December 2001 Meeting Agenda

December 4, 2001

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

TUESDAY, DECEMBER 11, 2001
SHERATON CRYSTAL CITY HOTEL
1800 JEFFERSON DAVIS HIGHWAY
ARLINGTON, VIRGINIA 22202
703-486-1111
Applicability of the Local Lymph Node Assay in Dermal Sensitization Testing

8:30 AM Introduction and identification of Panel members - Fumio Matsumura, Ph.D. (FIFRA SAP Session Chair)
8:45 AM Administrative procedures by Designated Federal Official Mr. Paul I. Lewis
8:50 AM Welcome Richard Hill, M.D. (Office of Science Coordination and Policy, Office of Prevention, Pesticides and Toxic Substances, EPA)
8:55 AM Introductory remarks Mr. Jay Ellenberger (Associate Director, Field and External Affairs Division, Office of Pesticide Programs, Office of Prevention, Pesticides and Toxic Substances, EPA)
9:00 AM Overview of test guideline activities Ms. Debbie McCall (Office of Pesticide Programs, EPA)
9:15 AM Introduction, goals and objectives on local lymph node assay Karen Hamernik, Ph.D. (Office of Pesticide Programs, EPA)
10:00 AM BREAK
10:15 AM Description of local lymph node assay procedure Jean Meade, Ph.D. (National Institute of Occupational Safety and Health)
10:45 AM Hypersensitivity testing: OPP/OPPT positions Ms. Debbie McCall (Office of Pesticide Programs, EPA)
11:15 AM Review of Agency questions Karen Hamernik, Ph.D. (Office of Pesticide Programs, EPA)
11:20 AM Public Comments
Martin L. Stephens, Ph.D. on behalf of The Humane Society of the United States
12:30 PM LUNCH
1:30 PM Panel Discussion
1. The LLNA is generally applicable to testing a wide range of chemicals except for metallic compounds and substances which do not sufficiently adhere to the ear, such as aqueous materials. Compared to currently accepted guinea pig methods, the LLNA:

(a) provides quantitative as well as qualitative data and an assessment of dose-response;

(b) is suitable for testing colored substances since an erythematous response is not produced; and,

(c) provides various advantages for animal welfare (e.g. less animal discomfort, shorter test duration, and potentially fewer animals).

Question: Does the Panel agree with the Agency's proposal that, when appropriate, the LLNA should be the preferred dermal sensitization test?

Lead Discussants: Drs. Luster and Patterson

2. ICCVAM recommended and EPA agrees that a concurrent positive control should be included as part of each LLNA to assess proper assay conduct and to use as a standard for comparison of results between studies and laboratories.

Question: Does the Panel agree that a concurrent positive control should be included with each chemical assessed by the LLNA? If not, what does the panel suggest?

Lead Discussants: Drs. Chu and Freeman

3. EPA proposes that both stimulation index and statistical evaluations of dosed versus control animals be developed to aid in the evaluation of the test outcome.

Question: Has enough guidance been provided in the revised guidelines as to what constitutes a positive hypersensitivity response in the LLNA? If not, what guidance does the Panel suggest?

Lead Discussants: Drs. deGeorge and Bowes

4. LLNA, guinea pig and human patch test outcomes are available for some 200 chemicals. Results in the LLNA compared favorably with those from the guinea pig. The LLNA was at least as good as the guinea pig test in predicting human responsiveness.

Question: Does the Panel agree that the LLNA guideline can be used for chemicals regulated in both the pesticides and toxic substances programs?

Lead Discussants: Drs. Patterson and Bowes

5. The OPPTS guideline builds upon the recommendations made by ICCVAM and it is harmonized with the guideline recently approved in principle by OECD.

Question: Is the draft LLNA test method complete and clearly presented in the revised OPPTS guideline for skin sensitization? If not, please supply guidance for improving the presentation.

Lead Discussants: Drs. Luster and Patterson
3:30 PM ADJOURNMENT

Please be advised that agenda times are approximate. For further information, please contact the Designated Federal Official for this meeting, Mr. Paul Lewis, via telephone: (202) 564-8381; fax: (202) 564-8382; or email:lewis.paul@epa.gov.

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)
OPEN MEETING
DECEMBER 11-12, 2001

December 2001 Meeting Agenda

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