The Toxicology Forum is an international, nonprofit organization that is devoted to conducting open dialogues among various segments of society concerned with problems in toxicology.
At our meetings, views are exchanged among experts from domestic and international government regulatory and health agencies, industry, academia, 'political policymakers', and public interest groups. The Toxicology Forum aims to provide a scrupulously balanced approach to the topics and issues presented at The Forum, with alternative positions presented for each issue.
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Topics anticipated for our upcoming meeting in Washington, DC (January 26–28, 2015) include:
Keynote Speaker: Dr. Richard Hodes, Director, National Institute on Aging, NIH
Waiting for Food Allergen Reference Doses
Threshold-based risk management has long been used for hazards in food but has not been adopted by regulatory agencies in the management of food allergens. Numerous publications indicate that sufficient data are available to establish reference doses, all from the sensitive subpopulation. Those with food allergies and their families must deal with labels that indicate a presence of an allergen (“contains peanut”) but without knowing whether the amount is of any biological consequence and precautionary statements (e.g., “may contain peanut”) that have an unclear and sometimes ambiguous meaning. The food processing industry must label even trivial levels to protect itself and follow the law. And regulatory agencies need reference doses to handle existing and new laws (i.e., FALCPA and FSMA in The USA). If all sectors are in an unsustainable situation and there are sufficient and sound data that are equivalent to what is typically used to reach safety decisions, the time seems right for advancement of food allergen thresholds into reference doses. This session will look at the data that exists on thresholds, any gaps, and what needs to be done to convert existing data into reference doses.
Use of Genotoxicity Data in Quantitative Risk Assessment: Are We Ready for a Paradigm Shift?
Genetic toxicity data have traditionally been used only qualitatively to identify a hazard, which could then be used to conclude the potential for a mutagenic or cancer hazard. As such, dose-response data and determination of a point-of-departure (POD) such as a no-observed-genotoxic-effect-level (NOGEL) was not a priority as genotoxicity data were not used in quantitative risk assessment. In fact, demonstration of mutagenic activity at any dose, no matter how high, was taken as evidence that a mutagenic mode-of-action (MOA) was operating for any cancer response and thus a low-dose linear extrapolation was the correct approach to any quantitative cancer risk assessment. While quantitative cancer risk assessment (i.e., to establish an exposure limit) has traditionally relied on the availability of tumor data from a chronic cancer bioassay in rodents, there are alternatives proposed. More recently, TTC and/or SAR have also been used to establish exposure limits, but ultimately these also rely on bioassay data in some fashion. Significant work has been conducted in recent years to provide data on dose-response for genotoxicity data, including dose-response modelling and identification of NOGELs and other PODs. Such data can inform quantitative risk assessment in many ways, such as determination of PODs for mutagenic effects from chemicals of interest. The new data and dose-response modelling approaches, along with MOA data to understand the biology behind the dose-response relationships, will be presented and implications for regulatory incorporation of these new approaches will be discussed.
Efficacy of Low Calorie Sweeteners
Several low caloric sweeteners are available for use in food and beverages. Although several studies have shown them to be effective in weight loss and weight maintenance others have not. A few studies have suggested that they actually stimulate consumers to eat additional calories. Recent studies and a meta-analysis of randomized controlled trails as compared to observational studies will be discussed. Both sides of the debate will be presented.
Debating the Varying Criteria for Incorporating “Mechanistic Data” into Cancer Classification
The International Agency for Research on Cancer recently published a report “IARC Monographs on the Evaluation of Carcinogenic Risks to Humans: Report of the Advisory Group to Recommend Priorities for IARC Monographs during 2015-2019”. It is understood that the Advisory Group was asked to consider prospects for the evaluation of mechanistic data in the context of Monograph evaluations. A key element of the recommendation is to understand the criteria for utilizing “mechanistic data/mode of action” in classification decision making. In addition, other organizations consider how to utilize mode of action / mechanistic data to guide decisions on cancer hazard assessments. This Toxicology Forum session will allow for discussion about the approaches various organizations take or are considering taking in the future; criteria and standards of acceptance and specifically what and how such information is needed for decision making will be discussed.
1. MRI Imaging as a Preclinical Biomarker of Neurotoxicity
2. Neurobehavioral Effects of Caffeine
3. Testosterone Therapy: Clinical & Safety Issues
4. Effects of Climate Change on Environmental Chemicals
5. Dose-Response Evaluation of Health Effects of Partially Hydrogenated Oils (PHOs)
6. Tox21 Survey Review
The Fairfax at Embassy Row
2100 Massachusetts Ave, NW
Washington, DC 20008
A luxury Washington, DC hotel that embraces the style and grace of a bygone era. Nestled among world-class boutiques, unrivaled dining and iconic monuments, The Fairfax at Embassy Row, Washington, DC. is perfectly situated in Dupont Circle, one of Washington's most vibrant neighborhoods. With the Dupont Circle Metro less than two blocks away from the hotel, famed Washington, DC attractions such as The White House, National Mall, and the Lincoln Memorial are at your fingertips.
The Toxicology Forum has reserved a limited block of discounted rooms for meeting attendees.
Attendee Room Rate: $209.00
Housing Reservations: 202.835.2116
Online Hotel Reservations
Housing Deadline: January 4, 2015
When making your hotel reservation, please mention that you are attending the Toxicology Forum Winter Meeting or use the Toxicology Forum Online Reservation link above to receive the discounted rate. Hotel room rates are subject to applicable state and local taxes (currently 14.5%) in effect at the time of check-out. The room rate is offered three days prior to and three days following the meeting based on availability for reservations made before the cut-off date. The Hotel does not call guests directly to assist with booking hotel rooms. If you are contacted by someone saying they represent the hotel, please let Amy Willis know.
Government employees may make a reservation by calling Hotel Reservations’ phone number above to receive the government rate for January 26–28, during the meeting. Government rated rooms are very limited and a Government ID is required upon check-in.