SCIENTIFIC ADVISORY PANEL (SAP) OPEN MEETING OCTOBER 23, 24, and 25, 2001

OCTOBER 18, 2001

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

TUESDAY OCTOBER 23, 2001
Sheraton Crystal City Hotel
1800 Jefferson Davis Highway
Arlington, VA 22202
(703) 486-1111

OFFICE OF PESTICIDE PROGRAMS' PRELIMINARY EVALUATION OF THE NON-DIETARY HAZARD AND EXPOSURE TO CHILDREN FROM CONTACT WITH CHROMATED COPPER ARSENATE (CCA)-TREATED WOOD PLAYGROUND STRUCTURES AND CCA-CONTAMINATED SOIL.

8:30 AM Introduction of Panel Members - Stephen Roberts, Ph.D. (FIFRA SAP Session Chair)
8:45 AM Administrative Procedures by Designated Federal Official - Ms. Olga Odiott
8:50 AM Welcome - Vanessa Vu, Ph.D. (Director, Office of Science Coordination and Policy, Office of Prevention, Pesticides and Toxic Substances, EPA)
8:55 AM Opening Remarks - Mr. James Jones, (Deputy Director, Office of Pesticide Programs, Office of Prevention, Pesticides and Toxic Substances, EPA)
9:00 AM Introduction and Overview - Mr. Norm Cook, Antimicrobials Division, Office of Pesticide Programs, EPA SESSION I: HAZARD ENDPOINTS
9:25 AM Use Profile of CCA and Overview of Chemistry of Arsenic and Chromium - Nader Elkassabany, Ph.D., Antimicrobials Division, Office of Pesticide Programs, EPA
9:40 AM Arsenic - Hazard Assessment and Toxicology Endpoints - Timothy McMahon, Ph.D., Antimicrobial Division, Office of Pesticide Programs, EPA
10:15 AM Chromium - Hazard Assessment and Toxicology Endpoints - Timothy McMahon, Ph.D., Antimicrobial Division, Office of Pesticide Programs, EPA
10:45 AM Break
11:00 AM Bioavailability - Jonathan Chen, Ph.D., Antimicrobial Division, Office of Pesticide Programs, EPA
11:30 AM Overview of Superfund short-term approach - Bob Benson, Ph.D., Region 8 , EPA
12:00 AM Arsenic Health Effect Review and Status of Arsenic Regulation in EPA's Office of Water - Charles Abernathy, Ph.D., Office of Water, EPA
12:30 AM Lunch
1:30 PM Public Comments
Mike McGrath, Private Citizen

Jane Houlihan, on behalf of Environmental Working Group

Cristopher Williams, Ph.D., on behalf of Ecology and Environment Inc.

Ligia Mora-Applegate, M.S.P., M.P.A., M.P.H., on behalf of Florida Department of Environmental Protection

H. Vashen Aposhian, Ph.D, on behalf of Arch Chemicals Inc.

Pascal Kamdem, Ph.D., on behalf of American Forest and Paper Association

Barbara Beck, Ph.D., Gradient Corporation, on behalf of Osmose and Arch Chemicals, Inc.

Jay Feldman, on behalf of Beyond Pesticides/NCAMP
3:30 PM Break
3:45 PM Public Comments (cont.)
Yvette Lowney, on behalf of the American Chemistry Council

John Butala, M.S., on behalf of American Chemistry Council Arsenical Wood Preservatives Task Force

Joyce Tsuji, Ph.D., E^xponent, on behalf of American Forest and Paper Association

5:30 PM ADJOURNMENT

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)
OPEN MEETING
OCTOBER 23, 24, and 25, 2001

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

WEDNESDAY, OCTOBER 24, 2001
Sheraton Crystal City Hotel
1800 Jefferson Davis Highway
Arlington, VA 22202
(703) 486-1111

8:30 AM Introduction of Panel Members - Stephen Roberts, Ph.D. (FIFRA SAP Session Chair)

8:45 AM Administrative Procedures by Designated Federal Official - Ms. Olga Odiott

8:50 AM Welcome - Vanessa Vu, Ph.D. (Director, Office of Science Coordination and Policy, Office of Prevention, Pesticides and Toxic Substances, EPA)

SESSION II: EXPOSURE SCENARIOS FOR PLAYGROUND ASSESSMENT

9:00 AM Introduction - Mr. Norm Cook, Antimicrobials Division, Office of Pesticide Programs, EPA

9:05 AM Exposure Assessment Methodology - Ms. Doreen Aviado, Antimicrobials Division, Office of Pesticide Programs, EPA

