OECD Efforts to Harmonize New Chemicals Testing: Variations on a Theme

Joachim Ernst von Marschall

Mr. von Marschall, at present a Visiting Scholar at the Environmental Law Institute, is a Resident at the Hamburg, West Germany, Court of Appeals. The author would like to gratefully acknowledge the editorial assistance of Messrs. Phillip D. Reed, Editor-in-Chief of the ENVIRONMENTAL LAW REPORTER and Jeffrey Trauberman, Director, Toxic Substances Program, Environmental Law Institute, Washington, D.C.

[12 ELR 15038]

When in the fall of 1982 the Chemicals Group of the Organisation for Economic Co-operation and Development (OECD)¹ assembles it is expected to conclude more than two years of the Organisation's efforts to harmonize² the legal terms under which chemical testing has to be conducted in member countries.³ As more and more countries regulate the manufacture or marketing of chemicals,⁴ the need for international standards has been widely recognized. In September 1979, the Council of the European Community (EC) issued a directive commonly called the Sixth Amendment,⁵ which attempts to establish a supranational framework⁶ for consistent chemicals regulation. However, since some major chemical producers are outside the jurisdiction of the EC Council,⁷ EC harmonization efforts have a limited significance.Because of its broader membership, the OECD activity has attracted great interest.⁸ While the Organisation's preliminary efforts suggested that it would take strong action requiring member countries to mandate extensive testing by those wishing to market new chemicals, a shift in the United States' position seems likely to produce a less definitive action which will leave broad discretion to member countries in shaping their chemical testing rules.

Underlying these international efforts is the understanding that problems created by toxic substances are not confined to national territories, in part because they can travel across those boundaries when discharged as wastes into the air or rivers, and in part because they travel even more freely in international commerce. Perhaps even more influential is the fact that differing national regulations can create non-tariff trade barriers,⁹ thus distorting competitive positions in international markets. At present about 10 percent of total trade between OECD member countries is in chemicals, accounting for 90 percent of total world trade in chemicals or $100 billion in 1980. Eighty percent of all chemicals produced worldwide originate in OECD countries. In view of the considerable costs involved in chemical testing, international coordination could reduce the economic burden of regulation to government and industry, mainly by avoiding duplicative testing.

Since 1974, two OECD groups have been involved in chemicals control: the Chemicals Group of the Environment [12 ELR 15039] Committee and the "Special Programme on the Control of Chemicals" of the Management Committee.¹⁰ The Chemicals Group is concerned primarily with updating test guidelines,¹¹ step sequence testing (SST), hazard assessment, and an economic program. The Special Programme focuses on good laboratory practice (GLP),¹² confidentiality of data, a standard glossary of key terms, and information exchange, including the concept of Mutual Acceptance of Data (MAD).¹³

The work of the SST subgroup of the Chemicals Group is of special interest.¹⁴ Its task has been to reach an agreement on what data should be developed on new chemicals in order to enable the assessment of possible risks to health and the environment before the chemicals can enter the market. The result of its efforts was the Minimum Premarketing Set of Data (MPD).¹⁵ As its name implies, the MPD does not constitute a complete analysis of the risks embodied in a new chemical. Rather it is designed to identify a range of basic risks. In addition to the MPD issue, the SST subgroup has on its agenda the development of data on those chemicals which, after passing basic MPD testing,¹⁶ later are found to pose sufficient risk to warrant follow-up testing. While OECD member countries generally have acknowledged the usefulness of the MPD for the purpose of risk assessment, considerable disagreement has surfaced, mainly between the U.S. and the EC, with regard to the concept of national chemicals regulation within which the MPD should be developed.

This paper examines the attempts of the OECD to harmonize the legal requirements for testing chemicals, with emphasis on the implications for the existing U.S. and EC chemicals control programs. While there are other national programs of this kind in existence, these two have been chosen for discussion because the eleven countries they cover represent most of the major producers of chemicals. In addition, OECD harmonization efforts have been largely shaped by the interests of the U.S. and the EC countries.After briefly describing the two programs (which have been compared in more detail elsewhere),¹⁷ the paper discusses the OECD Draft Decision Concerning the Minimum Premarketing Set of Data in the Assessment of Chemicals (the Draft)¹⁸ and an as yet informal alternative proposal (the Proposal)¹⁹ A comparison of Draft and Proposal highlights significant differences in their purposes and likely efficacy in bringing greater consistency and rationality to the field of chemical risk assessment. Closer examination reveals that the Draft would better serve the goal of harmonization, but that sufficient political support for its adoption appears to be lacking. The paper concludes with some critical remarks and the suggestion of an alternative that lacks the political liabilities of the Draft, but would achieve greater harmonization than the Proposal.

Chemical Testing Law and Policy

Some General Aspects of Chemical Testing Policy

Laws requiring chemicals to be tested by their manufacturers are an important part of the array of legislation enacted over the last decade to combat the serious health and environmental risks which chemicals can pose. Countries have empowered their governments to regulate the manufacture, marketing, use, and disposal of chemicals in a variety of ways, ranging from requiring protective packaging or labelling and imposing conditions on use, to banning the manufacture or sale of particularly dangerous substances.

The key to the effectiveness of such protective tools is information on what chemicals can be dangerous in what situations. Experience with the numerous new chemicals developed since the Second World War has provided mountains of data on their impacts. That experience has also demonstrated that, while many manmade substances prove to be quite benign, some can have long-delayed, but devastating and often irreversible effects on public health and the environment if allowed wide distribution without safety measures. Many believe it is imprudent to wait until the effects of chemicals are demonstrated before governments exercise their regulatory authority. Prevention of harm requires an assessment of the potential risks to man and the environment before they are exposed to new chemicals. We can learn much about these risks from estimating techniques or existing data on familiar substances which are chemically similar to new ones. [12 ELR 15040] However, such secondary information often gives an incomplete or inaccurate picture. Where this is the case testing is essential to supply the necessary safety data.

Chemical testing policies must reconcile several conflicting goals. For the sake of health and environmental protection, the more testing, the better. At the same time testing takes time and can be very expensive. At some level, the costs of testing can destroy the incentive to develop potentially useful new chemicals. In addition, the more testing, the higher the price consumers must pay for products and the more government must spend to review the data produced. Finding a balance where the costs of testing are reasonable in light of the health and safety benefits it produces is the challenge facing policy makers in this field.

In searching for the right balance, several aspects of testing policy are of primary importance: (1) whether testing should be mandatory, (2) if so, what should be tested, (3) when required testing should be conducted, and (4) what types of tests should be mandated. A brief look at the general costs and benefits of the alternatives presented in each of these four sets of choices provides a framework for understanding the U.S. and EC testing programs and the OECD efforts to harmonize them.

With respect to whether to require testing, one must start from the premise that industry will test chemicals prior to marketing even in the absence of government action. The incentive for industry to do so is its need for data for production purposes and its concern for the quality of its products or, expressed in negative terms, the prospects of being held liable in case a product causes damage. Leaving the matter to industry saves government the cost of administering a regulatory program potentially affecting hundreds of chemicals yearly. On the other hand, one disadvantage of purely voluntary testing is that the data produced may not reach the public or the government, thus precluding them from taking protective action. This problem is easily corrected by requiring that chemical producers submit to the government any safety data they produce through voluntary testing.

