e s o l u b i l i t y i s an inverse function of pH (Ward and Weber, 1968). Temperature has the opposite e f f e c t . As temperature increases s o l u b i l i t y increases. As mentioned, the other major c h a r a c t e r i s t i c s of chemicals such as p o l a r i t y , fl-W and vapour pressure have a s i m i l a r e f f e c t i n water as in a i r . 2.4.3 T e r r e s t r i a l Interaction The National Academy of Science (1975) points out that the major in f l u e n c i n g factors on chemicals i n the s o i l are adsorption and leaching. Those chemicals which are strongly i o n i c such as inorganic s a l t s or organic cations tend to be adsorbed onto clay s e l l through an exchange mechanism making them le s s mobile than neutral organics adsorbed from an aqueous solution through a physical process. Adsorbtion i s inversely related to s o l u b i l i t y and to leaching. As adsorption increases, leaching decreases. ,  48 2.4.4 Microbial Interaction Microbial action on chemicals i s probably the most important factor to consider i n the aquatic and t e r r e s t r i a l geospheres and t h e i r interface. The importance i s derived from the a b i l i t y of microorganisms to cope with naturally occurring toxic compounds through synthesis and degradation. An anaerobic bacterium (Yamada and Tancmura, 1973) and a s t r a i n of fungus (Landner, 1971) for example, were shown to change inorganic mercury to methlymercury (a far more toxic form for humans). Of further importance i s the a b i l i t y of organisms to reduce or oxidize heavy metals to a l l valence states. The National Academy of Science (1975) uses the example of mercury detoxified from Hg 2* to methyl and dimethyl mercury or to Hg° and methane. The implications of the a b i l i t y to a l t e r metals through th e i r f u l l valence range are ominous to man. The valence states 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 limited t o x i c p o t e n t i a l whereas methyl mercury i s very toxic i n comparison. The behavior of t o t a l l y synthetic compounds may be more amenable to prediction because the a b i l i t y of microorganisms to transform natural toxins comes from the se l e c t i v e pressure of exposure over many generations (National Academy of Science, 1S75). Since the organisms have not been exposed to synthetic toxins, there i s a strong chance that the microbes have not evolved an e f f i c i e n t means of degrading them. However, i f a synthetic substance i s an analogue of a natural metabolite, i t 49 may be a c t i v e l y accumulated in organisms. In time, organisms can be expected to evolve the necessary enzymes and mechanisms to process synthetic toxins as well. Jin approximation of the time t h i s would take may be possible by increasing mutation rates under i n v i t r o lab conditions to simulate the natural evolution cn a compressed temporal scale (National academy of Science , 1975). Other factors r e l a t i n g to accumulation of synthetic chemicals are a high degree of l i p i d s o l u b i l i t y causing the chemical to concentrate i n f a t and the tendency of metallic compounds to form organo-metallic complexes. These factors can increase the exposure of predators to toxic substances. 2.4.5 Prediction Capability The National Academy of Science (1975, pp. 56-57) f e e l s that the a b i l i t y to predict chemical reactions i n the environment i s s u f f i c i e n t l y developed how. On the basis of e x i s t i n g knowledge, i t i s generally possible for microbiologists, biochemists and chemists working together to determine metabolic sequences for both natural and t o t a l l y synthetic compounds and to i d e n t i f y those that may pose environmental problems. , A large assumption i s i m p l i c i t i n t h e i r a t t i t u d e . Current information must be available. Chemicals previously used for commercial purposes are probably f a m i l i a r enough to s c i e n t i s t s to predict t h e i r environmental rates and behaviors. 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 imperative, i f f u l l use i s to be made of available expertise, that information be accessible. Necessary data would cover: oxidation; reduction; hydrolysis; a l k y l a t i o n and dealkylation; conjugation with metabolites such as amino acids, polypeptides or saccharides and the rates and extent of reactions (National Academy of Science, 1975) . Also, basic c h a r a c t e r i s t i c s of the chemical must be known: melting point; boiling point; decomposition temperature; flas h point; physical state; vapour pressure; and c r y s t a l i n e form. F i n a l l y , f o r the monitoring and testing of micro amounts, absorption spectra for the various l i g h t wave frequencies must be known. One further point must be made. Since commercial chemicals are not a single, pure chemical, impurities may have a s i g n i f i c a n t impact on behaviour. The introduction of foreign matter through handling, storage or transportation, the residues of reactants and solvents and the products of side reactions are a l l probable contaminants of i n d u s t r i a l chemicals. They may be more dangerous than the p r i n c i p l e chemical. For example, tetrachloro-p-dibenzodioxin i n the pesticide 2,4,5-T i s f a r more toxic than the pesticide i t s e l f (Wilson; 1971). Thus, care must be taken to test both the chief chemical and i t s impurities. ., 51 2.5 CONCLUSIONS A review of the foregoing analysis reveals that there seldom i s complete information on any of the elements presented. Exposure i s a useful c r i t e r i o n for a screening system when used i n concert with other c r i t e r i a . But, the analysis reveals the near i m p o s s i b i l i t y of determining actual exposure accurately by measurement or c a l c u l a t i o n . Accidents, inadvertent exposure through misuse and environmental fac t o r s such as persistence tend to mitigate aginst such an approach. Also, the e f f e c t of the exposure can d i f f e r because of syn e r g i s t i c interactions or variations i n personal s u s c e p t i b i l i t y . F i n a l l y , the cost i n time and d o l l a r s of obtaining detailed information may be p r o h i b i t i v e . The use of an esposure proxy, such as the ITC index, p a r t i a l l y solves the problems. I t i s r e l a t i v e l y inexpensive and straightforward to use. As well, necessary information i s av a i l a b l e . I t does not, however, deal with the variation in i n d i v i d u a l s e n s i t i v i t y to chemicals. The use of analogy as an aid to establishing p r i o r i t i e s i s of d i r e c t use i n many cases. A dire c t examination of the effects of a naturally occurring chemical may y i e l d s i n n i f i c a n t information. Epidemiology and occupational exposure provide a check on chronic and acute hazard i n such cases. However, i n most cases such approaches are limited to feedback after exposure to new chemicals has occurred. In spi t e of th 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 provide the main source of information on the chemical e f f e c t s on l i v i n g systems., 52 The National Academy of Science f e e l s that i t i s possible to at l e a s t predict the major aspects of the environmental behavior of chemicals through structure and physical 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 strongly related to a chemicals attributes. For instance, the p r i n c i p a l factors influencing chemicals i n s o i l are adsorption and leaching which depend i n turn on the s o l u b i l i t y and charge of a chemical. Similar influencing factors 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 therefore important to obtain basic information about a p a r t i c u l a r chemical. The National Academy of Science suggests that necessary data should cover at least basic reactions and basic c h a r a ct e r i st i cs . A r a t i o n a l approach to designing a screening system involves making the best use of information. To th i s end the following decision framework i s discussed. A major focus of concern should be the minimization of chemical hazard to man and evironment within the constraints imposed by limited resources (or maximization of the net benefit i f a cost/benefit approach i s taken). The impact of a chemical i s a function of two variables, exposure and consequences. Thus, an obvious candidate for regulation i s a chemical with high exposure and disastrous consequences. Conversely, a chemical with low exposure and ne 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 i s the cases that have i n s u f f i c i e n t information to c l e a r l y categorize a chemical that cause d i f f i c u l t y . An 53 appropriate strategy f o r these cases would be to examine the information that i s available for indications of high exposure or high hazard. I f , for example, a chemical i s produced i n large amounts, i s widely d i s t r i b u t e d and i s persistent, prudency dictates a close examination of health consequences. S i m i l a r l y , a highly toxic chemical warrants futher information about exposure. In summing up, a screening system could be a weighted composite of the three approaches. A rat i o n a l approach to control could involve an index for exposure: a high index would mean s t r i c t e r testing for t o x i c i t y . A scheme for determining the e f f e c t s of a chemical on l i v i n g tissue would u t i l i z e animal and i n v i t r o tests. Because of time and expense, preliminary screening for health e f f e c t s may be done with i n v i t r o t e sts which are cheaper and f a s t e r . A b u i l t - i n bias (toward detection of carcinogens, f o r example) could reduce the chance of missing toxic chemicals. Those chemicals which te s t as toxic would be tested further., S i m i l a r l y , knowledge that a chemical i s toxic would indicate the need fo r c a r e f u l review of existing information and possibly further research to determine persistence or d i s t r i b ution etc.. Epidemiological studies could provide feedback on those po t e n t i a l l y toxic chemicals tent a t i v e l y cleared for large scale manufacture. This would allow a check on the accuracy of the screening system and of i n d i v i d u a l t e s t s . , 0 f course, chemicals whose structure indicated a potential hazard would reguire careful review as well. 54 The analysis has indicated the complexity of the two variables, exposure and consequences. To assess probable impact, the many aspects of each variable must be examined and weighed. Given the size and complexity of such a system, most chemicals cannot be dealt with by the use of a formal decision making model. Even though weights may be assigned to specifed c r i t e r i a to generate a formal decision model, knowledgeable s c i e n t i s t s w i l l be needed to integrate and inte r p r e t data derived from di f f e r e n t sources and through d i f f e r e n t methodologies. This has two implications: one, an attempt to process large numbers of chemicals w i l l necessarily require many trained s c i e n t i s t s and decision makers who may not be readily available; two, an extensive information system w i l l be needed to provide relevant data to aid i n the decision process. another major factor to consider i s the cost of contro l . Heinstein (1979) points out that the ITC, although putting great e f f o r t into establishing "reasoned" p r i o r i t i e s has considered "control cost only i m p l i c i t l y at the end" (p. 371). Consideration must be given to establishing the economic worth of further information so that a r a t i o n a l decision about further research and other information costs can be made. 55 Is . 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 guestion of what standards to apply must be answered. Burton and Kbyte (1S78) note that i t i s through the design of standards that s c i e n t i f i c evidence and public opinion are melded into laws and regulations. Various methods e x i s t to guide the development of standards. Acceptance of such standards by both industry and the public i s important. ; Ultimately, any useful standard must be "acceptable" since public r e j e c t i o n may have profound e f f e c t s . In our society r e j e c t i o n may range from p o l i t i c a l lobbying to law su i t s or c i v i l disobedience. Such results are generally undesirable to a public decision maker. Unfortunately, a problem becomes evident when an attempt i s made to substantiate the elusive d e f i n i t i o n of acceptable. Lcwrance (1976, p. 78), i n searching for a functional meaning, quotes the OS Congress Joint Committee on Atomic Energy. Ac c e p t a b l e 1 i s used to mean such d i f f e r e n t things as (a) a conscious decision perhaps based on some balancing of good and bad or progress and r i s k , (b) a decision implying a comparison, possibly subjective, with hazards from other causes, these l a t t e r being •acceptable 1 i n turn i n one of the senses given here, or perhaps just h i s t o r i c a l l y and possibly unconsciously, (c) the passive but substantive fact that nothing has been done to eliminate or c u r t a i l the thing deemed 'acceptable'. 56 Although f a i l i n g to discover a circumscribed d e f i n i t i o n . Lev ranee offers 'guides to a c c e p t a b i l i t y * augmented with further 'considerations' which are in present use. These factors are u t i l i z e d by decision makers in varying circumstances as an aid to choosing an appropriate standard. A comparative analysis of these alternative standard setting techniques follows. As a conceptual framework, the analysis w i l l be roughly ordered between the two extremes: no r i s k and r i s k - b e n e f i t trade o f f . 