[Code of Federal Regulations]
[Title 16, Volume 2]
[Revised as of January 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 16CFR1700.20]
[Page 742-749]
TITLE 16--COMMERCIAL PRACTICES
CHAPTER II--CONSUMER PRODUCT SAFETY COMMISSION
PART 1700--POISON PREVENTION PACKAGING--Table of Contents
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 requirements and the applicable adult
test requirements of this Sec. 1700.20.
(ii) Condition of packages to be tested. (A) Tamper-resistant
feature. 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,
one of the following situations applies:
(1) In the child test, the package is removed from the outer
package, and the outer package is not given to the child.
(2) In both the adult tests, if the outer package bears instructions
for how to open or properly resecure the package, the package shall be
given to the test subject in the outer package. The time required to
remove the package from the outer package is not counted in the times
allowed for attempting to open and, if appropriate, reclose the package.
(3) In both the adult tests, if the outer package does not bear any
instructions relevant to the test, the package will be removed from the
outer package, and the outer package will not be given to the test
subject.
(B) Reclosable packages--adult tests. In both the adult tests,
reclosable packages, if assembled by the testing agency, shall be
properly secured at least 72 hours prior to beginning the test to allow
the materials (e.g., the closure liner) to ``take a set.'' If assembled
by the testing agency, torque-dependent closures shall be secured at the
same on-torque as applied on the packaging line. Application torques
must be recorded in the test report. 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.
(2) Child test. (i) Test subjects. (A) Selection criteria. Use from
1 to 4 groups of 50 children, as required under the sequential testing
criteria in table 1. No more than 20% 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% of the children in each group
shall be of age 45-48 months, and 30% 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.,
[GRAPHIC] [TIFF OMITTED] TC14NO91.026
(3) Multiply the difference in years by 12 to obtain the number of
months in the difference in years, and add this
[[Page 743]]
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) Gender distribution. The difference between the number of boys
and the number of girls in each age range shall not exceed 10% of the
number of children in that range. The children selected should have no
obvious or overt physical or mental handicap. A parent or guardian of
each child shall read and sign a consent form prior to the child's
participation. (The Commission staff will not disregard the results of
tests performed by other parties simply because informed consent for
children is not obtained.)
(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 number of
units that a child opens or gains access to is interpreted as the
individual units from which the product has been or can be removed in
whole or in part. The determination of the amount of a substance that
may produce serious personal injury or serious illness shall be based on
a 25-pound (11.4 kg) 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's Office of
Compliance.
(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% 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
[[Page 744]]
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, if assembled by the testing agency, shall be
properly secured at least 72 hours prior to the opening described in
instruction number 3 to allow the materials (e.g., the closure liner) to
``take a set.'' Application torques must be recorded in the test report.
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. Reclosable packages shall be opened and properly resecured one
time (or more if appropriate), by the testing agency or other adult
prior to testing. 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.) If multiple
openings/resecurings are to be used, each of four (4) testers shall open
and properly resecure one fourth of the packages once and then shall
open and properly resecure each package a second, third, fourth, through
tenth (or other specified number) time, in the same sequence as the
first opening and resecuring. The packages shall not be opened and
resecured again prior to testing. The name of each tester and the
package numbers that he/she opens and resecures shall be recorded and
reported. It is not necessary for the testers to protocol test the
packages that they opened and resecured.
4. 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.
5. The testing shall take place in a well-lighted location that is
familiar to the children and that is isolated from all distractions.
6. The tester, or another adult, shall escort a pair of children to
the test area. The tester shall seat the two children 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) or other timing devices 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 (e.g., ``please try to open the package'').
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.''
[[Page 745]]
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
immediately before beginning the second 5-minute period, ``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.'' If children were told that they could use their teeth,
the tester shall say, ``I KNOW I TOLD YOU THAT YOU COULD USE YOUR TEETH
TODAY, BUT YOU SHOULD NOT PUT THINGS LIKE THIS IN YOUR MOUTH AGAIN'' 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 a group of 100 senior
adults. Not more than 24% 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.
Twenty-five percent of the participants shall be 50-54 years of age, 25%
of participants shall be 55-59 years of age, and 50% of the participants
shall be 60-70 years old. Seventy percent of the participants of ages
50-59 and ages 60-70 shall be female (17 or 18 females shall be
apportioned to the 50-54 year age group). No individual tester shall
administer the test to more than 35% of the senior adults tested. The
adults selected should have no obvious or overt physical or mental
disability.
