HSRB Chair Summary of October 20 Recommendations

1. Sean Philpott, PhD, MSBioethics HSRB Chair October 21, 2009 HSRB Chair Summary of October 20 Recommendations

2. Newton and Breslin (1983) 1. Is the Newton and Breslin (1983) study scientifically sound, providing reliable data? Given the substantial limitations of the study, the Board recommended that the Agency be cautious in its use of the data published in this study, limiting its consideration of this study to a careful consideration of its qualitative contribution to the overall weight of evidence.

3. Newton and Breslin (1983) 2. Is the Newton and Breslin (1983) study relevant to an assessment of the proposition that exposures to pyrethins/pyrethoids may be associated with asthmatic or allergic respiratory responses? The Board concluded that the study provides, at best, some data to assess the association of the particular aerosol spray used in the study with the relevant responses, but the lack of appropriate controls does not allow an assessment of exposures to pyrethins/ pyrethoids with asthmatic or allergic responses.

4. Newton and Breslin (1983) 3. What limitations of the Newton and Breslin (1983) study should be taken into account by EPA in assessing the proposition that exposures to pyrethins/pyrethoids may be associated with asthmatic or allergic respiratory responses? The substantial limitations of this study include, but are not limited to: the limited sample size; incomplete description of the methodolgy; the lack of complete data for most participants; the lack of appropriate controls; the lack of statistical analysis; the subjective response measured; etc.

5. Newton and Breslin (1983) 4. Is there clear and convincing evidence that the conduct of the Newton and Breslin (1983) study was fundamentally unethical or significantly deficient relative to the standards of ethical research prevailing when it was conducted? Given the limited information available, the Board concluded that there was no clear and convincing evidence that the study was fundamentally unethical or significant deficient.

6. Lisi (1992) 1. Is the Lisi (1992) study scientifically sound, providing reliable data? Given the brevity of the report, which makes a complete evaluation of the methodology and data difficult, the Board recommended that the Agency be cautious in its use of the data published in this study, limiting its consideration of this study to a careful consideration of its qualitative contribution to the overall weight of evidence (particularly within a framework of hazard identification).

7. Lisi (1992) 2. Is the Lisi (1992) study relevant to an assessment of the proposition that exposures to pyrethins/ pyrethoids may be associated with allergic contact dermatitis or sensitization responses? The Board concluded that the study provides some data to assess the association of the compounds tested (particularly the cyanopyrethoids) with the relevant responses. The low response rate, coupled with the information in footnote 1 to the data table, suggest that the reactions seen are likely irritant responses.

8. Lisi (1992) 3. What limitations of the Lisi (1992) study should be taken into account by EPA in assessing the proposition that exposures to pyrethins/ pyrethoids may be associated with allergic contact dermatitis or sensitization responses? The substantial limitations of this study include, but are not limited to: the limited description of the methodolgy; uncertainty about participant compliance; the lack of appropriate controls; the lack of statistical analysis; etc.

9. Lisi (1992) 4. Is there clear and convincing evidence that the conduct of the Lisi (1992) study was fundamentally unethical or significantly deficient relative to the standards of ethical research prevailing when it was conducted? Given the extremely limited information available, the Board concluded that there was no clear and convincing evidence that the study was fundamentally unethical or significant deficient.

10. AEATF II Aerosol Application 1. Is the research likely to generate scientifically reliable data, useful for assessing the exposure of handlers who apply antimicrobial pesticides formulated as aerosol sprays? If revised as recommended and performed as described, the protocol is likely to generate reliable useful data. The Board also provided several recommendations for study improvement, including consideration of consumer users (in this or a subsequent study), criteria for exclusion of participants who deviate grossly from the protocol, likely differences in the air sampling results depending on the method used, and careful consideration about other variables that may influence measurement of exposure.

11. AEATF II Aerosol Application 2. Is the research likely to meet the applicable requirements of 40 CFR part 26, subparts K and L? If revised as recommended and performed as described, the protocol is likely to meet the applicable requirements. The Board also provided several recommendations for study improvement, including consideration of broader community notification (e.g. the risks to other guests at the hotels used as testing sites), reconsidering the reading level and idioms used in the English and Spanish versions of the consent document, and exclusion of immunocompromised or other participants who may be at increased physical risk of participation.