Management of TSCA-Mandated Information - ACS Symposium

8 Management of T S C A - M a n d a t e d Information

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C. ELMER and J. R. CONDRAY Monsanto Company, St. Louis, MO 63167

The Toxic Substances Control Act contains several sections which require the government to collect and manage information obtained from industry and other sources. This paper itemizes these requirements, and reviews the status and implications of each. Industry's experience in collecting appropriate information is outlined as are some unanticipated benefits derived from mandated information management. Examples of one company's experience in managing information will be detailed. Relationships with information requirements in other countries and their implication to U. S. corporations in responding to TSCA regulations are discussed. EPA's requirements for broad information collection and implementation of management has resulted in only partial compliance. Some of the future activities as well as foreseeable problems are discussed. One response to a TSCA mandate has been the development of a Chemical Substances Information Network (CSIN). Although the concept is recognized as valid it may be expanding beyond its originally envisioned scope. Benefits as well as potential dangers in making unevaluated information readily available to undiscriminating users are cited with examples. The Toxic Substances Control Act or TSCA, contains no less than 6CL authorities for developing or disseminating information. - These can be categorized into 15 significant classes of information of which 8 related to requirements by industry, as shown on Table 1. Congress charged the Environmental Protection Agency (EPA) to administer TSCA and, in assigning authority provided two basic routes for implementation. In the first case, Congress spelled out in the act what information EPA was to provide and made such 0097-6156/83/0213-0107$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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Table I

TSCA MANDATED REQUIREMENTS FOR DEVELOPING AND REPORTING OF INFORMATION BY INDUSTRY

Section 5(a)

5(e)

Premanufacturing Notice and S i g n i f i c a n t New Uses Submission of Test Data as required by S e c t i o n 4(a) Regulation pending adequate information

8(a) 8(b) 8(c) 8(d) 8(e)

General Record-keeping Inventory Records of A l l e g a t i o n s Health and Safety Studies Notice of S u b s t a n t i a l Risk

5(b)

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


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requirements e i t h e r immediately e f f e c t i v e or to be t r i g g e r e d by some other TSCA a c t i v i t y . In the second case, Congress provided EPA with a u t h o r i t y f o r information gathering. However, i n t h i s case, EPA must go through a formal r e g u l a t o r y rulemaking process with o p p o r t u n i t i e s f o r p u b l i c comment. In the l a t t e r case, the submission of voluntary information to the agency i s many times p r e f e r r e d by both the regulated community as w e l l as EPA. Volunt a r y sharing of information i s a form of mandatory information submission. The cooperation of the regulated community i s o f f e r e d o f t e n i n the hope of s a t i s f y i n g EPA's information needs, without EPA i s s u i n g p o t e n t i a l l y overburdensome r e g u l a t i o n s . Likewise, EPA b e n e f i t s through c l o s e r i n t e r a c t i o n with the information sources and the e l i m i n a t i o n of time consuming, resource i n t e n s i v e rulemaking a c t i v i t y . Manufacturers, processors and/or d i s t r i b u t o r s of chemical substances i n the chemical i n d u s t r y are faced with three b a s i c types of TSCA-mandated information s i t u a t i o n s : 1. Those mandated by Congress d i r e c t l y i n the act; 2. Those required by EPA through formal rulemaking as authorized by the a c t ; 3. Those v o l u n t a r i l y provided i n a n t i c i p a t i o n or i n l i e u of formal rulemaking. While these three approaches apply to many sections of TSCA, t h i s paper w i l l concentrate on only three: S e c t i o n 5 - Manufact u r i n g and Processing Notices, Section 8 - Reporting and Ret e n t i o n of Information and Section 10 - Research Development, C o l l e c t i o n , Dissemination, and U t i l i z a t i o n of Data. Monsanto's experience i l l u s t r a t e s both the p o s i t i v e and negative impacts on one chemical company under TSCA sections 5 and 8. For a broader p e r s p e c t i v e , r e f e r to the Chemical Manuf a c t u r e r s A s s o c i a t i o n p u b l i c a t i o n "The F i r s t Four Years of the Toxic Substance Control Act." The authors' views are a l s o presented r e l a t i v e to EPA's management of information under s e c t i o n 10. P e r t i n e n t Sections and

