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Society For Risk Analysis Annual Meeting 2008

Risk Analysis: the Science and the Art

Session Schedule & Abstracts

* Disclaimer: All presentations represent the views of the authors, and not the organizations that support their research. Please apply the standard disclaimer that any opinions, findings, and conclusions or recommendations in abstracts, posters, and presentations at the meeting are those of the authors and do not necessarily reflect the views of any other organization or agency. Meeting attendees and authors should be aware that this disclaimer is intended to apply to all abstracts contained in this document. Authors who wish to emphasize this disclaimer should do so in their presentation or poster. In an effort to make the abstracts as concise as possible and easy for meeting participants to read, the abstracts have been formatted such that they exclude references to papers, affiliations, and/or funding sources. Authors who wish to provide attendees with this information should do so in their presentation or poster.

Common abbreviations

Chemicals Policy: REACH and CHAMP

Room: Commonwealth A   4:00-5:30 PM

Chair(s): Jay West, Ron White

T4-D.1  16:00  EPA’s new Chemical Assessment and Management Program (ChAMP) and EPA’s efforts under ChAMP. Sheridan D*; U.S. ENVIRONMENTAL PROTECTION AGENCY

Abstract: EPA’s Office of Pollution Prevention and Toxics (OPPT) will profile efforts under its new Chemical Assessment and Management Program (ChAMP). ChAMP facilitates EPA in fulfilling the U.S. commitments made under the Security and Prospertiy Partnership of North America (SPP). The SPP of North America Leaders’ Summit, held in Montebello, Canada, in August 2007, called for cooperation on chemicals and outlined commitments on behalf of the United States, Canada, and Mexico to work together to ensure the safe manufacture and use of industrial chemicals. Each country is sharing scientific information and approaches to chemical testing and risk management. To fulfill its part of the SPP commitment, the United States will, by 2012, complete screening-level risk characterizations and take action, as appropriate, on more than 6,750 chemicals produced above 25,000 pounds per year. The U.S. commitment to complete assessments and take action on these chemicals will apply the results of EPA’s work on High Production Volume (HPV)—those chemicals produced or imported in the United States in quantities of 1 million pounds or more per year—and extend its efforts to moderate production volume chemicals—those produced or imported in quantities above 25,000 and less than 1 million pounds per year. As part of the efforts under ChAMP, EPA is developing screening-level documents that summarize basic hazard and exposure information on HPV chemicals, identify potential risks, note scientific issues and uncertainties, and indicate the initial priority being assigned by the Agency for potential future appropriate action. The EPA began posting the first set of Hazard Characterization documents in September 2007 and subsequently posted the first risk-based prioritization documents in March 2008. EPA is expecting to continue to make its efforts public via its website (

T4-D.2  16:20  The animal welfare perspective on the benefits of tiered testing: Application of the 3R’s: Refinement, reduction, replacement. Beck N*; PHYSICIANS COMMITTEE FOR RESPONSIBLE MEDICINE

Abstract: For many years, tiered testing strategies have been recognized as useful tools in setting testing priorities. Benefits of this approach have been increased efficiency in utilization of resources by industry and government, e.g., cost and time. From the animal welfare perspective, these varied approaches to tiered testing are particularly significant in the application of the 3R’s: refinement, reduction and replacement of animals in testing. Several tenets have been used to establish tiered testing. For example, one approach is based on levels of potential or known exposure to humans or the environment. This approach is evident as practiced in programs administered by EPA, e.g., industrial chemicals as well as pesticides. Exposure may be assessed by surrogate measures (production volumes, e.g., high production volume versus moderate production volume) or use profiles (pesticides, e.g., minor use versus food use). Another tenet is the use of screening level hazard data. Several regulatory programs have successfully used these types of data (which generally use fewer animals) to set priorities, e.g., the Screening Initial Data Set (SIDS) used in EPA’s HPV program and OECD’s Existing Chemicals program. Such testing provides preliminary hazard data which may or may not trigger further testing. The application of the 3R’s, where possible, is an internationally recognized goal, and tiered testing has been successfully utilized in this effort, not only in the US but also the OECD. Initiatives to develop/validate alternatives to the use of animals to assess hazard to chemicals are also underway in the US (ICCVAM) and Europe (ECCVAM). The application of these principles and their ability to reduce the numbers of animals used in chemical testing will be presented, along with quantitative examples.

T4-D.3  16:40  Methods and approaches for evaluating chemicals in commerce: Using science to meet policy challenges. West J*, Becker R; AMERICAN CHEMISTRY COUNCIL

Abstract: Risk-based prioritization of commodity chemicals is an efficient means of evaluating large numbers of chemicals for potential impacts to health and the environment. Risk-based prioritization identifies critical information needs and helps regulators and the regulated community focus testing and risk management resources effectively and efficiently. To be of value, screening batteries must be able to differentiate chemicals based on their intrinsic properties. Discussing prioritization approaches is particularly timely. Under U.S. EPA’s Chemical Assessment and Management Program (ChAMP), the agency will develop screening-level risk prioritizations and determine the potential need for additional risk management actions for the approximately 6,750 chemicals produced in or imported into the U.S. in quantities greater than 25,000 pounds annually, the vast majority of chemicals in commerce by volume. One input to ChAMP will be the information that industry is providing on more than 2,200 high production volume (HPV) chemicals through the HPV Challenge Program and its international companion program. The HPV Challenge employs the Screening Information Data Set (SIDS) developed by the member countries of the Organization for Economic Cooperation and Development (OECD) to develop a consistent baseline of screening-level information. This talk will present an industry perspective on different screening methods developed to prioritize commodity chemicals both in the U.S. and internationally, as well as a summary of recent literature on prioritization approaches. Several tools that can facilitate prioritization, including qualitative structure-activity relationships, chemical categories, and screening-level use and exposure information, will be considered. The talk will conclude with a discussion of opportunities and challenges with prioritization processes, including the need for clear communication when prioritization results are made publicly available.

T4-D.5  17:20  Application of REACH with respect to US companies: An Opportunity to Improve Chemicals Management Activities in the United States. Tickner JA*; University of Massachusetts Lowell

Abstract: The passage of REACH highlights the growing divide between the United States and Europe with regards to assessment and management of toxic substances. While US companies will have to comply with REACH, there has been little movement at the federal level in the US to support compliance with REACH or raise the standard of U.S. federal chemicals management policy. While new federal programs such as CHAMP are a step in the right direction, there has been little attention to reform of the 30 year old Toxic Substances Control Act. In absence of this reform, the states have begun to fill the gap of federal leadership by developing and passing far reaching new legislation. Many leading companies are also taking steps towards application of safer chemicals and products. This presentation will provide an overview of the implications of REACH for US policy and an analysis of the drivers and directions of chemicals policy in the US into the future.

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