Harmonizing the Regulation of New Chemicals in the United States

4 Harmonizing the Regulation of New Chemicals in the United States and in the European Economic Community B L A K E A. BILES Downloaded by UNIV OF ROCHESTER on January 13, 2018 | http://pubs.acs.org Publication Date: May 1, 1983 | doi: 10.1021/bk-1983-0213.ch004

Jones, Day, Reavis, & Pogue, Washington, DC 20006 In the l a t e 1970's, both the United States and the European Economic Community (EEC) enacted laws — TSCA and the S i x t h Amendment r e s p e c t i v e l y — that r e q u i r e companies to n o t i f y the government before they commercialize new chemicals. Although these n o t i f i c a t i o n programs are s i m i l a r i n many r e s p e c t s , t h e i r enactment and initial implementation(2) have h i g h l i g h t e d s i g n i f i c a n t i n c o n s i s t e n c i e s and, i n a few cases, d i r e c t c o n f l i c t s . As a r e s u l t , governments and industry on both sides of the A t l a n t i c have focused considerable a t t e n t i o n upon the issue of "harmonizing" the two regulatory approaches, p a r t i c u l a r l y to reduce any n o n - t a r i f f trade b a r r i e r s that otherwise might occur. This paper discusses and compares the U.S. and EEC r e q u i r e ments f o r new chemicals, i n c l u d i n g e f f o r t s to achieve harmony between the two n o t i f i c a t i o n programs. REGULATION OF NEW SIXTH AMENDMENT

SUBSTANCES UNDER TSCA AND

THE

This part compares basic p r o v i s i o n s of the U.S. premanufacture and the EEC premarket n o t i f i c a t i o n programs.(3) Section 5 of TSCA,(4) "Manufacturing and processing n o t i c e s , " e s t a b l i s h e s the U.S. premanufacture n o t i f i c a t i o n program. Sect i o n s 3, 8(a)&(b), 15-17, and 19 a l s o are important. A r t i c l e s 5-8 and Annexes VII and VIII i n the S i x t h Amendment(5) contain the key p r o v i s i o n s of the EEC's premarket notification program. A r t i c l e s 2, 9-13, and 20-23 a l s o are p a r t i c u l a r l y relevant. Basic Framework and Scope Persons and A c t i v i t i e s Covered. TSCA § 5 creates a premanuf a c t u r e n o t i f i c a t i o n program, whereas the S i x t h Amendment requires the submittal of premarket n o t i f i c a t i o n s . Thus, U.S. PMN s must be submitted no l a t e r than 90 days p r i o r to the completion of R&D a c t i v i t i e s , unless EPA grants permission to produce l i m i t e d amounts f o r t e s t marketing purposes. In c o n t r a s t , companies i n 1

0097-6156/83/0213-0039$08.00/0 © 1983 American Chemical Society

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

Downloaded by UNIV OF ROCHESTER on January 13, 2018 | http://pubs.acs.org Publication Date: May 1, 1983 | doi: 10.1021/bk-1983-0213.ch004

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TSCA: IMPACT ON SOCIETY AND CHEMICAL INDUSTRY

the EEC may manufacture, process, or otherwise produce new substances before submitting PMN's, provided they f i l e the PMN's p r i o r to a c t u a l l y marketing the substances i n the Community. However, the two laws are s i m i l a r i n that they both apply to imported substances. In a d d i t i o n , they apply only to the product i o n and marketing of new substances f o r commercial purposes.(6^) Under TSCA, the f i r s t company that intends to manufacture a new substance i n the U.S. must submit a PMN f o r that substance. However, once EPA completes i t s 90-day review of the PMN, and a f t e r that company begins to manufacture the substance f o r non-R&D purposes, the substance becomes an " e x i s t i n g " chemical i n t h i s country. This means that, i n the f u t u r e , n e i t h e r the PMN submitt e r nor any other company w i l l be required to submit any f u r t h e r PMN s f o r that substance, i r r e s p e c t i v e of any s i g n i f i c a n t changes i n production volume or use, and whether any new t o x i c i t y data are developed at a l a t e r date.(_7) The S i x t h Amendment's premarket n o t i f i c a t i o n requirements d i f f e r markedly from TSCA i n three important r e s p e c t s . F i r s t , new substances i n the EEC always w i l l be considered "new" under the S i x t h Amendment, because the n o t i f i c a t i o n requirements are persons p e c i f i c — i . e . when one company submits a PMN f o r a p a r t i c u l a r substance, t h i s does not r e l i e v e any other company from the requirement to submit i t s own PMN before that second company may place the same substance on the EEC market.(8^) Second, the D i r e c t i v e includes a scheme f o r regular follow-up r e p o r t i n g on the commercial development of new substances, with p r o g r e s s i v e l y more extensive (and expensive) t e s t i n g requirements. F i n a l l y , the S i x t h Amendment creates a one-time n o t i f i c a t i o n f o r each company ( f o r each new substance), throughout the EEC. Thus, once a Member State has completed i t s review of a company's PMN (without taking any a c t i o n to r e q u i r e f u r t h e r t e s t i n g or to impose l i m i t a t i o n s upon production or use), that company i s not required to provide a PMN to any other EEC country i n which i t subsequently markets the substance. (9^) f

Chemicals covered. Both laws exclude c e r t a i n c a t e g o r i e s of chemicals from t h e i r PMN requirements, p r i m a r i l y those substances that are covered by other e x i s t i n g h e a l t h and environmental laws. These i n c l u d e p e s t i c i d e s , drugs and m e d i c i n a l products, and r a d i o active materials.(10) In a d d i t i o n to these general e x c l u s i o n s , n e i t h e r TSCA nor the S i x t h Amendment r e q u i r e PMN s f o r new mixtures or p r e p a r a t i o n s , which g e n e r a l l y are defined as combinations of substances that do not r e s u l t from chemical r e a c t i o n s . However, both laws e f f e c t i v e l y r e q u i r e PMN s f o r the marketing of new mixtures that are new ( i n p a r t ) because they contain new substances.(11) F i n a l l y , both laws provided general exemptions f o r (commerc i a l ) R&D substances. To q u a l i f y , companies must comply with c e r t a i n s t a t u t o r y l i m i t a t i o n s concerning production volume, use, and ( i n the case of the EEC) numbers o f customers.(12) TSCA i t s e l f does not e x p l i c i t l y exempt any other categories of chemicals. However, i n i t s r u l e s and p o l i c y guidance to 1

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date, EPA has excluded a m a j o r i t y o f s i t e - l i m i t e d intermediates. Further, the Agency p r e s e n t l y i s developing r u l e s under §5(h)(4) to exclude most polymers, the remaining s i t e - l i m i t e d intermediates, and a broad c a t e g o r y ( i e s ) of low-volume substances. EPA a l s o has i n d i c a t e d i t s w i l l i n g n e s s to e n t e r t a i n p e t i t i o n s f o r s i m i l a r exemptions ( e i t h e r c h e m i c a l - s p e c i f i c or f o r general categories) from the PMN requirements. Because the S i x t h Amendment i t s e l f exempts most of the chemic a l s that are subject to EPA's current rulemaking, i n general the Commission does not need to commence any exemption a c t i v i t i e s analogous to EPA's e f f o r t s . Thus, the EEC's premarket program covers only those new polymers that c o n t a i n 2% or more of a monomer(s). (Any new monomer _is_ subject to the n o t i f i c a t i o n requirements.) Further, because PMN's must be submitted only f o r new substances that are "placed on the [Community] market," the EEC's PMN requirements g e n e r a l l y do not apply to the manufacture and use of intermediates ( o r of any other new substances, f o r that matter) by one company a t one s i t e . ( 1 3 ) Likewise, the S i x t h Amendment d i f f e r s s u b s t a n t i a l l y from TSCA i n i t s exemption f o r "substances placed on the market i n q u a n t i t i e s of l e s s than one tonne per year per manufacturer." A r t . 8(1). This exemption i s p e r s o n - s p e c i f i c , but contains no time l i m i t a t i o n s — i . e . a manufacturer may q u a l i f y f o r the exemption and thus avoid the PMN requirements i n d e f i n i t e l y , so long as the company does not market more than one tonne annually.(14). This low volume exemption i s contingent upon the manufacturer providing a l i m i t e d n o t i c e to each Member State i n which the substance i s marketed, and complying "with any c o n d i t i o n s imposed by those a u t h o r i t i e s " i n the various Member States. Neither TSCA nor the S i x t h Amendment exclude or exempt substances from the PMN requirements j u s t because they are produced by small companies. However, many o f the exemptions p r e s e n t l y being considered by EPA, and s e v e r a l of those contained i n the S i x t h Amendment, m i t i g a t e the burdens that the PMN programs otherwise impose upon small companies. This i s p a r t i c u l a r l y true f o r exemptions based upon production or marketing volume. Preemption. Unlike most other U.S. environmental laws, TSCA i s administered and enforced e x c l u s i v e l y by EPA. None of i t s rulemaking or compliance a c t i v i t i e s are delegated to the States, and TSCA r u l e s g e n e r a l l y preempt any comparable state ( o r l o c a l ) laws and regulations.(15) In c o n t r a s t , as a D i r e c t i v e by the EEC C o u n c i l to the Member States, the S i x t h Amendment i s not self-implementing, and i t i s not d i r e c t l y enforceable against i n d i v i d u a l companies. Rather, each EEC country must implement i t s own premarket n o t i f i c a t i o n laws, r e g u l a t i o n s , and a d m i n i s t r a t i v e p r o v i s i o n s . These must be c o n s i s t e n t with the o v e r a l l framework of the S i x t h Amendment, and they must not create the types of c o n f l i c t s or intra-EEC b a r r i e r s that the D i r e c t i v e was intended to prevent i n the f i r s t p l a c e . Nonetheless, they may be d i f f e r e n t from one another, to r e f l e c t l o c a l p o l i c i e s and approaches to s p e c i f i c r e g u l a t o r y matters.


