[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
Feasibility, Practicability, and Appropriateness,'' CPSC, Health
Sciences, March 1988.
13. Wilbur, C.J., ``Adult, 60-75 & 18-45 Years of Age, Protocol
Tests with Child Resecuring Verification and a 200 Child Protocol
Test, Innovative Child Resistant Packaging System (ICRPS), 38 mm
ASTM, IA Screw Type CR Package with Cap Tool Slot on a Square
Plastic 125 ML Container--Status Report,'' CPSC, Health Sciences,
April 1990.
14. Thein, W.M.A., Rogmans, W.H.J., ``Testing Child-Resistance
for Access by Infants and the Elderly,'' Consumer Safety Institute,
Amsterdam, The Netherlands, Accid, Anal. & Prev., Vol. 16, No. 3,
pp. 185-190, 1984.
15. Breault, H.J., ``Five Years with 5 Million Child-Resistant
Containers,'' Windsor Poison Control Center, Windsor, Ontario,
Canada, Clinical Toxicology 7(1), pp. 91-95, 1974.
16. Sterndal, B., Bobbink S., Robertson, W.O., ``Poisoning From
Samples,'' Seattle Poison Center, Seattle, Washington, Vet Hum
Toxicol, 28(6), December 1986.
17. Jacobson, B.J., et al., ``Accidental Ingestions of Oral
Prescription Drugs: A Multicenter Survey,'' AjPH, Vol. 79, No. 7,
pp. 853-856, July 1989.
18. Schacter, L., ``Unintentional Ingestions of Medications by
Children Under 5 years of Age (January-March 1989),'' CPSC,
Epidemiology, February 10, 1990.
19. Hunter, M.M., Hunter, R.M., ``Cognitive Skill Based Child-
Resistant Medicine Container,'' U.S. Department Health and Human
Services, National Institute of Child Health and Human Development,
Yellowstone Environmental Science, Bozeman, Montana, January 1989.
20. Initial Regulatory Flexibility Analysis, CPSC, Economics,
March 15, 1990.
21. Potential Environmental Effects of Proposed Changes to PPPA
Protocol, CPSC, Economics, March 30, 1990.
22. White, V.A., ``Draft Proposal to Revise the Poison
Prevention Packaging Act (PPPA) Testing Protocol,'' CPSC, Program
Management, April 10, 1990.
23. Robins, M.P., ``Commission Request for Child-Resistant
Closure Market Share Information,'' CPSC, Economics, May 14, 1990.
24. Robins, M.P., ``Effective Date for Implementation of the
Proposed Protocol Revisions,'' CPSC, Economics, May 23, 1990.
25. Schacter, L.A., ``Response to Commission Questions and
Comments from the PPPA Protocol Revisions Briefing (May 2, 1990),''
CPSC, Epidemiology, May 22, 1990.
26. Deppa, Shelley W., ``Human Factors Issue Raised in
Commission Briefing on PPPA Protocol Revisions,'' CPSC,
Epidemiology, May 24, 1990.
27. Wilbur, C.J., ``PPPA Protocol Revisions--Manufacturers
Preview--Effective Date,'' CPSC, Health Sciences, May 1990.
28. Eberle, S., ``Protocol Revisions: Additional Information in
Response to Commission Questions,'' CPSC, Program Management, May
25, 1990.
29. Wilbur, C.J., ``PPPA Protocol Revisions One Minute Test
Period Technical Feasibility, Practicability, Appropriateness,''
CPSC, Health Sciences, July 1990.
30. Summary of Comments on Advance Notice of Proposed
Rulemaking, July 22, 1987.
31. Letter from Williamson D.J., Closure Manufacturers
Association, to Chairman Jones-Smith, January 8, 1990.
32. Letter from Hunter, F.T., to President George Bush, March 1,
1990.
33. Gross, R., EPA, ``CPSC Proposed Rule on Requirements for the
Special Packaging of Household Substances,'' March 20, 1990.
