Sixth Amendment

Where necessary the manufacturer must carry out, or arrange for, safety testing. Many countries operate mandatory premanufacturing and premarketing notification schemes of which safety testing is the cornerstone. Within the European Community under Directive 67/548/EEC and its sixth amendment 79/831/EEC, Competent Authorities must be... 

REGULATION OF NEW SUBSTANCES UNDER TSCA AND THE SIXTH AMENDMENT... 

Articles 5-8 and Annexes VII and VIII in the Sixth Amendment ) contain the key provisions of the EEC s premarket notification program. Articles 2, 9-13, and 20-23 also are particularly relevant. 

Persons and Activities Covered. TSCA 5 creates a premanufacture notification program, whereas the Sixth Amendment requires the submittal of premarket notifications. Thus, U.S. PMN s must be submitted no later than 90 days prior to the completion of R D activities, unless EPA grants permission to produce limited amounts for test marketing purposes. In contrast, companies in... 

The Sixth Amendment s premarket notification requirements differ markedly from TSCA in three important respects. First, new substances in the EEC always will be considered "new" under the Sixth Amendment, because the notification requirements are person-specific — i.e. when one company submits a PMN for a particular substance, this does not relieve any other company from the requirement to submit its own PMN before that second company may place the same substance on the EEC market.(J3) Second, the Directive includes a scheme for regular follow-up reporting on the commercial development of new substances, with progressively more extensive (and expensive) testing requirements. Finally, the Sixth Amendment creates a one-time notification for each company (for each new substance), throughout the EEC. Thus, once a Member State has completed its review of a company s PMN (without taking any action to require further testing or to impose limitations upon production or use), that company is not required to provide a PMN to any other EEC country in which it subsequently markets the substance.(9)... 

In addition to these general exclusions, neither TSCA nor the Sixth Amendment require PMN s for new mixtures or preparations, which generally are defined as combinations of substances that do not result from chemical reactions. However, both laws effectively require PMN s for the marketing of new mixtures that are new (in part) because they contain new substances.(11)... 

Because the Sixth Amendment itself exempts most of the chemicals that are subject to EPA s current rulemaking, In general the Commission does not need to commence any exemption activities analogous to EPA s efforts. Thus, the EEC s premarket program covers only those new polymers that contain 2% or more of a monomer(s). (Any new monomer iis subject to the notification requirements.) Further, because PMN s must be submitted only for new substances that are "placed on the [Community] market," the EEC s PMN requirements generally do not apply to the manufacture and use of intermediates (or of any other new substances, for that matter) by one company at one site.(13)... 

Likewise, the Sixth Amendment differs substantially from TSCA in its exemption for "substances placed on the market in quantities of less than one tonne per year per manufacturer." Art. 

Neither TSCA nor the Sixth Amendment exclude or exempt substances from the PMN requirements just because they are produced by small companies. However, many of the exemptions presently being considered by EPA, and several of those contained in the Sixth Amendment, mitigate the burdens that the PMN programs otherwise impose upon small companies. This is particularly true for exemptions based upon production or marketing volume. 

In contrast, as a Directive by the EEC Council to the Member States, the Sixth Amendment is not self-implementing, and it is not directly enforceable against individual companies. Rather, each EEC country must implement its own premarket notification laws, regulations, and administrative provisions. These must be consistent with the overall framework of the Sixth Amendment, and they must not create the types of conflicts or intra-EEC barriers that the Directive was intended to prevent in the first place. Nonetheless, they may be different from one another, to reflect local policies and approaches to specific regulatory matters. 

Both the Sixth Amendment and several national premarket laws and regulations authorize individual Member States to (1) contest companies claims that certain data (in the Annex VII base set) are not necessary or are not technologically possible (2) to require the development of additional information and data and (3) to impose production or use restrictions pending the development of such additional data. Further, EEC countries may act without having to follow many of the procedures that TSCA imposes upon EPA, and the findings necessary to take these actions appear to be less stringent than TSCA requires of the Agency. 

The Sixth Amendment does not elaborate upon either the substantive or procedural aspects of this authority. Rather, it simply states that if a country can justify the need for the data (in terms of risk assessment), it may ask for the additional... 

Article 6(1) of the Sixth Amendment requires PMN s to contain information and data necessary for evaluating the potential risks of new substances to humans and the environment. This specifically includes certain exposure information listed in Annex VII, concerning proposed uses and estimated yearly production volumes (in ranges, and broken down by use categories). Further, Article 6(1) requires submission of "a declaration concerning the unfavourable effects of the substance in terms of the various uses envisaged," which appears to require statements of the risks that may be associated with the use categories provided under Annex VII.(26)... 

Followup Reporting and Testing Under the Sixth Amendment. Followup reporting and testing are integral parts of the Sixth Amendment s premarket notification scheme. The Directive itself... 

TSCA and the Sixth Amendment are quite different in many important respects, and it would require some fundamental changes to standardize them or even make them consistent. However, because they deal in part with the same general subject matter — Industry notification and government review of new chemicals — and because they may lead to trade barriers and the inefficient use of scarce technical and scientific resources, it is useful to consider how they might be brought closer in line with one another. "Harmonization" is a term commonly applied to such efforts. 

First, to the extent that TSCA and the Sixth Amendment do not have the same general scope and coverage, this necessarily will mean that companies in some cases will face regulation of their (new) chemicals and commercial activities in one country(ies), but not in another, and vice versa. Almost by definition, this will create certain artificial competitive advantages and disadvantages for companies, depending upon at which end they lie in the trade of those particular chemicals. 

Through the end of 1983, it is unlikely that there will be any major new developments resulting in the harmonization of TSCA and the Sixth Amendment — either from multilateral agreements as such, or from parallel developments in the implementation of the two laws. This stems primarily from the EEC s focus upon intial implementation of its own requirements, and from recent changes in the U.S. s approach to OECD and other multilateral discussions. 

Based upon discussions conducted directly between the U.S. and the EEC (as well as bilateral talks involving Canada and, possibly, Japan), some "harmonization" may be reached concerning "base set" testing of new substances and fundamental criteria for evaluating PMN s. These will not, however, be reflected in any major treaties or conventions, or through discussions within the OECD. Rather, TSCA and the Sixth Amendment will continue to develop in parallel, and the U.S. and the EEC may reach accord on some very basic regulatory matters. 

L 259/10 of October 15, 1979). This Directive is referred to as the "Sixth Amendment" because it represents the sixth time that the Council has amended Council Directive No. 67/548 of June 27, 1967 (O.J. No. L 196/1 of August 16, 1967) concerning Classification, Packaging and Labelling of Dangerous Substances. 

Article 8(1) of the Sixth Amendment specifies three different types of exemptions for R D substances. The third appears to be analogous to the TSCA 5(h)(1) exemption for test marketing activities. 

It is important to note the meaning of two terms used in connection with TSCA and the Sixth Amendment, because they often have different interpretations under the two laws. "Hazard" generally is used in the Sixth Amendment (and in other EEC directives) to mean what U.S. scientists and regulators often call "risk" — i.e. an assessment or evaluation that considers both the effects and exposures that are associated with particular substances. In this country, the term "hazard" usually refers to the inherent toxicity or effects of a substance, or to the unsafe characteristics of particular chemicals or products. The latter meaning is the one used... 

EINECS European Inventory of Existing Commercial Chemical Substances. This is the inventory of existing substances required by Article 13(1) of the Sixth Amendment. 

On the European front, there will be some accommodation of the conflicts, perhaps through an adjudicative mechanism for specific products that does not depend on the central listing device of the Sixth Amendment inventory. 

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