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Great Lakes Marketing Child Resistant Protocol Test
Senior Panel
Lori Mitchell Dixon, PhD, Project Director
July, 2004

Introduction

Great Lakes Marketing conducted a test of the KEY-PAK F1 with Tear Resistant Board, using a panel of adults aged 50-70 and the test procedures as defined in the Federal Register 16 CFR, Part 1800, Vol. 60, No. 140.

Summary of Test Results

Package Preparations: Packages were received from the client to test. The testing was not conducted specifically to any product, but as a "generic" test. The testing protocol is in Appendix One.
Panel: 70 females
30 Males
100 total Panel
Number of Failures: 0 Failed to Open Package A
0 Failed to Open Package B
0 Failed to Open Package B within the required 60 seconds
0 Total Failures
Effectiveness: 100% Effective. A panel of 100 seniors is required for a full protocol. An effectiveness level of 90.0% is required

Outcome of Test (Failures include those who were unable to open the first or second package or the second package in the required 60 seconds.)
  AGE IN YEARS GENDER
  TOTAL 50-54 55-59 60-70 Male Female
Respondents 100 25 25 50 30 70
Passed Test 100
100.0%
25
100.0%
25
100.0%
50
100.0%
30
100.0%
70
100.0%

Opinion of Package (Asked only if they opened the second package)
  AGE IN YEARS GENDER
  TOTAL 50-54 55-59 60-70 Male Female
Respondents 100 25 25 50 30 70
Very Easy 6
6.0%
4
16.0%
1
4.0%
1
2.0%
1
3.3%
5
7.1%
Easy 25
25.0%
5
20.0%
2
8.0%
18
36.0%
11
36.7%
14
20.0%
Average 35
35.0%
6
24.0%
11
44.0%
18
36.0%
11
36.7%
24
34.3%
Hard 23
23.0%
7
28.0%
9
36.0%
7
14.0%
4
13.3%
19
27.1%
Very Hard 11
11.0%
3
12.0%
2
8.0%
6
12.0%
3
10.0%
8
11.4%