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I n i t i a l premarket implementation a c t i v i t i e s have demonstrated that t h i s c o n s t r u c t of one o v e r r i d i n g d i r e c t i v e implemented through ten n a t i o n a l laws and r e g u l a t i o n s creates many t e c h n i c a l , s c i e n t i f i c , and l e g a l problems f o r companies intending to market new substances i n the Community. Further, i n c o n t r a s t to most other C o u n c i l d i r e c t i v e s ( i n c l u d i n g the other ones d e a l i n g with h e a l t h and environmental matters), s u c c e s s f u l implementation of the EEC s PMN program may r e q u i r e the development of d e f i n i t i v e EEC-wide guidance on a number of c r i t i c a l matters.(16) f


Contents

of PMN's, I n c l u d i n g T e s t i n g

T e s t i n g and Other Risk Data.(17) TSCA § 5(d)(1)(B)&(C) required each PMN to contain any ( i . e . a l l ) h e a l t h and environmental e f f e c t s data that the n o t i c e submitter has i n h i s "possess i o n or c o n t r o l , " as w e l l as a " d e s c r i p t i o n " of other data that are "known to or reasonably a s c e r t a i n a b l e " by him. Thus, a company must provide EPA a l l t e s t data that i t has developed or otherwise obtained concerning i t s new chemical, and must inform the Agency concerning any other s i m i l a r data of which i t i s aware. However, TSCA does not r e q u i r e companies to perform t e s t s or otherwise develop s p e c i f i c data, as a p r e r e q u i s i t e to the submission of PMN s.08) To date, EPA has done three things to encourage and, i n some l i m i t e d cases, r e q u i r e companies to t e s t t h e i r new substances.(19) F i r s t , from time to time EPA has issued r e p o r t s , published speeches, prepared Congressional testimony, and otherwise p u b l i c i z e d i t s view that many PMN s l a c k necessary data to adequately assess the subject chemicals' h e a l t h and environmental e f f e c t s . Second, on a PMN-by-PMN b a s i s EPA has negotiated with i n d i v i d u a l companies to provide a d d i t i o n a l data and analyses. And t h i r d , EPA has i n i t i a t e d a c t i o n s under § 5(e) to r e q u i r e a d d i t i o n a l t e s t i n g f o r a very small number of new substances (and to l i m i t or t o t a l l y p r o h i b i t production and use of these chemicals).(20) The S i x t h Amendent i s c o n s i d e r a b l y d i f f e r e n t from TSCA concerning i t s requirements f o r companies to develop t o x i c i t y i n f o r mation and other t e s t data on t h e i r new chemicals. In general, PMN's i n the EEC must i n c l u d e the r e s u l t s of a required base set of t e s t s concerning physicochemical p r o p e r t i e s , acute t o x i c i t y , screening f o r c a r c i n o g e n i c i t y and mutagenicity, and sub-acute toxicity. Subsequent follow-up reports may t r i g g e r a d d i t i o n a l t e s t i n g requirements i n v o l v i n g sub-chronic and chronic t e s t s f o r long-term h e a l t h and environmental e f f e c t s . The t e s t i n g p r o v i s i o n s do not contain d e c i s i o n c r i t e r i a or other r u l e s f o r determining s p e c i f i c t e s t i n g programs. Further, the D i r e c t i v e includes language that may enable companies to avoid t e s t i n g i n c e r t a i n circumstances. A r t i c l e 6(1) s t a t e s that each PMN must i n c l u d e a " t e c h n i c a l d o s s i e r " which s u p p l i e s "the i n f o r m a t i o n necessary f o r e v a l u a t i n g the foreseeable r i s k , whether immediate or delayed, which the substance may e n t a i l f o r man and the environment." This includes the f

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r e s u l t s of the studies r e f e r r e d to i n Annex VII, together with a d e t a i l e d and f u l l des c r i p t i o n of the studies conducted and of the methods used or a b i b l i o g r a p h i c a l reference to them · · · · Annex V I I s p e c i f i e s s i x categories o f information, four of which are p a r t i c u l a r l y relevant as a "base s e t " : Category 1 - I d e n t i t y of the Substance; Category 3 - Physico-Chemical P r o p e r t i e s of the Substance; Category 4 - T o x i c o l o g i c a l Studies;(21) and Category 5 - E c o t o x i c o l o g i c a l Studies. Within each of these c a t e g o r i e s , the Annex l i s t s s p e c i f i c information requirements that must be met.(22) Neither A r t i c l e 6(1) nor Annex V I I contain any exemptions from the need to perform the e n t i r e b a t t e r y of base set t e s t s . However, the i n t r o d u c t o r y language to the Annex contains an "escape clause" f o r m i t i g a t i n g the t e s t i n g requirements f o r part i c u l a r substances ( o r c l a s s e s of substances): " I f i t i s not t e c h n i c a l l y p o s s i b l e or i f i t does not appear necessary to give information, the reasons s h a l l be s t a t e d . " Although n e i t h e r the Commission nor i n d i v i d u a l countries have issued any guidance concerning how t h i s p a r t i c u l a r language w i l l be a p p l i e d , i t i s most l i k e l y that countries w i l l require any j u s t i f i c a t i o n s (not to t e s t ) to be based upon t e c h n i c a l and s c i e n t i f i c r a t i o n a l e s , rather than economic and other commercial considerations.(23) Both the S i x t h Amendment and s e v e r a l n a t i o n a l premarket laws and r e g u l a t i o n s authorize i n d i v i d u a l Member States to (1) contest companies claims that c e r t a i n data ( i n the Annex V I I base s e t ) are not necessary o r are not t e c h n o l o g i c a l l y p o s s i b l e ; (2) to r e q u i r e the development of a d d i t i o n a l information and data; and (3) to impose production or use r e s t r i c t i o n s pending the development of such a d d i t i o n a l data. Further, EEC c o u n t r i e s may a c t without having to f o l l o w many o f the procedures that TSCA imposes upon EPA, and the f i n d i n g s necessary to take these a c t i o n s appear to be l e s s s t r i n g e n t than TSCA r e q u i r e s of the Agency. Under A r t i c l e 7(1), i f the country that receives a n o t i f i c a t i o n concludes that f u r t h e r data and information are needed f o r performing h e a l t h and environmental assessments of the new substance, i t may r e q u i r e the n o t i c e submitter to provide those data. This may i n v o l v e completion of the Annex VII "base set" ( f o r PMN s that invoke the "escape c l a u s e " ) , and/or performance of f u r t h e r t e s t s s p e c i f i e d i n Annex V I I I , i n a d d i t i o n to those contained i n Annex VII.(24) Annex V I I I s p e c i f i e s a s e r i e s of sub-chronic and chronic t e s t s , as w e l l as other extensive (and expensive) data requirements that may be required as a part of followup n o t i f i c a t i o n s once a chemical enters commercial production and i t s product i o n volume increases s u b s t a n t i a l l y . The S i x t h Amendment does not elaborate upon e i t h e r the subs t a n t i v e or procedural aspects of t h i s a u t h o r i t y . Rather, i t simply s t a t e s that i f a country can j u s t i f y the need f o r the data ( i n terms of r i s k assessment), i t may ask f o r the a d d i t i o n a l 1

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INDUSTRY

information. Further, the D i r e c t i v e i s s i l e n t upon the r e l a t i o n ship between t h i s request f o r a d d i t i o n a l information (and any response by the n o t i f i e r to the r e q u e s t ) , and the running of the 45-day premarket review p e r i o d . Taken i n conjunction with the "escape clause" i n Annex VII (which a l s o appears i n Annex V I I I ) , t h i s general a u t h o r i t y to request f u r t h e r information and data appears to g i v e the Member States c o n s i d e r a b l e d i s c r e t i o n and f l e x i b i l i t y i n t h e i r review of PMN s and t h e i r n e g o t i a t i o n s with i n d i v i d u a l companies. Over time, t h i s could l e a d to s i g n i f i c a n t d i f f e r e n c e s between the PMN requirements which companies a c t u a l l y face i n the various EEC Member S t a t e s .


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Information Concerning Production, Use, and Commercial Development . TSCA § 5(d)(1)(A) r e q u i r e s each PMN to i n c l u d e informat i o n concerning the new substance's (proposed) categories of use, production volumes (by category of use), byproducts from product i o n and use, estimated exposure to workers, and d i s p o s a l methods. As with t o x i c i t y data, t h i s production and use information must be provided only to the extent that i t i s "known to or reasonably a s c e r t a i n a b l e " by the n o t i c e submitter. Because the PMN i s submitted p r i o r to manufacture f o r non-R&D purposes, most of t h i s information w i l l be p r o s p e c t i v e i n nature, and i t therefore w i l l be expressed e i t h e r i n estimated ranges (where i t i s q u a n t i f i a b l e at a l l ) or i n other, more q u a l i t a t i v e terms.(25) A r t i c l e 6(1) of the S i x t h Amendment r e q u i r e s PMN s to c o n t a i n information and data necessary f o r e v a l u a t i n g the p o t e n t i a l r i s k s of new substances to humans and the environment. This s p e c i f i c a l l y includes c e r t a i n exposure information l i s t e d i n Annex V I I , concerning proposed uses and estimated y e a r l y production volumes ( i n ranges, and broken down by use c a t e g o r i e s ) . Further, A r t i c l e 6(1) r e q u i r e s submission of "a d e c l a r a t i o n concerning the unfavourable e f f e c t s of the substance i n terms of the various uses envisaged," which appears to r e q u i r e statements of the r i s k s that may be a s s o c i a t e d with the use c a t e g o r i e s provided under Annex VII.(26) 1

Information Concerning C l a s s i f i c a t i o n and L a b e l i n g i t s e l f , and Recommended Precautions and Emergency Measures. TSCA does not c o n t a i n any general requirements f o r the packaging and l a b e l ing of hazardous substances. Therefore i t i s not s u r p r i s i n g that there are no such requirements or s i m i l a r terms f o r new chemic a l s . (27^) Of course, many companies w i l l apply the same general hazard warnings and packaging standards to t h e i r new substances that they use f o r t h e i r e x i s t i n g chemicals and products. This includes the use of l a b e l s and data sheets recommended by the American National Standard I n s t i t u t e (ANSI). On the other hand, f o r more than a decade the EEC has required c e r t a i n dangerous substances to be packaged and l a b e l e d according to requirements contained i n t h i s same D i r e c t i v e . ( 2 8 ) A r t i c l e 5(1) thus r e q u i r e s companies to package and l a b e l t h e i r


