[Federal Register Volume 59, Number 54 (Monday, March 21, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-6281]


[[Page Unknown]]

[Federal Register: March 21, 1994]


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CONSUMER PRODUCT SAFETY COMMISSION

16 CFR Part 1700

 

Requirements for the Special Packaging of Household Substances; 
Request for Comment on Additional Data Concerning Proposed Rule

AGENCY: Consumer Product Safety Commission.

ACTION: Proposed rule; request for comment.

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SUMMARY: On October 5, 1990, the Commission proposed to amend its 
requirements under the Poison Prevention Packaging Act of 1970, as 
amended, for child-resistant packaging. These amendments would change 
the child and adult tests under which child-resistant packaging is 
evaluated. In a Federal Register document published March 5, 1991, the 
period for submitting written comments was extended to July 1, 1991, 
and comment was solicited on a change to the adult test protocol that 
was suggested during the original comment period. Oral comments were 
received on December 5, 1990, and September 12, 1991.
    The Commission received a number of comments on various aspects of 
the proposed rule. The Commission's staff also continued to analyze 
available data and contracted for additional tests of child-resistant 
packaging to address issues raised by the comments.
    In this document, the Commission requests comment on data that have 
become available since the original proposal and on changes to the 
proposed test protocols suggested by the new data.

DATES: Written comments are due no later than May 20, 1994.

ADDRESSES: Written comments and data should be mailed to the Office of 
the Secretary, Consumer Product Safety Commission, Washington, DC 
20207, or delivered to room 502, 4330 East-West Highway, Bethesda, MD 
20814.

FOR FURTHER INFORMATION CONTACT: Suzanne Barone, Project Manager for 
Poison Prevention, Directorate for Health Sciences, Consumer Product 
Safety Commission, Washington, DC 20207; telephone (301)504-0477.

SUPPLEMENTARY INFORMATION:

I. Background

    The Poison Prevention Packaging Act of 1970 (PPPA), 15 U.S.C. 1471-
1476, authorizes the Consumer Product Safety Commission to issue 
requirements that certain household substances be sold in child-
resistant packaging. Under the PPPA, the Commission has defined and 
established standards for such ``special'' packaging. 16 CFR 
1700.1(b)(4), 1700.3, 1700.15, and 1700.20. The Commission has also 
determined which household substances are required to have the special 
packaging. 16 CFR 1700.14.
    To comply with the special packaging requirements, a package must 
resist entry by most young children and must not be difficult for most 
adults to open and properly resecure, within specified time periods. 
The existing requirements were developed before the widespread use of 
child-resistant packaging and, therefore, without the benefit of the 
actual use experience and test data that since have become available.
    In the Federal Register of October 5, 1990, the Commission proposed 
to amend its requirements under the PPPA. 55 FR 40856. The current 
regulations provide that a package design must be capable of resisting 
opening by 85 percent of a panel of 200 children after a 5-minute 
period and by 80 percent of the panel after a single demonstration of 
how to open the package and an additional 5-minute period. The package 
must also be able to be opened and, if appropriate, properly closed 
within 5 minutes by 90 percent of a panel of 100 persons (70 percent 
female) of ages from 18-45 years.
    Because some persons, especially older persons, find certain types 
of child-resistant packaging difficult to open and resecure properly, a 
number of people either purposely purchase products in packages that 
are not child-resistant or do not properly resecure the package after 
opening it initially. The Commission concludes that if these difficult-
to-use packages were replaced with packages that are easier to use, 
more people of all ages would purchase and properly use child-resistant 
packaging, with a reduction in the number of poisonings of children. In 
order to accomplish this goal, the Commission proposed to substitute a 
panel of 100 older adults, ages from 60-75 years, for the current panel 
of 18-45 year-olds. The Commission believes that substituting a panel 
of older adults, who as a group are less able to open child-resistant 
packaging, will exclude the more difficult-to-use designs that now can 
pass the test with the younger panel. In addition, the Commission 
proposed to reduce the time provided for the adults to open and, if 
appropriate, properly resecure the packages from 5 minutes to 1 minute. 
In order to allow the use of new packaging designs that are unfamiliar, 
the originally proposed 1-minute opening/resecuring test would have 
been preceded by a 30-second period that the test subject can use to 
become familiar with how the package operates. The Commission stated 
that if it concluded that it is not feasible to substitute a panel of 
60-75 year-olds for the present panel of 18-45 year-olds, it proposed 
to reduce the time allowed for the 18-45 year-olds to 30 seconds, 
preceded by a 30-second familiarization period.
    Other proposed amendments are intended to simplify the current test 
procedures, without reducing the ability of the test to determine 
child-resistance. These amendments include testing for child resistance 
by using sequential groups of 50 children, rather than using the full 
200-child panel each time, until a statistically valid determination of 
whether the package is child-resistant is obtained, or until the 
current number of children tested, 200, is reached. Also, the 
Commission proposed to use 3 age groups, of 42-44, 45-48, and 49-51 
months, with 30, 40, and 30 percent of the children in each age group, 
respectively, instead of the current 10 age groups between 42 and 51 
months.
    The remaining proposed amendments are intended to ensure that the 
test protocol produces more consistent results. These amendments are: 
to add a procedure for determining whether the package has been secured 
adequately by the adults; to limit the number of subjects that could be 
tested by any one tester to no more than 30 percent of the children or 
35 percent of the adults; to limit the children in each group who are 
tested at or obtained from any given site to not more than 20 percent; 
to limit the percentage of the total number of adults tested who are 
tested at or obtained from any given site to not more than 35 percent; 
and to issue guidelines for standardized instructions to be used when 
testing.
    The proposal specified that written comments would be received 
until January 3, 1991, and oral comments were received by the 
Commission on December 5, 1990. The written and oral comments included 
several requests that the comment period be extended for periods up to 
180 days. The requests stated that the testing and evaluations needed 
to respond to the proposal required the additional time. Some requests 
also asked for a second opportunity to submit oral comments at the end 
of the extended period for submitting written comments.
    The Commission considered these requests and granted an extension 
of 180 days, until July 1, 1991, for submission of written comments. 
Additional oral comments were received on September 12, 1991.
    During the original comment period, a suggestion was received for a 
variation of the adult test that had not been discussed specifically in 
the proposal. In the original proposal, the Commission indicated that 
it was considering shortening the present 5-minute test time for the 
adult panel to 1 minute, but providing a 30-second period prior to the 
test that the test subject would use to become familiar with how to 
open the package. A commenter suggested that the proposed 30-second 
familiarization period be extended to 5 minutes and that the test 
subject must be able to open the package during that time. The subjects 
who are successful in opening the package during the familiarization 
period would then be tested to see if they could then open and resecure 
the package within 1 minute. Subjects would have to be successful in 
both time periods in order for the package to pass the adult test. The 
commenter suggested that the longer familiarization period would allow 
time for test subjects to learn how to operate unfamiliar designs. The 
Commission preliminarily concluded that this suggestion may have merit 
and requested comment on it. 56 FR 9181.
    The Commission received a number of comments in response to the 
proposed rule and the additional request for comment. Some of the 
commenters' concerns can be alleviated by changes to the proposed rule. 
The staff also contracted for additional testing to obtain information 
to address the comments received on the proposed 5-minute/1-minute 
test. The test data and the Commission staff's analyses of the data are 
available from the Commission's Office of the Secretary.
    The remainder of this notice describes the comments that required 
additional information to address or that the Commission currently 
believes may require changes in the proposed test procedure. This 
notice also describes the new data and the changes to the test 
procedures that the Commission preliminarily concludes are appropriate. 
Any other comments will be addressed at the time the Commission 
considers issuance of a final rule.
    This notice does not necessarily repeat background information, 
rationale for the proposed rule, findings, etc., that were in the 
earlier Federal Register notices discussed above, which should be 
consulted by persons not familiar with them.