3.1.1 The Delaney Pri n c i p l e The Delaney p r i n c i p l e , which has been applied to food, i s the embodiment of the no-risk approach. ,.Its essence i s that "no additive s h a l l be deemed safe i f i t i s found ... a f t e r tests which are appropriate for the evaluation of the safety of food additives to induce cancer i n man 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 useful tool for decision makers since i t automatically bans carcinogenic additives from food, i t has been invoked sparingly i n actual practice. Its main e f f e c t seems to be as a guide, representing as i t does, the s p i r i t of the law which i s to provide food at the lowest possible r i s k . Food i s accepted as a s p e c i a l case by decision makers and regulatory agencies. Three of the main elements that make i t unique are the facts that exposure i s universal, involuntary 57 and without alternatives (Upton, 1979).Given these f a c t o r s , there i s a strong public feeling that confidence i n the quality and purity of food should be maintained even at high cost. However, the same status i s not granted to water. Implementing the Delaney p r i n c i p l e i s fraught with d i f f i c u l t y and contradiction. F i r s t , Lowrance points out that i t applies only to carcinogenic food additives. Other toxic agents are excepted. Second, closer examination reveals that i t requires 'appropriate* tests to i n d i c a t e carcinogenicity. Third, i t precludes the e x p l i c i t use of cost-benefit judgments although trade-offs are made i m p l i c i t l y . If the objective i s to minimize hazard i n food, why i s the Delaney p r i n c i p l e not applied generally, instead of only to carcinogenic food additives? One of the main arguments against a general application i s that everything seems to have a l i t t l e of everything else in i t . , 4 s s c i e n t i s t s develop micro-techniques that can detect and measure progressively smaller amounts i t becomes in f e a s i b l e to remove a l l known toxic chemicals that can be detected. The concept of purity stands only u n t i l a more sensitive detection technology leads to the discovery of i n f i n i t e s i m a l amounts of contaminant in the food. The second point mentioned questions the meaning of •appropriate* tests. The wording, perhaps purposefully, leaves the meaning open to discussion, a r e f l e c t i o n of limited knowledge in t h i s area, at any rate, much uncertainty e x i s t s as to what i s appropriate since many factors can influence the results of a test. K r a y b i l l (1979) l i s t s eleven such fac t o r s including route of administration, test species chosen, 58 influence of dose on metabolic pathways and contaminants i n test chemicals, a l l these elements are thought to impinge on the assessment of carcinogenicity and judgment of i t s si g n i f i c a n c e to man. Hith such a high l e v e l of uncertainty, just selection of the required test by a decision maker requires 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 (1976, p. 83) quotes the President's Science advisory Committee regarding the exclusion of cost-benefit trade-offs by the Delaney p r i n c i p l e . The r i g i d s t i p u l a t i o n s of the Delaney Clause, springing from presently inadequate b i o l o g i c a l knowledge, places the administrator i n a very d i f f i c u l t position. He i s not allowed, for example, to weigh any known benefits to human health, no matter how large, against the possible r i s k s of cancer production, no matter how small. Such a decision must be, in r e a l i t y , dealt with in some manner, the Delaney Clause not withstanding. In order to contend with problems such as the use of n i t r i t e s i n meat (they are necessary to reduce the r i s k of botulism 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 with cert a i n amines become nitrosamines (Lijinsky and Epstein, 1970) a known carcinogen, so the dilemma e x i s t s . A trade-off must be made between the r i s k of cancer and the r i s k of botulism. The f a c t that n i t r i t e s are s t i l l used turns on the fine point of l e g a l interpretation: The chemical i s deemed not to be a carcinogen at the time of addition and i t i s therefore permissible (Kessler, 1977). Other chemicals, possibly carcinogenic, remain i n food by virtue of being ignored 59 (Lowrance, 1976). Contamination of water i s among the other complications that exist.,Hater meeting public health standards i n other respects does not meet the requirements of the Delaney clause when added to food during processing. This anomaly a r i s e s because of the presence of complex organic compounds which are carcinogenic in t h e i r own right ( K r a y b i l l , 1979) or become so when combined with the chlorine added to reduce b a c t e r i a l content..Thus, the context i n which a carcinogen i s found affects the application of the Delaney clause. also, some ri s k / b e n e f i t trade-off may be possible, although a heterogeneous population may not have a threshold below which a contaminant would not cause detrimental e f f e c t s (Calabrese, 1978) i t i s possible that i n d i v i d u a l s do. Stokinger (1972) shows that the body has enzymes which can detoxify some foreign materials. Orbach (1975) l i s t s three repair mechanisms that can reduce or remove the e f f e c t of DNa damage. These f a c t s support Cornfield (1977) who maintains that the existence of a threshold depends on whether or not d e t o x i f i c a t i o n and repair mechanisms become saturated, a l e v e l which d i f f e r s from person to person. This may imply that some small amount of toxic contaminant may be safely consumed by most people, allowing some l a t i t u d e f o r cost-benefit trade-offs. , In summary, the Delaney clause appears to be a comfortable myth, unsubstantive in form, of the type postulated by Zeckhauser (1975) confirming the idea that l i f e cannot be traded off f o r other considerations at any cost. This may be changing. Smith (1979b, p. 1221) reports that a majority of the 60 I n s t i t u t e of Medicine and National Academy of Science panel recommends that "health r i s k s of a hazardous food be balanced against the economic benefits to food supplies and others". Even the minority dissenters tend to see i t more as a symbol of an i d e a l to be stri v e d for (Abramson, 1979) than as a r e a l i s t i c p r i n c i p l e since i t was introduced when detection of minute quantities was not possible. Thus, as a standard-setting t o o l i t provides a symbolic i d e a l rather than a s c i e n t i f i c r e a l i t y . However, i n that sense, i t may serve as a guide for decision and a r e s t r a i n t for hazardous actions. 3.1.2 No Detectable Adverse E f f e c t The next three standard setting guides that Lowrance suggests have been linked together f o r purposes of analysis on the basis of t h e i r s i m i l a r i t y . They are: (1) no detectable 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 threshold p r i n c i p l e . These three guides admit some s p e c i f i c l e v e l of a toxic substance but accept that l e v e l as benign..This contrasts with the no-risk approach of the Delaney clause used as a benchmark., The 'no detectable adverse e f f e c t ' approach i s l i b e r a l l y applied at present.„For example, the Onion of Soviet S o c i a l i s t Republics uses such a pri n c i p l e i n setting t h e i r maximum permissible concentrations (MPC) (Roschin and Timofeevaskaya, 1975 p. 32) for occupational exposure. The d e f i n i t i o n of MPC i s given as: 61 the concentrations which, with a workday of not more than 8 hours through the whole of the service record, do not cause any disease or have any other adverse e f f e c t s on the health status of the workers that could be detected by the modern methods of investigation either d i r e c t l y in 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 establishing a l e v e l of no detectable adverse e f f e c t i t i s noted that there i s no consensus on what the l e v e l i s . The Soviet HPC's are generally lower that the OS threshold l i m i t values (TLV) applied to the same chemicals, a major reason being that most TLV's are weighted mean concentrations rather than maximum single time exposures (Roschin and Timofeevskaya, 1975).Another major consideration i s the s e n s i t i v i t y of those people tested. Naturally, i f those most sensitive to the chemical are not tested, the permissible l e v e l w i l l be higher than i t would be otherwise, allowing a small percentage of workers to suffer adverse e f f e c t s . These points show that although the p r i n c i p l e may be useful, i n operaticnalizing i t , f a c t o r s such as who i s tested, the type of exposure (average versus maximum single dose) and the state of development of the testing technology employed can influence the standard chosen. 62 3.1.3 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 Levels Hany of the c r i t i c i s m s which apply to the above guide are applicable to the p r i n c i p l e of • 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 ' , Lowrance comments that t h i s approach i s sometimes taken with some types of food chemicals. Administrative d i s c r e t i o n would be exercised in setting the 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 . Chemicals subject to t h i s regulation might be: those that have existed commercially f o r an adequate period of time without evidence of hazard; those about which l i t t l e i s known but whose structure has certain c h a r a c t e r i s t i c s . Such an approach considers lack of negative information as an indication of a lack of negative e f f e c t s . In the absence of knowlege about a mechanism of action for a chemical t h i s assumption may be dangerous. .Other c r i t i c i s m s could revolve around the state of the technology, the e f f o r t expended on looking for toxic e f f e c t s , the time elapsed for toxic e f f e c t s to appear and the a r b i t r a r i n e s s of the standard set. 3.1.4 The Threshold Principle One of the most controversial standard setting techniques i s the l a s t of t h i s group of three, the 'threshold p r i n c i p l e * . As pointed "The threshold hypothesis assumes that there i s a no-effect dose of carcinogen below which induction of cancer cannot occur or occurs with extremely low p r o b a b i l i t y . " (Maugh I I , 1978, p. 37). As pointed out e a r l i e r and reiterated by 63 Lowrance (1976), the determination of a threshold for the i n d i v i d u a l f o r certain substances seems possible. Indeed, K r a y b i l l (1979) presents instances where substances present naturally i n metabolic cycles of the body become toxic 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 (Calabrese, 1978), thresholds f o r carcinogens and other toxic chemicals are not l i k e l y to be a useful standard setting device. Infact, using standard animal t e s t s , which are at present the accepted method of •proving 1 carcinogencity, i t may be impossible to resolve the threshold guestion. The experimental and human error i s too large to make such studies useful for defining the existence or absence of a threshold by s t a t i s t i c a l means (Maugh I I , 1978). 3.1.5 Standard of Osage The next standard setting technigue to be analyzed i s •custom of usage'. This technique i s of major importance to the flavour industry (Schlegel, 1978). It i s based on the p r i n c i p l e that i f a substance i s consumed i n t r a d i t i o n a l food whose safety i s confirmed, then an i d e n t i c a l synthetic substance can be consumed safely i n other foods as long as ingestion remains on the same order of magnitude. (The FDA reviewed the hundreds of food additives that i t established as 'generally recognized as safe' i n 1958 but aside from cyclamate had found no toxic substances (Spiher, 1974)). There are two main points to be 64 made about t h i s approach. I t should be subject to periodic review (Lowrance, 1976) and although no evidence has yet come to l i g h t , there remains the potential f o r a synthetic chemical to be hazardous. This may r e s u l t from a contaminant produced during the production process as occurred in the manufacture of the f i r e retardent tris-bp and i t s impurity 1,2-dibromo-2-chloropropane a proven carcinogen i n rats and mice. Strawberry aldehyde flavouring was also found to contain an impurity (suspected to be the cause of par a l y s i s of the hind limbs of rats) (Butterworth, 1978). 3. 1.6 P r a c t i c a l Constraints Next i n order of increasing acceptance of r i s k trade-offs i s Lowrance's guide: best available practice, highest practicable protection and lowest practicable exposure. Here again the u t i l i t y of t h i s approach varies with the context of i t s use. In the context of food where the aim i s to reduce r i s k to a minimal amount with l i t t l e regard to cost, i t s use has substantial value. I t s adoption, however, must integrate with the enforcement technology and resources available since there i s l i t t l e use in promulgating laws when i n f r a c t i o n s cannot be detected. , (An exception to t h i s may occur i f the objective of the decision maker i s to decrease public pressure by the appearance of action without actually attempting to change the situation.) i t s main drawback i n t h i s instance i s that d e f i n i t i o n s of 'best' and 'practicable 1 are vague guides for an 65 administrator (Lowrance, 1976). Such vagueness in l e g i s l a t i o n leaves many questions open to i n t e r p r e t a t i o n . Burton and Whyte (1978, p. 168) l i s t four such questions. 1. What factors are to be included in the assessment? 2. .From whose point of view i s p r a c t i c a l i t y to be defined? 3. Who defines what i s practicable? 4. Does the 'best practicable means* include the extreme case of prohibition of the cause i n order to reduce pollution to zero? Thus, t h i s approach places the burden of interpretation on to the administrator who i s then forced to make p o l i t i c a l decisions..Companies disagreeing with the ruling may go to the courts for c l a r i f i c a t i o n i s no other appeal system i s a v a i l a b l e . 