34. Letter from Hellander, I. and Wolfe, S.M., Public Citizen,
to Secretary, CPSC, March 21, 1990.
35. Gross, R., EPA, ``Consumer Product Safety Commission
Proposed Rule on Requirements for the Special Packaging of Household
Substances,'' April 5, 1990.
36. Letter from Hunter, M., Yellowstone Environmental Science,
to Chairman Jones-Smith, CPSC, April 18, 1990.
37. Letter from Hunter, R., Yellowstone Environmental Science,
to Chairman Jones-Smith, CPSC, April 25, 1990.
38. Letter from White, V., CPSC, to Wolfe, S. and Hellander, I.,
Public Citizen, April 26, 1990.
39. Ewell, H., ``Changes to Draft Federal Register Notice to
Propose PPPA Protocol Revisions,'' May 1, 1990.
40. Letter from Williamson, D.J., Closure Manufacturers
Association, to Chairman Jones-Smith, May 25, 1990.
41. Dunn, S.E., CPSC, ``Minutes of Commission Meeting,'' May 31,
1990.
42. Wilbur, C.J., ``Final Report (CPSC-C-88-1226),'' June 11,
1990.
43. Letter from Paolello, P., Calmar Inc., to S. Eberle, CPSC,
June 14, 1990.
43. White, V.A., ``Request for Closed Meeting with Closure
Manufacturer,'' June 29, 1990.
44. Wilbur, C.J., ``PPPA Protocol Revisions One Minute Test
Period Technical Feasibility, Practicability, Appropriateness,''
CPSC, July 1990.
45. Gross, R., EPA, ``CPSC Proposed Rule on Requirements for the
Special Packaging of Household Substances,'' July 3, 1990.
46. White, V.A., ``Draft Proposed Rule on PPPA Protocol
Revisions,'' CPSC, July 13, 1990.
47. Ewell, H., ``Changes to PPPA Protocol Revision FR,'' July
18, 1990.
48. White, V.A., Log of Meeting with Sunbeam Plastics Corp.,
July 18, 1990.
49. Gross, R., ``CPSC Proposed Rule on Requirements for the
Special Packaging of Household Substances,'' July 20, 1990.
50. Letter from Paolello, P., Calmar, Inc., to M. Robins, CPSC,
July 20, 1990.
51. White, V.A., ``Draft Proposed Rule on Protocol Revisions
under the PPPA,'' July 20, 1990.
52. Robins, M., Log of Meeting with Calmar, Inc., July 25, 1990.
53. Ewell, H., ``EPA Comments on Draft Federal Register Notice
to Revise the PPPA Test Protocol,'' July 25, 1990.
54. Letter from Williamson, D.J., Closure Manufacturers
Association, to T. Stevenson, CPSC, July 27, 1990.
55. White, V., ``Final Contract Report on Innovative Child-
Resistant Packaging Systems,'' July 31, 1990.
56. Letter from Paolello, P., Calmar, Inc., to M. Robins, CPSC,
August 3, 1990.
57. Letter from Hunter, M.M. and Hunter, R.M., Yellowstone
Environmental Science, to P. Scheidt, NIH, January 30, 1989.
58. White, V., ``Status and Outlook for Protocol Revisions
Project,'' January 30, 1989.
59. Prunella, W.J., ``Briefing Package on Proposed Rule for PPPA
Protocol Revisions,'' February 27, 1989.
60. Letter from Gross, R., United States Environmental
Protection Agency, to V. White, CPSC, February 27, 1989.
61. Letter from Hunter, M., Yellowstone Environmental Science,
to M. Millonig, March 1, 1989.
62. White V.A. , ``Briefing Package on Proposed Rule for PPPA
Protocol Revisions,'' March 2, 1989.
63. Letter from Hunter, M.M., Yellowstone Environmental Science,
to B. Bush, The White House, March 3, 1990.
64. Letter from White V., CPSC, to R. Gross, EPA, March 16,
1989.
65. Letter from Wilbur, C.J., CPSC, to M.M. Hunter, March 27,
1989.