II. Response to Comments

    The comments on the proposal that have resulted in changes to the 
proposal, other changes to the proposal, and relevant new data are 
discussed under the subject matter groupings given below. Other 
relevant comments will be addressed when the Commission considers a 
final rule.

1. Variability of the 60-75 Year-Old Age Group

    In the previously proposed rule, the senior test panel consisted of 
100 adults between the ages of 60-75 selected at random. Several 
comments were received concerning the lack of a defined age 
distribution of the participants throughout the 60-75 age group. 
Commenters stated that a random sample would result in 50-60 percent of 
the participants being in the 71-75 year old age group. The lack of 
homogeneity, and the variability of the 60-75 year age group were also 
commented on. The commenters placed special emphasis on the variability 
of the 71-75 year-old age group, as measured by the participants' time 
to open the packages. The commenters requested that the 71-75 age group 
be dropped from the test due to high variability and the lack of 
homogeneity.
    To address the comments concerning distribution, the Commission's 
staff recommends dividing the 60-75 year old age group into three age 
groups: 60-64, 65-70, and 71-75. This would assure a more uniform 
spread of subjects throughout the age range.
    The allocation of the participants to the three groups was 
determined by analyzing child-resistant package test data obtained from 
testing persons 60-75 years of age in 1984 and 1985. These data were 
presented previously (55 FR 40858 and (Wilbur, C. J., 1985)). The 
analysis of the data indicated that the 60-64 year old group and the 
65-70 year old group performed similarly (Kissinger, 1993). The 71-75 
year old group had a lower proportion of success and therefore was more 
variable with respect to whether the participants were successful or 
unsuccessful. The staff recommends allocating a larger number of 
participants to the 71-75 year old group to decrease overall 
variability. The 3 age groups would be allocated as 30 percent ages 60-
64, 30 percent ages 65-70, and 40 percent ages 71-75. The proportions 
of success from the 3 age groups would then be weighted equally, so 
that the 71-75 year old group is not more heavily represented.
    The recommended age distribution and allocations were applied in 
testing contracted by CPSC (CPSC-C-91-1135) to establish their validity 
for various reclosable and non-reclosable child-resistant packages. The 
results confirmed that the performance of the 60-64 year-old age group 
and the 65-70 year-old group were not significantly different; 
therefore, it was valid to allocate the same number of participants to 
these groups. The performance of the group 71-75 years of age was 
significantly lower than the performance of the younger two age groups. 
This confirms that a larger sample size for the age group is warranted.
    The larger sample size for the 71-75 year-old group adjusts for the 
slightly greater variability seen in that group using a pass/fail 
response variable in which a fixed amount of time for opening and 
closing the package is allotted to each participant. The variability 
discussed by the commenters pertained to the variability in the mean 
time to open packages by the different age groups. This is a different 
response variable from the pass/fail response variable used by CPSC. 
However, time to open is not a valid response variable in a pass/fail 
test that allows a fixed amount of time for opening and closing.
    In addition to distribution and variability, comments were received 
about the lack of homogeneity of the 60-75 year age group. The 
commenters did not define the term homogeneity. Homogeneity is defined 
by the CPSC staff as the similarity of the subjects of different ages 
within a particular age group in their ability to successfully open and 
resecure the various child-resistant packages. The CPSC staff 
statistically analyzed the homogeneity of the three age groups using 
the results of tests with reclosable and non-reclosable packages. No 
significant differences were found in performance within each of the 
three age groups (60-64, 65-70, and 71-75) for either reclosable or 
non-reclosable packages (Kissinger, 1993a). The CPSC testing used a 
minimum of five sites in each test. The senior-adult protocol is 
therefore being modified to include this limitation.

2. Sequential Test

    Many comments were received questioning the Commission's 
preliminary statutory findings that the proposed protocol is 
technically feasible and practicable. The commenters stated that 
although the Commission included data on packages that passed the 1-
minute senior test with a senior-adult use effectiveness (``SAUE'') 
greater than 90 percent, the probability of these packages passing 
consistently was unknown. The commenters stated that SAUE of 95 percent 
in 1 test is required to assure that the package will pass consistently 
at 90 percent. Commenters stated that the protocol must be designed to 
avoid failing an effective package with a true proportion a little 
greater than 90 percent, or passing a marginal package with a true 
proportion a little less than 90 percent. Various commenters suggested 
that this could be accomplished by eliminating the 71-75 year-old age 
group, or by decreasing the SAUE acceptance criterion to 85 percent.
    To address these comments, the CPSC's staff developed a sequential 
testing scheme. The test maintains the senior age range of 60-75 years 
of age and the acceptance criterion of 90 percent, while assuring a 
high level of confidence for passing packages (Kissinger, 9/18/92). 
Seniors are tested sequentially in panels of 100, until a statistically 
reliable pass/fail determination can be made or a total of 400 adults 
are tested. Providing for a larger number of adults to be tested for 
packages that perform near the 90 percent criterion will increase the 
likelihood of making the correct decision of passing or failing.
    Each panel of 100 seniors between the ages of 60-75 years is 
divided into three age groups (30 percent 60-64, 30 percent 65-70 and 
40 percent 71-75), which are given equal weighting. The results of the 
test of the first 100-senior panel are then evaluated to determine if 
the package passed (significantly greater than the 90 percent 
acceptance criterion), if it failed (significantly less than the 90 
percent acceptance criterion), or if further testing is required to 
make the determination. If further testing is required, another panel 
of 100 seniors is tested and the determination of passing, failing, or 
performing further testing is made based on the combined results of the 
200 participants. This process continues using additional panels of 100 
seniors until a passing or failing criterion is met or 400 subjects are 
tested for a particular package.
    The decision points for passing, failing, and continuing to test 
seniors are in proposed Sec. 1700.20(a)(3) below. For the calculated 
values, for the first three 100 senior panels, a 98 percent confidence 
interval lies entirely above or below the 90 percent acceptance 
criterion for the passing and failing decision points.
    The sequential testing procedure for senior adults was applied to 
four reclosable and four non-reclosable child-resistant packages. Each 
package was tested by 400 participants to verify the testing procedure. 
Fewer than 400 participants would have to be tested to determine 
passing results in the actual application of the sequential test with 
the samples tested by CPSC. One reclosable and 3 of the non-reclosable 
packages may have required testing 200 participants to determine 
passing using the acceptance criteria, depending on the order of the 
panels. The decision of passing could be made for the other 4 packages 
after testing 100 seniors. Even though packaging exists on the market 
that will pass the revised test methods with a high level of confidence 
after testing 100 or 200 people, the staff recommends extending the 
sequential test scheme to allow up to 400 participants. This addresses 
the commenter's concerns about ``borderline'' packages by using 
additional testing when the true proportion is close to the .900 
acceptance criterion.