3.1.7 Degree of Necessity of Benefit Be f l e c t i o n on * degree of necessity of benefit' reveals that in the context cf environmental po l l u t i o n , e x p l i c i t evaluation of r i s k / b e n e f i t trade-offs i s acknowledged. However, with food, the connotation of e f f i c a c y i s added. The Environmental Mutagen Society (1970, p. 509) states: 66 given a reasonable c a l c u l a t i o n of the genetic hazard posed by an environmental mutagen, i t then becomes necessary to consider how acceptable such a r i s k w i l l be to the population at large. Guiding p r i n c i p l e i n a l l cases should be that no risk whatsoever i s acceptable when the mutagenic compound presents no clear benefits, or when an alte r n a t i v e nonmutagenic compound i s available. Lowrance (1976) gives an example of the application of the pr i n c i p l e r e l a t i v e to DDT. William Ruckelshaw of the EPA reviewed the benefits and costs of DDT and concluded that costs out weighed benefits with the existence of other "equally e f f e c t i v e pesticides available" (Lowrance, 1976, p. 77) playing a s i g n i f i c a n t role in the decision. With regard to food, i n addition to meeting the requirements of safety, the additive must also be e f f i c a c i o u s , l e s s toxic, improve supply or n u t r i t i v e value, or decrease cost. This criterium at l a s t o f f e r s the decision maker a sharp delineation of what i s acceptable and what i s n ' t . Onfortunately, few chemicals are so obliging as to 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 cited and most unimpeachable p r i n c i p l e i n safety judgments". This, with the l a s t of Lowrance's guides to ac c e p t a b i l i t y 'prevailing professional practice' i s characterized by serious weakness. Lowrance points out that 67 reasonableness may d i f f e r considerably with the point of view of those deciding. What i s reasonable to industry may not be reasonable to a community or a union. Also, such factors as ignorance, f a m i l i a r i t y , age and the necessity of taking the r i s k can influence reasonableness (National Commission on Product Safety, 1970). Thus, from the point of view of a decision maker, t h i s guide has l i t t l e v a l i d i t y . 3.1.9 P r e v a i l i n g Professional Practice The prevailing professional practice guide suffers from the lack of a r a t i o n a l basis. Although i t i s in growing use, unless the soundness of present practice i s evaluated and j u s t i f i e d , such acceptance of conventional wisdom i s guestionable (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 reliance i s placed on t h i s approach since the support t r a d i t i o n a l l y provided by employing a common practice i s l o s t i f innovative methods are introduced. I t s main appeal seems to be in the sense of process that established procedures bring about. This may be as important as e f f i c i e n c y tc a decision maker. Zeckhauser (1975) asserts that i t i s sometimes as important how you do something as what you do. Decision makers sometimes prefer a procedure that can be j u s t i f i e d and explained rather than a more e f f i c i e n t but esoteric approach whose methodology i s not obvious (Slovic et a l . , 1975). 68 3.2 MODIFIERS OF STANDARD SETTING APPROACHES The former standard setting techniques represent some of the major approaches that have been used. Decisions about acceptable l e v e l s may be made on the basis of these methods alone but usually the choice of a technique and the f i n a l determination of the l e v e l i s modified by what Lowrance {1976, p. 86) terras "an array of considerations". These represent i n part a manifestation of people's perception of r i s k which varies with the attendant circumstances and i n part a measure of the extent and probability of the consequences of a pote n t i a l hazard. Although these factors are known to modify the standard setting techniques the amount of t h e i r e f f e c t and their d i r e c t i o n i s sometimes uncertain. For example, the probability of an event, perhaps a disaster, i s often judged according 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) point out that our a b i l i t y to assimilate conceptual data i s limited by the extent of our short term memory and the speed at which long term memory i s l a i d down. Thus, when judging an improbable event we may overestimate the probability of i t s occurrence because the news media has recently brought i t to our attention. Slovic et 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 bias. Is sometimes reversed, perhaps because of c u l t u r a l bias. A study comparing Austrian perception with Canadian perception of r i s k showed that the Austrians tended to increase t h e i r perception of probability of events they could not remember while Canadians decreased t h e i r perception of pr o b a b i l i t y as memory of the experience faded 69 (Otway and Pahner, 1876). 3.2.1 Voluntary Versus Involuntary Risk The f i r s t consideration introduced by Lowrance i s the concept of involuntary or voluntary r i s k . Starr (1969, 1972) asserts that r i s k assumed vo l u n t a r i l y i s deemed more acceptable than r i s k assumed i n v o l u n t a r i l y . He gives the example of public p a r t i c i p a t i o n in highly hazardous sports and pastimes contrasting with public resistance to the nuclear hazards which are calculated to be less r i s k y . The concept of voluntary and involuntary r i s k i s more complex than i s f i r s t apparent, Rowe (1977) recognizes at l e a s t three important elements: "(a) equity of r i s k and benefit d i s t r i b u t i o n , (b) the a v o i d a b i l i t y of r i s k and a v a i l a b i l i t y of alternatives and (c) the manner n which risk i s imposed on the ri s k taker" (p. 119). In examining the equitableness of r i s k he contends that for a r i s k to be voluntary the r i s k taker must be the r e c i p i e n t of both r i s k and benefit. I f exposure to r i s k brings no concomitant benefit, allowing only the alternative of f l i g h t to avoid or reduce r i s k , then i t i s neither equitable nor voluntary. In addition, the extent of knowledge available to the r i s k taker modifies the s i t u a t i o n . I f a person at r i s k does not have s u f f i c i e n t information about the amount of r i s k exposure, then even i f benefit i s received, the r i s k i s inequitable and involuntary since no means to balance r i s k and benefit e x i s t s . The lack of information may r e s u l t from 70 deliberate withholding by an informed (possibly exploitative party) or lack of intere s t i n available information on the part of the r i s k taker. Howe, in explaining the sig n i f i c a n c e of 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 s e l f -imposed ri s k and externally imposed r i s k . In some cases inequitable r i s k can be self-imposed such as the case of a person who r i s k s injury to save a l i f e . Externally imposed r i s k can a r i s e by f i a t (e.g. compulsory m i l i t a r y service), by natural causes (e.g. earthquakes) or other causes. 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 alternatives and the avoidance of risk. In determining i f a r i s k i s voluntary the presence of viable alternatives i s c r i t i c a l . In addition to f l i g h t from r i s k , alternatives with less r i s k even at higher cost must be avail a b l e . Thus, a l l these factors act to characterize voluntary and involuntary r i s k . Howe contents that when a r i s k taker i s informed and alternatives e x i s t , r i s k , whether self-imposed or eguitable and endogenously imposed i s voluntary. 3.2.2 Temporal Di s t r i b u t i o n of Bisk The second consideration introduced by Lowrance i s the temporal d i s t r i b u t i o n of r i s k . Fischhoff et a l . (1978) found that perception of r i s k seemed les s when, among other factors, consequences were immediate. This contrasts with the findings of Howe (1977) who takes the view that r i s k i s discounted over 71 time. That i s , the further away i n time the consequences are the greater 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 that the consequences w i l l not be manifest f o r many years. The discrepancy may be at l e a s t p a r t i a l l y explained by the building of anxiety about the consequences once a r i s k i s taken. Zeckhauser (1975) speculates that anxiety plays a large part i n r i s k perception. The longer the time between exposure and consequences the greater the anxiety can become. However, the large amount of apparent discounting behavior needs further examination and c l a r i f i c a t i o n . 3.2.3 The Certainty cf Bisk The next consideration involves the extent of our knowledge about the certainty of r i s k . An example of t h i s i s the increased perception the public has of new technologies e.g. nuclear e l e c t r i c plants versus bicycles, old r i s k s are often perceived as less than unfamiliar new ones even though the new r i s k may be s t a t i s t i c a l l y l e s s . Fischhoff et a l . (1978) found f a m i l i a r i t y with the r i s k to be one of the major factors influencing perception of r i s k . 72 3.2.4 Necessity of Exposure hn adaptive coping mechanism may operate i n conjunction with t h i s next consideration, necessity of exposure. Otway and Pahner (1976) point out that the public often exhibits dichotomization i n i t s behavior when excessive r i s k i s perceived. One action i s to withdraw and ignore the threat. The other i s to form inter e s t groups generally with the intent of removing the source of the r i s k . Withdrawal behavior may be appropriate when r i s k i n unavoidable., Bowe (1977) supports t h i s contention with observations of man's a b i l i t y to r a t i o n a l i z e when confronted with the inescapable consequences of war and terminal disease. The perception of consequences i s reduced to a manageable size through the coping mechanism. 3.2.5 occupational and Bon-Occupational Bisk The divergence between occupational and non-occupational exposure to hazard has been j u s t i f i e d on the grounds that the extra r i s k i s paid for (Lowrance, 1976) . .Indeed, many workers incurring high r i s k s are paid large amounts e.g... • high-steel' workers on the s t e e l frame of skyscrapers or daredevil performers performing improbable f e a t s . Unfortunately, the economics of the work place often encourage poorer workers to accept high r i s k for low pay. Economic theory suggests that the r i s k rejected by the r i c h i s accepted by the poor because t h e i r marginal u t i l i t y for the benefit i s much higher. Empirical studies show that the job r i s k a worker w i l l accept i s 73 negatively related to wealth and supports the concept of increased pay for increased r i s k (Viscusi, 1978). The OSSB states their intention to equalize occupational and common public exposure (Roschin and Timofeevkaya, 1975) but even with the best of intentions, the extent and complexity of occupational environments combined with t r a d i t i o n a l attitudes means that attainment of such a goal i s improbable in the foreseeable future. 3.2.6 Common Versus Dread Bisk When the comparison between common and dread hazards are considered the influence of perception becomes of major importance. News media build-up of p a r t i c u l a r l y t e r r i b l e accidents or feared diseases l i k e cancer can cause resources to be expended out. of proportion to i t s actual benefit to society. As Lowrance (1976) observes, t h i s i n e f f i c i e n c y 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. Cardiovascular diseases take more l i v e s than cancer (National Center for Health S t a t i s t i c s (US), 1S79). But cancer i s often perceived as being the more hazardous and therefore receives more attention. The perception of dread hazards as having greater r i s k can seriously skew our approach to r i s k management. 74 3.2.7 Varying S u s c e p t i b i l i t y to Bisks The s e n s i t i v i t y of the persons affected i s a factor p a r t i c u l a r l y important when considering standards for toxic agents. As pointed out previously and supported by Lowrance (1976), the v a r i a b i l i t y of a population makes i t v i r t u a l l y impossible to protect everyone. Calabrese (1978) states that s e n s i t i v i t y i s modified by exotic factors l i k e blood disorders (e.g. .Methemoglobinemia), homeostatic-regulatory disorders (e. g. Cystinuria) and magnesium deficiency, and by such common factors as age, sex and l i v i n g habits. . 3.2.8 Chemical Propensity f o r Misuse Other considerations such as the propensity for misuse and the r e v e r s i b i l i t y of the consequences can help to arrive at an acceptable standard. Some of the points discussed by Lowrance include the amount of extra protection that must be b u i l t - i n for the few that might misuse a product compared to the cost imposed on the rest cf society. Flame-retardants i n f a b r i c s , for example, may protect people smoking in t h e i r beds from f i r e at the expense of e x p l o i t i n g others' s e n s i t i v i t y to cancer. Blum and Ames (1977) have shown that a major f i r e retardant in f a b r i c i s carcinogenic to mice. Here i s a s i t u a t i o n i n which two l i f e threatening forces must be balanced. Must flame retardants expcse others to the r i s k of cancer to protect those who choose to abuse f i r e in t h e i r homes? How far should such a trade-off go? 7 5 3.2.9 R e v e r s i b i l i t y of Effects In examining the potential 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 persistence 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 was u t i l i z e d i n large quantities i n a way that allowed dispersion throughout the environment. I f the chemical were found l a t e r to cause i r r e v e r s i b l e e f f e c t s , e.g. cancer, and was persistent, a double bind would e x i s t . Such a chemical would not only cause irreparable harm by would be a c t i v e l y present f o r generations a f t e r i t s use has been discontinued. Such a s i t u a t i o n was feared with DDT (Lowrance, 1976). Because of i t s great persistence t h i s ubiquitous chemical was serverely r e s t r i c t e d on the basis of merely suspected deleterious long term e f f e c t s . Decision makers f e l t that the consequences would be catastrophic i f DDT caused toxic e f f e c t s and judged the r i s k too great i n l i g h t of the a v a i l a b i l i t y of suitable substitutes. On the other hand, a s i t u a t i o n i n which a widely used chemical was transient i n nature would l i k e l y leave decision makers more amenable to controlled use. In t h i s case i t i s clear that i f post market monitoring revealed chronic e f f e c t s , removal of the chemical from the market would constitute e f f e c t i v e immediate control not possible i n the case of a persistent chemical. Thus, the threat of i r r e v e r s i b l e damage perpetuated by a persistent chemical must be considered. a second view of r e v e r s i b i l i t y considers 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 pote n t i a l for misuse. An agent which may cause an ailment which 76 i s passing or treatable may be marketed with less stringent standards and with greater 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 considerations and others such as people's cognizance of a hazard and the f a m i l i a r i t y of the technology of a hazard, have a sense of scale i n them. At one end of the scale a hazard i s unacceptable but, at the other, i t i s l i k e l y to be accepted. Decision makers t r y to assess the point on the scale at which a hazard i s perceived as acceptable. This point often has l i t t l e connection with the actual r i s k of any given hazard because of the influence of a variety of psychological and physiological constraints which d i s t o r t perception. Methodology to establish the point of acceptance i s currently being researched. Two of the approaches used are derived from h i s t o r i c a l behavior (Starr, 1969) and from a survey of present preferences (Slcvic et a l . , 1S75). Other influencing factors can e x i s t . To i l l u s t r a t e , the evolution cf the US Public Health Service water standards w i l l be examined. Borchard and Walton (1971) point out that the composition of the advisory body aff e c t s the substantive nature of the recommendation. Personal l i m i t a t i o n s and views of the participants often dictate the outcome of a meeting. Borchard and Walton (1971, p. 17) comment on one of the f i r s t committees to set water guality standards. 