Impact on Corporate Structure and Procedures - ACS Symposium


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Impact on Corporate Structure and Procedures

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DAN R. HARLOW Diamond Shamrock Corp., Washington, DC 20006 Corporations have responded to the Toxic Substances Control Act (TSCA) by traditional means such as added personnel and facilities as well as by new and innovative initiatives such as new management functions, new expertise in toxicology, and new computerized information systems. The size of a corporation as measured by annual sales is the most important determiner of how an organization responds to TSCA's new demands; large corporations generally add new personnel and facilities while smaller corporations tend to add TSCA requirements to existing jobs. None of these responses can be ascribed to TSCA alone since corporations are responding to a myriad of environmental/health laws with similar demands. The Toxic Substances Control Act (TSCA) was signed into law in late 1976. It was a bitterly-debated piece of legislation; it arose at the height of the combined environmental concern and "cancerphobia" fears distinctive of that time. In order to understand how corporations have responded to TSCA, it is important to recall the situation at that time in the knowledge of carcinogenesis, in the environmental movement, in the political scene and, finally, in the corporations themselves. The author feels it his responsibility at this point to apprise the reader of the fact that there is little "hard" data on corporate responses to TSCA, especially at the management level. Hence, this paper has taken the role of an overview and qualitative look at corporate responses to TSCA rather than a quantitative document based on estimated numbers of personnel added and other costs of complying with TSCA. Such "hard" data approaches on various specific aspects of TSCA such as pre-manufacturing notification and inventory have been attempted with some successes and some failures. At this overview level, 0097-6156/83/0213-0121$06.00/0 © 1983 American Chemical Society Ingle; TSCA's Impact on Society and Chemical Industry ACS Symposium Series; American Chemical Society: Washington, DC, 1983.

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the a b i l i t y to a s c r i b e p a r t i c u l a r responses e n t i r e l y to TSCA or apportion that part of the response due to TSCA alone i s d i f f i c u l t i f not impossible. To the extent that t h i s r e s u l t s i n an anecdotal and personal approach to the impacts of TSCA with no c i t e d r e f e r e n c e s , the author apologizes f o r t h i s shortcoming.

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The H i s t o r y The Toxic Substances C o n t r o l Act was a combined product of the environmental movement and the cancer f e a r s d i s t i n c t i v e of that e r a . Much of the h e a l t h emphasis of the Act f e l l on cancer. Huge resources were a l l o c a t e d to "conquer cancer", especially through f e d e r a l l y - f u n d e d programs such as the N a t i o n a l I n s t i t u t e s of Health. (By the mid-1970 s the N a t i o n a l Cancer I n s t i t u t e , one of eleven i n s t i t u t e s , had r i s e n to c l a i m more than h a l f of the e n t i r e NIH budget and have the only politically-appointed institute director.) President Nixon announced that i f we could go to the moon, we could c e r t a i n l y conquer cancer, and do i t w i t h i n seven years! The prevalent models f o r cancer e t i o l o g y i n the e a r l y 1970's were the v i r u s model and the chemotherapy approach, both of which had l o s t the promise of p r o v i d i n g the o v e r a l l answer to c a r c i n o g e n e s i s . Hence, as the chemical m o d i f i c a t i o n of DNA model gathered momentum, i t became a t t r a c t i v e to the N a t i o n a l Cancer I n s t i t u t e as i t s new hope f o r the answer. A f t e r i t was stated i n the e a r l y 1970's that 60%-90% of a l l cancers are environmentally induced, the stage was set f o r chemicals and environment as the issues of focus. We s t i l l don't know the e t i o l o g y of cancer—we do know that some s p e c i f i c s t i m u l i such as some v i r u s e s , c e r t a i n kinds of r a d i a t i o n and s p e c i f i c chemical s t i m u l i can cause a v a r i e t y of d i f f e r e n t malignant diseases under c e r t a i n c o n d i t i o n s perhaps by a c t i v a t i n g to oncogenes found i n normal c e l l s . As e a r l y as the 1930 s, acute t o x i c o l o g y t e s t i n g was recognized as a n e c e s s i t y f o r companies d e a l i n g with substances which might present acute h e a l t h hazards. Indeed, i n d u s t r y became a leader i n b u i l d i n g the f i e l d of acute t o x i c o l o g y . With cancer, however, science i t s e l f was reticent i n accepting chronic t e s t i n g . The M i l l e r s of the U n i v e r s i t y of Wisconsin, pioneers i n chronic t e s t i n g , r e c e n t l y stated that i n the 1940's when they began chronic t e s t i n g i n t h e i r l a b o r a t o r i e s that they were looked upon with s u s p i c i o n and some d i s d a i n even by t o x i c o l o g i s t s (who were then i n v o l v e d only i n acute t e s t i n g ) to say nothing of the l a c k of regard expressed by other s c i e n t i s t s . The often-repeated statement that most cancers are due to environmental s t i m u l i (environmental was o r i g i n a l l y intended and r e c e n t l y emphasized to i n c l u d e such f a c t o r s as d i e t , smoking, l i f e s t y l e , s t r e s s , etc.) capped the cancer f e a r and sent us headlong i n t o a massive "search and destroy" mission f o r environmental carcinogens. Particularly suspected among environmental s t i m u l i were manufactured chemicals. This i s 1