Status

A b r i e f d e s c r i p t i o n and status of these three sections w i l l help set the stage. Section 5 deals with the n o t i f i c a t i o n to EPA of new substances or s i g n i f i c a n t new uses of e x i s t i n g chemicals. Table 2 o u t l i n e s the information requirements of t h i s s e c t i o n . The Premanufacturing Notice (PMN) requirement of the a c t , as required under s e c t i o n 5 ( a ) ( 1 ) ( A ) , went i n t o e f f e c t , as mandated by Congress, 30 days a f t e r the TSCA inventory was published, according to Section 8(b). Since taking e f f e c t on J u l y 1, 1979, over 1250 PMN's have been submitted. This a c t i v i t y has been one of the top agency p r i o r i t i e s . Other s e c t i o n 5 requirements have e i t h e r not been f i n a l i z e d or are t i e d i n some fashion to the PMN a c t i v i t y .


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Table II


TSCA SECTION 5 INFORMATION REQUIREMENT STATUS

SubSection

Authority

Status

5(a)(1)(A)

Submit a n o t i c e , at l e a s t 90 days p r i o r to manufacture or processing of a chemical substance not on the inventory required under Section 8 (b)

Went i n t o e f f e c t on J u l y 1, 1979 (30 days, a f t e r p u b l i c a t i o n of inventory) as mandated by Congress. To date over 1250 n o t i c e s have been submitted. EPA published guidance i n the form of i n terim p o l i c y (44FR63006) and s e v e r a l proposed r u l e s , the most recent being (44FR59764).

5(a)(1)(B)

Submit a n o t i c e at l e a s t 90 days before an " e x i s t i n g " chemical substance can be manufactured or processed f o r a use that EPA has determined by r u l e s , i s a " s i g n i f i c a n t new use"

Not f i n a l i z e d . Proposed r u l e issued f o r N-methane-sulfonyl-ptoluenesulfonamide which would require a n o t i c e i f the volume exceeds 1000 pounds, (45FR78970).

5(b)(1)

Submit t e s t data with n o t i c e as r e quired under Section 5(a)(1)(A) i f covered by a Section 4 t e s t rule

Went i n t o e f f e c t J u l y 1, 1979 when 5(a)(1)(A) a c t i v a t e d . No submissions to date.


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Table I I (cont.)

Sub

Status

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Section I f substance i n question i s on Risk L i s t under s e c t i o n 5(b)(4) then, submit data with n o t i c e as required under s e c t i o n 5(b)(1)(A) which shows substance with respect to n o t i c e w i l l not present and unreasonable r i s k

Went i n t o e f f e c t J u l y 1, 1979 when 5(a)(1)(A) activated. No submissions to date (see 5(b)(4)).

5(b)(4)

The Administrator may r u l e , compile and keep a current l i s t (Risk L i s t ) of substances that may be present and unreasonable r i s k of i n j u r y to h e a l t h or the environment

No

5(d)

Defines the content of a n o t i c e under s e c t i o n 5(a) to be described i n S e c t i o n 8(a)(2) A-D and F-G

Went i n t o e f f e c t J u l y 1, 1979 when 5(9)(1)(A) activated.

5(e)

Require a submitter of a n o t i c e under s e c t i o n 5(a) to submit a d d i t i o n a l information i f EPA has i n s u f f i c i e n t information and have reason to b e l i e v e the substance may present an unreasonable r i s k of i n j u r y to h e a l t h or environment

EPA has issued s e v e r a l 5(e) orders. None has been c h a l lenged, and a l l n o t i f i e r s to date have withdrawn the not i c e s rather than submit additional i n formation.


5(b)(2)

action.

( C o n t . on n e x t page)


Ill


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Table II (cont.)

Sub Section

Authority

Status

5(h)(1)

The a d m i n i s t r a t o r may upon a p p l i c a t i o n exempt any person from the n o t i f i c a t i o n requirements of sect i o n 5(a) or (b) i f the substance i n question i s l i m i t e d to t e s t marketing

Numerous t e s t marketing a p p l i cations have been submitted and approved.

5(h)(4)

The a d m i n i s t r a t o r may upon a p p l i c a t i o n and by r u l e exempt the manufacturer from a l l or p a r t of the s e c t i o n 5 requirements

Applications for exemption have been f i l e d by i n d i v i d u a l s and several industry associations. Nothing f i n a l i z e d to date.