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new substances i n accordance with the D i r e c t i v e ' s general r e q u i r e ments for e x i s t i n g substances. Further, PMN's must include i n f o r mation concerning "the proposed c l a s s i f i c a t i o n and l a b e l i n g of the substance i n accordance with t h i s D i r e c t i v e . " A r t . 6(1). Member States may use t h i s information to review l a b e l s and require any changes i n them. Both A r t i c l e 6(1) and Annex VII r e q u i r e n o t i f i e r s to provide information concerning recommended methods and precautions for safe handling, storage, use, and transport of t h e i r substances. Annex VII a l s o s p e c i f i e s that n o t i f i c a t i o n s must i n c l u d e emergency measures i n the case of " a c c i d e n t a l s p i l l a g e " or " i n j u r y to persons (e.g. p o i s o n i n g ) . " Regulation

of New

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TSCA "Unreasonable Risk" Regulations, and Other R e s t r i c t i o n s . During the three years that companies have been submitting PMN's to EPA, the Agency has developed a number of means f o r i n f o r m a l l y r e g u l a t i n g the production and use of c e r t a i n new chemicals. In a d d i t i o n , § 5 ( f ) authorizes EPA to i n i t i a t e more formal r e g u l a t o r y actions, primarily involving lawsuits. Because n o t i c e s for many new substances do not contain s u f f i c i e n t information and data for e v a l u a t i n g t h e i r t o x i c i t i e s (espec i a l l y re chronic e f f e c t s ) and probable exposure patterns, EPA's primary focus i n reviewing PMN's has been to determine whether i t w i l l request f u r t h e r t e s t i n g . In some cases, the e x e r c i s e (or threat of e x e r c i s e ) of the Agency's a u t h o r i t y has proven s u f f i c i e n t to persuade a company e i t h e r to hold up production of the substance v o l u n t a r i l y (while f u r t h e r data are developed), or to cease a l t o g e t h e r i t s plans f o r b r i n g i n g the chemical to market. Production and use of new substances can be l i m i t e d i n a number of other ways as w e l l . F i r s t , the only duty to submit a PMN may impose costs and h i g h l i g h t unanswered s c i e n t i f i c and techn i c a l questions s u f f i c i e n t to persuade a company t h a t , on balance, i t should drop the substance. In a d d i t i o n , EPA o f f i c i a l s o f t e n w i l l d i s c u s s , n e g o t i a t e , and otherwise "jawbone" n o t i f i e r s to ensure that adequate production and use l i m i t a t i o n s are imposed to protect a g a i n s t any s i g n i f i c a n t r i s k s that might occur. These informal requests may be given added weight by the Agency's d e c i s i o n to extend the usual 90-day n o t i c e review period for up to an a d d i t i o n a l 90 days (under § 5 ( c ) ) . In f a c t , i n a small number of cases the submitters have agreed to suspend the n o t i c e review p e r i o d i n d e f i n i t e l y , while f u r t h e r d i s c u s s i o n s and data development a c t i v i t i e s are pursued. In a d d i t i o n to these informal means for r e g u l a t i n g , § 5 ( f ) authorizes EPA to seek r e s t r i c t i o n s upon the production, d i s t r i b u t i o n , use, and d i s p o s a l of new substances that "present or w i l l present an unreasonable r i s k " of i n j u r y to h e a l t h or the environment. To ban a new chemical o u t r i g h t , the Agency must obtain an i n j u n c t i o n from a U.S. d i s t r i c t c o u r t . Any other r e s t r i c t i o n s



46


must be imposed v i a an expedited rulemaking that i s s i m i l a r to the general rulemaking a c t i o n s under TSCA § 6 f o r e x i s t i n g substances. For s e v e r a l reasons, EPA to date has n e i t h e r i n i t i a t e d , nor even s e r i o u s l y considered t a k i n g , any a c t i o n s under § 5 ( f ) . F i r s t , the required f i n d i n g of an "unreasonable r i s k " to h e a l t h or the environment i s very d i f f i c u l t to make f o r most new substances, simply because of the general l a c k of i n f o r m a t i o n and data that are needed f o r assessment and e v a l u a t i o n purposes. Second, because both court a c t i o n s and rulemakings r e q u i r e a s i g n i f i c a n t expenditure of Agency time, personnel, and other resources, the procedural aspects of § 5 ( f ) impose considerable r e s t r a i n t s upon the e x e r c i s e of t h i s a u t h o r i t y . F i n a l l y , EPA has expressed i t s concern about the p r o p r i e t y of r e g u l a t i n g i n d i v i d u a l chemicals under § 5 ( f ) , when those chemicals probably belong to broader c l a s s e s of substances ("me-too") chemicals) that not only present many of the same r i s k s to h e a l t h or the environment, but do so on a much broader scale.(29) In sum, EPA never has e x e r c i s e d i t s § 5 ( f ) a u t h o r i t y and i t probably w i l l do so only r a r e l y , i f at a l l , i n the f u t u r e . Regulation Under the S i x t h Amendment. Consistent with the requirement that new substances must comply with the S i x t h Amendment s general p r o v i s i o n s f o r the packaging and l a b e l i n g of dangerous substances, the country which r e c e i v e s a PMN may amend the n o t i f i e r s l a b e l i n g scheme to ensure such compliance. In a d d i t i o n , i f the country requests f u r t h e r information and t e s t i n g , i t a l s o may "take appropriate measures r e l a t i n g to safe use" to the extent that these are "necessary f o r the e v a l u a t i o n of the hazard [ i . e . r i s k ] " that the substance may cause, and pending Community a c t i o n . A r t . 7(1). But beyond these two general a u t h o r i t i e s , the D i r e c t i v e does not c o n t a i n a p r o v i s i o n comparable to TSCA § 5(f).(30) f

1

Rather, A r t i c l e 23 a u t h o r i z e s i n d i v i d u a l c o u n t r i e s to impose p r o h i b i t i o n s or other s p e c i a l c o n d i t i o n s upon the marketing of new substances, pending Commission or C o u n c i l a c t i o n . However, t h i s a u t h o r i t y i s r e s t r i c t e d by three c o n d i t i o n s . F i r s t , the country must have d e t a i l e d evidence that [the] substance, although s a t i s f y i n g the requirements of [the S i x t h Amendment] c o n s t i t u t e s a hazard [ i . e . r i s k ] f o r man or the environment · · · · Second, the p r o h i b i t i o n or l i m i t a t i o n a p p l i e s only to marketing w i t h i n the country's own t e r r i t o r y , so that a company would be f r e e to market i t s substance i n other EEC c o u n t r i e s unless they a l s o enact s i m i l a r r e s t r i c t i o n s . F i n a l l y , any a c t i o n s under A r t i c l e 23, whether taken by the country of n o t i f i c a t i o n or another Member S t a t e , are " p r o v i s i o n a l " — i . e . they may be imposed only pending Commission or Council a c t i o n on the substance.


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In t h i s regard, although the country that r e c e i v e s the o r i g i n a l PMN has the primary r e s p o n s i b i l i t y f o r reviewing the new substance, other Member States may p a r t i c i p a t e i n that review and take r e g u l a t o r y a c t i o n s . The country that r e c e i v e s a PMN must provide the Commission a copy (or summary) of the PMN, and the Commission then must forward the PMN i n f o r m a t i o n to the other Member S t a t e s . Upon r e c e i p t of t h i s i n f o r m a t i o n , any other count r y may act under A r t i c l e 23 to p r o h i b i t or l i m i t sale of that substance i n i t s own t e r r i t o r y . However, t h i s second country's a c t i o n must be based upon a f i n d i n g with " d e t a i l e d evidence" that the substance c o n s t i t u t e s a r i s k to humans or the environment i n that country.(31) Followup Reporting and T e s t i n g Requirements TSCA and the S i x t h Amendment are fundamentally d i f f e r e n t i n t h e i r approaches to "followup" r e p o r t i n g and t e s t i n g of substances f o r which PMN's have been submitted. TSCA § 5 does not e s t a b l i s h such a program, and although EPA has c o n s i s t e n t l y i n d i c a t e d i t s i n t e n t i o n to r e q u i r e c e r t a i n types of followup r e p o r t i n g , the Agency has yet to implement any such scheme. Conversely, followup r e p o r t i n g i s an i n t e g r a l part of the S i x t h Amendment, and the Member States may apply t h e i r t e s t i n g and r e g u l a t o r y a u t h o r i t i e s (over PMN's) to these subsequent n o t i f i c a t i o n s as w e l l . Followup Reporting Under TSCA. Since 1978, EPA repeatedly has stated i t s i n t e n t i o n to r e q u i r e followup r e p o r t i n g f o r c e r t a i n PMN substances once they complete the 90-day n o t i c e review period and enter commercial production. The Agency has o f f e r e d s e v e r a l reasons f o r implementing a followup program. F i r s t , i n cases when EPA l a c k s s u f f i c i e n t information and data to evaluate the p o t e n t i a l t o x i c i t i e s and exposures of new substances, the Agency may face an e i t h e r / o r d e c i s i o n ( e i t h e r i n i t i a t e a § 5(e) a c t i o n or take no a c t i o n ) , where a middle ground of followup r e p o r t i n g would be more d e s i r a b l e . Second, because TSCA PMN's are not p e r s o n - s p e c i f i c , any "voluntary" agreements reached with the o r i g i n a l n o t i f i e r s ( f o r example, concerning the development of a d d i t i o n a l data or the i m p o s i t i o n of c e r t a i n production or use r e s t r i c t i o n s ) , are not binding upon any other companies that subsequently produce the substance. Followup r e p o r t i n g or n o t i f i c a t i o n requirements a p p l i c a b l e to a l l such p a r t i e s (or to the major ones) might help s o l v e t h i s problem. T h i r d , because TSCA e s t a b l i s h e s a premanufacture n o t i f i c a t i o n scheme, and not a r e g i s t r a t i o n or approval program, EPA o f t e n faces severe time c o n s t r a i n t s upon i t s a b i l i t y to f u l l y assess notices. Some type of future r e p o r t i n g could provide a r e l e a s e valve of s o r t s from these l i m i t a t i o n s upon the Agency's a b i l i t y to perform an adequate review of those substances.

American Chemical Society Library 1155 16th St. N. w. Ingle; TSCA's Impact on Society and Chemical Industry Washington, 0. C. Society: 20030Washington, DC, 1983. ACS Symposium Series; American Chemical


48

TSCA! IMPACT ON SOCIETY AND CHEMICAL INDUSTRY

F i n a l l y , by t y i n g c e r t a i n types of followup r e p o r t i n g to the development of a d d i t i o n a l i n f o r m a t i o n and t e s t data, EPA might be able to more r e a l i s t i c a l l y take account of the economic cons t r a i n t s f a c i n g manufacturers when they submit t h e i r PMN's (part i c u l a r l y small companies or producers of s p e c i a l t y c h e m i c a l s ) . In f a c t , some U.S. companies and trade a s s o c i a t i o n s have suggested that EPA could adopt a type of "pay-as-you-go" approach to the PMN program — i . e . EPA would accept minimal l e v e l s of i n f o r m a t i o n and data i n the o r i g i n a l PMN's, but subsequently would obtain a d d i t i o n a l i n f o r m a t i o n f o r c e r t a i n "problem" chemicals once they achieve increased production volumes (and thus can j u s t i f y the costs of the t e s t i n g ) . However, EPA and i n d u s t r y never have concurred on some of the most b a s i c p r o v i s i o n s of such a program — i n c l u d i n g the c r i t e r i a f o r i d e n t i f y i n g chemicals f o r tracking i n t h i s manner, as w e l l as the a p p r o p r i a t e means f o r ensuring f o l l o w up t e s t i n g and r e p o r t i n g (e.g., v o l u n t a r y agreements, r u l e s ) . EPA has c i t e d two s t a t u t o r y a u t h o r i t i e s that i t might use f o r followup. F i r s t , § 5(a)(2) a u t h o r i z e s the Agency to issue s i g n i f i c a n t new use r u l e s (SNUR's), which would require § 5 n o t i f i c a t i o n s f o r substances (designated i n the SNUR's) when c e r t a i n exposure-related " t r i g g e r s " or c r i t e r i a are met (e.g., s i g n i f i c a n t changes i n production volume). The b a s i c concept would be that a s u b s t a n t i a l change i n exposure(s) ( r e s u l t i n g from a new use) may lead to a s i g n i f i c a n t new r i s k ( s ) , and i t thus merits EPA's review under § 5. SNUR n o t i f i c a t i o n s would be subject to the same b a s i c data requirements and review a u t h o r i t i e s described above f o r PMN's. Second, EPA c o u l d issue r u l e s under § 8(a) to r e q u i r e p e r i odic reports concerning the commercial development of c e r t a i n new substances once they enter production. Unlike SNUR's, § 8(a) requirements would not prevent companies from continuing t h e i r production and marketing a c t i v i t i e s . Rather, EPA would review information contained i n the § 8(a) r e p o r t s , and then could pursue c o n t r o l a c t i o n s under i t s other TSCA a u t h o r i t i e s f o r r e g u l a t i n g e x i s t i n g chemicals ( i . e . § 4 t e s t r u l e s , or § 6(a) "unreasonable risk" regulations). To date, EPA has proposed only one SNUR f o r a PMN substance, and the Agency has not issued any § 8(a) r u l e s . For the most part, EPA has i n d i c a t e d i t s i n t e n t i o n to use both of these authori t i e s s p a r i n g l y and, i n p a r t i c u l a r , to b u i l d any major followup r e p o r t i n g e f f o r t s around § 8 ( a ) , with only very l i m i t e d use of SNUR's. However, because both of these a u t h o r i t i e s r e q u i r e rulemaking, and f o r a v a r i e t y of other reasons, i t appears h i g h l y improbable that EPA w i l l use e i t h e r of them to any s i g n i f i c a n t degree during the next s e v e r a l years. Followup Reporting and T e s t i n g Under the S i x t h Amendment. Followup r e p o r t i n g and t e s t i n g are i n t e g r a l parts of the S i x t h Amendment's premarket n o t i f i c a t i o n scheme. The D i r e c t i v e i t s e l f