Seconds to Open Package A: (The exact seconds are listed in the far left column. The Number (top) and percentage (bottom) of people opening it in that number of seconds are shown in the columns.)
  AGE IN YEARS GENDER
  TOTAL 50-54 55-59 60-70 Male Female
Respondents 100 25 25 50 30 70
10 1
1.0%
0
0.0%
1
4.0%
0
0.0%
0
0.0%
1
1.4%
11 5
5.0%
1
4.0%
0
0.0%
4
8.0%
2
6.7%
3
4.3%
12 1
1.0%
1
4.0%
0
0.0%
0
0.0%
1
3.3%
0
0.0%
13 1
1.0%
0
0.0%
0
0.0%
1
2.0%
0
0.0%
1
1.4%
14 4
4.0%
0
0.0%
2
8.0%
2
4.0%
1
3.3%
3
4.3%
15 2
2.0%
0
0.0%
0
0.0%
2
4.0%
0
0.0%
2
2.9%
16 4
4.0%
1
4.0%
3
12.0%
0
0.0%
1
3.3%
3
4.3%
17 2
2.0%
2
8.0%
0
0.0%
0
0.0%
1
3.3%
1
1.4%
18 3
3.0%
0
0.0%
0
0.0%
3
6.0%
1
3.3%
2
2.9%
19 4
4.0%
1
4.0%
1
4.0%
2
4.0%
1
3.3%
3
4.3%
20 3
3.0%
1
4.0%
1
4.0%
1
2.0%
0
0.0%
3
4.3%
21 1
1.0%
0
0.0%
0
0.0%
1
2.0%
0
0.0%
1
1.4%
22 3
3.0%
1
4.0%
2
8.0%
0
0.0%
0
0.0%
3
4.3%
24 5
5.0%
1
4.0%
2
8.0%
2
4.0%
3
10.0%
2
2.9%
25 2
2.0%
0
0.0%
0
0.0%
2
4.0%
0
0.0%
2
2.9%
26 1
1.0%
1
4.0%
0
0.0%
0
0.0%
1
3.3%
0
0.0%
27 6
6.0%
3
12.0%
1
4.0%
2
4.0%
1
3.3%
5
7.1%
28 4
4.0%
2
8.0%
0
0.0%
2
4.0%
1
3.3%
3
4.3%
29 2
2.0%
1
4.0%
0
0.0%
1
2.0%
0
0.0%
2
2.9%
31 5
5.0%
2
8.0%
2
8.0%
1
2.0%
2
6.7%
3
4.3%
32 2
2.0%
2
8.0%
0
0.0%
0
0.0%
1
3.3%
1
1.4%
33 1
1.0%
0
0.0%
0
0.0%
1
2.0%
0
0.0%
1
1.4%
34 2
2.0%
0
0.0%
0
0.0%
2
4.0%
1
3.3%
1
1.4%
35 1
1.0%
0
0.0%
0
0.0%
1
2.0%
0
0.0%
1
1.4%
36 2
2.0%
0
0.0%
1
4.0%
1
2.0%
0
0.0%
2
2.9%
38 2
2.0%
0
0.0%
1
4.0%
1
2.0%
1
3.3%
1
1.4%
39 1
1.0%
0
0.0%
0
0.0%
1
2.0%
1
3.3%
0
0.0%
40 2
2.0%
0
0.0%
1
4.0%
1
2.0%
1
3.3%
1
1.4%
41 6
6.0%
1
4.0%
1
4.0%
4
8.0%
1
3.3%
5
7.1%
42 2
2.0%
0
0.0%
2
8.0%
0
0.0%
0
0.0%
2
2.9%
43 2
2.0%
0
0.0%
0
0.0%
2
4.0%
1
3.3%
1
1.4%
44 1
1.0%
0
0.0%
1
4.0%
0
0.0%
0
0.0%
1
1.4%
45 1
1.0%
0
0.0%
1
4.0%
0
0.0%
0
0.0%
1
1.4%
46 1
1.0%
0
0.0%
0
0.0%
1
2.0%
1
3.3%
0
0.0%
50 2
2.0%
1
4.0%
0
0.0%
1
2.0%
0
0.0%
2
2.9%
51 1
1.0%
1
4.0%
0
0.0%
0
0.0%
1
3.3%
0
0.0%
54 2
2.0%
1
4.0%
0
0.0%
1
2.0%
1
3.3%
1
1.4%
55 1
1.0%
0
0.0%
1
4.0%
0
0.0%
0
0.0%
1
1.4%
60 1
1.0%
0
0.0%
0
0.0%
1
2.0%
0
0.0%
1
1.4%
61 1
1.0%
0
0.0%
0
0.0%
1
2.0%
0
0.0%
1
1.4%
64 2
2.0%
0
0.0%
0
0.0%
2
4.0%
1
3.3%
1
1.4%
69 1
1.0%
0
0.0%
0
0.0%
1
2.0%
1
3.3%
0
0.0%
83 1
1.0%
0
0.0%
0
0.0%
1
2.0%
1
3.3%
0
0.0%
102 1
1.0%
1
4.0%
0
0.0%
0
0.0%
0
0.0%
1
1.4%
107 1
1.0%
0
0.0%
1
4.0%
0
0.0%
1
3.3%
0
0.0%
121 1
1.0%
0
0.0%
0
0.0%
1
2.0%
0
0.0%
1
1.4%

Methods to open Package A
  AGE IN YEARS GENDER
  TOTAL 50-54 55-59 60-70 Male Female
Respondents 100 25 25 50 30 70
Normal Opening 92
92.4%
23
92.0%
23
92.0%
46
92.0%
28
93.3%
64
91.4%
Other 8
8.0%
2
8.0%
2
8.0%
4
8.0%
2
6.7%
6
8.6%

