Transcript Independent Risk Assessment and Toxicology Assistance Proposal

Toxicology Excellence for Risk Assessment
About TERA:
• a non-profit,501(c)(3) corporation
• mission to protect public health
• founded in 1995 with a current technical staff of 12 and
several visiting scientists and associates.
• Complete roughly 50 technical projects per year for
government and industry sponsors (strive for 50:50
balance)
• Focus on – solving risk issues by 1) technology
leadership, 2) building bridges and using collaborative
processes
http://www.tera.org
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Michael L. Dourson
Ph.D., DABT
Director/President
Toxicology Excellence for Risk Assessment (TERA)
Officers and
Program Managers
Lynne Haber
Ph.D., DABT
Research
Andrew Maier
Ph.D., CIH, DABT
Associate Director
Jacqueline Patterson
M.En.
Peer Review
Andrea Wullenweber
M.S.
ITER
Jay Zhao
Ph.D., DABT
VERA
Staff Scientists
Dan Briggs
Ph.D., DABT
Bernard Gadagbui
Ph.D.
Olliver Kroner
B.S.
Patricia Nance,
M.Ed., M.A.
Ann Parker,
B.S.
Joan E. Strawson
M.S., J.D.
Administration
Meg Poehlmann,
B.A.
Director of Administration
Judy Pollock
Valerie Ayers
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TERA Program Areas
• Verifiable Estimates for Risk Assessment
(developing new risk values)
• Peer Review and Peer Consultation (expert
input on risk values and methods)
• Research Program (developing state-of-thescience methods and guidance in risk
assessment
• International Toxicity Estimates for Risk (ITER) –
comparative database of risk information
• StateHELP – pro bono risk support for State and
local risk assessors.
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Recent Pesticide Related Projects
• Chlorpyrifos – evaluation and manuscript on
cholinesterase vs. developmental neurotoxicity as critical
effect for RfD. Presented to Israel Dept. of Health.
• Captan reclassification for cancer – peer review on
tumor mode of action. Results accepted by EPA OPP as
external review.
• Chloropicrin – used advanced dose-response modeling
to develop acute inhalation exposure limits. Results
considered by State of California in setting ambient
levels and POD estimate received positive comment
from EPA OPP.
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Other Pesticide Related Projects
• EPA Star proposal developing linked PBPK and
exposure model for evaluating biomonitoring data –
pyrethroids used as case study
• Tumor MOA analysis for Telone – led to additional
studies by Dow.
• Support for pesticide Inert reevaluations.
• ACC supported research project used warfarin and
parathion to quantfy impact of gene polymorphism on
variability in tissue dose.
• Ongoing TERA work for EPA on drinking water criteria
documents and 6-year reviews based on reproductive
and developmental toxicity
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Alliance for Risk Assessment
(ARA)
A proposal to provide federal, state, tribal, and
private stakeholders with additional…
scientifically-based, independently-derived, peerreviewed, & verifiable risk values & methods for…
environmental decision making
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Alliance for Risk Assessment (ARA)
Alliance “Menu” Options
Stakeholder Process
States,
Fed. Agencies,
Public Interests,
Industry
Steering
Committee
Risk Document
Development
Initiation of
Risk Issue
Document
Draft
Training and
Certification
Hazard Assessment
Notification
System (HANS)
Non-profit
Collaborators
Risk
Communication
Risk Research
And Tools
Peer
Reviews
Peer Consult
Peer Review
Release to
Public
ITER
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Key Benefits of the Alliance
• Promotes science-based decision making to protect
human health
• Enhances harmonization and consistency in risk
assessments thru an open, transparent, multistakeholder approach
• Provides user control of own process, while providing
parallel process for shared help.
• Maintains essential core group of experts that are
normally not available within a single agency or state
• Shares costs and human resources among multiple
stakeholders to increase output
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ARA Work Flow
Steering Committee
Role: Provides Advise
to Non-Profits on:
Steering
Committee
Federal Agencies,
Industry
Mission-related
COI
Task Priority
Funded Projects
Membership:
Hazard Assessment
Notification
System (HANS)
States,
Tribes,
Env. NGOs
Unfunded Project
Requests
(2) Federal Agency
(2) State Ag.
(1) Tribe
TERA and
Non-Profit
Collaborators
(1) NLM
(1) TERA
(1) Env. NGO
(1) Industry
(1) Academic
NonProfits/Collaborators
ITER
Concurrent Technologies
Corp.
