1

Kevin Sweeney

Eric Bohnenblust, Ph.D.

Maureen Lydon

Office of Pesticide Programs

EPA Review of i2LResearch 

USA, Inc. Protocol 

Testing of S.C. Johnson Personal Tick Repellent 

Products to Support their Use of the EPA 

Repellency Awareness Graphic.
Overview

i2LResearch submitted a protocol for 

testing insect repellent products against 

ticks in the laboratory to determine the 

Complete Protection Time (CPT) of their 

18 skin applied repellent products to 

support the use of the EPA Repellency 

Awareness Graphic. 

2
Overview (2)

Testing will be conducted by i2L Research 

USA, Inc. in Baltimore, Maryland. 

Testing will be conducted against 3 tick 

species with up to 30 different human 

subjects per product (10 per species). 

3
Comparisons to Skin-Applied Repellent 

Protocols Reviewed by the HSRB

In this protocol:

 Aerosol and lotion products are proposed to be tested at 1 

g/600cm2

 Spritz/pump sprays are proposed to be tested at 0.5 

g/600cm2

 A dosimetry phase is not proposed.

• This is a departure from the design of repellent efficacy studies that that have been 

reviewed and approved by EPA and the HSRB in recent years, which have 

experimentally determined the dose.

4
What is the Repellency Awareness 

Program?

A program to raise public awareness of the health 

protectiveness of mosquito and tick repellents 

applied to the skin.

Purposes:

 Raise consumer awareness of the efficacy of skinapplied insect repellents.

 Increase EPA and consumer confidence in the efficacy 

claims on labels.

 Improve consumer protection against vector borne 

diseases, such as Lyme disease and West Nile virus.
EPA Repellency Awareness Graphic

6
Repellency Awareness Graphic

The graphic clearly informs consumers 

about the duration of repellent protection 

so that they can make informed choices 

about the repellent products they 

purchase and use. 

7
8

Science Assessment: 

Testing of S.C. Johnson Personal Tick 

Repellent Products to Support their Use of 

the EPA Repellency Awareness Graphic

Kevin Sweeney

Eric Bohnenblust, Ph.D.

Registration Division

Office of Pesticide Programs
9

Study Objectives

To determine the complete protection time 

(CPT) of up to eighteen EPA registered skin 

applied repellent products from S.C. Johnson & 

Son, Inc. in the laboratory against adults of 3 

tick species using volunteer human subjects to 

support use of the EPA Repellency Awareness 

Graphic on the product label. 
Study Objectives (2)

The data provided from this research can be 

used by the EPA to support the addition of the 

Repellency Awareness Graphic to skin applied 

insect repellent labels, thereby allowing for 

better protection of consumers from nuisance 

arthropod bites and bites that lead to 

arthropod-borne diseases. 

10
11

Acute Toxicity of the Test Materials

All test materials are S.C. Johnson Products 

registered by the EPA as skin applied insect 

repellents.

 Acute Dermal LD50 >2,000 mg/kg body weight

 Minimally irritating to the skin and eyes.

 Not skin sensitizers.
12

Margin of Exposure (MOE) Estimate

S.C. Johnson prepared an estimate of the Margin 

of Exposure via the dermal route for each of the 

18 products to be tested. 

The proposed exposures to the subjects in these 

tests are not of concern for the three active 

ingredients to be tested. 
Calculated Margins of Exposure for DEET Products

Product Dose 

(mg)1

Acute

Product2

LD50

(mg/kg)

MOE

Adj. Acute

Product6

LD50

(mg/kg)

Adj. 