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49

contains c r i t e r i a f o r such r e p o r t i n g , and i t s p e c i f i e s a v a r i e t y of t e s t s that i n d i v i d u a l Member States may impose once they r e c e i v e the subsequent n o t i c e s . Under A r t i c l e 6(4), any company that p r e v i o u s l y submitted a PMN f o r a substance must inform the appropriate government concerning any of the f o l l o w i n g : s i g n i f i c a n t changes i n annual or t o t a l q u a n t i t i e s marketed; new t o x i c i t y data; new uses f o r which the substance i s marketed; or changes i n chemical p r o p e r t i e s r e s u l t i n g from a m o d i f i c a t i o n of the substance. Although reports under A r t i c l e 6(4) do not automatically r e q u i r e the development of more t o x i c i t y information and test data, under Annex V I I I , Level 1, the Member State that receives the n o t i f i c a t i o n may require a d d i t i o n a l t e s t i n g i f production volume exceeds t e n tonnes per year, o r a t o t a l of f i f t y tonnes, and i f other relevant f a c t o r s (e.g., e x i s t i n g test data, uses) j u s t i f y the need f o r more t o x i c i t y data. Several studies may be required under t h i s a u t h o r i t y : f e r t i l i t y , t e r a t o l o g y , sub-chronic and/or chronic (from 90 days to two y e a r s ) , mutagenesis, e c o t o x i c o l o g i c a l . Further, although Annex VIII contains the same "escape clause" that i s found i n Annex VII, as with base set t e s t i n g the country probably can overr u l e the company's objections and require the advanced t e s t i n g . Annex VIII also contains "Level 2" n o t i f i c a t i o n t e s t i n g requirements, t r i g g e r e d i f a PMN n o t i f i e r ' s production of a new substance subsequently reaches 1,000 tonnes per year or a t o t a l of 5,000 tonnes. The company must provide a followup n o t i c e and the country then must draw up a t e s t program f o r the n o t i f i e r . This may include t e s t s f o r chronic t o x i c i t y , c a r c i n o g e n i c i t y , f e r t i l i t y (e.g., three-generation study), teratology (non-rodent s p e c i e s ) , acute and sub-acute t o x i c i t y (on second s p e c i e s ) , a d d i t i o n a l t o x i c o k i n e t i c c h a r a c t e r i s t i c s , and various e c o t o x i c o l o g i c a l f a c t o r s ( i n c l u d i n g accumulation, degradation, and m o b i l i t y ) . The same basic packaging and l a b e l i n g requirements described above f o r PMN's, and the a u t h o r i t y f o r p r o v i s i o n a l r e g u l a t i o n of new hazardous substances, a l s o apply to the Member S t a t e s ' review o f followup n o t i f i c a t i o n s . Thus, i f subsequent n o t i c e s and a d d i t i o n a l t e s t data warrant changes i n packaging and l a b e l ing p r o v i s i o n s , or j u s t i f y the imposition of production or use r e s t r i c t i o n s , the Member States may take a c t i o n to impose such requirements. ACTIVITIES OF THE ORGANIZATION FOR ECONOMIC COOPERATION AND DEVELOPMENT During the l a s t f i v e years, the Organization f o r Economic Cooperation and Development (OECD) has d i r e c t e d s e v e r a l programs and a c t i v i t i e s concerning the r e g u l a t i o n of new chemicals. Most of these have been organized under the general goal of achieving i n t e r n a t i o n a l "harmonization" i n the c o n t r o l of chemical substances. This part summarizes the OECD work.


50

TSCA:


The

IMPACT

ON

SOCIETY

AND

CHEMICAL

INDUSTRY

I n s t i t u t i o n a l Framework

The OECD was e s t a b l i s h e d by Convention i n 1960,(32) and grew out of the Marshall Aid Plan's Organisation f o r European Economic Co-operation. It has a membership of 24 c o u n t r i e s , i n c l u d i n g the U.S., a l l ten members of the EEC, Scandinavian c o u n t r i e s , Canada, Japan and A u s t r a l i a . In a d d i t i o n , the EEC "takes part" i n OECD activities. The OECD Council i s the organization's main governing body. I t c o n s i s t s of ambassadors or m i n i s t e r s from each of the member c o u n t r i e s . The Council u s u a l l y reaches one of two types of coope r a t i v e agreements with regard to the major subjects that come before i t . ( 3 3 ) Council Decisions are binding upon a l l Members, who must implement them i n accordance with appropriate n a t i o n a l procedures and requirements. Recommendations, on the other hand, are not b i n d i n g , but are submitted to the Members who then must decide whether to implement them through t h e i r own n a t i o n a l laws. Thus, the exact status of a p a r t i c u l a r Council a c t i o n i s s i g n i f i cant i n s o f a r as whether i t r e q u i r e s , or only suggests, implementat i o n at the n a t i o n a l l e v e l . The OECD performs i t s work through various committees and groups, with representatives designated by the p a r t i c i p a n t countries. In a d d i t i o n , s p e c i f i c t e c h n i c a l issues often are addressed by "expert groups," comprised of s p e c i a l i s t s from the p a r t i c u l a r countries i n v o l v e d . The OECD's o f f i c e s and s t a f f , l o c a t e d i n P a r i s , provide much of the day-to-day c o n t i n u i t y and support f o r Organization a c t i v i t i e s . The OECD Chemicals Programme The OECD Environment Committee has general supervisory r e s p o n s i b i l i t i e s f o r environmental and h e a l t h matters. This Committee supervises the work of the Chemicals Group, which i n turn has o v e r a l l r e s p o n s i b i l i t y f o r issues i n v o l v i n g the c o n t r o l of substances. The OECD Chemicals Programme has two p a r t s . Part I Programme. As a r e s u l t of Council Recommendations i n 1974 and 1977, f o r almost f i v e years now the Chemicals Group has been responsible f o r a number of a c t i v i t i e s which together comprise Part I of the Chemicals Programme. Three of these are of p a r t i c u l a r relevance to t h i s paper: (1) The production and subsequent updating of OECD t e s t g u i d e l i n e s (containing standard methods f o r performing various h e a l t h and environmental t e s t s , but not i n c l u d i n g e i t h e r r i g i d p r o t o c o l s or d e c i s i o n r u l e s / c r i t e r i a concerning the circumstances when the t e s t s should be performed); (2) The development of approaches to "step sequence" t e s t i n g ; and (3) Work on p r i n c i p l e s and g u i d e l i n e s f o r hazard ( i . e . r i s k ) as ses sment·(34)


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Part I I Programme. In 1978 the OECD i n s t i t u t e d i t s Part I I Programme, the S p e c i a l Programme on the C o n t r o l of Chemicals. This work i s supervised by the Management Committee.(35) To date, the Part I I Programme has focused upon four major projects: (1) The development and implementation of a set of P r i n c i p l e s of Good Laboratory P r a c t i c e (GLP's); (2) R e s o l u t i o n of issues concerning C o n f i d e n t i a l i t y of Data; (3) Development of a Glossary of Key Terms; and (4) Development of g u i d e l i n e s and other procedures f o r the exchange of information (e.g., r e t e s t data, the export of hazardous chemicals, and the l a b e l l i n g of hazardous chemicals)· Work To Date. From 1977-80, the most i n t e n s i v e and product i v e OECD a c t i v i t i e s focused upon Mutual Acceptance of Data (MAD) and the development of t e s t g u i d e l i n e s and GLP's. E f f o r t s also were devoted to the Step Sequence Group and, i n p a r t i c u l a r , that body's e f f o r t s to develop a Minimum Pre-Marketing Set of Data (MPD). T e c h n i c a l and s c i e n t i f i c work a l s o progressed on the various hazard assessment issues; and expert groups worked on recommendations concerning c o n f i d e n t i a l data, d e f i n i t i o n s of key terms, and p r i n c i p l e s of information exchange. In May 1980, the Chemicals Group endorsed recommendations from three of i t s groups concerning GLP's, t e s t g u i d e l i n e s , and the MPD, and endorsed the p r i n c i p l e of Mutual Acceptance of Data. Thereafter, the Environment Committee a l s o endorsed these recommendations. A year l a t e r , i n May 1981, the OECD C o u n c i l considered these recommendations and issued a D e c i s i o n e s t a b l i s h i n g the following p r i n c i p l e of Mutual Acceptance of Data (MAD): [D]ata generated i n the t e s t i n g of chemicals i n an OECD Member country i n accordance with OECD Test G u i d e l i n e s and OECD P r i n c i p l e s of Good Laboratory P r a c t i c e s h a l l be accepted i n other Member c o u n t r i e s f o r purposes of assessment and other uses r e l a t i n g to the p r o t e c t i o n of man and the environment. In Annexes accompanying i t s D e c i s i o n , the Council incorporated the s p e c i f i c GLP's endorsed by the Chemicals Group, as w e l l as those test g u i d e l i n e s that had been developed to date.(36) The Council did not endorse any a c t i o n concerning the MPD. It should be noted that the Council's D e c i s i o n does not commit members of the OECD to adopt these test g u i d e l i n e s and GLP's as enforceable requirements. Rather, the C o u n c i l issued a Recommendation that "Member c o u n t r i e s , i n the t e s t i n g of chemicals, apply" the g u i d e l i n e s and GLP's. Thus, while the D e c i s i o n commits Members to accept, f o r purposes of t h e i r own assessments and e v a l uations, any data that are generated i n accordance with these g u i d e l i n e s and p r i n c i p l e s , Members remain f r e e to s e l e c t these or any others f o r t h e i r own n a t i o n a l use.