More troublesome is the question of whether voluntary testing will produce enough information so as to effectively protect health and the environment. Experience strongly suggests that often it will not.²⁰ In addition, a voluntary testing policy does not ensure that uniform minimum standards are observed when testing is performed. The issue of voluntary versus mandatory testing is of importance in the OECD debate, because the U.S. relies essentially on voluntary basic testing, combined with mandatory submission of test data, while the EC has legislated mandatory basic testing and data submission.

The question of how comprehensive a testing requirement should be reflects the balance between public health protection and testing costs most clearly. Basically the alternatives are whether all chemicals or only those suspected of being harmful should be tested. From an economic viewpoint testing only suspect chemicals can have the advantage of allocating resources where they are most needed, i.e. where the potential risk is especially high. Unfortunately, however, in the absence of some basic data it often is not possible to determine whether a substance deserves further attention. Thus, there are strong arguments for applying a base set of tests such as those under the MPD approach to all substances, even though society must then bear the costs of testing numerous harmless chemicals and handling the masses of data produced.²¹ While the U.S. relies generally on a philosophy of case-by-case testing, the EC has adopted a comprehensive approach.

With respect to the question of when to require testing, there are several options. Testing can be done before a substance is manufactured, before it is marketing, after marketing has started, or at two or all three of these points in a chemical's life. On one hand, testing is more economical the later in the life of a substance it occurs, because research and development (R&D) expenses are paid off more quickly by revenues from sales of the product. Moreover, premarket testing is less costly than premanufacture testing, because many substances are manufactured, but never marketed.²² From an environmental and health point of view, however, it is desirable to know as much as possible about a substance as early as possible. For example, while the greatest exposure to chemicals comes after they are marketed, even limited manufacture exposes workers and creates wastes and chemical products that may pose environmental threats after disposal. Again, the U.S. and EC approaches differ. The former imposes its limited testing and general notification requirement before manufacture, while the latter requires compliance with its testing and notification mandate before marketing. Both, however, provide for follow-up testing at any stage in a chemical's life when evidence of a previously unsuspected risk comes to light.

The fourth general issue in testing policy is whether to specify the types of tests to be conducted whenever testing is required, or to leave this to the manufacturer. The range of testing, from simple and relatively quick acute toxicity tests to long and expensive chronic toxicity studies, is large. A legal determination of the types of tests will ensure both that a minimum standard of analysis and data will be met and that the data submitted will be uniform, thus facilitating the government's administrative [12 ELR 15041] job. On the other hand, the manufacturer might be better able to judge which tests to conduct, because it already has some basic knowledge about the substance. Moreover, if the government chooses to prescribe extensive basic testing, it must also address the question of exceptions from the general testing requirement for those substances which can be shown not to require such high standards. In order to cover risks such as chronic toxicity, teratogenicity, and oncogenicity, very complicated and costly tests are required.²³ The relatively small number of substances which, according to empirical evidence, can be expected to involve these risks,²⁴ might warrant a fairly broad exception for the most sophisticated testing. If, on the other hand, the standard of basic testing is relatively low, the authority to require follow-up predictive or confirmative testing at a later stage becomes more important. The U.S. has avoided this issue by not requiring general basic testing, while the EC combines both approaches, requiring moderate basic testing, but allowing certain exceptions, and saving certain rigorous analyses for case-by-case follow-up testing.

Testing Under TSCA

Legal provisions for regulating toxic substances (and thus, for chemical testing) were adopted in the U.S. in 1976 when the Toxic Substances Control Act (TSCA) was enacted.²⁵ TSCA § 2(b)(1) states that, as a general policy,

adequate data should be developed with respect to the effect of chemical substances and mixtures on health and the environment and that the development of such data should be the responsibility of those who manufacture and those who process such chemical substances and mixtures.²⁶

The testing provisions of TSCA distinguish between new²⁷ and existing²⁸ substances, basically in terms of whether manufacture has begun.There is no general requirement for basic testing under TSCA. Instead the manufacturer²⁹ of a new substance has to submit a premanufacture notification (PMN)³⁰ to the Environmental Protection Agency (EPA), containing certain basic, primarily descriptive, information and any health or environmental impact test data that are in the possession of the manufacturer.³¹ Thus, as to basic testing TSCA's approach is essentially voluntary.

Testing can be required in certain specified cases, however. A general condition mandated by TSCA is that environmental, economic, and social impacts are to be considered when a decision concerning testing is made.³² The testing of existing substances can be required by rule pursuant to § 4(a) for categories of substances whose chemical properties suggest they may be dangerous. Such a rule can be issued at any time after manufacturing has been started. Testing for new substances can be required under § 5(e)(1)(A), by means of an order before manufacturing has begun, or, under § 5(b)(1)(A), if the new substance belongs to a category of chemicals for which a rule pursuant to § 4(a) has been issued. All three testing provisions can be applied when the information available to the Administrator is insufficient for the purposes of a risk assessment, and there is the potential for either an unreasonable risk to health and the environment or the substance is being manufactured in substantial quantities.³³

In practice, TSCA's testing provisions have had very little use to date. In the last days of the Carter administration [12 ELR 15042] EPA proposed a rule³⁴ setting forth a comprehensive premanufacture testing policy which was based on the MPD approach of the OECD-Draft. Although this proposal did not impose any legal obligation upon chemical manufacturers, it would have had a significant de-facto effect if EPA had considered PMNs incomplete unless the MPD had been submitted with them.

The Reagan Administration rejected this somewhat aggressive interpretation of TSCA's testing provisions.³⁵ With respect to new substances it will generally rely on PMN data.³⁶ Where EPA deems testing necessary it will negotiate with manufacturers for the voluntary submission of data. Only where this proves unsuccessful will EPA order testing.³⁷

The control of existing chemicals has proven to be a difficult task for EPA as well. Since it would be economically unfeasible to systematically review all of the 55,000 substances presently on the U.S. market, § 4(e) of TSCA provides for an Interagency Testing Commission (ITC) whose duty it is to recommend a list of priority chemicals³⁸ for which the Administrator must consider the promulgation of testing rules. So far no such rules have been issued.

In addition, the use of TSCA's testing provisions is inhibited by the costs of enforcement, rulemaking, and risk assessment. Moreover, the statutory conditions under which testing can be required are not very practical. The Administrator has to determine first whether the information received in the PMN is "insufficient" for the purpose of assessing a possible risk before she can require testing.Yet the insufficiency of information could in many cases only be determined if the Administrator already had the testing data. This paradoxical situation can only partly be overcome through existing secondary information and estimation techniques.³⁹ One solution would be to interpret the relevant provisions to shift the burden of proof concerning the "sufficiency" of information in the PMN from the Administrator to the manufacturer, considering all information insufficient that does not clearly permit a reasoned evaluation of the substance's safety. This interpretation, however, would lead to a de facto testing requirement and has been officially rejected by EPA.⁴⁰

Testing Under the Sixth Amendment

In September 1979, the EC enacted the Sixth Amendment,⁴¹ which requires all member countries to establish national chemicals control legislation in compliance with the Amendment's provisions. Article 6(1) of the Sixth Amendment requires each manufacturer⁴² of a chemical substance⁴³ to file a premarketing notification (PMkN) at least 45 days before marketing the substance.⁴⁴ The PMkN must, among other things,⁴⁵ contain a technical dossier which supplies the authorities with "the information necessary for evaluating the foreseeable risks, whether immediate or delayed, which the substance may entail for man and the environment." It must, at a minimum, contain a base set of data specified in Annex VII of the Amendment.⁴⁶ The development of these data has to follow certain uniform test methods and standards, including GLP.