77 It i s also evident that the recommended and accepted standards were limited tc the b a c t e r i o l o g i c a l quality only because the commissioners had been unable to agree on s p e c i f i c physical and chemical requirements. & second factor influencing what standards are set and at what l e v e l , i s the simple fact of awareness of a hazard. For example, standards for lead were set very early while others were included l a t e r as s c i e n t i s t s became cognizant of a new threat and gathered enough information to i n i t i a t e action. This awareness of risk i s tied d i r e c t l y to 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 sensitive testing must be available. I f the standard i s more rigorous than can be r e l i a b l y tested by current technigues then the standard i s useless. Second, in some cases, water i n p a r t i c u l a r , the necessary technology to meet stringent standards was simply not available. Here again i t was not practicable to set standards at a lower l e v e l than could be met by the industry since the water was needed. The answer was to to l e t standards become progessively more stringent as technology was developed and the industry became more sophisticated. Such a strategy 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 available technology (Environment Beporter, 1978). a t h i r d influence i s the l o g i s t i c s of t e s t i n g . It may not be possible to t e s t for every pot e n t i a l contaminant. Borchard and Walton point 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 test for the presence of 78 every organism. The strategy f i n a l l y adopted was to use the presence of the most numerous, robust organism as an ind i c a t o r . If these organisms were not detected 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 also absent. Such a strategy may work for chemicals also i f a production process always produces a certa i n group of chemicals together so that a r e l i a b l e i n d i c a t o r e x i s t s . In any case, with the multitude of di f f e r e n t chemicals present i n water, i t i s not possible to test for a l l of them that may be harmful. F i n a l l y , reactions to a standard must be considered. The reaction of the public and the industry are important. Public reaction to regulations intended to protect i t may, i n f a c t , increase the r i s k to which they are exposed. The construction of dams to control flood waters i s an example of such an occurrence. Since the dam was perceived by inhabitants of the flood p l a i n to control the water and reduce r i s k , population and develpment on the flood plain increased. When a major flood, beyond the capacity of the dam occurs, the loss of l i f e and property w i l l be larger than the potential loss before the construction of the dam (Slovic et a l . , 1975). I f an increased sense of safety leads to increased public use or consumption of a hazardous product, a standard may cost more than i t benefits society. Industry actions can also negate the purpose of a standard. Eorchard and Walton (1971) point out that one of the factors considered i n the setting of water g u a l i t y standards was industry's reaction to i t . The fear was that a standard l i m i t i n g pollution to amounts below a certain l e v e l would cause 79 industry to just meet the maximum l e v e l allowed, slowing e f f o r t s to reduce contamination below that l e v e l . Present day experience shews that t h i s sometimes occurs. Larger, more established firms with, perhaps, th e i r reputations i n mind, tend to meet and exceed minimal requirements so that company standards may be more rigorous than government requirements (John Wessel, FDA, 1979). However, smaller firms, with a more tenuous existence, have less to lose and may tend to just meet government standards. Many factors, considerations and methods impinge on standard setting decisions. These include: the people se t t i n g the standards as well as the b e n e f i c i a r i e s , the technology for detecting transgressions of standards and the technology f o r complying to them, and the many moral and philosophical approaches to establishing an operating p r i n c i p l e . Some provide more guidance than others but most serve simply to increase awareness of the ramifications of any p a r t i c u l a r decision made. Few of the approaches and modifiers are de f i n i t e administrative aids to the control of toxic chemicals. Modern a n a l y t i c a l methods have challenged the effectiveness of the Delaney p r i n c i p l e and turned i t into only a useful myth. The v a l i d i t y of other approaches such as 'no detectable 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 challenged as well. Often, what i s acceptable i n one country i s not acceptable i n another. In f a c t , with the exception of 'degree of necessity of benefit' and perhaps, • r e v e r s i b i l i t y of e f f e c t s ' , which provide f a i r l y objective guidelines, a l l of the approaches and modifiers r e l y 80 on judgment. If •judgment' i s the only useful method to combine s c i e n t i f i c knowledge of chemical hazard with public opinions of tolerable l e v e l s of hazard, strategies to ensure an acceptable judgment should be implemented. A r a t i o n a l approach could u t i l i z e r i s k / b e n e f i t methodology. The end resu l t could be the reduction of o v e r a l l r i s k and increased benefits. Unfortunately, the methodology necessary to apply r i s k / b e n e f i t analysis to questions involving human morbidity and mortality i s not f u l l y developed. Public misperceptions caused by factors such as temporal d i s t r i b u t i o n , certainty, and dreadness of r i s k make i t d i f f i c u l t to define the elements of ri s k / b e n e f i t analysis. For example, what discount rate would make a death i n the future equal to a death at present? Should a ling e r i n g death by cancer have the same value as a sudden f a t a l accident? 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 of analysis but r i s k / b e n e f i t analysis may s t i l l be used as a guide to aid r a t i o n l decision making. A second approach to standard setting emphasises the need for a process to 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 possible as an aid to r a t i o n a l i z i n g decisions. An important consideration here i s the cost of regulation versus the benefits. A f u l l study may not be possible, however, even a p a r t i a l examination of the costs and benefits of various methods of control may be he l p f u l in choosing the best available approach. Submissions from 81 industry, from the public and from government agencies would be sought. The accumulation of information would ensure at least that decision makers were exposed to relevant data. An independent body, acceptable to the three 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 s a t i s f i e d with an o r i g i n a l decision. The success of such a process would depend on the a v a i l a b i l i t y of information to the participants.„Organizations already e x i s t to present industry's point of view (e.g. The Canadian Chemical Producers 1 Association and The Manufacturers' of Chemical Sp e c i a l t i e s Association). Such associations have access to industry's information and the resources to argue a case. The public, having more dif f u s e i n t e r e s t s , has more d i f f i c u l t y i n assembling the resources necessary to gather information or to present a case. The success of this consultative process therefore, would require government assistance. Both information and f i n a n c i a l help may be reguired. 82 4. INFORMATION SYSTEMS 4.1 INFOBMATION SYSTEMS 4.1.1 Necessity The foregoing analysis indicates that decisions concerning the regulation of toxic chemicals requires access to a structured and e f f i c i e n t data base. Economical information development and access requires the creation of an appropriate information system. , The problem facing chemical information systems i s often not a lack of information but rather a lack of the right information. Burton and Whyte (1979) point out that we are being overwhelmed by data and that what i s needed i s a method of choosing pertinent information from the glut of i r r e l e v a n t data. The word "information" i s used rather loosely as a synonym for data. However, s t r i c t l y speaking, data are not information u n t i l a user has located and assimilated them. In many cases, potential users are not even aware of the existence of data. Adams (1978) points out that not only are potential users not aware of the 'universe* of data but they cannot locate s p e c i f i c data within the 'universe'. I t seems t h i s i s not only a contempory problem. Fifty-two years ago s c i e n t i s t s were lamenting the lack of an e f f i c i e n t 83 data system as t h i s quote from, December 15, 1928 i l l u s t r a t e s (Journal of Information Science, 1978, p. 3 ) . The precise extent to which research workers are wasting energy repeating experiments that have already been made i s d i f f i c u l t to estimate; but those who have given much attention to the study of the l i t e r a t u r e of t h e i r s p e c i a l subjects are aware that the proportion of labour which i s wasted f o r lack of information on previous work i s very high. ... perhaps i t i s l e s s well perceived that the same proportion of useful work i s published only to be buried out of sight. ...attention should be concentrated on the indexing of recorded information so that hard won data may be found at need and play t h e i r part as a basis for further progress. It i s obvious that duplication and i n a c c e s s a b i l i t y of data are expensive i n terms of time, money and l o s t opportunity. The existing multitude of data sources have many f a u l t s which contribute to that excessive expense. Data are often stored in information systems which are incompatible i n t h e i r access methodology. Also, di f f e r e n t systems were b u i l t to meet di f f e r e n t needs. Therefore, no common nomenclature i s used. Chemicals are stored 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, chemicals may be stored according to chemical structure i n contrast to storage by commercial or common name (TSSC, 1979). This heterogeneity makes e f f i c i e n t data exchange very d i f f i c u l t . There are important s o c i a l consequences of i n e f f i c i e n t data systems as well. For example, i t i s usual i n Canada for the Department of National Health and Welfare to a l e r t physicians to food and drug problems. This has not ca r r i e d over to the dissemination of information about carcinomas of 84 chemical o r i g i n (Science Council of Canada, 1977) in t h i s case, recent data linked vi n y l chloride to a s p e c i f i c type of l i v e r cancer, yet the Department of National Health and Welfare f a i l e d to a l e r t pathologists to these findings. Given t h i s information, i t i s possible that much could have been done to reduce the v i n y l choride hazard to Canadians. Information dissemination i s an important t o o l to combat such hazards. The latent and subtle e f f e c t s of some chemicals requires a comprehensive data base as one of the few e f f e c t i v e means of detecting and d i s t r i b u t i n g information to control such hazards as v i n y l chloride. Data from medical research, workers compensation, occupational settings and various applicable p r o v i n c i a l agencies must be known to exis t and be accessible to other relevant users i f i t i s to be exploited to i t s potential. A properly 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 step toward such a goal. E f f i c i e n t chemical data systems can of f e r many advantages to government and private sectors. Seduced duplication of research and data reporting save time and money. Not only i s information available f a s t e r , but i n some cases, uncertainty can be reduced and new ideas stimulated by the new combinations and associations possible through computer use (TSSC, 1 9 7 9 ) . Information systems could do for s c i e n t i s t s and regulators what the Polaroid camera system did for photographers. I t could decrease the time spent on research and allow e f f o r t and c r e a t i v i t y to focus on synthesizing and developing innovative ideas. International cooperation can improve information 85 dissemination and hazard detection by increasing the u t i l i z a t i o n of present information. Dse of computers to search and cross-reference the expanded data base should prove useful to private and public agencies both nationally and i n t e r n a t i o n a l l y . Various methods of chemical data compilation, storage and r e t r i e v a l have been t r i e d . These systems, ranging from standard manual methods to sophisticated computer models (some even able to translate data from foreign languages (Dubois, 1979)) are designed to minimize certain problems and maximize certa i n advantages to a p a r t i c u l a r user. Depending on the user's needs, parameters such as access methods, cost, speed of r e t r i e v a l , type of information and system capacity can be adjusted. Three example models i n various stages of development w i l l be outlined and t h e i r common and unique problems discussed to i l l u s t r a t e the present state of the information systems f i e l d . 