66. Letter from Vogel P.E., Department of Health and Human
Services, to Mary M. Hunter, March 30, 1989.
67. Erb, C., ``Heading Off Headaches,'' Futures, Mich. State
Univ., Vol 7, No. 2, Spring/Summer 1989.
68. Letter from Kimm, V., EPA, to M.M. Hunter, April 14, 1989.
69. Letter from Koop, E., Department of Health and Human
Services, to M.M. Hunter, May 11, 1989.
70. Letter from Baucus M., United States Senate, to B. Hunter,
May 11, 1989.
71. Letter from Williams, T.F., MD, Department of Health and
Human Services, to M.M. Hunter, May 12, 1989.
72. Letter from Hunter, B., Yellowstone Environmental Science,
to Acting Chairman Graham, CPSC, May 25, 1989.
73. Letter from Hunter, B., Yellowstone Environmental Science,
to Commissioner Dawson, CPSC, May 25, 1989.
74. Letter from Lott, T., U.S. Senate, to Mr. & Mrs. Hunter, May
31, 1989.
75. Closure Manufacturers Association, ``Closure Manufacturers
Association Position Statement On Proposed Changes In Child
Resistant Packaging Protocol,'' June 1989.
76. Letter from Johnson J.B., U.S. Senate, to Mr. & Mrs. Hunter,
June 2, 1989.
77. Letter from Bryan, R.H., U.S. Senate, to Mr. & Mrs. Bob
Hunter, June 5, 1989.
78. Letter from Hollings, E., U.S. Senate, to Mr. and Mrs.
Hunter, June 12, 1989.
79. Wilbur, C.J., Log of Meeting with Yellowstone Environmental
Science, June 16, 1989.
80. Letter from Hunter, M.M., Yellowstone Environmental Science,
to C.E. Koop, National Safe Kids Campaign, June 23, 1989.
81. Wilbur, C.J., ``Older Adult Use Effectiveness, Child
Resistant Effectiveness,'' CPSC, July 1989.
82. Letter from White, V.A., to M.M. Hunter, Yellowstone
Environmental Science, July 5, 1989.
83. Taillefer, R., Consumer and Corporate Affairs Canada,
``Reports of Meetings and Other Information,'' July 7, 1989.
84. Letter from Burns, C., U.S. Senate, to Dr. Duane Alexander,
NIH, July 10, 1989.
85. Letter from Williamson D.J., Closure Manufacturers
Association, to Acting Chairman Graham, CPSC, July 18, 1989.
86. Letter from Hunter, M.M., Yellowstone Environmental Science,
to V. White, CPSC, July 28, 1989.
87. Hunter, M.M. et al., ``Child-Resistant Packaging Can Be Easy
For Older Adults To Use,'' July 28, 1989.
88. Letter from Williamson D.J., Closure Manufacturers
Association, to V. White, September 6, 1989.
89. White V., ``Log Meeting on Status of Protocol Revisions
Project,'' September 7, 1989.
90. White V., Log of Meeting with Closure Manufacturers
Association, September 15, 1989.
91. Letter from Clark, D.E., Department of Health and Human
Services, to R.M. Hunter, September 27, 1989.
92. Letter from Hunter, M.M., Yellowstone Environmental Science,
to V. White, October 11, 1989.
93. Letter from Hunter M.M., Yellowstone Environmental Science,
to C.J. Wilbur, October 11, 1989.
94. Unified Agenda, Item 3781, 54 FR 45525 (October 30, 1989).
95. Letter from Hunter, M.M., Yellowstone Environmental Science,
to D.E. Clark, NIH, November 9, 1989.
96. Peirson, J., ``Form & Function,'' Wall Street Journal,
December 1, 1989.
97. Letter from Hunter, M.M., Yellowstone Environmental Science,
to V. White, CPSC, December 15, 1989.
98. Dychtwald, K. and Flower, J., ``Age Wave: The Challenges and
Opportunities of an Aging America,'' 1989.