3. Technical Feasibility, Practicability, and Appropriateness

    Many commenters contended that the Commission failed to make the 
required findings of technical feasibility, practicability, and 
appropriateness for the 1-minute test published in the proposed rule. 
Commenters indicated that the results from the child-resistant 
continuous-thread package testing were too close to the 90 percent 
effectiveness criterion to be reliable. The commenters stated that, 
although child-resistant-snap and child-resistant-lug packages had 
passing SAUE, these packages were not appropriate for many of the 
household substances regulated by the PPPA. To address these comments, 
CPSC's staff contracted testing to develop and verify an alternative 
test method and to demonstrate that effective packaging was technically 
feasible, practicable, and appropriate for the range of substances 
regulated by the PPPA.
    Four commercially available child-resistant reclosable packages 
were tested using the 5-min./1-min. test. A lug (ASTM type IIA), a snap 
(ASTM type IIIA), and two continuous-thread packages (ASTM types IA and 
IB) were tested. The closures and bottles cover a range of sizes that 
are appropriate for PPPA-regulated substances. All four reclosable 
child-resistant packages passed the senior test with SAUE above the 
0.951 acceptance criterion for 100 subjects. The majority of test 
participants indicated that the child-resistant packages were easy to 
use. The results provide evidence that senior-effective packaging can 
be developed (technically feasible), can be mass produced 
(practicable), and can provide adequate packaging for the range of 
PPPA-regulated products (appropriate).

4. Child-Resistant Effectiveness

    Many commenters expressed concerns that child-resistant 
effectiveness would be reduced in order to develop packaging that is 
``senior-friendly.'' A discussion of the influence of the senior adult-
use effectiveness on child-resistant effectiveness was published in the 
proposed rule. Child testing was conducted using the same reclosable 
package types to verify the child-resistance effectiveness of these 
``senior friendly'' packages. Child testing was conducted in panels of 
50 children, according to the proposed changes. (The exception was the 
child-resistant continuous-thread IA, for which an adult resecuring 
test was performed.) All reclosable packages tested had child-resistant 
effectiveness above the regulated acceptance criterion after 10 minutes 
and a single demonstration.
    This demonstrates that it is possible to manufacture packaging that 
both is easy to use by seniors and maintains a high level of child-
resistance.

5. Non-Reclosable Packaging

    In the proposed rule the Commission had no data to indicate that 
senior-effective non-reclosable packages (pouches and blisters) were 
technically feasible, practicable, and appropriate. Many commenters 
stated that the senior test protocol would eliminate unit dose 
packaging from the market. However, commenters supplied very little 
data to support this claim.
    The CPSC contracted for tests to obtain data on the senior 
effectiveness of currently marketed non-reclosable child-resistant 
packaging. Four non-reclosable child-resistant packages were tested: 
ASTM type IV-A (pouch), ASTM type IV-C (pouch with tool), ASTM Type 
VIII-E (blister with tool), and ASTM Type VIII-D (blister). All 4 
package types passed with SAUE above 0.940 for 200 participants. Three 
of the 4 packages passed with a SAUE above 0.951 for 100 participants.
    The data provide evidence that non-reclosable child-resistant 
packaging is technically feasible and practicable. Non-reclosable 
child-resistant packaging is currently available that can pass the 
senior effectiveness requirement with or without the use of a tool. The 
majority of the participants thought the various types of non-
reclosable packages were easy to open.

6. Screening Tests

    The proposed rule stated that the senior test panel would be 
composed only of adults who have successfully passed 1-minute screening 
tests using non-child-resistant packaging. A non-child-resistant snap 
and continuous-threaded package are the two screening packages. The 
participants have to open and to resecure the two non-child-resistant 
packages within 1 minute for each package. People unable to open either 
of these packages do not participate in the test. The screening test 
was proposed to eliminate individuals with limited ability. The range 
of movement and strength required to open and close non-child-resistant 
snap and continuous-threaded packages serves as the baseline for test 
participation.
    Several commenters argued that the screening process should apply 
to people who failed the child-resistant packages during the first 5-
minute test period. The testing firms indicated that participants were 
frustrated and confused by the number of packages they were asked to 
open. The CPSC staff adopted the practice of screening only those who 
fail to open the test package during the first 5-minute period in the 
testing conducted under contract CPSC-91-1135. The Commission proposes 
to amend the test procedures to incorporate this change.
    Many commenters disagreed with the choice of the screening packages 
used by CPSC (non-child-resistant snap and continuous-thread packages). 
Commenters indicated that the screening packages should be the non-
child-resistant version of the type of child-resistant package being 
tested. One commenter requested that the screening process be done in 
the beginning of the test with the non-child-resistant version of the 
test package to help the participants become more familiar with the 
operation of the cap.
    The purpose of the screening test is not to familiarize 
participants with package types. The senior test has an initial 5-
minute period, which allows ample time for participants to read 
instructions and become familiar with the packaging. The screening test 
was designed to eliminate people with limited function, as measured by 
the ability to open common non-child-resistant packaging. People unable 
to open these packages probably require assistance opening any kind of 
packaging.
    Many commenters requested a separate screening test for non-
reclosable (unit dose) package testing. The commenter supplied the 
results of testing a non-child-resistant blister, in which 9 out of 94 
participants failed to open the package within 1 minute. The commenters 
stated that if non-child-resistant blister packaging does not meet the 
opening times, the proposal is unrealistic for child-resistant non-
reclosable packages.
    The results of CPSC testing of non-reclosable child-resistant 
packages indicate that senior-effective non-reclosable child-resistant 
packages are technically feasible and practicable. The definition of 
child-resistance for unit dose packaging is determined by the toxicity 
of the product in the packaging or eight units, whichever is less. 
There are no standards for non-child-resistant unit-dose packaging.
    The CPSC tested a ``non-child-resistant'' non-reclosable package. 
All 100 seniors were able to open one unit of the blister package 
within the allotted time periods.
    The purpose of the screening test is to eliminate individuals with 
limited ability. The non-child-resistant snap and continuous-thread 
serve this function, and there is no need to use packaging of the 
particular type being tested. In addition, a non-child-resistant 
blister packaging screening test could introduce unreliable results 
unless performance standards were specified for such packaging.
    One comment was received regarding the use of a vision/reading test 
to eliminate people who had limited vision or were illiterate. The 
Commission concludes that this is unnecessary. As part of the process 
of informed consent prior to testing, participants read and fill out a 
consent form. People who state they don't have their glasses or cannot 
read the sheet for any reason are not included in the test. Since CPSC 
is required by the regulations for the Protection of Human Subjects (16 
CFR part 1028) to use informed consent in all human testing, 
participants read the form, give their birth date, and sign the form as 
part of the test. It is not necessary to include a separate vision or 
reading test.