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l a r g e l y true today, although r e c e n t l y i n i t i a t e d cancer studies are focusing on d i e t and l i f e s t y l e f a c t o r s which w i l l l i k e l y change the emphasis of "search and destroy" missions i n the future. In the change of emphasis from acute to chronic e f f e c t s many s c i e n t i s t s were unprepared to deal with the new concerns. When the f u l l force of the cancer f e a r and t a r g e t i n g of manufactured chemicals h i t , the science of chronic t e s t i n g and much of the chemical i n d u s t r y were not w e l l prepared. Public concern was expressed through a v a r i e t y of laws i n c l u d i n g the Toxic Substances C o n t r o l Act. The industry responded to the challenge i n a v a r i e t y of ways according to company unique c h a r a c t e r i s t i c s . Those companies which had strong acute t e s t i n g programs were b e t t e r prepared to deal with demands f o r chronic t e s t i n g than those which had l e s s a c t i v e acute programs. Some companies were aware of the growing need f o r chronic t e s t i n g and were on the leading edge of i t s development while others were l e s s aware. Those companies which had d e a l t with o c c u p a t i o n a l hazards to h i g h l y t o x i c , acute or even f i r e and s a f e t y hazards were more l i k e l y to be monitoring workplace concentrations of v a r i o u s substances and had i n d u s t r i a l hygiene programs i n p l a c e ; those that d i d not d e a l with such hazards d i d not. The science of chronic t e s t i n g was not well-formed i n the years j u s t preceding the implementation of TSCA and even today i s undergoing m o d i f i c a t i o n s and r e - e v a l u a t i o n . F o r i n s t a n c e , a t the time of TSCA implementation, the N a t i o n a l Cancer I n s t i t u t e bioassay was considered the " s t a t e of the a r t " f o r cancer t e s t i n g , although the NCI i t s e l f considered i t only a screening mechanism. This bioassay procedure, based on MTD (maximum t o l e r a t e d dose) l i f e t i m e exposure to rodents, has undergone m o d i f i c a t i o n s and c r i t i c i s m s to the extent that many of the bioassays done i n the e a r l y 1970*s are no longer considered reliable. In a d d i t i o n , new modes of t e s t i n g have a r i s e n since TSCA's debut, making the job of chronic h e a l t h t e s t i n g a "moving target." These changes are not decreasing with time; i n f a c t , there have been demands to develop new, f a s t e r and l e s s expensive t e s t i n g methods f o r carcinogens. S i m i l a r changes and pressures have been seen i n environmental t e s t i n g which, i n general, i s even l e s s w e l l - d e f i n e d than carcinogen t e s t i n g . At the same time that this increased awareness to environmental carcinogens arose, the environmental movement was i n f u l l bloom. Since i t s e s t a b l i s h e d p o l i t i c a l goals were quite c o n s i s t e n t with environmental carcinogen f e a r s , the two were quite complementary. The h i s t o r y and development of the environmental movement are a f a s c i n a t i n g and complex s t o r y i n i t s e l f ; however, i t i s not an appropriate subject f o r t h i s paper. L e t i t s u f f i c e to say that i t was the combination of the cancer f e a r s and the environmental movement that gave the p o l i t i c a l s t r e n g t h to pass TSCA i n t o law.

Ingle; TSCA's Impact on Society and Chemical Industry ACS Symposium Series; American Chemical Society: Washington, DC, 1983.

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Thus, at the time of implementation of TSCA, companies e x h i b i t e d a wide v a r i e t y of s o p h i s t i c a t i o n and understanding of what TSCA would demand from them, and the science of carcinogen and environmental t e s t i n g were i n the development stage. What kinds of responses have been generated from these pressures? I w i l l t r y i n the f o l l o w i n g pages to c h a r a c t e r i z e the responses of some companies. One must remember that we cannot at t h i s time w r i t e the requiem f o r how companies have responded to TSCA since corporations are s t i l l responding to the on-going implementation of TSCA.

