Assessing Carcinogenicity: Hazard Identification, Classification, and Risk Assessment. A Toxicology Forum State-of-the-Science Workshop
This workshop is tentatively scheduled for the following dates/location. As additional information for this meeting including the detailed agenda, hotel, registration, and other details are confirmed, they will be available here.
December 7–9, 2020 | Embassy Suites Alexandria in Alexandria, Virginia
Workshop Overview: As our understanding of chemical carcinogenesis has grown significantly over the last several decades, it is appropriate to look at whether long-standing test methods and risk assessment approaches should be updated based on new understandings. The US EPA is now in the process of updating its guidelines for risk assessment, which includes the 2005 Guidelines for Carcinogen Risk Assessment. These guidelines are used throughout the US EPA, as well as by numerous other federal and state agencies, to aid regulatory decision-making and set research priorities. This workshop will provide an opportunity for national/international experts and stakeholders to engage in an information exchange regarding these revisions, which will be of great value to guide next steps towards the modernization of carcinogenicity identification and risk assessment.
The US EPA Administrator has challenged EPA to significantly reduce the use of animal toxicity testing. This coincides with new directions being taken by the NTP to eventually move away from the chronic rodent bioassay toward human-relevant testing methods that significantly reduce or move away from animal testing altogether. Also, others are involved in the development of non-animal methods that are being proposed for use in cancer risk assessment and human-relevant chemical carcinogens identification, including toxicogenomics, cell transformation assays, high-throughput screening assays (e.g., ToxCast) used to identify “Key Characteristics of Carcinogens”, as well as weight of evidence assessments ongoing for pharmaceuticals (ICH S1 update) and agrochemicals (US EPA ReCAAP project). Although these newer methods are still in development, they are already starting to be used by some regulatory agencies, increasing the need for an information exchange on how these tests should be conducted and how data should be interpreted. It is of value to reflect international experience because of the efficiencies resulting from achieving harmonized guidance across geographies to the greatest extent possible.
This 3-day workshop will dedicate two days to presentations and discussions on “Carcinogenicity problem formulation”, “current cancer risk assessment approaches”, “Mode-of-action state-of-the-science” and “New approach methodologies.” Presentations and discussions from these two days will form the basis for breakout group discussions and reporting on the final day.
Throughout the workshop presenters and attendees will be able to gain greater insight and understanding around the following key challenges:
- Is there new science that better informs how we determine if a chemical causes an increased risk of cancer at relevant doses or contributes to an increased risk of cancer in the presence of other chemicals or stressors?
- Is there new understanding about key events, key characteristics, and AOPs that informs this question?
- Are there new kinds of data that better inform judgments about human relevance or dose-response?
- Is there new science that establishes adverse outcome pathways to cancer in a chemical-agnostic and quantitative form?
- Is there new data or new science that informs how to extrapolate from observed responses to responses at “acceptable” or “de minimis” risk levels?
- Is there new data or new science that better informs understanding of population variability in response?
Workshop Co-Chairs: Susan Felter (P&G); Edward Ohanian (US EPA);
Virunya Bhat (ToxStrategies, Inc.)
Chris Borgert (Applied Pharmacology & Toxicology)
Phil Botham (Syngenta)
David Bussard (US EPA)
Warren Casey (NIEHS/NTP)
Suzanne Fitzpatrick (US FDA)
Wally Hayes (University of South Florida)
Gina Hilton (PETA International Science Consortium)
Kelly Magurany (NSF International)