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PROJECTS
Infoscientific.com participates in ongoing projects with USEPA and the
private sector, offering applications development, modeling, exposure
assessment and technical support in a variety of areas.
CARES
The
1996 Food Quality Protection Act (FQPA) generated the need for multiple
models to address new risk assessment standards and data requirements
for pesticides and formulation inert chemicals. In 2000, CropLife America
funded the Cumulative and Aggregate Risk Evaluation System, CARESTM, to
address FQPA mandates for short-term, intermediate duration and lifetime
dietary, drinking water and residential aggregate and cumulative exposure
and risk calculations. CARES development has proceeded through a cooperative
team effort of CropLife America staff and member company scientists and
expert exposure and risk assessment consultants, infoscientifc.com, Inc.,
Novigen Sciences, Sielken & Associates Consulting, Inc. and Summit
Research with participation by EPA and USDA.
CropLife
America has made the CARES source code freely available to all stakeholders
and government agencies. There are several features that differentiate
CARES from other risk assessment models. The NotitiaTM,
proprietary product of infoscientific.com, Inc., serves as the software
engine to run CARES and to house data. The Notitia framework also affords
the flexibility to introduce and link exposure scenarios to assess their
potential impact for products already in the marketplace and new registration
candidates still in evaluation. The population generator, POP GENTM, from
Sielken & Associates Consulting, Inc., is based on the U.S. Census
and enables CARES to match individual and population attributes across
single or multiple exposure databases to generate a one-day or 365-day
profile. CARES calculations are transparent. The software has a contribution
and sensitivity analysis module that allows the user to drill down and
identify contributing factors, for chemicals, sources and routes of exposure,
that impact risk most and could, if changed, make a difference in affecting
the outcome.
CARES software
is user-friendly, and government, academic and public stakeholders have
successfully run the software. A FIFRA Science Advisory Panel reviewed
CARES methodology on April 30 - May 1, 2002 and encouraged CLA to further
its development and use for risk assessment.
CARES version
1.1 CD and installation instructions can be obtained by contacting Angelina
Duggan, CropLife America Director of Science Policy, aduggan@croplifeamerica.org,
or (202) 872-3885. Additional information about CARES and its development
are available on the CropLife America website at www.croplifeamerica.org.
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Outdoor Residential Exposure
Task Force (ORETF)
infoscientific.com is assisting the ORETF, which is sponsoring a project
to assess human activities on residential lawns with respect to incorporation
of time-activity data for assessing post-application exposures to residential
turf chemicals. The Outdoor Residential Exposure Task Force (ORETF) is
a consortium of 33 member companies that have joined in response to a
data call-in on exposure information for individuals reentering residential
lawns that have been treated with pesticides. The staff of infoscientific.com
will be working with Stanford University (which has conducted videotaping
to quantify the frequency and duration of specific time-activity data
for children, including frequency of contact with surfaces and frequency
of hand-to-mouth activities for assessing incidental oral ingestion exposures)
for this work. The object of this effort is to develop a protocol for
specific structured exercise or activity regimens on turf to simulate
the contact with treated turf for each specific age group, which can then
be used as a basis for exposure assessment.
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Non-Dietary Exposure Task Force
(NDETF)
infoscientific.com is currently providing full FQPA-related support, including:
1) regulatory strategy, 2) evaluation of toxicological data, 3) screening-level
dietary exposure and risk assessment, 4) screening-level and refined (Monte
Carlo) nondietary exposure/risk assessment for indoor and outdoor residential
uses, 5) design and implementation of an exposure monitoring program in
simulated residential environments to measure dislodgeable residues, dissipation
of airborne levels over time, biomonitoring in adult volunteers exposed
to treated surfaces through normal contact activities, and a variety of
satellite studies (e.g., collection of time-activity data for children),
and 6) development of aggregate risk estimates.
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REJV
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REx
REx (Residential Exposure Assessment Model) is a spreadsheet (EXCEL) based
exposure/dose assessment model that allows aggregating product use scenarios.
REx is implemented in a user-friendly environment such that both simple
deterministic and complex stochastic exposure and dose assessments can
be made. The product use scenarios in REx are those based on EPA's Residential
SOPs draft document. One or more (up to six) scenarios can be aggregated
to estimate exposure and dose to receptors of interest. Receptors included
in this version of REx are adults and three categories of children (<
1 year, 1 year < age < 6 years, and age > 6 years). Aggregation
can be done for "day 0" during and post application scenarios
The EPA
site offers general information on performing aggregate
exposure and risk assessments.
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THERdbASE
The Total Human Exposure Risk Database and Simulation Environment (THERdbASE)
was a USEPA-sponsored modeling platform that provided a common basis for
conducting all residential exposure assessments. THERdbASE married an
array of data files with a suite of indoor and outdoor residential and
ambient models, and permited a "cafeteria" approach to selection
of datafile subsets and models for accomplishing specific modeling activities.
Data files included demographic data, food consumption data, physiological
data (e.g., distributional data on inhalation rates and body weights),
monitoring data on pesticides, and other useful information. THERdbASE
received recognition as the "gold standard" for exposure modeling
platforms, and was adopted as the standard modeling tool across all offices
within the USEPA. The format of THERdbASE readily permited integration
of a product use information database with a suite of customized exposure
assessment models.
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Projects
CARES
ORETF
NDETF
REJV
REx
THERdbASE
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