National Library of
Medicine
Mitretek
TERA
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ARA Funds Flow
Federal Agencies
Federal Funds
ARA
Process
Unfunded
State Projects
100 Risk Issues
per
Year by Year 5
Industry
Contracts
Funded
Projects
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Why Would Diverse Groups
Provide Funding?
•
•
•
•
The Alliance for Risk Assessment (ARA) mission…
– Aligns with many public health goals.
– Provides value as a timely resource for technical products with
enhanced credibility.
– Allows Stakeholder input – e.g., via involvement in Science Steering
Committee, as participants in technical panels.
– Gives an opportunity for harmonizing risk values and methods – which
eases burden for stakeholders that must meet requirements in multiple
constituencies.
Over the years nonprofit corporations have demonstrated the concept can
work [e.g., peer consultation with Voluntary Children’s Chemical Evaluation
Program (VCCEP) of EPA].
NLM & TERA have success in building ITER; ~200,000 hits per month
demonstrates likely value of ARA
Aligns with stated needs of stakeholders – e.g., Environmental Council of
States (ECOS) call for harmonized process.
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ITER Daily Users
Number of Users per Day
450
400
350
NSF Intl & IARC
300
National Library
of Medicine
250
200
150
IRIS, ATSDR &
Health Canada
100
Independent Values
50
RIVM
0
01/3 01/4 02/1 02/2 02/3 02/4 03/1 03/2 03/3 03/4 04/1 04/2 04/3 04/4 05/1 05/2 05/3 05/4 06/1 06/2
Year and Quarter
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NLM’s Toxnet
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Does Stakeholder Interest
Exist?
• In exploring the needs for this ARA, TERA has provided briefing
and/or received input from many potential stakeholders (over 100
individuals) Including:
–
–
–
–
–
–
20 States
2 Tribes
4 Environmental NGO’s
30 Industry groups
6 U.S. Federal Agencies
4 Countries
• Feed back has been positive. Suggestions have led to refinements
in the proposed ARA. Nearly all responding contacts have
encouraged moving forward.
• Diverse groups are beginning to provide funding or suggest projects
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Does This Effort Duplicate Current
Federal Efforts?
• This effort does not duplicate ATSDR MRLs, EPA IRIS,
FDA ADIs, Health Canada TDIs or RIVM TOCs.
• To the contrary, ARA shares resources to avoid
duplication because:
– It does not replace individual regulatory processes; ARA users
tap in as appropriate.
– Many risk values/issues will never be worked by federal groups.
– Current federal approaches have resource limitations; thus, new
chemicals addressed without duplicate effort.
– Update of older values can benefit federal groups as one
technical input to internal deliberations.
– ARA goes beyond risk values/issues – it is also a shared
resource for training and data communication.
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ARA Supports Existing Risk Values
• Provides guidance for
sources of toxicity
information that may
be used in performing
human health risk
assessments
• ITER can supplement
existing toxicity data
• ARA can provide
Tier III values
EPA OSWER Directive 9285.7-53
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Why a non-profit?
From a government perspective, non-profit status has four benefits:
• Independence / Objectivity. We are chartered to operate and act
free of commercial or political bias, so we take an objective stance.
• Superior Value. All monies go to supporting our mission, allowing
us to devote the greatest resources to our work and delivering the
highest value for the government dollar.
• Usable Results. We are outcome driven and results oriented; our
value is measured by the utility of our work—we help sponsoring
organizations make a difference.
• Kindred Spirit. We share the spirit of public service; we understand
the inner workings and detailed tasks that are the key to achieving
progress.
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Mitretek Integration Capability
Systems & Technology
• IT architecture systems
• Telecommunications network
• Information security
Enterprise Planning & Analysis
• Strategic & technology plans
• Business engineering &
operational analysis
• Cost analysis
Acquisition Support &
Contractor Oversight
• Concept development
• Acquisition planning
• Requirements, RFP prep
Environmental, Biological
& Chemical Sciences
• Environmental impact
• Health & environ assessments
• Environmental management
• Chemical & biological defense
www.mitretek.org
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ARA Next Steps
• We are seeking ideas, comments, steering
committee nominations, or project requests.
• How to contact us:
• Soon to be released website at
www.allianceforrisk.org
• TERA – Andrew Maier; [email protected]; 513542-7475
• Mitretek - Andrew Rak;
[email protected]; 703-610-2166
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