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The Response The i n s t i t u t i o n a l resources which a business e n t e r p r i s e can devote to the pressures and demands of TSCA g e n e r a l l y f a l l w i t h i n f i v e large c a t e g o r i e s ; a v a r i e t y of other i n t e r n a l a c t i v i t i e s , and e x t e r n a l a c t i v i t i e s . • Personnel - new s t a f f support f u n c t i o n s added • T e s t i n g F a c i l i t i e s - new t e s t i n g f a c i l i t i e s added • Recordkeeping and S u r v e i l l a n c e Programs - computerized or non-computerized, new computer software programs or manual recordkeeping procedures • Research and Development - new product development • Compliance Burdens - impacts of "bans" under TSCA • Other I n t e r n a l A c t i v i t i e s • External A c t i v i t i e s These a d d i t i o n a l personnel, f a c i l i t i e s , programs and other expenses, of course, e x i s t i n the corporate s t r u c t u r e as added costs of doing business and are accounted f o r i n the cost to the consumer of the business e n t e r p r i s e ' s products and s e r v i c e s . Personnel. More than any other area, we are o f t e n asked: "How many people has your c o r p o r a t i o n added due to TSCA?" I don't know of anyone who has a concise answer to t h i s question. Complicating the s i t u a t i o n i s the f a c t that the I960's and 1970's saw a number of environmental and h e a l t h laws go i n t o effect: the Clean A i r Act, Clean Water Act, Occupational Safety and Health Act, Safe D r i n k i n g Water Act, F e d e r a l Water P o l l u t i o n C o n t r o l Act, TSCA, F e d e r a l Food, Drug and Cosmetic Act, Hazardous M a t e r i a l s T r a n s p o r t a t i o n Act, F e d e r a l I n s e c t i c i d e , Fungicide and Rodenticide Act, Resource Conservation and Recovery Act, and Comprehensive Environmental Response, Compensation and L i a b i l i t y Act, to mention the major ones. T h i s mixture of a c t s , with some s i m i l a r i t i e s of purpose, developing w i t h i n a time span of 10-15 years, has made a v a r i e t y of s i m i l a r demands. I t i s not easy at t h i s point to a t t r i b u t e the a d d i t i o n of s t a f f support personnel to an i n d i v i d u a l law such as TSCA. The same observation i s a p p l i c a b l e to a l l corporate resources which have f e l t the e f f e c t s of TSCA; however, i n order to

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prevent r e p e t i t i o n i t w i l l not be r e s t a t e d i n the f o l l o w i n g pages. TSCA has r e s u l t e d i n increased s t a f f support i n f i v e areas: (1) Legal - i n t e r p r e t a t i o n of the law (2) T e c h n i c a l - understanding of t e c h n i c a l aspects of the law (3) Engineering - knowledge of c o n t r o l procedures f o r manufacturing processes, e t c . (4) Toxicology/Testing - t o x i c o l o g y / t e s t i n g advisors to management and f o r t e s t i n g requirements (5) Management - new management functions f o r TSCA (1) L e g a l . I t i s common f o r l a r g e companies to have the TSCA r e s p o n s i b i l i t y assigned to a s p e c i f i c s t a f f attorney or attorneys. T h i s may be a f u l l - t i m e job i n the l a r g e s t companies or may be a part-time f u n c t i o n . In smaller companies i t i s c e r t a i n to be a part-time f u n c t i o n among the many jobs of the few attorneys. In even smaller companies, who may not have a l e g a l s t a f f at a l l , there may be an outside counsel i n v o l v e d , i f there i s any l e g a l f u n c t i o n at a l l . These small firms may depend on trade a s s o c i a t i o n l e g a l support and/or a non-attorney i n the company with a b a s i c knowledge of the law. Rather than discuss a group of s p e c i f i c corporations and t h e i r responses to TSCA (which vary g r e a t l y depending on t h e i r individual structures, product mixes, sizes, number of employees, e t c . ) , a range of corporations from small to l a r g e based on annual chemical s a l e s was s e l e c t e d as examples. This range, as you w i l l see, has a s i g n i f i c a n t impact on how they have responded to TSCA. (Very large=$5 b i l l i o n annual chemical s a l e s ; large=$1.5 b i l l i o n ; medium=$650 m i l l i o n ; small=$20-50 million.) I t has been suggested that an a d d i t i o n a l category—"extremely small=$l-10 m i l l i o n " — b e added. I t was found that these are o f t e n one or two manager operations and, thus, a l l of the TSCA burden f a l l s on the one or two managers a t the expense of t h e i r other v i t a l d u t i e s . I t should t h e r e f o r e be noted that t h i s group of companies was deleted from the f o l l o w i n g comparison charts only because the entry would be r e p e t i t i v e ; that i s , the one or two managers must p i c k up the added burdens. I t can be p e r s u a s i v e l y argued that these "extremely small companies" have indeed experienced the greatest impact from TSCA and f i n d t h e i r businesses imperiled by i t s added burdens. The reader i s asked to mentally add the "extremely s m a l l " company and i t s burden on i t s few managers to each comparison chart. Firm 1 - Very l a r g e . Part-time (half-time) attorney at corporate, f i v e h a l f - t i m e attorneys a t operating companies. Firm 2 - Large. One attorney assigned r e s p o n s i b i l i t y ; a t times f u l l - t i m e , now part-time. General counsel o f f i c e support as needed.