(ii) Screening procedures. Participants who are unable to open the
packaging being tested in the first 5-minute time period, are given a
screening test. The screening tests for this purpose shall use two
packages with conventional (not child-resistant (CR) or ``special'')
closures. One closure shall be a plastic snap closure and the other a CT
plastic closure. Each closure shall have a diameter of 28 mm18%, and the CT closures shall have been resecured 72
hours before testing at 10 inch-pounds of torque. The containers for
both the snap- and CT-type closures shall be round plastic containers,
in sizes of 2 ounce\1/2\ ounce for the CT-type
closure and 8 drams4 drams for the snap-type
closure. Persons who cannot open and close both of the screening
packages in 1-minute screening tests shall not be counted as
participants in the senior-adult panel.
(iii) SAUE. The senior adult use effectiveness (SAUE) is the
percentage of adults who both opened the package in the first (5-minute)
test period and opened and (if appropriate) properly resecured the
package in the 1-minute test period.
(iv) Test procedures. 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 that 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. Any appropriate language from the consent form may be
used to recruit potential participants. The form shall include the basic
elements of informed consent as defined in 16 CFR 1028.116. Examples of
the forms used by the Commission
[[Page 746]]
staff for testing are shown at Sec. 1700.20(d). Before beginning the
test, the tester shall say, ``PLEASE READ AND SIGN THIS CONSENT FORM.''
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 ACCORDING TO THE INSTRUCTIONS ON THE
CAP.'' (Specify other instruction locations if appropriate.) If the
package contains product, the tester shall say, ``PLEASE EMPTY THE
(PILLS, TABLETS, CONTENTS, etc.) INTO THIS CONTAINER.'' After the
participant opens the package, the tester says, ``PLEASE CLOSE THE
PACKAGE PROPERLY, ACCORDING TO THE INSTRUCTIONS ON THE CAP.'' (Specify
other instruction locations if appropriate)
8. 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.
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. The participant may remove and replace
the closure more than once if the participant initiates these actions.
If the participant does not open the package and stops trying to open it
before the end of the 5-minute period, the tester shall say, ``ARE YOU
FINISHED WITH THAT PACKAGE, OR WOULD YOU LIKE TO TRY AGAIN?'' If the
participant indicates that he/she is finished or cannot open the package
and does not wish to continue trying, skip to Instruction 13.
10. To begin the second test period, the tester shall give the
participant another, but identical, package and say, ``THIS IS AN
IDENTICAL PACKAGE. PLEASE OPEN IT ACCORDING TO THE INSTRUCTIONS ON THE
CAP.'' (Specify other instruction locations if appropriate.) If the
package contains product, the tester shall say, ``PLEASE EMPTY THE
(PILLS, TABLETS, CONTENTS, etc.) INTO THIS CONTAINER.'' After the
participant opens the package, the tester says, ``PLEASE CLOSE THE
PACKAGE PROPERLY, ACCORDING TO THE INSTRUCTIONS ON THE CAP.'' (Specify
other instruction locations if appropriate.)
11. The participants are allowed up to 1 minute (60 full seconds) 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
finished closing the package, whichever comes first, the tester shall
take all the test materials from the participant. The participant shall
not be allowed to handle the package again. If the participant does not
open the package and stops trying to open it before the end of the 1-
minute period, the tester shall say, ``ARE YOU FINISHED WITH THAT
PACKAGE, OR WOULD YOU LIKE TO TRY AGAIN?'' If the participant indicates
that he/she is finished or cannot open the package and does not wish to
continue trying, this shall be counted as a failure of the 1-minute
test.
13. Participants who do not open the package in the first 5-minute
test period are asked to open and close two non-child-resistant
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 time to
open and resecure, or 61 seconds, whichever is less, shall be recorded
on the data sheet.
14. Participants who cannot open and resecure both of the non-child-
resistant screening packages are not counted as part of the 100-seniors
panel. Additional participants are selected and tested.
15. No adult may participate in more than two tests per sitting. 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% of whom
are female, shall
[[Page 747]]
comprise the test panel for younger adults. Not more than 35% of adults
shall be obtained or tested at any one site. No individual tester shall
administer the test to more than 35% of the adults tested. 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 of 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 (unit) package.
(b) The standards published as regulations issued for the purpose of
designating particular substances as being subject to the requirements
for special packaging under the act will stipulate the percent of child-
resistant effectiveness and adult-use effectiveness required for each
and, where appropriate, will include any other conditions deemed
necessary and provided for in the act.