99. Dawson, C., CPSC, Workshop: ``Special Issues: Poison
Prevention Packaging and Older Consumers,'' 1985.
100. Letter from Vander, N., Brockway Plastics, to V. White,
CPSC, January 12, 1988.
101. Wind, M., CPSC, ``Protocol Revisions Back-up Document,''
February 9, 1988.
102. Letter from Sanzo, K., Morgan, Lewis & Bockius, to V.
White, CPSC, February 9, 1988.
103. White, V.A., Log of Meeting with Closure Manufacturers
Association, February 10, 1988.
104. Letter from Sawyer, S.F., Registrations Plus, to V. White,
February 12, 1988.
105. Letter from Vander, N., Closure Manufacturers Association,
to Chairman Scanlon, CPSC, May 4, 1988.
106. White, V.A., CPSC, ``Final Reports on Grants for Innovative
Child-Resistant Packaging,'' May 4, 1988.
107. Butts, S., ``Submissions on Priorities for FY 1990,'' May
11, 1988.
108. Letter from Scanlon, T., CPSC, to N. Vander, May 25, 1988.
109. Letter from Tinsworth, E., EPA, to V. White, August 2,
1988.
110. Letter from Vander, N., Closure Manufacturers Association,
to Chairman Scanlon, CPSC, August 31, 1988.
111. Agenda, CPSC/EPA Meeting on Economic Survey for CRP
Protocol Testing Changes, September 30, 1988.
112. Gross, R., Consumer Product Safety Commission and
Environmental Protection Agency Child-Resistant Packaging Meeting
Minutes, November 9, 1988.
113. Wilbur, C.J., CPSC, ``ANPR Protocol Revisions Responses to
Comments Received,'' February 25, 1987.
114. Simpson, G., ``Cost Effects of the Proposed Revised
Protocols for Testing Child Resistant Closures,'' March 24, 1987.
115. Wiseman, H.M., et al., ``Accidental Poisoning in Childhood:
A Multicentre Survey. 1. General Epidemiology 2. The Role of
Packaging in Accidents Involving Medications,'' Human Toxicology,
Vol 6, No 4, pp 303-314, July 1987.
116. Wilbur, C.J., CPSC, ``Protocol Revisions: Health Sciences
Recommendations,'' July 7, 1987.
117. Ewell, H., CPSC, ``Revisions to PPPA Protocol--VOTE
SHEET,'' July 22, 1987.
118. White, V.A., CPSC, ``Briefing Package on Recommendations
for Revision to the Poison Prevention Packaging Act (PPPA) Testing
Protocol,'' July 22, 1987.
119. White, V.A., CPSC, ``Supplemental Package to the Briefing
Package on Recommendations for Revision to the Poison Prevention
Packaging Act (PPPA) Testing Protocol,'' July 23, 1987.
120. Dunn, S., Secretary, CPSC, Minutes of Commission Meeting,
``Revisions to Poison Prevention Packaging Act (PPPA) Testing
Protocol,'' August 6, 1987.
121. White, V.A., CPSC, ``Schedule for Briefing Package on Draft
Proposal for PPPA Protocol Revisions,'' August 24, 1987.
122. Madison, R.L., CPSC, ``Paper on Sequential Sampling,''
August 25, 1987.
123. Letter from Myers, C.E., American Society of Hospital
Pharmacists, to C. Wilbur, CPSC, October 8, 1987.
124. Letter from White, V. to C.E. Myers, ASHP, October 1987.
125. Wilbur, C.J., HSPS, Log of Meeting with ASTM Committee
D10.31, October 29, 1987.
126. Letter from Vander, N., Closure Manufacturers Association,
to V. White, December 22, 1987.
127. Letter from Myers, C.E., American Society of Hospital
Pharmacists, to V. White, CPSC, December 23, 1987.
128. Wilbur, C.J., CPSC, ``Special Packaging Requirements
Suggested Changes,'' February 12, 1986.
129. Robbins L.J. et al., ``Child-Resistant Packaging and the
Geriatric Patient,'' JAOGS, Vol 32, No. 6, June 1984.
