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TERA is proud to
announce its Dose-Response Assessment Boot Camp, a
new initiative providing intensive, in-depth hands-on training in hazard
characterization and dose-response assessment for developing human
health risk assessments.
Current Courses
This week-long course
with emphasis on dose response assessment will be based on our popular
chemical risk assessment training sessions developed and presented to
various audiences in the past decade. It is designed to provide
systematic training in current assessment practices as well as in the
latest methods in human health chemical risk assessments. The course is
for beginners through experienced toxicological risk assessors who wish
to learn advanced methods and enhance their understanding and skills in
the basics. The students will learn all aspects of hazard
characterization and dose response assessment, and practice the skills
learned in the classroom. Upon completing the course, the participants
will be able to derive or evaluate risk values for noncancer and cancer
risk assessments and will receive a certificate documenting their
successful completion of the course.
What you will
learn
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Noncancer and cancer risk assessment principles and methods
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Dosimetric adjustment methods in dose response assessment
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Benchmark dose modeling and application in risk assessment
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Principles for the development and application of uncertainty factors
and Chemical Specific Adjustment Factors (CSAFs)
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Comprehensive risk assessment practice and peer review process
Who should attend?
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Risk assessors and toxicologists who conduct and write chemical
assessments
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Risk assessors and toxicologists who review chemical assessments
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Risk managers or policymakers who use the results of chemical
assessments and want to fully understand the processes involved in
risk value development
Participant
requirements - participants should have:
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A basic understanding of toxicology
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An interest in developing their skills in human
health risk assessment
 Course Description
(Course
Description Brochure)
1.
Noncancer and Cancer Risk Assessment Principles and Methods
An
overview and basic concepts of noncancer and cancer risk assessment will
be presented followed by detailed discussion of the methods used in
chemical risk assessment. This session will focus on standard methods
for chemical risk and safety assessments including considerations for
critically analyzing effect data for risk assessment purposes,
incorporation of uncertainty factors, frameworks for considering mode of
action and human relevance, information synthesis approaches for hazard
characterization and critical study identification, and calculation of
risk values for noncancer (e.g., reference doses or tolerable intakes)
and cancer endpoints (e.g., cancer slope factors). The presentation will
also cover the application of the latest methodologies used in
dose-response assessment. A step-by-step discussion of case studies
will serve to further elaborate on the decision making process in
noncancer and cancer risk and safety assessment.
2. Dosimetric
Adjustment Methods in Dose Response Assessment
This
session is designed to provide basic training in methods used for the
dosimetric adjustments required for completing basic dose-response
assessments derived from animal toxicology data. The topics will
include interspecies oral dose adjustment for noncancer and cancer
assessment, cancer unit risk or slope factor conversion, inhalation
exposure concentration unit conversion, and human equivalent
concentration (HEC) calculation for particle and vapor exposure using
various modeling approaches. Applications of the results of
physiologically-based pharmacokinetic (PBPK) modeling will also be
introduced. The participant will be provided with sufficient working
knowledge of the various techniques to conduct typical noncancer and
cancer risk assessments.
3. Benchmark Dose
Modeling and Application in Risk Assessment
This
session is designed to provide an overview of benchmark modeling for
noncancer and cancer dose-response assessments, and provide hands-on
experience in using the latest EPA software. Through this training
course, participants will learn the basic concept of the BMD approach,
appropriate application of BMD modeling in noncancer and cancer
dose-response assessment, model and parameter selection during BMD
modeling, data selection and model run, and selecting the appropriate
BMD as a point of departure in a human health risk assessment. This
training will cover all the BMD models available in the latest version
of EPA’s BMDS software, such as: continuous models, dichotomous models,
cancer model, and nested models. The participants will practice BMD
modeling methods with sample data and develop final point of departure
estimates based the model results.
4. Principles
for the Application of Uncertainty Factors and Chemical Specific
Adjustment Factor (CSAF) Methodology
During this session, the participants will
learn the concept of uncertainty factors and how they are used in
noncancer risk and safety assessment by USEPA and other organizations.
A review of the use of uncertainty factors and historical perspective on
the reliance on quantitative data to develop values for inter- and
intra-species extrapolation will be presented as background. Newer
methods in this area will be discussed, such as the use of
chemical-specific adjustment factors (CSAFs), a refinement to the
uncertainty factor approach; methods according to the International
Programme on Chemical Safety (IPCS) guidance will be discussed. This
guidance addresses the use of mechanistic and toxicokinetic data to
replace default uncertainty factors for interspecies extrapolation and
intraspecies variability in deriving risk values such as RfDs and
Tolerable Concentrations (TCs). The course will focus on the IPCS
methodology for CSAF development, including the thinking process and
steps used for evaluating data. Examples and classroom activities will
be used as instructional aids.
5. Comprehensive
Risk Assessment Practice with Peer Review
To
provide additional practice and help integrate the concepts presented
throughout the course, students will develop an assessment for a complex
sample chemical over the course of the entire week. The participants
will be given the basic information on the sample chemical at the
beginning of the training sessions. After each session,
participants will practice the skills learned during the
individual training session such as: characterization of the overall
database, dosimetry adjustment, identification of the critical effect,
estimation of the point of departure based on BMD modeling,
identification of the uncertainty factors and CSAFs, and derivation of
safe doses or concentrations (e.g., RfD and RfC) for the sample
chemical. In addition, participants will also be given an opportunity
to work through a comprehensive cancer risk assessment for a sample
chemical. At the end of the class exercise, participants will be
required to present their assessment during a peer review by a panel of
their peers. Each participant will also serve as a peer reviewer to
evaluate other participants’ assessments.
For more information, please contact Ms. Patricia Nance at
513-542-7475 x25 or nance@tera.org
or for specific course content contact Dr. Lynne Haber at 513-542-7475 x 17 or
haber@tera.org.
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