7. Age Calculation for Children

    The proposed rule modified the child test protocol by reducing the 
number of age groups for testing from 10 to 3. The proposal specifies 
that the children be selected at random and that the inclusive ages of 
the children are such that 30 percent of the children are from 42 to 44 
months, 40 percent are from 45 to 48 months, and 30 percent are from 49 
to 51 months. A comment was received requesting that the calculation of 
age be based on ``near age'' rather than on the month in which the 
child was born. The commenter indicated that ``near age'' makes it 
possible to calculate a child's age plus or minus 15 days. If the month 
of birth is used, the distribution could range from plus or minus 30 
days.
    The current PPPA test procedures defined in 16 CFR 1700.20(a)(1) 
indicate a distribution of children by ``nearest age.'' The term 
nearest age was not included in the proposed revisions. The child-
resistant package testing contracted by CPSC uses a standardized 
formula for the calculation of the children's age to the ``nearest'' 
month. In response to the comment, the calculation for near age will be 
included as part of the child-test procedure to standardize the 
definition of the children's age range.

8. Evaluation of the 5-Minute/1-Minute Test Protocol

    The 5-minute/1-minute test was proposed by CPSC following 
commenters' concerns that the proposed 1-minute senior test would 
eliminate innovative packages. Commenters stated that if the 
participants learned how to open the unfamiliar package during an 
initial 5-minute period, less time would be required for the second 
opening. The two-time-period (5-min./1-min.) test allows participants 
to read the instructions and become familiar with the package and 
requires them to open the package within the 5-minute period. The 
second test period provides 1 minute for the participant to properly 
open and resecure a second package.
    The test results from the four reclosable and four non-reclosable 
packages were analyzed to determine if people ``learned'' from the 
first time period. The difference in the time for the first and second 
openings was compared for each successful participant. The results show 
a significant decrease in the amount of time it takes a participant to 
open the package the second time. This is true for all eight package 
types, including ASTM type IB (CT) and the non-reclosable packages that 
may be less familiar to the general population.
    Although the 1991 request for comment stated that the second test 
period was 1 minute, CPSC's contractor timed the second test period to 
5 minutes to determine if a longer second-test time period was 
appropriate. A second time period of 1 minute was found to be ample. 
When the appropriate controls are applied (age distribution, tester and 
site restriction, etc.), the 5-minute/1-minute senior test appears to 
be a valid method for measuring SAUE for all types of packages tested, 
and the Commission proposes to adopt it.

9. Definition of the Test Procedure

    The current PPPA regulations do not include the test instructions 
used by CPSC for the child and adult test. The Commission proposed 
adding a recommendation to Sec. 1700.20 for the use of standardized 
instructions as guidelines for conducting the child and adult tests. 
Recommended standardized test instructions for the 1-minute senior test 
were published in the previously proposed rule. The Commission received 
comments supporting standardization of the test procedures.
    The Commission agrees that the procedures and instructions for the 
senior and child tests should be followed closely to ensure the 
statistical reliability of these tests and control variability. 
Accordingly, the Commission proposes to include mandatory standardized 
instructions for the child and senior-adult tests in the rule.

10. Calculation of Senior Adult Use Effectiveness (SAUE)

    SAUE is calculated by averaging the proportion of success for the 
three senior age groups. Successful participants are those who open the 
test package within the first 5-minute period and open and properly 
resecure the test package within the second 1-minute time period. The 
proportions of success for 60-64, 65-70, and 71-75 year old age groups 
are averaged so that the 71-75 year old age group is not more heavily 
represented. The calculated SAUE is compared to the acceptance criteria 
for the sequential test. The SAUE is calculated in the same manner for 
100, 200, 300, or 400 participants. A formula for the calculation of 
SAUE and some examples are in Sec. 1700.20(d)(3) of the proposed rule 
set forth below.

11. Adult-Resecuring Test

    The PPPA requires that adults be able to use child-resistant 
packaging properly, which includes both opening the package and 
resecuring it to a child-resistant condition. The adult resecuring test 
was proposed by CPSC as a procedure to determine whether packages have 
been resecured when an objective determination that the package has 
been resecured to a child-resistant condition cannot be made otherwise. 
Packages which have been opened and appear to be resecured by the 
adults are given to children to open according to the child test 
protocols. Openings by children, in excess of the number of openings 
that represent standard child-resistant effectiveness, count as 
failures to resecure by adults. However, the use of the 5-min./1-min. 
senior test protocol has resulted in several changes in the procedure 
and calculations in the adult-resecuring test that are incorporated in 
the proposed rule set forth below. In addition, the calculation of 
failures in the adult resecuring test has been simplified by using only 
the 80 percent child-resistant effectiveness that applies after both 5-
minute periods (10 minutes total), and not the additional 85 percent 
effectiveness criterion applicable after the first 5-minute period of 
the regular child test.

III. Comment Period

    The Commission believes a 60-day comment period is adequate since 
the changes are largely in response to previous comments and industry 
has been aware of many of the changes for some time. The staff has been 
providing technical support to a project on inter-laboratory testing of 
child-resistant packaging being conducted by ASTM's Institute for 
Standards Research. This project uses the protocol that is in the 
revised proposal set forth below, and the industry thus is already 
familiar with the revised proposal.

IV. Commission Findings

    Except as noted above, the changes to the proposed rule do not 
warrant any changes in the Commission's findings concerning the 
statutory findings required by the PPPA, the effective date, the 
initial regulatory flexibility analysis, or the lack of environmental 
effects of the rule.

List of Subjects in 16 CFR Part 1700

    Consumer protection, Drugs, Infants and children, Packaging and 
containers, Poison prevention, Toxic substances.

V. Conclusion

    For the reasons given above, the Commission proposes to amend 16 
CFR Part 1700 as follows:

PART 1700--[AMENDED]

    1. The authority citation for part 1700 is revised to read as 
follows:

    Authority: 15 U.S.C. 1471-76. Secs. 1700.1 and 1700.14 also 
issued under 15 U.S.C. 2079(a).

    2. In Sec. 1700.15, paragraph (b)(2) is revised and paragraph (e) 
is added to read as follows:

Sec. 1700.15  Poison prevention packaging standards.

    (2) Senior adult use effectiveness (SAUE) of not less than 0.900 
for the senior-adult panel test of Sec. 1700.20(a)(3).

* * * * *

    (e) When it is determined by rule that the younger-adult test of 
Sec. 1700.20(a)(4) shall apply instead of the senior-adult test of 
Sec. 1700.20(a)(3), the effectiveness shall be not less than 90 
percent.
    3. In Sec. 1700.20, paragraph (a) is revised and paragraph (d) is 
added to read as follows:


Sec. 1700.20  Testing procedure for special packaging.

    (a) Test protocols--(1) General requirements--(i) Requirements for 
packaging. As specified in Sec. 1700.15(b), special packaging is 
required to meet the child test and senior-adult test requirements of 
this Sec. 1700.20. The younger-adult test is retained in the 
regulations for use in the event the Environmental Protection Agency 
determines that the senior-adult test is not appropriate in particular 
instances.