(c) It is recommended that manufacturers of special packaging, or
producers of substances subject to regulations issued pursuant to the
act, submit to the Commission summaries of data resulting from tests
conducted in accordance with this protocol.
(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. CPSC will use
the adult-resecuring test where an objective determination (e.g., visual
or mechanical) that a package is properly resecured cannot be made. The
adult-resecuring test is performed as follows:
Adult-Resecuring Procedure
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
[[Page 748]]
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. Adult use effectiveness.
1. 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% of the apparently-resecured packages,
equals the total number of failures.
2. 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
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
1. 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.
(4) Consent forms. The Commission uses the following consent forms
for senior-adult testing reclosable and unit-dose packaging,
respectively.
1. Reclosable packages.
[Testing Organization's Letterhead]
Child-Resistant Package Testing
The U.S. Consumer Product Safety Commission is responsible for
testing child-resistant packages to make sure they protect young
children from medicines and dangerous household products. With the help
of people like you, manufacturers are able to improve the packages we
use, keeping the contents safe from children but easier for the rest of
us to open.
Effective child-resistant packages have prevented thousands of
poisonings since the Poison Prevention Act was passed in 1970. The use
of child-resistant packages on prescription medicines alone may have
saved the lives of over 350 children since 1974.
As part of this program, we are testing a child-resistant package to
determine if it can be opened and properly closed by an adult who is
between 50 and 70 years of age. You may or may not be familiar with the
packages we are testing. Take your time, and please do not feel that you
are being tested--we are testing the package, not you.
Description of the Test
1. I will give you a package and ask you to read the instructions
and open and properly close the package.
[[Page 749]]
2. I will then give you an identical package, and ask you to open
and properly close it.
3. I may ask you to open some other types of packages.
4. The packages may be empty or they may contain a product.
5. I will ask you whether you think the child-resistant package was
easy or hard to use.
Consent Form for Child-Resistant Package Testing
The Consumer Product Safety Commission has been using contractors to
test child-resistant packages for many years with no injuries to anyone,
although it is possible that a minor injury could happen.
I agree to test a child-resistant package. I understand that I can
change my mind at any time. I am between the ages of 50 and 70,
inclusive.
Birthdate_______________________________________________________________
Signature_______________________________________________________________
Date____________________________________________________________________
Zip Code________________________________________________________________
Office Use
Site:___________________________________________________________________
Sample Number:__________________________________________________________
Test Number:____________________________________________________________
Package Number:_________________________________________________________
2. Unit-dose packages.
[Testing Organization's Letterhead]
Unit Dose Child-Resistant Package Testing
The U.S. Consumer Product Safety Commission is responsible for
testing child-resistant packages to make sure they protect young
children from medicines and dangerous household products. With the help
of people like you, manufacturers are able to improve the packages we
use, keeping the contents safe from children but easier for the rest of
us to open.
Effective child-resistant packages have prevented thousands of
poisonings since the Poison Prevention Act was passed in 1970.
The use of child-resistant packages on prescription medicines alone
may have saved the lives of over 350 children since 1974.
As part of this program, we are testing a child-resistant package to
determine if it can be opened by an adult who is between 50 and 70 years
of age. You may or may not be familiar with the packages we are testing.
Take your time, and please do not feel that you are being tested--we are
testing the package, not you.
Description of the Test
1. I will give you a package and ask you to read the instructions,
open one unit, and remove the contents.
2. I will then give you an identical package, and ask you to open
one unit and remove the contents.
3. I may ask you to open some other types of packages.
4. I will ask you whether you think the child-resistant package was
easy or hard to use.
Consent Form for Child-Resistant Package Testing
The Consumer Product Safety Commission has been using contractors to
test child-resistant packages for many years with no injuries to anyone,
although it is possible that a minor injury could happen.
I agree to test a child-resistant package. I understand that I can
change my mind at any time. I am between the ages of 50 and 70,
inclusive.
Birthdate_______________________________________________________________
Signature_______________________________________________________________
Date____________________________________________________________________
Zip Code________________________________________________________________
Office Use
Site:___________________________________________________________________
Sample Number:__________________________________________________________
Test Number:____________________________________________________________
Package Number:_________________________________________________________
[38 FR 21247, Aug. 7, 1973, as amended at 60 FR 37735, 37738, July 22,
1995]