MOE6

Acute3

Active 

Ingredient

LD50

(mg/kg)

MOE4

5% DEET Spritz (4822-415) 567 >2,000 >282 5000 >705 4280 >8161

5.6% DEET Towelette (4822-552) 1133 >2,000 >141 5000 >353 4280 >3645

7% DEET Spritz (4822-395) 567 >2,000 >282 5000 >705 4280 >5829

15% DEET Aerosol (4822-380) 1133 >2,000 >141 5000 >353 4280 >1361

15% DEET Aerosol (4822-543) 1133 >2,000 >141 5000 >353 4280 >1361

25% DEET Aerosol (4822-167) 1133 >2,000 >141 5000 >353 4280 >817

25% DEET Towelette (4822-258) 1133 >5,000 >353 4280 >817

25% DEET Spritz (4822-399) 567 >5,000 >705 4280 >1632

25% DEET Aerosol (4822-572) 1133 >5,000 >353 4280 >817

30% DEET Aerosol (4822-397) 1133 >5,000 >353 4280 >680

98.25% DEET Spritz (4822-276) 567 4280 >615

13

Table 1: 
Calculated Margins of Exposure for Picaridin Products

Product Dose1

(mg)

Acute 

Produ

ct

LD02

(mg/kg)

MOE

Acute 

Active

LD03

(mg/kg)

MOE

5% Picaridin Spritz (4822-

536)

1133 >5,020 354 >2000 12494

5% Picaridin Lotion (4822-

535)

1133 >5,040 356 >2000 2824

20% Picaridin Spritz(4822-

556)

1133 >5,020 354 >2000 3124

20% Picaridin Aerosol

(4822-564

1133 >5,020 354 >2000 3124

14

Product Dose1 (mg)

Acute 

Product2

LD50

(mg/kg) MOE

Acute 

Active LD50

(mg/kg)3

MOE

5% Picaridin Spritz (4822-536) 567 >5,020 >708 >2000 >24974

5% Picaridin Lotion (4822-535) 1133 >5,040 >356 >2000 >2824

20% Picaridin Spritz(4822-556) 567 >5,020 >708 >2000 >6244

20% Picaridin Aerosol (4822-564) 1133 >5,020 >354 >2000 >3124

Table 2: 
Calculated Margins of Exposure for 

p-Methane-3, 8-Diol (PMD) Products

Product Dose1 (mg)

Acute 

Product2

LD50

(mg/kg)

MOE

Acute

Active3

LD50

(mg/kg)

MOE4

8% PMD Towelette(4822-

526)

1133 >5,000 >353 >5000 >4413

10% PMD Lotion (4822-515) 1133 >5,000 >353 >5000 >3529

10% PMD Spritz(4822-528) 567 >5,000 >705 >5000 >7055

15

Table 3: 
Dosage and Product Application 

i2LResearch will not include a dosimetry phase to 

determine “typical consumer dose.” 

Instead, i2LResearch proposes standardized rates 

of:

 1 g/600cm2 for aerosol and lotion products 

 0.5 g/600cm2 for Spritz/pump sprays

16
Dosage and Product Application (2)

A set dose can be related to known 

consumer behavior based on past tests 

reviewed by the HSRB where dosimetry 

was employed for skin applied insect 

repellent products. 

17
Dosage and Product Application (3)

The HSRB determined during their April meeting that a dose of 1 

g/600cm2 was appropriate for all product types.

However, based on analysis of dosimetry results from repellent 

studies reviewed since 2006, EPA recommends the following 

doses be used for studies conducted using this protocol:

 Aerosol/lotion – 1 g/600cm2

 Towelette/pump spray 0.5g/600cm2

Data may be bridged from a pump spray to a towelette because 

pump spray and towelette formulations are usually similar and the 

pump spray is applied at a lower dose.

18
Experimental Design 

For each test, 10 subjects (5 males and 5 females) will 

be treated with the test substance. Two additional 

subjects (one male and one female) will serve as 

alternates for each test.

 The test subjects will be selected at random from a pool of 

potential subjects from the area around Baltimore, MD.

19
Experimental Design (2)

For each product there will be a total of up to 30 

different treated subjects and up to 6 different alternate 

subjects.

 The subjects will not be blinded to the test substances with 

which they are treated. 