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The Minimum Ρre-Marketing Set of Data

AND

CHEMICAL

INDUSTRY

(MPD)

Perhaps the most c o n t r o v e r s i a l aspect of the OECD's work con cerning new chemicals has been i t s e f f o r t s to develop a Minimum Pre-Marketing Set of Data, sometimes r e f e r r e d to as a "base s e t " . This a c t i v i t y i s the f i r s t of the Step Sequence Group's e f f o r t s to i d e n t i f y p r i n c i p l e s and c r i t e r i a f o r determining when various t e s t s should be performed. As d i s t i n g u i s h e d from the work to develop GLP's and t e s t g u i d e l i n e s , t h i s e f f o r t has focused upon the a p p l i c a t i o n of those g u i d e l i n e s to d i f f e r e n t types or catego r i e s of chemicals and i n various production and use s i t u a t i o n s . Thus, i t r a i s e s the fundamental issue of s o - c a l l e d d e c i s i o n r u l e s , c r i t e r i a , and other s i m i l a r g u i d e l i n e s f o r deciding under what circumstances the s p e c i f i c t e s t s should be performed. As noted above, i n May 1980 the High Level Meeting of the Chemicals Group endorsed the MPD, with f u l l support from the U.S. representatives. The data components of the MPD were l a r g e l y s i m i l a r to those contained i n the base set of t e s t s found i n Annex VII to the S i x t h Amendment. The MPD a l s o would include " p r o v i s i o n s f o r f l e x i b l e a p p l i c a t i o n s " of the MPD to p a r t i c u l a r chemicals, using language s i m i l a r to the "escape clause" found i n Annex VII. The d r a f t Council D e c i s i o n read, i n pertinent p a r t : [The MPD] s h a l l be generated or obtained and a p p l i e d f o r the purpose of i n i t i a l assessment of new chemicals, and i n t h i s regard the data components of the [MPD] and the p r o v i s i o n s f o r i t s f l e x i b l e a p p l i c a t i o n are set f o r t h i n the Annex to t h i s D e c i s i o n and form i n t e g r a l parts thereof. The Environment Committee endorsed the MPD and recommended i t to the Council f o r a c t i o n at i t s May 1981 meeting. However, the Council, i n the face of new U.S. o p p o s i t i o n to enactment of the MPD as w r i t t e n , f a i l e d to enact e i t h e r a D e c i s i o n or a Recommen dation concerning MPD. This change i n o f f i c i a l U.S. p o l i c y came as a r e s u l t of l o b bying that the American chemical i n d u s t r y ( p r i m a r i l y the Chemical Manufacturers A s s o c i a t i o n (CMA)) undertook with the new Adminis t r a t i o n a f t e r i t assumed o f f i c e i n January 1981. The major con cern that CMA stated was that the proposed Council D e c i s i o n on MPD, as w r i t t e n , might l e g a l l y bind the U.S. to amend TSCA and require the MPD as part of PMN's i n t h i s country. CMA long had opposed any concept of "base set" t e s t i n g f o r a l l new substances under TSCA, and viewed the MPD, p a r t i c u l a r l y i f incorporated i n a Council D e c i s i o n , as being d i r e c t l y contrary to that p o s i t i o n . As a r e s u l t , i n d u s t r y p r e v a i l e d upon the (new) U.S. o f f i c i a l s to oppose enactment at t h i s time of any Council measure dealing with MPD; the U.S. r e p r e s e n t a t i v e s at the May 1981 Council meeting opposed the d r a f t Decision; and the Council did not act upon i t .


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Subsequent to the Council meeting, d i s c u s s i o n s have c o n t i n ued, both w i t h i n t h i s country and i n f o r m a l l y at a number of OECD meetings, to attempt to r e s o l v e the present U.S. o p p o s i t i o n to the e a r l i e r d r a f t D e c i s i o n . A t t e n t i o n r e c e n t l y has focused upon a d r a f t " i n t e r p r e t i v e statement" to be added to the o r i g i n a l d r a f t MPD D e c i s i o n , which would make i t c l e a r that enactment of the Decision i n no way would bind the U.S. to amend TSCA or otherwise incorporate MPD i n t o the U.S. PMN program. However, no consensus has been reached to date.


HARMONIZATION AND

OTHER FUTURE DEVELOPMENTS

TSCA and the S i x t h Amendment are quite d i f f e r e n t i n many important respects, and i t would require some fundamental changes to standardize them or even make them c o n s i s t e n t . However, because they deal i n part with the same general subject matter — industry n o t i f i c a t i o n and government review of new chemicals — and because they may lead to trade b a r r i e r s and the i n e f f i c i e n t use of scarce t e c h n i c a l and s c i e n t i f i c resources, i t i s u s e f u l to consider how they might be brought c l o s e r i n l i n e with one another. "Harmoniz a t i o n " i s a term commonly applied to such e f f o r t s . The Concept of Harmonization Webster defines "harmony" to mean "correspondence, accord . . . [as in] ' l i v e s i n harmony with her neighbors.'" Thus, to "harmonize" i s "to bring i n t o consonance or accord." The term "accord" i s defined as "balanced i n t e r r e l a t i o n s h i p : harmony."(37) None of those persons a c t i v e i n i n t e r n a t i o n a l discussions c o n c e r n i n g t h e r e g u l a t i o n o f new c h e m i c a l s has a r g u e d t h a t "harmonization" w i l l r e s u l t i n the development of any standardized, world-wide scheme f o r the submission and review of PMN's. Rather, most have viewed harmonization as being goal-oriented — i n the words of one OECD o f f i c i a l , Harmonization i s something more than c o o r d i nation — which doesn't convey the idea of shared o b j e c t i v e s — but something l e s s than s t a n d a r d i s a t i o n — since there i s g e n e r a l l y a v a r i e t y of acceptable ways to a t t a i n agreed goals.(38) Thus, given d i v e r s e l e g a l and economic frameworks, e f f o r t s to achieve harmony on major p o l i c i e s and procedures depend upon the various p a r t i e s reaching accord on t h e i r b a s i c goals. With regard to the t e s t i n g and r e g u l a t i o n of new chemicals, i t i s not at a l l c l e a r that, with the exception of the most fundamental goal of p r o t e c t i n g man and the environment from c e r t a i n chemical r i s k s , the major p a r t i e s involved i n these issues have reached an accord on fundamentals. In f a c t , experience to date i n d i c a t e s that r e a l "harmonization" often n e i t h e r r e f l e c t s nor



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c o n s t i t u t e s a goal of m u l t i l a t e r a l d i s c u s s i o n s , but i s c i t e d i n support of other desired outcomes once they have been achieved through such d i s c u s s i o n s . Of course, ongoing dialogue between representatives of the various governments and i n d u s t r i e s involved may lead to a common understanding of the d i f f e r e n t regulatory frameworks and of the various p a r t i e s ' i n t e r e s t s i n them. But beyond t h i s most b a s i c outcome, there appear to be at l e a s t four l e v e l s of concurrence at which some s o r t of "harmony" could conceivably be achieved concerning n o t i f i c a t i o n and review of new substances: (1) The development of common methodologies and g u i d e l i n e s (e.g., concerning t o x i c i t y t e s t s , economic a n a l y s e s ) , and agreements to accept the data derived from these methods; (2) Agreements to employ these methods as the recognized ("approved"?) approaches to developing the p a r t i c u l a r data and analyses; (3) Concurrence on j o i n t c r i t e r i a and " d e c i s i o n r u l e s " f o r developing data and information (addressing the circumstances under which the methods and g u i d e l i n e s should or must be employed); and (4) J o i n t or common approaches to the a c t u a l review and r e g u l a t i o n of new substances. Using these l e v e l s as a reference p o i n t , the f o l l o w i n g d i s c u s s i o n evaluates developments to date and what may l i e ahead. Harmonizing TSCA and the S i x t h Amendment C o n f l i c t s Between the Two PMN Programs. Inconsistent and c o n f l i c t i n g PMN requirements a r i s e i n each of the four areas described i n the f i r s t part of t h i s paper. F i r s t , to the extent that TSCA and the S i x t h Amendment do not have the same general scope and coverage, t h i s n e c e s s a r i l y w i l l mean that companies i n some cases w i l l face r e g u l a t i o n of t h e i r (new) chemicals and commercial a c t i v i t i e s i n one c o u n t r y ( i e s ) , but not i n another, and v i c e v e r s a . Almost by d e f i n i t i o n , t h i s w i l l create c e r t a i n a r t i f i c i a l competitive advantages and disadvantages for companies, depending upon at which end they l i e i n the trade of those p a r t i c u l a r chemicals. S i m i l a r l y , d i f f e r e n t t e s t i n g and other data requirements may create n o n - t a r i f f b a r r i e r s to trade. If countries reach agreement concerning the use of common t e s t methods and g u i d e l i n e s , and i f they f u r t h e r harmonize concerning both the use (e.g., the OECD's MAD) and sharing of information and data, some of these b a r r i e r s w i l l be reduced. But to the extent that the substantive t e s t i n g c r i t e r i a are a t variance, e i t h e r as w r i t t e n or as a p p l i e d by n a t i o n a l regulatory o f f i c i a l s (e.g., r e the "escape clause" i n the S i x t h Amendment's base set of t e s t s ) , very r e a l b a r r i e r s w i l l remain. The i n c o n s i s t e n t or c o n f l i c t i n g r e g u l a t i o n of new chemicals probably represents the most obvious manner i n which the PMN laws can create b a r r i e r s to trade. Given the fundamental d i f f e r e n c e s between the U.S. and European PMN programs, as w e l l as the i n h e r ent s e l f - i n t e r e s t s involved because the EEC and the U.S. are