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Section 8 i s the primary information gathering a u t h o r i t y under TSCA. Requirements and implementations status i s shown on Table 3. S e c t i o n 8(a) grants broad a u t h o r i t y to the Administrator of EPA and permits EPA to o b t a i n reports as they may "reasonably r e q u i r e . " EPA's only burden i s to request the information through a formal rulemaking procedure. To date, EPA has not f i n a l i z e d any rulemaking under s e c t i o n 8(a) except r e p o r t i n g requirements f o r two s p e c i f i c chemicals. (TRIS and PBBs). The agency has a c t i v e l y pursued s e c t i o n 8 implementation. However, i t has f i n a l i z e d r u l e s f o r only the inventory requirements ( s e c t i o n 8(b)) and has organized to handle the management of s u b s t a n t i a t e d r i s k n o t i c e s mandated by Congress under s e c t i o n 8 ( e ) . This paper does not address EPA plans f o r f u r t h e r implement a t i o n of s e c t i o n s 5 and 8 of TSCA. The agency i s a c t i v e i n both areas. For information on future p l a n s ^ r e f e r to the most recent EPA p u b l i c a t i o n of i t s events calendar - and EPA.Office of Toxic Substances report P r i o r i t i e s f o r OTS Operation - . Section 10 i s a Congressional mandate to EPA f o r management of the massive amounts of information that flow i n t o the agency under TSCA a u t h o r i t y . Under S e c t i o n 10(b)(1), r e s p o n s i b i l i t y i s assigned to an interagency committee to e s t a b l i s h , w i t h i n EPA, an e f f e c t i v e system f o r c o l l e c t i o n , dissemination to other f e d e r a l departments and agencies, and use of data submitted under TSCA. Paragraph (2) of the same s e c t i o n c a l l s f o r e s t a b l i s h i n g an e f f e c t i v e system f o r r e t r i e v a l of t o x i c o l o g i c a l and other s c i e n t i f i c data which could be u s e f u l to the administrator i n c a r r y i n g out the purposes of TSCA. Under s e c t i o n 10 a u t h o r i t y , EPA has a Chemical Substances Information Network (CSIN) prototype under t e s t by i n d u s t r y , academia, unions and s t a t e government o f f i c e s . The system i s intended to permit e a s i e r access to e x i s t i n g data resources. Monsanto's Experience Monsanto's experience with management of information mandates under sections 5 and 8 f a l l i n t o the three categories as o u t l i n e d above: (1) Compliance with TSCA (Congress) mandates; (2) Compliance with EPA TSCA rulemaking; (3) Voluntary submission and a c t i o n s . Monsanto, l i k e many chemical f i r m s , had a product s a f e t y program i n place long before passage of TSCA. The Monsanto program from i t s i n c e p t i o n embraced the s p i r i t and i n many cases the l e t t e r of what l a t e r appeared as the law. In some s i t u a t i o n s TSCA has improved the focus of Monsanto's information management and has been b e n e f i c i a l . In other cases we have provided cons t r u c t i v e c r i t i c i s m of EPA proposed r u l e s which required informat i o n submission and management with no s p e c i f i c o b j e c t i v e .


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TABLE I I I

TSCA Section 8 Information Requirement

SubSection

Status

Retain and submit to EPA reports as the Administrator may require

Not f i n a l i z e d . Proposed r u l e issued which would require submission of general exposure information f o r 2300 chemicals (45FR13646).

Submit n o t i c e of manufacture or import of T r i s (2,3-dibromopropyl) phosphate and Polybrominated Biphenyls

F i n a l rule issued 44FR33525. Proposed r u l e f o r record keeping r e p o r t i n g of Asbestos issued 44FR8200. Not finalized.

8(b)

Compile, keep current and p u b l i s h an invent o r y of each chemic a l manufactured or processed i n the United States

F i n a l r u l e issued 42FR64572. Invent o r y compiled and published. Invent o r y kept current by EPA and updates p e r i o d i c a l l y publ i s h e d , the most recent issue June 1980.

