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April 2002 Meeting Agenda

April 18, 2002


OPEN MEETING
TUESDAY, APRIL 30, 2002

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/
OPP Docket Telephone: (703)305-5805

Sheraton Crystal City Hotel
1800 Jefferson Davis Highway
Arlington, VA 22202
(703) 486-1111

8:30 AM Introduction of Panel Members - (FIFRA SAP Session Chair)
8:45 AM Administrative Procedures by Designated Federal Official - Ms. Olga Odiott
8:50 AM Welcome - Ms. Sherry Sterling (Deputy Director, Office of Science Coordination and Policy, Office of Prevention, Pesticides and Toxic Substances, EPA)
9:00 AM Opening Remarks - Ms. Marcia Mulkey (Director, Office of Pesticide Programs, EPA)

Cumulative and Aggregate Risk Evaluation System (CARES) ™
Model Operation Review

9:10 AM Introduction and Overview - Mr. Frances Suhre and Mr. David Miller (Health Effects Division, Office of Pesticide Programs, EPA)

9:30 AM CARES Development Team - Angelina Duggan, Ph.D. (CropLife America)

9:45 AM CARES Model Overview- Charles Breckenridge, Ph.D. (Novartis)

10:45 AM BREAK

11:00 AM Model Construct and Software Code - Muhilan Pandian, Ph.D. (Infoscientific.com)

12:00 PM LUNCH

1:00 PM Model Demonstration - Muhilan Pandian, Ph.D. (Infoscientific.com)

1:30 PM Public comments
2:30 PM Questions to the Panel - Mr. Francis Suhre (Health Effects Division, Office of Pesticide Programs, EPA)

Documentation and Operation
CARES Documentation in the form of a User Guide, Technical Manual, and Code Manual were provided to the SAP to assist in their review of the CARES software.

Question 1: The User Guide provides installation instructions and 5 case study tutorials to illustrate operational features of the CARES software. Is the Technical Guide complete and understandable? Were Panel members able to load the software on to their computers and complete some or all of the case study tutorials?

Lead Discussants: Dr. Lauren Zeise and Dr. Nu-May Ruby Reed

3:00 PM BREAK

3:15 PM Questions to the Panel (Cont.)

Question 2: The Technical Manual provides an overview of the CARES model and detailed descriptions of key model components. Is the Technical Manual complete and understandable, and are the descriptions of specific model components scientifically sound?

Lead Discussants: Dr. Bernard Engel and Dr. Patrick Durkin


Question 3: The Code Manual provides annotated code for select risk assessment algorithms used in the model. Do the algorithms in the annotated code perform the functions defined in the CARES Technical Manual?

Lead Discussants: Dr. Kenneth Portier and Dr. Peter Macdonald

4:30 PM ADJOURNMENT


FIFRA SCIENTIFIC ADVISORY PANEL (SAP)
OPEN MEETING
WEDNESDAY, MAY 1, 2002

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/
OPP Docket Telephone: (703)305-5805

Sheraton Crystal City Hotel
1800 Jefferson Davis Highway
Arlington, VA 22202
(703) 486-1111

8:30 AM Introduction of Panel Members - (FIFRA SAP Session Chair)
8:45 AM Administrative Procedures by Designated Federal Official - Ms. Olga Odiott

Cumulative and Aggregate Risk Evaluation System (CARES) ™
Model Operation Review

8:55 AM Questions to the Panel (Cont.) -Francis Suhre, M.S., Health Effects Division, Office of Pesticide Programs, EPA

Model Design

Question 4: The key data sources used in CARES include the US Census /PUMS and the CSFII/FCID. Is the methodology used by the CARES Population Generator to create the CARES Reference Population based on appropriate consideration of demographics factors (vector of individual characteristics) and statistical representativeness?

Lead Discussants: Dr. Steven Heeringa, Dr. Kenneth Portier, and Dr. Natalie Freeman, and Dr. Dale Hattis

Question 5: The CARES reference population constructs a 365-day dietary profile by matching similar individuals in the CSFII database using specific matching rules. Does the CARES approach provide a reasonable and realistic construct with respect to temporal variability in magnitude and frequency of food consumption?

Lead Discussants: Dr. Dale Hattis, Dr. Peter Macdonald, and Dr. Nu-May Ruby Reed

10:30 AM BREAK

10:45 AM Questions to the Panel (Cont.)

Question 6: What can the panel say about how these databases were used together in estimating dietary exposure? Are there other publicly available sources of relevant data? What research opportunities would support a refined calendar based, probabilistic exposure and risk analyses using CARES?

Lead Discussants: Dr. Bernard Engel, Dr. Nu-May Ruby Reed, and Dr. Lauren Zeise

12:30 PM LUNCH

1:30 PM Questions to the Panel (Cont.)

Question 7: The CARES residential model uses an Event Allocation Module to create a temporal profile of residential-related product use occurrences, and includes a product co-occurrence matrix that can be derived from available survey instruments. Does the CARES approach provide a reasonable and realistic construct with respect to temporal variability in magnitude and frequency of residential use and the likelihood of exposure co-occurrence events?

Lead Discussants: Dr. John Adgate, Dr. Patrick Durkin, and Dr. Natalie Freeman

Model Results

Question 8: Case studies described in the Users' Manual and provided on the CARES - CD illustrate the complexity of conducting Monte Carlo simulations in a PC environment ( multiple parameters for multiple chemicals, where dose and risk from multiple vectors of exposure are calculated over 365 days). Does the SAP believe that an iterative testing strategy with CARES could be developed (conduct of multiple simulations with progressive refinement once risk drivers have been identified) that will permit the user to obtain information on source contribution necessary for decision making?

Lead Discussants: Dr. Dale Hattis, Dr. Steven Heeringa, Dr. Peter Macdonald, and Dr. Thomas Potter

3:00 PM BREAK

3:15 PM Questions to the Panel - (Cont)

Question 9: What types of contribution/sensitivity analysis are recommended by the panel to be most useful in making scientifically-sound regulatory decisions for one or more pesticides and their associated agricultural, professional and consumer uses? What should be routinely reported as part of a CARES assessment with respect to inputs and outputs? Are there certain key graphs and tables that should be reported? What types of model evaluation steps does the panel recommend to further refine and advance models such as CARES?

Lead Discussants: Dr. Steven Heeringa, Dr. Peter Macdonald, and Dr. Thomas Potter

4:30 PM ADJOURNMENT

FIFRA Scientific Advisory Panel (SAP) April Meeting Agenda


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