Jump to main content.


October 28 - 29, 2003 Agenda


Revised 10/06/2003

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)
OPEN MEETING
October 28 and 29, 2003
FIFRA SAP WEB SITE https://www.epa.gov/scipoly/sap/
OPP Docket Telephone: (703)305-5805

ENSURING DATA QUALITY FOR IN VITRO TESTS USED AS ALTERNATIVES
TO ANIMAL STUDIES FOR REGULATORY PURPOSES: A CONSULTATION

Tuesday, October 28, 2003
Holiday Inn Hotel
1900 North Fort Myer Drive
Arlington, VA 22209
(703) 807-2000

Please note that all times are approximate.

8:30 AM Meeting Opening - Stephen M. Roberts, Ph.D. (Chair of the FIFRA SAP)
8:35 AM Introduction of Panel Members - Steven Heeringa, Ph.D. (FIFRA SAP Session Chair)
8:40 AM Administrative Procedures by Designated Federal Official - Mrs. Myrta R. Christian
8:45 AM Welcome - Mr. Joseph Merenda (Director, Office of Science Coordination and Policy, EPA)
8:50 AM Opening Remarks - Mr. Jim Jones (Director, Office of Pesticide Programs, EPA)
8:55 AM Background on use of In Vitro Alternative Test Methods - Amy Rispin, Ph.D. (Office of Pesticide Programs, EPA)
Legal Considerations Pertaining to Use of Proprietary Test Methods (PTMs) in Agency Guidelines - Donald Sadowsky, Esq. (Office of General Counsel, EPA)

10:30 AM Break
10:45 AM Validation of new, revised, and alternative test methods: Updated ICCVAM submission guidelines and development of performance standards for Proprietary Test Methods (PTMs) William Stokes, D.V.M. (NIH, NIEHS)

11:45 AM Lunch

1:00 PM Good Laboratory Practices and Quality control requirements - Frances Liem, Ph.D. ( Office of Enforcement and Compliance Assurance, EPA)

1:45 PM Application of ICCVAM and Agency Quality Control Approaches: Performance Standards for Three Validated In Vitro Corrosivity Methods - Deborah McCall (Office of Pesticide Programs, EPA)

The Role of Controls, benchmarks, calibration sets, training sets and data reporting in quality control for in vitro methods - John Harbell, Ph.D. (Institute for In Vitro Sciences, Inc.)

3:15 PM Break
3:30 PM Public Comments
5:00 PM Adjournment


Wednesday October 29, 2003
Holiday Inn Hotel
1900 North Fort Myer Drive
Arlington, VA 22209
(703) 807-2000

Please note that all times are approximate.

8:30 AM Meeting Opening - Stephen M. Roberts, Ph.D. (Chair of the FIFRA SAP)
8:35 AM Introduction of Panel Members - Steven Heeringa, Ph.D. (FIFRA SAP Session Chair)
8:40 AM Administrative Procedures by Designated Federal Official - Mrs. Myrta R. Christian
8:45 AM Questions to the Panel

I. Performance Standards

The Agency plans to adopt the Performance Standards developed by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) as a means of communicating the basis by which each of three validated in vitro test methods, Corrositex®, EPISKIN™/EpiDerm™, and Transcutaneous Electrical Resistance (TER), are deemed acceptable for providing dermal corrosivity data. Performance Standards consist of descriptions of (1) essential test method components, which are the essential structural, functional, and procedural elements of a validated test method that should be included in the protocol of a proposed mechanistically and functionally similar test method; (2) a minimum list of Reference Chemicals, which is used to assess the accuracy and reliability of the similar test method; and (3) comparable accuracy and reliability values that should be achieved by the proposed test method when evaluated using the minimum set of Reference Chemicals.

10:00 AM Break
10:15 AM Questions to the Panel (continued)

II. Quality Control

The Agency is proposing quality control measures that should be considered when evaluating the reliability of test kits for regulatory purposes. Please address the following specific issues.

12:00 PM Adjournment

As noted above, please be advised that agenda times are approximate. For further information, please contact the Designated Federal Official for this meeting, Mrs. Myrta R. Christian, via telephone: (202) 564-8450; fax: (202) 564-8382; or email:christian.myrta@epa.gov

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)
OPEN MEETING


Local Navigation


Jump to main content.