4.1.2 Systems Models Port (1978) outlines three information systems as examples, describing methods of access, capacity, potential users and information handled. 86 Nationa1 The national system has the acronym DESCNET standing for Network Of Data On Environmentally S i g n i f i c a n t chemicals. It was o r i g i n a l l y designed by the Department of the Environment of the O K to provide the government and others with information on chemicals. The structure resembles a spider's web i n that i t i s organized as a network around a centre. The peripheral nodes store data on chemicals i n a common format to f a c i l i t a t e information exchange with each other and with other information systems. The centre would act as a reference for sources and guestions. A p i l o t project has been i n i t i a t e d to determine answers to guestions of f e a s i b i l i t y and of the needs of users. ,. European The European system described by Port (1978) i s being developed at the Joint Research Centre of the European Communities (Norager et a l . , 1978). I t s name, ECDIN i s the acronym for European Chemicals Data and Information Network. The information system can be visualized more as a spoked wheel than as a network since i t stores i t s data in a single data bank at the hub of the wheel. Osers with compatible computer terminals w i l l have access through the EUBONET which l i n k s users through phone lines at post o f f i c e s . Data on about 30,000 chemicals w i l l be segmented into ten categories of information on each chemical and each category w i l l be divided further into f i e l d s and subfields to a t o t a l of 200 properties. Each w i l l be retrievable separately. The 87 categories include s c i e n t i f i c information on structure and properties as well as production information such as use, transportation methods and dispersion i n the environment. The design of the data base i s such that simple information such as s o l u b i l i t y can be retrieved or a sophisticated r e t r i e v a l progam c a l l e d ADABAS can oversee the r e t r i e v a l of cross-referenced information such as a breakdown of chemicals that: (1) are pesticides; (2) are found in milk and; (3) are carcinogenic to rats (Port, 1978) . As part of the p i l o t project a portion of the Registry of Toxic E f f e c t s of Chemical Substances data from NIOSH (National I n s t i t u t e of Occupational Safety and Health) was incorporated into the data base (Norager et a l . , 1978). The data on the approximately 5 0 0 0 chemicals (Johnson, 1978) were taken at face value from the Begistry: t h e i r i n t e g r i t y unquestioned, "of necessity we rely on editing provided by the s c i e n t i f i c community before publishing." (Norager et a j . . , 1978, p. 135) 1 . International The i n t e r n a t i o n a l information system model described by Port (1978) i s under the auspice of the United Nations Environmental Program (UNEP) and i s t i e d into the UNEP Global Monitoring System (0*Sullivan, 1976). The organizational structure of IBPTC (International Begistry of Po t e n t i a l l y Toxic 1. The question of v a l i d i t y and cross c e r t i f i c a t i o n of data and inferences i s addressed l a t e r i n t h i s thesis. 88 Chemicals) i s a network with a centre but i t has more emphasis on secondary data bases than the OK DESCNET. although the centre at Geneva w i l l carry out administrative duties such as providing r e f e r r a l s and answering questions as well as acting as a computer data storage centre, the peripheral nodes of the network named •National Correspondents' w i l l be encouraged to build up a s e l e c t i v e semi-autonomous data base. This w i l l develop a capacity to answer questions pertinent to a p a r t i c u l a r geographic area (Huismans, 1978) without going through the centre at Geneva. IBPTC w i l l cover a geographically larger area and have a somewhat broader mandate than most other information systems. Users w i l l be globally distributed and w i l l include such i n s t i t u t e s as the World Health Organization and the International agency for Research on Cancer as well as divers member countries, as a r e s u l ^ of this width and breadth IBPTC has unique goals and constraints. Huismans (1978) points out four functional objectives of IBPTC. IBPTC w i l l not attempt to c e n t r a l i z e a l l data but rather may refer requests for information to the appropriate National Correspondent. Thus, a National Correspondent may participate i n two ways: the data base may be stored c e n t r a l l y at the Progam a c t i v i t y Centre as has occurred with data from NIOSH i n the US; information may be released d i r e c t l y from i n d i v i d u a l f i l e s on reguest. In any case, an additional function of each National Correspondent w i l l be to search out required information from his s p e c i f i c sector and to make i t avai l a b l e throughout the network. 89 A second function of IRPTC takes advantage of the extensiveness of the network to i n order to reveal global information d e f i c i e n c i e s i n toxic chemical data and to d i r e c t research to reduce the gaps. This w i l l be accomplished through the cooperation and collaboration of various programs world wide. The t h i r d function w i l l revolve around the i d e n t i f i c a t i o n of potential chemical hazards. Here the agencies w i l l u t i l i z e the network to achieve a fan-out of data on current chemical hazards and controls of global i n t e r e s t . Members w i l l be alerted tc current chemical r i s k s throughout the world and to steps taken to control such r i s k s . F i n a l l y , Huismans (1978) expects that IBPTC w i l l disseminate data on the regulaory approaches and p o l i c i e s of member countries by whatever means seem appropriate. This might range from regular b u l l e t i n s f o r routine information to s p e c i a l a l e r t s for more urgent information. , According to Port (1975) the actual chemical data base i s expected to be smaller than the 30,000 chemical capacity of ECDIN. The organization of the f i l e s also w i l l be s l i g h t l y d i f f e r e n t . They w i l l be comprised of only eight categories divided into 140 attributes. The information w i l l include chemical c h a r a c t e r i s t i c s (molecular formula, molecular weight and t o x i c dose) and regulatory information (reviews, standards and regulations) (Huismans, 1978). To aid i d e n t i f i c a t i o n and cross-referencing of chemicals, approximately 80,000 synonyms w i l l be stored in the f i l e s . 90 Other Systems Other systems have been developed i n response to the s p e c i f i c needs of a pa r t i c u l a r user. The US Council on Environmental Quality has formed CSIN (Chemical Substances Information Network) (TSSC, 1979) . It w i l l have a large capacity (about 500,000 chemicals) and i s expected to serve federal agencies as well as private groups i n industry and public i n t e r e s t groups. Software, management and funding are seme of the areas with guestions pending. The US has several other systems which provide spec i a l i z e d data bases. Merian (1978) mentions: MEDLABS, TOXLINE, CHEMLINE and TOX BANK administered by the National Library of Medicine; data banks maintained by NIOSH, CPSC (Consumer Product Safety Commission) and EMIC (Environmental Mutagens Information Centre); and also the extensive 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 fur wassergefahrdeude steffe) and DIMI-systems (Deutsches I n s t i t u t fur medizinische Dokumentation und Information) (Merian, 1978). These are but a few of the many systems in the chemical information system f i e l d . As mentioned, most are not compatible with others and so represent not only duplication of e f f o r t but also 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 such systems presents several problem areas. 91 4 . 1 . 3 Problem Areas Hany of the advantages and disadvantages of computerized data systems are the same as those brought by a computer to any system. ,A computer can scan a tremendous amount of data i n a short time with greater accuracy than a manual searcher can. However, the computer adage 'garbage i n garbage out* s t i l l applies. Several problem areas are evident when a system design i s attempted. The data i t s e l f must be of good q u a l i t y . The program to handle the f i l e s must be sound and e f f i c i e n t . .The needs of the p o t e n t i a l users must be met i n such areas as access, structure, funding and c o n f i d e n t i a l i t y . F i n a l l y , experts must be available to prepare data and run the system. Data Quality Different data are important to d i f f e r e n t users. This has a profound e f f e c t on the c r i t e r i a used to develop a comprehensive, current and accurate data base. For example, a user seeking only information to physically characterize a chemical requires stable data which i s f a i r l y easy to obtain. The accuracy i s simple to v e r i f y and not subject to excessive d i s t o r t i o n as i t passes through the data gathering system. Such data may include molecular weight, melting point, st r u c t u r a l formula and other 'hard' f a c t s . Since these data are obtained through the physical sciences using established procedures, there i s l i t t l e judgment involved. .The f i e l d i s limited so i t can be covered comprehensively and data can be gathered e a s i l y 92 on thousands of chemicals (Port, 1978) . However, other data users such as a regulatory agencies or public i n t e r e s t groups are interested in the implications of data. Port (1978) points out that i n these cases summaries and interpretations are needed. What are to be treated as relevant data becomes a policy guestion involving judgment. Because of t h i s s u b j e c t i v i t y , a complete coverage of 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 i n keeping information current since limited resources constrain the f i e l d s of new data that can be examined, as well as the selection and the entry speed for that data that i s considered relevant. The bibliography data base, TOXLINE, fo r example, lags months behind current journals (Port 1978) . So i n addition to reduced currency and comprehensiveness, accuracy may suffer i n two ways. One, since much of the information for regulatory decisions and public use requires i n t e r p r e t a t i o n of data, a substantial amount of judgment bias can be introduced i n t o the the f i n a l data base. The data chosen for entry or exclusion as well as the manner i n which data i s worded becomes the product of the researcher and subject to his p r o c l i v i t i e s (National Academy of Science, 1975). Two, yet, any errors made in transcribing the data are d i f f i c u l t to detect. The volume of data to be covered makes errors unavoidable. The d i f f i c u l t y of maintaining data quality w i l l vary with the complexity, s u b j e c t i v i t y and volume of the data stored. Some suggestions have been developed to improve data quality and to reduce the impact of errors and omissions. Port 93 (1978) advocates the establishment of data bases in conjunction with i n s t i t u t e s doing research i n the same subject area. This would increase data quality by providing expert advice on the in t e r p r e t a t i o n and the inclusion or exclusion of data for the bank. Adams (1978), in summarizing the r e s u l t s of the National Forum on S c i e n t i f i c and Technical Communications, stresses the need to educate those concerned with the system (from data generator through data provider to data user) about the standards of the system. Adams also points out the need f o r the people entering the data to understand both the s c i e n t i f i c area involved and the information system being used. Design Problems Much work i s being done on data storage and r e t r i e v a l methods with the result that systems are improving, However, problems remain. Some of the blocks i n the chemical data systems are: (1) a universal method of r e f e r r i n g to a p a r t i c u l a r chemical does not e x i s t ; (2) the optimal organizational structure of a system i s uncertain. (3) there i s a problem i n characterizing the uses of chemicals; and (4) methods available to t i e other f i l e s to computer systems raise other guestions.. A standardized method of r e f e r r i n g to a chemical must be established i f inter-system and inter-agency data exchange i s to occur. At present, a chemical may be referred to by formula, by commercial or trade name, by common name or by any of several chemical names in English or a foreign language. To 94 r a t i o n a l i z e chemical data systems i t i s important that a l l the information attached to various names be retrieved when only one chemical name i s given. One solution to the the problem i s to assign a unique number to each chemical no matter what synonym i s used. The American Chemical Society has been using such a system for i t s Chemical Abstracts Service (CAS) and has already assigned numbers to four m i l l i o n chemicals. Adoption of such a plan seems feasible (TSSC, 1979)^ A portion of the problem not addressed by the CAS numbering system i s that raised by mixtures./TSSC (1979) points out the d i f f i c u l t y of i d e n t i f y i n g and categorizing mixes such as tar. ,Hany other complex organic mixes such as flavouring chemicals may f a l l i nto t h i s problem area (Schlegel, 1978). The problem of system organization i s unlikely to be solved u n t i l the p o t e n t i a l users are i d e n t i f i e d . However, some of the considerations may be delineated. , One consideration i s whether to use a data centre or a network approach to oraganization. Each has i t s advantages. A network allows a base to be geographically c l o s e r to major users or data generators. Proximity to data generators may improve data guality by increasing the a v a i l a b i l i t y of subject expertise, as mentioned e a r l i e r , while proximity to users may reduce cost of access. A single data centre, on the other hand, allows greater u t i l i z a t i o n of the computer's cap a b i l i t y to manipulate data f o r crcss-referencing and l i n k i n g (Port, 1978). Such a system conserves scarce expertise and provides a more stimulating and supportive enviroment. In addition, greater control over the data generally i s possible. 