A manufacturer may be granted an exception to this basic testing requirement "[i]f it is not technically possible or if it does not appear necessary to give information …"⁴⁷ All deviations must be "justified," but the Sixth Amendment does not specify the character of the justification. It can be assumed that only those based upon technical and scientific rationales (as opposed to economic ones) will be accepted.⁴⁸ In case the manufacturer does [12 ELR 15043] not supply the required information or an appropriate justification for non-compliance, production or use restrictions may be imposed.⁴⁹

Besides the information required under the base set rule, additional information and/or verification tests may be required for a substance if several conditions are met. The statutory first conditions are that the level of production exceeds specified volumes, and the results of the assessment based upon the base set data submitted earlier suggest a possible hazard.⁵⁰ If the potential risk seems great, the production volume requirement can be waived. In this case the burden of proof that additional information is necessary shifts to the authority ordering the tests. Additional testing can consist of completion of the base set (in case an exception had been granted earlier) and/or of additional tests set forth in Annex VIII. As in the case of basic testing under Annex VII, there is an "escape clause" from additional tests⁵¹ which is identical to the one for basic testing. In order to enable the authorities to determine whether additional testing is necessary, a manufacturer is required under Article 6(4) of the Sixth Amendment to inform the authorities about significant changes in quantities marketed, new toxicity data, new uses for which the substance is marketed, or changes in properties resulting from a modification of the substance.

The OECD Testing Approach

On March 25, 1981, the OECD Council issued its draft decision on the adoption of the Minimum Premarketing Set of Data. The draft decision was based on the work of the Environment Committee's Chemicals Group and the Management Committee's Special Programme on the Control of Chemicals and initiated by the High Level Meeting of the Chemicals Group in May 1980. At its meeting in December 1980, the Environment Committee endorsed the proposal for action coming from the Chemicals Group and in May 1981, recommended the Draft to the Council for action.

Generally, the forum where the OECD takes such formal actions is the General Council, which directs the work of the Organisation. There the delegates of the member countries vote on the proposals developed by working groups and approved by the Committees. Council actions are either decisions or recommendations.⁵² The former are binding for the member countries (unless they abstain from the vote),⁵³ requiring them to enact or to amend national legislation accordingly. The latter, however, function merely as policy guidelines. The significance of a recommendation, although signalling a general endorsement of policy, is limited with respect to its potential to cause changes in national policies.⁵⁴ However, even decisions, if worded broadly enough, can allow members considerable flexibility. As in so many cases where public international law is involved, the legal character of the actions taken is less crucial for the response of nations than policy considerations underlying those legal actions.

The OECD Draft Decision (1981)⁵⁵

An analysis of the important issues concerning the Draft highlights its implications for national chemicals testing programs. The Draft would represent a significant step toward more comprehensiveness and intensive premarket screening of new chemical substances. It would also provide a basis for elimination of some significant differences in testing policies among OECD member countries.

The Draft consists of a Preamble, the decision to adopt the MPD ("Decision");⁵⁶ two internal policy orders to the Environment Committee ("Instructions"); an "Annex" setting forth the type of data required under the MPD approach; and finally, as part of the "Annex," provisions for flexible application of the basic testing requirement (Flexibility Clause").

The Preamble outlines the rationale for the efforts of the OECD to harmonize rules governing testing of new chemicals among its member countries. It furthermore stresses the close relationship between the different activities of the two OECD programs dealing with chemicals testing.⁵⁷ Basic testing under the MPD approach is intended to be an integral part of an overall testing concept.⁵⁸ The Preamble concludes with the general statement of a need for sufficient information to allow an initial hazard assessment.

The "Decision" itself would require all member countries to adopt a hazard assessment program for all new chemicals. In addition, the hazard assessment would have to develop the MPD. However, where the MPD data set or parts of it have already been generated in another country the testing would not have to be repeated. Thus, the Draft both calls for mandatory basic testing and specifies the data to be produced.

Establishing a mandatory hazard assessment program [12 ELR 15044] and requiring development of the MPD are not necessarily interconnected. Each has valuable independent functions. A hazard assesment can be undertaken based on data other than the MPD, and the MPD can be used in cases where a hazard assessment is merely optional or required only in individual cases. It is a key characteristic of the Draft, however, to combine these two elements in a single system.⁵⁹

While the "Decision" part of the Draft is fairly specific as to what testing should be done it does not specify which types of chemicals are covered and when a chemical is to be considered "new" for the purpose of testing. These critical determinations are left to the national legislatures.

The "Annex" to the Draft specifies the data to be included in the MPD. As a general rule all of these data have to be developed or obtained for each new chemical. However, the Draft acknowledges that without some provision for flexibility this would run counter to the policy in the Preamble concerning the effective and economic use of test resources. Therefore, the "Annex" includes the "Flexibility Clause," which reflects the fact that there are chemicals which demand less, more, or different testing than required under the MPD approach. Under this Clause a manufacturer may omit or substitute for some of the MPD if it gives a scientific justification including, in case of substitution, a demonstration of the equal or superior performance and predictive power of the alternative tests.

Another provision of the "Flexibility Clause" reflects the possibility that the hazard assessment based on the MPD may reveal the need for additional testing. It provides the national authorities with the option to require such testing either to complete the MPD (where originally some of the MPD had been omitted or substituted) or to supplement it if the whole MPD set had been developed but proved inadequate to assess all the potential risks. The latter option represents a follow-up program such as is to be developed by the Step-Systems Group of the Chemicals Programme. Additional testing may only be required on a case-by-case basis. In addition, the requirement of additional tests must be justified. As opposed to the provision to omit tests, which requires scientific justification, the provision for additions does not specify the nature of the necessary justification. Thus the "Flexibility Clause" would appear to give theauthorities more discretion in requiring additional testing than they have in passing on a request for omission of a test. It would, for example, allow consideration of both economic and scientific aspects of testing.

Apart from the question of its effect on national laws governing testing, the question arises whether the MPD approach in fact represents an appropriate balancing of health and environmental protection on the one hand and the economic benefit of efficient use of public and private money on the other.⁶⁰ In the U.S., one of the few countries with some experience is chemicals control (and thus, testing), the MPD has received an evaluation by administrators and scientists which — in general terms — has been positive. Industry, on the other hand, largely questions its value. EPA has routinely evaluated most of the properties listed in the MPD during premanufacture review.⁶¹ In those cases where EPA took informal action and testing was conducted, the data requested have typically been those included in the MPD.⁶² It should also be noted that some large chemical companies routinely develop much of the MPD during their R&D stage, suggesting further that the data set provides useful basic information. Yet in the vast majority of cases the MPD is not produced in premanufacturer testing in the U.S.⁶³ On the other hand, the MPD has limited value with respect to chronic effects, such as carcinogenicity, teratogenicity, and oncogenicity. It needs to be supplemented by professional judgment based on structure-activity relationships or additional testing where such effects are indicated. The cases, however, where EPA would have considered the MPD insufficient have been few so far.⁶⁴

The Impact of the Draft on U.S. and EC Law

Should the OECD Council issue a Decision implementing the Draft, member countries would have to bring their laws into compliance with its provisions. Where specific requirements of the Draft are more stringent or more lenient than national legislation, the latter would have to be adjusted accordingly. On subjects on which [12 ELR 15045] the Draft is silent or provides only general guidance, national legislation could stay unchanged.