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competitors i n the world-wide chemicals trade, i t i s h i g h l y u n l i k e l y that any s i g n i f i c a n t agreements ever w i l l be reached concerning the j o i n t r e g u l a t i o n of new substances. At the very most, and only a t some point i n the d i s t a n t f u t u r e , i t might be p o s s i b l e to reach some basic accord concerning the f a c t o r s to be considered i n making regulatory judgments ( i . e . h e a l t h and environmental r i s k s , the e f f i c i e n c y of c o n t r o l options, economic impacts of the r e g u l a t i o n s ) . Perhaps the best evidence of t h i s i s the f a c t that even w i t h i n the EEC i t s e l f , the r e g u l a t i o n of chemicals — a l b e i t p r o v i s i o n a l — i s l e f t l a r g e l y to the d i s c r e t i o n of i n d i v i d u a l Member States. F i n a l l y , the d i f f e r e n t approaches to followup n o t i f i c a t i o n and t e s t i n g impose a d d i t i o n a l requirements upon substances i n Europe that do not apply to the same chemicals when they are marketed i n the U.S. In the short term, a t l e a s t , t h i s d i s c r e p ancy may w e l l work to the advantage of companies doing business i n t h i s country (whether U.S.- or foreign-based). But, over time t h i s a l s o could lead European companies to seek changes ("harmonization"?) which e i t h e r make the EEC requirements l e s s s t r i n g e n t or incorporate an EEC-type of followup scheme i n t o TSCA.(39) Developments to Date. I t o f t e n has been stated that the basic p o l i c y o b j e c t i v e of e f f o r t s to harmonize the U.S. and European laws i s the achievement of c o n s i s t e n t and e f f e c t i v e p r o t e c t i o n of h e a l t h and the environment. However, economic considerations — i n p a r t i c u l a r , the avoidance (or minimization) of n o n - t a r i f f trade b a r r i e r s — c o n s t i t u t e the p r i n c i p a l f o r c e behind v i r t u a l l y a l l of these m u l t i l a t e r a l e f f o r t s . The trade i n chemicals and chemical products c o n s t i t u t e s a s i g n i f i c a n t part of the o v e r a l l trade between Western i n d u s t r i a l i z e d nations. S p e c i f i c a l l y , the U.S. enjoys a favorable balance i n i t s chemicals trade, and t h i s i s p a r t i c u l a r l y s i g n i f i c a n t given the current r e c e s s i o n . Thus, any unnecessary b a r r i e r s to t h i s trade may impose s u b s t a n t i a l burdens upon c e r t a i n segments of the American chemical i n d u s t r y , and may c o n s t i t u t e v i o l a t i o n s of the i n t e r n a t i o n a l General Agreement on T a r i f f s and Trade (GATT). To date the U.S. and the EEC have implemented t h e i r respecT t i v e PMN programs l a r g e l y independent of one another. Because they have needed to d r a f t basic r u l e s and p o l i c y statements, implement inventory r e p o r t i n g requirements, and s t a f f up and prepare f o r the r e c e i p t of PMN's, i t i s hardly s u p r i s i n g that the r e s p e c t i v e governing o f f i c i a l s have focused t h e i r time and resources upon " g e t t i n g t h e i r own acts together," with only secondary a t t e n t i o n devoted to reaching accord on many of the i n c o n s i s t e n c i e s and c o n f l i c t s described i n t h i s paper. Further, to p a r t i c i p a t e i n any meaningful d i s c u s s i o n s and negotiations with t h e i r counterparts abroad, representatives from the several countries and organizations must have developed t h e i r own ( i n i t i a l ) approaches to the many complex issues that they face.



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Following passage of TSCA i n 1976, and during EPA's i n i t i a l implementation of the premanufacture program i n 1977-78, the U.S. recognized the need to p a r t i c i p a t e i n m u l t i l a t e r a l d i s c u s s i o n s concerning c o o r d i n a t i o n and "harmonization" of i t s regulatory activities. For a v a r i e t y of reasons, U.S. o f f i c i a l s selected the OECD as the primary forum f o r such d i s c u s s i o n s (and n e g o t i a t i o n s ) . Thus, except on a purely i n f o r m a t i o n a l b a s i s , the U.S. chose not to d i s c u s s or negotiate d i r e c t l y with the EEC concerning implement a t i o n of TSCA and the S i x t h Amendment. Further, the lead U.S. r e p r e s e n t a t i v e s to the OECD chemicals work ( i n c l u d i n g the U.S. c h a i r s of the Chemicals Group, the Management Committee, and of various expert groups) were drawn from EPA and other f e d e r a l health and environmental p r o t e c t i o n agencies, and they d i d not consider commercial and economic issues to be t h e i r primary concern i n these e f f o r t s . Of course, the work that has gone on to date w i t h i n the OECD demonstrates the usefulness of focusing upon r e l a t i v e l y noncontrov e r s i a l and a p o l i t i c a l issues upon which agreement can be reached at an e a r l y stage. The recent OECD D e c i s i o n concerning MAD, t e s t g u i d e l i n e s and GLP's represents a very c o n s t r u c t i v e outcome of these harmonization e f f o r t s , and i t bodes w e l l f o r the success of s i m i l a r "Level 1" e f f o r t s ( 4 0 ) — i n c l u d i n g agreements concerning the g l o s s a r y o f key terms and the mechanisms f o r information exchange. But f a l l i n g short, as they do, of r e q u i r i n g consistency i n matters of s c i e n t i f i c , l e g a l , or regulatory judgment (e.g., whether to perform c e r t a i n t e s t s , and the use to which r e s u l t i n g information and data should be p u t ) , these e a r l y successes should not be taken as an i n d i c a t i o n that s i m i l a r consensus can be reached concerning issues r e q u i r i n g a higher l e v e l of understanding and agreement. The debate over adoption of the MPD i s the f i r s t , and probably not the l a s t , evidence of t h i s . Prospects f o r the Future. During the next few years, a number of f a c t o r s — f o r the most part, missing u n t i l now — may provide a more concrete basis f o r productive dialogue on major PMN i s s u e s . These i n c l u d e the f a c t that the EEC w i l l begin to develop some r e a l experience with i t s own program, which should enable the Community to b e t t e r understand i t s own system and i d e n t i f y those parts i n which changes a r e both necessary and f e a s i b l e . This i s p a r t i c u l a r l y true with regard to such major issues as t e s t i n g and followup n o t i f i c a t i o n s . In a d d i t i o n , as a second generation of government o f f i c i a l s and l e g i s l a t o r s assume r e s p o n s i b i l i t y f o r implementing (and, as necessary, amending) these laws, they may be more f l e x i b l e concerning major p o l i c y issues than the persons who have been responsible f o r e s t a b l i s h i n g the i n i t i a l s t r a t e g i e s f o r the PMN programs. With the change i n A d m i n i s t r a t i o n and turnover of EPA o f f i c i a l s i n the U.S., such m o d i f i c a t i o n s already are evident. Presumably, the same scenario w i l l develop i n the EEC. Although the p o l i t i c a l and p h i l o s o p h i c a l views of the new persons o b v i o u s l y



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w i l l i n f l u e n c e t h e i r approaches to the new chemicals program, the mere f a c t that d i f f e r e n t persons are involved should, i n and of i t s e l f , s e t the stage f o r f u r t h e r d i s c u s s i o n s on major harmonization issues. However, the basic d i f f e r e n c e s between the U.S. and EEC laws never w i l l be r e c o n c i l e d i n one common approach to the r e g u l a t i o n of new chemicals, and i t i s h i g h l y improbable that major m u l t i l a t e r a l agreements w i l l be reached on key regulatory i s s u e s . Thus future e f f o r t s , both at the OECD l e v e l and i n v o l v i n g d i r e c t U.S.-EEC d i s c u s s i o n s , w i l l be most p r o f i t a b l e i n f o s t e r i n g mutual understanding about how the two systems a c t u a l l y operate, and then i n achieving Level 1 agreements s i m i l a r to those reached to date. At most, i t may be p o s s i b l e to reach consensus on c e r t a i n Level 2 issues concerning the standard a n a l y t i c a l methods and g u i d e l i n e s to be employed i f n a t i o n a l laws otherwise require performance of the underlying t e s t s and analyses. Beyond t h i s , the prospects f o r achieving any high l e v e l s of harmony are, a t best, p r e t t y s l i m . Rather, based upon t h e i r cumulative experiences with PMN's, and i n response to domestic ( i n c l u d i n g intra-EEC) economic and p o l i t i c a l f a c t o r s , during the next few years the U.S. and EEC each w i l l f i n e tune i t s own laws through a combination of r e g u l a t i o n s , p o l i c y statements, a d m i n i s t r a t i v e d e c i s i o n s , and j u d i c i a l a c t i o n s . These adjustments might r e s u l t i n greater consistency between TSCA and the S i x t h Amendment, but d i r e c t "harmonization" w i l l not be the d r i v i n g f o r c e behind most of these changes. Thus, both indust r y and government should a n t i c i p a t e only l i m i t e d ( i f any) success i n e f f o r t s to eliminate the major d i f f e r e n c e s i n the two laws treatment of s i g n i f i c a n t PMN i s s u e s . The f o l l o w i n g d i s c u s s i o n p r e d i c t s some of the major developments concerning the U.S. and EEC PMN programs. Admittedly, i t i s quite s p e c u l a t i v e and subject to considerable change based upon a v a r i e t y of f a c t o r s . Nonetheless, i t should give some idea of what we may expect during the next decade of PMN n o t i f i c a t i o n and review. 1

1982-1983. Through the end of 1983, i t i s u n l i k e l y that there w i l l be any major new developments r e s u l t i n g i n the harmoniz a t i o n of TSCA and the S i x t h Amendment — e i t h e r from m u l t i l a t e r a l agreements as such, or from p a r a l l e l developments i n the implement a t i o n of the two laws. This stems p r i m a r i l y from the EEC's focus upon i n t i a l implementation of i t s own requirements, and from recent changes i n the U.S.'s approach to OECD and other m u l t i l a t e r a l discussions. There w i l l be three major developments i n the EEC: (1) r e porting and compilation of the EINECS(41) inventory; (2) submiss i o n of the f i r s t wave of PMN's to the various Member States, and t h e i r subsequent review and response to those PMN's; and (3) i n i t i a l work at the Commission l e v e l ( i n c o n s u l t a t i o n with the Member States) to i d e n t i f y and then address major issues that