8(c)

Retain and submit to EPA records i f s i g n i f i c a n t adverse r e actions to h e a l t h or the environment, a l l e g e d to have been caused by a substance or mixture

Not f i n a l i z e d . Proposed r u l e issued which would require automatic r e porting after 3 allegations received (45FR47008).

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TABLE I I I (Cont.)

SubSection 8(d)

Authority

Status

Submit l i s t s of h e a l t h and s a f e t y studies conducted or i n i t i a t i e d or known t o , or reasonably ascert a i n a b l e and when required submit a c t u a l copies of studies

Not f i n a l i z e d . F i n a l r u l e issued (43FR30984) but revoked (44FR6099) Rule reproposed which l i s t e d 67 chemicals or categories of substances which would require reporting (44FR77470).

Submit n o t i c e to EPA of information which reasonably supports the conclusion that a substance or mixture presents a subs t a n t i a l r i s k of i n j u r y t o h e a l t h or the environment.

Immediately e f f e c t i v e on passage o f TSCA October 11, 1976. EPA published guidance f o r comp l i a n c e (42FR45362) and (43FR11110). Over 400 n o t i c e s f i l e d to date.


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The f i r s t s p e c i f i c information a c t i v i t y i n i t i a t e d under TSCA was the development of a p o l i c y and procedure f o r handling sect i o n 8(e) n o t i c e s . I t went i n t o e f f e c t immediately a f t e r passage of the act since t h i s requirement was a congressional mandate. A corporate system was e s t a b l i s h e d to permit i n d i v i d u a l s i n the o r g a n i z a t i o n to discharge t h e i r personal r e s p o n s i b i l i t y by rep o r t i n g up through a communications channel. The system i s s t i l l i n place and f u n c t i o n i n g . Since t r i v i a l concerns that enter the system must be processed, i t has placed a burden that d i d not e x i s t under our previous product s a f e t y program. The process has, however, improved communication flow. The 8(b) inventory accumulation was the next major a c t i v i t y . For a d e c e n t r a l i z e d company l i k e Monsanto or, f o r that matter, most major chemical companies, the experience of c e n t r a l i z e d information gathering was a new experience. However, we b e l i e v e that the experience not only was novel, but proved to be benef i c i a l from s e v e r a l p o i n t s of view. F i r s t of a l l , i t enabled us to evolve a network of e x p e r t i s e . Second i t gave us a c e n t r a l data-base on which to b u i l d other information important from a corporate p o i n t of view, and permit a one-time expense f o r developing a system. T h i r d , i t revealed that we needed to improve our data f i l e s i n some areas. And, f o u r t h , i t gave our c e n t r a l s t a f f departments some s u r p r i s e s as to substance l o c a t i o n s . We used the Chemical Abstract Service R e g i s t r y P r o f i l e c a p a b i l i t i e s to gather a l l the known synonyms and added our i n t e r n a l numeric and common i d e n t i f i e r s to access the f i l e v i a dozens of p o s s i b l e names or numbers. The inventory of products, i s o l a t e d intermediates, imports and u s e f u l byproducts was i n i t i a l l y c o l l e c t e d i n a complex database with room f o r a d d i t i o n a l substances and a t t r i b u t e s . For TSCA submission, computer tapes were then e a s i l y produced with appropriate p l a n t l o c a t i o n grouping and CAS R e g i s t r y number and inventory number i d e n t i f i c a t i o n . This not only saved cons i d e r a b l e c l e r i c a l e f f o r t but assured accuracy i n t r a n s c r i p t i o n and form preparation. For Monsanto, the core inventory n a t u r a l l y l e d to an expanded corporate inventory which was placed i n t o t h i s new database. I t now includes raw m a t e r i a l s , supplies and a considerable l i s t of other types of substances and p h y s i c a l agents encountered i n the workplace. The o r i g i n a l inventory f i l e has grown i n t o a wide ranging data-base with u t i l i t y f o r emergency response, M a t e r i a l Safety Data Sheet information and i s the cornerstone f o r Monsanto's Occupational Exposure and Medical Systems. Therefore, the o r i g i n a l c e n t r a l i z e d e f f o r t has borne considerable f r u i t i n a d d i t i o n to and independent of the TSCA inventory. Monsanto's experience with information-gathering and reporting under s e c t i o n 8(d) - Health and Safety Studies - has not been as rewarding as the inventory a c t i v i t y . On J u l y 8, 1978 EPA issued a F i n a l Rule r e q u i r i n g submission of l i s t s and copies of