Seconds to open Package B: (The exact seconds are listed in the far left column. The Number (top) and percentage (bottom) of people opening it in that number of seconds are shown in the columns.)
  AGE IN YEARS GENDER
  TOTAL 50-54 55-59 60-70 Male Female
Respondents 100 25 25 50 30 70
4 2
2.0%
1
4.0%
0
0.0%
1
2.0%
1
3.3%
1
1.4%
5 1
1.0%
0
0.0%
1
4.0%
0
0.0%
0
0.0%
1
1.4%
6 5
5.0%
3
12.0%
1
4.0%
1
2.0%
4
13.3%
1
1.4%
7 3
3.0%
1
4.0%
0
0.0%
2
4.0%
1
3.3%
2
2.9%
8 6
6.0%
1
4.0%
1
4.0%
4
8.0%
3
10.0%
3
4.3%
9 9
9.0%
2
8.0%
4
16.0%
3
6.0%
3
10.0%
6
8.6%
10 6
6.0%
1
4.0%
2
8.0%
3
6.0%
2
6.7%
4
5.7%
11 5
5.0%
2
8.0%
2
8.0%
1
2.0%
1
3.3%
4
5.7%
12 5
5.0%
1
4.0%
2
8.0%
2
4.0%
2
6.7%
3
4.3%
13 7
7.0%
2
8.0%
2
8.0%
3
6.0%
1
3.3%
6
8.6%
14 9
9.0%
1
4.0%
3
12.0%
5
10.0%
1
3.3%
8
11.4%
15 7
7.0%
0
0.0%
1
4.0%
6
12.0%
0
0.0%
7
10.0%
16 4
4.0%
2
8.0%
1
4.0%
1
2.0%
3
10.0%
1
1.4%
17 5
5.0%
2
8.0%
1
4.0%
2
4.0%
1
3.3%
4
5.7%
18 1
1.0%
0
0.0%
0
0.0%
1
2.0%
0
0.0%
1
1.4%
19 4
4.0%
1
4.0%
0
0.0%
3
6.0%
2
6.7%
2
2.9%
20 1
1.0%
0
0.0%
1
4.0%
0
0.0%
0
0.0%
1
1.4%
21 1
1.0%
0
0.0%
0
0.0%
1
2.0%
0
0.0%
1
1.4%
22 2
2.0%
1
4.0%
0
0.0%
1
2.0%
1
3.3%
1
1.4%
23 3
3.0%
2
8.0%
0
0.0%
1
2.0%
1
3.3%
2
2.9%
24 3
3.0%
1
4.0%
0
0.0%
2
4.0%
0
0.0%
3
4.3%
26 2
2.0%
0
0.0%
0
0.0%
2
4.0%
1
3.3%
1
1.4%
27 1
1.0%
1
4.0%
0
0.0%
0
0.0%
0
0.0%
1
1.4%
29 1
1.0%
0
0.0%
0
0.0%
1
2.0%
1
3.3%
0
0.0%
30 2
2.0%
0
0.0%
1
4.0%
1
2.0%
0
0.0%
2
2.9%
31 1
1.0%
0
0.0%
0
0.0%
1
2.0%
0
0.0%
1
1.4%
36 1
1.0%
0
0.0%
0
0.0%
1
2.0%
0
0.0%
1
1.4%
37 2
2.0%
0
0.0%
1
4.0%
1
2.0%
0
0.0%
2
2.9%
50 1
1.0%
0
0.0%
1
4.0%
0
0.0%
1
3.3%
0
0.0%

Methods to open Package B
  AGE IN YEARS GENDER
  TOTAL 50-54 55-59 60-70 Male Female
Respondents 100 25 25 50 30 70
Normal Opening 91
91.0%
22
88.0%
23
92.0%
46
92.0%
27
90.0%
64
91.4%
Other 9
9.0%
3
12.0%
2
8.0%
4
8.0%
3
10.0%
6
8.6%