95 The t h i r d problem i n v o l v e s a method to c a t e g o r i z e chemical use i n a standard way. At present the TSSC (1979) points 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 provide 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 chemical f u n c t i o n and a p p l i c a t i o n to generate about 800 terms. Used s i n g l y or together, the terms can c h a r a c t e r i z e a chemical use i n a uniform and unique way. One example i s the f u n c t i o n •adhesive* which i s subdivided 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 to t i e e x i s t i n g and f u t u r e f i l e s together. Techniques l i k e epidemiology need methods of r e l a t i n g extensive personal f i l e s c o n t a i n i n g demographic, medical and occupational data on i n d i v i d u a l s to chemical use and exposure data. .This i s d i f f i c u l t because of personal 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 Insurance Number (SIN)• Unfortunately, i t i s f e l t by many tha t use of the SIN presents severe t h r e a t s t o personal privacy s i n c e i t represents a p o t e n t i a l l y powerful t o o l to surppress personal freedom by both government and p r i v a t e 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 study i n Canada by a f e d e r a l commission. P r i v a t e companies have expressed concern about the c o n f i d e n t i a l i t y of computer data.,Dueltgen (1979), speaking f o r a p r i v a t e company i n the US, recognizes the value of computer i n f o r m a t i o n to the p r i v a t e s e c t o r , but emphasizes the cost of unauthorized d i s c l o s e r e of p r o p r i e t a r y data. He points out that 96 p o s s e s s i o n of manufacturing data on chemicals may be a s i g n i f i c a n t market advantage to other companies i n the i n d u s t r y . He questions the l e g a l s t a t u s of data i n such areas as accuracy and proper use..Dueltgen f e e l s at present, t h a t the chemical i n d u s t r y i n the OS i n c l i n e s to n o n - d i s c l o s u r e of s e n s i t i v e i n f o r m a t i o n pending s a t i s f a c t o r y r e s o l u t i o n of the c o n f i d e n t i a l i t y q u e s t i o n . A s i m i l a r i n d u s t r y a t t i t u d e appears to e x i s t i n Canada (Neff and Mutton, 1980). The Canadian problem may be compounded by circumstances i n the US s i n c e Canada depends h e a v i l y on US data bases and i n f o r m a t i o n s e r v i c e s (Herdel and S t e e l e , 1978). Canadian companies may not wish t o r i s k t h e i r i n f o r m a t i o n i n US data banks i f the American a t t i t u d e to data c o n f i d e n t i a l i t y c r e a t e s g r e a t e r r i s k of d i s c l o s u r e . One method of handling the problem of p r o p r i e t a r y or other r e s t r i c t e d i n f o r m a t i o n i s to segment a f i l e system as the EPA has done. I n f o r m a t i o n f o r TOSCA i s s p l i t i n t o p u b l i c i n f o r m a t i o n 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 a v a i l a b l e t o the EPA o n l y (TSSC, 1979).,Thus, the p u b l i c and other companies are ref u s e d l e g a l a ccess to p r o p r i e t a r y data through s e c u r i t y mechanisms. Such mechanisms r e s t r i c t a ccess to computer f i l e s through three broad methods designed to v e r i f y the i d e n t i t y of an a u t h o r i z e d user (Lowe, 1976) . V e r i f i c a t i o n may be based on some p h y s i c a l possession such as a key or magnetic c a r d , some property of the user such as a f i n g e r p r i n t o r s i g n a t u r e , or some knowledge of the user such as a password or answers to a s e r i e s of q u e s t i o n s . However, no s e c u r i t y system i s p e r f e c t . At 97 best these f e a t u r e s , when combined with others provide "a high degree of s e c u r i t y " (p. ,17). A t r a d e - o f f between c o s t and d i f f i c u l t y of o p e r a t i o n on one hand and the importance o f data s e c u r i t y on the other must be made, keeping i n mind i n d u s t r y ' s 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 adequate s e c u r i t y . Funding and Users S a t i s f a c t o r y methods of fund i n g i n f o r m a t i o n systems have yet to be developed. A given system cannot meet a l l the needs of d i v e r s e users (Adams, 1979). P o t e n t i a l users such as government, p r i v a t e c o r p o r a t i o n s , s c i e n t i s t s and the p u b l i c a l l make d i f f e r e n t demands of a system (Port, 1978). The attempted r e c o n c i l i a t i o n o f user's needs and fund sources makes c o n f l i c t e v i d e n t . I f the needs o f the p r i v a t e s e c t o r are met then i t i s u n f a i r to use l a r g e amounts of p u b l i c money to fund the system. Yet, i f a system i s designed only f o r government use then much of the economic b e n e f i t w i l l be l o s t i f the p r i v a t e s e c t o r cannot e x p l o i t the system to advantage. Furthermore, p r i v a t e users are i n t e g r a l l y i n v o l v e d i n the i n f o r m a t i o n system, being the source of much of the data and a p r i n c i p a l reason f o r the system's e x i s t e n c e i n the f i r s t p l a c e . I f a system does not meet the needs o f p r i v a t e users then the c o o p e r a t i o n r e q u i r e d from the p r i v a t e s e c t o r may not be forthcoming. Even i f government i s the main user problems e x i s t . Within government, s c i e n t i s t s and r e g u l a t i n g agencies have d i f f e r e n t 98 requirements. S c i e n t i s t s need f u l l data and r e f e r e n c e s while r e g u l a t o r s need summaries and i n t e r p r e t a t i o n s of r e l e v a n t data. Given l i m i t e d r e s o u r c e s , a system may be compromised so t h a t n e i t h e r group i s s a t i s i f i e d . T e c h n i c a l E x p e r t i s e It i s obvious t h a t a gre a t d e a l of t e c h n i c a l e x p e r t i s e i s r e q u i r e d to e x t r a c t a f a i r r e t u r n from i n f o r m a t i o n system e x p e n d i t u r e s . Krentz (1978) p o i n t s out the need f o r o p e r a t o r s t o be w e l l t r a i n e d i n both i n f o r m a t i o n systems and i n a c l i e n t s • s u b j e c t area i f data i s t o be entered and r e t r i e v e d e f f e c t i v e l y . As w e l l , the demands f o r data q u a l i t y , e s p e c i a l l y i n the areas of i n t e r p r e t a t i o n and summarization, h i g h l i g h t the need f o r expert reviewers able t o s e l e c t , and e v a l u a t e data i n the v a r i o u s r e l e v a n t f i e l d s . Thus, a requirement f o r h i g h l y t r a i n e d p r o f e s s i o n a l s w i l l be generated with the i n t r o d u c t i o n of i n f o r m a t i o n systems., t».2 CONCLUSIONS Computerized i n f o r m a t i o n systems can p r o v i d e the i n f o r m a t i o n necessary to a i d i n d e c i s i o n s about p r i o r i t i e s f o r chemical s c r e e n i n g and about a c c e p t a b l e standards f o r the chemical c a n d i d a t e s chosen. Although there a re advantages, some qu e s t i o n s remain to be answered. The main advantages of i n f o r m a t i o n systems are those 99 derived from computer use. The speed o f the computer a l l o w s a user to scan a v a i l a b l e data q u i c k l y f o r those which are r e l e v a n t , a v o i d i n g d u p l i c a t i o n of p r e v i o u s r e s e a r c h . The high speed a l s o a l l o w s f o r i n c r e a s e d use of data and a broader data base. I n t u r n , the enlarged data base can provide more r e l e v a n t i n f o r m a t i o n f o r d e c i s i o n making thereby r e d u c i n g u n c e r t a i n t y . F i n a l l y , the unique c h a r a c t e r i s t i c s of computers o f f e r two other 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 a s s o c i a t i o n s of data, i n o v a t i o n can be s t i m u l a t e d . D i f f i c u l t i e s with computerized i n f o r m a t i o n systems are t y p i c a l l y concerned with the human elements. One important qu e s t i o n i s data v a l i d i t y . To be very u s e f u l , a system must provide data that i s c u r r n e t and c o r r e c t . D n f o r t u n a t e l y , judgment must be used i n d e c i d i n g what i s to be placed i n f i l e s and how i t i s t o be recorded. Such judgment can i n t r o d u c e a b i a s to the data. B i a s when combined with e n t r y e r r o r s , produces a s u b s t a n t i a l p o t e n t i a l f o r m i s r e p r e s e n t a t i o n . Thus, techniques must be introduced t o maintain data v a l i d i t y . One approach to improving data v a l i d i t y i s the esta b l i s h m e n t o f data e n t r y p o i n t s a t r e s e a r c h c e n t r e s whereexpertise i s a v a i l a b l e t o monitor e n t r i e s . A second major concern i s the c a t e g o r i z a t i o n and r e t r i e v a l o f d ata. Storage and r e t r i e v a l of chemical data entered under many synonyms can be achieved through the use of common CAS numbers. U n f o r t u n a t e l y , t h i s approach does not apply w e l l to the c a t e g o r i z a t i o n of chemi c a l mixes. However, the problem of c a t e g o r i z i n g chemical uses can be reduced by u t i l i z i n g the EPA approach of f u n c t i o n s and a p p l i c a t i o n s . 1 0 0 also, unanswered questions about data exchange and use remain. Different users have c o n f l i c t i n g reguirements. a system that e f f i c i e n t l y meets one set of needs may not meet others. , The cost of providing duplicate data i n two or more d i f f e r e n t forms may be very high. Thus, in meeting the needs of d i f f e r e n t users (e.g. regulators 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 be taken, a system organization similar to that of IBPTC may be used. A federal system would serve as the centre of the network providing a centralized data base while p r o v i n c i a l computer systems would serve as •National correspondents' to meet specia l i z e d needs and provide regional information. C o n f i d e n t i a l i t y i s a fourth major concern. Standard setting and screening w i l l reguire industry to provide the federal government with proprietary information i t wishes to keep confidential.,. However, the regulation of chemicals requires federal and p r o v i n c i a l cooperation and information exchange as well as in t e r a c t i o n with public inte r e s t groups. C o n f i d e n t i a l i t y w i l l be threatened. Thus, although the f e d e r a l government may share most information, some information must remain r e s t r i c t e d . One method to do so i s u t i l i z e d by the EPa and involves s p l i t t i n g the data base. Data i n one part of the base would be r e s t r i c t e d for the use of authorized users only, a second element of c o n f i d e n t i a l i t y revolves around the status of Canadian information i n American data banks. Canadian information i n the OS may be subject to american freedom of 1 0 1 information laws i n which case i n d u s t r i a l prorietary information may be divulged. Understandably, Canadian industries may not y i e l d c o n f i d e n t i a l information under these circumstances. Further implications of transferring information across international borders must be examined. Compatibility among information systems, both national and in t e r n a t i o n a l i s important. Since most provinces maintain t h e i r own computer systems i s important that t h e i r systems be compatible with a federal system. The overlapping and integated federal and p r o v i n c i a l environmental l e g i s l a t i o n necessitates cooperation among governments. E f f i c i e n t information exchange i s a s i g n i f i c a n t step toward such an objective. Information systems improve decisions only i f their,data are v a l i d . To ensure v a l i d i t y , systems must have a means of cross v e r i f i c a t i o n and vali d a t i o n . This implies that data from d i f f e r e n t sources w i l l be compatible for exchange and comparison among systems. Thus, methods of data c o l l e c t i o n and storage must be standardized. Besides the steps taken to r a t i o n a l i z e the information systems themselves, attempts are being made to standardize national and international research techniques to f a c i l i t a t e data comparison. For example, the OECD i s currently engaged in reaching international agreement on uniform laboratory practices. In any case, i t i s important that information systems include a mechanism to i d e n t i f y data that has been proven robust, i e . has been validated by comparison with data from d i f f e r e n t sources. Conversely, l e s s r e l i a b l e data should be designated as such. Users of the data would then be able to 102 give a datum the proper weight i n a decision. International compatibility may be as important to a functioning system as national compatibility. The US, f o r example, in addition to providing much relevant, general s c i e n t i f i c information, i s also a major exporter of chemicals to Canada. S p e c i f i c information from US tests of imported chemicals w i l l aid i n screening and standard setting decisions. Therefore, the design of any Canadian information system should consider compatibility at l e a s t with the American system. An important aspect of screening and standard se t t i n g i s feedback about the e f f e c t s of previous decisions. Epidemiology, the main method of detecting and tracing chemical e f f e c t s depends on extensive, current data. These data are obtained from sources including occupational and medical records. Modern mobility makes the maintenance of such data bases d i f f i c u l t . Although the use of the So c i a l Insurance Number to t i e personal f i l e s together i s not presently accepted, procedures to reduce the danger of misuse and ensure privacy must be developed to improve a c c e p t a b i l i t y or a substitute.method must be found. One further aspect of the operation os a Canadian information system remains f o r discussion. The e f f i c i e n t functioning of such a system depends on trained people able to 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 , relevance and r e t r i e v a l of data. .Without v a l i d data and proper use, correct decisions cannot be made. The users of the system must be familiar with i t s strengths, weaknesses and operation and be able to interface 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 cf 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 professionals associated with the information system must be encouraged and f a c i l i t a t e d i f a Canadian system i s to reach i t s potential. 