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Chemistry International
Vol. 23, No. 4
July 2001

Long-Range Research Initiative (LRI) of the American Chemistry Council (cont')

Carol J. Henry and James S. Bus

Summary
Introduction
Development of the Long-Range Research Initiative
Technical Implementation Panels
Operating Principles
Selected Examples of Ongoing Projects
Alternative Bioassays
Conclusions

Technical Implementation Panels

The Technical Implementation Panels (TIPs) of the American Chemistry Council are organized to provide technical support and assistance for each of 10 scientific areas (Table 2). The TIPs consist of outside experts working in partnership with scientific specialists from member companies of the American Chemistry Council to support the Long-Range Research Initiative (LRI). CIIT derives support from the LRI for research in chemical carcinogenesis; endocrine, reproductive, and developmental toxicology; neurotoxicology; respiratory toxicology; and risk assessment methods. Other research organizations are supported through an extramural, competitive, request-for-proposals process that addresses scientific issues in endocrine modulation and reproductive and developmental toxicology, epidemiology, exposure, immunotoxicology, neurotoxicology, and risk assessment. Requests for proposals are posted on the American Chemistry Council Web site <http://www.americanchemistry.com> under the overview information on the LRI.

Table 2 Technical implementation panels (TIP) of the American Chemistry Council.

Atmospheric Chemistry TIP
Explores the role of chemicals in atmospheric science that will increase our understanding of the processes affecting formation, transport, and removal of pollutants in the atmosphere.

Chemical Carcinogenesis TIP
Examines the biological mechanisms and dose-response relationships involving cancers that may be associated with exposure to various substances. Extrapolation of results from animals to humans, the role of biomarkers, and gene-related differences in biological responses are among the issues explored.

Endocrine TIP
Considers the effect that exposure to chemicals might have on the endocrine, reproductive, and developmental health of human and wildlife populations.

Environmental TIP
Addresses research on issues of environmental exposure assessment, ecological risk assessment and management, and ecosystem dynamics.

Epidemiology TIP
Increases scientific understanding of the potential hazards of chemicals and improves epidemiological methods and their application in assessing human health risks.

Exposure Assessment TIP
Addresses research designed to characterize human exposure to chemicals and reduce the uncertainty for quantitative estimates of exposures associated with the potential human health effects of chemicals.

Immunotoxicology TIP
Sponsors research to develop animal models that predict the ability of chemicals to induce or exacerbate allergic and other immune responses.

Neurotoxicology TIP
Examines biologically significant changes in the structure or function of the nervous system that may result from chemical exposure.

Respiratory Toxicology TIP Sponsors research to improve risk assessment methods of inhaled reactive gases, understand the pathobiology and dosimetry of particles and fibers, and improve animal models of particulate-induced disease.

Risk Assessment Methods TIP
Addresses research to advance human health risk assessment methodologies for chemicals.describe research supported by the LRI at CIIT as well as at other research organizations.

 

Operating Principles

The six research principles under which the Long-Range Research Initiative (LRI) operates reflect the commitment of industry to scientific excellence:
(1) studies will complement existing research by government, academia, and others;
(2) collaborations with key internal stakeholders, academia, and government are emphasized;
(3) experts from academia, government, and industry will participate in decision-making and provide advice on the quality, direction, and value of the research conducted;
(4) individual researchers will determine the methods and procedures to be used in conducting the research;
(5) rigorous scientific principles and laboratory practices will be used at all times; and
(6) results will be made public regardless of outcome.

The global LRI is coordinated through the Long-Range Research Initiative Steering Committee of the International Council of Chemical Associations (ICCA). The United States chemical industry is represented at ICCA through the American Chemistry Council, the European chemical industry through the European Chemical Industry Council (CEFIC), and the Japanese chemical industry through the Japan Chemical Industry Association (JCIA). Each organization has the responsibility for implementing ICCA principles, which address scientific excellence, open processes and results, fair and unbiased conduct, and relevance to the chemical industry.

Selected Examples of Ongoing Projects

An overview of studies being conducted as part of the Long-Range Research Initiative (LRI) illustrates the depth and breadth of industry efforts (Table 3). Some studies involve species extrapolation issues, such as the chloroform studies conducted at CIIT.

CIIT research on the mechanism of chloroform toxicity was extremely valuable in assessing the risk to human health from low-level environmental exposures to chloroform. The examples presented in Table 3 describe research supported by the LRI at CIIT as well as at other research organizations.