Zip Code
  AGE IN YEARS GENDER
  TOTAL 50-54 55-59 60-70 Male Female
Respondents 100 25 25 50 30 70
43435 1
1.0%
0
0.0%
0
0.0%
1
2.0%
0
0.0%
1
1.4%
43465 1
1.0%
0
0.0%
1
4.0%
0
0.0%
0
0.0%
1
1.4%
43528 4
4.0%
0
0.0%
1
4.0%
3
6.0%
1
3.3%
3
4.3%
43537 1
1.0%
1
4.0%
0
0.0%
0
0.0%
0
0.0%
1
1.4%
43545 1
1.0%
0
0.0%
1
4.0%
0
0.0%
0
0.0%
1
1.4%
43551 1
1.0%
0
0.0%
1
4.0%
0
0.0%
1
3.3%
0
0.0%
43558 1
1.0%
1
4.0%
0
0.0%
0
0.0%
0
0.0%
1
1.4%
43560 1
1.0%
0
0.0%
1
4.0%
0
0.0%
0
0.0%
1
1.4%
43567 1
1.0%
0
0.0%
0
0.0%
1
2.0%
0
0.0%
1
1.4%
43602 1
1.0%
1
4.0%
0
0.0%
0
0.0%
0
0.0%
1
1.4%
43604 2
2.0%
0
0.0%
2
8.0%
0
0.0%
0
0.0%
2
2.9%
43605 4
4.0%
1
4.0%
0
0.0%
3
6.0%
2
6.7%
2
2.9%
43607 9
9.0%
4
16.0%
2
8.0%
3
6.0%
4
13.3%
5
7.1%
43609 4
4.0%
1
4.0%
0
0.0%
3
6.0%
1
3.3%
3
4.3%
43611 1
1.0%
1
4.0%
0
0.0%
0
0.0%
0
0.0%
1
1.4%
43612 2
2.0%
0
0.0%
0
0.0%
2
4.0%
1
3.3%
1
1.4%
43613 6
6.0%
3
12.0%
1
4.0%
2
4.0%
3
10.3%
3
4.3%
43614 3
3.0%
3
12.0%
0
0.0%
0
0.0%
0
0.3%
3
4.3%
43615 7
7.0%
0
0.0%
3
12.0%
4
8.0%
3
10.0%
4
5.7%
43616 8
7.0%
1
4.0%
1
4.0%
6
12.0%
3
10.0%
5
7.1%
43617 1
1.0%
1
4.0%
0
0.0%
0
0.0%
1
3.3%
0
0.0%
43619 1
1.0%
0
0.0%
0
0.0%
1
2.0%
0
0.0%
1
1.4%
43656 1
1.0%
1
4.0%
0
0.0%
0
0.0%
1
3.3%
0
0.0%
43017 2
2.0%
0
0.0%
0
0.0%
2
4.0%
1
3.3%
1
1.4%
44044 1
1.0%
0
0.0%
0
0.0%
1
2.0%
1
3.3%
0
0.0%
44129 1
1.0%
0
0.0%
1
4.0%
0
0.0%
0
0.0%
1
1.4%
44133 1
1.0%
0
0.0%
0
0.0%
1
2.0%
0
0.0%
1
1.4%
44136 3
3.0%
1
4.0%
0
0.0%
2
4.0%
2
6.7%
1
1.4%
44149 3
3.0%
0
0.0%
1
4.0%
2
4.0%
0
0.0%
3
4.3%
44212 1
1.0%
0
0.0%
0
0.0%
1
2.0%
0
0.0%
1
1.4%
44280 1
1.0%
0
0.0%
0
0.0%
1
2.0%
0
0.0%
1
1.4%
44817 2
2.0%
0
0.0%
0
0.0%
2
4.0%
0
0.0%
2
2.9%
44830 2
2.0%
0
0.0%
1
4.0%
1
2.0%
1
3.3%
1
1.4%
44883 1
2.0%
0
0.0%
1
4.0%
0
0.0%
1
3.3%
0
0.0%
45804 1
1.0%
0
0.0%
0
0.0%
1
2.0%
0
0.0%
1
1.4%
45814 1
1.0%
0
0.0%
1
4.0%
0
0.0%
1
3.3%
0
0.0%
45817 1
1.0%
0
0.0%
0
0.0%
1
2.0%
0
0.0%
1
1.4%
45840 8
8.0%
1
4.0%
3
12.0%
4
8.0%
0
0.0%
8
11.4%
45842 1
1.0%
0
0.0%
0
0.0%
1
2.0%
0
0.0%
1
1.4%
45843 1
1.0%
1
4.0%
0
0.0%
0
0.0%
0
0.0%
1
1.4%
45858 1
1.0%
0
0.0%
1
4.0%
0
0.0%
0
0.0%
1
1.4%
45859 1
1.0%
1
4.0%
0
0.0%
0
0.0%
1
3.3%
0
0.0%
48159 1
1.0%
0
0.0%
0
0.0%
1
2.0%
0
0.0%
1
1.4%
48161 1
1.0%
1
4.0%
0
0.0%
0
0.0%
0
0.0%
1
1.4%
48162 2
2.0%
1
4.0%
0
0.0%
1
2.0%
1
3.3%
1
1.4%
48166 1
1.0%
0
0.0%
0
0.0%
1
2.0%
0
0.0%
1
1.4%