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r e q u i r e EEC-wide d i s c u s s i o n and r e s o l u t i o n ( i n c l u d i n g the d e v e l opment of some types of guidance). As a r e s u l t of these three e f f o r t s , both the Commission and the i n d i v i d u a l States w i l l begin to develop a track record on e x a c t l y how they w i l l approach the PMN program, as a basis f o r the development of more general p o l i c i e s and procedures. The major work under TSCA w i l l be to conclude the c u r r e n t , h i g h l y - p u b l i c i z e d e f f o r t s to develop broad exemptions from the PMN program f o r polymers, s i t e - l i m i t e d intermediates, and c e r t a i n low volume substances. EPA probably w i l l p u b l i s h general PMN r u l e s and n o t i f i c a t i o n forms which e s s e n t i a l l y r e s t a t e the a p p l i c a b l e s t a t u t o r y terms, and which may r e f l e c t the Agency's conclusions concerning the minimal data that i t would encourage submitters to provide. Also, the Agency w i l l take few ( i f any) actions under § 5 ( e ) , and w i l l i n i t i a t e only a s k e l e t a l followup r e p o r t i n g program. F i n a l l y , there w i l l be a general weakening of the OECD's r o l e as the major forum f o r harmonizing the two PMN systems. The present e f f o r t s concerning information exchange w i l l continue, as w i l l others dealing with n o n c o n t r o v e r s i a l t e c h n i c a l and s c i e n t i f i c matters. But the OECD probably w i l l have l i t t l e success i n addressing and r e s o l v i n g any key regulatory o r p o l i c y matters, i n c l u d i n g the Council's c o n s i d e r a t i o n at MPD. 1984-1986. TSCA and the S i x t h Amendment w i l l continue to develop l a r g e l y i n p a r a l l e l , but a type of "harmony" may emerge i n d i r e c t l y as a r e s u l t of changes that the U.S. and EEC make concerning the b a s i c scope and coverage of t h e i r laws. Thus, the U.S. w i l l have completed i t s i n i t i a l § 5(h)(4) exemption r u l e makings, and the EEC w i l l have b e t t e r defined which chemicals and a c t i v i t i e s are subject to i t s PMN requirements. Also, both sides w i l l continue to develop better methods and data bases concerning fundamental s c i e n t i f i c and economic i s s u e s , which i n turn w i l l enable them to more p r o f i t a b l y compare and d i s c u s s areas of incons i s t e n t or c o n f l i c t i n g r e g u l a t i o n . S p e c i f i c a l l y , under the S i x t h Amendment companies w i l l have begun to r e f i n e t h e i r procedures f o r submitting PMN's and then negotiating with i n d i v i d u a l Member States concerning data needs and p o s s i b l e use r e s t r i c t i o n s . T h i s , i n turn, w i l l lead some companies to a type of "forum shopping" — i . e . they w i l l s e l e c t those c o u n t r i e s i n which, f o r a v a r i e t y of reasons, i t i s most opportune to submit t h e i r PMN's, and they w i l l avoid those i n which i t i s not. Also, the Commission w i l l have issued ( o r otherwise expressed i t s t a c i t approval o f ) guidance on some fundamental t e c h n i c a l i s s u e s , p a r t i c u l a r l y concerning the contents of PMN's. Several Member States w i l l have taken some regulatory a c t i o n s on new chemicals, thus r a i s i n g basic l e g a l and regulatory issues concerning the extent to which the EEC can and w i l l permit i n d i v i d u a l



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Members to r e g u l a t e substances ( w i t h i n t h e i r own t e r r i t o r i e s ) when other c o u n t r i e s (and the EEC i t s e l f ) do not concur with such regulations. In the U.S., Congress f o r the f i r s t time w i l l give serious c o n s i d e r a t i o n to making major amendments i n TSCA, p r i m a r i l y to cut back on some of i t s more egregious p r o v i s i o n s and to otherwise focus upon p a r t i c u l a r types of h e a l t h and environmental problems. EPA w i l l continue to issue exemptions f o r s p e c i f i c c a t e g o r i e s of substances, and w i l l develop some general followup requirements f o r a few, w e l l - d e f i n e d c a t e g o r i e s — i . e . those f o r which PMN's c o n s i s t e n t l y demonstrate p o s s i b l e h e a l t h and environmental r i s k s , once commercialization begins. Also, the Agency w i l l move to p u b l i s h a more e x p l i c i t set of c r i t e r i a f o r s e l e c t i n g t e s t s to assess the r i s k s presented by c e r t a i n c a t e g o r i e s of non-exempt chemicals, i n c o r p o r a t i n g concepts of " f l e x i b i l i t y " analogous to the general "escape clause" found i n the S i x t h Amendment. These c r i t e r i a and other r e l a t e d guidance w i l l r e f l e c t a c o n s i d e r a t i o n of the economic c o n s t r a i n t s involved i n the t e s t i n g of new substances. The OECD w i l l continue i t s t e c h n i c a l work, but i t s focus w i l l s h i f t p r i m a r i l y to e x i s t i n g chemicals. In a d d i t i o n , the Organizat i o n w i l l i n c r e a s i n g l y focus i t s a t t e n t i o n upon waste management i s s u e s , again f o l l o w i n g the approach taken f o r new chemicals — emphasizing the need to reach consensus on fundamental t e c h n i c a l and s c i e n t i f i c matters, as w e l l as on the exchange of information and data. 1987-1991. Based upon d i s c u s s i o n s conducted d i r e c t l y between the U.S. and the EEC (as w e l l as b i l a t e r a l t a l k s i n v o l v i n g Canada and, p o s s i b l y , Japan), some "harmonization" may be reached concerning "base s e t " t e s t i n g of new substances and fundamental c r i t e r i a f o r evaluating PMN's. These w i l l not, however, be r e f l e c t e d i n any major t r e a t i e s or conventions, or through d i s cussions w i t h i n the OECD. Rather, TSCA and the S i x t h Amendment w i l l continue to develop i n p a r a l l e l , and the U.S. and the EEC may reach accord on some very b a s i c regulatory matters. Within the EEC, there w i l l be moves to regulate a few categories of (new) "problem" chemicals, p r i m a r i l y those that several Members repeatedly have i d e n t i f i e d as being of concern f o r marketing on a Community-wide b a s i s . Also, the Commission w i l l recommend ( t o the Council) c e r t a i n amendments, p r i m a r i l y to make changes i n the D i r e c t i v e that already have been accepted i n p r a c t i c e by Member S t a t e s . Under TSCA, EPA a l s o w i l l turn i t s a t t e n t i o n to r e q u i r i n g a d d i t i o n a l up-front t e s t i n g and other data development f o r c e r t a i n categories of new substances that c o n s i s t e n t l y l a c k data ( i n the PMN's), and which are known to be i n h e r e n t l y t o x i c . The primary v e h i c l e f o r these a d d i t i o n a l requirements w i l l be the § 5(b)(4) " r i s k l i s t , " although some § 4 t e s t r u l e s also may be used. By t h i s time, too, the Agency w i l l have r e f i n e d i t s means f o r


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imposing production or use r e s t r i c t i o n s absent formal rulemakings or court a c t i o n s , and the Congress may consider amending TSCA to i n c o r p o r a t e some o f these e x t r a l e g a l approaches i n t o the Act. FOOTNOTES 1.


2.

Paper presented to the Symposium on TSCA Impacts on Society and the Chemical Industry, American Chemical Society 183rd National Meeting, Las Vegas, Nevada, A p r i l 1, 1982 — Blake A. B i l e s , Jones, Day, Reavis & Pogue. The U.S. premanufacture n o t i f i c a t i o n (PMN) requirements have been i n e f f e c t f o r approximately three years, and more than 1250 PMN s have been submitted to EPA. The EEC's premarket n o t i f i c a t i o n requirements took e f f e c t i n September 1981, so that to date only a handful of PMN's have been filed i n Europe. This d i s c u s s i o n comparing the two PMN programs is substantially shortened from the paper presented at the Las Vegas ACS program. Copies of the o r i g i n a l , more d e t a i l e d text are a v a i l a b l e from the author. Toxic Substances Control Act, 15 U.S.C. 2601 e t seq., Pub. L. No. 94-469. Council D i r e c t i v e No. 79/831 of September 18, 1979 (O.J. No. L 259/10 of October 15, 1979). This D i r e c t i v e i s r e f e r r e d to as the " S i x t h Amendment" because it represents the s i x t h time that the C o u n c i l has amended C o u n c i l D i r e c t i v e No. 67/548 of June 27, 1967 (O.J. No. L 196/1 of August 16, 1967) concerning C l a s s i f i c a t i o n , Packaging and L a b e l l i n g of Dangerous Substances. EPA has construed t h i s " l i m i t a t i o n " quite broadly, so that only those activities that are c a r r i e d out in government or u n i v e r s i t y (or s i m i l a r n o n - p r o f i t ) research l a b s , and that are not t i e d to any subsequent commercial e x p l o i t a t i o n , are outside the scope of the premanufacture requirements. The EEC can be expected to take a s i m i l a r approach to i n t e r preting what is "commercial." See the d i s c u s s i o n concerning EPA's i n t e n t i o n to impose followup r e p o r t i n g or n o t i f i c a t i o n requirements upon the producers of some PMN'ed substances. Similarly, i f one person i s exempt from the EEC's notificat i o n requirements, t h i s does not r e l i e v e any other person from the requirement to submit a PMN if that second person i s not also e n t i t l e d to the exemption. However, m u l t i p l e PMN's may be required f o r substances manufactured i n more than one EEC country, due to the i n c o r p o r a t i o n of s e v e r a l l e g a l e n t i t i e s i n the various Member States. f

3.

4. 5.

6.

7.

8.

9.


4.


10.

11.

12.

13.

14.

15. 16.

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Other exclusions under TSCA i n c l u d e tobacco and tobacco produ c t s , f i r e a r m s , and other substances and products that are regulated under the Federal Food Drug and Cosmetic Act. The Sixth Amendment s i m i l a r l y excludes several broad c a t e g o r i e s of substances and activities: n a r c o t i c s ; the transport of dangerous substances by rail, road, i n l a n d waterway, sea or a i r ; wastes that are regulated under other Council d i r e c t i v e s ; substances that are imported into the EEC and then exported without being processed or used i n any manner while i n the Community; fertilizers that are regulated under other EEC requirements; and substances that are "already subject to s i m i l a r t e s t i n g and n o t i f i c a t i o n requirements under e x i s t i n g Directives. " However, EPA has stated that the TSCA PMN requirements do apply to the import of new substances as a part of mixtures. If the premanufacture requirements only a p p l i e d to the import of new substances i n bulk, companies could avoid-the PMN requirements by producing new (to the U.S.) substances abroad, formulating them i n t o mixtures abroad, and then importing the new mixtures i n t o t h i s country. A r t i c l e 8(1) of the S i x t h Amendment s p e c i f i e s three d i f f e r e n t types of exemptions f o r R&D substances. The t h i r d appears to be analogous to the TSCA § 5(h)(l) exemption f o r test marketinactivities. However, new substances that are imported i n t o the Community and then used at the s i t e of import are subject to the EEC PMN requirements. Further, because the volume r e s t r i c t i o n r e l a t e s to marketing rather than manufacturing, it appears that a company is e n t i t l e d to manufacture s e v e r a l tonnes of a chemical i n one year, and then market it over a period of s e v e r a l years (at l e s s than one tonne per y e a r ) , without being required to submit a PMN f o r the substance. See TSCA § 18, "Preemption." Examples of these issues include the current u n c e r t a i n t y over the scope of the D i r e c t i v e ' s general exemption f o r polymers; the p r e c i s e i n t e r p r e t a t i o n of the e x c l u s i o n s f o r p e s t i c i d e s and medicinal products; c o n f l i c t i n g n a t i o n a l approaches to the d e f i n i t i o n and p r o t e c t i o n of c o n f i d e n t i a l business information; and d i f f e r e n c e s of o p i n i o n (between i n d i v i d u a l Member States) concerning the a p p l i c a b i l i t y o f the PMN requirements to substances p r e v i o u s l y marketed i n c e r t a i n countries but not in others.


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17.

18.

19.