    (ii) Condition of packages to be tested. Any tamper-resistant 
feature of the package to be tested shall be removed prior to testing 
unless it is part of the package's child-resistant design. Where a 
package is supplied to the consumer in an outer package that is not 
part of the package's child-resistant design, the time required to 
remove the outer package is not counted in the times allowed for 
attempting to open and, if appropriate, reclose the package.
    (2) Child test--(i) Test subjects. (A) Use from 1 to 4 groups of 50 
children, as required under the sequential testing criteria in table 1. 
No more than 20 percent of the children in each group shall be tested 
at or obtained from any given site. Each group of children shall be 
randomly selected as to age, subject to the limitations set forth 
below. Thirty percent of the children in each group shall be of age 42-
44 months, 40 percent of the children in each group shall be of age 45-
48 months, and 30 percent of the children in each group shall be of age 
49-51 months. The children's ages in months shall be calculated as 
follows:
    (1) Arrange the birth date and test date by the numerical 
designations for month, day, and year (e.g., test date: 8/3/1990; birth 
date: 6/23/1986).
    (2) Subtract the month, day, and year numbers for the birth date 
from the respective numbers for the test date. This may result in 
negative numbers for the months or days. (e.g., 

                             8 / 03 / 1990                              
                            -6 / 23 / 1986                              
                        --------------------------                      
                                   2-20 4                               
------------------------------------------------------------------------

    (3) Multiply the difference in years by 12 to obtain the number of 
months in the difference in years, and add this value to the number of 
months that was obtained when the birth date was subtracted from the 
test date (i.e., 4 x 12=48; 48+2=50). This figure either will remain 
the same or be adjusted up or down by 1 month, depending on the number 
of days obtained in the subtraction of the birth date from the test 
date.
    (4) If the number of days obtained by subtracting the days in the 
birth date from the days in the test date is +16 or more, 1 month is 
added to the number of months obtained above. If the number of days is 
-16 or less, subtract 1 month. If the number of days is between -15 and 
+15 inclusive, no change is made in the number of months. Thus, for the 
example given above, the number of days is -20, and the number of 
months is therefore 50-1=49 months.
    (B) The difference between the number of boys and the number of 
girls in each age range shall not exceed 10 percent of the number of 
children in that range. The children selected should have no obvious or 
overt physical or mental handicap. Each child's parent or guardian 
shall read and sign a consent form prior to the child's participation.
    (ii) Test failures. A test failure shall be any child who opens the 
special packaging or gains access to its contents. In the case of unit 
packaging, however, a test failure shall be any child who opens or 
gains access to the number of individual units which constitute the 
amount that may produce serious personal injury or serious illness, or 
a child who opens or gains access to more than 8 individual units, 
whichever number is lower, during the full 10 minutes of testing. The 
determination of the amount of a substance that may produce serious 
personal injury or serious illness shall be based on a 25-pound child. 
Manufacturers or packagers intending to use unit packaging for a 
substance requiring special packaging are requested to submit such 
toxicological data to the Commission.
    (iii) Sequential test. The sequential test is initially conducted 
using 50 children, and, depending on the results, the criteria in table 
1 determine whether the package is either child-resistant or not child-
resistant or whether further testing is required. Further testing is 
required if the results are inconclusive and involves the use of one or 
more additional groups of 50 children each, up to a maximum of 200 
children. No individual shall administer the test to more than 30 
percent of the children tested in each group. Table 1 gives the 
acceptance (pass), continue testing, and rejection (fail) criteria to 
be used for the first 5 minutes and the full 10 minutes of the 
children's test. If the test continues past the initial 50-child panel, 
the package openings shown in Table 1 are cumulative. 

Table 1.--Number of Openings: Acceptance (Pass), Continue Testing, and Rejection (Fail) Criteria for the First 5
                         Minutes and the Full 10 Minutes of the Children's Protocol Test                        
----------------------------------------------------------------------------------------------------------------
                                                                  Package openings                              
                        Cumulative -----------------------------------------------------------------------------
      Test panel        number of        First 5 minutes                        Full 10 minutes                 
                         children  -----------------------------------------------------------------------------
                                        Pass       Continue       Fail         Pass       Continue       Fail   
----------------------------------------------------------------------------------------------------------------
1....................           50          0-3         4-10          11+          0-5         6-14          15+
2....................          100         4-10        11-18          19+         6-15        16-24          25+
3....................          150        11-18        19-25          26+        16-25        26-34          35+
4....................          200        19-30  ...........          31+        26-40  ...........         41+ 
----------------------------------------------------------------------------------------------------------------

    (iv) Test procedures. The children shall be divided into groups of 
two. The testing shall be done in a location that is familiar to the 
children; for example, their customary nursery school or regular 
kindergarten. No child shall test more than two special packages. When 
more than one special package is being tested, each package shall be of 
a different ASTM type and they shall be presented to the paired 
children in random order. This order shall be recorded. The children 
shall be tested by the procedure incorporated in the following test 
instructions:

Standardized Child Test Instructions

    1. Reclosable packages with closure liners shall be properly 
resecured at least 72 hours prior to beginning the test to allow the 
liner to ``take a set.''
    2. All packages shall be handled so that no damage or jarring 
will occur during storage or transportation. The packages shall not 
be exposed to extreme conditions of heat or cold. The packages shall 
be tested at room temperature.
    3. The children shall have no overt physical or mental 
handicaps. No child with a permanent or temporary illness, injury, 
or handicap that would interfere with his/her effective 
participation shall be included in the test.
    4. The testing shall take place in a well-lighted location that 
is familiar to the children and that is isolated from all 
distractions.
    5. Reclosable packages shall be opened and properly resecured 
one time by the tester who will be conducting the test. The opening 
and resecuring shall not be done in the presence of the children. 
(In the adult-resecuring test, the tester must not open and resecure 
the package prior to the test.)
    6. The tester, or another adult, shall escort a pair of children 
to the test area. The tester shall ask the two children to sit down 
in chairs that are positioned so that there is no visual barrier 
between the children and the tester.
    7. The tester shall talk to the children to make them feel at 
ease.
    8. The children shall not be given the impression that they are 
in a race or contest. They are not to be told that the test is a 
game or that it is fun. They are not to be offered a reward.
    9. The tester shall record all data prior to, or after, the test 
so that full attention can be on the children during the test 
period.
    10. The tester shall use a stopwatch(s) to time the number of 
seconds it takes the child to open the package and to time the 5-
minute test periods.
    11. To begin the test, the tester shall hand the children 
identical packages and say, ``PLEASE TRY TO OPEN THIS FOR ME.''
    12. If a child refuses to participate after the test has 
started, the tester shall reassure the child and gently encourage 
the child to try. If the child continues to refuse, the tester shall 
ask the child to hold the package in his/her lap until the other 
child is finished. This pair of children shall not be eliminated 
from the results unless the refusing child disrupts the 
participation of the other child.
    13. Each child shall be given up to 5 minutes to open his/her 
package. The tester shall watch the children at all times during the 
test. The tester shall minimize conversation with the children as 
long as they continue to attempt to open their packages. The tester 
shall not discourage the children verbally or with facial 
expressions. If a child gets frustrated or bored and stops trying to 
open his/her package, the tester shall reassure the child and gently 
encourage the child to keep trying.
    14. The children shall be allowed freedom of movement to work on 
their packages as long as the tester can watch both children (e.g., 
they can stand up, get down on the floor, or bang or pry the 
package).
    15. If a child is endangering himself or others at any time, the 
test shall be stopped and the pair of children eliminated from the 
final results.
    16. The children shall be allowed to talk to each other about 
opening the packages and shall be allowed to watch each other try to 
open the packages.
    17. A child shall not be allowed to try to open the other 
child's package.
    18. If a child opens his/her package, the tester shall say, 
``Thank You,'' take the package from the child and put it out of the 
child's reach. The child shall not be asked to open the package a 
second time.
    19. At the end of the 5-minute period, the tester shall 
demonstrate how to open the package if either child has not opened 
his or her package. A separate ``demo'' package shall be used for 
the demonstration.
    20. Prior to beginning the demonstration, the tester shall ask 
the children to set their packages aside. The children shall not be 
allowed to continue to try to open their packages during the 
demonstration period.
    21. The tester shall say, ``WATCH ME OPEN MY PACKAGE.''
    22. Once the tester gets the children's full attention, the 
tester shall hold the demo package approximately two feet from the 
children and open the package at a normal speed as if the tester 
were going to use the contents. There shall be no exaggerated 
opening movements.
    23. The tester shall not discuss or describe how to open the 
package.
    24. To begin the second 5-minute period, the tester shall say, 
``NOW YOU TRY TO OPEN YOUR PACKAGES.''
    25. If one or both children have not used their teeth to try to 
open their packages during the first 5 minutes, the tester shall 
say, ``YOU CAN USE YOUR TEETH IF YOU WANT TO.'' This is the only 
statement that the tester shall make about using teeth.
    26. The test shall continue for an additional 5 minutes or until 
both children have opened their packages, whichever comes first.
    27. At the end of the test period, the tester shall say, ``THANK 
YOU FOR HELPING.'' In addition, the tester shall say, ``NEVER OPEN 
PACKAGES LIKE THIS WHEN YOU ARE BY YOURSELF. THIS KIND OF PACKAGE 
MIGHT HAVE SOMETHING IN IT THAT WOULD MAKE YOU SICK.''
    28. The children shall be escorted back to their classroom or 
other supervised area by the tester or another adult.
    29. If the children are to participate in a second test, the 
tester shall have them stand up and stretch for a short time before 
beginning the second test. The tester shall take care that the 
children do not disrupt other tests in progress.

