TERA

As regulatory frameworks increasingly seek a general way to approach toxicological issues in addition to cancer, the importance of determining appropriate “adverse effects” in toxicological assessments has been on the rise. In this full-day course, participants will gain an understanding of the general legal background that gives weight to adverse effects, the differences among agency approaches to determining what is considered an adverse effect, and the complicated scientific issues upon which such a determination rests. The morning will begin with an overview of the statutory and regulatory background central to adverse effects, including how different federal agencies approach risk assessment concerning adverse effects. The course will then lead participants through an examination of four cases, each of which will raise a different issue with an adverse effect determination. Issues will range from using biomarkers as surrogates for deciding that an adverse effect is present, to the challenge of extrapolating from adverse neurological effects in animals to humans, to deciding when, in a continuous spectrum of response, the response becomes adverse. The day will conclude with a step back from the specifics of cases to summarize the general challenges involved with adverse effects as a key regulatory designation, including a discussion of whether formal guidance on determining adversity would be useful or helpful.

The full-day course will consist of introductory talks, detailed talks and discussion concerning specific examples of choosing between different adverse effects, and approaches for defining whether an effect is adverse, as well as focused discussion about the potential need for formal guidance on determining what is adverse.

· Welcome and statement of the course objectives: What's the problem?
Steve Lewis, Ph.D. (Integrative Policy and Science, Inc.) 8:30 - 9 a.m.

· Statutory and regulatory background: 'Adverse Effects' and Similar Terms in US Law. Jonathan Wiener, J.D. (Duke University School of Law) 9 – 9:30 a.m.

· How determination of an "adverse effect" is used in toxicological risk assessment, including consideration of differences among agency practices
Gary Foureman, Ph.D. ( EPA, NCEA, RTP, N.C.) 9:30 – 10:15 a.m.

· Examples of problems / issues. For each example, a short paper outlining the observations at issue and the implications of making different choices will be prepared and distributed. Time for discussion will be allowed.

· Why ethical values are unavoidable: The Complex Terrain of Adverse Effects
Heather Douglas, Ph.D. (University of Tennessee) 2:15-2:45 p.m.

· Discussion: Where do we go from here? Does there need to be formal guidance, and if so, what and how do we get there?
Jim Wilson, Ph.D. (Resources for the Future, retired) 3:15-4:45 p.m.

The pre-registration fee is $325. After the deadline, the registration is $350. You do not need to register for the Annual Meeting to attend the workshop. To register, go to the SRA website at http://www.sra.org/events_2006_meeting.php and either register online or print out and submit the registration form.

Venue

The room for the event has not yet been determined; check with the hotel concierge. To reserve a room at the hotel, call 800-468-3571 before 1 November 2006. Be sure to identify yourself as a SRA Annual Meeting attendee to receive the SRA group rate of LAST YEAR'S RATE=$135 per night (single or double occupancy) plus 12.5% tax. Cancellations must be made at least 48 hours in advance. See a description of the hotel at http://www.marriott.com/dpp/PropertyPage.asp?MarshaCode=BWISH.

Adverse Effects: What’s Adverse?/What’s Not? Why You Should Care
SRA 2006

Risk Analysis in a Dynamic World: Making a Difference

December 3-6, 2006 — Baltimore, Maryland

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