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

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 0.807

0.807

2..................................................... 200

0.940 0.838

0.838

3..................................................... 300

0.934 0.851

0.851

4..................................................... 400

0.900 ................. 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

Type IX, Mechanical Dispensers, Perritt Laboratory, No. 1126-006,

SAUE Five Minute Test & 50 Count Child Protocol Test, Perritt

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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

pouch with internal (hidden) tear notch opening Packaging, Child and

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137. Sheffner, A. Leonard, PhD, ASTM IV A, Non-Reclosable CR

pouch (PP/PE/F/PE) with internal (hidden) tear notch opening

Packaging, Child and Adult Protocol Tests, Foster D. Snell, Inc.,

Florham Park, New Jersey 07932, March 10, 1975. (Confidential.)

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

Park, New Jersey 07932, January 9, 1978.

139. Sheffner, A. Leonard, PhD, ASTM IV A, Non-Reclosable CR

pouch with internal (hidden) tear notch opening Packaging,

polyester/LDPE, Child and Adult Protocol Tests, Foster D. Snell,

Inc, Florham Park, New Jersey 07932, March 28, 1978. (Confidential.)

140. Johnstone, N., ASTM IV A, Non-Reclosable CR pouch with

internal (hidden) tear notch opening Packaging, polyester/LDPE,

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141. Ward, W. A., ASTM IV A, Non-Reclosable CR Pouch with

internal (hidden) Tear Notch Opening Packaging, Foil two tab pouch,

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(Confidential.)

142. Perritt, Alex, PhD, ASTM VIII I, Non-Reclosable CR Blister

with internal (hidden) Tear Notch Opening, 10 Tablet (2x5) Blister

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Hightstown, New Jersey, 08520, No. 1118-002, 2/23/87.

(Confidential.)

143. Perritt, A. Ph D, ASTM IB, Reclosable, 24mm, Localized

Squeeze Force Must BE Applied To A Designated Location, Child

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11, 1993. (Confidential.)

144. Perritt, A. Ph D, ASTM IB, Reclosable, 24mm, Localized

Squeeze Force Must BE Applied To A Designated Location, Senior

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3, 1993. (Confidential.)

145. Perritt, A. Ph D, ASTM IB, Reclosable, 24mm, Localized

Squeeze Force Must BE Applied To A Designated Location, Child

Protocol, Perritt Laboratories, Hightstown, NJ, No. 1089-117, Aug.

11, 1993. (Confidential.)

146. Perritt, A. Ph D, ASTM IB, Reclosable, 24mm, Localized

Squeeze Force Must BE Applied To A Designated Location, Senior

Protocol, Perritt Laboratories, Hightstown, NJ, No. 1089-120, Aug.

3, 1993. (Confidential.)

147. Perritt, A. Ph D, ASTM IB, Reclosable, 24mm, Localized

Squeeze Force Must BE Applied To A Designated Location, Child

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10, 1993. (Confidential.)

148. Perritt, A. Ph D, ASTM IB, Reclosable, 24mm, Localized

Squeeze Force Must BE Applied To A Designated Location, Senior

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12, 1993. (Confidential.)

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

Cap (Plastic/Metal), ASTM IA, Push Down & Turn to Open Child

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151. Kissinger, T. L., CPSC, Epidemiology, ``The Appropriateness

of the Statistical Analytical Methods of ASTM for the Child-

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152. Kissinger, T.L., CPSC, Epidemiology, ``Critique of the ASTM

Proposal for a Joint Study on Interlaboratory Variability in the CRC

Project,'' July, 13, 1992.

153. Kissinger, T.L., CPSC, Epidemiology, ``Evaluation of Test

Data From Two Different Testing Agencies with Senior Adult Subjects

Using ASTM Type IIA Child-Resistant Packaging,'' August 12, 1993.

154. Barone, S. Health Sciences, `` ASTM/ISR Proposal for Inter-

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155. Whitmore, R., Kelly, J., Reading, P., ``National Home and

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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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176. Comments on proposed rule. On file in the Office of the

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177. Transcript of oral comments - December 5, 1990.

178. Transcript of oral comments - September 12, 1991.

179. Barone, S. Health Sciences, ``Child-Resistant Packaging

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180. Kissinger, T., CPSC, Epidemiology, ``The Derivation of the

30:30:40 Sample Size Allocation Scheme Used in Testing of Senior

Adults with CR Packaging,'' June 28, 1993.

181. Kissinger, T., CPSC, Epidemiology, ``Application of the

Sequential Testing Procedure for Senior Adults to Data for Four

Reclosable Child-Resistant Packages and Related Analysis,'' August

4, 1993.

182. Kissinger, T., CPSC, Epidemiology, ``Application of the

Sequential Testing Procedure for Senior Adults to Four Non-

Reclosable Child-Resistant Packages and Related Analysis,'' August

4, 1993.

183. Kissinger, T., CPSC, Epidemiology, ``The Sequential

Hypothesis Testing Procedure in the Older Adult Testing of Child-

Resistant Packaging,'' September 18, 1992.

184. Wilbur, C. and Barone, S., ``PPPA Senior Adult Use

Effectiveness Protocol Tests--Reclosable Packaging,'' September,

1993.

185. Wilbur, C., and Barone, S., ``PPPA Senior Adult Use

Effectiveness Protocol Tests--Non-reclosable Packaging,'' September,

1993.

186. Kissinger, T., CPSC, Epidemiology, ``Tests of Significance

for the Difference in Mean Opening Times in CPSC Senior Adult

Testing of Child-Resistant Packaging,'' August 26, 1993.

[FR Doc. 94-6281 Filed 3-18-94; 8:45 am]

BILLING CODE 6355-01-P