 If subjects participate in more than 1 test, the tests must be 

separated by a minimum of 2 days. Subjects are required to 

wash after each test.

A positive control substance will not be used. 

20
Experimental Design (3)

Each subject will have one forearm treated with the 

repellent product to be tested, and the other arm will 

serve as the untreated control. 

 Assignment of the test substance to the subject’s arms will 

be randomized. 

 The control arm will be used to qualify ticks that are active, 

and determine the attractiveness of the subject to ticks.

The data collected from the control arm will not be used 

to calculate the Median Complete Protection Time. 

21
Experimental Design (4)

Four lines will be drawn on both of the subjects’ 

forearms as follows:

 ‘Release line’ 3 cm above the wrist bone towards the elbow 

 ‘Boundary line’ 3 cm above the release line towards the 

elbow (this will be the edge of the treated area) 

 ‘Crossing line’ 3 cm above the boundary line 

 An upper boundary line 12 cm above the boundary line; this 

will not be used during testing and serves only to denote the 

boundary of the treated area. 

22
Experimental Design (5)

23

‘Release line’ 

‘Upper boundary’ 

‘Crossing line’ 

‘Boundary line’ 
24

‘Release line’ 

‘Boundary line’ 

‘Crossing line’ 

‘Upper boundary’ 
Experimental Design (6)

Ticks will be trialed to make sure they will actively quest.

To qualify this behavior, ticks will be placed at the ‘release 

line’ on the untreated control arm and then must cross the 

boundary line within 3 min.

Treatments will be challenged with 1 tick every 15 minutes 

(4 ticks/h).

25
Experimental Design (7)

 Once qualified, the ticks will be placed at the ‘release line’ on 

the treated arm.

 After the tick begins to move up the arm, it will be given 3 

minutes to cross the ‘boundary’ and ‘crossing’ lines on the 

treated arm.

 Ticks are considered repelled if in 3 min. they do not:

 Reach the ‘boundary’ line

 Reach the ‘crossing’ line

 Ticks are considered not repelled if in 3 min. they reach the 

crossing line.

26
27

Experimental Design (8) – DEET Products

Repellent Product 

EPA Reg. No. Product Type 

Number of Tick 

Species

Number of

Human 

Subjects per 

Tick Species

(Replicates)

Total 

Replicates 

per 

Product

Maximum 

Number of Tick 

Exposures per 

Species 

/Product Test

(18 hours)

4822-415 5% DEET Spritz 3 10 30 72/206

4822-552 5.6% DEET Towelette 3 10 30 72/206

4822-395 7% DEET Spritz 3 10 30 72/206

4822-380 15% DEET Aerosol 3 10 30 72/206

4822-543 15% DEET Aerosol 3 10 30 72/206

4822-167 25% DEET Aerosol 3 10 30 72/206

4822-258 25% DEET Towelette 3 10 30 72/206

4822-399 25% DEET Spritz 3 10 30 72/206

4822-572 25% DEET Aerosol 3 10 30 72/206

4822-397 30% DEET Aerosol 3 10 30 72/206

4822-276 98.25% DEET Spritz 3 10 30 72/206
28

Experimental Design (9) – Picaridin Products

Repellent Product 

EPA Reg. No. Product Type 

Number of 

Tick 

Species

Number of 

Human 

Subjects per 

Tick Species 

(Replicates) 

Total 

Replicates 

per 

Product

Maximum 

Number of

Tick 

Exposures 

per Species 

/Product 

Test

(18 hours)

4822-536 5% Picaridin Spritz 3 10 30 72/206

4822-535 5% Picaridin Lotion 3 10 30 72/206

4822-556 20% Picaridin 

Spritz 

3 10 30 72/206

4822-564 20% Picaridin 

Aerosol 

3 10 30 72/206
Experimental Design (10) – PMD Products

29

Repellent Product

EPA Reg. No. Product Type 

Number of 

Tick Species

Number of

Human 

Subjects per 

Tick Species

(Replicates)

Total 

Replicates 

per 

Product

Maximum 

Number of

Tick Exposures

Per 

Species/Product 

Test

(18 hours) 

4822-526 8% PMD Towelette 3 10 30 72/206

4822-515 10% PMD Lotion 3 10 30 72/206

4822-528 10% PMD Spritz 3 10 30 72/206
30

Endpoints and Measures 

 Unit of measure for determination of the 

repellent effects is Complete Protection Time 

(CPT).