The effect of the Draft would vary from country to country. The U.S. and the EC illustrate the potential difference in impact. While the system set forth by TSCA would have to undergo significant changes, chemicals testing under the Sixth Amendment would require little change. The following discussion is limited to the "Decision," "Annex," and "Flexibility Clause" since they contain the action-forcing elements of the Draft.

The Impact on TSCA

The major difference between TSCA and the Draft can be seen in the respective data and testing requirements of the PMN and MPD. TSCA is consistent with the Draft in terms of the types of substances it addresses and the way in which it defines "new" substances, largely because the Draft is so general in this respect. However, there are significant differences in what testing is required and when it is conducted.

Although data concerning identification, production, use, and disposal required by TSCA and the Draft overlap, TSCA's PMN does not comprise any of the data that form the heart of the MPD and that must be obtained through testing. Thus the question arises whether TSCA's case-by-case testing provisions satisfy the Draft's requirement for general basic testing. The answer ultimately determines whether TSCA would have to be amended.

EPA once took the position that basic testing could be implemented without an amendment of TSCA.⁶⁵ However, the U.S. agencies involved in negotiations with the OECD on chemicals testing now argue that amendments would be required. It appears that the law supports the current position. Section 26(c)(2)(A) provides that testing cannot be ordered on the basis of a rule which groups together chemicals just because they are new. Thus the only options under TSCA coming close to a general basic testing policy are to (1) establish basic testing as a voluntary policy,⁶⁶ or (2) systematically require testing in each individual case on the basis of § 5(e).⁶⁷ Both options, however, would not represent legally adequate solutions: the voluntary testing policy because it does not provide for enforcement in cases of non-compliance; the § 5(e) approach because it could only be implemented as an informal policy rather than on the basis of a rule (which would be incompatible with § 26(c)(2)(A)). It is questionable whether such an informal policy would comply with the OECD Draft's standards, which call for formal national rulemaking or legislative action. Therefore TSCA probably has to be amended to comply with the Draft.

Another difference between TSCA and the Draft is that the former calls for premanufacture notification while submission of the MPD is due prior to marketing. The legal implications of a premarketing testing requirement under TSCA are hypothetical since TSCA does not have a basic testing requirement. However, existing provisions of TSCA do allow for testing not just prior to manufacture but also (pursuant § 4(a)) prior to marketing. More central to the issue is the fact that a basic testing requirement attached to the current TSCA PMN rule would produce a heavy economic burden for U.S. companies because they would be required to test the large number of substances for which a PMN is filed but which subsequently are not marketed.⁶⁸ The waste of resources that would result under this approach has often been used as an argument against the adoption of OECD's MPD approach. It must be remembered, though, that implementation of basic testing under a TSCA amendment would not necessarily have to result in testing prior to manufacture. However, shifting the testing to the premarket stage would deprive EPA of data on many substances which still might find their way into the environment or affect workers at the manufacturing plant.

It is difficult to assess the Draft's compatibility with TSCA as far as the "Flexibility Clause" is concerned. TSCA does not allow for deviations once testing has been ordered and could therefore be considered more rigid than the Draft. To this extent, TSCA would have to be amended. Another incompatibility between TSCA and the Draft concerns additional testing: additional tests under TSCA can be required only under a § 4(a) rule specifying categories of substances to be tested. Additional testing under the Draft must be ordered case-by-case. On the other hand, TSCA's requirement to take economic and scientific factors into consideration when ordering additional testing is fully compatible with the Draft's broad requirement that additional testing must be "justified."

In summary, the Draft appears to require significant changes in TSCA's testing provisions. Sections 4 and 5 would have to be amended to require general basic testing for all new chemicals. The provisions of § 26(c)(2)(A) would have to be eliminated. Furthermore, the data to be developed under the general basic testing policy (i.e., the MPD) would have to be specified in a statutory provision. Finally, TSCA would have to include a provision allowing for deviations from basic testing requirements in cases where this would be scientifically justifiable and one limiting additional testing requirements to individual cases. In total, this would represent a fundamental change of the policies which TSCA embodies in its present form.

The Impact on the Sixth Amendment

A comparison between the Draft and the Sixth Amendment shows many basic similarities. They are found in the basic testing requirement, the required testing data specified in the Annex, and the adoption of a Flexibility Clause. In fact the OECD Draft would implement most of the EC program, reflecting the strong European influence on its drafting.

As far as the "Decision" part of the Draft is concerned, no amendments of the Sixth Amendment would be necessary. The failure of the Draft to specify the substances covered as well as to define the term "new" substance allows the Sixth Amendment to stay unchanged.

On the other hand, the OECD Draft is somewhat more demanding in terms of the testing required. A comparison [12 ELR 15046] of the MPD in the Annex of the Draft and the base set of data required under Annex VII of the Sixth Amendment shows that the former requires some physico-chemical data (hydrolysis; spectra; adsorption-desorption; dissociation constant; and particle size), ecotoxicity data (growth inhibition test on alga), and data concerning bioaccumulation that the latter does not. These additions, however, are of rather minor significance in relation to the total amount of data required.⁶⁹

The relationship between the Draft and the Sixth Amendment with regard to the substitution of tests is not completely obvious, since the Sixth Amendment does not provide for substitutions to be made. However, since the substitution of a test represents a smaller deviation from the testing requirement than its complete omission, an option provided for in the Sixth Amendment, authority to substitute tests may be implied. At most a simple technical amendment to the Sixth Amendment would be necessary to bring in into formal compliance with the Draft. Finally, the provisions for additional testing under the Sixth Amendment are fully compatible with the Draft as well. The Draft's language is broad enough to allow for the general specification of data in Annex VIII of the Sixth Amendment.

In summary, the OECD draft would require only limited changes in the EC's Sixth Amendment. The discrepancies between the two programs, which mainly concern the data required in Annex VII of the EC program, are quite minor in comparison to the substantial rewrite of TSCA that appears to be required.

The Alternative Proposal

Since June of this year, an informal draft proposal,⁷⁰ labelled an "OECD" proposal, but by its content revealing U.S. authorship, has circulated among members of the OECD groups dealing with chemicals testing. Although not on any official agenda, it seems to enjoy a favorable view from both the U.S. and most of the European member countries of the OECD.⁷¹ Therefore it is likely to be considered at the upcoming High Level Meeting of the Chemicals Group and might eventually even form the basis for a final OECD Decision.

The position of the U.S. with respect to the MPD approach has changed markedly during the last two years. While the U.S.originally had been the instigator of OECD actions aimed at the harmonization of chemicals regulation, its enthusiasm for the MPD approach has cooled considerably since the Reagan administration took office in January, 1981. This development follows the growing conviction on the part of the U.S. that compliance with the Draft would not be possible without amending TSCA, and that an amendment would run counter to U.S. interests. At present, EPA has no interest in such an amendment⁷² and is unlikely to change that point of view in the near future.