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Medium. Part-time basis for two in-house attorneys. Small. No in-house attorney, Research D i r e c t o r handles TSCA matters.

(2) T e c h n i c a l . A d d i t i o n a l t e c h n i c a l support i n companies other than t e s t i n g personnel w i l l a r i s e from the need f o r a d d i t i o n a l recordkeeping, such as the annual reports and TSCA inventory (§§8(a) and ( b ) ) , records of s i g n i f i c a n t adverse reactions to health or environment (§8(c)), records of a p p l i c a b l e h e a l t h and s a f e t y s t u d i e s (§8(d)), and n o t i c e s of s u b s t a n t i a l r i s k to h e a l t h or environment (§8(e)). In l a r g e r companies, chemical t e c h n i c a l personnel may work with computer personnel to put the information into computerized recordkeeping. In smaller companies, there may or may not be computerized s e r v i c e s ; i n the small companies there w i l l not be computerized recordkeeping but w i l l be some form of manual records g e n e r a l l y kept by t e c h n i c a l personnel. In a d d i t i o n to d i r e c t burdens of recordkeeping which f a l l on t e c h n i c a l and t e c h n i c a l management personnel, another burden of major s i g n i f i c a n c e i s the i n t e r p r e t a t i o n and determination of p o t e n t i a l impacts of TSCA on a c o r p o r a t i o n . Due to the h i g h l y complex, technical nature of TSCA, the major job of i n t e r p r e t a t i o n and impact a n a l y s i s f a l l s upon t e c h n i c a l , not l e g a l , experts. T h i s burden i s e s s e n t i a l l y u n i v e r s a l , impacting a l l companies r e g a r d l e s s of s i z e and other c h a r a c t e r i s t i c s . The primary s i g n i f i c a n c e here i s that e i t h e r these TSCA d u t i e s d e t r a c t from the other t e c h n i c a l d u t i e s ( i n smaller companies even research and development a c t i v i t i e s ) or r e s u l t i n new t e c h n i c a l e x p e r t i s e being added to e x i s t i n g s t a f f . Firm 1 - Very Large. One f u l l - t i m e t e c h n i c a l person at corporate l e v e l , f i v e part-time at operating companies. About f i v e other s t a f f personnel i n various a c t i v i t i e s . Firm 2 - Large. One technical persons in corporate headquarters; about 15 people part-time in d i v i s i o n s of the company. Firm 3 - Medium. One t e c h n i c a l person i n headquarters, four to f i v e people i n other parts of the company. Firm 4 - Small. Research D i r e c t o r maintains records. (3) Engineering. Environmental engineering s t a f f s have had to respond to the many environmental laws as d e t a i l e d earlier. TSCA has had a minimal a d d i t i o n a l impact here s i n c e the primary focus of TSCA i s information and t e s t i n g . Engineers o f t e n p a r t i c i p a t e i n r e p o r t i n g , such as §8(e), i n l a r g e r companies with engineering s t a f f s . In the smaller companies without such s t a f f s , engineering consultants provide the s e r v i c e or the t e c h n i c a l s t a f f performs the f u n c t i o n .

Ingle; TSCA's Impact on Society and Chemical Industry ACS Symposium Series; American Chemical Society: Washington, DC, 1983.

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Very Large. In-house engineering s t a f f provides s e r v i c e on an as-needed b a s i s . Large. In-house engineering staff provides s e r v i c e on an as-needed b a s i s . Medium. In-house engineering staff provides s e r v i c e s on an as-needed b a s i s . Small. At t h i s p o i n t , engineering i s not needed.