104 5i COHCJ.UglOlS The instruments of control have been reviewed and e x i s t i n g Canadian l e g i s l a t i o n surveyed to provide a general background. Such l e g i s l a t i o n provides for federal and/or pr o v i n c i a l control 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 covers most gaps. L i t t l e new l e g i s l a t i o n seems necessary, however both governments have extensive powers to enact needed l e g i s l a t i o n . ; 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 introduction of toxic chemical regulations. Instead, constraints on regulations arise from the large number of chemicals to regulate and the paucity of information. The development of new policy revolves not around designing l e g i s l a t i o n but in esta b l i s h i n g p r i o r i t i e s and gathering information for developing s p e c i f i c 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 to c o l l e c t nearly any information or to finance any research required. Constraints on information gathering are of a p o l i t i a l or economic nature. Some constraints can be avoided by the governments 1 power to r e s t r i c t public access to government information. Thus, industry's reluctance to y i e l d proprietary information to governments may be reduced. Governments have powers to ensure compensation for damages from chemicals. Compensation funds may be set up and financed 105 either from general revenue or from l e v i e s on industry. In addition, governments can a s s i s t those harmed by chemicals by ensuring private r i g h t s of action against responsible companies. fo ensure e f f e c t i v e chemical control p o l i c y , federal and prov i n c i a l cooperation i s needed since much of the l e g i s l a t i o n overlaps. Cooperation would be assisted by information exchange. Also, pre-market screening and regulations w i l l reguire adeguate information. The elements of a strategy to establish p r i o r i t i e s f or chemical regulations were appraised. Exposure to chemicals and the consequences of that exposure are found to determine the extent of the impact on health and the environment. Adequate information on both elements would make screening a t r i v i a l exercise. However, such information seldom e x i s t s ; therefore, judgment must be used. The complexity of the system makes the use of a formal decision model u n l i k e l y . If reliance i s to be placed on the judgment of s c i e n t i s t s and regulators, then careful t r a i n i n g and as much relevant information as possible are necessary to reduce uncertainty.. The approaches to transform public opinion and s c i e n t i f i c knowledge into standards for chemical regulations have been presented. The factors a f f e c t i n g the standard setting procedure have been reviewed as well. These include personal l i m i t a t i o n s of standard setting bodies, technology a v a i l a b l e , resources available, l o g i s t i c a l constraints and reaction to p o l i c i e s . No clear method i s available to establish optimum standards. Therefore, a consultative process and p a r t i c i p a t i o n of the 106 three sectors (public, government, and industry) i s necessary to ensure a c c e p t a b i l i t y . An appeal to an independent board may be necessary to resolve some issues. Governments may also provide assistance in the form of information and finances to public int e r e s t groups to increase meaningful pa r i c i p a t i o n . F i n a l l y , information systems were reviewed as a means of providing data for screening and standard s e t t i n g processes. The main advantages of a computerized information system are speed, capacity and cross referencing a b i l i t y . „ Disadvantages such as problems with data v a l i d i t y and currentness arise 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 must be given to cross indexing synonyms for the same chemical and categorizing chemical uses. These problems can be reduced by adoption of the CAS unique numbering method and the EPA functions and applications approach to categorization respectively., A system organization must be decided on. ,,A Canadian system may incorporate a network approach s i m i l a r to the IBPTC organization with the federal government acting as a central data base and the provinces as peripheral nodes catering to sp e c i a l i z e d , regional needs. This compromise u t i l i z e s the computer a b i l i t y to cross reference data while allowing s p e c i a l i z e d needs to be met. However, the sharing of cost, compatibility and methods of maintaining c o n f i d e n t i a l i t y requires f e d e r a l / p r o v i n c i a l cooperation. Compatibility with other systems i s stressed* National compatibility i s a necessity. Also, compatibility with the systems i n other countries, notably that of the OS, must be 1 .07 given thorough consideration. 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Attention w i l l centre mainly on the United Kingdom (UK) and the United States (US). The UK i s important because of 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 legal commonalities. As a r e s u l t , both Canada and the UK have adopted a sim i a l r consultative approach to chemical control with an emphasis on consensus. This i s i n contrast to the approach of the US which uses adversary proceedings and r e l i e s heavily on the courts to resolve 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 , grographical proximity 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 countries w i l l be reviewed as well to provide a more complete overview. A.I United Kingdom The Control of Pollution Act of 1974 was enacted to cover situations where ex i s t i n g l e g i s l a t i o n i s not applicable, especially where emergency action i s required (OECD, 1976). It enables the administrator, the Department of the Environment , to co n t r o l or ban the import, commercial use or d i s t r i b u t i o n of any chemical to prevent environmental or human damage. Before 119 regulations are promulgated, consultation occurs with those affected. , To control pesticides, the OK has i n s t i t u t e d a non-statutory agreement between manufacturers and government agencies. The agreement allows f o r government n o t i f i c a t i o n of new pesticides. Recommendations, i n conjunction with an Advisory Committee, are made with respect to r e s t r i c t i o n s on marketing and use. The t i t l e i s Pesticides Safety Precautions Scheme. The OECD report points out that the control of environmental contaminants has occurred in three main areas, general pollutants, s p e c i f i c chemicals, and cer t a i n uses. The control approach to general pollutants of a i r and water and to waste disposal has been to allow l o c a l autonomy. Authorities consider a l l factors, l o c a l conditions not excepted, and then set type and l e v e l of controls to s u i t . As a r e s u l t , controls in d i f f e r e n t areas of the country vary considerably. The control of s p e c i f i c chemicals i s achieved through a mix of statutes and agreements.,For instance, on the one hand, detergents are regulated by a voluntary agreement covering the screening of new chemicals to be used in domestic detergents. Sulphur, on the other hand, i s regulated under Section 76 of the Control of Poll u t i o n Act which provides for l i m i t s on the amount of sulfur in fu e l o i l . F i n a l l y , certain uses are covered, for example, i n the work place the manufacturer i s bound to ensure that only chemicals safe under normal conditions are used. Under the Health and Safety At Work Act (1974), constant monitoring by the Health and Safety Executive 120 (HSE) i s aimed at regulating p o t e n t i a l l y harmful chemicals. These chemicals are controlled by o f f i c i a l guidelines reinforced by health and safety statutes as required. In a recent release, desiqned to e l i c i t industry response. N o t i f i c a t i o n Scheme for Toxic Substances, HSE outlined i t s approach (Hay, 19 79). The philosophy i s to keep test costs down by requiring the minimum amount of information necessary to move to the next step of chemical development i f more than 100 kg/yr i s marketed. The idea i s that preliminary t o x i c i t y testing w i l l be carried out at a sub-acute l e v e l for 20 days. Should t h i s raise suspicions, long term research must be implemented. This contrasts with the US Environmental Protection Agency (EPA) requirements for a r i g i d series of tests before a chemical i s registered (registration i s required fo r marketing). The UK changed i t s approach to the control of pharmaceuticals with the introduction of the Medicines Act of 1971. The Act introduced formal procedures f o r pre-market screening of new drugs (Grabowski et a l . , 1978).These included proof of e f f i c a c y and an approved plan for testing i n animals and humans. This represented a major s h i f t i n emphasis from a post-market, l a r g e l y voluntary program to pre-market formal screening. 121 A.2 United States of America In 1976, after six years of e f f o r t , the Toxic Substances Control Act (TOSCA.) was passed. The reason f o r i t s inception i s summed up by President Carter (1977). ...the presence of toxic chemicals in our environment i s one of the grimmest discoveries of the i n d u s t r i a l era. Rather than coping with these hazards aft e r they have escaped into cur environment, our primary objective must be to prevent them from entering the environment i n the f i r s t place. The act gives the SPA an extensive range of authority to i n s t i t u t e pre-market controls (Cleary et a l . , 1978): E x i s t i n g chemicals are being catalogued and the EPA receives notice of a l l new chemical and e x i s t i n g chemicals with new uses; Industry tests of chemical and chemical mixes can be required; Chemicals with i n s u f f i c i e n t information and s i g n i f i c a n t exposure can be withheld from the market; Chemicals, new or e x i s t i n g , presenting unreasonable r i s k can be banned or r e s t r i c t e d and; The act reguires extensive record keeping and report production. Already industry i s objecting to EPA proposals under the Act (Hay, 1979). The proposed approach requires a r i g i d battery of s p e c i f i c t e s t s , long and short term, before allowing a chemical to be marketed. Industry anticipates high cost, decreased innovation and a shortage of s k i l l e d technicians to carry out the work as a r e s u l t of such a policy. The OS has s p e c i f i c l e g i s l a t i o n designed to control pesticides although TOSCA may be applied i f the administrator 1 2 2 f e e l s i t i s i n the public's best i n t e r e s t (Cleary gt a l , , 1978), The l e g i s l a t i o n requires the r e g i s t r a t i o n of a l l pesticides with the EPA and their examination f o r ef f i c a c y and for safety to man and environment. Present regulations pertain to c l a s s i f i c a t i o n and provide guidelines concerning user safety, proper procedures and permits f o r experimental use. As with TOSCA, potential hazard i s emphasised. Various other laws are germane to the control of to x i c chemicals. Some of the major l e g i s l a t i o n administered by the EPA follows. The Clean Air Act and amendments requires the establishment of national emission standards for various contaminants. The Hater Po l l u t i o n Control Act and amendments has stated goals: "(1) to obtain, by 1983, an interim l e v e l of water qua l i t y that provides f o r the protection of f i s h , s h e l l f i s h and wi l d l f e and recreation; and (2) to achieve the elimination of the discharge of a l l pollutants into the waters of the United States by 1985" (OECD, 1976, p. 82). A s i g n i f i c a n t point made by the OECD report i s that standards are based on future technology and not on presently available technology. The Marine Protection Research and Sanctuaries Act l i m i t s or prohibits the disposal of harmful materials into the ocean e.g. chemicals, b i o l o g i c a l warfare agents and radioactive wastes.„It s p e c i f i c a l l y includes consideration of potential environmental damage as well as danger to human health and welfare. F i n a l l y , the Resources Conservation and Recovery Act deals with the dumping of toxic chemicals or other dangerous material i n l a n d f i l l s , disposal through incineration and other means. Introduced i n 1970, the Act was to encourage recycling 123 of waste material. The EPA provides guidelines f o r recycling and designs programs for waste management under the law. The Food and Drug Administration (FDA) administers an important piece of l e g i s l a t i o n , the Food, Drujg and Cosmetic Act • C o n t a i n i n g the Delany clause, i t prohibits the addition of any carcinogens to foods and cosmetics, although hair dyes are s p e c i f i c a l l y exempt from i t s provisions. Also, i n 1962, following the Thalidomide tragedy, the Kefauver-Harris Amendments were introduced requiring firms to substantiate the e f f i c a c y and safety of new drugs. Some economists have claimed a substantial loss cf innovation and a r i s e i n industry concentration as increased product cost and r i s k force the closing of the smaller firms (Grabowski and Vernon, 1977). Various laws under the Department of Transport (DOT) are designed to promote the safe transport of toxic chemicals (OECD, 1976). Chemical and o i l s p i l l s from ships are covered by the O i l Pollution Act of 1976. Host other aspects of transportation are covered by the Dangerous Cargo Act, Transportation Safety Act of 1974 and others. They give the Secretary of Transport power over a l l facets of transport e.g. packaging and l a b e l l i n g . The use of chemicals i n the work place i s regulated through the Occupational Safety and Health Administration (OSHA) (OECD, 1976). Broad powers are given the Secretary of Labour through the Occupational Safety and Health Act of 1970. I t has provisions f o r the s e t t i n g of standards, recording of employee exposure, inspections and investigations. Immediate corrective action may be taken i f danger ex i s t s . Also, i n 124 consultation with Health, Education and welfare (HEW), research of occupational safety and health factors