One option open to the U.S. Government in its efforts to avoid the consequences of OECD's adoption of the Draft would be to abstain from any such OECD decision. As a consequence, pursuant to Article 5(2) of the OECD Convention,⁷³ the decision would not be binding for the U.S. The U.S. could then continue its present chemicals testing policy under TSCA without violating the international convention to which it is a party. An abstention also would enable the U.S. to wait to see how the MPD approach works in other OECD member countries before making a final decision regarding amendment of TSCA. However, abstention could result in the political isolation of the U.S.

The second option available is to promote adoption of the MPD approach as a recommendation of the OECD Council rather than a decision. The U.S. would avoid isolating itself while at the same time it could maintain its present policies regarding chemicals control. However, this strategy is internally inconsistent, a fact recently acknowledged by a senior State Department official who reportedly stated that accepting legal language in a Council recommendation which the U.S. would not agree to in a decision would be hypocritical.⁷⁴

After several unsuccessful attempts to introduce into the discussion concerning the Draft an interpretive statement⁷⁵ aimed at maintaining the status quo in those countries which have already enacted chemicals control legislation, the U.S. apparently has finally decided to fall back on advocating the MPD approach in the form of a recommendation. The Proposal reflects this position, yet its language seems broader and more flexible than necessary to avoid amendment to TSCA. As a result it may unnecessarily forestall achievement of the U.S.-supported goal of harmonizing chemical testing. Following is a short examination of the Proposal and a comparison with the earlier Draft. The differences will be assessed with respect to whether they are warranted in view of the goal to avoid amendment of TSCA.

The basic structure of the Proposal resembles that of the Draft but the effect would be very different.The part concerning basic testing and the MPD approach is split into a "Decision" and a "Recommendation." In addition, the "Flexibility Clause" is different. It expressly states that national legislatures may determine what substances shall be covered. Also, it includes a general statement ofthe "Interpretive Clause" that "[d]ue regard may be given on a case-by-case basis to the scientific and economic factors that may influence the need for and the scope of testing." On the other hand, the Proposal retains the Draft's uncertainty as to its exact scope. It does not specify the chemicals covered nor does it define "new" substances.

Unlike the Draft, the Proposal entirely fails to specify when tests must be performed. Its "Decision" acknowledges the need for "meaningful assessment" of the hazards to man and the environment that may be posed [12 ELR 15047] by new chemical substances. Thus the Proposal implies, independent of the question of the scope of the assessment procedure, that such an assessment must generally take place. Yet the "Decision" goes on to say that in order to ensure such a meaningful assessment, "sufficient information should be available …." (Emphasis added.) This formulation, substituting for the specific MPD requirement of the Draft, is so vague as to defeat the purpose of harmonizing chemical testing. As has already been pointed out in connection with TSCA's testing requirements,⁷⁶ it is not possible to make a meaningful assessment of chemical hazards if basic information concerning a new chemical is lacking. Since the Proposal adopts the ambiguous language found in TSCA it can hardly be expected to promote the "meaningful assessment" that it calls for. In light of the "Interpretive Clause," according to which the scope and extent of testing have to take economic factors into consideration — thus providing industry with a safeguard against overly broad data requirements — the vagueness of the formulation seems even less justified.

The "Interpretive Clause" also clarifies that the need for testing shall be determined solely on a case-by-case basis, i.e., not as a general policy. Thus, basic testing as it is treated in the Draft is effectively barred. On its face, however, this provision seems to prohibit existing policies such as TSCA's testing requirement for categories of substances pursuant to a rule issued under §§ 4(a) and 5(b)(1)(A) as well as existing general testing requirements such as Article 6(1) of the Sixth Amendment. It is unlikely that the authors of the Proposal had intended to go that far, but a revision of the section may be the only way to correct that impression.

In its "Recommendation," which addresses what tests should be performed if any are required by national legislation, the Proposal recommends that the MPD, in connection with the approach set forth in the "Flexibility Clause," "can serve as a basis" for the hazard assessment.⁷⁷ The Proposal thus suggests that the MPD is only one of many data sets that can serve the assessment purpose.

The Proposal's failure to require compilation of the MPD in those cases where testing is required by national law is clearly not mandated by any need for compliance with TSCA. That Act does not prohibit a generalized specification of testing data for those chemicals for which testing is required.⁷⁸ In fact the U.S. issued an interpretive statement prior to the Proposal in which it had called for the application of the MPD in all cases where under national laws, testing was required.⁷⁹ The choice of a loose recommendation for the MPD approach appears to be even less justified in view of the "Flexibility Clause," which allows for deviations (i.e., omission of tests listed in the MPD) from the general requirement. Finally, the additional cautioning "can serve" not only appears to be unwarranted by TSCA (for the same reasons as the use of a recommendation), it also deprives the MPD of its role as the preferred base set of data and thus strips it of its significance.

The "Flexibility Clause" of the Proposal differs substantially from that of the Draft with regard to the conditions under which a manufacturer can omit tests listed in the MPD. Since the Proposal's "Interpretive Clause" demands consideration not only of scientific but also of economic factors when a determination of the scope of testing is being made, it would not be sufficient under the Proposal to allow for deviations from the MPD solely based on scientific grounds as provided for in the Draft. However, this difference appears necessary to make the Proposal consistent with § 2(c) of TSCA.

As far as additional testing is concerned, the Proposal states that "certain tests can be asked for in a later stage of initial assessment." This language is more general than the equivalent passage of the Draft — "information beyond MPD." Also, the Proposal states that additional testing should be required only in the "stage of initial assessment." If taken literally, this would exclude a step-sequence testing policy as it is being developed by the Chemicals Group. Passages in the Proposal's Recommendation, however, indicate that its authors did not intend to abandon SST. Instead it is more likely that they merely wanted to point out that the scope of the Proposal is limited to basic testing (as opposed to advanced tests at a later stage). If so, an additional clarification would be desirable.

Conclusion

Officially, no conclusion has been reached with regard to basic testing and the MPD approach. Yet no matter what the language of a final Council decision or recommendation will be, this much seems certain: it will be broad enough to permit OECD member countries (notably the U.S. and EC countries) to continue their present chemical control laws unchanged. There will not be a general basic testing requirement as included in the Draft. Final OECD action is likely to resemble the Proposal more than the Draft, especially since a certain consensus seems already to have been reached informally with regard to the Proposal.

The implications of a failure to adopt the MPD approach as a means to the harmonization goals set forth in the Preambles of the Draft and Proposal are several. First,trade barriers from different national testing standards will continue to exist. If it turns out that countries with basic testing requirements, such as the EC member countries, produce chemicals at overall higher costs, they might be less competitive unless their products are recognized as qualitatively superior to those substances less intensely tested. Second, those countries which have stricter testing standards and thus develop more data on the characteristics of chemicals will be at a disadvantage under [12 ELR 15048] any international data exchange system (such as the one planned in the MAD approach). Eventually, some kind of financial compensation system would be needed to remedy this inequity. Third, the goal of reduction of health and environmental risks caused by chemicals probably will be served less, because fewer comprehensive hazard assessments will be performed. Finally, since the MPD is a central part of a coherent broader program, other elements of the OECD approach such as MAD, SST, GLP, testing guidelines, etc. will be stripped of much of their significance. Efforts to standardize information concerning toxic substances on an international scale and to assure that all major chemical producing countries adhere to minimum data and testing standards will be hampered by a failure to adopt the MPD approach.