 “The CPT for each tick species will be calculated as 

the time from test substance application to the time 

of the First Confirmed Crossing. The time in hours for 

each individual test subject will be used to calculate 

the median protection time for each species 

separately.”
Endpoints and Measures (2)

 A ‘Crossing’ occurs when a tick crosses the 

‘crossing line’ within 3 min. on the treated 

arm of a subject. 

 A ‘First Confirmed Crossing’ is that which is 

followed by the subsequent tick crossing in 

the next exposure period, or the first 

subsequent tick is repelled but the second 

subsequent tick is recorded as not being 

repelled.

31
Statistical Analysis Plan 

 The objective of the data analysis is to 

estimate the Median Complete Protection 

Time. 

 The Median CPT of all test subjects will be 

calculated using the Kaplan-Meier Survival 

Analysis, which is advantageous since 

CPTs may not be normally distributed. 

32
Statistical Analysis Plan (2)

Sample

size

Distributional

position for

95% LCL

Distributional

position for

95% UCL

Percent of 

values above 

LCL

10 1 8 90%

12 2 10 83%

15 3 11 80%

20 5 15 75% 33

Table 1:Kaplan-Meier Median Confidence Limits for a Range of Sample Sizes.

As evidenced by the table, sample sizes larger than ten would 

provide only marginal increases in precision relative to the increase 

in the number of exposed test subjects. 
Statistical Analysis Plan (3)

The Kaplan-Meier Survival Analysis has 

been accepted by EPA and the HSRB for 

the Median CPT calculation in past 

efficacy studies using repellents and is 

also recommended by the World Health 

Organization for CPT calculation from 

these data sets. 

34
Statistical Analysis Plan (4)

The proposed sample size of 10 subjects 

per study represents a reasonable 

compromise between increasing precision 

and limiting costs based on past analyses 

by the EPA.

35
36

Measures to Ensure Reliability

 Good Laboratory Practices, as defined by 40 CFR part 160 will be followed throughout all 

studies. 

 Study staff will conduct a training session with the subjects on a day prior to the test date. 

 Study staff will treat the skin of the exposed limb with the test substance and the limb will 

be measured in advance. 

 Study staff will place ticks on the untreated and treated arms. 

 Study staff will monitor and record tick movement and the start and stop times for each 

exposure period. 

 Study staff and the study director will track test substance samples, closely monitor the 

testing, and data recording. 

 Alternate subjects will be enrolled to ensure adequate sample size. 

 A Quality Assurance Unit will be in place to monitor all study activities and data collection.

 Test subjects can only take part once in any two-day testing period. If scheduled to 

participate in two studies within one week, there will be two calendar days in between test 

days. 
37

Compliance with Scientific Standards

The following elements are adequately 

addressed:

 Available toxicity studies with DEET, picaridin, and 

PMD.

• Adequately characterize toxicological profile of 

the formulations.

• Data to support estimate of acceptable Margin 

of Exposure (MOE).
Compliance with Scientific Standards

The following elements are generally 

acceptable but require refinement and 

clarification: 

•Pre-Training

•Experimental Design

•Data Analysis

38
Science Comments and 

Recommendations 1

1) EPA comment: “Pre-training of subjects is 

barely described. More information is required. 

The protocol should be explicit with regard to 

the training outline and specific topics to be 

addressed.” 

S.C. Johnson & i2L response: Revised 

section 2.2.5 with an outline providing specifics 

for pre-training.