    (3) Senior-adult panel--(i) Test subjects. Use from 1 to 4 groups 
of 100 senior adults, as required under the sequential testing criteria 
in table 2. Not more than 24 percent of the senior adults tested shall 
be obtained from or tested at any one site. Each group of senior adults 
shall be randomly selected as to age, subject to the limitations set 
forth below. Seventy percent of each group shall be female. Thirty 
percent of the senior adults in each group shall be 60-64 years old, 30 
percent of the senior adults in each group shall be 65-70 years old, 
and 40 percent of the senior adults in each group shall be 71-75 years 
old. The senior adults selected should have no obvious or overt 
physical or mental handicap. Only persons who can open and close 
conventional (not child-resistant) snap and continuous-threaded type 
plastic closures in 1-minute screening tests shall be included in the 
senior-adult panel. The screening tests for this purpose shall use snap 
and continuous-threaded (CT) plastic closures having a diameter of 28 
mm 18 percent, the CT closures having been resecured 72 
hours before testing at 10 inch-pounds of torque. The containers shall 
be round plastic containers, in sizes of 2 ounce \1/2\ 
ounce for the CT-type closure and 8 drams 4 drams for the 
snap-type closure.
    (ii) Sequential test. (A) No individual tester shall administer the 
test to more than 35 percent of the senior adults tested. The 
sequential test is initially conducted using 100 senior adults. 
Depending on the results, the criteria in Table 2 determine whether the 
package is either senior adult use effective or not senior adult use 
effective or whether further testing is required. Further testing is 
required if the results are inconclusive and would involve the use of 1 
or more additional groups of 100 senior adults each, up to a maximum of 
400 senior adults. Table 2 gives the acceptance (pass), continue 
testing, and rejection (fail) criteria to be used for the senior-adult 
test.

 Table 2.--Calculated Senior Adult Use Effectiveness (SAUE): Acceptance (Pass), Continue Testing, and Rejection 
                               (Fail) Criteria for the Senior-Adult Protocol Test                               
----------------------------------------------------------------------------------------------------------------
                                                         Cumulative                                             
                      Test panel                           senior        Pass       SAUE continue        Fail   
                                                           adults                                               
----------------------------------------------------------------------------------------------------------------
1.....................................................          100                                  
                                                                           0.951      <0.951->0.807  
                                                                                                           0.807
2.....................................................          200                                  
                                                                           0.940      <0.940->0.838  
                                                                                                           0.838
3.....................................................          300                                  
                                                                           0.934      <0.934->0.851  
                                                                                                           0.851
4.....................................................          400                                  
                                                                           0.900  .................       <0.900
----------------------------------------------------------------------------------------------------------------

    (B) SAUE. The calculated senior adult use effectiveness (SAUE) is 
calculated by averaging the proportions of success for the 3 age groups 
(ages 60-64, 65-70, and 71-75). The proportion of success for each age 
group is calculated by dividing the number of persons in that age group 
who opened the package in the first (5-minute) test period and who 
opened and (if appropriate) properly resecured the package in the 1-
minute test period by the total number of persons in that age group who 
were tested. Thus, the equation for calculation of the SAUE is:

TP21MR94.005

For example, for results after the test of the first group of 100 
senior adults, if:

29 of 30 subjects 60-64 successful = 0.967 proportion of success
28 of 30 subjects 65-70 successful = 0.933 proportion of success
36 of 40 subjects 71-75 successful = 0.900 proportion of success

0.967 + 0.933 + 0.900 = 2.800; dividing by 3 = 0.933 SAUE

(with this SAUE, testing would continue). If the test continues past 
the first panel of senior adults, the number of successes and the 
number tested are cumulative. Thus, for results after the test of the 
second group of 100 senior adults, (200 total), if:
59 of 60 subjects 60-64 successful = 0.983 proportion of success
57 of 60 subjects 65-70 successful = 0.950 proportion of success
74 of 80 subjects 71-75 successful = 0.925 proportion of success

0.983 + 0.950 + 0.925 = 2.858; dividing by 3 = 0.953 SAUE

(with this SAUE, testing would stop because the SAUE exceeds the 
acceptance criterion for 200 senior adults).
    (iii) Test procedures. (A) Reclosable packages with closure liners 
shall be properly secured, if appropriate, at least 72 hours prior to 
beginning the test to allow the liner to ``set.'' Torque-dependent 
closures shall be secured at the same on-torque as applied on the 
packaging line. All packages shall be handled so that no damage or 
jarring will occur during storage or transportation. The packages shall 
not be exposed to extreme conditions of heat or cold. The packages 
shall be tested at room temperature.
    (B) The senior adults shall be tested individually, rather than in 
groups of two or more. The senior adults shall receive only such 
printed instructions on how to open and properly secure the special 
packaging as will appear on or accompany the package as it is delivered 
to the consumer. The senior-adult panel is tested according to the 
procedure incorporated in the following senior-adult panel test 
instructions:

Test Instructions for Senior Test

    The following test instructions are used for all senior tests. 
If non-reclosable packages are being tested, the commands to close 
the package are eliminated.
    1. No adult with a permanent or temporary illness, injury, or 
disability which would interfere with his/her effective 
participation shall be included in the test.
    2. Each adult shall read and sign a consent form prior to 
participating. If an adult cannot read the consent form for any 
reason (forgot glasses, illiterate, etc.), he/she shall not 
participate in the test.
    3. Each adult shall participate individually and not in the 
presence of other participants or onlookers.
    4. The tests shall be conducted in well-lighted and distraction-
free areas.
    5. Records shall be filled in before or after the test, so that 
the tester's full attention is on the participant during the test 
period. Recording the test times to open and resecure the package 
are the only exceptions.
    6. To begin the first 5-minute test period, the tester says, ``I 
AM GOING TO ASK YOU TO OPEN AND PROPERLY CLOSE THESE TWO IDENTICAL 
PACKAGES ACCORDING TO THE INSTRUCTIONS FOUND ON THE CAP.'' (Specify 
other instruction locations if appropriate.)
    7. The first package is handed to the participant by the tester, 
who says, ``PLEASE OPEN THIS PACKAGE.'' After the participant opens 
the package, the tester says, ``PLEASE CLOSE THE PACKAGE.'' 
Participants are allowed up to 5 minutes to read the instructions 
and open and close the package. The tester uses a stopwatch(s) or 
other timing device to time the opening and resecuring times. The 
elapsed times in seconds to open the package and to close the 
package are recorded on the data sheet as two separate times.
    8. If the package contains product, the tester shall say, 
``PLEASE OPEN THE PACKAGE. PLEASE EMPTY THE (PILLS, TABLETS, 
CONTENTS, etc.) INTO THIS CONTAINER.''
    9. After 5 minutes, or when the participant has opened and 
closed the package, whichever comes first, the tester shall take all 
test materials from the participant.
    10. To begin the second test period, the tester shall give the 
participant a NEW package and say, ``PLEASE OPEN THIS PACKAGE.'' 
After the package is opened, the tester says, ``PLEASE CLOSE THIS 
PACKAGE.''
    11. The participants are allowed up to 1 minute to open and 
close the package. The elapsed times in seconds to open and to close 
the package are recorded on the data sheet as two separate times. 
The time that elapses between the opening of the package and the end 
of the instruction to close the package is not counted as part of 
the 1-minute test time.
    12. After the 1-minute test, or when the participant has opened 
and closed the package, whichever comes first, the tester shall take 
all the test materials from the participant.
    13. Participants who do not open the package in the first 5-
minute test period are asked to open and close two non-CR screening 
packages. The participants are given a 1-minute test period for each 
package. The tester shall give the participant a package and say, 
``PLEASE OPEN AND PROPERLY CLOSE THIS PACKAGE.'' The tester records 
the time for opening and closing, or 61 seconds, whichever is less, 
on the data sheet. The tester then gives the participant the second 
package and says, ``PLEASE OPEN AND PROPERLY CLOSE THIS PACKAGE.'' 
The times to open and resecure or 1 minute, whichever is less, shall 
be recorded on the data sheet.
    14. Participants who cannot open and resecure both of the non-CR 
screening packages are not counted as part of the 100-senior panel. 
Additional participants are selected and tested.
    15. No adult may participate in more than two tests. If a person 
participates in two tests, the packages tested shall not be the same 
ASTM type of package.
    16. If more adults in a sex or age group are tested than are 
necessary to determine SAUE, the last person(s) tested shall be 
eliminated from that group.

    (4) Younger-adult panel. (i) One hundred adults, age 18 to 45 
inclusive, with no overt physical or mental handicaps, and 70 percent 
of whom are female, shall comprise the test panel for younger adults. 
The adults shall be tested individually, rather than in groups of two 
or more. The adults shall receive only such printed instructions on how 
to open and properly resecure the special packaging as will appear on 
the package as it is delivered to the consumer. Five minutes shall be 
allowed to complete the opening and, if appropriate, the resecuring 
process.
    (ii) Records shall be kept of the number of adults unable to open 
and the number of the other adults tested who fail to properly resecure 
the special packaging. The number of adults who successfully open the 
special packaging and then properly resecure the special packaging (if 
resecuring is appropriate) is the percent of adult-use effectiveness of 
the special packaging. In the case of unit packaging, the percent of 
adult-use effectiveness shall be the number of adults who successfully 
open a single package.
* * * * *
    (d) Recommendations. The following instructions and procedures, 
while not required, are used by the Commission's staff and are 
recommended for use where appropriate.

    (1) Report Format for Child Test:

A. Identification

    1. Close-up color photographs(s) clearly identifying the package 
and showing the opening instructions on the closure.
    2. Product name and the number of tablets or capsules in the 
package.
    3. Product manufacturer.
    4. Closure model (trade name--e.g., ``KLIK & SNAP'').
    5. Closure size (e.g., 28 mm).
    6. Closure manufacturer.
    7. Closure material and color(s) (e.g., white polypropylene).
    8. Closure liner material.
    9. TAC seal material.
    10. Opening instructions (quote exactly, e.g., ``WHILE PUSHING, 
DOWN, TURN RIGHT''). Commas are used to separate words that are on 
different lines.
    11. Symbols, numbers, and letters found inside the closure.
    12. Package model.
    13. Package material and color.
    14. Net contents.
    15. Symbols, numbers, and letters on the bottom of the package.
    16. Other product identification, e.g., EPA Registration Number.

B. Procedures

    1. Describe all procedures for preparing the test packages.
    2. Describe the testing procedures.
    3. Describe all instructions given to the children.
    4. Define an individual package failure.

C. Results

    1. Openings in each 5-minute period and total openings for males 
and for females in each age group.
    2. Opening methods (e.g., normal opening, teeth, etc.).
    3. Mean opening times and standard deviation for each 5-minute 
test period.
    4. The percentage of packages tested at each site as a 
percentage of total packages.
    5. The percentage of packages tested by each tester as a 
percentage of total packages.
    6. Child-resistant effectiveness for the first 5-minute period 
and for the total test period.
    (2) Standardized Adult-Resecuring Test Instructions:
    The adult-resecuring test is used by the CPSC to determine if 
torque-dependent continuous-threaded packages have been properly 
resecured. It may be appropriate for other package designs where an 
objective determination of resecuring is not easily made. The adult-
resecuring test is performed as follows:
    1. After the adult participant in either the senior-adult test 
of 16 CFR 1700.20(a)(3) or the younger-adult test of 16 CFR 
1700.20(a)(4) has resecured the package, or at the end of the test 
period (whichever comes first), the tester shall take the package 
and place it out of reach. The adult participant shall not be 
allowed to handle the package again.
    2. The packages that have been opened and appear to be resecured 
by adults shall be tested by children according to the child-test 
procedures to determine if the packages have been properly 
resecured. The packages are given to the children without being 
opened or resecured again for any purpose.
    3. Using the results of the adult tests and the tests of 
apparently-resecured packaging by children, the adult use 
effectiveness is calculated as follows:
    a. Senior adult use effectiveness (SAUE)--i. Procedure. The SAUE 
of a package following an adult resecuring test is calculated in the 
following manner.
    (A) If the proportion of children who opened the package in the 
full 10 minutes of the resecuring test is 0.200 or less, the 
apparently resecured packages were resecured to a child-resistant 
condition, and the SAUE is calculated normally in the manner 
provided in 16 CFR 1700.20(a)(3)(ii)(B). In this event, all the 
persons who apparently resecured their package are counted as 
successes, regardless of whether the package subsequently was opened 
by a child in the adult resecuring test.
    (B) If the proportion of children who opened the package in the 
full 10 minutes of the resecuring test exceeded 0.200, the excess 
over 0.200 is subtracted from the adult average proportion of 
apparent success to calculate the SAUE. Example: If, in a 100-senior 
test, 29 of 30 participants 60-64 opened and appeared to resecure 
the package, 28 of 30 participants 65-70 opened and appeared to 
resecure the package, and 36 of 40 participants 71-75 opened and 
appeared to resecure the package, then 93 of the tested packages 
were opened and apparently resecured. These 93 packages are then 
tested with 93 children. If 22 children opened the packages, the 
proportion of children who opened the packages is 0.237. Since this 
exceeds 0.200 by 0.037, 0.037 is subtracted from the average 
proportion of apparent success for the senior adults. Since the 
average proportion of apparent success for the senior adults is