The OECD might do several things to dampen the discordant effects of its likely decision not to adopt the Draft. Taking into consideration that any current OECD action on chemical testing must not force national legislatures to change existing laws, it would make good sense for the OECD to avoid unnecessary vagueness in whatever action it takes in order to maintain the authority and credibility of the Organisation's work. Concretely, the OECD action should stress the fact that the development of sufficient information is a key prerequisite for any meaningful hazard assessment. Failure to acknowledge this would be equivalent toi defeating the purpose of the chemicals regulation. In addition the OECD should make the application of the MPD in connection with the "Flexibility Clause" as set forth by the Proposal mandatory whenever testing is required by national laws. This would recognize the utility of the MPD, independent of a basic testing requirement, as an approach to help harmonize the standards of information on chemicals. And it would not require an amendment to TSCA. Finally, the OECD should make concrete determinations with regard to the scope of substances covered by its action. In addition, it should define "new substance." Unless the substances covered are clearly specified, some member countries, for example the U.S., can control the scope of their testing program through mere administrative rulemaking.

Even if the OECD should fail to implement the MPD approach on a mandatory basis, changes among the national chemical testing laws of the OECD member countries may occur in the long run as a result of political and economic pressures. Experience with the approach chosen under the Sixth Amendment, which strongly resembles the MPD approach of the Draft, may provide an incentive for other OECD member countries to adopt the MPD at a later time. In the meantime, however, even though its application is merely recommended, the MPD might set de facto standards for chemical testing in all OECD member countries. Thus it can serve as a guideline as to whether the hazards of a chemical have been assessed properly (e.g., in the determination of negligence in product liability suits). Under these circumstances it could serve the purpose that one author may have had in mind when he stated that "[i]t would seem wiser to recognize that non-binding agreements may be attainable when binding treaties are not and to seek to reinforce their moral and political committments when they serve ends we value."⁸⁰

1. The OECD was set up under a Convention on December 14, 1960, basically providing for the promotion of the qualitative and quantitative economic growth of its member countries, and of world trade in general.

2. This term is commonly defined as "something more than coordination but less than standardization." Gillespie, OECD Harmonization of Chemicals Control, 3 TOXIC SUBSTANCES J. 336, 338 (1982).

3. At present, the member countries are: Australia, Austria, Belgium, Canada, Denmark, Finland, France, West Germany, Greece, Iceland, Ireland, Italy, Japan, Luxembourg, the Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, Turkey, the United Kingdom (UK) and the United States (U.S.). Yugoslavia enjoys a special status.

4. Until now, a total of 10 member countries have enacted chemicals control legislation and at least three more have drafted such legislation. Among the most important chemicals producers are: Switzerland (Federal Law on Trade in Toxic Substances (soon to be substituted by the Federal Law on Environment Protection) (1969), [1972] RECUEIL OFFICIEL DES LOIS ET ORDONNANCES DE LA CONFEDERATION SUISSE [ROLF] 435); Japan (Law Concerning the Examination and Regulation of Manufacture, etc., of Chemical Substances (Law No. 117 of 1973), reprinted in INT'L ENV'T REP. (BNA), Reference File 2, 91:6401-26); Canada (Environmental Contaminants Act, 1974-75-76, II Can. Stat. ch. 72, at 1427 (1975), reprinted in INT'L ENV'T REP. (BNA), Reference File I, 51:2501-04); United States (Toxic Substances Control Act, 15 U.S.C. §§ 2601-29, ELR STAT. & REG. 41335); West Germany (Act on the Protection Against Dangerous Substances (Chemicals Act), Federal Gazette I [BGB1I], 1718 et seq. (Sept. 16, 1980), reprinted in INT'L ENV'T REP. (BNA), Reference File 3,241:4101-08).

5. Directive Amending for the Sixth Time the Directive (67/548/EEC) Concerning the Classification, Packaging and Labelling of Dangerous Substances (79/831/EEC), 22 O.J. Eur. Comm. (No. L 259) 10 (1979), reprinted in INTL ENV'T REP. (BNA) Reference File 2, 161:0221-0239 [hereinafter cited as Sixth Amendment]. A directive mandates the enactment of legislation in the member countries which must be in compliance with the provisions set forth in the directive.

6. EC law is often distinguished from other international law because in some specifically determined fields it substitutes for national legislation of the member countries. To this extent, the (legislative) sovereignty of the member countries has been delegated to the legislative body of the EC, i.e., the EC Council.

7. The EC member countries are: Belgium, Denmark, France, West Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, and the U.K.

8. In addition to the activities of the OECD and the EC in this respect, the harmonization of chemicals regulation has been the subject of interest of, among others, the International Agency for Research on Cancer, the International Register of Potentially Toxic Chemicals, and the United Nations Environment Programme (UNEP), and of meetings between the U.S. and Japan and the U.S. and the EC (1979-80). On an intercontinental basis, however, the OECD efforts have retained the most importance. For a more detailed discussion see Alston, International Regulation of Toxic Chemicals, 7 ECOLOGY L.Q. 397, 409 (1978).

9. Earlier efforts to cope with non-tariff trade barriers led to the General Agreement on Tariffs and Trade (GATT) to which most important chemicals producers are signatories. A special clause in the GATT-treaty, however, allows for deviations from the free trade requirements where necessary for the sake of national health, safety, and environmental protection. Such barriers are considered unlawful under the treaty only where they are used in a discriminatory manner. It is the existence of these "backdoor" provisions that has left a considerable potential for non-tariff trade barriers and thus created a need for harmonization efforts.

10. The "Special Programme" was established by OECD Decision (C(78)127 (Final)) following a 1978 meeting of 16 OECD member countries and six international organizations, on "The Control of Chemicals with Special Regard to Environmental Chemicals." This meeting prompted a considerable acceleration of the OECD's efforts with respect to chemicals regulation.

11. Established in OECD Council Recommendation (C(74)215).

12. Established in OECD Council Recommendation (C(78)127 (Final)).

13. The principle of Mutual Acceptance of Data was established in OECD Council Decision (C(78)127 (Final)). According to this decision, "data generated in one country in accordance with approved Test Guidelines and Principles of Good Laboratory Practice [are] accepted in another country as appropriate for assessment purposes and other uses relating to protection of man and the environment."

14. The Step-Systems-Group, established in 1977, addresses the following issues: (1) further definition of the base set of data, (2) studying existing and planned step-sequence testing systems; and, (3) determination of the types of step-sequence testing systems needed in different circumstances.

15. According to the official definition, the term "MPD" is "the minimum information which, as a rule, should be provided to allow an initial assessment of a new chemical before a decision is taken to put it on the market." Proposed Council Action on Chemicals, OECD Environment Committee paper (ENV.(80)31) 13 (1980).

16. "Basic testing" is the procedure that leads to the development of a base set of data, such as the MPD.