(4) T o x i c o l o g y / T e s t i n g . Perhaps the greatest v a r i e t y i n response to TSCA i s i n the t e s t i n g area. The v a r i e t y g e n e r a l l y revolves around the question of in-house t e s t i n g facilities versus e x t e r n a l t e s t i n g f a c i l i t i e s . Among the l a r g e s t companies with massive t e s t i n g f a c i l i t i e s , a l a r g e amount of in-house t e s t i n g can be expected, but even i n these cases the demand f o r t e s t i n g i n general (not j u s t TSCA) has overloaded the system. Hence, much t e s t i n g i s done outside the companies facilities and added personnel to monitor and assure the q u a l i t y of outside t e s t i n g can be a t t r i b u t e d to other demands as w e l l as TSCA. The general demand f o r a b i l i t y to analyze t o x i c o l o g i c a l data has resulted i n the employment of t o x i c o l o g i s t s i n the l a r g e companies who, i n a d d i t i o n to t h e i r s p e c i f i c d u t i e s i n t e s t i n g , a l s o advise management and operating u n i t s on v a r i o u s aspects of TSCA and other laws. F o r i n s t a n c e , they w i l l l i k e l y be involved in substantial risk determinations under §8(e). Smaller companies do not employ t o x i c o l o g i s t s or other t e s t i n g personnel but c o n t r a c t outside t e s t i n g and t o x i c o l o g y c o n s u l t a n t s . Firm 1 - Very Large. Toxicology s t a f f of 25 provides advice on a l l aspects of t o x i c o l o g y i n c l u d i n g TSCA. Firm 2 - Large. Two t o x i c o l o g i s t s full-time and one part-time at corporate l e v e l f o r TSCA. Firm 3 - Medium. Toxicology testing and expertise outside. Firm 4 - Small. Toxicology t e s t i n g and e x p e r t i s e o u t s i d e . 1

(5) New Management Functions. The i n f r a - s t r u c t u r e of support described above to provide TSCA-required s e r v i c e s i s a l l w i t h i n the s t a f f f u n c t i o n s of the s p e c i f i c companies. As a r e s u l t of the uniqueness of c o r p o r a t i o n s , s t a f f personnel e x i s t i n a wide v a r i e t y of l o c a t i o n s : at one extreme, they may be a highly centralized corporate staff department with line a u t h o r i t y to operating u n i t s ; on the other extreme, they may be d e t a i l e d out to the operating u n i t s themselves r e p o r t i n g to the operating u n i t managers. There i s no pure and simple company example f o r each of these two extremes; companies are mixtures of the two with a preponderance i n the l a r g e companies of a corporate s t a f f r e p o r t i n g to the top corporate managers with no l i n e a u t h o r i t y to operating u n i t s . In smaller companies, the r e p o r t i n g i s d i r e c t l y to the corporate o f f i c e r s themselves.

Ingle; TSCA's Impact on Society and Chemical Industry ACS Symposium Series; American Chemical Society: Washington, DC, 1983.

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In large companies there has g e n e r a l l y been the emergence of a new corporate s t a f f department of environment and h e a l t h with a corporate l e v e l v i c e president ( e i t h e r a s t a f f v i c e president or v i c e president/corporate o f f i c e r ) . This job i s g e n e r a l l y a r e l a t i v e l y new one and i s o f t e n the focus point f o r the staff i n f r a - s t r u c t u r e not only f o r TSCA but for a l l environmental, s a f e t y , i n d u s t r i a l hygiene and medical a f f a i r s . Again, how corporations s t r u c t u r e t h i s r e p o r t i n g v a r i e s with individual companies. In some larger companies, the TSCA-related requirements are sufficient to justify the existence of a "TSCA Co-ordinator" or " D i r e c t o r of TSCA Regulation," e t c . who r e p o r t s to the v i c e p r e s i d e n t . This person's r e s p o n s i b i l i t y i s to focus TSCA matters corporate-wide; advise the operating u n i t s on TSCA matters which a f f e c t them; report the r e s u l t s and progress i n TSCA matters to the v i c e president who i n turn reports to the top corporate o f f i c e r s . In smaller companies, the management of TSCA i s added to the other business functions of the few corporate managers. Firm 1 - Very Large. Senior v i c e president (member of board) heads a l l h e a l t h and environment s t a f f . F u l l - t i m e TSCA coordinator at corporate level, part-time Washington o f f i c e support. Firm 2 - Large. S t a f f v i c e president manages h e a l t h , environmental and s a f e t y , i n c l u d i n g TSCA. Firm 3 - Medium. V i c e p r e s i d e n t , environmental h e a l t h and safety. Firm 4 - Small. D i r e c t o r of Government A f f a i r s f u n c t i o n added to e x i s t i n g Research D i r e c t o r . Testing F a c i l i t i e s . As mentioned, there i s wide v a r i a t i o n among companies as to in-house testing capacities. Some companies, even l a r g e ones, r e l y e n t i r e l y on contracted outside t e s t i n g f o r a v a r i e t y of reasons; e.g., overhead management c o s t s , acceptance of r e s u l t s by the government and the p u b l i c , etc. Smaller companies have used outside c o n t r a c t o r s f o r t e s t i n g where r e q u i r e d . There i s no doubt that TSCA i s r e q u i r i n g a d d i t i o n a l t e s t i n g — t h e only question i s where i t i s being done. Firm 1 - Very Large. Very large in-house testing facilities, about 50% TSCA-related in-house, about 50% contracted out. Firm 2 - Large. Limited facilities for in-house toxicology testing; a l l TSCA-related testing contracted out. Firm 3 - Medium. In-house t e s t i n g f a c i l i t i e s f o r chemical and p h y s i c a l p r o p e r t i e s , not t o x i c o l o g y . Firm 4 - Small. In-house t e s t i n g f a c i l i t i e s f o r chemical and p h y s i c a l p r o p e r t i e s , not t o x i c o l o g y .

