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Biomedical subjects

E D Weiler

Publications and source records attributed to E D Weiler.

11 recordsLinked to original sources
PubMed1999

Chemical control laws on polymers: A case for harmonization.

All industrial countries, and several emerging and developing countries, have established regulations to control chemical substances, with a view toward limiting the risks to workers and the public, as well as reducing the impact on the environment. However, the lack of harmonization among such international schemes is creating international trade difficulties. In this context, polymers, and particularly specialty polymers, are a unique case. Polymers are less easily characterized than other substances, and parameters used by governments to control them may vary greatly, leading to national regulations that are significantly dissimilar, or even incompatible. This paper reviews chemical control laws on polymers, identifies the major differences between them, and suggests model legislation for polymers that would reduce barriers to international trade in polymers while maintaining a high degree of human and environmental protection.

Economic Competition↗
PubMed1996

Product safety, risk assessment, and responsible care in the biocide chemical industry.

Manufacturers of biocides recognize a need to control the risk from their products. This paper discusses some of the history and critical aspects of these activities and outlines the needs under the current initiatives of Responsible Care. Biocide product safety risk assessment is operationally defined in this context and presented as the fundamental tool of the process. The need for data and the criteria for its dissemination are discussed along with the requirement that the data-gathering effort be combined in joint efforts with scientists in industry, academia, and the regulatory community.

Biological Availability↗
PubMed1995

Review of international criteria and mixture rules for health hazard classification.

The presentation of consistent hazard information in the face of conflicting inter- and intranational regulations and standards is a formidable task. The principal challenge arises from the varying definitions of what is and is not a hazardous chemical and the differing rules that regulate the disclosure of components on material safety data sheets (MSDS) and labels. Some of the effects on hazard communication of nine health hazard classification systems of the United States, Canada, and the European Union are analyzed. The additional complication of differing rules that govern the hazard classification of mixtures is also discussed. The combination of inconsistent hazard classification of individual chemicals and dissimilar mixture rules can result in different conclusions about the hazard classification of commercial products. Faced with this situation, hazard communicators must focus on developing clear statements of the health effects that may arise from overexposure to a chemical, which is the essential purpose of developing MSDS and labels. These statements may be distinct from the terminology derived from the various classification systems. All national MSDS systems make provisions for including statements of hazard and also for providing the toxicology information that is the basis for translation into the locally governing classification terminology. Requirements for labels are often more restrictive, and the complete resolution of conflicting communication must await international harmonization of hazard classification systems including mixture rules.

Air Pollutants, Occupational↗
PubMed1995

Quality initiatives in a corporate toxicology laboratory.

Quality improvement initiatives for a corporate toxicology group require a high level of managerial commitment to a bring about lasting change, a well-enunciated plan, professional training, effective communication, and reward and accountability systems. Learnings are shared which should be applicable to other toxicology or corporate staff groups.

Humans↗
PubMed1993

Personnel training: a key aspect of a quality program in the chemical process industry.

Effective training is key to quality improvement activities and should be organized as a system which integrates core company principles, has high professional standards, is appropriate to the technology, has management support, and meets employee needs. This paper deals with a training and awareness program required for quality assurance systems in the chemical process industry. Practical examples are provided.

Chemical Industry↗
PubMed1993

Quality requirements for biocides in the 1990s.

Increasing regulatory and product safety standards along with the enhanced expectations of today's consumer public have dramatically changed the manner in which new biocides are researched, developed, and marketed. Potential candidates face ever rising quality hurdles regarding Product Efficacy, Toxicology, Human Health and Environmental Risk Assessment and Risk Management, and, ultimately, Product Stewardship. These pressures have resulted in long lead times for new products with few companies entering into the biocide market. Another resultant trend has been a strong tendency to expand the life cycles of existing products. This report outlines and summarizes recent activity associated with these quality issues and their relationship to the successful marketing of biocides in the future.

Chemical Industry↗
PubMed1992

Regulation of existing chemicals under TSCA: information disclosure as the route to reducing risk and increasing available data.

The Toxic Substances Control Act (TSCA) empowers the Environmental Protection Agency (EPA) to regulate risk associated with the use of existing chemicals and the introduction of new chemicals into commerce. Due to a number of concerns, however, the authority to regulate existing chemicals under TSCA has enjoyed limited success. A more generic and flexible approach is needed to achieve significant risk reduction for existing chemicals. This paper presents a frame-work for a generic approach to the regulation of existing chemicals. Under this framework, EPA would officially recognize that the distribution of chemical substances without evaluating and communicating to the user how to avoid operationally undesirable exposures represents an unreasonable risk to health or the environment. Acting under the authority of TSCA, EPA would then generically require suppliers to communicate acceptable exposure levels and information regarding safe use. This framework is consistent with the express policy of TSCA, which states that development of data with respect to the effects of chemical substances and mixtures on health and the environment should be the responsibility of manufacturers and processors of chemicals. The approach outlined here is consistent with and complements initiatives of the Office of Toxic Substances (OTS) and would enable OTS to accomplish some of the fundamental goals of TSCA.

Chemical Industry↗
PubMed1992

A quality process for chemical product risk assessment.

One cannot manage a health or environmental risk of unknown dimension. Thus, the rational and cost-effective control of any risk lies first in its reasoned assessment. The assessment of risk is a scientific endeavor which embodies the intellectual use of information to reach a determination or assignment of an ascribed level of danger. It is, however, a decision process and approach whose details are substantially value laden. As such, it is potentially subject to a myriad of subjective interpretations from individuals with special interests and perspectives. Given this nature, it is incumbent upon those responsible for risk assessment in any organization to formulate a broad-based scientific consensus regarding the principals of quality assurance for the risk assessment process in their organization. This paper attempts to outline a rational and prudent consensus-based system for the quality assurance of risk assessment concerned with the danger to human health and the environment posed by the use of chemical products. We present it as a model that we hope could be accepted and implemented.

Chemical Industry↗
PubMed1991

A corporate product integrity assurance process.

One of the more difficult challenges that confronts the chemical industry throughout the industrialized world is how to effectively manage the various and often diverse regulatory requirements. What follows is a description of a process designed to help with new product introductions. The process is generic and is applicable to almost any corporate environment and structure.

Chemical Industry↗
PubMed1991

Management of process change in a chemical company.

Management of process changes in a multibusiness and multinational chemical company is a significant challenge for most organizations. A generic process that focuses first on a clean, documented baseline definition of manufacturing processes and second on defined responsibilities, procedures, and guidelines for reviewing proposed changes in processes is described. A corporate database is recommended to provide comprehensive data on products and manufacturing processes. Process stewards should be identified for each major product line or technology.

Chemical Industry↗