17. See, e.g., Comment, Control of Toxic Substances: The Attempt to Harmonize the Notification Requirements of the U.S. Toxic Substances Control Act and the European Community Sixth Amendment, 20 VA. J. INT'L L. 417 (1980). BILES, DIFFERENT SONGS AND DIFFERENT SINGERS: HARMONIZING THE REGULATION OF NEW CHEMICALS, paper presented to the Symposium on TSCA Impacts on Society and the Chemical Industry, American Chemical Society 183d National Meeting, Las Vegas, Nevada, April 1, 1982; copy on file in the offices of the ENVIRONMENTAL LAW REPORTER.

18. OECD Draft Decision (C(81)31) [hereinafter cited as Draft]. For the full text, see 1981 INT'L ENV'T REP. (BNA) 856-7.

19. Informal Proposal for Revision of the MPD Text (June 9, 1982) [hereinafter cited as Proposal]; copy on file in the offices of the ENVIRONMENTAL LAW REPORTER.

20. See, e.g., Borel v. Fibreboard Paper Products Corp., 493 F.2d 1076, 4 ELR 20133 (5th Cir. 1973) (liability for failure to warn of hazards associated with asbestos).The Borel court specifically noted that "a manufacturer has a duty to test and inspect his product." 493 F.2d at 1090 (footnote omitted). See also Sindell v. Abbott Laboratories, 26 Cal. 3d 588, 607 P.2d 92, cert. denied, 449 U.S. 912 (1980) (imposing "market share" liability for negligent manufacture of drug). The Sindell court indicated that the manufacturers of the drug "failed to test" it "for efficacy and safety." 607 P.2d at 926.

21. For the agency, these costs could partly be offset by savings from routinizing the administrative process. Also, the agency could seek at least partial reimbursement of its assessment expenses from industry. Industry, on the other hand, might often not be able to recover its testing costs through the revenues from marketing the substance. In 1980, 50 percent of the chemicals marketed in the U.S. had annual sales of $50,000 or less, and 85 percent had annual sales of less than $100,000 (De Reeder, Harmonization of Chemical Control Laws, 2 TOXIC SUBSTANCES J. 175, 184 (1981), while testing can cost far more than that (see infra note 23).

22. In the U.S., only about 25-30 percent of all substances for which a premanufacture notification is filed are eventually marketed. Interview with George W. Ingle, Director, Association Liaison, Chemical Manufacturers Association, Washington, D.C. (August 15, 1982) [hereinafter cited as Ingle interview].

23. The costs of such tests range between $300,000 and $700,000.44 Fed. Reg. 16240, 16250 (1979).

24. Of approximately 7,000 substances tested worldwide, about 1,500 (i.e., 20 percent) have been reported to be carcinogenic. Maugh, Chemical Carcinogens: The Scientific Basis for Regulation, 201 SCIENCE 1200 (1978).

25. 15 U.S.C. § 2601 et seq., ELR STAT. & REG. 41335. TSCA does not cover substances which are subject to other specific laws (i.e., drugs, pesticides, nuclear materials). Section 3(2)(B), 15 U.S.C. § 2602(2)(B), ELR STAT. & REG. 41336.

26. 15 U.S.C. § 2601(b)(1), ELR STAT. & REG. 41335. In addition, § 5(b)(2) states that manufacturers must submit data to the Administrator that show that no unreasonable risk to health or the environment exists in the case of those substances which the Administrator has determined by means of a rule issued pursuant to § 5(b)(4) bear the potential of such a risk.

27. A new substance is defined as any substance "which is not included in the chemical substance list ['Inventory'] compiled and published under § 8(b)," TSCA § 3(9), 15 U.S.C. § 2602(9), ELR STAT. & REG. 41336); "new substances" with respect to the legal requirements under TSCA also are those substances that fall under the "Significant New Use Rules (SNURs)" set forth under § 5(a)(2), 15 U.S.C. § 2604(a))2), ELR STAT. & REG. 41338. These rules are issued by the Administrator in case there is a significant change in either production volume or exposure to the human population or the environment.

28. From the definition of the term "new substance" (see supra note 27) follows that existing substances include both substances which have been listed in the "Inventory" after going through the premarketing notification procedure, and those substances for which marketing had begun prior to enactment of TSCA. Testing of the latter type of substances, sometimes termed "old substances," is excluded from discussion in this paper.

29. This includes the importer of a substance, TSCA § 3(7), 15 U.S.C. § 2602(7), ELR STAT. & REG. 41336.

30. TSCA § 5(a)(1), 15 U.S.C. § 2604(a)(1), ELR STAT. & REG. 41338. All substances which are equivalent to substances for which a PMN had been filed earlier, and substances used in small quantities for experimental or research purposes (§ 5(h)(3)) or test marketing purposes (§ 5(h)(1)) are exempt from this requirement. Furthermore, according to a proposed EPA rule certain polymeres, polyesters, site-limited intermediates, and low volume chemicals would be exempt from the PMN requirement; instead merely an informal notice would be required by EPA. EPA ENVIRONMENTAL NEWS (July 28, 1982). For a full text of the proposed policy, see 47 Fed. Reg. 33924 et seq. (Aug. 4, 1982). The exemption of low-volume chemicals reflects the fact that 30 percent of the chemicals marketed in the U.S. have an annual production of less than half a ton. De Reeder, supra note 20, at 183.

31. TSCA § 5(d), 15 U.S.C. § 2604(d), ELR STAT. & REG. 41339. In detail, the PMN shall include (1) data listed in § 8(a)(2), such as name, chemical identity, categories of use, amount to be produced, description of byproducts, number of individuals to be exposed, manner or method of disposal and (2) any test data in the possession or control of the person submitting the PMN, which are related to the effects of the substance on health or the environment from the manufacture and use, or a description of other data relating to effects on the environment or health.

32. TSCA § 2(c), 15 U.S.C. § 2601(c), ELR STAT. & REG. 41336.

33. Of lesser importance are the provisions of §§ 5(h)(4) and 5(f). According to the former, testing can be required by rule prior to manufacture if the manufacturer seeks an exemption from part or all of § 5, and according to the latter, testing can be ordered for monitoring purposes.

34. 46 Fed. Reg. 8986 (1981).

35. COUNCIL ON ENVIRONMENTAL QUALITY, 12TH ANNUAL REPORT at 120-1 (1981).

36. See S. GUSMAN, IMPLEMENTING THE U.S. TOXIC SUBSTANCES CONTROL ACT: AN INTERIM REPORT 9 (1982). This PMN-review policy reportedly addresses an "extremely narrow segment" of the possible risks which are represented by chemical substances.

37. Out of 1,650 premanufacture notifications filed with EPA since the passage of TSCA, testing has been formally ordered in only nine cases in which there had been reason to believe that carcinogenic risks were involved. In another 80 cases or so, testing has been done following informal negotiations between EPA and industry. Ingle interview, supra note 22.

38. The list must not contain more than 50 chemicals at a time and is revised every six months. Upon receiving the list the Administrator is required to either promulgate a testing rule or state reasons why she decided not to do so. With regard to its authority to promulgate testing rules, however, EPA is not constrained by the substances set forth in the ITC list.

39. In many cases estimation techniques are inaccurate and thus unreliable, especially where many different properties have to be estimated, thus leading to an accumulation of uncertainty. The lack of test data concerning acute toxicity has seriously impeded the assessment of many chemicals. U.S. ENVIRONMENTAL PROTECTION AGENCY, CHEMICAL CONTROL DIVISION, PERSPECTIVES ON THE MPD DRAWN FROM EXPERIENCE IN PMN REVIEW 4 (1982) [hereinafter cited as EPA MEMO].