Alternative Bioassays

Shortcuts or replacements for long-term bioassays used to determine the potential hazards of chemicals are being sought throughout the scientific community. These alternative bioassays are needed to save time and resources and reduce the number of animals used in toxicity testing. One of these new technologies, the p53 transgenic animal mouse model, may reduce the time to detection of tumors following chemical treatment. Before the p53 model can be used in risk assessments, however, the data from the model must be understood and interpreted. CIIT is conducting research to determine the relevance of the p53 model in predicting human health outcomes. Current CIIT projects involve the investigation of the carcinogenicity of benzene and the drinking water by-product bromodichloromethane.

Atmospheric Chemistry

Research in the atmospheric sciences sponsored by the LRI is intended to fill knowledge gaps and aid in the development of future environmental policies. The priority research themes include atmospheric degradation pathways, aerosol microphysics and chemistry, and organic compounds in the global atmosphere. For example, a project on the contribution of biogenic emissions to urban ozone leverages an existing research program of the Coordinating Research Council, a nonprofit organization that directs engineering and environmental studies on the interaction between automotive equipment and petroleum products.

Epidemiology Studies

The chemical industry has historically conducted many epidemiology studies to determine long-term mortality and cancer incidence in workers involved in the manufacture of chemical products. The American Chemistry Council has developed an inventory of mortality and cancer incidence studies available in the peer-reviewed literature. This worker population database is a valuable resource for the chemical industry and for the scientific community at large. The Health Studies Inventory Summary Report is available on the American Chemistry Council web site <http://www.americanchemistry.com>, and the database itself can be purchased by both Council members and nonmembers. The inventory was used for an interpretive review to assess the overall burden of disease for the population of chemical manufacturing workers.

Exposure Research

A critical issue for the chemical industry is in the area of exposure. As the high-production-volume (HPV) testing program is developed and implemented and large amounts of chemical, animal, and hazard toxicity data are generated, exposure data and models to predict patterns of exposure will be needed to understand better the potential hazards associated with HPV chemicals. Research is in progress to examine the limitations of existing models used to predict the occurrence and extent of human exposure. For example, the Exposure Assessment TIP is sponsoring research to examine models that predict chemical exposures from oral and dermal absorption as well as models that focus on an individual’s personal environment, or microenvironment. The Exposure Assessment TIP will also oversee projects aimed at understanding and developing a framework that focuses on combinations of exposure pathways and sources and the accumulation of these exposures over time. Exposure modeling is expected to lead to better exposure assessment for chemicals. Work on the exposure framework will help companies understand how a person’s exposure is influenced by activity patterns, age, gender, occupation, and other demographic factors.

Risk Assessment

The LRI is funding projects that address methods in risk assessment. One of these projects involved assessment of the human health risks from formaldehyde using benchmark dose analysis. The significance of the project was recognized in 1999 when CIIT scientist Dr. Paul Schlosser received an award from the Risk Assessment Specialty Section of the Society of Toxicology for his poster presentation on "Formaldehyde Risk Assessment by Benchmark Dose Analysis Using DNA-Protein Cross-Links as an Internal Dose Metric." Other research projects address pharmaco-kinetic modeling, cumulative risks, inter- and intraspecies variability in extrapolation modeling, and low-dose extrapolation modeling.

Wildlife Studies

The LRI is sponsoring research involving wildlife studies to develop animal models for detecting endocrine- active materials. Field studies of songbird reproduction and productivity are under way, and research is being conducted on fence lizards as a potential reptilian model for ecological assessment of endocrine-active materials.

Conclusions

Environmental regulation and product stewardship have been very effective in the last 20 years at reducing exposures to manufactured chemicals. Through Responsible Care, workers in the chemical industry are 4.5 times safer than those in all other manufacturing industries (calculated from tables in the Monthly Labor Review, July 2000). The chemical industry has also reduced EPA Toxic Release Inventory emissions between 1988 and 1998 by 63% while increasing production over 27% and is talking with its neighbors through some 300 Community Advisory Panels.

To understand the impact of chemicals on human health and the environment, the chemical industry and downstream chemical users are engaged in providing more information to improve understanding of how chemicals are manufactured, used, distributed, and ultimately disposed of. What are the potential effects on the environment or on human health associated with low-level exposures to chemicals? How can the scientific issues associated with sustainability and life-cycle analysis be identified and developed? Such questions can only be answered by effectively working with research communities in academia, government, and industry. In alliance with CIIT, the Long-Range Research Initiative (LRI) is actively engaged in improving our understanding about chemicals and finding answers to these questions

 

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