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Recordkeeping and S u r v e i l l a n c e Programs. As with t e s t i n g , the degree of s o p h i s t i c a t i o n v a r i e s g r e a t l y among companies. A small company with a few products and only a few employees cannot j u s t i f y a s o p h i s t i c a t e d computer soft-ware program while a large company would be f o o l i s h to t r y to keep such records manually. In large companies with computerized capability, i f operating u n i t s vary considerably i n the kinds of m a t e r i a l s used, TSCA information may be kept on a u n i t b a s i s and not at a large c e n t r a l corporate f a c i l i t y . However, there are s e v e r a l systems designed f o r c e n t r a l corporate use which b r i n g together the e n t i r e breadth of the corporate a c t i v i t i e s f o r TSCA, i n d u s t r i a l hygiene, environmental monitoring, e t c . For example, Diamond Shamrock Corporation has developed a patented soft-ware system f o r s a l e trademarked "COHESS®" (Computerized Occupational Health/Environmental Surveillance System). COHESS brings together on a corporate-wide basis three separate modules—people, places and things—for a centralized recordkeeping f u n c t i o n . The things module i s a l i s t of a l l chemical substances handled i n the company; p l a c e s i s a g r i d network system to allow i d e n t i f i c a t i o n of any p o i n t i n any plant s i t e or f a c i l i t y ; and f i n a l l y the l a r g e s t module i s people. The people module c o l l e c t s h e a l t h i n c i d e n t s f o r each employee ( c l i n i c v i s i t s , h e a l t h insurance claims, workmen's compensation, accident/safety incidents, medical absence and death certificates) and h e a l t h e v a l u a t i o n s f o r each employee (pre-employment p h y s i c a l exams, annual p h y s i c a l exams, p e r i o d i c exams, special e v a l u a t i o n s and personal sampling i n the workplace). The three modules are i n t e r c o n n e c t e d . For example, the people f i l e contains the g r i d numbers (as used i n the places module) of the s p e c i f i c workplace f o r each employee. In the things module, which can be the TSCA inventory, each chemical substance i s l i s t e d with the g r i d numbers from the places module where that p a r t i c u l a r chemical i s used. A l s o included i n the things file f o r each chemical a r e amounts and modes of environmental exposure and amount of human exposure. As one can see, there are many ways to use such a c e n t r a l i z e d computer file. I f , f o r instance, a p a r t i c u l a r employee shows symptoms, the COHESS f i l e can t e l l what h i s g r i d l o c a t i o n i s and from that determine the chemicals he or she i s exposed t o . In the reverse, i f the company suddenly d i s c o v e r s or i s t o l d that a p a r t i c u l a r chemical substance i s a h e a l t h hazard, the COHESS system can d i s p l a y the p o i n t s i n a l l the f a c i l i t i e s where that substance i s used and i d e n t i f y a l l employees working i n those areas. These r e l a t i v e l y simple maneuvers can be c a r r i e d out i n minimum time with a system such as COHESS. More complex retrospective epidemiological studies and long-term environmental studies can a l s o be performed u s i n g t h i s system since i t accumulates information throughout the time i t i s i n use.

Ingle; TSCA's Impact on Society and Chemical Industry ACS Symposium Series; American Chemical Society: Washington, DC, 1983.