TP21MR94.006

the SAUE is 0.933 - 0.037 = 0.896.
    b. Younger adult use effectiveness. i. The number of adult 
opening and resecuring failures, plus the number of packages that 
were opened by the children during the full 10-minute test that 
exceeds 20 percent of the apparently-resecured packages, equals the 
total number of failures.
    ii. The total number of packages tested by adults (which is 100) 
minus the total number of failures equals the percent adult-use 
effectiveness.
    (3) Report Format for Adult-Resecuring Test:

A. Identification

    Record the following items:
    1. Close-up color photograph(s) clearly identifying the package 
and showing the top of the closure.
    2. Product name and the number of tablets or capsules in the 
package.
    3. Product manufacturer.
    4. Closure model (trade name).
    5. Closure size (e.g., 28 mm).
    6. Closure manufacturer.
    7. Closure material and color(s) (e.g., white polypropylene).
    8. Closure liner material.
    9. Symbols, numbers, and letters found inside the closure.
    10. TAC seal material.
    11. Opening instructions (Quote exactly, e.g., ``WHILE PUSHING, 
DOWN, TURN RIGHT''). Commas are used to separate words that are on 
different lines.
    12. Package model.
    13. Package material and color.
    14. Net contents.
    15. Symbols, numbers, and letters on the bottom of the package.
    16. Other product identification, e.g., EPA Registration Number.

B. Procedures

    1. Describe all procedures for preparing the test packages.
    2. Describe the testing procedures in detail.
    3. Describe all instructions given to participants.
    4. Define an individual package failure and the procedures for 
determining a failure.

C. Results

Adult Test

    l. Total packages opened and total packages resecured; packages 
opened by males and by females; and packages resecured by males and 
by females.
    2. Mean opening times and standard deviation for total openings, 
total openings by females, and total openings by males.
    3. Mean resecuring times and standard deviation for total 
resecurings, total resecurings by females and total resecurings by 
males.
    4. The percentage of packages tested at each site as a 
percentage of total packages.
    5. The percentage of packages tested by each tester as a 
percentage of total packages.
    6. Methods of opening (e.g., normal opening, pried closure off, 
etc.)

Child Test

    1. Openings in each 5-minute period, and total openings, for 
males and females in each age group.
    2. Opening methods.
    3. Mean opening times and standard deviation for each 5-minute 
test period.
    4. The percentage of packages tested at each site as a 
percentage of total packages.
    5. The percentage of packages tested by each tester as a 
percentage of total packages.
    6. Section 1700.14(a) is revised by inserting ``meeting the 
requirements of Sec. 1700.20(a)'' after ``is such that special 
packaging''.

    Dated: March 14, 1994.
Sadye E. Dunn,
Secretary, Consumer Product Safety Commission.

Appendix 1--List of References

(This Appendix will not be printed in the Code of Federal 
Regulations)

    1. Madison, R., ``Sequential Testing for Child-Resistant 
Packaging,'' CPSC, Engineering Sciences, August 25, 1987.
    2. Wilbur, C.J., ``Special Packaging Requirements Suggested 
Changes,'' CPSC, Health Sciences, November 1985. pp. 11-14.
    3. Jacobson, B.J., et al., Prescription Drug Ingestion Study,'' 
CPSC, Health Sciences, September 10, 1986.
    4. Sherman, Dr. F.T., et al., Child-Resistant Containers for the 
Elderly, Journal of American Medical Association, March 9, 1979.
    5. Wilbur, C.J., CPSC, Health Sciences, ``PPPA, Protocol 
Revisions--Manufacturers Preview,'' January 1988.
    6. Spungen, H.S. and Schuirmann, D.J. ``Accessibility of Tamper 
Resistant Packaging to the Elderly,'' FDA, Center for Drugs and 
Biologies, 1984.
    7. Associated Testing Laboratories, Inc., Wayne, New Jersey, 
07470, ``Child-Resistant Blister 2 x 4 tablets, Peel Back and Push 
Out, ASTM-VIII-D, Protocol Test Report, No. T3999-001,'' November 
19, 1979.
    8. Product Manufacturer, Personal Communication, CR Blister 
Adult Protocol Test Results, Age Groups 18-45 and 46-70, Document 
Numbers 110685, November 1985.
    9. Wilbur, C.J., ``Determination of the minimum time to open and 
close CR packaging,'' CPSC, Health Sciences, January 1979.
    10. Madison, R., ``A Confirmation Test of a Child-Resistant 
Closure,'' CPSC, Engineering Sciences, June 1979.
    11. Howes, D.R., ``Analyses of Poison Packaging Protocol Test 
Data,'' CPSC Engineering Sciences, March 1979.
    12. Wilbur, C.J., ``PPPA Proposed Protocol Revisions--Technical 
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Tests with Child Resecuring Verification and a 200 Child Protocol 
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April 1990.
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for Access by Infants and the Elderly,'' Consumer Safety Institute, 
Amsterdam, The Netherlands, Accid, Anal. & Prev., Vol. 16, No. 3, 
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Containers,'' Windsor Poison Control Center, Windsor, Ontario, 
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Period Technical Feasibility, Practicability, Appropriateness,'' 
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1990.
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1990.
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18, 1990.
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Protocol Revisions,'' March 2, 1989.
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to B. Bush, The White House, March 3, 1990.
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1989.
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1989.
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Services, to Mary M. Hunter, March 30, 1989.
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May 11, 1989.
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to Acting Chairman Graham, CPSC, May 25, 1989.
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31, 1989.
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Hunter, June 12, 1989.
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to C.E. Koop, National Safe Kids Campaign, June 23, 1989.
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to V. White, October 11, 1989.
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to C.J. Wilbur, October 11, 1989.
    94. Unified Agenda, Item 3781, 54 FR 45525 (October 30, 1989).
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to D.E. Clark, NIH, November 9, 1989.
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December 1, 1989.
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to Chairman Scanlon, CPSC, August 31, 1988.
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[FR Doc. 94-6281 Filed 3-18-94; 8:45 am]
BILLING CODE 6355-01-P