Age of Senior Adult in Years
  AGE IN YEARS GENDER
  TOTAL 50-54 55-59 60-70 Male Female
Respondents 100 25 25 50 30 70
50-54 25
25.0%
25
100.0%
0
0.0%
0
0.0%
8
26.7%
17
24.3%
50 4
4.0%
4
16.0%
0
0.0%
0
0.0%
1
3.3%
3
4.3%
51 6
6.0%
6
24.0%
0
0.0%
0
0.0%
4
13.3%
2
2.9%
52 4
4.0%
4
16.0%
0
0.0%
0
0.0%
0
13.3%
4
5.7%
53 5
5.0%
5
20.0%
0
0.0%
0
0.0%
2
6.7%
3
4.3%
54 6
6.0%
6
24.0%
0
0.0%
0
0.0%
1
3.3%
5
7.1%
55-59 25
25.0%
0
0.0%
25
100.0%
0
0.0%
7
23.3%
18
25.7%
55 4
4.0%
0
0.0%
4
16.0%
0
0.0%
1
3.3%
3
4.3%
56 5
5.0%
0
0.0%
5
20.0%
0
0.0%
1
3.3%
4
5.7%
57 7
7.0%
0
0.0%
7
28.0%
0
0.0%
4
13.3%
3
4.3%
58 2
2.0%
0
0.0%
2
8.0%
0
0.0%
0
0.0%
2
2.9%
59 7
7.0%
0
0.0%
7
28.0%
0
0.0%
1
3.3%
6
8.6%
60-70 50
50.0%
0
0.0%
0
0.0%
50
100.0%
15
50.0%
35
50.0%
60 5
5.0%
0
0.0%
0
0.0%
5
10.0%
0
0.0%
5
7.1%
61 7
7.0%
0
0.0%
0
0.0%
7
14.0%
4
13.3%
3
4.3%
62 6
6.0%
0
0.0%
0
0.0%
6
12.0%
0
0.0%
6
8.6%
63 3
3.0%
0
0.0%
0
0.0%
3
6.0%
1
3.3%
2
2.9%
64 8
8.0%
0
0.0%
0
0.0%
8
16.0%
2
6.7%
6
8.6%
65 3
3.0%
0
0.0%
0
0.0%
3
6.0%
2
6.7%
1
1.4%
66 6
6.0%
0
0.0%
0
0.0%
6
12.0%
2
6.7%
4
5.7%
67 4
4.0%
0
0.0%
0
0.0%
4
8.0%
1
3.3%
3
4.3%
68 5
5.0%
0
0.0%
0
0.0%
5
10.0%
2
6.7%
3
4.3%
70 3
3.0%
0
0.0%
0
0.0%
3
6.0%
1
3.3%
2
2.9%

Test Sites
  AGE IN YEARS GENDER
  TOTAL 50-54 55-59 60-70 Male Female
Respondents 100 25 25 50 30 70
Southwyck Mall
Toledo, OH
9
9.0%
2
8.0%
3
12.0%
4
8.0%
1
3.3%
8
11.4%
E. Kahle Sr. Ctr.
Toledo, OH
7
7.0%
2
8.0%
0
0.0%
5
10.0%
4
13.3%
3
4.3%
Our Lady of Lourdes
Toledo, OH
20
20.0%
5
20.0%
7
28.0%
8
16.0%
9
30.0%
11
15.7%
Findlay Village Mall
Findlay, OH
22
2.0%
3
12.0%
10
40.0%
9
18.0%
5
16.7%
17
24.2%
Kroger, Navarre
Oregon, OH
14
14.0%
2
8.0%
3
12.0%
9
18.0%
4
13.3%
10
14.3%
Strongsville Sr. Ct.
Strongsville, OH
13
13.0%
1
4.0%
2
8.0%
10
20.0%
4
13.3%
9
12.9%
Kroger, Southland
Toledo, OH
10
10.0%
8
32.0%
0
0.0%
2
4.0%
2
6.7%
8
11.4%
Frenchtown Sr. Ct.
Monroe, MI
5
5.0%
2
8.0%
0
0.0%
3
6.0%
1
3.3%
4
5.7%