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Other companies have developed various types of computerized systems to achieve s i m i l a r o b j e c t i v e s . I t should be pointed out here that the COHESS p r o j e c t was s t a r t e d i n Diamond Shamrock i n 1973, three years before TSCA became law. Thus, i t i s d i f f i c u l t to say that i t was developed i n response to TSCA. I t does, however, respond to many of the recordkeeping requirements i n TSCA. Companies without computer c a p a b i l i t y and smaller companies g e n e r a l l y must stay with manual recordkeeping, at l e a s t f o r the present time. Several years ago, some consultants o f f e r e d to " p o o l " small companies u n t i l s i z e was sufficient to make computerization p o s s i b l e . P o t e n t i a l customers r e j e c t e d this option out of f e a r of l o s i n g trade secret information on mixtures and processes. Firm 1 - Very Large. Very complex centralized computerized system i n c l u d i n g medical records, industrial hygiene, environmental effects, t o x i c o l o g y and m a t e r i a l s (TSCA i n v e n t o r y ) . Firm 2 - Large. C e n t r a l i z e d corporate-wide computerized system f o r workers, workplace and employees. Firm 3 - Medium. Computerized records kept on substances (TSCA inventory) and on i n d u s t r i a l hygiene. Firm 4 - Small. Manual records kept. Research and Development. Among the most discussed impacts of TSCA on companies i s the impact on i n n o v a t i o n . With PMN review, companies have been required to f a c t o r i n environmental and h e a l t h concerns very e a r l y i n the product development c y c l e ; that i s , at the research and development stage. A potential product can be dropped due to negative environmental or h e a l t h information at v a r i o u s stages, s t a r t i n g at the p r e l i m i n a r y review of e x i s t i n g knowledge of the p o t e n t i a l product. As the product moves f u r t h e r and f u r t h e r along the process, a l l e x i s t i n g knowledge about the m a t e r i a l must be gathered and evaluated u n t i l the point of d e c i s i o n on commercialization, when there may be a d e c i s i o n to t e s t or not t e s t , depending on what i s known about the substance. The research and development departments draw on a l l other personnel and t e s t i n g c a p a b i l i t i e s , as discussed above, i n a c h i e v i n g t h i s review. Research and development personnel are made aware of the impacts of TSCA i n t h e i r r o u t i n e f u n c t i o n s . As i t i s now a part of the R&D c y c l e , i t would be very d i f f i c u l t to a s s i g n a s p e c i f i c burden on personnel and f a c i l i t i e s s i n c e i t reaches i n t o v a r i o u s p a r t s of e x i s t i n g companies as described above. In general i t i s b e l i e v e d that TSCA has r e s u l t e d i n a slow down i n developing new chemicals. Compliance Burdens. Under §6 of TSCA, the banning of p a r t i c u l a r chemical substances has had a s i g n i f i c a n t impact on companies who manufacture those substances. For example, the

Ingle; TSCA's Impact on Society and Chemical Industry ACS Symposium Series; American Chemical Society: Washington, DC, 1983.

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banning of p o l y c h l o r i n a t e d biphenyls (PCBs) has had a s i z e a b l e impact on the manufacturers of these products. A similar situation occurred with banning of c h l o r o f l u o r o c a r b o n s i n c e r t a i n l e s s c r i t i c a l uses. The "downstream e f f e c t s " , that i s , the economic e f f e c t s on users of these substances has a l s o been substantial since more expensive and/or less effective s u b s t i t u t e s must be used. The e f f e c t s of such banning i n the chemical s p e c i a l t i e s markets has been s t r i k i n g with e x i s t i n g companies being s e v e r l y damaged and new companies being c r e a t e d . In some cases such as the PCB i s s u e , the economic impacts went f a r beyond the chemical i n d u s t r y and i t s user i n d u s t r i e s to the u t i l i t y industry where the f i n a l economic impact w i l l be borne by the r e s i d e n t i a l e l e c t r i c ratepayer and consumers of goods produced by e l e c t r i c i t y . As §6 a c t i o n s continue, such "cascade e f f e c t s " as the PCB s i t u a t i o n w i l l be seen; the f i r s t stages impacted w i l l be the manufacturer whose product l i n e w i l l be modified. The next l e v e l of e f f e c t w i l l be the user i n d u s t r i e s who a r e the primary consumers; the f i n a l economic impact w i l l f a l l on the consumer of the product or s e r v i c e . Other I n t e r n a l A c t i v i t i e s . Under §8(e) of TSCA a company must report " s u b s t a n t i a l r i s k s to h e a l t h or environment" to EPA. The guidance published f o r §8(e) committees e x i s t i n most l a r g e companies and there i s a r e g u l a r r e c e i p t by EPA of §8(e) notices. As other sections of the Act are being implemented, companies w i l l i n s t i t u t e i n t e r n a l review committees to handle these p a r t i c u l a r requirements. External A c t i v i t i e s . The chemical i n d u s t r y responds to TSCA through a v a r i e t y of a c t i v i t i e s e x t e r n a l to the i n d i v i d u a l c o r p o r a t i o n or company. Such organizations d i d not a r i s e as a r e s u l t d i r e c t l y of TSCA but do respond to some of TSCA's requirements. F o r example, the C U T (Chemical Industry I n s t i t u t e of Toxicology) c a r r i e s on t e s t i n g of v a r i o u s chemical substances f o r the chemical industry, thus preventing d u p l i c a t i v e t e s t i n g by each manufacturer or user. In a d d i t i o n , i t s separate i d e n t i t y from the chemical industry increases the a c c e p t a b i l i t y of i t s t e s t r e s u l t s . The American I n d u s t r i a l Health C o u n c i l (AIHC) was created i n 1977 to address generic chronic h e a l t h i s s u e s and has i n t e r e s t s i n chronic h e a l t h t e s t i n g such as may be used i n TSCA §4 i n a general sense. In a d d i t i o n to these two s p e c i f i c o r g a n i z a t i o n s , the wide range of trade a s s o c i a t i o n s s e r v i n g p a r t i c u l a r i n d u s t r y segments have involved themselves with v a r i o u s aspects of TSCA. The impact on c o r p o r a t i o n s of these e x t e r n a l a c t i v i t i e s i s the demand upon c o r p o r a t i o n s f o r employee time to work with the o r g a n i z a t i o n s . T h i s so c a l l e d "sweat e q u i t y " or c o n t r i b u t i o n of time of key corporation employees i n c l u d i n g o f f i c e r s and CEOs