10:00 AM BREAK

10:15 AM Dislodgeable residue data - David E. Stilwell, Ph.D., Connecticut Agricultural Experiment Station, University of Connecticut

10:45 AM Sealants - David E. Stilwell, Ph.D., Connecticut Agricultural Experiment Station, University of Connecticut

11:15 AM Soil Residue Data - Timothy Townsend, Ph.D., Department of Environmental Engineering Sciences, University of Florida, Gainsville, FL

11:45 AM Buffering Materials -Timothy Townsend, Ph.D., Department of Environmental Engineering Sciences, University of Florida, Gainsville, FL

12:15 PM LUNCH

1:30 AM Exposure Assumptions Used in Superfund Program - Bob Benson, Ph.D., Region 8 , EPA

1:50 PM Questions to the Panel - Hazard Endpoints - Tim McMahon, Ph.D., Antimicrobials Division, Office of Pesticide Programs, EPA

Short- and Intermediate-term Endpoint Selection for Inorganic Arsenic

Question 1: Please comment on the Agency's selection of the 0.05 mg/kg/day LOAEL value for use in assessing risks to the general population as well as children from short-term and intermediate-term incidental oral and dermal exposures, and the appropriateness of the use of a 10x factor for severity of the toxic effects observed in the Mizuta study. Please provide an explanation and scientific justification for your conclusions as to whether the presented data are adequate or whether other data should be considered for selection of this endpoint.

Lead Discussants: Drs. Bruckner, Francois, and Steinberg

Relative Bioavailability of Inorganic Arsenic

Question 2: Please comment on the choice of this data set and value chosen for representation of the relative bioavailability of inorganic arsenic from ingestion of arsenic-contaminated soil. Please discuss the strengths and weaknesses of the selected data and also provide an explanation as to whether this 25% value is appropriate for estimation of bioavailability in children.

Lead Discussants: Drs. Bates, Bruckner, Kosnett, and Styblo

3:30 PM BREAK

3:45 PM Questions to the Panel (cont.)

Dermal Absorption Value for Inorganic Arsenic

Question 3: Please comment on the selection of the value of 6.4% for dermal absorption of inorganic arsenic and whether or not this value will be appropriate for use in all scenarios involving dermal exposure to arsenic from CCA -treated wood, including children's dermal contact with wood surface residues and contaminated soils.

Lead Discussants: Drs. Bates, Hopenhayn-Rich, and Kosnett

Selection of Hazard Database for Hazard Characterization of Inorganic Chromium inCCA-Treated Wood

Question 4: As available monitoring data do not differentiate among chromium species found in CCA dislodgeable residues on wood surfaces and in soils, and as Cr (VI) is the more toxic species of chromium, please comment on whether use of the hazard data for chromium (VI) is the best choice for characterizing hazard and risk from exposure to chromium as a component ofCCA-treated wood. Please provide a scientific explanation and justification for your recommendation on the choice of either the chromium (III) or chromium (VI) hazard database.

Lead Discussants: Drs. Chou, Morry, and Mushak

Short - and Intermediate-term Endpoint Selection for Inorganic Chromium

Question 5: Please comment on the Agency's selection of the 0.5 mg/kg/day NOAEL value for use in assessing risks to the general population as well as children from short-term and intermediate-term incidental oral exposures to inorganic chromium as contained inCCA-treated wood. Please provide an explanation and scientific justification for your conclusions as to whether the presented data are adequate or whether other data should be considered for selection of these endpoints.

Lead Discussants: Drs. Lees, Shi, and Styblo

Selection of Endpoints for Dermal Risk Assessments for Inorganic Chromium

Question 6: Please comment on whether the significant non-systemic dermal effects from dermal exposure to inorganic chromium should form the basis of dermal residential risk assessments, and, if so, how the Agency should establish a dermal endpoint for such an assessment.

Lead Discussants: Drs. Lees, Morry, and Wargo
5:30 PM ADJOURNMENT FIFRA SCIENTIFIC ADVISORY PANEL (SAP)
OPEN MEETING
OCTOBER 23, 24, and 25, 2001

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

THURSDAY, OCTOBER 25, 2001
Sheraton Crystal City Hotel
1800 Jefferson Davis Highway
Arlington, VA 22202
(703) 486-1111
8:30 AM Introduction of Panel Members - Stephen Roberts, Ph.D. (FIFRA SAP Session Chair)
8:45 AM Administrative Procedures by Designated Federal Official - Ms. Olga Odiott

8:50 AM Welcome Vanessa Vu, Ph.D. (Director, Office of Science Coordination and Policy, Office of Prevention, Pesticides and Toxic Substances, EPA)
9:00 AM Questions to the Panel- Exposure Scenarios for Playground Assessment- Doreen Aviado, Antimicrobials Division, Office of Pesticide Programs, EPA
Selection of Parameters and Methodology for Characterizing Child Exposures

Question 7: Please comment on whether OPP's choices of central tendency and high end values for different parameters should, collectively, produce estimates of the middle and high end of the range of potential exposures. If the Panel thinks that OPP's approach may not estimate the high ends of the exposure range (because it produces values that are either higher or lower than the upper end of the exposure range), please comment on what specific values should be modified to produce estimates of the high end of potential exposure.