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Health and Safety Studies f o r the chemicals and chemical categories included on the f i r s t two Interagency T e s t i n g Committee Priority lists. Monsanto manufactured, processed or d i s t r i b u t e d s e v e r a l m a t e r i a l s on the l i s t i n c l u d i n g some that f e l l i n t o the categories given. Unfortunately, EPA d i d not define the scope o f categories l i s t e d . This l e d to a great deal of confusion as t o the coverage o f the r u l e . Monsanto's submission f o r one category, the a l k y l phthalates, numbered over s i x t y r e p o r t s . A great deal of c l e r i c a l work was necessary to organize, reproduce and to submit the one-foot-high stack of r e p o r t s . We l a t e r found out, much to our concern, that t h i s information had not been made a v a i l a b l e to a l l groups i n EPA responsible f o r a l k y l phthalates. Monsanto b e n e f i t e d from EPA's rulemaking as a r e s u l t o f the mandated o r g a n i z a t i o n a c t i v i t y . However, the primary o b j e c t i v e of making the information a v a i l a b l e to EPA f o r use was not accomplished. On January 31, 1979, EPA revoked the 8(d) r u l e and has since reproposed a new r u l e . Monsanto's comments on the reproposal address the concerns experienced with the f i r s t r u l e and other suggested m o d i f i c a t i o n s . Monsanto's experience i n implementing Section 5(a)(1) - PMN requirements - again h i g h l i g h t e d the need f o r c e n t r a l i z a t i o n . While e x i s t i n g product s a f e t y programs f o r new products were i n p l a c e , a need surfaced to assure corporate u n i f o r m i t y , to prevent p o s s i b l e d u p l i c a t i o n and to coordinate i n t e r n a l information management and EPA submissions. A c e n t r a l s t a f f department now provides a TSCA management f u n c t i o n to a s s i s t i n submissions and c o o r d i n a t i o n of a l l documentation. This has worked w e l l f o r the PMN's submitted to date. We have not waited f o r r e g u l a t o r y mandates as to the type and amount o f t o x i c o l o g y t e s t i n g to develop or submit, but have followed our i n t e r n a l t e s t i n g p o l i c i e s p r i o r to commercialization of a product. A l l Monsanto PMN's submitted to date have v o l u n t a r i l y i n cluded information beyond that mandated by the a c t . This has, i n some cases, included: M a t e r i a l Safety Data Sheets, Label information, d e t a i l s regarding the i n d u s t r i a l hygiene programs i n the proposed manufacturing s i t e ( s ) , r i s k assessment i n f o r mation and other r e l a t e d information. While t h i s information i s not mandated, we b e l i e v e i n most s i t u a t i o n s i t i s to our b e n e f i t to a s s i s t the agency i n t h i s way. EPA's Information Management Information management by EPA, as mandated under TSCA has centered on the development o f CSIN (Chemical Substances I n f o r mation Network). In response to Section 10(b) t h i s information management system has evolved to r e t r i e v e t o x i c o l o g i c a l and other s c i e n t i f i c data which could be u s e f u l to the Administrator i n c a r r y i n g out the act. A f t e r s e v e r a l years and about an equal number o f m i l l i o n s of d o l l a r s , c u r r e n t l y a prototype networking