39
Science Comments and 

Recommendations 2

2) EPA comment: “Please provide more details on the 

exact timing of the testing. The protocol needs to 

explicitly describe the amount of time the technician has 

to do testing and the amount of time in a 15 minute 

period that requires the subject to be seated and 

exposed to ticks.” 

S.C. Johnson & i2L Research response: Revised 

protocol to include specific details regarding testing.

40
Science Comments and 

Recommendations 3

3) EPA comment: “Repellent sample size 

selection: The protocol cites one example of the 

effect of sample size on mean confidence 

interval width when changed from 10 to 20 

subjects. Submit a simulation showing the 

impact of increasing sample size on the width of 

95% confidence interval of median CPT where 

median CPT will be estimated using Kaplan 

Meier method. This can be presented in table 

form.” 

41
Science Comments and 

Recommendations 3 continued

S. C. Johnson & i2L Research 

response: “Sample size is adequate and 

is unlikely to overestimate CPT due to 

selection of the lowest CPT value, and 

historical precedent.”

42
Science Comments and 

Recommendations 3 continued

S. C. Johnson & i2L Research 

response continued: 

“The confidence limits associated with the 

Kaplan-Meier median are positional values 

in the distribution, rather than calculated 

values as in the case of a confidence 

interval around the mean.” 

43
Science Comments and 

Recommendations 3 continued

S.C. Johnson & i2L Research response 

continued: 

“The table from slide 32 indicates which positions in the 

distribution of values constitute the lower confidence 

limit (LCL) and upper confidence limit (UCL) of the 

median for various sample sizes. The assumption is that 

the values are sorted in increasing order, so value “1” in 

the distribution refers to the smallest value (i.e., the 

minimum).”

44
Science Comments and 

Recommendations 4

4) EPA Comment: A randomization 

mechanism needs to be inserted into 

sections 2.3.8 and 2.3.9. 

S.C. Johnson & i2L Research 

response: Will use a random number 

generator from a statistical software 

package (e.g., Minitab, Excel)

45
46

Science Comments and 

Recommendations 5

5) EPA Comment: Amend the protocol to 

require subjects to wait at least two calendar 

days (48 hours) between tests if they participate 

in multiple tests. 

S.C. Johnson & i2L Research response: 

Amended the protocol to require subjects wait 

two days between participating in different tests
Compliance with Scientific Standards

As amended to address the concerns raised in the EPA review, the 

i2L Research USA protocol entitled “Testing of S.C. Johnson 

Personal Tick Repellent Products to Support their Use of the EPA 

Repellency Awareness Graphic” is likely to yield scientifically 

reliable information, satisfying the following scientific criteria from 

the framework recommended by the HSRB:

 It would produce important information that cannot be 

obtained except from research with human subjects.

 It has clear scientific objectives.

 The study design should produce adequate data to achieve 

those objectives.

47
48

Ethics Assessment:

Testing of S.C. Johnson Personal Tick 

Repellent Products to Support their use of the 

EPA Repellency Awareness Graphic

Maureen Lydon

Office of the Director

Office of Pesticide Programs
49

Value to Society

 Proposed study will determine the 

complete protection time (CPT) of up to 18 

EPA-registered insect repellent products 

against ticks

 Up to 3 different active ingredients (AIs) 

and variety of products, all previously 

registered and assessed by EPA, will be 

tested for duration of efficacy 

 Product-specific efficacy testing is required 

to support use of EPA’s Repellency 

Awareness Graphic on product labels.
50

Value to Society 2

 Consumers who use tick repellents to avoid 

tick bites cannot readily assess the 

duration of repellency.

 If EPA’s Repellency Awareness Graphic is 

added to the label, consumers can make 

informed decisions by knowing the length 

of time each product repels ticks.
51

Subject Selection

 Participants will be recruited through 

advertising using digital and social media. 

 Recruitment firm will also use Spanish 

language advertisement and on-line 

Spanish newspaper that advertises in the 

recruitment area.

