23Sponsor is developing 145No Mas146 as a lowcost repellent for distribution in developing countries spectrum efficacy against more than 40 species of mosquitoes including four of the most important ID: 876639
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1 2 Test material is called ‘No Mas&#
2 Test material is called ‘No Mas’‘No Mas’ is a lotion formulation containing 16% PMD and 2% lemongrass oilResearch conducted in California, at two sites, in July 2011Fina
2 l report submitted to EPA in August 2011
l report submitted to EPA in August 2011 3 Sponsor is developing ‘No Mas’ as a low-cost repellent for distribution in developing countries spectrum efficacy against more than 40 spe
3 cies of mosquitoes, including four of th
cies of mosquitoes, including four of the most important The purpose of the present study was to test the product for efficacy against three mosquito EPA Science Review of Carroll-Loye Effic
4 acy Test of NO-MAS 003, MRID 48577201. U
acy Test of NO-MAS 003, MRID 48577201. Unpublished document prepared by Carroll-Loye Biological Research. 411 p. by Clara Fuentes, Ph.D.Field Test of Mosquito Repellency for p-menthane-3,8-d
5 iol (PMD) and Lemongrass Oil-Based Repel
iol (PMD) and Lemongrass Oil-Based Repellent ‘No Mas’ Clara Fuentes, Ph.D.Biopesticidesand Pollution Prevention Division EPA Science Review of Carroll-LoyeBiological Research Compl
6 eted Study ‘No Mas003’ Assess
eted Study ‘No Mas003’ Assess the validity of the efficacy data for evaluating the performance of ‘NO MAS’ Provide scientific review of the study and its consistency with
7 approved protocol NO MAS- EPA Scientific
approved protocol NO MAS- EPA Scientific AssessmentThe Carroll-LoyeEfficacy Test, NO-MAS 003, MRID 48577201, was conducted in a manner substantially consistent with the study protocol reviewe
8 d by EPA and the HSRB Protocol amendment
d by EPA and the HSRB Protocol amendments were approved prior to study initiation The reported deviation is expected to improve data quality. to estimate the mean value of Complete Protection
9 time (CPT) within 95% confidence interv
time (CPT) within 95% confidence intervalto provide efficacy data required to support Standard consumer dose for arms and legs was determined from grand mean of 10 subject means (5 males an
10 d 5 females).Sample size: 10 treated sub
d 5 females).Sample size: 10 treated subjects (5 males and 5 females) per site.Test sites: 2 different mosquito habitats Number of treatments: 1 lotion formulationNegative control: 2 untreate
11 d subjects/ site to monitor landing acti
d subjects/ site to monitor landing activity DosimetryEndpoint and Standard Consumer DoseDosimetryEndpoint: Standard Consumer Dose Arms = 1.14 mg/cmLegs = 0.99 mg/cmStandard consumer dose us
12 ed for testing efficacy;Arms = 1.14 mg/c
ed for testing efficacy;Arms = 1.14 mg/cm(0.9524 kg/L) =1.20 µl/cmLegs = 0.99 mg/cm(0.9524 kg/L) =1.04 µl/cm Arms MOE � 583Legs MOE � 287 mg/kg b.w. and standard dose Effica
13 cy Endpoint and Other Measurements Compl
cy Endpoint and Other Measurements Complete Protection Time (CPT)Landing pressure (threshold=1 LIBe/minute)Exposure delay (min)-time between application -Site 1 = 3.2 hours-Site 2 = 6 minutes
14 Duration of exposure: 1 minute every 15
Duration of exposure: 1 minute every 15 minutes Results from Field Test: Time Distribution of CPT by Site 14 CPT (Yes orNumber 11.171189.60 CPT (Yes orr of .25 Results from Field Test: Mosqui
15 to species by Site 15 Mosquitoescollecte
to species by Site 15 MosquitoescollectedMosquitoTotalcollectedTotalcollectedControlTreatedvexansTotal MosquitoescollectedMosquitoTotalcollectedTotalcollectedControlTreatedAedesvexansCulextar
16 salisTotal Statistical AnalysisDosimetry
salisTotal Statistical AnalysisDosimetry procedure Average testing dose was the grand mean (±SD) across 10 subjects’ Sample size: 10 subjects/test site.Statistical methods employed to
17 calculate CPT within 95% CI:Kaplan-Meie
calculate CPT within 95% CI:Kaplan-Meier median, and Complete Protection Time Values by Site(from Carroll-LoyeBiological Research) CPT (hours)Lower 95%Upper 95%Weibull meanWeibull meanCPT va
18 lues within 95% CI by test site Statisti
lues within 95% CI by test site Statistical Questions for the HSRBWhich statistical method is appropriate to calculate the Complete Protection Time for the NO MAS repellent?Parametric (with W