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system i s under e v a l u a t i o n by up to 50 o r g a n i z a t i o n s . A wide ranging user group - i n terms o f both i n t e r e s t and c a p a b i l i t y - i s p r o v i d i n g a f i r s t pass to e s t a b l i s h u t i l i t y of the system. Simply put, the CSIN concept appears to be pure information management. I t does not create or store data or references. I t p o i n t s and s e l e c t s - with a broader choice of data-bases and v i a e a s i e r techniques than heretofore p o s s i b l e . An analogy o f a l i b r a r y might be u s e f u l . V i s u a l i z e a c e n t r a l catalogue f o r a vast i n t e r d i s c i p l i n a r y l i b r a r y with book and j o u r n a l holdings which contains a l l references to a p a r t i c u l a r subject regardless of the p a r t i c u l a r source document. Access to the system i s through a terminal which responds to r e l a t i v e l y easy i n s t r u c t i o n s . Current data-bases would be compared to many independent l i b r a r i e s , i n d i f f e r e n t l o c a t i o n s , with i n d i c e s which have d i f f e r e n t methods f o r searching. CSIN enables the user to search a l l of these v i a a c e n t r a l i z e d , u n i f i e d , methodology. CSIN a d m i n i s t r a t i o n and planning have been performed by about 25 f e d e r a l agencies, i n c l u d i n g EPA, DHHS, HTP and CEQ. EPA has played the c e n t r a l r o l e i n implementation of plans. Two concerns a r i s e which CSIN a d m i n i s t r a t i o n has not addressed so f a r . F i r s t , the emphasis has been to provide access only through w e l l - e s t a b l i s h e d e x i s t i n g sources. No apparent e f f o r t has been made to consider the need f o r drawing together the m u l t i p l i c i t y o f information submitted to the EPA O f f i c e o f P e s t i c i d e s and Toxic Substances i n an e a s i l y a c c e s s i b l e form f o r agency use. With the exception o f information contained i n the Chemicals In Commerce Information System (CICIS), developed p r i m a r i l y to accommodate TSCA Inventory and other r e l a t e d i n f o r mation, r e g u l a t o r y personnel o f t e n are not aware what i s already a v a i l a b l e and request r e p e t i t i v e submissions from i n d u s t r y . Furthermore, conclusions are drawn only from p u b l i c l y a v a i l a b l e data-bases. Data already a v a i l a b l e w i t h i n the agency are not r e a d i l y a c c e s s i b l e f o r i t s own personnel. Apparently, t h i s s i t u a t i o n i s a r e s u l t of non-responsiveness, so f a r , to TSCA S e c t i o n 10's mandate. The second concern or problem i s more d i f f i c u l t to deal with and could have more f a r - r e a c h i n g i m p l i c a t i o n s . I t involves the l a c k of d i s c r i m i n a t i o n i n the choice of information f i l e s made a v a i l a b l e through CSIN as w e l l as the lack of concern about the r e l i a b i l i t y o f the information received. The greater the techn i c a l e x p e r t i s e of users, the l e s s concern f o r these questions since t h i s group w i l l seek the o r i g i n a l source and d i s c r i m i n a t e between "good" and " u n r e l i a b l e " data. CSIN, however, attempts to make exhaustive searches a v a i l a b l e through s i m p l i f i e d methodo l o g i e s with the i m p l i c a t i o n that the u n s o p h i s t i c a t e d or nont e c h n i c a l user can r e a d i l y obtain " a l l " a v a i l a b l e data. Our experience has shown that computerized searching f o r information r e s u l t s i n a f a l s e sense o f c r e d i b i l i t y f o r what i s r e t r i e v e d . A d d i t i o n a l confidence, p a r t i c u l a r l y on the p a r t of



8.