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It is important to note the meaning of two terms used i n connection with TSCA and the S i x t h Amendment, because they o f t e n have d i f f e r e n t i n t e r p r e t a t i o n s under the two laws. "Hazard" g e n e r a l l y i s used i n the S i x t h Amendment (and i n other EEC d i r e c t i v e s ) to mean what U.S. s c i e n t i s t s and regulators often c a l l " r i s k " — i . e . an assessment or e v a l u a t i o n that c o n s i d ers both the e f f e c t s and exposures that are associated with p a r t i c u l a r substances. In t h i s country, the term "hazard" u s u a l l y r e f e r s to the inherent t o x i c i t y or e f f e c t s of a substance, or to the unsafe c h a r a c t e r i s t i c s of p a r t i c u l a r chemicals or products. The l a t t e r meaning i s the one used in t h i s paper. In January 1981, EPA published a Premanufacture Testing P o l i c y c o n t a i n i n g general t e s t methods and g u i d e l i n e s f o r a l a r g e number of human and environmental e f f e c t s . 46 Fed. Reg. 8986, Jan. 27, 1981. Although t h i s guidance would not have imposed any l e g a l o b l i g a t i o n upon companies to conduct t e s t s f o r those e f f e c t s , i t endorsed the OECD's "Minimum Pre-Marketing Set of Data" (MPD), a "base set" of t e s t s to be performed on most new chemicals. However, following the change in A d m i n i s t r a t i o n i n 1981, the U.S. withdrew its a c t i v e support f o r the MPD. For a f u r t h e r d i s c u s s i o n of t h i s i s s u e , see the next part of t h i s paper. EPA possesses a f o u r t h means f o r obtaining a d d i t i o n a l t e s t data from i n d u s t r y , although the Agency has never used t h i s a u t h o r i t y . Under § 4 ( a ) , EPA may impose t e s t i n g r e q u i r e ments f o r c a t e g o r i e s of chemicals, provided the Agency makes c e r t a i n f i n d i n g s about the need f o r such data and about the c h e m i c a l s p o t e n t i a l f o r exposure to human or environmental populations. Section 5(b)(1) provides that any PMN f o r a new substance covered by such a t e s t i n g category must c o n t a i n the r e q u i s i t e t e s t data. Taken together, these p r o v i s i o n s author i z e EPA to impose t e s t i n g requirements upon new chemicals i n c e r t a i n c l a s s e s , as a c o n d i t i o n f o r the submittal of PMN's for those substances. Under § 5 ( e ) , f o l l o w i n g r e c e i p t and review of a PMN EPA may order a company to develop t e s t data " s u f f i c i e n t to evaluate the h e a l t h and environmental e f f e c t s " of the new substance. However, if the PMN submitter objects to the order (and provides s u f f i c i e n t grounds f o r that o b j e c t i o n ) , the order does not take e f f e c t and EPA must o b t a i n an i n j u n c t i o n from a U.S. district court to impose the data requirements (and any appropriate production or use r e s t r i c t i o n s ) . Category 4 lists three types of studies f o r human health effects: basic acute t o x i c i t y t e s t s , a 28-day animal study ( r e f e r r e d to i n other d i s c u s s i o n s as a "sub-chronic" t e s t ) , and a s e r i e s of two (or more) screening t e s t s f o r mutagenicity and c a r c i n o g e n i c i t y . 1

20.

21.

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4.


22.

23.

24. 25.

26.

27.

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The D i r e c t i v e contains these other requirements concerning t o x i c i t y information and t e s t data: (1) N o t i f i c a t i o n s must include d e s c r i p t i o n s of the s t u d i e s conducted and methods used ( A r t i c l e 6(1), and Annex VII, Introductory Statements); (2) The t e s t s must be performed according to the methods s p e c i f i e d i n Annex V ( A r t i c l e 3 ( 1 ) ) , and must be "recognized and recommended by the competent i n t e r n a t i o n a l bodies where such recommendations e x i s t " (Annex V I I , Introductory Statements); (3) The persons who c a r r y out the t e s t s must comply with the p r i n c i p l e s of current good l a b o r a t o r y p r a c t i c e (Annex VII, Introductory Statements); and (4) The notifications must include the composition of samples used i n t e s t i n g , and the name of the persons r e s p o n s i b l e f o r c a r r y ing out the studies (Annex VII, Introductory Statements). Under Article 6(2), if a p a r t i c u l a r substance p r e v i o u s l y was the subject of a PMN by another company, the n o t i f i e r may r e l y upon data submitted i n the p r i o r n o t i f i c a t i o n ( s ) . However to take advantage of t h i s "me-too" p r o v i s i o n , a company must o b t a i n agreement (1) from the relevant government a u t h o r i t y that reference to the e a r l i e r r e s u l t s i s s a t i s f a c t o r y , and (2) from the previous submitter to use that submitter 's data. For a d i s c u s s i o n of the a u t h o r i t y o f other Member States to request a d d i t i o n a l t e s t i n g , see footnote 31. Upon r e c e i p t of a PMN, EPA has little d i r e c t recourse f o r r e q u i r i n g a company to develop and otherwise provide more production and use information. Section § 5(e) i s EPA's major l e g a l a u t h o r i t y f o r obtaining a d d i t i o n a l information, and that s e c t i o n focuses upon h e a l t h and environmental e f f e c t s data, rather than exposure information. The D i r e c t i v e does not s p e c i f y any other exposure-related information (e.g., production processes, e f f l u e n t and emiss i o n data, information on worker exposures), and it does not mention economic or other non-risk information. However, i n d i v i d u a l Member States may attempt to r e q u i r e t h i s type of information under t h e i r general a u t h o r i t y to r e q u i r e a d d i t i o n a l information and data beyond those s p e c i f i e d i n A r t i c l e 6(1) and Annex VII. Although TSCA § 6(a)(3) authorizes EPA to issue requirements containing hazard warnings and i n s t r u c t i o n s , the Agency never has proposed any such r u l e s . This may be due i n part to the f a c t that OSHA has proposed c e r t a i n hazard communicat i o n requirements (47 Fed. Reg. 12091, March 19, 1982) which may become e f f e c t i v e during 1983.


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29.

30.

31.

32. 33. 34.

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As noted e a r l i e r , the " S i x t h Amendment" enacting the premarket n o t i f i c a t i o n requirements c o n s t i t u t e s the s i x t h time that the EEC has amended the D i r e c t i v e concerning the C l a s s i f i c a t i o n , Packaging and L a b e l l i n g of Dangerous Substances. This D i r e c t i v e was enacted on June 27, 1967 (O.J. No. L 196/1 of August 16, 1967). The key p r o v i s i o n s concerning packaging and l a b e l i n g i n the D i r e c t i v e (as now amended) are A r t i c l e s 16-18 and Annexes I-IV; also see A r t i c l e s 2-4, 14-15, and 20-23. This "me-too" issue a l s o has been debated i n the context of p o s s i b l e § 5(e) a c t i o n s , concerning the merits of r e q u i r i n g t e s t s f o r new chemicals when t h e i r broader c l a s s e s of substances are not a l s o being t e s t e d . Of course, the impact even of temporary measures can be s i g n i f i c a n t , p a r t i c u l a r l y i f the time it takes f o r the Community to take a c t i o n , and f o r the notifier then to comply with that a c t i o n , i s long r e l a t i v e to the notifier's need to introduce the chemical onto the market. A l s o , t h i s r e g u l a t o r y authori t y may provide considerable leverage to any data-gathering requirements imposed under Article 7(1), j u s t as prospective TSCA § 5(e) a c t i o n s can have a s i g n i f i c a n t impact upon n o t i c e submitters i n the United S t a t e s . Other Member States a l s o may use the PMN i n f o r m a t i o n and data that they r e c e i v e as a b a s i s f o r requesting further t e s t s or information from the PMN submitter ( i n a d d i t i o n to any such requests from the country that r e c e i v e s the PMN). However, the second country first must suggest to the n o t i f i e d country that the l a t t e r request the f u r t h e r t e s t i n g or other informat i o n from the company. If the two countries then disagree concerning data to be requested from the company (or disagree on the need to request any a d d i t i o n a l data at all), e i t h e r country may ask the Commission to request such information. Thus, the primary r e s p o n s i b i l i t y f o r requesting a d d i t i o n a l information and t e s t i n g l i e s with the country of notificat i o n , and to have an impact, any other Member State must convince e i t h e r the o r i g i n a l country or the Commission that the a d d i t i o n a l data must be requested. Convention of the Organisation f o r Economic Co-operation and Development, December 14, 1960. The C o u n c i l also may enter into agreements with Members, nonmember s t a t e s , and i n t e r n a t i o n a l o r g a n i z a t i o n s . The other major elements of the Part I Programme are an Economics Programme ( s t u d i e s and other analyses of the economic impacts of assessment procedures, g u i d e l i n e s , r e g u l a t i o n s , and laws); the Complementary Information Exchange Procedure (concerning the exchange of information about various laws and r e g u l a t i o n s ) ; and concerted a c t i o n s on s p e c i f i c chemicals (re PCB's and mercury, to d a t e ) .


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36.


37. 38.

39.

40. 41.

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The Part I I Programme was organized under a separate Management Committee ( r a t h e r than the e x i s t i n g Chemicals Group) in order to o b t a i n the necessary funding, but not to e s t a b l i s h a separate supervising committee. The Management Committee and the Chemicals Group c l o s e l y coordinate t h e i r a c t i v i t i e s and have overlapping memberships. At the time of the Council D e c i s i o n , approximately 50 guidel i n e s were i n f i n a l form. An equal number were in various stages of d r a f t i n g , and are to be incorporated i n t o the Annex as they are completed. Webster's New C o l l e g i a t e D i c t i o n a r y , 8, 519 (1981 ed.). "OECD Harmonization of Chemicals C o n t r o l , " p. 2, Speech by B. G i l l e s p i e , Administrator, OECD Chemicals D i v i s i o n , presented to CMA/IAG Seminar on Compliance with I n t e r n a t i o n a l Chemc a l Regulations, Washington, D.C., A p r i l 29, 1981. In a d d i t i o n , the requirements and p o l i c i e s concerning the handling and treatment of c o n f i d e n t i a l business information (CBI) are and will continue to be an important t o p i c of "harmonization" d i s c u s s i o n s . In a number of ways, different approaches to CBI (between the EEC and the U.S.) will) d i r e c t l y a f f e c t the CBI p r o t e c t i o n s a v a i l a b l e w i t h i n each c o u n t r y ( i e s ) . This is p a r t i c u l a r l y true concerning the e f f e c t s that the d i s c l o s u r e of p r o p r i e t a r y information i n one country will have upon industry's ability to protect CBI from d i s c l o s u r e i n other n a t i o n s . See my d i s c u s s i o n above of the four " l e v e l s " of p o s s i b l e harmonization. EINECS: European Inventory of E x i s t i n g Commercial Chemical Substances. This i s the inventory of e x i s t i n g substances required by A r t i c l e 13(1) of the S i x t h Amendment.

RECEIVED

December

14,

1982


Harmonizing the Regulation of New Chemicals in the United States

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