 Ad will contain link to study-specific website 

with prescreening qualification form.
Subject Selection 2

 Once completed, pre-screening 

qualification form will be uploaded to 

secure and encrypted portal, that only 

i2LResearch staff can access.

 The respondents who meet the 

eligibility criteria will be contacted 

initially by the recruitment firm or 

i2LResearch.

52
Subject Selection 3

 The respondents will be asked some 

basic eligibility questions and told about 

the test using the telephone script.

 Eligible/interested respondents will 

receive follow-up call from i2lResearch 

to review study steps, identify training, 

inclusion/exclusion factors, payment, 

and offer to provide consent form. 

53
Subject Selection 4

 Next step is 2 hour training prior to 

each study. 

 As part of training, consent form will be 

provided and reviewed. Questions will 

be asked to ensure understanding.

 Eligible interested subjects will sign 

consent form.

54
Inclusion/Exclusion Criteria

 15 inclusion/exclusion criteria are 

complete and appropriate, except:

o Add exclusion for sensitivity to tick bites or 

latex.

o Add exclusion for individuals with skin 

disease, skin problems such as eczema, 

psoriasis or atopic dermatitis.

55
Inclusion/Exclusion Criteria 2

 One of the inclusion criteria:

o Read and speak English fluently.

Rationale:

o Current repellent product labels in English

o Language does not affect attractiveness to 

ticks

56
Inclusion/Exclusion Criteria 3

Rationale (continued):

o To target users that understand product 

labels, will recruit English speaking 

subjects with minimum 10% bilingual

o Research offers no benefits to subjects

o Limiting recruitment to English speakers 

with 10% bilingual, is not expected to 

result in equity of access issues

57
58

Informed Consent Process

 Proposed consent process with EPA 

comments included is satisfactory

• Potential subjects meet with i2LResearch for 2 hour 

training. Subjects given consent form, time to read it, 

opportunity to ask questions

• As part of training, the study, subject’s role, potential 

length of test day, inclusion/exclusion criteria will be 

reviewed

• Questions will be asked to ensure understanding

• Pregnancy test within 48 hours prior to test day

 Revised consent form includes all elements 

required by regulations
59

Informed Consent 2

 To confirm understanding of the consent 

form, subjects will be asked 6 questions:

1. What will study staff place on your 

arm, monitor, take off & discard in order 

to collect study data?

2. What type of product will be applied to 

your arm and remain on your arm during 

the exposure period of the study?

3. How long could one test day last?
60

Informed Consent 3

 To confirm understanding of the consent 

form, subjects will be asked 6 questions:

4. What are the potential discomforts or 

hazards from this study?

5. Do you have the freedom to quit or 

withdraw from the study at any time?

6. If you quit or withdraw from the study, 

for how many hours will you be paid?
Highlights of EPA Comments

 Revise protocol to include details of 

training and what will occur. 

• i2LResearch & SCJ: Revised accordingly 

 Revise description of recruitment 

process and provide details. Also, 

include Spanish language ad and use of 

online Spanish newspaper 

• i2LResearch & SCJ: Revised accordingly 

61
EPA Comments 2

 Add breaks during test day. Provide 

breakfast, lunch, dinner to subjects

• i2LResearch & SCJ: Revised accordingly 

 Increase proposed compensation for 

participating in training and test day

• i2LResearch & SCJ: Revised accordingly 

62
EPA Comments 3

 Reduce length of 2 hour prep time on 

test day

• i2LResearch & SCJ: Revised accordingly 

 Pregnancy test should occur within 48 

hours prior to test day instead of on 

test day

• i2LResearch & SCJ: Revised accordingly 

63
EPA Comments 4

 Draft questions to ensure 

understanding of consent form

• i2LResearch & SCJ: Revised accordingly 

 Clarify when and how often consent 

form will be signed if subject 

participating in more than 1 study 

• i2LResearch & SCJ: Revised accordingly 

64
EPA Comments 5

 In consent form, include:

o section on Test Material

o detailed description of training 

o provision of breaks 

o provision of breakfast, lunch and dinner 

o discomfort of and fatigue from long test 

day as another risk

• i2LResearch & SCJ: Revised accordingly 

65
EPA Comments 6

 Revise phone scripts for initial and 

follow-up contact to:

Clarify length of test day and 

training, explain use of code 

numbers for privacy, update 

compensation figures, highlight 

freedom to withdraw 

• i2LResearch & SCJ: Revised accordingly 

66
EPA Comments 7

 For the follow-up contact script, also 

add that breaks and meals will be 

provided

• i2LResearch & SCJ: Revised accordingly 

 Add support to help bolster subject’s 

arm when it’s being held at 45 degree 

angle during test

• i2LResearch & SCJ: Revised accordingly 

67
EPA Comments 8

 Add that closest hospital to lab and 

directions will be identified prior to test 

date.

• i2LResearch & SCJ: Revised accordingly 

 Add that sharing new information or 

results with subjects will occur “in 

timely manner”

• i2LResearch & SCJ: Revised accordingly 

68
EPA Comments 9

 i2LResearch and SC Johnson agreed to 

address EPA’s comments.

69
70

Risks and Risk Minimization

 Revisions to protocol describe appropriate 

measures to minimize 5 types of hazards 

o Adverse reaction to test material

o Exposure to ticks

o Exposure to potential tick-vectored diseases 

o Unanticipated loss of confidential information 

o Fatigue and/or physical discomfort from length 

of test day
71

Benefits

 No direct benefit to subjects

 Primary direct beneficiary is sponsor

 Another beneficiary is consumer who 

uses tick repellents

 If EPA’s Repellency Awareness Graphic is 

added to product label, consumer will 

know how long the tick repellent will be 

effective in repelling ticks 
72

Risk:Benefit Balance 

 Risks have been effectively 

minimized

 Risks are reasonable in light of the 

expected societal benefits of the 

knowledge likely to be gained
73

Independent Ethics Review

 Schulman Associates IRB (SAIRB) reviewed 

and conditionally approved the protocol 

and informed consent materials 

 Final approval is conditioned on the 

sponsor obtaining HSRB review

 SAIRB has AAHRPP accreditation, is 

registered with OHRP, and is independent 

of the investigators
74

Respect for Subjects

 Effective methods for protecting 

subjects’ privacy

 Revised level of compensation is 

appropriate

 Subjects will be free to withdraw at any 

time 

 Sponsor will reimburse subjects for cost 

of any medical care if research-related 

injuries occur
75

Applicable Ethical Standards

 This is a proposal for third-party research involving 

intentional exposure of human subjects to a pesticide, 

with the intention of submitting the resulting data to 

EPA under the pesticide laws

 The primary ethical standards applicable to the 

conduct of this research are 40 CFR 26, Subparts K 

and L, and FIFRA 12(a)(2)(P)

 Attachment 1 to the EPA Review contains a point-bypoint evaluation of how this protocol addresses the 

requirements of 40 CFR 26 Subparts K and L
76

Findings in EPA Ethics Review

 i2LResearch and SC Johnson agreed 

to address EPA’s comments

 No deficiencies relative to 40 CFR 26, 

subparts K and L, or to FIFRA 

§12(a)(2)(P) 

 Protocol meets the applicable 

requirements of 40 CFR part 26, 

subparts K and L
77

Charge Questions

If the lab repellency study protocol is amended 

as suggested in EPA’s and the HSRB’s review and 

if the research is performed as described: 

1. Is this protocol likely to generate scientifically 

reliable data, useful for estimating the complete 

protection time of various EPA-registered S.C. 

Johnson skin-applied tick repellents in the lab against 

three species of ticks?

2. Is the research likely to meet the applicable 

requirements of 40 CFR part 26, subparts K and L?