Management

of

TSCA

Information

119

n o n - t e c h n i c a l l y t r a i n e d searchers i s gained since t h i s i s a government created system. We know t h i s doesn't n e c e s s a r i l y make sense or sound r a t i o n a l . However, we are d e a l i n g with people and subjects which are not always r a t i o n a l . A need to substantiate or j u s t i f y an emotionally based opinion v i a s o - c a l l e d "hard" data, regardless where i t comes from or how r e l i a b l e i t i s , can r e s u l t i n wide-spread and f a r - r e a c h i n g implications. As an example, the NIOSH-RTECS (Registry of Toxic E f f e c t s of Chemical Substances) i s a reasonable b a s i s f o r beginning a search regarding the t o x i c i t y of a substance. The p r i n t e d v e r s i o n contains some 47,000 materials and i t s contents are thoroughly documented i n i t s i n t r o d u c t i o n and f i l e d e s c r i p t i o n . The most commonly reported e f f e c t i s the LDLo or lowest l e t h a l dose found i n a species or the LD50 which i s the l e t h a l dose f o r 50 percent of the group under t e s t . ONLY THE LOWEST DOSES ARE PRESENTED IN RTECS, REGARDLESS OF TEST OR LABORATORY RELIABILITY. To the u n s k i l l e d , these s e l e c t i o n c r i t e r i a can e a s i l y be missed, and c r i t i c a l judgements made on the b a s i s of one h i g h l y v a r i a b l e t e s t method. The f i l e l i s t s a l l chemicals on which t o x i c i t y data have been found. In other words, the t i t l e i s not: R e g i s t r y of Toxic Substances. Yet, some b e l i e v e that a l l substances i n the Regist r y are n e c e s s a r i l y t o x i c under any conditions of use. Some s t a t e regulations have even been d r a f t e d based on t h i s b e l i e f . Computerized data-base versions of RTECS give the c a p a b i l i t y of e x t r a c t i n g substance l i s t s by " C l a s s i f i c a t i o n Codes." For example, one might ask the system to search f o r a l l compounds with c l a s s i f i c a t i o n Code of TUMORIGEN. How many users w i l l have read the user's guide c a r e f u l l y enough to know that t h i s means only that these compounds may have been reviewed by IARC or NTP but NOT that they have been i n d i c t e d as tumorigenic? Now, what can EPA or anyone e l s e do about t h i s e l u s i v e but r e a l problem? A s t a r t has already been made v i a a data q u a l i t y workshop which was i n i t i a t e d by the CMA (Chemical Manufacturers A s s o c i a t i o n ) and co-sponsored by EPA, NBS (National Bureau of Standards) and NAS (National Academy of Sciences). This r e s u l t e d i n a group of about 40 experienced p a r t i c i p a n t s from government, i n d u s t r y and academia reviewing c r i t e r i a f o r data q u a l i t y i n four areas of information r e l a t i n g to p r o p e r t i e s , h e a l t h and environmental e f f e c t s . From t h i s beginning, we e v e n t u a l l y hope to see the contents of data-bases or data f i l e s i d e n t i f i e d as to the l e v e l of r e l i a b i l i t y of extracted information. The user w i l l then at l e a s t have the a b i l i t y to judge the value of the information he received. Conclusion The vast majority of major,chemically-oriented

companies


has


120

TSCA: IMPACT ON SOCIETY AND CHEMICAL INDUSTRY

maintained on-going, socially responsible attitudes towards the public and the environment in relation to their products long before TSCA came into being. This, despite the hue and cry of the media and certain public factions who continue to feel that industry's concern for health and the environment must be legally mandated. Toxicity and environmental evaluations go back at least 20 years and, in some cases, forty years, using best available science and techniques available at that time. Material Safety Data Sheets, describing hazards and precautionary measures, have been produced for an equal period. Reviews of new products prior to commercialization have been mandatory in our company well before PMN rules appeared. Laws and regulations by their very nature place constraints and burdens on the regulated community. TSCA is no exception. Monsanto's experience with sections 5,8 and 10 of TSCA has, however, indicated that in addition to the burdens imposed by the mandate, there are also tangible benefits. Such benefits help offset some of the burdens and satisfy the intent of Congress as indicated in Section 2(c) of TSCA. "It is the intent of Congress that the Administrator shall carry out this Act in a reasonable and prudent manner, and that the Administrator shall consider the environmental, economic and social impact of any action the Administrator takes or proposes to take under this Act." The challenge facing EPA, industry and the public interest groups is to design and implement information management rules and systems that satisfy both the needs mandated by TSCA and the congressional intent on economic impact. To quote Monsanto's Vice Chairman, Dr. Louis Fernandez, from a recent speech to the National Association of Manufacturers, "it's clear that industry is committed to and capable of achieving our nation's environmental goals. We hope the regulatory agencies have come to recognize this and that we can work together to shape effective and reasonable regulations in the future".

LITERATURE CITED 1. Chemical Reporting and Recordkeeping Authorities under 15 Environmental and Consumer Acts, (EPA Report 560/3-78-001) 1978 2. Frost, Edmund B., Cox, Geraldine V., Hutt, Peter Barton The First Four Years of the Toxic Substances Control Act (A Review of the Environmental Protection Agency's Implementing TSCA,) Chemical Manufacturers Association 1981 3. 46 FR53995 Environmental Protection Agency Regulatory Agenda, Toxic Substances Control Act, October 30, 1981 4. EPA Office of Toxic Substances, Priorities for OTS Operation Office of Toxic Substances, U.S. EPA, January 1982 RECEIVED

September 1, 1982


Management of TSCA-Mandated Information - ACS Symposium

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