Lead Discussants: Drs. Freeman, Heeringa, and Macdonald

Question 8: Please comment on whether the existing data bases on the variability of the different parameters affecting potential exposure are adequate to support the development of probabilistic estimates of potential exposure. If the Panel regards the data bases as adequate for that purpose, please identify which parameters should be addressed using a distribution of values and which data bases should be used to supply the distribution for particular parameters.

Lead Discussants: Drs. Clewell, Heeringa, and Macdonald

10:30 AM BREAK

10:45 AM Questions to the Panel (cont.)
Transfer of Residues from Wood Surface to Skin

Question 9: OPP is assuming that a one-to-one relationship applies to the transfer of residues from wood to skin. The Panel is asked to address whether this is a reasonable assumption, and if not, to provide guidance on other approaches.

Lead Discussants: Drs. Freeman, Hopenhayn-Rich, and Kissel

Selection of a Soil Adherence Factor

Question 10: The Panel is asked to comment on whether the proposed AF of 1.45 mg/cm² for hand contact with commercial potting soil is a realistic value for use in estimating the transfer of residues from playground soil to skin in this assessment.

Lead Discussants: Drs. Adgate, Chou, and Kissel

Variability of Residue Data Available for Soil and Wood

Question 11: OPP will need to calculate intermediate-term, and possibly long-term exposures in this assessment using available wood/soil residue data. The Panel is asked to recommend a credible approach for selecting residue data values for use in OPP's risk assessment, taking into consideration the inherent variability of the data sets. Please advise us on which values are best for representing central tendency and high end exposures. Also, the Panel is asked to discuss the feasibility of combining data from individual data sets.

Lead Discussants: Drs. Adgate, Clewell, and Leidy
12:30 PM LUNCH
1:30 PM Questions to the Panel (cont.) Combining Multiple Exposure Scenarios into a Comprehensive Estimate of Risk
Question 12: Does the Panel have any recommendations for combining the four scenarios (oral/wood, dermal/wood, oral/soil, dermal/soil) such that a realistic aggregate of these exposure routes may be estimated?

Lead Discussants: Drs. Leidy, Steinberg, and Wargo

Inhalation Exposure Potential from Wood/Soil Media

Question 13: Can the Panel comment on whether OPP should conduct a child playground inhalation exposure assessment, taking into consideration the hazard profile for chromium (VI) as an irritant to mucous membranes? If so, can the Panel comment on whether the endpoint described above is appropriate for assessing the risk to children from such an exposure? Lead Discussants: Drs. Bruckner, Gordon, and Shi
3:00 PM BREAK
3:15 PM Questions to the Panel (cont.)
Consideration of Buffering Materials as a Source of Exposure

Question 14: Data on the effectiveness of reducing exposure by using buffering materials are limited. Does the Panel have recommendations as to whether additional studies to obtain this information are warranted? Does the Panel have suggestions on how OPP can best evaluate child exposures attributed to contact withCCA-contaminated buffering materials ?

Lead Discussants: Drs. Ginsberg, Smith, and Solo-Gabriele

Effectiveness of Stains/Sealants/Coatings at Reducing Leaching of CCA Compounds from Treated Wood

Question 15: The Panel is asked to comment as to whether stains, sealants and other coating materials should be recommended as a mitigation measure to reduce exposure to arsenic and chromium compounds from CCA treated wood. If so, can the Panel comment on the most appropriate way for the Agency to recommend effective coating materials when the current data on long-term performance are limited and sometimes inconsistent, and should the Agency specify a time interval for the re-application of these selected coating materials? Can the Panel make recommendations for additional studies?

Lead Discussants: Drs. Ginsberg, Smith, and Solo-Gabriele
4:30 PM ADJOURNMENT

Please be advised that agenda times are approximate. For further information, please contact the Designated Federal Official for this meeting, Ms. Olga Odiott, via telephone: (703) 305-5369; fax: (703) 605-0656; or email:Odiott.Olga@epa.gov.

SCIENTIFIC ADVISORY PANEL (SAP) OPEN MEETING OCTOBER 23, 24, and 25, 2001

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