Appendix One

Senior Adult Panel Test Protocol

Adults who did not successfully open the child-resistant packages during the first five minute time period were asked to attempt to open and resecure two conventional (non-child resistant) packages:

  1. An 8 dram (+/- 4 drams) round plastic package with 28mm (+/- 18%) non-child-resistant snap closure.
  2. A 2 ounce (+/- 1/2 ounce) round plastic package with 28mm (+/- 18%) non-child-resistant continuous threaded closure. The closures were resecured to 0 torque inch-pounds at least 72 hours after testing.
Test Procedures
  • All packages were handled so that no damage or jarring occurred during storage or transportation. The packages were not exposed to extreme heat or cold. The packages were tested at room temperature.
  • The adults had no physical or mental handicaps. No adult with a permanent or temporary illness, injury or handicap that would interfere with his/her effective participation was included in the test.
  • Before beginning the test, the tester said, "PLEASE SIGN THIS CONSENT FORM". Adults who could not read the consent form for any reason (forgot glasses, illiterate, etc.) did not participate in the test.
  • Each adult participated individually and not in the presence of other participants or onlookers.
  • The test area was well lighted and free from distractions.
  • Records were filled in prior to, or after, the test so that the tester's full attention was on the participant during the test period. The only exception was to record the test times to open the package.
  • To begin the first five minute test period, the tester said, "I AM GOING TO ASK YOU TO OPEN TWO IDENTICAL PACKAGES ACCORDING TO THE INSTRUCTIONS ON THE PACKAGE."
  • The tester gave the participant a package and said "PLEASE OPEN THIS PACKAGE ACCORDING TO THE INSTRUCTIONS ON THE PACKAGE." After the participant opened the package, the tester said, "PLEASE REMOVE ONE OF THE PILLS."
  • The participant was allowed up to five minutes to read the instructions and open the package. The tester used a stopwatch or other timing device to record the opening times. The elapsed time in seconds to open the package was recorded on the data sheet.
  • After five minutes or when the participant had opened the package, whichever came first, the tester took all test materials from the participant. If a participant did not open the package and stopped trying by the end of the first five minute period, the tester said, "ARE YOU FINISHED WITH THE PACKAGE OR WOULD YOU LIKE TO TRY AGAIN?" If the participant indicated that he/she was finished or could not open the package and did not wish to continue trying, the participant was asked to open two screening packages. The adult participant was given a one-minute test period for each package. The tester gave the participant a package and said, "PLEASE OPEN AND PROPERLY CLOSE THIS PACKAGE." The tester recorded the time for opening and closing or one minute, whichever was less, on the data sheet. The tester then gave the participant the second package and said "PLEASE OPEN AND PROPERLY CLOSE THIS PACKAGE." The time to open and resecure or one minute whichever was less was recorded on the data sheet. Any participant who could no open and resecure both of the non-child resistant screening packages was not counted as part of the panel. Additional adults were selected and tested.
  • To begin the second test period, the tester gave the participant an NEW package and said "THIS IS AN IDENTICAL PACKAGE. PLEASE OPEN IT ACCORDING TO THE INSTRUCTIONS ON THE PACKAGE." After the participant opened the package, the tester said, "PLEASE REMOVE ONE OF THE PILLS."
  • The participant was allowed up to one minute to open the package, The elapsed time in seconds to open the package was recorded on the data sheet.
  • After one minute or when the participant had opened the package, whichever came first, the tester took all test materials from the participant. If a participant did not open the package and stopped trying by the end of the one minute test period, the tester said, "ARE YOU FINISHED WITH THE PACKAGE OR WOULD YOU LIKE TO TRY AGAIN?" If the participant indicated that he/she was finished or could not open the package and did not wish to continue trying, this was counted as a failure to the one minute test.
  • No adult participated in more than two tests per sitting. If a person participated in two tests, the packages tested were not the same type of package.

Package Identification

KEY-PAK F1 with Tear Resistant Board
No. of cavities per card: 14
No. of Rows: 2
Blister Layout: WADE CR 7