Objectives of Legislation

Section 4 of TSCA spells out the mechanism for requiring industry to study the existing chemicals that are already on the market and in the environment. To date over two hundred chemicals have been subject to test rules, either through administrative rulemaking or through voluntary consent orders.  

Calculated from Sunset Dates of Chemicals Subject to Final TSCA Section 4 and Related 12(b) Actions, September 1,2009, available at http //www.epa.gov/oppt/chemtest/pubs/sunsettable. html. This total does not include studies performed pursuant to the voluntary initiatives such as the High Production Volume challenge, but does include HPV chemicals that were not voluntarily studied and were later the subject of test rules. See Chapter 10. Voluntary Initiatives, for a discussion of the HPV and other voluntary programs. 

However, the EPA is withdrawing those plans because, among other things, it is reassessing how to prioritize actions on existing chemicals.  

Section 4 of TSCA permits the EPA to require manufacturers and processors of chemicals that are already in production to test the chemicals they make and process. There are threshold determinations that the EPA must make before it can issue a test rule, and these deal with the risk that may be posed by the chemical, the extent of exposure to the chemical, and whether there is a genuine need for new data. The testing requirement of 4 looks mandatory on the surface—the EPA must require testing if the statutory preconditions are met. Of course, however, the EPA is afforded substantial deference when deciding if the preconditions are met. 

Congress created the Interagency Testing Committee (ITC) to come up with a list of priority chemicals for 4 testing.  

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State legislation should serve two objectives. First, it should ensure that manufacturers and doctors apply safe medical devices. This is the proactive objective of legislation. Second, it should encourage safe behaviour and damage control by means of sanctions and a duty to financially compensate the damages. This is the reactive or repressive objective of legislation. 

Directives, on the other hand, are addressed to member states and require that they enact national legislation so as to achieve the objectives of the directives. Thus, a directive allows flexibility in how national legislation is enacted. In practice, national legislation will frequently refer you back to the directive, particularly when a directive contains large amounts of detailed technical requirements. 

In 1978 the International Federation of Clinical Chemistry produced a comprehensive summary of the objectives of External Quality Assessment (IFCC 1978). The first six points of Table 4.1 summarize the IFCC objectives the seventh has developed since that time and is of considerable importance in many countries where strict control over laboratories undertaking particular types of work is required by legislation or by appropriate professional organizations. 

The objective of this presentation is to provide an overview of the industry practices to fulfil the obligations in the field of food contact materials and articles, and in addition to discuss elements which are currently not fully covered by legislation. Obligations and burden of proof are discussed with reference to requisites for compliance, evidence of compliance, and liability. 

The decade of the 1970 s has seen mushrooming growth in concern for environmental health and the broader issues of the natural environment. This attitude is reflected in much legislation. Following incidents involving chemical pollutants, and recognition of chemical hazards and potential impacts of toxic substances, the Toxic Substances Control Act (TSCA) was added to prior law. Objectives of TSCA and its impacts on the chemical industry are addressed elsewhere within this symposium. The present paper addresses education to meet the mandates of TSCA. 

As a result of the adoption of the above directives legislation is now in place to ensure that there is confidence not only in national laboratories but also those of the other Member States. As one of the objectives of the EU is to promote the concept of mutual recognition, this is being achieved in the laboratory area by the adoption of the AMFC directive. The effect of the AMFC Directive is that organisations must consider the following aspects within the laboratory its organisation, how well it actually carries out analyses, and the methods of analysis used in the laboratory. All these aspects are inter-related, but in simple terms may be thought of as ... 

Almost a million copies of the published report were distributed by the Chemical Foundation to doctors, heads of women s organizations, legislators and other public officials, heads of commercial organizations, educators, libraries, etc. The Foundation spent more than 80,000 in the publication and distribution of the report (78). The object, of course, was to stimulate widespread interest in the need for chemo-medical research. 

The details of the reform and the large number of legislative changes introduced in relation to medicines for human use are beyond the scope of this chapter. However, the key objectives of the review of EU medicines legislation and reform of the regulatory regime can be summarised as follows ... 

The objective of the EU community legislation is to protect human health and to prevent different national legislation that may hinder free trade within the EU. 

For example, once implemented, the European Commission s new chemicals policy REACH (Registration, Evaluation and Authorization of Chemicals) -endorsed in 2003 - would require manufacturers and importers of over one ton per year of any chemical substance to gather information on the properties, hazards, and use of that substance, and submit the data to the European Chemicals Agency. The Agency would then determine if the chemical substance needed to be further regulated, restricted, or banned from use. It is estimated that about 30,000 existing chemicals produced in or imported into Europe would be subject to REACH. Key objectives of the European Commission s initiative on the reformulation of chemicals policy are to raise human and environmental safety levels as well as to simplify and standardize the current legislation. 

The Ministry of Health, Labour and Welfare is the governmental body responsible for enacting legislation for pharmaceutical affairs. The regulation of clinical trials and new drug approval in Japan is based on the Pharmaceutical Affairs Law and related ordinances. The objective of the Ministry is to secure a safe medical environment through a consolidated structure of accurate reviews of pharmaceuticals and medical devices and postmarketing safety measure implementation. 

In the United States the basis of the relative legislation covering chemicals in the workplace is the Occupational Safety and Health Act (OSHAct) which is enacted via the Occupational Health and Safety Administration (OSHA). The objectives of this body are as listed below [B-17]. 

The primary objective of the TSCA Inventory is to define what chemical exist in U.S. commerce for purposes of implementing the Toxic Chemicals Control Act. Specifically, chemicals not included on the Inventory are considered to be new chemicals under TSCA and are subject to the premanufacture notification (PMN) requirements stipulated under section 5 (a) of TSCA. The purpose of the TSCA Inventory is to identify those chemicals that exist in U.S. commerce, which have commercial applications that are not specifically addressed under other existing environmental legislation. 

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