19 eibulldistribution) or 2. Non-parametric
eibulldistribution) or 2. Non-parametric (Kaplan-Meier)? Summary Assessment of Reliability Test material was applied by laboratory technicians. Summary Assessment of Reliability (Cont.)Measu
20 rement of uncertainty Mean CPT was calcu
rement of uncertainty Mean CPT was calculated across all 10 subjects/site, and was presented within 95% Weibulldistribution. The following elements are adequately addressed: Prerequisite acut
21 e toxicity research to characterize toxi
e toxicity research to characterize toxicological profile of the formulation and calculate DosimetryExperimental design Verification of subject attractiveness to mosquitoes21 The study is sci
22 entificallyacceptableThe data provides s
entificallyacceptableThe data provides scientifically reliable It has a defined scientific objective 23 Carroll-LoyeBiological Research Completed Study ‘No Mas003’ Recruiting proces
23 s outlined in the protocol was followed3
s outlined in the protocol was followed32 subjects were selected randomly from a pool of 92 subjects10 subjects participated in the dosimetry phase22 subjects participated in the field testin
24 g at one or both sites6 subjects were en
g at one or both sites6 subjects were enrolled as alternates MSD sheet, study synopsis, consent form, California Experimental Bill of Rights, and No reported or unreported deviations related
25 Field testing, at each site:Treated sub
Field testing, at each site:Treated subjects: 5 males, 5 femalesUntreated controls: 1 male, 1 femaleAll subjects over the age of 18 Research was conducted without No adverse events or incide
26 nts of 28 No Mas003: Protocol ReviewPro
nts of 28 No Mas003: Protocol ReviewProtocol was approved by IIRB, Inc. and submitted EPA’s science and ethics review found the protocol Reviewed by the HSRB on 10/27/10HSRB concurred w
27 ith EPA, recommended minor Amendment 1 d
ith EPA, recommended minor Amendment 1 dated 11/15/10, addressed most EPA and HSRB comments; approved by IIRB 11/16/10Amended protocol was approved by CDPR on 29 No Mas003: Amendment 1Adjust
28 s wording in the protocol and consent fo
s wording in the protocol and consent form per recommendations from EPA, HSRB, the sponsor or researchers 30 Most of EPA’s/HSRB’s comments from the protocol review were addressed in
29 Amendment 1:Employees of the sponsor we
Amendment 1:Employees of the sponsor were excluded as permissible subjectsSymptoms of heat stress and equine encephalitis were added to Most drafting recommendations were incorporatedThe acr
30 onym PMD was not spelled out when first
onym PMD was not spelled out when first used“Child/Minor” was not added to the list of exclusion criteria, although the inclusion criteria specify that subjects must be between 18-5
31 5 years old 31 One deviation: reformatti
5 years old 31 One deviation: reformatting of dosimetry 32 The primary study report, MRID 48577201, is All requirements of 40 CFR 26.1303 for documentation of ethical conduct are satisfied 3
32 3 Substantive Acceptance Standards40 CFR
3 Substantive Acceptance Standards40 CFR 26.1703Prohibits reliance on data involving intentional exposure of pregnant or nursing women or of children40 CFR 26.1705Prohibits reliance on data u
33 nless EPA has adequate subparts A throug
nless EPA has adequate subparts A through L for 40 CFR 26Makes it unlawful to use a pesticide in human tests without fully informed, fully voluntary consent 34 No Mas 003 did not involve inte
34 ntional exposure of pregnant or nursing
ntional exposure of pregnant or nursing women or of ‘No Mas 003’ was conducted in substantial compliance with all applicable requirements of 40 CFR part 26, subparts K and L 35 If N
35 o Mas 003 is determined to be scientific
o Mas 003 is determined to be scientifically acceptable, I find no barrier in 36 No Mas003 Completed Study: sound, from a scientific perspective, to be used to estimate the duration of compl
36 ete protection against mosquitoes provid
ete protection against mosquitoes provided by the tested 2. Does available information support a determination that the studies were conducted in substantial compliance with 40 CFR part 26, s
37 ubparts K and L? 1 Clara FuentesKelly Sh
ubparts K and L? 1 Clara FuentesKelly ShermanOffice of Pesticide Programs EPA Review of theCarroll-LoyeBiological Research Completed Study No Mas003Field Efficacy Test of a PMD-‘No Mas&#