may be carried out leading to the formation of c r i t e r i a and standards for handing to x i c chemicals. Examples of actions taken are the emergency vi n y l chloride unit standards set in 1974 and the arsenic standards i n 19 75. laws for the protection of consumers are administered by the Consumer Product Safety Commision (CPSC). Four major acts allow f o r the control of products and the enforcement of e a r l i e r laws. The Consumer Product Safety Act of 1972, although i t excludes tobacco, foods, drugs and cosmetics, has the authority to set standards on a variety of products as well as the mandate to enforce previous laws. Other acts are the Federal Hazardous Substances Act of 1927, the Flammable Fabrics Act of 1953 and the Poison Prevention Packaging Act which respectively regulate dangerous or i r r i t a t i n g chemicals i n consumer products, domestic f a b r i c s and cl o t h i n g , and c h i l d -proof caps. A.3 Other OECD Countries France The purpose of the Control of Chemicals Disjgersed i n the Environment B i l l i s to 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 chemicals. The b i l l introduces screening of chemicals before large scale manufacture i s 125 commenced (OECD, 1976).,Under the E i l l , a manufacturer of a new chemical or an existing chemical coming under suspicion must provide information to allow an estimation of pot e n t i a l hazards. The evaluation uses s p e c i f i c c r i t e r i a e.g. LD50 (the dose l e t h a l to half cf the t e s t animals) to assess the r i s k to man and environment. On the basis of the r i s k , the chemical w i l l be placed in Category I (absolute e c o l o g i c a l danger) or Category II (potential ecological danger). Various r e s t r i c t i o n s regarding sal e , use, storage and disposal may be applied and chemicals in Category I may be t o t a l l y banned. Expenses incurred i n providing the information are borne by the manufacturer i n the case of new chemicals but i n the case of e x i s t i n g chemicals are shared among producers i n proportion to the amount marketed in 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 provides f o r the control of a g r i c u l t u r a l pesticides under the administration of the ministry of Agriculture (OECD, 1976), various commissions: set and revise standards i n consultation with industry; examine data in order to set r e s t r i c t o n s ; and c l a s s i f y and determine the e f f i c a c y of the chemical. The intent of the l e g i s l a t i o n has broadened to include protection of the general public and the general environment from i t s previous narrower focus on e f f i c a c y and user protection. According to the OECD report other French l e g i s l a t i o n has organized controls according to the point of d i s t r i b u t i o n in the environment, type of industry, method of transport and forms of 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 directed at s p e c i f i c substances thereby leaving possible gaps 126 i n coverage. For example, i n d u s t r i a l discharges are chemically complex whereas regulations are enacted only for a few sp e c i f i e d substances such as a small number of the many electro-plate plant chemicals discharged. A more general approach i s being developed., Japan The Chemical Substances Control Act was enacted i n 1973 to answer the need for control of persistent chemicals dramatized by such disasters as the Minamata disease (caused by mercury) and the Kanemi r i c e bran o i l disease (caused by poly-chlcrinated biphenyls) (PCB) (OECD, 1976). The intent of the act was to allow for pre-market examination and control of new chemicals. I t s provisions include submission of information and review with regard to persistence, accumulation and t o x i c i t y before production or importation i s permitted. Testing i s quite thorough, involving micro-organisms, s o l u b i l i t y , condensing rate in f i s h , t o x i c i t y (broadly and s p e c i f i c a l l y ) using i n vivo tests on metabolic defects, and pharmaco-dynamics. Those chemicals considered dangerous are lab e l l e d "specified substances" and are l i a b l e to be banned or r e s t r i c t e d i n use as well as i n manufacture and importation. The cost of the research i s distributed under the Pollution Control Public works Cost Allocation Law . The aim of the A g r i c u l t u r a l Chemicals Regulation Law i s to provide stable production and human and evironmental safety through standardization of chemical quality and ensurance of 127 proper use. Begulations cover r e s t r i c t i o n s , prohibitions, safety c r i t e r i a concerning t o x i c i t y and persistence, and detailed i n s t r u c t i o n s on the use to which cert 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 available for inspection before marketing. Other regulations allow for post-market and p o l l u t i o n monitoring (OECD, 1S76). The Basic Law for Environmental  Protection allows the use of broad powers to implement measures necessary to control p o l l u t i o n . More s p e c i f i c laws are i n the areas of: p o l l u t i o n control with r e s p o n s i b i l i t y f o r establishing and revising standards, monitoring and introducing p o l l u t i o n control programs; a i r p o l l u t i o n c o n t r o l with r e s p o n s i b i l i t y to designate and enforce controls on a l l gases from combustion, cert a i n toxic 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 others. B. Analysis of OECD Hodels The two approaches in t o x i c chemical control most apparent over the l a s t few years have been (1) l e g i s l a t i o n to cover gaps in j u r i s d i c t i o n of l e g i s l a t i o n and (2) the s h i f t i n emphasis from post-market monitoring to pre-market cont r o l . In t h i s respect Canada has taken similar action. The Environmental Contaminants Act i s designed to f u l f i l l those two functions. In contrast to the US TOSCA, but in accordance with the UK approach, consultation with industry i s e x p l i c i t l y included. This contrast between US and Canadian l e g i s l a t i o n i s perhaps 128 due to the difference in l e g a l structure since, i n general, Canadian courts do not serve the same purpose as OS courts do in testing agency decisions. Confrontations between government agencies and industry are avoided as much as possible by the consultative process. Thus, the approach i s p o l i t i c a l l y accommodating while extensive i n t e r a c t i o n with affected groups should enable the design of acceptable and e f f i c i e n t l e g i s l a t i o n . &s mentioned, a l l of the selected OECD countries have implemented some form of pre-market control to detect hazards before production. This i s , perhaps, i n recognition of the insi d i o u s nature of many of the toxic chemicals produced (as mentioned e a r l i e r , they are often toxic i n very small amounts, persistent and have latent e f f e c t s ) . I t i s the implementation of the regulations attached to the acts which have caused controversy. The regulations accompanying TOSCA for example, have caused an acrimonious debate between the EPA and the chemical industry (Hay, 1979)• The EPa proposes a r i g i d and extensive ser i e s of tests conducted before r e g i s t r a t i o n i s permitted. The chemical companies (who bear the cost) f e e l the cost of this approach i s exorbitant and much favour the UK approach which includes a more f l e x i b l e schedule of te s t s . In the UK, i f preliminary r e s u l t s prove acceptable, the chemical can be marketed. Only i f suspicions are aroused are long term tests necessary. The p r i n c i p l e drawback of pre-market testing i s the cost incurred in processing each of the large number of chemicals introduced. The US has committed vast resources to simply 129 establishing a l i s t of chemicals for r e g i s t r a t i o n . In addition to d i r e c t costs of testing, reporting and record keeping, there may be i n d i r e c t i n t e r n a t i o n a l cost and domestic costs (Ross, 1S78). The OS has a $6 b i l l i o n d o l l a r chemical export industy which may be jeopardized. TOSCA could force foreign companies to test 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 in e f f e c t , a non-tarrif barrier. If other countries were to react by banning US imports the American i n d u s t r y ^ export business could be destroyed. But, Canadian exports are not as extensive and are generally l e s s refined in nature reducing the importance of 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 be a step toward resolution of the problem for the future. Domestic cost that may occur are the decrease in innovation and the loss of smaller companies leading to decreased competition. Grabowski et a l . (1977,1978) investigated the e f f e c t of l e g i s l a t i o n reguiring pre-market proof of e f f i c a c y and safety on the American drug industry.. They contend that the increased cost of testing and of r i s k of f a i l u r e resulted in fewer useful new drugs and reduced the number of companies in the industry without a balancing r i s e i n s o c i a l benefit. In the chemical industry, the d i r e c t cost of t e s t i n g , reporting, record keeping and time delay may have a si m i l a r r e s u l t . In addition, the r i s k of f a i l u r e or l o s s of a competitive edge could lead tc a reduction i n the amount of money spent on research and development. Extensive and c o s t l y research may go into a chemical that i s then designated as requiring more testing. Not only i s i t s introduction delayed. 130 perhaps for years, but each agency handling i t represents a possible leak of trade secrets to competitors. These extra "costs" may force otherwise competitive companies from the industry. also, t h i s domestic cost 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 industry i n Canada. But because research and development i n the Canadian chemical industry i s not as extensive at that of i t s american counterpart, the e f f e c t may not be as strong. Canada's industry deals largely i n bulk chemicals which involves only a small amount of research and innovation, however, expansion of the more innovative part of the industry may be i n h i b i t e d . with regard to standard s e t t i n g , stategies employed can be categorized into at least three areas: (1)guidelines versus fixed statues, (2) central versus l o c a l c o ntrol, and (3) meeting standards by present versus future technology. The OK, in an occupational context, uses guidelines backed by statutes as necessary. This approach allows for f l e x i b i l i t y i n content and procedure with the hint of more r i g i d regulations should they be necessary. A weakness with t h i s approach i s the i n a b i l i t y of independent third parties to monitor the compliance of industry. Since, i n Canada, information i s d i f f i c u l t for the public to obtain, there may be a tendency f o r enforcers to i d e n t i f y with the regulated rather than the regulators. The public may perceive t h i s as lax enforcement. ,.0n the other hand, problems with standards written into law are: f i r s t , the d i f f i c u l t y i n providing precise wording to guide administrators; second,the i n f l e x i b i l i t y 131 should change be required; and f i n a l l y , the amount of time necessary to pass such laws. Both environmental and industry i n t e r e s t groups are l i k e l y to to confront government with strong lobbies on each issue causing delay and increased court costs. In considering the benefits and costs of l o c a l versus central control of environmental standards, a compromise seems possible. There i s much variation i n l o c a l conditions across Canada and therefore, 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 excessive damage. Also, the benefits tc l o c a l areas may vary considerably. Economic i n e f f i c i e n c y i s l i k e l y to r e s u l t i f strong standards prevent regions from adjusting t h e i r own levels. However, some minimal guidelines seem desirable to prevent i r r e v e r s i b l e damage to s o c i a l l y or geographically i s o l a t e d areas. Thus, minimal federal standards could be applicable i n the absence of other more rigorous standards. An unusual aspect of t h i s area l i e s in the existence of a " t e r r i t o r i a l imperative". The present p o l i t i c a l trend i n Canada seems to be away from c e n t r a l control and toward p r o v i n c i a l autonomy. The t e r r i t o r i a l imperatives of both the federal and pr o v i n c i a l governments can lead to a competition to control p o l l u t i n g companies. Such a competition can be manifest as alternating increases i n standards as each government vies with the other to have the most stringent and therefore c o n t r o l l i n g standards. One of the fears of setting standards i s that they become maximum as well 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 established companies who have a reputation to protect. This i s explained by the fact that the smaller companies have l e s s to lose i n terms of c a p i t a l and business and therefore, have limited l i a b i l i t y f o r damage. The larger companies have correspondingly more to lose and greater l i a b i l i t y . One way of insuring against such abuse i s to write more stringent standards into law ahead of available technology such as the OS has done with i t s water act. The danger of course i s that the technology w i l l not evolve rapidly enough to meet the standards or that i t w i l l prove uneconomical. Such stategies reguire constant surveillance to ensure that an industry i s not over or under regulated. A second approach which may be e f f e c t i v e i s the introduction of personal l i a b i l i t y for corporate executives. Knowledge and control of company p o l i c y would then carry with i t the 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 such policy and make senior executives personally l i a b l e for damages and penalties. 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 establishing the degree of control each executive might have (hence the amount of r e s p o n s i b i l i t y ) and the d i f f i c u l t y i n providing insurance to responsible executives. Such a policy may then act to constrain entrepreneurial a c t i v i t i e s as well as decreasing public r i s k . A net l o s s of s o c i a l benefit may occur. 

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