40. 46 Fed. Reg. 8989 (1981).

41. Supra note 5.

42. This term includes importers. Sixth Amendment, art. 2(1)(b).

43. The term "chemical substance" in this context excludes drugs, foodstuff, and radioactive substances. Sixth Amendment, art. 1(2). Also, for economic reasons there are some exemptions from the basic testing requirement for all polymerizates, polycondensates, and polyadducts (except for those containing in combined form 2 percent or more of an unmarketed monomer) and substances placed on the market in quantities less than one (metric) ton per year and manufacturer. Sixth Amendment, art. 8(1). Site-limited substances are effectively exempted, since the submission of a notification to the authorities is due only when a substance is placed on the market and made available to third parties. There is no provision for further exemptions in the Sixth Amendment.

44. Under the Sixth Amendment each substance marketed by a manufacturer for the first time is "new"; thus, a PMkN is due even in those cases where an identical substance had previously been marketed by another manufacturer.

45. Other items to be included in the PMkN are: a declaration concerning the unfavorable effects of the substance with regard to its use; the proposed classification and labelling; and proposals for any recommended precautions concerning the safe use of the substance.

46. These are: the identity of the substance and methods of its detection; the proposed use; estimated production levels; recommended handling methods; physico-chemical properties; toxicological data (acute and subacute toxicity, mutagenicity, and carcinogenic screening); ecotoxicological data; and information on how to render the substance harmless.

47. Sixth Amendment, Introduction to Annex VII.

48. The West German Chemicals Act, supra note 4, drafted after the enactment of the EC Sixth Amendment, provides, in § 7(2), that adherence to the base set is not necessary "where the testing of a substance is not technically possible or where it appears to be unnecessary in view of the present state-of-the-art of scientific knowledge." Ultimately, of course, technical possibilities are partly determined by economic factors as well. The requirement of a technical (as opposed to an economic) justification, however, rules out the application of a justification based on standard cost-benefit analyses.

49. Sixth Amendment, Art. 23.

50. Sixth Amendment, Art. 7(1), in connection with Annex VIII.

51. Sixth Amendment, Introduction to Annex VIII.

52. OECD Convention, Art. 5.

53. OECD Convention, Art. 6(2).

54. Von Moltke, National Implementation of European International Agreements Regarding New Chemical Substances, 1982 A.B.A. ENVT'L L. SYMP. 17, 24.

55. See supra note 18.

56. This term refers to the section of the Draft which is marked "Decision." This term, as well as the others, referring to sections of the Draft, are used for purposes of identification since the Draft itself does not provide formal designations for these sections.

57. See supra, text accompanying notes 10-13.

58. Test guidelines and laboratory practice standards are designed to guarantee certain minimum standards. Only if these standards are obeyed must the authorities of a member country accept test data developed in another member country and submitted to it. The whole concept is thus based on the hypothesis that tests are being conducted. In the absence of a general testing requirement the efforts inhereint in developing and enforcing this concept would be largely moot. The same is true with regard to follow-up tests under the SST approach which presuppose that some basic testing has already been conducted.

59. This connection results in the terms "MPD" and "basic testing requirement" being used interchangeably in the context of the OECD Draft.

60. The costs for developing the MPD have been estimated by OECD sources to range between $32,000 and $61,000. 46 Fed. Reg. 8989-92 (1981). Industry sources estimate the costs to range between $50,000 and $100,000. Letter from Edmund B. Frost, Vice President, Chemicals Manufacturer Association (CMA) to James Malone, Assistant Secretary, Dept. of State (April 2, 1981). It has to be noted that overall costs under the MPD approach may differ in different countries, basically depending on the extent to which national legislation requires different standards of testing within the framework set by the OECD Draft. Among the main variables are differences in the definition of a "new chemical" and in the point in the chemical's life at which testing is required. For example comparing TSCA and the Sixth Amendment: (1) the Sixth Amendment has a broader definition of "new" than TSCA because even identical substances are new whenever they are marketed by a new manufacturer and (2) the Sixth Amendment would require testing of only about 20 percent of the substances subject to testing under TSCA, because of differences in the substances covered and the fact that TSCA requires testing at an earlier stage (if one assumes that basic testing under TSCA would take place at the same time the PMN is to be submitted under the present provisions, i.e., prior to manufacturing). CMA International Affairs Group, Position Paper on MPD for Discussion at April 14-16, 1982, International Affairs Group/Japanese Chemical Industry Association Meeting, Tokyo/Japan. Of course, the difference in coverage could be substantially eliminated by shifting to premarket testing under TSCA. In this case only about 25-30 Percent of the substances now falling under the PMN requirement would have to be tested. Supra note 22. This figure would even further decrease under the proposed EPA rule (47 Fed. Reg. 33924 et seq. (1982)) exempting certain substances from PMN and thus practically from testing.

61. EPA MEMO, supra note 39, at 3.

62. Id. at 7.

63. Small companies cannot afford extensive testing most of the time. Provisions exempting chemicals produced in small quantities can help to mitigate, but cannot be expected to completely eliminate, the burden imposed on small companies by a basic testing requirement.

64. Those are basically the cases where EPA ordered testing because of carcinogenic risks.EPA MEMO, supra note 39, at 5.

65. Former EPA Administrator Douglas Costle and former Assistant Administrator Steven D. Jellinek. 1981 INT'L ENV'T REP. (BNA) 1112.

66. This policy had been proposed by EPA under the Carter Administration. 46 Fed. Reg. 8986 et seq. (1981).

67. See supra note 40 and accompanying test.

68. See supra note 22 and accompanying test.

69. The average additional costs per test would amount to about $5,000 to $6,200 according to OECD-estimates. 46 Fed. Reg. 8989 et seq. (1981).

70. See supra note 19.

71. Officially, however, no agreement has been reached on the issue as yet. 1982 INT'L ENV'T REP. (BNA) 309.

72. Interview with Irwin L. Fuller, Jr., Office of Pesticides and Toxic Substances, EPA (August 12, 1982).

73. See supra note 1.

74. Remarks of Robert D. Hormats, Assistant Secretary of State-Designate, at a CMA seminar in Washington, D.C., on May 1, 1981. 1981 INT'L ENV'T REP. (BNA) 823.

75. There have been at least three such proposals, all of which have been rejected by representatives from other OECD-member countries.

76. See supra note 39 and accompanying text.

77. This language has been rejected by other representatives of OECD member countries, which instead proposed the wording "shall serve as a basis," 1982 INT'L ENV'T REP. (BNA) 309 (emphasis added). Support for a subsequent compromise ("serves as a basis") seems to have been of short duration.

78. In this context it is appropriate to once again stress the need to distinguish between the question whether testing should be done at all and the question which tests should be conducted. The "Recommendation" of the Proposal refers only to the latter question.

79. For the full text of this interpretive statement, see 1982 INT'L ENV'T REP. (BNA) 5-6. The language of the interpretive statement, however, was termed "ambiguous" by U.S. officials shortly after it was drafted.Id.

80. Schachter, The Twilight Existence of Nonbinding International Agreements, 71 AM. J. INT'L L. 296, 304 (1977).