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Summary The chemical i n d u s t r y has responded to the demand presented by TSCA i n d i f f e r i n g ways. A d d i t i o n a l resources have been added in (1) personnel, (2) testing facilities, and (3) r e c o r d k e e p i n g / s u r v e i l l a n c e systems. Other e f f e c t s have been increased t e s t i n g , impacts of banned substances and a v a r i e t y of new or increased i n t e r n a l and e x t e r n a l a c t i v i t i e s . I t i s d i f f i c u l t to i s o l a t e concise numbers of personnel added s i n c e very few are employed f u l l - t i m e f o r TSCA; they have other d u t i e s which flow, d i r e c t l y or i n d i r e c t l y , from r e l a t e d health/environmental/occupational h e a l t h laws. One area of s t a f f support on which TSCA may have had a s i z e a b l e q u a n t i t a t i v e impact i s i n t o x i c o l o g i s t s , who appear to have increased i n numbers on corporate p a y r o l l s with the implementation of TSCA. Although the volume of t e s t i n g has increased as a r e s u l t of TSCA requirements, many of the other r e l a t e d acts r e q u i r e t e s t i n g . Since much of the t e s t i n g even p r i o r to TSCA was done outside company t e s t i n g f a c i l i t i e s , the increase i n t e s t i n g volume i s to be seen i n outside t e s t i n g f a c i l i t i e s rather than i n company in-house f a c i l i t i e s . New management f u n c t i o n s are at l e a s t p a r t i a l l y due to TSCA. Recordkeeping and s u r v e i l l a n c e systems development has r e c e i v e d a boost from TSCA. A v a r i e t y of systems ranging from simple, manual to complex, c e n t r a l i z e d corporate computerized systems e x i s t . Further pressure f o r such systems may increase as TSCA i s implemented. In general, the l a r g e r corporations respond to TSCA demands much as they would to any other demand presented to them. There have been a d d i t i o n a l resources added; the a d d i t i o n a l costs w i l l be expressed i n the cost of products and s e r v i c e s provided by the c o r p o r a t i o n . With smaller companies, the general r e s u l t has been to add the TSCA burdens to e x i s t i n g personnel, p a r t i c u l a r l y i n t e c h n i c a l / r e s e a r c h and development f u n c t i o n s . The final r e s u l t i n these smaller companies may be l e s s innovation and productivity. In the smallest companies, the burdens have f a l l e n on the few managers whose time i n general management f u n c t i o n s i s reduced. Less p r o d u c t i v i t y may be the r e s u l t here. So f a r as newly created corporate responses, the new management f u n c t i o n s (health and environmental V i c e Presidents) and a d d i t i o n a l t o x i c o l o g y e x p e r t i s e are most apparent. RECEIVED

November 22,

1982

Ingle; TSCA's Impact on Society and Chemical Industry ACS Symposium Series; American Chemical Society: Washington, DC, 1983.