130. Proceedings of the Human Factors Society 28th Annual
Meeting, Volume 1, October 22-26, 1984.
131. Proceedings of the Human Factors Society 27th Annual
Meeting, Norfolk VA, Volume 1, October 10-14, 1983.
132. Orzech, D., CPSC, ``Summary of Comments Received Re: ANPR
Protocol Revisions,'' October 14, 1983.
133. Letters from 85 Consumers to Acting Chairman Graham, CPSC,
July 1990.
134. Perritt, Alex, PhD, Child Resistant Trigger Sprayer, ASTM
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135. Perritt, Alex, PhD, ASTM IA, Reclosable, 38 mm, Push Down &
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136. Sheffner, A. Leonard, PhD, ASTM IV A, Non-Reclosable CR
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137. Sheffner, A. Leonard, PhD, ASTM IV A, Non-Reclosable CR
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138. Sheffner, A. Leonard, PhD, ASTM IV A, Non-Reclosable CR
pouch with internal (hidden) tear notch opening Packaging,
polyester/LDPE, Child Protocol Tests, Foster D. Snell, Inc, Florham
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139. Sheffner, A. Leonard, PhD, ASTM IV A, Non-Reclosable CR
pouch with internal (hidden) tear notch opening Packaging,
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141. Ward, W. A., ASTM IV A, Non-Reclosable CR Pouch with
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142. Perritt, Alex, PhD, ASTM VIII I, Non-Reclosable CR Blister
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143. Perritt, A. Ph D, ASTM IB, Reclosable, 24mm, Localized
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144. Perritt, A. Ph D, ASTM IB, Reclosable, 24mm, Localized
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145. Perritt, A. Ph D, ASTM IB, Reclosable, 24mm, Localized
Squeeze Force Must BE Applied To A Designated Location, Child
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146. Perritt, A. Ph D, ASTM IB, Reclosable, 24mm, Localized
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147. Perritt, A. Ph D, ASTM IB, Reclosable, 24mm, Localized
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148. Perritt, A. Ph D, ASTM IB, Reclosable, 24mm, Localized
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149. Wilbur, C. J., Laboratory Report, Form 221, 35mm Overcap,
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150. Wilbur, C. J., Laboratory Report, Form 221, 1\1/4\'' Metal
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151. Kissinger, T. L., CPSC, Epidemiology, ``The Appropriateness
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152. Kissinger, T.L., CPSC, Epidemiology, ``Critique of the ASTM
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153. Kissinger, T.L., CPSC, Epidemiology, ``Evaluation of Test
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154. Barone, S. Health Sciences, `` ASTM/ISR Proposal for Inter-
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156. Letter from Barone, S. to H. Lockhart, Michigan State
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157. Letter from Barone, S., to M. Buie, Child Related Research,
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158. Letter from Charles Kumkumian, FDA to S. Barone, November
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159. Letter from Peterson, E. to Anne McKlindon, ISR, February
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160. Wind, M., Health Sciences, ``ASTM Proposal for a Joint
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177. Transcript of oral comments - December 5, 1990.
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179. Barone, S. Health Sciences, ``Child-Resistant Packaging
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180. Kissinger, T., CPSC, Epidemiology, ``The Derivation of the
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181. Kissinger, T., CPSC, Epidemiology, ``Application of the
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4, 1993.
182. Kissinger, T., CPSC, Epidemiology, ``Application of the
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4, 1993.
183. Kissinger, T., CPSC, Epidemiology, ``The Sequential
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184. Wilbur, C. and Barone, S., ``PPPA Senior Adult Use
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185. Wilbur, C., and Barone, S., ``PPPA Senior Adult Use
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186. Kissinger, T., CPSC, Epidemiology, ``Tests of Significance
for the Difference in Mean Opening Times in CPSC Senior Adult
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[FR Doc. 94-6281 Filed 3-18-94; 8:45 am]
BILLING CODE 6355-01-P
